NPR: On The Air, But Not In The Open
The latest saga of an undisclosed connection between experts and pharma comes to us courtesy of Slate. This is how a new piece begins: “A few weeks ago, devoted listeners of National Public Radio were treated to an episode of the award-winning radio series The Infinite Mind called “Prozac Nation: Revisited.”
The segment featured four experts discussing the controversial link between antidepressants and suicide. In their considered opinions, all four said that worries about the drugs have been overblown, Slate writes. The radio show, which was broadcast nationwide and paid for in part by the John D. and Catherine T. MacArthur Foundation, was hosted by Fred Goodwin, a former director of the National Institute of Mental Health.
But Slate writes that he never revealed to listeners that all four experts, including himself, have financial ties to drugmakers that sell antidepressants. Also unmentioned: “unrestricted” grants the show has received from drugmakers, including Lilly, which sells Prozac and Cymbalta. The mag goes on to write that it remains unclear how much funding was provided or when the show last received any funding, since neither Goodwin nor the show’s producers responded to repeated requests for interviews. We have left our own message for Bob Lichtenstein, whose company produces the show.
What are the connections? Goodwin is on the board of directors of Center for Medicine in the Public Interest, an industry-funded group that receives a majority of its funding from drugmakers. CMPI prez Peter Pitts was one of Goodwin’s three guests for “Prozac Nation.” Slate asked him to identify the companies that fund his group, but he told the mag, “I don’t want to go into that.”
However, Slate writes that CMPI took in more than $1.4 million in 2006 and, according to its tax forms, spent $210,000 to influence the media through a large conference, a blog the group maintains, op-eds published in major newspapers, and multimedia programs and podcasts. Pitts, by the way, is also senior vp for global health affairs at Manning Selvage & Lee, which reps Lilly, Pfizer, Glaxo and others, although Slate writes that, on the show, Pitts was identified only by his title as “a former FDA official.” Pitts tells Slate that he doesn’t know why his ties to industry weren’t revealed on the show.
The second guest on “Prozac Nation,” Andrew Leuchter, is a professor of psychiatry at UCLA who has received research money from drugmakers, including Lilly, Pfizer, and Novartis. The third guest, Nada Stotland, president-elect of the American Psychiatric Association, has served on the speakers’ bureaus of Glaxo and Pfizer. Their ties weren’t revealed to listeners. Instead, each was introduced as a prominent academic.
Slate did learn one thing - the mag reports that Lichtenstein Creative Media was dissolved by the state of Massachusetts on March 28 for failing to file annual reports since its establishment in 2004.
Lisa Van S
Peter Pitts, Have you no shame!!… Does anyone have the DSMIV diagnosis for habitual Lieing.
Dan
There are several doctors, mainly, who take a different stance on meds and the pharma industry. Where are they when interviewed by mass media? There are at least a dozen, and they are authors who have researched such topics.
NPR has just simply attempted to narrow the minds of its receivers. Don’t be one of them.
University Update - UCLA - NPR: On The Air, But Not In The Open
[...] State University NPR: On The Air, But Not In The Open » This Summary is from an article posted at Pharmalot » News, Comment and Conversation on Tuesday, [...]
Justice in Michigan
Mon dieu. Peter Pitts is to “former FDA official” what Robespierre is to “former French guy.”
Not false. Just a little … minimalist.
Peter Pitts
I think it’s important to point out that I spoke with one of the “journalists” who wrote the story in Slate for quite some time on the actual issue of the media’s coverage of the SSRI debate. None of that made the article. I think it’s also worth noting that at least on the the authors has, er, issues with accuracy. Google both names and check out the article in the New York Times. A robust debate on the SSRI issue is very important. Trying to stifle debate by personal attacks just shows a lack of intellectual rigor — and cowardice.
Peter Pitts
I think it’s important to point out that I spoke with one of the “journalists” who wrote the story in Slate for quite some time on the actual issue of the media’s coverage of the SSRI debate. None of that made the article. I think it’s also worth noting that at least one the the authors has, er, issues with accuracy. Google both names and check out the article in the New York Times. A robust debate on the SSRI issue is very important. Trying to stifle debate by personal attacks just shows a lack of intellectual rigor — and cowardice.
Ed Silverman
Hi Peter,
Can you be more specific?
Thanks,
ed
pg
Personal Attacks - a Few Examples?
http://drugwonks.com/blog/kooksrus
http://drugwonks.com/blog/david-graham-public-health-enemy
http://drugwonks.com/blog/dr-stupak-on-ssris-and-suicide
http://drugwonks.com/blog/fearmongering-on-ssris-as-a-pr-tool
Lisa Van S
Peter,
A robust debate on the SSRI issue is very important. Trying to stifle debate by personal attacks just shows a”lack of Intellectual Rigor,… and cowardice”.
Wow look who is calling the kettle black. How about the personal attack you and your fellow colleagues at FDA lodged upon a dead child. You had no problem with attacking a dead child who no longer had a voice, a child who no longer lives to defend himself. That was “Cowardice”,.. maybe you should practice what you preach!!
Im guessing you never took the time to read this letter that was addressed to you inn February 2004.
http://baumhedlundlaw.com/media/ssri/paxil/fdahearing/tierneyletter.htm
Lisa Van S
Ed,
Peter doesnt know how to be more sspecific,.. clearly his comments to slate lacked substance,… or maybe even truth.
pg
Lisa, have you got another link to it?
Lisa Van S
pg,
I dont,.. please google Jennifer Tierney fda. I dont know why the link isnt working
pg
Lisa, thanks for the search keywords hat tip which brought up a slightly different link to the letter you referred to in your comment to Peter Pitts above.
Now I understand better just what you were getting at and noticed in the third paragraph of the letter how “conclusions” were considered “biased” if they were for presenting the case for risks, but ‘unbiased’ if they were in agreement of how SSRIs were safe and effective for children - which meant no chance of a robust debate I guess.
The link: http://www.baumhedlundlaw.com/media/ssri/paxil/FDAHearing/TierneyLetter.htm
Peter Pitts
I challenge the authors of the article to give Ed a copy of my taped interview. And I give Ed my permission to use it.
Lisa Van S
Peter,
We are all ears,…
Your former position at FDA has Educated you quite well. You know darn well, that, the authors have no intention of sharing their work product with another reporter!! It was a nice try anyway. You could always put out a written rebutal,. But again the safety of antidepressants in children was never a concern of yours, its just another child hanging themselves,.. right!
Peter Pitts
They taped it. Let them share it.
Lisa Van S
Peter,
How Juvenile!!…
Eskimo
Mr. Pitts, looking at all those posts on drugwonks.com, I couldn’t tell who was making the personal attacks, the “kooks” and the “document stealers” or the site’s authors who label them that way.
pg
That 3rd paragraph re Peter P apparently believing that only people who say that SSRIs are “safe” and “beneficial” to children - but anyone who brings up the other side, the risks, are “biased” in a way reminds me of this old drugwonks piece of work
“February 01, 2006
Freedom of Speech? Sure. But Only If You Agree With Me
By Peter Pitts”
which at the moment is at http://web.archive.org/web/20060202140553/http://drugwonks.com
Peter Pitts
The New York Times
January 17, 2005
Dispute Puts a Medical Journal Under Fire
By BARRY MEIER
Last year was an especially bad one for the pharmaceutical industry, which experienced controversies over how drug studies are disclosed and the implosion of the painkiller Vioxx. Now, as a result of the recent publication of an article about the antidepressant Prozac, it appears that the staid, usually methodical world of medical journals could suffer its own black eye.
On New Year’s Day, the British medical journal BMJ published a news article suggesting that “missing” documents from a decade-old lawsuit indicated that Eli Lilly & Company, the maker of Prozac, had minimized data about the drug’s risks of causing suicidal or violent behavior.
Within days, the article was cited in hundreds of television and newspaper reports. An outraged Washington lawmaker demanded to know if Lilly had hidden the information from the Food and Drug Administration. While company officials refuted the article’s assertions, it was still repeatedly cited. And last Thursday, Lilly spent about $800,000 to run full-page advertisements in 15 major publications to dispute the article.
The incident may prove to be a messy one for the BMJ, which is based in London and owned by the British Medical Association, a professional group. Much of the journal, formerly known as the British Medical Journal, is devoted to research reports about medical issues that are reviewed by experts. But the BMJ, like some other medical journals, also has a separate news section that prints articles like the recent one about Prozac. As it turns out, some of the Eli Lilly documents, which the BMJ said it received from an anonymous source, have been circulating for years. And, Lilly officials said, the BMJ and its reporter declined to provide the company with copies of the documents at issue prior to the article’s publication.
The American freelance reporter who wrote the article, Jeanne Lenzer, declined to be interviewed, referring all questions to the BMJ. Officials there did not respond to written questions, but a spokeswoman, Emma Dickinson, said in an e-mail message on Friday that the publication “takes this issue very seriously” and will address Lilly’s concerns after reviewing them.
The BMJ, which is considered a leading medical journal, may have little choice. While Lilly has not taken legal action, its lawyers have notified the publication that the company considers the article to be “inaccurate and defamatory,” asserting that the records were not missing and that all their relevant data had been previously submitted to the F.D.A. Also, Lilly issued an analysis last week of the 52 pages of records that the BMJ had received, which the company said supported its claims. Lilly said it got the documents from a congressman who received them from the BMJ.
“You put something out on the newswire with the imprimatur of a medical journal and people think it is fact,” said Dr. Alan Brier, the chief medical officer of Eli Lilly, which is based in Indianapolis.
