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After announcing its quarterly earnings and a 24 percent increase in 2011 profits, AstraZeneca (AZ) today made public its decision to eliminate another 7,300 jobs. Earlier this week there was speculation that job cuts were likely but the exact numbers were not disclosed. 

The reasons given for the layoffs despite increased annual profits? Government spending cuts for healthcare and stiff generic competition for several of its blockbuster drugs including Seroquel XR (depression), Atacand (hypertension) Crestor (cholesterol-lowering) and Symbicort (asthma); all of which have lost or will be losing patent protection in the near future. According to a company press release generic competition cut revenues by $2.0 billion in 2011 whereas government price interventions cost the company another $1.0 billion. The announced job cuts are expected to save AZ $1.6 billion by 2014—great news for shareholders but not so much for the employees who are losing their jobs!

Most of the cuts will take place in R&D. To that end, the company will close its facility in Montreal and layoff staff at its Soedertaelje site in Sweden. Interestingly, the company plans on focusing more on neuroscience and intends to hire 40 to 50 scientists in its new Innovative Medicine unit which is partly based in Boston, MA and Cambridge in England.

While layoffs at AZ were expected, the size of the current layoff does not bode well for other pharmaceutical employees. It is becoming increasingly clear that big pharma companies are getting out of R&D and focusing their efforts on M&A and licensing deals to fill their thinning pipelines. Also, while shedding R&D and sales jobs in developed markets, big pharma companies are investing heavily in building facilities and hiring thousands of R&D and sales personnel in emerging markets. From my perspective, it appears that big pharma has consciously decided to abandon developed Western markets where sales growth is in the single digits in favor of emerging ones where double digit growth is expected for the next decade.

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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Increasingly, healthcare professionals, patients and consumers are turning to and using their mobile devices for healthcare information. Further, development of mobile software platforms and associated are allowing patients to more regularly directly communicate with their physicians. To help sort out the growing complexity of the mobile healthcare communications industry, the Business Development Institute (BDI) entitled “Mobile Healthcare Communications 2012:Case Studies and Roundtables” will be held on Thursday, January 26, 2012 from 8:00 AM to 1:00 PM at The Graduate Center of the City University of NY (365 5^th Ave, NY, NY 10016).

Registration fee for the event is $195 per attendee. BioJobBlog readers who wish to attend should use promo code BC for a discounted rate of $175.

Speakers and roundtable moderators include:

1. Lance Hill, CEO, Within3
2. Scott Hopkins, Executive Vice President, Anderson Direct Marketing
3. Dr. Katherine Malbon, Assistant Professor of Pediatrics, Division of Adolescent Medicine, Mount Sinai Hospital
4. Talya Miron-Shatz, PhD, Marketing Department, Wharton, University of Pennsylvania 
5. Jenna Mons, Consumer Product Manager for LAP-BAND®, Allergan 
6. John Vieira, Daiichi-Sankyo

Event sponsors include:

BioCrowd, PR Newswire; Within3 ; Anderson Direct Marketing; Cinchcast; Journal of Communication in Healthcare; Manhattan Research; New York University; Society for Healthcare Strategy and Market Development; Pixels & Pills

For event related questions and registration, please contact Maria Feola-Magro at mfeola@bdionline.com or 212.765.8043.

For sponsorship/speaking opportunities, including pricing, please click here or contact Jennifer Brous at jbrous@bdionline.com or 212-765-8358.

For additional information, including registration, please click here to visit the event website.

See you at the conference!

Until next time....

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

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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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Not a day goes by without some report about pharma’s ongoing problems with illegal drug promotions, class action suits against blockbuster medications or civil or criminal settlements with state and federal governments. A quick perusal of articles posted to the Pharmalot Blog in November alone revealed no fewer than eight big pharma companies including Lilly, Merck, GlaxoSmithKline, Bayer, Pfizer, Novartis and Amgen that were involved in some sort of legal action regarding inappropriate marketing claims or failure to disclose potential side effects of blockbuster drugs. To make matters worse, a larger than usual number of pharma companies have experienced manufacturing problems that have resulted in drug recalls or shortages. This list includes companies such as Genzyme, Baxter, Johnson & Johnson, GlaxoSmithKline and most recently Boehringer Ingelheim. While chronic legal and manufacturing problems are extremely troubling (some assert it is just the cost of doing “business”), I believe that the amount of money spent lobbying Congress for legislation favorable to the industry is even more egregious.

According to a recent post on Knowledge Ecology International, the pharma industry has so far spent $115,571,832 on lobbying in 2011 (this number is sure to go higher by the end of this fiscal year). Interestingly, the biggest year for pharmaceutical industry lobbying was in 2009—a year after the Affordable Health Care Bill was passed—with totals in excess of $186,000,000. Just think about how many jobs could have been saved if companies reinvested the money into R&D rather than greasing the palms of lobbyists to induce Congress to pass laws to continue to get favorable tax rates, improve ROI and bolster the stock prices of those companies! To wit, Newt Gingrich, a Republican Presidential candidate and Former Speaker of the House has been accused of lobbying former congressional colleagues to vote for a Medicare drug subsidy while he was a paid consultant to AstraZeneca. Gingrich vehemently denies these allegations; probably because he realizes that most Americans don’t like big pharma and may vote against him if the claims are proven to be true and he wins the Republican presidential nomination.

Not withstanding the legal issues and unnecessary lobbying, what is really hurting the pharmaceutical industry is its lack of communication and transparency with patients and its unfailing practice of putting profits before healthcare. While every big pharma company I know always talks about fulfilling unmet medical needs, meeting those needs always comes at great costs (literally) to patients. Sadly, many patients can no longer afford the costs of potentially lifesaving medicines and treatments. Unless pharma begins to change the way it presents itself to the American public, it will continue to suffer the lost of confidence and trust of the American people. And, if the industry is unable to regain the public’s trust, its inability  will ultimately result in legislation that allows the US government to control drug prices: something that exists in most other countries in the world and big pharma has been desperately trying to prevent for the past 50 years!

Until next time...

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

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Ed Silverman, the intrepid author of the Pharmalot Blog, reported today that the average price of prescription drugs through last month rose 7.2 per cent; which tops the annual price rate increases over the past decade. The cost analysis was done on 130 prescription drugs.

The biggest winners were: Suboxone, marketed by Reckitt Benckiser to treat opioid addiction which rose 21 percent. Cephalon raised the price of its Provigil narcolepsy pill by 15 percent and Sunovion Pharma hiked the prices of its Xopenex asthma and COPD med by 9.8 percent. Other drugmakers on the list included Genentech, Merck and Abbott Laboratories.

Ed cautioned that “the price changes are based on WAC, or wholesale acquisition cost, for more than 90 percent of the drugs, which means that less than 10 percent of increases are based on direct price or suggested wholesale price” Nevertheless, any wholesale price increases are always passed on to the end users aka patients!

It is troubling that in these tough economic times that drug prices continue to rise at unprecedented rates. And access to reasonably priced medicines continues to diminish.  Not surprisingly, prices continue to rise in advance of healthcare reform legislation that doesn’t kick in entirely until 2014.

Until next time

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

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As I mentioned in numerous previous posts, health or healthcare informatics is one of the hottest and fasting growing sectors of the US economy. And, not surprisingly, career counselors and job prognostication experts are predicting job shortages unless more Americans are trained for these job opportunities.  To that end, William Hooper of HealthTechTopia sent me a link to a list of 25 online health informatics resource collections. 

Those of you who are interested or considering pursuing a career in the emerging health informatics field ought to check it out!

 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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An article in today’s NY Times entitled “New Ways to Exploit Raw Data May Bring Surge of Innovation, a Study Says” suggests that persons with quantitative skills and a firm grasp of the scientific method will be in high demand in the near future. This is because there is a current data surge coming from “sophisticated tracking of shipments, sales, suppliers and customers, as well e-mail, Web traffic and social network comments.” And, the quantity of business data has been estimated to double every 1.2 years!

According to the report “Big Data: The Next Frontier for Innovation, Competition and Productivity” put together by the McKinsey Global Institute, harvesting, managing, mining and analyzing “big new data sets” can lead to a new wave of innovation, accelerated productivity and economic growth. And, the place where this may be felt first is the US healthcare system. The report asserts that better management of big data sets can lead to as much as $300 billion in savings. Also, American retail companies could possibly increase their operating profit margins by as much as 60 percent. However, one of the major hurdles to this paradigm shift is a talent and skills gap. The US alone will likely need 140,000 to 190,000 with expertise in statistical methods and data-analysis skills. McKinsey also notes that an additional 1.5 million data-literate manages will be required. Accordingly, “Every manager will really have to understand something about statistics and experimental design going forward,” noted one of the report’s authors.

As far as jobs for scientists in the healthcare realm are concerned, the report suggests that

“....the biggest slice of the $300 billion gain is expected to come from more effectively using data to inform treatment decisions. The tools include clinical decision support to assist doctors, and comparative effectiveness research to make more informed decisions on drug therapy.” That said, life scientists with backgrounds in statistical analyses, bioinformatics, genomics, public health, epidemiology and quantitative analysis will be ideal candidates for these new job opportunities."

While these types of jobs (mainly health informatics) are certain to available in the future, it isn’t clear how soon. This is because the big-data trend has just begun and, according to economists, it may take years to recognize its financial advantages and benefits. In any event, it is something for life scientists who may be considering alternate career options, to think about. To that end, if you begin to train for these opportunities now, you may find yourself in the right place at the right time in the not-to-distant future.

Until next time....

