I noticed a new banner ad for Binge Eating Disorder in my Yahoo pages last night for the first time. It is one of those sophisticated ads that becomes a video clip when you click on it. The main message of the video clip is that "Binge Eating Disorder is a real medical disorder" and it provides a link to the web site bingeeatingdisorder.com. If you go to that site and click on the health care professionals link, you are taken to what is essentially a massive infographic on binge eating disorder with descriptions of what is known about the epidemiology and theory of B.E.D. There is no mention of treatment or the specific FDA approved medication from this pharmaceutical company that has been approved for B.E.D. My speculation is that is coming once the advertisers analyze their web traffic and see how well the ad campaign is accepted. Specifically will there be the usual outcry that pharmaceutical companies are making up diagnoses in order to sell drugs and of course the evil psychiatrists that are involved. If a lot of that blowback occurs it would be easy to cancel the campaign, take down the web site and either come up with another campaign or go with more traditional advertising to a much less politically adept audience, namely physicians through medical journals. I admit, the brain graphic with a slice of pizza replacing the parietal lobe is eye catching.
This ad allows me to make a couple of points. The first is the reason that we have epidemics of addictive drugs. The general process is an increase in availability and exposing more people to the drug. We do not know the genotypes at risk but in general a significant part of the population will have euphorigenic responses to addictive drugs. Wider availability generally equates to larger numbers of users and people at risk for addiction. An example I like to use is growing up in northern Wisconsin. Back in the 1970s, even though it was the hippie generation, the main exposure in remote areas was alcohol and marijuana. Flash forward 40 years and now there is widespread availability of practically all drugs of abuse in rural areas, including intravenous heroin. Anytime an addictive drug comes into the marketplace there is a risk that level of availability will lead to more addiction and complications of addiction. In the case of the first amphetamine epidemic, it was marketing and general use for a number of disorders that did not respond to the medication and marketing products like benzedrine inhalers that could be easily abused. In the end there were thousands of amphetamine containing products until all of them were moved to Schedule II and under much tighter regulation.
The second point is that the FDA clearly does an inadequate job of preventing addiction and complications of addiction. There should be no doubt that the main objective of the FDA is to get pharmaceuticals out into the marketplace as soon as possible. Although politicians like to grandstand on the idea that the FDA prevents the release of life-saving drugs or builds regulatory hurdles that lead to unnecessary expense there appears to be less and less evidence that is true. Those same politicians seem to favor quicker release and less regulation. It is fairly clear that the FDA has minimal scientific requirements. The release of multiple new opioids during the time of an opioid epidemic of overdose deaths and against the recommendations of the Scientific Committee would be a case in point. A further case in point is that none of these new opioid drugs is a unique compound. They are all basically mixes and matches of old compounds in patentable dose sizes and various possibly tamper proof formulations. Even as I type this note I am being informed that the FDA has accepted an application for reviewing a new drug that is a combination of extended release oxycodone and naltrexone.
The FDA clearly has a lax approach to potentially addictive compounds and they cannot depend on post marketing surveillance or their so-called REMS (Risk Evaluation and Mitigation Strategies). A reasonable approach would be to use a gatekeeper strategy and monitor those physicians for complications from prescribing controlled substances. Since agencies and regulators at all levels seem to believe that they can teach all physicians to prescribe controlled substances with an equal low level of skill, the time of the gatekeeper option is in the past. The main FDA approach is post marketing surveillance or basically waiting to see what happens. In the case of addictive drugs this is even a worse idea than with other risky medications. The post marketing surveillance depends on reports from physicians, patients or other health care professionals. Reporting a complication from a controlled substance is much less likely to happen for a number of reasons. Physicians working in the addiction field may be working in settings where there is a higher standard for confidentiality than typical medical records. Any time there is the potential interpretation of diversion or inappropriate prescribing reporting is less likely. For these reasons post marketing surveillance is not a good approach to monitor a new pharmaceutical to see if it is being overprescribed and abused.
What is a good approach? For decades there have been large databases that compile the prescriptions of all physician in the US. This data was typically sold to pharmaceutical companies to gauge the success of their marketing efforts by the number of prescriptions written. It is time that the FDA ran a database and looked at real numbers and trends in prescribing. They would have first hand knowledge of how many new Vyvanse prescriptions were written for binge-eating disorders and where any potential prescription mills were located. They could intervene before there was a years long or decades long problem.
I conclude the Binge-Eating Ad is good advertising. Someone once said that an addictive drug sells itself. I think that is true in terms of the place that stimulants have in the collective consciousness of Americans. They are seen as magical performance enhancing drugs that are good for whatever ails you. I can see the pressure building in primary care clinics for Vyvanse prescriptions for Binge-Eating Disorder and patients expressing their severe disappointment if they hear their clinic will not prescribe it. They will not understand that good advertising is not necessarily good medicine.
Creating demand for a medication with definite addictive potential seldom is.
George Dawson, MD, DFAPA