Evelyn Pringle May 2009
This week, journalist Philip Dawdy reported on the popular website Furious Seasons that Wyeth's Effexor me-too drug Pristiq, FDA approved in early 2008, had already generated 1,272 adverse event reports in the FDA's MedWatch system through the end of 2008, and wrote with live links to the reports:
"It's discouraging that 17 of those reports involve completed suicides through the end of 2008. There are also 48 reports of suicidal ideation through the end of 2008."
"That's a lot in such a short period of time, especially considering that this drug isn't exactly widely used," Dawdy points out.
The FDA's system reportedly captures only between 1% and ten percent of drug-induced adverse events.
The Adverse Psychiatric Drug Reaction website summarizes reports submitted to the FDA MedWatch system. For a two-year period between January 2004 and December 2006, the top 20 most commonly reported adverse events for Zoloft included 154 suicides and 162 suicide attempts. Paxil's top 20 events for the same time period included 841 suicides and Prozac had 187 suicides and 68 attempts. Celexa had 232 suicide reports and Lexapro had 189 suicides and 87 suicide attempts.
On August 11, 2008, the Evansville Courier & Press reported a near record number of 23 suicides in the first seven months of 2008 in Vanderburgh County, Indiana. Vanderburgh County chief deputy coroner and a member of the local suicide prevention coalition, told the Courier that in the results of a preliminary investigation "one element" stands out:
"In a majority of the cases investigated, the victim was on antidepressant medication. And none of the victims were in counseling."
Big Pharma funded front groups are constantly pumping out false claims that more people, and especially kids, are committing suicide due to the FDA's adding a black box warning about an increased risk of suicide to the labels of SSRI and SNRI antidepressants, in blatant attempts to increase sales for the makers of the drugs.
Most notably, the drug company funded Center for Medicine in the Public Interest, founded by ex-FDA official Peter Pitts, runs a propaganda feeding internet blog called Drug Wonks, where Pitts and his side-kick, Dr Robert Goldberg, go so far as to accuse the people who pushed for the black box warnings of being directly responsible for dying kids in the US.
For instance, on December 21, 2007, Pitts' DrugWonk's blog claimed that FDA career scientist Dr David Graham, "helped push through the statistical analysis and organize the public outcry over SSRIs that resulted in a decline in antidepressant use and a corresponding increase in teen suicides."
In a February 15, 2008 blog, Goldberg wrote that Congressman Bart Stupak "held several fear-drenched hearing about antidepressants in 2003-2004," and: "He is partially responsible for the decline in SSRI prescription use and the corresponding increase in adolescent suicide."
The facts are that the FDA announced the black box warnings would be added in October 2004 but they were not added until the spring of 2005. The government statistics show suicides for children aged one through eighteen in 2004 were 1,471. In 2005, there were 1,408 suicides in this age group and in 2006, the latest year posted, there were 1,296.
On July 24, 2008, Ed Silverman reported on data released by the Agency for Healthcare Research and Quality on Pharmalot that showed antidepressant prescriptions rose in 2005. "The increase amounted to roughly 10 percent, and that occurred in a year in which new and controversial Black Box warnings were added to the labeling," he wrote.
In a November 19, 2008 speech on the Senate Floor, Senator Charles Grassley of Senate Finance Committee revealed that CMPI board member, Dr Fred Goodwin failed to disclose that he earned at least $1.3 million between 2000 and 2007 giving marketing lectures for drug makers, while hosting the radio show "Infinite Mind," including one program titled “Prozac Nation: Revisited," in March 2008 for which Goodwin opened with the line, "As you will hear today, there is no credible scientific evidence linking antidepressants to violence or suicide."
"After listening to a recording of the show," Grassley said, "it appeared to me that the real effect of this particular episode was to undercut any criticism that antidepressants might be linked to an increased risk of suicide."
That very same week, Goodwin earned about $20,000 from Paxil and Wellbutrin maker GlaxoSmithKline. “Based upon the information provided to my staff, Dr. Goodwin was also very active on behalf of Glaxo in 2005," Grassley said. "That year, Glaxo paid Dr. Goodwin over $300,000 in speaking fees and around $25,000 in expenses to discuss their products."
For a DrugWonks blog on November 21, 2008, Goldberg posted the headline: "Generic Attack on Fred Goodwin," and stated about Goodwin:
"He is being slimed by the same small-minded group that wants to savage science and replace it with a contorted combination of anger, unmedicated anecdotes and trial lawyer inspired opportunism."
"Here's the difference between Goodwin and his attackers: Fred has helped reduced the number of suicides among the mentally ill. They have helped increase them."
"They have to live with their legacy. I am sure Fred will be content with his."
On December 9, 2008, the British Medical Journal reported that "besides GlaxoSmithKline [Goodwin] has been paid by Pfizer, Solvay, Janssen, Eli Lilly, AstraZeneca, and Bristol-Myers Squibb."
Another guest on Goodwin's "Prozac Nation," was Nada Stotland, the 2008-09 president of the American Psychiatric Association. “There was no good reason for the black box warning,” Stotland told the listening audience.
