The FDA Guerillas of Wonky DrugWonks - Part I

Former Bush Administration officials have formed a pharmaceutical industry guerilla group called the Center for Medicine in the Public Interest, described on its website as "a non-partisan, non-profit educational charity," and a "new vital force in health care policy."

However, for all intents and purposes, the mission of CMPI front group is to promote back-door efforts at tort reform, including pushing complete drug maker immunity through federal preemption, to pump out rapid-response propaganda on the internet to deflate scandals involving the pharmaceutical industry and the FDA, and to discredit anyone who would dares to criticize the industry or the FDA.

Former FDA associate commissioner, Peter Pitts, is the president. He is also the Senior Vice President of Global Health Affairs at Manning Selvage and Lee, a Public Relations firm described as "a top five healthcare communications practice with a 50-year history," representing, "major pharmaceutical, biotech and medical device companies."

Former FDA chief counsel, Daniel Troy, the Godfather of preemption, sits on an advisory board for CMPI. His bio brags that he "played a principal role in FDA’s generally successful assertion of preemption in selected product liability cases." He represented drug companies before he was chief counsel and returned to the same role when he left.

In the March 8, 2008, Mother Jones magazine, Stephanie Mencimer points out that Mr Troy's "career is an illustration of how the Bush administration's revolving door has allowed industry lawyers to radically reshape regulatory agencies to benefit the big businesses they once represented and then profit from those changes when they return to the private sector."

Robert Goldberg is vice president of CMPI. He was previously the Director of the Manhattan Institute's Center for Medical Progress and Chairman of its 21st Century FDA Task Force, according to his bio.

On the CMPI website, Mr Pitts and Mr Goldberg set up the internet blog, DrugWonks, supposedly to provide a forum that offers "rigorous and compelling research on the most critical issues affecting current drug policy."

But in truth, DrugWonks serves as a defacto media outlet to provide services offered by MS&L to pharmaceutical clients and to counteract damaging information as it comes out in the media with rapid responses on the internet.

“Media is the lifeblood of MS&L and our healthcare practice,” the firm explains on its website. “Our experts immerse themselves in the needs and changes occurring within the media,” it says.

MS&L services include: “Developing communications strategies to support or thwart issues, including outreach to key agenda-setters, coalition-building, e-fluencer campaigns and media outreach”.

Under the leadership of Mr Pitts in the Global Affairs unit, “MS&L helps clients understand and influence government thinking on key health policy issues,” according to the website. “Monitoring emerging health issues to protect clients, particularly legislative and regulatory activities,” is a service offered.

To that end, whenever the “monitoring” spots a potential problem for an industry client involving the FDA or legislation pending or investigations in Congress, Mr Pitts and Mr Goldberg automatically shift into overdrive to either deflate, deflect or defend with information released on the internet through DrugWonks.

In 2006, tax records show, CMPI spent $210,000, to influence the media through a large conference, DrugWonks, editorials in published in major newspapers, and multimedia programs and podcasts, according to Slate Magazine

In the line of fire

DrugWonks is also used to pump out unsubstantiated, vicious and unprofessional comments aimed at destroying the reputations and credibility of anyone who dares to speak out against the pharmaceutical industry or the FDA, including doctors, researchers, lawmakers and even journalists.

Attorneys are regularly attacked, but only those who defend the little guy against the drug giants. Those who represent industry clients receive the highest praise. The same goes for expert witnesses. An medial expert who consults with attorneys for a plaintiff is referred to as "a gun for hire." Those on the other side have only the best of intentions.

Mr Pitts and Mr Goldberg demonstrate a special “fondness” for all consumer advocacy groups and public health activists who criticize the FDA or pharmaceutical industry. They are referred to collectively with titles like "whack jobs," or "conflict of interest capos," or "Luddites," whatever that means.

They attacked four medical journals in one whack in a December 10, 2005, blog on DrugWonks. "Too many people are now not taking important medicines for pain, depression and other illnesses because the NEJM, JAMA, The Lancet and the British Medical Journal have allowed their political love fest with the leftists in the media and their hatred of drug companies to pollute their ability to remain objective," the blog said.

In June 2008, Mr Pitts and Mr Goldberg double-teamed Senator Charles Grassley (R Iowa), and reporter, Gardiner Harris, for three days when the New York Times reported on the investigation by the Senate Finance Committee into the nondisclosure of millions of dollars received by Harvard academics Joseph Biederman, Timothy Wilens and Thomas Spencer from drug companies.

