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

FDA Shields Drug Companies From Lawsuits

Evelyn Pringle February 2006

Last month, the FDA revealed its latest protective policy for drug companies in a statement that said people who believe they have been injured by drugs approved by the FDA should not be allowed to sue drug companies in state courts.

“We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don’t have the same scientific knowledge,” said Scott Gottlieb, the FDA’s deputy commissioner for medical and scientific affairs.

The agency’s assertion of “federal preemption” was included as a preamble to its new drug labeling guidelines.

The claim of preemption was quickly attacked by trial lawyers and members of Congress as another effort by the Bush administration to limit the public’s ability to bring and win lawsuits, according to the January 19, 2006 Washington Post.

“Eliminating the rights of individuals to hold negligent drug companies accountable puts patients in even more danger than they already are in from drug company executives that put profits before safety,” said Ken Suggs, president of the Association of Trial Lawyers of America.

“The fact that the drug industry can get the FDA to rewrite the rules so that CEOs can escape accountability for putting dangerous and deadly drugs on the market is the scariest example yet of how much control these big corporations have over our political process,” Mr Suggs told the Post.

In response to the FDA’s announcement, Senator Kennedy issued a statement that said: “It’s a typical abuse by the Bush Administration — take a regulation to improve the information that doctors and patients receive about prescription drugs and turn it into a protection against liability for the drug industry.”

The National Conference of State Legislatures, a bipartisan group that represents state lawmakers, accused the FDA of trying to seize authority that it did not have.

Over the past several years, lawmakers have been turning up the heat on both the FDA and the pharmaceutical industry in response to their combined failure to reveal problems found during studies conducted on top selling drugs like Vioxx.

At one point, Senator Charles Grassley (R-Iowa), Chairman of the Senate Finance Committee, came right out and accused the FDA of suppressing studies in order to protect pharmaceutical industry profits and the careers of certain FDA officials.

“The Vioxx example showed that the FDA and Merck were too close for comfort,” Senator Grassely told Health News on March 12, 2005. “Testimony and documents at our Finance Committee hearing showed that the FDA allowed itself to be manipulated by Merck,” he said.

Based on a trial that took place in 2000, both the FDA and Merck were aware that heart attacks were five times more likely in patients taking Vioxx than among those taking a similar drug, Sen Grassley pointed out, but the FDA did nothing to change the labeling on the drug for nearly two years, while Merck aggressively marketed its product on nightly TV.

Back on November 18, 2004, he generated enormous media attention when he held hearings on Vioxx, and FDA scientist, Dr David Graham, who works in the FDA Office of Drug Safety, testified that Vioxx may have been responsible for tens of thousands of heart attacks and strokes but that his superiors had pressured him to keep silent about his findings.

“The estimates range from 88,000 to 139,000 Americans,” Dr Graham told the committee. “Of these, 30 to 40 percent probably died,” he advised.

“For the survivors,” he added, “their lives were changed forever.”

To put this large number of injuries into perspective, Dr Graham told members of the committee that instead of a serious side-effect of a prescription drug, to think of it as if they were talking about jetliners.

“If there were an average of 150 to 200 people on an aircraft,” he said, “this range of 88,000 to 138,000 would be the rough equivalent of 500 to 900 aircraft dropping from the sky.”

“This translates to 2-4 aircraft every week,” he noted, “week in and week out, for the past 5 years.”

“If you were confronted by this situation,” Dr Graham asked the committee, “what would be your reaction, what would you want to know and what would you do about it?”

He condemned the FDA’s failure to acknowledge the risks that Vioxx posed to millions of people in the 5 years it was allowed to remain on the market. “I strongly believe that this should have been, and largely could have been, avoided,” Dr Graham told the committee.

The Vioxx matter caught the attention of the Senate Finance Committee basically because of the Vioxx related costs to government programs like Medicaid and Medicare. The committee is responsible for oversight of the two programs. At the November 18, 2004 hearing, Senator Max Baucus said:

“In the 5 years that Vioxx was on the market, Medicaid spent more than $1 billion on the drug.”

“And Medicaid bears the cost of any additional medical care necessary when drugs cause injury,” he pointed out.

The hearings followed a study that estimated between 28,000 and 160,000 deaths may have been caused by the Vioxx since it gained FDA approval in 1999.

By far, the Vioxx debacle is the most serious public health failure to occur since the FDA took on the authority for safety oversight of medical products in 1938.

On September 3, 2005, Shane Ellison, M.Sc, a former pharmaceutical chemist turned whistleblower and author of the book, “Health Myths Exposed,” gave an interview to Crusador Magazine and discussed Vioxx and some of the problems within the FDA.

His book which was published before Vioxx began making headlines, referred to Vioxx as the “silent killer.”

According to Mr Ellison, the FDA and Merck knew about the dangers associated with Vioxx for at least 4 years before it was taken off the market. “Instead of removing the drug immediately,” he said, “they kept it on the drug market for matters of wealth not health.”

Mr Ellison says pharmaceutically compliant politicians have “democratized” the drug industry. “This means that drug approval is a matter of 51% telling the other 49% that deadly drugs are safe and necessary,” he reports. “Science and choice no longer prevail at the FDA or at pharmaceutical companies,” he added.

“To go against the 51% means losing your career,” Mr Ellison said. “Therefore, the majority of scientists choose to please drug companies, not the general public.”

To substantiate this claim, Dr Ellison pointed to Dr Curt Furberg, a member of the FDA’s drug safety advisory committee.

In the wake of the Vioxx revelations, Dr Furberg went public with findings that Pfizer’s drug Bextra also caused heart attacks and strokes and said studies “showed that Bextra is no different than Vioxx, and Pfizer is trying to suppress that information,” in the British Medical Journal.

“Immediately thereafter,” Mr Ellison said, “Dr. Furberg was barred from serving on the panel that was responsible for considering the safety of cyclo-oxygenase-2 (COX 2) inhibitors.”

“The end result being more votes in favor of COX 2 inhibitors, the drug company wins by votes – not science,” he told Crusador.

A little-mentioned fact is that many FDA employees end up working for the pharmaceutical industry. “The old joke is that the FDA is sort of like a showcase for a future job in the drug industry,” Robert Whitaker, author of Mad In America, said in an August 2005 interview with Street Spirit.

“You go there, you work awhile, then you go off into the drug industry,” he said, “the progression that people make, in essence they’re making good old boy network connections, so they’re not going to be so harsh on the drug companies.”

Critic say the passage of the Prescription Drug User Fee Act in 1992 contributed to the current problems within the FDA. The Act allows the agency to collect a fee from a drug company seeking approval for a new drug. In return, the FDA is expected complete the review process within 12 months.

User fees now account for about 40% of the approval process, which means the FDA is dependent on drug companies for nearly half of its funding.