In 2006, the pharmaceutical industry accounted for about 30% of the American Psychiatric Association’s $62.5 million in financing, according to the July 12, 2008 New York Times.
Pfizer's grant report shows the Zoloft maker donated more than $700,000 to this "non-profit" in 2008. Eli Lilly, the maker of Prozac, Cymbalta and Symbyax (Prozac and Zyprexa combined), also gave the APA grants totaling more than $600,000 in both the first and second quarter of 2008. In 2007, the group received over $400,000 from Lilly and Lilly also gave roughly $450,000 to the American Psychiatric Foundation.
A fact also not revealed on the show was that Stotland has served on the speakers' bureaus of Glaxo and Pfizer, according to Slate Magazine.
Peter Pitts appeared on "Prozac Nation," as well, touting his credentials as a former FDA official and president of CMPI, and claiming the suicide warnings caused a drop in the SSRI use with kids and an increase in suicides a year or two later. He specifically stated:
"And the result was that a lot of doctors stopped prescribing the medications because they are afraid of liability. And a lot of parents stopped giving their children medicines that had been prescribed. And not surprisingly one or two years later very large studies came out to show that in fact teen suicidality had shown an increase – so there was really a direct correlation. And I think the media bears a lot of the responsibility for that…."
But here too, Pitts failed to mention that he was then a senior-vice president at the PR firm Manning Selvage & Lee, whose clients included SSRI makers Lilly, Pfizer, and Glaxo. Him and Goodwin also failed to mention that CMPI received more than $1.4 million in 2006 from the pharmaceutical industry, as was later revealed in Slate.
Infinite Mind spoke of Pitts on the show as “a former FDA associate commissioner 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,” according to Bill Lichtenstein, senior executive producer of Infinite Mind, in a May 9, 2008 written statement posted on Pharmalot.
“What we didn’t know, because he didn’t disclose it to us,” Lichtenstein said, “was that Pitts is currently working for a public relations firm whose clients include major pharmaceutical companies.”
An excellent indepth commentary with transcribed portions of "Prozac Nation," and details on Goodwin's orchestration of the whole show was provided by Dr Jonathan Leo on July 29, 2008 [Link] .
During the heated debate over conflicts of interest not being disclosed by Pitts, a blogger on Pharmalot posted links to four DrugWonks blogs with personal attacks on people who pushed for the suicide warnings on SSRIs. Clicking on the links today brings up the statement: "The Page you are looking for has been moved or deleated. Try searching for the information you are looking for." (Misspelling of deleted and all).
Pitts' major claim to fame is citing his former title of FDA associate commission. He always lists his dates of service as running from 2002 to 2004. But in checking the press releases for his hiring and departure dates, it appears that Pitts has been fudging his credentials on his public resumes because he barely put in year at the FDA.
On March 12, 2009, the PR firm, Porter Novelli, announced that Pitts would be joining the agency in new gig as "Partner and Director" of Global Health Care.
"Porter Novelli has worked for, or partnered with, most of the major companies in the pharmaceutical industry," the firm's website points out. Clients listed on the site include AstraZeneca, Johnson & Johnson, Merck, Shire, Wyeth, and the Robert Wood Johnson Foundation.
The press release announcing his hiring claimed that: "From 2002 to 2004, Pitts served as the U.S. Food and Drug Administration's associate commissioner for External Relations, where he acted as senior communications and policy adviser to the Commissioner." His bio on the CMPI website also said Pitts was associate commissioner from 2002 to 2004.
However, an April 21, 2003 press release on his hiring date with the heading: "Peter J. Pitts Appointed Associate FDA Commissioner for External Relations," states: "Commissioner of Food and Drugs Mark B. McClellan, M.D., Ph.D., today announced the appointment of a new Associate FDA Commissioner for External Relations."
Less than fourteen months later, on June 4, 2004, FDA News reported that: "Peter Pitts ... will be leaving his position, effective June 18, to become senior vice president for health affairs in the New York City office of public relations firm Manning, Selvage and Lee."
On November 1, 2004, Medical Marketing & Media noted that the FDA had appointed Sheila Dearybury Walcoff as associate commissioner, "succeeding Peter Pitts, who left the agency in June to join Manning, Selvage & Lee."
Pharmaceutical Executive published an interview with Pitts under the heading: "Thoughtleader: Peter Pitts, DrugWonk.com Get Up, Stand Up" on January 1, 2007.
He was described as the "chief voice" of DrugWonks, "a blog hosted by the Center for Medicine in the Public Interest." In the interview Pitts states:
"There are lots of politicians, Senator Grassley and Representative Waxman to name just two, who often say FDA is in the pharmaceutical industry's pocket. But anybody that has ever worked with FDA realizes not only is that not right, it's comically wrong."
The most "comical" remarks in the interview come when Pitts describes his "pet peeve."
"People look at FDA and they don't realize that anybody there could walk out the door and triple their salary in a day," he says. "They don't because they're on a personal public health mission."
Admittedly, Pitts apparently did stretch out his "personal public health mission" for about a year so he could pump up his resume with the title of ex-FDA official but he should at least be required to give employers the correct dates for his limited time of service.