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As reported by the Chicago Tribune, U.S. District Judge Bill Wilson has ordered that thousands of pages of Wyeth documents be unsealed. At issue is Wyeth’s marketing practices and the safety of their hormone replacement therapy drugs, Prempro and Premarin. The release request was made by The New York Times and the biomedical journal Public Library of Science (PLoS).
The data is relevant in a case involving 8,000 combined lawsuits which will be heard by Judge Wilson. Of interest is whether Wyeth properly reported the risks of breast cancer from hormone therapy.
As described in a Decwember 12, 2008, New York Times article, Wyeth had relinquished the documents to Sen. Grassley for use in a Congressional investigation regarding the pharmaceutical industry’s influence on doctors.
“Wyeth, the pharmaceutical company, paid ghostwriters to produce medical journal articles favorable to its female hormone replacement therapy Prempro, according to Congressional letters seeking more information about the company’s involvement in medical ghostwriting.” See: Wyeth’s Use of Medical Ghostwriters Questioned - NYTimes.com
Although shown to a jury, the documents have been under a confidential seal and not made available to the public. However, on June 17, 2009, the Times joined PLoS in their attempt to have the documents released.
“‘These documents will educate the public and allow them to better understand materials they use every day in making their often life-depending health care decisions,’ said Little Rock attorney Gerry Schulze, who represented the Times.’”
Questions: If Wyeth is found to have hid and embellished medical data, who is the most guilty?
A. Wyeth?
B. The doctors who signed or allowed their names to be used in published articles?
C. Our legal system for allowing such information to be kept from the public?
D. All of the above
What should be done to protect the public?
To read all about it, see: Judge orders Wyeth papers unsealed -- chicagotribune.com, Associated Press, July 25, 2009
Wednesday, July 29, 2009
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In such situations, the company bears primary responsibility, although "they can't do it alone," needless to say.
ReplyDeleteIn my view, the worst instances are when companies do/have done/have written studies to suggest precisely the opposite of what they know to be true.
Thus, if there is the suggestion that Drug A is associated with Cancer B, we may see a flock of studies appear under the rubric, "Drug A Useful in the Treatment of Cancer B."
Criminal misinformation.
If Wyeth wants to continue to push the envelope on ethics, a slap on the hand is not the reasonable thing to do.
ReplyDeleteI think that all the above are responsible parties and all of the above should be caused to change their "habits" and methods.
It looks like severe punishment and radical change are in order if being a party to murder is the final charge.
Unfortunately I would guess that the doctors involved in endorsing the product did not get access to the raw data.
ReplyDeleteWe have brought up this subject before. From an ethical point of view, Doctors should not sign off on these studies unless they have been able to freely and independently examine all of the raw data. Otherwise, if they sign off without doing so, then they should certainly be held responsable for the misinformation that leads to patients being inured or being put at serious risk of injury because they have not been given all the facts.
I wonder if we are getting closer to having general warnings put on all products. Something along the lines of:
Caveat Emptor: You are being prescribed this drug by your doctor. Do you know why he/she is prescribing it for you? Have you done your due dilligence? Are you aware that your doctor may not have been given independent un-biased information about this drug and it uses? Has your doctor clearly communicated the risk/benefit profile for this drug?