The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Lawmakers Say FDA Better Clean Up Its Act

Evelyn Pringle February 2007

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

“I smell a cover-up,” he stated.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

“Then the administration appointed Andrew Von Eschenbach as interim commissioner, creating another conflict,” he noted.

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

But even worse, he said, “the administration appointed Scott Gottlieb as deputy commissioner.”

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

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

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

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

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

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

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

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

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

Pfizer Makes List of Worst Corporate Evildoers

Evelyn Pringle March 6, 2006

On January 3, 2006 the Global Exchange Report named the top fourteen “Worst Corporate Evildoers” in the world for 2005. Pfizer, one of the most profitable drug companies on earth, with sales over $52 billion in 2004, made the list of Evildoers.

Pfizer’s participation in the cover-up of the deadly side effects of Bextra surely contributed to its membership. Because the drug was promoted and sold off-label for so many unapproved uses, the company made hundreds of millions of dollars in pure profits during Bextra’s short life on the market. However, experts predict that when all is said and done, the total amount of the drug’s damage to consumers will be in the billions.

Bextra belongs to the same class of drugs as Vioxx and Celebrex, known as Cox-2 inhibitors. Millions of people world-wide have taken these drugs.

It is now apparent that Pfizer knew Bextra was associated with extremely harmful side effects long before it was yanked off the market. However, Pfizer had good reason to stall its inevitable removal after Vioxx was recalled.

Bextra was on the market for about 3.5 years, but did not reach its full sales potential until Vioxx was eliminated from the competition. After the Vioxx recall, in one month alone, Bextra prescriptions went from 1.15 million in September 2004, to 1.48 million in October. All total for 2004, Pfizer generated sales of about $1.3 billion.

The marketing history of Bextra involves a train of suspicious conduct. On November 16, 2001, the drug’s original maker, Pharmacia won FDA approval for treatment of pain associated with osteoarthritis, adult rheumatoid arthritis and menstrual pain only and immediately went into overdrive promoting the drug for off-label use.

In July 2002, Pfizer acquired Bextra from Pharmacia in a $58 billion dollar deal that was not approved by the FTC until the following year in April 2003.

An FDA Talk Paper on the agency’s web site on November 15, 2002, announced new warnings on Bextra and said, “labeling is being updated with new warnings following postmarketing reports of serious adverse effects including life-threatening risks related to skin reactions – including Stevens Johnson Syndrome, and anaphylactoid reactions.”

The following month, the “Congress of California Seniors,” filed a lawsuit against Pharmacia in a Superior Court in Los Angeles, alleging the company had illegally promoted Bextra for off-label use.

According to the group, after the FDA refused a request to approve Bextra for pain related to impacted molars, Pharmacia helped fund a study that claimed Bextra could be useful in fighting acute dental pain and got it published in dental journals which led to the suit alleging secretive encouragement of ‘off label’ uses and attempting to circumvent the FDA’s refusal.

On November 2, 2003, after a year-long analysis of prescribing records, Knight-Ridder reported that more than half of Bextra pills sold were for off-label use.

About 5 months later, on March 14, 2004, Pfizer disclosed in a regulatory filing that the Justice Department was investigating the company’s marketing practices of Bextra for uses not approved by the FDA.

In October, 2004, the New England Journal of Medicine carried two editorials calling for renewed scrutiny of all Cox-2 inhibitors to assess whether the other drugs also caused heart problems.

In one editorial, cardiologist, Eric Topol, one of the first people to raise a red flag on Vioxx, from the Cleveland Clinic in Ohio, called for a government investigation into why Merck and the FDA allowed Vioxx to remain on the market for so long after its association with heart risks were revealed.

The FDA’s inaction was also noted by the Washington Post pointing out that in the late 1990s, the FDA took action when safety concerns were raised by withdrawing 10 drugs within 3 years. “But until the Vioxx withdrawal, only one other drug had been pulled since the Bush administration began, leading some to conclude that the agency had made a quiet policy change that emphasized “benefit” and sought to manage “risk” less intrusively,” the Post said on April 11, 2005.

As it turns out, Pfizer knew Bextra was every bit as dangerous as Vioxx and that the incidence of heart attack and stroke among patients using Bextra was more than 2 times that of patients taking placebos, which was revealed in a study presented on November 9, 2004, during the annual meeting of the American Heart Association in New Orleans.

Dr Curt Furberg, a professor at Wake Forest University School of Medicine, helped conduct the study and said: “Basically, we showed that Bextra is no different than Vioxx, and Pfizer is trying to suppress that information.”

