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Those of you who manufacture products approved by the US Food and Drug Administration (FDA) are well aware of the importance of complying with Current Good Manufacturing Practices (cGMP) during FDA mandated inspections of your manufacturing facilities. Failure to comply with cGMP requirements during an inspections results in the issuance of 483s. And if you fail to adequately address the concerns of the agency outlined in 483s, it may ultimately result in issuance of warning letter to your company.

FDA is more vigilant and aggressive than ever before with its 483 and warning letter enforcement procedures. In the words of Commissioner Margaret Hamburg, FDA is quick, visible and vigilant.  With this in mind, it may be worthwhile to participate in a webinar offered by Expert Briefings.com entitled “Top Compliance Trends for 483 and Warning Letters for 2012—Based on Rare FDA Data.”

The webinar will be held on March 8, 2012 from 2:00-3:30 PM EST and Dennis Moore, Managing Partner, AUK Technical Services and a 28 year veteran FDA investigator will lead it. 

Topics to be covered include:

• Top warning letter trends for 2012, such as more 806 enforcement
• The Top 10 QS 483 Observations for 2010 and 2011
• Most common quality system failures for drugs for 2010
• Top drug and device citations in 483s for 2010
• Top drug and device warning letter citations for 2010
• Total 2010 BIMO inspections for CDER, CBER, CDRH, and CVM
• Details on clinical investigator, sponsor/monitor and IRB audits for 2010
• Most common sponsor deficiencies for 2010
• The rising trend of ‘cease to market’ letters, one of which hit a NY pharma company in 2011
• The total number of 483s issued in 2010 and 2011 – an all time high
• Total CAPA 483 observations in 2010
• How long to receive a warning letter, based upon which offices issues it
• 483 inspection targets for drugs and devices for 2010, 2011, and 2012
• Total warning letters issued by drug and device category in 2010
• Which district offices write the most warning letters
• How long to receive a warning letter, based upon issuing office
• Warning letters issued by QS system for 2010
• 483s broken down by QS subsystem for 2010
• Warning letters by CFR section
• Top device 483 observations for 2010
• Details on process validation observations for 2010
• Design control 483 observations by category for 2010
• Click here to visit Expertbriefings.com.

Click here to visit Expertbriefings.com.

I hope to see (hear ?) you at the webinar!

 

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I started BioJobBlog in 2007 primarily as a means for me to express myself about life science careers and issue and challenges confronting the biotechnology, pharmaceutical and medical devices industry. That said, I never thought that BioJobBlog would ever amount to much; it was simply a vehicle for me to rant and rave about things that were important to me! It is a daunting challenge to begin a blog with no readers and then realize that 5 years later over 2.0 million unique readers have visited to read my thoughts and ideas about a wide breadth of topics.

I want to thank the readers who continue to visit BioJobBlog. And, I hope that what I have written over the past five years has either helped or induced you to think about issues in the life sciences industry. While I have no plans to stop blogging; my schedule is becoming increasingly challenging and I can no longer post articles as frequently as I have in the past. Nevertheless, I will continue do what I can to keep the content at BioJobBlog interesting, fresh and thought-provoking. 

Please feel free to contact me with ideas, thoughts or comments about the blog (or anything else for that matter). 

Thanks for supporting BioJobBlog!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

 

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Chicago-based Abbott Laboratories today announced that it would lay off 700 employees from its medical devices and diagnostics division as part of an ongoing restructuring effort. 

Most of the layoffs will take place in the Chicago area and affect employees that manufacture the company’s cardiovascular stents and diagnostic tests. According to a company spokesperson approximately 500 persons who work in stent manufacturing and 200 who work in diagnostics will lose their jobs.

The restructuring of Abbott’s manufacturing operations began several years ago and about this time last year the company layed off about 1,900 employees in Lake County, Illinois.

In October, Abbott surprised investors and analysts with the announcement that it would spin off its branded drug business, including Humira (psoriasis and rheumatoid arthritis) it’s largest selling branded pharmaceutical product. Company executives argued that the split would allow stakeholders and investors to separately and more accurately value Abbott’s other less risky businesses which include nutritional (baby) formula, generic drugs and medical devices and diagnostics.

Despite signs of economic recovery, it appears that layoffs are still occurring at a pretty good clip at many pharma and biotech companies. It now appears that medical devices and diagnostic company employees, who were once immune to downsizing and reorganization, are now fair game.

Until next time...

Good Luck and Good Job Hunting!!!!

 

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The past several years I have been touting healthcare informatics technology (HIT) as an alternate career option for life scientists. For those of you who may not know, healthcare informatics is a field tasked with organizing, mining and distributing electronic health records (EHRs) to physicians and other healthcare providers. Persons with a background in medicine/biology and familiarity with computer software and managing and manipulating large digital data sites are ideal candidates for HIT jobs

The US federal government is mainly responsible for the growth of the US HIT field because it is offering financial incentives (mandated in the 2009 federal stimulus package) to healthcare providers who switch from paper to EHRs. The government began to disburse the money last May to those institutions and providers who applied for the funds. To date, hospitals and healthcare providers have received $2.5 billion of a potential $27 billion in stimulus funds.

At present, nearly 40 percent of American primary care physicians and approximately 25 percent of hospitals use EHRs. Thousands more are likely to adopt EHRs this year to qualify for federal stimulus monies. 

So, which major companies are hiring health informatics employees? They include:

1. Epic Systems
2. Allscripts
3. Meditech
4. Cerner
5. IBM
6. McKesson
7. Siemens
8. GE Healthcare

Of course, there are smaller companies and start-ups that are also looking for health informatics employees. To that end, persons with a strong background in biology who are comfortable writing code or working with software packages that handle large datasets ought to consider careers in HIT.

Until next time...

Good Luck and Good Job Hunting (check out Epic in Madison, WI)

 

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Mark Senak, author of the EyeonFDA blog and a life sciences/healthcare social media enthusiast, wrote a fantastic piece yesterday that provides cogent ideas and insights into the need for FDA to expeditiously craft guidance on the use of social media in the pharmaceutical and healthcare industries.

Here are the facts. First, according to the Pew Internet and American Life Project, social media has fundamentally changed the way in which we interact with one another and ushered in a new era of communication. Unlike the old, so-called “broadcast communication method”—information is continuously streamed from a static source, websites, television, radio etc, to perspective customers and stakeholders—the new paradigm requires that communications must be personal, portable and participatory for effective messaging. Second, the primary source of information sought by most persons who use the Internet is healthcare and medical information. While much of the content is accurate, some is not; which may put persons seeking medical information at great risk. In other words, social media is not just about marketing and medical education; it is also about preserving public health.

The agency has historically been unable to issue guidance on new forms of communication. For example, FDA held its first public meeting in 1996 on Internet use by life sciences and healthcare companies. Sadly, the agency has yet to issue any official guidance on this topic. In late 2009, FDA held another public meeting and promised that draft guidance on the internet and social media would be forthcoming by the end of 2010. Unfortunately the guidance did not materialize in 2010 and it has been delayed twice in 2011. Recently, the agency publicly reaffirmed its commitment to issuing the guidance but without a specific timetable for its release. Consequently, it is anyone’s guess when or if the guidance will be released.

Unlike many, I do not believe that FDA guidance on the Internet and social media is absolutely necessary. However, I will admit that issuance of said guidance will provide drug and healthcare companies with some of the assurances that they need in order to actively use social media to engage patients, physicians and other stakeholders. For this reason alone, FDA ought to issue the guidance (which is never perfect and always a work in progress) and end the social media stalemate that currently exists. Failure to do so may have serious consequences on the public health of many Americans.

Hat tip to Mark!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

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Abbott Laboratories today announced that it will split itself into two companies by spinning off its branded prescription drug business and creating a second company responsible for its medical implants, diagnostic tests and baby formula businesses.

The pharmaceutical company will exclusively sell its branded prescription drugs (including its blockbuster biologic Humira) and will be lead by Abbott’s Richard Gonzalez who currently head the company’s pharmaceutical business. Current Abbott CEO Miles White will lead the diversified medical products company. 

The reason for the split is to allow investors to value each of the companies on their distinct characteristic. Abbott’s decision to split the company is consistent with the prevailing notion that companies that sell both prescription drugs and consumer products don’t perform well. This led Bristol Myers Squibb to sell off its medical devices and consumer products divisions several years ago. Interestingly, prescription pharmaceuticals/consumer products/medical devices were de rigueur in the 1990s and early 2000s. Abbott’s decision leaves companies like Pfizer, Novartis and Johnson & Johnson as examples of the few remaining companies that still house pharmaceuticals, devices and consumer goods under one roof. Don’t be surprised if in the future these companies also decide to spin off or divest themselves of their consumer goods/medical devices divisions.

Finally, while the split may be good for investors, it may not be that great for Abbott employees. Usually, spin offs or divestitures

Until next time..

Good Luck and Good Job Hunting!!!!!!!!!!!!!!

 

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Last week, US Food and Drug Administration (FDA) Commissioner unveiled a “blueprint” that contained immediate and actionable steps that can be taken to spur innovation in the life sciences. The report’s proposals stem from a review of FDA’s current policies and practices, as well as months of meetings with major stakeholders nationwide, including key industry leaders, small biotech, pharmaceutical and medical device company owners, members of the academic community, and patient groups. Entitled “Driving Biomedical Innovation: Initiatives for Improving Products” the report focuses on seven major actions:

1. rebuilding FDA’s small business outreach services
2. building the infrastructure to drive and support personalized medicine
3. creating a rapid drug development pathway for important targeted therapies
4. harnessing the potential of data mining and information sharing while protecting patient privacy
5. improving consistency and clarity in the medical device review process
6. training the next generation of innovators
7. streamlining and reforming FDA regulations

The blueprint was issued in response to growing concerns that—despite record investments in biomedical R&D—the drug pipelines at many US life sciences companies has grown exceedingly thin. Not surprisingly, most life sciences companies blame the agency for the thinning pipelines but in reality both side have contributed to the problem. Hamburg’s bold plan seems reasonable. But, it can only be implemented if Congress provides sufficient funding to underwrite the new initiatives proposed in the plan. And, while these funds ought to be allocated, it is not clear whether or not it is likely given the poor economy and the current, unprecedented political divisiveness that exists in Washington these days.

Moreover, Mark Senak, author of the Eye on FDA blog, suggests that FDA can improve its effectiveness by learning how to communicate better with its stakeholders. Mark, a social media advocate provides this compelling insight into FDA’s communication problems and the agency’s inability to grasp that the Internet and social media can help to improve its communication skills:

"The extremely long track record of FDA in attempting to figure out the Internet (first public meeting held in October 1996) and social media (first public meeting held in November, 2009) has yielded no guidance, with little transparency into the process.  It is time for FDA to seek outside communications expertise to help the agency better formulate policy on a timely basis."

While I believe that Commissioner Hamburg’s blueprint for improvement is a good one, it isn’t clear whether she will get the necessary support to implement it.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

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Recruiting, retaining and managing patients that participate in clinical trials for approval of new medicines and devices have becoming very challenging in the past decade or more. Ironically, the ready availability of experimental new medicines in the US for certain therapeutic areas including oncology, neuroscience and vaccines have forced life sciences companies and CROs to conduct many Phase I and Phase II trials outside of the US. In turn, the globalization of clinical trials has forced many sponsors to increasingly rely on e-based and mobile solutions for patient recruitment, retention and compliance.

The Advance Learning Institute’s conference entitled “Patient Recruitment, Compliance And Retention For Clinical Trials: Integrating The Latest Technologies With Traditional Tools To Maximize Patient Engagement” that will be held in Manhattan on October 24-26, 2011 will provide attendees with insights into the best practices to maximize patient engaged in clinical trials. Presentations will be given by a variety of pharmaceutical companies, CROs and academic institutions including Pfizer, Merck Research Laboratories, Shire Pharmaceuticals, Celgene Corporation, Quintiles, Omniscience Mobile, Albert Einstein College of Medicine and the Michael J. Fox Foundation for Parkinson’s Research. A complete agenda for the conference can be found here.

Those of you who mention BioJobBlog or BioCrowd when registering for the conference will receive a $200 registration discount.

See you at the meeting!!!!!!!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

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During the Bush Administration I, along with many others, was a harsh critic of the US Food and Drug Administration (FDA). The criticisms that I levied against the agency were mainly based on its inability to adequately maintain the safety of the American drug and food supply and Bush’s repeated attempts to politicize the organization and render it useless. That said, it is amazing how much has and will change at the agency during the Obama Administration. To wit, Margaret Hamburg, the current FDA Commissioner yesterday announced plans that would dramatically transform the agency and largely change the way it does business.

In an unusually rare special report entitled “Pathway to Global Product Safety and Quality” Hamburg points out the monitoring problems currently facing the agency and proposes a four-point plan on how to fix them. To understand the importance of this document it is necessary to point out some little know facts about the American food and drug supply.

First, almost two-thirds of all fruits and vegetables and nearly 75 percent of all seafood consumed by Americans is imported. This year the number of these types of food shipments is expected to grow to 24 million through 300 or more ports. A little as a decade ago, the agency was responsible for overseeing and policing six million shipments annually. Second, it is estimated that over 80 percent of the active pharmaceutical ingredients (APIs) found in approved drugs are made in manufacturing plants found mainly in China, India and Latin America. Because of funding and “manpower” shortages, most of these API manufacturing facilities are rarely inspected for regulatory compliance. According to the report, many kinds of antibiotics, oncology drug and other medications are no longer produced in the US or in many cases anywhere in the Western world. Finally, roughly 50 percent of all approved medical devices sold in the US are made in foreign production facilities.

In 2008, government officials determined that the agency would need approximately 13 years to inspect all foreign drug manufacturing plants, 27 years to check every foreign medical device production facility and a whopping 1,900 years to check every foreign food production plant! This is because FDA has only several hundred inspectors who are empowered to perform these inspections. Consequently, only a fraction of the food and APIs imported to the US are inspected. For example, less than one pound in a million of imported seafood gets as much as a “visual inspection” to determine whether or not it is fit for American consumption. This led the report’s authors to contend that “the safety of America’s food and medical products remain under serious threat.”

Yet, despite this ongoing threat, Republican lawmakers last week voted to cut the agency’s budget rather than increase it to perform the necessary number of food and drug inspections. Further, the same lawmakers oppose any corporate or consumer fees, whether voluntary or forced, to help to underwrite the inspections calling them an unacceptable tax. This has forced the agency to enlist the help of regulators in other nations to create a global coalition or network to perform the required inspections to insure the regulatory compliance and safety of foods, drugs and devices imported into the US. While the FDA has limited cooperation agreements with regulators in Europe and other Western countries, it just recently stationed its own inspectors in emerging markets like China, India and Central America. In theory this should work. However, in the past, some of the governments of these countries have refused to fully cooperation with FDA. Further, and perhaps more problematic, is that regulatory agencies in some other countries are largely corrupt or nonexistent. Finally, some outspoken former FDA employees and critics contend that improvements in the communication between FDA in Washington and its field offices in US states may be necessary before the agency can effectively enlist the cooperation of foreign regulators.

There is no doubt that contaminated foods, counterfeit medical devices and tainted drugs are increasingly finding their way into the US. It is FDA’s legislated responsibility to insure that all foods and drugs sold in the US are safe and effective for all Americans. Republican lawmaker’s refusal to increase FDA’s budget to allow the agency to fulfill its mandate is unconscionable and indefensible. The safety and health of all Americans is critically important for the well being of the nation and ought to take precedent over budget shortfalls and a looming US trade deficit.

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

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One of the new “hot career” opportunities in the life science industry is something called a medical science liaison or MSL. Increasingly, graduate students and postdocs are beginning to mention MSL as a possible career option. Of course, the first thing that I ask these persons is “Do you know what an MSL is or does on a daily basis?” In most cases, most of these would-be MSLs sheepishly admit that they don’t!

With this in mind, I invited Dr. Samuel Dyer an experienced MSL and CEO and Founder of the Medical Science Liaison Corporation and MSL WORLD to better inform those who may be interested in pursuing a career as an MSL.

What is a Medical Science Liaison?

By Samuel Dyer

The MSL is a therapeutic specialist (e.g. Oncology, Cardiology, Infectious Diseases, Central Nervous System) within pharmaceutical, biotechnology, medical devices, and clinical research organizations (CRO) who has advanced scientific training and generally a "terminal D" degrees in the life sciences (PhD, PharmD, MD).  It's important to note that MSL's are not sales reps and their function is very different.  The primary purpose of the MSL role is to be scientific or disease state experts for internal colleagues (sales and marketing), but more importantly for doctors in the Therapeutic Area of the Medical community in which they work (i.e. Oncology, Cardiology, CNS etc.).  The focus of the role has changed over the years, but the primary responsibility of the MSL role remains to establish and maintain peer-peer relationships with leading doctors, referred to as Key Opinion Leaders (KOL's).

Medical Science Liaison’s (MSLs) were first established by Upjohn pharmaceuticals in 1967 as a response to the need for professionally-trained field staff that would be able to build rapport with Key Opinion Leaders (KOLs) in various therapeutic areas of research. Although originally called Medical Science Liaisons by Upjohn, over the years and today, pharmaceutical companies have used various names for the role including: Medical Liaisons, Medical Managers, Regional Scientific Mangers, Clinical Liaisons, and Scientific Affairs Managers among others.  

Originally, the first MSLs were selected from experienced sales representatives that had strong scientific backgrounds to bring a higher degree of clinical and educational expertise to the medical professionals they were working with to influence sales. Over the years, MSL teams have been made up of individuals with various scientific backgrounds including: “super” sales reps, those with nursing backgrounds, those with various doctoral level degrees or other clinical backgrounds.  However, the required educational and scientific background and purpose of MSL’s has progressively changed over the years since they were first established.  In the late 1980’s, a number of companies began to require those applying to MSL roles to hold a terminal “D” degree such as an MD, PharmD, or PhD degrees.  

Although, historically, the educational standard in the industry did not require MSL’s to have a terminal “D” degree, however, today the terminal “D” degree has become standard in the industry.  Today according to one benchmark study more than 90% of current MSLs hold terminal “D” degrees.  

While the MSL role has received some attention, including a CNN Money article entitled "#1 Job in Pharmaceuticals-10 Jobs for Big Demand-Good Pay”, it remains one of the best kept secrets and one of the most difficult roles to break into.  Few people know about it, and little is written about the role.  In fact, the MSL community is quite small when compared to other professions in the pharmaceutical industry however there has been an explosion in the growth of the position. According to a recent benchmark study, there has been an average growth of 76% of the MSL role since 2005 across the industry in the U.S.

