The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Merck Not Losing Sleep Over Vioxx Disaster

Evelyn Pringle June 16, 2006

Merck’s top management team reportedly remains unphased by Vioxx litigation woes. In fact, Prudential Equity Group analyst, Timothy Anderson, says Merck’s Chief Executive, Richard Clark, specifically told him that “Vioxx does not keep him up at night.”

According to Mr Anderson, “the company believes that lower court cases will be overturned on appeal, and it is even considering trying to reintroduce Vioxx.”

“A reintroduction might help Merck’s legal case,” Mr Anderson states, “as long as the FDA or its advisers do not decide that Merck’s risks really do outweigh its benefits,” he said in a June 21, 2006, article in Forbes.com.”

Critics say that’s not even a remote possibility because the FDA is still under fire for its own part in the Vioxx disaster and it wouldn’t dare pull a stunt like that.

When it comes to saving Merck in the Vioxx litigation, the FDA is at odds with some of the most powerful leaders in Congress. Senator Charles Grassley (R-Iowa), chairman of the Senate Finance Committee, is on record as saying the Vioxx debacle has shown that the FDA has gotten too cozy with drug companies to conduct proper oversight.

“The Vioxx example showed that the FDA and Merck were too close for comfort,” he said in a speech. “Testimony and documents at our Finance Committee hearing showed that the FDA allowed itself to be manipulated by Merck.”

Documents indeed reveal that the FDA knew about the problems with Vioxx very early on. A memo written by Shari Targum, MD, Project Manager for the Division of Anti-inflammatory Drug Products, clearly shows that as of November 18, 1999, the Data and Safety Monitoring Board of the VIGOR study, a committee independent from Merck, was concerned over the deaths from cardiovascular events in the Vioxx group, compared to the group taking another painkiller.

This memo documents a clear date of recognition by the FDA of when cardiovascular events were brought to the attention of Merck.

Admittedly, if it was up to the Bush administration, the FDA would allow Vioxx back on the market today. Bush does everything in his power to protect the profits of Big Pharma, the industry most responsible for his 8-year rent free lease of the White House.

Under Bush, the FDA has in fact become Big Pharma’s chief enabler when it comes to getting away with murder. A newly released report on June 26, 2006, titled, “Prescription for Harm: The Decline in FDA Enforcement Activity,” says that FDA enforcement actions have declined by 50% since Bush took office.

“The number of warning letters issued by the agency for violations of federal requirements,” the report said, “has fallen by over 50%, from 1,154 in 2000 to 535 in 2005, a 15-year low.”

“During the same period,” it noted, “the number of seizures of mislabeled, defective, and dangerous products has declined by 44%.”

Bush has never hesitated to utilize the FDA in the Big Pharma protection racket. For instance, on January 18, 2006, the FDA issued new regulations for labeling prescription drugs, supposedly aimed at providing doctors and patients with clearer information about their risks. But in the preamble to the regulations, the FDA inserted a claim that lawsuits alleging a failure to warn of known or reasonably knowable risks are preempted by federal law.

Also, amicus briefs filed by FDA attorneys appointed by Bush, on behalf of the drug companies, have tried to claim that because private lawsuits threaten to disrupt the nation’s system of drug regulation, federal standards preempt requirements established by state judges and lawmakers, and that if a state court finds that a drug is unsafe, it is in direct conflict with the conclusion reached by the FDA.

With Bush using the FDA to do the dirty work, Republicans lawmakers up for reelection this fall, don’t have to make a spectacle of themselves fighting for such blatant industry-friendly legislation during an election year.

A partner in the LA based Baum Hedlund law firm, attorney Karen Barth Menzies, has been litigating claims against drug companies for more than a decade and says “the Vioxx public health debacle has served to highlight deep-seeded problems within the FDA.”

“Drug companies are profit-driven,” she explains, “and are loath to issue warnings about risks associated with their drugs, even those that become quite clear.”

“Medicine is no longer about health,” Ms Menzies notes, “its about market share and profits.”

Since Bush took office, the FDA has sent out its legal squad to assert the preemption argument on behalf of drug companies in attempt to defeat private citizens in lawsuits numerous times. However, Ms Menzies’ team of Baum Hedlund attorneys has knocked the FDA briefs out of the ball park in a several cases, including Witczak v Pfizer and Motus v Pfizer.

But “the FDA’s legal arm has continued to intervene in private civil lawsuits on the side of drug companies,” she says, “arguing that FDA’s decisions should not be second-guessed by anyone, the federal preemption argument.”

In the past 15 plus years, Ms Menzies notes, the FDA has been worse than “comatose” as the New York Times recently described the agency. “It has sided with industry and become an adversary against consumers,” she points out.

“And it is precisely for this reason,” she says, “that the public is in such desperate need for an agency that advocates for them, rather than the drug industry.”

In light of recent disasters like Vioxx that have resulted in large part due to a lack of regulatory oversight, Ms Menzies contends that the “FDA’s decisions must be second-guessed for the safety of the public.”

Medical experts agree that the FDA must be second-guessed. “With an FDA that regularly displays incompetence and negligence in its deliberations about the efficacy and safety of medications,” says Dr Grace Jackson, author of, Rethinking Psychiatric Drugs: A Guide to Informed Consent, “it cannot possibly be the case that this federal agency possesses the institutional expertise to which courts or litigants should now defer.”

“Indeed,” she notes, “if the FDA is preempting anything, it is the sound practice of medicine, and the integrity of American health care.”

It will truly be a fatal day for the concept of separation of powers when a federal agency like the FDA can wield the power to enact federal law by filing legal briefs in private lawsuits, funded by tax dollars, to defeat American citizens who are already up against one of the most profitable industries on earth.

Moreover, if FDA attorneys are going waste tax dollars, the least they can to is come up with a few valid arguments. The argument that drug companies are not allowed to warn the public by adding a new warning to a label when dangers become known because it would violate FDA regulations, is ridiculous. There is not now, and there has never been, a law that prevents a drug maker from strengthening a warning or labeling consistent with the company’s specific regulatory ability to do so under 21 CFR 314.70(c)(6)(iii)(A).

The guy responsible for this silly argument is the FDA’s Chief Counsel, Daniel Troy, recruited straight off of Pfizer’s legal team, was Big Pharma’s inside man until he quit the FDA in the fall of 2004.

Instead of going after the drug companies for killing off citizens with lethal drugs in the name of profits, he devoted much of his time filing Joe Tax Payer funded briefs, on behalf of his former industry clients, and even invited drug company attorneys to submit their cases to him for amicus brief consideration.

On March 1, 2004, Jessica Rae Dart, an attorney involved in civil litigation against Pfizer, filed an affidavit in support of a plaintiff’s motion and described a lecture she attended by Mr Troy that clearly shows him offering the FDA’s services to trial lawyers representing drug companies.

On December 15, 2003, Ms Dart said, Daniel Troy, Chief Counsel of the FDA, 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” in New York City.

During Troy’s “Case for Preemption” talk, she said, Troy 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. Specifically, he stated, “I am not the only one who decides,” but “I am the initial proposer.”

