Talk:Professionalism/David Franklin, Parke-Davis, and Neurontin

Taken Out of WikiBook
''Not sure if we have room for this: New England Journal of Medicine, "Employees of Parke–Davis, the medical-education companies it hired, and many physicians (consultants, advisors, educators, and researchers) all participated knowingly. Universities, hospitals, professional organizations, and foundations also participated, and oversight agencies such as the FDA and the Department of Justice did not intervene quickly. Apparently, there was a shared acceptance that Parke–Davis’s marketing was simply business as usual." ''

Research
So I have been doing some research. Here is a description of the medication (neurontin) posted on the pfizer website which might be helpful to understand what is has been approved for and should be marketed for:

http://www.pfizer.com/files/products/uspi_neurontin.pdf

Parke-Davis is a distributor of the drug (it is a division within pfizer) as posted on the label. Neurotin is the brand name, but the actual drug name is gabapentin.

Here is a newsweek article about the controversy over the drug:

http://www.newsweek.com/2008/10/07/pfizer-s-headache.html

Apparently, Parke-Davis was marketing the drug as an effective treatment for bipolar disorder, migraines, headaches and neuropathic pain. However the FDA did not approve it for this use and therefore it cannot be marketed this way. This was the main issue in the 2004 lawsuit in which pfizer admitted to unlegal advertising of the drug and settled a $430 million lawsuit. Additionally, in 2008, a new lawsuit was issued over the drug because the prosecutors claimed to have evidence that pfizer knew the drug was ineffective at treating the marketed disorders and delayed publications of studies that supported its ineffectiveness. David Franklin was the whistleblower in this case. He worked for Parke-Davis and was a fellow at Harvard Medical School (according to wikipedia).

This is a New York Times article written in 2002 before the case was settled. It is interesting because it provides some of the evidence that Franklin used in the law suit. He started working for Parke-Davis in 1996 and resigned later that year. He claims that Pfizer paid doctors to put their names as coauthors on studies supporting neurontin. He provided recorded telephone conversations and internal documents to support his lawsuit.

http://query.nytimes.com/gst/fullpage.html?res=9805EED71339F937A25750C0A9649C8B63

I think there is a lot of information out there - it is just a matter of compiling it all and making truth out of the story. It reminds me a lot of the Merck case except for it is not has lethal. Jackie Jpiccolo (discuss • contribs) 22:42, 2 April 2011 (UTC)

http://www.youtube.com/watch?v=h8yUsBJsNTM&feature=related

http://www.sacbee.com/static/weblogs/health-and-fitness/Neurontin%20Legacy.pdf

^New England Journal of Medicine, "These marketing methods were not found to be illegal per se; they were illegal insofar as they promoted off-label prescription."; "Second, such comprehensive marketing involves many people and institutions that apparently failed to recognize the serious ethical and legal problems with their actions. Employees of Parke–Davis, the medical-education companies it hired, and many physicians (consultants, advisors, educators, and researchers) all participated knowingly. Universities, hospitals, professional organizations, and foundations also participated, and oversight agencies such as the FDA and the Department of Justice did not intervene quickly. Apparently, there was a shared acceptance that Parke–Davis’s marketing was simply business as usual."; "Will our profession soon feel compelled to advocate for such actions to preserve our integrity, our social contract, and ultimately our privileges? Neurontin’s most important legacy may be promoting our discussion of these issues and perhaps pushing us beyond the tipping point to action."

http://www.npr.org/player/v2/mediaPlayer.html?action=1&t=1&islist=false&id=1895708&m=1895709

http://www.uic.edu/com/dom/gim/FLIP/flip_neurontinsettlement.htm "I want you out there every day selling Neurontin . Look this isn't just me, it comes down from Morris Plains that Neurontin is more profitable . . . . we know Neurontin's not growing adjunctive therapy, beside that is not where the money is. Pain management now that's money . Monotherapy, that's money. We don't want to share these patients with everybody, we want them on Neurontin only. We want their whole drug budget, not a quarter, not half, the whole thing . . . . We can't wait for them to ask, we need to get out there and tell them up front . . . That's where we need to be holding their hand and whispering in their ear Neurontin for pain, Neurontin for monotherapy, Neurontin for bipolar, Neurontin for everything . . . I don't want to see a single patient coming off Neurontin until they have been up to at least 4800 mg/day . I don't want to hear that safety crap either, have you tried Neurontin, every one of you should take on just to see there is nothing, it's a great drug.

