- Joined: April 19th, 2005, 7:01 pm
[Federal Register: November 15, 2006 (Volume 71, Number 220)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0414]
<STRONG><FONT size=4>Psychopharmacologic Drugs Advisory Committee; Notice of Meeting</FONT></STRONG>
AGENCY: Food and Drug Administration, HHS.
<STRONG><FONT size=4>This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
<FONT size=4><STRONG>Name of Committee: Psychopharmacologic Drugs Advisory Committee</STRONG></FONT>.
General Function of the Committee: <FONT size=4><STRONG>To provide advice and recommendations to the agency on FDA's regulatory issues.</STRONG>
<FONT size=4><STRONG>Date and Time: The meeting will be held on December 13, 2006, from 8 a.m. to 5 p.m.
<STRONG><FONT size=4>Addresses: Electronic comments should be submitted to
</FONT></STRONG>http://frwebgate.access.gpo.gov/cgi-bin ... /ecomments.
Select <STRONG><FONT size=4>``2006N-0414 Suicidality data from Adult Antidepressant Trials'' </FONT></STRONG>and follow the prompts to submit your statement.
Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, by close of business on December 1, 2006. All comments received will be posted without change, including any personal information provided. Comments received on or before December 1, 2006, will be provided to the committee before the meeting.
Location: Hilton Washington DC/Silver Spring, The Maryland
Ballroom, 8727 Colesville Rd., Silver Spring, MD. The hotel phone
number is 301-589-5200.
Contact Person: Cicely Reese, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: [url=mailto:Cicely.Reese@fda.hhs.gov]Cicely.Reese@fda.hhs.gov[/url],
or FDA Advisory Committee Information Line, 1-800-741-8138 (301 443-0572 in the Washington, DC area), code 3014512544. Please call the Information Line for up-to-date information on this meeting.
<STRONG><FONT size=4>Agenda: The committee will discuss the results of the FDA ongoing meta-analysis of suicidality data from adult antidepressant trials. The background material will become available no later than the day before
the meeting and will be posted on FDA's Web site at
</FONT></STRONG>http://frwebgate.access.gpo.gov/cgi-bin ... acmenu.htm.
Under the heading ``Psychopharmacologic Drugs Advisory Committee (PDAC).'' (Click on year 2006 and scroll down to PDAC meetings).
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before November 21, 2006.
<STRONG><FONT size=4>Oral presentations from the public will be scheduled between approximately 10 a.m. and 12 noon.</FONT></STRONG>
Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before November 21, 2006.
Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session.
The contact person will notify interested persons regarding their request to speak by November 27, 2006.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
<FONT size=4><STRONG>FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs</STRONG>.</FONT> <STRONG><FONT size=4>If you require special accommodations due to a disability, please contact Cicely Reese at least 7 days in advance of the meeting.</FONT></STRONG>
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: November 1, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-19248 Filed 11-14-06; 8:45 am]
BILLING CODE 4160-01-S
Last edited by peagee on December 12th, 2006, 11:17 am, edited 1 time in total.
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- Joined: January 1st, 1970, 12:00 am
<SPAN name="Konabody"><FONT size=2>This thread.
</FONT><FONT size=2>http://www.agoravox.com/article.php3?id ... 5398</FONT>
<SPAN name="Konabody"><FONT size=4><STRONG>Health: SSRIs and Conflicts of Interest</STRONG></FONT></SPAN>
An FDA reviewer last week concluded that antidepressant medicines trigger suicidal thoughts and even suicide in some young adults suffering from depression. This week, the Food and Drug Administration will hold an advisory committee meeting to air this issue.</SPAN>
This is a subject where opinions are highly predictable where you stand depends very much on where you sit. <STRONG><FONT size=4>The psychiatry profession is among the most compromised in modern medicine. Its practitioners, having lost their ability to command reimbursement from the insurance companies for talk therapy, have become purveyors of pills, and have allowed the drug industry through consulting deals and other emoluments to make up for some of their lost revenue.
However, there are some psychiatrist-physicians who arent on the take from the drug industry. And, when a high profile meeting like the one that will take place this week comes up, <STRONG>youd think the FDA would reach out to find them</STRONG>. Alas, the FDA organizers of this meetings still havent gotten the message. <STRONG><FONT size=4>The agency placed three people with ties to the drug industry on the panel.
They include <STRONG><FONT size=5>Andrew Leon,</FONT></STRONG> a professor of public health at Cornells Weill Medical School who is a permanent member of the committee. <STRONG><FONT size=4>Leon has received between $10,001 and $50,000 per year as a member of a data monitoring board for an undisclosed firm that sells antidepressants,</FONT></STRONG> according to the FDA waiver that will allow him to sit on the committee. According to independent research by the Center for Science in the Public Interest, <STRONG><FONT size=4>Leon has also consulted for Cyberonics, makers of the Vegas Nerve Shock Therapy System which treats severe depression, and Cortex Pharmaceuticals, which make a class of compounds used for Alzheimers and depression</FONT></STRONG>. In addition, <STRONG><FONT size=4>Leons research has been sponsored by Forest Laboratories, which make Celexa, a selective serotonin reuptake inhibitor (SSRI).
Another panelist will be <STRONG><FONT size=5>Bruce Pollock</FONT></STRONG>, who works at the Rotman Research Institute in Toronto. He will not be allowed to vote in on the issue because he receives as much as <STRONG><FONT size=4>$10,000 per year sitting on the advisory board and speakers bureau for an antidepressant maker. Pollock also advises and speaks on behalf of Forest Labs, which makes the best-selling antidepressants, Celexa and Lexapro; for GlaxoSmithKline, maker of the antidepressant Paxil; and for Pfizer, maker of Zoloft, a popular anti-depression drug.
A third waiver was issued to <STRONG><FONT size=5>Jean Bronstein</FONT></STRONG>, a retired nurse who will be the consumer representative on the committee. <STRONG><FONT size=4>She owns stock valued from $5,001 to $100,000 in two drug firms that make antidepressants.</FONT></STRONG> Dozens of affected "consumers" will be speaking during the public portion of the meeting. It will be ineresting to see how much support they receive from Bronstein."</SPAN>
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- Joined: January 1st, 1970, 12:00 am
<SPAN name="Konabody"><FONT size=2> </FONT>This thread.
The credibility of the FDA is a laughable as that of the MHRA.
<DIV class=story id=post-1332>
Controversy Swirls Around FDA Meeting on Drug Coated Stents
A planned FDA safety review regarding the use of drug-coated stents is facing intense scrutiny after it was revealed that <STRONG><FONT size=5>six doctors on the advisory panel have financial links to stent makers Johnson & Johnson and Boston Scientific. </FONT></STRONG>The meeting, set for Thursday and Friday of this week, has been scheduled in order to discuss <STRONG><FONT size=5>significant risks of blood clotting associated with the use of drug-coated stents</FONT></STRONG>. The FDA granted <STRONG>conflict-of-interest waivers to all six of the physicians in question.</STRONG>
In advance of the meeting, the FDA released documents today related to an FDA staff review that noted that the <STRONG>drug-coated stents are associated with a small but significant risk of late-stent thrombosis. </STRONG>Stents are wire-mesh devices used to unclog arteries. The drug-coated stents are intended to prevent scar tissue from forming in the arteries, but preliminary research has determined that the coated stents may increase the probability of adverse events, including heart attacks and strokes.
<STRONG><FONT size=5>Agency critics are amazed and appalled that the FDA would allow panel members with significant ties to the companies whose devices are being reviewed. </FONT></STRONG>In a statement last month, Merrill Goozner of the Center for Science in the Public Interest said, <STRONG><FONT size=5>The scientists who advise the FDA should be free of all financial ties to firms whose products are under review</FONT></STRONG>. The publics faith in the integrity of the process will be undermined by any reform legislation that allows physicians and scientists with conflicts of interest to continue serving on these committees.
