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Sunday, 24 April 2005

Princess Health and NIH Dissidents Keep Fighting Conflict of Interest Rules. Princessiccia

Princess Health and NIH Dissidents Keep Fighting Conflict of Interest Rules. Princessiccia

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The LA Times reported that over at the National Institutes of Health (NIH), the dissident Assembly of Scientists is ramping up its fight to preserve the ability of NIH physicians, scientists, and leaders to personally hold pharmaceutical and biotechnology stocks, and to take fees in addition to their salaries to consult for pharmaceutical and biotechnology companies.
The Assembly has hired the firm of Arent Fox PLLC as its representative. The LA Times article alleged that Arent Fox also has represented makers of pharmaceuticals, medical devices, and dietary supplements, and one of its clients is the Biotechnology Industry Organization. Apparently, the Assembly of Scientists is getting these services at a discount, for reasons that are unclear. Furthermore, it turns out that Rep. Chris Van Hollen (D-MD), who asked NIH Director Zerhouni to delay implementation of more stringent conflict of interest rules, is a former partner in Arent Fox.
My comment is that the more that top NIH scientists and leaders seem focused on keeping their lucrative outside consulting work for biotechnology and pharmaceutical corporations, the more doubts will be raised about where their true loyalties lie. Are they first loyal public servants, or industry consultants? If the latter, are their writings and actions primarily meant to advance science, or advance the commercial interests of their consulting clients?
Princess Health and NIH Dissidents Keep Fighting Conflict of Interest Rules.Princessiccia

Princess Health and NIH Dissidents Keep Fighting Conflict of Interest Rules.Princessiccia

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The LA Times reported that over at the National Institutes of Health (NIH), the dissident Assembly of Scientists is ramping up its fight to preserve the ability of NIH physicians, scientists, and leaders to personally hold pharmaceutical and biotechnology stocks, and to take fees in addition to their salaries to consult for pharmaceutical and biotechnology companies.
The Assembly has hired the firm of Arent Fox PLLC as its representative. The LA Times article alleged that Arent Fox also has represented makers of pharmaceuticals, medical devices, and dietary supplements, and one of its clients is the Biotechnology Industry Organization. Apparently, the Assembly of Scientists is getting these services at a discount, for reasons that are unclear. Furthermore, it turns out that Rep. Chris Van Hollen (D-MD), who asked NIH Director Zerhouni to delay implementation of more stringent conflict of interest rules, is a former partner in Arent Fox.
My comment is that the more that top NIH scientists and leaders seem focused on keeping their lucrative outside consulting work for biotechnology and pharmaceutical corporations, the more doubts will be raised about where their true loyalties lie. Are they first loyal public servants, or industry consultants? If the latter, are their writings and actions primarily meant to advance science, or advance the commercial interests of their consulting clients?
Princess Health and Some Evidence of the Rising Tide of Health Care Malfeasance. Princessiccia

Princess Health and Some Evidence of the Rising Tide of Health Care Malfeasance. Princessiccia

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In the Boston Globe is a story about lawsuits filed under the US False Claims Act, which allows people to sue goverment contractors for "wrongdoing" in concert with the Department of Justice. Formerly, most suits under this act were against defense contractors. But now, by far the most frequent targets are in health care. For example, in fiscal 2004, settlements and judgments from fraud affecting the US Department of Health and Human Services totaled $502 million, while those from fraud affecting the Department of Defense were $27 million. A US Assistant Attorney General stated "We have 100 or more cases involving many different pharmaceutical manufacturers and other entities such as pharmacy benefit managers, doctors, and hospitals. In all, the cases name over 225 defendants. They involve a myriad of different drugs; at present count over 500 drugs."
This is just a bit more suggestive data of the rising tide of malfeasance that threatens to engulf health care, and sweep away physicians' professional values.
Princess Health and Some Evidence of the Rising Tide of Health Care Malfeasance.Princessiccia

