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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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About two years, I posted an opinion piece on BioJobBlog which argued that pharma’s reluctance to engage in social media because of fears of being swamped with adverse events (AEs) reports was little more than a red herring.

In that piece I opined “what is really at stake, is the systemic changes that would be required to transform a historically, opaque and unresponsive industry into a transparent, accountable and responsive one that would be required if it embraces social media as an integral part of its business model.” Nevertheless, two years later, there is still no FDA guidance on the use of social media in the pharmaceutical industry and while some companies have warmed up to the concept, it has not been wholly embraced by most companies.

However, there is new data that may put the “fear of being swamped by AEs reporting” argument to rest. The Pharmalot Blog reported today that a new study conducted by Visible Technologies, a social media monitoring and software firm, showed that only 0.3 percent of more than 257,000 posts about 224 different products —33 antacid over-the-counter meds, 38 over-the-counter decongestants, 10 prescription statins and 143 prescription drugs used to treat high blood pressure—mentioned an AE. For a more detailed analysis of the study please click here.

According to the Pharmalot post the study was conducted over a recent 30-day period and posts were collected from millions of social media sources including “blogs; forums; message boards; message groups; social networks, notably Facebook and LinkedIn; Twitter; regular news sites; specialized health sites, such a WebMD; and video and photo sites, such as YouTube and Flickr.” The study’s focus on statins, blood pressure medications, over-the-counter decongestants and antacids was intentional because tens of millions of persons use these products and therefore, would be more likely to comment on them at social media sites. The bottom line: the use of social media by pharma companies will not overwhelm their existing AE reporting networks nor will it require that more persons be hired. In fact, as I argued in my previous post, using social media for AE report may actually help companies better managed approved and marketed drugs as part of their FDA-required post marketing drug surveillance programs. 

At this point, I am at a loss as to why pharma has not yet embraced social media and leveraged it to their advantage like other industries. I suspect that most companies will not act until FDA issues the social media guidance it has been promising for the past two years. Sadly, it is anyone’s guess when the agency will finally issue the guidance—it has already been delayed several times over the past two years!

Until next time...

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

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Several years ago RNAi was hot and it was touted as a technology that would revolutionize modern pharmaceutical science. I never thought RNAi had much promise beyond being a research tool but what do I know? 

With this in mind, I felt exonerated today after reading that Roche had divested all of its RNAi assets to a small Madison, WI drug discovery company called Arrowhead Research. In exchange for the assets, Roche acquired an equity position in the company.  About a year ago Roche formally announced that it was exiting the RNAi business, but until now was unable to find a buyer. 

According to a press release, Arrowhead now owns the Roche Madison Inc facility (formerly the Mirus R&D facility in Madison, WI), which employs a team of 40 scientists. Arrowhead also gets licenses from several leading firms, including Tekmira Pharmaceuticals for RNAi drug delivery technology and Alnylam for RNAi intellectual property and short interfering RNA structures. Arrowhead was already in the RNAi delivery space.

Previously, Roche spent roughly a half-billion dollars to amass its position in RNAi, including $331 million paid to Alnylam Pharmaceuticals in 2007 for access to RNAi technology and $125 million for the purchase of Mirus Bio in 2008. Arrowhead, in contrast, is paying Roche no money for these and other assets; instead it is giving the Swiss firm an ownership stake of slightly under 10%.

Many other big pharma companies have also abandoned their efforts in the RNAi space. While RNAi works in the lab as a research tool, the inability to successfully deliver it to internal cellular targets has prevent companies from commercializing it. I hate to say it, but “I told you so.”

Until next time....

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

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Crowdsourcing—using the collective talent of the Internet to solve problems—has been increasingly used to solve problems and find solutions in the computer software and electronics industry. Over the past few years, several forward-thinking life scientists had proposed the idea that crowdsourcing could possibly be used to solve the molecular structure of proteins that could be used as drug targets. To bring this possibility to reality, in 2008 a team of scientists at the University of Washington created an online, interactive, protein-folding game call Foldit that showcased the principle and properties of protein biochemistry. The thought was that Foldit and its worldwide cadre of users could be used to solve the molecular structure of certain proteins. Since 2008, over 100,000 have downloaded Foldit software and turned into a large, worldwide, multiplayer competition.

Earlier this week a group of scientists reported in the journal Nature Structure & Molecular Biology that Foldit users helped them to determine the molecular structure of a simian HIV protease that had baffled scientists for 15 years. The actual three dimensional structure of the protein that was predicted by Foldit was confirmed by X-ray crystallography. According to the paper’s authors (that included the Foldit players who helped solve the protein’s structure),

“Although much attention has recently been given to the potential of crowdsourcing and game playing, this is the first instance that we are aware of in which online gamers solved a longstanding scientific problem. These results indicate the potential for integrating video games into the real-world scientific process: the ingenuity of game players is a formidable force that, if properly directed, can be used to solve a wide range of scientific problems.”

Crowdsourcing is a new concept that is beginning to be embraced by the life sciences community including academics as well as industrial scientists. To learn more about crowdsourcing and its use in drug discovery and design, please read an article that I wrote for LifeScienceLeader this past July.

Until next time...

Good Luck and Good Gaming!!!!!!!!! 

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Mark Senak, author of the outstanding EyeonFDA blog, tweeted today, that Eli Lilly & Co had launched a YouTube Channel. According to a post on the company’s blog Lilly Pad, its new channel dubbed the “Lilly Health Channel” will “videos on health and wellness, employee and community outreach efforts, health innovation, Lilly programs and other non-product-branded initiatives.”

While the announcement of a launch of another pharma-sponsored YouTube channel is no longer new or novel, Eli Lilly has been trying to transform itself into a modern, social media and crowdsourcing-focused pharmaceutical company. For example, Lilly is one of only a handful of big pharma companies that sponsors its own corporate blog. Moreover, the company is a leader in using so-called crowdsourcing to discover and develop potential new drugs. It has spun off at least two ventures that utilize a crowdsourcing approach to new drug discovery. Finally, unlike most other big pharma CEOs, its chief executive John Lechleiter has been outspoken about the lack of innovation and available workforce talent in the US life sciences industry. 

Is Lilly truly the pharmaceutical company of the future? That remains to be seen! 

Until next time... 

Good Luck and Good Viewing!!!!

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For the past several days, the rumor mill has been rampant with suggestions that UK-based Shire may acquire Cubist, a publicly traded Massachusetts-based biotechnology company that sells Cubicin, an antibiotic indicated for the treatment of certain infections caused by methicillin-resistant Staphylococcus aureus (MRSA).

Rumor has it that Shire approached Cubist about a month ago with a $44.5-a-share proposal ($2.0 billion) and the pair have been in talks about a deal ever since. Last week, Shire announced that it had entered into a deal to acquire private-held Advanced BioHealing for $750 million. Connecticut-based Advanced BioHealing markets and develops products to enhance wound healing and treat diabetic foot infections in patients with diabetes. Shire’s acquisition of both companies would provide it with a substantial US presence in the antibacterial treatment and diabetes markets.

While Cubist may be a good “fit” for Shire, it is not clear whether or not the company will prevail in its takeover bid. Last month, Cubist settled a patent dispute Teva Pharmaceuticals over Cubicin, which lessened the threat of generic competition by the Israeli drug maker. This sparked speculation among a number of Wall Street analysts that other pharmaceutical companies including AstraZeneca and Johnson & Johnson who are themselves facing generic competition, may consider acquiring Cubist in an attempt to add new antibiotics to their antibacterial portfolios. 

This is not the first time that analysts have speculated that Cubicin may be ripe for acquisition. Almost two years ago, word-on-the-street had it that Novartis may acquire the company. Nevertheless, Cubist is one of the few remaining publicly-traded biotechnology companies that specialize in new antibacterial drug discovery. Its potential acquisition by a big pharma company may signal the end of innovative drug discovery in the antibiotics discovery space. Here’s hoping that Cubist remains independent!

Until next time...

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

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The loss of patent protection and a decline in revenues for a number of blockbuster brand name antibiotics has caused many big pharmaceutical companies to exit the antibacterial drug discovery market. The three remaining big pharma companies still actively engaged in antibacterial research are GlaxoSmithKline, AstraZeneca and Novartis (all European owned companies).

A new report by UK-based Datamonitor entitled “Forecast Insight: Antibacterials” predicts that antibiotic sales revenues will decline from $19.6 billion in 2009 to about $16.4 billion in 2019. Not surprisingly, the report blames the projected decline on generic competition and the lack of new antibiotic launches over the past 10 years.

At present, the top seven antibiotic markets in the world include the US, Japan, France, Germany, Italy, Spain and the UK. According to Datamonitor’s analyses, total sales in these markets have fallen by about 1.6 percent annually since 2005 and will continue to decline by almost 2.0 percent a year through 2019. In 2009, three antibiotics had sales of about or more than $1.0 billion; Johnson & Johnson’s Levaquin (market leader), and Pfizer’s Zosyn, and Zyvox. Interestingly, Pfizer recently decided to shut down its US-based antibacterial drug discovery program and move it to China and Johnson & Johnson recently announced that it was getting out of the antibiotic discovery business. 

Big pharma’s decision to abandon antibiotic research could not have come at a worse time. The incidence of antibiotic resistance among both Gram positive and Gram negative bacteria is rising at unprecedented rates. And while safe and effective treatments for Gram positive infections including MRSA (methicillin-resistant Staphylococcus aureus) still exist, the number of treatment options to treat Gram negative infections caused by Acinetobacter spp, Pseudomonas aeruginosa and enteric bacteria is severely limited. The recent description and rapid spread of a beta-lactamase enzyme called NDM-1 that inactivates the antibiotic carbapenem—the last safe and effective antibiotic to universally treat infections caused by Gram negative bacteria —is extremely troubling and worrisome.

While much of the focus over the last decade was on MRSA, infections caused by untreatable, multiple drug resistant Gram negative bacteria will pose the greatest public health threat over the next 10 years. Unfortunately, it is much harder to develop new antibiotic treatments for Gram negative infections as compared with ones caused by Gram positive bacteria. Further, at present, most of the companies that remain in the antibiotic space continue to focus on new treatment for MRSA and related bacteria. Consequently, new treatments for Gram negative infections may be more than a decade away!