In response to the latest controversy, Goozner told the Newark Star-Ledger: There are literally thousands of experts all over this country who are well-schooled in the details of this field. But instead of reaching out to that community to get a totally unbiased look at this question, the FDA appointed a committee on which a substantial fraction have conflicts of interest directly with manufacturers of products being evaluated. Its almost impossible to have confidence in the outcomes of this kind of deliberation.
According to Bloomberg News, one member of the advisory panel is Robert Harrington, who runs a Duke University research institute funded by both J&J and Boston Scientific.
Drug-coated stents have been used in 4 million patients and have sales in the $6 billion range annually. They are significantly more expensive than bare stents, but apparently they are more dangerous as well. "
This group isn't amazed, its very like the FDA (and the MHRA) to give industry a hand. You have to guess why.
BUT we ARE APPALLED.
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- Joined: January 1st, 1970, 12:00 am
<SPAN name="Konabody"><FONT size=2> </FONT><STRONG><SPAN name="Konabody">An appeal received yesterday to write to the FDA</SPAN></STRONG>This thread.
<SPAN name="Konabody">"To the Food and Drug Administration
5600 Fishers Lane, Rockville MD 20857
<FONT size=5><STRONG>Families for Depression Awareness </STRONG></FONT>is slated to address the Food and Drug Administration (FDA) as they convene for the Psychopharmacological Drugs Advisory Committee (PDAC) meeting, December 13.
Families for Depression Awareness refuses to publicly reveal funding sources.
This group must not be allowed to testify as an impartial patient advocacy group If it is receiving drug company donations.
In order to prevent a conflict of interest, The FDA must demand full disclosure of any drug industry funds received by Families for Depression Awareness or any other non profit group testifying before The F.D.A.
<SPAN name="Konabody"><FONT size=6><FONT size=3>If</FONT> </FONT><FONT size=5><STRONG>Families for Depression Awareness </STRONG></FONT>is receiving any moneys from drug companies and is allowed to to Testify to the FDA's Psychopharmacological Drugs Advisory Committee, Then this information MUST be made public.
<STRONG><SPAN name="Konabody">Well, we don't know what funding FAMILIES FOR DEPRESSION AWARENESS receive as their records don't state WHERE they get their thousands of dollars, but we do know what ties their ADVISORY BOARD have with the pharmaceutical industry, teenscreen, trialling ADHD drugs on infants, and general disease mongering....</SPAN></STRONG>
<STRONG><SPAN name="Konabody">...AND SO CAN YOU! See:</SPAN></STRONG>
<STRONG><SPAN name="Konabody">http://www.network54.com/Forum/281849/m ... 1165691991</SPAN>
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<H3 class=post-title><FONT color=#000066>Public Testimonies at FDA-SSRI-Suicidality Hearings</FONT></H3>
<DIV>"In this Infomail, Dr. David Cohen, AHRP Secretary gives his brief personal impressions from the December 13 meeting of the FDA's Psychopharmacologic Drugs Advisory Committee preceded (Dec. 12) by two press briefings convened by AHRP and Woodymatters.com. [Conflict of interest issues will be dealt with elsewhere.]
Only if one assumes that the FDA sees the drug industry as its client can some sense be made of December 13's meeting of the FDA's Psychopharmacologic Drugs Advisory Committee in Silver Springs, Maryland.
I carefully read the two clinical reviews conducted and released by the FDA for this meeting, and I attended most of the meeting. I left thinking that I had watched a surrealistic play.
<STRONG>One highlight of the meeting for me was watching Tom Laughren, Director of the Division of Psychiatry Products of FDA's Center for Drug Evaluation and Research, intently take notes and never look up as a long line of individuals made their 3-minute presentation to the committee, alternatively condemning and praising antidepressants (see summary below). Dr. Laughren never looked up even when Dr. David Healy charged him, on the public record, with being the sole author of an article in which suicidal events from drug-treated groups were arbitrarily switched to placebo-treated groups.</STRONG>
And when the committee members were given time to question the FDA officials about any aspect of the data they were given, or comment on any of the presentations they had just heard, no one picked up on Healy's extraordinarily relevant charge.
<STRONG>I expected a committee member to ask, "Dr. Laughren, is Dr. Healy's statement true? If so, can you tell us precisely how common occurrences of fake data are in the database the FDA is using to determine the risk of antidepressant-induced suicidality? If the FDA doesn't have this information for us now, should we adjourn this meeting until it is provided to us?"</STRONG>
It seems to me that if the FDA took the suicidality issue seriously this time around, it would have asked some of the major independent critics and researchers, who have been discussing this issue for over 15 years, just how they would analyze the clinical trial data, what specific associations they would examine, etc. The FDA could of course have then proceeded to do exactly what it wished, but at least, even from a public relations point of view, it could have said that even naysayers had been consulted. This is after all a major analysis of nearly 400 trials with 100,000 patients, that requires very careful planning and comes after 15 years of FDA denial of the importance of the issue.
Yet I watched as FDA officials admitted not having asked drug manufacturers for specific adverse event data (such as akathisia and other instances of drug-induced activation, which the literature has long associated with sudden suicidality) for this review, or having arbitrarily decided to ignore any drug-withdrawal related data, or not having presented specific data bearing on the efficacy of antidepressants besides this single sentence: "Approximately 50% of subjects who received active drug and 40% of subjects who received placebo were designated as responders" (p. 31). Given that the entire scientific case for antidepressants rests on this 10% difference, a clear analysis of what factors in clinical trials might contribute to it--besides treatment--is definitely indicated in a report on risks of treatment that relies only on clinical trial data.
Although several committee members did ask some relevant questions, there was really no follow-up in spite of the FDA officials' frequent admissions of "No, we didn't ask for this data," or "No, we don't have this data." There were a number of embarassing silences following these admissions, but never followed by "Why not?" It seemed as if all participants recognized the futility of the exercise but had agreed not to comment on this futility in public.
AHRP Press Conferences on December 12 On December 12, AHRP, in association with WoodyMatters.com, organized two press conferences, one at the National Press Club in Washington and the second at the Silver Springs Hilton in Maryland, at which public and media were briefed on the issues. Presentations were made by Kim Witczak and Eric Swann, and by Vera Hassner Sharav, Joseph Glenmullen, MD, David Healy, MD, John Abramson, MD, David Cohen, Ph.D, and Karen Barth Menzies, Esq. of the legal firm Baum Hedlund.
Kim Witczac and Eric Swann gave the personal perspective of the tragic suicide of Woody, a vibrant, healthy 37 year old man who was prescribed Zoloft for insomnia. His mental health deteriorated in ways later confirmed to be Zoloft-related in Pfizer documents. He committed suicide.
Vera Sharav compared antidepressants which had been marketed as "magic bullets" to "snake oil," noting the long list of indications for which the drugs were approved--despite lack of benefit--and the even longer list of indications for which they are being prescribed off-label. She questioned FDA's truncated inclusion criteria for this analysis--to one day after ingesting the drug during the randomized phase. This contradicts good clinical practice and the FDA approved labels which stress the importance of monitoring during initiation and dose changes. She then noted the disparity between the UK analysis of the same trial data (2005) which reported 16 suicides and 177 attempts in 40,000 patients compared FDA's report of 8 suicides and 133 attempts in 100,000 patients. She also questioned FDA's claim that the data showed "no treatment effect" on suicides when the data shows: Suicidal Behavior by those on the drugs: Age <25: RR = 2.30 (1.04 - 5.09) Age 45 - 54: RR = 2.29 (0.73 - 7.14) Age 45 - 64: RR = 1.75 (0.68 - 4.48)
Joseph Glenmullen, MD, gave a detailed historical review of a large number of previous signals in the literature concerning antidepressant-induced suicidality. He made the point that confusing it with "ordinary" suicidality is a false issue, as it can be easily recognized in connection with an activating syndrome (including mania and akathisia) that regularly accompanies it. He charged that the FDA has systematically swept the issue under the carpet since 1991, when it already possessed ample data to conclude that antidepressants are implicated. Glenmullen believes that fearing that warnings will scare patients is a bugaboo. He asked: if you had to make the decision to take or prescribe a drug, would you want to know the risk?
