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Direct-To-Consumer Science

Dr. Olivier Ameisen is a prominent French cardiologist who believes that the muscle-relaxant drug baclofen relieves the cravings of alcoholism. This is indeed an interesting, and as yet unsettled, scientific medical question. Dr. Ameisen has decided to take his personal scientific opinion directly to the public in his book – Le Dernier Verre (The Last Glass). The result has been a surge of interest among alcoholics for this new “miracle cure” for their affliction.

Increasingly the medical community is caught between two opposing imperatives. There is the desire to make medical information freely available and the process of medical research transparent. On the other hand, the public is best served when new ideas in medicine are put through the mill of science before they become part of medical practice. As we enter headlong into the information age these two imperatives are increasingly at odds.

Problems arise when a new treatment, syndrome, intervention, or concept in medicine is promoted to the public prior to undergoing a reasonable degree of scientific vetting. What is the point, after all, of spending tremendous resources on medical research if proponents are going to bypass the process altogether to market their modalities and promote their ideas directly to the public?

The downside of evading the process of science (even though it can be frustratingly slow) manifests in many ways. Patients who hear about a new possible treatment are likely to demand it from their doctors. Or they may seek the treatment from a paraprofessional or even non-professional (take bee-venom therapy, for example).  Charlatans who set themselves up as gurus in their own clinic exploit this phenomenon to market their fraudulent treatments and products. Research may be hampered as patients are unwilling to enter a study and perhaps be assigned to the placebo arm.

Direct-to-consumer promotion of new untested or inadequately tested ideas also undermines the public confidence in science-based-medicine. Most new ideas turn out to be false, and this will inevitably lead to disillusionment. Appropriate skepticism toward the new claim often seems to the public (and is sometimes deliberately made to seem so) as obstructionism, protectionism, and closed-mindedness.

And of course bypassing the scientific community puts the public at risk for being subjected to unsafe or ineffective treatments.

Let’s take a look at the baclofen controversy. Dr. Ameisen is convinced of the efficacy of baclofen because of his own personal experience. He is a recovering alcoholic who treated himself with baclofen and feels it significantly decreased his desire for alcohol. So his conviction is based mostly on personal anecdotal experience. This is a particularly weak form of evidence, although it is a human foible that it is also very compelling, even though it shouldn’t be.

There are currently no published trials of baclofen for alcohol dependence (although one study is in progress that I could find). Dr. Ameisen decided to try baclofen because of a few published studies of its use in cocaine dependence.  There is likely a common mechanism underlying some forms of addiction, including alcohol and cocaine, so this was not entirely unreasonable.

Therefore at present baclofen for alcohol dependence is a plausible but unstudied treatment. This is not sufficient to recommend it as a treatment, it is only sufficient to warrant performing clinical trials. Most plausible treatments in fact do not work, and that is why research should come before promotion to the public.

One rationale for using unproven but plausible treatments is compassionate care – for serious or terminal incurable diseases. There are already standard therapies for alcoholism, however. In fact the treatment community is concerned about the hype surrounding baclofen partly because it undermines a more proper focus on multi-modality treatment in favor of a silver bullet approach. (Admittedly, this is a separate issue.) In any case the situation does not appear desperate enough to bypass research for compassionate use. And further, compassionate use should be done, whenever possible, in the context of a clinical study (even if open label) in order to gather some useful data.

The baclofen story is, unfortunately, not an isolated case. The mental health field is rife with practitioners who come up with some new treatment philosophy and then bypass the research path in order to write a popular book. This leads in some cases to widespread adoption, dedicated institutions, and popular belief in a treatment that is unlikely to work. This is exactly what happened with the recovered memory (now called the false memory) syndrome. The Courage to Heal by Ellen Bass sparked an industry of recovered memory therapy that still lingers decades later, even after the research showed it to be harmfully misguided.

The public is best served when the time is taken for new ideas in medicine to be tested and for controversies to be reasonably settled before the standard of care is altered and new treatments are accepted.  But there is a huge temptation to popularize one’s work and ideas (and the internet makes this an almost trivial exercise) without first going through the tedium and often harsh confrontation involved in the scientific process.

I will follow with interest the story of baclofen for alcohol dependence, and I hope it turns out to be an effective treatment. I also hope it does not take on a life of its own, becoming popularized and politicized in a way that is independent of the scientific evidence and ultimately distorts the process of science. We will see.

Posted in: Science and Medicine

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12 thoughts on “Direct-To-Consumer Science

  1. Karl Withakay says:

    It’s too bad that if it turns out to be effective, Ameisen will likely claim he and his methods have been vindicated. He’ll become another of the prophets crying out in the wilderness that we all should listen to.