Finally, like MRSA, most infections caused by multiple drug resistant Gram negative bacteria are nosocomial in nature (although the incidence of community acquired infections is also on the rise). This means that the most likely place to become infected with these bacteria is institutionalized healthcare settings including hospitals and nursing homes.

In the past, we have relied on pharmaceutical and biotechnology companies to discover new antibiotic treatments. The decision of many of these companies to leave the antibacterial space for purely financial reasons is unfortunate and regrettable. However, the growing incidence of antibiotic resistance among both Gram positive and Gram negative bacteria suggests that new antibiotics are necessary and that alternate approaches to new antibiotic drug discovery must be implemented. Whether this is through public/private partnerships or strictly through government programs is irrelevant. The bottom line is that we need new antibiotics; and if they are not discovered soon, many patients will die from previously treatable bacterial infections!

Until next time...

Good Luck and Good Job Hunting (start an antibiotic drug discovery company)

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Depending upon the source, the cost of bringing a new prescription drug to market these days ranges from roughly $1.2 to 1.5 billion. While there is no question that clinical studies represent the most costly aspect of getting new drugs approved, the hidden costs—mainly promotion and marketing—are what actually inflate the costs of new drug development. Not surprisingly, drugmakers fail to disclose that these costs are included in the estimates for new drug development. If these costs were eliminated from the total, then the cost of developing new drugs will be significantly less than the current $1.2 to $1.5 billion price tag.

I suspect that many BioJobBlog readers—mainly those who work in the drug industry—will likely write me off as someone who doesn’t know what he is talking about. But, an interesting tidbit that I found in an article in today’s New York Times entitled “A Fight Over How Drugs are Pitched” suggests that my claims ought not be summarily dismissed simply because I am a “left-leaning histrionic democrat.” To wit, according to IMS Health (a competitive intelligence firm that tracks physician prescription rates) in 2009 alone, the branded prescription drug industry spent about $6.3 billion on marketing visits to doctors! This amount does not include costs associated with marketing and advertising that support direct-to-consumer (DTC) advertising campaigns that are run by companies that sell approved prescription drugs. DTC costs are generally much higher than those spent on direct marketing to physicians.

It is important to remember that a drug maker’s main goal is to convince physicians to prescribe “their” drugs. After all, physicians not patients write prescriptions! That said, physician prescribing behaviors are vitally important to the success or failure of a marketed prescription drug. Consequently, it should come as no surprise that marketing costs are factored into the cost associated with new drug development. Obviously, if less money was spent on marketing than the cost of bringing new drugs to market would likely be substantially less.

Interestingly, the States of Vermont, New Hampshire and Maine recently enacted laws to limit the uses of a doctor’s prescription records for marketing. On Tuesday, the US Supreme Court will hear arguments in a case, Sorrell v. IMS Health that tests whether Vermont’s prescription confidentiality law violates the free speech protections of the First Amendment. The federal government, the attorneys general of several dozen states, AARP, professional medical associations, privacy groups and the New England Journal of Medicine have filed briefs in support of Vermont’s law. The National Association of Chain Drugstores, the Association of National Advertisers and news organizations like Bloomberg and The Associated Press have filed briefs aligning themselves with the data firm.

Although a Vermont federal district court upheld the law after a lawsuit challenging the statute brought by IMS Health and the Pharmaceutical Research and Manufacturers of America, an appellate court overturned the decision suggesting that it violates free speech provisions afforded by the First Amendment of the US constitution.

It will be interesting to see how the “Supremes” adjudicate the appeal given the growing recognition that laws and regulations designed to control medical costs and minimize safety risks associated with newly approved drugs are becoming increasingly necessary.

Until next time...

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

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Big pharma continues to lament the increased scrutiny being imposed on it by the US Food and Drug Administration (FDA). Like it or not, the agency’s directive is to insure that the drugs that it approves are safe and effective for the American public. And, for the most part, the agency does its job and frequently catches companies that attempt to break the rules.

To that end, an article that appeared in FiercePharma last October noted that eleven big pharma companies had paid a total of over $6.0 billion in fines to the US government over the last two years or so. The biggest losers include Eli Lilly paid over $1.4 billion in fines because of alleged illegal marketing of its anti-psychotic drug Zyprexa and Pfizer which paid $2.3 billion for marketing missteps with three drugs including Bextra (pain), Geodon (schizophrenia) , Lyrica (neuropathic pain) and Zyvox (antibiotic). 

More recently, GlaxoSmithKline agreed to pay $750 million fine in a whistle blower lawsuit that alleged that the company had sold "adulterated products" manufactured in a Cidra Puerto Rico production facility. Also, the company announced last February that it intends to pay $3.4 billion to settle lawsuits alleging the improper promotion and sale of several of its products including the blockbuster diabetes drug Avandia and Paxil (depression).

The article also included a timeline of some of the other major settlements that have recently taken place (seen below)

Novartis
With: U.S. Attorney's office for the Eastern District of Pennsylvania
When: Sept. 30, 2010
Infraction: Novartis agreed to a $422.5 million settlement with the Eastern District of Pennsylvania for its off-label promotion of Trileptal and other allegations against Diovan, Exforge, Sandostatin, Tekturna and Zelnorm.

Forest Labs
With: Dept. of Justice
When: Sept. 15, 2010
Infraction: After marketing Levothroid, an unapproved thyroid drug, Forest Labs received its penalty, to the tune of $313 million. The settlement also covered Forest's off-label use of Celexa for children's use.

Allergan
With: Dept. of Justice
When: Sept. 1, 2010
Infractions: Allergan's $600 million Department of Justice settlement was broken into two parts: $375 million in fines and $225 million in civil penalties, all of which stemmed from its off-label use of Botox for headaches, pain management and cerebral palsy.

Elan
With: U.S. Attorney's Office in Massachusetts
When: July 15, 2010
Infraction: The Irish drugmakers received its $203.5 million fine for its marketing tactics of Zonegran, an epilepsy drug. Also, the company's U.S. branch pled guilty to a misdemeanor and the company will enter into a corporate integrity agreement with the HHS Inspector General.

Johnson & Johnson
With: Department of Justice
When: April 29, 2010
Infraction: Though J&J's more infamous woes stem from its phantom recalls, two of the troubled drug maker’s subsidiaries received a $81 million penalty for off-label promotions of Topamax, an epilepsy drug.

AstraZeneca
With: U.S. Attorney's office in Philadelphia
When: April 27, 2010
Infraction: In the same week as the J&J settlement, AstraZeneca was hit with a $520 million penalty for its antipsychotic, Seroquel. The company misled doctors and patients about the drug's safety.

Despite concerted efforts by the US Food and Drug Agency to limit off-label promotion of prescription drugs, most pharma companies continue to see how far they can push the envelope before the agency catches up with them. Given the current budget woes facing FDA, don’t be surprised if the frequency of off label promotion and misrepresentation of prescriptions drugs continue to rise.

Until next time...

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

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

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

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

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

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

Until next time...

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

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There has been some buzz on LinkedIn and Facebook about an article that appeared in the March 3, 2011 issue of Nature Magazine. The article entitled “Traditional Drug-Discovery Model Ripe for Reform” and basically chronicles the decline in emphasis being placed by most companies on traditional in-house drug discovery as a source for new candidate molecules. Also, it points out that most big pharma companies now agree that they are not good at drug discovery but excel in clinical development and marketing of new medicines. Industry’s new view of itself is supported by the fact that over 200,000 pharmaceutical and biotechnology workers—roughly 50% were discovery scientists—have their lost jobs in the past three years or so. This begs the question “who is going to discover the new molecular entities that large drug companies are going clinically evaluate and ultimately market? According to the article, academic researchers are likely to play a pivotal role in this newly emerging drug discovery paradigm. 

The new model proposed in the article goes something like this. First, all intellectual property rights for certain compounds will be lifted or removed. Compounds of interest would subsequently be evaluated in small clinical trials for safety and possible efficacy. And, interested drug makers would only compete with one another on specific molecules after they were deemed safe and potentially effective. Up until this point, all data on prospective drug candidates would be openly published and freely available to interested parties.

Proponents of the model contend that the approach would allow drug targets to be more quickly validated and developed less expensively because there would less duplication of research activities. Further, it would reduce the exposure of patients to experimental molecules that have already deemed to be ineffective. Interestingly, the new model would rely exclusively on academic scientists who would be supported by a global initiative that cost about $325 million per years— with half coming from the pharmaceutical industry and half from the public. Finally, drug candidates identified in the initial screening process would be available to companies that participate in the initiative (presumably to the company that invested the most?)

While the proposed model is clearly “wishful thinking” on behalf of academics who are struggling to win grant support, it is deeply flaw and was obviously proposed by academic scientists who lack a clear understanding of the industrial drug development process. First, intellectual property (IP) and patents are the life blood of the industry and are in fact what allows drug companies to prevent competition in certain therapeutic areas maximize their return on investment on the drugs that they develop. Therefore, it is highly  unlikely that any drug maker would agree to lift or suspend IP around a novel new molecule. Second, must academic scientists are not qualified nor trained to engage in industrial drug development. Unlike academic science, industrial research is highly regulated and must be performed according the regulations and guidelines established by various regulatory agencies like the US Food and Drug Administration. If the research is not conducted in a regulatory compliant manner, then the prospective new drug will not be able to win regulatory approval. Third, eliminating IP would prevent university tech transfer offices—which exist almost entirely to manage a university’s IP—from negotiating lucrative licensing deals with interested companies or other parties. This, in turn, would reduce the contribution of funds by technology transfer offices that is used to run many academic research centers. Finally, the model is based upon the assumption that academic scientists (unlike drug companies) willfully and freely share information with one another for the “common good.” However, based on my experiences as an academic for over 20 years, most scientists don’t subscribe to the level of altruism and philanthropy attributed to them in the article. In fact the ego-involvement and competition amongst academics is so fierce, that  many academic refuse to share important new information or breakthroughs with their colleagues until grants are funded or the data are published in peer reviewed journals. Put simply, most academics are trained to work by themselves in their own laboratories and are neither interactive nor collaborative by nature.

