Pharmageddon (39 page)

SJ:
The interesting thing is that GlaxoSmithKline actually acknowledged internally three years before you even published Study 329 that it had failed to show that Paxil was better than placebo. They took a marketing decision to effectively pick out the best bits of the study and see if they could get it published.

MD:
That may be. That's not something that journals have any access to, that information.

SJ:
Do you have no regrets about publishing the study?

MD:
I don't have any regrets about publishing at all. It generated all sorts of useful discussion, which is the purpose of a scholarly journal. The purpose of a scholarly journal is not to tell people what to do. The purpose of a scholarly journal is to put out the data….

SJ:
I can tell you that GlaxoSmithKline thought [publication] was fantastic and their sales reps were using your journal's name and influence to then say to doctors, here look, there's a published study, it works.

MD:
Well, I think we all see salesmen of a whole variety of kinds, whether they are drug company salesmen or insurance salesmen and we certainly have no control over how they use something.

SJ:
But, given what you know now about this drug and what it can do to children, don't you have any regrets that that published article was able to use your journal's good name to basically, as a cloak of respectability to say look, I have been in this journal. It must be true, look at the authors.

MD:
I can't control the authors. No, I don't have regrets…. If someone misuses our journal we really have very little control over that….

SJ:
Are you aware that 329 was ghost written?

MD:
I have no way of knowing that. It doesn't surprise me to know it happens, but we have no way of259 having that information.

SJ:
Does it worry you, do you think it matters?

MD:
Well, certainly if I were an author I would not put my name on anything that I didn't feel was accurate. I can't speak to what those authors, to the extent, how much they saw the data. Someone can write something and you may or may not agree with it. The fact that someone puts the words together may be a good thing or a bad thing depending on what the words are….
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In contrast to what one imagines the position of the editor of the
New York Times
might be had they published Study 329, Mina Dulcan seems completely unfazed by her role in the publication of one of the most notorious studies of all time. At some point it is going to take a gutsy academic editor to risk being shut down by industry or the rest of us to consider whether we would be safer if publication of clinical trials happened in the
New York Times
and academic journals were reclassified as periodicals and academic meetings as trade fairs.

The response of many to these issues may be that we need a beefedup FDA to police what is going on. We don't. It would do no harm to beef up, or exit, those in the FDA who are weak and bureaucratic. But the FDA's primary brief is to regulate the wording of advertisements rather than to care about patients. When these drugs were made available by prescription only it was because legislators thought to put them in the hands of an institution that looked a lot more powerful than the FDA and a lot more concerned about the welfare of patients—medical doctors. If medicine and its academics have been neutered, any other beefed-up agency or set of regulations can be too. Any regulations should follow from our values rather than substitute for them—and the values in this case are that if the data aren't available it's not science.

When it comes to the risks of treatment, the company trials that now dictate clinical practice are like the subprime mortgage market, in which risk was so cut up that all parties could act as though the hazards of lending had somehow vanished. By running small studies, the pharmaceutical industry has similarly cut up the appearance of risk to patients, using statistical significance to make these risks vanish. It then has come as a huge shock when large and independent studies show the risks to be alive and flourishing for Vioxx, Avandia, Advair, and other drugs. These shocks have been handled by denial.

Faced with these scenarios both doctors and patients cast around for a wizard for help but it has been as difficult to spot any influence for the good from the FDA as it was to spot any good from the financial regulators in the recent financial turmoil. In this case, doctors are the scarecrows, tin men, and lions who need to be told that they have the brains, hearts, and courage for the job. In the case of the FDA, we need a Dorothy to pull back the curtain and reveal the wizard as a simple auditor. But we have instead—to the benefit of no one except industry—drifted slowly into the position where professional bodies within medicine have turned to the FDA for a lead on the safety and efficacy of drugs where in the Kefauver hearings of 1962 it was envisaged that medicine would offer the FDA a lead. Given the failure of medicine to step up to the plate and the fact that the current regulations governing drugs have been in place for an extraordinary length of time—over fifty years, it is perhaps time to revisit what might be done.

PRESCRIPTION-ONLY STATUS

The problem within medicine, unlike the financial crisis, is not that we have abandoned regulations, but rather that the current regulations aren't working or are being manipulated to our disadvantage, in particular prescription-only regulations. Prescription-only status makes doctors, not patients, the primary consumers of our blockbuster drugs but this is a consumer group that in the 1950s effectively disbanded one of its only consumer bodies when the AMA stopped running its independent program of drug assessments. Medicine ever since has been like a frigate or tanker adrift on the high seas whose rudder is not functioning, a clear target for pirates.

Because doctors have always written prescriptions, and because today's doctors have only practiced in a prescription-only world, they think key medicines have always been available by prescription only. But prescription-only status is very recent, and just as with the French Revolution it may still be too early to judge all the consequences.

The initial prescription-only arrangements introduced in 1914 were a police function aimed at controlling the use of substances like heroin and cocaine. This seemed incompatible with the practice of medicine to many. We have since lost any perspective we once had that giving a doctor exclusive control over access to something as important as life-saving remedies might corrupt the doctor. The subsequent impetus to prescription-only status ironically first arose in the United States, the home of the free market, rather than in Europe or elsewhere. This restriction on the availability of drugs assumed that the doctors who prescribed medicines would be like Philippe Pinel in Paris two hundred years ago, Alfred Worcester a century ago in Massachusetts, or Nancy Olivieri in Toronto today (who lost her job after speaking out about the hazards of deferiprone as a treatment for thalassemia), doctors who were skeptical that all treatments were as beneficial as companies claimed and who were not afraid to speak out in defense of their patients.
⁸
If these hopes had been realized, we might not have the degradation of medical care we now have.