Mr Pitts was especially incensed over the Mr Harris’ acknowledgment of Dr Biederman as: “A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children.”

"How did a phrase like "fuel an explosion" make it past an editor?" he demanded to know in a June 9, 2008 blog. "This is journalism?" he asked.

“The McCarthyite Mugging of Joe Biederman,” was the June 8, 2008 headline on DrugWonks, where Mr Goldberg refers to the investigation as the, “Grassley witch-hunt,” and credits the Times’ story in large part to, “Charles Grassley’s McCarthyite machine.”

There are other agendas at play here, Mr Pitts claimed on June 9, 2008. "When it comes to Conflicts of Interest," he says, "its COI polloi."

"The not-so-hidden agenda," he explains, "is that anyone who supports the use of psychiatric pharmaceuticals for any reason needs to be humiliated and destroyed."

Mr Goldberg says the non-disclosures amount to nothing more than “bad bookkeeping” or a “bookkeeping problem.” His theory might hold water if not for the fact that the problem continued for 7 years before Senator Grassley caught the glitch. The investigation of money paid to academic included about 30 psychiatrists at 20 universities, at last count.

Conflicted DrugWonker exposed

Its seems Mr Pitts himself does always disclose that he’s sleeping with the devil. However, bloggers on Pharmalot, and other popular websites, made his bed partners widely known after a conflict of interest scandal erupted over his appearance on the radio show, “Prozac Nation: Revisited,” aired on “The Infinite Mind,” and broadcast by National Public Radio on March 26, 2008.

CMPI board member, Dr Fred Goodman, hosted the show and told the audience: "There is no credible scientific evidence linking antidepressants to suicide or violence."

On May 6, 2008, Ed Silverman’s Pharmalot headline read: “NPR: On The Air, But Not In The Open,” for a report on, “Stealth Marketers,” by Shannon Brownlee and Jeanne Lenzer, in Slate Magazine with the byline: “Are doctors shilling for drug companies on public radio?” In describing the SSRI discussion on “Prozac Nation,” the authors noted:

“The segment featured four prestigious medical experts discussing the controversial link between antidepressants and suicide. In their considered opinions, all four said that worries about the drugs have been overblown.”

Not mentioned, Slate says, was the fact that all four experts had financial ties to the antidepressant makers. Mr Pitts was identified only as "a former FDA official.” “Also unmentioned were the "unrestricted grants" that The Infinite Mind has received from drug makers, including Eli Lilly, the manufacturer of the antidepressant Prozac,” Slate wrote.

Infinite Mind spoke to Mr 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 response to “Stealth Marketers,” posted on Pharmalot.

“What we didn’t know, because he didn’t disclose it to us,” Mr Lichtenstein says, “was that Pitts is currently working for a public relations firm whose clients include major pharmaceutical companies.”

The MS&L website shows Mr Pitts’ many drug company clients include Lilly, Pfizer and GlaxoSmithKline, the marketers of the SSRI antidepressants Prozac, Zoloft and Paxil.

Mr Pitts also failed to mention his PR job when he appeared on NPR’s Talk of the Nation and News Hour with Jim Lehrer, according to Mr Lichtenstein. He posted a link to “Prozac Nation,” on DrugWonks in April, 2008 without disclosing the conflicts of interests when describing the experts as well.

In their article, Ms Brownlee and Ms Lenzer noted the undisclosed affiliations of Mr Pitts and Dr Goodman with CMPI, which they described as “an industry-funded front, or "Astroturf" group, which receives a majority of its funding from drug companies.”

In a blog defending himself, Mr Pitts wrote: “I think it's important to note that, per full disclosure, I was never asked. I would like to assume that when I am called for interviews that the producers have done their due diligence.”

“I also want to be clear that on the other programs mentioned,” he said, “I was asked by the producers about my various affiliations. I answered fully and honestly -- and the decision was made not to mention it on the air.”

“When you go to www.cmpi.org, one click on my name tells you everything,” Mr Pitts pointed out. Which begs the question of how would listeners to a radio program know to look for a link on this website when his association with CMPI is not even mentioned?

When the story broke, blogger, Lisa Van S, kicked off the internet slugfest on Pharmalot on May 6, 2008, by writing: “Peter Pitts, Have you no shame!!… Does anyone have the DSMIV diagnosis for habitual Lieing.”

