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Research Protections and Bioethics News December, 2004

NB: Not all articles remain available on the internet.

FDA OKs Ecstasy Study in Cancer Patients. Lolita C. Baldor. Associated Press. 2004-12-28.
URL: http://apnews.myway.com/article/20041228/D878OEN00.html

Related:   Testing Ecstasy on Subjects Diagnosed with PTSD and the Use of Internet Recruiting. CIRCARE InfoMail. 2004-02-02. Available from http://www.circare.org/im/im2Feb2004.htm

The Ultimate Gift: 50 Years of Organ Transplants. Lawrence K. Altman. The New York Times. 2004-12-21.
URL: http://www.nytimes.com/2004/12/21/health/21orga.html (Requires free registration.)

Pfizer to Halt Advertising of Celebrex to Consumers. Alex Berenson. The New York Times. 2004-12-20.
URL: http://www.nytimes.com/2004/12/20/business/20drug.html?8br (Requires free registration.)

Medicine Fueled by Marketing Intensified Trouble for Pain Pills. Barry Meier. The New York Times. 2004-12-19.
URL: http://www.nytimes.com/2004/12/19/business/19drug.html (Requires free registration.)

Related:   FDA Statement on the Halting of a Clinical Trial of the Cox-2 Inhibitor Celebrex. FDA Press Release. 2004-12-17. Available from http://www.fda.gov/bbs/topics/news/2004/new01144.html

After Baby's Grim Diagnosis, Parents Try Drastic Treatment. Denise Grady. The New York Times. 2004-12-19.
URL: http://www.nytimes.com/2004/12/19/health/19baby.html?pagewanted=print&position= (Requires free registration.)

Lung-Cancer Drug Shows Unfavorable Trial Results. Andrew Pollack. The New York Times. 2004-12-20.
URL: http://www.nytimes.com/2004/12/20/business/20iressa.html?8br (Requires free registration.)

Related:   FDA Statement on Iressa. FDA Press Release. 2004-12-17. Available from http://www.fda.gov/bbs/topics/news/2004/new01145.html

Flawed Device Places F.D.A. Under Scrutiny. Barry Meier. The New York Times. 2004-12-15.
URL: http://www.nytimes.com/2004/12/15/business/15device.html?oref=login (Requires free registration.)

Federal Agency Disputes Pill's Benefits. Marilynn Marchione. Associated Press. 2004-12-15.
URL: http://ap.washingtontimes.com/dynamic/stories/T/THE_PILL?SITE=DCTMS&SECTION=HOME&TEMPLATE=DEFAULT

In reading the following stories on Nevirapine reported by the Associated Press, readers may wish to consider the following:

HIVNet 012, the trial conducted in Uganda, was published in the Lancet in 1999, with a follow up in 2003; the US Office For Human Research Protections issued a determination letter to the Ugandan researchers in 2002 — the point being that this isn't a new issue.

Dr. Fishbein began his employment at NIH in June 2003. This makes it difficult to interpret his attorney's claims that Dr. Fishbein was the first to expose the circumstances and issues surrounding HIVNet 012.

Dr. Fishbein is in the midst of an employment dispute with NIH: while this does not mean his statements are de facto incorrect, but it complicates the issues.

NIH, WHO, and a number of nonprofits and AIDS advocacy organizations have issued vigorous responses to Dr. Fishbein's allegations; such universal responses are extremely rare. One particularly lucid response is linked below, directly after the AP articles and their associated document links.

A panel was convened last fall at the Institute of Medicine to evaluate NIH's handling of HIVNet 012. The panel was convened at the request of NIH, and its report is due in the spring of 2005. Dr. Fishbein was invited to testify before this panel, and did so on 2005-01-07.

Great weight is given to a pre-audit inspection conducted by Westat Inc. under contract with NIH, and it's implied that the audit uncovered serious difficulties that nobody knew about. What is not mentioned is the fact that this audit was conducted because an earlier audit by Boehringer Ingelheim (manufacturer of Nevirapine) identified data collection and management problems, which BI disclosed to NIH, who in turn contracted for the Westat audit.

One serious issue tends to get lost in the hyperbole: survivors of Ms. Hafford (decedent in the more recent U.S. Nevirapine trial) claim she enrolled in the trial because she wanted the best possible medical care to prevent HIV transmission to her unborn child. The belief that research enrollment is equivalent to medical treatment is a common misunderstanding. If Ms. Hafford's survivors' statement is accurate, it's important to find out why she misunderstood what she was agreeing to when she signed the study informed consent, and to put this understanding into practice to prevent similar misunderstanding in the future.

Woman Died During AIDS Study. John Solomon and Randy Hershaft. Associated Press. 2004-12-16.
URL: http://hosted.ap.org/dynamic/stories/A/AIDS_DRUG_DEATH?SITE=OHCIP&SECTION=HOME

Related Documents:   E-mail exchange on Aug. 8, 2003, between NIH AIDS Division chief Dr. Edmund Tramont and NIH's Dr. Jonathan Fishbein about Tennessee patient Joyce Anne Hafford's death from liver failure during a nevirapine trial. Available from http://wid.ap.org/documents/nevirapine/memphis.pdf

The official case review, which notes that the Memphis hospital failed to review lab results which would have shown liver failure starting well before Ms. Hafford's death. Available from http://wid.ap.org/documents/nevirapine/memphis_site_visit.pdf