To learn more about the MSL role and find free resources go to www.mslworld.com

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

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Mark Senak, author of the highly informative and well written Eye on FDA blog, reported today that a recent article that appeared on the American Medical News website suggests that the US Food and Drug Administration (FDA) may be considering regulating mobile apps that contain medical or clinical components. While the agency has yet to officially publish guidance on the use of social media in the life sciences industry, it now appears that FDA may be turning its attention on the development of mobile apps; one of the fastest growing segments of the social media movement.

The reason why FDA is taking notice of mobile apps is because a handful of app developers have sought and received FDA clearance for their mobile apps that—because of clinical components —are considered to be “medical devices.” As many of you may know, medical devices which include band-aids, surgical instruments, heart monitors, cardiovascular stents and diagnostic kits, all must receive marketing approval by the agency before they can be sold in the US. Although the agency yet to craft any guidance for clinical/medical app development, it makes sense that FDA ought to evaluate and regulate these products to insure that they are medically-effective and safe. 

According to the American Medical News article, the first app developer to receive FDA market clearance was AirStrip Technologies in San Antonio, for its AirStrip OB application. The app, which was approved in 2009, allows physicians to monitor mother and newborn remotely during delivery. In February, the FDA granted clearance to MobiUS, an app developed by Mobisante, a medical device company in Redmond, Wash. The app permits viewing of medical images for diagnostic purposes. Mobile MIM, a remote diagnostic imaging tool developed by Cleveland-based MIM Software, was also granted market clearance that month. A number of pharmaceutical companies, most notably Pfizer, have been extremely active in the mobile clinical app development space.

The reason why it makes sense for FDA to regulate certain clinical/medical apps is because physicians will rely on them to make medical decisions. For example, the AirStrip OB mentioned above will ostensibly allow physicians to remotely monitor a mother and neonate during delivery. Consequently, the app, aka device, must be evaluated by the agency to determine whether or not it can be used safely and effectively by physicians during childbirth. In this case, the app is similar to a heart monitor that is used during childbirth. And, like all other medical devices, the heart monitor required FDA clearance to determine its safety and effectiveness, before it could be used in real-life childbirth situations. To that end, the agency has hinted that it will be much more proactive in monitoring this new class of devices.

I have no doubt that many pharmaceutical companies and medical devices manufacturers will not be pleased when they learn that the agency is going to “stick its nose” into mobile app development. Nevertheless, in my opinion, if a mobile app is going to be used in possible “life or death” situation, then it ought to be regulated by FDA—the agency that is legally responsible for regulating these types of products. That said, Eye on FDA’s Mark Senak raises a number of valid and insightful points about FDA and its possible role in mobile app development.

“Related to a possible guidance for apps, there are a lot of questions that need to be answered when considering its development – when is an app a medical app?  When does it require regulation?  Who will pay for the oversight – will there be App Developers User Fee Act (ADUFA?) and if so, what will that do to the price and to access.  Will insurance companies have to cover apps?  And what will the process for approval be – something like a 510(k)?”

Finally, I think that the app developers who proactively approached FDA for guidance abut the clinical apps that they were developing “got it right.” This will get the agency “thinking” about clinical/mobile apps and how they ought to be approved and regulated in the future. In turn, this will provide future app developers with a clear regulatory framework that will guide the development of cost effective, safe and efficacious mobile clinical apps.

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

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Science and medical conference season is in full swing and tens of thousands of persons are attending scientific and medical meeting all over the US. While social media is no longer a new “thing” only a few scientific and medical societies understand its power and ways in which it may be harnessed to improve the experiences of their members who attend their national meetings. 

At most of the scientific conferences that I attend (usually four to fiver per year), people still lug around and are tethered to printed program guides. Further there is no easily accessible electronic repository (aside from the conference website) or guide that conference attendees can use to optimize time management and see “everything” that they want to at the meeting. Unfortunately, most scientific and medical conferences are still being run the same way that they have been for the past 30 years despite improvements to internet access and bandwidth, the advent of social media and the recent explosion of mobile devices and apps.

Finally, and perhaps most egregiously, rather than publicly disseminating what is being reported at these meetings, conference attendees and the lay public must rely on carefully orchestrated press releases (chosen in advance by the organizing committees of the meetings) for information and late-breaking news from the events. This is so web 1.0 that it is almost laughable.

Until last week, I thought that I was the only person who felt this way about social media and medical and scientific congresses. Imagine my surprise when no fewer than three others social media enthusiasts including Mark Senak, author of the EyeonFDA blog, Brian Reid, author of the WCG Common Sense Blog and Sally Church, author of the Pharma Strategy Blog, last week authored posts on the topic! It is always refreshing to find like-minded individuals to confirm that you are not alone!

Unfortunately, many scientific and medical societies like to tightly control information flow, limit access to it and, not surprisingly, are quite suspicious of social media. This is because the use of social media decreases the ability of these societies and their journals to control their messaging and content dissemination. With this in mind, is it any wonder why American scientific and medical literacy is pretty much in the “toilet?”  While the lay public may not be able to understand peer-reviewed scientific and medical publications, they have grown accustomed to gathering information on Facebook, Twitter and most importantly blogs. Why not use these vehicles to better inform the public about scientific or medical breakthroughs that have been validated and generally regarded as authentic?

Like it or not, social media is here to stay. And if leveraged correctly, it can be an extremely effective educational tool. I think that it is time for scientific and medical societies to consider using social media at their annual meetings. A failure to do so may have negative consequences for future membership in these societies and also reduce their effectiveness as purveyors of timely and accurate scientific and medical information!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!!

 

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I am not a big fan of top ten lists but I decided to take a look at the list compiled by Cecilia Capuzzi Simon in a recent article that appeared in the April 13, 2011 New Times Education supplement. Entitled “Top Ten List: Where the Jobs Are.” The article was extremely well written and based on the Bureau of Labor Statistics’ list of the fastest-growing occupations. 

The Bureau gleefully announced that it expects there to more than a million new jobs by 2018, and a “worker pool that may not be trained to fill them.” While this may seemingly appear to be great news—given the almost 10 percent unemployment rate that has been plaguing the US for the past three years—I was puzzled by appearance of biomedical engineering (#1), medical scientists (#6) and biochemists and biophysicists (#9) on the lists mainly because I know that persons who are trained in these fields are having extremely difficult times finding jobs in the current economy. That said, with most life science R&D being shipped over seas or outsourced, it hard to see that any of these jobs will be in great demand in the US over the next seven years. Maybe the bureau knows something that I don’t? Or maybe, it is the US government’s way of gently nudging people into careers that they anticipate will be highly valued in the future? Whatever the reason, it is going to be tough to convince college freshman to major in these fields if the current job market for these professions is currently so bleak.

What is even more puzzling then the ranking of these three career choices list is the actually numbers of new jobs that are anticipated to be created. The total number of new jobs expected in these fields by 2018 is roughly 65,000 (biomedical engineers-12,000; medical scientists-44,000; and biochemists and biophysicists-9,000). Compare this with the number of jobs anticipated by 2018 for network systems and data communication analysts (156,000), home health aide (461,000), personal and home care aide (376,000) or physician assistants (29,000) and you will get a better idea about the urgency for biomedical engineers and other life scientists.

There is no question that life scientists will command higher salaries and wages than home health aids or possibly a physician’s assistant but life sciences jobs typically require a minimum of a MS or PhD degree. Moreover, the economic theory of supply and demand suggests that it will be much easier for healthcare informaticists or home healthcare aides to find a job as compared with a biomedical engineer or PhD biochemist—even by 2018. In other words, don’t expect the US job market for life scientists to get better any time soon. 

While it is unfortunate that the US is beginning to seriously lag behind much smaller countries in science, math and engineering preparedness, the current demand for these types of jobs is waning and undergraduate college students—who lived through the recent financial meltdown—will likely (and rightly) choose to pursue careers where the likelihood of future employment is greatest. Unfortunately, the life sciences isn’t one of them.

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

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Can getting high be more important than sex? Probably not if you are in your teens or early 20s, but if you are of  an age where managing the nausea associated with cancer chemotherapy or the pain of glaucoma then medical marijuana is likely to be more important than the need for sex! But, to be fair, despite the title of this post, Viagra will lose patent protection shortly (in some places it already has) and the drugs sales have been shrinking. Nevertheless, a report authored by See Change LLC, a Colorado company that provides investment advice to businesses found that the sale of  that medical marijuana has already reached $1.7 billion (in states where it is legal) as compared with annual Viagra sales of $1.9 billion!  

Unfortunately, See Change LLC is charging $1,150 for the report. And since I don't have the money to purchase  it, I cannot determine the veracity or accuracy of the report. But, according to comments made by the editor of the report roughly 1 in 4 Americans lives in a state in which medical marijuana is legal, and that nearly 25 million people in those states have medical problems for which the drug can be prescribed. The report suggests that medical marijuana sales will reach $8.9 billion in five years.

Despite repeated scientific findings that medical marijuana can be used to effectively treat a variety of clinical indications that include chronic pain, nausea and anxiety, the myth of marijuana as a gateway drug to more serious drug like cocaine, heroin and others has been indelibly burned into the American psyche—not withstanding the statistics that show that prescription drugs like OcyContin, fentanyl and methamphetamine are the most abused drugs in America.  

While marijuana hasn’t been a part of my life for over 35 years, there is no question that it has enormous therapeutic value and ought to be legally prescribed when appropriate. In my opinion, the only thing that is preventing marijuana from being legalized is a business model that allows corporate America and the US government to maximize profits  from sale of the "deadly weed." 

 

 

It is time for Americans to forever expunge the "unbridled horrors" of Refer Madness from their collective psyches!

Until next time...

Good Luck and Good Job Hunting (be careful out there)

 

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Medtronic one of the world’s largest medical devices manufacturer earlier this week announced that it will cut its workforce by 5 percent which translates into 1,500 to 2,000 fewer jobs. Most of the cuts will come from the company’s struggling external heart defibrillators unit (Physio-Controls) which it would like to sell. Revenues from pacemakers and defibrillators, Medtronic’s largest selling products, fell 2 percent in the last quarter. 

In a statement, the Minneapolis-based Medtronics will cut 4 percent to 5 percent of its employees with voluntary programs, retirements and layoffs. 

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

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Many life sciences company executives will tell you that getting US Food and Drug Administration (FDA) approval for their products has gotten tougher than it has been in the past 10 years or so. This shouldn’t come as a surprise to most BioJobBlog readers because there was almost know regulation of pharmaceutical, biotechnology and medical devices products during the eight years that Bush was in power. Seemingly, many life sciences companies have forgotten that FDA’s mission is to provide the American public with SAFE and efficacious drugs and devices; not to quickly approve products to bolster a company’s stock share price. That said, some medical devices companies, like their pharmaceutical and biotechnology cousins, have begun to complain about the FDA regulatory process for medical devices.

Historically, the regulatory challenges for getting medical devices approved have always been much lower than those for garnering approval of prescription drugs, vaccines and other biological products. Since 2000, the regulations guiding regulatory approval for medical devices had grown extremely lax.  For example, there has recently been a spate of recalls for certain previously-approved devices including cardiovascular stents, implantable cardiac devices and hip replacements.

The Obama administration is attempting to restore the rigor of the approval process and some medical devices companies are extremely unhappy about it. This renewed effort has forced some devices companies to eschew the lucrative US devices market entirely in favor of European and Asian markets; mainly because they were unable to garner FDA approval for their devices. Interestingly, the companies that are complaining the loudest are start ups rather than established medical devices companies. Their main complaints are the ever-increasing size of the clinical trials and length of time it takes to win regulatory approval for their products. Not surprisingly, these complaints are mostly driven by financial pressures at the start ups. Because of the recession, many of the venture capitalists who backed these companies have less money to invest and demand quicker and higher returns on their investments. Consequently, many of the star tups are under capitalized and simply don’t have the financial resources to stay in business and wait for FDA approval. While I understand their business pressures and urgency, winning FDA approval is suppose to be about safety and efficacy not about ROI. Maybe start up devices companies experiencing these difficulties ought to retool or reinvent their business plans!

To be clear, FDA approval rates for medical devices are down; 19 premarket approvals (PMA) were granted in 2010 as compared with 48 in 2000. Also, the average time to win 510(k) clearance (less stringent than PMA and used for most devices) rose to 116 days in 2008 from 97 days in 2002. There is no question that winning regulatory approval for new medical devices may seem to be getting tougher than in the recent past. But, if that helps to improve efficacy and patient safety than I don’t necessarily think that it is such a bad thing. And as Stephen Oesterle, MD senior vice president for medicine and technology at Medtronic (one of the world’s largest medical devices companies) aptly said in a recent NY Times article “The FDA is asking for larger trials, more thoughtful trials, all in the interest of the American public.”

Until next time...

Good Luck and Good Job Hunting!!!!

 

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In a first-of-its-kind study, researchers at the Public Citizen’s Health Research Group tracked the civil and criminal financial penalties levied against the pharmaceutical industry for wrongdoing over the past 20 years. 

The main findings of the study revealed:

1. Of the 165 settlements comprising $19.8 billion in penalties during this 20-year interval, 73 percent of the settlements (121) and 75 percent of the penalties ($14.8 billion) have occurred in just the past five years (2006-2010).
2. Four companies (GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough) accounted for more than half (53 percent or $10.5 billion) of all financial penalties imposed over the past two decades. These leading violators were among the world’s largest pharmaceutical companies.
3. The practice of illegal off-label promotion of pharmaceuticals has been responsible for the largest amount of financial penalties levied by the federal government over the past 20 years. This practice can be prosecuted as a criminal offense because of the potential for serious adverse health effects in patients from such activities.
4. Deliberately overcharging state health programs, mainly Medicaid fraud, has been the most common violation against state governments and is responsible for the largest amount of financial penalties levied by these governments. This type of violation is also the main factor in the considerable increase in state settlements with pharmaceutical companies over time.
5. Former pharmaceutical company employees and other “whistleblowers” have been instrumental in bringing to light the most egregious violations and have been responsible for initiating the largest number of federal settlements over the past 10 years. From 1991 through 2000, qui tam (whistleblower) cases made up only 9 percent of payouts to the government, but from 2001 through 2010, they comprised 67 percent of total payouts.

The companies, their missteps and the fines imposed are shown below:

The authors conclude:

"Over the past two decades, especially during the past 10 years, there has been a marked increase in both the number of government settlements with pharmaceutical companies and the size of the accompanying financial penalties. Given the relatively small size of current financial penalties when compared to the perpetrating companies’ profits, both increased financial penalties and appropriate criminal prosecution of company leadership may provide a more effective deterrent to unlawful behavior by the pharmaceutical industry."

Interestingly, about a month ago officials at the US Food and Drug Administration signaled that were willing to prosecute company executives to the fullest extent possible (including criminal prosecution) to reduce the incidence of fraud, off-label marketing and manufacturing violations that have become commonplace in the pharmaceutical industry in the past five years.

Until next time....

Good Luck and Good Job Hunting!!!!

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Medical/science writing is increasingly becoming popular among PhD life scientists are having trouble finding traditional laboratory-based, research jobs. The transition from laboratory research to writing is not an onerous one; especially if you like to write.

As many of you may know, I am a freelance medical/science writer who entered the field about 10 years ago.  Because most freelancers work from home offices, the lack of communication with others can be overwhelming at times. Consequently, many of us subscribe to e-mail-based listservs which allow us to stay in touch with other writers and frreelancers. Most of these medical writing listservs are run and maintained by the American Medical Writers Association (AMWA). In order to access and participate at the listservs, you must be an AMWA member which costs $145 or more per year.

While the AMWA forums are very popular, AMWA officials assiduously monitors them and at times, restricts some of the content that can be posted. For example, members of the 'freelance business only listserv' are strictly prohibited from posting jobs or alerting others to potential freelance opportunities. AMWA officials contends that these posts are inappropriate and disruptive. However, the real reason for the prohibition may be that AWMA operates a separate, fee-based service that allows freelancers to hawk their services.  In other words, allowing  users to mention freelancing gigs or job opportunities on 'freelance business only' listserv, could potentially jeopardize an additional AMWA revenue stream.

Occasionally, freelancers like me break the rules (go figure) and mention "hot" jobs or employers who may be looking for writers. I do this because, as a freelancer, I am painfully aware that my success as a freelancer is contingent upon my ability to maintain a regular, ongoing stream of freelance gigs. Unfortunately, the AMWA officers who monitor the listservs (many of whom are not freelancers), don’t understand this. Consequently, repeat offenders-- like me--have been threatened with financial sanctions and possible expulsion from the listserv.

Because I don't like feeling oppressed and being told what to do, I decided to create my own forum where freelancers can freely exchange information, post jobs, alert others about potential gigs and jobs and generally have an open and ongoing discussion about medical and science writing.  To that end I launched the BioWriters Forum about two weeks ago. The forum is hosted by BioInsights, Inc and is sponsored by BioJobBlog and BioCrowd. The forum is free but membership is required in order to participate. Please check it out and join if you like.

For those of you who decide to join, please feel free to send me any ideas, thoughts, suggestions, kudos, kvetches etc, that you may have.  Enjoy!

Until next time....

Good Luck and Good Freelancing!!!!!!!!!

Employers

 

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“My style was fire-and-brimstone but I realized that people respond more favorably to positive motivation.”

—David Schlotterbeck, Chairman and CEO of CareFusion, a medical device company in San Diego

 

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Regulatory affairs professionals (RAP) are by far some of the most important employees at pharmaceutical, biotechnology and medical devices companies. Without RAPs, the requisite regulatory documents would not be filed and new drugs and devices would not be approved for marketing and sale.

Unlike other life sciences disciplines, a career in regulatory affairs is highly industry- specific and rarely taught at most academic institutions. In other words, if you are considering a career in regulatory affairs, don’t expect to get the training that you need in a PhD or postdoctoral training program; you will have to get it elsewhere!

A recent report compiled by the Regulatory Affairs Professionals Society (RAPS) entitled the “2010 Scope of Practice & Compensation Report for the Regulatory Profession” highlights the growing value and importance of regulatory affairs personnel in the life science industry. The report was compiled from the results of a survey of over 3000 regulatory affairs employees in 55 different countries.

The results show regulatory professionals are taking on a wider range of responsibilities, including becoming increasingly involved in critical business functions. Despite the economic downturn since the previous survey in 2008, overall compensation continued on an upward trend, although it grew at a slightly slower pace. The report also points to the continuing globalization of the profession, increased involvement with multiple product types and 6% higher compensation for professionals with Regulatory Affairs Certification (RAC).