This situation is the root of a major conflict of interest according to Dr Graham: “This culture (at the FDA) views the pharmaceutical industry it is supposed to regulate as its client. It overvalues the benefits of the drugs it approves, and seriously undervalues, disregards and disrespects drug safety,” he told members of Congress.

Another problem he cited is that even when the FDA does try to take measures to limit harm, the agency lacks the enforcement authority to force drug companies to comply. In the case of Vioxx, Dr Graham said it took more than 2 years to get Merck to add the increased risk of heart attack and stroke to its label.

Then there are the conflicts of interests involving the FDA panels that advise the agency on matters such as which drugs should be approved, what their warning labels should say, and how studies should be conducted.

The 300 experts on the 18 committees make decisions that affect billions of dollars in sales and with few exceptions the FDA follows their recommendations.

Members of the panels are supposed to be free of conflicts of interest relating to products they consider. But the FDA can grant a waiver if a member’s expertise is deemed to outweigh the risk of a conflict or if the financial interest is minimal. Waivers are liberally granted all the time.

For instance, in February 2005, when the highly publicized hearings were held to determine whether the COX-2 inhibitors, manufactured by Merck and Pfizer, should be permitted to remain on the market, an advisory committee that was mired with conflicts of interest was exposed. Out of the 32 advisers voting on the issue, ten had served as consultants to Merck and Pfizer in recent years.

This revelation prompted Senator Mike Enzi, (R-WY), the chairman of the Health, Education, Labor and Pensions Committee, along with Senators, Edward Kennedy (D-MA), and Richard Durbin (D-IL), to ask the General Accounting Office to look into the FDA’s practice of letting scientists serve on panels when they have conflicts of interest.

“We are concerned about the process that supports FDA’s decisions to waive conflicts of interest rules for scientists with financial ties to the manufacturers of the products under consideration, or their competitors,” said a letter to the GAO, signed by Senators in September 2005.

“These practices appear to have undermined the public’s faith in the objectivity and fairness of FDA’s advisory committees,” they wrote. The Senators specifically noted the conflicts among the panels that studied the Cox-2 inhibitors like Vioxx.

According to the Associated Press on January 24, 2006, Merck currently faces 9,200 Vioxx lawsuits, with about 4,050 in federal courts and the rest in state courts. Without state product liability laws, drug companies like Merck will be able to escape liability for injuries and deaths caused by drugs like Vioxx.

Filed under: 2006, FDA, Gottlieb, Preemption

Big Pharma Braces For Democrat Hurricane

Evelyn Pringle November 2006

The morning after the mid-term elections, shares of drug company stock fell as Americans handed control of Congress back to the Democrats. Shares of Eli Lilly were down 1% in early trading, shares of Pfizer as much as 3%, and Schering-Plough dropped 3.7%.

Over all, since the election, major drug stocks have dropped more than 5%, according to Forbes.com on November 16, 2006. In fact, knowledge of the sure to come pressure from a Democratic Congress, caused stocks to fall across the board not only for drug companies, but for health insurers and pharmacy benefit managers as well.

Health insurers were hit the hardest. For instance, with Humana Inc, shares dropped nearly 6%, and shares of UnitedHealth Group were down 3.2%. Democrats say these firms have reaped great profits from the new Medicare prescription drug program that should have been passed on to seniors in the form of cheaper drug prices.

But the pharmaceutical industry itself remains at the top of the Democratic hit list. Democrats are pushing for stricter safety regulations at the FDA and plan to investigate drug pricing, direct-to-consumer advertising, and the marketing of drugs for off-label uses not approved by the FDA.

Democrats now have the power to hold hearings on the profits that drug makers, health insurers and pharmacy benefit managers have made since the prescription drug bill went into effect earlier this year.

And last but not least, Democrats reportedly will work to eliminate some of the liability protections the Republicans granted vaccine makers.

First up on the agenda is the promise to pass legislation to allow consumers to import cheaper drugs from Canada and have the government to negotiate for lower prices with drug companies on behalf of Medicare beneficiaries.

According to the November 24, 2006 New York Times, Big Pharma executives have been busy planning their battle strategy. “It’s all hands on deck,” Ken Johnson, a senior vice president at Pharmaceutical Research and Manufacturers of America, the industry’s trade group, told the Times.

“It’s like a hurricane warning flag,” he told the Times. “You don’t know where it will hit. You don’t know who will be affected. But everybody has to be prepared,” he said.

However, skeptics who question the ability of Democrats to make radical changes are quick to point out that Bush will still have the authority to veto any new legislation and his political appointees who run the FDA and Centers for Medicare & Medicaid, can drag their heels when it comes time to implementing provisions that will have a negative effect Big Pharma.

Moreover, as long as the Bush administration is in power, the FDA will no doubt continue to be the industry’s strongest ally and there remains that nagging little matter involving the FDA’s recently enacted “preemption rule” that seeks to ban private citizen lawsuits against drug makers in state courts once a drug and its label have been approved by the FDA.

The FDA apparently elected itself to be the sole authority for decisions regarding scientific and public health issues related to prescription drugs, including whether a drug’s label contains an adequate description of indications, risks and benefits. In presenting this multi-billion dollar prize to Big Pharma, the FDA told drug makers:

“We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don’t have the same scientific knowledge.”

The statement was made by FDA deputy commissioner, Scott Gottlieb, who recently managed a coup of his own by successfully gaining FDA approval to bring silicone gel breast implants back on the market, much to the joy of one of his former employers. Presumably, women who are injured by the implants will be barred from suing Mr Gottlieb’s former employer as well in state courts.

Legal experts say the preemption rule was used to bring tort reform through the back door of the White House when the administration could not get it through the front. According to attorney, Ted Parr, of the Washington law firm of Ury & Moskow, “The FDA’s position was a direct result of this administration’s tort reform effort – after the administration failed to obtain tort reform in Congress, they decided to seek reform through administrative fiat.”

Why would the administration engage in such a blatantly unlawful power grab? According to FDA career scientist, Dr David Grahma, “Because Big Pharma co-conspirators have realized that lawsuits threaten to bankrupt the drug companies.”

“The products of these companies,” he said during a June 29, 2006 interview for News Target, “are so universally harmful, and their ability to hide this truth is slipping away so rapidly, that the financial burden of settling lawsuits (or defending them in court) threatens to crush the entire pharmaceutical empire.”

Dr Graham says the arrogance and greed in the industry will ultimately be its downfall. “They have pushed too hard, too far,” he states, “and they have landed themselves in a realm of such obvious scientific fraud and criminal negligence that the backlash is inevitable.”

The preemption claim comes at a time when experts are saying today’s FDA is both unwilling and incapable of protecting consumers against Big Pharma. And the strongest criticism comes from within. On October 9, 2006, Dr Curt Furberg, of Wake Forest University Baptist Medical Center, was one of five current and former members of the FDA’s Drug Safety and Risk Management Advisory Committer, who called for Congress to change how the FDA polices Big Pharma in the Archives of Internal Medicine journal.

