How drugs are promoted isn’t a freedom of speech issue

How drugs are promoted isnt a freedom of speech issue

I learned of a disturbing decision from the Court of Appeals for the Second Circuit. In an insane ruling, two of judges determined that a drug rep promoting “off-label” uses for a drug was exercising his freedom of speech. Let’s stroll to the back of a typical doctor’s office to see how this plays out.

Of all the ways pharmaceutical companies market drugs, two are especially distasteful (i.e. annoying, immoral, and dangerous). The first is direct-to-consumer advertising (“Having chest pain? Take Brand A aspirin! Oh, and call 911!) The other is the practice of drug company marketers (drug reps) visiting doctors’ offices.

In both cases, people whose job it is to sell a product are doing their best to get patients asking for a drug and doctors prescribing it. The drug companies argue that they are providing a necessary service: educating doctors about new drugs, the obvious fallacy being that their incentive isn’t to “educate” but to inculcate. One of the ways this practice has been regulated historically is by telling drug reps they can only promote the drug for uses approved by the FDA.

So, for example, if NewSuperDrug has been shown to improve hair growth, and that’s what the FDA has approved it for, a drug rep cannot (except perhaps in the Second Circuit) also say, “By the way, it’s also great for blood pressure. Give it a try.”

Here’s where it gets sticky. It may be true that the drug is good for blood pressure. A doctor may choose to prescribe it for that. But when it comes to marketing, the manufacturers have to stick to what they proved to the FDA (except perhaps in the Second Circuit).

This is bad—really bad. First of all, doctors shouldn’t be getting their information from drug reps. It’s hard enough parsing through the literature, with its publication biases, decline effect, and drug company shenanigans—hard, but not impossible. What’s not so hard is finding appropriate non-corporate-sponsored Continuing Medical Education (CME) credits. Conferences, websites, medical associations all give docs access to information, information less biased than that from the people who stand to benefit from your prescribing habits.

Drug reps are, by reputation, young, attractive, and sociable. They also tend to want to feed you. Many medical centers, especially the ones that participate in medical education, have banned drug reps. But doctors offices often let them in. (Full disclosure: we let them in, but don’t let them bring lunches. Certain drugs, like ALL asthma drugs, aren’t available as generics, and we need the samples.)

It’s hard for a doc like me to see how free speech enters into limiting what these folks can say. The obvious analogies (theater, fire, etc.) aren’t even needed. We regulate advertisers all the time, for example, prosecuting certain types of deception. Bait-and-switch advertising isn’t OK and we don’t see limiting it as an onerous imposition on free speech.

Drugs are pretty damned complicated and important. Telling drug companies they can’t promote their drugs except for the uses they managed to get approved is actually a good thing. Allowing them to say whatever they want gives them license to increase their sales by convincing busy doctors to prescribe for off-label uses that may or may not be OK. Yes, docs like me are supposed to know the difference, but studies have clearly shown that we are influenced by drug reps, whether we think so or not.

My advice: docs shouldn’t talk to drug reps. Cut of their access, and the companies will have to find other ways to promote their products. But since we can’t and probably shouldn’t prevent drug companies from marketing their products to doctors, we have to make it clear that this isn’t a free speech issue, but a safety and public health issue.

My guess would be that the current Supreme Court, where this case may end up, will think it’s just fine for drug reps to say whatever they want, so it’s time for doctors to stop listening.

“PalMD” is an internal medicine physician who blogs at White Coat Underground.

Image credit: Shutterstock.com

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  • http://www.facebook.com/beau.ellenbecker Beau Ellenbecker

    I find drug reps rarely have unbiased literature to review. When I demand that all of them have independent studies, few can follow through. So there presentation of their own data is often significantly flawed.

    • http://twitter.com/Fenbeast Fenbeast

      How can the drug reps have unbiased literature when the pharmaceutical companies are publishing only those studies that favor their products? There is no such thing as unbiased literature on drug efficacy, at least not in American medical publishing.

      • Suzi Q 38

        And why would you expect it? You have to realize that pharmaceutical reps have a clear agenda. They are here to promote and sell more of their products. There is no harm in that.
        If you want to promote your business, would you spend the time talking about how much better the doctor is down the street?

        If you have ever been asked by your hospital to speak to the community about disease that relates to your specialty, you then hand out your business cards at the end.
        Now you have just done what the pharmaceutical rep has done… you have promoted yourself or your practice.

        Years ago, reps used to make their own detail pieces. We used to call it “cut and paste.” They used to find newer studies, compile percentages of success, and insert the approved FDA sales pieces along with it. It was far more interesting back then. I remember having to choose doctors for free medical meetings in other states, or countries….most expenses paid. Lots of gadgets, pens and pads to give away…I used to laugh and say that I was a very good caterer…..Things have changed. The FDA is very strict now, and some of these practices are not allowed.