But these hopes have not been realized. Rather than a bulwark against industry, prescription-only privileges have become a bulwark for physicians against competitors in the health domain, like homeopaths, psychologists, nurses, and others—a “precious” just like the Ring of Power in
Lord of the Rings
to be guarded jealously. A ring that puts physicians directly in the gun sights of the most sophisticated marketing on the planet. All the while, doctors seem be shrinking as did Gollum, the figure in J. R. R. Tolkien's novel who, under the influence of the Ring, became a twisted shadow of what he should have been. Given this, it is unbelievable that there does not appear to be a single medical course anywhere that offers physicians any education on marketing. The only doctors who seem to know something about marketing are those who have worked in the pharmaceutical industry. In the
Lord of the Rings
, in true market style, it was ultimately the self-interest of Gollum that saved everyone else. But that was only a fable—and while saving us, Gollum's self-interest destroyed him.

If we are to continue with prescription-only status as we have it now, our safety depends critically on doctors stepping up to the plate. They need to report on hazards and need to find a way to ensure their reports aren't airbrushed out of existence. They need to insist on companies undertaking adequate studies of drugs. Moreover, if companies are to be allowed to market their drugs under the banner of science, doctors need to ensure that companies adhere to the norms of science and make the data from these studies available, or else they need to undertake the appropriate studies themselves. They do, after all, report on the hazards of over-the-counter medicines and, funded by federal monies, doctors have undertaken research on drugs like tobacco, aimed at nailing down its hazards. Prescription-only arrangements once seemed like a mechanism to enhance the ability of medicine to interrogate the companies producing these “ethical” drugs. If it has become instead a mechanism that neuters medicine, it is time for medicine to take stock and then take action.

There are alternate arrangements to the current ones. We could make new medicines available by prescription only for a limited period before a decision was made as to whether they could be sold over the counter, during which time doctors would work hard to establish all the hazards of the new drugs. Alternatively, rather than have all new drugs available by prescription only, we could opt to make just highly toxic drugs available indefinitely by prescription only. We might distinguish between drugs used for traditional medical purposes and drugs for something closer to lifestyle enhancement, with the first group being available by prescription only and the second not.

The SSRIs offer an instructive example of what happens when essentially the same drugs are available by prescription only and over the counter. The SSRIs are antihistamines that inhibit serotonin reuptake. Available by prescription only, one set of selective serotonin reuptake inhibitors lead to agitation and suicidality, while very similar SSRIs available over the counter for allergies have occasionally been linked to irritability but appear in general to cause fewer problems than their prescription-only cousins. In part the differences likely stem from the difficulties described in
chapter 7
in the case of Victor Motus: it is not easy to stop a treatment that doesn't suit a particular patient when a doctor has told that patient they need to remain on the treatment for several weeks before it “works.”

Doctors like Dr. Trostler, whom Victor Motus went to for help, have no training in the many things they do, aside from issuing a prescription for medication, that may enable or disable the people for whom they are trying to care from contributing to that care. They appear to have no feel for the fact that prescription-only arrangements put them in the position of a Roman emperor, with their patients in the role of tasters.

At a time when pregnant women have learned to shun over-thecounter drugs, even down to coffee, doctors have for over a decade dramatically increased their patients' prenatal consumption of SSRIs in the face of growing evidence these drugs double the rate of major birth defects and miscarriages. Drug companies like GlaxoSmithKline are aware that farmers have known for centuries to keep their herds out of fields in which the serotonin-reuptake-inhibiting St. John's wort grows as it leads to miscarriages, but these same drug companies have still manipulated doctors very successfully into herding women into the pastures in which their serotonin reuptake inhibitors grow.
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There are other benefits that might flow from lifting the prescriptiononly status of many drugs. The current arrangements constrain new drugs within a disease framework. If this were changed, a range of diseases from social phobia to osteopenia would vanish overnight. In the case of the antidepressants, for example, some that enhance appetite and sleep might be marketed as tonics rather than for depression. The SSRIs are more like St. John's wort and might be marketed similarly—for stress or burnout. At present, to get Prozac a person has to be labeled as suffering from depression or social phobia or obsessivecompulsive disorder first. If the drugs were marketed instead for stress or burnout there would be much less stigma in using them. In the case of the statins for cholesterol or biphosphonates for osteoporosis, the marketing would likely be aimed more for keeping arteries or bones young and not for supposed diseases. There might have been no fewer drugs sold but we would have fewer diseases. There would be a greater dividing line between medicine and daily life than there is now.

If many more drugs were available over the counter, company marketing would doubtless throw up a different set of abuses. It is doubtful, though, if the abuses could be any worse than the marketing of the proprietary panaceas that dominated the drug market in the late nineteenth and early twentieth centuries. But a century ago, when faced with these panaceas, there was a group of skeptics we could turn to— doctors. There are no skeptics now, and there need to be.

Where in the 1960s there was a gulf between the pharmaceutical and tobacco industries, partly owing to prescription-only arrangements, now it is increasingly difficult to distinguish between the two, except insofar as medicine supports one and not the other. If our current blockbusters were available over the counter, there is little doubt that the pharmaceutical industry would have marketed them as vigorously as the tobacco industry marketed cigarettes and likely caused as much damage with them as tobacco has. Would we be safer if our current blockbusters came with warnings that have the clarity of those found on tobacco products?