Because of the FDA’s poor performance in regulating the industry, Dr Furberg said, “new drugs are introduced on the market with inadequate safety documentation.”

“Serious adverse drug reactions are later reported from the marketplace, and a large number of patients are unnecessarily injured before the drugs are withdrawn or better managed,” he said.

The FDA’s new preemption position breaks a long-standing presumption by the agency against preempting state tort claims and critics say the guy most deserving of the credit for the fiasco, is the FDA’s former Chief Counsel, Daniel Troy, appointed to his position at the FDA straight from Pfizer’s greenest pasture.

For a couple years, Mr Troy served as Big Pharma’s right-hand man until he quit the FDA in the fall of 2004, to return to the much more lucrative field of working directly for drug companies, but not before he stirred up plenty of grief for private citizens.

In the midst of the Vioxx and SSRI disasters, instead of prosecuting the drug makers for knowingly injuring consumers with dangerous product, Mr Troy devoted the majority of his time on the clock to filing 5 briefs on behalf of drug companies and against the private citizens who were paying his salary.

He even went so far as to give lectures on preemption during which he would invite Big Pharma attorneys involved in litigation against private citizens to submit their cases for his consideration and approval for future filing of amicus briefs by the FDA.

On March 1, 2004, an attorney in a case against Pfizer by the name of Jessica Rae Dart, filed an affidavit in support of a motion to describe a lecture given by Mr Troy in New York City that she attended. Ms Dart explained in great detail how he offered the FDA’s services to attorneys who were representing the giant drug companies.

On December 15, 2003, Ms Dart said in the affidavit, Daniel Troy headed a discussion for pharmaceutical firms and defense attorneys titled, “The Case for Preemption,” at the 8th Annual Conference for the In House Counsel and Trial Attorneys, Drug and Medical Device Litigation.

During Mr Troy’s portion of, “The Case for Preemption” discussion, she said, he stated that he was the initiator behind all the FDA Amicus Briefs and/or Statement of Interest filed on behalf of manufacturers “since the new administration” took over.

More specifically, he told the group, “I am not the only one who decides,” but “I am the initial proposer.”

Mr Troy made it clear, Ms Dart noted in the affidavit, that he wanted to file more briefs on behalf of Big Pharma and told attorneys in the audience how to submit successful requests for briefs, stating “we can’t afford to get involved in every case,” we have to “pick our shots,” so “make it sound like a Hollywood pitch.”

In 2004, Congressman, Maurice Hinchey (D-NY), sharply criticized the Bush administration for “seeking to protect drug companies instead of the public,” and persuaded Congress to eliminate $500,000 from the budget of the Chief Counsel’s office as a penalty for the FDA’s aggressive opposition to lawsuits filed by private citizens.

In his amicus briefs, Mr Troy focused his main attention on protecting the profits of the makers of SSRIs starting off with Pfizer. These drugs are second only to Vioxx when it comes to a drug company’s concealment of studies and information that if revealed, could have prevented tens of thousands of deaths and injuries over the years.

Although there have not been many successes when drug makers try to convince a court to dismiss a lawsuit based on the preemption rule, In re Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, No M: 05-1699 CRB, 2006 WL 2374742 (ND CA, August 16, 2006), another case against Pfizer, the court threw out the state failure-to-warn claims, saying the FDA specifically considered the safety risks alleged in the lawsuit and determined the risks should not be included on the label.

The court said the failure-to-warn claims “conflict with the FDA’s determination of the proper warning and pose an obstacle to the full accomplishment of the objectives of the FDCA.”

However, the court did not preempt the false advertising claims. The plaintiffs argued that Celebrex ads were false and misleading because they exceeded the labeled and approved gastrointestinal benefits and minimized the established risks.

Pfizer argued that because it submitted its ads for FDA approval, and the FDA did not object to them, the FDA had determined that the ads were both accurate and struck a fair balance between the risks and the benefits of the drug.

The court refused to preempt the false advertising claims without a record showing that the FDA had reviewed each ad and approved it. The court also noted the FDA’s silence about whether its regulations preempt false advertising claims, in contrast to its stated position on failure-to-warn claims.

However, according to Attorney Parr, state court judges overseeing other Bextra and Celebrex cases are likely to reach conclusions regarding preemption that are inconsistent, both with the federal court and with each other to some extent. “We really do not know yet how extensive the preemption problem will be nationwide,” he says.

In May 2006, a federal court in Pennsylvania also applied the FDA’s preemption rule to the failure-to-warn claims against Paxil maker GlaxoSmithKline, and generic Paxil maker Apotex, in Colacicco v Apotex, Inc, Civ No 05-cv-5500, 2006 WL 1443357 (ED Pa May 26, 2006).

In this case, the FDA went to bat for the drug makers and filed a brief with the court stating in part, that in October 2003, when Paxil was prescribed to the suicide victim, “there was no reasonable evidence available at the time of an association between adult use of the drug and suicide.”

On the other hand, the plaintiff has now drawn amicus support from a dozen scientists and doctors who evaluate pharmaceutical products and contend that preemption “would threaten the public health and eliminate an important counterpart to the public health objectives of the FDA.”

The cases are currently making their way through the appellate process and experts predict that applications for review will proceed all the way up the US Supreme Court.

However, while the appeals process drags on for years, legal analysts say to look for more lawsuits with claims of consumer fraud, false advertising, and injuries from defective products which are not specifically implicated by the new preemption rule.

Filed under: 2006, Colacicco, FDA, Gottlieb, Graham, Preemption, Troy

Lawmakers Say FDA Better Clean Up Its Act

Evelyn Pringle February 2007

For six years, the Bush administration has placed pharmaceutical industry interests ahead of public interest by appointing persons with strong ties to drug companies to high level positions at the FDA, and as a result, Congressional investigations and a recent survey indicate that the health and safety of all Americans is being compromised. 

On July 20, 2006, the Union of Concerned Scientists published the results of a survey that showed an insidious political influence of science within the FDA. According to the UCS press release, the survey was co-sponsored by Public Employees for Environmental Responsibility (PEER), and was sent to 5,918 FDA scientists.

The survey found that 61% of the responding scientists knew of cases where the “Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions.”

In responding to the survey, one scientist wrote: “Over the last several years I have noticed a significant increase in the number of decisions that have become politicized (e.g., increasing requests to review even simple regulations and changes, both by Congress and the Commissioner’s office and to make apparently politically-motivated changes in language and sometimes to alter bottom line results), and I think the integrity of scientific work could be improved by minimizing the ‘politics’ of the process.”

Out of the nearly 1000 scientists who responded, close to one-fifth or 18.4%, said they had “been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or their conclusions in a FDA scientific document.”

In addition, 40% of the scientists said they fear retaliation for voicing safety concerns in public and more than one-third said they did not feel they can express safety concerns even inside the agency.

