“What is the difference between a doctor and a pilot?” Dr. David Healy asked during a recent talk at the CUNY Graduate Center. The answer? A doctor isn’t going to go down with you.
Healy, a psychiatrist, psychopharmacologist and scientist, is the author, most recently, of Pharmageddon, a book about the “hijacking” of American healthcare by the pharmaceutical industry and what can be done about it. During his talk, Healy observed that doctors, not patients, are the consumers of medicine. And because doctors, unlike pilots, are not going to be personally affected by every professional decision they make, they may be less critical of “evidence” put forth by pharmaceutical companies, and more willing to overlook potential risks associated with the drugs they prescribe.
Healy argues that we have become too comfortable with the randomized control trial as our only source of drug evaluation. Evidence from clinical trials now trumps the values of patients and the expertise of doctors, despite the fact that, in Healy’s opinion, these trials have become mechanical and thoughtless. Because of dependence on control trials, prescription drugs are seen as innocent until proven guilty, and the pharmaceutical industry, rather than doctors, is playing an increasingly large part in curing disease.
In Pharmageddon, Healy cites examples of clinical trials that showed significantly different evidence of a drug’s effects than were actually published. “The unpublished trials primarily are negative,” he said in his talk, but pharmaceutical companies have strategies for turning negative trials into positive reports. Healy pointed to Eli Lilly’s Prozac trials from 1986. Data on suicides and suicidal acts while on Prozac were compared to the same events on placebo, no drug, or older drugs. For U.S. trials, Eli Lilly listed four suicides on Prozac and one on placebo, as well as 26 suicide attempts on Prozac and nine on other treatments. The corporation took this data and discounted seven of the nine suicide attempts on Prozac as non-genuine, while none of the placebo attempts were discounted. Four of the nine suicide attempts on placebo were in patients who had recently discontinued fluoxetine treatment (fluoxetine is the generic name for Prozac). Ultimately, the data that ended up in a 1991 BMJ article that reported on these trials looked quite different from the original 1986 data. Healy goes into further detail on this and other examples in Pharmageddon and on his blog.
“When the range of ways the suicide data were handled by Eli Lilly in this case or other companies in other cases do come up,” he writes, “companies tend to portray themselves as not statistically sophisticated. The implication is that if things went wrong, they did so by accident.” Accident or not, there is a lack of consistency between what the literature says and the trial results. Healy calls this the greatest divide in all of medicine.
Because of our dependence on randomized control trials and resulting uncritical acceptance of new drugs, we are suffering, according to Healy, from a new disease he calls “Pharmacosis.” One thing we can do to prevent the spread of this disease is to shift from evidence-based medicine to data-based medicine. We can do this by providing access to the data from randomized control trials, not just to the published reports.
We also need to give greater weight to anecdotal evidence. Currently, doctor and patient observations of drug effects are disregarded, despite the fact that most of these observations turn out to be correct. Though reports of adverse events from taking a drug may be anecdotal, Healy believes that it is still important for the system to pay heed and change as a result. This is why Healy has started www.RxISK.org, a patient adverse event reporting system. Through this website, patients can enter side effects they are experiencing from a particular drug, learn more about that drug, and view how many other people in their area are experiencing similar effects. People experiencing adverse events from a particular drug may believe that they are isolated, but this system will allow them to see whether others are having similar problems, and ideally mobilize them to do something about it.
In a video clip on Rxisk.org, Maria Bradshaw, whose son died by suicide 15 days after taking Prozac and experiencing a range of adverse reactions, discusses how sharing these reactions is important. She says that the trial populations pharmaceutical companies use to test their drugs are not representative of people who actually take them. “The only way that we’re actually going to learn about how these drugs work on people in the general population is for people like me and everyone else out there who’s using these drugs to file adverse reaction reports,” she urges. Healy’s hope is that people will use Rxisk.org to do just that, giving us a mechanism besides control trial reports through which to judge drugs, ideally reversing the effects of Pharmacosis.