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

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BioJobBlog and BioCrowd co-sponsoring the Business Development Institute and PR Newswire's Healthcare and LIfe Sciences Communications Leadership Forum that will be held on June 9, 2011 in San Diego CA

The forum is comprised of a group of senior marketing and communications executives from prominent biotechnology, pharmaceutical, hospital groups, medical device, and managed care companies. The forum focuses on how healthcare and life sciences brands achieve business objectives with social media and social technologies. The event consists of case study examples from well respected organizations in an intimate setting at AMN Healthcare in San Diego, CA.

• What are the best examples of how to connect with consumers and healthcare professionals through social approaches?
• What are the best case studies of how healthcare brands create and execute content strategies and content based marketing?
• How do you integrate social with your traditional customer service and marketing platforms?
• How are leading brands organizing themselves to best deliver results across the enterprise?
• How have others overcome the compliance and legal challenges with social communications?
• How do you plan, manage, integrate, and leverage data from social, online, and offline programs?
• How are mobile and location-based technologies being applied in healthcare?
• What are the tools, technologies, and best practices for monitoring and measuring social communications?

Speakers:

For additional information, including registration, please click here to visit the event website.

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Bloomberg news today reported that Bayer AG’s Chief Executive Officer Marijn Dekkers said that he would consider a “merger of equals” to bolster the company’s sagging healthcare division. The division, a minor revenue source for Bayer AG, posted $25.1 billion in sales last year.

While Dekkers did not name the companies that he considers to be Bayer’s “equals”, convention wisdom suggests the list is likely to include Eli Lilly & Co, Bristol Myers Squibb (BMS) and Amgen, one of the last remaining, large, independent biotechnology companies. Lilly and BMS both  had  sales revenue similar to Bayer's last year whereas Amgen had lower sales of $15.1 billion. 

The reasons for a potential merger are not entirely clear. However, Bayer Healthcare is waiting to hear about regulatory approval of its new anticoagulant Xarelto medicine for irregular heartbeat patients who face the risk of a stroke. Analysts predict that Xarelto may exceed $2.5 billion in global sales. Approval of Xarelto will change Bayer’s valuation and consequently, don’t expect merger talks to begin until after FDA renders its decision on the drug.

Meanwhile, Bayer’s top-selling multiple sclerosis (MS) treatment betaseron faces competition from a similar Novartis drug called Extavia, and from its new oral MS medication Gilenya. Sales of betaseron fell 5 percent in the first quarter. Moreover, sales of Bayer’s birth-control pill Yaz dropped 18 percent after Teva Pharmaceutical Industries Ltd. introduced a generic version of the medicine.

Lilly, BMS and Amgen all face significant challenges in the future and both BMS and Amgen have been repeatedly mentioned as takeover targets. However, from a historical perspective mergers of mediocre or struggling companies rarely yield stronger, more financially robust ones! But, what do I know, I am just a scientist!

Stayed tuned for more updates.

Until next time...

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

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Twitter was largely ignored by college-age students after it was introduced over three years ago. At that time, Facebook was on the rise and texting appeared to be sufficient to meet the needs of much college students. Nevertheless, over the past year or so, university researchers have begun to assess Twitter as an education tool in addition to the role it has played in shaping today’s social media usage. 

According to a recent study published in the Computer Assisted Learning, Twitter can apparently bolster student interest and engagement and grade-point average. The study followed 125 undergraduate health studies majors at a public mid-sized US university. Half of the students used Twitter whereas the other half (control) group did not. The results of the study showed that Twitter users had an average GPA half a point higher than their non-tweeting counterparts. Also, the tweeting cohort more frequently participated in class and sought out their professors to discuss course material outside of class. 

Tweeters mentioned that Twitter was a less intimidating means to express themselves in large classes. In other words, Twitter was a less anxiety ridden means to ask questions during lecture. And, perhaps more importantly, Twitter users had much greater access to instructors outside of class. Also, instructors we able to send out tweets during lectures to keep their students engaged and awake! After all, who doesn’t look at their cell phones when they are vibrating and buzzing?

Until next time...

Good Luck and Good Tweeting  

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The buzz at the JP Morgan Healthcare Conference that is taking place in San Francisco this week is that Sanofi-Aventis and Genzyme are close to inking a deal. As you may recall, Sanofi made an unsolicited offer last summer to buy the troubled orphan drug manufacturer. Sanofi offered to purchase Genzyme for $69 per share but the offer was summarily rejected as “too low” by Henri Termeer, Genzyme’s embattled CEO who has been running the company for over 20 years since its inception.

The very public and often acrimonious haggling over the purchase price has become legion in some investment banking and bioventure circles. Nevertheless, most industry and financial analysts predict that Sanofi will prevail and ultimately acquire Genzyme possibly for a share price in the low to mid $70s.  Sanofi desperately needs Genzyme to get into the biotechnology fracas; a field that it seemingly chose to largely ignore for the past 20 years--go figure!  Consequently, it is likely that Sanofi will eventually give Genzyme everything it wants to consummate the deal

Yet, despite progress being reported from the conference, Termeer and Sanofi Aventis CEO Chris Viehbacher haven’t met face-to-face to discuss the terms of a possible deal. However, Viehbacher did mention that Sanofi was “still committed” to purchasing Genzyme.

Stay tuned for the next installment of the saga.

Until next time...

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

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The $789 billion American Recovery and Reinvestment Act that was passed in 2009 included funding for the Health Information Technology for Economic and Clinical Health (HITECH) act to promote the adoption of electronic health record (EHR) technology in health. Beginning next year, doctors and eligible medical providers can receive Medicaid incentive payments over a five-year period if they adopt a certified EHR technology platform and adopt so-called "five goals" established by the Centers for Medicare and Medicaid Services

The act is expected to create more than 50,000 new health information technology (HIT) jobs. With many hospitals and physicians making the transition from paper charts to electronic medical records, there is a growing demand for specialists trained in the latest medical record technology. Recognizing the surging demand for HIT workers many universities including two- and four- year colleges and for profit institutions like DeVry University have created HIT certificate and degree programs.

There is no question that HIT professionals will be in high demand over the next decade or so. That said, if you have an interest in biology or medicine and like IT, HIT may be a good career choice for you! Don’t wait; act now.

Until next time...

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

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While the debate rages on over the use of social media in the life sciences industry, industry experts and insiders have largely ignored the growing importance of mobile healthcare and its use by healthcare professionals and patients. Consumers and professionals are increasingly using their mobile devices for healthcare information. They are also interacting with healthcare providers and colleagues on their mobile phones. 85% of US consumers have cell phones and growing vs. only 65% of Americans which have broadband access. Further, the divide between mobile use and broadband Internet access is increasing. According to a Manhattan Research report 70% of Physicians say PDAs/Smartphones are "essential" to their practice.

Because of the growing importance of mobile healthcare communications, the Manhattan-based Business Development Institute decided to organize a conference around this theme. The primary goal of the conference is to address the following questions:

1. How do healthcare brands connect and interact with consumers via mobile strategies?
2. How do healthcare brands connect and interact with healthcare professionals via mobile strategies?
3. What are the leading technologies being used for mobile strategies?
4. How do you deal with regulatory hurdles when implementing mobile campaigns?
5. How do you integrate your mobile strategies into your enterprise-wide marketing, communications and social media platforms?
6. What are the leading monitoring and measuring approaches/technologies being employed for mobile campaigns?

Person giving presentations at the meeting include:

Lance Hill, CEO, Within3
Ray Kerins, Vice President/Worldwide Communications, Pfizer Inc.
Marc Monseau, Director, Corporate Communications and Social Media, Johnson & Johnson
Todd Siesky, Public Relations Manager, Roche Diabetes Care
 
Date: Wednesday, January 19, 2011
Time: 8:00 a.m. - 1:00 p.m.
Location: The Graduate Center of The City University of NY; 365 Fifth Avenue; New York, New York 10016
Registration Fee: $195
Website:http://www.bdionline.com/mobilehealthcare.html

For more information, including registration, please click here to visit the event website. Use promo code BC for a discounted rate of $155.

Please contact Steve Etzler at setzler@bdionline.com or 212-765-8045 for additional information.

See you at the meeting!

Until next time...

Good Luck and Good Job Hunting!!!!!

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Johnson & Johnson’s McNeil Consumer Healthcare, already under Congressional investigation for selling allegedly tainted Tylenol, announced late Tuesday that it was recalling other products made in the Puerto Rico manufacturing facility in question.

According to an article in today’s New York Times, “McNeil Consumer Healthcare, the Johnson & Johnson unit, said that it was recalling four lots of certain Benadryl allergy tablets and one lot of Extra Strength Tylenol gel pills. McNeil did not respond to a reporter’s query about how many bottles those lots amounted to.”

Since last November, McNeil has recalled about 11.7 million bottles of various Motrin products and about 6.3 million bottles of Tylenol Arthritis Pain caplets made at the Puerto Rico plant in question. The company began the product recall after receiving numerous consumer complaints about a moldy odor emanating from some of its products.

Company representatives contend that the moldy smell was caused by contamination from a chemical byproduct of a substance used to treat wooden transport pallets. Further, McNeil suggested that the risk of serious medical problems was remote and people should not stop using the products (yeah right).

The current recall just adds to McNeil’s growing manufacturing problems. The company is already under scrutiny by the House Committee on Oversight and Government Reform over a recall last April of an estimated 136 million bottles of liquid pediatric Tylenol, Motrin, Benadryl and Zyrtec.

I suspect that more problems will be uncovered as the FDA and Congressional investigations continue. Serious manufacturing and quality problems can almost always be avoided or minimized when company executives and management makes a bona fide commitment to quality systems. Clearly, the heads of McNeil Consumer Healthcare might benefit from remedial current good manufacturing practices (cGMP) training.

Until next time...

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

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Johnson & Johnson is arguably one of the world leaders in bringing social media to the pharmaceutical industry. Marc Monseau and his dedicated team oversee a network of blogs, video channels and Twitter feeds while some of J&J’s brand companies even sponsor patient advocacy communities like ADHD Moms and ADHD Allies. However, the company’s recent handling of manufacturing problems and recall of Tylenol and other pediatric medicines seemingly flies in the face of openness and transparency; two of the underlying tenets and guiding principles of social media.

