The Bitter Pill

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FDA Officials Form Hit Squad to Protect Avandia Profits

Evelyn Pringle August 2007

The FDA’s latest campaign to protect the profits of a drug company over the safety of Americans is unprecedented, and the organizers include a gang of current and former FDA officials largely credited with turning the nation’s regulatory beagle into a lapdog for Big Pharma under the Bush Administration.

FDA spokesman Douglas Arbesfeld, apparently the industry’s new inside guy, kicked off the campaign by sending an e-mail to journalists which was intended to discredit Dr Steven Nissen and the Cleveland Clinic. Dr Nissen’s study appeared online on May 21, 2007, in the New England Journal of Medicine and warned that GlaxoSmithKline’s diabetes drug Avandia increased the risk of heart attacks by 43% and death from cardiovascular events by possibly 64%.

The talking points for the media were obviously agreed upon ahead of time because the stories that appear on the internet refer to Dr Nissen with names like “St Steven”, “Patron Saint of Drug Safety” and “Saint Steven the Pure.”

In his email to journalists, Mr Arbesfeld pasted portions of an article which appeared on the Heartwire website, containing umpteen critical comments about Dr Nissen and the Avandia study, as well as comments made by an anonymous blogger on the internet which said that business at the Cleveland Clinic is run similar to a Mafia TV series. The full bog states:

“Wake up pharmaceutical companies, this is a call from Dr. Nissen, if you don’t hire the Cleveland Clinic for your big trials then you face the firing squad from Nissen and Company.”

“The Cleveland Clinic was one of the most respected names in medicine, now they are positioning themselves as candidates to take over for a new series on HBO to replace the Soprano’s — the Clinico’s ‘next week who should we wack ……’ — Bata bing bata boon. Comment by Brian A – May 22, 2007.”

However, it could just as easily be inferred that Mr Arbesfeld authored the slanderous blog and supplied it to Heartwire with the intention of quoting it later from a “reputable” web site. For its part, Heartwire has since removed what it says are “unsubstantiated remarks about Dr Nissen and the Cleveland Clinic”, and states: “In retrospect we regret that we published those sentences, as they do not meet the highest standards of journalistic or scientific integrity or credibility.”

The smear campaign has federal lawmakers up in arms. At a June 6, 2007, hearing before the House Oversight and Government Reform Committee, in response to questions about Mr Arbesfeld sending the e-mail under his official title of FDA spokesman, FDA Commissioner Andrew von Eschenbach told the lawmakers, “It was an inappropriate and unfortunate act on the part of an individual which has been addressed through disciplinary procedures.”

Dr Nissen is none to happy about the stunt either. “I’m a pretty tough guy,” he told ABC News on May 30, 2007, “but I’ll tell you, having this kind of an e-mail that questions my motives, broadcast to the major journalists with whom I work and have established a reputation, is — it’s an outrage.”

As for his part, Mr Arbesfeld told the Boston Globe that the email reflected his own personal views and not the FDA’s. Any assertion that the email reflected his own personal views is not quite credible considering that his previous employment was always promoting the views of the industry.

A few articles in the media mentioned that Mr Arbesfeld worked for Johnson & Johnson, but his employment with public relations firm Manning Selvage & Lee was not noted. On December 16, 1999, the Healthcare Marketing & Communications Council reported that Mr Arbesfeld had joined Manning as Senior Vice President in New York.

On January 5, 2001, the firm issued a press release to announce the promotion of Mr Arbesfeld and others and referred to Manning as “one of the largest healthcare practices worldwide and has a broad array of clients including Allergan, Amgen, Eli Lilly and Company, Genentech, Hoffmann La-Roche, Kaiser Permanente, Novartis, Pharmacia and Procter & Gamble.”

In reading the press release, Mr Arbesfeld’s email expertise is apparently a bi-product of his work for Manning. “In this role,” it said, “Arbesfeld will help healthcare clients maximize internet-relations in the marketing and communications mix, and will expand the Practice’s strategic e-product offerings.”

On August 5, 2002, he identified himself in a Reuters article as representing none other than Glaxo, along with six other drug giants including Bristol-Myers, Aventis, J&J, AstraZeneca, Abbott Labs and Novartis, in a campaign to promote the “Together Rx” prescription drug card program for senior citizens. In 2005, the Reporters Handbook listed him as the contact person for J&J subsidiaries, Janssen Pharmaceutica, Ortho-McNeil Pharmaceutical and Ortho Biotech Products.

Less than a week after Mr Arbesfeld’s hatchet job on Dr Nissen, ex-FDA Deputy Commissioner Dr Scott Gottlieb planted an editorial in the May 29, 2007, Wall Street Journal entitled, “Journalist Malpractice,” accusing the New England Medical Journal of intentionally publishing the Nissen study to make the FDA look impotent. “The publication was timed,” he wrote, “to get ahead of the Food and Drug Administration’s more careful evaluation of the same issues.”

“The journal seemed bent on beating the FDA to the punch,” Dr Gottlieb claimed.

“The goal?” he said, “Painting the FDA as impotent, in order to argue for legislation winding through Congress that would increase regulatory hurdles for drug approvals.”

The only problem with the Nissen-NEJM conspiracy theory is that the issue under investigation in Congress right now is why the FDA did not warn the public about Avandia heart risks six months before the Nissen study was ever published.

In the end, when it comes to “Journalistic Malpractice,” the larger question would seem to be how was it that so many industry shills were able to get the major media outlets and medical journals to immediately publish commentaries and editorials attacking the NEJM and the Nissen research with headlines splashing all over the internet.

In his editorial, Dr Gottlieb notes that there are “questions” whether Avandia is associated with heart risks, but says they are “so far unsupported by more rigorous, randomized studies and extensive review by the FDA and other authorities around the world.”

“When it comes to the issue du jour, drug safety,” he wrote, “no description of medical research in a medical journal comes close to the detail level or scrutiny imposed by the FDA on study results before approval.”

There is no doubt much truth to this assertion, but the problem is that the industry insiders running the FDA refuse to act on the advice of the agency’s top scientists. In a July 26, 2007, speech on the Senate floor, Senator Charles Grassley (R-Iowa), of the Senate Finance Committee, said that, in the case of Avandia, “Not only did the FDA disregard the concerns and recommendations from the office responsible for post-marketing surveillance, but I have found that it also attempted to suppress scientific dissent.”

In the past two months, he told his fellow senators, “I’ve had to write to the FDA regarding the suppression of dissent from not one but two FDA officials involved in the review of Avandia.”

The Heartwire website conveniently echoed Dr Gottlieb’s sentiments by featuring portions of a May 23, 2007, unsigned editorial from the medical journal The Lancet, which claimed that the verdict on Avandia should await the results of a Glaxo sponsored trial called RECORD, not due out until 2009.

“Taken together,” the editorial said of Dr Nissen’s findings, “these results, although based on very small numbers of events, certainly raise a signal of concern and indicate the need for more reliable information about rosiglitazone’s safety.”

“But the FDA, physicians, and patients can reasonably await the results of RECORD, a phase 3 trial designed specifically to study cardiovascular outcomes,” it said.

“Until the results of RECORD are in,” the Lancet noted, “it would be premature to overinterpret a meta-analysis that the authors and NEJM editorialists all acknowledge contains important weaknesses.”