There is no question that the old industrial drug discovery model is in transition and a new one will ultimately emerge. However, the role of academics in the new model is likely going to be less than proposed in present article. Too many systemic changes would be required for this model to be effective. That said, providing graduate students and postdocs with training in regulatory affairs and new drug development could be a step in the right direction! Nevertheless, a better solution to the problem may be a greater role for government in new drug discovery and development. To that end, the UK Medical Research Council has established the Developmental Pathway Funding Scheme that supports the development of promising basic science research into new drugs and medical devices. Also, Francis Collins, the current head of the National Institutes of Health has proposed the creation of a National Center for Advancing Translational Sciences to transform basic science into prospective new drugs and treatments.

Despite the good intentions of the article, the path forward for academic scientists is not going to be easy. To make matters worse, it is becoming increasingly difficult for PhD-trained scientists to find jobs. That said, if you are truly interested in industrial drug discovery and development I highly recommend that you take some regulatory affairs course or enroll in a certificate or MS degree program in biotechnology that teaches the business side of the life sciences industry.

Until next time...

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

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BioJobBlog readers who understand Current Good Manufacturing Practices (CGMP) for pharmaceuticals and biologics know that the US Food and Drug administration is mandated to review approved drug manufacturing facilities once every two years. While this is the mandated inspection schedule, most industry insiders know that manufacturing plant inspections now take place once every three or more years. This has resulted because of an increased reliance by US drug makers on foreign manufacturing facilities to produce licensed pharmaceuticals and biologics, a lack of regulatory oversight by the agency during the Bush administrations and funding shortfalls that have resulted in a shortage of FDA inspectors.

Congress recently took the agency to task about a lack of oversight for food and drugs manufactured in foreign countries. In September, the Government Accountability offices reported that FDA inspects foreign drug facilities on average once every nine years as compared with every 30 months or more with US plants. To correct this, FDA announced that it aims to increase reliance on third party inspectors in other countries to maintain better oversight of ex-US manufacturing plants. In other words, it is less costly to train and work with inspectors already in foreign countries rather than send US inspectors overseas.

In a post last week on the Pharmalot Blog, Ed Silverman reported that Bloomberg News reviews almost 10,000 inspections at US manufacturing plants from 2000 until September 30, 2010. While the Bloomberg report did not provide details on the frequency and nature of violations uncovered at the inspections, the results of the reports were eye-opening. According to Ed:

“The FDA makes 0.9 visits, on average, to each facility each year, compared with 0.6 visits annually when George W. Bush was in the White House. Looked at another way, the agency NOW visits each of the 2,567 plants registered in the US almost once a year.”

Further he noted:

“Some of the biggest drugmakers do not have a good track record when it comes time for FDA inspectors to visit their plants. Overall, the FDA found violations at 54 percent of plants inspected last year, up 20 percent from a decade low in 2007, according to data obtained from the agency by Bloomberg News. And 80 drugmakers failed more than half of their inspections.”

So, which companies had the poorest inspection track records? Ed noted

“Abbott Labs failed 59 percent of 111 inspections; Pfizer flunked 57 percent of 202 inspections; Merck bombed out on 52 percent of 134 visits and Johnson & Johnson failed 48 percent of 161 inspections. By contrast, [generic drug manufacturer] Mylan passed 79 percent of 56 inspections!”

Republicans are threatening to slash FDA funding for US inspections mainly because the agency is focusing more on overseas manufacturers and suppliers. In response to the funding cut threats, the Obama Administration proposed that drug manufacturers whose production plants fail inspections would be required to pay fines of roughly $49,000. At present, there are no mandatory fines levied against drug makers that fail FDA inspection (the agency can and does impose fines if companies that fail inspections refuse or are reluctant to fix the problems that were uncovered).

I find it interesting that despite the numerous drug recalls and problems with drug safety of approved drugs over the past few years that the Republicans, could in good conscience, threaten to cut FDA funding to increase the frequency of inspections to bring them in line with the mandated once every two years rather than once every 2.5 to 3.0 years that has been the norm for the last decade.

Until next time....

Good Luck and Good Job Hunting!!!!!

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The Japanese drug maker Eisai, Co announced that it will cut at least 900 jobs over the next five years to improve operating margins to offset the impending lost of patent protection for Aricept its blockbuster Alzheimer’s  disease treatment. The company did not specify where the cuts would take place.

In other news, based Eli Lilly & Co announced plans to outsource its R&D bioanalytical functions to Advion Biosciences a contract research organization that is building new laboratories Lilly’s home town of Indianapolis, Indiana. Ithaca NY-based Advion is building a 22,000 sq ft facility that will focus on ADME and toxicology experiments that are required for new molecules to enter human clinical testing.

Advion offers a range of Good Laboratory Practice-compliant and discovery bioanalytical services, including liquid chromatography-tandem mass spectrometry (LC/MS/MS) for determining small-molecule drugs, macromolecule therapies and biomarkers; immunoassay services; ADME (absorption, distribution, metabolism, and excretion) screening; cytochrome P450 inhibition and induction study support; metabolism profiling; metabolite identification; sample management; and sample storage.

According to a press release:

 “Lilly will transition its own drug discovery bioanalytical capabilities to Advion and will offer employees affected by the move the opportunity to join Advion. The new laboratory is expected to be fully operational by the end of May 2011.”

This is another example of big pharmaceutical companies exiting the R&D space. Because of the rampant downsizing and outsourcing of R&D functions to CROs, now could be one of the better times in years to start a biotech company. Big pharma is relying on starts up companies and academic laboratories to be the major source of new molecules that they develop. That said, the age of big “in-house” drug discovery operations at big pharmaceutical companies is drawing to an end. 

Until next time...

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

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Despite assertions to the contrary, scientists are pretty much like most other people. They eat, sleep, work, party and for the most part are social creatures. Therefore, it should come as no surprise that scientists are also susceptible to hype and succumb to research “fads.” In my former life as an academician, these fads were not so obvious and, for the most part, they unobtrusively helped to advance scientific research. However, after I abandoned academia for the private sector, these fads became blatantly obvious to me.  And, for the most part, were primarily driven by potential profits rather than advancing scientific knowledge for the common good.

First, there was combinatorial chemistry in the mid-1990s. Honestly, I never understood the hubris of the pioneers in this field who thought that by randomly mixing chemicals in a laboratory they could outdo nature when it came to creating new drugs. Nevertheless, the combinatorial chemistry fad over time resulted in high throughput screening, laboratory automation and sophisticated assay development technologies which serve as the foundation for modern drug discovery and development.

Next, there was the Human Genome Project that was supposed to provide drug developers with a plethora of previously undiscovered, potential new drug targets. While sequencing the human genome did provide scientists with a treasure trove of new biological targets, drug makers quickly ascertained that progress in drug discovery was not being hindered by the lack of targets but by a dearth of new drug candidates! Ironically, the lack of drug candidates resulted mainly from abandoning natural product drug discovery in favor of combinatorial chemistry. Like combinatorial chemistry, sequencing the human genome helped to improve DNA sequencing technology, sequence analysis and ushered in the fields of genomics and bioinformatics.

After the human genome was sequenced, scientists began to focus on the fields of computational biology and molecular modeling to help to discover and develop new drugs. While computational biology and molecular modeling yield some small successes, its use in drug discovery and development was limited. Ultimately, these fields morphed into something called translational science or medicine; a discipline that I don’t fully understand.

Finally, in the early 2000s, RNA interference (RNAi) became the technology du jour. RNAi was a powerful laboratory-based discipline that was sexy enough to garner its creators a Nobel Prize. Because of this, many drug companies had high hopes for RNAi and quickly jumped on the RNAi bandwagon. Billions of dollars were invested in the technology with the hope that RNAi would speed new drug discovery and also yield new drug candidates. At the outset, it was clear to many industry experts that RNAi molecules would be difficult to develop as new drug candidates. This is because RNAi molecules are difficult to deliver to cell-based targets and have short biological half lives. Despite these obvious shortcomings, many venture capitalists and large drug companies adopted a “damn the torpedoes, full-speed ahead” attitude and invested countless dollars and hours into RNAi research.  A doubter from the beginning (and pretty vocal about it too), I was not surprised to read an article in today’s Science Times entitled “Drugmakers’ Fever for the Power of RNA Interference Has Cooled” which describes the likely demise of RNAi as a source of new drug candidates.

Today, the new fad appears to be personalized medicine. While I don’t think that personalized medicine is yet “ready for prime time” I believe that it will become a commercial and medical reality in the next 10 to 20 years. Yet, despite lessons learned from past research fads, personalized medicine is being over hyped and oversold by the scientific and medical communities as well as the lay press.

Fads come and go in science as they do in real life. After all, we scientists are humans! That said, scientists are obliged to “go where the data takes you rather than where you (financially or intellectually) want it to go.  If scientists fail to live by this credo, countless research hours will be spent on ideas that cost a lot but yield little.

Until next time..

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

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According to a post on the Pharmalot Blog, Abbott Laboratories today announced that it will eliminate 1,900 jobs or six percent of its workforce. The company cited its thinning pipeline and the current challenging regulatory environment for the corporate reorganization and downsizing. In other words, we are having trouble getting our new drugs approved and we can’t afford to continue to pay people’s salaries and benefits who aren’t delivering for us. The Pharmalot post didn’t provide specifics on the layoffs.  However, Lisa Madden a Delta  Pharma Recruiter and BioCrowd member  sent me a message and told me that 1,000 of the layed off workers were onsite employees and the remaining 900 were sales reps

Like it or not, this is the new reality for life sciences R&D types, So, if I were a  graduate student or postdoc considering a career in the life sciences industry, I highly recommend a well developed and carefully thought out “Plan B.”

Until next time,

Good Luck and Good Job Hunting!!!!!

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Aptuit, a drug discovery and development company announced that it will be cutting 340 jobs in Scotland over the next year. The company cited the worldwide economic downturn as the culprit. Likewise, the Austrian vaccine maker Intercell announced that it would be laying off an unspecified number of employees and dramatically cutting R&D expenses (by 40%) after it killed development of its enterotoxigenic Escherichia coli vaccine patch. The company pulled the plug on the vaccine after it failed to reduce the incidence of diarrhea in a randomized and placebo-controlled Phase III study involving 2036 participants.

On the bright side, PPD, a global contract research organization, announced that it plans to invest $28 million to expand its Lab Services Division in Henrico County, Virginia and add 190 new jobs over the next three years. 

Until next time...

Good Luck and Good Job Hunting (try Virginia)!!!!!!

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Pfizer today announced that it will purchase Bristol, TN-based King Pharmaceuticals for $3.6 billion in cash or $14.25 per share: an approximately 40% premium over King’s closing share price yesterday.

