Physicians should not be used for FDA ad enforcement

One of the advantages of marrying an immigrant is having intense exposure to another culture. My wife’s Russian heritage, and her family, have enriched my own life immeasurably. The trip that I took with her and my brother to Russia in 1990, where she served as our personal translator, was unforgettable.

During the early years of our relationship, I heard stories about her family that seemed incredible to an American like myself who was raised in ordinary circumstances in suburbia.

In Russia, her father, uncle and close relatives were arrested and imprisoned on absurd charges. Her family, like so many others, was subjected to persecution and anti-Semitism. One would imagine that her family would celebrate when Stalin died in 1953. Instead, I am told that my mother-in-law, whose family had suffered under his brutal fist, was in tears, demonstrating the deep reach that this tyrannical leader had on the populace. He had a cult of personality, an intoxicant that numbed the senses of even his victims. To this day, I am sure there are still pockets within the former Soviet Union that celebrate him.

One of Stalin’s most feared institutions was his security apparatus. In addition to conventional law enforcement and intelligence apparatus, there was a nebulous web of informers across the country, ordinary citizens who were recruited to spy on their neighbors. Imagine this scenario. Your coworker confides to you that he thinks that their Communist boss is inept. However, this is not innocent factory floor banter. The coworker is an informer and was coerced under threat to approach you by the KGB, or some similar agency. You are subsequently arrested for failure to report him to the authorities.

Our own government, albeit on a much smaller scale, is currently recruiting physicians to serve as government informers. As an ardent James Bondophile, I have always fantasized about life as a spy using secret cameras, recording devices and driving the famed Aston Martin. Any male who denies having a similar fantasy couldn’t pass a lie detector test.

The Food and Drug Administration (FDA) wants physicians to turn in Big Pharma marketing and promotional materials that are misleading, that are poisoning us with information that reaches beyond FDA’s approved indications and regulations. This new government initiative is called the ‘Bad Ad’ program, a name so absurd, that it must have taken months of committee meetings to create. Physicians who encounter a rogue drug rep, or promotional materials that promise more than the FDA permits, can anonymously report the offender via an email address and phone number, which I will not provide here.

There is a Stalinesque aura to all of this. If I ask a drug rep about off label use of a drug, am I doing so to acquire medical information for a patient, or am I serving as a government agent, a G-Man, who is setting a trap?

Is this a good idea? Will this foster collaboration and trust between the medical profession and the pharmaceutical industry? Is it physicians’ role to serve as an enforcement arm of the government?

Personally, I believe that the FDA regulations on marketing to physicians is overly restrictive. For example, every physicians prescribes off label medicines, but we can’t discuss these uses with Pharma reps who are often excellent resources on unapproved medication uses. These sales folks may call on leaders in the field and may be able to relate to us nuances and new uses of medicines that can benefit our patients.

I know that these guys and gals are not physicians, but are trying to sell products, like everyone else in the marketplace. Sometimes, marketers go over the line. For example, Kellogg, the cereal company, had to take back two health claims:

• Frosted Mini-Wheats can improve kids’ attention spans.
• Rice Krispies can enhance kids’ immunity.

In these cases, the Federal Trade Commission was right to intervene. Drug promotion can also go over the line and need to be reined in and sanctioned. I am not sure, however, that the line is in the right place presently. What is your view?

I don’t like the ‘bad ad’ program, and I don’t intend to have the FDA on my speed dial. I don’t like the precedent of folks being encouraged to turn in colleagues. Imagine where this idea could take us.

This post has riled me up and I need to calm down. I need an ‘off label’ anxiolytic.  It’s time for a Vodka Martini, shaken not stirred.

Michael Kirsch is a gastroenterologist who blogs at MD Whistleblower.

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  • Payne Hertz

    Fraudulent and corrupt marketing practices by pharmaceutical companies cost the country billions of dollars every year and endanger the health and safety of patients. Pfizer was recently fined $2.3 billion under the False Claims Act—the highest such award ever—for its deceptive and often criminal marketing practices. A recent report by Al Jazeera documents the widespread fraud in the system which includes drug companies paying doctors kickbacks to promote the drugs and also to prescribe them to patients, as well as providing doctors with fraudulent information about drugs.

    “Sharon Ormsky, FBI Financial Crimes Unit states, “Pharmaceutical fraud is one of our top three threats — everybody is touched by these frauds in the extent that when you look at the billions of dollars that go into healthcare for the United States, a good percent, 3-10% of that is believed to be siphoned off into fraud—that’s money that could be going to very needy patients.”

