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I suspect that many of you (after reading the title of this post) might be expecting another rant about the need for new antibiotics to treat infections caused by multiple drug resistant strains of bacteria. Sorry to disappoint you because that isn’t what this post is about. After reading and listening to several seemingly disparate radio and newspaper stories this morning, I decided to combine three different stories into a single post that touches on several common themes.

First, I heard a story on NPR this morning (while driving my daughter to middle school) about FDA’s initiative to require that oysters harvested from the Gulf of Mexico be pretreated before they can be served in restaurants and eaten raw. The reason for this initiative is that a majority of live oysters harvested from the Gulf of Mexico are usually contaminated with the opportunistic bacterial pathogen Vibrio vulnificus and other Vibrio species. Approximately, 15 or more immunocompromised patents die each year and many more get ill after ingesting raw Louisiana oysters infected with V. vulnificus. FDA, (which for those of you who don’t know also regulates the food and cosmetic industries in addition to the drug and devices industries), spent the past few years crafting regulatory guidelines that called for mandatory  treatment (irradiation or pasteurization) of oysters from the Gulf of Mexico before they are served “raw” at restaurants and other commercial food operations. The regulations were to be implemented sometime in 2011. While many of the larger commercial Louisiana-based raw oyster producers already pre-treat their oysters before they are sold to restaurants, the pretreatment requirement would be economically onerous and challenging to “mom and pop” oyster business throughout Louisiana. Not surprisingly, given the economic devastation caused by hurricane Katrina several years ago, FDA was assaulted by oyster manufacturing trade groups and Louisiana politicians and lobbyists asking the agency to delay implementation of the new rules. Unfortunately, FDA officials caved and yielded to the onslaught and agreed to conduct a pilot study designed to assess the effectiveness of the program before forcing the new rules on the Gulf Coast oyster industry.  For the record, I love eating raw oysters and the thought of eating a so-called “raw oysters” that have previously been pasteurized or irradiated seems unseemly and unappealing to me. However, FDA’s mission is to provide Americans with a safe food supply and to minimize the incidence of any public health risks associated with or caused by it. The fact that FDA was cajoled and yielded to calls that that the agency placed economic concerns ahead of known public health risks is lamentable and truly regrettable. Rather than spending excessive amounts of money on lobbying efforts to delay appropriate public health initiatives, the Gulf Coast oyster industry and its trade groups and lobbyist ought to consider investing in efforts to combat global warming and Gulf of Mexico water pollution, which in turn, would reduce the bacterial load of live oysters harvested from the Gulf of Mexico and serve to raw oyster enthusiasts. 

On a more upbeat note about infectious diseases (sort of), there was an article in today’s Science Times which reported the results of a study that linked exposure to five so-called common pathogens, Chalmydia pneumoniae, Helicobacter pylori, cytomegalovirus and Herpes simplex types 1 and 2 to increased risk of stroke. According to the article, each of these pathogens may persist after acute infections and contribute to an ongoing chronic low level infection. These low level infections coupled with chronic inflammation of blood vessels induced by the infections may contribute to the increased likelihood of stroke. While intriguing, authors of the study warn that their results don’t establish a cause-and-effect relationship between these infections and stroke. More research will be required to determine whether or not there is a definitive link between these infections and the incidence of stroke..

Speaking of stroke and heart attacks, I want to turn my attention to the clinical trial results reported yesterday by Merck & Co about its cholesterol-lowering drugs Zetia and Vytorin. As you may recall, a brouhaha erupted about a year ago about whether or not the cholesterol-lowering effects of  Merck’s  blockbuster drugs Zetia and Vytorin (which is a combination of Zetia and the statin Zocor) actually protected patients from increased risk of heart attack and stroke. The results of the long awaited study which were presented at an American Heart Association meeting on Monday support previous findings of two earlier clinical studies which showed that despite lowering LDL cholesterol levels, Zetia and Vytorin don’t reduce the risk of heart attack or stroke in at-risk patients. 

In the study patients who were at risk for cardiovascular disease were treated with statins in combination with either Zetia or Niaspan (a prescription, controlled-release formulation of over-the-counter niacin supplements that exhibits cholesterol-lowering properties). Patients who received statins plus Niaspan had decreased thickening of the walls (caused by atherosclerosis) of the carotid artery whereas those treated with Zetia failed to inhibit arterial plaque buildup. In other words, Zetia (and Vytorin) which are expensive prescription drugs don’t provide any health benefits beyond those offered by statins, many of which (including Merck’s Zocor) are available as low-cost generics.

Despite the lack of any clear medical or health benefits, sales of Zetia and Vytorin generated about $4.8 billion in sales last year. You would think that Merck and its stakeholders would be devastated by the results of the new study. However, they were actually happy about the news—they were fearful (based on data from the earlier studies) that Zetia may actually increase the risk of heart attack and stroke! What is particularly revealing (and disturbing) about the whole Zetia/Vytorin story is that Merck is relieved that an expensive drug that it heavily promoted as being beneficial and safe is in reality not beneficial. When did it become acceptable that the only requirement for FDA approval of prescription drugs is safety? Doesn’t a drug have to also show a positive therapeutic and clinical effect (over previously approved drugs for the same indication) before it wins regulatory approval? The fact that physicians continue to prescribe ineffective, multi-billion dollar drugs like Zetia instead of cheaper and effective generic versions of cholesterol-lowering drugs another troubling sign of  our current economic situation and the need for healthcare reform in the US.

Finally, for you patent aficionados, there was an illuminating and incisive op-ed piece in today’s NY Times that shed light on the problems with the current US patent approval process. While I have substantial experience in this area, I learned more from reading this article than I did from the many years that I worked closely with patent and intellectual property attorneys. This article is a must read for those persons considering careers in intellectual property and patent law and entrepreneurial individuals who are interested in starting up life sciences companies.

Until next time...

Good Luck and Live and Learn!!!!

