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

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

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

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

Until next time…

Good Luck and Good Job Hunting!!!!

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

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

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

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

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

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

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

Until next time...

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

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