Other important findings included in RAPS’ report include:

• US respondents with the RAC credential reported average total compensation that was 6% higher than their peers without the RAC. Forty-four percent of all survey respondents are RAC certified.
• The percentage of RACs is especially high in Canada (54%) and the US (47.2%). A little more than 21% of European-based respondents reported having the RAC.
• Overall, about 34% of respondents said they were involved in comparative effectiveness research and reimbursement, up from 23% in 2008.
• Half of all senior-level respondents reported being involved in government affairs.
• About 70% of respondents said their work is either global in nature or focused on multiple regions of the world.
• More than 68% reported involvement with multiple product types, a 6.3% increase from 2008.
• Overall, just 5.7% reported working with biosimilars, a product category that was added to the survey for the first time, but 22% of respondents from Asia and Latin America reported involvement with biosimilars.
• Nearly all respondents have a university degree; many have advanced degrees. The percentage of respondents whose highest degree earned is a master’s is up to 37.5%, a 17.2% increase from 2008. The percentage of respondents with MBAs and postgraduate certificates also increased.
• Respondents reported significant professional experience outside regulatory, an indication that many have transitioned into regulatory from another, related field. Most have educational backgrounds in life sciences, clinical sciences or engineering.

If this sounds like a career option for you, I highly recommend that you visit the RAPS website. If you already have a PhD, masters’ degree or even a bachelor’s degree, getting RAC certification will certainly increase the likelihood of landing a regulatory affairs job in the life sciences industry. One caveat: the RAPS courses are not inexpensive and may require a substantial amount of time in order to pass the RAC examination.

If the RAC route doesn’t seem realistic or reasonable, try getting an entry-level job with the US Food and Drug Administration. Being an ex-agency employee will guarantee employment in the life sciences industry until you retire!

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!

 

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Unlike PhD-trained scientists, physicians and other healthcare professionals must be licensed to practice medicine and are annually required to participate in continuing medical education courses (CME), seminars and lectures. CME training is required by medical licensing agencies to insure that healthcare practitioners are update to date with the latest clinical practices and informed about medical development within their respective fields. 

While all medical licensing agents require CME training, they do not fund or provide any of the content or learning materials required to implement that training. Historically, pharmaceutical, biotechnology and medical devices/diagnostic companies have underwritten the development for most CME courseware. Critics of this practice suggest that this represents clear conflict of interest concerns. And, in recent years, regulatory authorities like the US Food and Drug Administration, the American Medical Association and others have begun to agree with these suppositions. Consequently, the regulations that guide CME writing have drastically changed in recent years causing confusion among CME training providers and writers.

Despite growing concerns about the regulatory aspects of CME, there is still a high demand for persons who develop and write CME materials. While CME training is primarily geared towards physicians and other healthcare professionals, most of the content and training materials are prepared by PhD-trained scientists. Although a PhD in the life sciences is not an absolute requirement, many CME providers are beginning to hire persons with advanced degrees as developers and writers. Unfortunately, becoming a CME writing professional is not as easy as it sounds and requires some additional training beyond the PhD to break into the field. 

To that end, I recently became aware of a company called InQuill Medical Communications that offers training to life scientists interested in pursuing careers in CME writing. In addition to their courseware, InQuill offers a paid internship program to selected program graduate. The company is run by Johanna Lackner Marx who has over 15 years of experience in medical writing and developing and writing CME materials.

For more information about their training programs and some free information about careers in CME, please click here.

In the spirit of full disclosure, BioJobBlog is affiliated with InQuill. However, despite my over ten years of experience as a medical and science writer, I have had limited success in landing CME writing gigs because of my lack of formal writing and regulatory training in this area. That said those of you who may be interested in pursuing a career as a CME writer may benefit from the InQuill program!

Until next time...

Good Luck and Good Job Hunting!!!!!

 

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A recent study conducted by University of California San Diego Extension ranks careers in the health and life sciences fields at the top for recent college graduates. Sandy Bloom of GreatDegree.com recently wrote an article (see below) that provides insights and tips on how recent college graduate may be able to “snag” one of these up and coming hot jobs!

Hot Careers for College Graduates in 2010

By Sandy Bloom

For college graduates, landing a first job can be daunting, especially in hard economic times. But a recent report released by UC San Diego Extension, “Hot Careers for College Graduates in 2010,” shows that for certain career paths, finding a job may be easier than you think.

Nearly half of the top careers listed in the study stem from the health and bio fields, including the areas of health information technology and health law.

After earning a health degree or online biology degree, you can soon be working in one of these hot jobs, too.  Here’s how:

Health Information Technology

The report ranks careers in health information technology at the top because physicians and hospitals must update their medical records systems to be completely electronic in the coming years. Health information technicians are responsible for organizing these medical records, ensuring the records are accurate and complete, and updating the patients’ files electronically. According to the Department of Labor, employment of medical records and health information technicians is expected to increase by 20 percent over the next eight years.

Those looking to work in this high-demand profession should earn an associate’s degree with coursework in health information. Most employers prefer hiring credentialed medical record and health information technicians who have passed a credentialing exam. Experienced medical records and health information technicians advance their careers by earning bachelor’s or master’s degrees in biology, math, chemistry, health, and computer science.

Clinical Trials Design and Management For Oncology

The second ranked “hottest” career is clinical trial managers, specifically for cancer drugs. According to the report, “as the population ages, diseases are becoming more prevalent” and cures for those diseases are in demand. Clinical trial managers must oversee researchers who dedicate years to researching and testing before getting experimental drugs approved and brought to the market.

To become a clinical trial manager, you should earn a bachelor’s degree in chemistry, biology, or another life science. Then, receive a post-baccalaureate certificate to be certified by the Academy of Clinical Research Professions. Those working toward this in-demand career should partake in observation study courses or internships to observe a clinical trial in progress. Lastly, sign up to take online computer science courses to become familiar with Clinical Trial Management Systems.

Geriatric Health Care

According to last census in 2000, some 14 million seniors ages 65 and older report some level of disability that needs extra care. That means there is a huge demand for elder care professionals such as nurses, doctors, and nursing care professionals specializing in geriatric health care. In addition, because of the increasing incidence of mental illness among the aging, there is also a high demand for psychology professionals trained to treat older patients.

Training to be a nurse, a doctor, or psychiatrist or psychologist requires a bachelor’s degree in science as well as completion of board exams and residencies.

Occupational Health and Safety

Occupational Health and Safety Specialists (OHSS) analyze work environments to prevent injury by studying trends or patterns of injury and illness. They then suggest policy changes and develop and implement programs to improve conditions or practices that are dangerous. Environmental health and safety officers, ergonomists, health physicists, and industrial hygienists all perform this type of work.

To become an occupational health and safety specialist, you should earn a bachelor’s degree in a science or engineering discipline or a Master’s degree in science or in public health. All specialists must be trained on the law and inspection procedures through classroom and on-the-job training.

Other careers to consider include synthetic biology, regenerative medicine, stem cell research and medical devices including molecular diagnostics.

Hat tip to GreatDegree.com

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

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BioJobBlog and Career Management Source, a producer of online applications for streamlining job searching and hiring, have teamed to create BioCareers, a life sciences job board and career center. For job candidates, BioCareers offers real time job listings, application tracking, and e-mail job alerts. Employers can post jobs, advertise jobs, search resume databases and have jobs listed on other jobs like Job Job-Job Health and Twitter jobs. 

The search engine that powers BioCareers automatically pulls life sciences jobs in real time and updates job searches when positions are filled or new ones become available. Candidates can search for jobs by location or job title. One of the nicer features of BioCareers is candidate e-mail alerts when new jobs are posted or added in real time by the search engine.

I have been looking for a dedicated life sciences jobs search engine and career management solution for the past 10 years. I stumbled upon the Career Management Source platform quite by accident but I am glad that I did. And, the best part of the deal was that I didn’t have to do any of the work—the design, setup and implementation was completed by Career Management Source representatives.

You can test the BioCareers search engine capabilities by conducting a job search using the widget found in the BioJobBlog sidebar (look left). If you are interested in viewing and checking out the BioCareers website please click here.

For those of you, who may be interested in adding a career center to your blog or website, please visit www.JobJobHealth.com or e-mail Career Management Source or call 888-865-8914.

Until next time..

Good Luck and Good Job Searching!!!!!!!!

 

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The Internet and print media were buzzing this past week about the decision by a US Food and Drug Administration (FDA) panel of expert medical reviewers to not recommend approval of Boehringer Ingelheim flibanserin; a new medication to treat female sexual dysfunction or perhaps more apt lack of sexual interest.

Flibanserin was originally developed as an antidepressant but while it failed to treat depression women who participated in clinical trials reported increased sexual interest. The lack of drugs to treat female sexual dysfunction propelled Boehringer to continue to develop flibanserin to treat low libido in women. Previously, drug makers attempted to develop Viagra-like drugs and testosterone patches (testosterone increases sexual desire) to increase female libido—neither worked (without substantial side effects) to warrant approval. The FDA panel decided to not recommend flibanserin for approval because its modest effects on heightening female sexual desire did not outweigh side effects like dizziness and nausea.

A 2005 article in Nature Reviews Drug Discovery suggested that the size of the female sexual dysfunction market in the US could exceed $4 billion annually with only about 15 per cent of patients receiving treatment. Not surprisingly, many pharmaceutical companies have invested billions to develop new drugs to treat this indication.

There is no question that quality of life drugs like Viagra, Latisse and Botox generate billions of dollars in sales each year. While these drugs may help small numbers of patients who truly suffer from serious medical conditions, they are mainly used for so-called recreational purposes (sexual performance and beauty enhancement) by a majority of “patients.” That said, pharmaceutical companies have the right to develop whatever drugs or treatments that they choose. However, I contend that there are more serious medical conditions out there than failure to achieve orgasm or the need to not apply mascara on a daily basis.

Hat tip to Ed at Pharmalot for some outstanding investigative reporting!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!!

 

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The US Food and Drug Administration (FDA) announced on Friday that it will begin monitoring and investigating the services offered by consumer-focused, personal genomic testing companies. In warning letters to five companies, the agency notified company executives that their tests are considered medical devices and therefore must be federally approved as safe and effective. None of the companies have submitted their products for approval, according to the FDA. Further, the agency contends that personal genomic tests as medical devices must be “analytically and clinically accurate so that individuals are not misled by incorrect test results or unsupported clinical interpretations." Previously, the agency hadn’t definitively classified the tests as medical devices. However, the agency has become increasingly concerned that results from the tests may ultimately be used for diagnostics and prognostic purposes by various entities including insurance companies and employers.

The companies that received letters on Friday included California-based 23 and Me (backed by Google Health), Navigenics and Illumina and Knome of Cambridge, Mass.; and deCode Genetics of Lake Barrington, Ill. The FDA sent a similar letter in May to Pathway Genomics of San Diego, after Pathway announced it intended to sell its tests through Walgreens drugstores. Many industry insiders believe that the proposed Pathway Genomic-Walgreens was the proverbial “straw that broke the camel’s back” which prematurely forced the agency to take regulatory action.

The letters deal with specific tests marketed by: 23andMe Inc., deCODE Genetics, Illumina, Navigenics and Knome Inc. FDA asks each of the companies to contact the agency to make arrangements for submitting their tests for review. 23andMe and Navigenics and DeCode Genetics, sell tests that scan a person’s DNA, looking at genetic variations that can suggest whether a person is at a higher or lower risk of getting certain diseases like cancer or diabetes. Illumina sells DNA chips that are used by some companies to do the DNA scans whereas Knome offers consumers a complete sequence of their DNA, which can be used to glean disease risk information. While 23 and Me is pushing back, deCode Genetics CEO stated that the company will work with the agency to legitimize its tests as part of “standard medical care.” Knome, whose whole genomic sequencing platform will ultimately supplant the services offered by 23 and Me, Navigenics and Pathway Genomics, has also expressed a willingness to work with the agency.

Despite the existence of theGenetic Information Nondiscrimination Act (GINA) enacted in May 2008—which ostensibly would shield patients from potential “genetic discrimination”—many privacy and medical information advocates fear that loopholes will allow insurance companies and prospective employers to abuse the results from personal genomic analyses. To that end, GINA does not cover life, individual disability insurance, or long-term care insurance, and the potential for genetic discrimination still exists in these areas. For example, a person at genetic risk for developing Alzheimer’s could be denied long-term healthcare insurance because Alzheimer’s patients have been known to live for long periods of time, and their care is costly.

Another legitimate concern raised by some people is ownership of the results of personal genomic analyses. Surprisingly, at present, it isn’t clear who owns or ultimately controls a person’s genetic information data after it is generated. For example, it is likely (but not certain) that a consumer who purchases whole genome sequencing services from a personal genomics company owns and controls his/her sequence data. Ownership and control of the information isn’t likely to be straightforward or easily defined until rules and regulations are crafted to clarify how genomic information is owned, stored, and accessed by individuals and third parties.

While companies like 23 and Me and their ilk aren’t pleased that FDA has finally classified their tests as medical devices, they had to know that regulatory oversight of the personal genomic testing business was inevitable. This is because the results from personal genomic tests have been and will continue to be used by various and sundry entities a diagnostic and prognostic tools.

It is obvious to almost everyone in the life sciences industry that there are huge sums of money to be made in the personal genomic testing space. Consequently, the last thing that personal genomics company executives wanted was regulatory oversight by FDA (it tends to interfere with business and profit margins). However, we all have experienced first hand what happens when companies are allowed to operate in the absence regulatory oversight.

Hat tip to FDA for finally taking a stand on this important issue!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

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Pharmaceutical giant GlaxoSmithKline (GSK) and MedTrust Online, an online oncology information site announced the development of CancerTrials App, the first free geo-locating oncology clinical trials application for the Apple iPhone and iPad platforms.

According to a press release, oncologists can easily find and share information about experimental therapies in clinical trials with their patients. CancerTrials App provides a quick search menu based on 12 common cancers and more advanced features that refine searches based on criteria such as gender, age, trial status and more. Once relevant clinical trials are found, results can be mapped relative to the location of the iPhone or iPad running the application. These features should help oncologists connect patients to appropriate regional and local clinical trials for which they may be eligible. Obviously, the app will help to bolster clinical trial enrollment in the oncology space.

While not a full blow geo-based social media platform like FourSquare,the Cancer Trials app is a step in the right direction and demonstrates the power of mobile medical applications and the potential of social media to improve clinical drug development. 

CancerTrials App for the iPhone and iPad is the first release of the application that connects to MedTrust Online's proprietary databases of oncology information. Other apps for RIM's BlackBerry and Google's Android operating systems will be released over the next several months.

Hat tip to GSK which has boldly gone where no other pharma company has gone before!

Until next time....

Good Luck and Good Job Hunting!!!!!

 

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I came of age in the freewheeling 1960s and early 70s when the counterculture revolution was in full swing and people were regularly experimenting with marijuana and psychedelic drugs aka hallucinogens.

As a veteran of that era, I am well acquainted with these drugs and can personally tell you that they are not for everyone. However, the pharmacological active ingredients of marijuana (tetrahydrocannabinol) and the naturally-occurring hallucinogens found in peyote (mescaline) and magic mushrooms (psilocybin) have long been known to possess inherent therapeutic value. Unfortunately, because these drugs are associated with a particularly tumultuous period in American history, research into their use as therapeutic agents has long been stymied by the federal agencies that fund basic research in the US. 

Despite these formidable obstacles, a small number of intrepid researchers have managed to demonstrate that these long-vilified and illegal drugs can be used in some cases to treat cancer patients suffering from difficult-to-treat depression and other forms of mental illness. To that end, there was a fascinating article in yesterday’s New York Times that described a Johns Hopkins clinical study that showed that psilocybin can be used to manage untreatable depression in a small number of cancer patients.

The results from the study suggest that psilocybin, when administered using rigorous protocols and safeguards, can help to alleviate many of the symptoms of severe depression experienced by cancer patients undergoing chemotherapy. The researchers also contend that the use of hallucinogens can be transformative and may help to identify an endogenous neural pathway that may be responsible for so-called religious epiphanies.

Researchers from around the world are gathering this week in California for the largest conference on psychedelic science held in the United States in four decades. Attendees are expected to discuss studies of psilocybin and other psychoactive hallucinogens to treat depression in cancer patients, obsessive-compulsive disorder, end-of-life anxiety, post-traumatic stress disorder and addiction to drugs or alcohol.

Because reactions to hallucinogens can vary among individuals (primarily depending on the setting and external environment), researchers have developed stringent guidelines to set up a comfortable environment with expert monitors in the room to deal with adverse reactions. Also, they have established standard protocols so that the drugs’ effects can be assessed more accurately by scanning the brains of people who have taken hallucinogens. This is in marked contrast with the recreational use of hallucinogens which generally take place in a variety of sometimes difficult to control social settings; which may be responsible for some of the highly publicized “bad trips” experienced by hallucinogen users.

While there is no question that hallucinogens are very powerful psychoactive drugs—and their misuse can have serious cognitive and emotional consequences—it has never made sense to me why their use as potential therapeutic agents had been so discouraged. Ironically, marijuana and other illegal and so-called “dangerous illegal drugs” may actually be safer and more beneficial than some similar FDA-approved including certain antidepressants.

To be clear, I am not advocating the use of illegal drugs. However, in my experience, there is no obvious correlation between the legality of drugs and their potential therapeutic benefits. For example, both cigarettes and alcohol are legal drugs whereas marijuana (in many places) is not. A quick perusal of the number of people who are maimed or die each year from smoking pot as compared with those who die from lung cancer or are injured or killed by drunk drivers tends to emphasize this assertion. The bottom line: don’t throw any potential drug candidates on the pharmaceutical junk heap until they have been thoroughly researched and vetted as prospective therapeutic agents!

Until next time…

Good Luck and Good Job Hunting!!!!! (Right on man)

 

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For the past decade or more multiple drug resistant strains of bacteria such as methicillin resistant Staphylococcus aureus (MRSA), enterococci and other Gram positive cocci have been highlighted and showcased in the medical and lay press. While the incidence of infections caused by MRSA and other Gram positive cocci has steadily risen, antibacterial drug discovery experts have long known that the greatest disease threat in the future will be from emerging multiple antibiotic resistant strains of Gram negative bacteria including Acinetobacter baumannii, Klebsiella pneumoniae, Serratia marcescens and Pseudomonas aeruginosa.

Last Spring, in an interview that I conducted with Barry Eisenstein, MD, Senior Vice President of Scientific Affairs at Cubist Pharmaceuticals and an antibacterial drug discovery expert, he indicated that there are currently no drugs in development to treat infections caused by antibiotic resistant Gram negative bacteria. He warned that this, coupled with the loss of interest in antibiotic development by large pharmaceutical companies, will cause infections caused by multiple drug resistant Gram negative bacteria to become a serious unmet medical need in the not so distant future. The appearance of an article in the New York Times this past Saturday chronicling the rise of infections caused by antibiotic resistant Gram negative bacterial suggests that the not so distant future may have already arrived! For the record: would newspaper and television reporters please refrain from identifying bacteria as “germs.” It is an anachronistic term which was coined in the 19^th century before bacteria and viruses were conclusively identified as the cause of most infectious diseases.