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Unlike many of my social media colleagues, I’m not attending the FDA public hearing taking place in Washington, D.C today (Friday the 13^th oh my). I wanted to attend and actually testify but I didn’t understand how the process works and blew my opportunity. However, I will be prepared for rounds 2 and 3 and beyond. I can assure you that this will not be the last public meeting organized by the agency to develop guidance for the use of social media in pharmaceutical marketing and advertising. 

The brouhaha over social media and its use in the life sciences industry is purportedly taking place because of the lack of regulatory guidance on the topic. While I agree that FDA needs to craft a reasonable regulatory policy for the use of social media for promotional purposes, the discussion taking place has little to do with the medium and everything to do with the fair balance of ads that are used to promote drug sales. For those of you who may not know, fair balance (in regulatory parlance) means that drug manufacturers are required to fully disclose in print, television, radio and internet ads the benefits as well as the side effects and risks associated with a specific product. Unfortunately, too often, drug makers tend to promote the therapeutic benefits of a drug but downplay its side effects and risks. This isn’t surprising because drug makers, like other for-profit companies, must sell as much product as possible to generate sufficient revenues to remain profitable.  And, as we all know, consumers and physicians are more likely to use or prescribe drugs that have therapeutic benefits without many side effects or risks.

Since the inception of direct-to-consumer advertising, FDA and drug makers have been playing a cat-and mouse-game with the fair balance issue. Most drug makers understand the “balance” that FDA requires for traditional promotional ads, but rather than abide by the rules, many choose to determine how far they can bend the rules before they appear on FDA’s radar. Therefore, it should come as no surprise that drug companies have adopted the same strategy when it comes to Internet advertising and search result ads. To be fair, FDA hasn’t crafted any definitive guidance on Internet advertising or search ad fair balance requirements. However, rather than apply what they have learned over the years about fair balance in print and television advertising, many drug makers chose to ignore fair balance requirements for Internet advertising simply because there are no written regulations or rules. To that end, 14 pharmaceutical and biotechnology companies recently received warning letters about their misuse of promotional drug ads that appeared with Google search results. FDA cited the lack of fair balance in the search ads as reasons for the warning letters. By issuing identical warning letters to 14 different drug companies, the agency was essentially saying “c’mon guys, who are you trying to kid—you ought to know better by now!”

Unfortunately, even when there are regulations, many companies spend hundreds of millions of dollars to look for deficiencies and loopholes that can be exploited to increase and improve drug sales. Therefore, I contend, that regardless of the social media guidance that FDA ultimately issues, drug and device manufacturers will continue to look for work arounds to regulations that they perceive hinder product sales.  

Social media is all about transparency, accessibility and communications between participants. The guidance that FDA issues about the use of social media in the life sciences industry will likely be circumspect and open to interpretation as it usually is. As one FDA legal expert explained to me, “FDA crafts the laws but it is up to the judiciary  to interpret how they ought to be applied.”

I suspect little will change until drug manufacturers realize that full disclosure and transparency, not half-truths and opaqueness, will ultimately lead to improved drug sales in the future.

Until next time...

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

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

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

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

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

Until next time...

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

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The New York Times that W. Scott Harkonen, MD the former chief executive of InterMune, a Brisbane, CA biopharmaceutical company, was convicted yesterday for issuing what federal prosecutors called a misleading press release that contributed to off-label sales of the company’s drug Actimmune.

Actimmune is bioengineered form of interferon gamma approved in 2000 to treat children and adults with chronic granulomatous disease (CGD) and severe, malignant osteopetrosis—two relatively rare genetic diseases. But the main sales of the drug, which peaked at $141million in 2003, came from an unapproved use: treating idiopathic pulmonary fibrosis, a scarring of the lungs that can be fatal. While licensed physicians in the US can prescribe approved drugs for off label, it is illegal for drug makers to promote the use of prescription drugs to treat indications for which the drug didn’t receive approval.

According to the Times article, InterMune conducted a large clinical trial testing Actimmune as a treatment for the lung disease. The drug did not achieve the clinical endpoints of the trial, which was to improve lung function of patients receiving Actimmune as compared with patients receiving a placebo. However, a review of the statistical analyses of the trial revealed that if only the patients in the trial with mild or moderate disease were considered, those who got the drug lived longer than those who received the placebo .The company highlighted the “survival benefit” of patients treated with Actimmune in a news release, issued in August 2002.  Following the press release, sales of Actimmune (which costs about $50,000 per year) peak at $141 million in 2003—the drug was mainly being used to treat idiopathic pulmonary fibrosis an indication for which the drug hadn’t received regulatory approval. Because of this, federal prosecutors contended that the news release was part of a scheme to induce off-label sales of Actimmune. Interestingly, in 2007, a second large clinical trial of Actimmune found that the drug didn’t prolong the lives of patients with pulmonary fibrosis.

The InterMune case isn’t unique in the life sciences industry. Time and time again companies are charged with off-label promotional activities and typically these cases are settled before they go to trial. To that end, the InterMune case is an exception but Harkonen’s conviction sends a warn drug company executives that the US government takes off label promotion seriously and it will no longer be tolerated.

While it can be argued that off label drug use can benefit patients and ought to be allowed, off label promotion of previously approved drugs allows drug companies to benefit financially without investing in expensive clinical trials to win regulatory approval for the off label indication. In other words, off label promotion of prescription drugs can be a financial windfall for companies and induce them to place profits ahead of patient safety and drug efficacy. This is why promotion of off label use of prescription drugs is illegal and a prosecutable crime. 

It is important to remember that prescription drugs are required to undergo a rigorous regulatory review to insure that they are safe and efficacious. While the use of approved drugs to treat off label indications may benefit some patients, the drugs in question must be rigorously tested for safety and efficacy to treat the indication before they are used to in large numbers of patients. And, as we have seen in recent years, even drugs that have gone through clinical testing and garnered regulatory approval may not be as effective or safe when used to treat billions of patients!

Until next time...