In an article in today’s New York Times, Natasha Singer reports that “a Congressional investigation into a recent recall of children’s Tylenol and other pediatric medicines has been stymied by the manufacturer, Johnson & Johnson, raising the prospect that new measures — like issuing of subpoenas to compel cooperation — could be invoked.”

McNeil Consumer Healthcare, the unit that manufacturers Tylenol and other over-the-counter medications, is no stranger to scrutiny by the US Food and Drug Administration (FDA). It is currently being investigated for a pattern of violations in manufacturing practice and quality control issues that have led to recalls of several medications. Last month, the agency suggested that it was considering criminal penalties or other actions against McNeil executives.

According to the times article, the House committee opened its investigation in early May shortly after McNeil announced a voluntary recall of liquid pediatric Tylenol, Motrin, Benadryl and Zyrtec. FDA investigators uncovered evidence that the products, made at a company plant in Fort Washington, Pa., may have included metal particles, or too much of the active drug ingredient, or inactive ingredients that did not meet testing standards.”

Manufacturing problems are not uncommon in the pharmaceutical industry and it isn’t clear what J&J has to lose by not fully cooperating with FDA officials. In fact, failure to cooperate could lead to harsher penalties and larger fines. However, I suspect that McNeil hasn’t been forthcoming because of allegations of a so-called “phantom recall” that took place last year, where J&J contractors secretly removed alleged defective products from store shelves.” Nevertheless, ongoing media coverage of the recall and the circumstances behind it are beginning to cast a very negative light on McNeil products and the J&J brand.

Pharmaceutical social media advocates contend that one of the reasons why pharma companies ought to use social media tools is information dissemination and so-called damage or crisis control. While I haven’t been assiduously screening all of the J&J social media channels, it seems like now would be an ideal time to begin to leverage them. 

It is unfortunate that an innovative and progressive pharmaceutical company like J&J has come under fire. However, product quality and safety is of paramount importance to consumers. And companies that cannot ensure those product attributes must move quickly and decisively to reinstate them. To that end, J&J ought to fully cooperate with FDA regulators, fix its Tylenol problems and then use its abundant social media channels to reinstate public confidence in McNeil Consumer Healthcare and the J&J brand! After all, isn’t that what social media is all about?

Until next time...

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

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About a year ago I posted an article to BioJobBlog that suggested that social media can be leveraged to improve clinical trial recruitment to test investigational new drug candidates. Yesterday, Mark Senak, author of the EyeonFDA posted an article which suggested that the use of video on YouTube and other video-viewing sites makes complete sense to recruit prospective participants for human clinical trials. Here are some of Mark’s thoughts on the topic:

“The reasons I think video is a good way to expose people to learning about clinical trials are multiple. First, it allows me as a prospective clinical trial participant to learn about a clinical trial when I want to learn about it and where I want to learn about it - a hallmark of social media.  Second, it is private - I can learn from a video that can be developed to address a wide range of issues - issues that I might not be so comfortable addressing with a live person.  Thirdly, and perhaps most importantly, I learn about the clinical trials perhaps from someone on a video who is very much like me.  He can be someone with my condition - someone who has gone through a trial, and talk about how his concerns were addressed, what his fears were and what the benefits of participation were.  That, I think, is a much more convincing way to learn about a trial than an ad in a newspaper or even a discussion with a clinical person.  Video can't replace the medical professional, but it sure can get my interest and perhaps trust to make recruitment much easier.”

While the industry’s use of social media for this purpose is not quite there yet, there are some signs that pharmaceutical and biotechnology companies may be trending in that direction. First, a growing number of clinical research organizations (CROs) which help companies plan and manage clinical studies are already using social media tools to recruit prospective clinical trials participants. Second, as Mark reported yesterday, Pfizer launched a YouTube channel called PfizerClinicalTeam last July which presumably would bolster clinical trial recruitment. Unfortunately, as Mark pointed, its most recent video was posted in April, 2010, regarding a new study on schizophrenia. Don’t be surprised if other companies launch social media-focused clinical trials recruitment campaigns in the not too distant future. Like Mark, I believe that social media tools are ideal for this purpose!

In other news, Pfizer, a late entrant to the fledgling pharmaceutical social media space, is showing signs that it is beginning to embrace the social media web. Yesterday, Pfizer and Epocrates announced a collaboration to create an application for the iPhone that gives healthcare providers mobile access to the Pfizer Medical Information Group to obtain medical and science information about Pfizer products or to report adverse events. According to Pfizer, it is creating the app to: “enable easy, direct access to its Medical Information services, via the Epocrates channel, in an effort to enhance the safe and effective use of its medicines, and help improve the quality of patient care.”

Direct access to medical information via mobile devices is growing in popularity among physicians and other healthcare providers because it enables them to get answers on the go without wasting time to fire up a laptop or find a tethered computer to use outside of the clinic.

Despite assertions to the contrary by most pharmaceutical and biotechnology companies, social media tools are ideal vehicles for adverse event reporting and post market drug surveillance activities. Pfizer’s creation of a mobile medical information app coupled with the launch last week of a joint US Food and Drug Administration (FDA) and National Institutes of Health drug safety portal called Safety Reporting Portal (original eh?) suggest that the use of social media tools for online adverse event reporting and drug safety purposes is not too far off. Let’s see what develops over the next year or so after FDA issues regulatory guidance on the use of social media in the life sciences industry.

Until next time...

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

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The conversation about follow-on biologics became extremely muted after passage of the US Healthcare Reform Act which included a 12 year period of data exclusivity for innovator company products. This provision inhibits biosimilar manufacturers from introducing generic versions of branded biologics for 12 years from the date the US Food and Drug Administration granted a license for the branded product. While this may effectively limit activity in the follow-on biologics space in the US, it didn’t stop Merck from launching its BioVentures Division (dedicated to follow-on biologics development) almost two years ago.

At the time of the announcement Merck executives in charge of the BioVentures Division divulged that its first product would be a PEGylated version of Amgen’s anemia drug Epogen (EPO). Unfortunately, a PEGylated version of EPO doesn’t qualify as a follow-on biologics because PEGylated proteins are considered new molecular entities (NMEs) by regulatory agencies. Nevertheless, Merck also said it would develop other follow-on products and that its efforts would be based primarily on the proprietary humanized yeast biomanufacturing platform it acquired after purchasing Glycofi, a New Hampshire-based biopharmaceutical company that developed the technology. Interestingly, two weeks ago Merck announced that it was abandoning the PEGylated-EPO product that it mentioned two years ago at the BioVentures kick off press conference.

It isn’t clear whether or not Merck jettisoned the project because of patent infringement litigation, regulatory concerns or possibly because of the increasingly fierce competition in the EPO space. Another possibility is that pharmaceutical companies have finally realized that biologically-active proteins are costly to manufacture and have limited therapeutic applicability as compared with monoclonal antibodies (MAbs) which are taking the biopharmaceutical industry by storm. At last count, there were over 300 MAbs in various phases of pre-clinical development with and about 125 in late stage clinical development. Last week, Teva and Lonza announced plans to develop a biosimilar version of Roche’s anti-inflammatory and cancer MAb Rituxan (rituximab)—kicking off a new era in the biosimilar industry.

For those of you who are unfamiliar with or remain interested in the follow-on biologics debate, I came across a nice PowerPoint presentation given by Teruhide Yamaguchi at the Division of Biological Chemistry and Biologicals at the National Institutes of Health.

Quality Safety and Efficacy of Follow-on Biologics

Until next time...

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

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I want to state at the onset of this post that I am an ardent supporter of online patient communities because I believe that the exchange of information between people who suffer from the same or similar medical conditions is vital to their health and well being. Further, I believe that social media will force physicians, the medical community and the US healthcare system to become more transparent, open and interactive. That being said, in this past Sunday’s New York Times, Natasha Singer wrote an extremely revealing article about some possible, unforeseen “side effects” associated with membership in online patient communities.

The reason why these online communities exist is for patients to commiserate with one another and exchange personal stories and medical information. While personal stories may be emotionally satisfying for patients, it is their medical information and demographic data that is extremely valuable to drug makers. To that end, many online patient communities inform their members that they reserve the right to share information and data for research purposes. And many of them do!

To be clear, I am not suggesting that the people who create or manage online patient communities have avaricious, nefarious or otherwise unsavory ulterior motives for the medical and patient demographic data that they collect. However, these communities need to generate revenue in order to stay in business and drug makers are willing to pay for access to it.

According to Singer, the popular PatientsLikeMe community admits that it sells health and medical data gathered from member profiles (but with certain identifying information removed) to pharmaceutical companies and others for scientific and marketing research purposes. Further, a large number of unbranded “disease awareness” pages have recently begun to appear on Facebook and YouTube. In her article, Singer contends that “drug companies may pay people to moderate patient forums [in the community] or give testimonials but might not prominently display that fact to participants. Other sites collect consumer health data to help drug makers’ aim at specific kinds of consumers, using psychological cues.” At a medical communications meeting that I attended several years ago, a MySpace sales rep freely admitted to me that it allow pharmaceutical companies to mine profile data in order to develop targeted marketing campaigns. Is Facebook next?

Finally, while the Health Insurance Portability and Accountability Act of 1996 (HIPAA) restricts the way health care providers use and disseminate patients’ information, consumer health websites and online patient communities aren’t subject to its privacy provisions. In other words, there are no regulations guiding the privacy and use of medical information and data collected using social media tools! Essentially, this means that the persons who run online patient communities can do pretty much whatever they like with the medical and personal information that they collect!

