Saturday, August 22, 2009

A Public Service Announcement -- Wyeth Ghostwriting Document Cache Now Online, In Full. . . .

This is only tangentially related to Schering-Plough -- in that Merck has ghost-writing issues of its own -- and Merck is buying Schering-Plough. Wyeth seems to have tumbled even more deeply into the rabbit hole than Merck has. See it all at PLoS Medicine:

. . . .In July 2009, a US federal court decision resulted in the release of approximately 1,500 documents detailing how articles highlighting specific marketing messages written by unattributed writers, but "authored" by academics, are strategically placed in the medical literature -- a practice known as ghostwriting. To release these documents, PLoS Medicine, represented by the public interest law firm Public Justice, and the New York Times, acted as "intervenors" in litigation against menopausal hormone manufacturers by women who developed breast cancer while taking hormones. PLoS Medicine argued that sealed documents identified during the discovery process for the court case, demonstrating the practice of ghostwriting, should be made available to the public. . . .

As PLoS Medicine Chief Editor Ginny Barbour stated in the motion to intervene, ghostwriting "gives corporate research a veneer of independence and credibility" and may "substantially distort the scientific record"; "threaten[ing] the validity and credibility of medical knowledge." On July 24, 2009, U.S. District Judge William Wilson, Jr., in Little Rock, Arkansas, granted the motion to make discovery materials public as of July 31, 2009.

PLoS has created this web page to make the released documents publicly available without delay. The documents are organized as they were received following the court's decision. PLoS is working with the Drug Industry Documents Archive at the University of California, San Francisco, to develop an indexed archive of the documents. . . .

Click here to browse the documents.


Anonymous said...

Actually it may not be so tangential to SP.

The nonprofit organization Alliance for Human Research Protection (AHRP) has some interesting things on their site.

First let me explain that AHRP is probably one of the foremost advocacy organizations regarding abuses of the pharmaceutical industry in the area of psychiatric drugs. In fact they were name in a lawsuit regarding the distribution of the Zyprexa papers that indicated that Lilly knew they had problems with Zyprexa and diabetes.

I was doing a google search on asenapine and found a very intesting article on from August 16th on Asenapine on their 'Top News' page.,com_frontpage/Itemid,1/

After reading the asenapine article I noticed an article on ghostwriting on the same page so I took a look at it since ghost writing was in the news (NYTimes) and this has been a focus of Sen. Grassley who has also been focusing on pharmaceutical corruption with respect to antipsychotics and especially pediatric bipolar.

It seems that 2 days after the asenapine article on Aug 18 AHRP ran the ghostwriting article but pointing out the fairly extensive documentation of pharmaceutical industry ghostwriting and Dr. Tom Laughren the FDA Psychiatry Division Director who wrote the approvable memo for asenapine.

Direct links to these 2 articles are below. Do Read!


Ghostwriting Aug 18th

I've also been doing some checking on others who are listed as reviewers on asenapine, and Robert Levin the medical reviewer is a coauthor on an article with Laughren representing FDA views on proposed standards for approving drugs effecing neurocognitive (negative) and another on negative symptoms of schizophernia. It's interesting since these begin in 2005 and mirror the timing of meetings the FDA held with Organon on standards for their trials for negative symptoms with schizophrenia (see page 194 in asenapine background package which discusses meetings the FDA had on this with Organon in 2004. I came across this serendipitously today since I still have not read through all the reviews for the first time yet.)

Also very interesting is that Gwen Zornberg the Psych Team Leader on asenapine wrote 4 articles on Neurontin in conjunction with key opinion leaders while she employed with Pfizer. Neurontin has also been the subject of ghostwritten articles and is even discussed in a book Science in the Public Interest and articles in the NY Times (2002). I find it very interesting that she worked on asenapine at FDA as the overall FDA coordinator for it which was basically developed by Pfizer while she was employed by them working on Psych drugs.

I also found an article by her while employed by Pfizer discussing the relationship between neonatal hypoxia and development of schizophrenia later in life. Now neonatal hypoxia can be due to neonatal PAH, SIDS (which can be misdiagnosed PAH), and poor placental development which also appears to be due in certain to serotonin effects and drugs that effect serotonin systems.

What's most interesting is she wrote and article in Dec 2008 in the journal Drug Safety discussing the hypothetical risks of pediatric cardiovascular effects of drugs including effects of metabolites and taking a we need to monitor attitude. Yet dismissing the clinical pharmacologist's concerns on this issue with asenapine in her review 6 months earlier.

A very interesting set of circumstances indeed.


Condor said...

Gret stuff, Salmon -- I'm going to run all of this as a new lead story, with a few observations -- on Monday morning.

So, if you have more, feel free to leave it here!

Thanks again!


Anonymous said...

Thank you.

Going back and looking at it again I noticed another coincidence. The date of the End of Phase 2 meeting on asenapine where Organon and the FDA first discussed studies of negative symptoms was held on April 27th, 2004.

Only 4 days after the FDA, Pharma, academia meeting on April 24th on setting standards for approving antipsychotics for negative symptoms. Very interesting timing. N.B. Organon would have had to requested the FDA meeting 2 months in advance and there would have also been likely a lead time for a meeting of a few months.

Plus Zornberg in the abstract of her Dec 2008 article on long term cardiovascular toxicities of drugs in children ends by indicating let's not let it stand in the way of using drugs in childrn.

Other than the asenapine background document, the links for the above are

Drug Safety. 31(12):1083-1096, December 01, 2008.
Hausner, Elizabeth; Fiszman, Monica L; Hanig, Joseph; Harlow, Patricia; Zornberg, Gwen; Sobel, Solomon;jsessionid=KwNLgX2hqk1FGXxvT6pVN1LYT74JcJLKpRWL1m4GmqwQgJcgyYDk!-1104825961!181195629!8091!-1