David Healy, MD, discussed how the effectiveness of antidepressants is misconstrued. He emphasized that data shows that only one in 10 patients taking antidepressants can be said to respond specifically to drug rather than to nonspecific and placebo factors. He showed how suicide-related events in several previous trials were arbitrarily switched from drug-treated to placebo-treated groups. He gave several examples of ghostwriting of clinical trial reports purporting to show efficacy and safety of antidepressants. He showed how data obtained from British drug regulators contradict the FDA-released data. Overall, Healy questioned the validity of the information typically used to draw conclusions about antidepressant-induced suicidality.
In my presentation, I emphasized that clinical trials now used by the FDA to explore the link between antidepressants and subtle adverse events such as suicidality were completely unsuited for that purpose. I pointed out that these trials were only conducted by sponsors for the purpose of showing a tested drug's superiority to placebo or equivalency to an existing drug, not to determine just how a drug might be psychologically influencing those who take it for weeks or months. I emphasized that if the FDA really wants to approve safe and efficacious psychotropic drugs, it needs to request from manufacturers studies that take as a starting point that these drugs are indeed psychotropic and have, by definition, complex and variable effects. More attention paid to creative methods to detect psychological and behavioral toxicity in Phase I studies is needed.
John Abramson, MD, gave an overview of the overwhelming penetration of industry influence and incentives inside what should be the most scientific and evidence-based forums of general and primary care practitioners. His slides showed the ubiquitous presence of drug industry advertising in every aspect and location of the annual convention of PCPs, including prominent drug ads at every registration desk, in the toilets, and even on the cards given to each doctor to record his or her attendance at courses for continuing education credits.
Karen Barth Menzies briefly reviewed the numerous instances of suppressed data on suicidality from various internal industry and FDA documents that were only made public because of litigation. She questioned the true purpose of holding the Advisory Committee at this late December date, with no expected vote for its members, and, given previous outcomes, expressed some pessimism.
Key Points of Public Speakers at December 13 FDA Advisory Committee Meeting The following are my brief notes summarizing what I understood as the key points made by almost every speaker who testified for 3 minutes during the public portion of the December 13 meeting.
- Julie Totten represented Families for Depression Awareness. She said that families often don't know how to accompany people who suffer from depression, and she promoted her group's Depression Wellness Guide.
- Suzanne Gonzalez spoke of losing her husband who committed suicide at age 40 while on Paxil.
- John Mann, professor of psychiatry, emphasized the negative consequences of depression, especially suicide.
- Allen Jones, whistleblower and formerly on AHRPs' Board of Directors, highlighted rampant conflicts of interests at the FDA and in its advisory committees, including this one.
- Nick Korzie, 16 years old, spoke of his experience as a depressed teenager prescribed psychiatric drugs. "I was given antipsychotics though I wasn't psychotic, I was given anti-seizure drugs though I've never had seizures." He ended with: "We, are the people. You, the FDA, should protect the people."
- Christopher Kratochvil, a psychiatrist and clinical trial researcher, spoke on behalf of the American Academy of Child and Adolescent Psychiatry. I missed most of his talk.
- Darrel Regier, director of research at the American Psychiatric Association, said that the FDA database is limited because clinical trials don't evaluate suicidality; only prospective trials can do so. He asked the committee to provide realistic guidelines, stating that some doctors refuse to initiate antidepressant treatment because they can't guarantee 7 visits in 12 weeks for patient monitoring, as the latest FDA advisory indicated.
- Moira Doilan spoke for the Medical Accountability Network. She deplored that the FDA only used a single suicidal event per subject in its analysis and let the manufacturers decide what constituted such events. She asked that warnings of the possibility of antidepressant drug-emergent suicidality be quickly publicized by the FDA.
- Scott Gruder spoke of his father who killed himself 13 days after being prescribed Paxil.
- Deborah Gruder spoke of her husband and Scott's father, who loved life and whose suicide was completely unexpected. She shouted to committee members that antidepressant-induced suicides were "nothing but a blood bath and mass murder."
- Gwen Olsen spoke of her 20 year-old niece on antidepressants who self-immolated immediately after failing to hang herself. Olsen used to work as a pharmaceutical representative and discussed how she was trained to persuade doctors to prescribe drugs.
- Beverly Hatcher spoke of her mother with no history of depression who killed herself after 16 days on Paxil.
- Ellen Liversidge, a member of AHRP, spoke of her son who was put on Zyprexa and gained 100 lbs, then fell into a coma and died.
- Lisa Van Syckel spoke of her 15 year-old daughter who attempted suicide while on Paxil.
- Charles Carpenter broke down as he spoke of his wife who killed herself while on Paxil. A psychologist she consulted because she occasionally "jumped in the car" recommended she take Paxil, which was then prescribed by her primary care doctor.
- Paula Clayton, psychiatrist, spoke for the American Foundation for Suicide Prevention. She's prescribed antidepressants since 1958. She urged the committee not to issue a black box warning.
- Diane Dorlester spoke for the National Mental Health Association. She described her positive experience on antidepressants and asked the committee not to restrict access to these drugs.
- Lewis Kopolow, President of the Maryland Psychiatric Association, stated that depression is a disease, that it affects physical health, and that half of depressed people don't get help.
- Joseph Glenmullen, psychiatrist at Harvard Student Health service, said that the FDA never did the promised gold standard study on suicidality and has swept the problem under the carpet for 15 years. He said that drug-induced suicidality was a distinct, easy-to-recognize phenomenon.
- Dan Reidenberg, director of the National Council for Suicide Prevention, urged the FDA not to make it difficult to get life saving antidepressants.
- Karen Menzies, lawyer, expressed astonishment that the FDA did not look at adverse effects, especially akathisia, in connection with sucidality. She stated that data were regularly hidden by the drug companies, and had provided examples to the committee. <STRONG>She urged the committee to use its legal powers to ask for this data, but deplored that "You just don't!" </STRONG>
- Michelle Moore spoke of her husband who was "murdered." He committed suicide 1 day after being switched to Paxil from 30 days of Prozac. He was not depressed and had given no clue.
- Tony Noll, whose father committed suicide on an antidepressant, said "I came to speak to you on behalf of the statistically insignificant."
- Mary Margaret Neill spoke of her five depressive episodes and the multiple medication regimen she has been on, and that her current one is working.
- Donna Barnes spoke for the National Organization for People of Color against suicide. She stated that Blacks use relatively less psychiatric treatment, and comply less. She urged the FDA not to put a black box warning.
- Sarah Bostock's daughter Cecily killed herself on Paxil. Bostock has set up SSRIstories.com, where over 1200 media stories on SSRI induced violence and suicide since 1998 are compiled and analyzed. She invited committee members to view this database.
- Kim Witczak's husband Woody committed suicide after being prescribed Zoloft for insomnia. Witczak said Woody loved life and had no serious personal problems. She described in layperson's terms what seemed like a sudden preceding episode of akathisia. WoodyMatters.com publicizes his story and the issues.
- Joseph Weiner, psychiatrist at Long Island University Medical Center, disclosed financial support for his testimony from the American Psychiatric Association. He described his "personal victory over major depression due in large part to antidepressant treatment. If only I'd received antidepressants earlier, I would have avoided years of excruciating suffering."
- Angela Heck described the fear and ongoing bewildering consequences of an episode when her husband, in an antidepressant-induced dissociative episode, tried to kill her with a knife.
- Sheila Matthews spoke for Able Child. She emphasized the subjectivity of psychiatric diagnosis, then gave results of two surveys her group commissioned on public knowledge of Medwatch, the FDA's spontaneous adverse drug reaction reporting system. She asked to FDA to set up public campaigns to let consumers know where/how to report ADRs, as consumers detect effects sooner than providers.
- Robert Carolla spoke for National Alliance on Mental Illness. He described frustrating talk therapy in pre-drug days, his medication experiences and his long road to recovery. Suicidality is frequent and subtle, he said. He asked the FDA not to discourage people from taking antidepressants.
