Pharma: Tamed But Still A Big Beast

By Neuroskeptic | February 2, 2011 9:05 am

Everyone knows that Big Pharma go around lying, concealing data and distorting science in an effort to sell their pills. Right?

Actually, not so much. They used to, but most of the really scandalous stuff happened many years ago. The late 80’s through to about the turn of the century were the Golden Age of pharmaceutical company deception.

This is when we had drugs that don’t work getting approved, with the trials showing that they don’t work buried, and only now being uncovered. Data on drug-induced suicides seemingly fudged to make them seem less scary. Textbooks “written by” leading psychiatrists that were, allegedly, in fact ghost-written on behalf of drug companies. Ghost-writing programs with chuckle-some names like CASPPER. And so on.

But today, we have to give credit where credit’s due: things have improved. Credit is due not to the companies but to the authorities who put a stop to this nonsense through rules. Mandatory clinical trial registration to ensure all the data is available and stop outcoming cherrypicking. Anti-ghostwriting rules (albeit they’re not universal yet.) etc.

What’s shocking is how long it took to get these simple rules in place. The next generation of scientists and doctors will look back on the 1990s with disbelief: they let them do what? But at least we woke up eventually.

Still, there’s more left to do. At the moment, the main problem, as I see it, is that different jurisdictions have different rules, with the best ideas being confined to one particular place. For instance, the USA has by far the most sensible system of clinical trial registration and reporting. Europe needs to catch up (we are, but slowly.)

Yet the USA is also one of the only countries (with New Zealand) to permit direct-to-consumer (DTC) advertising for prescription drugs. To the rest of the world, this is really weird. We all have a right to free speech. But drug companies pushing drugs directly to patients just isn’t a free speech issue, in Europe. Corporations don’t speak, they advertise.

By encouraging self-diagnosis and self-treatment, DTC replaces medical judgement with marketing, undermining the doctor-patient relationship. The patient is meant to present his symptoms and the doctor is meant to make a diagnosis and prescribe a treatment. DTC encourages self-diagnosis and self-prescription: the fact that a doctor is still, technically, in charge and has to sign that prescription, means little in practice.

So there’s a lot to be happy about, but there’s also a lot still to do.

CATEGORIZED UNDER: antidepressants, drugs, media, politics, science
  • ex-hedgehog freak

    OK, I'll be the first to go out on a limb and say that I am not 100% opposed to DTC marketing. I believe there are well-documented times when it is helpful. For example, the increase in marketing of agents used to treat BPH has had an overall beneficial impact on the number of older men actually talking to their doctor about what is a sensitive issue for them.

    The one area where I believe DTC marketing is completely inappropriate is not surprisingly psych/neuro. I don't believe any psychoactive drug should be marketed directly to the public. Let's face it, when I see concerns about patients that are on a cocktail of agents and their overall mental health has not improved, it is pretty good evidence that some psychiatrists can't even get this right – so what chance does the public have?

  • Mr Goo

    “””The patient is meant to present his symptoms and the doctor is meant to make a diagnosis and prescribe a treatment. “””

    This is not the most sensible course of action.

    The patient is meant to present his symptoms.
    The doctor is meant to make a diagnosis
    The pharmacist is supposed to prescribe a treatment (if drugs are required).

    They know a lot more about the medicine than the doctors do.

  • pacificpsych

    The reality is that in the United States most people treat their doctors as a slave, whose only function is to write the script the 'consumer' wants.

    I think that most medications/drugs should be OTC for adults, the exception being things such as antibiotics which are a public health issue. I see no reason why people shouldn't be able to put whatever they want in their bodies. Having removed the impediment of requiring a physician to write a script, i.e., forcing a physician to put pen to paper, people will also shoulder the burden of any consequences. There will be no one to blame but themselves. Instead of all the anger, blame and lawsuits directed at physicians, adults can be adults.

    People might even start going to physicians for the right reasons — to be treated and educated by a knowledgeable and caring professional.

  • Neuroskeptic

    Exhedgehogfreak: There may be cases where DTC has benefits but I'd say that even there its better done by public health authorities. Eg rather than selling treatments, which incidentally raises awareness of a genuine problem…the government should just raise awareness.