The problem with waiting two years for the results of the RECORD trial is that FDA scientist Dr David Graham reviewed the results of this study thus far and told an FDA advisory panel that the study design is so flawed that the results should not be considered in any risk benefit analysis of Avandia now, or in 2009, in a July 26, 2007 report.

In fact, Dr Graham says the RECORD study is so useless that it’s probably unethical to allow it to continue because no possible benefit can be achieved by allowing it to go on and that Avandia should be pulled off the market now because thousands of patients are being injured each month by using the drug.

At the end of his editorial, Dr Gottlieb lists himself as a physician and a resident fellow at the American Enterprise Institute who was Deputy Commissioner of the FDA from 2005 to 2007. However, back on August 24, 2005, the Seattle Times provided a much better picture of his background and highlighted the oddity of the FDA hiring him in the first place in light of his solid alliance with the industry. “Only a month ago,” the article states, “Dr Scott Gottlieb was a Wall Street insider, promoting hot biotech stocks to investors.”

“Now Gottlieb holds the No. 2 job,”” the Times notes, “at the federal agency that approves new drugs, oversees their safety and affects the fortunes of companies he once touted.”

“Now, as one of three deputy commissioners,” the article said, “Gottlieb will help oversee such major policies as the FDA’s fast-track approval process for drug and biotech products, a priority for many Wall Street funds and the pharmaceutical industry.”

The Times also noted that a half-dozen current and former FDA officials said they did not know of anyone else from Wall Street ever moving directly into such a high-level job at the agency.

A couple months later, the November 12, 2005, Boston Globe reported that Dr Gottlieb could not participate in formulating the nation’s defense plan against the avian flu due to conflicts of interest. He “was recused from key parts of the planning effort because his past consulting work for Manning Selvage & Lee involved companies whose products would be used to combat a flu pandemic,” it said.

The article pointed out that Dr Gottlieb’s former clients included Roche, the manufacturer of Tamiflu, and Sanofi-Aventis, the parent company of the nation’s sole flu vaccine maker.

According to the Globe, Manning paid Gottlieb a $12,500 monthly retainer for nine months for projects that included eight companies, and he was also paid $9,000 for private consulting work for VanGen Inc, a firm that won a $878-million contract to supply the US government with 75 million doses of anthrax vaccine.

In communicating with the FDA, lawmakers have mentioned that they found it “troubling” that Mr Arbesfeld might be trying to settle old scores with Dr Nissen because they were on opposite sides regarding the approval of the heart failure drug Natrecor.

However, Dr Nissen and Dr Gottlieb’s disputes go way back as well. In fact, on August 2, 2006, they participated in a debate on the topic: “Government Science Panels: Fair and Balanced?” sponsored by the Center for Science in the Public Interest, and reported on by Russell Mokhiber and Robert Weissman in Common Dreams.

Much to his credit, Dr Nissen openly communicated his objections to the industry’s infiltration of the FDA. While sitting right next Dr Gottlieb, he candidly described the conflicts of interest which he stated were “evident at the highest levels of the FDA.”

“For years,” he said of FDA leadership, “we had an interim FDA Commissioner, Lester Crawford, who shortly after confirmation, abruptly resigns, apparently because he and his wife owned stock in regulated companies.”

“Then the administration appointed Andrew von Eschenbach as interim commissioner creating another conflict,” he said. “In his role as director of the National Cancer Institute, von Eschenbach must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict,” he noted.

“But even worse,” Dr Nissen stated, “the administration appointed Scott Gottlieb as deputy commissioner.”

“He came to this job with no regulatory experience, directly from Wall Street, where he served as a biotech analyst and stock promoter,” Dr Nissen told the audience.

Dr Gottlieb’s response to Dr Nissen’s comments was basically that he would not dignify the comments with a response.

Firms that Dr Gottlieb was involved with prior to his gig at the FDA, according to the Globe, also include the Inamed Corp, one of two companies that were seeking to return silicone gel implants to the market and on November 17, 2006, the FDA announced that it would lift restrictions on the sale of the implants.

When Dr Gottlieb left the FDA, he headed right back to greener pastures with the drug giant Novartis. The press release to announce his hiring read: “Bench International Places Eminent Regulatory Advisor Scott Gottlieb, M.D., as Senior Counsel to Novartis.”

“Under an exclusive consulting agreement,” the release stated, “Scott Gottlieb, M.D., will provide advisory services to Novartis on matters of global regulatory policy and strategy.”

The FDA recruited two members of its alumni, Peter Pitts and Robert Goldberg, to take another swipe at Dr Nissen in a June 6, 2007, commentary in the Washington Times, using the same talking points as the anonymous blogger, by referring to Dr Nissen as a “self-appointed and media-anointed Patron Saint of Drug Safety” and “Saint Steven the Pure.”

For much of the childish commentary, they poke fun at Dr Nissen because he acknowledged in the NEJM that he consults for many drug companies but said he “requires them to donate all honoraria or consulting fees directly to charity so that he receives neither income nor a tax deduction.”

At the end of the commentary, Mr Pitts says he is a former FDA associate commissioner, and both men list their affiliation with the Center for Medicine in the Public Interest; but as usual, that listing really does not give credit where credit is due.

On its web site, the Center describes itself as “a non-partisan, non-profit educational charity,” and Mr Pitts is indeed listed as President, but his bio also says he is the Senior Vice President for Global Health Affairs at none other than Manning, Selvege & Lee.

The Manning firm apparently fills two important roles. It’s a breeding ground for industry moles preparing to enter “public service” and serves as an employment hub for industry shills once they finish their on average 2- to 3-year stint inside the Bush Administration.

In his CMPI bio, Mr Pitts describes his duties as the FDA’s Associate Commissioner from 2002 to 2004 as serving as the agency’s “Chief Messaging Officer.”

On June 7, 2007, Mr Pitts had this to say in defense of fellow hit-man Mr Arbesfeld on the Pharmalot web site: “I know Doug Arbesfeld and he is a guy devoted to advancing the public health.”

According to Mr Pitts, in sending the derogatory e-mail about Dr Nissen to journalists, Mr Arbesfeld was just standing up for the FDA and that people should know about the sacrifice he made by accepting a job in government.

“He is also a guy,” Mr Pitts says, “who took a pretty significant pay cut to put in some time in public service.”

Some would no doubt argue that it’s difficult to imagine that Mr Arbesfeld will end up in the poor house as a result of serving as the top industry mole inside the FDA.

Mr Pitts’ sidekick, Mr Goldberg, is indeed listed as the vice president of CMPI, but Mr Goldberg’s bio also says he used to be Director of the Manhattan Institute’s Center for Medical Progress and Chairman of its 21st Century FDA Task Force.

In fact, a review of the CMPI web site turned up a whole nest of ex-moles who served the industry in one capacity or another in the Bush Administration’s FDA. For instance, Daniel Troy, the former FDA Chief Counsel, also known as the “Godfather of Preemption,” sits on this “charity’s” Advisory Board.

His bio points out that he “played a principal role in FDA’s generally successful assertion of preemption in selected product liability cases.”