King is a diversified specialty pharmaceutical drug delivery and clinical development company with expertise in delivery of easy to abuse or misuse pain medicines, self injecting delivery devices and animal health

The acquisition will help Pfizer push forward with its new emphasis on biopharmaceuticals and rare disease drugs; both currently require parenteral administration to patients.

The King acquisition is consistent with Pfizer’s M&A strategy to enter new therapeutic areas and markets. In the last 10 years or so Pfizer has acquired Warner Lambert, Pharmacia, Wyeth and several smaller companies including Sugen, Copely Pharmaceuticals, Encysive Pharmaceuticals, Serenex and others.

Whether or not Pfizer can successfully integrate King’s expertise and business units into its existing monolithic corporate structure remains to be see. Pfizer is still trying to right itself after it acquired Wyeth Pharmaceuticals for $65 billion early last year.

Big pharma companies—flush with cash—have been on a buying spree of late. Unfortunately, the availability of this cash is directly related to the massive downsizing and layoffs that have taken place in the industry over the past few years. That said, if I were a King employee, I would be dusting off my resume!

Until next time

Good Luck and Good Job Hunting

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The pharmaceutical industry, not unlike all big business during the disastrous Bush Administration, was virtually unregulated. Bush and his cronies managed to accomplish this feat by destabilizing the US Food and Drug Administration (FDA) and essentially hamstringing any regulatory authority that it had. Not surprisingly, many pharmaceutical companies saw an opportunity to increase their bottom lines by engaging in off label marketing of many of their approved drugs—a practice clearly forbidden by the agency. 

Despite the fact that off label marketing is illegal, many big pharma companies knowingly and willfully engaged in the practice. Luckily, the Obama administration has reinvigorated and restored the regulatory powers at the agency and FDA is now aggressively investigating and punishing companies that had promoted off-label use of their products over the last decade.

The New York Times today reported that Novartis joins a growing list of pharmaceutical companies that have settled government investigations into health care fraud in the last few years, including Pfizer, which paid $2.3 billion; Eli Lilly, $1.4 billion; Allergan, $600 million; AstraZeneca, $520 million; Bristol-Myers Squibb, $515 million; and Forest Laboratories, $313 million. Pfizer, Lilly, Allergan and Forest pleaded guilty to crimes in the cases. The company was fined $422 million settle criminal and civil investigations into the marketing of the antiseizure medicine Trileptal and five other drugs. 

According to the article, the five other drugs involved in the civil settlement are Diovan, a hypertension drug that is the company’s top-selling product, at $6 billion last year; Sandostatin, a drug to treat a growth hormone disorder that had worldwide sales of $1.2 billion last year; Exforge, a hypertension drug that sold $671 million; Tekturna, a blood pressure medicine that sold $290 million; and Zelnorm, a medicine for irritable bowel syndrome and constipation that was later withdrawn from the United States market.

It is important to make a distinction between the practices of off-label drug use and off label marketing. As many of you may know, licensed US physicians are allowed to prescribe any FDA-approved drugs if they believe that their use will benefit patients. This is off-label drug use. However, in contrast, it is illegal for companies to actively promote or market approved drugs for therapeutic indications for which they have not received regulatory approval. This is off-label marketing and a strategy that has been used by companies to increase sales of approved products without having to spend money on expensive clinical trials that are required to prove safety and efficacy for a new drug to gain regulatory approval. While this may be a backdoor strategy for companies to boost product sales, it clearly puts patients at risk because the actual safety and efficacy for the indications has not been adequately tested and proven.

Many drug makers have been critical of FDA’s increase scrutiny of drug safety and have argued that it has negatively impacted the regulatory approval rates of new experimental medicines. While this may be troubling to many pharmaceutical executives, the FDA was created to insure that all approved drugs are safe and effective and the risk to Americans who use them is minimal. In other words, the agency is simply doing its job—something it was prevented from doing for the past eight years!

Until next time,

Good Luck and Good Job Hunting!!!!

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When I saw one of today’s headlines, ‘FDA Warns on Increased Death Risk with Pfizer Antibiotic’ I immediately dropped what I was doing to read the article. Expecting the worse, I learned that the US Food and Drug Administration (FDA) announced today that it was modifying the label for Pfizer’s antibiotic called Tygacil.

The reason for the label changes was new clinical information that showed that patients with ventilator-associated pneumonia (VAP) and diabetic food infections that are treated with Tygacil are at increased risk of death as compared with those treated with other antibiotic treatments.

"The FDA said it looked at 13 trials with patients given Tygacil for both approved and unapproved indications by type of infection comparing the overall mortality for Tygacil with other antibiotics. Overall, the studies showed death occurred in 4% of patients receiving Tygacil, or 150 out of 3788, and 3% of patients, or 110 of 3646, receiving comparator antibiotics."

While I didn’t find the difference in the mortality rates that shocking, it is important to point out that Tygacil is not an FDA-approved treatment for either VAP or diabetic foot infections. Nevertheless, the antibiotic is routinely used by many infectious diseases physicians as a treatment for both infections. This is because many VAP and diabetic foot infections are caused my multiple drug resistant bacteria and physicians are willing to resort to unapproved treatments (like Tygacil) to treat high risk patients. Put simply, there is generally little choice; either use Tygacil or the patient may die! 

Further, the 1% difference in mortality rates between Tygacil and other antibiotics may not be clinically significant because many of the treated patients are seriously ill and near death anyway. Finally, differences in the mortality were based on retrospective results from clinical studies that were designed to assess the safety and efficacy of Tygacil for indications other than VAP or diabetic foot infections. Consequently, it is difficult to conclusively say whether or not Tygacil is less safe than other antibiotics to treat patients with severe bacterial infections like VAP and diabetic foot.

Nevertheless, Tygacil's label has already been updated to warn doctors about the possible death risk. Pfizer sent a letter dated July 26 to health care professionals detailing the new label. The label change is listed below:

"Alternatives to Tygacil should be considered in patients with severe infections. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:"

The bottom line: the jury is still out on the safety and efficacy of Tygacil as a treatment for VAP and diabetic foot infections. This can only be determined when well controlled, statistically-relevant clinical trials are designed and conducted. While FDA was correct to insist that Pfizer send a note to infectious diseases physicians alerting them of possible increased risks, I don’t think that the label change was newsworthy enough to earn the headline ‘FDA Warns on Increased Death Risk with Pfizer Antibiotic’ It is a shame that journalists continue to insist on publishing sensationalistic and often times inaccurate scientific headlines. While it may garner some additional readers, it does little to instill American confidence in our public health system.

Until next time...

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

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Despite the brouhaha surrounding the publication of an article about new South Asian strains of antibiotic resistant bacteria that carry the NDM-1 gene, some good may actually come from it. The Pharmalot Blog reported today that an article entitled “Are You Ready for a World without Antibiotics” appeared in the UK’s Guardian newspaper just two days after the first report about NDM-1.

While the Guardian piece is a little heavy handed in parts, it does a good job accurately portraying the growing lack of antibiotics left in the armamentarium to treat infections caused by many drug resistant Gram positive and Gram negative bacterial pathogens. As I have noted numerous times before, large pharma, for the most part, quietly exited antibiotic drug discovery and development in the late 1990s. 

Only a handful of biotechnology companies are developing new drugs to combat infections caused by antibiotic resistant bacteria. Unfortunately, many of these companies have hit regulatory snags for these drugs and the likelihood of approval is questionable. And if something isn’t done soon e.g. government funded initiatives, people may begin to succumb to bacterial infections at rates that haven’t been seen since the pre-antibiotic era which ended in the 1940s.

Until next time...

Good Luck and Good Job Hunting!!!!!

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Despite assertions by its CEO that there isn’t enough scientific talent in the US, Eli Lilly announced that it will lay off a couple of thousand employees within the next 90 days. Most of the cuts will take place in Indianapolis at four different sites where the company currently employees about 13,000 workers. According to an article in today’s Indianapolis Star

“The struggling Indianapolis company, which has been cutting thousands of jobs in recent months, told the state on Monday that its downsizing is not temporary, but for the long haul.

The reductions in force at the Indianapolis sites of employment are expected to be permanent," wrote Kay Jackson, Lilly's senior director of human resources, in a letter to the Indiana Department of Workforce Development. She added that the cuts, when added up, are not expected to be more than 33 percent of the head count at any one site, or more than 500 workers at any site."

Like most of its rival big pharma companies, Lilly has cut the number of full-time equivalent workers by about 2,100 worldwide since last September. That's when it announced it would cut a total of 5,500 workers worldwide by 2011 to save $1 billion in annual costs. The reason for the cuts; an expected steep falloff in revenues over the next few years when the patents on Lilly's blockbuster drugs begin to expire and face low-priced generic competition  

John C. Lechleiter, Ph.D, Lilly’s CEO, contends that the lack of innovation and new product development at most American pharmaceutical companies can be explained by a dearth of qualified and adequately trained American scientists. Maybe this is why most pharma R&D job are currently being outsourced to China, India, Brazil and Eastern Europe? Alternatively, it may be cheaper to employ US-trained foreign nationals in these places rather than high priced American scientists who perform similar jobs in the US.  

Until next time...

Good Luck and Good Job Hunting (forget Indiana-not there is anything wrong with it)

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

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

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

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

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

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

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

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

Until next time...

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

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For many years, I taught medical students that the emergence of antibiotic resistant strains of bacteria primarily resulted from the overuse and misuse of antibiotics by physicians. While this seemed to make sense, I started chatting in the late 1990s with Steve Projan— a well known and highly respect maven on bacterial antibiotic resistance—who told me that the physician story was an urban legend and that the main reason for the emergence of antibiotic resistance was directly related to the use of antibiotics as growth enhancers in livestock feed. Not surprisingly, shortly after my conversations with Dr. Projan, papers began appearing in the literature that corroborated the claims.

Despite a growing body of convincing scientific evidence, the Bush administration did nothing to regulate or reduce the use of antibiotics in live stocks feeds in the US for almost a decade. Last year it is estimated that 35 million pounds of antibiotics were used in the US. Interestingly, 70% were used in cows, chickens and pigs. It is important to point out that the US isn’t the only culprit; recent estimates suggest that 50% of the global antibiotic supply is used by the livestock industry. Recognizing a growing problem, the European Union and other developed countries (not the US) have adopted strong limits on the use of antibiotics for livestock purposes.