According to the affidavit, Troy made it clear that he wanted to file more amicus briefs on behalf of the drug companies and actually invited members of the defense attorney’s audience to approach him with requests for briefs, stating “we can’t afford to get involved in every case,” we have to “pick out shots,” so “make it sound like a Hollywood pitch.”

However, in an obvious effort to try and level the playing field for the little guy, in 2004, Representative, Maurice Hinchey (D-NY), chastised the administration for taking the FDA in a radical new direction, “seeking to protect drug companies instead of the public,” and persuaded the House to cut $500,000 from the budget of the chief counsel’s office as a penalty for the FDA’s aggressive opposition to citizen’s lawsuits.

Although the FDA’s current Chief Counsel, Sheldon Bradshaw, might not have the direct and visible financial links to Big Pharma of his predecessor, critics say, he certainly does not represent a changing-of-the-guard in political leadership at the FDA.

“In fact,” Attorney Menzies says, “following in his predecessor’s footsteps, Bradshaw submitted a legal brief in support of Pfizer’s federal preemption arguments.”

Judges across the nation have flat-out rejected the FDA’s argument. A Minnesota court said it declined “to treat statements from a single FDA legal brief as declarations afforded the preemptive force of law.”

A California court ordered the brief stricken from the record calling it “hearsay and irrelevant,” and an Illinois judge said it “contains nothing more than legal argument by [FDA] counsel.”

Most recently, in a June 6, 2005, Vioxx court hearing, the FDA’s position on preemption hit a major road block with New Jersey State Court Judge, Carol Higbee, who is handling the Vioxx cases, when she labeled the FDA’s Final Rule’s preamble “a political statement by the FDA.” She scoffed at the agency’s preemption claim and said:

“It is contrary to the U.S. Supreme Court’s decisions. It is contrary to all the law on preemption. … In addition to being contrary to the law of the land, it is also contrary to the Constitution of the United States.”

Judge Higbee ended her comments by throwing cold water on any planned attempt by Merck’s legal team to give the preemption argument a whirl, by telling them right-out in open court: “I am not going to allow you to use it.”

Speaking to the Consumer Federation of America in March 2005, Senator Grassley, basically said the FDA can’t be trusted to protect citizens against dangerous drugs like Vioxx because the agency is to “cozy” with companies like Merck.

Based on a clinical trial that took place in 2000, he told the audience, both the FDA and Merck were aware that heart attacks were 5 times more likely in patients taking Vioxx than among those taking a similar drug, but the FDA did nothing to change the labeling on the drug for nearly two years, while Merck aggressively marketed Vioxx on nightly TV.

Describing whistleblowers as “patriots” who risk their careers in the interest of public safety, Senator Grassley recounted the controversy over Vioxx that was fueled in large part by the efforts of FDA scientist, Dr David Graham, to shed light on the drug’s potential risks.

Senator Grassley described how the FDA “disregarded and stonewalled” concerns raised by its own scientist. “Dr. Graham completed a study that found an increased risk of heart attacks and strokes in patients taking Vioxx,” he told the Federation. “His immediate supervisor, however, dismissed this study as ‘scientific rumor.'”

“The very same month that Dr. Graham warned the FDA of the cardiovascular risks of Vioxx,” Senator Grassley continued, “the FDA approved the use of Vioxx for children.”

He told the audience how the director of FDA’s office of new drugs suggested that Dr. Graham water down his Vioxx conclusions and how Dr Graham replied that in good conscience he could not. “When Dr. Graham was asked to present his findings at my committee’s Vioxx hearing,” the Senator said, “he was also undermined.”

News reports that day show that acting FDA Commissioner Lester Crawford called Dr Graham a “maverick who did not follow agency protocols.”

“This statement,” Senator Grassley told the Federation, “made on the eve of the hearing, could logically serve no purpose other than to intimidate Dr. Graham.”

The Vioxx matter became the focus of the Senate Finance Committee, basically because of the drug’s cost to public health care programs, and the Committee is responsible for oversight of the Medicaid and Medicare programs.

During a November 18, 2004, hearing, the ranking Democrat on the finance committee, Senator Max Baucus, discussed the tax dollars wasted on Vioxx: “In the 5 years that Vioxx was on the market, Medicaid spent more than $1 billion on the drug,” he said.

In addition, he complained about the fact that government programs are now paying the medical bills for patients harmed by Vioxx. “Medicaid bears the cost of any additional medical care necessary when drugs cause injury,” Senator Baucus said.

Merck’s last CEO, Raymond Gilmartin, resigned on May 5, 2005, the same day that another Congressional Committee, the House Committee on Government Reform, released more than 20,000 pages of documents showing how Merck continued to promote Vioxx long after it was aware of the safety problems.

Documents released that day at a Reform Committee hearing on Merck’s marketing practices, described in detail how Merck directed its 3,000-strong sales force to avoid discussions about the cardiovascular risks identified in the 2000 VIGOR study. During visits with doctors, sales reps were instructed to rely on a “Cardiovascular Card” that claimed Vioxx was actually protecting the heart rather than damaging it. The sales reps were specifically trained on how to speak, smile, and position themselves most effectively when talking to doctors.

If doctors asked about Vioxx increasing the risk, the sales reps were instructed to give them a pamphlet written by Merck’s marketing department that claimed Vioxx was eight times safer for heart patients than similar pain medications, and omitted Merck’s findings that Vioxx produced a 5-fold increase in the risk of heart attack and stroke compared with naproxen, the other painkiller used in the study.

The company’s training efforts were obviously successful because Vioxx was approved by the FDA in May 1999, and the drug reached $2 billion in sales in two years, faster than any drug in Merck’s history.

In 2000, the same year the VIGOR study was completed, Vioxx was the most heavily advertised drug in the US with $160.8 million spent on mass media promotion. And the blitz paid off well. In one year, retail sales of Vioxx rose from $329.5 million in 1999, to $1.5 billion in 2000, up 360%, according to a November 2001, report by the National Institute for Health Care Management.

For the same year, Pepsi only spent $125 million advertising its products. Vioxx also beat out Budweiser’s spending of $146 million, and matched Dell Computer’s ad expenditures of $160 million. And by far, the drug beat out Nike’s advertising budget of $78.2 million for shoes, and Campbell soup’s $58 million.

The increase in Vioxx sales from 1999 to 2000 accounted for 5.7% of the one-year increase in total prescription drug spending, more than any other single drug, the report said, and Vioxx was the 13th best selling drug in 2000.

In 2003, Merck upped the anti even more and spent 499.8 million on Vioxx promotion including the cost of sales reps detailing office and hospital-based physicians, advertising in medical journals and the retail value of samples passed out to doctors, according to IMS Health, Integrated Promotional Services in April, 2004. In return Vioxx saw growth of 24% and became the 6th best selling drug.

What’s that old saying about the bigger they are the harder they fall?