Despite the media hype about antibiotic resistant Gram positive bacteria, a variety of new drugs have been developed to treat infections caused by these bacteria. Interestingly, because of greater public awareness about MRSA infections and improved hospital infection control and surveillance programs, the incidence of disease caused by MRSA and other Gram positive bacteria is finally beginning to wane. Unfortunately, the same is not true for infections caused by antibiotic resistance Gram negative bacteria.

For those of you who may not know, the cell wall architecture of Gram negative bacteria (and a multitude of antibiotic resistance mechanisms) makes it much more difficult and costly to develop new antibiotics to treat Gram negative infections. Consequently, research in this area has been largely ignored for the past 15 years or so. This means that in the future the morbidity and mortality associated with infections caused by antibiotic resistant Gram negative bacteria is certain to rise. With this in mind, persons at the greatest risk of developing these infections include patients in hospitals and long term care facilities and individuals receiving implantable medical devices.

Because most large pharmaceutical companies abandoned antibiotic drug discovery in the mid to late 1990s, it is unlikely that new Gram negative antibiotics will come from the pharmaceutical sector. While there are several small biopharmaceutical start ups working on antibiotics for Gram negative bacteria (KaloBios Pharmaceuticals, Calixa Therapeutics and Novexel) the increasing regulatory scrutiny and rising development costs suggests that these companies may have trouble bringing new antibiotics to market. Sadly, this places the onus of new Gram negative antibiotic discovery squarely on the shoulders of the US government. To that end, as much as it pains me to say this, it will likely take the death of government official or family member before sufficient resources are allocated to address this rapidly growing unmet medical need. Maybe the Obama Administration ought to think about allocating stimulus monies to begin to address the problem!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

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Ed Silverman, over at the newly reinvigorated Pharmalot Blog, today reported that a recent study publicized in the Journal of the American Medical Association showed that, after a decade of doubling, the rate of increase in biomedical research funding slowed from 2003 to 2007, and after adjusted for inflation, the absolute level of funding from the National Institutes of Health and industry appears to have decreased by 2 percent. The NIH remains the largest federal contributor to biomedicalresearch, accounting for 84% of total federal funding in 2007 

Further, the report indicated that research funding provided by pharmaceutical and biotechnology companies and medical devices and diagnostics manufacturers rose from $40 billion in 2003 to $58.6 billion in 2007; an increase (adjusted for inflation) of roughly 25 percent. Most of the funding came from large pharmaceutical companies. Interestingly, however, the sector of the life sciences industry that exhibited the greatest increase in growth over the same period was diagnostic and device makers (59 percent), followed by biotechnology (41 per cent) and lastly, pharmaceutical companies (25 per cent).

While the results of the study are not surprising, it is clear that the life science sector is beginning to focus more on device and diagnostics than on small molecules and even biotechnology products. Further, reductions in federal funding are forcing researchers to increasingly rely on grants and contracts from private sector companies. This suggests that an ever expanding percentage of the research conducted at many academic institutions will be financed and underwritten by for profit companies. Although more product-focused academic research is not necessarily a bad idea, it does call into question the direction and possible breadth of academic research and the availability and sharing of important scientific information, data sets and discoveries. 

Until next time...

Good Luck and Good Grant Writing!!!!!!!!!

 

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As part of their licensure requirements, all physicians and other healthcare providers (HCPs) in the US must participate in continuing medical education (CME). CME requirements are established on a state-by-state basis HCPs who fail to meet annual quotas face reprimand, censure and possibly loss of their medical licenses. As you may imagine, CME is a big business and, not surprisingly, there is no dearth of CME content developers and providers. Unfortunately, CME course development costs are high and, despite state mandated licensure requirements, no one seems to want to sponsor or underwrite the CME development programs except drug and devices companies. Obviously, this creates the potential for monumental conflicts of interest mainly because physicians and other HCPs are drug and device company primary customers.

While I don’t profess to be an expert on CME rules and regulation, I know that the rules and regulations that guide CME content development have become increasingly restrictive over the past few years. In the past, drug and devices manufacturers were able to identify relevant product-related topics within certain therapeutic areas, engage a CME provider to create a curriculum and then offer a product-focused program to physicians. Today, drug companies aren’t allowed to create CME program built around specific products. Instead, CME developers compete for grant monies from drug and device manufacturers and are asked to create CME around relevant issues in certain therapeutic areas. Of course, most of the companies that award the grants have products in those therapeutic areas; but i digress. Companies that award the grants cannot participate or influence the content that appears in the CME programs. Of course this is impossible!

For example, several years ago I was working at an agency that received a “grant” from a client that was developing a new treatment for a virus-associated metabolic syndrome. While we weren’t allowed to highlight or suggest specific treatment options we did receive in direct and subliminal guidance (through various company channels) regarding messaging around content development. To that end, while the company wasn’t directly involved in content development, its medical affairs and marketing departments were “aware” of the content that we were developing. While this was appropriate and well within regulatory guidelines, it is not difficult to see that potential conflicts of interest and bias may have existed in this instance.

Over the last year or so, questionable medical writing practices and conflict of interest concerns about CME course development have come under intense scrutiny in the US Congress. Consequently, there have been ongoing and repeated calls to prohibit industry participation in CME content development. While this may be a great idea, if drug companies no longer are allowed underwrite or sponsor CME course development, there isn’t likely to be any CME in the future. And, if there is no CME, physicians and other HCPs won’t be able meet state-mandated CME requirements to maintain their licenses to practice? What a conundrum!

One solution to the problem is to require state governments, the American Medical Association, university medical schools, hospitals and other organizations (insurance companies?) to underwrite CME development costs! After all, these are the entities that require CME for HCPs to retain their licenses. While this is a perfectly logical solution to a vexing problem, don’t expect any of them to step up to the plate anytime soon. The bottom line: drug companies support and underwrite CME because they recognize that it is a viable marketing vehicle—albeit a subtle one—that is certain to improve product awareness and ultimately sales. For example, if Pfizer sponsors a CME program on erectile dysfunction at a high end resort in some exotic locale and, its logo or mention of a grant to develop the curriculum is acknowledged, it is not unreasonable to assume that physicians attending the course may possibly choose to prescribe Viagra over a competitor’s product. To make matters worse, CME sponsors often time help to defer costs of hotel accommodations, provide support for meals, and even sponsor receptions for physicians who attend CME training programs.

I suspect that some of you may be wondering why I am ranting and raving about CME today. Well, there was an article in today’s New York Times about Stanford Medical School receiving an unrestricted, three-year $3.0 million grant from Pfizer to develop unspecified new CME curricula for physicians. Philip Pizzo, MD, dean of Stanford’s medical school lauds this as the beginning of a new age in CME and suggests that Pfizer will have no say on how the grant monies will be spent. 

Dr. Pizzo contends that the “no-strings-attached” provisions of the grant will insure that the new curricula will be devoid of drug industry influence that has permeated CME courses in the past. Stanford plans to set up “unbiased programs” of postgraduate education on the Stanford campus rather than the industry-selected topics of the past that have been presented to rooms full of doctors at hotels and resorts.” While the new grant sounds promising, I wonder whether or not Stanford is going to disclose the amount of research funding it annually receives from Pfizer. Further, will faculty members who receive or previously have received research monies from Pfizer be prohibited from contributing to content development?  The point I want to make is that, despite Stanford’s good intentions and assertions to the contrary, there is no way to insure that there will be no bias or conflicts of interest in the new curriculum that is developed. 

Finally, I don’t think that there is any question that CME is essential to insure that Americans receive the latest and best possible medical treatments that are available. However, to insure farness and no bias, drug makers and device manufacturers should not be allowed to underwrite or participate in CME content development. This activity should be in the purview of not-for-profit entities (that don’t receive drug industry money) and state government agencies. Like it or not, we live in a quid pro quo society and drug and devices companies (like all “for profit” companies) don’t make investments unless there is an anticipated or guaranteed return on the investment!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

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Novartis AG today announced it plans to take over Alcon Inc. by paying $38.5 billion for the 77 percent stake it does not already own in a deal that would make it one of the biggest players in the global market for eye-care products.

The Swiss pharmaceutical and generics giant had already purchased 25 percent of Alcon from Nestle in April 2008 for $11 billion, with the option of buying the food and drinks company's remaining stake at a later date. With the acquisition of Alcon, Novartis will control about 70% of the world’s vision market (it already owns the Ciba Vision brand). Alcon is based in Huenenberg, Switzerland, and has its U.S. headquarters in Fort Worth, Texas. The company employs some 15,000 people worldwide and specializes in surgical equipment and devices, contacts lens solutions and other consumer eye-care products.

Daniel Vasella, MD, Novartis’ Chairman and CEO, said "This is the right time to simplify Alcon's ownership to eliminate uncertainties for employees and shareholders." He added "It will also allow us to strengthen innovation power by combining R&D efforts and grow our global market presence thanks to our complementary product portfolios."

If I were a betting man, I would say that Novartis is the pharmaceutical company to watch over the next decade. Like Johnson and Johnson, the company has diversified its business to include consumer goods, vaccines and perhaps most importantly generic pharmaceuticals via its Sandoz division. One area that Novartis hasn’t fully embraced to date is devices. However, as we enter the age of personalized medicine, don’t be surprised if the company acquires or invests in a variety of medical devices and diagnostic companies!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

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Pfizer was the first to bring us ED (erectile dysfunction) and now two companies—one large (Johnson and Johnson) and one small (Sciele Pharma)—are daring to boldly go where no MAN has gone before: to conquer PE aka premature ejaculation!

According to a brilliantly-crafted story by Natasha Singer published in this Sunday’s New York Times business section, JnJ developed a pill called Priligy which is intended for men who ejaculate before intercourse or within a few seconds after beginning. Priligy which is intended to help to prolong latency before orgasm is approved and sold in nine countries but hasn’t been approved for sale in the US. On the other hand (so to speak), little known, Atlanta, GA-based Sciele Pharma is planning to seek regulatory approval for a prescription aerosol-based product that is sprayed on the skin (in this case the penis) to prolong latency and forestall ejaculation. While the true incidence of PE is uncertain, the manufacturers of these medications want men (and women) to believe that the condition is more pervasive and prevalent than reported. 

Interestingly, the worldwide sales of Pfizer’s Viagra were approximately $1.93 billion last year. As previously noted on BioJobBlog, Viagra celebrated its 10th anniversary of marketing approval last March. If you do the math, almost $20 billion dollars worth of Viagra prescriptions were written over the past decade. This suggests that many millions of men must suffer from ED worldwide. However, for those of you who may not know, Viagra also works quite well for healthy, sexually active males who don’t suffer from ED. It is generally acknowledged that it is this segment of the male population that is responsible for the annual blockbuster sales of Viagra and related medications. Also, it is important to note that prior to the introduction of Viagra, ED wasn’t a recognized clinical indication (it was known as impotence) and there were very effective treatments for it. And while ED is a legitimate quality-of-life issue, it occurs in only a small percentage of sexually active males; mostly in older men with hypertension, cardiovascular conditions or those who have had their prostates removed.

Viagra, like Botox, Latisse and others, is classified as a so-called “lifestyle” drugs. Generally speaking, lifestyle drugs are developed to improve the quality of life of patients not treat potentially life threatening diseases or conditions. In her article, Ms. Singer takes the pharmaceutical industry to task about the development of  blockbuster lifestyle drugs.

“But creating a blockbuster quality-of-life drug like Viagra involves more than just being innovative or being first. Sometimes it requires a drug maker to create and market a whole new category of disease.

The template goes something like this: Start with a legitimate quality-of-life issue — like fitful sleep or shyness — that does not yet have its own prescription medication and is debilitating to a few people a lot of the time. Next, position the quality-of-life issue as a medical condition with symptoms so common it covers vast numbers of people who had previously not identified themselves as having a health problem, or who thought they were just experiencing an occasional and normal annoyance.

Articles in medical journals with high estimates on the prevalence of the issue help convince doctors and journalists of its scope. F.D.A. approval of the new drug legitimizes the condition as a problem with a medical solution.

While there is no doubt that some men are distressed about their inability to control their orgasms, there is little concrete evidence to suggest that there is an epidemic of premature ejaculation”

Although I have never used Viagra, I have a few “older male friends” who swear by it! And, while I have no doubt that Viagra and the new medications being developed to treat PE may benefit a few men, is it appropriate to elevate premature ejaculation to a bona fide clinical indication and spend billions to develop and market treatments for it? Don’t get me wrong; I am not trying to minimize the emotional distress and discomfort associated with PE. But, the last time I checked, PE didn’t make the top ten lists of the world’s most devastating and debilitating clinical indications or unmet medical needs!

Until next time...

Good Luck and Good Job Hunting!!!!

 

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I realize that I have been blogging about adverse events for the past couple of day but, let’s face it; the pharmaceutical industry lives or dies by the number of adverse events (AEs) that are reported for approved and marketed drugs. In any event, I came upon an interesting post in a Pharmaceutical Processing e-blast about the results of a survey  (conducted by Pfizer) which revealed that physicians are more likely to report side effects and adverse events through an electronic health records (EHR) system as compared with traditional paper methods. Nearly 60 percent of the 300 physicians who responded to the survey also agreed that AE reporting through an EHR would improve patient care.

While the results of the survey are not surprising (to me anyway), they suggest that the use of electronic methods for adverse events reporting may be a boon to drug manufacturers that are required (by FDA and other regulatory agencies) to collect information regarding the safety and tolerability of approved and marketed drugs.

In a previous post, I opined that social media would be an ideal platform for AE reporting. The results of the Pfizer survey tend to support this supposition. While EHR aren’t exactly social media, they are electronic and, it appears to me (based on Pfizer survey results), that healthcare providers and consumers may be more likely to report potential AEs using electronic as compared with conventional methods. Put simply, electronic reporting is much simpler, quicker and more facile than the current pen and paper model for AE reporting. And, in today’s rapidly paced and hectic world, time savings can translate into cost savings and improved efficiencies.

Paradoxically, the Pfizer survey results tend to contradict the notion that social media would be a bane to AE reporting for most drug makers. As I mentioned yesterday, many drug makers who have almost universally shunned social media, contend that the use of social media would overburden their AE reporting systems and possibly put them at enormous legal and regulatory risk. However, as I pointed out many times in the past, AEs are an expected reality in the pharmaceutical, biotechnology and medical devices industries. And, while drug makers are deathly afraid of AEs and reluctant to learn of them, the more information this is available about potential safety and tolerability issues, the better off most drug manufacturers may be. For example, if Merck was alerted earlier about the cardiovascular problems that Vioxx patients were experiencing, then possibly fewer patients may have been affected and harmed and perhaps, an improved version of Vioxx, an effective pain medication, might still be availability to patients who benefit from it.

To that end, providing physicians, healthcare workers and consumers with an accessible e-based AE reporting system built around social media would allow drug makers to quickly determine whether or not one of their drugs exhibits tolerability or safety issues that might warrant further investigation.  And, I believe that putting the appropriate social media AE reporting systems in place would allow drug and device manufacturers to monitor the performance of their products in real time and more accurately monitor, collect and analyze safety and tolerability data for certain drugs. This, in turn, would likely lead to the development of improved safer and more effective medications and devices, lower drug development and manufacturing costs and ultimately reduce drug makers’ exposure to legal and regulatory actions.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

 

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The public hearing held by FDA last week in Washington DC to address social media and promotional advertising in the pharmaceutical seems to have altered the agency’s perspective on all things digital. Today, according to a press release, marked the agency’s completion of a coordinated week long international effort called the International Week of Action (IIWA) that was intended to curb illegal actions involving medical and pharmaceutical products.

During the effort, the FDA's Office of Criminal Investigations (OCI), in conjunction with the Center for Drug Evaluation and Research and the Office of Regulatory Affairs, Office of Enforcement, targeted 136 Web sites that appeared to be engaged in the illegal sale of unapproved or misbranded drugs to U.S. consumers. None of the Web sites are for pharmacies in the United States or Canada.

The agency issued 22 warning letters to the operators of these Web sites and notified Internet service providers and domain name registrars that the Web sites were selling products in violation of U.S. law. In many cases, because of these violations, Internet service providers and domain name registrars may have grounds to terminate the Web sites and suspend the use of domain names. Apparently, FDA has taken to sending warning letter en masse—it previously sent identical warning letters to 14 different pharmaceutical companies for improprieties associated with Google search ads.

Is there really a sea change taking place at FDA? Will a carefully and thoughtfully- crafted guidance document on the use of social media be next; now that the agency is no longer afraid to navigate the Internet? Only time will tell....hopefully sooner, rather than later!

Until next time...

Good Luck and Good Surfing!!!!!!!!!

 

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For the past 10 years or so, I have been providing career counseling and development seminars and workshops for life scientists. In the early years, students, postdocs and a smattering of faculty members would attend to learn about industry trends, the job market and more recently, alternate careers for PhDs and postdoctoral fellows. However, over the last few years, a disturbing trend has emerged—the lack of faculty participation at these events. 

Yesterday, I was invited to participate as a panel member to moderate a career development event sponsored by the graduate student and postdoctoral associations at the University Of Rochester School Of Medicine. The event was well attended (over 85 participants) and the discussion lasted for more than 2 hours. Joining me on the panel was a PhD-trained scientist/manager from Bristol Myers Squibb and a healthcare company executive who received his PhD degree from the university about 16 years ago.

Many of the questions asked by the participants were spot on and revealed that graduate students and postdoctoral fellows are extremely anxious about their futures. The panel did its best to describe what it takes to get a job in the life sciences, the process and steps required to successfully win jobs and some ideas for alternate career options for PhD-trained scientists. Unfortunately, not a single University of Rochester medical school faculty member attended the event. In fact, I met the PI of one of the postdocs who sponsored my visit and he said with all sincerity (I think) “Thanks for coming...the students are really looking forward to your talk.” Obviously, I don’t think that it ever crossed his mind that he, like his students and postdocs, might learn and benefit from a discussion about career options and hear (probably for the first time) how anxious and fearful his and other students are about future job prospects.

The fact that faculty members are routinely eschewing career development seminars and forums is troubling and extremely disturbing for a variety of reasons. First, as I have said many times before, I believe that PIs have moral and ethical obligations to help their students determine what careers that they are best suited for. I don’t think that it is too much to ask or very labor-intensive for PIs to learn about the job market outside of academia.

Despite an ongoing lack of tenured track faculty positions and the extremely fierce competition to win them, academicians continue to exclusively train and prepare students for academic careers. This makes absolutely no sense from a “supply and demand” perspective. Second, the lack of faculty support and participation sends a clear message to graduate students and postdocs that their anxieties, fears and concerns about job prospects simply isn’t that important to their PIs.  The mantra of most academicians —“just continue to do good science and everything will be okay”— is outdated, anachronistic and self serving (for PIs) at best.  

Finally, and perhaps most importantly, the failure of  tenured faculty members to actively engage and participate in discussions about career options reveals the unbridled contempt that most academicians have for scientists who work outside of academia. Most academics choose to not concern themselves with non-academic and mundane issues like jobs and careers. And why should they? Once they win tenure, their lives are set because they are guaranteed jobs and benefits for life!

