[Ip-health] The FDA Guerillas of Wonky DrugWonks

[Miles Teg]

The FDA Guerillas of Wonky DrugWonks

by Evelyn Pringle / August 8th, 2008

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 =97 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!!=85 Does anyone have the DSMIV diagnosis for habitual Lieing
[sic -- ed.]."

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 =85
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) =85"

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 =97 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: "=85Where 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 =97 or at the very least =97 uncritical coverage by the media a=
s
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 =97 unfiltered =97 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=85way 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.

http://www.dissidentvoice.org/2008/08/the-fda-guerillas-of-wonky-drugwonks/



The FDA Guerillas of Wonky DrugWonks: Part 2

by Evelyn Pringle / August 13th, 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 =97 past Janet
Woodcock who officially speaks for the FDA =97 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 =96 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 =96 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=97it 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 =97 from an
LA Times article =97 about why Andy von Eschenbach, Sandy Kweder, Janet
Woodcock and the FDA's cafeteria guy should resign=85"

The drug companies know that this administration =85 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 =97 Hyped Up Safety Fears on ADHD Drugs =
=97
Does Medicaid Kill Poor People," and wrote: "Yet another show trial held
by another congressional committee on the FDA=85 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 =97 using real time technology to promote full time
compliance =97 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 =97 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 =97 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 =97 some of whom were at the meeting =
=97
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
=97 which an FDA advisory committee considered to be a rather shoddy piece
of research =96 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 =85 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 pre-announced 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.

Read Part 1.

Evelyn Pringle is an investigative journalist focused on exposing
corruption in government and corporate America. She can be reached at:
evelyn-pringle@sbcglobal.net. Read other articles by Evelyn.

This article was posted on Wednesday, August 13th, 2008 at 5:59 am and
is filed under Corporate Globalization, Corruption, Health/Medical.

http://www.dissidentvoice.org/2008/08/the-fda-guerillas-of-wonky-drugwonks-=
part-2/