The survey also found that only 47% think the “FDA routinely provides complete and accurate information to the public,” and 81% agreed that the “public would be better served if the independence and authority of FDA post-market safety systems were strengthened.”

In a complaint aimed at the FDA’s Office of Regulatory Affairs, one scientist said it should “not ostracise scientists or black ball them because their foresight sees a problem with a drug, device, food, biologics, etc. that possess a potential hazard to health now or in the future.”

In response to the concerns raised by FDA scientists, the UCS recommends:

–  Accountability: FDA leadership must face consequences if they side with commercial or political interests and not with the American people.

–  Transparency: Scientific research and reviews should be open so any undue manipulation is immediately apparent.

–  Protection: Safeguards must be put in place for all government scientists who speak out.

“These disturbing survey results make it clear that inappropriate interference is putting people in harm’s way,” said Dr Francesca Grifo, Senior Scientist and Director of UCS’s Scientific Integrity Program, in the press release.

“All federal scientists,” he said, “need protections so they can speak out when their science is manipulated, and all federal agencies need fully functioning independent advisory committees.”

“FDA leaders,” Dr Grifo noted, “should act now to improve transparency and accountability and renew respect for independent science at the agency.”

“FDA leadership,” he stated, “must understand and support independent science and it is up to Congress to hold them accountable.”

But nothing about this survey is news to FDA officials. By use of the FOIA, the UCS and PEER, recently obtained a copy of a previously unpublished survey by the Health and Human Services Office of Inspector General from late 2002, that polled 846 FDA scientists, and with nearly half responding determined that:

Nearly one in five said that they “have been pressured to approve or recommend approval” for a drug “despite reservations about the safety, efficacy or quality of the drug”

Two-thirds lacked confidence that the FDA “adequately monitors the safety of prescription drugs once they are on the market”
 
Only 12% of the responding scientists were completely confident that FDA “labeling decisions adequately address key safety concerns,” and 30% were not at all or only somewhat confident
 
More than one-third were not at all or only somewhat confident that “final decisions adequately assess the safety of a drug”
 
Despite the above results, the report published by the OIG in March 2003, included the conclusion that FDA scientific reviewers “have high confidence in decisions FDA makes.”

On August 8, 2006, the UCS briefed acting FDA Commissioner, Andrew von Eschenbach, on the latest survey and discussed the political inference at the FDA. To restore integrity, UCS recommended that Dr von Eschenbach adopt and enforce three basic commitments:

(1) to ensure that data or results are never softened for any audience. Rigorous scientific debate must be valued at the FDA;

(2) to pledge to support scientists who speak out by taking adverse employment action against any manager who retaliates against a reviewer; and

(3) to commit to a culture that supports a collaborative process of testing and challenging scientific hypotheses.

Along with the recommendations, the group’s August 8, 2006, press release said, “The FDA must allow an open scientific process and recognize the need for scientists to pose and answer questions without consequences related to their status at the FDA.”

Critics claim that a major issue that needs to be addressed involves the rampant conflicts of interest among members of the FDA’s advisory panels who have financial ties to the pharmaceutical industry. In November 2005, a new law was passed that required members of the committees to disclose all financial ties to drug companies.

The categories for disclosure were broken down into dollar amounts and time frames, such as less than $10,000 a year or between $10,000 and $50,000 a year. After reviewing the financial disclosure forms, the FDA is permitted to grant waivers that allow experts to sit on panels even if they have financial ties to a drug company.

However, on April 21, 2006, the Boston Globe discussed the practical effects of the law since it was enacted and reported that FDA critics “say the new transparency has changed little, and scientists who have conflicts of interest can still guide FDA decision making.”

In less than 6 months after the law went into effect, the Globe determined the FDA had granted close to 100 waivers.

One of the latest FDA fiascoes, involves the approval of the antibiotic, Ketek, despite serious concerns about the drug’s safety and lack of efficacy, by top officials with full knowledge that the studies submitted to support its approval were fraudulent.

Several employees at told FDA officials that the liver damage associated with Ketek was known to its maker, Sanofi-Aventis, early in clinical trials but was covered up.

According to the FDA’s senior scientist, Dr David Graham, who blew the whistle on the agency’s mishandling of the Vioxx debacle, Ketek is at least as toxic to the liver as three other drugs that have been removed from the market and the FDA’s original approval of the drug was based on a study that the agency’s top officials knew was fraudulent.

Internal FDA emails that surfaced during the investigation show that at least four FDA safety officials, Dr David Graham, Dr Charles Cooper, Dr David Ross and Dr Rosemary Johann-Liang, had voiced serious concerns about the safety of the drug.

“I tried to argue that given Aventis’s track record in which they have proven themselves to be nontrustworthy that we have to consider the possibility that they are intentionally doing a poor job of collecting the postmarketing data to protect their drug sales,” Dr Cooper said in an email.

“It’s as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin is concerned,” Dr David Graham wrote in an email that recommended Ketek’s “immediate withdrawal.”

“We don’t really know if the drug works;” he said, “no one is claiming it works better than other, safer drugs; and we’re flying blind as far as safety goes, except for our own A.D.R. data that suggests telithromycin is uniquely more toxic than most other drugs.”

In May 2006, Dr Johann-Liang called for a halt to tests of Ketek in children with ear infections, arguing that cutting the duration of ear pain by one day was hardly worth risking death.

The FDA’s actions in regard to Ketek are being investigated by Senator Charles Grassley’s (R-Iowa), Senate Finance Committee, and by Representatives, Edward Markey of Massachusetts, and Henry Waxman of California, ranking Democrats on the House Government Reform Committee.

In May 2006, the lawmakers released a statement that said although “the FDA has consistently assured the public of Ketek’s safety and efficacy, public documents obtained and examined by Representatives Markey and Waxman’s staff indicate that the approval process for this drug was seriously flawed.”

As Chairman of the Senate Committee, Senate Grassley has called for a “major overhaul and a culture change at the highest levels” of the FDA. In a May 1, 2006, press release, he noted concerns over the FDA’s complicity with the drug maker and its subsequent failure to ensure the integrity of a study on the benefits and risks of Ketek.

The Senator called it “mystifying” on May 16, 2006, that the FDA would continued to provide information that it knew was fraudulent, and warned that he planned to keep the pressure on the FDA to provide more information about Ketek’s approval and post-market surveillance.

“It’s no surprise to learn that the FDA didn’t listen to Dr. Graham on the dangers of Ketek,” Senator Grassley was quick to point out. “The FDA has made it their business to discredit Dr. Graham and others who aren’t willing to cater to the drug companies,” he noted.

In October 2001, doctors began enrolling subjects for the Ketek clinical trial known as Study 3014, and were paid $100 for each patient that signed up. The participating doctors would also receive another $150 when the study results were submitted, and a final $150 when all questions related to the study were resolved, according to the May 1, 2006, Wall Street Journal.