As I stated at the beginning of the post, I am a social media enthusiast who subscribes to the notion that if used correctly, social media can help to better inform and improve the lives of people suffering from various disease. That said, I also believe that people who choose to participate in online communities MUST be fully informed about the potential uses of the personal information and data that they contribute. Until the Food and Drug Administration provides some regulatory guidance on the use social media to collect and disseminate medical information patients will be at the mercy of the entities that run online patient communities. Let’s hope that they see fit to “do the right thing.”

Until next time...

Good Luck and Be Careful What You Say Out There!!!!!!!!!

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In case you haven’t heard, the Business Development Institute is hosting its Second Annual Social Communications and Healthcare event next Tuesday, May 11, 2010 at the The Graduate Center of The City University of New York in midtown Manhattan, New York City. 

The meeting, which starts at 8:30 AM and continues until 1:00 PM, will consist of a serious of plenary talks followed by moderated round table discussions on a variety of social media and healthcare-related topics. Yours truly will be leading a roundtable discussion on non-promotional uses of social media in the life sciences industry.

Agenda

For more information, including registration, please click here to visit the event website. Or contact Steve Etzler at setzler@bdionline.com or 212-765-8045.

BioJobBlog readers can use promo code BC for a discounted rate of $155.

I hope to see you at next week's meeting!!!!

Until next time …

Good Luck and Good Tweeting!!!!!!

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While I was pleased that President Obama and the Democrats were finally able to deliver much needed reform to an ailing American healthcare system, the compromises that were made to pass the bill are troubling. First, language allowing reimportation of lower cost drugs from Canada and other developed nations was eliminated from the bill. Second, the provisions allowing the contentious 12 year data exclusivity provision for generic versions of biologic and biotechnology drugs remained in the final bill. Finally, and perhaps most importantly, any language alluding to or implying that the US government, may, in the future, be able to negotiate or regulate drug prices was obliterated. In short, the pharmaceutical and biotechnology industries received all of the assurances and guarantees that were in the deal brokered by Billy Tauzin, the former head of the lobbying group PhRMA, between the White House and PhRMA over a year ago. Surprisingly, Tauzin was fired by PhRMA several weeks ago because its leadership mistakenly thought that Tauzin conceded “too much” to the Obama Administration when he brokered the original health reform package with the White House. (At the time that Tauzin was fired, health care reform legislation appeared to be on life support and all but dead).

In the final analysis, big pharma and biotech will give back $85 billion over ten years —largely by agreeing to give back some of the profits it was allowed to collected from the egregiously flawed Medicare Part D legislation passed during the odious Bush Administration. While $85 billion may seem like a lot (to the average American citizen) to give back, it is important to note, that the size of the global pharmaceutical and biotechnology markets is over $600 billion per year. Although growth in these markets is beginning to slow in developed nations like the US and Japan (to high single digits), it is beginning to explode in heavily populated developing nations like China, India and Brazil where it is roughly $12-18%. Put simply, despite assertions to the contrary, business in the biotechnology and pharmaceutical markets is booming and likely to continue for the foreseeable future. In other words, the newly passed healthcare reform legislation is a “sweetheart deal” for the US life sciences industry.

Ironically, while the healthcare reform bill insures that almost all Americans will be entitled to healthcare coverage and that insurance companies cannot deny healthcare benefits to persons with pre-existing medical conditions, the legislation may actually limit the access of Americans to potentially life-saving biotechnology drugs. This is because the 12 year data exclusivity period for generic versions of branded, biotechnology drugs (otherwise know as follow-on biologics or biosimilars) remained in the final version of the healthcare reform bill.

As I previously mentioned, this provision disallows approval of follow-on biologics for a period of 12 years from the data that the original biologic received US regulatory approval. For example, if a branded biologic or biotechnology product garners US regulatory approval in 2010, the earliest date that a generic version of this product would be able to appear on the US market would be 2022. Moreover, in some instances, the 12 year data exclusivity provision may extend the so-called patent life of a product. Using the example above, if the patents protecting the product happen to expire in 2019, the innovator company is guaranteed an additional three years of marketing exclusivity before generic versions of the product can appear on the US market. Finally, the 12 year data exclusivity provision effectively prevents foreign biosimilar manufacturers from competing in the US biotechnology market until about 2018; a strategy designed to allow the US to maintain its dominance of the global biotechnology market. Interestingly, despite the approval of six or more biosimilars in Europe, these products have failed to catch on and are not able to compete with their branded, innovator counterparts.

In conclusion, I laud President Obama’s persistence and give him props for his ability to deliver (as promised) health reform to the American public. I have no doubt that the legislation will help to improve the delivery of healthcare in the US and hopefully improve the overall health of Americans. However, while the new healthcare reform legislation is a first, positive step, the American healthcare system will never entirely be “fixed’ until US drug prices are regulated—like they are in the rest of the world. Then, and only then, will the US government be able to control and contain healthcare costs in America.

Until next time…

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

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Most scientists fantasize about that so-called eureka moment when, after years of hard work, academic challenges and mental anguish, it all makes sense. While I have experienced these moments from time to time during my career as a scientist, it has happened less frequently as a lay person. This morning, while reading a Science Times article on Thomas R. Friedan , former New York City health commissioner and current head of the Centers for Disease Control in Atlanta, GA, I had one of those moments.

After reading the passage:

campaigns to ban trans fats, post calorie counts in chain restaurants, reduce salt in processed food and tax high-calorie sodas. He had a supportive boss in Mayor Michael R. Bloomberg and a receptive populace in New York, but if he were to try anything similar at the C.D.C., tough Congressional hearings could be in his future because conservative lawmakers on Capitol Hill often oppose such measures

it finally dawned on me that conservatives, in general, don’t give a damn or care about human health. Or perhaps, the underlying message may be: “don’t tell me how to eat or take care of myself; it’s my life and I know what is best for my health and me.” Unfortunately, since over half of the American population is obese or overweight and the incidences of diabetes and hypertension among younger and older adults has reached unprecedented epidemic proportion it is becoming increasingly evident that most Americans, regardless of their political affiliations, don’t know how to adequately manage their health.  And, to make matters worse, the inability or unwillingness of these individuals to maintain their health increases the cost and may block access of otherwise healthy Americans to adequate healthcare.

As an American, I strongly believe in individuals’ rights and freedom of expression. However, I also believe that summarily opposing unobtrusive measures to improve human health—based almost exclusively on political philosophy or personal financial gain—is morally bankrupt and overtly un-American!

Until next time…

Good Luck and Good Eating!!!!

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In case you did not know, the 12 years of market exclusivity proposed for follow-on biologics by supporters and lobbyists for the pharmaceutical and biotechnology industries is part of the impending US healthcare reform legislation currently pending in Congress. While President Obama has publicly announced that he supports a five year period of data exclusivity for biologics (the same as the exclusivity period for generic small molecule drugs, it is unlikely that the President will be able to convince or coerce legislators to reconsider the 12 year data exclusivity provision. However, there was a brilliant Op-Ed piece in today’s New York Times written by Anthony So and Samuel Katz at Duke University which offers a plethora of financial and business reasons why the five year period makes a lot of sense!

1. Generic small molecule drugs have been estimated to save the American healthcare system as much as $734 billion over the past 25 year or so since the inception of the Hatch Waxman Act.
2. Biologics cost on average 22 times more than equivalent brand name prescription small molecule drugs
3. In 2008, 28% of sales of the life science industry’s top 100 products came from biologics and biotechnology products: by 2014 that share is expect to rise to about 50%
4. The Medicare Payment Advisory Commission found that the top six selling biologics which include Epogen (Amgen) Avastin (Genentech) and Remicade (Centocor) accounted for $7.0 billion (43%) of Part B drug spending in 2007 (Part B covers the cost of doctor spending and outpatient visits)
5. Between 2006 and 2007, Medicare Part D (prescription drug coverage) spending on biologics increased by 36% as compared with a 22% increase in spending for small molecule drugs
6. Prices for biologics and biotechnology products have increased more rapidly than those for small molecule drugs
7. While industry leaders and their lobbyist contend that it costs more and takes longer to develop biologics and biotechnology products than small molecule drugs, based on reports by various industry trade groups it costs about $1.2 billion to develop biologics and roughly $1.318 billion for small molecule drugs
8. The US Federal Trade Commission, the independent federal agency whose main goals are to protect consumers and to ensure a strong competitive market by enforcing a variety of consumer protection and antitrust laws, recommended that the data exclusivity period for follow-on biologics should not exceed six years.

Despite the likelihood that follow-on biologics will substantially reduce prescription drug costs and healthcare spending, Congress has chosen to support questionable legislation that will delay access of Americans to less costly, efficacious follow-on biologics until at least 2020.

Until next time...

Good Luck and Good Job Hunting

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The rising cost of healthcare, increasing drug prices and the restrictive nature of the formularies of many insurers and third party payers is forcing a growing number of Americans to rely almost exclusively on generic prescription drugs. The trouble is that most Americans know very little about generic drugs; mainly because big pharma has done its best to minimize the discussion about generics and continues to portray generic manufacturers as less than reputable purveyors of prescription drugs. Because of this, I think that American ought to begin to understand an industry that increasingly will play a major role in the US healthcare system. So here goes:

1. According to IMS Health, generic drugs accounted for 70 percent of the 2.9 billion prescriptions filled in the US in 2009
2. Generic drugs accounted for only 15 percent of almost $300 billion spent on prescription drugs last year in the US
3. Since 2003, the US Food and Drug Administration (FDA) received 800 new generic drugs applications; up from an average of 330 applications per year in the last decade
4. Five years ago, it took FDA regulators an average of 16.3 months to review and approve generic new drug applications; by 2009 the average time to approval had ballooned to 27.7 months
5. There is a backlog of nearly 2,000 pending generic new drug applications, almost double the backlog at the agency in 2005
6. FDA’s division of generics had a budget of only $41 million in 2009; its budget for 2010 is $511 million
7. Unlike branded pharmaceuticals, companies seeking regulatory approval for new generic drugs don’t pay user fees
8. According to FDA Commissioner Dr. Margaret Hamburg generics saved American consumers almost $750 billion over the last decade.