Nowadays, instead of spending hundreds of millions of dollars promoting Vioxx, shareholders are paying hundreds of millions a year for attorney fees. As of December 31, 2004, in its 2005 annual report, Merck said it had a reserve of $675 million solely for its future legal defense costs related to Vioxx. And in the fourth quarter of 2005, Merck said it recorded another charge of $295 million to increase the reserve.

“This reserve is based on certain assumptions,” the annual report said, “and is the best estimate of the amount that the Company believes, at this time, it can reasonably estimate will be spent through 2007.”

There is no money listed anywhere in Merck’s financial filings set aside to pay damages to any injured party, at least through 2007. The whole wad goes for Vioxx “legal defense costs.”

And to think, Republicans have the nerve to say that personal injury attorneys who go up against attorneys with a war chest of close to $700 million a year are financial gluttons.

However, thanks to a helpful group of plaintiff’s attorneys, going up against Merck in jury trials is getting bit easier. The group put together what they call a pre-made Vioxx trial package, complete with a guide to pursuing a claim against the corporate giant.

The package reportedly organizes and edits all of the information that shows Merck knew about the dangers of Vioxx but failed to inform consumers and includes the most damaging documents and evidence available against the drug maker. The package is offered on a small contingency fee basis and costs nothing until the lawsuit is won.

This month, Merck’s legal eagles were hit up once again when the New England Journal of Medicine issued a correction to a paper it published last year on Vioxx that mistakenly said that heart risks only became apparent after 18 months. The Journal editors deleted the 18 month statements saying a statistical error by Merck undermined the evidence for them.

All through litigation thus far, Merck’s main argument has been that the risk to patients from Vioxx did not begin until after 18 months of use, and with one sweep of the pen, the NEJM blew a hole in that defense.

But then juries are not buying into the 18 month defense in any event. In the first jury trial, in August 2005, the jury held Merck liable for the death of Vioxx victim, Robert Ernst, age 59, who died after only taking Vioxx for eight months.

Internal company documents introduced at the trial showed that Merck was aware of the problems with Vioxx as early as 1997. Attorney, Mark Lanier, showed jurors documents and e-mails to prove that Merck scientists knew about the cardiovascular risks (CVs), two years before the drug was approved.

For instance, one 1997 email written by Merck scientist Dr Alise Reicin, said: “The possibility of increased C.V. events is of great concern.”

“I just can’t wait to be the one to present those results to senior management,” he wrote.

As evidence to prove that physicians were deliberately misled, the jury was shown a 2001 Dear Doctor letter, in which Merck specifically stated that in the largest study ever of more than 4000 patients taking Vioxx, only 0.5%, or about 20 patients, had incurred CVs, when in fact, 14.6% of the patients, or 590, had cardiovascular problems, according to a Merck report submitted to the FDA.

It was also proven at trial that in April 2001, the doctor who prescribed Vioxx to Mr Ernst, had received the letter with the fraudulent statistics.

Mr Lanier played a video for the jury that showed sales reps were told that Vioxx did not increase heart attacks and were trained to view doctors concerns about CVs as “obstacles” to be avoided or dismissed. Another training document told sales reps to play “Dodgeball” if doctors raised questions about CVs.

In a more recent on-going trial, on July 5, 2006, more damaging testimony against Merck was given by Dr Lemuel Moye, a professor of biostatistics at the University of Texas, in a California case filed by a 71-year-old, Stewart Grossberg, who told the jury that Merck’s clinical trials conducted as far back as 1996, showed patients taking Vioxx were at risk for heart attacks and strokes, long before the drug went on the market, and that after reviewing the trials, he concluded that Vioxx carried more risks to patients than benefits.

But legal experts say that back in April 2006, Merck received the worst news possible when it lost an appeal to deny certification of a Vioxx-related class action lawsuit. They says the court’s decision to certify third-party payers, like health insurance companies, HMOs, and unions, has to be the most disturbing development for the company to date.

By ruling against Merck, the court gave the OK to apply New Jersey’s consumer fraud statutes to all members of the class, even to plaintiffs from states that have different laws. Experts predict that the consequences of this ruling will be profound and far-reaching, and the costs to Merck potentially staggering.

In light of the verdict in the April 2006, trial of Cona v Merck and McDarby v Merck, in which the jury said Merck violated New Jersey’s consumer fraud statute because it misled physicians about the cardiovascular risks of Vioxx and concealed information about those risks from doctors, experts say, the appeals court’s ruling might just turn out to be the nail in the coffin for Merck.

Christopher Seeger, the lead lawyer in the class action filed by HMOs, insurers, and unions, says that Judge Higbee, who is overseeing about 5,000 Vioxx cases, should apply the findings of this jury to the class action, which he said could be worth $10 billion.

Mr Seeger told Bloomberg News on April 5, 2006, that this was devastating for Merck: “This jury just said ‘Yes’ to consumer fraud, so I think we go right to damages.”

Mr Seeger is referring to collateral estoppel a situation in which the judgment in one case prevents, or estops, a party from litigating the same issue in future cases. Because of the consumer fraud verdict, Mr Seeger contends that Merck may now be permanently bound by the jury’s ruling.

Indeed, Bloomberg says, a judge could decide that the ruling that Merck failed to warn of Vioxx’s risks could be applied to thousands of future trials in New Jersey, leaving the jury to decide only whether Vioxx caused specific heart attacks.

Barry Turner is an academic lawyer in the UK who has taught medical ethics and for a number of years has been involved in litigation activities related to the pharmaceutical industry.

He has been advocating the use of federal and state false claims statutes against Big Pharma for years. “I take the view that because of the harsh penalties imposed when these actions are successful,” he explains, “that this is the legal strategy that will work against these people.”

“PI suits,” he says, “may very well be morally righteous but they will never make this industry change its ways.”

“What is at issue,” he continues, “is that companies factor litigation costs into ‘research and development’ and other costs of sales, so it does not hurt them to pay out in damages, what they already budgeted for.”

“The Federal and State False Claims Act actions are different,” he notes, “a drug company hit by a big one of these will have to pay out colossal amounts in fines and damages, hundreds of millions in most cases,” he says, “and these come out of profits.”

“Then the stock will go down,” he explains, “and they can be hit again under the Sarbanes Oxley Act.”

“And if anyone thinks that Sarbanes Oxley is feeble legislation,” he says, “they can always ask the Enron executives.”

“As well as defrauding the taxpayer,” Mr Turners notes, “the consequences of these deliberate and deceitful acts hurts shareholders when the litigation causes serious downturns in stock value.”

“This is a violation of Sarbanes Oxley,” he says, “and sooner of later there will be a major action here.”

In each of the cases Merck has lost, the juries have ordered the drug giant to pay large punitive damage awards, creating additional problems for the company. Punitive damages are awarded to punish a defendant and deter future misconduct. They are not covered by insurance because the conduct is an intentional act on the part of the insured; and the intent of punitive damages would be lost if a defendant could avoid payment simply by buying more insurance.