This “assertion of preemption” says that, as long as the FDA has approved a drug and its label, private citizens in state courts cannot sue the drug company for failing to warn about a product’s serious health risks, even in cases where it can be shown that the company concealed studies that revealed the risk from the public and the FDA.

Now that he’s switched back to private practice, Mr Troy’s CMPI bio says he currently specializes in constitutional and appellate litigation, as well as strategic counseling with “particular focus” on what else – clients regulated by the FDA.

The Advisory Board also includes, Tomas Philipson, whose bio says he served as the Senior Economic Advisor to the commissioner of FDA during 2003 and 2004 and as the Senior Economic Advisor to the administrator of the Centers for Medicare and Medicaid Services in 2004 and 2005.

That would mean that Mr Philipson served Mark McClellan, and they are now apparently joined at the hip because, as part of a program called “Patient-Centric and Prospective Medicine,” CMPI says it has created the Patient-Centric Health Forum and that Mr McClellan, “former Medicare administrator and FDA commissioner, will chair the group.”

So, it would appear that anyone looking for the retirement home for industry hit men who served in the Bush Administration’s FDA can find it right in the middle of cyberspace on the CMPI web site.

(This article is part of the Avandia Update series sponsored by the Baum Hedlund law firm)

Filed under: 2007, Avandia, CMPI, FDA, FDA hearing, Glaxo, Goldberg, Gottlieb, Manning, Pitts, stroke

Antidepressant Suicide Reports Continue to Mount

Evelyn Pringle May 2009

This week, journalist Philip Dawdy reported on the popular website Furious Seasons that Wyeth’s Effexor me-too drug Pristiq, FDA approved in early 2008, had already generated 1,272 adverse event reports in the FDA’s MedWatch system through the end of 2008, and wrote with live links to the reports:

“It’s discouraging that 17 of those reports involve completed suicides through the end of 2008. There are also 48 reports of suicidal ideation through the end of 2008.”

“That’s a lot in such a short period of time, especially considering that this drug isn’t exactly widely used,” Dawdy points out.

The FDA’s system reportedly captures only between 1% and ten percent of drug-induced adverse events.

The Adverse Psychiatric Drug Reaction website summarizes reports submitted to the FDA MedWatch system. For a two-year period between January 2004 and December 2006, the top 20 most commonly reported adverse events for Zoloft included 154 suicides and 162 suicide attempts. Paxil’s top 20 events for the same time period included 841 suicides and Prozac had 187 suicides and 68 attempts. Celexa had 232 suicide reports and Lexapro had 189 suicides and 87 suicide attempts.

On August 11, 2008, the Evansville Courier & Press reported a near record number of 23 suicides in the first seven months of 2008 in Vanderburgh County, Indiana. Vanderburgh County chief deputy coroner and a member of the local suicide prevention coalition, told the Courier that in the results of a preliminary investigation “one element” stands out:

“In a majority of the cases investigated, the victim was on antidepressant medication. And none of the victims were in counseling.”

Big Pharma funded front groups are constantly pumping out false claims that more people, and especially kids, are committing suicide due to the FDA’s adding a black box warning about an increased risk of suicide to the labels of SSRI and SNRI antidepressants, in blatant attempts to increase sales for the makers of the drugs.

Most notably, the drug company funded Center for Medicine in the Public Interest, founded by ex-FDA official Peter Pitts, runs a propaganda feeding internet blog called Drug Wonks, where Pitts and his side-kick, Dr Robert Goldberg, go so far as to accuse the people who pushed for the black box warnings of being directly responsible for dying kids in the US.

For instance, on December 21, 2007, Pitts’ DrugWonk’s blog claimed that FDA career scientist Dr David Graham, “helped push through the statistical analysis and organize the public outcry over SSRIs that resulted in a decline in antidepressant use and a corresponding increase in teen suicides.”

In a February 15, 2008 blog, Goldberg wrote that Congressman Bart Stupak “held several fear-drenched hearing about antidepressants in 2003-2004,” and: “He is partially responsible for the decline in SSRI prescription use and the corresponding increase in adolescent suicide.”

The facts are that the FDA announced the black box warnings would be added in October 2004 but they were not added until the spring of 2005. The government statistics show suicides for children aged one through eighteen in 2004 were 1,471. In 2005, there were 1,408 suicides in this age group and in 2006, the latest year posted, there were 1,296.

On July 24, 2008, Ed Silverman reported on data released by the Agency for Healthcare Research and Quality on Pharmalot that showed antidepressant prescriptions rose in 2005. “The increase amounted to roughly 10 percent, and that occurred in a year in which new and controversial Black Box warnings were added to the labeling,” he wrote.

In a November 19, 2008 speech on the Senate Floor, Senator Charles Grassley of Senate Finance Committee revealed that CMPI board member, Dr Fred Goodwin failed to disclose that he earned at least $1.3 million between 2000 and 2007 giving marketing lectures for drug makers, while hosting the radio show “Infinite Mind,” including one program titled “Prozac Nation: Revisited,” in March 2008 for which Goodwin opened with the line, “As you will hear today, there is no credible scientific evidence linking antidepressants to violence or suicide.”

“After listening to a recording of the show,” Grassley said, “it appeared to me that the real effect of this particular episode was to undercut any criticism that antidepressants might be linked to an increased risk of suicide.”

That very same week, Goodwin earned about $20,000 from Paxil and Wellbutrin maker GlaxoSmithKline. “Based upon the information provided to my staff, Dr. Goodwin was also very active on behalf of Glaxo in 2005,” Grassley said. “That year, Glaxo paid Dr. Goodwin over $300,000 in speaking fees and around $25,000 in expenses to discuss their products.”

For a DrugWonks blog on November 21, 2008, Goldberg posted the headline: “Generic Attack on Fred Goodwin,” and stated about Goodwin:

“He is being slimed by the same small-minded group that wants to savage science and replace it with a contorted combination of anger, unmedicated anecdotes and trial lawyer inspired opportunism.”

“Here’s the difference between Goodwin and his attackers: Fred has helped reduced the number of suicides among the mentally ill. They have helped increase them.”

“They have to live with their legacy. I am sure Fred will be content with his.”

On December 9, 2008, the British Medical Journal reported that “besides GlaxoSmithKline [Goodwin] has been paid by Pfizer, Solvay, Janssen, Eli Lilly, AstraZeneca, and Bristol-Myers Squibb.”

Another guest on Goodwin’s “Prozac Nation,” was Nada Stotland, the 2008-09 president of the American Psychiatric Association. “There was no good reason for the black box warning,” Stotland told the listening audience.

In 2006, the pharmaceutical industry accounted for about 30% of the American Psychiatric Association’s $62.5 million in financing, according to the July 12, 2008 New York Times.

Pfizer’s grant report shows the Zoloft maker donated more than $700,000 to this “non-profit” in 2008. Eli Lilly, the maker of Prozac, Cymbalta and Symbyax (Prozac and Zyprexa combined), also gave the APA grants totaling more than $600,000 in both the first and second quarter of 2008. In 2007, the group received over $400,000 from Lilly and Lilly also gave roughly $450,000 to the American Psychiatric Foundation.

A fact also not revealed on the show was that Stotland has served on the speakers’ bureaus of Glaxo and Pfizer, according to Slate Magazine.