We are living in very challenging and troubling times. In the past three years, over 180,000 pharmaceutical workers have  lost their jobs and national unemployment will likely hit 15%. Academic and government jobs are hard to come by and the competition for these jobs is ferocious and extremely competitive. And, sadly, current academic training programs are woefully inadequate to prepare graduate students and postdocs for alternate career opportunities in the life sciences. 

As I have stated numerous times before, life science graduate training programs are in dire need of systemic change and must be overhauled to remain relevant. Unfortunately, systemic changes are unlikely because tenured faculty members can’t be forced or induced to change their attitudes or beliefs. While a minority of life sciences faculty members realizes that the system is broken, the majority doesn’t.  To that end, if graduate students and postdoctoral fellows want change to occur, than they must band together and collectively send a message to their PIs and mentors that “We are mad as hell and we aren’t going to take it anymore!” Anything short of a widespread, massive protest will be ineffectual!

To learn how to more effectively manage employees, please check out the 360 feedback solution.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

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In today’s edition of the incisive EyeonFDA blog, Mark Senak, provides a historical perspective on events leading to the US Food and Drug Administration public hearing on the use of social media and medical promotion that will be held on Thursday and Friday, November 12 and 13, 2009. As Mark points out, registration for the meeting was closed because of an overwhelming response and the number of people who wanted to offer testimony on the topic. Many social media enthusiasts view the public hearing as something of a “game changer” that may influence the future direction of social media in the life sciences industry. But, as Mark, astutely points out, only four pharmaceutical companies and one or two trade organizations will be participating at the hearing. 

The lack of industry participation at the meeting is curious given that 14 companies received warning letters several months ago about their misuse of ad associated with the results obtain by Google search. Further, pharmaceutical companies have consistently and publicly stated that their aversion to social media is contingent upon the lack of FDA’s regulatory guidance for its use. By not actively participating in the public hearings later this week, many pharma companies have chosen to remain silent and will likely allow FDA to craft social media policies that guide the promotional activities of drug makers on its own. This begs the question: why would drug makers allow a federal regulatory agency to unilaterally dictate policy, when the policy will likely affect their bottom lines, i.e. sales and profits? The industry’s refusal to actively participate in these hearings is another example of the cat and mouse game that drug makers like to play with FDA. Put simply, drug makers expect and want FDA to commit (in writing) to certain policies and guidelines and once established, company regulators and lawyers are instructed to find loopholes and work-arounds. I liken the drug industry’s refusal to actively participate in the upcoming public hearings to the now infamous rope-ad-dope strategy Mohammed Ali used to knock out George Foreman in the now infamous Rumble in the Jungle in 1974. This is how wikipedia defines the rope-a-dope: “The rope-a-dope is performed by a boxer assuming a protected stance, in Ali's classic pose, lying against the ropes, and allowing his opponent to hit him, in the hope that the opponent will become tired and make mistakes which the boxer can exploit in a counterattack.” I hope that I am wrong about the drug industry’s strategy and motives.

Without active industry participation it isn’t clear how effective the FDA public hearing on social media will be. As Mark adroitly points out in today’s post, “The bulk of the other presentations are tertiary stakeholders perhaps sensing a vehicle for free self-promotion such as advertising and public relations firms and bloggers, but they aren't the real stakeholders in this issue.  The real stakeholders are those who are referred to in the meeting notice - the medical products industry.” I would also add the American public to the stakeholder list who also has considerable “skin in the game.”

Pharma’s active participation at many of the social media conferences that I recently attended indicates that something must be in it for pharma; otherwise they wouldn’t attend. There is no question that social media isn’t a passing fad and is now an integral part of the Web 2.0 experience. That said, for the first time in many years, drug makers have a unique opportunity to actively voice their ideas and concerns and collaboratively work with FDA to craft meaningful social media regulatory guidance. As many of us “outside observers” know, the agency doesn’t have all the answers and we would like to think that drug makers would extend a helping hand to avoid confusion and misunderstandings about the use of social media to promote their products and services. While only 4 companies are scheduled to speak at the hearings, I suspect that there will be many life science company representatives in attendance. Nevertheless, despite what may happen at this week’s hearings, I hope that, going forward, drug makers and device manufacturers will begin to view FDA as a partner rather than an adversary!

Until next time...

Good Luck and Good Job Hunting!!!!

 

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For the past month or so I have been working on a piece about chemotherapy induced nausea and vomiting (CINV) that is common among patients being treated for cancer. While not a pleasant topic, it is a reality for many patients who undergo cancer chemotherapy treatment.  Although CINV is less common with some of the newly-developed anti-cancer monoclonal antibody treatments, it is still a troublesome and debilitating problem that must be managed during conventional cancer chemotherapy treatment regimens. 

There is a growing body of evidence that marijuana (delta-9-tetrahydrocannabinol is the active ingredient) and related cannabinoid-like agents may help to effectively manage and control CINV in certain patients who are undergoing cancer chemotherapy. Recognizing this, 14 states have already legalized marijuana for medicinal purposes. Interestingly, according to Newsweek Magazine (November 2, 2009), the US government could save as much as $13.5 billion annually if it stopped enforcing laws against marijuana. To that end, the Justice Department says it will no longer prosecute people who use if for medicinal purposes in the 14 states where that's legal.

While I am not advocating illegal drug use, it seems silly to me that the inherent, medically-beneficial properties of  marijuana haven't been fully utilized to treat patients who are suffering from potentially life-threatening illnesses like cancer.  Further, there are legal and medical precedents for the use of illegal drugs that offer medical benefits. For example, while opium use is illegal in the US but morphine and related products (which are derived from opium and poppy plants) are legal prescription drugs that are regularly used to control acute and chronic pain in millions of Americans. Unfortunately, research on development of cannabinoid-like drugs to treat CINV has been stifled because of the illegality of marijuana.

The number of patients being treated for cancer rises each year. Isn't it time to start offering patients the best and most effective medical treatments available to them rather than continuing to adhere to out dated and unevenly enforced US drug laws?

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

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Yesterday, after giving a talk on social media to a great NYC-based PR firm called Ricochet,I decided to take an uptown trip to visit Professor Vincent Racaniello at Columbia University Medical School to talk about the new applications that we plan to introduce to BioCrowd.

When I arrived at Professor Racaniello’s office, which has an outstanding view of the Hudson River and George Washington Bridge, he was in the middle of taping this week’s This Week in Virology (TWiV) podcast with co-hosts Dick Despommier and Alan Dove. Much to my surprise, Vincent invited me to join the conversation although I am a bacteriologist not a virologist. The podcast was devoted mainly to answering questions that listeners had submitted to the show. One listener alerted us to a post at Newsweek Online entitled “Fight Flu and Falsehoods” while we didn’t agree with the author’s assertion that “that hand washing doesn’t affect the transmissibility of influenza”—it does reduce infections rates of other viruses, bacteria and parasites, so it is a good idea to continue to wash your hands—accompanying the article was an outstanding online quiz that assesses how much you really know about influenza and other viruses. 

I think it would be fun for BioJobBlog readers to take the quiz, report scores and then tabulate the results.

To take the quiz, click here and to report your score click here!  I will tabulate the results and share them in a later post if enough BioJobBlog readers and their friends take!

Until next time

Good Luck and More Luck On the Quiz!!!

 

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Cliff Mintz, BioCrowd co-founder and the mastermind behind BioJobBlog, is featured today in an online article at the Science Careers website entitled “Life After Rejection.” The piece was expertly crafted by Siri Carpenter, PhD a free lance science writer based in Madison, Wisconsin— coincidentally, the institution that awarded me my PhD. 

Being denied tenure as an Assistant Professor of Microbiology and Immunology was one of the most devastating events in my professional life. It literally took me over 10 year to come to terms with the implications of the decision. But, I am here to tell you (and in the article) that there IS life after being denied tenure; and in many ways, it is quite liberating. My tenure denial empowered me to explore careers that were previously closed to me as an academician and perhaps, more importantly, to find out who I am and what I really wanted to do with the rest of my life!

Don't get me wrong; it still bugs me that I wasn’t awarded tenure—mostly because being refused tenure implies that you “weren’t smart enough” to make it in academia. Not surprisingly, the “not-being-smart-enough label” doesn’t do much for a person’s self esteem and, many who are denied tenure (including me) tend to view themselves as abject failures in the eyes of their colleagues and friends.

However, looking back, being denied tenure was probably one of the best things that had ever happened to me. Truth be told, I would have been a lousy academic. I am too social and entrepreneurial to have flourished in a system that is rigid, parochial and not conducive to change.  That said, if I sound bitter and a bit envious of those who were granted tenure, you are correct!  After all, who wouldn’t be envious of  people who come and go as they please, don’t have to answer to a boss and are guaranteed a job for life; regardless of their social skills, academic performance or contribution to education?

The point that I want to make is that being denied tenure is an emotionally devastating and traumatic event that nobody ought to experience. However,  if  you should to find yourself in the uncomfortable position of being denied tenure, please remember to continue to believe in yourself, don't give up and, as corny as it may sound, "follow the advice of your heart" when making your next career move!

Until next time....

Good Luck and Good Job Hunting!!!!!

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I don’t want to brag but I have been touting career options in health informatics and health information technology (HIT) for the past year or so. Today, I came across a post by CareerBuilders declaring health informatics and HIT are the hottest new career trends to hit the market in recent years. 

As the drive towards digitizing medical and healthcare records continue, there will be literally thousands of job opportunities for people with the right skill sets. Getting a nursing degree is one of the steps to achieve a great career in health informatics!

Health informatics will put technology in place that provides hospitals and other health-care providers with access to an electronic network of vital patient information such as like medical histories and prescriptions. The information age finally meets healthcare administration.

The facts
The health informatics initiative won’t succeed unless employees — that’s you! — bring the specialized skills needed to build and expand the network. All other pieces are in place:

• The American Recovery and Reinvestment Act of 2009 includes $20.6 billion to help providers drive adoption and development of the IT infrastructure needed
• The U.S. Bureau of Labor Statistics (BLS) projects health information management employment to grow nearly 18 percent by 2016
• The BLS projects a need for more than 6,000 new professionals each year through 2014 — but only 2,600 graduates have entered the field this past year 

Your opportunity
To succeed, health informatics (HIM) will demand a wide variety of specialized positions across IT and health care. It will engage conventional experience from both areas — such as registered nurses and LPNs/LVNs, or IT implementation specialists and IT project managers — if you’re looking for a new twist on your current career.

But new positions will also thrive in this hybrid field. Look for new HIM job titles in your next job search, like health IT professionals, HIM coders, HIM medical records professionals and various health informatics specialists, including trainers, researchers and analysts.

Get online to check out the job titles mentioned above and listed below for related descriptions, and see if you might need any additional training to meet requirements: 

Nursing
- Telemedicine clinical professionals

- Chief nursing information officers

- Clinical IT liaisons 

Again, getting a nursing degree is one of the steps to achieve a successful career in health informatics

Health-care administration
- Medical and health services managers

- Document scanners

- Data entry clerks

- File clerks

IT specialists
- Senior programmers

- Senior clinical analysts

- Database analysts

- Developers

- Business analysts

- Software engineers

- Data integration specialists

Not too shabby of a list! In a previous blog post I identified a variety of training options for people interested in pursuing careers in health informatics and HIT. Check it out!

Until next time....

Good Luck and Good Job Hunting!!!!!!!

 

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The answer to this question is not yet! However, the The Wall Street Journal recently reported that 64% of U.S. physicians are using smart phones (up 50% from two years ago) and increasingly are relying on them to find medical information, manage patients and transmitting clinical data. To that end, a post at the Medical Translation Insights blog discusses the changing role of smart phones in healthcare and the regulatory challenges they may face if classified as medical devices.

 When Cell Phones Become Medical Devices

The definition of "medical device" is shifting, quickly and dramatically.  The revised MDD now includes stand-alone software in the definition. In other words,if software has a medical purpose, it probably can/must be CE marked. And smart phones are quickly becoming the conduit of choice for collecting and researching, disseminating, and evaluating clinical data.

As Bob on Medical Device Software points out, its unique user interface, display, and broadband capabilities make the Apple iPhone a particularly attractive platform for medical applications. For example, the AirStrip OBSERVER suite of applications is custom-designed for the iPhone, makes some components available for download at the Apple App Store, and received FDA clearance for some modalities.

While most medical apps fall into the reference category, applications are getting more sophisticated and are taking advantage of the devices networking abilities. A trio of applications developed by researchers at the University of Utah aptly demonstrate these advances. Another factor is the appeal and widespread use of these devices. The Wall Street Journal reports [login required] today that 64% of U.S. physicians are using smart phones.

There are several big questions and unknowns hanging over these developments: First and foremost, there is the question of data security. As quoted in the same WSJ article, Deborah Peel of Patient Privacy Rights worries that "the vast majority of health information technology has not been designed to ensure that patients control access to that data and use of that data". So, paradoxically, the more ways that doctors can access patients' records, the more their confidentiality is threatened.

Second, what is the quality threshold for smart phone applications? Just because something is on the iPhone doesn't mean it's necessarily a quality application

Regulators around the world are bound to tackle these questions. FDA, for instance, is already looking at this issue and sooner or later will regulate certain phones. It's certainly not the end of the world to be classified as a medical device, but verification and validation of these applications won't be easy.

 As these applications get developed and become part of a networked medical device, language will also become an issue again. Translation service providers will need to become familiar with smart phone development and localization issues and support consistently translated content across multiple platforms and media.

Until next time...

Good Luck and Good Job Hunting

ForeignExchange Translations provides specialized language services to pharmaceutical and medical device companies

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In a previous post I lauded health information technology (HIT) aka health informatics as a possible new career choice for scientists with life sciences PhD degrees who also have a proclivity for software development and data base management. Shortly after I posted the piece, I happened to read an article in a local publication about a NJ-based company called the MISI Company that is at the forefront of the HIT field and developing software to help digitize American healthcare records. 

I invited Dave Roth, an MISI executive, to share his views on the future of HIT and what ought to be done to insure that e-medical records are appropriately and successfully created. BTW, for my bioinformatics and genomics friends, MISI is looking to hire a few talented men and women who are interested in HIT careers.

HIT: The Other Missing Link

by Dave Roth

Health information technology (HIT) is hot. There’s every reason to believe that HIT will play a major role in the reforms envisioned for our health care system. From President Obama announcing $5B in grants to aid medical research, to bioinformaticists developing tools for predicting genetic predisposition to diseases, to software developers working on electronic medical records (EMR) systems, HIT is a burgeoning field. What concerns people like me – read: people who are users of technology rather than the developers of it – is that all this HIT talk seems to have very little mention of us in it.

Not long ago, I wrote an article called The Missing Link in Healthcare IT: The Consumer. In it I pointed out that none of the current government definitions being proposed for "meaningful use" of electronic medical record (EMR) systems define meaningful from the healthcare consumer's perspective. I also noted that whatever rules the government establishes for receiving stimulus money for the development of HIT solutions, none of them will exclude technologists from collaborating with consumers in the development of their solutions. I posited that technologists would be doing us all a favor if they would stop to consider for a moment how their systems will affect the consumer’s experience of health care services.

I was encouraged when David Goldhill, in his cover story in the September 2009 issue of Atlantic Monthly, How American Health Care Killed My Father, wrote, “[A] guiding principle of any reform should be to put the consumer, not the insurer or the government, at the center of the system.” Goldhill’s prescription for a better health care system begins with advocating for the consumers of services and focusing on how to get the best outcomes for those consumers at a reasonable cost. He was channeling the views of many people, such as Harvard Business School professor Regina Herzlinger, who believe consumer-driven health care is the only reform that will truly be meaningful.

The growing visibility of the consumer in this debate has gotten me to thinking there is real opportunity in the HIT job market for another missing link: Consumer-centric Health IT Developers. It is a rare developer who brings to his/her craft an appreciation of the importance of understanding who you are developing for. Rarer still is the developer who is aware of and employs tools and techniques for capturing end-users’ feedback during the development process. More often than not, user-centered design (UCD) is considered a luxury that burns up time and precious dollars. This misconception is largely the result of development teams typically waiting until they are too far into the development cycle before engaging with those who will be using their creation. Inevitably, problems are discovered with the usability or utility of the system that will hinder adoption. But the problems are discovered too late to be fixed by the target launch date and/or within budget. Users/Consumers become the enemy in this scenario.

There is another way. HIT technologists should understand how and why to engage their target audience at the beginning of the development process, long before anything is actually developed. They should begin by understanding who they are developing for, what these people are looking to accomplish, and how they can best help them accomplish it. Using such techniques has been shown to actually reduce downstream development work and increase adoption. I believe technologists schooled in the techniques of consumer-centered design will be central to any successful, long-term health care reform.

Dave is Vice President and  heads MISI Company's Experience Design (XD) group - a group of strategists, experience architects, visual designers and technologists whose mission is to help ensure the success of every interaction between a business and its target audience. His career spans 30 years and includes award-winning work in documentary and corporate film/video, print advertising, and interactive software application development for computers and the Internet. Dave is a Stanford University grad, a SF 49ers fan and a member of the Single Malt Scotch Whiskey Society.

 

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Mark Senak at the EyeonFDA blog reported yesterday that the US Food and Drug Administration (FDA) is seeking public input on the use of social media in the pharmaceutical, biotechnology and medical devices/diagnostic industry. Meetings to solicit input will be held in Washington DC on November 12 and 13^th.  This will be the first opportunity for industry representatives and the public to begin a discussion with FDA on the policies that will guide the use of social media in the life sciences industry.

According to EyeonFDA, on Monday, the agency will publish a notice in the Federal Register announcing this historic event (see excerpt below)

Questions have arisen regarding the application of the prescription drug and device advertising and labeling provisions, regulations, and policies of promotion on the Internet, especially with regard to the use of emerging technologies such as blogs, microblogs, podcasts, social networks and online communities, video sharing, widgets, and wikis. This section briefly discusses the issues the agency has identified as most frequently raised by regulated companies and other interested parties. It should be noted that although a question may raise a particular issue, that does not necessarily mean that the agency will issue guidance or a regulation on that issue. The agency invites comment at the public hearing on the general concept of Internet promotion, positive or negative; on any aspect of Internet promotion that is of interest to the presenter; and on the topics outlined in the following paragraphs. We are specifically interested in data and research on the use of social media tools in promotion, including data from companies on their own experiences, the extent to which health care professionals and consumers are using and are influenced by various social media tools, and the impact of Internet and social media promotion on the public health.

