Substituting Robust Marketing For Scientific Evidence: Industry Pursues Legal “Free Hand” For Off-Label Promotion.

Posted on | November 3, 2016 | Comments Off on Substituting Robust Marketing For Scientific Evidence: Industry Pursues Legal “Free Hand” For Off-Label Promotion.

SOURCE: OFF LABEL: A FILM

Mike Magee

Over the past fourteen years, the pharmaceutical industry in the U.S. has successfully beaten back proposals to allow drug reimportation from Canada. These proposals were advanced by multiple members of Congress and big city mayors, and were supported by the majority of Americans. But President Bush, in negotiations for passage of the Medicate Modernization Act in 2003, and President Obama, in the negotiations for passage of the Affordable Care Act in 2009, were both willing to prohibit the practices on the basis of safety in return for industry support for their legislative initiatives.

Over time, it has become clear that America’s “arbitrage drug” gray market within our own borders makes any safety issues related to secure importation of Canadian drugs from a small number of approved vendors, infinitesimally small by comparison. The true purpose of the pharmaceutical industry’s opposition has little to do with counterfeit drugs, and everything to do with profitability. This reality is rarely admitted, but occasionally, as in this 2010 Wall Street Journal, does surface.

The author said then, “But there is an even more important reason why importing drugs is dangerous. Importing foreign drugs or reimporting American-made drugs is a back-door way of introducing price controls in America. Many foreign countries, including Canada, impose price controls on drugs, which is why reimporting American-made drugs is cheaper than simply buying drugs that haven’t left the country.”

In fact, approximately 50% of the U.S. multi-national pharmaceutical industry’s profitability derives directly from sales inside U.S. borders. This differential financial success has little to do with the quality of the products (most are available throughout the developed world), and much to do with three other factors. First, the U.S. government is the only developed governing body in the world with no mechanisms to moderate drug prices within their borders. Second, the U.S. is one of only two nations in the world (New Zealand being the second is actively reconsidering this position) which allows Direct-To-Consumer advertising. Third, as the recent man-made opioid epidemic has so clearly demonstrated, U.S. physicians may just win the price as the most naive prescribers in the world, ready to believe crazy messages like the Purdue-Pharma backed “pain is the 5th vital sign” message on a moments notice.

Unrestrained prices, “Ask Your Doctor” push ads, and naive sloppy prescribing do indeed spell enormous financial success. But as the recent scandalous price hikes for everything from Epi-Pen’s to insulin (up 200% in the past 8 years), industry’s avarice on American shores knows no bounds. Their leaders are unable to demonstrate restraint. The latest case in point is the drug and biologic industry’s moves to promote a loosening of regulations that have prohibited pharmaceutical representatives from promoting the use of their drugs for “off-label” purposes.

The Food, Drug, and Cosmetic Act allows physicians to exercise their knowledge and judgement in prescribing drugs for purposes not listed on the drug’s approved label. What gets on that label must be supported by scientific evidence coming from approved clinical trials. This is the system in place to assure our medications are both safe and effective. But the government has permitted physicians as the “learned intermediaries” to wander into unapproved areas of use when they believed it was in the patients best interests. Studies have shown that a quite remarkable 21% of prescriptions doctors write in the U.S. are “off-label”. The same Act that permitted doctors this freedom at the same time outlawed pharmaceutical representatives from marketing their drugs for “off-label” use, allowing them only to respond to doctors specific questions and requests for “peer reviewed” information. Over the past few decades, the law has been strictly enforced, and the fines for wrong doing have been in the billions.

But now, with some success, industry backed suits have challenge these consumer protections. In 2012, a pharmaceutical representative named Alfred Caronia was proven to have pushed his companies drug, Xyrem, approved for narcolepsy, for a range of off-label conditions including insomnia, Parkinson’s and fibromyalgia. An Appeal’s court reversed their initial conviction by arguing that Caronia’s sales pitch was free speech protected by the First Amendment. Several other cases are now being argued on the same basis, and industry is simultaneously lobbying the FDA for liberalization of these historic regulatory constraints.

Congress enacted these regulations for a reason. They protect patients, and also incentivize industry to perform the proper scientific research if they wish to commercialize their discoveries. The system has worked, and industry frequently submits additional research to allow legal expansion of indications. Nearly have of the FDA’s approvals are for such expansions of existing products.

The current subversive attempts are based on greed, and would replace critical science with robust marketing. All of the evidence – from price gouging, to push advertising, to sloppy prescribing, to back-door subversive legal maneuvering – suggests the need for more government oversight, not less. “Trust me” doesn’t cut it. Evidence, science, responsible citizenship, mature professionalism, earned respect – these are the virtues that cut it and demand our support.