Peter Pitts appeared on “Prozac Nation,” as well, touting his credentials as a former FDA official and president of CMPI, and claiming the suicide warnings caused a drop in the SSRI use with kids and an increase in suicides a year or two later. He specifically stated:

“And the result was that a lot of doctors stopped prescribing the medications because they are afraid of liability. And a lot of parents stopped giving their children medicines that had been prescribed. And not surprisingly one or two years later very large studies came out to show that in fact teen suicidality had shown an increase – so there was really a direct correlation. And I think the media bears a lot of the responsibility for that….”

But here too, Pitts failed to mention that he was then a senior-vice president at the PR firm Manning Selvage & Lee, whose clients included SSRI makers Lilly, Pfizer, and Glaxo. Him and Goodwin also failed to mention that CMPI received more than $1.4 million in 2006 from the pharmaceutical industry, as was later revealed in Slate.

Infinite Mind spoke of Pitts on the show as “a former FDA associate commissioner who was involved in the FDA’s 2004 ‘black box’ labeling of antidepressants as carrying a risk of suicidal thoughts and behavior, and who was at the time the ‘go-to’ guy for the FDA on that issue,” according to Bill Lichtenstein, senior executive producer of Infinite Mind, in a May 9, 2008 written statement posted on Pharmalot.

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

An excellent indepth commentary with transcribed portions of “Prozac Nation,” and details on Goodwin’s orchestration of the whole show was provided by Dr Jonathan Leo on July 29, 2008 [Link] .

During the heated debate over conflicts of interest not being disclosed by Pitts, a blogger on Pharmalot posted links to four DrugWonks blogs with personal attacks on people who pushed for the suicide warnings on SSRIs. Clicking on the links today brings up the statement: “The Page you are looking for has been moved or deleated. Try searching for the information you are looking for.” (Misspelling of deleted and all).

Pitts’ major claim to fame is citing his former title of FDA associate commission. He always lists his dates of service as running from 2002 to 2004. But in checking the press releases for his hiring and departure dates, it appears that Pitts has been fudging his credentials on his public resumes because he barely put in year at the FDA.

On March 12, 2009, the PR firm, Porter Novelli, announced that Pitts would be joining the agency in new gig as “Partner and Director” of Global Health Care.

“Porter Novelli has worked for, or partnered with, most of the major companies in the pharmaceutical industry,” the firm’s website points out. Clients listed on the site include AstraZeneca, Johnson & Johnson, Merck, Shire, Wyeth, and the Robert Wood Johnson Foundation.

The press release announcing his hiring claimed that: “From 2002 to 2004, Pitts served as the U.S. Food and Drug Administration’s associate commissioner for External Relations, where he acted as senior communications and policy adviser to the Commissioner.” His bio on the CMPI website also said Pitts was associate commissioner from 2002 to 2004.

However, an April 21, 2003 press release on his hiring date with the heading: “Peter J. Pitts Appointed Associate FDA Commissioner for External Relations,” states: “Commissioner of Food and Drugs Mark B. McClellan, M.D., Ph.D., today announced the appointment of a new Associate FDA Commissioner for External Relations.”

Less than fourteen months later, on June 4, 2004, FDA News reported that: “Peter Pitts … will be leaving his position, effective June 18, to become senior vice president for health affairs in the New York City office of public relations firm Manning, Selvage and Lee.”

On November 1, 2004, Medical Marketing & Media noted that the FDA had appointed Sheila Dearybury Walcoff as associate commissioner, “succeeding Peter Pitts, who left the agency in June to join Manning, Selvage & Lee.”

Pharmaceutical Executive published an interview with Pitts under the heading: “Thoughtleader: Peter Pitts, DrugWonk.com Get Up, Stand Up” on January 1, 2007.

He was described as the “chief voice” of DrugWonks, “a blog hosted by the Center for Medicine in the Public Interest.” In the interview Pitts states:

“There are lots of politicians, Senator Grassley and Representative Waxman to name just two, who often say FDA is in the pharmaceutical industry’s pocket. But anybody that has ever worked with FDA realizes not only is that not right, it’s comically wrong.”

The most “comical” remarks in the interview come when Pitts describes his “pet peeve.”

“People look at FDA and they don’t realize that anybody there could walk out the door and triple their salary in a day,” he says. “They don’t because they’re on a personal public health mission.”

Admittedly, Pitts apparently did stretch out his “personal public health mission” for about a year so he could pump up his resume with the title of ex-FDA official but he should at least be required to give employers the correct dates for his limited time of service.

Filed under: 2009, DrugWonks, FDA, Goldberg, KOL, Pitts, SSRIs, suicide

FDA Avandia Mole Defends Off Label Marketing of Natrecor

Evelyn Pringle August 12, 2007

It looks like that Mafia guy, Dr Steven Nissen, leader of the Cleveland Clinic gang, who blew the whistle on the diabetes drug Avandia and before that Vioxx, was on to something when he voted against the FDA’s approval of the heart failure drug Natrecor in 2001.

Giving once- or twice-weekly outpatient injections of Natrecor does not reduce the risk of death or hospitalization for heart or kidney problems, according to research presented at the American College of Cardiology meeting in New Orleans in March 2007.

In fact, the study of 920 patients found that outpatient use of Natrecor provided absolutely no benefit. The finding should halt the practice of giving once- or twice-weekly Natrecor to outpatients, said researcher Dr Clyde Yancy, medical director of the Baylor Heart and Vascular Institute in Dallas, Health Day reported on March 26, 2007.

Of course, the revelation that Dr Nissen was running the Cleveland Clinic Mafia and that they were out to get GlaxoSmithKline by publishing a study that showed Avandia increased the risk of heart attacks and deaths came in an email to reporters from FDA spokesman Douglas Arbesfeld, which included the warning to other drug companies, “if you don’t hire the Cleveland Clinic for your big trials then you face the firing squad from Nissen and Company.”

Mr Arbesfeld left his position as a highly-paid spokesperson for Johnson & Johnson to become a dedicated public servant at the FDA, if his supporters are to be believed.

When his conduct of sending the email came under scrutiny, Peter Pitts, who co-authored a June 6, 2007, critical commentary in the Washington Times about the Avandia study and fondly referred to Dr Nissen as a “Patron Saint of Drug Safety” and “Saint Steven the Pure,” put out a statement on the internet saying that, by sending the email, Mr Arbesfeld was just defending the FDA and praised his selfless work, stating:

“I know Doug Arbesfeld,” he wrote, “and he is a guy devoted to advancing the public health,” he wrote.

“He is also a guy who took a pretty significant pay cut to put in some time in public service,” Mr Pitts pointed out.

In response to that assertion, it could certainly be argued that a mole at the FDA would be in a position to earn far more money by selling invaluable insider information to all the drug companies than as media person working for one company.

It should be noted that in his email to reporters, Mr Arbesfeld also referred to Dr Nissen as St Steven – surely just by coincidence.

For the record, the Cleveland Clinic is rated as the top cardiac center in the country by US News and World Report, and Dr Nissen holds the number 72 position on Time Magazine’s list of the 100 most influential people in our world.

An effort that included at least 50 different google searches on the internet over a period of several days found no similar praise listed for Mr Arbesfeld other than Mr Pitts’ recent two-liner that showed up on about every search.

