The Bitter Pill

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FDA Guerillas of Wonky DrugWonks – Part II

Evelyn Pringle August 12, 2008

The tribe of Guerillas operating a Big Pharma public relations firm under cover of the Center for Public Integrity in Medicine may soon be on the path to extinction and the blogs on DrugWonks by the two out-of-control top bananas will likely be cause.

Former FDA officials from the Bush Administration organized this industry funded front group a few years ago and made Peter Pitts, President, and Robert Goldberg, Vice President. DrugWonks is the defacto media outlet used to distribute information over the internet as a services to drug company clients of the public relations firm Manning Selvage and Lee, where Mr Pitts is Senior Vice President of Global Affairs.

In a September 1, 2006 posting, Mr Pitts bragged that DrugWonks received over 100,000 visits in August 2006. “And considering we’re not a “mass” blog, we think that’s pretty terrific,” he noted.

“According to Technorati (the folks who measure blog audience numbers) of the 55 million blogs out there, drugwonks.com has cracked the elite top 100,000. We’re Number 92,165,” he reported on December 22, 2006.

A partial list of Big Pharma loyalists who have served, or currently serve, in the Bush Administration’s FDA, can be found in a June 30, 2006 blog, in which Mr Pitts provides the details of what he described as the “memorable launch party” for “the Center for Medicine in the Public Interest (the public policy home of drugwonks.com.)”

Memorable for many reasons, he said, but mostly because of who attended. The attendees included FDA Deputy Commissioners, Janet Woodcock and Dr Scott Gottlieb. That would be the Dr Gottlieb who was recruited for a job at the FDA from MS&L, before moving on to employment with the drug company Novartis.

Anna Barker, the deputy director of the National Cancer Institute, also attended the bash, along with Julie Goon, described by Mr Pitts as “the new White House health care policy guru.”

Referred to as a “former FDA colleague,” Daniel Troy, former chief counsel of the FDA, best known as the Godfather of Preemption, was at the party and serves on the CMPI advisory board. He recently landed a top job with MS&L client GlaxoSmithKline.

John Taylor, the former National Institute of Mental Health director, now a CMPI board member, also attend the grand-opening, along with Dr Fred Goodwin, who sits on a CMPI board and belongs to a gang of academic quacks paid by the makers of SSRI antidepressants like Paxil, Prozac and Zoloft, to sign their names to bogus studies misrepresenting the efficacy of the drugs and concealing the suicide risks.

The keynote speaker for the kick-off party was former FDA Commissioner, Mark McClellan, described by Mr Pitts as, “the hardest working man in health care.”

Slanderland in cyberspace

Mr Pitts and Mr Goldberg operate as a two-man Guerilla hit squad on DrugWonks. Its their job to recognize any reports in the media that could be damaging to the FDA, or negatively effect Big Pharma profits, and publish a response to discredit or distort the story and lessen the impact.

They keep a running tab of all persons who represent a threat to Big Pharma with some of the most highly respected medical experts in the world at the top of their hit list. New enemies are added all time and among those regularly attacked are lawmakers on the powerful committees in Congress that oversee health care, career scientists at the FDA, reporters who write damaging articles, and public health advocates.

The mere mention of a “Black Box Warning,” is a threat to drug profits and requires immediate damage control. For instance, on October 24, 2005, in response to a request by the consumer safety group, Public Citizen, for a black box warning on erectile dysfunction drugs, Mr Pitts ridiculed the leader of group by writing:

“Sidney Wolfe, Public Citizen’s General Secretary of Junk Science has just filed a Citizen’s Petition with the FDA calling for a Black Box warning on ED medications because of 48 events of NAION (non-arteritic ischemic optic neuropathy, a loss of vision that is frequently irreversible). “

“Suggesting that Sidney have his eyes examined would only be a partial diagnosis,” Mr Pitts wrote in the blog.

He was particularly annoyed over Dr Wolfe saying FDA “has once again failed in this responsibility. These drugs need much stronger warnings, especially a black box warning such as the one we have proposed.”

“USA Today” was attacked on November 15, 2007, under the headline: “USA Today Adds Its Own Avandia Warning,” for quoting FDA career scientist, Dr David Graham, when discussing the cardiac risks of GlaxoSmithKline’s diabetes drug, Avandia, instead of talking to the FDA official from the CMPI team. “Here’s USA Today crawling through the mud — past Janet Woodcock who officially speaks for the FDA — to talk to David Graham about Avandia,” Mr Goldberg wrote.