Over at DrugWonks on May 6, Mr Goldberg began a “destroy the messenger” campaign against Ms Lenzer, in a blog titled, “I Dream of Jeannie ... Retracting,” and the comment, “Talk about tight Jeannes!” with a January 17, 2005, New York Times article titled, “Dispute Puts a Medical Journal Under Fire,” pasted in the blog.

The “Dispute” refers to an article by Ms Lenzer in the January 2005 BMJ, which reported that the FDA was to review confidential Eli Lilly documents that had been sent to the BMJ by an anonymous source and that these documents had gone "missing" during a 1994 product liability suit filed against Lilly. After Lilly complained, the BMJ investigated the matter and issued a retraction of the “missing” statement and explained:

“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.”

Out of Ms Lenzer’s whole article, one single statement was retracted, but on DrugWonks, Mr Goldberg wrote: “BMJ was forced to retract one of her articles.”

Later in the same blog he wrote: “Here is the BMJ retraction AND apology as it pertains to Lenzer's unethical and sleazy behavior,” and pasted a copy of the retraction which shows that only one statement was corrected.

The Lenzer distraction idea was obviously chosen as the main talking point early because Mr Pitts pasted the exact same articles on Pharmalot. But on May 7, blogger pg, responded with a January 17, 2005 article that said the Associated Press reported that BMJ editor, Kamran Abbasi, said the apology was limited to the issue of whether the documents were missing from the court case. On May 13, Professor Jonathan Leo, a well-recognized SSRI expert, posted comments on the Slate website and quoted an e-mail to CNN from Kamram Abbasi, which stated:

"The London-based BMJ, formerly called the British Medical Journal, did not retract its contention that the documents show the antidepressant is linked to increased risk of suicide or violence. All we have retracted is the statement that these documents went missing."

Pharmalot’s pg, posted quotes from Lilly documents in a May 9, blog, from exhibits in a Prozac trial presented to the jury in a timeline to show that Lilly knew Prozac caused patients to become violent or suicidal long before the drug was approved in 1988. For example, a May 1984 document states: “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) . . .”

In a May 7, Pharmalot blog, Mr Pitts complained that the Slate article did not mention issues he raised about media coverage of the SSRI debate during an interview with one of the journalists. “A robust debate on the SSRI issue is very important,” he wrote. “Trying to stifle debate by personal attacks just shows a lack of intellectual rigor — and cowardice,” he said.

Pharmalot’s pg, responded to this charge by writing, “Personal Attacks - a Few Examples?” with links to 5 blogs on DrugWonks. In a May 8 blog, pg, posted this example: “…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?”

Attacks of this kind are posted all over DrugWonks, as part of a PR campaign to restart the mass sale of SSRIs to children obviously. The claim is that the black box suicide warning is causing all these kids to kill themselves because doctors are afraid to prescribe the drugs to depressed kids, and the persons who fought to add the warning are responsible for the deaths.

After reading the blogs written by Mr Pitts and Mr Goldberg, Pharmalot’s Eskimo wrote: “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.”

On May 8, in a blog with the DrugWonks headline, “Slate ‘n Slime,” Mr Goldberg wrote: “Shannon Brownlee and Jeanne Lenzer did a smear job on Peter and Dr. Fred Goodwin in Slate”. He also stated:

“Drugwonks rarely expects other bloggers to focus on substance . Rather, we are flogged for the source of our contributions as if others uncovered a corrupt connection instead of the truth, which is that we proactively provided information.”

In the same blog, Mr Goldberg later wrote: “we will do what ever it takes, including legal action, when facts are deliberately omitted, misrepresented and distorted and then willfully repeated to set the records straight.”

“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,” he said. “Still we expect accuracy and for others to provide some context even as they take their shots as they are entitled to in a free society.”

The next day in a Pharmalot blog, Jane reported that: “drugwonks changed their article - it orginally was titled “Slime-alot, Slime a lttile then ignore the real issues” and threatened to sue Ed.” That would be the Ed Silverman who runs Pharmalot.

In response to DrugWonks blogs accusing critics of lacking intellectual bandwidth and being immature, several Pharmalot bloggers simply pasted more links to more blogs written by Mr Goldberg and Mr Pitts on DrugWonks. But a May 9 blog from pg stated: “Woah Mr Pitts. What a shame you sold YOUR intellectual bandwidth (and your integrity) out to the pharmaceutical industry.”