At the end of his Times commentary, Mr Pitts listed himself as the president of the Center for Medicine in the Public Interest and a former FDA associate commissioner, but a little checking revealed that he is also a Senior Vice President at the public relations firm of Manning, Selvage & Lee.

A review of the Manning website shows that the firm’s clients have included Pfizer, Eli Lilly, AstraZeneca, Sanofi-Aventis, Johnson & Johnson, Genentech, Novartis, Amgen and Hoffmann La-Roche.

A review of Mr Pitts’ articles on the internet clearly shows that he is in lockstep with his industry clients against: (1) allowing Americans to import drugs from other countries to cut costs; (2) allowing the government to negotiate lower drug prices; (3) barring drug makers from promoting their drugs for uses not approved by the FDA; (4) cutting back on direct-to-consumer advertising, and (5) adding black box warnings to product labels.

As luck would have it, a bit more checking found a December 16, 1999, press release by the Healthcare Marketing & Communications Council which reported that Mr Arbesfeld had joined Manning, Selvage & Lee as Senior Vice President.

The list of pharmaceutical companies that Mr Arbesfeld has worked for over the years includes Ciba-Geigy in 1994, and Rhone Poulenc Rorer Pharmaceuticals in 1998, the same year the company announced that it would merge with Hoechst AG to become Aventis, which merged with Sanofi-Synthelabo in 2004 to become Sanofi-Aventis.

In 1999, Mr Arbesfeld would have been working for the Manning clients listed above, and on August 5, 2002, he identified himself to Reuters as promoting a prescription drug card program called “Together Rx” for 7 drug companies that included Bristol-Myers, Aventis, GlaxoSmithKline, Johnson & Johnson, AstraZeneca, Abbott Laboratories and Novartis.

Finally, Mr Arbesfeld is listed as the contact person for Johnson and Johnson subsidiaries Janssen Pharmaceutica, Ortho-McNeil Pharmaceutical and Ortho Biotech Products in the 2005 Reporters Handbook.

While his supporters say Mr Arbesfeld’s email to reporters was justified, lawmakers on Capitol Hill see it differently and have launched an investigation into what they refer to as a smear campaign against Dr Nissen. At a June 6, 2007, hearing before the US House Oversight Government Reform Committee, in response to questions about Mr Arbesfeld email stunt, FDA Commissioner Andrew von Eschenbach claimed that he did not approve of the email and told the lawmakers, “I completely concur with you that it was inappropriate and unacceptable.”

“It was an inappropriate and unfortunate act on the part of an individual,” he said, “which has been addressed through disciplinary procedures.”

In a letter to the FDA Commissioner, the lawmakers said they found it troubling that Mr Arbesfeld might be trying to settle old scores with Dr Nissen because he cast the lone vote against the approval of the heart drug Natrecor (nesiritide) and later spoke out against the off-label use of the drug in a New York Times article in which Mr Arbesfeld spoke on behalf of the drug’s maker J&J subsidiary Scios.

The fact is, a review of the regulatory history behind Natrecor proves that Dr Nissen was right then, just as he is now about Avandia.

The drug was approved for limited use by hospitalized patients with acute congestive heart failure, to be administered intravenously under close supervision. However, due to a massive off-label marketing campaign, the drug was soon being administered in outpatient settings at a much greater dose and for longer periods of time than recommended.

In May 2005, the New York Times reported that tens of thousands of patients were undergoing “tune-ups” at outpatient clinics by receiving weekly infusions of Natrecor over a period of months.

In the July 14, 2005, New England Journal of Medicine, apparently another Mafia guy from the Cleveland Clinic gang, Dr Eric Topol, was out to get J&J because he reported that the company was encouraging physicians to open their own infusion centers to bill Medicare for Natrecor treatment and that company documents instructed doctors to bill Medicare $408 for eight hours of observation during the infusion, above and beyond the actual cost of the drug, which was around $500 per vial, he said.

In addition, the company set up a toll-free telephone hotline for “Natrecor Reimbursement Support” and published a 46-page reimbursement and billing guide to provide doctors with specific Medicare billing codes.

“Natrecor was never shown to be superior for reducing death or reducing the need for repeat hospitalizations,” Dr Topol said, and asked: “How could this happen? All of a sudden we have 600,000 people using this drug.”

He also pointed out that other drugs, costing less than $10 a dose, were equally effective.

The Natrecor infusion-for-profit scheme was indeed on a roll. J&J had recruited doctors and nurses with experience in administering infusions to deliver presentations at medical seminars, and some clinics had programs set up to administer Natrecor to patients twice a week for up to 12 weeks. In 2004, Natrecor brought in about $400 million for J&J, and sales were projected to be $700 million for 2005.

However, the profiteers were hit with a ton of bricks on April 20, 2005, when a study appeared in the Journal of the American Medical Association that reported patients treated with Natrecor were 80% more likely to die in the 30 days following the treatment than patients given a placebo, by Dr Jonathan Sackner-Bernstein of the North Shore University Hospital in Manhasset, NY; Drs Marcin Kowalski and Marshal Fox, of St Luke’s-Roosevelt Hospital Center in NY; and Dr Keith Aaronson of the University of Michigan.

On April 26, 2005, in response to the findings of the study, Mr Arbesfeld told HeartWire, “We take any question about the safety of Natrecor seriously.”

“At the same time,” he said, “a review of Scios’s full clinical study data set does not show a statistically significant difference in mortality.”

Although the collective data from the studies reflects a 23% higher death rate for those taking Natrecor, Mr Arbesfeld said, the number of patients in the studies was too small to produce conclusive results of death risk, in a Reuters article on April 25, 2007.

In response to comments about Natrecor not being approved for outpatient use, Mr Arbesfeld told the Times that the FDA label did not specify where the drug could be administered, so giving it in an outpatient setting did not run counter to its approved use.

However, that Mafia guy from the Cleveland Clinic, Dr Nissen, told the Times that treating patients in ambulatory settings was “inappropriate and cannot be recommended.”

Before long, more doctors began speaking out. Cardiologist Dr Milton Packer, chairman of the advisory panel that voted to approve the drug, told the Times on May 17, 2005, that Natrecor was not intended for outpatient use. “We said this is a drug that should be approved for patients who are short of breath at rest, who are hospitalized,” he said.

He also faulted the FDA’s approval of a label that did not specify that Natrecor was for hospital use only.

Dr Sackner-Bernstein expressed outrage in the Health Day Report. “The people involved at Scios and others who knew about this data should be hanging their heads,” he said.

“What is wrong with everybody,” he continued, “that you’ve got a drug that increases renal dysfunction and death, and costs 50 times as much as a regular treatment, and yet it’s given to hundreds of thousands of people?”

After the April study came out, J&J hired a heart specialist, Dr Eugene Braunwald, to form a committee to review the studies, and the committee reached the same conclusion, that it was inappropriate to use Natrecor except with acutely ill hospitalized patients.

Specifically, the panel said, Natrecor should be used only when patients show up at a hospital with acute heart failure; that it should not replace diuretics as the front-line treatment; and that it should not be used where patients schedule appointments to receive the drug ahead of time.

Their report also stated: “Scios should immediately undertake a proactive educational program to inform physicians regarding the conditions and circumstances in which [Natrecor] should and should not be used.”