Road to Extinction

In a July 30, 2008 blog, Mr Pitts seemed really rattled over a story by Alicia Mundy in the Wall Street Journal with some pretty good hints that the tribe of CMPI Guerillas promoting Big Pharma’s agenda, with the help of industry insiders at the FDA, might soon be on the path to extinction, when reporting that:

“Powerful members of Congress want to remake the Food and Drug Administration by giving it broad powers to levy fines, order drug recalls and restrict drug-industry advertising.”

Leading the drive are Rep John Dingell (D Mich) and Senator Chuck Grassley (R Iowa), she said. “Perhaps most importantly, they want the next president to appoint a tough FDA commissioner completely independent from the industry,” Ms Mundy reported.

In a DrugWonks rapid response, Mr Pitts asked, “isn’t the FDA already an entirely independent government agency?”

“To lay the groundwork for their FDA overhaul,” Ms Mundy reports, “Messrs. Dingell and Grassley and their allies have ordered about 20 investigations of drugs and issues involving the FDA.”

“Mr. Grassley began his campaign to overhaul the FDA in 2004 during an uproar about the agency’s slow reaction to potential links between popular antidepressants and teen suicides,” she notes. “Now he has four staffers and a parade of FDA whistleblowers helping him investigate a plethora of FDA controversies, such as its approval of the antibiotic Ketek,” she reports

Mr Pitts calls this revelation about the opening of a new website to air criticisms of top FDA officials, “some really shoddy reporting”:

“Some current and former FDA safety reviewers have opened a whistleblower website to air their concerns that FDA leaders are pushing them to approve some drugs”

He points out that this site defines itself as “a website launched and operated by current and former US Food and Drug Administration staff who believe public health is being put at unnecessary risk. These concerned civil servants and ex-civil servants have either experienced or are aware of wrongful directives by US FDA upper management – directives that put public health at avoidable risk.”

Apparently Mr Pitts took the time to check it out and found Jim Dickinson, who is not a former FDA employee, registered the website, and is a “long-time FDA antagonist,” he says. But then Mr Pitts is a “long-time antagonist” of Senator Grassley and whistleblowers as well. He can be found taunting the Senator on DrugWonks as early as November 18, 2005, in calling him, “the new father-confessor of disgruntled FDA employees.”

On February 21, 2008, he posted the headline, “Not the real FDA – a Grahamatization,” in highlighting what he described as an, “Interesting omnibus piece from by Warren Ross of Medical Marketing & Media on the various slings and arrows being tossed at the worlds premier medical regulatory agency,” in which Mr Pitts just happens to be quoted.

“Here’s what I had to say,” he writes in the blog, “about the David Grahmatization of the whistleblower culture:”

Pitts also takes a dim view of people who go outside the agency to complain. A professional, he maintains, should not “weep and whine and try to get decisions made that are based on politics rather than on science.” Whistleblowers, he acknowledges, at least deserve “grudging respect” for letting it be known who they are, “but what is truly damaging are the silent leakers” who try to force political pressure on FDA decisions. “The motive may be either to get drugs approved or not approved—it cuts both ways.”

The blog concludes with the comment: “As Jimmy Durante said, ‘I’m surrounded by assassins.’”

Mr Pitts seemed particularly riled up over Ms Mundy’s report that Senator Grassley believes the FDA Office of New Drugs has been compromised by its relations with industry lobbyists, and among them “former top FDA officials.”

“And what does that mean?” He demands to know on DrugWonks. “Any evidence to back up such blowhard accusations?” He asks in his blog.

FDA officials “are too cozy with the companies they regulate,” Senator Grassley told the Journal, and new leadership must “fix the culture.”

“What does “too cozy” mean?” Mr Pitts asks in his blog. “Really, what does it mean?” He demands to know.

Industry insider protection by DrugWonks

Mr Goldberg identified three cozy FDA officials that lawmakers wanted gone in a blog on February 20, 2008, when responding to what he described as “Anna Mathews puff piece” on Bart Stupak, the Michigan Democratic Congressman, in the Wall Street Journal.