In the state of New Jersey, punitive damages are allowed to be as much as 5 times the amount of compensatory damages. The Texas $229 million punitive damage award against Merck, even when reduced, will still be about $26 million. Legal analysts say no company could avoid financial ruin if ordered to pay tens of thousands of $26 million punitive damage awards.

Punitive damages provide a basis for a derivative lawsuit seeking damages for conduct that compromised the value of the investments of shareholders. These types of lawsuits are being filed for much less than what Merck pulled with Vioxx.

For instance, in March 2005, a class action lawsuit was filed in the US District Court for the District of Massachusetts, on behalf of shareholders in Elan Corp PLC, after the company’s withdrawal of the multiple sclerosis drug Tysabri, with many of the same allegations that can be made against Merck.

The complaint alleges that Elan failed to disclose and misrepresented material adverse facts in connection with Tysabri including serious immune-system side effects and that the information was concealed in order to fast track Tysabri for FDA approval.

In any event, notwithstanding that Merck continues to contend that it will try every single case, legal analysts say, state courts will never be able to handle the trials for the lawsuits already filed, much less the additional cases still being filed on a regular basis.

“At some point courts are going to be clogged with these cases and judges will start to put pressure on Merck and the plaintiffs to settle these cases,” according to John Leubsdorf, professor of law at Rutgers Law School, on CNN Moneyline on April 26, 2006.

“The only scenario in which they won’t settle,” he says, “is if they win so much that all the plaintiffs go away.”

But experts say that is definitely not going to happen.

Filed under: 2006, FDA, FDA Crawford, Graham, Merck, Preemption, stroke, Troy, Vioxx, whistleblower

FDA and Big Pharma Gang Up On Joe Citizen

Evelyn Pringle November 6, 2006

The botched safety processes at the FDA have had an extremely negative impact on the nation’s public health and tens of thousands of people have died as a result of its negligent handling of the Vioxx debacle alone.

Americans today can no more trust what’s in their medicine cabinets than could the pioneers in the 1800s who filled their medicine chests when the snake oil salesmen came to town.

The FDA is now apparently claiming infallibility by telling consumers that if it says a drug is safe and the warnings on a drug’s label are sufficient, no consumer can bring a lawsuit against a drug’s maker in a state court for injuries caused by a drug, even if it is shown that the drug company actively concealed information about known injuries associated with the drug not only from consumers, but from the FDA as well.

Throughout the FDA’s 100 year history, state consumer protection laws have played an important role in protecting Americans from unsafe pharmaceutical products, and consumer protection advocates are rightfully questioning whether the FDA can or will provide the same protection.

Its no secret that the Bush-sanctioned FDA is bent on protecting drug company profits and doesn’t care enough about protecting consumers from unsafe drugs. A March 2006 report to Congress issued by the Government Accountability Office, after an investigation of the FDA ability to monitor drug safety, said the FDA’s performance was undermined by infighting between drug evaluation administrators whose allegiance is with industry and the Office of Drug Safety.

According to Attorney, Jim Gottstein, who recently scored a major victory in the Alaska Supreme Court protecting patients in state institutions from forced drugging with psychiatric medications, “the fact that current leaders of the FDA have taken the extraordinary step of interjecting the FDA into cases to argue pre-emption, leaves no doubt that it has abdicated its duty to protect the public from unsafe drugs in favor of protecting pharmaceutical profits.”

State lawmakers are also crying foul over the FDA’s arrogant undermining of state consumer protection laws because under Executive Order 13132, the FDA is required to consult with state authorities about the effects of regulations it issues on states. In the original proposed rule, the FDA specifically said that the regulation would not preempt state laws so state officials had no chance to object to the preemption rule.

According to the National Conference of State Legislatures, the preemption language in the preamble to the Final Rule is a thinly veiled attempt on the part of the FDA to confer upon itself authority it does not have by statute and does not have by way of judicial ruling. The NCSL called the FDA’s action an abuse of agency process and a complete disregard for our dual system of government.

According to Baum Hedlund attorney, Karen Barth Menzies, “the FDA’s statement is nothing more than the policy position of appointed officials with an agenda unrelated to public safety.”

“As such,” she says, “it should have zero preemptive effect.”

When Congress enacted the Federal Food, Drug, and Cosmetic Act in 1938, it specifically rejected a proposal to include a private right of action for damages caused by products regulated by the FDA, on the grounds that a right of action already existed under state common law.

The new FDA preemption rule provides no exceptions even in cases like Vioxx where the FDA asked the company to change the warning label based on reports of serious adverse effects, and a drug maker like Merck refuses to change the label for more than 18 months while many more patients are killed and injured.

In addition, the FDA contends that the agency’s approval of the drug label preempts not only claims related to label warnings but also claims related to false advertising.

Given the on-going heated debate over the FDA’s ability to police the pharmaceutical industry as a whole, critics say it is a particularly inappropriate time to eliminate the role that private citizen lawsuits in state courts play.

But then again, what can we expect when the agency’s top attorney, Daniel Troy, is recruited directly from Pfizer’s stable of lawyers. Troy began the administration’s preemption war against Joe Citizen to protect Big Pharma profits as soon as he set up shop at the FDA, by filing amicus briefs on behalf of drug companies, including Pfizer.

Even though Pfizer had been one of his clients and Troy’s firm was paid over $350,000 for work he performed in the year before he was appointed chief counsel, Troy agreed to file a brief in support of Pfizer on behalf of the FDA, arguing, unsuccessfully, that state tort claims should be preempted.

He later justified writing the brief by claiming that he did not become involved in the case until after the 1-year period in which government employees may not participate in cases involving former clients. In hindsight, the 1-year grace period reportedly expired less than a month before Troy agreed to go to bat for his former client.

In stark contrast to Troy’s pro drug company stance, in a 1996 speech, the Clinton appointed FDA chief counsel, Margaret Jane Porter, said the FDA had a “longstanding presumption against preemption” and that “FDA’s view is that FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection.”

When simply filing amicus briefs did not work because no judge accepted the FDA’s at best feeble and at worst ridiculous arguments, in January 2006, the FDA added the preamble to the new drug labeling rules stating that the Food, Drug and Cosmetic Act “pre-empts conflicting or contrary state law.”

Judges are having mixed reactions to the FDA’s preemption position. In a stinging rebuke, New Jersey judge, Carol Higbee, during a June 6, 2006 hearing involving Vioxx lawsuits, called the Final Rule’s preamble “a political statement by the FDA.”

As for the claim that state lawsuits should be preempted, she said, “It is contrary to the U.S. Supreme Court’s decisions. It is contrary to all the law on preemption.”

“In addition to being contrary to the law of the land,” she stated, “it is also contrary to the Constitution of the United States.”

She ended her comments by telling Merck’s Vioxx attorneys, “And I am not going to allow you to use it.”

On June 2, 2006, the Associated Press reported that a federal judge had refused to dismiss a lawsuit filed against Pfizer and Wyeth, on behalf of the parents of an 11-year-old boy who committed suicide after taking the antidepressants Zoloft and Effexor.

The judge rejected the preemption argument stating: “Federal labeling laws are minimum standards; they do not necessarily shield manufacturers from state law liability.”