The article’s appearance follows the recent controversy over whether drug makers adequately disclosed the risks that antidepressants like Prozac posed to pediatric patients. And its comes as a South Carolina teenager faces trial for murder as an adult on charges that he killed his grandparents when he was 12. The teenager, Christopher Pittman, has acknowledged the crime, but his lawyers have based his defense on the argument that he became violent after taking the drug Zoloft, an antidepressant similar to Prozac.
It was in a little-noticed article written by Ms. Lenzer in the Dec. 11 issue of the BMJ about the Pittman case that she first mentioned that the publication had received “a set of documents that mysteriously went missing from a U.S. mass murder case ten years ago.”
That article did not go into specifics. But in her article on Jan. 1, Ms. Lenzer wrote that the documents in question were connected to a Prozac-related lawsuit that grew out of a shooting rampage in 1989 by a Kentucky man, Joseph Wesbecker, that left nine people dead, including Mr. Wesbecker.
Lawyers representing the victims sued Lilly, asserting that Mr. Wesbecker’s killing spree was caused by Prozac, a drug he had been prescribed just before the crimes. During the 1994 trial of the case, Lilly pointed to Mr. Wesbecker’s long history of severe psychological problems and said that Prozac was safe.
To combat those assertions, plaintiffs’ lawyers introduced hundreds of Lilly documents. They argued that the records showed that Lilly had fully disclosed to the F.D.A. in the late 1980’s the potential of Prozac to produce suicidal thinking or acts of violence, including all the reviews by drug regulators in Germany of the issue at that time. Lilly disputed that.
The jury found in favor of Lilly. But a legal controversy over the trial later erupted when it was revealed that plaintiff lawyers and Lilly lawyers had reached an undisclosed financial deal just before the case went to the jury to effectively settle by agreeing not to appeal the verdict.
A Lilly spokesman, Phil Belt, said that Ms. Lenzer, who lives in Kingston, N.Y., first contacted the company on Dec. 13, a few days after her article about the Pittman case appeared.
Mr. Belt said Ms. Lenzer asked where a published report about the data in a specific 1988 internal Lilly report had appeared. At that time, she also requested an interview with the company’s chief executive, Sidney Taurel, to discuss what she described as “missing” Lilly documents, Mr. Belt said.
Mr. Belt said the company told Ms. Lenzer that Lilly needed to see the records at issue before it proceeded. He added that Ms. Lenzer later told Lilly that she could not do so, saying that the source of the documents was anonymous.
As the Christmas and New Year’s season approached, Mr. Belt said that Ms. Lenzer told Lilly officials that they could pick up the issue after the holidays.
At some point in December, however, Ms. Lenzer or her editors apparently sent the documents it had received to Congressman Maurice Hinchey, Democrat of New York, and to the F.D.A. And a few days before New Year’s, the BMJ distributed Ms. Lenzer’s article to other news organizations with the provision they could not write about it until its publication date on Jan. 1 - a practice known as an “embargo.”
That article carried the headline, “FDA to Review ‘Missing’ Drug Company Documents,” which caught the attention of other news organizations. Mr. Belt said that when Lilly became aware of the embargoed news release, it tried to reach editors at BMJ but was unsuccessful. Both Ms. Lenzer and the BMJ did not respond to written questions about the publication’s interactions with Lilly, including why the documents were not shown to the drug maker.
The only Lilly document specifically mentioned in the BMJ article was a 1988 report that stated that 38 percent of depressed patients taking Prozac during clinical trials experienced side effects like agitation, insomnia and nervousness, a rate twice that of those taking a placebo.
Such side effects, which are sometimes referred to as “activation,” reflect the fact that some depressed patients who take Prozac and drugs like it often experience a surge of physical energy well ahead of psychological recovery. Some experts have long expressed concerns that such reactions can be so severe in a few patients that they may ultimately act on suicidal or violent impulses.
For procedural reasons, the 1988 Lilly memo itself was not introduced as evidence in the Wesbecker case, said Nancy Zettler, one of the two plaintiffs’ lawyers involved. But Ms. Zettler said that one of her expert witnesses, Dr. Peter Breggin, testified extensively about its contents at that trial.
Ms. Zettler said that she was so perplexed by the BMJ article that she contacted Ms. Lenzer after it appeared. “Her original article made it seem like we had deep-sixed some of this stuff and I was curious,” she said.
Both Ms. Zettler and Paul Smith, the other plaintiffs’ lawyer in the Wesbecker case, said that Ms. Lenzer did not contact them prior to the article to talk about the records or ask for others from that case.
Another plaintiffs’ lawyer who has used Lilly documents in other lawsuits, Arnold Vickery, also said he did not discuss the records with Ms. Lenzer prior to her report. Mr. Vickery and another lawyer are representing Christopher Pittman.
Dr. Breggin has written articles arguing against the use of Prozac and other drugs and has mentioned the 1988 Lilly memo in his writings; he is scheduled to be an expert witness in the Pittman case.
Several pages sent to the BMJ were not produced by Lilly but are photocopies of slides produced by an F.D.A. official who presented them at a 1991 public hearing that reviewed the possible suicide risks of Prozac. After its review, that agency panel decided not to issue any additional warnings.
Ms. Zettler said she still thinks the issue of what Lilly told the F.D.A. in the mid-1980’s about Prozac’s potential risks is unsettled. But after more than 15 years of the drug’s use, numerous lawsuits and public reviews, it may also be largely moot.
As a result of the recent controversy about the potential suicide risks posed by antidepressants to children and teenagers, the F.D.A. last week sent out final new labeling language about those dangers to all makers of such drugs, including Lilly.
A spokeswoman for the agency, which is still reviewing the records sent to BMJ, said that it had not yet found anything new in them. Ms. Dickinson, the publication’s spokeswoman, said that it was reviewing Lilly’s rebuttal to its article.
pg
Peter P, are you saying that the early 2005 news piece you posted above more or less summarises the topic of the tape as in you comment “They taped it, let them share it” ?
Justice in Michigan
I’m also lost. Is some or all of the below not true?
“Goodwin is on the board of directors of Center for Medicine in the Public Interest, an industry-funded group that receives a majority of its funding from drugmakers. CMPI prez Peter Pitts was one of Goodwin’s three guests for “Prozac Nation.” Slate asked him to identify the companies that fund his group, but he told the mag, “I don’t want to go into that.”
However, Slate writes that CMPI took in more than $1.4 million in 2006 and, according to its tax forms, spent $210,000 to influence the media through a large conference, a blog the group maintains, op-eds published in major newspapers, and multimedia programs and podcasts. Pitts, by the way, is also senior vp for global health affairs at Manning Selvage & Lee, which reps Lilly, Pfizer, Glaxo and others, although Slate writes that, on the show, Pitts was identified only by his title as “a former FDA official.” Pitts tells Slate that he doesn’t know why his ties to industry weren’t revealed on the show.”
pg
Regarding Peter P’s post with article of 17th Jan 2005 - it didn’t finish there and this is an extract from 10 days later:
Eli Lilly Prozac Documents: What do They Reveal?
“Thu, 27 Jan 2005
A report in the BMJ (formerly the British Medical Journal) that relied on internal Eli Lilly documents to challenge Lilly’s claims about the safety of Prozac has stirred a prickly hornet’s nest. [1] The documents show, among other things, that a 1988 review of clinical trials found that 38% of patients taking Prozac compared to 19% of patients on placebo experienced “activation,” which is linked by the FDA in current labeling to violent and suicidal behavior. [2] [PZ-477] .
Lilly took out a full page advertisement (”An open letter to patients and doctors” signed by Lilly CEO, Sidney Taurel) in 15 newspapers nationwide stating: “it was simply wrong to suggest that information on Prozac was missing, or that important research data on the benefits and possible side effects of the drug were not available to doctors and regulators.” [3] The BMJ has just issued a correction and an apology to Eli Lilly for suggesting that documents went “missing” stating: “all the documents supplied to the BMJ were either Eli Lilly documents or were in the hands of Eli Lilly [and] had in fact been disclosed during the suit.” [4]
The Associated Press reports that BMJ editor, Kamran Abbasi, said the apology was limited to the issue of whether the documents were missing from the court case. “Whether or not Eli Lilly made all of the information available to the FDA at the appropriate times is a question for the FDA to answer…. we await their response.” Morry Smulevitz, a spokesman for Lilly, said the company also awaited the FDA’s finding. [5]
Inasmuch as the documents’ authenticity is not in dispute, and the information about the hazardous drug effects contained in the documents (stamped “confidential) is of vital importance to public health - we will focus on their content rather than be diverted by who said what to whom. The documents reveal that as early as 1984 - years before the FDA approved the drug - Lilly knew or should have known that Prozac frequently induced severe adverse side effects, including “activation” and suicidality [6]:
“…frequency of side effects was very high (partly more than 90%) and side effects resulted nearly in each study in drop outs. The frequency of side effects depended on the dose, the age, and the duration of treatment… the clinical significance of side effects is not only the frequency of their occurrence but also their severity.…”
Its a bit long to post it all, a lot there and these has been a lot more since.
pg
Peter P, it seems you chose to leave out the “correction” at the end of the article you posted which link is at:
http://www.nytimes.com/2005/01/17/business/media/17journal.html?_r=1&pagewanted=2&oref=slogin
The CORRECTION, at the end of the article (page 2) is:
“Correction: January 19, 2005, Wednesday:
An article in Business Day on Monday about the fallout over a medical journal report on a 1994 Prozac-related lawsuit involving Eli Lilly & Company omitted a word in describing the plaintiffs’ position, reversing the meaning. The sentence should have read, “They argued that the records showed that Lilly had NOT fully disclosed to the F.D.A. in the late 1980’s the potential of Prozac to produce suicidal thinking or acts of violence.”