- Erin Crowley spoke for the National Coalition for Drug Awareness. I missed most of her talk.
- Andy Vickery, lawyer, said that controlled trials are not designed to evaluate suicidality. He asked why the FDA abandoned its own algorithm for determining causality in individual cases of drug reactions. He asked why is this committee meeting if it's not asked to vote on anything?
- John R. Hayes spoke for Eli Lilly and Company. He urged the panel to be rational.
- Heidi Bryan, speaking on behalf of the Feeling Blue Suicide Prevention Council, described how antidepressants saved her life.
- Donald Farber, lawyer, urged committee members to be honest. He said that the committee was not meeting to decide who should get what treatment, but first and foremost to decide on the most accurate description of the risk of antidepressant-induced suicidality.
- David Healy, psychiatrist and researcher, presented slides showing how drug companies routinely alter data, switching suicide-related events from drug-treated groups to placebo groups, and charged that Thomas Laughren himself, in a single-authored article, did the exact same thing.
- Luis Fuller [spelling?] spoke for Citizens' Commission on Human Rights. He presented Oregon data showing increases in suicide attempts positively associated with antidepressant treatment. He stated that ER visits from antidepressant-induced suicidality are more frequent than all similar events from heroin, cocaine, methamphetamine, and other illicit drugs combined.
- Carolyn Rabinowitz, a child and adolescent psychiatrist, emphasized that depression hurts a lot and that drugs help.
- Sheri Walton says she has major depression, that it went untreated and undiagnosed for 20 years and ruined her life, and that antidepressants saved her and gave her back her life. She believes that unecessary warnings may scare people away from treatment.
- Jane Richner spoke of her 20 year-old son who was given a 90-day prescription of Celexa for situational anxiety during a 10-minute medical visit. Life was all coming together for him, but he hung himself. He manifested definite akathisia beforehand. She emphasized the importance of drug-induced fatal withdrawal effects.
- Nancy Sharby described a long family history of suicide, and she and her children have been diagnosed with mood disorders. She emphasized the burden of depression.
- Vera Hassner Sharav, president of AHRP, highlighted numerous flaws in the FDA clinical review's approach and analysis, and pointed out major discrepancies with British studies of similar data. [Her full presentation is available on this website.]
- Kendrick Moxon, lawyer for Citizens' Commission on Human Rights, described how completely conflicted the FDA's advisory committees were, especially the 1991 committee that ruled against warning about SSRI-induced suicidality.
- David Shern of Mental Health America argued that the availability of SSRIs has led to a decrease in suicide rates. He stated that a black box warning won't promote a public health agenda.
- Alison Malmon of Active Minds, Inc., spoke of the large unmet need for help and support among depressed and distressed youths in high school and college.
- Ann Blake Tracy spoke on behalf of International Coalition for Drug Awareness. She emphasized the harm that widespread use of SSRIs has produced for two decades.
- Eric Caine, professor of psychiatry and president of Suicide Prevention Action Network acknowledged some funding from drug industry. He urged FDA not to scare people away from care.
- Rosemary Dorsett spoke of how her son got screened for depression during his physical, got Prozac from his GP, quickly became insomniac, lost weight, heard voices, and shot himself in chest. She emphasized how he loved life and this was totally out of character.
- Mary Ellen Whitter spoke of her daughter who loved life, her life, and people, and was happy and extremely functional. After graduation, she became insomniac and anxious, received Paxil. Immediately worsened across the board, and hung herself after 7 days on drugs.
- Nada Stotland, physician and with Mental Health America, stated that antidepressants save lives and the risk of a back box warning is that patients will be frightened to take them.
- Roger Peele, psychiatrist, spoke of his long family history of suicide and argued that suicides are depression-related, not drug-related.
- Eric Swann, brother in law of Woody Whitczak who killed himself on antidepressants, urged the committee to do the right thing and recommend a back box warning for adult suicidality.
- Dawn Jeronowitz described how she was diagnosed with anxiety as no physical cause for pain in her finger was detected, and was prescribed Paxil. She experienced outright mania, which she described in harrowing detail. She asked how such dangerous drugs could be legally pushed on people without any information provided on their major adverse effects.
- Allen Routhier said his was given an "unmarked free sample of Wellbutrin" by her doctor and was dead within one week. He said this meeting was a circus side show, with the real action being the unfettered sale of dangerous drugs for corporate profits. He said he was at such meetings three times now, with nothing ever getting done. He wondered if new Nuremberg trials were needed.
- Ann Sheffield spoke of her three books on the negative impact of depression. She said: "I'd be dead if it weren't for antidepressants."
- Laurie Yorke spoke of Paxilprogress.org, a website which offers peer support for people undergoing withdrawal from antidepressants.
- Hanna Stotland, a lawyer, said that she was crippled by depression, and drugs saved her life and allowed her to have a productive career. "Untreated depression is the danger we need to fear most."
- Charles Reynolds, psychiatrist, spoke for the American Association of Geriatric Psychiatry. I missed most of his talk.
- Peter Breggin, psychiatrist, told the committee "The data you're looking at is junk!" He said drug companies routinely hide damaging data, and that as expert in numerous cases of drug-induced damage, he's seen "innumerable" instances that have never made it to the FDA or publications, examples of which he's provided to the committee.
- Robert Gibbons, Center for Health Statistics at University of Illinois at Chicago, stated that data from Netherlands show that drop in prescriptions of SSRIs are associated with increases in youth suicide rates.
- Carl Salzman, psychiatrist, spoke for the American College of Neuropsychopharmacology. He said he was concerned about unintended consequences of a black box warning.
- Derek Braslow, lawyer, stated that data relied upon by the FDA isn't reliable. "The science is here, in the people."
- Robert Valuck of the University of Colorado argued with supporting slides that fewer prescriptions of antidepressants would definitely result from a black box warning.
- Steven Davis, physician, believed that as a result of a black box warning, physicians will be scared to prescribe antidepressants."</LI>
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http://www.nytimes.com/2006/12/18/busin ... ref=sloginThis thread.
<STRONG><FONT size=5>"Drug Files Show Maker Promoted Unapproved Use </FONT></STRONG>
By ALEX BERENSON
Published: December 18, 2006
<STRONG><FONT size=4>Eli Lilly encouraged primary care physicians to use Zyprexa, a powerful drug for schizophrenia and bipolar disorder, in patients who did not have either condition, according to internal Lilly marketing materials.</FONT></STRONG>
The marketing documents, given to The New York Times by a lawyer representing mentally ill patients, detail a multiyear promotional campaign that Lilly began in Orlando, Fla., in late 2000. In the campaign, called Viva Zyprexa, Lilly told its sales representatives to suggest that doctors prescribe Zyprexa to older patients with symptoms of dementia.
A Lilly executive said that she could not comment on specific documents but that the company had never promoted Zyprexa for off-label uses and that it always showed the marketing materials used by its sales representatives to the Food and Drug Administration, as required by law.
We have extensive training for sales reps to assure that they provide information to the doctors thats within the scope of the prescribing information approved by the F.D.A., Anne Nobles, Lillys vice president for corporate affairs, said in an interview yesterday.
<FONT size=4><STRONG>Zyprexa is not approved to treat dementia or dementia-related psychosis, and in fact carries a prominent warning from the F.D.A. that it increases the risk of death in older patients with dementia-related psychosis. </STRONG></FONT>Federal <STRONG>laws bar drug makers from promoting prescription drugs for conditions for which they have not been approved</STRONG> a practice known as off-label prescription although doctors can prescribe drugs to any patient they wish.
Yet in 1999 and 2000 Lilly considered ways to convince primary care doctors that they should use Zyprexa on their patients. In one document, an unnamed Lilly marketing executive wrote that these doctors do treat dementia but do not treat bipolar; schizophrenia is handled by psychiatrists.
As a result, dementia should be first message, of a campaign to primary doctors, according to the document, which appears to be part of a larger marketing presentation but is not marked more specifically.
Later, the same document says that some primary care doctors might prescribe outside of label.