Princess Health and Some Evidence of the Rising Tide of Health Care Malfeasance.Princessiccia

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In the Boston Globe is a story about lawsuits filed under the US False Claims Act, which allows people to sue goverment contractors for "wrongdoing" in concert with the Department of Justice. Formerly, most suits under this act were against defense contractors. But now, by far the most frequent targets are in health care. For example, in fiscal 2004, settlements and judgments from fraud affecting the US Department of Health and Human Services totaled $502 million, while those from fraud affecting the Department of Defense were $27 million. A US Assistant Attorney General stated "We have 100 or more cases involving many different pharmaceutical manufacturers and other entities such as pharmacy benefit managers, doctors, and hospitals. In all, the cases name over 225 defendants. They involve a myriad of different drugs; at present count over 500 drugs."
This is just a bit more suggestive data of the rising tide of malfeasance that threatens to engulf health care, and sweep away physicians' professional values.
Princess Health and Ghosts Busted: Some Additional Sources. Princessiccia

Princess Health and Ghosts Busted: Some Additional Sources. Princessiccia

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Here is some additional background on the Journal of General Internal Mediciine / RcComms
/AstraZeneca ghost writing story.
The World Association of Medical Editors (WAME) List Server Discussion
The story first appeared in cyberspace as an edited transcript of a WAME list server discussion
that took place in January, 2005. For those interested, it makes for worthwhile reading. And it turns out that none of the points I made on Health Care Renewal this week were very original.
The Pharma Watch Report
The WAME discussion was picked up on the Pharma Watch blog out of Australia, (in a post entitled "Bleeding Misleading") and here things got interesting. A single comment was posted to this blog. The comment pointed out that the story seemed to contradict testimony of Dr. John Patterson, the Executive Vice President for Product Strategy, Licensing, and Business Development for AstraZeneca [UK] given to the UK House of Commons denying that the company had ever had articles ghostwritten, and also included a somewhat rude remark about that Dr. Patterson.
Pharma Watch's blogger, Michael Lascelles, then received a message from an AstraZeneca official asking him to remove these "potentially defamatory" remarks made in the comment. Lescelles removed the potentially offensive parts of the comment, but later noted (in a post entitled "I'm Going to be Sued Over This, But What the Heck,") that the story as told in the JGIM article suggested that "Dr John Patterson's comments to the House of Commons committee [were] inaccurate, to say the least."
The Portland Tribune Article
Finally, there was a news article in the Portland Tribune about the case, including an interview
with Dr. Martha Gerrity, one of the two co-editors of JGIM. In it she stated "the intent was to
bias the medical literature in favor of a pharmaceutical company's product.... This isn't
telling the truthful story about warfarin."
The Tribune article also included details about Rx Communications' and AstraZeneca's responses to the allegations made about them. The Tribune article stated that Rx Communications said that "there were actually two papers on warfarin in development, and the paper submitted to JGIM was indeed the work of the named author. According to their explanation, portions of the article Fugh-Berman was later asked to review were mistakenly sent to her when she was solicited to write a different article." Furthermore, AstraZeneca's public relations director, Julia Walker, said "the named author provided significant contributions over many months to the content and focus of the article." But Dr. Fugh-Berman called these explanations "ridiculous," given that "the article she was asked to write came to her not as an outline but as a completed 2,850-word manuscript, including 65 references and a title page with her name already on it."
The best way to conclude would be to again quote the JGIM editorial by Dr. Gerrity and Dr. William Tierney, " ghostwriting as apparently occured in this case "injects bias and untruth into the scientific dialogue in order to enhance corporate profits."
Princess Health and Ghosts Busted: Some Additional Sources.Princessiccia