“Defendant’s pre-emption argument ultimately fails because Congress has not expressed a specific intent to pre-empt state consumer-protection laws in the area of prescription-drug labeling,” the court said.

“In the absence of Congress’s express statement,” the judge stated, “defendant must overcome the presumption against implying congressional pre-emptive intent. It has not done so.”

In what can only be viewed as a rare ruling, In Bextra and Celebrex, on August 16, 2006, the US District Court for the Northern District of California dismissed the state law failure-to-warn claims saying they conflict with the FDA’s determination of the proper warning and pose an obstacle to the full accomplishment of the objectives of the Food, Drug and Cosmetic Act.

The court attempted to justify the FDA’s “180-degree reversal of its prior position” on preemption, by noting that an agency’s view may change over time and especially with a change in administration.

But in New Jersey on September 29, 2006, a federal district court in McNellis v Pfizer Inc, refused to allow the preemption defense and based on the fact that the text of FDA regulations had remained unchanged for years, ruled that the regulations did not conflict with New Jersey’s failure-to-warn laws.

The court also said that FDA regulations allow increased warnings when new risks emerge and that the Food, Drug and Cosmetic Act does not contain a preemption clause.

Following the McNellis decision, on October 16, 2006, a federal court in Pennsylvania refused to grant the drug maker’s preemption motion in Perry v Novartis Pharma Corp, noting concerns about the effectiveness of the FDA’s monitoring of recently approved drugs, making the availability of state tort suits an “important backstop to the federal regulatory scheme.”

On October 5, 2006, the 2nd Circuit Court of Appeals was also critical of the FDA’s preemptive reach stating, “[W]hatever deference would be owed to an agency’s view … an agency cannot supply, on Congress’s behalf, the clear legislative statement of intent required to overcome the presumption against preemption,” in Desiano v Warner-Lambert et al.

Three weeks later, on October 28, 2006, the Associated Press reported another state court victory against preemption in a case where Wyeth was ordered to pay nearly $6.8 million to a Vermont women after the Vermont Supreme Court upheld a lower court’s ruling.

The court’s decision said federal labeling requirements “create a floor, not a ceiling” for state regulation, noting that the FDA regulations allow drug companies to go beyond required warnings.

“When further warnings become necessary, the manufacturer is at least partially responsible for taking additional action, and if it fails to do so, it cannot rely on the FDA’s continued approval of its labels as a shield against state tort liability,” the court wrote.

Peter Lurie, deputy director of the health research group at Public Citizen, told the Associated Press that the case appeared to mark a push-back against efforts by the industry, the administration and the FDA to preempt state regulation of prescription drugs.

“If you have a wide enough berth that you can strengthen the label,” he said, “you can’t use the FDA-approved label as an automatic protection against lawsuits.”

Since May 2006, all eyes in the legal field have been on the appeal in the case of Colacicco v Apotex, Inc, – F Supp 2d -, 2006 WL 1443357 (ED Pa), in the 3rd Circuit Court of Appeals, where the lower court ruled against a man whose wife committed suicide after taking Paxil.

Joseph Colacicco filed a lawsuit against both drug makers alleging that his wife committed suicide in October 2003, just 21 days after she began taking Paxil for mild depression with claims of wrongful death, negligence and a failure to warn her doctor of a link between Paxil and an increased risk of suicide.

In moving for dismissal, Paxil maker, GlaxoSmithKline, and Paxil generic maker, Apotex, relied on the FDA’s position that state failure-to-warn claims are preempted.

The judge ruled that the defendants were entitled to a dismissal of all claims because the FDA controls the content of warnings and requires generic drug makers to use the same labeling as approved for the drug’s original maker.

In this case, the judge on his own initiative, asked the FDA to submit an amicus brief. And in response, on the tax payer’s dime, the FDA wrote a brief asking the court to rule against the American citizen and dismiss the lawsuit against the drug companies.

In fact the FDA was the strongest supporter of preemption in this case because according to the attorneys handling the case, Glaxo itself barely addressed the preemption issue during oral arguments on the motion.

In a decision that experts predict may end up before the US Supreme Court, the judge ended up dismissing the claims without ever considering whether the FDA regulations pose a conflict to the plaintiff’s state tort claims.

Attorneys Derek Braslow, Harris Pogust and Matthew Leckman from the Conshohocken, Pennsylvania firm of Pogust & Braslow are representing the plaintiff in the case.

Attorney, Harris Pogust, says the judge’s ruling “could potentially do away with all failure-to-warn pharmaceutical cases”

The FDA action he notes, “does not seem to be a public health concern as much as a political concern.”

According to Mr Braslow, “the Judge readily admits that he did not analyze whether there is or was a conflict between state law and federal law and surmises that he probably would not find a conflict if he actually did the analysis.”

“But, the Judge explained,” he said, “that it doesn’t matter – if the FDA says there is preemption, then there must be preemption. Far be it for a Judge to interpret the law.”

“The Bush-era FDA,” Mr Braslow notes, “in a complete reversal of the position it took in its 2000 rule proposal, has now officially cemented its role as a pawn for the pharmaceutical industry.”

“It was not that long ago,” Mr Braslow points out, “that the FDA came forward with amicus briefs on behalf of the consumer in prescription drug litigation.”

“Now,” Mr Braslow says, “an argument first put forward in a couple Zoloft suicide cases, has become the primary argument in every prescription drug case, and could,” he warns, “potentially, mean the end for anyone seeking recourse from injuries resulting from prescription drugs, no matter how fraudulent the drug company’s conduct.”

“Make no mistake,” he states, “the position taken by the Bush-era FDA is an attempt by the current administration to achieve tort reform for the benefit of big pharma and at the expense of the injured consumer, without the consent of Congress.”

“The Bush-era FDA takes this position,” he warns, “unconcerned by the reality that preemption would allow drug companies to peddle their drugs with impunity and avoid being justifiably called into court for deceiving the public about the safety and effectiveness of those drugs.”

“Notwithstanding the FDA’s position on preemption,” Mr Braslow says, “courts examining this issue, if they take any time to actually look at the FDA regulations in question, would realize that there is no conflict between federal drug regulations and state tort claims.”

“Federal drug regulations specifically mandate drug companies to strengthen their drug’s label,” he explains, “as soon as there is reasonable evidence of an association of a serious hazard with their drug.”

“A state tort claim,” Mr Braslow points out, “does not force a drug company to take any action that is not already permitted by federal regulations.”

“Because federal regulations for prescription drugs are minimum standards,” he notes, “federal regulations can never conflict with a state common law claim.”

“The District Court erred,” he states, “in abdicating to FDA legal opinion, as opposed to interpreting the law.”

“What the Colacicco court did,” he says, “was improperly abdicate to the FDA’s legal opinion.”

Critics say it’s time for the FDA to get back to protecting consumers from dangerous products, rather than protecting the profits of the pharmaceutical industry.