Ms. Nobles said that the company had never promoted its drug for any conditions except schizophrenia and bipolar disorder. Older patients who seem to have dementia may actually have schizophrenia that has gone untreated, Ms. Nobles said.
Several psychiatrists outside the company said yesterday that they strongly disagreed with Lillys claim. Schizophrenia is a severe disease that is almost always diagnosed when patients are in their teens or 20s. Its symptoms could not be confused with mild dementia, these doctors said.
Zyprexa is by far Lillys best-selling product, with $4.2 billion in sales in 2005, 30 percent of its overall revenues. About two million people worldwide received it last year. Based in Indianapolis, Lilly is the sixth-largest American drug company.
The issue of off-label marketing is controversial in the drug industry. Nearly every company is under either civil or criminal investigation for alleged efforts to expand the use of its drugs beyond the specific illness or condition for which they are approved.
Lilly faces federal and state investigations over its marketing of Zyprexa. In its annual report for 2005, Lilly said that it faced an investigation by federal prosecutors in Pennsylvania and that the Florida attorney generals office had subpoenaed the company seeking production of documents relating to sales of Zyprexa and our marketing and promotional practices with respect to Zyprexa.
Since Lilly introduced Zyprexa in 1996, about 20 million patients worldwide have received the drug, which helps control the hallucinations and delusions associated with schizophrenia and severe mania. But Zyprexa also causes weight gain in many patients, and the American Diabetes Association found in 2004 that Zyprexa was more likely to cause diabetes than other widely used drugs for schizophrenia.
Lilly says that no link between Zyprexa and diabetes has been proven.
As part of the <STRONG>Viva Zyprexa</STRONG> campaign, in packets for its sales representatives, <STRONG>Eli Lilly created the profiles of patients whom it said would be suitable candidates for Zyprexa</STRONG>. Representatives were told to discuss the patient profiles with doctors. One of the patients was <STRONG>a woman in her 20s who showed mild symptoms of schizophrenia, while another was a man in his 40s who appeared to have bipolar disorder.</STRONG>
The<STRONG> third patient was Martha</STRONG>, a widow with adult children who lives independently and has been your patient for some time. Martha was described as being agitated and having disturbed sleep, <STRONG>but without the symptoms of paranoia or mania that typically marked a person with schizophrenia or bipolar disorder.</STRONG>
Ms. Nobles said that Lilly had actually intended Marthas profile to represent a patient with schizophrenia. <STRONG>But psychiatrists outside the company said this claim defied credibility, especially given Marthas age. Instead, she appeared to have mild dementia, they said.</STRONG>
<STRONG>Itd be very unusual for this to be a schizophrenic patient, said Dr. John March, chief of child and adolescent psychiatry at Duke University medical center. Schizophrenia is a disease of teenagers and young adults.</STRONG> Dr. March serves on Lillys scientific advisory board.
Diagnostic criteria for schizophrenia include delusions, hallucinations, disorganized and incoherent speech, and grossly disorganized behavior. They also include so-called negative symptoms like social isolation and a flattening of the voice and facial expressions.
The documents also show that Lilly encouraged primary care doctors to treat the symptoms and behaviors of schizophrenia and bipolar disorder <STRONG>even if the doctors had not actually diagnosed those diseases in their patients.</STRONG> Lillys market research had found that many primary care doctors did not consider themselves qualified to treat people with schizophrenia or severe bipolar disorder.
The campaign was successful, the documents show. <STRONG>By March 2001, about three months after the start of Viva Zyprexa, the campaign had led to 49,000 new prescriptions, according to a presentation that Michael Bandick, the brand manager for Zyprexa, gave at a national meeting of Lilly sales representatives in Dallas.</STRONG> Mr. Bandick did not say how many of those new prescriptions were for older patients with dementia.
Over all, <STRONG>sales of Zyprexa doubled between 1999 and 2002, rising from $1.5 billion to $3 billion in the United States. In 2002, the company changed the name of the primary care campaign to Zyprexa Limitless and began to focus on people with mild bipolar disorder who had previously been diagnosed as depressed even though Zyprexa has been approved only for the treatment of mania in bipolar disorder, not depression.</STRONG>
In a 2002 guide for representatives, Lilly presented the profile of Donna, a single mother in her mid-30s whose chief complaint is, I feel so anxious and irritable lately. Several doctors appointments earlier, she was talkative, elated, and reported little need for sleep.
Lillys efforts to promote Zyprexa to primary care doctors disturbed some physicians, the documents show. In August 2001, a doctor in Virginia sent an e-mail message to Lilly and the F.D.A., complaining about a presentation from a Lilly sales representative who had discussed the hypothetical Martha with him.
<STRONG>The representative presented an elderly female patient who was presented to her physician by her family complaining of insomnia, agitation, slight confusion, and had no physical finding to explain her state, the doctor wrote. The representative then suggested that the doctor prescribe Zyprexa.</STRONG>
<STRONG>I inquired what Zyprexa was indicated for she then indicated that many physicians might prescribe an antipsychotic for this patient. I then asked for her package insert and read to her that her product was indicated for schizophrenia and bipolar mania neither of which the presented patient had been diagnosed with, the doctor wrote.</STRONG>
He added that he had never contacted the F.D.A. before but was genuinely concerned about the promotion of this powerful drug to my peer community of primary care physicians outside of its approved and intended purpose.
Tara Ryker, a spokeswoman for Lilly, said the company no longer uses Martha or Donna in its marketing. We are constantly developing new promotional materials and new profiles, she said.
The Zyprexa documents were provided to The Times by James B. Gottstein, a lawyer who represents mentally ill patients and has sued the state of Alaska over its efforts to force patients to take psychiatric medicines against their will.
Mr. Gottstein said yesterday that the information in the documents should be available to patients and doctors, as well as judges who oversee the hearings that are required before people can be forced to take psychiatric drugs.
The courts should have this information before they order this stuff injected into peoples unwilling bodies, Mr. Gottstein said.
Lilly originally provided the documents, under seal, to plaintiffs lawyers who sued the company claiming their clients developed diabetes from taking Zyprexa. Last year, Lilly agreed to pay $700 million to settle about 8,000 of the claims, but thousands more are pending. Mr. Gottstein, who is not subject to the confidentiality agreement that covers the product liability suits, subpoenaed the documents in early December from a person involved in the suits.
The Viva Zyprexa documents also provide color about Lillys efforts to motivate its sales force as they marketed Zyprexa whose generic name is olanzapine to primary care doctors.
<STRONG>At the 2001 meeting in Dallas with Zyprexa sales representatives, Mr. Bandick praised 16 representatives by name for the number of prescriptions they had convinced doctors to write, according to a script prepared in advance of the meeting. More than 100 other representatives had convinced doctors to write at least 16 extra prescriptions and thus maxed out on a pretty sweet incentive, he said.</STRONG>
Olanzapine is the molecule that keeps on giving, Mr. Bandick said."
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<STRONG><FONT size=5>"Eli Lilly Said to Play Down Risk of Top Pill"</FONT></STRONG>
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<STRONG><FONT size=4>The drug maker </FONT></STRONG><A title="Eli Lilly" href="http://www.nytimes.com/mem/MWredirect.html?MW=http://custom.marketwatch.com/custom/nyt-com/html-companyprofile.asp&symb=LLY"><FONT color=#004276 size=4><STRONG>Eli Lilly</STRONG></FONT></A><STRONG><FONT size=4> has engaged in a decade-long effort to play down the health risks of Zyprexa, its best-selling medication for schizophrenia, </FONT></STRONG><STRONG><FONT size=4>according to hundreds of internal Lilly documents and e-mail messages among top company managers. </FONT></STRONG>
<DIV class=image><IMG height=255 alt="" src="http://graphics10.nytimes.com/images/2006/12/17/business/17drug.1.190.jpg" width=190 border=0>
The documents, given to The Times by a lawyer representing mentally ill patients, show that Lilly executives kept important information from doctors about Zyprexas links to <A title="Recent and archival health news about obesity." href="http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/obesity/index.html?inline=nyt-classifier"><FONT color=#004276>obesity</FONT></A> and its tendency to raise blood sugar both known risk factors for <A title="Recent and archival health news about diabetes." href="http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/diabetes/index.html?inline=nyt-classifier"><FONT color=#004276>diabetes</FONT></A>.