So what did J&J do in response? According to Dr Packer, who was a member of the panel, the committee members were shocked several weeks later when they received invitations from a mass mailing to enroll in a continuing medical education program, sponsored by Scios, that appeared to promote the outpatient use.

“We were flabbergasted,” Dr Packer told the Times on August 1, 2005. “Scios was sponsoring meetings to discuss nesiritide and its potential use in outpatients.”

As so often happens these days, this drugging-for-profit scheme caught the attention of lawmakers because about 80% of the patients receiving Natrecor were on Medicare.
D-Day came on December 5, 2005, when the Centers for Medicare and Medicaid Services announced that Medicare would no longer pay for outpatient infusions.

But the Natrecor story is far from over because, according to Johnson & Johnson’s 2006 Annual Report, the company received a subpoena from the US Attorney’s Office, District of Massachusetts, in July 2005, seeking documents related to the sales and marketing of Natrecor, and in August 2005, J&J was advised that the investigation would be handled by the US Attorney’s Office for the Northern District of California in San Francisco.

The latest news came on March 12, 2007, when J&J revealed that it had received 3 new subpoenas from the US Attorneys’ offices in Philadelphia, Boston and San Francisco wanting information for the investigation into the company’s sales and marketing of Natrecor.

More recently, in an apparent repeat of the exact same scam, investigators have found that J&J and Amgen have been paying doctors to administer the anemia drugs Aranesp, Epogen and Procrit off label for profit. On May 9, 2007, the New York Times reported that drug makers are paying “hundreds of millions of dollars to doctors every year in return for giving their patients anemia medicines.”

The Times cited documents obtained from a former employee of a group of 6 cancer doctors which showed that between them, the 6 doctors received $2.7 million from Amgen for prescribing $9 million worth of anemia drugs in 2006.

On May 10, 2007, the Wall Street Journal cited a document provided by a former J&J sales representative-turned-whistleblower which showed that a doctor who purchased nearly $1 million worth of Procrit over 15 months would receive $237,885.

In March 2007, the FDA ordered black box warnings on the drug’s labels about an increased risk of numerous adverse events and issued a public health advisory warning health care providers to administer the lowest possible dose necessary to treat anemia.

According to the FDA, as of March 2007, there are five clinical trials that demonstrated decreased survival time in cancer patients receiving the drugs compared with those receiving transfusion support.

The agency also reported a higher rate of blood clots, strokes, heart failure, heart attacks and death were found in patients with chronic kidney failure when the drugs were given to raise hemoglobin levels higher than recommended.

The FDA advisory also noted a higher risk of blood clots in patients who were scheduled for major surgery and received the anemia drugs and also warned of an increased rate of tumor growth in patients with advanced head and neck cancer receiving radiation therapy and metastatic breast cancer patients receiving chemotherapy, when the drugs were given to maintain levels higher than recommended.

J&J is already facing several class-action lawsuits filed by shareholders as a result of the revelation of this latest drugging-for-profit scheme, and the company has also received a subpoena from New York’s attorney general requesting information on the sales and promotional activities related to Procrit.

But then, why should J&J worry over a minor little investigation by the NY attorney general. The feds have been investigating the Natrecor fiasco for more than 2 years, and the J&J executives who reaped the benefits have probably not lost one wink of sleep.

Filed under: 2007, Amgen, anemia drugs, Aranesp, Avandia, Epogen, FDA, Johnson and Johnson, Manning, MEDICAID, MEDICARE, Natrecor, Pitts, Procrit

FDA Henchmen Protect Avandia Profits

Evelyn Pringle August 19, 2007

The FDA’s latest campaign to protect the profits of a drug company over the safety of Americans is unprecedented, and the organizers include a gang of current and former FDA officials largely credited with turning the nation’s regulatory beagle into a lapdog for Big Pharma under the Bush Administration.

FDA spokesman Douglas Arbesfeld, apparently the industry’s new inside guy, kicked off the campaign by sending an e-mail to journalists which was intended to discredit Dr Steven Nissen and the Cleveland Clinic. Dr Nissen’s study appeared online on May 21, 2007, in the New England Journal of Medicine and warned that GlaxoSmithKline’s diabetes drug Avandia increased the risk of heart attacks by 43% and death from cardiovascular events by possibly 64%.

The talking points for the media appear to have been formulated and agreed upon ahead of time between Arbesfeld and others (see below) because more than one story from ostensibly different sources later appeared in the media and on the internet referring to Dr Nissen with such names as “St Steven”, “Patron Saint of Drug Safety” and “Saint Steven the Pure.”

In his email to journalists, Mr Arbesfeld pasted portions of an article which appeared on the Heartwire website, containing umpteen critical comments about Dr Nissen and the Avandia study, as well as comments made by an anonymous blogger on the internet who said that business at the Cleveland Clinic is run similar to a Mafia TV series. The full bog states:

“Wake up pharmaceutical companies, this is a call from Dr. Nissen, if you don’t hire the Cleveland Clinic for your big trials then you face the firing squad from Nissen and Company.”

“The Cleveland Clinic was one of the most respected names in medicine, now they are positioning themselves as candidates to take over for a new series on HBO to replace the Soprano’s — the Clinico’s ‘next week who should we wack ……’ — Bata bing bata boon. Comment by Brian A – May 22, 2007.”

However, it could just as easily be inferred that Mr Arbesfeld authored the slanderous blog and supplied it to Heartwire with the intention of quoting it later from a “reputable” web site. For its part, Heartwire has since removed what it says are “unsubstantiated remarks about Dr Nissen and the Cleveland Clinic,” and states: “In retrospect we regret that we published those sentences, as they do not meet the highest standards of journalistic or scientific integrity or credibility.”

The smear campaign has federal lawmakers up in arms. At a June 6, 2007 hearing before the House Oversight and Government Reform Committee, in response to questions about Mr Arbesfeld sending the e-mail under his official title of FDA spokesman, FDA Commissioner Andrew von Eschenbach told the lawmakers, “It was an inappropriate and unfortunate act on the part of an individual which has been addressed through disciplinary procedures.”

Dr Nissen is none too happy about the stunt either. “I’m a pretty tough guy,” he told ABC News on May 30, 2007, “but I’ll tell you, having this kind of an e-mail that questions my motives, broadcast to the major journalists with whom I work and have established a reputation, is — it’s an outrage.”

As for his part, Mr Arbesfeld told the Boston Globe that the email reflected his own personal views and not the FDA’s. Any assertion that the email reflected his own personal views is not quite credible considering that his previous employment was always promoting the views of the industry.

A few articles in the media mentioned that Mr Arbesfeld worked for Johnson & Johnson, but his employment with public relations firm Manning Selvage & Lee was not noted. On December 16, 1999, the Healthcare Marketing & Communications Council reported that Mr Arbesfeld had joined Manning as Senior Vice President in New York.

On January 5, 2001, the firm issued a press release to announce the promotion of Mr Arbesfeld and others and referred to Manning as “one of the largest healthcare practices worldwide and has a broad array of clients including Allergan, Amgen, Eli Lilly and Company, Genentech, Hoffmann La-Roche, Kaiser Permanente, Novartis, Pharmacia and Procter & Gamble.”