Under the headline “WSJ Overlooks Stupak Stupor,” Mr Goldberg wrote: “Good thing she didn’t include this stirring Stupak statement — from an LA Times article — about why Andy von Eschenbach, Sandy Kweder, Janet Woodcock and the FDA’s cafeteria guy should resign…”

“The drug companies know that this administration … will do nothing to them. There is no fear of the FDA. With this culture with laissez faire oversight and regulation, I think they should be gone. If we get rid of them, it will put the drug companies on notice.”

On April 23, 2008, in the midst of the Heparin scandal, Mr Goldberg ran the headline: “Heparin Hypocrisy – Hyped Up Safety Fears on ADHD Drugs – Does Medicaid Kill Poor People,” and wrote: “Yet another show trial held by another congressional committee on the FDA…There have been four or five over the last two months on heparin alone.”

“Andy von Eschenbach,” he said, “who is gaining momentum, along with the FDA, in shifting the agency towards a science and systems based approach to regulation — using real time technology to promote full time compliance — has to sit and take the following from the likes of Bart Stupak (D-Michigan):”

“Last year, this nation’s regulatory failures resulted in dead dogs and cats. This year, it has tragically led to the deaths of people,” said Rep. Bart Stupak, D-Mich. “If we don’t make some rapid progress on fixing the foreign drug inspection program, the next melamine or heparin tragedy will soon be upon us.”

“That’s rich,” Mr Goldberg said, “coming from a guy who helped push up the suicide rates by scaring parents away from antidepressants. and who is pushing for drug importation at a time when Al Qaeda and Hezbollah are involved in drug counterfeiting.”

“Andy must have to shower after sitting through such a show trial,” he added.

“Meanwhile the Steve Nissen fear factory spews out another piece of tabloid medicine: EKG monitoring of all kids getting stimulants for ADHD,” Mr Goldberg continued, referring to the world-renowned cardiologist from the Cleveland Clinic.

“Now there’s a way to achieve Nissen (who has never studied ADHD) goal of making a physician’s hand quiver before writing a scrip for the drug,” he wrote.

Evidence of “cozy” relationships can also be found in the names of the guests at the “memorable launch party.” On August 24, 2005, Mr Pitts pumped out syrupy defense when the Seattle Times criticized the FDA’s hiring of industry insider, Scott Gottlieb, directly from the MS&L stable. Without mentioning that he also was employed by MS&L, Mr Pitts wrote:

“Scott Gottlieb is a lot of things. Public servant. Physician. Pundit. He is my former colleague at the FDA. Most importantly, he is my friend.”

“And my blood boils with anger and frustration at today’s scurrilous attack on him in the Seattle Times“.

“Scott I know personally. I know that he takes his work at the FDA seriously. I know that he takes his government oath to protect the public health seriously. I know that he is highly ethical and honest. And I know how much this article must hurt him personally.”

“And, I’m sure, that is precisely why certain lupine elements are gleefully forwarding this ugly hit piece to their friends and colleagues.”

“If people don’t agree with his policy positions they should dispute them, firmly, strongly, logically — and respectfully,” Mr Pitts wrote.

“That they have chosen character assassination only shows the weakness of their intellectual arguments as well as their disappointing lack of character,” he wrote. “For shame.”

On January 15, 2006, Dr Sidney Wolf, was again ridiculed when the LA Times cited his criticisms of what Mr Pitts described as the FDA’s “new and better way to establish drug safety that solves a one of the more serious problems in drug development, namely that animal studies are often a poor and inaccurate substitute for what happens in human.”

The “better way” involved earlier testing on humans. Dr Wolf questioned whether the FDA had a strong enough scientific argument for speeding the early stages of drug research, the Times noted.

In his blog, Mr Pitts dismisses the legitimacy of Dr Wolf’s concerns with the statement: “Sid Wolfe has opposed every effort to speed drugs to dying patients since he has been on his anti-patient jihad starting in 1970.”

“Wolfe has a self-interest in trashing new medicines,” he also explained, “since his organization makes money by hawking a book Worst Pills, Best Pills that argues the most drugs are dangerous.”

Blowhard accusations

The majority of proof to support Senator Grassley‘s “blowhard accusations,” will likely come directly from the CMPI website and the years of incriminating blogs by Mr Pitts and Mr Goldberg filled with nothing but lobbying campaigns for the drug companies.

Rarely does a month pass where the two top bananas are not pumping out propaganda to boost profits for MS&L clients Eli Lilly, Glaxo and Pfizer, with false claims that SSRIs are effective and do cause suicide, along with vicious attacks on anyone who says otherwise.