That correction may well defend ‘your’ argument re that date - or not, I haven’t taken it all in, but whichever it works it would be good to see the ‘whole’ thing, along with the link so that we can all check, don’t you think?
Jane
http://drugwonks.com/blog/slime-alot_slime_a_little__then_ignore_the_real_issue/ Someone is mad Ed!
Lisa Van S
Jane,
Peter Chooses not to defend himself,… Why?.. Guilty conscience maybe?…
He knows that antidepressants induce Homicidal/Suicidal thinking and gestures in the Pediatric population,..He’s just not man enough to admit it,..
Peter J. Pitts
“BMJ 2005;330:211 (29 January), doi:10.1136/bmj.330.7485.211-a
Correction and apology, Lenzer, BMJ 330 (7481) 7
Correction and apology
Eli Lilly: Correction and apology
An article by Jeanne Lenzer in our 1 January issue (BMJ 2005;330:7) reported that the US Food and Drug Administration was to review confidential Eli Lilly documents that had been sent to the BMJ by an anonymous source.
The article stated that these documents had gone “missing” during a 1994 product liability suit filed against Eli Lilly.
That statement has been the subject of a detailed investigation conducted by the BMJ following a complaint by Eli Lilly. That investigation has revealed that all of the documents supplied to the BMJ that were either Eli Lilly documents or were in the hands of Eli Lilly had in fact been disclosed during the suit.
At the end of the trial, all the documents were preserved by Court Order or were disclosed by Eli Lilly to the plaintiffs’ lawyers in related Prozac claims.
The BMJ did not intend to suggest that Eli Lilly caused these documents to go missing. As a result of the investigation, it is clear that these documents did not go missing. The BMJ accepts that Eli Lilly acted properly in relation to the disclosure of these documents in these claims. The BMJ is happy to set the record straight and to apologise to Eli Lilly for this statement, which we now retract, but which we published in good faith.
The same article described Dr Peter Breggin as “the medical witness for the Wesbecker case.” He was, in fact, the expert witness for the plaintiffs.”
pg
http://bmj.bmjjournals.com/cgi/eletters/330/7485/211-a#95276
“Arguments about which group of lawyers or experts saw or did not see the files in question are nothing more than distractions from the more important question. Of much more importance to physicians is: Why did Eli Lilly not share this data with the general medical community?“
pg
Points 14 and 17 regarding a Lilly ‘defender’ in the FDA HERE might help answer the question directly above.
pg
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00892.html
April 21, 2003
“We’re fortunate to have Peter [Pitts] on our team,” said Dr. McClellan. “He’s a seasoned, innovative, and strategic communicator. Effective communication is essential in fulfilling FDA’s mission of protecting and promoting the public health.”
A LETTER was sent to Peter Pitts in 2004 but I can’t find a reply as yet.
The only ’seasoned, innovative and strategic’ references to the author of the polite and well informed letter so far appear to be by way of personal attacks such as
http://drugwonks.com/blog/what-s-really-depressing/
“…Where will Healy, David Graham and the rest go to wash the blood off their hands? And will the FDA do the right thing and stop handing black boxes out to protect themselves from Senator Grassley and the press?”
pg
On ‘blaming’ suicide rate on the use of antipsychotics as purported in http://drugwonks.com/blog/what-s-really-depressing - if that is correct then it could be based on evidence:
MAY 2008 pub. On the rise of antipsychotic use in children
“…CONCLUSIONS. The overall prevalence of antipsychotics almost doubled [in the UK] between 1992 and 2005; however, the rate of increase was much lower than the reported figures in the United States. The prescribing of atypical antipsychotic drugs has increased despite the lack of conclusive evidence showing their superiority over older conventional antipsychotics. Additional investigation is required to evaluate their efficacy and safety in children and adolescents.”
On suicidality and the antipsychotic Zyprexa:
“…What’s more, the rate of completed suicides linked to Zyprexa is higher than any other drug in its class, according to clinical trial data supplied to the US Food and Drug Administration (FDA) by Eli Lilly itself. The data revealed that out of 2500 patients taking Zyprexa, there were 12 completed suicides as compared with none with patients on placebo.
What isn’t known is the number, from clinical trial data, of suicides not completed. While no one would dispute that an unsuccessful suicide is a merciful preservation of a human life, the context of someone driven to suicide and making the attempt is equally serious.
Beatriz E. Ebel vs. Eli Lilly & Company cites the latter as over-promoting Zyprexa, achieving tremendous success in so doing. Zyprexa accounts for a third of Eli Lilly’s revenue, and is easily the top-selling drug in its class.
However, such success often comes in a vacuum, and in this case it is alleged that Eli Lilly suppressed the most damming side effects relating to suicide. To this end Dr. David Healy, professor of Psychiatry at the University of North Wales, claims in a statement that Eli Lilly “suppressed data on suicidal acts on Zyprexa from these trials. The data are not available in the scientific literature, nor from FOI [Freedom of Information Act] requests to the FDA, nor from enquiries to the company.“
Lisa Van S
pg,
gotta, love ya…
Lisa Van S
pg,
Here in the U.S., the antipsychotics Seroquel and Abilify carry an FDA Black Box Warning of suicide/violence in the Pediatric Population.
pg
“Can we say Conflicts of Interest?”
(http://drugwonks.com/blog/what-s-really-depressing again)
Can we? Until drugwonks / ‘Center for Medicine in the Public Interest’ (mostly funded by drugmakers) starts to achieve its purported objective and work in the interests of the public where medicine is concerned, I think we can safely say YES.
pg
Hi Lisa, thanks for both comments. We crossed comments I think as I was putting the last comment on CMPI (above) together. I have to go offline now and will probably get back to take a look tomorrow. Hope you have a good day :)
Jane
drugwonks changed their article - it orginally was titled “Slime-alot, Slime a lttile then ignore the real issues” and threatened to sue Ed.
Hadamar Lager
Goodwin, what a charmer. Scroll down to “The Second Violence Inititative”:
http://www.breggin.com/racistfedpol.html
The Infinite Mind
The Infinite Mind responds to “Stealth Marketers.”
http://fray.slate.com/discuss/forums/thread/1237086.aspx?ArticleID=2190775
From Bill Lichtenstein
Senior Executive Producer, The Infinite Mind
In their May 6 Slate article, Jeanne Lenzer and Shannon Brownlee use The Infinite Mind’s recent program “Prozac Nation: Revisited” to frame an argument that pharmaceutical companies are planting “stealth marketers” inside seemingly objective media outlets to manipulate public opinion. The article suggests that as public radio producers we have allowed our guests on our national weekly program to hide financial links with pharmaceutical companies for the purpose of promoting the use of dangerous prescription drugs.
Ironically, “Prozac Nation: Revisited” was intended to examine the way the media has handled links between violent behavior, suicide and antidepressants. Our interest in the story began with press reports about Steven Kazmierczak, whose shooting rampage at Northern Illinois University left six dead and 16 wounded. We wanted to know: Why did the major news media uniformly target Steven’s withdrawal from an antidepressant as explanation for his violent act? Why did the media ignore any number of other factors, such as his gun collection, his work as a prison guard, or his troubled childhood? We were interested in exploring the reflexive public reaction that ends up making the medication the culprit, and so simplifies a disturbing violent act while stigmatizing the already vulnerable people who take or consider taking prescription medication for depression.
And at the core of the program, we asked the question we always ask, the question that has guided the past 10 years of The Infinite Mind: Where is the best science on this particular issue? In this case, does the science find links between antidepressant medications and out-of-control behavior?
To help us, we turned to recognized experts in the field. Framing the discussion, we began with Dr. Andrew Leuchter, director of UCLA’s Laboratory of Behavior and Pharmacology, who himself has conducted much of the important research in this area.
Next, we spoke with Dr. Nada Stotland, current president of the American Psychiatric Association and an expert in medical ethics. Dr. Stotland, another distinguished research scientist and clinician, spoke about the gap between public perception and the research about violence, suicide and psycho pharmaceutical medications.
Finally, we talked to Peter Pitts, a former associate commissioner for the Food and Drug Administration who was involved in the FDA’s 2004 “black box” labeling of antidepressants as carrying a risk of suicidal thoughts and behavior, and who was at the time the “go-to” guy for the FDA on that issue.
What we didn’t know, because he didn’t disclose it to us, was that Pitts is currently working for a public relations firm whose clients include major pharmaceutical companies. If we had known, and (full mea culpa here) we should have, we would have disclosed that connection. Pitts apparently didn’t disclose it elsewhere, either - he’s appeared on NPR’s Talk of the Nation as well as PBS’ News Hour with Jim Lehrer, without either of those programs mentioning the PR company ties.
In any case, to suggest that distinguished researchers such as Drs. Stotland and Leuchter are shills for the drug industry is bad journalism. Pharmaceutical companies fund the lion’s share of research being conducted today. There are strict ethical codes and laws governing the use of such funds. Journalists covering this industry know that, and routinely disclose only those ties that are likely to raise serious questions about a researcher’s neutrality. It would be patently ridiculous, for example, to presume that Dr. Stotland, speaking for all American psychiatrists as president of the APA, would somehow distort the truth because of some past connection to an industry speakers’ bureau.
It is important to state that we stand by the program and its editorial content. There is, as our guests observed, no credible evidence that the use of antidepressants contributes to the sort of violence that erupted at NIU. There is, on the other hand, a study by the Centers for Disease Control and Prevention suggesting that more young people may be dying in part because of the chilling effect of the FDA “black box” warning. While some will take issue with these studies, we believe they are important, that they deepen the public dialog, and that they’ve gotten lost in superficial media coverage of a complex issue.
