Wednesday, December 07, 2005

Power Speaking to Truth

A number of stories that have appeared on Health Care Renewal recently share an unfortunate theme.

In chronologic order, first there was the story of a scientist, Dr. Victoria Hampshire, at the US Food and Drug Administration (FDA) who raised concerns about a veterinary drug, ProHeart 6, an anti-heartworm drug made by Wyeth. Since then, reports in the New York Times and the Newark Star-Ledger documented how Wyeth attempted to discredit and intimdate Dr. Hampshire. Wyeth's CEO, Robert A Essner, complained about Hampshire directly to the then FDA commissioner, Lester M. Crawford. Wyeth hired a private investigator to "dig up dirt" on Hampshire. After the investigator found that Hampshire had received fees (all of $196 over four years) from a veterinary pharmacy related to her small part-time veterinary practice, the FDA launched a criminal investigation of her. (Thanks to Pharma Watch for the tip.) (See our previous post here.)

Then there was the story of Aubrey Blumsohn, who was suspended from his faculty position at Sheffield University for talking to the press about his unsuccesful attempts to get and analyze the raw data produced by a research study Blumsohn supposedly lead from the study's "sponsor," Procter & Gamble. The Times (UK) Higher Education Supplement reported that Blumsohn was suspended, and was in danger of being fired "for 'conduct incompatible with the duties of office'. This includes charges of raising serious complaints outside agreed university procedures, of 'briefing journalists' and of 'distributing information, including a Times Higher article, to third parties with apparent intent to cause embarrassment'." Blumsohn apparently had a bad experience when he previously reported allegations of misconduct to university officials. (Thanks to an anonymous commentator on this blog reminding me of this.) (See our previous post on this story here and here.)

And then there was the story of Dr. Eric Topol, the prominent Cleveland Clinic cardiologist. After Topol had written an article critical of Merck's cox-2 inhibitor drug Vioxx, now withdrawn from the Market, the CEO of Merck, Raymond Gilmartin, called the chair of the Cleveland Clinic's board to complain about Topol. (See our previous posts here and here.)

So the theme is intimidation, coercion, and/or threatened punishment of health care professionals who dare to speak out about dangers of drugs or potential reseach misconduct of pharmaceutical companies. Particularly distressing was that in two cases (but presumably not that of Dr. Topol, to the credit of the Cleveland Clinic), pressure by a commercial entity apparently resulted in adverse action by the the professional's employer, even though the employers in these cases, a UK university, and a US federal agency, ought by their very natures and stated missions to protect the rights of their professional employees to honestly communicate about scientific and medical matters.

Thus these cases are disturbingly similar to some infamous cases of the last century, in which physician-researchers who blew the whistle about potential hazards to patients were punished by their hospitals and universities apparently under pressure from commercial interests (not always pharmaceutical companies) threatened by revelations of these hazards.

In our last discussion of these cases (see post here), I argued that "clinical research should be open, transparent, not confidential or secret (except for the identities of the research subjects, and perhaps in some special cases involving national security)." Clinical research will not be open and transparent as long as those who do or evaluate research are at risk of investigations, law-suits, or loss of their jobs should they say or write anything negative about some commercial (or political) vested interest in the course of their work. And patients (and of course, doctors) will suffer as long as research is not open and transparent.

We need some leaders of universities and government agencies who are willing to stand up a protect their researchers' rights to speak truth to power. But right now, it is more often power that speaks to truth.


Hellmut said...

I wish I could say that I was surprised. Researchers and academics need to organize to protect themselves against these intrusions. Any suggestions where we can turn?

Anonymous said...

Now Dr. Topol has been removed of his position in the medical school and the Clinic governing board. It looks like Merck won that fight.

Michael Polidori said...

Public persecution and punishment of courageous people who are doing their jobs has apparently become rampant.
In the case of Vioxx, which Topol & Nissen exposed, the deliberate acts of Merck led to the deaths of over 45,000 Americans & injury to 120,000 more.
But the corporation Merck can't be charged with murder or manslaughter, nor should it be. But the executives, scientists, doctors & researchers who actually made these decisions should be put on trial for murder & manslaughter.
The lives lost & destroyed should not be merely "compensated"... these decision making individuals "working for Merck" should be publicly punished for their crimes.
This will restore some integrity to the drug industry... prosecute!!
And stop punishing the whistleblowers...
Topol & Nissen went on to expose the diabetes drug Pargluva in 2005 for the deaths it was causing. Again they based their study on the data Merck & Bristol Meyer Squibb submitted to the FDA (just like the Vioxx data).
How does Merck know the FDA won't check that the data in their studies matches their safety conclusions?
Put Ralph Nader in charge of all the regulatory agencies with absolute power to hire & fire whom he pleases.