    Sales reps are encouraged to give misleading and false claims about the side effects of drugs, as well as lying to promote off-label uses that have no basis in science or clinical practice. I strongly urge anyone concerned with this problem to watch this video:

    Surely doctors have a moral and ethical responsibility to report these kinds of abuses, including reporting other colleagues who accept kickbacks or other illegal gratuities for prescribing drugs. These abuses have only come to light as the result of whistleblowers in the system pointing them out. The FDA is doing the right thing by establishing a convenient mechanism for the reporting of these kinds of abuses.

    There is no comparison whatsoever between the FDA creating a means for doctors to come forward and report evidence of abuses that endanger public health and human lives and the crimes of the Soviet system.

  • Asya

    It’s true, Stalin is still revered by many in Russia:

    In response to your main point, I think it’s interesting that FDA is using on-the-ground physicians to give them feedback. I think using the social network in the trenches is an extremely powerful tool (precisely why Stalin used it), and I’m not sure I agree that it amounts to a Big Brother atmosphere. I can’t comment on how right the FDA is on discouraging off-label drug use, because I don’t know much about the issue. But I think their use of doctor feedback is a great thing, and I think that should be discussed separately from the off-label drug issue.

  • BladeDoc

    Well, it certainly explains why the reps I saw today recoiled like vampires from the sun when I mentioned how I mostly use their antibiotic for an off label use. Interesting, I usually torture drug reps by asking about abstruse pharmacokinetics, now I can get them frightened I am a narc for the FDA.

  • Barb Chamberlain

    Speaking as a patient, not a provider–

    I’d feel a lot better as a patient about your argument if the colleague you were consulting were a pharmacist–not the person in your office who’s paid to get you to choose that drug over another one. One person’s “nuance” is another person’s “nasty (fatal?) side effect.”

    That rep also doesn’t know anything my individual case, whereas my pharmacist knows everything I’m taking and can be consulted that day, the next week, and the next month.

    I place a great deal of confidence in the physicians, pharmacists, nurses and nurse practitioners who provide my health care because I believe they give me the highest standard of care and uphold their ethical commitments as professionals.

    Their commitment is to me as their patient–not to someone whose motive is to sell them something.

    I also don’t know who else BUT the physician would know if a rep makes unfounded claims in an office visit. Stuff in the ads that anyone can see–that, I can research for myself. But I can’t be there for the marketing pitch you hear.

    Seems to me it’s in everyone’s interest for good, professional reps to succeed (as in, be able to sell things) and for any true bad apples to be identified.

    What alternative system would you propose for the underlying problem they’re trying to get at? Or are you saying there’s no such problem?

  • Michael Kirsch, M.D.

    I do not know the extent of the problem. I suspect that most reps are doing the right thing, at least that is my experience. I am not convinced that we should be squealing to the federal government to report allegations of reps stepping over the line. Careers are at stake. If a rep is discussing off label use with me, which may be at my request, is this a reportable offense? Where is the line? What should my response be when a colleague (or myself) orders a medical test for the wrong reason? Should the physician be reported to Medicare? As I noted in the post, if the ‘Bad Ad’ program is a model for the medical profession, and beyond, then one could imagine the adverse consequences. We need other mechanisms besides surreptitious squealing to promote ethical and lawful behavior. Most of us are doing right each day, and not because we fear being turned in by a colleague or a coworker. Obviously, there are circumstance that demand reporting an individual to the authorities, or to his company’s leadership; but these should not be routine responses.

  • AC

    Dr Kirsch, you’re using the same tactics that Stalin did…nice going.
    Either there is a complete lack of understanding of what the that system was all about, in which case you shouldn’t use it in your argument, or there is an underlying motive.
    I think is a little bit of both.

    The comparison is completly flawed. Most reps are individuals with only a marketing or business degree and a very little to none science understanding. You’ll be surprised but many of them don’t even know the science behind the drugs they actually sell. It’s kind of scary to think that you would be actually getting scientific information from this source. Regulations prohibiting reps to sell off label have been in place for a while, but not all respect them. And that’s plain wrong especially when you’re talking about people’s lives.

  • Michael F. Mirochna, MD

    I’d be okay with reps giving out off-label uses of products if there was data to suggest that it actually worked and that insurance companies, medicare, medicaid and the population of the United States didn’t have to foot the bill for the experimental use of tier 3 drugs (but the patient only has to pay a $25 dollar co-pay with this coupon card, so it makes it comparable to the 15 other drugs that are just like this one that are already tier 1 or 2).