For the past year or more, many bloggers and other social media enthusiasts have taken FDA to task for not taking action on the topic. Finally, the agency realized that something had to be done given the growing use and popularity of social media tools and strategies in other less regulated industries. Earlier this week, in an unexpected move, FDA launched its first Twitter feed. Perhaps this was a hint that FDA is beginning to emerge from the dark ages into the digital world of Web 2.0 and social media.

Hat tip to Mark!

Until next time...

Good Luck and Good Twittering !!!!!!!

 

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Eli Lilly & Co announced today that it is eliminating another 5,500 jobs or roughly 14% of its global workforce over the next two years. This would reduce to size of Lilly’s worldwide workforce from 40,500 to 35,000 by 2011. In addition to the job cuts, the company is reorganizing itself into 5 business units and hopes to save about $1.0 billion in annual costs.

These newly announced job cuts come after the company eliminated 4,000 sales representative jobs this past August and restructured its sale force. Also, prior to the recent cuts, Lilly launched the Lilly Phenotypic Drug Discovery Initiative or PD² a new program to ostensibly strengthen relationships with academic institutions to speed drug discovery and thereby reduce its reliance on internal drug discovery efforts to keep its pipeline full.

Unlike other major pharmaceutical companies that conducted massive layoffs over the past two years, Lilly was content, until the past few months, to lay off small numbers of employees and offer others retirement packages. Unfortunately, the loss of patent protection on several of its blockbuster drugs coupled with generic encroachment on several brands and impending health care reform, forced Lilly to take more draconian action.

Layoffs have been something of rarity in the life sciences sector over the past eight months or so, but this is usually the time that marks the beginning of the corporate “layoff season.” Don’t be surprised if other large life sciences companies announce similar layoffs in the coming months. Luckily, the economy seems to be improving and there are signs that hiring is beginning to ramp up in the pharmaceutical, biotechnology and devices industries.

Speaking of pink slips, those of you who have been downsized or find yourself out of a life sciences job may be interested in a new organization called Pink Slip mixers. According to a description on the group’s website:

“Our Pink Slip Mixers are about hundreds of professional, mid- to upper-level executives who are (might be) victims of the "economic downturn" of 2008. Our parties are about banding together, networking and bonding with the recently "Pinked". We will share our experiences of why we were let off, what companies are hiring, and the "buzz words" that specific hiring managers want to hear. Aside from the usual imbibing, commiseration and fun that every pink slip party brings, headhunters, direct-hire companies, and recruiting firms will also on-hand to learn a little bit more about what you do. Maybe you'll meet a new contact, or find a new job!” 

Sounds like these mixers might be good networking opportunities and a place to kick back and commiserate with others who are no longer gainfully employed. I am planning to attend a Pink Slip Mixer when one is organized in the NYC metropolitan area. Like many of you, I lost my full time contract copywriting job over a year ago!

Until next time...

Good Luck and Good Job Hunting!!!!

 

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There was another article in today’s New York Times lamenting the marketing practices utilized by drug companies to inform physicians about their products. While these practices may be troubling to legislators and the American public, everybody who works in the life sciences industry including regulatory agencies like the US Food and Drug Administration (FDA) understands the “rules of the game” and how it is played. However,

over the past three years, there has been a full frontal assault on direct-to-consumer advertising and marketing and sales practices used by drug makers to hawk their products to physicians and the American public. This has largely been an over reaction to the lack of regulatory oversight of drug manufacturers during the Bush administration. The new regulations have severely limited what sales representatives can offer physicians e.g. gifts and free lunches and dinners, for more face time to sell their products. Consequently, the only means left available to drug makers to reach large numbers of physicians is marketing through medical education.

This is how it works. Companies annually budget monies to pay highly recognized physicians aka key opinion leaders (KOLs) to give lectures to physicians that might influence their prescribing habits. These lectures often take the form of informational seminars that focus on treatment options for certain therapeutic indications which often times subliminally highlight the advantages of the sponsor’s product over its competitors. Not surprisingly, the effectiveness and success of these programs is usually directly proportional to the sums of money invested in them. For example, in 2004, Forrest Laboratories (the subject of the NY Times article) planned on spending “$34.7 million to pay 2000 physicians to deliver 15,000 marketing lectures about Lexapro (an antidepressant) to their peers in one year.” The investment appears to have paid off; sales Lexapro reached $2.3 billion in 2008 even though a lower cost generic version of the drug is available. And, while the Forrest investment in medical education may appear to be a large one, it pales in comparison to the sums invested in medical education programs by much larger companies like Pfizer, Merck and others.

While certain members of Congress may be “shocked and outraged,” these practices are sanctioned by FDA. And, as long as drug makers are compliant and adhere to the rules they shouldn’t be faulted or penalized for their efforts. The point that I am trying to make is that drug makers, like all other for-profit entities, must maximize sales to generate sufficient profits remain in business. Therefore, it should come as no surprise to legislators or the American public for that matter, that drug makers use all legally available means to maximize the sale of their products. If Congress doesn’t like what drug makers are doing, then they ought to stop complaining and legislate changes to the rules. Put simply, it’s time for Congress to “put up or shut up.”

Until next time...

Good Luck and Good Job Hunting!!!!

 

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I suspect that a majority of BioJobBlog readers have at one time or another been prescribed a drug to treat a particular medical condition or ailment. Like most of you, I assumed that my prescription information and history was private and that only healthcare professionals were privy to it. However, after reading an article in this Sunday’s NY Times, I learned how wrong I was! Much to my dismay,  I learned that prescription information including the name and dosage of a drug, the name and address of the physician who prescribed as well as a patient’s address and social security number is a commodity that is regularly bought and sold usually with a patients’ knowledge or permission. And apparently, this practice is perfectly legal as long as patient’s names are removed or encrypted before the information is sold, typically to drug manufacturers.

Unfortunately, privacy experts and information technology specialists contend that it isn’t difficult to match names, addresses, and social security numbers to reconstruct information that had supposedly been rendered anonymous. To make matters worse, until very recently, federal patient privacy and data security rules were loosely enforced and frequently abused by medical marketers, advertisers, drug manufacturers and retail pharmacies. Finally, re-identifying a patient’s prescription drug information and history provides drug makers with a powerful tool to target and market drugs to specific patient populations.

Tracking prescriptions and mining prescription data is not new—it has been big business for many decades. The major players in the drug mining business are companies like IMS Health, Verispan and CVS Caremark. Also, large discount pharmacy retailers like Walgreens and Target engage in this practice and they all sell their prescription information data to interested parties. Prescription drug data-mining companies say that their services are valuable and warranted because gathering and analyzing information from tens of thousands of patients helps drug manufacturers to identify trends and potential safety and tolerability issues with prescription drugs. Nevertheless, despite assertions that prescription drug data are anonymous when it is sold, class action and private lawsuits alleging this not to be the case have been filed against some of the major players including Walgreens, IMS Health and CVS Caremark. While this is troubling, loopholes in the current prescription drug data mining regulations allow pharmacy companies like Walgreens and others to accept money from drug manufacturers to mail advice and reminders to customers to take their medications without first obtaining their permission. The loopholes also allow drug makers to send customers’ promotional information and materials about drugs other than the ones that they are already taking.

Under the Obama Administration’s $19 billion healthcare stimulus package, selling prescription drug data to drug makers will still be allowed (only if patient’s names are removed). Also, subsidized marketing by drug makers will be allowed to continue but companies will no longer be able to promote drugs other than those the customer already buys. While the new legislation allows data mining and the sale of prescription drug information to continue, its primary goal is to tighten and insure patient privacy so that personal prescription drug history and information can no longer be used to exploit the buying habits and behaviors of individual American consumers.

Until next time...

Good Luck and Good Job Hunting!!!!

 

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Despite dire predictions, the biotechnology industry appears to be weathering the recession better than most. According to a CNN Money.com post “Biotechnology leapt ahead as the biggest recipient of U.S. venture capital money in the second quarter, but first-time venture investments in companies overall dropped to a 15-year low.”

Biotechnology funding grew 54% to $888 million in 85 deals, software came in flat at $644 million in 135 deals and Internet companies fell 15% to $524 million in 124 deals. While biotechnology company investments are leading the pack, the current funding levels pale in comparison to those of the late 1990s and early 2000s. Also, it is important to note that many of the biotechnology company investments were in mid to late stage ventures. Fewer investments were made in seed or early stage companies which historically have outpaced funding in late stage ones.

Venture capitalists may be favoring biotechnology investments because there is a clear exit strategy—there are more acquisitions and initial public offerings in life sciences as compared with other industries.

Look for continuing investments in the biotechnology sector—especially in molecular diagnostics and medical devices.

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

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BioJobBlog and BioCrowd along with the Business Development Institute, the Journal of Communication in Healthcare and others are co-sponsoring a meeting entitled “Social Media and Healthcare” that will be held on July 23, 2009 in NYC at the Graduate Center of The City University of NY (365 Fifth Avenue at 34th Street). Topics that will be covered include:  

1. Managing regulatory and legal issues when planning and implementing social media strategies
2. Is there a role for social media in President Obama’s healthcare reform plans?
3. Why real-time social media tools like Twitter are gaining momentum and when it makes sense to use them
4. How social media has affected crisis communications in the healthcare industry
   
5. Selling social communications projects and proving ROI to senior management
   
6. Creating and participating in communities to achieve communication, educational and branding objectives
7. Planning and executing a social communications plan with little or no budget
8. Building relationships and partnerships with new healthcare media leaders beyond advertising
9. Best practices for using social communications to connect internally with employees and stakeholders
   
10. Tools, technologies, and best practices for monitoring and measuring social communications

The meeting’s agenda features case study presentations and a series of roundtable discussions on social media topics. I will be leading a roundtable discussion called “How to Build a Social Networking Site for Bioscientists.” Approximately 300 senior marketing, communications and media professionals from Fortune 1000, middle market and emerging growth companies are expected to attend from leading pharmaceuticals, medical technology/device companies, managed care providers, hospitals, healthcare media companies, government and nonprofit organizations.  

BioCrowd members can register for the meeting at a discounted rate of $155. Check it out—it will be money well spent!

Hat tip to Steve Etzler at the BDI and Mario R. Nacinovich Jr., Editor-in-Chief, Journal of Communication in Healthcare for organizing this topical and important meeting.

I hope to see you at the meeting next Thursday!!!!

 

 

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The medical  science  liaison  (MSL) professional focuses on providing scientific and educational  support  and collaboration between healthcare stakeholders like physicians, patients and and  bipharmaceutical companies.

 According to Dr. Samuel Dyer, CEO of MSL WORLD the MSL role has evolved from originally being a support to sales reps to the forefront of pharmaceutical companies serving as the primary contact with KOLs, prescribers, and other Health Care Providers. 

PhDs have faced tremendous entry barriers to the MSL career for two major reasons. First, most PhDs lack clinical (or patient care) experience that are inherent in PharmD and MD training programs. Most PhD research projects deal with cells and mice — considered preclinical by industry standards. Second, and perhaps more insidious, is the perception that "PhDs lack people skills". People conjure stereotypes of scientists in white lab coats as eccentric, antisocial or lacking in social graces. Unfortunately, this perception also exists within biopharma, and PhDs aiming for alternative careers beyond the bench have to be prepared to "explain themselves".

PhDs who want to become a MSL can maximize their chances of breaking into this highly competitive career by doing the following:

Understand the mindset of MSL hiring managers

The biggest complaint I've heard over the years of coaching and mentoring aspiring MSLs is "they want MSL experience, but I can't get that unless I become a MSL". I've heard this so many times that I titled my MSL career book, "All MSLs Started with No MSL Experience!"  This catch-22 situation has evolved because many entry level MSL candidates don’t possess many of the basic skill sets that hiring managers are looking for. Consequently, hiring managers prefer experienced MSL candidates because they can be reasonably assured that person understands the “ins” and “outs” of what it takes to be an MSL.

Invest in tools, resources, and coaching
Perform due diligence and read everything you can about the MSL role. This six -figure career niche is extremely small, which makes the job market fiercely competitive. There is a dearth of "free" MSL resources because service providers in this niche make their living by focusing on the biopharma clients with big budgets.

Become a master networker

Networking is your only option to get into the minds of hiring managers or learn what you need to know if you can't or aren't willing to invest in tools, resources, or coaching related to the MSL career. You can start with your school's career center or the local postdoc association and see what resources may be available related to an MSL career.

Scientific complexity is increasing in treatment options as biologics are entering markets long dominated by small molecules. This is matched with cross-sector collaboration complexity, as biopharmaceutical companies navigate regulatory and public scrutiny. The MSL profession is only 40 years old, but the MSL role is becoming one of the "rising stars" of biopharma's career offerings. Look for the life sciences industry to hire increasing numbers of MSLs as more biotechnology products enter the market.

To learn more about the MSL career pathway please check out Jane’s new book, "All MSLs Started with No MSL Experience! The Guide to Becoming a Medical Science Liaison" or visit the MSL Jobs website to look for employment opportunities or visit the MSL Jobs website to look for employment opportunities.

 

 

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I just learned from Diego Pineda who runs the Medical Writer Blog and Medical Writing social network about an interesting internship possibility at Science magazine. For those of you social media enthusiasts interested in the opportunity, here is a job description.

“Science, the world's leading journal of original scientific research and global news, seeks a three-month intern to help implement and manage social media projects for its news department. The candidate should be very familiar with Facebook, Twitter, and other social networking platforms, and should have experience creating content for these platforms. Other duties will include promoting news content on the internet, moderating comments on our daily news site, and repurposing news content for multimedia projects. Some writing and research assistance for our online news site is possible. The ideal intern will have a science background-or at least a strong interest in science-and some journalism experience. The internship will be at our Washington, D.C. headquarters.”

For consideration, send a resume and cover letter to AAAS, Human Resources Department, 1200 New York Ave., NW, Suite #101, Washington, DC 20005.  (Attn:  Requisition #1763) You may also reach us by Fax at 202-682-1630 and e-mail at jobs@aaas.org.

It appears that Science is finally getting into the social networking.  For those of you, who can’t wait for the Science network, please check out BioCrowd, a social networking community focused on career development for bioprofessionals.

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!!!

 

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There is a growing worldwide shortage of nurses and other typically female-dominated medical professionals. The acute shortage of nurses in Europe has induced at least one Czechoslovakian clinic to develop a novel—albeit somewhat controversial— approach to retain and recruit hospital personnel. According to an article in today’s New York Times (which was also reported on NPR several weeks ago) “When Petra Kalivodova, a 31-year-old Czechoslovakian nurse, was considering whether to renew her contract at a private health clinic special perks helped clinch the deal: free German lessons, five weeks of vacation, and a range of plastic-surgery options, including complimentary silicone-enhanced breasts.” She opted for cosmetic breast surgery (which normally cost about $3,500) and also had liposuction on her thighs and stomach citing that she her appearance is important to her and her patients.  Perhaps, more importantly, she could never have afforded to have the procedures done on her current salary which is lower than most bus drivers. Of the 50 nurses working at the clinic, 10 opted for plastic surgery, while several more were considering it. And, at least one male employee is seriously considering liposuction.

While offering plastic surgery as an inducement to recruit and retain hospital employees is somewhat controversial, it highlights the need to improve the salaries and benefits of nursing and other medical care professionals. In many places in Europe, nurses and other hospital employees make considerably less than bus, truck drivers and other non-technical workers. The same is true in the US which has also been experiencing ongoing nursing shortages. But, hospitals and clinics here have yet to offer plastic surgery options to recruit or retain medical and support staff personnel. Unlike Europe, where cosmetic surgery is booming, plastic surgery procedures have dropped about 9 per cent this year as compared with years past.

Like it or not, cosmetic surgery is an option in today’s world and, accordingly, people ought to have the right to choose whether or not it is right for them. However, it is important to remember that cosmetic surgery is invasive and potentially serious medical complications including infection, disfiguration and death can occur. The fact that 20 per cent of the Czech nurses chose cosmetic surgery over more vacation time or free German lessons may be indicative of the growing pressure placed on both women and men to look young, vibrant and remain sexy. Further, there are marketing and employment studies which suggest that younger more attractive people get hired more easily and advance their careers more rapidly than average, older-looking ones.

When Petra Kalivodova, the 31-year-old Czechoslovakian nurse who opted for breast augmentation and liposuction was asked about her choice she said “People of my mother’s generation look down on me for getting the surgery—“I see it in their eyes. But I don’t care. I did this because I wanted to and I didn’t ask anyone’s permission, including my boyfriend.” I think her comments reflect a changing and growing attitude among women 35 and under who believe that personal choice, feminine beauty and pursuing professional careers are no longer mutually exclusive.

Until next time.

Good Luck and Good Job Hunting!!!!

 

 

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Medtronics, the world's largest medical-device company, announced today that it will lay off 1,500-1,800 employees after posting a fiscal fourth-quarter profit that plunged 69 percent on slipping sales,restructuring and other charges. About 400 employees already have accepted buyout offers and will leave the company by the end of the month.

Until now, the medical devices and diagnostic industries, unlike pharma and biotech had had remained unscathed by the current economic downturn. Medtronic’s financial woes are mainly a result of questions about its implantable devices which have come under fire recently because of safety concerns. Nevertheless, don’t be surprised if you see other medical devices and diagnostic companies begin to layoff workers as the financial crisis deepens and medical and healthcare costs continue to rise.

Hat tip to Iguana Bio.

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

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Are you a life sciences or healthcare professional with a passion for computers, IT or software development? If so, you might want to consider a career in health informatics—one of the hottest, new fields in the life sciences and healthcare industries. Health informatics specialists typically have expertise in medical records and claims, clinical care and programming. In other words, they have a foot in two worlds— medicine and technology — and can easily bridge the often daunting gap between them. It is important to point out that there is a difference between healthcare IT and informatics personnel. The health IT people run the servers and install software, but the informatics people are the ones who analyze and interpret clinical/ medical information and work with clinical and other healthcare staff to advise and help them.

According to an article in this Sunday’s NY Times, health informatics specialists usually start as computer programmers or as doctors, nurses, pharmacists or health record administrators. After earning a graduate health informatics degree, they find jobs as mid level or senior employees at hospitals, doctor’s offices, insurance companies, pharmaceutical companies or other organizations concerned with health data. Mid level jobs, like those for clinical analysts or informatics analysts, are usually about $70,000 a year, but salaries can be much higher for more senior level positions.  Senior level jobs, which sometimes require a Ph.D., include chief clinical information officer or other management/leadership roles at medical devices, life sciences or insurance companies. Consulting firms are also hiring health informatics experts to serve many of their health care clients who frequently don’t have the resources to hire permanent informatics staff.

At present there are no educational, licensing or credential requirements to become a health informaticist. However, a growing need for health informaticists has resulted in the creation of a number of degree programs at two and four year colleges and universities. For example, within the past four years, Columbia University, St. Louis University, the University of Minnesota and Oregon Health and Science University have all added master’s programs or certificates in health informatics. Other schools offer short courses or part-time certificate programs to healthcare employees or programmers. Still others are adding undergraduate majors or associates degrees programs to their curricula.