Quote from John Ford, Park-Davis executive speaking to marketing managers"

from FLIP -Formulary Leveraged Improved Prescribing: "FLIP is funded by a U.S. Attorney General Consumer and Prescriber Grant Program (AGCPGP) grant made possible by the $430m settlement with Pfizer over the marketing of the drug gabapentin. "

http://www.nytimes.com/2003/03/12/business/doctor-explains-why-he-blew-the-whistle.html "We weren't driving 60 in a 55-mile-per-hour zone, he said. We were reckless driving. - David Franklin "Dr. Franklin remembers one of his supervisors telling the group that anyone who was not comfortable with aggressively selling Neurontin should leave, he said..He said he felt threatened when at least one executive told him that if he talked publicly about the company's marketing he would be made a scapegoat and be described as a rogue employee in a company that played by the rules." -- sign on power of authority?

http://www.usatoday.com/money/industries/health/drugs/2004-05-13-pfizer-whistleblower_x.htm "The microbiologist ended up blackballed in the pharmaceutical industry and had to endure an emotionally and financially draining odyssey as a whistle-blower. " "So he started gathering documents and voice mails that would prove the company was trying to get around the law by promoting unapproved uses of the drug. After he quit his job, he took the information to attorney Tom Greene of Greene & Hoffman, who brought it to the U.S. Attorney's office in Boston, which launched a criminal investigation. " -- how long do you wait? "Louis Clark, president of the Government Accountability Project, says even well-compensated whistle-blowers often keep working because settlements energize them. "Whistle-blowers are usually the hardest-working people in the office to begin with and have the highest standards, which is what led them to blow the whistle in the first place," Clark says. " the money 26.6M will not change him

these articles caught my eye because of the titles: they call franklin a whistleblower and i know that was a term we brought up in class

http://www.cbsnews.com/stories/2004/05/13/health/main617223.shtml "Drug Whistleblower Collects $24M"

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1125531/?tool=pmcentrez "Whistleblower charges drug company with deceptive practices"

http://query.nytimes.com/gst/fullpage.html?res=9805EED71339F937A25750C0A9649C8B63 (same as above) "Whistle-Blower Says Marketers Broke the Rules To Push a Drug"

franklin got 26.6 million for being the whistleblower

http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2004/05/14/BUGKK6L0LB1.DTL

interesting websites - directed those who want to file a pharmaceutical whistleblower case and encourages them to contact the company for a lawyer

http://www.consumerinjurylawyers.com/whistleblower/pharmaceutical.html

http://www.attorneysforwhistleblowers.com/

http://www.whistleblowerlawyerblog.com/2010/08/indiana_attorney_general_invit_1.html

http://www.coreynahman.com/whistle_blower_law_qui_tam.html

http://www.youtube.com/watch?v=QjTIDyc_4AY

journal article about the case/documents

http://www.annals.org/content/145/4/284.full

editorial calling for the doctor to be active player in cases like these

http://www.annals.org/content/145/4/305.full?etoc

collection of case documents, we should definitely use these at some point

http://dida.library.ucsf.edu/search?query=cs%3Aneurontin*&ct=1&page=1

NS

Singhsts (discuss • contribs) 21:38, 3 April 2011 (UTC)

http://www.newsweek.com/2008/10/07/pfizer-s-headache.html http://www.msnbc.msn.com/id/3079883/ns/dateline_nbc/ http://www.conquerchiari.org/subs%20only/volume%201/issue%205/daily%20living%20%20neurontin%201%285%29.asp http://pharmagossip.blogspot.com/2009/08/pfizer-neurontin-david-franklin-and.html Affadavit with primary source evidence: http://dida.library.ucsf.edu/pdf/oha00a10

Here is a similiar case in which Doug Durand in marketing whistleblew on TAP Pharmaceuticals about marketing a prostate cancer drug, Lupon. http://faculty.msb.edu/homak/homahelpsite/webhelp/Pharma_Whistleblower_Lupron_BW_6-24-02.htm And here is an article about the dark side of whistleblowing: http://www.forbes.com/forbes/2005/0314/090_print.html 128.143.38.175 (discuss) 01:52, 6 April 2011 (UTC) 128.143.38.175 (discuss) 01:48, 6 April 2011 (UTC)

http://www.youtube.com/watch?v=ukCJG9Kw1kg neurontin add

Multiple citations of the same reference or footnote
The instructions for the wiki code you need are here: Help:Editing and there is an example of its use here: An_Introduction_to_Molecular_Biology/Cell_Cycle. Regards Recent Runes (discuss • contribs) 18:54, 25 April 2011 (UTC)