In the end, the war ignited by “Prozac Nation” would rage on for weeks. Finally, on May 27, 2008, under a heading, “Disturbing Behavior,” Mr Goldberg claimed that he and Mr Pitts had gotten a taste of what others were subjected to on a regular basis, described as:

“abuse from out-of-control and obsessive hatemongers who receive succor and support -- or at the very least -- uncritical coverage by the media as the fail to engage on the substance of issues and instead attack motives and indulge in misleading and distorted use of selective reporting.”

“Our willingness to challenge those who have been responsible for scaring people from using antidepressants have diverted attention away from the consequences of a decrease in use with blind fury,” he said, “moving from antidepressants to antipsychotics without regard to the original argument or point, harping instead on funding sources with an obsession that reveals a lack of intellectual bandwidth and genuine hatred that borders on the personal.”

“The blogs that have allowed these posting -- unfiltered -- know better and bear a responsibility for allowing the attacks and vitriol to become so unhinged and personal,” Mr Goldberg wrote, and specifically mentioned Pharmalot.

“These are sad, hateful people,” he said, “The problem is they often reflect and influence the thinking of people like Brownlee and Lenzer who are considered mainstream.”

“We at CMPI are simply trying to insure that people get the right medicine at the right time,” he says. “No more, no less.”

Major story gone missing

Mr Pitts never misses a change to promote preemption on DrugWonks by publishing new stories about CMPI advisory board member, and former FDA chief counsel, Daniel Troy, who kicked-off the preemption campaign by filing the first FDA brief in support of a drug maker in an SSRI suicide case while serving as chief counsel. However, notably missing in the month of July, is a story on DrugWonks bragging about Mr Troy’s new job at Glaxo. But Ed Silverman reported the news on Pharmalot on July 22, 2008, writing:

“The preemption prince is joining the big drugmaker as senior vice president and general counsel on September 2. This is a coup for Glaxo, because Troy is widely known - some might say notorious - for being supportive of the pharmaceutical industry”.

“He also laid the groundwork for the current legal battle over preemption, which says FDA approval supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining agency actions are the final word on safety and effectiveness.”

In response to the news, Pharmalot blogger, Laurie, wrote: “Wow.. GSK takes on the one person who has been the poster boy for all that’s bad with pharma and the FDA…way to help your public relations.”

The fact is, Glaxo hired the “poster boy” while facing mounting legal problems due to concealing Paxil’s suicide risk for decades. With the kinds of insider information he could bring to the table, Mr Troy was already the best man for the job. But also important was likely the fact that he knew people were dying from Paxil for years and never cared.

Glaxo has been under investigation by the Department of Justice since 2004 over Paxil. In June 2008, the Wall Street Journal reported a widening of that investigation. In February 2008, Senator Grassley started a new investigation by the Finance Committee, after an expert witness report in a Paxil-suicide case was unsealed by a court that showed Glaxo knew back 1989, that Paxil patients in clinical trials were 8 times more likely to attempt or commit suicide than patients taking a placebo.

The Committee’s investigation of the money paid to academics also includes Paxil researcher, Dr Martin Keller at Brown University, who oversaw the Glaxo-funded trials on children, and was the lead author on the fraudulent papers used to promote the off-label sale of Paxil to children with false claims that it worked and did not cause suicide.

On June 23, 2008, Mr Pitts made a feeble attempt to throw out some sort of defense for his MS&L client with the DrugWonks headline: “What's Behind the Paxil Investigation?”

“There's money in it, maybe for the plaintiffs attorneys,” he wrote. “But there is also the Holy Grail of overturing FDA pre-emption,” he added.

The main problem with this theory is that Mr Pitt’s buddy, Dan Troy, seems to be the only attorney moving up the pay ladder.

In Stealth Marketers, Ms Lenzer and Ms Brownlee report that CMPI took in more than $1.4 million from the pharmaceutical industry in 2006. Mr Pitts was asked to identify the companies and apparently decided against it. “I don’t want to go into that,” he told Slate.

With all that drug money rolling in, CMPI could surely afford to hire an editor to clean up the blogs of the media expert and his side kick on DrugWonks. Although allowances for errors in typing, grammar and spelling are commonly extended to internet bloggers, the daily ramblings of Mr Pitts and Mr Goldberg appear on the official CMPI website and should at least be legible.

evelyn-pringle@sbcglobal.net

(Evelyn Pringle is a columnist for OpEd News and an investigative journalist focused on exposing corruption in government and corporate America)

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