On November 18, 2004, Dr David Graham, head of the FDA’s Office of Drug Safety, testified before the Senate Finance committee and listed Bextra as one of five drugs whose safety needs ”to be seriously looked at.”

On December 9, 2004, the FDA announced that Bextra would come with a new bolded warning contraindicating its use in patients undergoing coronary artery bypass graft (CABG) surgery.

The FDA knew Bextra was being widely marked for off-label use. Its December 9, Talk Paper, noted that Bextra was “not approved for use in the treatment of postoperative pain of any type;” but added: “however, FDA believes that these new findings should be made available to healthcare professionals and patients, and the bolded warning specifically contraindicates Bextra for treatment of pain immediately following CABG.”

The FDA also ordered a black boxed warning on the label stating that patients taking Bextra had reported serious, potentially fatal skin reactions, including Steven-Johnson Syndrome and toxic epidermal necrolysis.

Come to find out, as of November 2004, the FDA had received reports of 87 cases of SJS associated with Bextra. Thirty-six patients required hospitalizations, and 4 people died. Twenty involved patients with a known allergy to sulfa.

Although the other Cox-2 selective inhibitors also showed a risk for SJS, the FDA found reported cases to be greater with Bextra.

SJS is a devastating reaction affecting the skin and mucous membranes, causing severe burning, blistering and sloughing of involved tissue. SJS commonly causes blindness and results in death in 10 to 30 percent of the cases, according to a December 12, 2004 press release by the SJS Foundation.

People also develop SJS as a reaction to other commonly prescribed drugs, including antibiotics, anti-convulsants, and non-steroidal inflammatory drugs (NSAIDS), including over-the-counter drugs such ibuprofen products.

On January 26, 2005, Jean Farrell McCawley, the founder of the SJS Foundation testified before a joint meeting of the FDA’s Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

Ms Farell-McCawley told the panel that although SJS was referred to as a rare skin reaction, since 1995, the SJS Foundation had been notified of far more cases of the condition than those recorded by the FDA.

By one estimate, each year, SJS effects three to eight people per million in the US. However, the frequency is thought to be much higher since the FDA acknowledges that only between one and 10% of all adverse drug reactions are reported each year.

“SJS is not as rare as we are led to believe,” Ms Farrell McCawley advises. “During the winter months, we learn of 15 new cases a week, and that’s only people with Internet access,” she says.

It is hard to imagine a more severe adverse drug reaction than SJS. In the April 2005 SJS Newsletter, SrA Tanner Claybaugh published a letter describing what his sister, Mollie, went through after developing SJS as a reaction to children’s Advil.

Shortly after taking drug, Mollie developed blisters and rashes all over her body and was hospitalized. “She was put in the Intensive Care Unit (ICU) where there were countless machines keeping her alive,” SrA says.

“After about a weeks time,” he continued, “she was put in the burn unit as if she had burns from a fire, but the allergic reaction was the cause of her third degree burns.”

She was hanging on to life by a thread for weeks. “Back and forth she went,” her brother said, “from the burn unit to ICU.”

“As soon as her condition improved it worsened,” he noted. “It was always the same pattern entering ICU,” he recalls, wash your hands with warm water and soap and then put on medical mask and gloves.

“I was an 11 year old boy,” he wrote, “who had to do this just to watch my sister through a glass door of an isolation room.”

Mollie’s head had to be shaved and her skin was covered in blisters. “Her whole body was wrapped in gauze to stop the bleeding blisters,” SrA recalls.

“I remember sitting in her burn unit room watching two therapists lift her up and try to sit her in a wheelchair,” he said and described how drops of blood would fall from Mollie’s burnt flesh.

SrA says Mollie could not even scream out in pain. “All she could do is cry because her vocal cords had been burned,” he said.

After five months in the hospital Mollie was allowed to go home.

“Our living area transformed into that of a hospital room,” SrA said, “it had a ventilator for her tracheotomy, IV stand, stomach tube stand, heart rate monitor, and medications galore.”

Therapists came everyday and a nurse was always with Mollie giving her care. She required surgeries almost every other week to stretch her esophagus and the ligaments in her feet and hands. She also had cornea surgery.

According to SrA, today Mollie cannot walk, see, or talk very well. “She is fed through a stomach tube and it’s hard for her to breath,” he says.

Before SJS, Mollie was a dancer. “She was suppose to perform in the opening show for the 1996 Olympics in Atlanta,” her brother says. However, the room where she used to practice her dance moves and back flips has now become a rehabilitation center.