On July 24, 2002, drug maker Aventis submitted the results of the study to the FDA, but when FDA officials submitted the study to the advisory committee for review, they did not disclose that the Division of Scientific Investigation and Office of Criminal Investigation was investigating the integrity of the study.

The misconduct that took place during the clinical trials is so serious that critics say it calls the validity of the entire study into question. For instance, the doctor who signed up the 3rd highest number of patients, was in a chronic state of cocaine addiction while conducting the clinical trial, and was arrested and found to have cocaine hidden in his underwear, while holding his wife hostage with a gun, the same month the study results were submitted to the FDA.

Another doctor who participated in the study was totally disqualified as an investigator and prohibited from conducting any clinical trials in the future, and another who signed up 150 patients was cited for 20 violations of the study’s instructions.

Dr Anne Campbell, the doctor with the highest number of subjects in the study, was sentenced to nearly 5 years in prison in March 2004, after being charged in a 21-count indictment over her misconduct.

Senator Grassley is demanding a face-to-face interview with the FDA investigator who discovered the fraud and misconduct in the trials, who he contends “is key to understanding what the FDA did when it became clear that the safety study required by the FDA in order to approve the drug was fraudulent and faulty.”

This investigator authored a March 25, 2004, memorandum from the Division of Scientific Investigations titled, “DSI Recommendations on Data Integrity,” that states in part, that Study 3014 involved “multiple instances of fraud” and that “the integrity of data from all sites involved in [the] study … cannot be assured with any degree of confidence.”

After months of trying unsuccessfully to get an interview, Senator Grassley finally marched right over to the Department of Health and Human Services headquarters and asserted a congressional right to speak to the investigator.

After a brief conversation with senior officials, he left mad as a hornet. “This is extraordinary to me,” he said outside HHS headquarters. “I haven’t had to go to an agency like this since 1983 to get information I requested.

“I smell a cover-up,” he stated.

On June 22, 2006, Senator Grassley publicly announced a not too subtle warning to officials at the agency. “Two years ago I called a congressional hearing to probe the FDA’s handling of the withdrawn painkiller Vioxx,” he said in a statement.

“It might be time,” he warned, “to round up another oversight hearing after the runaround I got recently at the FDA.”

“The FDA,” he wrote, “refused to allow me to question an internal investigator who is leading an inquiry into alleged fraud involved with clinical trials for the antibiotic Ketek.”

“So for only the second time in 23 years,” he said, “I resurrected in June my unconventional means to fulfill my Constitutional oversight responsibilities.”

He said, “I appeared at the FDA’s doorstep,” and noted that agency officials refused to let the investigator speak to him.

However, he warned, “Bureaucratic stonewalling won’t deter this U.S. Senator.”

“I won’t rest,” Senator Grassley said, “until the light of day exposes what ought to be available for public consumption.”

“It all boils down to keeping the government accountable,” he wrote, “to the people and strengthening the public trust in government.”

In another statement released on June 29, 2006, he stated, “Ketek is another example where the F.D.A. accommodated a drug maker and turned a blind eye to serious safety concerns.”

Over the past couple of years, the suppression of the scientific process and the muzzling of scientific dissent at the FDA became evident first when officials forced Dr Andrew Mosholder to suppress a link he found between SSRI antidepressants and suicide in children, and Dr Graham went public with allegations about the FDA’s mishandling of the Vioxx matter.

On March 10, 2005, Senator Grassley gave a speech to the Consumer Federation of America and said these two whistleblowers had done more to shake up a complacent FDA than probably anybody in recent history and relayed parts of the story saying:

“Early last year I heard that the FDA was muzzling one of its own scientists. In February 2004 the FDA held a meeting to decide whether there was a link between some antidepressant drugs and suicidal behavior in kids.

“Dr. Andrew Mosholder – the FDA’s expert in this area — concluded there was a link. However, FDA management disagreed. So, when Dr. Mosholder stuck by his findings, his supervisors canceled his presentation to an advisory committee.

“Instead of allowing Dr. Mosholder to present his findings publicly and subject them to committee scrutiny, the scientific process and his peers, the FDA effectively muzzled him.”

But despite the FDA’s best efforts, Senator Grassley said, Dr Mosholder wouldn’t be silenced and months later he was proven right.

Citing information from the Department of Justice, he told the audience that there are currently under seal in the neighborhood of 100 whistleblower cases involving allegations against over 200 drug companies.

“During the past four years,” he stated, “the department recovered nearly 2 and a half billion dollars from whistleblower cases against drug companies.”

Senator Grassley called Dr Mosholder and Dr Graham great patriots. “Think about the guts it takes to undermine your career, and to go against your supervisors at a huge federal agency,” he said, “and in this case, the multi-billion-dollar drug companies.”

In an August 30, 2005, interview with Manette Loudon, the lead investigator for Dr Gary Null, Dr Graham discussed how FDA officials attempted to suppress the results of his study on Vioxx a year earlier. According to Dr Graham, prior to his Senate testimony in mid-November of 2004, there was an orchestrated campaign by senior FDA managers to intimidate him so that he would not testify about the adverse affects of Vioxx to Congress.

One attack he says, came when the acting FDA Commissioner, Lester Crawford, contacted the editor of the Lancet, a UK medical journal, and told him that Dr Graham had committed scientific misconduct and that the journal should not publish the paper that he had written showing that Vioxx increased the risks of heart attack.

The second attack came from other high level officials, he said, who contacted Senator Grassley’s office in attempt to prevent Senator Grassley from calling him as a witness.

And the third he says came from senior FDA officials who contacted Tom Devine, Dr Graham’s attorney at the Government Accountability Project, and attempted to convince him that the GAP should not represent Dr Graham because he was guilty of scientific misconduct.

According to Dr Graham, these officials posed as whistleblowers themselves, and told Mr Devine that Dr Graham was a “bully,” a “demigod,” and a “terrible person” that could not be trusted.

In one more last ditch effort to thwart Dr Graham’s testimony the week before he testified, he says, the acting Commissioner offered him a job in the Commissioner’s Office to oversee the revitalization of drug safety if he would just leave the Office of Drug Safety.

“Obviously he had been tipped off,” Dr Graham said in the interview, “by people in the Senate Finance Committee who are sympathetic to the FDA’s status quo that I was going to be called as a witness.”

To preempt his testimony, he told Ms Loudon, he was offered a job “which basically would have been exile to a fancy title with no real ability to have an impact.”

According to Dr Graham, by allowing Vioxx to stay on the market, the FDA is responsible for 140,000 heart attacks and 60,000 dead Americans. “That’s as many people as were killed in the Vietnam War,” he points out.

He says the FDA could have prevented many of the heart attacks and deaths simply by banning the high dose Vioxx back in 2000 when the agency learned about the results of the VIGOR Study. “But the FDA did nothing for almost two years,” he states. “They were “negotiating” with the company over a label.”