        It is sad, though that some reps and drug companies had to be indicted and fined before the practice stopped.

      • Suzi Q 38

        You have to think about the pharmaceutical rep as a 5 minute “commercial” of certain products that their company wants to promote.
        Most doctors don’t have the time for this anymore.
        If you have the time, it is a nice break.
        Think about the pharmaceutical companies that are buying commercial time on television.
        They are not going to be talking about other drugs for the most part.
        You are allowed to ask about how other drugs compare when you talk to these reps, but keep in mind that they are taught that their drugs are better.

        In the end, may or may not be the ultimate truth.

        The reality is that ALL DRUGS WORK.

        Some just work better for certain patients than others, because patients are all different.

      • Suzi Q 38

        “How can the drug reps have unbiased literature when the pharmaceutical companies are publishing only those studies that favor their products? ”
        You are right on. The reps can only use promotional materials that are given to them, and they are NOT unbiased…They are FDA approved. This is a big difference. You have to be the “judge” of what information is credible or not.

        Think about a lawsuit that requires medical experts.
        I can find a doctor tomorrow that will do a negative report on a patient for his competency. I had go down the street and hire another physician that will evaluate the same patient and give me the opposite view.

        They are doctors, for goodness sake. Who is right?
        Are they both talking about the same patient?
        You wouldn’t know from their so called “independent” evaluations.

        The difference is who is signing their paycheck for the service rendered.

        My point is, cut the sales reps a break. They are only doing their job.

    • Suzi Q 38

      So what? I understand that you want both sides, but their company isn’t going to give it to them. On the other hand, you know what the drug can do. The samples alone are good. As a patient, I appreciate it when a doctor gives me new samples.
      I had to go on a cholesterol med, and many gave me achy muscles, aslo some gave me constipation. It took several rounds of free samples to finally settle on a drug that worked best for me.
      I appreciated that.

  • ninguem

    I doubt it it will make much difference. Actually, if kept away from physicians, I can see the drug companies using their influence on administrators to force the physicians and patients into their favored drug.

  • bladedoc

    When you talk about limiting drug reps speech you need to separate into suppressing UNTRUE speech (i.e. false advertising) which you correctly state is illegal and suppressing TRUE speech that the government doesn’t like for whatever reason. It may be the fact that allowing drug reps to talk about off-label uses of medications has negative effects, but comparing this regulation to the limitations of untrue speech is specious.

    The clichéd example of “yelling ‘fire’ in a crowded theater” is a perfect example. This act is only illegal if it is untrue. It is perfectly legal (and may even be required) to alert people of a fire if in fact one exists.

  • NormRx

    “Drug reps are, by reputation, young, attractive, and sociable”
    I use to be like that. But, after 27 years of calling on doctors I am old, grumpy and anti-social

    • Suzi Q 38

      After 13 years I quit. I am still attractive….at least my husband still thinks I’m attractive.

  • DavidBehar

    The above left wing propaganda is dangerous to clinical care, and needs rebuttal. There should be zero tolerance for such bias and hate speech.

    1) Off label use represents half of prescriptions.

    2) Off label use is the single biggest source of clinical innovation, and at no additional cost.

    3) Commercial speech may be regulated more than political speech, but usually for fraud or bad faith. It may not be suppressed.

    4) So presenting articles on off label use should be protected, not suppressed, for the purpose of free speech, but also as a matter of policy, to accelerate the spread of an effective treatment.

    I am also demanding the real name of this doctor, and the reason we cannot have it. Then, I propose a boycott by all service and product providers of this enemy of freedom and advances in clinical care. His hate speech is free, but we can respond accordingly.

    I plan to buy shares of every drug company, then to intervene in future prosecutions for off label promotions. I have standing in place of my patients, and will sue on their behalfs, the whistleblowers, seek the personal destruction of the DOJ mad dog prosecutors. To deter.

    • UncleStu

      To agree with you is to believe that the FDA should just approve every drug for any purpose whatsoever. You probably also believe the FDA should just disappear, and that we ought to go back to the days of the carnival snake oil salesman.

      You certainly value free speech, especially what you call “commercial speech”. Nevertheless, you are willing to restrict the right of the author to exercise his/her free speech, even going so far as to threaten him/her with boycotts.

      And you have the gall to call this article “hate speech” and the Department of Justice prosecutors mad dogs.

      I think you should calm down, read the Constitution and the history of our laws. Please stop worrying about the health of the pharmaceutical companies, since they have proven to be well able to take care of their own interests without you. (or are you part of that industry?)