In reading the press release, Mr Arbesfeld’s expertise with using the Internet is apparently a bi-product of his work for Manning. “In this role,” it said, “Arbesfeld will help healthcare clients maximize internet-relations in the marketing and communications mix, and will expand the Practice’s strategic e-product offerings.”

On August 5, 2002, Arbesfeld identified himself in a Reuters article as representing none other than Glaxo, along with six other drug giants including Bristol-Myers, Aventis, J&J, AstraZeneca, Abbott Labs and Novartis, in a campaign to promote the “Together Rx” prescription drug card program for senior citizens. In 2005, the Reporters Handbook listed him as the contact person for J&J subsidiaries, Janssen Pharmaceutica, Ortho-McNeil Pharmaceutical and Ortho Biotech Products.

Less than a week after Mr Arbesfeld’s hatchet job on Dr Nissen, ex-FDA Deputy Commissioner Dr Scott Gottlieb planted an editorial in the May 29, 2007, Wall Street Journal entitled, “Journalist Malpractice,” accusing the New England Medical Journal of intentionally publishing the Nissen study to make the FDA look impotent. “The publication was timed,” he wrote, “to get ahead of the Food and Drug Administration’s more careful evaluation of the same issues.”

“The journal seemed bent on beating the FDA to the punch,” Dr Gottlieb claimed.

“The goal?” he said, “Painting the FDA as impotent, in order to argue for legislation winding through Congress that would increase regulatory hurdles for drug approvals.”

The only problem with the Nissen-NEJM conspiracy theory is that the issue under investigation in Congress right now is why the FDA did not warn the public about Avandia heart risks six months before the Nissen study was ever published.

In the end, when it comes to “Journalistic Malpractice,” the larger question would seem to be how was it that so many industry shills were able to get the major media outlets and medical journals to immediately publish commentaries and editorials attacking the NEJM and the Nissen research with headlines splashing all over the internet.

In his editorial, Dr Gottlieb notes that there are “questions” whether Avandia is associated with heart risks, but says they are “so far unsupported by more rigorous, randomized studies and extensive review by the FDA and other authorities around the world.”

“When it comes to the issue du jour, drug safety,” he wrote, “no description of medical research in a medical journal comes close to the detail level or scrutiny imposed by the FDA on study results before approval.”

Assuming this is true, the problem is that the industry insiders running the FDA refuse to act on the advice of the agency’s top scientists with first hand access to the underlying data. In a July 26, 2007 speech on the Senate floor, Senator Charles Grassley (R-Iowa), of the Senate Finance Committee, said that, in the case of Avandia, “Not only did the FDA disregard the concerns and recommendations from the office responsible for post-marketing surveillance, but I have found that it also attempted to suppress scientific dissent.”

In the past two months, he told his fellow senators, “I’ve had to write to the FDA regarding the suppression of dissent from not one but two FDA officials involved in the review of Avandia.”

The Heartwire website conveniently echoed Dr Gottlieb’s sentiments by featuring portions of a May 23, 2007, unsigned editorial from the medical journal The Lancet, which claimed that the verdict on Avandia should await the results of a Glaxo sponsored trial called RECORD, not due out until 2009.

“Taken together,” the editorial said of Dr Nissen’s findings, “these results, although based on very small numbers of events, certainly raise a signal of concern and indicate the need for more reliable information about rosiglitazone’s safety.”

“But the FDA, physicians, and patients can reasonably await the results of RECORD, a phase 3 trial designed specifically to study cardiovascular outcomes,” it said.

“Until the results of RECORD are in,” the Lancet noted, “it would be premature to overinterpret a meta-analysis that the authors and NEJM editorialists all acknowledge contains important weaknesses.”

The problem with waiting two years for the results of the RECORD trial is that FDA scientist Dr David Graham reviewed the results of this study thus far and told an FDA advisory panel that the study design is so flawed that the results should not be considered in any risk benefit analysis of Avandia now, or in 2009.

In fact, Dr Graham says the RECORD study is so useless that it is probably unethical to allow it to continue because no possible benefit can be achieved by allowing it to go on and that Avandia should be pulled off the market now because thousands of patients are being injured each month by using the drug.

At the end of his editorial, Dr Gottlieb lists himself as a physician and a resident fellow at the American Enterprise Institute, as well as former Deputy Commissioner of the FDA from 2005 to 2007. However, back on August 24, 2005, the Seattle Times provided a much better picture of his background and highlighted the oddity of the FDA hiring him in the first place in light of his solid alliance with the industry. “Only a month ago,” the article states, “Dr Scott Gottlieb was a Wall Street insider, promoting hot biotech stocks to investors.”

At the time, the Times noted, “Now Gottlieb holds the No. 2 job at the federal agency that approves new drugs, oversees their safety and affects the fortunes of companies he once touted.”

“Now, as one of three deputy commissioners,” the article said, “Gottlieb will help oversee such major policies as the FDA’s fast-track approval process for drug and biotech products, a priority for many Wall Street funds and the pharmaceutical industry.”

The Times also noted that a half-dozen current and former FDA officials said they did not know of anyone else from Wall Street ever moving directly into such a high-level job at the agency.

A couple months later, the November 12, 2005, Boston Globe reported that Dr Gottlieb could not participate in formulating the nation’s defense plan against the avian flu due to conflicts of interest. He “was recused from key parts of the planning effort because his past consulting work for Manning Selvage & Lee involved companies whose products would be used to combat a flu pandemic,” it said. Yes, the very same Manning Selvage & Lee at which Arbesfeld held the Senior Vice President position. Does anyone smell a rat (or several)?

The article pointed out that Dr Gottlieb’s former clients included Roche, the manufacturer of Tamiflu, and Sanofi-Aventis, the parent company of the nation’s sole flu vaccine maker.

According to the Globe, Manning paid Gottlieb a $12,500 monthly retainer for nine months for projects that included eight companies, and he was also paid $9,000 for private consulting work for VanGen Inc, a firm that won a $878-million contract to supply the US government with 75 million doses of anthrax vaccine.

Dr Nissen and Dr Gottlieb’s disputes are not new. In fact, on August 2, 2006, they participated in a debate on the topic: “Government Science Panels: Fair and Balanced?” sponsored by the Center for Science in the Public Interest, and reported on by Russell Mokhiber and Robert Weissman in Common Dreams.

Likewise, lawmakers have mentioned in their communications with the FDA that they found it “troubling” that Mr Arbesfeld might be trying to settle old scores with Dr Nissen because they were on opposite sides regarding the approval of the heart failure drug Natrecor.

Much to his credit, Dr Nissen openly communicated his objections to the industry’s infiltration of the FDA. While sitting right next to Dr Gottlieb, he candidly described the conflicts of interest, which he stated were “evident at the highest levels of the FDA.”

“For years,” he said of FDA leadership, “we had an interim FDA Commissioner, Lester Crawford, who shortly after confirmation, abruptly resigns, apparently because he and his wife owned stock in regulated companies.”

“Then the administration appointed Andrew von Eschenbach as interim commissioner creating another conflict,” he said. “In his role as director of the National Cancer Institute, von Eschenbach must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict,” he noted.

“But even worse,” Dr Nissen stated, “the administration appointed Scott Gottlieb as deputy commissioner.”