On February 15, 2008, Mr Goldberg was again blaming a non-existent decline in the prescribing of SSRIs, and the increased suicides, on Rep Stupak, as head of the Health subcommittee on Energy Commerce. He held “several fear-drenched hearings about antidepressants in 2003-2004,” and he “is partially responsible for the decline in SSRI prescription use and the corresponding increase in adolescent suicide,” Mr Goldberg wrote. “So the question is,” he said:

“And this guy is head of the Health subcommittee? Why is he being taken seriously? Why isn’t he being held accountable?”

In the blog, Mr Goldberg includes the following statements made by Rep Stupak a hearing, which he claims are “scientifically incorrect,” “misleading” and “dangerous”:

“SSRI’s have not been proven effective in treating adolescent depression. To the contrary their use may actually increase the suicide rate of its young patients.

“In response to these reports of increased suicide rates with SSRI use, FDA officials suppressed their own post marketing surveillance, prohibited FDA employees from discussing the report, and launched an investigation to find the person who leaked information to the press. Today, SSRIs remain on the market without a clear medical benefit to the patient.”

“There should be a black box warning around everything Stupak says regarding medicines,” Mr Goldberg declares, “particularly SSRIs which have been shown to benefit patients and are associated with a decline in suicides.”

Prolific smear campaigns are directed at medical experts who testify against Big Pharma in litigation or government hearings. A life-time reputation of credibility and high regard may be targeted for assassination as punishment for this capital crime. Attempts to destroy the reputation of Dr David Healy, the world-famous expert on psychopharmacology, with 20 books to his name, appear frequently on DrugWonks. For instance, on December 19, 2006, Mr Pitts wrote:

“Dr. Healy recently testified at the FDA hearing on antidepressants. He is a psychiatry professor at Cardiff University in Wales but also, according to the New York Times, has worked for plaintiff’s lawyers in cases brought against pharmaceutical companies. That’s transparency.”

“When I served as Associate Commissioner at the FDA, Dr. Healy visited with me — but he never mentioned that he worked for the tort bar,” Mr Pitts said. “That’s dishonesty.”

The untold story here is that Dr Healy traveled to Washington on his own dime in 2004, for the meeting of the FDA Advisory Committee to consider the suicide risks of SSRIs. During his visit, Dr Healy and a group of people that included parents of children who committed suicide while taking SSRIs, also met with Mr Pitts and other FDA officials.

As a follow-up to the meeting, Dr Healy prepared a lengthily report with summaries of all the available suicide data on each SSRI, including his own studies, and sent copies to Mr Pitts and the other FDA officials, free of charge. Dr Healy’s trip to Washington to testify at the advisory committee meeting in December 2006, was also on his own dime.

In an email, Dr Healy was asked whether he would like to respond to the above allegations by Mr Pitts on DrugWonks. In a return email, Dr Healy explained that he consults as an expert in litigation for drug companies and trial lawyers alike, and wrote:

“When I went into the FDA to meet with Peter Pitts, I made no efforts to conceal my links to trial attorneys – some of whom were at the meeting – and no efforts were made to conceal my links to the pharmaceutical industry, all of which were well known.”

“I went,” he said, “because in my experience Republicans such as Senator Grassley and staffers working for them such as Emilia DeSanto have appeared more concerned about and more effective on the issue than anyone else and as a Republican appointee I thought Peter Pitts’ heart might be in the right place.”

“What was not well-known at the time was that Peter Pitts was transiting between working for pharmaceutical companies – or perhaps not even transiting,” Dr Healy wrote. “I’m not sure how many of us would have felt it worth going if we had known his background,” he noted.

“Retrospectively,” Dr Healy says, “it seems astonishing to me now that with people like Peter Pitts in FDA that it was ever possible to bring the suicidality issues to light.”

It seems even more astonishing after reading Mr Goldberg’s blog on February 15, 2008, which declares: “And again, there is no link to SSRIs and in increase in suicides, rather some unclear evidence based on an unvalidated measure called suicidality that includes just talking about self harm in general.”

On March 9, 2008, Mr Goldberg called Dr Healy an expert “whose flawed study about SSRI’s and suicide triggered a series of events which lead to less SSRI use and more suicide.”