Thankfully, the pressure against the use of antibiotics in agriculture and livestock production is rising. The World Health Organization concluded this year that surging antibiotic resistance is one of the leading threats to human health, and the White House last month said the problem is "urgent." Also this year, the three federal agencies tasked with protecting public health — the Food and Drug Administration (FDA), CDC and U.S. Department of Agriculture — declared drug-resistant diseases stemming from antibiotic use in animals a "serious emerging concern." And, this past summer, FDA deputy commissioner Dr. Joshua Sharfstein told Congress that farmers need to stop feeding antibiotics to healthy farm animals.

Pharmaceutical companies and agricultural lobbyists argue that antibiotics keep animals healthy and meat costs low, and have successfully help to defeat a series of proposed limits on their use. To that end, in 2009, drug makers spent $135 million and agribusiness companies another $70 million, lobbying against new limits on the use of antibiotics as livestock growth enhancers. FDA official say that without new laws the agency’s options are fairly limited. Ironically, the agency approved antibiotic use in animals in 1951, before concerns about drug resistance were recognized. And, the only way to withdraw that approval is through a drug-by-drug process that can take years of study, review and comment.

Previous attempts by FDA to limit antibiotic usage have consistently met with limited success. For example, in 1977 the agency proposed a ban on penicillin and tetracycline in animal feed, but it was defeated after criticism from interest groups. In 2000 FDA ordered the antibiotic Baytril (used in the poultry industry) off the market. Five years later, after a series of failed judicial appeals, poultry farmers finally stopped using the drug as a growth enhancer. Finally, in 2008 the FDA issued its second limit on an antibiotic used in cows, pigs and chickens, citing "the importance of cephalosporin drugs for treating disease in humans." But the Bush Administration — in an FDA note in the federal register — reversed that decision five days before it was going to take effect after receiving several hundred letters from drug companies and farm animal trade groups.

Luckily, we now have a President who believes in regulation of big business to protect the health and welfare of Americans and is smart enough to make the scientific connections between emerging antibiotic resistance in animals and human. Maybe some real change will be coming soon....one can only hope!!!!!!!!!!

Hat tip to Ed at the Pharmalot Blog

Until next time...

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

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Johnson & Johnson today announced it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for ceftobiprole. The agency requested additional information and recommended additional clinical studies be conducted in order to consider a future approval of ceftobiprole in this indication. J&J’s New Drug Application (NDA) for ceftobiprole was originally submitted to the FDA in May 2007 for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot infections.  The company received an approvable letter in March 2008 and submitted what it thought to be the necessary information necessary to garner approval of the new antibiotic

Ceftobiprole is a novel, broad-spectrum, anti-MRSA cephalosporin with activity against methicillin-resistant Staphylococcus aureus (MRSA), penicillin-resistant Streptococcus pneumonia and many clinically important Gram-negative bacteria, including Pseudomonas. The antibiotic was licensed from Swiss-based Basilea Pharmaceutica Ltd. in February 2005. 

The regulatory review process is ongoing in Europe and other countries for the use of ceftobiprole in adults for the treatment of complicated skin and skin structure infections. Ceftobiprole is approved in Canada, Switzerland, Russia, Azerbaijan, Ukraine and Hong Kong.

J&J intends to discuss the best path forward with the FDA as soon as possible. New antibiotics are necessary to combat the growing trend of multiple drug resistant strains of bacteria that are responsible for an increasing amount of bacterial infections.

Until next time...

Good Luck and Good Job Hunting!!!!

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

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

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

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

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

Until next time...

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

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The 2009 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) is currently taking place in San Francisco. For those of you who may not know ICAAC, is an annual meeting mainly attended by infectious disease physicians and researchers where the latest and most cutting edge research on infectious agents is reported. Things must have been a little slow at this year’s meeting (except for H1N1 of course) which led the newswires to pick up a story about the isolation of methicillin resistant Staphylococcus aureus  (MRSA) at public beaches in Washington State. While MRSA infections are certainly a public health concern, particularly among infants, older adults and immunocompromised individuals finding MRSA at public beaches isn’t particularly surprising nor newsworthy.

S. aureus is an opportunistic pathogen that isn't particularly virulent and is incapable of causing disease unless it is accidentally introduced into a wound, surgical incision or similar environment. In humans, the bacterium colonizes mainly the nasal passages, but it may be regularly found in most other anatomical locales, including the skin, oral cavity and gastrointestinal tract. Epidemiological studies have demonstrated that over 70% of people transiently carry S. aureus in their nasal passages at one time or another in their lives. This means that S. aureus is very common and ubiquitous in human populations. Consequently, I wasn’t surprised when I learned that Seattle researchers had isolated S. aureus at public beaches in Washington State. Nor was I shocked to learn that some of the isolates were MRSA strains!  After all, the incidence of methicillin-resistant S. aureus has been steadily increasing in the US and elsewhere for the past 20 years. And, healthy people who carry MRSA (and regularly shed it from their bodies) do like to go to beach and lay in the sand when the weather is warm. That said, I would have flabbergasted if the researchers didn't isolate MRSA from the beach sand samples that they surveyed. As an aside, I want to let my readers know that I isolated S. aureus from a soil sample while an undergraduate microbiology  major at Cornell University. Finally, while some MRSA infections can be fatal, those that are diagnosed correctly and early are usually easy to eliminate with conventional antibiotic regimens.

Because the work mentioned in the ICAAC press release hasn’t been published, it is  difficult to evaluate the results and implications of the study's findings.  Nevertheless, I don’t think it was prudent for the scientists who conducted the research to issue a press release about finding MRSA at public beaches—especially when the American public is already jittery about infectious agents like H1N1. If the authors’ intent was to make a big splash (pun intended) by mentioning the “dreaded MRSA” in their press release, they were successful—the story is all over the news. However, in my opinion, we are obliged as scientists to accurately inform the lay public about important scientific and public health issues—not play into its worse fears and misconceptions about them.

Until next time...

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

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There are many natural products from animals, plants, fungi and bacteria that possess antibacterial properties. This makes complete sense from an evolutionary standpoint. Therefore, it should comes as no surprise that spices like cinnamon and natural products like honey possess inherent antibacterial properties. Nevertheless, despite my over 30 years as a card-carrying bacteriologist, I always pleased and pleasantly surprised when I learn that a common substance like cinnamon oil has potent antibacterial activity against antibiotic-resistant bacterial pathogens.

A recent study showed that a cinnamon oil solution was capable of killing a variety of nosocomial bacterial pathogens including Streptococcus pneumoniae and methicillin-resistant Staphylococcus aureus (MRSA). Moreover, the cinnamon oil appeared to be as effective as several antiseptics and disinfectants widely used in many hospitals. And, this isn’t the first report on the antibacterial effects of cinnamon oil. In a 2008 study, French researchers showed cinnamon oil solutions of 10% or less were effective against S. aureus, Escherichia coli and several antibiotic resistant strains of bacteria.  Further, there is a precedent for the use of cinnamon-derived products as an antiseptic. In the Middle Ages thieves who stole jewelry from dead bodies and used “thieves oil”—a concoction consisting of cinnamon bark, lemon oil and eucalyptus—rarely got ill. Finally, cinnamon oil when topically applied to the skin is generally safe. However, in some people it can cause an allergic reaction.

This is good news for a country that has grown increasingly obsessed with chemically-based antibacterial soaps and sanitizers whose overuse may actually be selecting for the emergence of strains of multiple antibiotic resistant bacteria. Nevertheless, the use of natural antiseptics like cinnamon and other plant oils as sanitizers may help to reduce the growing incidence of  drug resistance among nosocomial bacterial pathogens.

Until next time....

Good Luck and Remember to Wash Your Hands (with plain soap, not antibacterial-containing products!)

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The media frenzy surrounding the impending H1N1 swine flu pandemic has spawned a recent spate of articles and television news segments on “germs.” In the last 48 hours, articles on germs have appeared in the New York Times, my local paper (The Trenton Times via the Chicago Tribune), on news channels and most recently this morning on the Today Show on MSNBC. Most of these have focused on where “germs” are found, how they are spread and ways to minimize or prevent their transmission. For those of you who may be interested, the word germ was first coined in 1664 and is defined as a “small mass of living substance capable of developing into an organism or one of its parts” or more conventionally, as a “microorganism that causes disease.” While these media pieces are intended to inform the public about infectious agents and their transmission, most people who read or see these reports don’t understand that the word germ can encompass viruses, bacteria and fungi. And, to make matters worse, most Americans don’t know that viruses, bacteria and fungi are different microorganisms.

Unfortunately, after reading newspaper articles and seeing reports on television about so-called germs, many consumers rush out to their local groceries and purchase a variety of antibacterial soaps and detergents—erroneously believing that these products will protect their families from infection by the dreaded H1N1 virus and other pathogens. Although frequent hand washing and the appropriate use of viricidal disinfectants can help to reduce transmission of H1N1 and other viruses, antibacterial products are generally less effective (or ineffective) against viruses and overuse can result in emergence of multi-drug resistant bacteria.

To that end, I think it is high time that the news media eschew the use of the anachronistic term germ in favor of bacteria, virus or fungi when referring to causative agents of infectious diseases. Promulgating the use of the word germ will continue to keep the lay public in the dark about infectious agents and the diseases they cause and hinder people from making informed decisions about treatment and preventing their transmission.

Until next time...

Good Luck and Good Job Hunting!!!!

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It’s no secret that major pharmaceutical companies are no longer investing in internal drug discovery initiatives as much as they have in the past. However, I was unaware how drastic the decline in R&D spending was until I read an article entitled “Significant Change Predicted for Bioindustry” by Benjamin J. Conway in the July issue of Genetic Engineering & Biotechnology News. 

Mr. Conway notes that in 1989 more than 50% of the pharmaceutical industry’s budget was spent on preclinical drug discovery and development. During the 1990s, the percentage slowly declined and was approximately 44% by 1999. He asserts that beginning in 2000, “the drop became precipitous” as pharmaceutical companies spent increasing amounts of their R&D budgets on downstream activities including expanded clinical trials. By 2006, big pharma was spending about 25% of its budget on R&D. Strikingly, Mr. Conway contends that “when measured in terms of constant absolute dollars, spending on pre-clinical R&D activities actually declined 0.4% annually over the period, despite annual increases of nearly 7% in total R&D spending.” 