Based on these facts, it is evident that FDA is seriously under funded, under staffed and overwhelmed by the spike of new generic drug applications in recent years. Interestingly, President Obama’s proposed 2010 budget included $38 million in user fees from generic manufacturers to process new drug applications. Not surprisingly, generic manufacturers are not willing to pay these fees unless the approval time for their products is drastically shortened. To that end, FDA is hiring 50 more reviewers and hopes that personnel increases will eliminate the generic drug application backlog by 2012. 

Dr. Hamburg is also looking to streamline some aspects of the generic drug application review process. For example, she proposed giving higher priority to generic drugs applications for branded drugs whose patent expiry is imminent as compared with applications for drugs that have several more years of patent protection remaining.

Nevertheless, the bottom line is that the agency needs a much larger budget and staff to keep up with the ongoing torrent of new generic drug application. With this in mind, the agency ought to consider reallocating existing resources—rather than wait for budget increases in these financially uncertain times—to process new generic drug applications in a timely fashion. This may be possible because of the annual number of drug applications for new, branded prescription drugs has steadily been decreasing for the past five years.

Hat tip to the New York Times!

Until next time...

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

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As many of you already know, I talk to a lot of graduate students and postdoctoral fellows who are disillusioned with the prospect of remaining in the laboratory for the rest of their lives. Frequently, students mention regulatory affairs as an alternate career option and ask me what type of training and skills are required to transit into a regulatory career. Unfortunately, regulatory affairs is an industry specific career and regulatory affairs training programs with the possible exceptions of the courses offered by the Regulatory Affairs Professionals Society (RAPS) and the Drug Information Association (DIA) (which can be costly) are not readily accessible to graduate students and postdoctoral fellows. Consequently, I recommend that PhD-trained scientists who are interested in regulatory affairs check out employment opportunities at the US Food and Drug Administration (FDA). This is because there is no better place than FDA to learn the “ins and outs” of regulatory affairs!

Until recently, jobs, fellowships and training programs at the agency were scarce. However, while reading an industry trade magazine I came across an ad (posted below) announcing fellowship opportunities for PhD level life scientists, healthcare professionals, pharmacists and even engineers(although they only need a bachelors degree to be eligible.

This is an opportunity for those interested in a regulatory affairs career to give it a shot! For more info visiting the agency’s website

Until next time...

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

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Billy Tauzin, a former Congressman and high profile lobbyist, unexpectedly resigned as President of the Pharmaceutical Research and Manufacturers of America, (PhRMA), a pharmaceutical industry lobby and trade organization. According to a report in today’s New York Times, his resignation resulted from internal disputes over PhRMA’s pact with the White House to trade political support for favorable terms in the proposed health care reform bill. The trade group issued a news release on Thursday night confirming Mr. Tauzin’s departure, effective June 30.

When he first took the helm at PhRMA in 2005, Tauzin’s publicly-stated goal was to improve the group’s image and reduce the “number of its enemies.” Prior to Tauzin’s arrival at PhRMA, it was an obscure lobbying group that was little more than a “rubber stamp” for the agenda set by pharmaceutical companies. Under Tauzin's tutelage, the trade group adopted a more progressive strategy and tried to set a new agenda for the pharmaceutical industry.

In exchange for favorable terms in the original Obama healthcare reform package, PhRMA spent more than $100 million on ads to promote the overhaul. But after healthcare reform stalled, some industry leaders felt the trade group had gone too far giving concessions and could lose on some important legislative issues without gaining the political protection it had sought.

Despite publicly accusing the White House of reneging on its original deal, Tauzin’s willingness and zeal to help to reform healthcare ultimately led to his demise. I suspect that the next person chosen to lead PhRMA will likely be a pharma insider willing to "tow the party line."  While I wasn’t originally keen on Tauzin’s appointment, he proved to be an extremely effective  leader, who unlike most of his PhRMA predecessors, was forward-thinking and had a clear vision for the future of an industry currently in transition.

Tauzin’s departure signals that many pharma executives believe that healthcare reform is dead and companies can continue with “business as usual.” While failed healthcare reform may be beneficial to big pharma in the short term, it ultimately may lead to pharmaceutical price control legislation. This is because—in the absence of healthcare reform— drug and devices prices will continue to skyrocket and  legislators will have little choice but to regulate and cap drug and devices prices.

Until next time,

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

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Many progressives and left-leaning individuals (like me) voted for President Obama because he presented himself as somebody who will stand up for what he believes. Until recently, I, along with others, have been deeply disappointed in his performance and it was no longer clear to me what he truly believes in. However, his recent stand on healthcare reform (sadly without a public option), his performance at the global warming summit and most recently his quick response and unequivocal support for Haitian earthquake victims suggest to me that we are finally beginning to see what President Obama believes and what he is made up. To that end, Obama has turned up the heat to reduce the proposed 12 period of data exclusivity for biosimilars (aka follow-on biologics) in the bill that was passed by both the US House and Senate. Both the President and Rep. Henry Waxman, D-CA (of Hatch-Waxman fame) are trying to reduce the 12 year exclusivity 10 years or less. Obama previously went on record saying that he favored a 7 year exclusivity period for biosimilars.

Not surprisingly, the move has met with fierce opposition from the pharmaceutical and biotechnology industries that argue the longer period is needed to encourage investment and R&D required to produce biopharmaceutical products. Lobbying by both sides has dramatically increased as healthcare reform is pretty much a done deal. However, brand companies have spent many millions more than generic manufacturers to lobby Congress on the 12 year period.

It is about time that an American President is willing to do what is in the best interest of the American public instead of what lobbyists and special interests are demanding. And, to those companies that steadfastly hold to the notion that biopharmaceuticals take an inordinately long time to bring to market I ask: “What’s in your pipeline?”

Until next time...

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

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Officials for the Centers for Medicare and Medicaid Services announced on Wednesday that the agency plans on distributing billions in stimulus monies to upgrade the nation’s paper medical records to electronic ones. Under the proposal, doctors and hospitals that keep UPDATED electronic medical records (EMR) of their patients could receive bonus payments for using EMR-based software systems. While the proposal that was floated is not definite, it was posted to the agency’s website and is open for public comment for 60 days before the final guidelines are issued. 

According to agency spokespersons, healthcare professionals (HCPs) who use EMR for 80 per cent of their medical instructions could receive bonus payments. This means that HCPs would have to provide patients with printouts of their medical history and use computers for potential drug-drug interactions. Further, hospitals would be required to complete 10 per cent of medical orders electronically. Separately, the agency laid out technology standards that EMR software should meet to qualify for the program.

Although technology standards for government-based EMR systems have now been delineated, similar standards for private sector EMR keeping systems have yet to be clearly enunciated by the government. Many hospitals and HCP organizations hastily threw together EMR plans to qualify for stimulus monies that were disbursed early last year. Unfortunately, at present, there is still no general consensus on the software platforms and middleware programs that will need to be developed so that different EMR systems can communicate with one another! Consequently, the national drive to digitize paper medical records is occurring in a haphazard and piecemeal fashion. To realize improved efficiencies and cost savings, I contend that general guidelines ought to be issued before too much private sector work goes on. Allowing the private sector to dictate technology standards may not be in the best interest of a national EMR effort. Nevertheless, as I mentioned an earlier post this week, healthcare informatics is one of the fasted growing industries in the US!

Until next time...

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

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Healthcare informatics (HCI) is one of the fastest growing professions in the US. This is because the Obama administration has allocated billions of stimulus dollars to create electronic healthcare records (EHR) in an attempt to reduce healthcare costs. 

To qualify for EHR stimulus monies organizations must develop a plan and then take steps to implement it! Not surprisingly, because of the short ramp up phase for EHR, the number of available jobs far outstrips the numbers of qualified and skilled employees to fill them. The acute shortage of qualified HCI employees resulted in a cover story in the December 2009 issue of Health Informatics entitled “Got People?” It is a great read and provides insights into the types of employees that HCI companies are looking to hire.  The EHR Initiative will likely create over 500,000 new jobs in the next few years. For those of you, who may be interested in pursuing a career in HCI, check out this list of the top 100 HCI companies to work for.

Finally, a group of bioinformatics and genomics PhD students and postdoctoral fellows approached me to help them find sponsors for a Health Informatics Career Development symposium that they are trying to develop for the 2010 Intelligent Systems for Molecular Biology (ISMB) conference that will be held in Boston, MA from July 9-13, 2010.  

If you are interested in sponsoring the HCI symposium please contact me.

Until next time...

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

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It has been a long time coming, but legislation reforming the US healthcare system will likely be realized in 2010. While the law will likely be passed in 2010, many of its provisions and actionable items won’t be enacted until 2014 (at least in the current bill). I hope that negotiations between the House and Senate change the start date and that the law takes effect in 2010.

I refrained from commenting on healthcare reform until now because, as a progressive who vehemently supports a public option (at the very least), I was very angry and frankly, let down by the unfulfilled promises made by President Obama during his presidential campaign. However, after seeing the despicable and repugnant exhibited by both Republican and Democratic senators (most notably Lieberman and Hogan) during the debate on healthcare reform, it finally dawned on me that Obama had little choice but to chart the course that he ultimately chose to follow to insure that healthcare reform became a reality. Put simply, it is obvious to me, that congressional not presidential reform will be necessary to right a broken system and put the US back on a track to prosperity. It has become increasingly obvious that lobbying by special interest groups has corrupted the system and our congressional representatives are no longer voting their conscience but voting on behalf of the powers at be who finance their re-election campaigns. While seasoned politicos will argue that I am naive and that this is the way that business has always be done, there comes a time when a system is so broken that it simply needs to be changed in the best interests of ALL Americans.