New warning on nevirapine, issued by the NIH's Pediatric AIDS Clinical Trials Group (PACTG) to researchers in late August 2003 after Ms. Hafford's death, detailing liver complications that could arise from use of the drug. Available from http://wid.ap.org/documents/nevirapine/memphis_warning.pdf

The 15-page NIH-approved consent form used for the drug trial. At the top of the list of serious side effects, on page six, is inflammation of the liver which rarely may lead to severe and life threatening liver damage and death. Available from http://wid.ap.org/documents/nevirapine/memphis_consent.pdf

AIDS Research Chief Rewrote Safety Report, Ordered Clinic Opened Over Objections. John Solomon, Associated Press. 2004-12-14.
URL: http://wid.ap.org/home1/storyhome1.shtml

Related Documents:   A nine-page letter sent by the Department of Health and Human Services, Office for Human Research Protections outlining problems which it said showed that HHS violated federal rules and patient protections. Available from http://wid.ap.org/documents/nevirapine/hhs_uganda.pdf

Uganda study site audit report by Westat Corp., paid for by the NIH. Available from http://wid.ap.org/documents/nevirapine/westat_audit.pdf

Shorthand minutes from a meeting on March 1, 2002 among top officials at the NIH as they reviewed the findings of auditors and doctors who had visited the Ugandan test site. Available from http://wid.ap.org/documents/nevirapine/2002minutes.pdf

A report Dr. Tramont put out summarizing the March 2002 Westat audit, pointing out that there is no evidence that the study's scientific results are invalid. Available from http://wid.ap.org/documents/nevirapine/daids_summary.pdf

A report by drugmaker Boehringer Ingelheim critical of the Uganda trials. Of special note is the hand-written instruction on the first page by an NIH official directing the report to be destroyed when audit is upon us. Available from http://wid.ap.org/documents/nevirapine/bi_audit.pdf

Nevirapine Misinformation: Will It Kill? John S. James. AIDS Treatment News. 2004-12.
URL: http://www.aidsnews.org/2004/12/nevirapine-ap.html

Summary: In mid December 2004 three Associated Press stories created widespread doubts about nevirapine, a well-known, critically important drug that can prevent HIV in many of the 1,800 babies now infected every day by their mothers in childbirth. The media allegations that went around the world grew out of a bitter personal and personnel dispute between two employees at the U.S. National Institutes of Health. No new information about nevirapine was released; doctors know that it still has the same risks and benefits after the newspaper stories as before. But many experts fear that the emotions released by the worldwide misinformation will result in many HIV-positive mothers getting no treatment and unnecessarily infecting their children with HIV. Here is background that has been missing in many of the news reports.

Activists and researchers rally behind AIDS drug for mothers. Erika Check. Nature. 2004;432:935.
URL: http://www.nature.com/cgi-taf/DynaPage.taf?file=/nature/journal/v432/n7020/full/432935a_r.html&filetype=&dynoptions=

19 subpoenas issued as botulism probe focuses on improper sales. Paula McMahon. The Florida Sun-Sentinel. 2004-12-10.
URL: http://www.sun-sentinel.com/news/local/southflorida/sfl-botox10dec10,0,399412,print.story?coll=sfla-home-headlines

Nobel Prize Winner Didn't Disclose Herbalife Contract (Update1). David Evans. Bloomberg News. 2004-12-08.
URL: http://www.bloomberg.com/news/commentary/evans.html

At F.D.A., Strong Drug Ties and Less Monitoring. Gardiner Harris. The New York Times. 2004-12-06.
URL: http://www.nytimes.com/2004/12/06/health/06fda.html?pagewanted=print&position= (Requires free registration.)

Doctor attacked over 'miracle cures' based on aborted foetuses. Damien McElroy. UK News Telegraph. 2004-12-05.
URL: http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2004/12/05/wchin05.xml&sSheet=/news/2004/12/05/ixworld.html

Strokes Halt U.S. Sickle Cell Study. Daniel Yee. Associated Press. 2004-12-06.
URL: http://apnews.myway.com/article/20041206/D86PRL780.html

Sickle-Cell Transfusions Are Found Critical. Warren E. Leary. The New York Times. 2004-12-05.
URL: http://www.nytimes.com/2004/12/05/health/05sickle.html?oref=login (Requires free registration.)

Technology raises expectations — and tort risk. Tanya Roberts. American Medical News. 2004-12-13.
URL: http://www.ama-assn.org/amednews/2004/12/13/prl21213.htm

Researcher Pulls His Name From Paper on Prayer and Fertility. Benedict Carey. The New York Times. 2004-12-04.
URL: http://www.nytimes.com/2004/12/04/science/04prayer.html?oref=login&oref=login (Requires free registration.)

Ethics issue leads doctor to quit fund. Roger Mezger. The Cleveland Plain Dealer. 2004-12-03.
URL: http://www.cleveland.com/news/plaindealer/index.ssf?/base/news/1102074957136370.xml

HHS Secretary Tommy Thompson resigns. CNN. 2004-12-03.
URL: http://www.cnn.com/2004/ALLPOLITICS/12/03/hhs.secretary.ap/index.html

Gov. Bush appeals to Supreme Court on Schiavo case. CNN. 2004-12-01.
URL: http://www.cnn.com/2004/LAW/12/01/schiavo.supreme.court/index.html

I don't know how it 'works.' UK Guardian. 2004-12-01.
URL: http://www.guardian.co.uk/china/story/0,7369,1363339,00.html


Last Updated: 2006-07-29

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