Not surprisingly, the almost decade-long decrease in pharmaceutical R&D spending is best reflected in the lack of new drug approvals over the past five years or so. According to Mr. Conway, throughout the 1990s more than 50% of all new drug approvals originated at big pharma companies. By 2001, these companies were responsible for approximately 60% of new drug approvals. However, since then, pharma’s new drug approvals have plunged to 25% to 30% of annual totals. Some analysts suggest that the figure has been as low as 15%. The decline in new drug approvals almost parallels the decrease in R&D spending at most major pharmaceutical companies. Many industry analysts and thought leaders contend that big pharma companies have gotten too big and unwieldy and can no longer innovate. The unprecedented drops in pharma’s new drug approval rates tend to support that assertion. Mr. Conway points out that the so-called “innovation gap” has been filled by biopharmaceutical companies that “today account for 75% or more of new therapeutics developed each year.”

These changing market dynamics suggests that big pharma must reconfigure the business model that it has clung to for the past 50 years to remain competitive. Not surprisingly, almost all of the major pharmaceutical companies have begun to do just that! For example, over the past three years more than 60,000 R&D scientists have lost their jobs with little likelihood that the vacated jobs will ever be resurrected. Further, big pharmaceutical companies have increasingly begun to outsource many R&D activities to Asia, Eastern Europe and elsewhere. Finally, most big pharma companies have publicly demonstrated—through mergers and acquisitions—that biotechnology products as well as small molecules are in their future.

While big pharma may be retrenching and evolving, don’t expect the pharmaceutical industry on internal drug discovery initiatives —or small molecules for that matter— to disappear any time soon. The industry is going through a transitional period and the companies of the future will look only slightly different than they do today. These companies will still be large and well capitalized, but likely more diversified in their product portfolios (which will surely contain biotechnology drugs). Also, they will continue to excel in new product development, marketing and distribution. However, unlike the past, much less emphasis will be placed on internal R&D programs to discover new molecular entities. This means that pharmaceutical R&D operations will remain lean and companies will increasingly rely on M &A and licensing deals (with smaller specialty pharma and biotechnology companies) to keep their pipelines full.

Until next time...

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

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The drug maker Eli Lilly and Co quietly launched a new website today for a program dubbed Lilly Phenotypic Drug Discovery Initiative or PD². According to the company, “The PD² initiative is a unique opportunity for investigators from external institutions to submit proprietary compounds for potential screening in Lilly's phenotypic assay panel. This highly collaborative process is enabled by a web-based application that facilitates efficient transfer of information between Lilly and the investigator. The PD² screening panel is currently comprised of five modules which are relevant to therapeutic areas of long-term strategic interest, including oncology, neurological disorders, and metabolic diseases. This panel may change over time to reflect additional research interests.”

Company officials believe that program will allow it to evaluate and possibly license treatments from biotech companies and academic institutions "that are never fully evaluated as potential drug candidates." The launch of the PD² website—perhaps the first of its kind—clearly sends a signal that pharmaceutical companies are reducing their reliance on internal discovery programs to identify prospective new molecular entities and are eager to enter into licensing deals to find and acquire them. 

Membership in the PD² requires that a legal representative from the investigator's academic institution or biotech company executes a Material Transfer Agreement (MTA). Once the MTA is reviewed and approved by Lilly officials, the institution can create an account. Until that time, use of the site is limited to browsing only. I have no doubt that technology transfer offices at most major universities will be signing up for membership in short order.

I think the PD² initiative is an innovative and timely one given the massive reductions in R&D jobs that have taken place at many pharma companies over the past two years. Expect other pharma companies to follow Lilly’s lead.

Until next time....

Good Luck and Good Job Hunting!!!!!

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A much-anticipated Federal Trade Commission (FTC) report was released on Wednesday that will likely help House Energy and Commerce Chairman Henry Waxman bolster support for his fledgling follow-on biologics (FOB) bill. For those of you who haven’t been closely following the debate over proposed legislation to create a regulatory framework for approval of FOBs in the US, I provide a brief synopsis.

The Promoting Innovation and Access to Life-Saving Medicines Act (H.R.1427) introduced by US Representatives Henry Waxman (D-CA), Frank Pallone (D-NJ) and Nathan Deal (R-GA) calls for an abbreviated development pathway (at the discretion of the agency), the possibility of substitution or interchangeability (if the follow-on biologics manufacturer can prove a high degree of structurally similarity and an identical mode of action) and five years of data exclusivity. In contrast, The Pathways for Biosimilar Act (H.R. 1548) introduced by US Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA) and Joe Barton(R-TX) requires clinical data, rigorous immunogenicity testing and limits on interchangeability and substitution provisions for follow-on biologics. Further, it calls for a minimum of 12 or up to 14 years of data exclusivity for innovator companies—a period during which FDA can’t rely on innovator data to approve follow-on biologics. For example, if a biotechnology drug was approved in 2009, the earliest that FDA could consider and approve an application for a competing follow-on product is 2021.

The FTC report concluded that a 12- to 14-year wait is unnecessary because follow-on biologics will not be offered at the same steep discounts as traditional generic drugs. It also pointed out that no evidence exists that biologic patents will not hold up. The agency estimates follow-on biologics would be sold at discounts ranging from 10 percent to 30 percent. Not surprisingly, the FTC did not recommend a specific number of exclusivity years. This allows legislators to continue to squabble and debate the point ad nauseum, until concessions are made by both innovator and follow-on biologics proponents.

The measure by Eshoo and Barton has garnered 88 co-sponsors, while Waxman and Deal's bill has 11. In the Senate, the Health, Education, Labor and Pensions Committee reached a bipartisan compromise on follow-on biologics in 2007 that allowed for 12 years of exclusivity, but that deal seems unlikely. Democrats are trying to address generic firms' concerns that brand companies could make slight changes to their products and start the exclusivity period over again. Some senators introduced a more generic-friendly bill like Waxman's earlier this year.

Conventional wisdom suggests that the data exclusivity provisions in the final legislation will be five years—a period identical to that provided stipulated in the 1984 Hatch Waxman Act, which created the US generic pharmaceutical industry. 

Stay tuned for new updates on this unfolding drama!

Until next time...

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

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Since 2007, approximately 80,000 pharmaceutical jobs have been eliminated. The recent consolidation in the industry, e.g., Merck-Schering, Pfizer-Wyeth and Roche-Genentech suggests that many more life sciences jobs will be lost over the next year or so. Typically, to avoid law suits and possible discrimination claims, most companies will layoff a mixture of experienced and entry level employees that cover the racial, religious and age spectra. For those of you who may not know, Americans who are 40 and older constitute a “protected class of employees.” In other words, companies that layoff employees cannot disproportionately give pink slips to employees 40 years of age or older. This law was enacted because older employees typically have higher salaries and have accrued more benefits and vacation time than their more junior counterparts and eliminating them can drastically cut costs. While most companies are careful to layoff a mixture of junior and senior employees during large layoffs, a quick perusal of the demographics of employees who lose their jobs reveals that many of them are older, more experienced workers. Sacrificing a few entry level employees (to prevent any red flags) is worth it to the accountants who charged with cutting costs and orchestrating large corporate layoffs.

Unlike consumer goods, pharmaceutical and biotechnology drug development is arcane, complex and may take up to 15 years to complete. There are many “go” or “no go” decisions that must be made during the drug development process. Typically, these decisions are rendered by experienced employees who have been “down the road” many times before and are able to recognize the oft-time nuanced attributes of successful drug candidates. Without the benefit of these employee and their experiences, drug companies may struggle to make the “right decisions” for new products being developed. Also, the loss of experienced employees can disrupt the flow of essential “corporate knowledge” to entry level and more junior employees. This is important because— while most entry level and junior employees are academically and technically qualified—it usually takes them years (under the tutelage of mentors and senior employees) to understand a company’s best practices. Put simply, the unrelenting loss of experienced pharmaceutical workers can alter the standing or dominance of pharmaceutical companies in certain therapeutic areas. While massive layoffs of experienced pharmaceutical employees bolster drug stock prices in the short term, the long term effects of these layoffs on the overall health of the pharmaceutical industry remains uncertain.

Jeff Kindler, Pfizer’s CEO, mentioned yesterday during a CNBC interview, that eight Wyeth senior executives will keep their jobs after the Pfizer-Wyeth deal closes later this year. Not surprisingly, he failed to mention how many “rank and file” employees of the combined company would keep their jobs after the merger. Don’t be shocked when Pfizer-Wyeth announces massive layoffs after the deal closes—Pfizer’s stock price has fallen 21% since it announced the Wyeth acquisition late last fall.

Until next time....

Good Luck and Good Job Hunting!!!

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Rumors are rife that Novartis is going to purchase Lexington, MA-based Cubist for $1.6 billion. Wall Street analysts are speculating that Novartis may announce the deal as early as Monday.

Cubist manufactures Cubicin (daptomycin), one of only a handful of new antibiotics brought to market in the past 20 years that is effective against many infections caused by Gram-positive bacteria, most notably methicillin-resistant Staphylococcus aureus (MRSA). The company is developing new lipopeptide antibiotics similar to Cubicin and also has an active anti-viral drug discovery program.

Over the past 10 years, big pharma companies largely abandoned antibiotic research and placed all discovery efforts in the hands of only a few smaller public companies and startups. Cubist is the only independent biopharmaceutical company that successfully brought a new antibiotic to market. 

Novartis’ possible acquisition of Cubist signals, that at least one major pharmaceutical company sees opportunities and upside in the antibiotic drug discovery market. Several years ago, Pfizer acquired another antibiotic discovery company, Vicuron (formerly Versicor) but to date the acquisition has not yielded any new antibiotics. While Novartis’ acquisition of Cubist is yet another sign of consolidation that is taking place in the life sciences sector, it may bolster new efforts in the antibacterial drug discovery area. Unlike Cubist, Novartis has enough money and marketing muscle to increase Cubin sales and develop some of the exciting new molecular entities in Cubist’s drug development pipeline.

Until next time…..

Good Luck and Good Job Hunting!!!!