    Oh, I guess those would then be called FDA approved uses if they actually did the studies to prove the “off-label” uses.

  • Marya Zilberberg

    Interesting post! As someone who is well informed on both, Stalinist tactics and off-label promotions, I found your logic… well, illogical. Do you remember the Neurontin case, where reps were told by the company to convince doctors to prescribe it for anything and everything? Non-existent data, misrepresented results, financial incentives, all culminating in a huge whistle-blower case and a law suit. Most of our colleagues have trouble with nuances of data. How can a young barely-out-of-college kid trying to make his bonus and a trip to the Caribbean be expected to get the intricacies of research studies? It is true that there are some reps who are smarter than some MDs, but those are rare.
    I suggest that if you want to discuss off-label indications, you go through a pathway that most companies have to have the rep bring in a member of the Medical Affairs group, usually a pharmacist, a doctor or a nurse, who has really delved into the data and, believe it or not, is trained to give a balanced view of the research.
    Reps really have no business promoting off-label uses, and companies should have zero-tolerance for that.

  • IVF-MD

    To intelligently discuss the pros and cons of allowing a single entity have a monopoly on the regulation of drugs, one would have to consider:

    How many good outcomes resulted (lives saved or harm avoided) by the FDA preventing bad drugs from reaching the people?

    How many failures were there where patients were harmed or killed by drugs that were actually approved by the FDA?

    How much more expensive is health care as a result of the regulations imposed by the FDA? And the related question of how much good can be done by spending that money towards other things?

    How many lives were lost or patients harmed by being deprived of drugs that were good and safe, but did not pass FDA requirements?

    How many lives were lost or patients harmed by being deprived of good drugs that were never brought to market because the researching companies made a smart business decision that the limited group of people who would be helped did not warrant the great expense of clearing the drug through the FDA?

    What would be relative harm or good that would come from people being allowed to choose whether or not to personally take “unsafe” drugs that might help them tremendously at low cost while having let’s say a 1 in 100 chance of causing them significant harm in some way?

    How much more or less efficient would it be if there were two or more entities that competed to police drug accessibility?

  • SkeptVet

    I find your references to Stalinism histrionic and polemical. There is clearly an anti-government philosophical agenda behind this rhetoric that goes well beond any rational discussion of the merits of this particular FDA program or any other.

    Apart from that, I absolutely agree that physicians and, as in my case, veterinarians should be encourage to report illegal, fraudulent, and misleading advertising of drugs and other medical interventions. The label claims guidelines and other FDA regulations are sensible efforts to protect the public from ineffective and unsafe therapies sold under false pretences. Such therapies were widespread, and did much harm, before the era of government regulation of medicine, and though most of us are now too young to remember that time, the danger of allowing drugs and treatments to be marketed with msileading or false claims has not gone away. Just as we continue to recommend vaccination to prevent infectious diseases that haven’t been major public health hazards in our own lifetimes, we must continue to support restrictions on advertising with false claims even if such restrictions have made the dangers they guard against less prevalent and readily identifiable.

  • Michael Kirsch, M.D.

    @IVC, appreciate comment.

    Regarding skeptvet’s comment, “we must continue to support restrictions on advertising with false claims…” There’s a difference between a false claim and published medical information on unapproved use of medications.

    No, I do not rely upon drug reps to keep me informed, but I have learned from some of them over the years.

  • SkeptVet

    “There’s a difference between a false claim and published medical information on unapproved use of medications”

    Of course. There’s a continuum from outright false advertising to promoting uses for which there is evidence but which have not achieved approval for a label claim. However, the rules exist to prevent claims that are not adequately established by evidence in the opinion of a neutral party, since the company selling a drug is naturally going to be made up of people inclined to interpret the evidence in the most positive light, as well as to have potential motives to exaggerate claims. Without meaningful enforcement of the rules, they become ineffecive.

    The overwhelming majority of drugs I use are off-label since there is insufficient financial motivation to drive companies to seek FDA approval for veterinary indications most of the time. This is necessary to allow me access to vital therapeutics, but it also means that the FDA essentially doesn’t enforce label claims in the vet med industry. As a consequence inappropriate uses of dugs based on extrapolation from humans or merely personal hunches is commonplace, and I suspect there is a cost to our patients as a result.

    I understand the potential of the regulations to limit appropriate therapeutic uses of drugs, but I see even more acutely the need for meaningful enforcement of the regulations to protect against inappropriate use of therapeutics for unapproved indications.

  • AC

    Getting off label information from a drug rep is like asking the office manager to perform surgery.

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