So finally, let’s tackle the other question raised in the Slate article: Is it acceptable for a public radio program about the human mind to take grants from the pharmaceutical industry?
Back in 1994, I came face to face with that question. Preparing to produce a program about people living with schizophrenia, I met with Delano Lewis, who was at the time president of National Public Radio. I told Lewis that I had offers of unrestricted educational grants from several pharmaceutical companies who were interested in helping lift some of the stigma about this misunderstood and feared disease, but that I wasn’t sure whether it would be proper to accept the grants.
The conversation that we had helped set the ground rules that have governed our underwriting ever since. Lewis began by observing that in many cases, especially on difficult and unpopular subjects, it would be hard to find support from organizations without some kind of substantial interest in the subject matter. The important thing, he said, was to assure listeners and stations that there was an absolute firewall between funding sources and editorial decision-making.
With this in mind, 14 years ago, we created a system with the following rules: We would take no more than 15 percent of our total budget from any one industry sector. We would not take substantial amounts from any one company. Corporate support would have to come in the form of unrestricted “no strings attached” educational grants. Corporate funding would be mixed with support from other sources (in the case of The Infinite Mind, that’s been sources like the MacArthur Foundation, the National Institutes of Health and the National Science Foundation.) We would list underwriters on the air. Under no circumstance would producers ever have editorial discussions with any funder; and it’s probably important to note that in the case of the pharmaceutical industry, such conversations would be a violation of federal law as well as a violation of our own ethics as journalists. And, we would require employees to sign a code of conduct that requires disclosure of any potential conflict of interest and makes failure to disclose a fireable offense.
By the way, our 1994 program on schizophrenia, with substantial and disclosed support from the pharmaceutical industry, won a Peabody Award and was credited with changing the way Americans look at people with serious mental illness. Over the past 18 years, following these rules, our programming on the human mind has been honored with more than 60 awards for journalistic excellence and offering insight into issues that society would often prefer to ignore.
In the interest of full disclosure, I also should note for the record that Lenzer, who co-authored the Slate article, called me a few days after the “Prozac Nation: Revisited” program aired to pitch a program that she wanted us to do for The Infinite Mind, called “Journalists on Prozac,” which would feature her and her writing partner Shannon Brownlee. Checking into Lenzer’s credentials, I found a troubling article in The New York Times taking her to task for a British Medical Journal article that suggested that Eli Lilly and Company, which makes Prozac, had concealed documents about the link between anti-depressants, suicide and violence. The BMJ subsequently retracted the article, with full apologies, and the whole matter was widely covered in the news media.
After we told Jeanne Lenzer that we would not be proceeding with a program featuring her, she and Brownlee wrote the article for Slate.
pg
“Our interest in the story began with press reports about Steven Kazmierczak, whose shooting rampage at Northern Illinois University left six dead and 16 wounded. We wanted to know: Why did the major news media uniformly target Steven’s withdrawal from an antidepressant as explanation for his violent act?”
Really? Where did you find “major news media that uniformly targetted Steven’s withdrawal from antidepressants as an explantion for his violent act”?
If you google Steven Kazmierczak, I don’t think you’ll find the ‘majority’ of the media mentioned it at all. The ‘majority’ of the media seem very comfortable with not mentioning any involvement with anything to do with pharmaceutical companies - in any case where prescription drugs are involved.
In just about ANY homicide/suicide, it takes a lot of searching amongst news media to find ANY mention of drug involvement.
The “majority” of news media… do as they’re told.
pg
They ‘do as they’re told’ just like the majority of front groups such as that described by the “Infinite Mind” with its “substantial and disclosed support from the pharmaceutical industry”.
Seasoned, innovative and strategic moves all round, and thats drug makers, FDA and front groups - and there’s no loyalty amongst thieves (or pharma fronts) when drugs are at stake.
pg
Those ’seasoned, innovative and strategic moves’ are precisely now drug makers and their ‘key opinion leaders’ and ‘funded front groups’ make their money all round - isn’t that so Peter Pitts of Drug Wonks, certain members of the FDA and Infinite Mind?
pg
http://drugwonks.com/blog/slime-alot_slime_a_little__then_ignore_the_real_issue
“…We are aware that our critics don’t have the intellectual bandwidth or the maturity to actually engage on the issues or respectfully disagree or debate…”
Woah Mr Pitts. What a shame you sold YOUR intellectual bandwidth (and your integrity) out to the pharmaceutical industry.
HorusCat
“Activation” is not synonymous with homicidal/suicidal/violent behavior. Attempts to conflate the latter with the former are egregiously misleading.
pg
What rubbish Horus. Completed suicides in clinical trials
(see further up: The data revealed that out of 2500 patients taking Zyprexa, there were 12 completed suicides as compared with none with patients on placebo)
are NOT attempts to mislead. The ‘misleading’ is done by people like Pitts who clearly attack those who bring these issues to attention.
Will you next be saying that these files on a different risk are attempts to mislead?
http://www.furiousseasons.com/zyprexadocs.html
pg
I’ll rephrase that. The documents ARE attempts to mislead, attempts by Eli Lilly to mislead physicians and ultimately their patients, but the exposure of those documents are not.
HorusCat
You haven’t rebutted my point. Activation is not the equivalent of violent behavior. Psychiatrists define activation very broadly, including negatively-connotated terms such as restlessness, insomnia and anxiety AND positively-connotated words such as energized, brightened up, brought out of lethargy. For a sluggish, couch-bound depressive, activation can be a good thing. For an already hypomanic bipolar, it is a bad thing.
Suicide is suicide; to argue that every individual “activated” by a medication is suicidal is horse-hockey and dilutes your argument.
HorusCat
pg,
Full disclosure: your blurb about Zyprexa and suicide was found on a trial lawyer’s website.
Akathisia is ALSO not activation. Akathisia is a much more strictly defined term, denoting physical restlessness to the point of being almost non-stop. An activated person will say he feels restless and anxious. An akathetic person literally will be unable to remain seated. There is a gradient in between, of course, and a careful physician asks many questions and observes a patient closely.
pg
Horus, you are TRYING to dilute or shift the argument. If you read the links above perhaps you could follow what is being said.
Or are you intentionally defending conflicts of interest and corruption?
pg
Personally, I wouldn’t in any want to be seen to be in Peter Pitts corner. Goodnight.
pg
should read: I wouldn’t in any way want to be seen to be in Peter Pitts corner…
Do you defend corruption Horus?
pg
Horus, lawyers have some purpose here, they get to SEE the evidence often.
I think you’ll find that the other links are NOT to lawyer sites.
pg
And yes, I do give the links - there was no ‘non disclosure’ on my part - the link you chose to criticise clearly lead you to a lawyers site!
Once again Horus - are you defending corruption?
HorusCat
pg,
You do intend to mislead–knowing that most won’t follow your links, you present your information as though it were an article in a reputable newspaper, not an enticement to contact an attorney “published” on a trial lawyers’ website.
Here are the data from the trials, in clear contradistinction to your “facts” and “links.” BTW, this comes from the plaintiffs’ attorneys in the Alaska case–where lawyers get to SEE the evidence:
Completed Suicides – HGAJ
for Olanzapine subjects: 9/2500 = 0.4%
for Placebo subjects: 1/236 = 0.4%
for Haldol subjects: 1/810 = 0.1%
Suicide: Olanzapine 12 (of 3139 subjects)
Information about suicide attempts is presented only for the HGAJ trial (page 47):
Suicide attempts - HGAJ
Olanzapine 3.4%
Placebo 4.0 %
These results were not found to be statistically significant.
1) suicide / suicide attempts:
Olanzapine does not appear to be any more or less effective than placebo in terms of completed suicide. Olanzapine may be associated with a higher rate of suicide than older neuroleptics.
So, where do your trial lawyers get their information? If the Alaska plaintiffs’ attorneys couldn’t posit a causative relationship between olanzapine and suicide, how are you doing so? The trial lawyers’ site you link clearly lies. There were obviously completed suicides in the placebo arms of the trials.
There’s corruption for you, pg. Trial attorneys exploiting patients’ pain to fill their coffers. The law firms get rich while any successful plaintiff gets nearly zip, zero, zilch, nada. Are you an attorney, pg? How can you sleep with yourself? Are you defending corruption? Are you defending people who would scare the severely mentally ill and their caregivers away from useful medications…thus actually leading to MORE suicide, since untreated schizophrenics are often successful suicides.
Lilly does not claim that olanzapine is suicide-preventive. Only Clozarel can make that claim among the antipsychotics. But you are patently mistaken in asserting that the use of olanzapine is associated with suicide and suicidal behavior.
I am no fan of Zyprexa and would vigorously admonish anyone in my family against using it when there are alternatives. However, I paid $250 for a complete list of the adverse events reported post-marketing with Zyprexa in 2002. I read every single page, and there were scores of pages. Suicide was not a signal.
Once again, pg, my suspicions about your motivation point me to the Scientology cabal…
pg
Horus, are you - as you appear to be- posting in defense of corruption? The issues are actually clear, the corruption involved is also perfectly clear. The FDA have the data on the suicidal acts (or haven’t you read it through?).
Unlike you and Peter Pitts, I leave LINKS so that YOU and others can follow them to read article around the extract I leave and can so confirm that I have not altered an extract.
For instance, further above again I didn’t even leave an extract, I simply referred to “points 14 and 17″ in a link.