SrA says Mollie cannot receive any more therapy because of the healthcare budget cuts so his mother became a nurse to take care of Mollie.

SrA believes there needs to be more public awareness of the dangers associated with the drugs that cause this horrible reaction.

In January 2005, the Bextra related cardiovascular problems were back in the news when the results of two trials were released that showed the drug tripled the incidence of heart attack and stroke in coronary bypass graft surgery patients.

On February 14, 2005, the Associated Press reported that while Vioxx and Celebrex increased patients’ risk of heart attack and stroke by about 20 percent, Bextra increased the risk by 50%, citing a study by WellPoint Inc.

In April 2005, Pfizer finally took Bextra off the market at the request of the FDA. At the same time, the FDA told Pfizer to include a black box warning on Celebrex.

In a prepared statement, Pfizer reported that the FDA said Bextra’s risk to the heart was not distinguishable from other drugs and that it was the skin reaction that led to the decision.

The FDA advisory said it “concluded that the overall risk versus benefit profile is unfavorable and has requested that Pfizer, the manufacturer of Bextra, voluntarily withdraw Bextra from the market.”

The FDA explained that the request to recall the drug was based on:

1) The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse CV events in short-term coronary artery bypass surgery (CABG) trials that FDA believes may be relevant to chronic use.

2) Reports of serious and potentially life-threatening skin reactions, including deaths, in patients using Bextra. The risk of these reactions in individual patients is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use.

The FDA also cited a lack of any demonstrated advantages for Bextra compared with other NSAIDs and instructed patients taking Bextra to contact their physicians and consider alternative treatments.

At the same time, FDA officials said all painkillers in the category known as “nonsteroidal anti-inflammatory drugs,” or NSAIDS, would have to carry stronger warnings about risks of heart attack, stroke, ulcers, internal bleeding or skin reactions, the Philadelphia Inquirer announced on April 9, 2005.

The warnings affected dozens of medications sold by prescription, as well as over-the-counter, with worldwide sales of at least $18.7 billion, according to the British pharmaceutical research firm Lead Discovery.

The drugs included Wyeth’s biggest-selling over-the-counter product Advil, which had sales of $620 million in 2004, Wyeth spokesman Doug Petkus told the Inquirer.

Teva Pharmaceutical’s ibuprofen, diclofenac and naproxen were included as also McNeil’s biggest-selling NSAID Motrin.

A report in the San Francisco Chronicle on February 27, 2005, said the “painkillers Vioxx, Celebrex and Bextra may go down in history as a classic example of the danger posed by aggressive industry promotion of prescription drugs to both patients and doctors.”

“In 2003,” the report said, “their manufacturers spent more than $1.5 billion to promote the drugs through television spots, print ads and pitches to doctors,” the report wrote.

And the $1.5 billion turned out to be a sound investment because by 2003, combined sales of the 3 drugs topped $5.3 billion, according to IMS Health, a pharmaceutical information and consulting company.

People who helped derail this deadly money train by standing up to the giant drug makers responsible for marketing this class of drugs often end up with a bitter pill. In the third civil lawsuit against Vioxx, Dr Topel gave testimony against Merck in a deposition and less than a week after his videotaped testimony was played in a Houston courtroom, he lost his title as chief academic officer of the Cleveland Clinic’s medical college.

On December 10, 2005, Dr Topol told the New York Times he was fired as a result of going up against Merck and said in part:

“The hardest thing in the world is just trying to tell the truth, to do the right thing for patients, and you get vilified. No wonder nobody stands up to the industry.”

But the icing on the cake for the Cox-2 inhibiter saga came on December 2, 2005, when Gooz News ran an article titled, “Pricey Pain Pills No Better at Reducing Tummy Distress.”

“It looks like the billions spent on expensive new Cox-2 inhibitors,” Gooz said, “was wasted – and not just because Vioxx was the likely cause of tens of thousands of heart attacks among its users.”

Citing a report in the British Medical Journal that day, Gooz said that “Cox-2 inhibitors do not reduce the gastrointestinal side effects of over-the-counter pain pills like ibuprofen.”

“This was the whole rationale for justifying the drug industry’s massive investment in this new class of medicines,” Gooz noted, “since they don’t reduce pain any more effectively than older pain pills.”

Filed under: 2006, Bextra, NSAIDs, Pfizer, SJS, Truthout

SJS – Called A Fate Worse Than Death

Evelyn Pringle January 29, 2006

Until Susie Orme developed Stevens Johnson Syndrome, it was a condition she read about in medical textbooks and a difficult topic to study for on her postgraduate exams. Susie is a doctor and as such, she was able to diagnose her own SJS.