Princess Health and Ghosts Busted: Some Additional Sources.Princessiccia

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Here is some additional background on the Journal of General Internal Mediciine / RcComms
/AstraZeneca ghost writing story.
The World Association of Medical Editors (WAME) List Server Discussion
The story first appeared in cyberspace as an edited transcript of a WAME list server discussion
that took place in January, 2005. For those interested, it makes for worthwhile reading. And it turns out that none of the points I made on Health Care Renewal this week were very original.
The Pharma Watch Report
The WAME discussion was picked up on the Pharma Watch blog out of Australia, (in a post entitled "Bleeding Misleading") and here things got interesting. A single comment was posted to this blog. The comment pointed out that the story seemed to contradict testimony of Dr. John Patterson, the Executive Vice President for Product Strategy, Licensing, and Business Development for AstraZeneca [UK] given to the UK House of Commons denying that the company had ever had articles ghostwritten, and also included a somewhat rude remark about that Dr. Patterson.
Pharma Watch's blogger, Michael Lascelles, then received a message from an AstraZeneca official asking him to remove these "potentially defamatory" remarks made in the comment. Lescelles removed the potentially offensive parts of the comment, but later noted (in a post entitled "I'm Going to be Sued Over This, But What the Heck,") that the story as told in the JGIM article suggested that "Dr John Patterson's comments to the House of Commons committee [were] inaccurate, to say the least."
The Portland Tribune Article
Finally, there was a news article in the Portland Tribune about the case, including an interview
with Dr. Martha Gerrity, one of the two co-editors of JGIM. In it she stated "the intent was to
bias the medical literature in favor of a pharmaceutical company's product.... This isn't
telling the truthful story about warfarin."
The Tribune article also included details about Rx Communications' and AstraZeneca's responses to the allegations made about them. The Tribune article stated that Rx Communications said that "there were actually two papers on warfarin in development, and the paper submitted to JGIM was indeed the work of the named author. According to their explanation, portions of the article Fugh-Berman was later asked to review were mistakenly sent to her when she was solicited to write a different article." Furthermore, AstraZeneca's public relations director, Julia Walker, said "the named author provided significant contributions over many months to the content and focus of the article." But Dr. Fugh-Berman called these explanations "ridiculous," given that "the article she was asked to write came to her not as an outline but as a completed 2,850-word manuscript, including 65 references and a title page with her name already on it."
The best way to conclude would be to again quote the JGIM editorial by Dr. Gerrity and Dr. William Tierney, " ghostwriting as apparently occured in this case "injects bias and untruth into the scientific dialogue in order to enhance corporate profits."
Princess Health and More evidence of ghostwriting. Princessiccia

Princess Health and More evidence of ghostwriting. Princessiccia

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Yet more on ghost writing of scientific papers as posted here and here:

Quoting a New York Times article, Evidence in Vioxx Suits Shows Intervention by Merck Officials, April 24, 2005:

The Advantage trial [of VIOXX] was completed in 2000, but its results were not published until 2003, when they appeared in the Annals of Internal Medicine, a well-regarded journal. Dr. Jeffrey R. Lisse, a rheumatologist at the University of Arizona who is listed as the study's first author, said in an interview that at least two other journals had rejected the study because its results were not novel.

In the published study, Dr. Lisse reported that five patients taking Vioxx had suffered heart attacks during the trial, compared with one taking naproxen, a difference that did not reach statistical significance. But the paper never mentioned the three additional cardiac deaths of patients taking Vioxx, including the 73-year-old woman.

Dr. Lisse said that while he was listed as the paper's first author, Merck actually wrote the report, an unusual practice. "Merck designed the trial, paid for the trial, ran the trial," Dr. Lisse said. "Merck came to me after the study was completed and said, 'We want your help to work on the paper.' The initial paper was written at Merck, and then it was sent to me for editing."
Dr. Lisse said he had never heard of the case of the woman who died, until told of it by a reporter. "Basically, I went with the cardiovascular data that was presented to me," he said.
Just how "unusual" is this practice of ghost-writing in the pharmaceutical industry?

-- SS
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