  • Anonymous

    It's fatuous to suggest DTC “just isn't a free speech issue.” At least in America, there's a longstanding tradition of protecting the promotion of legal commercial transactions.

    Would it similarly not be a free speech issue to have a law prohibiting me from publicizing the quality of the food at my restaurant?

  • Bernard Carroll

    NS, be careful. You risk coming across as a Pollyanna when you say there’s a lot to be happy about and that “…most of the really scandalous stuff happened many years ago. The late 80's through to about the turn of the century were the Golden Age of pharmaceutical company deception.”

    The last decade makes the 1990s look innocent when it comes to Pharma manipulation of the biomedical literature. Within the last 10 years we have seen the Martin Keller –orchestrated publication of the infamous Study 329 concerning Paxil (Seroxat) in adolescent depression. People are still calling for its retraction. We saw the Nemeroff-orchestrated, ghostwritten review of vagus nerve stimulation for depression in Neuropsychopharmacology, a journal that Nemeroff himself edited. He lost the editorship over that incident. We saw a Janssen – funded publication make false claims of efficacy for risperidone in treatment of depression. By some process of Immaculate Conception, a p value of 0.4 was reported as p < 0.05 in the text and the Abstract. Nemeroff orchestrated that publication in his own journal also. We saw Alan Schatzberg and his colleagues associated with Stanford University make multiple exaggerated claims for the efficacy of mifepristone in psychotic depression. Schatzberg and the others used academic journal outlets to promote a positive climate of opinion for their patented drug. We also saw grotesque programs like Glaxo’s PsychNet team created to push Paxil (Seroxat) through complaisant KOLs.

    Most worrisomely, we saw Pharma conduct a full court press for adoption of atypical antipsychotic drugs in treating nonpsychotic depression – with scandalous glossing over the weak efficacy, the metabolic side effects, and the risk of tardive dyskinesia. Lilly, Janssen, and AstraZeneca are the front runners in this effort. There has been no shortage of KOLs willing to push this marketing message in academic journals.

    The way I see it, there is not a lot to be happy about. The last decade saw the worst excesses of nonprofessional behavior by venal KOLs.

  • Anonymous

    I agree with Dr. Carroll. Things here in the US are still pretty scandalous. And it took a Senate Committee (Grassley)to begin to round up the rascals. Otherwise, the sociopathic KOL's would still be flying high.

  • A Bitter Pill

    I still think DTC is weird in the US even though its been here for a decade thanks to Clinton of all presidents. What that was about, I don't know, probably some kind of tit-for-tat I imagine.

    Anyway, there are limits to commercial speech and the change to DTC was an executive decision, IIRC, and was never considered a constitutional free speech issue here. Advertisements of cigarettes and liquor continue to have restrictions of various kinds in the US.

    Has DTC made over use of meds worse in the US? Likely so, but one gets acclimated to it after awhile and its like everything else. It makes for some entertaining advertising I suppose.

  • Neuroskeptic

    A Bitter Pill: Oh dear. I didn't know it was a Clinton policy.

    As for whether it's a free speech issue, I'm no expert on the legal details but this NEJM article from 2007 suggested that DTC bans might be held un-Constitutional.

  • Neuroskeptic

    Bernard Carroll: Hmmm. Those are all good points. Maybe I was being over-optimistic.

    However, it certainly seems as though Pharma is going to have to work harder in future, thanks to things like The Martin Keller Seroxat paper, for example, was published in 2001 and the trials were done in the 1990s before the current regulations came into force. Today, were the same study to be done, the original protocol and the original primary and secondary endpoints would be in the public domain from day 1.

    The atypicals in depression saga is certainly very worrying. However I wonder if it wouldn't have been much worse 10 years ago?

  • Anonymous

    I really enjoy your posts. I wonder why don't you install the social media sharing tools. Q-)




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About Neuroskeptic

Neuroskeptic is a British neuroscientist who takes a skeptical look at his own field, and beyond. His blog offers a look at the latest developments in neuroscience, psychiatry and psychology through a critical lens.


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