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

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Mark Senak who runs the EyeonFDA blog reported yesterday that the US Food and Drug Administration (FDA) had launched a Twitter account. As Mark aptly points out, FDA’s unexpected leap into social media is ironic given that the agency has been steadfastly reluctant to craft any guidance whatsoever on the use of Web 2.0  technology or social media by drug and device manufacturers. Maybe, the agency was tired of being overshadowed by the Centers for Disease Control in Atlanta, GA whose rapid adoption and use of social media for public health and related issues has been outstanding. 

For those of you FDA aficionados, FDA can be found on Twitter at @FDA_Drug_Info. Despite its very recent launch, the agency already has over 1,700 followers. Not surprisingly, FDA_Drug_Info is following only six individuals and is largely a one-way informational channel. Maybe somebody ought to tell the agency that social media, most notably Twitter, is suppose to be interactive and conversational? Also, couldn’t FDA staffers come up with a better Twitter handle? I mean the use of underlines to separate words in FDA_Drug_Info is so ......Web 1.0!!!! Finally, most of the information tweeted by the agency has to do with drug approvals, workshop announcements, safety warnings, etc. Maybe somebody also should tell them that most life sciences companies block Twitter and other forms of social media. Nevertheless, based on some recent tweets, it appears that the agency is targeting healthcare providers and consumers as their main audiences.

Despite FDA’s Twitter presence, I wouldn’t expect any Web 2.0 guidance or a drug and device social media policy any time soon. I say this because the agency yet to craft guidance on website design and Google Ads—two very ancient internet tools!!!! Maybe they ought to appoint a social media czar at the agency?

Until next time....

Good Luck and Good Tweeting!!!!

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

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

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

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

Until next time...

Good Luck and Good Job Hunting!!!!

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

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

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

Until next time...

Good Luck and Good Video Watching

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

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

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

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

Until next time...

Good Luck and Good Job Hunting!!!!

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Eli Lilly & Co. is offering buyouts to 4,000 U.S. sales representatives to eliminate several hundred jobs and restructure its operations. Sales representatives will be offered four months' pay in addition to the typical Eli Lilly severance package, which ranges from two to 18 months' salary depending on seniority. The company had a total of 40,500 employees at the end of 2008.

Lilly’s best-selling drugs include Zyprexa for schizophrenia and bipolar disorder, Cymbalta for depression, Byetta for type 2 diabetes, and Evista for osteoporosis. The patent supporting Zyprexa, which bought in $4.7 billion in revenue last year, will expire in 2011. The patents on the company's next three top drugs —Cymbalta, Humalog insulin, and cancer drug Gemzar —are set to expire in 2013.

The restructuring is expected to start in mid-November and take effect in January.

Sales reps and R&D scientists have suffered the most during pharma’s recent three year downsizing binge. While many R&D jobs have been shipped overseas, pharma sales reps might consider a new career in biotechnology drug sales. Growth in biotechnology and personalized medicine drugs is expected to increase for the foreseeable future.

Until next time...

Good Luck and Good Job Hunting!!!!!

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Mark Senak, author of the EyeonFDA blog and social media enthusiast, posted a great piece about pharma’s reluctance to adopt social media and the changes in adverse event reporting-- aka pharmacovigilance--requirements that may change this attitude. 

Hat tip to Mark!

Until next time...

Good Luck and Good Job Hunting

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Until today, direct-to-consumer advertising (DTC) has received very little attention during the recent spate of debates over healthcare reform. The NY Times reports that several members of Congress are introducing legislation that would curb the reach of DTC advertising. While reasons for introduction of new legislation vary—ranging from moral indignation over the mention of four hour erections during prime time to tax deductions for pharma companies that engage in DTC advertising—it appears that no stone will be unturned during the ongoing debate over US healthcare reform.

For those of you who may not know, DTC advertising is allowed in only two countries—New Zealand and the US. According to a Nielson Media Research report, in 2008 drug makers spent about $4.8 billion on DTC advertising for television, radio and print ads in magazines and newspapers. Not surprisingly, supporters of DTC point out that the amount of money spent by pharmaceutical and biotechnology companies on DTC advertising is negligible as percentage of total health care spending. Nevertheless, data convincingly show that DTC advertising can increase the number of prescriptions written for newly approved drugs. Of the $235 billion spent on prescription drugs last year, approximately $8 billion was attributed to DTC advertising.

Although some academic studies suggest that DTC advertising can help people who need to start taking drugs and others to remain compliant with existing treatment regimens, the lack of fair balance in many DTC ads that promote drug benefits and downplay risks is what is driving legislation to curb its use. The recent brouhahas over Pfizer’s Lipitor commercials, Bayer Pharmaceuticals’ ad that deceptively promoted its popular birth control drug Yaz and Merck and Schering Plough’s Vytorin ads that overstated the health benefits of the cholesterol lowering drug have convinced legislators that DTC must be fixed.

The US Food and Drug Administration (FDA) Division of Drug Advertising Marketing and Communications (DDMAC) oversees and has full responsibility for DTC advertising. However, it is important to note, that under current regulations, companies aren’t required to get approval from the agency before they appear. Sharing DTC ads with FDA is completely voluntary. However, if FDA receives enough complaints about particular ads, DDMAC will review them and notify the company if regulators believe that they contain information that is misleading, unbalanced or unsubstantiated. Companies that violate DDMAC policies and guidelines are typically required to show run all future DTC ads by FDA regulators before they can shown to the public.

Because of the small numbers of patients that are typically used during clinical evaluation of new drugs, it may take as long as five years before side effects and problems with certain drugs begin to emerge. With this in mind, DTC critics argue that there ought to be a five year waiting period or moratorium on DTC advertising after a drug is approved. Interestingly, about ten years ago, a friend who works for a major pharmaceutical company told me that she always waits five years before using a newly approved drug.  At the time, I thought it was an odd thing for her to say since she had been in the business for over 15 years. However over the past five years or so, several high profile drugs that were heavily promoted by DTC advertising had to be withdrawn from the market. To that end, while DTC advertising may be “great for business,” it may not always be in the best interest of American consumers who use prescription drugs!

Until next time...