Lillys own published data, which it told its sales representatives to play down in conversations with doctors, has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug, and some patients have reported gaining 100 pounds or more. But Lilly was concerned that Zyprexas sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes, according to the documents, which cover the period 1995 to 2004.
Zyprexa has become by far Lillys best-selling product, with sales of $4.2 billion last year, when about two million people worldwide took the drug.
Critics, including the American Diabetes Association, have argued that Zyprexa, introduced in 1996, is more likely to cause diabetes than other widely used schizophrenia drugs. Lilly has consistently denied such a link, and did so again on Friday in a written response to questions about the documents. The company defended Zyprexas safety, and said the documents had been taken out of context.
<STRONG><FONT size=4>But as early as 1999, the documents show that Lilly worried that side effects from Zyprexa, whose chemical name is olanzapine, would hurt sales. </FONT></STRONG>
<STRONG><FONT size=4>Olanzapine-associated weight gain and possible hyperglycemia is a major threat to the long-term success of this critically important molecule, Dr. Alan Breier wrote in a November 1999 e-mail message </FONT></STRONG>to two-dozen Lilly employees that announced the formation of an <STRONG>executive steering committee for olanzapine-associated weight changes and hyperglycemia. </STRONG>Hyperglycemia is high blood sugar.
At the time Dr. Breier, who is now Lillys chief medical officer, was the chief scientist on the Zyprexa program.
In 2000, a group of diabetes doctors that Lilly had retained to consider potential links between Zyprexa and diabetes warned the company that <STRONG><FONT size=5><FONT size=3>unless we come clean on this, it could get much more serious than we might anticipate,</FONT> </FONT></STRONG>according to an e-mail message from one Lilly manager to another.
And in that year and 2001, the documents show, <STRONG>Lillys own marketing research found that psychiatrists were consistently saying that many more of their patients developed high blood sugar or diabetes while taking Zyprexa than other antipsychotic drugs. </STRONG>
The documents were collected as part of lawsuits on behalf of mentally ill patients against the company. Last year,<STRONG> Lilly agreed to pay $750 million to settle suits by 8,000 people who claimed they developed diabetes or other medical problems after taking Zyprexa. Thousands more suits against the company are pending. </STRONG>
On Friday, in its written response, Lilly said that it believed that Zyprexa remained an important treatment for patients with schizophrenia and bipolar disorder. The company said it had given the <A title="More articles about the U.S. Food And Drug Administration." href="http://topics.nytimes.com/top/reference/timestopics/organizations/f/food_and_drug_administration/index.html?inline=nyt-org"><FONT color=#004276>Food and Drug Administration</FONT></A> all its data from clinical trials and reports of adverse events, as it is legally required to do. Lilly also said it shared data from literature reviews and large studies of Zyprexas real-world use.
In summary, there is no scientific evidence establishing that Zyprexa causes diabetes, the company said.
Lilly also said the documents should not have been made public because they might cause unwarranted fear among patients that will cause them to stop taking their medication.
As did similar documents disclosed by the drug maker <A title=Merck href="http://www.nytimes.com/mem/MWredirect.html?MW=http://custom.marketwatch.com/custom/nyt-com/html-companyprofile.asp&symb=MRK"><FONT color=#004276>Merck</FONT></A> last year in response to lawsuits over its painkiller Vioxx, the Lilly documents offer an inside look at how a company marketed a drug while seeking to play down its side effects. Lilly, based in Indianapolis, is the sixth-largest American drug maker, with $14 billion in revenue last year.
<STRONG><FONT size=4>The documents which include e-mail, marketing material, sales projections and scientific reports are replete with references to Zyprexas importance to Lillys future and the need to keep concerns about diabetes and obesity from hurting sales. But that effort became increasingly difficult as doctors saw Zyprexas side effects, the documents show.</FONT></STRONG>
<STRONG><FONT size=4>In 2002, for example, Lilly rejected plans to give psychiatrists guidance about how to treat diabetes, worrying that doing so would tarnish Zyprexas reputation.</FONT></STRONG> Although M.D.s like objective, educational materials, having our reps provide some with diabetes would further build its association to Zyprexa, a Lilly manager wrote in a March 2002 e-mail message.
<STRONG><FONT size=4>But Lilly did expand its marketing to primary care physicians, who its internal studies showed were less aware of Zyprexas side effects. Lilly sales material encouraged representatives to promote Zyprexa as a safe, gentle psychotropic suitable for people with mild mental illness."</FONT></STRONG>
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<SPAN name="Konabody"><FONT size=2> </FONT>This thread.
<SPAN name="Konabody"><FONT face=Verdana size=2><STRONG>And of course, Judge MANN ignores whats is right and the safety of other lives and serves a mandatory injunction on J</STRONG></FONT></SPAN><SPAN name="Konabody"><FONT face=Verdana size=2><STRONG>im Gottstein to return the documents to Eli Lilly.</STRONG></FONT>
<FONT face=Verdana size=2><STRONG>http://www.opednews.com/articles/genera ... li_lil.htm</STRONG></FONT>
<FONT face=Verdana size=2><STRONG>Alaskan attorney, Jim Gottstein, says that after being served with a mandatory injunction, he has returned the internal Eli Lilly documents that he obtained in litigation and provided to the New York Times to the court.
Information from the documents related to Lilly's antipsychotic drug, Zypexa, was highlighted two days in a row in front-page articles in the Times
The documents reveal the illegal marketing schemes used by Lilly to make Zyprexa its best-seller, which the company has managed to keep hidden for years by entering into out of court settlements in civil lawsuits which included confidentiality clauses and by getting judges to place the documents under protective orders to shield them from public view.
For instance, the documents under seal here are from a case where Lilly entered into an out-of-court settlement in June 2005, and agreed to pay $690 million to cover claims by about 8000 Zyprexa victims. But in order to get paid, the plaintiffs were required to sign a confidentiality clause and basically keep their mouths shut about Zyprexa from then on.
Its really comical the way Lilly keeps acting all indignant over the disclosure of these documents as if they contain brand new charges, when the company has been under federal and state investigations related to its off-label marketing of Zyprexa for several years already. The company is also facing Medicaid fraud charges in lawsuits all over the county.
In 1996, Zyprexa was approved for the treatment of adults with schizophrenia, and a few years later, it was approved for short-term treatment of adults with manic episodes associated with bipolar disorder.
Yet despite these extremely limited approved uses, Zyprexa went on to become the top selling antipsychotic worldwide with an estimated 20 million people having used the drug and Lilly's best-selling product, with $4.2 billion in sales in 2005, which translates into 30% of its total revenues.
The documents provided to Times, span a decade and clearly show that the company promoted off-label the sale of Zyprexa for uses not approved by the FDA as being safe and effective. They also reveal that Lilly knew about Zyprexa's link to drastic weight gain and diabetes for years but failed to inform prescribing doctors and consumers.
In fact according to the Times, Lilly knowingly distributed false information to doctors about the risks as late as 2001. On December 21, 2006, the Times reported that the information provided to doctors about the blood-sugar risks of Zyprexa did not match data circulated inside the company after a review of Lilly's clinical trials.
The Times quotes a Lilly report from November, 1999, that shows that after examining 70 clinical trials, Lilly found that 16% of patients taking Zyprexa for a year had gained over 66 pounds. But instead of making these findings public, the company used data from a smaller group of trials that showed roughly 30% of Zypexa patients gained 22 pounds.
Mr Gottstein is not involved in the case in which the judge issued a protective order In re: Zyprexa Products Liability litigation, MDL No. 1596, United States District Court, Eastern District of New York (MDL 1596), "in any manner whatsoever," he says.
He is the leader of, "The Law Project for Psychiatric Rights (PsychRights), a public interest law firm devoted to the defense of people facing forced psychiatric drugging against their will.
