[Ip-health] (US) Corruption - Pharma $$, CMPI, MS&L, DrugWonks and the FDA

[Miles Teg]

Corruption - Pharma $$, CMPI, MS&L, DrugWonks and the FDA
The pharmaceutical industry's stealth influence peddling, directed
toward healthcare professionals and the media, is carried out through
public relations front groups who are bankrolled by drug manufacturers.
For example, Professional Risk Management Services was retained by Eli
Lilly to assuage doctors' fears about prescribing Lilly's toxic
antipsychotic drug, Zyprexa, lest they be sued for the harm caused by
the drug. [Link]

PR firms contracted by drug companies retain medical
professionals--academics and former public officials--to disseminate
propaganda which is passed on to the public as infomercials that are
misrepresented as impartial drug safety information. No matter how
compelling the evidence of harm, patented drugs are described as "safe
and effective."

The most insidious pharmaceutical industry front group is the Center for
Medicine in the Public Interest (CMPI), which is the stomping ground of
high ranking FDA officials-- both current and former. We first learned
about CMPI--its funding source and smear campaigns--from an
investigative report by Shannon Brownlee and Jeanne Lenzer in Slate (May
2008). They reported that former FDA associate commissioner, Peter
Pitts, is President of CMPI as well as Senior Vice President for Health
Affairs at Manning, Selvage & Lee (MS&L), one of the largest PR firms
whose major clients are the pharmaceutical company giants. See Client
list: [Link] In 2006, CMPI took in $1.4 million from pharmaceutical
companies of which $210,000 was spent to influence the media and by
extension, the public at large. See: [Link]

Below is the second of a two-part report in OpEdNews.com by Evelyn
Pringle which describes how high ranking FDA officials move freely to
and from positions in Big Pharma's PR front groups-CMPI / MS&L. For
example, FDA's head of the Center For Drug Evaluation and Research
(CDER), Dr. Janet Woodcock, attended the launching party for CMPI, as
did former FDA Commissioner, Dr. Mark McClellan, who was the keynote
speaker. CMPI recently announced that Dr. McClellan will chair its
Patient-Centric Health Forum. [Link]

Another high ranking FDA official, the agency's former chief counsel,
Daniel Troy, serves on CMPI's advisory board. Mr. Troy is best known as
the architect of the preemption argument that would immunize drug
manufacturers from liability. On July 22, Mr. Troy was appointed Senior
Vice President and General Counsel for GlaxoSmithKline.

Prior to his stint as deputy FDA commissioner, Dr. Scott Gottlieb, was
employed by MS&L. He has since moved to the pharmaceutical company,
Novartis. See: SourceWatch: [Link]

Also in attendance at the CMPI bash were: Anna Barker, deputy director
of the National Cancer Institute; Julie Goon, described as "the new
White House health care policy guru;" and Dr Fred Goodwin, former
director of the National Institute of Mental Health, CMPI board member.

The Slate report described how stealth marketers are presented as
academic "experts" without disclosing their considerable financial ties
to drug manufacturers. The report identified "The Infinite Mind" a
nationally broadcast program on National Public Radio hosted by Dr.
Frederick Goodwin, whose biased show, "Prozac Nation Revisited," stands
in a class by itself for concealing conflicts of interest. In addition
to the show's unrestricted grants from Prozac's manufacturer, Eli Lilly,
Dr. Goodwin has a considerable commercial stake in the
psychopharmacologic drugs that he defends and promotes--including
partnership in "Best Practices," a commercial service to psychotropic
drug manufacturers. See: [Link] also: [Link]

NPR listeners were not informed either about Dr. Goodwin's conflicts of
interest nor about the financial ties that bind his invited guests to
the drug industry. Indeed, all three guests who appeared in the Prozac
broadcast had financial relationships with drug companies. Peter Pitts,
a guest was identified only as former FDA associate commissioner-with no
mention of his two executive positions in pharmaceutical funded PR
firms, CMPI and MS&L--nor was Dr. Goodwin's CMPI board membership disclosed.

CMPI and MS&L not only disseminate disinformation about drug safety,
they engage in pit bull guerilla tactics maligning critics who dare to
criticize the drug industry's dubious (some would say) criminal
marketing practices that conceal lethal risks. Messieurs Pitts and
Goldberg broadcast scathing attacks on DrugWonks, their blog set up on
the CMPI website which serves as the launching pad for unsubstantiated,
vicious and unprofessional attacks aimed at destroying the reputations
and credibility of anyone who dares to speak out against the
pharmaceutical industry or the FDA. Among their targets are doctors,
researchers, lawmakers, and even journalists. Brownlee and Lenzer were
targeted for fierce attacks following their expose in Slate.