      • DavidBehar

        I have legal training, and matters are 100 times worse than any lay person has any idea. I have called for the arrests of the entire lawyer hierarchy for their insurrection against the constitution. The lawyer profession is organized as a criminal cult enterprise. It is history’s greatest criminal syndicate.It has infiltrated the three branches of government, and lawyers make 99% of policy decision, for their own enrichment and empowerment. We pity Mexico because of corruption. In our country, the crime syndicate runs the entire government.

        The FDA needs to be disbanded as organized now. I hope you are healthy or satisfied with your current treatment, If not, thank the heartless FDA for the lack of innovation and adequate treatments for many of our major conditions. My interest is that of my patients. When they do well, my job is like heaven. When they do not do well, my job is like hell.

        I have every right to call for the boycott of an enemy of clinical care. That is highly protected political speech.

        I would welcome an investigation by the mad dog lawyer at the DOJ who enforce unconscionable FDA regulation. That is an opportunity to destroy their personal lives, and to drive them to suicide, as they hounded a doctor who did nothing wrong. They are not even human.

        Their self-dealt legal immunities even justify violence against this lawyer enemy in formal logic. If tort liability, as for this suicide, is a substitute for violence, then tort immunity if a justification for violence. The contra-positive of a true proposition is always true.

        I use my real name, and may be found any time the government wants to come and get me. Why can’t this traitor to clinical care do the same?

    • http://twitter.com/Fenbeast Fenbeast

      Hate speech? are you serious? No one is saying that off-label drug USE should be abandoned; only that off-label uses shouldn’t be MARKETED. There are occasions that off-label use leads to important breakthroughs (sometimes miraculous ones) in patient care; I recall, in particular, a case I read about 10-12 years ago in which a terminal patient with GIST was treated with imatinib mesylate (previously used only for CML) as a last-ditch effort, and underwent a positively jaw-dropping remission of her cancer. Off-label use of the drug literally brought her back from death’s door. However, that does not excuse blanket promotion of drugs that have not been shown to be effective in randomized, placebo-controlled clinical trials. Until they’ve been PROVEN to have positive benefits for patients, the reps have no business pushing them as beneficial. The fact that they often do makes them little better than snake-oil salesmen… and I cry shame on any medical doctor who listens to them without doing his/her homework.

      • DavidBehar

        Randomized, placebo control trial are worse than garbage science. They have the appearance of reliability but are worthless garbage. Furthermore, their parametric statistics do not apply to the on-off trial that is clinical care. The binomial statistic applies to that scenario, more akin to a coin tosses. I learned that Day One, 11th grade statistics. Most of the scientific leaders of the nation must have cut class that day.

        • Suzi Q 38

          I kind of agree at times.

          I see some these studies, and I wonder if the end result is skewed. There are more than a few doctors that run the studies know that the money comes from somewhere. Who needs to be made happy? When determining side effects, this is a clinical determination, many times.
          Some are included and some are excluded. Who decides this?

          They also carefully choose the patients. If there is any negative ailment that may not give them the result that they need, the patient is not chosen or excluded.

          For example, my sister was asked to participate in a study when receiving treatment for a certain cancer.
          She did not want to participate, because she was too stressed and to sick to deal with all of it.
          The clinicians asked her over and over again to reconsider, even treated her not so nice because she chose not to participate.
          She was only 52 and very strong, physically. She would have made a good patient for the study.
          Being choosy is helpful if they need a positive outcome.

      • Suzi Q 38

        I agree that off label use should not be marketed, but discussion of such makes the conversation more interesting.
        The is the something “new” that doctors at times want to hear.
        They are so busy that I am not sure the pharmaceutical “sharing” goes on in the doctor’s lounge at lunchtime.

  • Docbart

    This is certainly a fraught issue. One has to hear the message of reps with skepticism, but many of us would not hear what is genuinely new and useful in a timely way, if not for reps. It’s hard to stay abreast of even the real advances in pharm, not to mention the me-too meds.
    One has to avoid prescribing out of a sense of indebtedness to a rep, and this has been made a bit easier than before by elimination of many past “inducements” such as junkets, tchotchkes, preceptorships etc. Drug lunches are pretty small snares compared to the “advisory panels”, “speakers bureaus” and “seeding studies” i.e phony “post-market research” studies, which are all just thinly-veiled ways of paying docs to prescribe given products. Also, a big concern is pharma influencing published studies by ghost-writing, poor study design, etc.
    As for promoting drugs for off-label uses, this is an especially difficult area. There is rampant abuse going on by re-purposing drugs for wider use than the approved ones, or when they are failures in their indicated uses. There are, however, many valid off-label considerations, where the literature supports such uses. I think we might benefit from allowing at least a presentation of such literature, if accompanied by the disclaimer that such uses are off-label.

