December 14, 2006

If You Are Surprised By Vioxx's Risks, You're Fired

This was an op-ed I had written two years ago.  In light of the 12th trial win for Merck (they chose to fight each suit individually, rather than settle a class action), I'm reposting it here.

In the current politically polarized climate it is no surprise that yet another story of the evils of Big Pharma should surface. And why not? When everyone else abdicates responsibility, the easiest maneuver is to scapegoat the ones who actually create anything.

Consider the Vioxx debacle. By now, everyone knows that it was recently discovered that taking Vioxx is associated with an increased risk of heart attacks and strokes. What is not obvious from the news is that the data used to make this discovery has been in the public domain for years.  I even found it in a Yahoo! News article from 1999.

Merck halted a recent trial because it detected this increased risk; but other studies had already found this same risk even four years ago. So why now? And why are any doctors surprised? Were they not reading the journals all along? Were they simply accepting the word of the drug companies? But a recent New England Journal editorial goes further, blaming the Merck and the FDA for failing to protect the public. You’re blaming the FDA? Is the FDA prescribing the drug? Again, the data was already available to anyone with internet access. The fact is that any doctor who is surprised by the “new” data on Vioxx’s cardiovascular risk should never have been prescribing it in the first place.

The Journal goes on to say that Merck tried to minimize the significance of the risk. Even if true, it is irrelevant. The data was available. It doesn’t matter how marketing spins the data, because doctors, as medical scientists, are supposed to be able to ignore marketing and focus on the data. Doctors are supposed to know the data before they prescribe a medicine. Quoth the Journal:“If Merck would not initiate an appropriate trial (to formally asses cardiovascular risk) and the FDA did not ask them to do so, how would the truth ever be known?”

This is a joke, right? Is he seriously suggesting that it is the government’s responsibility to evaluate existing data? Yes: “I believe that there should be a full Congressional review of this case.”

The author fails to separate the responsibility of Merck with the responsibility of the physicians. Understand that I am not trying to absolve drug companies of their responsibility; I am trying to differentiate their responsibility from doctors' responsibility.   Published data becomes the responsibility of the doctor. They are practitioners; their role is to determine, specifically, if the risks of a treatment outweigh the benefits (and vise versa.) If they choose not to read everything available on their own, and to rely on the words of the FDA, or the drug companies, or anyone else—then the fault is the theirs, the liability is the theirs. Ask any lawyer. The data is the data. It doesn’t matter what the drug companies say, or the FDA says, or even what another doctor says, because this is science. it has hard facts I can check, I don’t actually have to trust anyone’s word. Medicine is still a science, right? We’re still sticking with that story?

But this almost never happens in actual practice, hence surprise at the "discovery" that Vioxx has cardiac effects. If doctors had done their jobs and understood, from the beginning, that Vioxx had a minor but still real increased cardiac risk, and modified their use of it  (i.e. not hadning it out like water) then Vioxx would still be on the market and this controversy would never exist.

Drug companies are an easy target, because they are large, impersonal, and very, very rich. The zeal which doctors now attack drug companies as “commercial” (seriously?) and “biased” borders on oedipal. This is because doctors do not create anything new. They are not inventors. When the TV tells you that “doctors have discovered a new cure for X” what they really mean is that a drug company has made this invention, and your doctor is using it. But to believe that doctors are making treatment discoveries during the course of ordinary practice completely misses how progress in medicine is made.

This is not to minimize their role; obviously, they are the ones who are doing the treating. But by consistently framing the issue for the public, politicians, and other doctors, as one of doctors against the pharmaceutical industry, or Pharma against the weak and the oppressed, we are grinding progress to a slow and purposeful halt.

Vioxx is an easy target because we don't "need" it.  But how do we know that someday they wouldn't discover it cured, for example, cancer?  Don't laugh: the trial Merck interrupted to pull Vioxx was for the prevention of colonic polyps. Is that worth the very small (1%) risk of a heart attack?   Now we'll never know.  That would have been a decision for doctors to make with their patients. This is the point, the only point.  But now, because doctors were not rigorous about their own practice or education, no one gets to try it. Who suffers? Answer: you. And this barely accounts for the massive strategic harm this does to Merck, in lost revenue as well as increased paranoia, risk aversion, etc.   It is unlikely that Merck will be as aggressive or spend as much to find the cure for, say, AIDS, tuberculosis, or cancer. Everyone happy with this outcome?