While many schools are beginning to offer health informatics programs, not all informatics programs are “created equal.” Generally speaking, “medical” or “biomedical” informatics programs focus on data that doctors need for treating patients. Bioinformatics” programs concentrate on biological or genetic data, while “health informatics” programs often emphasize clinical data and health records. Even among programs with the same name, the emphasis and expertise may vary at different institutions that offer the training.

By all accounts, health informatics —despite some early confusion—is one of the fastest growing careers in the bioscience and healthcare fields. Unlike other fields in the shrinking life sciences industry, there are plenty of jobs out there for health informaticists. Ironically, the failing US economy is what is driving the growth of the health informatics industry. The US government’s economic stimulus package has allocated $19 billion to hastening the adoption of electronic health records, so demand for health informatics specialists is skyrocketing. “My rough estimate is that we need about 70,000 health informaticists,” said Don E. Detmer, president and chief executive of the American Medical Informatics Association, a nonprofit industry group.

However, as a word of caution, it usually takes more than technical skills and an understanding of health care to succeed as a health informaticist. Diplomacy and conflict resolution skills are crucial when dealing with two potentially contentious groups: healthcare workers and programmers. Nevertheless, healthcare informatics is an ideal field for bioscientists and healthcare workers who also like to work with technology, computers or develop software. Based on my recent experiences as a bioscience career counselor, I know that there are thousands of you out there that fit this description. Now be the time to take a closer look at the exciting, new field of health informatics to determine whether or not it may be a career option for you!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

 

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The US economy has lost about 7.1 million jobs since December 2007 and nationwide unemployment is hovering around 8.5 percent. Despite the lost of  about 80,000 pharmaceutical jobs over the past three years and unprecedented consolidation taking place in the life sciences sector—Merck-Schering Plough, Pfizer-Wyeth and Roche-Genentech—the job prospects for scientists at biotech companies, medical devices and diagnostics, and government appear to be stronger than anticipated. While drug discovery and sales jobs may be scare, there are rapidly emerging opportunities in the fields of medical communications, regulatory affairs, biomanufacturing, clinical trials management , bioengineering, medical devices/diagnostics and website development and management.

President Obama’s promise to restore science to its rightful place, his reversal of the ban on federal funding for embryonic stem cell research and an unwavering commitment to alternate energy technologies suggest that the future may be very bright for bioscientists. For example, there are massive hiring initiatives at federal agencies like the US Food and Drug Administration (FDA) and the Unites States Department of Agriculture (UDSA) — as the Obama administration attempts to overall these agencies— and funding levels at the National Institutes of Health are on the rise (aided in part by a $200 million Challenge Grant stimulus program).

While the road to economic recovery may be a long one, graduate students and postdoctoral fellows who are currently engaged in life sciences research should “stay the course and not jump ship just yet.” The life sciences industry is more recession proof than others and it will be one of the first to experience an economic turn around. And, when it does it is best to prepared to find a job!

Until next time…

Good Luck and Good Job Hunting!!!!!!

 

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It has been a long standing practice of mine to avoid co-mingling science and religious issues in any of the materials that I post online. I have refrained from doing this because I believe that enough tension already exists between religious advocates and scientists.   However, I was unable to control myself today after my wife pointed out two interesting articles in Wednesday’s New York Times.

The first article dealt with Pope Benedict XVI’s views on condom use and HIV transmission in Africa. Yesterday in Cameroon, he publicly said, for the first time, that condoms are not the answer to Africa’s fight against AIDS. Not only did this statement send a collective shiver down the spines of many HIV health workers, clergy working with AIDS patients are divided on the issue. The pope told reporters that “You can’t resolve it with the distribution of condoms. On the contrary, it increases the problem.” Apparently, church dogma suggests that fidelity in marriage and abstinence from premarital sex are crucial weapons in the fight against AIDS. There are currently 22 million people in sub-Saharan Africa infected with HIV and three-quarters of all HIV/AIDS deaths occur in the region. Apparently, attempting to be faithful and just saying no doesn’t seem to work in Africa—or anywhere else! The pope’s statement prompted a representative from the Treatment Action Campaign in South Africa to say “Instead, his opposition to condoms conveys that religious dogma is more important to him than the lives of Africans.” Ironically, Africa is the fastest-growing region for the Roman Catholic Church.

The second article reported the results of a study which showed that terminally ill cancer patients who drew comfort from religion were almost three-times as likely to seek aggressive, life-prolonging treatments as compared with less religious patents. Also, the most religious patients were much more likely to ask doctors to do ‘everything possible to keep them alive.’  Study results showed that patients who were devout were three times as likely as less religious patients to be put on a mechanical ventilator to maintain breathing during the last week of life, and they were less likely to do any advance care planning, like signing a do-not-resuscitate order or preparing a living will. The findings prompted one of the study’s authors—it will appear in Wednesday’s Journal of the American Medical Association (JAMA)—to say “People think that spiritual patients are more likely to say their lives are in God’s hands — ’Let what happens happen’ — but in fact we know they want more aggressive care.” To explain this apparent paradox, the author speculated “To religious people, life is sacred and sanctified and there’s a sense they feel it’s their duty and obligation to stay alive as long as possible.” Alternately, in my opinion it may be that religious people haven’t adequately dealt with the possibility of their demise and are hoping for miracles—medical or religious— to keep them alive because they are deathly (pun intended) afraid of dying? Regardless, aggressive life-prolonging care is expensive, Medicare spends about one-third of its budget on people who are in their last year of life and much of that is spent on patients at the very end of their lives. Moreover, researchers have found that aggressive end-of-live care for terminal patients frequently can lead to a more painful process of dying and greater shock and grief for family members.

One of the few places in the world where the nexus of religion and science is difficult to fathom is the US—one of the most scientifically advanced and religious nations in the world. Several years ago, I met a scientist at a FASBEB Career meeting who, for the first time, was able to successfully articulate to me how science and religion can co-exist in American society (she taught in the South). While I can’t recall her exact words, she said something like “Both science and religion have their purpose and place in society. However, they are belief systems that are not interchangeable. That is why I can believe in God and still fully endorse and embrace evolution. They serve different purposes for me and help me to live my life.” With this in mind, I don’t think that religious dogma should be invoked when it comes to treating patients or inhibiting advances in public health, science and medicine.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!!!

 

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As many of you know, the life sciences industry, one of the most highly regulated industries of the economy has been hesitant and reluctant to embrace social media to reach out to patients, physicians and the lay public. This is because the US Food and Drug Administration, specifically Division for Drug Marketing, Advertising and Communications (DDMAC), has been mute on the subject and hasn’t issue one iota of guidance on the use of social media in the pharmaceutical, biotechnology or medical devices/diagnostic industries.

Mark Senak, a regulatory affairs lawyer and owner of the blog eyeonfda.com, invited Dr. Jean Ah Kang, Special Assistant at DDMAC in charge of Web 2.0 policy development to talk about FDA’s views and ideas about social media and its use in the life sciences industry. Listening to the 15 min podcast would be, according to Mark, “time well spent” for social media advocates in the pharmaceutical, biotechnology and medical devices/diagnostics sectors.

Hat tip and much “love” to Mark who wrote “BTW, I absolutely expect waves of love for this (the podcast)."

Until next time....

Good Luck and Good Listening!!!!!!!!!! 

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Like it or not, the best way to land a new job whether or not there is a recession is to network. While career counselors and recruiters trumpet the virtues of networking to job seekers, many people really don't understand what it is or how to do it correctly. I found an outstanding article that demystifies networking and offers tips on how to excel at it. 

For many scientists, online networking is ideal because they frequently lack the requisite skills to effectively network in real life situations. Until recently, face-to-face networking at conferences or "professional social events" was the only way to effectively network. However, the advent of web-based social networks allows job seekers to eschew the awkwardness and time requirements for  one-on-one networking in favor of a more convenient and less-threatening online experience. BioCrowd, a new online social network for scientists and other bioprofessionals, was created to help scientists advance their careers and find new jobs. While BioCrowd and similar online networking sites can help scientists make connections, it is still the face-to-face networking experience that will ultimately  help them land new jobs!

Because networking is not taught or emphasized in graduate school, it is not surprising that many graduate students and postdoctoral fellows are notoriously poor “networkers.” That said, for those of you who recognize the importance of networking and want hone your networking skills, Contacts Count a Maryland-based network training company may be worth a visit. I have no doubt that there other organizations and companies out there that specialize in network training. If you find any, let me know and I will gladly post them!

Until next time…

 

Good Luck and Good Job Hunting

 

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An article in today’s New York Times reports that several FDA scientists have accused the agency of granting market approval to several unsafe medical devices. According to published reports, “the House Committee on Energy and Commerce will investigate the accusations, first aired when eight agency scientists wrote a private letter in May to FDA commissioner Andrew von Eschenbach.”

Unfortunately, the allegations made by the eight scientists against the agency are nothing new. Frequently, agency managers (and sometimes political appointees) lean toward approving drugs or devices when the data pertaining to efficacy and safety are equivocal.

My sources at FDA suggest that this is what happened with approval of Merck’s ill-fated pain medication Vioxx.

Recently, there has been a spate of safety claims made against medical devices manufacturers. This is not surprising because the regulatory hurdles for marketing approval of devices are much lower for devices as compared with drugs and the medical devices and diagnostics business is the fastest growing sector in the life sciences. For an overview of the medical devices and diagnostics industry please read my recent article published in Science Careers.

Hopefully, new leadership at the agency will turn things around!!!!!!!

Until next time…

 

Good Luck and Good Job Hunting!!!!!!!!

.

 

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Beginning in 2009, Eli Lilly and Merck will post in online databases all payments made to doctors for speaking and consulting services. According to an article in today’s New York Times, the postings will “likely include” the names of the doctors, or will provide some other identifying information about them, along with the reason for the payments.

The lack of disclosure by physicians about their relationships with drug and medical devices companies have  plagued medical journals and continuing medical education programs for many years. For those of you who may not know commercial and business relationships (including consulting and speaker fees) are common between leading medical thought leaders and drug companies. In the last two decades alone, drug and device makers have made payments to tens of thousands of doctors and researchers in all medical specialties and areas of research. Critics of these practices (including the US Congress) are worried that this money could taint doctors’ research plans or clinical judgment when it comes to new drug/device approval. These concerns have prompted government agencies, medical journals and universities to look more closely at the deals. Many medical journals and granting agencies now require that physicians disclose all of their relationships to drug and device companies before their manuscripts and grants are reviewed.

Lilly and Merck’s decision to publicly disclose which physicians are on their payrolls is a step in the right direction. Full disclose and more transparency about the relationships between physicians and drug/devices makers is an important first step to limit subjectivity and conflict of interest issues when it comes to new drug/device approvals.

Until next time….

Good Luck and Good Job Hunting!!!!!!!

 

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Just when the medical device industry is gaining steam and poised to challenge pharma and biotech companies for market share and profits, some lawmakers have begun to question the medical devices industry’s direct-to-consumer (DTC) advertising practices. Last year, the medical device industry spent about $193 million for DTC advertising on television and the Internet—a mere fraction of what was spent on DTC consumer advertising for prescription drugs sold by pharmaceutical and biotechnology companies.

One reason given by lawmakers to justify its current scrutiny of medical devices DTC advertising practices is that “medical devices can have more of an impact on a patient’s well-being than a drug because devices often require surgery to implant and may remain inside the body for years.” However, in response, a representative from the Advanced Medical Technology Association, a medical devices trade group said, “While an advertisement may stimulate a patient to ask a doctor about device, the process of receiving one involves a discussion of its benefits and risks.” He went on to say “You may take a pill because it doesn’t involve very much. But you don’t undergo surgery unless you think you have a serious need for it.” 

Another reason cited by Herb Kohl, a Democrat from Wisconsin is “The medical device industry is just beginning to get into the game.” Yes, Mr Kohl’s assertion is absolutely correct. Unlike most pharma and biotechnology companies, which have engaged in unregulated DTC advertising for the past 10 years or so—and literally made billions— the medical devices industry was slow to recognize that DTC advertising could be used to effectively hawk its products. I guess the thought here is: “to head ‘em off at the pass!”

The current call for an investigation into the DTC practices of some medical devices companies raises several interesting questions. First, is the investigation simply a red herring to distract FDA from crafting new regulations to rein in and more tightly control DTC advertising by pharmaceutical and biotechnology companies? (While FDA has recently revised some of its DTC advertising guidelines, the changes are still not rigorous enough). Second, could the call for increased scrutiny of the medical devices industry simply be an attempt (by pharma and biotech lobbyists) to stifle the recent, explosive growth of the medical devices industry?  Finally, why are lawmakers rather than the agency (which oversees the device industry) investigating the DTC advertising practices of medical devices companies?

On a personal note, I support tighter regulations and increased scrutiny of the DTC advertising practices for all  life sciences companies. Although DTC ads are directly aimed at consumers, their real purpose is to influence prescribing practices of physicians by inducing patients to ask questions about whether or not the drugs or devices that they “saw on TV” are appropriate for them. That said, I believe that it is up to FDA to insure that all DTC ads are fairly balanced (risks vs. benefits) and medically accurate before they are viewed by the American public.

Until next time…

 

Good Luck and Good Job Hunting!!!!!!!!!!!

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As the old saying goes, nobody is indispensable.  On the heels of Friday's report about US unemployment reaching 6.1 per cent, I learned that my contract medical writing position would be ending 4 months sooner than expected.  I worked at the company for 1.5 years and was excepting to finish out a two-year stint.

Of course, given the precarious financial state of the pharmaceutical industry, I had been looking and was able to find several opportunities that may translate into freelance gigs or possible employment. That said, if anybody out there is looking for an experienced medical/science/promotional writer, please feel free to contact me by sending a comment to this post or via e-mail: cmintz@bioinsights.com.

I hope that your luck is better than mine!!!!!

Until next time....

Good Luck and Good Job Hunting (I will be looking too)!!!!!!!!!

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Ed Silverman at the Pharmalot blog reported that Abbott disclosed in a Securities and Exchange filing that it will cut about 1,000 jobs in medical diagnostics over the next four years to cut costs and save about $150 million per year.

According to an Abbot spokesperson “The streamlining includes the closing of a clinical chemistry plant in South Pasadena, California and transferring production of some diagnostic products to plants in Europe that are closer to a big part of the company’s customer base.”

I guess this is good news for Abbott employees—the company could have eliminated all 1,000 positions in one fell swoop. The four year timeline gives current Abbott employees some time to beef up their resumes.

 

Until next time…

 

Good Luck and Good Job Hunting!!!!!

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I became a medical/science writer after a rather circuitous, unconventional and sometimes, checkered career. Along the way, I learned a few things that I thought would be important to share with other PhDs who are seeking to change careers, t broaden their horizons and or simply to bring home a paycheck! I am sure that I missed a few things but here are my top 10 reasons to consider a career in medical/science writing:

 

10. Academic and industrial jobs are scare 
9.   No postdoctoral training is required
8.   Previous industrial experience is not a prerequisite for employment
7.   No laboratory work must be done to publish
6.   Starting salaries range from $40-$50 per hour or $75-90K annually 
5    There is a growing need for therapeutic area content experts
4.   Assignments change regularly and there is an enormous of amount of flexibility in when    and how you work 
3    Although a writer doesn’t perform any laboratory work, there is an opportunity to utilize the scientific skill sets (data analysis, thinking and problem solving) that you learned during your graduate training
2.   Even when times get tough, writers are always in high demand because publishing is the life blood of science
1.  You enjoy writing, thinking creatively and working with an eclectic bunch of people who are not scientists!

Until next time..... 

Good Luck and Good Writing!!!!!!!!

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In an attempt to assuage the jitters and financial concerns of investors who own stock in pharmaceutical, biotechnology and medical device companies, the US Food and Drug Administration announced yesterday that it will be change the format of the letter received by companies whose products are not ready for approval.

In the old days (at least until yesterday), when the agency determined that drugs were not suitable for sale, it would send companies a so-called non-approval letter. This letter was designed to inform drug and device makers that their products had issues that needed to be resolved before the agency will approve them. Apparently, (at least according to drug and device manufacturers), receipt of non-approval letters by companies signaled to investors that the product in question would never, under any circumstances, be approved by FDA. This urban legend was born because most companies that receive non-approvable letters decide against investing more time and money into products that FDA has deemed “unapprovable” i.e. there isn’t enough of a financial inducement or upside to continue further development.

Now, when new products are not up to snuff, companies will receive something called a “complete response letter.” According to the agency, the new letters will describe what is missing from a new drug or device application and, when, appropriate, offer advice on how to fix or address the problem(s). However, because contents of FDA letters are not released to the public, investors may now be less informed about the prospects of a new drug than in the past when the agency was able to send “approvable” or “non-approval” letters to companies.  “While this new plan may provide more detailed information to a company regarding issues that need to be addressed, investors will likely be kept in the dark on the true status of a drug’s approvability” said a pharmaceutical analyst after learning about the format changes. He went on to say “Investors will no longer know whether a drug is truly dead in the eyes of FDA.”

In my opinion, this is another example of FDA cow towing to the whims and wishes of industry. Whether you call it, a “non-approvable” or “complete response letter”, it still means the same thing—the drug or device is not ready for prime time! I don’t think that the change in semantics will do anything to assuage concerns of jittery investors. What it WILL do is force investors to rely solely on the honesty of the management teams that receives these letters—Oy!

I think that FDA ought to stick to the business of evaluating the safety and efficacy of drugs and be less concerned with the political and economic needs of the drug and device industries. Finally, it would be prudent for FDA to allow appropriately trained professionals to provide psychotherapy to all of the frightened and jittery investors out there!!

Until next time…

Good Luck and Good Job Hunting!!!!!!!

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Siemens, the Germany engineering, electronic and healthcare company is planning to layoff more than 17,000 workers worldwide.  Although primarily known for its engineering and electronic products like cellphones, Siemans has a large healthcare practice primarily in medical devices and diagnostics. A good portion of the layoffs are likely to take place in Germany and elsewhere in Europe.

The loss of this many jobs at one of the world's largest and most reputable companies may unfortuantely be a harbinger of things to come.

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!

 

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Somebody once said “Jews know two things—suffering and where to find good Chinese food”. Since I am Jewish, it is not surprising that I have experienced a fair amount of suffering throughout my life and, wherever I go, I seem to know where to find “good” Chinese food.  That said, my interest was piqued when I found a post in Yahoo Science News entitled “Study finds Chinese food good for your heart”. Given my lifelong fondness and penchant for Chinese cuisine, I thought that all of that eating that I had done had finally paid off. Unfortunately, after reading the subtitle of the article; “Chinese red yeast rice reduces repeat heart attacks/mortality rates” I realized that my joy and optimism were somewhat premature.