“He came to this job with no regulatory experience, directly from Wall Street, where he served as a biotech analyst and stock promoter,” Dr Nissen told the audience.

Dr Gottlieb’s response to Dr Nissen’s comments was, in essence, that he would not dignify the comments with a response.

Firms with which Dr Gottlieb was involved prior to his gig at the FDA, according to the Globe, also include the Inamed Corp, one of two companies that were seeking to return silicone gel implants to the market and on November 17, 2006, the FDA announced that it would lift restrictions on the sale of the implants.

When Dr Gottlieb left the FDA, he headed right back to greener pastures with the drug giant Novartis. The press release to announce his hiring read: “Bench International Places Eminent Regulatory Advisor Scott Gottlieb, M.D., as Senior Counsel to Novartis.”

“Under an exclusive consulting agreement,” the release stated, “Scott Gottlieb, M.D., will provide advisory services to Novartis on matters of global regulatory policy and strategy.”

Two more members of FDA’s alumni, Peter Pitts and Robert Goldberg took another swipe at Dr. Nissen in a June 6, 2007 commentary in the Washington Times, using the same talking points as the anonymous blogger, likewise referring to Dr. Nissen as a “self-appointed and media-anointed Patron Saint of Drug Safety” and “Saint Steven the Pure.”

For much of the childish commentary, they poke fun at Dr Nissen because he acknowledged in the NEJM that he consults for many drug companies but said he “requires them to donate all honoraria or consulting fees directly to charity so that he receives neither income nor a tax deduction.”

At the end of the commentary, Mr Pitts says he is a former FDA associate commissioner, and both men list their affiliation with the Center for Medicine in the Public Interest; but as usual, that listing really does not give credit where credit is due.

On its web site, the Center describes itself as “a non-partisan, non-profit educational charity,” and Mr Pitts is indeed listed as President, but his bio also says he is the Senior Vice President for Global Health Affairs at none other than Manning, Selvege & Lee.

The Manning firm apparently fills two important roles. It’s a breeding ground for industry moles preparing to enter “public service” and serves as an employment hub for industry shills once they finish their on average 2- to 3-year stint inside the Bush Administration.

In his CMPI bio, Mr Pitts describes his duties as the FDA’s Associate Commissioner from 2002 to 2004 as serving as the agency’s “Chief Messaging Officer.”

On June 7, 2007, Mr Pitts had this to say in defense of fellow hit-man Mr Arbesfeld on the Pharmalot web site: “I know Doug Arbesfeld and he is a guy devoted to advancing the public health.”

According to Mr Pitts, in sending the derogatory e-mail about Dr Nissen to journalists, Mr Arbesfeld was just standing up for the FDA and that people should know about the sacrifice he made by accepting a job in government.

“He is also a guy,” Mr Pitts says, “who took a pretty significant pay cut to put in some time in public service.”

Some would no doubt argue that it’s difficult to imagine that Mr Arbesfeld will end up in the poor house as a result of serving as the top industry mole inside the FDA.

Mr Pitts’ sidekick, Mr Goldberg, is indeed listed as the vice president of CMPI, but Mr Goldberg’s bio also says he used to be Director of the Manhattan Institute’s Center for Medical Progress and Chairman of its 21st Century FDA Task Force.

In fact, a review of the CMPI web site turned up a whole nest of ex-moles who served the industry in one capacity or another in the Bush Administration’s FDA. For instance, Daniel Troy, the former FDA Chief Counsel, also known as the “Godfather of Preemption,” sits on this “charity’s” Advisory Board.

Troy’s bio points out that he “played a principal role in FDA’s generally successful assertion of preemption in selected product liability cases.”

This “assertion of preemption” says that, as long as the FDA has approved a drug and its label, private citizens in state courts cannot sue the drug company for failing to warn about a product’s serious health risks, even in cases where it can be shown that the company concealed studies that revealed the risk from the public and the FDA.

Now that he’s switched back to private practice, Mr Troy’s CMPI bio says he currently specializes in constitutional and appellate litigation, as well as strategic counseling with “particular focus” on what else – clients regulated by the FDA.

The Advisory Board also includes, Tomas Philipson, whose bio says he served as the Senior Economic Advisor to the commissioner of FDA during 2003 and 2004 and as the Senior Economic Advisor to the administrator of the Centers for Medicare and Medicaid Services in 2004 and 2005.

That would mean that Mr Philipson served Mark McClellan, and they are now apparently joined at the hip because, as part of a program called “Patient-Centric and Prospective Medicine,” CMPI says it has created the Patient-Centric Health Forum and that Mr McClellan, “former Medicare administrator and FDA commissioner, will chair the group.”

So, it would appear that anyone looking for the retirement home for industry hit men who served in the Bush Administration’s FDA can find it right in the middle of cyberspace on the CMPI web site.

(This article is part of the Avandia Update series sponsored by the Baum Hedlund law firm)

Filed under: 2007, Avandia, CMPI, FDA, Glaxo, Goldberg, Gottlieb, Manning, Pitts, SSRIs, Troy

FDA Guerillas of Wonky DrugWonks – Part I

Evelyn Pringle August 6, 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 — and the decision was made not to mention it on the air.”

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

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

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

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

“The BMJ did not intend to suggest that Eli Lilly caused these documents to go missing. As a result of the investigation, it is clear that these documents did not go missing.”

“The BMJ accepts that Eli Lilly acted properly in relation to the disclosure of these documents in these claims. The BMJ is happy to set the record straight and to apologise to Eli Lilly for this statement, which we now retract, but which we published in good faith.”

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

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

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

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

Pharmalot’s pg, posted quotes from Lilly documents in a May 9, blog, from exhibits in a Prozac trial presented to the jury in a timeline to show that Lilly knew Prozac caused patients to become violent or suicidal long before the drug was approved in 1988. For example, a May 1984 document states: “During the treatment with the preparation (Prozac) 16 suicide attempts were made, 2 of these with success. As patients with a risk of suicide were excluded from the studies, it is probable that this high proportion can be attributed to an action of the preparation (Prozac) . . .”

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

Pharmalot’s pg, responded to this charge by writing, “Personal Attacks – a Few Examples?” with links to 5 blogs on DrugWonks. In a May 8 blog, pg, posted this example: “…Where will Healy, David Graham and the rest go to wash the blood off their hands? And will the FDA do the right thing and stop handing black boxes out to protect themselves from Senator Grassley and the press?”

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

After reading the blogs written by Mr Pitts and Mr Goldberg, Pharmalot’s Eskimo wrote: “Mr. Pitts, looking at all those posts on drugwonks.com, I couldn’t tell who was making the personal attacks, the “kooks” and the “document stealers” or the site’s authors who label them that way.”

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

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

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

“We are aware that our critics don’t have the intellectual bandwidth or the maturity to actually engage on the issues or respectfully disagree or debate,” he said. “Still we expect accuracy and for others to provide some context even as they take their shots as they are entitled to in a free society.”

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

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

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

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

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

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

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

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

Major story gone missing

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

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

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

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

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

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

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

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

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

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

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

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

Filed under: 2008, Avandia, CMPI, DrugWonks, FDA, Glaxo, Goldberg, Manning, NPR, Pitts, Preemption, SSRIs, Troy

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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