By Dr. Geoffrey Modest
The NY Times had yet another expose on drug companies, this time perhaps setting a really bad precedent for the FDA (see http://www.nytimes.com/2016/03/09/business/fda-deal-allows-amarin-to-promote-drug-for-off-label-use.html?_r=0 ). In this case a drug company sued the FDA to be able to market a triglyceride lowering agent without an approved indication. Details:
- Background: the FDA has a long-standing policy that drug companies cannot market drugs for off-label indications, and in recent years drug companies have paid billions of dollars in fines for doing so.
- The drug company (Amarin, which has only this product) had FDA approval in 2012 to market its fish oil variant Vascepa [icosapent ethyl, an ethyl ester of eicosapentaenoic acid (EPA)], to patients with triglycerides > 500 mg/dL. They subsequently wanted the right to market this drug to a much broader range of patients with lower triglyceride levels, without clinical trials showing documented benefit, stating that it was their first amendment right to advertise “truthful information to promote its drug”, and a district judge in Manhattan agreed. the FDA backed off and agreed to let Amarin use their “free speech” to promote this drug
- The FDA downplayed the implications of this action, stating that this was a narrow ruling, applying only to this case, and that their general approach has not changed.
- But, as quoted, Dr Michael Carome, director of health research at Public Citizen, a consumer advocacy group: “This really sends a signal to other companies that if you want to engage in off-label promotion, you can negotiate with the FDA”
So, this brings up a few issues:
- Clearly, this type of lawsuit is quite troubling, allowing the drug company to promote a drug without FDA-approval but based on a judge stating this is “free speech”. Drug companies naturally see it as in their financial interest to broaden marketing by adding on indications for drugs as much as they can. And they are likely to use their own sponsored studies to document benefit as “truthful information” for the clinicians and patients to go on. As noted in a myriad of blogs over the past 5 years (see below), there are many drug companies that will do pretty much anything to increase their markets. so, one issue is the legitimacy of all of these drug-company sponsored studies (clearly, there are many important studies sponsored by drug companies that appropriately influence medical practice. but there are also many documented sleazy studies, where drug companies have not allowed access to the data, where negative studies have been squelched and not published, etc. again, lots of examples in the blogs.)
- The Vascepa case, on my review, shows that the FDA based its original approval on a 12-week study in patients with fasting triglycerides between 500-2000 mg/dL, only showing a decrease in triglycerides. The FDA accepted this use of a surrogate endpoint (lowering triglycerides when they are very high) because of the known bad effects of very high triglycerides and with current guidelines suggesting treatment of such high levels [the best data are for the association of high triglycerides (>500, and esp >1000 mg/dL) and pancreatitis. the data on the relationship with coronary artery disease is pretty complicated and uncertain, to my reading]. So, extending the recommendation to those with lower levels of hypertriglyceridemia is a bit of a stretch. Of note, even for the higher levels of hypertriglyceridemia, there is a disclaimer in the drug labeling noting “the lack of evidence that treatment with Vascepa reduces the risk for pancreatitis in patients with severe hypertriglyceridemia”.
- So, the real concern is the slippery slope. The ability of this drug company to get the FDA to bend, based on the rather spurious argument (to me) that it is free speech (though there is really ZERO scientific evidence showing that there are improved clinical outcomes, only drug-company innuendo), really does open the door for the FDA being stripped of its regulatory, consumer-protective role.
- Also, there was an interesting report by STAT on drug company direct-marketing to the consumer (see http://statnews.com/2016/03/09/drug-industry-advertising/ ). It turns out that:
- Drug companies are spending $5.2 billion in 2015 (70% on TV ads) on direct-to-consumer advertising, growing dramatically each year (was $4.3 billion last in 2014). These numbers do not include hundreds of millions spent on digital and social media ads.
- 1/4 of advertising was for 5 drugs: humira (adalimumab, used in several inflammatory diseases), lyrica (pregabalin, for neuropathy etc.), eliquis (apixaban, a “novel” anticoagulant, see below for link to blogs critiquing them), cialis (tadalafil, used for erectile dysfunction), and xeljanz (tofacitinib, used for rheumatoid arthritis); all really really expensive and need to be taken for a very long time for continued efficacy.
- 9 drugs this year are on schedule to break $100 million/drug in TV ads (e.g. Harvoni, for hepatitis C)
- Of note, only the US and New Zealand are the only countries allowing direct-to-consumer advertising
- The AMA has called for a ban on this direct-to-consumer advertising
- And, shockingly to me (but perhaps I should not be surprised), drug companies get tax breaks for these ads; Senator Al Franken and others have introduced bills to eliminate these tax breaks, mostly based on the fact that these really expensive drugs add to the exorbitant costs of health care, and probably should not be subsidized by the populace….
See https://stg-blogs.bmj.com/bmjebmspotlight/category/pharmacy/ for several blogs on drug company malfeasance, including several on the novel anticoagulants, poor drug company compliance in reporting mandated data to the FDA, and even an earlier one (9/10/15) looking at Vascepa and with a review of FDA history
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