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That methicillin resistant Staphylococcus aureus (MRSA) is in the news again is not surprising. However, to my knowledge, Nicholas Kristof‘s article in today’s New York Times may be the first Op-Ed piece written by a non-scientist about the growing threat and seriousness of MRSA infections. Mr. Kristof apparently became aware of MRSA when he was contacted by Tom Anderson, MD, a Camden, Indiana physician who was experiencing “phenomenal levels of MRSA infections" in his community.

Beginning in the early 1990s, Dr Anderson noticed a rapidly rising incidence in the number of community acquired skin infections caused by MRSA among his patients. Most of Dr Anderson’s patients were swine farmers—the predominant industry in Camden. At first puzzled by the growing incidences of MRSA outbreaks, Dr. Anderson began to suspect that his patient’s pigs may be the source of growing number of cases of MRSA skin infections. He was reluctant to alert public health officials about his suspicions because any hint livestock-related health issues might jeopardize the livelihood of many of his neighbors and friends. By last fall, however, Camden’s MRSA epidemic had grown so large that Dr. Anderson could no longer remain silent. Rather than alert the authorities himself, he decided to invite Mr. Kristof, an investigative reporter, to visit him in Camden and break the story. Unfortunately, before Mr. Kristof could visit, Dr. Anderson died abruptly at age 54. There was no autopsy, but a blood test suggested he may have died from a heart attack or aneurysm. And—this is where the story gets interesting—a recent Dutch study has linked porcine MRSA isolates to a case of human endocarditis. Dr. Anderson had himself suffered at least three bouts of MRSA infections.

In another Dutch study conducted in 2004, MRSA strain ST398 (which caused the endocarditis in the more recent study) was isolated from three family members, three farm workers and 8 of 10 pigs from a single farm. Since then, strain ST398 has spread rapidly through the Netherlands — especially in swine-producing areas— and pig farmers there are 760 times more likely than the general population to carry MRSA. More recently, a study conducted by public health officials in Ontario, Canada showed that 20% of pig farmers were colonized by strains of MRSA genetically identical to those isolated from European pigs. Finally, a 2008 study conducted in Iowa, reported that strain ST398 was isolated from 45 percent of pig farmers and 49 percent of hogs that were tested. Together, these studies suggest that colonization of swine by MRSA and pig farmers is very common and that swine (and possibly other agricultural animals) could become an important reservoir for strains of MRSA.

While not conclusive, most infectious diseases experts believe that the emergence of MRSA and antibiotic resistant bacteria can be directly linked to the widespread and rampant use of antibiotics as growth enhancers in livestock feed. Despite the alarming emergence of multiple antibiotic resistance bacteria, livestock producers in the US and elsewhere continue to add antibiotics to livestock feeds. This led Mr. Kristof to lament that “we as a nation have moved to a model of agriculture that produces cheap bacon but risks the health of all of us.” Not surprisingly, as is frequently the case, big business has chosen to place profits before the health and safety of society.

Until next time...

Good Luck and Good Reading (look for Mr. Kristof’s Sunday column on the emergence of antibiotic resistant "superbugs")

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According to a report on NPR’s All Things Considered program, the Obama Administration has nominated Margaret Hamburg, MD to head the US Food and Drug Administration. Dr. Hamburg is a former health commissioner in New York City who has worked on issues surrounding infectious diseases and bioterrorism. In New York, she instituted a needle-exchange program to help prevent the spread of HIV. She also set up a program, in which health workers went to tuberculosis patients’ homes to help them manage their drug regimens.

A Harvard Med School graduate, Dr. Hamburg was an assistant secretary of health and human services during the Clinton administration and now works at the Nuclear Threat Initiative, which tries to cut the threat from nuclear, chemical, and biological weapons. She opposes abstinence-based sex education in public schools and has been a critic of the marketing practices of the pharmaceutical industry. Further, Dr. Hamburg is a leading advocate for changes in the nation’s public health policies and infrastructure, from local health departments to the highest levels of government. Finally, after eight years of mismanagement and poor leadership, the agency has somebody at the helm with intelligence, experience and is an advocate for change. 

Kudos to Team Obama!

Until next time...

Good Luck and Good Job Hunting (FDA is hiring)!!!!!

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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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Ever wonder how a drug makes it from the bench to the marketplace and what types of jobs are required to support the process? I created a PowerPoint presentation that describes the activities and the jobs required at each stage of the development process. I also listed the degree requirements that are necessary to secure various jobs from drug discovery through commercialization.

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U.S. regulators have delayed a decision on approval of an antibiotic from Johnson & Johnson and Basilea saying they need further audits of clinical sites, the two companies said on Wednesday.

Ceftobiprole, a broad-based spectrum antibiotic targeted mainly against infections caused by methicillin-resistant Staphylococcus aureus (MRSA), is Basilea's lead product and the news hit the Swiss biotech shares, which plummeted 27 percent.

In a so-called complete response letter on the drug's approval application, for complicated skin and skin structure infections, the Food and Drug Administration (FDA) said it was unable to review the clinical data submitted with the NDA until issues of data integrity had been resolved. The FDA has asked J&J to conduct additional audit work of clinical investigator sites and to address specific questions related to site monitoring."

Ceftobiprole is approved in Canada and Switzerland and has been recommended for approval in the European Union. A new application in the United States is planned within a year.

Late last week, FDA rejected an NDA for another antibiotic, iclaprim, being developed by Arpida, another Swiss company. It has been a bad two weeks at FDA for approval of new antibiotics—drugs that we desperately need.

Until next time….

Happy Thanksgiving

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Optimer, a San-Diego, CA-based biopharmaceutical company, reported positive Phase III clinical trial results for OPT-80, its lead treatment for Clostridium difficile gastroenteritis. C. difficile gastroenteritis is caused by exotoxins secreted by clostridia that have colonized the colon following prolonged antibiotic treatment for other bacterial infections. If left untreated, patients can die from a pseudo-membrane that forms in the colons of C. difficile-infected people. The incidence of C. difficile gastroenteritis has drastically increased over the past decade because of prolonged treatments with multiple antibiotics that are often necessary to eradicate infections caused by multiple drug resistant bacteria.

Historically, CHO-based drugs (with a few notably exceptions like heparin) have not fared well as therapeutic agents. To my knowledge, OPT-80 is the first synthetic carbohydrate (CHO)-based antibiotic to demonstrate anti-bacterial efficacy in a Phase III clinical trial. Having worked for Transcell Technologies (now defunct) and Alchemia,Pty—both of which attempted to develop CHO-based antibiotics—Optimer’s clinical success with OPT-80 is certainly noteworthy. I wish the company continued success in the future—mostly because I have always thought that carbohydrates would make good antibiotics!

Until next time…

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

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New Jersey-based Pharmacopeia, the first-ever combinatorial chemistry company, announced that it had agreed to be purchased by Ligand Pharmaceuticals in a stock deal worth about $70 million. Onetime a leader in combinatorial chemistry and high throughput screening, Pharmacopeia has struggled of late after it jettisoned its profitable molecular modeling division several years ago. While the company was able to advance several of its lead compounds into early phase clinical testing, its  longtime business model, predicated on multiple, small discovery deals with large pharmaceutical companies, was unable to provide enough capital to continue to sustain operations.

Pharmacopeia was established in 1993 after its founders licensed from Columbia University several of the first issued combinatorial chemistry patents. The company was a pioneer in combinatorial chemistry (and subsequently high throughput screening) and was the first to publicly tout the virtues of combinatorial chemistry in drug discovery. By the mid-1990s, many pharmaceutical companies had embraced combinatorial chemistry as the “next big thing” and began eliminating traditional natural product and medicinal chemistry jobs. The industry’s love affair with combinatorial chemistry grew so strong that many companies (most notably Merck), completely eliminated their natural products discovery departments in the late 1990s. Unfortunately, the role of combinatorial chemistry in drug discovery never lived up to its promised potential and was largely abandoned in the early 2000s. Although combinatorial chemistry is now part of the modern day drug discovery paradigm, this onetime “shining star” has largely been relegated to a minor supporting role.

I first became acquainted with Pharmacopeia in 1994 after I took a job with Transcell Technologies, a now-defunct biotechnology company that was co-located with Pharmacopeia in a research facility in Monmouth Junction, NJ. While Transcell and Pharmacopeia shared a cafeteria and some common laboratory equipment, Pharmacopeia employees were strictly forbidden to talk with Transcell employees— lest they inadvertently divulge proprietary combinatorial chemistry concepts that might jeopardize the company’s future. Coincidentally, a guy who lived two doors down from my family and me turned out to be Pharmacopeia’s in-house intellectual property attorney. Although, Ron and I became good friends, he was also extremely tight-lipped about the “goings-on” at Pharmacopeia. Privately-held Pharmacopeia went public in 1995 and at one time, its market capitalization was almost $1.0 billion.

By any reckoning, a 15-year run is outstanding for a biopharmaceutical company. However, as the old adage goes, “All good things must come to an end.” At present, it is not clear, whether or not California-based Ligand will relocate the company or cut jobs. Nevertheless, Pharmacopeia’s impending demise sends a clear signal that the golden age of combinatorial chemistry has ended!

Until next time….

Good Luck and Good Job Hunting!!!

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Daiichi Sankyo will buy a controlling interest (50.1%) of Ranbaxy, India’s third largest generic manufacturer.  Daiichi will pay as much as $4.6 billion for the opportunity.

The deal will put Daiichi Sankyo into ninth place in the $120 billion generic-drug market behind leaders Teva Pharmaceutical Industries Ltd. and Novartis AG's Sandoz unit. According to the report “Daiichi Sankyo is mimicking strategies pursued by Novartis and Johnson & Johnson to weather turbulence in the branded-drug industry by diversifying into other markets. The acquisition also gives the Japanese company more reach in emerging regions including India, China and Eastern Europe. “

I think after this deal, that other pharmaceutical companies may consider buying profitable generics businesses. I am not sure why it has taken innovator companies so long to realize that it is much easier to join (buy??) rather than compete with generic manufacturers. It just seems so obvious to me—and I don’t even have an MBA!  Maybe there is some truth to the age-old aphorism “missing the forest for the trees.”

Until next time…

Good Luck and Good Job Hunting!!!!!

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Novartis announced today that it intends to purchase Malvern, PA-based Protez Pharmaceuticals for $400 million. Protez is developing a novel spectrum carbapenem antibiotic that is active against variety drug-resistant Gram positive (most notably MRSA )and Gram negative bacterial pathogens. Its lead compound, PZ-601, is in Phase II human clinical testing. Protez acquired PZ-601 (formerly SMP-216601) in 2005 from Dainippon Sumitomo Pharmaceuticals.   