Surely anyone with any intelligence (or perhaps integrity) would realize that you NEED to go the links to see what I referred to rather than trying to discredit anyone who does leave a link.
Obviously this is not the case with you, so for your assistance I’ll leave copy over the whole lot, rather than just point to 14 and 17 which is regards to Prozac I believe and does indeed come from the lawyer’s site who recorded the documentation. The point numbers do not copy over, but you’ll be able to find the number and which lawyer recorded these by finding the post referring to points 14 and 17 somewhere above:
“Below is the time-line presented to the jury in the Forsyth v. Eli Lilly Trial. It was presented during closing arguments by the plaintiffs. It lists Lilly’s internal documents. The plaintiffs allege that it shows that Lilly knew about Prozac-induced suicidality and violence (even before Prozac was approved for marketing in the United States) and that this was withheld from the public.
Aug. 1978 - Team Meeting Minutes - “There have been a fairly large number of reports of adverse reactions . . . Another depressed patient developed psychosis . . . Akathisia and restlessness were reported in some patients.” Exhibit 30 (2nd page, end of 2nd paragraph)
May 1984 - BGA Comments - “During the treatment with the preparation (Prozac) 16 suicide attempts were made, 2 of these with success. As patients with a risk of suicide were excluded from the studies, it is probable that this high proportion can be attributed to an action of the preparation (Prozac) . . .” Exhibit 42 (page 3, 6th paragraph)
Jan. 1985 - Lilly receives reasons why the BGA will reject Lilly registration, one of which was because of “SUICIDAL RISK.” With instructions for “IMMEDIATE FOLLOW-UP ON ALL KEY OPINION LEADERS ON THE BGA COMMISSION FOR SELECTED VISITATION NEXT WEEK.” Exhibit 53
March 29, 1985 - “Benefit/Risk Considerations” - “The incidence rate (suicide) under fluoxetine (Prozac) therefore purely mathematically is 5.6 times higher than under the other active medication imipramine.” . . . “The benefits vs. risks considerations for fluoxetine (Prozac) currently does not fall clearly in favor of the benefits. Therefore, it is of the greatest importance that it be determined whether there is a particular subgroup of patients who respond better to fluoxetine (Prozac) than to imipramine, so that the higher incidence of suicide attempts may be tolerable.” Exhibit 58 (pages 18 & 22)
June 1986 - Draft of Proposed PRECAUTIONS and ADVERSE REACTIONS Sections of the Prozac Package Insert - “Mania and psychosis may be precipitated in susceptible patients by antidepressant therapy.” Exhibit 5 (1st page) (never included in actual inserts)
Aug. 1989 - Additional Feedback Regarding the Fluoxetine (Prozac) Review by the Commission A (Germany) - “3. The counterindication because of acute suicidality should become a warning whereby the physicians should be advised that in the absence of sedation, the risk of higher suicidality should be taken into account.” Exhibit 88
Nov. 17, 1989 - Letter to sales representatives on article about Prozac-induced akathisia authored by Dr. Lipinski and others. “In the article the authors voice their suspicion that ‘the triad of symptoms’ (anxiety, nervousness, and insomnia) reflects the syndrome of akathisia, ‘which, in their view is apparently related to fluoxetine (Prozac) therapy.” But the sales people are warned: “Use of this information in product discussions may violate federal law.” Exhibit 91 (1st page, 2nd paragraph and 2nd page, last sentence)
Jan. 1990 - PROZAC and SELF-DIRECTED VIOLENCE - “We have just received a pre-print of an article (not a letter to ed.) Which we understand is to appear in the February 1990 AMERICAN JOURNAL OF PSYCHIATRY suggesting that Prozac can induce severe, intense, obsessional suicidal ideation.” . . .” Exhibit 94
Jan. 30, 1990 - Letter to sales representatives giving the sales people a “heads-up” on the forthcoming Teicher article regarding Prozac and Suicide and instructing them as follows: “Because these issues (suicide) are not part of our current marketing plan, you should not initiate discussions on these articles. … “Again, because these issues are not part of our current marketing plan, discussions should not be initiated by you.” Exhibit 15 (bottom of second page)
Feb 1990 - Teicher article published “Emergence of Intense Suicidal Preoccupation During Fluoxetine (PROZAC) Treatment” - “The purpose of this report is to suggest the surprising possibility that fluoxetine (Prozac) may induce suicidal ideation in some patients.” . . . “In our experience, this side effect has occurred in 3.5% of patients receiving fluoxetine (Prozac) . . .” Exhibit 95
February 7, 1990 - Leigh Thompson Memo - “Anything that happens in the UK (England) can threaten this drug (Prozac) in the US and worldwide. We are now expending enormous efforts fending off attacks because of (1) relationship to murder and (2) inducing suicidal ideation.” Exhibit 97
February 7, 1990 - Leigh Thompson Memo - “I am concerned about reports I get re UK attitude toward Prozac safety. Leber (FDA) suggested a few minute ago we using CSM database to compare Prozac aggression and suicidal ideation with other antidepressants in UK. Although he is a fan of Prozac and believes a lot of this is garbage, he is clearly a political creature and will have to respond to pressures. I hope Patrick realizes that Lilly can go down the tubes if we lose Prozac and just one event in the UK can cost us that.” Exhibit 98
June 1990 - Letter to Lilly by concerned doctor - “I am writing to inform Eli Lilly Company that a disturbing number of suicides or suicide attempts associated with Prozac has come to my attention over the last several months.” I am concerned that the association with Prozac may be more than coincidental.” . . . “There appears to be growing concern that Prozac may somehow trigger a suicidal preoccupation in a small subset of patients and that their families should be warned of this potential risk. It is certainly possible that some of the cases reported are “coincidence” in that the depressed person may have attempted suicide independently of Prozac. However, some of these cases appear to be in patients taking Prozac for reasons other than depression.” Exhibit 102 (2nd page)
July 18, 1990 - Memo regarding call from Paul Leber at the FDA. “Paul Leber called yesterday; I contacted him at 6:15 am this morning and half-hour conversation, very, very pleasant . . .” “The call was about suicide.” . . . “He asked that we FAX nothing to him unless he has agreed before hand.” “Paul (Leber) is taking a position in talking with outside folks today that Lilly and FDA working together on the suicide issue and following closely the postmarketing events, but that there are no denominators and the best that can be done is to put a ‘cap’ on the number of events.” Exhibit 104 (top of 1st page and bottom of 2nd page)
August 3, 1990 - Letter to sales representatives regarding reports of suicidal ideation/behavior possibly associated with PROZAC therapy. “This information is not intended to replace our current promotional strategy but is being provided to enable you to respond to physicians when appropriate. You should not initiate discussion on these issues nor use this letter in detailing. However, if asked to comment on these issues by a health care professional, you should: 1. Reassure the health care professional that no casual relationship has been established between suicidal ideation and PROZAC therapy.” Exhibit 17 (bottom of 1st page and top of 2nd page)
August 31, 1990 - “Dear Doctor” letter assuring them that there is no “causal relationship between Prozac and suicidality (ideation or acts).” Exhibit 22
September 12, 1990 - Lilly memo between Max Talbot and Leigh Thompson- Talbot says “One possible strategy if FDA presses for an additional labeling change vis-a-vis suicide is a class-wide (i.e. ALL antidepressants) cautionary note; however we should take this position only as a last resort.” Thompson replies: “that report MUST move swiftly through approval and to Dr. Leber’s (FDA) hands - - he is our defender.” Exhibit 109
September 14, 1990 - Lilly memo between John Heiligenstein (Lilly) and Leigh Thompson - Heiligenstein says: “We feel caution should be exercised in a statement that “suicidality and hostile acts in patients taking Prozac reflect the patient’s disorder and not a causal relationship to Prozac - - - - Postmarketing reports are increasingly fuzzy and we have assigned ‘Yes, reasonably related’ on several reports.”. . . “You may want to note that trials were not intended to address issue of suicidality.” Exhibit 110
September 25, 1990 - Minutes of Lilly Meeting with FDA - discuss doing an in-hospital rechallenge of patients who met predefined criteria for suicidal acts and ideation and agrees to “analyze international data relating to suicide.” Exhibit 112
October 2, 1990 - Memo to Lilly employee Leigh Thompson to Lilly employee Robert Zerbe regarding an upcoming Prozac symposium in which the issue of suicidality is discussed. “Then the question is what to do with the ‘big’ numbers on suicidality. If the report numbers are shown next to those for nausea, they seem small.” Exhibit 113 (2nd page.)