Good Luck and Good Job Hunting

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Several weeks ago, I blogged about a growing need to improve the American public’s perception and understanding of the life sciences if the US wants to remain competitive in science and technology. Much to my delight, there was an article this Sunday’s NY Times entitled “Microbes R Us” which explores the evolutionary relationship with bacteria and humans. It was written by Dr. Olivia Judson an evolutionary biologist and author of “Dr. Tatiana’s Sex Advice to All Creation: The Definitive Guide to the Evolutionary Biology of Sex,” which was made into a three part television program.

While the evolutionary relationship between bacteria and humans isn’t as titillating as the biology of sex, the article sheds light on the importance of bacteria and how genetic changes in bacteria that normally inhabit the human intestinal track can have a positive impact on human nutrition and health. Many lay people believe that bacteria are “bad” because certain species can cause serious and potentially life threatening diseases. However, the benefits, advantages and uses of bacteria e.g., to make food, antibiotics and other medicines, far outweigh their negative impact on society. 

Articles like the one written by Ms. Judson, offer the public unqique insights into  the amazing and often fascinating world of microbiology. I hope that a few aspiring young scientists read the article and tell all their friends about it!

Until next time....

Good Luck and Good Reading!!!!!!

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Mark Sendak, a social media enthusiast and author of the Eye on FDA blog, wrote a great post today about an article he saw in the Washington Post entitled “Drug Firms Jockey for Space Online.”

Mark wrote: “Flock?  Flock?  FLOCK?  The only way you could use the term "flock" in connection with pharmaceutical firms and social media is to say that companies are a scared flock of geese.” He goes on to castigate FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) for a lack of a coherent regulatory framework and guidance for the use of social media in the life sciences industry.

Mark aptly describes DDMAC’s guidance surrounding social media and the pharmaceutical industry this way. “No one knows, and DDMAC apparently makes this stuff up as they go along. That is the kind of Whack-a-Mole game DDMAC plays.  We won't tell you what is off limits, until you do it and then WHACK! Is this anyway to run a pharmaceutical industry?

I am in total agreement with Mark on this issue. Despite the rapid adoption of social media by other industries, FDA has consistently been reluctant to issue any regulatory guidance what so ever on the topic despite assertions to the contrary. Unfortunately, when it comes to social media and the pharmaceutical industry, FDA’s usual approach to regulatory guidance—reactive rather than proactive—is still alive and well. As you may recall FDA previously sent warning letters to no fewer than 14 pharmaceutical and biotechnology companies admonishing them on their placement of product ads on search engine results pages. The fact that 14 different companies received warning letters on this issue reflects the confusion and lack of guidance offered by FDA on social media and the use of Web 2.0 technologies to promote or support the sale pharmaceutical products.

The growing popularity and inevitability of social media suggests that DDMAC officials along with industry representatives must begin to consider crafting a preliminary regulatory framework for its use in the life sciences industry. Like it or not, social media is here to stay!

Hat tip to EyeonFDA!

Until next time....

Good Luck and Good Job Hunting

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

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

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

Until next time....

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

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I was in the gym the other day, trying to regain my “girlish figure,” and I happened to see Brooke Shields in television ad hawking Latisse, the new eye lash-enhancing prescription medication from Allegan. For those women (or men for that matter) who haven’t heard, Latisse was recently approved for hypotrichosis of the eye lashes. Hypotrichosis is medically-defined as a reduced amount of hair, and in this case, it refers to eyelashes. Who knew that reduced eyelash hair was a burgeoning unmet medical need? Anyway, back to Brooke.

I like Brooke Shield and I think that her very personal and public account of her struggles with postpartum depression after the birth of her first child was courageous and laudable. And, I thought she was pretty damn good in Pretty Baby and the Blue Lagoon too. But, I question her decision to use her celebrity among women to promote a prescription drug that was approved almost exclusively for cosmetic use. Yes, I know that women’s cosmetics are a multibillion industry and woman worldwide work hard to get longer and fuller lashes. But, this begs the question: Are the possible health risks associated with Latisse—an attenuated form of botulism toxin used in Allergan’s anti-wrinkle treatment Botox—worth it, simply to get longer and fuller lashes; a look that can be achieved by daily application of non prescription and much cheaper mascara? Again, as is the case with most women’s healthcare choices, the decision should be left up to individuals.

Personally, I hope that Brooke’s eyebrows—which were quite formidable back in the day—remain as manageable as they appear to be today after using Latisse to thicken her eyelashes. Not that there is anything wrong with thick eyebrows!

Until next time...

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

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The National Institutes of Health (NIH) announced on Wednesday that it was creating a new program aimed at “finding treatments for some of the 6,800 rare diseases that collectively affect about 25 million Americans.” 

According to NIH officials, the NIH would work with researchers and patient advocacy groups to identify new molecular entities (NMEs) that represent potential treatments for rare disorders. Once identified, NMEs will be turned over to private companies for further development. Information about molecules that failed to make the cut for further development will be published in scientific and medical journals. The NIH stressed that the goal of the program is to work with the drug industry not compete with it to develop new treatments.

Because many rare diseases only affect a few hundred or a few thousand people, there are little financial incentives or profit motives for companies to develop treatments for them. To stimulate drug development for rare diseases, the US Congress passed The Orphan Drug Act (1983) that offers companies that develop drugs for diseases affecting fewer than 200,000 people tax incentives, financial support for clinical development and seven years of US market exclusivity, i.e. the company can sell the product without competition for seven years. Since its passage, the Orphan Drug Act has been a boon to many biotechnology companies, most notably Genzyme, a profitable biotechnology company whose business model is built almost exclusively on orphan drug development.

NIH’s entry into the orphan drug development arena ought to help speed discovery and development of potential new treatments for orphan indications. It will undoubtedly help to reduce some of the cost, time and risks typically associated will corporate drug discovery. Industry experts suggest that drug discovery can sometimes cost well over $10.0 million and take between two to four years to complete. However, the program is starting with only $24 million this year and is expected to receive the same level of funding each year until 2013. While this may limit the overall effectiveness of the program, it will likely bring government and the drug industry closer to forge new relationships with the common goal of discovering much needed new treatment for orphan indications.