However, on July 24, 2008, Pharmalot’s Ed Silverman reported on data just released by the Agency for Healthcare Research and Quality, a unit of the US Health and Human Services Department 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 on the medications,” he wrote.

In addition, government statistics for 2005, the year the warnings were added, show there was no increase in suicides. In fact, suicide deaths were down in all age groups. For children aged 5 to 14, there were 285 in 2004, and 270 in 2005. In young people aged 15 and 24, the number of suicides was 4,316 in 2004, and dropped to 4,139 in 2005.

Mountains of evidence

Much more evidence can able found in blogs beginning on December 10, 2007, which was another a memorable day at CMPI, when Mr Pitts announced that CMPI would present a new award called “The Golden Clipboard,” to those “who stand in the way of medical progress.”

Those “who stand in the way of medical progress,” refers to persons involved in exposing the FDA’s failure to protect the public from drugs such as the diabetes drug Avandia, Vioxx, and SSRI antidepressants, due to cozy relationships with the makers of the drugs.

CMPI published the names for the top award, and the runner-up winners of the Bronze Clipboard and Silver Clipboard on DrugWonks on December 21, 2007, along with comments about why they were chosen.

The highest honor went to Dr Graham: “For his persistence, zeal, and determination to damage not only the FDA but the public health, for his effectiveness in fear mongering and willingness to subordinate medical progress to his ascetic view of safety.”

“David Graham ostensibly works for the FDA,” Mr Pitts said, “but he seems to spend a lot of time in the Halls of Congress advising members and staff about which FDA medical reviewers should be hauled in for polite ‘conversations.’”

“Setting aside Dr. Graham’s contribution to the Vioxx Populi literature — which an FDA advisory committee considered to be a rather shoddy piece of research – he also 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,” he explained.

Mr Pitts also credited Dr Graham for “his assertion that Avandia should be taken off the market,” and said, Dr Graham is AKA (also known as) “Dr. Precautionary Principle.”

The Bronze award went to California Democratic Congressman Henry Waxman, who “is best remembered in 2007 as the conduit for Steve Nissen’s half-baked meta-analysis of Avandia,” Mr Pitts pointed out.

His oversight hearing “helped blow out of all appropriate proportion fear about drug safety in general and Avandia in particular,” the blog said.

Dr Nissen had to settle for the Silver Clipboard, but his “persistent undermining of the FDA came close to winning him Clipboard top honors for 2007,” Mr Pitts pointed out.

Many of the blogs leading up to the awards seemed to indicate that Dr Graham, Dr Nissen and Rep Waxman were locked in a tight race. But a review of all the blogs on DrugWonks clearly showed that Senator Grassley was never ruled out as the top contender.

For instance, on August 20, 2005, Mr Pitts ran the headline: “Leaves of Grassley. Not a Whit of Sense,” and referred to Mr Grassley as the “Senator from Blameland,” and “Body Slam Chuck, the King of Destructive Criticism.”

Mr Pitts was annoyed over the Senator’s comments about the FDA after Merck lost the first Vioxx trial, in stating: “The Food and Drug Administration was also negligent in the Vioxx case … Those running the nation’s public safety agency repeatedly dismissed the concerns of their own scientists and seemed to do everything possible to keep the public in the dark about emerging problems with Vioxx.”

“And talk about bellying up to the tort bar!” Mr Pitts wrote. “I wonder how much more money the Senator will get from the trial lawyer lizards as a reward for such vituperative rants?”

Of course, he failed to mention that the contributions by the “lizards” could never match the money doled out on Capitol Hill every year by the pharmaceutical industry.

Mr Goldberg’s April 18, 2007, blog pretty much preannounced the winner with the headline: “David Graham: Public Health Enemy,” and the statement that:

“Members of Congress and senior officials of the FDA should be ashamed of themselves for giving Graham the chance to not only rant on about Vioxx and SSRIs but to make the same claims about Ketek and drugs for schizophrenia.”

But all the Clipboard winners should feel equally honored by the CMPI awards, because judging by the number of slanderous attacks they each received, their combined efforts to expose drug safety issues and fix the broken FDA are obviously what’s working.

Filed under: 'ADHD', 2008, Avandia, CMPI, DrugWonks, FDA, Goldberg, Gottlieb, Heparin, Ketek, Manning, Pitts, SSRIs, Troy, Vioxx, whistleblower, Wolf

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