Earlier in the year, I had a discussion with a friend who, despite his undying support for a public opinion, suggested to me that any legislation passed to reform healthcare wouldn’t contain one. In response, I quipped, “then I hope that there isn’t any healthcare reform at all!” Since that declaration, my opinion (and that of some other progressives) has changed—mostly because I and others have come to realize that from a historical perspective, fundamental change in America doesn’t usually come neatly packaged in a single bill or law. Instead, change occurs incrementally and evolves over time. Realizing this, and the likelihood that the Democrats may lose their 60 vote majority in the senate in midterm elections, President Obama divined a healthcare reform strategy that he knew he could deliver by 2010. His informed and pragmatic approach to healthcare may not be what progressives like me envisioned but he will be the first US President to accomplish healthcare reform in almost 80 years! And, at the very least, 30 million Americans who previously didn’t have any health insurance will now be covered under the new law. This will be an important first step in the process to begin to overhaul the US healthcare system.

Hat tip to President Obama!

Until next time....

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

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Earlier this week, Mark Senak who writes the EyeonFDA blog, offered his insights and analysis of pharma’s relationship with Twitter. Today, he tackled YouTube and Pharma. While YouTube has been around a lot longer than Twitter, pharma’s use (with the exception of Johnson and Johnson, Sanofi-Aventis and Tibotec) of the popular video-sharing site has been extremely limited despite the ability of the entity that posts the video to eliminate or regulate the ability of users to leave and share comments after viewing it. 

I suspect that the industry’s reluctance to use YouTube may be related to the lack of regulatory guidance for this medium. Nevertheless, I don’t completely understand why drug makers have chosen not to use the widely popular video site to increase patient awareness about certain medical conditions or to promote patient wellness. These types of videos would likely be appreciated by the public and quite possibly help to repair tarnished image of the pharmaceutical industry held by many consumers and stakeholders.

Hat tip to Mark!

Until next time....

Good Luck and Good Viewing!!!!!

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A post on the Pharmalot blog today reports that spending on direct-to-consumer pharmaceutical advertising came bounding back in the third quarter —rising 15 percent to $1.16 billion, according to DTC Perspectives (which cited data from TNS Media Intelligence).

The increased spending marks the first quarterly gain in nearly two years after slumping 6.4 percent earlier this year from January to June. According to the Pharmalot post, “Internet spending increased the most—more than tripling between January and September to $221 million (display ads only). And, more ads were placed in newspapers, which showed a 25 percent gain to $104 million during the same period.

During the first nine months of 2009 the leading advertisers by brand (each of which spent more than $125 million each) were:

1. Lipitor (Pfizer)
2. Abilify (Bristol-Myers Squibb/Otsuka America)
3. Cymbalta (Eli Lilly) and
4. Advair (GlaxoSmithKline)

Could this be a sign that the pharmaceutical industry thinks that the economy is improving? Alternatively, maybe pharma marketers think that people might become increasingly stressed by the economy and drugs like Abilify and Cymbalta (a variety of psychiatric indications) and Lipitor (high blood pressure, cardiovascular disease ands stroke) may be in greater demand. And finally, from a completely cynical perspective, maybe drug makers want to sell as many drugs as possible before healthcare reform and possible price controls kick in?

Hat tip to Ed!!!!

Until next time...

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

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Late last week, the US Food and Drug Administration (FDA) approved GlaxoSmithKline’s cervical cancer vaccine Cervarix for use in girls and women ages 10 to 25 and also approved Gardasil —Merck’s cervical cancer vaccine previously approved in 2006 for use in girls and women—for boys and men ages 9 to 26. For those of you who may not know, over 99% of human cervical cancers are caused by infections with cancer-causing strains of the human papilloma virus (HPV) which also causes venereal warts. Vaccination with Cervarix protects against cervical cancer by inducing immunity against HPV 16 and 18 (which cause most cervical cancers in developed nations) whereas Gardasil affords protection against HPV 16 and 18 as well as HPV 6 and 11, strains that cause venereal warts (which don’t lead to cancer).

Despite FDA’s approval to vaccinate boys with Gardasil to prevent HPV infections, the Centers for Disease Control’s Advisory Committee on Immunization Practices (ACIP)— which guides national policy on use of vaccines—decided yesterday to recommend the use of the vaccine in girls and women but didn’t fully endorse its use in males. Typically, ACIP recommendations are adopted by professional medical associations and set the standards of practice for physicians. Also, its recommendations play a major role in determining whether or not insurers and third party payors will reimburse patients who are vaccinated. The new recommendations mean, in effect, that physicians and clinics may now administer the vaccine at their discretion to boys and men ages 9 to 26, but they are not expected to offer it. In contrast, vaccination of girls and women ages 10 to 25 will be strongly recommended, readily available and reimbursable. This means that parents may consider the vaccine as an option for their sons, but some health insurers may choose not to cover the shots—an option which is sure to severely limit the numbers of boys and men who are vaccinated with Gardasil.

The ACIP committee decided not to include Gardasil immunization for boys and men on its recommended list because several members, most notably a medical economist, questioned whether vaccinating boys would be cost effective in the long run. At the heart of the debate was whether or not it was appropriate and cost-effective to vaccinate boys for a problem (venereal warts) that can be embarrassing and uncomfortable but is not life-threatening. For those of you who may not know, Gardasil immunization is expensive and requires a series of three injections that cost $130 each ($390 total).  Cervarix, which also requires a series of three injections, is planned to be offered for $385.

Last year in the United States, about 37 percent of girls ages 13 to 17 started the Gardasil vaccine series, a national immunization survey showed, and about half of them completed it. Not a great track record for a vaccine demonstrated to prevent cervical cancer and dramatically reduce the transmission of venereal warts. Nevertheless, yesterday’s decision to recommend vaccination for girls and women but not boys and men makes no sense to me from a public health perspective and it almost smacks of gender bias. Let me explain.

Like all other sexually transmitted diseases (STDs), HPV is transmitted from men to women and visa versa. Based on years of epidemiological studies, the only effective way to reduce the overall incidence of STDs is to implement strategies that prevent infections in both females and males. While boys and men can’t develop cervical cancer, they do contract venereal warts and perhaps, more importantly, can serve as carriers or reservoirs of HPV infection in the population. In other words, infected males (who may or may not show symptoms of HPV infection) still possess the potential to transmit it to sexually-active, unvaccinated girls and women. Consequently, while the incidence of HPV infections may begin to decrease among women after immunization, it will never be completely eliminated and the possibility of developing cervical cancer will continue to be a public health concern.

While the ACIP’s understanding of the transmission of STDs is tragically flawed, its willingness to publicly disclose cost effectiveness as a reason to not endorse HPV vaccination for males is even more egregious! The agency’s decision begs the question: Which is more costly; 10,000 American women developing cervical cancer each year (and countless others going for unnecessary cervical biopsies because of “bad” Pap smears) or a heads up to insurance companies that they ought to cover the costs of male HPV immunizations? 

The ACIP’s reluctance to recommend male HPV vaccination based on economic and health care cost concerns rather than on public health implications is yet another example of how broken the US healthcare system is and how drastically it needs to be reformed. Allowing 3,700 women to die each year in the US from cervical cancer when there is a safe and effective way to prevent these deaths is, in my opinion, unconscionable!

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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I have refrained from commenting on healthcare reform until now because there wasn’t much I could add to the debate. That said, while reading an article in a local paper on bacterial antibiotic resistance and how to minimize it, the author—an infectious disease doc—offered a telling statistic that identified the root problem with our current healthcare system. According to the article, 65% of the time, physicians will prescribe antibiotics to patients suffering from upper respiratory tract infections who demand them, whether or not they are warranted. In marked contrast, 12% of patients with upper respiratory tract infections who don’t ask for antibiotics receive antibiotic prescriptions. The bottom line: physicians give patients the drugs and treatment they demand because they are afraid of losing them as customers knowing full well the patients will go to another physician who will give them what they want! After all, physicians are in business and to stay in business they need to make enough money to cover their overhead and make a profit. However, over prescribing antibiotics is one of the main reasons why we are in the midst of an epidemic of infections caused by multiple drug resistant bacteria. In my opinion, business outcomes should never supersede or trump medical or public health outcomes.

Don’t get me wrong, I am an entrepreneur and believe that people with good ideas ought to be rewarded for their efforts and make as much money as they can. However, in my opinion, for profit business practices and healthcare haven’t historically worked well for the American healthcare system. Removing profit incentives from healthcare would be an important first step to begin to repair our broken healthcare system. Can anybody say public option?

Until next time...

Good Luck and Support the Public Option!!!!

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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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For the first time in history, more people are searching the Internet for health information than asking doctors. Web 2.0 and social media tools are allowing people to discover new ways to connect, learn and engage one other in search of healthcare and drug information.

e-Patient Connections 2009 which will be held in Philadelphia, PA on  October 26 and 27 will feature a number of leading authorities on social media and digital health  Some of the featured speakers include Wired Magazine’s Thomas Goetz, Jay
Bernhardt of the CDC, and Lee Aase of the Mayo Clinic. The conference also offers case studies, 1:1 coaching sessions with industry experts and the latest products from digital health companies.

BioJobBlog readers can use the discount code kru500 to save $500 off the current price.

See you there!

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Mark Sendak, author of the incisive EyeonFDA blog and social media enthusiast, has been keeping a watchful eye (pun intended) on the growing number of pharmaceutical companies that are adding channels and videos to YouTube. 