According to career scientist, Dr David Graham, in a 2005 interview with Jeanne Lenzer in the journal Public Library of Science, “The pharma-FDA complex has to be dismantled and the American people have to insist on that, otherwise we’re going to have disasters like Vioxx that happen in the future.”

Filed under: 2006, Baum, Braslow, Colacicco, FDA, Preemption, Supreme Court, Troy

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

Daniel Troy – Godfather of Big Pharma Protection Racket

Evelyn Pringle December 2006

In hindsight, it’s now more than apparent that Daniel Troy, who fought against stricter prescription drug laws in private practice, was appointed Chief Counsel at the FDA for one reason, to serve as Godfather in setting up a protection racket for Big Pharma.

On August 20, 2001, when President Bush made him Chief Counsel, Mr Troy became the first political appointee to ever hold that post. After he completed his dirty work of installing the policy of preemption in record time, he went back into private practice to reap the financial rewards of the protection racket by once again working directly for Big Pharma, and throwing all conflict of interest rules to the wind.

And furthermore, he obviously could care less about who knows it.

In the October 9, 2006, Legal Times, Mr Troy said, “I was also at the FDA while January’s Physician Labeling Rule, which contains a statement in its preamble about the FDA’s pre-emption authority, was written.”

“And I now,” he brags, “advise and represent companies confronting state-law claims that implicate the pre-emptive effect of FDA requirements.”

His bio at the end of the article says Mr Troy is a partner in the DC office of Sidley Austin, “where he specializes in food and drug law as well as administrative litigation.”

Judging by the firm’s Web site, which side he represents calls for no description.

In the Times article, Mr Troy contends that private lawsuits are a great cause for concern. “There is no question,” he says, “that the current product-liability environment represses innovation, limits access, increases prices, and interferes with rational prescribing decisions.”

In another paper on March 31, 2006, he said that this environment has reduced the availability of drugs. “Not only are fewer drugs being researched and created,” he wrote, “but also existing beneficial drugs have been removed from the market because of crippling litigation.

However, these comments completely contradict what Mr Troy said on December 15, 2003, during a lecture given to drug company attorneys telling them how to use preemption to win lawsuits against private citizens, when he specifically said that the FDA has “no good evidence” demonstrating that product liability concerns “keep good products off the market” and that he had “combed the literature” to find such evidence, but had come up empty.

In fact, during his lecture, Mr Troy told the defense attorneys to get busy and find some evidence no matter how weak, stating: “you guys really shoot yourself in the foot by not funding research to this effect. … I’ll even take anecdotal evidence and stories if you have them.”

In his March 31, 2006, paper, Mr Troy says that until “an authoritative ruling requires all courts in the United States to recognize the validity of FDA’s exercise of preemptive authority over drug labeling, state-by-state legal reform will remain an important aspect of efforts to ensure a pharmaceutical-liability regime that serves the long-term health interests of all Americans.”

While Chief Counsel, in the midst of the Vioxx and SSRI antidepressant disasters, when it became known that the drug makers had for years concealed and manipulated studies that showed the harm caused by these drugs, instead of going after the drug makers for knowingly injuring hundreds of thousands of patients with dangerous drugs, Mr Troy devoted the majority of his time on the pubic payroll to filing briefs on behalf of pharmaceutical companies.

He spent so much money helping Big Pharma, that on July 14, 2004, Congressman Maurice Hinchey (D-NY), called for an amendment to cut funding for the FDA by $500,000 with the intention to cut the budget of Mr Troy’s office.

“The FDA’s Chief Counsel,” Rep Hinchey said in a speech on the floor of the House of Representatives on July 14, 2004, “has wasted taxpayer money on pursuits that are undermining FDA’s basic mission.”

“For the first time in history,” he told members of Congress, “FDA’s Chief Counsel is actively soliciting private industrial company lawyers to bring him cases in which FDA can intervene in support of drug and medical device manufacturers.”

The cases are private, State, civil litigation cases and according to the FDA, “it has spent over 622 hours on these cases,” he said.

The Congressman described what he called a pattern of collusion between the FDA and drug companies and medical device makers in three State court lawsuits.

One of Mr Troy’s previous clients at the law firm, Wiley, Rein, & Fielding, was Pfizer, which in the 3 years prior to his appointment to the FDA, Mr Hinchey said, paid the firm $415,000 for services provided directly by Mr Troy.

According to the Congressman, in July of 2002, Malcolm Wheeler, an attorney for Pfizer, called Mr Troy, and requested that the FDA get involved in a lawsuit filed by a private citizen against Pfizer in California. Less than 2 months later, the FDA through the Department of Justice, which represents the FDA in court, filed a brief in support of Pfizer saying the plaintiff’s claims were preempted by federal law.

In the brief, Mr Troy opposed the claim that Pfizer was required to warn that the antidepressant, Zoloft, caused suicide and noted that the FDA had considered whether such products increase the risk of suicidal thoughts and behavior and had concluded that the warning was not justified.

The brief maintained that the warning would have misbranded the drug. The court upheld the lower court’s dismissal on other grounds and never addressed preemption, but from then on, Big Pharma lawyers relied on the FDA’s briefs to support their preemption arguments in other cases involving antidepressants.

In July of 2002, Mr Troy also had a meeting with Michele Corash from the California based Morrison and Foerster law firm. At the time of the meeting, the firm was representing GlaxoSmithKline in a private lawsuit and Michelle Corash was the lead attorney.

In this case, the plaintiff wanted a label on nicotine replacement products with the following: “Warning: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm.”

In the alternative, the plaintiff sought an injunction requiring the following warning or a similar one: “If pregnant or breast-feeding, ask a health professional before use. Nicotine, whether from smoking or medication, can harm your baby. First try to stop smoking without the patch.”

On September 12, 2002, less than 2 months after Mr Troy’s meeting with Ms Corash, the FDA filed a brief in support of Glaxo in a case.

Rep Hinchey says this pattern of collusion continued in 2003, pointing out that on December 12, 2003, the FDA filed a statement of interest in the case of, Murphree v Pacesetter, in support of the medical device maker in a Tennessee lawsuit over a faulty pacemaker.

To substantiate this charge, Rep Hinchey described a letter to the FDA that he obtained, dated November 5, 2003, from the law firm representing Pacesetter, Feldman, Gale and Weber, that directed the FDA on how it should assist the company in the lawsuit against the private citizen whose heart device did not work.

Rep Hinchey also told members of Congress that another action by Mr Troy aimed at protecting Big Pharma, “was his publishing in the Federal Register a notice questioning whether FDA’s own regulations complied with the first amendment.”

This notice was troubling, the Congressman said, because it would be used against FDA in lawsuits. The Congressional Research Service looked for a precedent for any similar prior actions and reported: “We were not able to uncover any similar instance where a Federal agency issued a notice seeking the type of public comment on a constitutional issue and regulatory issue such as this one which was sought out by Mr. Troy.”

After receiving 700 filings and spending 600 hours on this matter, Rep Hinchey said, the FDA decided to drop it, once again wasting taxpayer money.