“The FDA made bad decisions,” Dr Graham said, “based of its culture and its institutionalized biases that favor industry, and as a result thousands of Americans died.”

During a July 18, 2005, speech on the Senate floor, Senator Grassley proclaimed, “this country’s confidence in the FDA has been shaken.”

It has not been shaken, he said, by one isolated incident or whistleblower. “It has been shaken because multiple drug safety concerns have been exposed by more than one courageous whistleblower.”

“Dr. Graham’s testimony before the Finance Committee,” he told members of Congress, “suggests that the problems are systemic.”

“Oversight of the FDA,” Senator Grassley advised, “exposed the cozy relationship that exists between the FDA and the drug industry.”

“It revealed that the FDA negotiated for almost two years with Merck,” he said, “about how to change the Vioxx label so people would know about the risk of heart attacks.”

According to Dr Graham, the Vioxx disaster would not have been as severe in the absence of direct-to-consumer advertising. “I submit,” he told Ms Loudon, “that the numbers would have been far lower than what they were.”

Due to heavy marketing of new drugs, Dr Graham says, lots of patients and doctors will use a new drug that is no better than another drug already on the market, even though the FDA does not require that new drugs be at least equivalent to, or better than, the drugs that are already there. All the drug maker has to prove is that a drug works better than a sugar pill, he says.

Silencing scientists to protect the industry has become habitual under the current politically appointed rulers of the FDA. According to Shane Ellison, author of “Health Myths Exposed,” pharmaceutically compliant politicians have “democratized” the drug industry. “This means that drug approval is a matter of 51% telling the other 49% that deadly drugs are safe and necessary,” he reports.

“Science and choice,” he warns, “no longer prevail at the FDA or at pharmaceutical companies.”

Mr Ellison is a former pharmaceutical industry chemist who says he felt a responsibility to reveal the truth about the industry’s sordid tactics after he witnessed first-hand how they deceive the public, according to a September 3, 2005, interview with Crusador Editor, Greg Ciola.

“To go against the 51% means losing your career,” Ellison said. “Therefore, the majority of scientists choose to please drug companies, not the general public.”

As an example, Mr Ellison discussed Dr Curt Furberg, a member of the FDA’s drug safety advisory committee. Dr Furberg, he says, came forward to reveal that Bextra also caused heart attack and stroke. In the British Medical Journal, Dr Furberg said that his studies showed Bextra to be no different than Vioxx, and warned that Pfizer was trying to suppress that information.

“Immediately thereafter,” Mr Ellison said, “Dr. Furberg was barred from serving on the panel that is responsible for considering the safety of cyclo-oxygenase-2 (COX 2) inhibitors.”

“The end result being more votes in favor of COX 2 inhibitors, the drug company wins by votes – not science,” Mr Ellison told Crusador.

In the case of the pain relieving Cox-2 inhibitors, the FDA’s advisory committee was stacked with experts with ties to the drug makers. Of the 32 advisers who would vote on the drugs, it has since become known that 10 of panel members had consulted in recent years for Vioxx maker, Merck, or Pfizer who made Celebrex and Bextra.

While the committee voted unanimously that all of the drugs significantly increased the risk of heart attack and stroke, in a 17-15 vote the panel said the FDA should allow Vioxx to remain on the market. A tally of the votes showed that without the 9 votes of the 10 members who consulted for the drug makers, the committee would have voted 14 to 8 to ban Vioxx.

However, the panel’s recommendation was met with scorn and outrage by medical experts and researchers alike in the media, and in a rare occurrence, the FDA went against the recommendation of its advisory panel and refused to allow Vioxx to remain on the market.

Critics also accuse the FDA of not properly monitoring the marketing activities of the pharmaceutical industry. An investigation by the House Committee on Government Reform found that since December 2001, there has been a sharp decline in enforcement actions taken against drug companies for illegally promoting their products.

The investigation determined that from 1999 to 2001, the FDA sent out 250 “Notice of Violation” or “Warning” letters to drug companies; but for the time period of 2002 through 2004, the agency sent out only 70 letters, which amounts to a reduction of more than two-thirds.

Since the Vioxx and SSRI debacles, Senator Grassley has jumped on the FDA every time there has been any indication that officials might be putting the industry’s interest over public safety. Earlier this year, he wrote a letter to the FDA saying he was concerned that it might be “dropping the regulatory ball” on stimulant drugs, prescribed to treat ADHD.

Specifically, he wrote, “I’m concerned FDA’s regulatory responsibilities haven’t kept pace with the explosion of prescriptions written to treat 2.5 million children with these drugs.”

Despite psychiatric and cardiovascular risk signals associated with the drugs, he noted, it appears the FDA has failed to promptly respond to their possible adverse effects. “Such events,” he wrote, “may include sudden unexplained deaths, strokes, cardiovascular irregularities or aggression, anxiety and depression.”

Sales of drugs, he said, “have zoomed to the moon, jumping from $759 million to $3.1 billion between 2000 and 2004.”

“And yet,” he wrote, “the FDA seems to have adopted a wait-and-see approach before charting a course of action to study these risks.”

In early February 2006, he noted, that an advisory panel had recommended adding the strongest black box warning to ADHD drugs to alert patients about the possible cardiovascular side effects.

“The recommendation,” Senator Grassley wrote, “brings even more urgency to the controversy surrounding the explosion of prescriptions being filled with these medicines.”

“As the debate unfolds,” he warned agency officials, “I will continue to closely track the FDA and urge its timely, thorough review of these drugs.”

“With millions of Americans, mostly children, regularly taking these medications,” he added, “it is essential the FDA leaves no stone unturned to investigate and review this class of drugs.”

No doubt in response to all the intense scrutiny from members of Congress, in late July 2006, the FDA outlined a series of changes it plans to make in the methods used to evaluate clinical trials. One of the proposed changes would require a drug company to notify the FDA immediately if it believes a researcher has committed fraud during a clinical trial.

As it is now, drugs companies are trusted to remove unreliable data and are not required to report any fraudulent activity to the FDA until they actually submit the application.

The agency also says it plans to clarify which adverse events in clinical trials must be reported to the review boards that monitor the studies. Other proposed change includes the standardization of forms used to collect information and a revision of the rules on how patients may qualify to participate in clinical trials.

However, people who are tempted to think that the FDA is capable of changing under the agency’s current team of politically appointed officials, had better think again.

According to an article by Russell Mokhiber and Robert Weissman, for Common Dreams on August 2, 2006, Dr Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, was recently a member of a panel debating the topic of: “Government Science Panels: Fair and Balanced?” which was moderated by National Public Radio’s Snigdha Prakash, and sponsored the Center for Science in the Public Interest.

Dr Nissen spoke about the conflict-of-interest problems “evident at the highest levels of the FDA,” the article says.