Currently, Mr Gottstein represents an Alaskan patient and says the injunction will prevent him from using the Lilly documents to show that the side effects of Zyprexa are well-established by the company's own clinical trials and therefore, his client should not be forced to take such drugs against his will.
In Myers v Alaska Psychiatric Institute, 138 P.3d 238 (Alaska 2006), a case argued by Mr Gottstein last summer, the Alaska Supreme Court ruled that Alaska's forced drugging procedures were unconstitutional because they did not require the court to find such drugging to be in the person's best interests, and that there were no less restrictive
In order to present the evidence in the case he is handling now, Mr Gottstein is looking to the Alaskan courts to issue a ruling that says his client's right to avoid forced drugging outweighs Lilly's right to keep the information about risks hidden.
He says the documents are highly relevant to a court inquiry, now required in Alaska, before a court can make an informed decision about whether to order forced drugging for his client.
In a December 17, 2006, letter to the court in the New York case, Mr Gottstein stated: "In large part, this state of affairs has been created by the lies told by the manufacturers of psychiatric drugs."
"My impression is," he wrote, "that Eli Lilly's lies about Zyprexa form the basis of the plaintiffs' claims in MDL 1596, but that is not PsychRights' focus."
"PsychRights' focus," he explained, "is helping people avoid being forcibly drugged pursuant to court orders, where the courts have been, in my view, duped by Eli Lilly and other pharmaceutical company prevarications."
"In my view," Mr Gottstein concluded, "the proper disposition of the question would be in favor of my client's right to inform the court of the extreme harm caused by Zyprexa, which Eli Lilly has successfully hidden for so long, while making its billions off the pill."
A court hearing was held in Brooklyn, New York, on a December 18, 2006, on a motion by Lilly, asking the court to order Mr Gottstein to the return the documents to the court, and to bar him from disseminating them any further.
According to the transcript, Lilly also asked the court to require Mr Gottstein to "preserve all emails and all correspondence of any kind, whether it's voice mail, written letters, emails, so that we can pursue a contempt proceeding against both he and Dr Egilman."
Even though the Lilly documents prove that the company knew that Zyprexa was causing diabetes, and kept pushing the drug anyways, potentially harming millions more patients, the judges gave Mr Gottstein hell and threatened to find him in contempt for doing nothing more than warning the public about the side effects of Zyprexa after Lilly concealed the information for a decade.
There is not one single word in the transcripts about Lilly knowingly injuring and killing people with Zyprexa or illegally pushing the drug to unwitting victims for off-label use.
Instead, Judge Brian Cogan, granted Lilly's motion, and told Mr Gottstein's attorney that his client, "deliberately aided and abetted Dr Egilman in getting these documents released from the restriction that they were under, under the protective order. He knew what he was doing, and he did it deliberately."
Judge Cogan went on to tell the attorney, "your client should be on notice that of this moment, he is under a mandatory injunction to return those documents ... to take them down from any websites that he may have posted them on, and to take any reasonable effort to recover them from any sites or persons to which he has delivered them."
On December 18, 2006, at an earlier telephone conference in Brooklyn, <STRONG><FONT size=5>Judge Roane Mann </FONT></STRONG>also did not utter one word about Lilly's illegal conduct, but instead admonished Mr Gottstein for not playing fair with poor Eli Lilly in making the information about Zyprexa public, stating:
"I personally am not in a position to order you to return the documents. I can't make you return them <STRONG>but I can make you wish you had</STRONG> because I think this is highly improper not only to have obtained the documents on short notice without Lilly being advised of the amendment but then to disseminate them publicly before it could be litigated. It certainly smacks as bad faith."
These judges apparently believe that an expert, such as Dr David Egilman, who is hired to review documents in a case and subsequently learns that people are being seriously injured and killed, should be forced to keep that knowledge a secret if a judge issues a protective order.
There is something very wrong with this picture. It begs the question of how can an ethical doctor not speak if he knows that patients are being harmed
The reason always cited for the need to keep documents under seal is the claim that the information contains trade secrets. However, just as Lilly has done here, drug companies have for too long been abusing the process by using protective orders to hide illegal conduct by concealing documents that show the company is illegally promoting the off-label use of a drug or that a drug can cause serious injuries or that a drug does not work.
In a case like this, if a court truly does not have a choice and is required to seal documents even when they show blatant illegal conduct on the part of a drug company, then Congress had better get busy and pass a law to stop the use the US court system to protect what could very easily be described as corporate murder.
In response to an earlier article on this issue, reader Larry Bone wrote and asked this author, "Is the corruption on this so widespread that no one would dare prosecute?"
"<STRONG><FONT size=5>It is criminal behavior," he points out, "on a huge scale that is being virtually totally ignored by the authorities responsible for the public safety</FONT></STRONG>."
"I just feel," Mr Bone wrote, "that there has to be an attorney or someone in a judicial or ethical capacity who would have the guts, and persistence to prosecute Lilly."
"It seems incredibly ridiculous," he states, "let alone obscene, that such blatant wrongdoing seemingly continues to be ignored by the legal authorities with jurisdiction over these sorts of cases."
"If these companies believe they have done nothing wrong," he says, "then let them prove their innocence in court."
Ellen Liversridge also wants a criminal investigation of Lilly. She lost her 30-year-old son, Rob, to the adverse effects of the drug. "He gained almost 100 pounds while taking Zyprexa," Ellen says.
"Rob lapsed into a coma," she recalls, "and died of profound hyperglycemia four days later on October 5, 2002."
"I believe that the people who did this should have a criminal trial," Ellen says. "Enron executives went to prison for wiping out people's life savings," she points out.
"Lilly executives should go to prison," she says, "for knowingly being responsible for people's deaths, shattered families; ruined and grieving families."
Ellen has nothing but praise for the New York Times and its source. "I am grateful to Jim Gottstein for making available this awful truth and hope it results in justice being done."
"If there can ever be justice for a crime as heinous as this," she adds.
Daniel Haszard, of Bangor Maine, feels the same way. In 1996, he was prescribed Zyprexa off-label to supposedly treat Post Traumatic Stress Disorder, and he remained on the drug for 4 years.
Although he paid $250 a month for the drug, Mr Haszard says the drug did not relieve his symptoms of PTSD at all and in early 2000, he was diagnosed with diabetes.
He was shocked to hear the diagnosis, he said, because there was no history of diabetes in his family. Just as thousands of other Zyprexa victims, Mr Haszard did not make the connection between his diabetes and the drug until he saw a commercial for a law firm in December 2005.
Zyprexa causes diabetes, he says, and public health programs are left to pick up the tab for the medial expenses. According to Mr Haszard, "there are now 7 states going after Lilly for fraud and restitution," related to the promotion of Zyprexa for off-label use and the concealment of its risks.
Dr Stefan Kruszewski, MD, a Harvard trained, certified psychiatrist in adult, adolescent, and geriatric psychiatry, from Harrisburg, Pennsylvania, also finds Lilly's conduct appalling.
"Neither health professionals nor consumers," he states, "can accurately provide information about the risk and benefits of a drug like Zyprexa - or any drug for any condition - without a comprehensive awareness of the risks and benefits."
"If the clinical research data regarding effectiveness, efficacy or safety is sequestered or misrepresented from observation studies, randomized drug trials or meta-analyses," he says, "then it is not possible for any provider to give any patient what he or she needs to make an informed consent."
"At that point," Dr Kruszewski says, "individuals receive drugs that may or may not help them, but always at their own peril."
"<STRONG>Zyprexa causes both a severe metabolic syndrome consisting of obesity, diabetes and cardiovascular problems," Dr Kruszewski advises, "at the same time that it continues to cause neurological side-effects like the older antipsychotics</STRONG>."
"Zyprexa and its antipsychotics cousins," he explains, "were marketed to be safer and easier to tolerate because the pharmaceutical companies said that the newer drugs caused fewer neurological injuries, like restlessness or 'akathesia,' and tardive dyskinesia."
