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

Gusty 12:56 Add Comment

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

Gusty 12:56 Add Comment

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

AstraZeneca ghost writing

Gusty 12:21 Add Comment

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

AstraZeneca ghost writing

Gusty 12:21 Add Comment

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

ghost writing Merck Vioxx

Gusty 06:58 Add Comment

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

Princess Health and More evidence of ghostwriting.Princessiccia

Princess Health and More evidence of ghostwriting.Princessiccia

ghost writing Merck Vioxx

Gusty 06:58 Add Comment

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

Princess Health and Additional ghostbusting thoughts. Princessiccia

Princess Health and Additional ghostbusting thoughts. Princessiccia

ghost writing

Gusty 08:18 Add Comment

The revelation about "ghost writing" and false accreditation in the Journal of General Internal Medicine , a practice apparently for such purposes as "paving the road" for new drugs, was quite concerning to me as a former pharma professional. It also raises several critical questions:

1) Who are the personnel responsible for a program of foisting prewritten papers on to clinicians/scientists for them to "edit" and then claim first-authorship, a tactic that I would view as academic fraud?

2) What were the roles of non-clinical MBA's and marketing execs in such programs and decision making? Creating and implementing projects like this would require a lot of planning and discussion within "business process-centric", hierarchical pharmaceutical companies in my experience. Do such people know the effects such activities could have on science and the public's trust in scientific research? Do they care?

3) What impact does this type of activity have on EBM (Evidence-Based Medicine)? Sue Pelletier of Capsules astutely observes that "... this whole situation really is unbelievable, isn't it? Or at least, it should be. It makes me question the value of evidence-based medicine, if the evidence it is based upon is based on "studies" like this one." I agree.

4) What is the true size of this scandal? How many other potentially misleading, inaccurate or faulty "ghost papers" misaccredited to primary authors are present in the recent medical literature as a result of such initiatives, and could pharmas and other corporate entities be made to reveal this, e.g., under the U.S. Racketeer Influenced and Corrupt Organizations (RICO) Act or other U.S. or non-U.S. laws and statutes?

On October 15, 1970, the Organized Crime Control Act of 1970 became law. Title IX of the Act is the Racketeer Influenced and Corrupt Organizations Statute (18 U.S.C. �� 1961-1968), commonly referred to as the "RICO" statute. The purpose of the RICO statute is "the elimination of the infiltration of organized crime and racketeering into legitimate organizations operating in interstate commerce." S.Rep. No. 617, 91st Cong., 1st Sess. 76 (1969). However, the statute is sufficiently broad to encompass illegal activities relating to any enterprise affecting interstate or foreign commerce.

In addition, as I wrote at "US senator says FDA needs independent safety office" , insights into process flaws, inadequate leadership skillsets, and perhaps even corruption in high-stakes industries can be gleaned by who they won't hire. Perhaps it's not a coincidence that after my layoff from pharma and more than year-long search for a new position (which is back in academic medical informatics), I could not even secure interviews with several "Medical Education Companies."

It's bad enough that the ghostwriting practice occurs, but it's even worse that the papers themselves may not even be of decent quality. I was also disappointed but not surprised to read in the Journal of General Internal Medicine editorial "Scientific Discourse, Corporate Ghostwriting, Journal Policy, and Public Trust" that the article in question on anticoagulants, according to Dr. Adriane Fugh-Berman, was of low quality:

[This manuscript] consists of collated case reports with little to no assessment of case report quality. It is transparently biased. Controlled trials assessing interactions are only mentioned spottily; the writers seem unaware of many more trials that exist. When trials are mentioned, it is dismissively, as if the case reports showcased were just as credible. The fish oil section is particularly egregious. There is only a single case report that I know of that reports a possible interaction. Two clinical studies specifically designed to test fish oil with warfarin show no interaction, and long-term studies of fish oil show no effect on bleeding parameters. PC-SPES didn't interact with warfarin. It was ADULTERATED with warfarin. I could go on with other errors and misleading statements .

As a medical informaticist and the former director of Merck's scientific research libraries where we prided ourselves on the proven ability to perform comprehensive searches of the world's scientific literature (even the very obscure) for our scientists, I likely would not have missed existing clinical trials in the literature. Exactly what kind of people, and with what credentials, are the MEC's hiring?

Finally, it didn't take a genius to find the name of the company and drug even though no names were used in the JGIM article. The following google searches based on phrases from the article are very revealing: A search on anticoagulant+orthopedic+surgery+france shows "Exanta" as the third hit and the linked article indicates A-Z as the maker; a search on exanta+fda+hepatotoxicity pretty much confirms this drug as the one mentioned in the articles.

Much like in recent politics, the "World Library Computer" formed by the Internet and its search engines makes concealing certain business activities much harder than in the past.

Addendum: In the Guardian article "Not in my name" it is written that AstraZenica said:

Most pharmaceutical companies, including AstraZeneca, use professional writers to assist in manuscript development, when the named authors lack the time or expertise to produce a well-written publication."

I thought having the expertise to produce well-written, primary-author publications was a major criteria for academic credibility, recognition and advancement. However, we seem to now be discovering that like many other corporate functions, it's simply viewed as a skillset to be outsourced to increase profit.

Incredible.

-- SS