“For years,” Dr Nissen said in describing 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 noted.

“In his role as director of the National Cancer Institute,” Dr Nissen said, “Von Eschenbach must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict.”

But even worse, he said, “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 stated.

“Between them,” he said, “Drs. Von Eschenbach and Gottlieb have whined incessantly about the need to speed drug development.”

“So while the American people worry about the safety of drugs,” he continued, “the top FDA leadership tells us we need faster drug approval.”

On November 12, 2005, the Boston Globe reported that prior to his job at the FDA, Dr Gottlieb worked for the PR firm of Manning Selvage & Lee and that his clients included Roche, the manufacturer of Tamiflu, and Sanofi-Aventis, the maker of Ketek, and the parent company to the nation’s sole flu vaccine maker.

According to the Globe, the Manning PR firm paid Dr Gottlieb a monthly retainer of $12,500 for nine months, for working on projects that involved eight companies. Other firms regulated by the FDA that he was involved with include Inamed Corp, a company seeking the return of silicone gel implants to the market.

Between May and July 2005, Dr Gottlieb also was paid $9,000 for consultant work performed for VaxGen, a company that won an $878 million government contract to supply the US with 75 million doses of anthrax vaccine.

In any event, no matter who’s in charge, the Senator from Iowa is keeping the heat on. In July 2006, he wrote a letter to the Daniel Levinson, the Inspector General at the Department of Health and Human Services, asking for an investigation into whether Dr Brian Harvey of the FDA, conspired against Dr Graham by providing Merck with details about Dr Graham’s presentation on Vioxx, prior to the hearing in 2004 to help the company refute his testimony.

“It is no secret that Dr. Graham was and is a critic of the FDA,” he wrote to Inspector. “However,” he said, “that does not mean the FDA should scheme with drug sponsors to discredit its own employees.”

Filed under: 2007, Avandia, Bextra, FDA, Gottlieb, Graham, Ketek, Manning, Merck, Pfizer, SSRIs, Vioxx, whistleblower

Ending FDA’s Love Affair With Big Pharma

Evelyn Pringle November 2006

With the Democrats back in power, critics say officials at the FDA and representatives of Big Pharma had better plan on spending much of their time testifying on Capital Hill in Congressional hearings in 2007.

Democrats have spelled out their plans to change how the administration chooses experts to sit on FDA advisory panels and put an end to the suppression of dissenting opinions of FDA scientists.

These panels advise the agency on which drugs should be approved, what their warning labels should say, and how clinical studies should be conducted. The approximately 300 so-called experts make decisions that potentially affect billions of dollars in sales for Big Pharma and the FDA follows their recommendations almost exclusively.

Critics are demanding stricter conflict of interest rules for members of the panels and a November 17, 2006, session of the Senate Committee on Health, Education, Labor, and Pensions, gave the Democrats their first opportunity to indicate how they will deal with the out of control FDA once they become the majority in Congress next year.

The hearing titled, “Building a 21st Century FDA: Proposals to Improve Drug Safety and Innovation,” was held to push forward FDA reform legislation Senate Bill 3807, the “Enhancing Drug Safe and Innovation Act of 2006,” previously introduced by outgoing committee chairman, Senator Michael Enzi (R-WY), together with incoming chairman, Senator Edward Kennedy (D-MA). The two Senators began working on the bill when Vioxx was pulled from the market after it was found to cause heart attacks and strokes.

Cleveland Clinic physician-scientist, Dr Steven Nissen, MD, who has served as an expert on FDA advisory panels, testified at the hearing and described “a crisis in public confidence in the FDA following an unprecedented series of revelations about drug and device safety” and referred to the Senate reform bill as a “major step forward.”

“I am a strong supporter of this bipartisan effort to enhance the FDA’s effectiveness and improve drug and device safety,” he said. “I believe that this legislation represents the best chance we have had in a long time to make a real difference for patients in this challenging area.”

Dr Nissen said new laws are needed to strengthen the authority of the FDA. “Currently,” he explained, “the Agency must “negotiate” with industry to make even simple changes in drug labels.”

“I served on a 2001 Advisory Panel that recommended a warning label for Vioxx,” he informed the panel, “but it took 14 months before the FDA could secure agreement from the company to accept a weakly written warning.”

As for enacting new conflicts of interest rules for advisory panels, Dr Nissen testified that improvements “in the Advisory Committee process will help to ensure that FDA consultants are less likely to be influenced by financial conflicts of interest.”

Merrill Goozner, Director of Integrity in Science Center for Science in the Public Interest, testified about the blatant conflicts of interest involving the expert panel that reviewed Vioxx and the other COX-2 inhibitors, and how the panel concluded that Vioxx was safe enough to stay on the market, even though Merck had already removed it from the market.

Mr Goozner told the Senate committee that ten of the 32 scientists on the panel had financial ties to the drugs’ makers. “Had their votes been eliminated,” he said, “two of the drugs in the class would have been voted down by the panel.”

“The best way to solve all these problems,” Mr Goozner stated, “without undermining the quality of the advice offered to the FDA – is to completely eliminate conflicts of interest from these committees.”

Jim Guest, president and CEO of Consumers Union, publisher of Consumer Reports, testified that improvements are needed to help prevent future drug safety disasters and called for a rule specifying that at least 90% of the members on advisory committees who decide whether a drug should be approved be free of conflicts of interest from the pharmaceutical industry.

In “the wake of the Vioxx and Paxil disasters,” he told the committee, where tens of thousands of Americans needlessly suffered, we’ve educated our more than 20 million readers on the need for stronger state and Federal drug safety laws.

During his testimony, Mr Guest pointed out that GlaxoSmithKline had concealed the results of clinical trials linking Paxil to an increased risk in suicidality among adolescents, as proven, he noted, by New York Attorney General, Eliot Spitzer’s successful lawsuit against Glaxo.

Furthermore, he told the committee, the hidden trials also revealed that Paxil was actually less effective than placebos among adolescents.

Mr Guest also told the committee that these abuses by drug companies have not ended. As recently as September 29, 2006, he noted, the FDA released a Public Health Advisory that said Bayer, maker of Trasylol, failed to inform an advisory committee during a hearing held 8 days earlier to discuss Trasylol, of a new study that revealed an increased risk of death, serious kidney damage, congestive heart failure and stroke.

In addition, Mr Guest described problems created by fraud and falsification of studies used in the drug approval process. “In the recent case of Ketek,” told the panel, “the FDA found multiple instances of fraud in the company’s clinical trial of about 24,000 patients, some cases of which the maker Sanofi already knew about yet failed to notify the agency.”

Internal FDA emails that surfaced during a previous Congressional investigation revealed that the FDA was aware of the dangers with the drug and that at least four FDA safety officials, Dr David Graham, Dr Charles Cooper, Dr David Ross and Dr Rosemary Johann-Liang, had voiced serious concerns about the safety of Ketek (telithromycin).