According to the Congressman, his amendment to cut funding to the Chief Counsel’s office was about more than just an FDA office wasting money. The FDA’s Chief Counsel, he warned, was taking actions to undermine the FDA’s ability to carry out its mission.

Mr Troy was shutting down avenues used to expose fraud in the drug industry and making it easier for drug companies to produce misleading advertisements, he said.

Rep Hinchey wanted to add funds to FDA’s Division of Drug Marketing, Advertising and Communication. A division, he said, which consisted of only seven people who were responsible for reviewing the accuracy of direct to consumer ads for prescription drugs. In 2003, he said, the 7 people reviewed 38,400 ads, a 6% increase over the year before.

However, he pointed out, despite the increase in ads reviewed, the number of enforcement letters sent to drug makers for false and misleading advertisements dropped 75% in 2003.

“The reason for this drop,” Rep Hinchey said, “was not that the drug companies suddenly cleaned up their act.”

In fact, all public information indicates the opposite. The real reason, he says, was a conscious effort by the FDA to weaken advertising regulations.

Shortly after he took office, Mr Troy instituted a policy in which all advertising warning letters had to go through the Office of Chief Counsel. Prior to this, all letters were sent to drug companies from the Division of Drug Marketing. So once the letters had to go through the Chief Counsel for approval there was a 75% reduction in letters sent.

Between January 1999 and December 2001, the Division issued more than 270 letters, or an average of about 90 a year, but under Mr Troy’s reign, that number dwindled to fewer than 30.

However, during an investigation instigated by the House Committee on Government Reform, the FDA provided no records from the Chief Counsel even though the June 26, 2006, report on the investigation, “Prescription for Harm: The Decline in FDA Enforcement Activity,” says a previous investigation had attributed a sudden decline in enforcement actions to a change in FDA policy in September 2001, that required all letters to be approved by the Chief Counsel before being issued.

Under the revised procedures, the report notes, the Chief Counsel is required to “state in writing the reason for nonconcurrence” whenever it objects to an enforcement action.

Yet when the FDA was asked to explain why there were no records from the Chief Counsel’s office, FDA staff said that the Chief Counsel does not maintain copies of its decisions on recommendations or even a record of which files it reviews.

“These recordkeeping and case tracking practices are inadequate and resulted in a
haphazard and untimely response to the Committee’s document requests,” the report said.

They also appear to violate the Federal Records Act, the report noted, which require agencies to create and maintain records “sufficient to … document the formulation and execution of basic policies and decisions and the taking of necessary actions, including all significant decisions and commitments reached orally.”

US News sought records for the meetings that Mr Troy had with the pharmaceutical industry under the Freedom of Information Act but said it was informed by his office that there are “no minutes, no memos, no nothing.”

When the preemption preamble in the new labeling rules for prescription drugs was made public, Congressman Hinchey was outraged. “This behavior is a four-year old political maneuver that blatantly contradicts the FDA’s historic position on this issue,” he stated, “as well as the purpose for which the agency was created: to protect the American people.”

“Drug companies must be held accountable when their products do serious harm,” he said in a statement released on January 18, 2006.

“If the drug industry is shielded from being held accountable,” he warned, “then they lose much of the incentive to be forthcoming with potentially harmful or lethal side effects.”

On its Web site, in listing Mr Troy’s accomplishments at the FDA, his new employer brags about the very conduct complained about by members of Congress that led to the $500,000 cut in funding for the Office of Chief Counsel, stating:

“He oversaw the agency’s warning and untitled letters, helped raise the agency’s focus on First Amendment issues, and played a principal role in the FDA’s generally successful assertion of preemption in selected product liability cases.”

Filed under: 2006, FDA, Preemption, SSRIs, Troy

FDA’s Preemption Gift to Big Pharma

Evelyn Pringle November 18, 2006

An item sure to end up on the chopping block with the Democrats back in power, is the Bush administration’s multi-billion dollar gift to Big Pharma, that bars people who have been injured by drugs approved by the FDA from suing the drug’s maker in state courts.

Under the FDA’s federal preemption position, victims injured by dangerous drugs would go uncompensated, the regulatory powers of the states would end, and the drug companies would only be answerable to the FDA.

The claim of preemption was inserted into the preamble of new drug labeling guidelines in January 2006. At the time, Ken Suggs, president of the Association of Trial Lawyers of America, told the Washington Post: “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,”

But then the FDA claimed it had preemptive authority long before the new rule was announced. The agency has repeatedly supported drug companies in failure-to-warn lawsuits since former Pfizer attorney, Daniel Troy, took over the helm of the FDA’s legal division.

Bush’s appointment of a Pfizer attorney as lead council at the FDA has been criticized far and wide. An investigation by Representative, Maurice Hinchey (D-NY), found that Mr Troy had received more than $350,000 in legal fees from Pfizer in the year before he took the FDA position, according to a July 13, 2004 Press Release from Rep Hinchey’s office.

As soon as he settled into his public employment, Mr Troy registered his on-going allegiance to Pfizer by filing an amicus brief in the Motus v Pfizer lawsuit, a case involving a widow whose husband committed suicide after taking the SSRI antidepressant, Zoloft.

In fact, the Bush administration’s FDA and Justice Department joined together in arguing that Pfizer should be immune from lawsuits in state courts by plaintiffs alleging that the company failed to properly inform the public about the increased risk of suicidality with Zoloft.

The court in the Motus case denied the motion noting that other courts had found FDA requirements to be minimum standards, and that FDA approval of a new drug did not shield the drug maker from liability, and that Pfizer had not cited a single case to the contrary.

Since the FDA brief was filed in the first case, Pfizer has used it, albeit with little success, to support its summary judgment motions in other Zoloft-induced suicide cases against private citizens.

With a large part of his work on behalf of Big Pharma completed, Mr Troy did not stay at the FDA for long, before he returned to private practice, but the FDA “ultimately drafted the formal Preemption Preamble before he left,” according to the October 23, 2006 report, “FDA Plays Both Sides,” by Melissa Davis, for The Street.com.

“Troy now offers his services,” Ms Davis reports, “to companies facing state lawsuits that could be derailed by the new rule.”

Houston attorney, Andy Vickery, has been battling the giant SSRI makers on behalf of injured victims for more years than he likes to count. He has represented clients in civil and criminal cases involving SSRI-induced violence and suicides.

Along with a majority of the nation’s attorneys, Mr Vickery views the FDA preemption position as an assault on the rights of everyday citizens. “For 38 years,” he says, “through both Democratic and Republican administrations, the FDA took the stance that private tort litigation was a good thing.”

“By and large,” he notes, “it avoided becoming embroiled in civil litigation but when it did intervene, usually with amicus briefs, its position typically protected consumers.”

Attorneys note the FDA’s total reversal in position from 1996, when the agency’s argument was favorable for private citizens against federal preemption in the medical device case of, Medtronic v Lohr, in the US Supreme Court.

In 1998, the FDA’s statements were that its labeling regulations established minimum standards, and in 2000, when the FDA published the proposed new labeling rule, the FDA said that it did not preempt state law. 65 Fed Reg 81082, 81193 (December 22, 2000) specifically stated: “FDA has determined that this proposed rule does not contain policies that have federalism implications or that preempt State law.”