On his blog today, Mark reviews several new channels developed by Novartis, Johnson and Johnson, Teva, Boehringer Ingelheim and AstraZeneca. While a growing number of pharmaceutical companies continue to add new channels on YouTube, Mark contends that the “success of these channels has varied greatly and several companies have obviously developed the channels without any idea of what they would like to do with them and some of the channels show obvious signs of neglect.”

To learn more about pharma’s incursion on YouTube, read Mark’s post!

Until next time...

Good Luck and Good Video Watching

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At the recent Social Communication and Healthcare conference I was invited to run a roundtable discussion entitled “How to Build a Social Networking Site for Bioprofessionals.” The discussions were well attended, primarily by employees several pharmaceutical companies and vendors who sell scientific equipment and reagents. Several bloggers and medical communications professionals also attended.

While microblogging platforms like Twitter are slowly supplanting traditional networking sites as the social medium of choice, themed online communities like BioCrowd--hich was exclusively designed for bioprofessionals ranging from scientists to venture capitalists—are still useful for jobseekers and people who are interested in a “richer” networking experience. For those of you who are interested in social networking sites, I wrote a brief synopsis of the two roundtable discussions that I conducted.

Please feel free to contact me with any additional thoughts, ideas or comments you may have about the piece.

 Until next time...

 Good Luck and Good Networking!

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I met Jonathan Richman,the author of the Dose of Digital blog, last week at the BDI Conference (#BDI) on Social Communication and Healthcare in NYC. BTW, for those of you who were unable to attend, you missed an informative and compelling meeting on the status of social media in the pharmaceutical and healthcare industries. Anyway back to Jonathan. He gave a great talk on pharma and social media which prompted me to visit his blog. While perusing Dose of Digital, I came upon a wiki that Jonathan maintains called --what else-- the Pharma and Healthcare Social Media Wiki.” 

It’s a comprehensive, cataloged list of social media initiatives underway at pharma, biotech and healthcare industries. Noticeably absent from the wiki, are social networking sites like BioCrowd that were specifically created for life scientists and other bioprofessionals. Hey, wait a minute, aren’t scientists the lifeblood of the life sciences industry? Would there be a life sciences industry without scientists? Hmmmm....I will have to talk to Jonathan about this!

I highly recommend you check out the wiki if you are a life sciences social media enthusiast!

Until next time...

Good Luck and Good Social Media Hunting!!!!!  

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The “Social Media and Healthcare” conference 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) is shaping up to be a great one. At present, over 350 people have registered for the meeting. There are a few slots left if you are interested in attending.

Several BioJobBlog readers have asked whether or not the sessions will be recorder and available online. Steve Etzler, one of the conference organizers told me that Blogtalkradio.com will broadcast and archive the audio from all of the case studies that will be presented during the morning sessions. Unfortunately, the round table discussions won’t be available.

As I may have mentioned, Cliff Mintz, Co-Founder of BioCrowd will be leading a roundtable discussion entitled “Building Social Networking Sites for Bioprofessionals.”

See you on Thursday!!!

Until next time....

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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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According to a report released by the president’s Council of Economic Advisers the biggest gains in job growth by 2016 will be in the areas of healthcare and education services. Moreover, most of these jobs will require postsecondary education degrees mainly in the form of certificates and associates degrees. To meet this demand, the report argues for ways to improve the US education system so that American workers can more easily adapt to a more skilled-base economy.

The report also notes that manufacturing will continue its long term decline and that small growth will occur in the business and financial sectors of the US economy. Construction and transportation are likely to begin to grow once the economy improves. However, the largest demand and increases will occur in healthcare services, environmental-related occupations and in education service providers. Whereas other sectors of the economy have been battered by the recession, growth in the healthcare and educational services sectors have remained robust.

In the past, emphasis has been placed on obtaining a baccalaureate degree to garner gainful employment. While this trend will likely continue, explosive growth is expected for occupations that require only an associate’s degree or postsecondary education certificate. Growth in these types of jobs is predicted to outpace occupations that require a bachelor’s degree or higher.

The report also describes goals that must be met to improve the American postsecondary education system. These include: improving early childhood, elementary and secondary education; better school curriculums; closer collaboration between employers and educational institution to ensure that students learn the skills that they need on the job, better financial aid; and accountability for education and workforce programs that don’t work. I have long contended that both undergraduate and graduate programs in the life sciences introduce skill-based workforce development activities into their curriculums. Unfortunately, my attempts have fallen upon deaf ears. Perhaps this report will induce the administrators who can institute this type of change to take their “heads out of the sand”and take notice.

Until next time...

Good Luck and Good Learning!!!!!!

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GlaxoSmithKline (GSK) inked a deal yesterday with the Indian generics manufacturer Dr. Reddy’s Laboratories giving it access to over 100 future generic drugs and a gateway to Asia’s emerging pharmaceutical markets. The therapeutic areas covered under the agreement include diabetes, cardiovascular, pain management, gastroenterology and oncology. Dr Reddy’s Laboratories is one of India’s largest generic drug manufacturers. Like many of its competitors, Dr. Reddy’s Laboratories also have active development programs for new biotechnology drugs and biosimilar products.

UK-based, GSK joins a growing number of pharmaceutical companies including Pfizer, Merck and others that have entered into deals with major generic drug manufacturers—or purchased smaller generics companies—to gain access to generics pipelines and an ability to compete in emerging  non-branded pharmaceutical markets. Impending US healthcare reform and downward pricing pressures (resulting from increased global competition) have forced drug makers to reevaluate the role that generic drugs will likely play in future pharmaceutical revenue streams.

While generic drug makers have outstanding manufacturing capabilities, they generally lack the marketing, sales and distribution channels necessary to penetrate foreign markets and quickly ramp up drug sales. I suspect that the number of deals between pharmaceutical companies and generic manufacturers will continue to increase as many of the patents for multibillion, blockbuster drugs continue to expire in the next few years.

Until next time....

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

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Pfizer, the world’s largest drug maker, announced on Thursday that it is unveiling a new program that will let people who have lost their jobs and health insurance to keep taking Pfizer medications — for free, and for up to a year. The company will provide more than 70 of its prescription drugs ranging from Viagra to Lipitor at no costs to unemployed and uninsured Americans who lost their jobs since Jan. 1 and have been taking Pfizer drugs for me than three months. It is not clear how much Pfizer will spend on the program and whether or not costs will be capped.

The announcement comes amid massive job losses caused by the recession and a campaign in Washington to rein in health care costs and extend coverage. The move could earn Pfizer some goodwill in that debate after long being a target of critics of drug industry prices and sales practices. The program also likely will help keep those patients loyal to Pfizer brands. Don't be surprised if other pharmaceutical companies announce similar program over the next few weeks.

Pfizer and the rest of the drug industry wants is trying to have a voice in the debate over how to overhaul the U.S. health care system, partly by joining in a pledge this week to help hold down inflation of health costs. In the mean time, drug companies have been raising prices on their drugs, partly to offset declines in revenue as the global recession reduces the number of prescriptions people can afford to fill.

Pfizer ought to be commended on the program and its concern for the health and well being of unemployed and uninsured Americans. However, it is important to point out that this is little more than a high profile, marketing campaign designed to improve the image of drug makers. More important, it is the first public acknowledgement that drug makers are willing to engage legislators in discussions about how to reform healthcare to reduce costs and cut expenditures. 

What really is at stake here is whether or not the US government will begin regulating drug prices as part of a comprehensive healthcare reform package. As many of you may know, the US government, unlike most other governments in the world, cannot negotiate or set prescription drugs prices. Not surprisingly, the US prescription drug market is the largest and most profitable in the world. It will be interesting to see how the US healthcare reform discussion unfolds—clearly a lot is at stake for the American prescription drug industry.

Until next time...

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

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Twitter, the microblogging platform, is the current rage in social media. According to @Shwen, who writes the Med 2.0 Blog, it grew by 752% in 2008. Shwen is a social media enthusiast who is trying to convince the life sciences industry that Twitter and other social networks can be leveraged to improve drug development and deliver healthcare.

According to a recent post on Med. 2.0, there are currently three pharmaceutical companies that are actively using Twitter: Novartis (@novartis), Boehringer Ingelheim (@Boehringer) and Astra Zeneca (AstraZenecaUS). Also, it appears that Johnson and Johnson (@JNJcomm) launched an account last week. Tweets from @novartis and @Boehringer occur fairly regularly whereas AstraZenecaUS tweets are rare. Unlike YouTube, where pharmaceutical sponsors who create channels can regulate and control content, it is much more difficult to manage Twitter because tweets are in real time, uncensored (for the most part) and can be globally disseminated within seconds.

Despite these issues, Med 2.0’s Shwen muses “I can only imagine that more pharma companies are going to be jumping on board the Twitter-train sooner rather than later. How they use it to engage, on the other hand, is going to vary greatly from company to company. At the very least, I see companies setting up accounts as “listening posts”, but others may choose to engage, like @boehringer does in an informal manner. Whatever the case, Twitter is fast becoming the new dominant space for listening and/or engaging the life sciences community.”

Like Shwen, I believe that it a matter of time before pharma and biotech realize that they must embrace social media (in all of its various forms) to remain competitive in today’s increasingly interconnected marketplace.

For those of you who may be interested, you can follow BioJobBlog (@Biojobblog) and Biocrowd (@Biocrowd) on Twitter too!

Until next time…

Good Luck and Good Twittering

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Late yesterday, drug maker and consumer healthcare giant Johnson and Johnson announced that it was buying Mentor, a Santa Barbara, CA maker of skin care products, liposuction equipment and MemoryGel breast implants. According to industry analyst the $1.07 billion that J&J will spend to purchase the company “represents a giant premium for Mentor.” Mentor will become a stand-alone unit of J&J’s Ethicon a leading supplier of sutures, mesh and other surgical products. The cosmetic surgery and anti-aging markets are huge and are expected t to grow as the baby boomer generation continues to age.