Until next time...

Good Luck and Good Research!!!!!!!!

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

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

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

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

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

Until next time...

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

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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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I just returned from a weekend of teaching regulatory affairs to biotechnology students at Georgetown University where I tried to convince them that the US Food and Drug Administration (FDA) is fundamentally sound despite its near demise during the Bush administration. Even before the Bush-induced wreckage, the agency was chronically understaffed, under funded and had serious leadership and morale problems. This, coupled with two nationwide Salmonella outbreaks in the past year, several highly publicized drug recalls, and steadily declining drug approval rates has prompted its critics to propose that FDA be split into two separate agencies—one that oversees the drug industry and another that would have responsibility for cosmetic and food safety. For those of you who may not know, FDA became responsible for oversight and regulation of the food and drug industries, in addition to the drugs, after passage of the Food, Drug and Cosmetic Act in 1938.

Drug industry advocates and longtime FDA critics contend that the agency as it exists today can no longer effectively oversee and insure the safety of American food and drug supplies. Critics argue that the history of FDA suggests that the agency focuses on medical products and only focuses on food safety when a crisis comes up. And when they occur, FDA is so distracted that it interferes with the drug review/approval process. While this is what FDA critics want you to believe, it is simply not the case. Despite its recent problems, the FDA has historically done an outstanding job when it comes to drug and food safety—when it is funded and staffed to appropriate levels.

Unbeknownst to the American public, food borne illnesses are very common and Americans are only alerted when the outbreaks reach a certain size. While the recent Salmonella outbreaks were larger in scope and breadth than past outbreaks, they were not extraordinary. However, they were extremely media worthy at the time that they were reported on. You may recall that at the time of the outbreaks, the American economy was beginning to fail and there was an inordinate amount of China, Mexico and free trade bashing going on in the US. Unfortunately, the news media decided to exploit the outbreaks to make a case that Americans ought to reduce their reliance on imported foods—a practice that was beginning to cut into the revenues of the US agriculture and food industries. Ironically, the Salmonella outbreaks might have been prevented if the production facilities (owned by American companies) were compliant with FDA mandated quality control and assurance regulations which were designed to insure food safety.

Drug industry advocates who argue that FDA ought to be split into two separate agencies have financial interests rather than safety concerns in mind.  As an investment banker or VC will tell you, slow, new drug approval rates can have serious financial consequences for the companies that are developing them—it can literally cost a company millions of dollars a day for every day the drug is kept off the market.  Interestingly, when FDA increased its drug approval rates in the late 1990s and early 2000s, there weren’t many industry insiders advocating a break up of the agency. Only recently, as FDA has become more risk adverse which in turn, has caused the new drug approval rates to slow again have critics begun to call for massive organizational changes at FDA.

Like I told my biotech students over the weekend, the only mechanism by which FDA can insure food and drug safety is by conducting regular inspections of drug and food manufacturing facilities. Unfortunately, FDA hasn’t been able to keep up with its mandatory inspections schedule because the agency has been under funded and poorly staffed for over a decade. Several FDA inspectors, who I talked with suggested that routine inspections of manufacturing facilities takes place every three to five years rather than every two years as required by FDA regulations. While in theory this shouldn’t affect a company’s ability to remain compliant with FDA regulations, in reality it does. Put simply, pharmaceutical and food companies, like most other for profit industries are incapable of policing themselves in the absence of regulatory oversight.

I ‘m not certain that the agency needs to be split into two separate agencies to continue to insure the safety of the American drug and food supplies. What I know is the agency needs more funding and much larger numbers of trained inspectors to be successful. In my opinion, the safety of the American food and drug supplies can only be guaranteed if the companies regulated by FDA make a commitment to quality manufacturing and play by the rules.

Until next time...

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

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Merck announced today that it was buying Schering Plough, the Kenilworth-New Jersey based drug maker, for $41.1 billion. The deal comes only six weeks after Pfizer said that it would purchase NJ-based Wyeth Pharmaceuticals. Superficially, the deal may make sense for the two struggling drug makers—they co-market the cholesterol-lowering drug Vytorin and also have collaborations in the respiratory diseases area. Also, Schering Plough has the European rights to the anti-arthritis drug Remicade and its 2007 purchase of the Dutch biopharmaceutical company Organon Biosciences NV provides access to several potential biotechnology drugs. Nevertheless, the impending merger will ultimately result in job losses and higher unemployment in the state of New Jersey.

Merck currently employs 55,200 workers and Schering-Plough—which grew significantly with its purchase of Organon—also has about 55,000 employees. While no immediate job cuts are planned, a company spokesperson acknowledged that the size of the combined workforce will be reduced by approximately 15%-20% over the next year or so. This means that as many as 20,000 pharmaceutical employees may lose their jobs—a time when unemployment in NJ is approaching 10 percent! My sources tell me that Merck employees are already on edge because of surprise layoffs that occurred in early September, 2008. I suspect that employee anxiety will be extremely high at both companies for the foreseeable future—never a good thing from a productivity point of view.

According to press releases, Schering-Plough's shareholders will get $10.50 in cash and 0.5767 Merck shares for each Schering-Plough share they own. That's a 34 percent premium to Schering-Plough's closing stock price on Friday. Merck's top executive, Chairman and CEO Richard Clark, will lead the combined company, which will attempt to remain a dominant player in treatment areas including cholesterol, respiratory, infectious disease and women's drugs, as well as vaccines. Schering-Plough's CEO, Fred Hassan, will participate in planning integration of the two companies until the close of the deal, which is expected in the fourth quarter. The transaction is to be structured as a reverse merger. Schering-Plough will be the surviving corporation but will take the name Merck. The new company will remain at Merck's headquarters in Whitehouse Station, N.J. and a company spokesperson indicated that a "substantial majority" of employees of Schering-Plough will remain with the newly-formed company. The combined revenue of both companies in 2008 was $47 billion.

