Off-label drug marketing: Who will decide what’s “truthful” when the evidence can’t be trusted?   

The following guest post is by Susan Molchan, MD, one of our regular contributors, who has previously worked at the FDA. She tweets as @SusanMolchan.

Off-label drug marketingEarlier this month, the Food and Drug Administration (FDA) held an important public hearing on “off-label” marketing of drugs and medical devices to physicians. “Off-label” refers the use of an FDA-approved medical product for a condition that it hasn’t been approved to treat — for example using a drug approved for depression to treat a different psychological problem such as insomnia.

Off-label promotion is currently illegal and with good reason: restricting the marketing of unapproved medical products is one of the main reasons why we have an FDA in the first place.  The FDA has lost ground on the issue in court in the past few years, with corporations successfully framing the restrictions as a free speech violation.

History of FDA media manipulation raises questions on timing

Given its potentially huge ramifications, the hearing was sparsely covered by the news media, perhaps because it took place on the Wednesday and Thursday after the hotly contested U.S. election.  A cynic might even wonder whether the FDA – which has displayed a troubling penchant for tactics that prioritize generating favorable media coverage over transparency – selected those dates with an eye toward minimizing public scrutiny of this issue.

There’s no proof of any such strategy and by all accounts, FDA officials listened attentively to both sides of the debate and asked thoughtful questions about the ramifications of a change in policy. The outlets that covered the meeting also did an excellent job of providing context and communicating the views of those for and against lifting the restrictions.  Here are some of the consumer-oriented news stories that I saw about the hearing:

STAT: FDA to hold two-day meeting on off-label drug marketing

CNN: FDA spotlights unapproved use of drugs, medical devices

Star-Tribune (Minneapolis): FDA hearing on off-labels use of devices explores risks to patients and  FDA urged to recognize need for exchange of info about unapproved uses of devices, drugs

Human lives, billions of dollars at stake

I was pleased to see that all of the articles appropriately related testimony from those seriously injured or whose loved ones had died a result of off-label use of drugs and medical devices.

CNN did an especially good job of putting the financial stakes in perspective, noting that drug companies spend around $27 billion annually on marketing. Indeed, fines of even billions of dollars for violations of off-label rules have been written off by the industry, some experts say, as merely “the cost of doing business.”

The CNN article also explains that some 80% of off-label prescribing is “not based on strong medical evidence.” Such prescribing is necessary in some cases, however, as many drugs are not tested in children or in people with rare diseases, for example — so doctors who treat these patients often must use drugs off label or not at all. Companies rarely invest in additional testing for such uses because once a drug’s patent protection expires, the potential to reap profits is greatly diminished.

Corporations say that it’s necessary to inform doctors about valid potential uses of their drugs, and that they should be able to advertise those uses with any information that is “truthful and non-misleading.” And there’s the rub. Who decides the truth? Who decides whether the evidence presented really does mean a drug or device is helpful and the risks it entails are worth it?

Evidence supporting claims may be biased in many ways

Unfortunately, one can’t depend on evidence from peer-viewed medical journals. Time and time again, even randomized controlled trials published in top journals – the “gold standard” of evidence —  are shown to be misleading. Companies can skew the results of those studies in any number of ways, including through the use of inappropriate statistical methods, or by leaving out data or participants they shouldn’t have.

Studies published by academic researchers are much more likely to show benefits from a drug or a device when the research has commercial sponsorship as compared with more independent funders such as the government. Marketing departments at sponsoring companies often have a hand in designing studies, and researchers conducting the studies are often paid by the companies as consultants, separate from their work on the published research.

Dr. John Ioannidis has established a field of study and a center at Stanford focusing on the inaccuracies and biases in research. In an article in Vox last year, in reference to clinical trials, he said, “ . . . half – or more – of the results that are published are interpreted inappropriately, with spin favoring preconceptions of sponsors’ agendas.” (Ioannidis also reflected on the news media’s flawed reporting of such studies in an interview with HealthNewsReview.org publisher Gary Schwitzer.)

Clinical practice guidelines are often no better, and are another way pharmaceutical corporations, with their overflowing coffers, bias medical practice, according to Dr. Ioannidis and many others.

Some studies of already-approved drugs, funded by corporations and published in medical journals, are conducted expressly for the purpose of marketing. The former chairman of psychiatry at Duke, Dr. Barney Carroll, coined the word for this practice: “experimercials.”

Corporate “free speech” is a cover for cranking up profits

Allowing companies to advertise drugs that are not approved would be a boon to their marketing departments. The FDA is already considered by many to be an agency captured by the industry it regulates, with standards for approval lower today than they were a decade ago. The agency is under-funded and much of the money to evaluate new drug applications comes from industry through user fees. The FDA is regularly caught in positions that show it bowing to industry demands to the detriment of public health and public budgets.

The story seems to be much the same at one of our other premier public health agencies, the Centers for Disease Control and Prevention (CDC). Last month the BMJ reported on the most recent ethical breach at the CDC, in which two of its scientists, also affiliated with a front organization for soda companies and the huge agricultural company Monsanto, influenced policies and public health messages by downplaying the effects of diet on obesity and other health problems.

Journalists covering future episodes of the off-label advertising saga would do well to remember this context and make sure that it is reflected in their coverage. “Free speech” in this case is a cover for targeting doctors and other health care providers with information of dubious value by the marketing machines of corporations. U.S. consumers pay the highest drug prices anywhere in the world, and these are not linked with higher quality of care. Corporate “free speech” won’t feel very free to those feeling the pinch of rising drug prices.

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Merrill Goozner

December 5, 2016 at 7:04 am

My thoughts ahead of the hearing: http://www.modernhealthcare.com/article/20161105/MAGAZINE/311059986