  2. tarran says:

    Dr Novella,

    The point is that your job is to serve your customers. If your customers want you to chant ‘Hare Krishna’ over them, you are faced with the choice of either doing it or not offering your services at all.

    I recognize that you are merely trying to persuade doctors not to offer unproven treatments rather than violently forcing them to stop vie government edict.

    However you should bear in mint that in the end if you ignore your customers’ desires you are going to lose them.People want to try the unproven treatments because the proven treatments, frankly, are unsatisfactory to the patients.

  3. CaladanGuard says:

    @tarran

    The unfortunate truth of the modern world is that many of the charlatans who promote not only unproven, but in some cases patently unsafe treatments are often much more charismatic and driven than we are.

    I believe in medicine, and I like to consider myself open-minded when it comes to new treatments, but the passion with which many of these people promote their ‘cures’ is a hard thing to face, especially with no scientific evidence to back them, and the unfortunate side for us, often very little evidence to disprove them either.

    I didn’t get into medicine for the money (not much these days), or the power and respect (even less than the money) I became a doctor to help people, and it saddens me when people throw the pharma-shill or protectionist arguments in my face, because all most doctors ever want is to help their patients in the best way they can, the best way they know how.

    I don’t refer patients to acupuncture, homeopathy, or any other ‘treatments’ that have not been proven (excepting the sorts of compassionate experimental-based cases Dr. Novella describes above) and I will speak out against my patients doing so of their own volition. If I lose a patient because of my unwillingness to waste their money, and risk their health on an unproven treatment, that is a shame, but I have done my best to protect them, and after all, they do have the right to choose their own path. I just wont enable them.

    You can’t help people who don’t want your help, no matter how much you might like to.

  4. Harriet Hall says:

    tarran said our job is to serve our customers. Yes, but our job is to give them what they need, not what they think they want.

  5. Harriet is right – they are not just customers (or clients) they are patients, and doctors have extra professional duties to their patients. Patients cannot demand unethical practice from their physicians, nor can physicians defend malpractice by claiming that it was what their patients wanted.

    So, ethically and medico-legally, patients are not treated as customers.

    However, from the point of view of service (as opposed to medical practice) they are customers. But service and medical practice must be distinguished.

  6. Karl Withakay says:

    tarran

    I used to work as an engineering technician/ pseudo engineer for a company that made joint sealant systems for secondary containment structures for hazardous chemicals. Our job was to serve our customers too, but we had ethical, legal, and liability obligations as well. When a customer asked us to supply a product that was incompatible with the intended application, we had to refuse, even though that is what our customer demanded. We occasionally had to walk away from business because the customer wanted to save money and buy a product that would not withstand the their intended application.

    If we sold the customer what they wanted, and the main chemical storage leaked into the secondary structure, the joint sealant in the structure would dissolve, and abra-cadabra, benzene in the ground water! We had an obligation to provide the customer the solution they needed, not just the solution they wanted.

  7. EmilyF says:

    I’m in a similar position as Karl, but from a point of view of even less responsibility – I’m a shop assistant for a lighting manufacturer.

    Even in my lowly position, I have a legal responsibility to refuse to sell lights for use in bathrooms or as exterior lighting without appropriate certification.

    I, for one, want my doctor to give me the benefit of his/her measured opinion, based on her/his lengthy and expensive medical training, if I’m sick – not ask me what I think might help!

  8. tarran says:

    For what it’s worth, I agree with all of you. I too have told clients I will not give them what they ask for.

    However, there is a disdain for the unwashed masses that I detect amongst a significant number of doctors (I teach a couple of math classes at a local pharmacy school and rub elbows with other faculty on occasion). Often the attitude seems to be that of of Basil Fawlty, “this hotel would run smoothly if it weren’t for the customers”.

    In the end, to earn a living, and ethical person must provide customers that which customers want and are willing to pay for. And, if a customer wants some ridiculous treatment and can find someone willing to provide it to them, that is their right. Just as it is Dr Novella’s right to call the provider a quack in public and to disparage the treatment.

  9. Karl Withakay says:

    tarran

    I don’t agree with you that someone has the right to any treatment they want. Where is this right to get whatever you want enumerated?

    Clearly in the world of real medicine, that right does not apply. If I believe that chelation therapy will cure my allergies, I don’t have a right to that therapy because I want it. I don’t have right to steroids because I want to bulk up.

  10. Karl Withakay says:

    RE:

    >>>However you should bear in mint that in the end if you ignore your customers’ desires you are going to lose them.People want to try the unproven treatments because the proven treatments, frankly, are unsatisfactory to the patients.