November 7, 1990 - Leigh Thompson memo - “I’d suggest that priorities are: (1) protect Prozac” . . . Exhibit 116
November 13, 1990 - Memo from Claude Bouchy (Lilly Germany) to Leigh Thompson Re: Adverse Drug Event Reporting - Suicide Fluoxetine - In response to Lilly’s request that he (Bouchy) change the event “suicidal ideation” to “depression,” Bouchy writes: “Hans (another Lilly employee in Germany) has medical problems with these directions and I have great concerns about it. I do not think I could explain to the BGA, a judge, to a reporter or even to my family why we would do this especially on the sensitive issue of suicide and suicidal ideation.” Exhibit 117
November 14, 1990 - Second memo from Claude Bouchy (Lilly Germany) to Leigh Thompson Re: Adverse Drug Event Reporting - Suicide Fluoxetine in which he states: “I personally wonder whether we are really helping the credibility of an excellent ADE system by calling overdose what a physician reports as suicide attempt and by calling depression what a physician is reporting as suicide ideation.” Exhibit 118
April 15, 1991 - Memo to Leigh Thompson called “Upcoming TV appearance” Section I. “MESSAGE GOALS - Whatever questions you are asked or direction the interview take, the three points we want to establish are: 2. ‘It’s in the disease, not the drug.’; Section III ‘If pressed, or as a postscript to the above, then make the point that absolutely no evidence indicates that PROZAC as a cause of such behavior (violence and suicide).’, and ‘Prozac defense . . . There is simply no medical or scientific merit to the argument.” Exhibit 123
April 23, 1991 - Leigh Thompson Memo re 20/20 Show in which he admits that on the issue of suicidality “I did NOT share the European data AT ALL.” and “She attacked on us hiding data by dividing up reports by many COSTART terms. She had numbers for suicide, overdose, intentional overdose, unintentional overdose and said they came to 1200 (or 1400) total suicides - - so we went around on OD not necessarily being suicide and COSTART, etc.” Exhibit 124 (bottom of 1st page and 4th paragraph of 2nd page)
May 15, 1991 - FDA Meeting to Discuss Fluoxetine Rechallenge Protocol - “we agreed to have the rechallenge protocol ready to go by September 1, 1991 Exhibit 125
August 1991 - Dr. David Healy’s Article “Antidepressant Induced Suicidal Ideation” - “These two cases suggest that the emergence of suicidal ideation on antidepressants cannot always be attributed to a lifting of psychomotor retardation but rather that the ideas may in some instances be produced by antidepressants.” Exhibit 126
October 29, 1991 - Lilly prepared draft for Dr. Beasley entitled “Suggested Reply Points to Oswald, Healy & Creaney” in which he acknowledges that item 3 of the HAMD is an insensitive measure of suicidality and states:”There was no specific rating scale for akathisia included in the trial designs for the studies reported, so the only source of data would be adverse event reports. Akathisia is a subjective phenomenon and hence would rely on patients volunteering information.” Exhibit 130 (2nd page)
December 1991 - Dr. Rothschild’s Article “Re-exposure to Fluoxetine After Serious Suicide Attempts by Three Patients: The Role of Akathisia” - “This is the first report, to our knowledge, of patients restarted on fluoxetine (Prozac) after a previous suicide attempt during fluoxetine treatment.” . . .”When re-exposed to fluoxetine, the patients again developed akathisia and suicidal ideation. The suicidal feelings abated when the akathisia was treated by the discontinuation of the fluoxetine (Prozac) or the addition of propranolol.” Exhibit 131 (Cross-examination)
January 23, 1992 - Lilly memo regarding upcoming meeting with Taiwanese doctors (Drs. Lu and Ko) to discuss the report on their study results entitled “suicidal attempts and fluoxetine (Prozac) treatment.” Exhibit 133
April 8, 1992 - Weinstein (Lilly employee) Report - “Mission Accomplished. Professor Lu will not present or publish his fluoxetine (Prozac) vs. maprotiline suicidality data.” Exhibit 144
March 3, 1993 - Forsyth’s deaths
1994 - Dr. David Healy’s Article “The Fluoxetine and Suicide Controversy” - Dr. Healy concludes: “In the opinion of this author, the volume of case reports and other studies is sufficient to demonstrate that antidepressants and antipsychotics may induce suicidal ideation in certain individuals under certain conditions.” Exhibit 153
1995 - Dr. Jick’s Study “Antidepressants and Suicide” - “The results indicate that only fluoxetine (Prozac) has a rate that seems to be substantially higher than that of the other antidepressants.” Exhibit 155
June 1998 - Dr. Roger Lane’s article “SSRI-Induced Extrapyramidal Side-Effects and Akathisia; Implications for Treatment” appears in the Journal of Psychopharmacology. “SSRI-induced akathisia is a relatively rare but is frequently unrecognized when it does occur.” . . . “The precise definition of akathisia is a matter of controversy, as is the relative importance of the objective and subjective aspects of the disorder. Is akathisia a movement disorder or an intense and uncomfortable mental state . . .” “It may be less of a question of patients experiencing fluoxetine (Prozac)-induced suicidal ideation, than patients feeling that ‘death is a welcome result’ when the acutely discomforting symptoms of akathisia are experienced on top of already distressing disorders.”
I hope that helps you Horus to understand what exactly it is that you appear to be defending.
Goodnight.
pg
Horus, your mention of “scientology” is ridiculous. I don’t even KNOW one personally! But what it does do, is show you use ridiculous strategies to discredit others. There are decent people all over the world (though you may not be aware of it) of all beliefs and faiths that do not appreciate corruption, particularly when it affects the lives of others. Scientologists are but one small part of those people and I am NOT a scientologist. Shame on you for using that very old tactic! I thought at least you were brighter than that.
Insider
Found a nice photo of Peter Pitts!
pg
Insider. Lovely photo :-)
pg
Zyprexa. ‘…in all of these scientific publications you aren’t able to find the fact that this is the drug with the highest suicide rate in clinical trial history…’
From an article October 2005, Columbia.
http://www.ahrp.org/COI/HealyColumbia1005/index.php
“…So this all leads us to this next point, which is data on completed suicides and suicidal acts in the trials of antipsychotics sent in to FDA for registration purposes. Now remember, people like me and like all of you in this audience I think if asked to review the evidence on Risperdal compared with the older drugs would have come to the same conclusion that we should be using Risperdal first. But if you remember FDA didn’t come to that conclusion. The difference is that the published articles aren’t showing the same thing as FDA has been seeing. What the FDA has been seeing, which isn’t in any of the published articles, are figures of this sort here which are the completed suicides and suicidal acts on Risperdal and Zyprexa (28). ”
28 links to a slide of trial suicide rates at http://www.ahrp.org/COI/HealyColumbia1005/Slide28.jpg
“If you look at the Zyprexa suicide figures, these come from 2500 people who were in 5 clinical trials. You repeatedly hear that one of the problems we’ve all got is that the pharmaceutical companies hide trials. Well far from hiding these trials, these 5 clinical trials have given rise, when I checked last, to 234 different publications, of which 41 are major publications. These trials haven’t been hidden. There are 8 articles or abstracts per trial. But in all of these scientific publications you aren’t able to find the fact that this is the drug with the highest suicide rate in clinical trial history. You aren’t able to find either from any of the articles that have been published or from the FDAs reviews of the drug how many people went on to suicidal acts. And, given that these figures suggest Zyprexa has the highest suicide rate in clinical trial history, you would have to think from the fact even FDA aren’t prepared to show what the figure of suicidal acts is that it may be rather high…”
pg
Note from the slide (in comment above) that completed suicides are 12 in 2500 participants, not 9 in 2500 as posted by Horus.
pg
Horus said: “Are you defending people who would scare the severely mentally ill and their caregivers away from useful medications…thus actually leading to MORE suicide, since untreated schizophrenics are often successful suicides.”
Actually that does not appear to be so.
Comparison of Suicide Rates in Treated Schizophrenia Patients Found 20-Fold Increase
“Wednesday, 01 March 2006
An analysis published in the current issue of the British J of Psychiatry (BJP) of the suicide rate among schizophrenia patients treated at the same hospital in North Wales (UK) before psychotropic drugs and patients treated (in and out of hospital) with neuroleptics and /or atypical antipsychotics, found a 20-fold increase in the suicide rate since use of psychotropic drugs…”
“…In an invited accompanying commentary, Dr. Trevor Turner, Consultant Psychiatrist and Clinical Director, Department of Psychiatry, of a university hospital in London, writes: “If their figures are carefully boiled down, they show that in the course of 5 years the historical cohort had 1 suicide in 594 individuals, whereas the present-day cohort had 7 suicides in 133 individuals.” Thus, patients treated with the latest antipsychotic drugs had a 20-fold increased risk of suicide compared to those treated without drugs in Victorian times.
These startling findings are certain to stir much controversy because they challenge a key mental health treatment goal — suicide prevention — which is also offered as the prime justification for mental screening in U.S. schools. These findings also challenge the widely cited 10% lifetime risk of suicide among schizophrenia patients…”
pg
Having difficulty with the link at the moment, but cached works:
http://216.239.59.104/search?q=cache:2ZidMnvN0NQJ:www.ahrp.org/cms/content/view/88/28/+antipsychotics+rise+in+suicide+rates&hl=en&ct=clnk&cd=4&gl=uk
pg
“Increased Risk of Suicide From Psychotropic Drugs
Clinical Psychiatry News online reports (below) that an independent analysis of the suicide rate in psychotropic drug trials– for drugs approved by the FDA between 1985-2000– found that the NEW DRUGS did NOT REDUCE the risk of suicide–they INCREASED the risk…”
http://www.namiscc.org/Research/2002/AntipsychoticSuicideRisk.htm
At a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health, Dr. Arif Khan raised serious concerns about the apparent link to suicide of the new psychotropic drugs: “‘We have to ask if medication is the only way’ to approach the prevention of suicide?” Dr. Kahn analyzed the data on suicide rates for more than 71,604 patients who were treated in clinical trials. He noted that despite the fact that in most clinical trials patients who are actively suicidal are excluded–the suicide rates in those trials are exceedingly high:
752 per 100,000 persons for those treated with atypical antipsychotics–risperidone, olanzapine, and quetiapine;
718 per 100,000 persons for those treated with all the selective serotonin reuptake inhibitors;
425 suicides for those treated for “social anxiety disorder” with nefazodone, mirtazapine, and bupropion;
136 suicides for those treated for panic disroder–with benzodiazepine alprazolam;
105 suicides for those treated for obesessive-compulsive disorder with anticonvulsant valproate.