“It’s as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin is concerned,” Dr Graham wrote in an email calling for “immediate withdrawal,” of Ketek.

On the Republican side of the isle, the Democrats have a strong ally in Senate Finance Committee chairman, Senator Chuck Grassley (R-Iowa), who also has been one of the FDA’s most out-spoken critics since the Vioxx and SSRI disasters.

His latest focus has been on the FDA’s handling of the Ketek debacle. In a May 1, 2006 press release, Senator Grassley expressed concerns over the FDA’s complicity with the drug company and its subsequent failure to ensure the integrity of a study on the benefits and risks of Ketek. In another statement released on June 29, 2006, he said, “Ketek is another example where the F.D.A. accommodated a drug maker and turned a blind eye to serious safety concerns.”

Critics say the worst conflicts of interest within the FDA are the result of major Big Pharma influence over the Bush appointed officials at the top.

According to Robert Brava-Partain, an associate attorney at the national law firm of Baum Hedlund, the FDA has become an “approval factory” for drugs that are ineffective and dangerous. “This factory is manned by doctors who, in any other setting,” he says, “would have irreconcilable conflicts of interest with the companies the agency is supposed to be monitoring.”

And at the top of the factory, he says are, “political appointees who make no apologies for engaging in promanufacturer advocacy.”

On November 12, 2005, the Boston Globe reported that prior to his job at the FDA, Deputy Commissioner of Medical and Scientific Affairs, Dr Scott Gottlieb worked for the PR firm of Manning Selvage & Lee and that his clients included Ketek maker Sanofi-Aventis, which is also the parent company to the nation’s sole flu vaccine maker, and Roche, maker of Tamiflu.

According to the Globe, Manning paid Dr Gottlieb a monthly retainer of $12,500 for nine months for work involving 8 companies, and he was also paid $9,000 for consultant work for VaxGen, a company that won an $878 million government contract to supply the US with 75 million doses of anthrax vaccine.

Dr Gottlieb and Dr Nissen recently went head to head when they both participated in a debate on the topic: “Government Science Panels: Fair and Balanced?” moderated by National Public Radio’s Snigdha Prakash, and sponsored the Center for Science in the Public Interest, reported on August 2, 2006, by Russell Mokhiber and Robert Weissman, in Common Dreams.

To his credit, Dr Nissen can never be called a back-stabber because while sitting next to fellow panelist, Dr Gottlieb himself, Dr Nissen very candidly described the conflicts of interest which he described as “evident at the highest levels of the FDA.”

“For years,” he said of the 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,” he noted, “creating another conflict.”

“In his role as director of the National Cancer Institute,” Dr Nissen said, “Von Eschenbach must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict.”

But even worse, after that, 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 reply to Dr Nissen’s remarks, was basically that he would not dignify the comments with a response.

This month, Dr Gottlieb presented an early Xmas gift to one of his former employers, Inamed Corp, when the FDA announced that it would lift restrictions on the sale of silicone gel breast implants on November 17, 2006.

Firms that Dr Gottlieb was involved with prior to his gig at the FDA, according to the Boston Globe, include “Inamed Corp., one of two companies seeking to return silicone gel implants to the market.”

As for the last FDA commissioner, 2 months after Mr Crawford was confirmed, MSNBC announced: “Embattled Food and Drug Administration Commissioner Lester Crawford abruptly resigned Friday, telling his staff that at age 67 it was time to step aside.”

In a resignation letter to Bush on September 23, 2005, Mr Crawford said his resignation was “effective immediately.”

On October 26, 2005, the Wall Street Journal stated: “As late as 2004, former Food and Drug Administration head Lester Crawford or his wife owned stock in companies that make or distribute products regulated by the agency.”

Six months later, on April 29, 2006, the New York Times reported that Mr Crawford, was under criminal investigation by a federal grand jury over allegations of financial improprieties and false statements to Congress, quoting his lawyer, Barbara Van Gelder.

On October 16, 2006, the Associated Press said that Mr Crawford had agreed to plead guilty to charges of failing to disclose a financial interest in firms regulated by his agency. “The Justice Department accused the former head of the Food and Drug Administration in court papers,” the article stated, “of falsely reporting that he had sold stock in companies when he continued holding shares in the firms governed by FDA rules.”

After leaving the FDA, Mr Crawford quickly moved on to a job with a firm called Policy Directions, Inc. A few of the firm’s accomplishments for clients listed on its Web site are: (1) achieved FDA advisory committee support for a product that had originally been voted down; (2) Interceded with FDA when the agency failed to provide final approval for client’s product because it had granted orphan drug status for a product by another company and client’s product was approved; (3) created a coalition of six biotechnology firms to promote legislation advantageous to client and meet with agency officials to prevent onerous rulemaking; (4) wrote industry-coalition draft of legislative authority for a regulatory agency that was included in final bill; (5) created and led coalition of universities, research institutions, pharmaceutical and biotechnology companies to lobby Congress to stop a federal agency from costly and ineffective rulemaking; and (6) led an industry coalition that stopped several negative amendments to agriculture/FDA appropriations bills.

On its Web site, the firm also states, “PDI has longstanding relationships with key personal and committee staffs in Congress, as well as with critical players at important agencies within the Administration.”

That appears to be an understatement since Mr Crawford joined the company. The firm should put modesty aside and inform potential clients that it now has inside information about the status of each and every drug, device, and company regulated by the FDA.

Although Mr Von Eschenbach has served as acting commissioner since Mr Crawford left in disgrace, critics say the likelihood of his confirmation as the permanent commissioner is not a done deal, especially now that Senator Grassley is protesting his confirmation and became the third Republican to join the campaign to block the nomination.

As for the Senator’s reasons, it seems that Mr Von Eschenbach has refused to cooperate with Senator Grassley’s investigation into the FDA’s approval of Ketek and has refused requests for agency documents and interviews with FDA staff, even after subpoenas were issued, according to a November 16, 2006 letter that Senator Grassley sent to Senate Majority Leader Bill Frist (R-TN).

“I am extremely disturbed,” Senator Grassley wrote, “by the Acting Commissioner’s continued failure to comply with the committee’s subpoenas over the past six months.”

There are three major FDA advisory committee meetings scheduled for December, 2006 to review: drug-eluting stents on December 7-8; SSRI use and adult suicidality on December 13; and Ketek on December 14-15.

But it does not appear that the FDA is too worried about improving the public image of the advisory panels because reports from persons wanting to speak at the SSRI hearing say the FDA is refusing to allow enough time for public comments and is refusing to release the complete list of names for members of the panel until the day before the hearing making it impossible to determine whether they have financial ties to SSRI makers.

Filed under: 2006, Avandia, FDA, FDA Crawford, Gottlieb, Ketek, Manning, Paxil, SSRIs, Trasylol

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

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