  • UncleStu

    I cannot, for the life of me, understand two things.
    (I wish it was really only two things.)

    1) A patient – a lay-person – sees a drug advertisement and asks the doctor for it. So, the doctor prescribes it, knowing it is useless for the problem at hand.
    The most common scenario is prescribing an antibiotic for a virus because the patient wants one.

    Why do some doctors do this? Doctors are the experts, not the patients or the TV ads. There is no legitimate excuse to do it – period!

    2) In the entire world, “direct to consumer” advertising for prescription drugs is only allowed in two countries, the USA (legalized in 1997) and New Zealand (legalized in 1981).

    Some of the commenters here, doctors, have said how difficult it is to keep up with the latest developments. Yet lay-people are supposed to chose their own treatments based on TV or magazine ads?

    Why is Direct to Consumer advertising allowed in the USA? It serves no legitimate public purpose. No good can, ever has, or ever will come of it – none. (unless you are a drug manufacturer, I suppose)

    • DavidBehar

      Direct to consumer advertising is great because it educates the public about diagnosis and treatment. There is no evidence of any harm to patients from either direct to consumer advertising nor from drug detailing by drug reps. There is only benefit in giving both patient and clinician more choice.

      • http://warmsocks.wordpress.com/ WarmSocks

        I don’t see much education in drug ads. Not that I watch many, but I notice those that use the word “arthritis” and they do more harm than good. The general public seems to believe that there are all sorts of drugs available to cure RA. Despite seeing advertisements, most people don’t realize there are different types of arthritis and they are treated differently. If drug ads actually did some educating about this fact, I might be supportive. As it is, this patient sees no benefit in DTC ads.

      • http://twitter.com/Fenbeast Fenbeast

        Educates? Let’s be clear: there is no education going on in direct-to-consumer advertising other than that which is mandated by the FDA (e.g., the side-effect profiles). What is going on in DTC advertising is MARKETING. Marketing is a communication in which the originator seeks to impel the recipient to take an action — make a purchase, or request a script from a doctor — that benefits the originator financially. Education may be used as a marketing tool, but marketing is not education. It’s manipulation, pure and simple: attempting to sway a person to perform an act that benefits oneself.

        • DavidBehar

          I think it is great that millions of TV watchers learned that ADHD can occur in adults, or the criteria for the diagnosis of depression, or the existence of restless legs syndrome. Duplicating that 1 minute lesson to millions would be impossible even for organized medicine. And government sponsored public service announcements are always placed on the extremes of the radio dial, late at night. Only dozens of insomniac college students hear those.

  • militarymedical

    This decision is hardly different in substance from the Supreme Court’s striking down of the “Stolen Valor” Act as unconstitutional because it infringes on free speech. (The Stolen Valor Act made it illegal to present oneself as the recipient of military awards, even those given for gallantry, up to and including the Congressional Medal of Honor.) In other words, it’s OK to lie about your military exploits because it’s your constitutional right to free speech that allows you to lie – even if running for elected office (which was the case brought before the court since it was so egregious). The court softened its position somewhat by admitting that claiming unearned awards, though protected speech, wasn’t a very nice thing to do. [Insert eye-roll here.]
    So yeah, I guess in the Second Circuit Court, it’s OK to market off-label use of drugs, devices and vaccines. It’s gonna be hard to squeeze this toothpaste back into the tube …

  • Suzi Q 38

    Are drug reps still bringing in food??
    I thought that the companies had to restrict this practice.

  • Suzi Q 38

    You are going to see less and less drug reps out there anyway.
    There are so many drug companies buying each other out.
    They don’t need all those pharmaceutical reps duplicated, so within a year or two, they lay off at least half of them.

    Eventually, they will figure out at way to remind all of you of their products….without so many reps. The reps may be there, but maybe aren’t as educated..maybe high school education, delivering samples and all you do is sign for them and receive the company FDA approved literature.

    I envision the pharmaceutical companies giving you a device or phone for you to look up products on…it may exist already.

    Some things change. Just as your industry has changed, theirs will too.

    You are physicians. They are NOT. Big difference.
    I will have to say that they know a lot about their products. This can be a good thing if you have a patient that could benefit from their drug.
    They are very focused and their information is somewhat narrow….
    related only to their products, their competition, and the patients that benefit from such.

  • Suzi Q 38

    I am so fascinated by this ruling by the Court of Appeals.
    I agree that what anyone says should be free speech, but isn’t the pharmaceutical rep presenting the views of the pharma company?

    When a physician, who is considered an expert, gives a speech to other doctors, and the treatment discussed involves pharmaceutical drugs, does the FDA have to approve his speech before tells other doctors about his experiences with the patient group and the drugs used?