[The suicide rate of persons in the population at large is 11 per 100,000 per year.]
pg
In conclusion, Peter Pitts’ attacks, such as the one on the late Loren Mosher for instance, appear to be finance driven and as misleading as personal attacks can get. No wonder the FDA are under criticism as to their ability to protect the public when they hire such morally dishonest individuals.
http://drugwonks.com/blog/kooksrus
“This kookery is being pushed by a group called the Alliance for Human Research Protection which was formed by Loren Mosher who believed that schizophrenia and other mental illnesses could be treated without any medication.”
It would seem from the evidence available, that Loren Mosher - and others who come under the ’strategic’ scrutiny of people like Peter Pitts - are working for the public interest, ie, working to save lives.
CMPI. Its a front group funded mostly by drug makers. It would be most aptly stand for ‘Center for Medicines in my Personal/pharmaceutical Interest’.
HorusCat
pg,
1. Dr. Healey presents no footnotes for his data. Where do they come from?
2. Dr. Healey’s analogy of the loaded gun is flawed. He implies that the placebo cohort has a completely unloaded gun. In fact, the placebo “gun” also contains bullets. The point of a statistical analysis is to determine which gun contains more bullets and if the difference is statistically significant. From there, the medical community must decide if the statistical difference is CLINICALLY significant. If the suicide rate is 0.4% and it is doubled to 0.8%, a physician would probably conclude that the difference is NOT clinically significant, but Dr. Healey would claim that a drug “doubled” the suicide rate.
3. Comparing the suicide rate of a cohort from the 1800s to a cohort from today is disingenuous. Social conditions and taboos have changed greatly. Other factors aren’t taken into consideration: family support, community support, hospitalization likelihood, etc. With the advent of the psychotropics came also the “patients’ rights” groups who argued vehemently for “least restrictive” conditions–meaning patients who had previously been hospitalized for lengthy periods of time (and therefore, far less likely to commit suicide) were set free in the community–often with little or no support. A schizophrenic homeless person getting a psychotropic in the 1990s is far more likely to commit suicide than a schizophrenic hospitalized person receiving no treatment (but probably spending a lot of time in restraints) in the 1890s.
4. The antipsychotics, except for clozapine, are not marketed for suicide prevention. Physicians don’t use them for that purpose. They use them to try to give the patients some semblance of a normal life and keep them out of the hospital. Every community mental health center that I have seen also offers–even requires–an array of ancillary services with social workers, nurses, group activities, clubhouses, ACT teams and therapists. All of this is designed to give the patient as much support as possible in the “least restrictive” environment.
5. Comparing the suicide rate of a schizophrenic or depressed/anxious population with the baseline suicide rate of a mixed population is an inappropriate comparison. Dr. Khan points out that suicide rates were higher in the placebo arms.
6. Citing volunteer studies of non-anxious persons receiving serotonergic drugs to inform our clinical use of serotonergic drugs needs to be interpreted under two caveats: a) volunteers receiving sertraline received a higher dose than what is typically used in the clinically anxious patient; b) serotonin is known to cause initial anxiety, resulting in anxiolytic activity after this initial anxiogenesis. Thus, patients would have to be monitored in the acute stage of treatment for anxiogenesis, with anxiolytic activity expected to follow after a longer course of treatment.
7. Dr. Healey’s citation of the CATIE trial is a red herring. The endpoint of that trial was suspect to clinicians. Patient adherence to medication regimes is not a clinical endpoint. Compliance is known to be the biggest hurdle clinicians face (in any population, not just the mentally ill). Psychiatrists have never thought the atypicals are more effective than the typicals (except for clozapine). They use the atypicals for reasons of tolerability (no drooling, more energy, no mental “fog”, so far, no tardive dyskinesia), not efficacy. Any doctor who has seen a $1 million verdict in a tardive dyskinesia trial is not likely to prefer the typicals over the atypicals, and the CATIE trial was not long enough to show any difference in TD rates.
My points are all mixed up up there, but I didn’t feel like going through and re-ordering and re-numbering.
Getting on the SSRIs is taking me off the subject–my initial observation was about olanzapine and suicide. Dr. Healey presents no citations to buttress his assertions about olanzapine.
As usual, your “data” come from those who agree with your position. You cannot produce original histories of patients or raw data from trials, only the interpretations of those who may have an axe to grind, such as Dr. Healey and organizations specifically formed to advocate against the use of psychotropic drugs. I am not necessarily saying his data are false–I just want to see sources and original documents, not his powerpoint presentation.
Once again, in contrast to Dr. Healey’s unsupported “evidence,” one need only look at the post-marketing experience with Zyprexa. If there were indeed a suicide signal, the competitors to this medication would have found it and trumpeted it. Believe me, selling against olanzapine used to be the most difficult challenge I faced. If patients had been commiting suicide willy-nilly, we would have been all over it. Like I pointed out, in my desperation I ordered the post-marketing AE reports on olanzapine. If suicide had been in there, I would have noticed. Instead, we had to point out that physicians were commiting slow homicide with metabolic risks.
Our treatment approach to the chronically mentally ill (schizophrenics)leaves much to be desired. They are a population with few advocates, treated by a specialty with a low reimbursement rate, misunderstood by the population at large (get those homeless people off the street!), with available resources getting scarcer all the time. As basic research progresses, it becomes clear that schizophrenia arises from multiple loci in the brain, with many neurotransmitters involved. It is a progressive disease, with medication success being far less likely as a patient moves through the disease state and organic function is lost forever. No clinician, researcher or pharmaceutical company believes that the current medication paradigm we have is even close to optimal. But the logical conclusion of what you assert seems to me to be that we should warehouse our chronically mentally ill, MAYBE using thorazine or haldol to sedate them, restraining them physically when they become agitated, and keeping them out of sight and out of mind.
pg
Cheers Horus, over to you and those blinding $ signs that somehow manage to cover your eyes as you present ‘information’.
HorusCat
Believing that schizophrenia, an provably organic disorder with a progressive course leading to brain atrophy and ventricular enlargement, should be lumped together with anxiety and depression (although pathogenic changes also occur with chronic mood disorders)and treated with “counseling” or “proper nutrition” is just idiotic.
HorusCat
pg,
Have you spent time in a community mental health center? I have. I have spent hours. These are people abandoned by the community, often abandoned by their families, struggling to live meaningful lives with some dignity and joy, fighting against a disease that robs them of emotion and motivation. The clinicians and others who serve them are, for the most part, truly caring and empathic people who have taken on a job most of us would shun. The pharmaceutical companies–made up of individuals who know first-hand the ravages of schizophrenia–seek medication options for these patients not just for profit, but for the satisfaction of doing something important and meaningful.
pg
Carry on Horus!
Once again:
“Increased Risk of Suicide From Psychotropic Drugs
Clinical Psychiatry News online reports (below) that an independent analysis of the suicide rate in psychotropic drug trials– for drugs approved by the FDA between 1985-2000– found that the NEW DRUGS did NOT REDUCE the risk of suicide–they INCREASED the risk…”
http://www.namiscc.org/Research/2002/AntipsychoticSuicideRisk.htm
At a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health, Dr. Arif Khan raised serious concerns about the apparent link to suicide of the new psychotropic drugs: “‘We have to ask if medication is the only way’ to approach the prevention of suicide?” Dr. Kahn analyzed the data on suicide rates for more than 71,604 patients who were treated in clinical trials. He noted that despite the fact that in most clinical trials patients who are actively suicidal are excluded–the suicide rates in those trials are exceedingly high:
752 per 100,000 persons for those treated with atypical antipsychotics–risperidone, olanzapine, and quetiapine;
718 per 100,000 persons for those treated with all the selective serotonin reuptake inhibitors;
425 suicides for those treated for “social anxiety disorder” with nefazodone, mirtazapine, and bupropion;
136 suicides for those treated for panic disroder–with benzodiazepine alprazolam;
105 suicides for those treated for obesessive-compulsive disorder with anticonvulsant valproate.
[The suicide rate of persons in the population at large is 11 per 100,000 per year.]
pg
Bye Horus. Do please keep going. It shows us all where you’re at.
HorusCat
pg,
Respond to my requests for actual raw data; don’t engage in ad hominem attacks. What are your credentials? How much time have you spent with those suffering from schizophrenia? How many times have you stopped outside the doors of a CMHC to chat with the smokers (who tell you that you are “lookin’ good today, sugar”)? How often have you been in state hospitals? How frequently do you visit the in-patient units or the psychiatric emergency rooms in urban hospitals? What resources do you provide the staff of the CMHCs to improve the lives of the chronically mentally ill? How many times has a physician told you that a patient who couldn’t leave his apartment has gone shopping with his ACT team (and the meager disability check provided by the state)?
You harangue and argue and hurl insults, but you provide no insight as to what you are doing to help those you would “protect.”
pg
Sorry Horus, you’re the pharma ‘expert’. I’m not. YOU do some REAL research for a change.
pg
Bye. Why not ‘email’ Peter Pitts, I’m sure he’ll help, you are clearly on the same side lol.
HorusCat
pg,
You also don’t respond to requests for more information. I asked for evidence or data from a source with no axe to grind. Instead, you refer me back to a website sponsored by a group that shares your biases.
I point out that the atypicals aren’t used for suicide prevention. You come back to suicide. I point out that comparing suicide rates from a mentally ill population to the at-large suicide of a relatively healthy population is like comparing malamutes to chihuahuas and you come back with the exact same citation.
You don’t advance the discussion; you merely repeat yourself, thinking that if you say the same thing over and over, it becomes more convincing.