    There’s a difference between ignoring a patient’s desires and addressing their desires while trying to steer them in a different direction, but refusing to assist them in achieving those desires that lead to unproven and ineffective treatment options.

    Unfortunately, Dr Gorski and others can testify to the fact, that those patients that leave him for CAM treatment will often return after CAM has completely failed them, and it’s too late for real medicine to do anything more for them other than to ease their suffering while they die.

    A key concept here is the timing of the concept of unsatisfactory. Someone who doesn’t want to suffer the side effects of chemo and radiation turns to CAM in hopes of finding a solution that will eliminate their cancer w/o side effects. Conventional treatment seems unsatisfactory on the front end, but the CAM option will likely prove unsatisfactory on the tail end.

    I am fascinated with the capacity of the human brain to make illogical decisions, and to use contradictory reasoning. We invest hope into our logical decision process where it shouldn’t apply. “I don’t like the side effects of a treatment with a good probability for success, so I choose a treatment with no side effects with a low probability of success that I hope works.”

    A person who plays the lottery with the extraordinarily remote chance of wining and then has unprotected sex with the significantly higher probability of producing an unwanted pregnancy or infection by social disease exercises inconsistent reasoning in their though process, and yet many people do this very thing all the time. (Slightly off topic, but I wanted to make the observation.)

  11. Prometheus says:

    I’m assuming that Dr. Ameisen is basing his use of baclofen for alcohol addiction on its functional similarity to acamprosate, another GABA agonist that has been touted as a “cure” for alcoholism.

    Baclofen, since it is a GABA agonist, may simply be substituting for alcohol, rather than preventing “craving” or other signs of addiction. Acamprosate, when it was first used for alcohol addiction, was also seen as a “miracle drug”, although larger, more rigorous studies have shown that it is no better than placebo for dealing with “craving” or in maintaining sobriety.

    I suspect that baclofen, which lacks the NMDA receptor effects of acamprosate, will be no more effective (i.e. no better than placebo).

    On the “meat” of the matter – the “direct to consumer” appeal – Dr. Ameisen is following in the footsteps of Fleischman and Pons, of “Cold Fusion” fame. While he may feel that he needs to speedily deliver his “wonderful news” to the people who need it, he risks sowing confusion and causing significant harm if his anecdotal findings are – in fact – incorrect.

    I have often heard that “direct to consumer science” or “peer review by press conference” is a hallmark of pseudoscience. I see nothing in Dr. Ameisen’s case.

    As far as the idea that physicians need to “… bear in mind that in the end if you ignore your customers’ desires you are going to lose them.” – that is pure nonsense.

    Physicians, like other professionals, have an obligation to advise their “clients”, to give them the relevant information and suggest the course of action that is in the “client’s” best interest. They are not doing their job if they merely give the “client” what they want.

    I understand that this may not be what the commentor meant, but I hear it all too often. It is used as an excuse by hospitals when they elect to provide “alternative” medical therapies or by doctors when they decline to confront their patients about their “alternative” medical therapies. Often, it is cited as “proof” that their therapies work from “alternative” practitioners (“If it didn’t work, people wouldn’t be asking for it”).

    They all say – in essence – “It’s what the patients want.” That seems, in their minds, to be adequate justification for – implicitly or explicitly – telling patients that “alternative” therapies are equal in validity and effectiveness to scientifically proven therapies.

    Using that “logic”, why wouldn’t a doctor prescribe morphine or cocaine to patients who wanted it? After all, you could argue that “it’s what the patients want” and even “if I don’t provide it to them, they’ll just go somewhere else”. Both are true statements.

    I will agree that doctors need to have a care to not pointlessly offend their patients who are misinformed about the validity and efficacy of various “alternative” therapies, but I don’t see that this means that the doctor (or hospital) needs to provide those “alternative” therapies if they are desired or even that they need to maintain a polite silence when a patient describes the pointless or even potentially harmful “alternative” therapies they employ.

    Doctors are used to telling patients things they don’t want to hear – “You need to stop smoking.”, “You need to quit drinking.”, “You need to exercise.” This – in my opinion – is no different from telling a patient “Your ‘alternative’ therapies are unproven and potentially harmful”.

    It can’t possibly be any worse than having your doctor tell you that you’re too fat.

    Prometheus

  12. The Blind Watchmaker says:

    Many of my patients want antibiotics everytime they get a cold. That is what my customers want. It would be unethical to just give them what they want. The doctors job is to figure out what they need.

    People should get their medical info from good sources like the average PBS pledge special…Er, wait, scratch that.

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