J&J is on something of a buying spree and will continue to buy specialty companies to to offset possible losses that may from a weak drug pipeline of its pharmaceutical division. In November, the company purchased Omrix for $438 million, a biopharmaceutical that develops biosurgical and passive immunity products. The deal is expected to close this month.

Unlike most other pharmaceutical companies, J&J has been able to successfully run a diversified conglomerate company that specializes in both pharmaceutical and consumer healthcare products. It is a cash rich company that has a reputation for treating its employees very well! Who said that “beauty is only skin deep?”

Until next time

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

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Bristol-Myers Squibb (BMS) made a presentation this morning at the Credit Suisse Healthcare Conference that showed the company plans on saving an additional $2.5 billion in “productivity initiatives.” According to its new CFO, the company plans to squeeze the savings out of “headcount and related costs” — which  likely means more downsizing and layoffs.  Rumors have it that these job cuts will take place by December 1, 2008 just prior to when employee bonuses are traditionally decided.

To make matters worse, the Pharmalot blog reported today  that "the drugmaker earlier this week sent a voicemail to employees saying a 2 percent cost of living increase will be given this year to those who are meeting or exceeding performance standards."  The announcement has lead to speculation among BMS employees whether or not the same ceiling will be applied to the bonuses and stock rewards handed to Bristol-Myers CEO Jim Cornelius and members of his executive team.

Heavy losses incurred  by its former CFO who "bet the store" on mortgage-backed securities coupled with the recent, highly publicized failure of Jim Cornelius to purchase ImClone (to gain complete control over the multi-billion dollar Erbitux franchise) suggests that the future of the company may be in serious jeopardy.

Until next time…

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

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I read today in the New York Times that healthcare costs are expect to ease slightly in 2009 for employers. According to Mercer, a healthcare consulting firm, healthcare benefit costs are expected to rise only 5.7% in 2009. Since 2005, annual increases in healthcare spending have hovered around 6.1%.

At first glance, this ought to be good news for the millions of workers employed by American companies. But, like most other reports and survey conducted during the disastrous Bush Administration, the numbers don’t tell the real story. In reality, employers are aggressively shifting the healthcare burden to employees by raising premiums and pushing deductibles and co-payments to all time record highs. For example, I learned the other day that my good friend Pete, who works as recruiter in the hospitality business, has to pay $50 each time he or any member of his family (he has 5 children) goes to the doctor. Unlike other people who have less onerous co-pays, Pete has to pick and choose which family aliments really require medical attention. These decisions must be extremely difficult and stressful for Pete, who had prostate cancer surgery less than a year ago.

Regardless of your political persuasions, it is obvious to me that healthcare reform is long overdue in the US. I hope that Barack Obama begins to address this ongoing, serious problem shortly after he is elected President in November, 2009.

Until next time….

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

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By now, you may have guessed that I am supporting Obama for President. My good friend Jack Goldenberg has created several Obama watch designs that he will be selling at the Democratic Convention in Denver, Co June 25-28, 2008.  For those of you attending, look for Jack and buy a watch (they are really elegant and cool).  If you are unable to attend the convention you can buy a watch online at Jack’s store. Use promotional code CLF and get a 15% discount!

Go Obama….

Until next time….

Good Luck and Campaign for Obama!

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Like my kids frequently say when I mutter something obvious…”Like..DUH.! According to an article in today’s New York Times, “American medical care may be the most expensive in the world, but that does not mean it is worth every penny. A study to be released Thursday highlights the stark contrast between what the United States spends on its health system and the quality of care it delivers, especially when compared with many other industrialized nations.” No surprises here—the US spends more per capital on healthcare than all other industrialized nations but a greater percentage of the US population is without adequate healthcare.

One of the things that irritate me the most is that many Americans still believe that US healthcare is second to none. True, Americans have greater access to experimental and new cutting-edge treatments than others in the world, but when it comes to preventing or prophylatically delaying the onset of chronic diseases like diabetes, high blood pressure, obesity etc, the American healthcare system is grossly deficient.  

Healthcare insiders and third party payors have known that the system has been failing for past 20 years. Unfortunately, the healthcare and drug maker company lobbies have effectively blocked and prevented any changes to correct the glaring deficiencies of the American healthcare system. Anytime, anybody utters the phrase “nationalized healthcare” a collective shudder is exhibited by most Americans. The truth is that Medicare, a government-run healthcare insurer, is responsible for covering almost 60% of all medicals claims that are filed annually in the US. This means that healthcare benefits supplied to a majority of Americans are under the auspices of a nationalized healthcare program. Why not go all the way and cover the medical costs of all Americans?????

Politicians can no longer deny that it’s time for a change—the health of America depends on it!

Until next time…

Good Luck and Good Job Hunting

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Siemens, the German conglomerate that manufactures everything from locomotives to medical imaging devices, officially announced on Tuesday that it will be sacking 4% of it workforce or 16,750 employees. Although the company didn’t specify where all of the cut would be taking place—it is a global workforce reduction—a company spokesperson did indicate that 1,500 administrative jobs in its healthcare division would be eliminated and most of those jobs are in the US. Many of these cuts will likely take place in the tri-state area (New York, New Jersey and Pennsylvania)—not welcome news for the already battered pharmaceutical and biotechnology industries in the region.

While the cuts seem pretty substantial to most people (especially those Siemens employees who are losing their jobs) one company executive quipped “If you have 400,000 people on your payroll, cutting 17,000 is not that big a deal” — only if you aren’t one of the people who is losing a job.

Until next time….

Good Luck and Good Job Hunting!!!!!

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Just when you thought the obvious couldn’t be anymore obvious to US lawmakers, the Congressional Budget Office (CBO) today released a long-awaited assessment of the cost of a biogenerics bill and found that the legislation, if enacted, would reduce total expenditures on biologics in the US by $25 billion over the next decade—duh!!!  

According to a post over at Pharmalot, “The report comes as a growing group of drugmakers, insurers and employers agitate over the high cost of biologics, which may only be rectified if Congress passes legislation that would give the FDA guidance on creating a so-called pathway to approve biogenerics, or follow-on biologics. Two House bills have been proposed that are similar to the Senate bill reviewed by the CBO, although the looming summer recess and election-year politics suggest passage may not occur this year.”

Unfortunately, as I suggested in a previous post, the bills currently under consideration are flawed and would give unwarranted patent exclusivity to innovator companies if enacted. Nevertheless, as Kathleen Jaeger, head of the GPHA (a generic manufacturing trade group) aptly stated “We are still reviewing the analysis, but we are pleased that CBO agrees that significant savings will be achieved by bringing biogeneric medicines to consumers and that even greater savings will result from removing harmful barriers to access, including brand evergreening and unprecedented market exclusivity provisions. With Americans growing increasingly concerned about health care costs, we should be increasing access to affordable medicines while fostering competition in the pharmaceutical marketplace. “

By the time that a US approval pathway for biogenerics is divined, European and Asian biogeneric manufacturers will already control the market and the “new” (what took you so long) American legislation will provide little financial incentive for US companies to enter the biogenerics market space.

Until next time…

Good Luck and Good Job Hunting!!!!

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Unlike many other countries with national healthcare systems, US healthcare and prescription drug costs are primarily shouldered by employers. As healthcare costs continue to rise, many American employers are calling for the US government to assume more of the costs through nationalized healthcare. The opposite situation is unfolding in the rest of the world, where overburdened nationalized healthcare systems are forcing employers to pay for workers supplemental health care costs.

A recent survey conducted by Watson Wyatt found that in countries like India, China and Russia healthcare is the number 1 benefit desired by a majority of workers. Globally, companies are projecting large year-to-year increases in medical and healthcare costs. In many places, medical and healthcare costs are rising faster than inflation.

Contrary, to popular belief, it appears that the US is not the only country struggling with skyrocketing healthcare and prescription drug costs. The graph below shows the expected increases in national healthcare costs from 2007 to 2008 (source Watson Wyatt).

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Health care spending in the United States grew 6.7 percent in 2006 to $2.1 trillion, or $7,026 per person. This represents a slight increase over the 6.5 percent rate in 2005 (which was the slowest growth since 1999). Health spending accounted for 16 percent of US gross domestic product in 2006, outpacing overall nominal GDP growth by 0.6 percent. However, total health care spending in the US is not the real story here.

The federal government reported that the new Medicare drug benefit called Part D, which was implemented in early 2006, contributed to an 18.7 percent increase in Medicare spending that year, the fastest rate of growth since 1981 and double the rise in 2005.  In 2006, Medicare spending rose to $401.3 billion, up from $338.0 billion a year earlier, according to the government’s annual health spending report.

The impact on funding sources that paid for prescription drug benefits varied. The public share of spending (federal and state)  increased from 28 percent in 2005 to 34 percent in 2006, while funding from private sources (insurers) fell from 72 percent to 66 percent.  The shift in funding was most dramatic for Medicare and Medicaid. Medicare’s share of total retail prescription drug spending surged from just 2 percent in 2005 to 18 percent in 2006, following Part D implementation. Meanwhile, Medicaid’s share fell from 19 percent to 9 percent.

At present, the US government cannot negotiate prescription drug pricing with drug companies that produce the medications–only drug distributors and third party insurers can do that! As the baby boomer retirement continues, the amount of government spending on prescriptions drugs will increase exponentially and ultimately cause healthcare costs in this country to explode. In my opinion there are two options: impose price controls on prescription drugs or provide all US citizens with a national healthcare system that allows the government to negotiate drug pricing directly with drug manufacturers. And for those of you who think national healthcare is a fantasy–over 60% of all healthcare claims in the US are currently handled and paid by Medicare–a federally finaced and run government healthcare system!  We are closer to a national health insurance program than you think!

Until next time...

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

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