According to the report, researchers at Jefferson Medical College found that a partially purified extract of Chinese red yeast rice, Xuezhikang (XZK), reduced the risk of repeat heart attacks by 45%, revascularization (bypass surgery/angioplasty), cardiovascular mortality and total mortality by one-third and cancer mortality by two-thirds. The multicenter, randomized, double-blind clinical study was conducted on about 5,000 heart attack patients, ranging in age from 18-70 during a five-year period at over 60 hospitals in the People's Republic of China. Study participants were given 300-milligram XZK capsules or a placebo and tracked over a five-year period. The XZK extract used in the study contained a combination of lovastatin, lovastatin hydroxyl acid, ergosterol and several uncharacterized components.

Based on study results, the study’s authors believe that XZK may offer therapeutic benefits to people at risk of heart attack and cardiovascular disease. However, they cautioned that the active pharmacologic ingredient (API) of the red yeast rice is unknown and it isn’t clear how XZK works to fight cardiovascular disease.

Chinese medicine practitioners have long touted the benefits of red yeast rice for heart patients. Nevertheless, this is the first controlled clinical study of red yeast rice that tends to substantiate these claims. According to the study authors it is important to note that “the commercially available over-the-counter supplement found in your average health food store is not what was studied here. Those over-the-counter supplements are not regulated (by the US Food and Drug Administration), so exact amounts of active ingredient are unknown and their efficacy has not been studied yet.”

It is unfortunate that I didn’t know about the benefits of red yeast rice during my recent trip to China. I certainly would have gone out of my way to try some. That said, given the plethora of exotic foods that I tasted in China, maybe I ate some XZK without knowing it!

Until next time

Good Luck and Good Eating (Chinese of course)……

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Much like Paul Revere back in the day, there have been repeated, urgent warnings about the impending recession that will strike the US economy. Not surprisingly, the Bush administration has done its best to deny the notion that the moribund US economy is actually in recession. 

Today, it was reported that the US unemployment rate hit 5.5% and nearly 49,000 people lost their jobs last month. This is the biggest monthly rise in the unemployment rate since 1986. So far this year, the Unemployed people grew by 861,000 in May rising to 8.5 million. To keep things in perspective, a year ago, the number of unemployed stood at 6.9 million and the jobless rate was 4.5 percent

Last month employers sharply cut jobs in manufacturing, construction, retailing and professional and businesses services. The recent and highly publicized meltdown of the airline industry insures that as many as 10,000 others or more will lose their jobs in the coming weeks. These layoffs, coupled with $4.00 per gallon gasoline, will undoubtedly have a substantial and lasting ripple effect on the American travel and leisure industries. Can anyone still believe that the US economy isn’t in recession (I can think of at least one!).

Until very recently, many of my disgruntled corporate colleagues (who I eat lunch with from time to time) indicated that they were actively seeking new employment. At lunch the other day, a soft spoken but vocal woman who previously said that “she couldn’t take it anymore and was outta here the first chance that she got” quipped; “What’s with all the complaining. We should all consider ourselves lucky that we even have jobs!” I think that says it all….

Until next time….

Good Luck and Good Job Holding!!!!!!

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Minnesota-based Medtronic, Inc., one of the world’s largest medical devices companies, announced  that it was cutting about 1,100 jobs; 350 of which will be in Minnesota. This is the first layoff at the medical devices manufacturer in over 5 years. According to a press release, slightly over a third of the layoffs will come from the company’s local operations, which has about 8,000 employees. The overall effect of the reorganization will be relatively small—affecting roughly 3% of the company’s worldwide workforce of 39, 500.

Medtronic attributes the realignment (not restructuring according to company executives) to slumping sales of its spinal and cardiac devices. Accordingly, the company’s cardiac rhythm and neuroscience businesses along with local operations will bear the brunt of the job cuts.

It looks as though the entire life sciences sector is under assault. Belt yourself in—it’s going to be a rough ride for the foreseeable future!

Thanks to Ed at Pharmalot for the heads-up!

Until next time….

Good Luck and Good Job Hunting (are there any left?)!!!!!

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Bristol-Myers Squibb announced today that it has sold its medical device and wound care business, ConvaTec, for approximately $4.1 billion to Nordic Capital and Avista Capital Partners. The divesture is part of BMS’s corporate restructuring that was announced late last year to become a “next generation biopharma” company—whatever that means.  

ConvaTec which became part of BMS after Bristol Myers bought Squibb back in the 1980s, will continue to operate as an independent entity according to analysts close to the deal.

I suspect that there may be some downsizing in ConvaTec’s future since it is no longer a part of the BMS.  This is not good news for New Jersey, which is already struggling with major pharma layoffs and ongoing corporate right sizing moves.

Until next time…

Good Luck and Good Job Hunting!!!!!!

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As I mentioned in a post about a month or so ago, the US Food and Drug Administration (FDA) floated a proposal to ease the rules regarding promotion of off-label use of previously approved drugs. According to the newly proposed rules, FDA would allow drug makers to provide physicians with reprints of journal articles that conspicuously promote off-label uses for previously approved products. At present, drug companies are strictly forbidden to promote off-label use of their products.  A major proviso of the proposed rule changes is that the articles/reprints must be published in peer reviewed medical journals before they can be disseminated to physicians and other healthcare professionals. Apparently, FDA officials believe that peer review can take the place of the rigorous regulations and requirements that are currently in place for US approval of drugs, biologics and medical devices!

For those of you who don’t know, an editorial appeared in last week’sJournal of the American Medical Association (JAMA) that took drug maker Merck to task for using alleged ghostwriters and ghost authors on clinical studies that were published about it painkiller Vioxx. As you all know, Merck voluntarily took Vioxx off the market in 2004 after it was revealed that the drug could lead to increased risk of heart attack and stroke.

The incendiary firestorm that has ensued since the appearance of the  Although I believe that the practices of ghostwriting and ghost authoring are not as widespread as the JAMA authors would like you to believe, I think that it is a good thing that FDA may scuttle its proposed new off-label drug promotion rules.

In my opinion (humble or otherwise), drug makers MUST be required to prove that off-label uses of previously approved products  don’t pose any serious safety or health risks before companies are allowed to promote them for new indications. As we have seen time and again in recent years, safety issues and serious health risks can arise for drugs even though they received FDA approval. With this in mind I ask: “Why would FDA allow drug makers to provide less rigorous proof for an off-label indication than that required for approval of the intended use of the original product?”  It makes little sense to me. However, looking more closely at the proposed rule changes,  it would obviate the need for companies to spend additional monies (possibly hundreds of millions) to garner FDA approval for a new product indication.  Hmmm….maybe I am beginning to see a pattern here!!!!!!!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!!!!

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There’s a ton of stuff online about what kinds of interview questions to expect, and how to answer them to impress the interviewer.  But, you have to remember (and it does wonders for your confidence if you do) that you’re interviewing them, also.  You need to find out if this is a medical sales company that you’re going to be happy working for.  So, what kinds of questions should you ask?  Here’s an article on 10 Questions to Dazzle Would-Be Employers to help you.  Some of my favorites:

“How do you see me benefitting the company?”  Find out what caught their eye about you in the first place, and then you can bring up those qualities for a better sell.

“Why did you choose this company?”  If they haven’t tried to sell you on the company already, this answer gives you some insight.

“When will a decision be made?”  Suprisingly, many people don’t ask that, and end up frustrated if it takes longer than they were expecting. 

Your questions about the company and the job will set you apart from other candidates and show how interested you are in the position.  Not to mention it will give you extra insight into your decision whether or not to work for them.

If you have any  questions for Peggy aka the Medical Sales Recruiter contac her  at: the medical sales recruiter blog!

Until next time.....

Good Luck and Good Job Hunting!!!!!!!!!!

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People who become scientists spend many years learning how to design, conduct, collect and analyze data from the experiments that they conduct. The ultimate goal of this seemingly endless exercise is to craft peer-reviewed publications that either support or refute the underlying hypotheses used to initiate the experiments in the first place. As part of our training, we are repeatedly reminded that it is our obligation to fastidiously and accurately report the results of our experiments and to assume “full ownership of the manuscripts and publications" that we author. The idea of allowing a person who didn’t participate in the design or execution of the research, to craft a manuscript for peer review is something that is virtually unheard of in the scientific community and, in the minds of some scientists, tantamount to scientific misconduct or fraud.

Physicians, on the other hand, who don’t learn how to conduct research or write scientific papers during their medical training, are frequently poor writers and have a little or no time to spend on writing scientific or medical manuscripts. Because of this, it is not uncommon for physicians who conduct medical research on behalf of pharmaceutical, biotechnology and medical devices companies to hire medical writers to write manuscripts for them. In fact, many physicians who work with pharmaceutical and biotechnology companies prefer and expect this arrangement. So, why the recent commotion over medical “ghostwriting”?

Drug companies typically hire medical communication agencies to develop and craft manuscripts that showcase the results of clinical or research studies that they have conducted. These companies will usually provide an agency with background information about a study, a research summary, clinical study reports, ideas or titles for proposed manuscript and a list of prospective authors (usually physicians who performed the studies on behalf of the company).  Medical writers, who are either employed by the agency or work as freelancers use these materials to craft a detailed outline for the proposed manuscript. After the outline is completed, the agency usually shares the outline with physicians who were named on the list to determine who may be interested in authoring the publication. After an author is identified, the medical writer works closely with the author to develop a first draft of the manuscript. After the draft is reviewed by the author, changes are made to the draft, a revised version is circulated and the process is repeated until all stakeholders are satisfied with the manuscript. Once the publication has been copyedited and undergone legal and regulatory review it is submitted for peer review.

For the record, in my five years as a medical writer, I have never encountered a situation where the primary author doesn’t have final say over what will and won’t appear in a manuscript. When scientific, medical or business disagreements do arise, the author(s), medical writer and company representatives usually negotiate mutually-agreed upon solutions. Rarely, have I seen a company remove an author from a publication because his/her views or interpretations of the data were not consistent with those of the company that sponsored the research. The reason why drug companies and medical communication agencies have recently come under fire for their “ghostwriting” practices is because they have repeatedly failed to disclose that many of their publications were written by medical writers —whose names didn’t appear anywhere on the publications. Although this practice still exists, it is no longer as widespread or commonplace as it once was. These days, the names of medical writers who author manuscripts routinely appear in the acknowledgement sections of many scientific and medical publications. Moreover, in some instances, a medical writer may be able to garner co-author status on a publication —depending upon his/her level of involvement in the project. 

In my opinion, there is little difference between graduate students, postdoctoral fellows and medical writers when it comes to preparing manuscripts for publication. It is not uncommon for the names of PIs, supervisors and others to appear as authors on publications even though their contribution to a project (or preparation of a manuscript) has been limited or nominal at best. Consequently, I fail to see any credible legal or ethical arguments against hiring a medical writer to write manuscript on behalf of an “author” as long as the “author” can demonstrate that he/she actively participated or was intimately associated with study design, conduct or analysis. Finally, to maintain the integrity and transparency of the medical writing process, it is imperative that medical writers who prepare manuscripts on behalf of study authors should be acknowledged or credited with “authorship” somewhere in a publication.

Until next time….

Good Luck and Good Job Hunting!!!!!!

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 A report on the state of the Massachusetts biotechnology industry suggests that global competition and shortages of trained workers might cause the state to loss its reputation as one of the world’s top life sciences cluster. The report points out that there simply aren’t enough trained workers to meet the growing demand from Massachusetts-based biotechnology companies-both because of a lack of adequate training programs and lack of interest from students.  

To help to remedy the situation, the study recommended that more job training programs ought to be created at two- and four-year state colleges and that Massachusetts should do more to encourage students to pursue careers in the life sciences. As usual, the report recommended that math and science education should be improved at the K-12 levels. Other suggestions included setting up a “summer bio camp” and launching an unpaid bioscience internship program.

Unfortunately, this report, which was prepared by Boston-based Mass Insight Corp and McKinsey & Co and was likely very expensive, is almost identical to other studies published over the past decade about ongoing workforce shortages in the life sciences industry. Like its predecessors, it contains the same tired and unimaginative recommendations that others have proposed to solve bioscience labor shortages. To learn more about some creative solutions to avert life sciences workforce shortages click here.

Despite what the experts and pundits would have you believe, the etiology of the workforce shortages in the life sciences industry is easy to decipher. Put simply, most universities and colleges don’t believe that job training or career development should be part of their academic initiatives or educational missions. Likewise, companies don’t feel that education or training should fall within their purview–according to industry executives, college and professional school graduates ought to be sufficiently prepared to enter the workforce after they complete their education.

Because neither academia nor industry wants to assume responsibility (financial or otherwise) to prepare or train students for careers in the life sciences, it should come as no surprise that there are workforce shortages in this industry. Although a number of federally-funded biotraining programs were initiated in the late 1990s, these programs were poorly promoted and are incapable of sustaining themselves without government support. Paradoxically, there are many more innovative, industry-focused biotechnology and bioscience training programs at the high school level as compared with the undergraduate and graduate levels. I suspect that many professors in undergraduate and graduate life sciences departments are more concerned about their own research programs than about the careers of their students. Go figure………!!!!!

There will continue to be workforce shortages in the biotechnology, pharmaceutical and medical devices industry until either academia, industry or both claims ownership of bioscience training and career development.  I think that it time for academicians and industry professionals alike to put their heads together to solve this serious and ongoing problem. Failure to do so will result in the loss of America’s global dominance in the life sciences industry.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!!!

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A Johnson & Johnson Co. plant in Bedford MA that manufactures medical devices was sold for $45 million in cash to an Indiana-based provider of orthopedic products used in arthroscopy, dental and other medical professions.

The plant’s 200 workers will keep their jobs, and additional jobs could be added in the future depending on customer demand, said Fred L. Hite, senior vice-president and chief financial officer of Symmetry Medical Inc.

Symmetry, a public company listed on the New York Stock exchange, purchased the 82,000 square-foot facility from DePuy Orthopaedics, Inc., which is owned by Johnson & Johnson. Both Symmetry and DePuy are headquartered in Warsaw, Ind., known to some as the orthopedic capital of the country.

According to a release from Symmetry, DePuy is required to make minimum purchases from the New Bedford plant for four years following the acquisition, which is expected to be completed within 60 days.

Until Next Time.....

Good Luck and Good Job Hunting!!!!!!!!!!

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Fellow blogger, Jacob Goldstein, over at the WSJ Health Blog posted a story today about a prominent hypertension researcher who was approached by a medical communications agency about  putting her name on an abstract (she did not participate in the research) that was being prepared by the agency for a pharmaceutical client. According to the Health Blog, the researcher was so outraged by the offer that she decided to go public about the alleged “ghost writing” incident. I have no doubt that the story is accurate.  That said,  I think that a comment posted to WSJ’s blog about the story sums it all up nicely:

 “So, this is some new revelation for the WSJ? There are plenty of studies in the medical literature which have been ghost written by an industry-sponsored medical writer, that was then submitted under the name of a highly-recognizable leader in the field–always at a steep price”.

As much as I hate to admit it, the person who posted the comment is right--sort of. Although ghost writing was commonplace in the medical communications industry as recently as a few years ago, the practice is no longer tolerated at most medcom agencies, and, perhaps more importantly, by the would-be authors whose names ultimately appear on the publications. That said, medcom agencies and their clients must remain vigilant in their attempts to eradicate ghost writing entirely so that all medical communications are written (and published) in the most scientifically-sound and ethical manner.

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Every major pharmaceutical company on the planet declares that it “invests billions of dollars into R &D to develop novel medicines to address unmet medical needs”. Further, pharmaceutical company advocates and lobbyists frequently justify the high costs of medicines by suggesting that they are necessary because companies must reinvest a portion of their profits into R & D to discover new drugs. After receiving several comments posted to BioJobBlog informing me that high drug prices are necessary in order for pharma companies to continue to meet unmet medical needs, I decided to delve a little deeper into what “addressing unmet medical needs” really means in the pharmaceutical industry.

My personal favorite that seems to fit pharma’s interpretation of “addressing unmet medical needs” is the development of no fewer than 3 medications (Viagra®, Levitra® and Cialis®, with several more in clinical trials) to treat erectile dysfunction (ED). For those of you who don’t know, all three drugs have almost identical mechanisms of action. Who knew that so many men had this serious, potentially life-threatening medical condition? Don’t get me wrong–there are men that must take these drugs to …well…rise to the occasion. That said, pharmaceutical marketers realized early on, that this class of drugs could yield billions of dollars–not necessarily as ED treatments (the number of men who actually suffer from ED is relatively small) – but as recreational drugs to enhance male sexual performance. The booming sales figures for these drugs indicate that the pharmaceutical marketers were absolutely spot on in their thinking. Thanks to these pioneering medical marketers men all over the world no longer have to fret about dying or succumbing to the perils of ED.



Another class of medications that warrants mention is the statins. This class of drugs is routinely used to lower blood cholesterol levels to reduce the risk of hypertension, heart attack and stroke. At present, there are 9 statins on the market (with almost identical mechanisms of action) and 3 combination products either marketed or being developed. Everyone knows (or should know by now) that high cholesterol is not good for your health. That said, is the unmet medical need in the cholesterol control market so large that it requires 12 different medications to deal with it? Or maybe (and I am just guessing here) that every company that developed a “new” statin in recent years did so to grab a piece of the $10 billion per year Lipitor® market that Pfizer created?

Finally, Lilly and Daiichi Sankyo are developing a new antiplatelet drug called prasugrel to treat thrombosis and related clotting disorders. Business analysts are extremely high on prasugrel and estimate that if approved, the drug could yield over $1.2 billion per year in sales. Prasugrel is touted to be more potent than Plavix®, the leading anti-clotting drug marketed by Sanofi-Aventis and Bristol-Myers Squibb. Not surprisingly, both clopidogrel (Plavix®) and prasugrel work in almost exactly the same way to prevent clotting (as their generic names indicate). However, in early clinical studies prasugrel caused 4 times as much uncontrolled bleeding than Plavix®. So, why are Lilly and Daiichi Sankyo willing to continue to spend billions of dollars to develop another clopidogrel-like molecule? Unfortunately, the answer is relatively simple– Plavix® will lose patent protection in 2011 and Lilly/ Daiichi Sankyo are betting that they can snatch a share of $6.0 billion dollar Plavix® market that will be eroded by generic competition. Why develop a new medication with a different, untested mechanism of action when a market for similar products has already been created for you by your competitors?

Paradoxically, pharmaceutical companies used to the most innovative companies in the world. However, in the past 20 years or so, pharmaceutical companies have jettisoned innovation in favor of a less risky “me too” approach to business. Simply put, it is less risky to develop drugs that work like previously approved drugs (and already have large established markets) than it is to invest larges sums of money to develop new unproven drugs that may actually address unmet medical needs. It is a good thing that the biotechnology industry came along when it did……!

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!!!!

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