Mr. Hassan, a talented, “turn-around” pharmaceutical executive, took over Schering-Plough six years ago as chairman and CEO—a time when the company was struggling with a $500 million fine (the largest ever at the time) imposed by the US Food and Drug Administration because of chronic manufacturing problems. While Schering-Plough is now in much better financial shape than when Mr. Hassan first arrived at the company, its stock price is currently almost identical to the price when he took over (it lost 50% of its value in the past 18 months). Let’s see whether or not Richard Clark, Merck’s current Chairman and CEO, has the mettle to run the combined company. While Schering-Plough has long been rumored to be a takeover target, I don’t think that the Merck-Schering Plough deal is a particularly good or strategic one. Both companies have been struggling of late because of near empty drug pipelines and the ongoing brouhaha over Zetia, Vytorin and Merck’s Vioxx. Further, both companies face price reductions and slumping sales in the next year or so because several blockbuster drugs will lose patent protection and face stiff competition from generic drug manufacturers.

Like the Pfizer-Wyeth deal, the Merck-Schering Plough merger may little more than a red herring. I still fail to see how merging two oversized, struggling pharmaceutical companies can possibly result in the creation of a single successful one. The only upside of the deal is that it allows the newly-formed company to restructure operations, eliminate tens of thousands of jobs and cut costs to bolster its stock share price. That said, I don’t think that an artificially-inflated stock share price necessarily translates into the innovation that historically has been required to create new drugs to treat unmet medical needs!

Until next time...

Good Luck and Good Job Hunting (avoid NJ at all costs)!!!!!!!

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The sequence of all known rhinovirus genomes reported in Science last week is an important advance for the field. Analyses of the sequences have revealed new relationships among the viruses, evidence for recombination, a new viral species, and conserved regions of the genome. These findings will be extremely valuable for those studying the biology, pathogenesis, and epidemiology of the common cold. But the press has over reacted to this work -  it was reported on the front page of the New York Times with the headline “Cure for the Common Cold? Not Yet, but Possible“.  Does the work deserve such fanfare?

The Times quoted Stephen Liggett, an asthma expert, as saying “We are now quite certain that we see the Achilles’ heel, and that a very effective treatment for the common cold is at hand.” He was apparently referring to the observation that a sequence within the 5′-noncoding region of the viral genome is highly conserved among the 99 rhinovirus sequences, in comparison with other regions of the viral RNA. He suggested that all 99 rhinovirus serotypes would therefore be susceptible to the same drug. But what kind of drug, and what function would it inhibit? The very 5′-end of the genome of enteroviruses and rhinoviruses binds viral and cellular proteins, and these interactions are essential for viral replication. So it might be possible to identify small molecules that block these protein-RNA interactions. But such drugs are very difficult to identify. Furthermore, if such a drug were identified, its efficacy would have to be tested against all rhinovirus serotypes. Therefore it is not clear that knowing that this sequence of the genome is conserved helps to identify drug targets and more readily than did the observations made years ago about the importance of RNA-protein interactions in this region. Clearly, many years of research are needed before such drugs are developed - not consistent with Dr. Liggett’s a treatment is ‘at hand’.

An even more crucial aspect of the problem was omitted from the Times article. Even if an antiviral drug could be identified that blocks essential RNA-protein interactions, it probably would not be useful in treating the common cold. As we discussed last week, rhinoviruses cause acute infections - characterized by rapid onset of disease, a relatively brief period of symptoms, and resolution within days. Most are complete by the time the patient feels ill, and the virus has already spread to another host. Antiviral therapy  must be given early in infection to be effective. There is little hope of treating most acute viral infections with antiviral drugs until rapid diagnostic tests are become available.

To be fair, some of the scientists quoted in the Times article were more realistic about the possibilities for rhinovirus treatments. One antiviral drug expert noted that it costs about $700 million to bring a drug to market. Because most rhinovirus infections are benign, who would pay for such an expensive drug, and would the Food and Drug Administration ever approve it? Ann Palmenberg, the lead author on the study, was even more realistic, admitting that a rhinovirus vaccine would not likely be made.

I cannot see how this new study identified a new or better target for therapeutic intervention. So why get the public excited by running a front page headline in the New York Times? It’s great to keep the public informed about scientific progress - but the press should not cry wolf. If this advance does not soon lead to a treatment for the common cold, the public will shake their heads and lose a bit more trust in science.

I’m not blaming the scientists for this over reaction to their study. I am sure that the journal Science engaged in strong pre-publication promotion: more publicity is better for their advertising revenues. And the newspapers are equally at fault: they should speak to a broader range of scientists to obtain a more balanced view. I particularly blame the author of the Times article, Nicholas Wade, for not sufficiently researching his article.

Perhaps Dr. Liggett and his colleagues would benefit from the lessons of history - specifically, the history of poliomyelitis and its conquest. On March 9, 1911, three years after the isolation of poliovirus, The Rockefeller Institute issued a press release, saying that it believed “that its search for a cure for infantile paralysis is about to be rewarded. Within six months, according to Dr. Simon Flexner, definite announcement of a specific remedy may be expected.” They quoted Dr. Flexner:  “We have already discovered how to prevent the disease, and the achievement of a cure, I may conservatively say, is not now far distant.” Dr. Flexner’s imminent ‘cure’ was a failure, and a successful poliovirus vaccine required another 44 years of research. Last week’s Times article seemed to have a similar overdose of hubris.

A. C. Palmenberg, D. Spiro, R. Kuzmickas, S. Wang, A. Djikeng, J. A. Rathe, C. M. Fraser-Liggett, S. B. Liggett (2009). Sequencing and Analyses of All Known Human Rhinovirus Genomes Reveals Structure and Evolution Science DOI: 10.1126/science.1165557

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The Bush administration spent the last eight years trying to weaken and dismantle the US Food and Drug Administration (FDA).  I thought the carnage at the agency would end in the waning days of one of America’s worst leaders. Sadly, I was mistaken.