I would hazard the guess that anyone who reads what I have to say versus what you have to say would fine more illumination and curiosity in my words than in yours, as others have pointed out in other discussions on this site. I am not getting rich from what I do. I don’t even sell an antipsychotic anymore. I am upfront about my motivation in doing my job–it is a source of income AND a source of intellectual and emotional satisfaction.
Share you motivation and activities, pg. Typing behind your curtain, you seem to me to be the Wizard of Oz.
HorusCat
pg,
Why this inability to actually converse? When I ask real questions and share my experience, you just insult me. You have no credibility when you do that. If you want to persuade me to see things your way, do more than just tell me to email Peter Pitts. Tell me what you have found that works better. Share your experience and insight into this population of people. I hear no compassion and empathy for the mentally ill in your words; I only hear venom and bitterness against the pharmaceutical industry.
pg
Before signing out, I need to add to this earlier comment - the additions will be in upper case:
“In conclusion, Peter Pitts’ attacks AND HORUS’ DEFENSE OF PETER PITTS, such as the one on the late Loren Mosher for instance, appear to be finance driven and as misleading as personal attacks can get. No wonder the FDA are under criticism as to their ability to protect the public when they hire such morally dishonest individuals.
http://drugwonks.com/blog/kooksrus
“This kookery is being pushed by a group called the Alliance for Human Research Protection which was formed by Loren Mosher who believed that schizophrenia and other mental illnesses could be treated without any medication.”
It would seem from the evidence available, that Loren Mosher - and others who come under the ’strategic’ scrutiny of people like Peter Pitts AND PHARMA REPS LIKE HORUS - are working for the public interest, ie, working to save lives.
CMPI. Its a front group funded mostly by drug makers. It would most aptly stand for ‘Center for Medicines in my Personal (PHARMACEUTICALLY FUNDED)Interest’.
Have a good weekend Horus! Don’t give up, its in your interest to keep it going. I don’t get paid ANYTHING for my effort by the way. In case you missed the point, as you do most things, I’m NOT a scientologist (or a lawyer, or anything else you’d like to smear me with either) as you tried to imply in an earlier post in that ‘pharmaceutically funded’ kind of way.
HorusCat
YOU do some REAL research for a change….
I would say spending 8 hours a day in community mental health centers, talking to inpatient docs, walking the halls of the state mental hospitals and actually talking to the chronically mentally ill and those who serve them qualifies as REAL research. You, on the other hand, apparently have nothing to offer but personal attacks.
pg
WIZARD OF OZ??
Get real Horus. I’m someone commenting in an attempt to help save … lots…of lives and, unlike you, I have no financial interest. I’m going offline. Do your best for damage limitation - your money depends on that.
HorusCat
pg,
Once again, you fail to engage, you just attack. I have not defended Peter Pitts. I have argued that the antipsychotics are helpful in the attempt to improve the lives of the chronically mentally ill. You have failed to refute my arguments. ??? I don’t know if you are a lawyer or a scientologist or the man in the moon; I just know that you seem unable to do anything but attack me.
pg,
Why don’t you engage me on a real and authentic level? You say that I shouldn’t stereotype you as a scientologist or lawyer, yet you engage in just such depersonalization. Your bitterness prevents you from acting like a human being. I just find that baffling.
pg
LOL, why should I engage someone with $$$ blinds on. Sorry Horus, I’ve put the facts, you don’t like them. Deal with it. I’m not playing your game ok? Tarraaa.
pg
In conclusion, Peter Pitts’ attacks, such as the one on the late Loren Mosher for instance, appear to be finance driven and as misleading as personal attacks can get. No wonder the FDA are under criticism as to their ability to protect the public when they hire such morally dishonest individuals.
http://drugwonks.com/blog/kooksrus
“This kookery is being pushed by a group called the Alliance for Human Research Protection which was formed by Loren Mosher who believed that schizophrenia and other mental illnesses could be treated without any medication.”
It would seem from the evidence available, that Loren Mosher - and others who come under the ’strategic’ scrutiny of people like Peter Pitts - are the ones working for the public interest, ie, working to save lives.
CMPI. Its a front group funded mostly by drug makers. It would … most aptly stand for ‘Center for Medicines in my Personal(pharmaceutically funded) Interest’.
pg
Drugwonks: “Center for Medicines in my Personal (pharmaceutically funded) Interest’
I hope this comes out with the intials in bold.
pg
On ‘biases’ and pharmaceutically funded definitions.
“Lisa, thanks for the search keywords hat tip which brought up a slightly different link to the letter you referred to in your comment to Peter Pitts above.
Now I understand better just what you were getting at and noticed in the third paragraph of the letter how “conclusions” were considered “biased” if they were for presenting the case for risks, but ‘unbiased’ if they were in agreement of how SSRIs were safe and effective for children - which meant no chance of a robust debate I guess.
The link: http://www.baumhedlundlaw.com/media/ssri/paxil/FDAHearing/TierneyLetter.htm “
Nathan
It’s nice to see the mainstream media be more rational about this suicide issue. I just saw an NBC news article a few days ago that was very balanced in its view. Clearly there are issues to investigate, but it’s nothing to panic about and nothing to think that the pharma industry is somehow “covering up” data. Here’s the link. Bravo NPR and bravo NBC.
http://www.msnbc.msn.com/id/24262690/
HorusCat
pg,
You present no “facts,” you just reiterate the s.o.s. Loren Mosher has been effectively countered by years of research on the most basic levels. You won’t “play games” with me because you CAN’T engage me on an intellectual level. All of your arguments and “data” are solipsistic. A says B, and B says A, so A must be true, because B is true because A says it is. Whew. Truly a powerhouse argument. Because you can’t actually debate a point, you throw around the $$ sign argument. Wow. That’s really a powerful, intellectually-honest, insightful response (end sarcasm). Tell you what–let’s go to pubmed and search “genetics and schizophrenia.” Link to the article and let’s discuss the pros and cons.
Oh, I read the excerpt about one of Mosher’s 16 year old patient’s urinating on herself and suckling at a Soteria House worker’s breast. Nice. Just what I want for my schizophrenic daughter.
pg
Interesting, Nathan.
You’ve just given us a very good example as to how the major news media work to perpetuate what drug makers want us to believe.
“The Infinite Mind” comment way up the board alleged:
“…We wanted to know: Why did the major news media uniformly target Steven’s withdrawal from an antidepressant as explanation for his violent act? Why did the media ignore any number of other factors, such as his gun collection, his work as a prison guard, or his troubled childhood?…”
AS IF the ‘major news media’ would take the risk of fighting against the pharmaceutical influence. Lol.
pg
HORUS: I am NOT playing your pharmaceutical game in which you have a financial interest. OK?
pg
Lets recap from further up the comments:
“Comparison of Suicide Rates in Treated Schizophrenia Patients Found 20-Fold Increase
“Wednesday, 01 March 2006
An analysis published in the current issue of the British J of Psychiatry (BJP) of the suicide rate among schizophrenia patients treated at the same hospital in North Wales (UK) before psychotropic drugs and patients treated (in and out of hospital) with neuroleptics and /or atypical antipsychotics, found a 20-fold increase in the suicide rate since use of psychotropic drugs…”
“…In an invited accompanying commentary, Dr. Trevor Turner, Consultant Psychiatrist and Clinical Director, Department of Psychiatry, of a university hospital in London, writes: “If their figures are carefully boiled down, they show that in the course of 5 years the historical cohort had 1 suicide in 594 individuals, whereas the present-day cohort had 7 suicides in 133 individuals.” Thus, patients treated with the latest antipsychotic drugs had a 20-fold increased risk of suicide compared to those treated without drugs in Victorian times.
These startling findings are certain to stir much controversy because they challenge a key mental health treatment goal — suicide prevention — which is also offered as the prime justification for mental screening in U.S. schools. These findings also challenge the widely cited 10% lifetime risk of suicide among schizophrenia patients…”
pg
More recapping. ZYPREXA - highest suicide rates in all clinical trials.
From an article October 2005, Columbia.
http://www.ahrp.org/COI/HealyColumbia1005/index.php
“Zyprexa. ‘…in all of these scientific publications you aren’t able to find the fact that this is the drug with the highest suicide rate in clinical trial history…’
“…So this all leads us to this next point, which is data on completed suicides and suicidal acts in the trials of antipsychotics sent in to FDA for registration purposes. Now remember, people like me and like all of you in this audience I think if asked to review the evidence on Risperdal compared with the older drugs would have come to the same conclusion that we should be using Risperdal first. But if you remember FDA didn’t come to that conclusion. The difference is that the published articles aren’t showing the same thing as FDA has been seeing. What the FDA has been seeing, which isn’t in any of the published articles, are figures of this sort here which are the completed suicides and suicidal acts on Risperdal and Zyprexa (28). ”
28 links to a slide of trial suicide rates at http://www.ahrp.org/COI/HealyColumbia1005/Slide28.jpg
“If you look at the Zyprexa suicide figures, these come from 2500 people who were in 5 clinical trials. You repeatedly hear that one of the problems we’ve all got is that the pharmaceutical companies hide trials. Well far from hiding these trials, these 5 clinical trials have given rise, when I checked last, to 234 different publications, of which 41 are major publications. These trials haven’t been hidden. There are 8 articles or abstracts per trial. But in all of these scientific publications you aren’t able to find the fact that this is the drug with the highest suicide rate in clinical trial history. You aren’t able to find either from any of the articles that have been published or from the FDAs reviews of the drug how many people went on to suicidal acts. And, given that these figures suggest Zyprexa has the highest suicide rate in clinical trial history, you would have to think from the fact even FDA aren’t prepared to show what the figure of suicidal acts is that it may be rather high…”