Novartis is buying Protez to sure up its antibacterial drug pipeline. Novartis already sells Cubicin, (manufactured by Massachusetts-based Cubist Pharmaceuticals Inc.,) in Europe and is developing other antimicrobials including Aurograb and Tifacogin to treat infections.

Like many of the newly marketed antibiotics, PZ-601 is injected and not orally bioavailable. Nevertheless, it is likely that PZ-601 will provide much needed help against the ever increasing number of drug resistant bacterial isolates. Swiss companies Basilea Pharmaceutica AG and Arpida Ltd. are also working on experimental medicines to treat MRSA.

It is not clear how the acquisition will affect Protez employees.  I suspect that most of the employees will keep their jobs except for Company officers.

Until next time…

Good Luck and Good Job Hunting!!!!!

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The Food and Drug Administration (FDA) announced today that it wants to hire 1,300 biologists, chemists, medical officers and others over the next several months. The agency currently employs more than 10,000 people and wants to add 600 new employees and backfill more than 700 that have been vacant by October. The new hires will triple the number hired from 2005 to 2007. Roughly 30% of all regular FDA staffers and approximately half of FDA managers are already eligible to retire.

An FDA spokesperson said that 400 of the new jobs will be related to drug application review and another 150 will be hired as inspectors to inspect drugs, foods and other related items. The agency will rely on user fees from drug companies to pay for all drug review jobs and about 100 other positions. The rest will come from the funds that were recently appropriated by Congress.

In addition to drug reviewers and inspectors, FDA is seeking consumer safety officers, nurse consultants, statisticians, epidemiologists, pharmacologists, pharmacists and veterinarians. Most of the positions are in the Washington D.C area but some are overseas and in other parts of the US.

This is one of the largest hiring initiatives in FDA’s history. It’s about time that Congress realized that the agency has been seriously under funded and understaffed ever since Bush was elected in 2001. I suspect that the impetus for the additional funding and hiring initiative has a lot to do with the beating that the agency has taken over the past few years. As we all know, FDA has been blasted by consumer advocates and lawmakers for lax oversight and inefficiency.

I can’t recall whether I said this before, but FDA is a great place “to be from”. Many of my colleagues who worked at FDA for three or more years are now highly paid regulatory consultants charging the companies that hire them about $3,000 to $5,000 per day. That said, as a bit of career advice; opportunity is knocking—don’t dither and wait too long before you apply.

Until next time….

Good Luck and Good Job Hunting (at FDA)!!!!!!!!!!

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I spent the entire morning reading various articles, blog posts and comments about what is wrong with the US Food and Drug Administration (FDA). Not surprisingly, phrases like “drug lag”, the large size and costs of clinical trials, political and corporate influence, reduced numbers of NME approvals etc appeared ad nauseum. These are the same old, tired complaints with the agency that have been bandied about for the past 10 years or so. 

In my opinion, the bottom line is this: the agency is egregiously under staffed and under funded despite the fact that companies pay steep user fees for regulatory reviews. I can understand why corporate America is dissatisfied with the service that it receives from FDA. It is natural to expect good customer service after paying large sums of money to a service provider.  However, it is important to note, that the words “customer service” don’t appear any where in the Food, Drug and Cosmetic Act of 1938 (although it can possibly be implied fromPDUFA in 1992 and FDAMA in 1997).  Nevertheless, what is mentioned in the FD&C is SAFE and EFFICACIOUS pharmaceuticals, biologics and medical devices. Put simply, safe and efficacious products, not customer service, is REAL the mission of FDA.  With this in mind, the agency is legally required to do everything in its power to provide Americans with carefully scrutinized and safe medical devices, pharmaceutical and biotechnology products.

If we Americans want FDA to accomplish its REAL mission, then the agency must be sufficiently funded, adequately staffed and have strong, non-partisan leadership. Unless this occurs, FDA will continue to struggle and remain dysfunctional well into the 21^st century.

Until next time…

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According to a press release by IMS, a company that tracks pharmaceutical sales, growth of the US pharmaceutical market shrank from 8% in 2006 to a meager 3.8% in 2007–the slowest growth rate since 1961. Total U.S. prescription sales in 2007 only reached $286.5 billion. The 2007 slowdown in sales was attributed to:

• Loss of patent exclusivity for branded products
• Fewer new drug approvals
• Effect of Medicare Part D on annual growth
• Renewed focus on safety issues by US Food and Drug Administration

Industry officials place the blame for the slow down on FDA because fewer newer drugs were approved in 2007 as compared with years past. However, I believe that the slow down has more to do with:

• Higher prices of branded medications as compared with generic drugs
• Lack of public confidence in the pharmaceutical industry
• Increased scrutiny by regulators on direct to consumer advertising and continuing medical education (CME)
• Fewer and less innovative drugs in company pipelines

Bashing FDA is easy. The willingness of the pharmaceutical industry to assume ownership of some of its own shortcomings and missteps is substantially more difficult to do!

Until next time….

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

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As the cost of prescription drugs continues to spiral upward, the affordability and accessibility to prescription drugs and healthcare will likely be fiercely debated and may influence the outcome of the presidential election next November. Despite growing public concern over the cost of prescription drugs in the US, Eli Lilly has vowed to fight federal legislation that will allow Americans to import lower-priced prescription drugs from Canada, Japan, Australia and many European nations. Lilly spokespeople and their lobbyists in Washington DC argue that the policy would put consumers at huge risk of consuming dangerous and unsafe counterfeit drugs. Big pharma has been using the drug safety argument for the past decade or so to stifle drug importation legislation. That said, blocking prescription drug importation legislation has very little to do with drug safety and everything to do with profit margins and corporate stock prices.

The stakes of prescription drug importation are high for drug makers. In contrast with the US, most other countries keep drug prices low through government distribution programs and strict price controls. Because the US government does not control prescription drug prices, American typically pay two-thirds more than Canadians, 80% more than Germans and 100 per cent more than French residents for identical prescription drugs. Lilly and other big pharma companies contend that price controls for prescription drugs stifle innovation and competition (tell that to the European and Japanese drug companies). Currently, according to government and industry surveillance data only a tiny fraction of counterfeit drugs (about 5 per cent) actually enter the US market. But Lilly and other pharmaceutical companies argue that there could be enormous increases in the number of counterfeit drugs that enter the US annually if Congress relaxes the federal ban on imported prescription drugs.

Pharma’s counterfeit drug argument is a convenient scare tactic that it has been using to lobby against relaxing current drug importation legislation. What the drug makers don’t tell you is that they routinely import and sell drugs in America that are manufactured in foreign production facilities. Further, many of drugs that are sold in Canada, Europe, Japan and Australia are manufactured in the same production facilities that supply drugs that are sold in the US. This begs the question —if drugs are manufactured in the same foreign production facilities and one lot is sold in the US and the other in Canada, would American consumers really be at a greater risk if they bought a Company’s drug in Canada or the US? The answer to the question is a resounding NO–unless you believe that the Canadian Regulatory Agency is less competent at monitoring and approving drugs than the US FDA The real story is this–.counterfeiters stand to make much more money selling bogus prescription drugs in the US than in other countries because there are no price controls in the US (which means much larger profit margins for the counterfeiters–duh!)

Let me propose a solution to the prescription drug counterfeiting that is plaguing and threatening the safety of American–reduce the price of American prescription drugs to prices that are consistent with prescription drug prices in the rest of the world. This would provide greater access of prescription drugs to all Americans and reduce the need for some Americans to purchase prescription drugs from dubious sources because they can’t afford to buy them at their local pharmacies. Further, price controls would certainly reduce the incidence of counterfeit drugs in American because counterfeiters would no longer be able to command high prices for their products which, in turn, would seriously cut into their profit margins.

Despite the logic and simplicity of my proposal, don’t expect there to be any changes in prescription drug importation policies any time soon! Profits not drug safety or open access to life-saving drugs is what drives big pharma-this is American after all!!!

Until next time….

Good Luck and Good Job Hunting (try Indiana) !!!!!!!!!

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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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In an attempt to dispel the notion that it is “dysfunctional” and "lax in policing drugs once they are on the market", the US Food and Drug Administration (FDA) earlier this week launched MedWatch - The FDA Safety Information and Adverse Event Reporting Program. An integral part of the new program is The Drug Safety Newsletter a quarterly publication that provides information on the findings of selected postmarketing drug safety reviews from FDA's Center for Drug Evaluation and Research.

The newsletter also provides information on important emerging drug safety issues and recently approved new molecular entities. FDA hopes the newsletter will raise awareness of reported adverse events, and stimulate additional adverse event reporting by healthcare professionals. The first issue of the newsletter contains reviews of the following products (information in the brackets are the most serious side effects)

• Rituximab (marketed as Rituxan): [Progressive Multifocal Leukoencephalopathy (PML)]
• Modafinil (marketed as Provigil): [Serious Skin Reactions]
• Temozolamide (marketed as Temodar): [Aplastic Anemia]
• Deferasirox (marketed as Exjade) -recently approved new molecular entity
  

Publication of this newsletter fulfills a commitment FDA made in its January 2007 response to the Institute of Medicine's (IOM) 2006 Report on The Future of Drug Safety - Promoting and Protecting the Health of the Public.

The newsletter is available at The FDA website.  Also, it will be sent electronically to those who subscribe to the Drug Safety Newsletter or to the MedWatch E-list.

To subscribe to this publication directly, go to the Drug Safety Newsletter section of the FDA site, enter your name and e-mail address in the appropriate fields, and select the "Join the List" button.  Hopefully, this new publication will inform consumers about the potential adverse effects and side effects of marketed prescription medications.

Until next time.....

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

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In addition to being used to speed drug review, the new fees will support post-market surveillance and post-market evaluation of drug safety. Further, for the first time, drug manufacturerers have agreed to provide user fees to support FDA review of direct to consumer advertising (DTC). At present, FDA has no authority over DTC ads prior to drug launch; companies submit copies of broadcast and print ads when they begin running. FDA is seeking the authority to review DTC ads before they can be aired or printed.

Increases in user fees suggest that the agency ought to be looking for a few "good women and men" to review regulatory submissions and institute its new focus on drug safety and surveillance.

Until next time......

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

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