As many of you may know, FDA regulations forbid drug companies from promoting off label use of previously approved drugs. Not surprisingly, drug companies were able to find loop holes in the regulations and off-label drug promotion reached unprecedented levels in the early 2000s. In response, the agency embarked on an aggressive, unrelenting campaign to combat off label drug promotion by drug manufacturers. This effectively changed the way in which pharmaceutical sales representatives interacted with physicians in the past few years. No longer would there be unsolicited gifts, lavish pizza lunches for office personnel or tickets to local sporting events. Neither the drug makers nor physicians were happy about the rule changes but the revised guidelines helped to lessen off label promotion of previously approved drugs. That said, it came as something of shock late last year, when FDA officials proposed a new set of guidelines that would ease the restrictions on off label drug promotion.

The new rules would allow drug makers to supply physicians with copies of published research reports describing off label uses of drugs that were previously approved for other therapeutic indication. As you might have guessed, the drug companies are ecstatic with the new guidelines. Who needs pens, mugs or pizza when you can simply hand a physician a reprint of article that show that off label use of an approved drug can treat potentially life threatening medical conditions.  What an ingenious way to boost sales of extant drugs for new indications without having to spend larges of money trying to win regulatory approval for them. While this would be a financial boon to the pharmaceutical industry, I don’t think it would be in the best interest of patients who may be prescribed a drug that hasn’t undergone the rigorous scrutiny of controlled, human clinical trials.

Many congressional democrats and drug industry critics opposed the guidelines when they were first proposed last year. But, like many other times over the past eight years, the Bush administration prevailed. Today, the agency announced (with little fanfare) that the new off label drug use guidelines would go into effect—one week before Barack Obama is inaugurated as President. 

Until next time…

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

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It seems that every day a new American industry asks the US government for a bailout because of impending financial exigency. That said, I was somewhat surprised to learn today that the biotechnology industry is planning to ask Congress for a bailout. The plan calls for Congress to temporarily changes tax laws to allow unprofitable biotech companies to get cash now, in exchange for tax credits that they would pledge not to take if they eventually become profitable. The companies that receive the cash would pledge that the money would be used ONLY for research and development activities. The reasoning behind the proposed government bailout is that the infused capital would allow struggling biotech companies to keep their current employees, stay in business and help to stimulate the US economy. It is not clear whether or not all biotechnology companies—publicly traded or privately held—would be eligible for the bailout package.

Currently, there are 327 publicly traded and roughly 1,000 privately held biotechnology companies in the US. A majority of these companies are not profitable and operate almost exclusively on institutional and private venture capital funds. According to the Biotechnology Industry Organization (BIO), 125 of 327 public companies currently have less than 6 months of cash on hand—nearly double the total last year. It is not surprising that the biotechnology industry like most other US industries is struggling and feeling the impact of recent financial meltdown—there simply isn’t enough liquidity in the system to keep all companies afloat. While I am not opposed in principle to government bailouts, there are several reasons why the proposed rescue plan for the biotechnology industry doesn’t sense to me.

First, unlike the automobile industry which employs millions of workers, the biotechnology industry only employs about 200,000 workers, many of whom have advanced degrees and possess specialized technical skills. And, studies show that during recessionary periods workers with specialized skills are more likely to find employment after losing a job than their unskilled counterparts. This suggest that it may be better for the American economy in the long run if the government bails out the auto industry before it even considers a bailout for biotech. Nevertheless, BIO is actively lobbying for a government bailout because it believes that a bailout will not only stimulate the American economy but also help to “preserve American innovation and competitiveness.” Of interest, the pharmaceutical industry which shed over 123,000 jobs in the last year or so is not asking for government assistance. As one Washington lobbyist aptly quipped after hearing about the proposed biotech bailout: saving “research-based companies that employ 30 people won’t necessarily stimulate the economy.”

Second, the biotechnology business is inherently a very risky one. The failure rate among biotech companies is roughly 90%. And, as many of you know, biotechnology companies are always started with venture capital from investors who are willing to invest in risky projects because of possible financially-lucrative returns. Because of this, biotechnology executives are generally beholden to their investors rather than their shareholders, stakeholders or employees. Unfortunately, important business decisions are frequently made at venture-backed biotech companies for financial reasons rather than scientific or medical ones. Further, many financially-challenged, biotechnology companies that would benefit from the bail out started up almost a decade ago when venture capital was abundant and IPOs were daily events. In retrospect, many of these companies shouldn’t have been started in the first place because their technology platforms were either inadequately vetted or their business models were fundamentally flawed. I believe that these financially troubled companies ought to be allowed to fail just like the technology companies that had to close down in the early 2000s after the Internet bubble finally burst.

Third, why should unprofitable companies without products or revenues be bailed out and rewarded for failure? As I posited in a previous post, a company really isn’t a business until it has a product, generates revenues and turns a profit (or at least break even). If a company cannot create a viable business after 5-10 years of capital investments then it wasn’t a good value proposition at the outset. Perhaps a better use of the proposed bailout money would be for the US government to create public funding vehicles for companies that have developed promising new drugs that already have proof of concept in humans and are ready for clinical testing.

Finally, over the past decade, the biotechnology industry has spent hundreds of millions of dollars lobbying against the reimportation of drugs from foreign companies and the development of so-called follow-on biologics (potentially cheaper versions of blockbuster biotechnology drugs that have lost patent protection). This decade-long lobbying effort was undertaken to preserve America’s biotechnology monopoly and to insure that biotech drug prices remain high. Maybe BIO and its member companies should have considered using some of those monies to help struggling biotechnology companies rather than using it to influence politicians for tax breaks and pork barrel legislative initiatives.

Lastly and perhaps most importantly, why should taxpayer dollars be used to bailout an industry that has actively opposed and steadfastly refused to provide ALL Americans with access to reasonably priced, potentially life-saving biotech drugs? Because the biotechnology industry isn’t fundamentally different than any other American industry, I believe that the Darwinian principle of “survival of the fittest ought” to be applied to it. Unless, of course, you work on Wall Street or in Detroit—but don’t get me started!