But the next year, after Bush took office, the FDA began what can only be viewed as the “kick-off” for its preemption campaign by filing briefs arguing in favor of drug companies.

Mr Vickery says the state tort system has worked well as a scheme of checks and balances for many years. Civil litigants and their lawyers, he reports, have on many occasions uncovered information about the hidden dangers of drugs that had escaped the attention of the FDA.

This is precisely what happened, he notes, with the issue of Paxil and suicidality. On June 6, 2001, in a Wyoming case he was handling against GlaxoSmithKline, a federal jury found that “Paxil can cause some people to commit homicide and/or suicide.”

In the wake of that verdict, Mr Vickery says, Glaxo should have issued a warning immediately and the FDA should have begun its reclassification and analysis immediately, but they did not.

“Instead,” he states, “the FDA rode to the defense of industry via its first pro-preemption brief in the Motus case.”

He currently represents Jackie Giles and Annabelle Dobbs, who he refers to as, “Effexor-widows,” against Effexor maker, Wyeth, in federal wrongful death actions.

Specifically, the lawsuits allege that Jackie Giles’ husband Jeff died from a self-inflicted gunshot wound on October 30, 2002, only two days after his general practitioner prescribed Effexor; and Terry Dobbs died on December 30, 2002, only 6 days after his doctor switched him from another SSRI to Effexor.

According to Mr Vickery, numerous federal courts have rejected preemption claims in the drug-induced suicide cases. “At the present time,” he says, “the only Article III judge to consider claims of preemption by Wyeth in Effexor-suicide cases has denied Wyeth’s motion,” in the case Jackson v Pfizer, et al.

He handled that case, in which the Jackson’s 11-year-old son was under the influence of both Zoloft and Effexor, when he killed himself, and the court refused to give deference to the FDA’s precatory preamble and advisory amicus briefs. The case has since been settled.

Mr Vickery also handled the Kallas v Pfizer lawsuit, another case in which the FDA filed a brief in support of the drug maker’s preemption position, but the action was settled before any decision was reached on Pfizer’s preemption motion.

In that case, Shyra Kallas was only 15 when she went to her doctor seeking treatment for warts and came home with a prescription for Zoloft on October 8, 2002.

A mere two days later, on October 10, 2002, the FDA formally asked Glaxo to reanalyze the pediatric data on Paxil, to help the FDA understand the “greater number of adverse events” it had observed in the data the company had submitted to the FDA.

Nonetheless, the FDA took the position in its amicus brief that it would have considered an added warning to Shyra’s physician about Zoloft “false and misleading” when her initial prescription was written two days before the agency formally asked Glaxo for an explanation about the increased number of adverse events.

Attorneys agree that this “false and misleading” argument is the most silly of all because, 21 CFR § 201.57(e) requires a manufacturer to provide warnings in a drug’s label “as soon as there is reasonable evidence of an association of a serious hazard with a drug.”

In fact, during a Vioxx trial in March 2006, a New Jersey judge told the jury, “I just want to advise you that the law under FDA regulations does allow a company to change their warnings, to warn consumers and physicians about dangers they find out about after the label is approved.”

“They’re allowed to make changes,” the judge said, “through a special procedure, without prior FDA approval.”

Mr Vickery says the hidden studies uncovered in the Wyoming litigation in 2001, as well as the jury verdict that said Paxil could cause some people to commit homicide and or suicide, at least started the ball rolling down the hill, as far as alerting the public about the suicide risks associated with SSRIs.

Since then, he points out, the Attorney General of New York sued Glaxo for fraudulently concealing the studies that showed the increased risks of Paxil-induced suicidality and the ineffectiveness of Paxil with children, and obtained a settlement that requires the company to post its clinical trial data on the internet.

The same year, there was also the revelation that the FDA itself had suppressed a study that showed SSRI-related suicidality in children by one of its own scientist, Dr Andrew Mosholder.

Attorneys point out that many more studies, some dating back to before many of the SSRIs were even approved for use, have been unearthed through private litigation that show the SSRI makers knew about the serious side effects associated with the drugs, but concealed the reports and only allowed the positive studies to become public.

The preemption rule could not have come at a worse time for consumers. Under the current Big Pharma backed administration, the FDA is not adequately policing the marketing activities of drug makers. A recent investigation by the House Committee on Government Reform, found a sharp decline in enforcement actions taken against the pharmaceutical industry since December 2001.

From 1999 to 2001, the investigators reported that the FDA had sent out 250 “Notice of Violation” or “Warning” letters to drug companies; but for the period between 2002 through 2004, the FDA only sent out 70 letters, or a reduction of more than two-thirds.

According to Robert Brava-Partain, an associate attorney with the Baum Hedlund law firm, “there has been a steady decline in the FDA’s consumer-based orientation resulting in an FDA that is a conduit for large drug and device manufacturers to gain access to the US market where they reap billions of dollars in profit.”

Mr Brava-Partain says the FDA has traditionally been known to favor the health and safety of consumers over the interests of drug makers, but says “this focus has recently shifted towards the protection of the companies whose drugs the agency is supposed to be regulating.”

Mr Brava-Partain is a member of Baum Hedlund’s pharmaceutical products liability department which handles SSRI-related suicide and suicide attempt cases. Along with other members of the firm, he has successfully defended against preemption arguments in cases, including Witczak v Pfizer, Cartwright v Pfizer, and Zikis v Pfizer.

Baum Hedlund is currently also handling SSRI-related birth defect lawsuits involving cases where infants of mothers who took SSRIs during pregnancy were born with serious heart birth defects or a life-threatening long disorder.

The antidepressants involved in litigation include the SSRIs Paxil, Zoloft, Prozac, Lexapro, and Celexa. Effexor, a slightly different antidepressant, is also known to be associated with many of the same adverse effects associated with the SSRIs.

The majority of judges in cases where FDA briefs were submitted, have been critical of the FDA’s position. In a Minnesota Zoloft-induced suicide case, the court rejected Pfizer’ attempt to use the FDA to support its arguments, stating that it “declines to treat statements from a single FDA legal brief as declarations afforded the preemptive force of law,” and called the arguments “perverse” and a “public policy argument gone awry.”

The fact is, only Congress has the authority to enact preemption legislation and it has not chosen to do so. And furthermore, with the Democrats in power, it is not likely to do so anytime soon.

In response to the FDA’s initial preemption announcement, Senator Edward Kennedy (D-MA), issued a statement making his opinion clear by stating, “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.”

Senator Kennedy will take over as chairman of the powerful Senate Committee on Health, Education, Labor, and Pensions when the Democrats regain control of the Senate in 2007, and legal analysts say to look for the FDA’s preemption gift to Big Pharma to be high on the list of priorities for change.

Filed under: 2006, Baum, Effexor, FDA, Glaxo, Pfizer, Preemption, SSRIs, suicide, Troy, Vickery

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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