Those assertions are false he says, and "what we have now is a drug whose massive revenues and promotion are based upon faulty disclosures by Eli Lilly."
Information for injured parties can be found at Lawyers and Settlements.com http://www.lawyersandsettlements.com/
Lets all Sing Along with Judge Mann...
<IMG alt=hush_a_bye_baby.gif src="http://www.network54.com/Realm/peageepi ... e_baby.gif">
Hush-a-bye Lilly in the tree top
If the wind blows the profits will rock.
If the bow breaks the profits will fall
And down will come Lilly, profits and all
<EM><STRONG>And we can't have that!</STRONG></EM>
Lilly still screams "I don't think its fair!
Judge Mann sits near in his rocking chair.
Forward and back the data he swings
And though Lilly's guilty, he hears money sing.
From the high courtroom "justice" is seen
'Lilly you're free to corrupt and to scheme!
Hush my sweet Lilly, I'll make it alright.
Now stop that crying and sleep through the night'.
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<STRONG><FONT size=5>Disparity Emerges in Lilly Data on Schizophrenia Drug </FONT></STRONG>
For at least a year, <A title="Eli Lilly" href="http://www.nytimes.com/mem/MWredirect.html?MW=http://custom.marketwatch.com/custom/nyt-com/html-companyprofile.asp&symb=LLY">Eli Lilly</A> provided information to doctors about the blood-sugar risks of its drug Zyprexa that did not match data that the company circulated internally when it first reviewed its clinical trial results, according to company documents.
<STRONG>The original results showed that patients on Zyprexa, Lillys pill for </STRONG><A title="Recent and archival health news about schizophrenia." href="http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/schizophrenia/index.html?inline=nyt-classifier"><STRONG>schizophrenia</STRONG></A><STRONG>, were 3.5 times as likely to experience high blood sugar levels as those taking a placebo, according to a February 2000 memo sent to top Lilly scientists</STRONG>. The memo is one of hundreds of internal Lilly documents provided to The New York Times by a lawyer in Alaska who represents mentally ill patients.
<STRONG>But the results that Lilly eventually provided to doctors until at least late 2001 were very different. </STRONG>Those results indicated that patients taking Zyprexa were only slightly more likely to suffer high blood sugar as those taking a placebo, or an inactive pill.
Another Lilly report, from November 1999, shows that Lilly found after examining 70 clinical trials that 16 percent of patients taking Zyprexa for a year gained more than 66 pounds.
The company did not publicly disclose that figure, instead focusing on data from a smaller group of clinical trials that showed about 30 percent of patients gained 22 pounds.
Weight gain and high blood sugar are important risk factors for <A title="Recent and archival health news about diabetes." href="http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/diabetes/index.html?inline=nyt-classifier">diabetes</A>, and the question of whether Zyprexa causes diabetes has been a subject of scientific debate for several years.
Lilly says no link has ever been proven.
In response to questions about the difference between its first view of the data and its subsequent public description, Lilly issued a statement yesterday saying that the later figures were accurate and the information in February 2000 was out of context.
In yesterdays statement, the company said that after the February 2000 memo, it re-examined its clinical trial results and found errors in its final, standard quality check of the data.
But the February 2000 document, which is labeled Confidential, does not indicate that the figures it contains are preliminary. In fact, in a footnote, it explains that the data exclude patients from whom there was a probable lab error.
A separate document from November 1999 includes handwritten figures identical to those from the February document, with additional detail about the increases in blood sugar that patients suffered.
The revised figures were shared with the <A title="More articles about the U.S. Food And Drug Administration." href="http://topics.nytimes.com/top/reference/timestopics/organizations/f/food_and_drug_administration/index.html?inline=nyt-org">Food and Drug Administration</A>, Lilly said. It did not say whether it had ever disclosed the initial data to the F.D.A.
The F.D.A. did not respond to requests for comment yesterday.
The 2000 memo indicates that it was prepared as Lilly considered changing Zyprexas prescription label to provide doctors with more information about the drugs potential to raise blood-sugar levels.
The issue was crucially important to the sales prospects of Zyprexa, which was introduced in 1996. Psychiatrists were already increasingly aware by 2000 that Zyprexa caused severe weight gain in many patients.
In 1999, we already were thinking this drug causes weight gain thats clear and there could be a lot of other metabolic consequences of that, Dr. David N. Osser, a psychiatry professor at <A title="More articles about Harvard University." href="http://topics.nytimes.com/top/reference/timestopics/organizations/h/harvard_university/index.html?inline=nyt-org">Harvard University</A>, said yesterday. The weight gain itself is a known risk factor for diabetes.
The February 2000 memo was prepared as background for a meeting of Lilly scientists to the possible changes for Zyprexas label.
According to the memo, Lilly scientists initially wanted to propose a relatively straightforward statement on the label that high blood sugar had been observed in patients taking Zyprexa in clinical trials. That change was never made.
Lillys analysis in early 2000 came at a time when some doctors and regulatory agencies were beginning to question whether Zyprexa could cause increases in blood sugar or diabetes. Although Lilly says that no link between Zyprexa and diabetes has ever been proven, <STRONG>the American Diabetes Association found in 2004 that Zyprexa was more likely to cause diabetes than other, similar drugs. </STRONG>
Zyprexa is by far Lillys best-selling product, with $4.2 billion in sales in 2005, which represented 30 percent of Lillys overall revenue. Zyprexas active ingredient is a potent chemical that binds to receptors in the brain to reduce the hallucinations and delusions associated with schizophrenia and acute <A title="Recent and archival health news about bipolar disorder." href="http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/bipolardisorder/index.html?inline=nyt-classifier">bipolar disorder</A>. About two million people worldwide took Zyprexa last year.
At the February 2000 meeting for which the memo was prepared, the agenda was to discuss Zyprexas tendency to cause high blood sugar, which is medically known as hyperglycemia.
<STRONG><FONT size=4>According to the memo, Lilly had reviewed data from its clinical trials and found that the incidence of treatment-emergent hyperglycemia in olanzapine group (3.6%) was higher than that in the placebo group (1.05%). Olanzapine is the generic name for Zyprexa. </FONT></STRONG>
But when Lilly subsequently discussed the clinical trial results with doctors, it used a different comparison. <STRONG><FONT size=4>Lilly told doctors that Zyprexa had caused 3.1 percent of patients not 3.6 percent to have high-blood sugar. And it said that 2.5 percent of patients on the placebo not 1.05 percent had high-blood sugar. As a result, the rates of high blood sugar in the two groups seemed almost identical in the revised data..."</FONT></STRONG>
<FONT size=4><STRONG>For a lot more on Eli Lilly's zyprexa saga </STRONG>and to view documentation, visit Jim Gottstein's site here:</FONT>
<P align=center><FONT face=Arial size=6>P</FONT><A style="TEXT-DECORATION: none" href="http://psychrights.org/default.htm" target=_top><FONT face=Arial color=#000000 size=6>sych</FONT><FONT face=Arial color=#993300 size=6>Rights</FONT><FONT face=Arial color=#993300 size=4>®</FONT><FONT face=Arial color=#993300 size=7>
</FONT><FONT face=Arial color=#993300><FONT size=2> Law Project for
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"...The Law Project for Psychiatric Rights, a non-profit, tax exempt 501(c)(3) organization, has a mission to bring fairness and reason into the administration of legal aspects of the mental health system, particularly unwarranted court ordered psychiatric drugging and electroshock. The public mental health system is creating a huge class of chronic mental patients through forcing them to take ineffective, yet extremely harmful drugs. The purpose of the Law Project for Psychiatric rights is to promote and implement a strategic legal campaign in support of psychiatric rights and against unwarranted court ordered psychiatric medication akin to what Thurgood Marshall and the NAACP mounted in the 40's and 50's on behalf of African American civil rights. Help us prevent unwarranted forced drugging with a secure on-line tax-deductible donation.
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<P align=center><FONT size=5>Featured/Timely Items:</FONT>
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<P align=center><FONT size=6><STRONG>The Zyprexa Documents Case is Described Here</STRONG></FONT>
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