Until next time…

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

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We in America have grown accustomed to the constant barrage of direct-to-consumer (DTC) advertising of prescription drugs provided to us daily by pharmaceutical and biotechnology companies. That said, some of you may be surprised to learn that DTC advertising of prescription drugs is only permitted in two countries in the world: New Zealand and the US.

According to William Burns, an executive at Roche Pharmaceuticals, “Direct-to-consumer promotion was the single worst decision for the industry." He added, "When industry says we're spending all the money on R&D but actually it's spending it on TV advertising to preserve margins, it doesn't get much credibility." It may not provide much credibility to the industry but is sure does help sales.  reported that a total of $4.2 billion was spent on DTC drug ads in the U.S. in 2005, up 330 percent from 1996.

Apparently Mr. Burns is not alone in his opinion. Angus Russell, chief executive of Britain's Shire Pharmaceuticals also condemned DTC.  As many of you know, I ‘m not a big fan of DTC nor am I flag-waving American but I find it rather curious that after almost 12 years of DTC advertising that European pharma executives are suddenly speaking out against the practice. Could this be little more than a ploy to get the European Commission to re-examine and possibly loosen it restrictions on the way prescription drugs are promoted in the EU? Quite coincidentally, the European Commission is in the process of drawing up legislation that would allow a degree of information to be disseminated about medicines by their makers, although advertising pharmaceuticals would remain banned. The legislation was initially expected to be unveiled by the European Union's executive arm last week but has been delayed.

Drug makers have long campaigned against rules that prevent them from talking directly to consumers in Europe, despite a wealth of often unreliable information being available on the Internet. I think this statement by Mr. Burns sums up the situation "You've got the two extremes on the planet, where we (drug makers) are given access to the public in America, which is too much, and in Europe we're not given access to information" (sounds like sour grapes to me).

Maybe a compromise between the two extremes would be a solution acceptable to both American and European regulators? 

Until next time…

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

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A little over a year ago, Bristol-Myers Squibb (BMS) launched its “productivity transformation initiative” (PTI) designed to “transform” the company into a next generation biopharma leader. As most of you may already know, PTI is corporate speak for layoffs and downsizing.

The PTI was largely in response to impending loss of patent protection in 2011 of its blockbuster Plavix, an anti-thrombosis drug that BMS co-markets with Sanofi Aventis. While BMS has a deep and innovative drug pipeline, the likelihood that the company will be able to replace Plavix revenues with one of its investigational drugs is remote.

To make matters worse, late last week, one of Plavix’s likely successors, an investigational anti-clotting drug called apixaban (being co-developed with Pfizer) failed to meet its primary clinical endpoints in a pivotal Phase III clinical trial called Advance 1 which was designed to evaluate the drug for prevention of venous thromboembolism in patients undergoing total knee replacement.  The 3,195-patient study compared apixaban, an oral Factor Xa inhibitor given at a dose of 2.5 mg, twice daily, to twice-daily 30mg injections of Sanofi-Aventis’ Lovenox (enoxaparin). This late stage clinical failure prompted the company to announce that it would no longer seek approval of apixaban in 2009 as previously planned.

Early this week, BMS ratcheted up the PTI and imposed a total hiring freeze for all permanent employees, consultants and leased workers (contractors). Previously, vacated permanent or temporary positions could be refilled if appropriate, qualified job candidates were identified. Finally, the company announced today that it would permanently ground its corporate fleet of jets that was operating out of Mercer County Airport in Trenton, NJ. According to an article in my local paper, the Trenton Times, BMS plans to sell four aircraft and layoff about 32 employees, mostly pilots and mechanics. 

Despite all of the other PTI initiatives implemented to date, the decision to sell all of its corporate jets sends a clear signal to stakeholders that BMS truly “means business”! I guess Jim Cornelius and other BMS executives will have to book commercial flights or take Amtrak to out-of-town meetings for the foreseeable future. That said, I doubt that Jim and others will be driving or taking the train to meetings in New York City or Washington—the corporate helicopter fleet is still operating!!!!!

Until next time….

Good Luck and Good Job Hunting (forget BMS)!!!!!!!

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

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

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

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

Until next time…

Good Luck and Good Job Hunting!!!!

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

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

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

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

Until next time….

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

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

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

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

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The US Food and Drug Administration announced late last week that it intends to post inspectors in embassies and consulates throughout the developing world to improve the quality of the food and medicines that flow into the US. FDA Commissioner Andrew C. von Eschenbach (Bush’s latest appointee to head the agency), said that he wants to have “boots-on-the-ground in developing nations like India and China and regions like Central and South America and the Middle East.” At present, less than 1% of the food imported into the US is inspected each year

As many of you know, FDA inspectors are required to visit both domestic and foreign manufacturing facilities that produce food, cosmetics and medicines that are sold in the US. By law, these inspections must take place every 3 years. Unfortunately, due to budget shortfalls and inspector shortages, routine inspections at domestic facilities are now taking place every 4 to 5 years– it is unclear how frequently inspections occur at foreign manufacturing facilities.  Based on von Eschenbach’s call for more foreign-based inspectors, the answer is likely “not frequently enough.”

The obvious solution to this problem is to increase the agency’s budget to hire and train new inspectors. However, despite repeated attempts by lawmakers, the Bush administration has steadfastly refused to endorse or consider budget increases for the agency. Instead, White House officials have urged the agency to uses any means possible to “bolster the aggressiveness and effectiveness of foreign health regulators” to prevent unsafe or tainted products from reaching the US market. I do not want to sound overly cynical but good will can go only so far with financial inducements or incentives.

Despite the obvious need for more inspectors, von Eschenbach admitted that his plan to post inspectors in foreign countries is “only in its infancy”. Also, he hasn’t decided whether he will ask Congress for additional funding for the agency or find money in the current budget for the foreign inspectors. I suspect that “finding money” in the current budget would translate into curbing other regulatory activities at FDA –something that would not bode well for the already-embattled agency. The inability of von Eschenbach to secure funding to train and deploy new inspectors is another reason why I believe that the FDA Commissioner ought not to be a political appointee!

Until next time…

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

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