Pringle reports that on Dec. 10, 2005, Messieurs Pitts and Goldberg
attacked four medical journals "in one whack": "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."

Their modus operandi is to respond by discrediting or distorting the
story so as to lessen the impact. Some of the most highly respected
medical experts in the world are at the top of their hit list. But three
scientists-Drs. David Graham, David Healy and Steven Nissen--whose
public criticism of dangerously toxic drugs led to withdrawal from
market (Vioxx), black box warnings of increased risk of suicidality
(SSRI antidepressants) or boxed warnings Re: CONGESTIVE HEART FAILURE
AND MYOCARDIAL ISCHEMIA (Avandia) have garnered the worst abuse.

Dr. Graham, Associate Director of FDA's Office of Drug Safety, who won
public accolades for testifying at a congressional hearing about Vioxx,
the worst drug disaster in history, has been mercilessly vilified on
DrugWonks for blowing the whistle on unsafe drugs.

"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." Pitts
derisively refers to Dr Graham as "Dr. Precautionary Principle."

Dr. Graham, it turns out, understated the carnage from Vioxx, when safe
alternatives were widely available. FDA estimated 32,000 heart attacks,
stroke, sudden death for patients who took Vioxx. Dr. Graham estimated:
88,000-130,000 in USA. Of these, 30-40% died

But those estimates were greatly understated: the number of cardiac
events due to Vioxx is staggering: 14 million higher risk patients took
Vioxx in the US--of these, 617,000 suffered cardiac events. 21 million
healthier patients took Vioxx--of these, 336,000 suffered cardiac events
Total cardiac events linked to Vioxx in the US = 953,000. [1]

Dr. Nissen, a prominent expert cardiologist who reported in the New
England Journal of Medicine that "GlaxoSmithKline's diabetes drug
Avandia increased the risk of heart attacks by 43% and death from
cardiovascular events by possibly 64%" was subjected to an orchestrated
vicious attack campaign kicked off by FDA spokesman Douglas Arbesfeld
who sent out a disparaging email to the news media. See: CounterPunch,
2007 [Link] .

Mr. Arbesfeld used his official FDA email account to send messages to
reporters with derogatory comments about Dr Nissen and his employer, the
Cleveland Clinic, with quotes from an anonymous blogger who basically
said they were out to get Glaxo, stating that the conduct of Dr Nissen
and the Clinic was similar to that seen on the Sopranos, a TV series
about a Mafia crime family. [Link]

Not coincidentally, Arbesfeld had worked at MS&L--as did former FDA
deputy commissioner, Dr. Gottlieb who ridiculed Dr. Nissen in a Wall
Street Journal editorial. [Link]

According to the moral compass of those affiliated with CMPI / MS&L
/DrugWonks, public disclosure of conflicts of interest is "COI polloi."
[Link]

In June 2008, they aimed their poison pens at Senator Charles Grassley
(R Iowa), and reporter, Gardiner Harris, when the New York Times
reported the Senate Finance Committee investigation findings that
Harvard psychiatrists failed to disclose millions of dollars received
from drug companies. DrugWonks' headline read: "The McCarthyite Mugging
of Joe Biederman." Sen. Grassley's investigation was dubbed the
"Grassley witch-hunt."

According to their code of ethics, public disclosure of drug safety
hazards is considered an atrocity--even when those hazards are
lethal--because disclosure might put diminish drug sales. The attacks
have escalated since black box warning labels were added to
antidepressants following public disclosure of a twofold increased risk
of suicidality compared to placebo.

Perhaps, nothing better captures the essence of what DrugWonks--its
funders, authors, and supporters are about--than one of its headlines:
"Slime-a lot, Slime a little, Then Ignore the Real Issue"

Reference:

Professor Donald Light, Institutional Foundations of Drug Disasters,
presentation at the American Sociological Association, Aug. 3, 2008.

[Link]August 11, 2008
The FDA Guerrillas of Wonky DrugWonks - Part II
By Evelyn Pringle

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
service 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.

http://ahrp.blogspot.com/2008/08/corruption-pharma-cmpi-ms-drugwonks-and.html