However, “no amount of training could prepare me for the pain ahead,” she said.

Susie’s SJS was a reaction to the anticonvulsant drug lamotrogine. It started with a headache. Susie thought she had the flu and that it would pass and went to bed.

When she awoke her mouth was ulcerated and her eyes had become swollen, blotchy and painful. Within 24 hours her lips had sloughed off and she began to spit rotting flesh and blood from her mouth. Her genitals were swollen and sore and it was agonizing to urinate.

Her overriding memory is one of excruciating pain, Susie recalls, “of feeling that my body was burning and that someone had poured acid into my eyes.” The pain was so extreme that even morphine provided limited relief.

As the SJS progressed, Susie appeared as badly on the outside as she felt on the inside. “I no longer looked like a human being,” she said, “it was terrible for my family to watch me suffer and awful for me to know that the staff who cared so well for me were also physically shocked and repulsed when they saw me.”

“I felt utterly beaten by this awful disease,” Susie recalls. “Each time I closed my eyes the eyelids stuck together and had to be painstakingly bathed apart by the nurses,” she said. Her eyes hurt so badly and her vision became so poor that Susie remembers fearing for her eye sight more than death.

A year has now passed since she acquired SJS, and Susie says that she is recovering but has not yet recovered.

Even after the acute SJS phase is over, its after effects can last a lifetime. For instance, the nailbeds on Susie’s hands are permanently damaged.

She continues to get corneal abrasions due to in-growing eyelashes and her eyes are still very bothered by bright light. Susie’s tear ducts have been permanently damaged and she says, “using artificial tears has become as routine as breathing.”

Overall Susie remains optimistic. “By some miracle considering the severity of my illness,” she notes, “I can see and if I wear sunglasses can manage to do most things without too much pain.”

“My face looks unfamiliar due to the scarring of my eyelids,” Susie said, “but does not look as disfigured as I envisaged it might.” There is scarring on her genitals and initially it was difficult to have sex but with patience this problem is now better, she says.

“At the start of this terrible disease it feels as if there is no hope,” Susie recalls. But she wants other people with SJS to know that there is hope and that with time, patience, and determination, they too “can overcome this terrible illness and its consequences.”

Adverse reactions to prescription and over-the-counter drugs are one of the leading causes of death in the United States. Yet, because there is no mandatory reporting system for post marketing adverse affects, less than one percent of events are ever reported to the FDA.

For this reason, no one can provide an accurate number of the cases of Stevens Johnson Syndrome in the US. Described in many drug package inserts as a “serious skin condition,” SJS is in most cases a devastating allergic reaction to a drug and has been described as “a fate worse than death.”

According to experts, SJS causes the immune system to turn on itself to rid itself of the offending drug, in effect burning the patient from the inside out. SJS often causes blindness and results in death in 10 to 30% of the cases.

SJS is characterized by an extremely painful blistering skin rash, peeling skin, and blistering sores in the mucous membranes including the mouth, throat, eyes, nostrils, and anal and genital areas. In the most severe forms of the disease, the skin peels off in sheets from large areas of the body, much like with severe burn injuries.

Although SJS continues to be listed as a rare condition and is virtually unheard of by most people, it is becoming much more common. The February 15, 2005 Pittsburgh Post-Gazette, reported that there are between 600-2,000 cases in the US each year.

With more than 40 percent of Americans taking at least one prescription drug (2004 CDC report), the potential for the deadly adverse drug reaction is increasing, according to a SJS Foundation warning in the December 13, 2004 Business Wire.

The Stevens Johnson Foundation was founded as a resource for SJS victims and their families. Its mission is to provide support services, and compile and distribute information about SJS to the public and medical professionals. It also works to promote awareness of the symptoms of SJS so that a quick diagnosis can be made.

“SJS is not as rare as we are led to believe,” said Jean McCawley-Farrell, president of the Foundation. “As prescription drug use increases, we are being contacted by increasing numbers of people,” she adds.

“During the winter months,” Jean reports, “we learn of 15 new cases a week, and that’s only people with Internet access.”

Experts agree that recognition of early symptoms followed by prompt medical attention is crucial in minimizing the long-term effects of SJS. Symptoms include:

Rash, blisters, or red splotches on skin
Persistent fever
Blisters in mouth, eyes, ears, nose, genital area
Swelling of eyelids, red eyes
Conjunctivitis
Flu-like symptoms
Recent history of having taken a prescription or over-the-counter medication

Dr Bernard Cohen, MD, of John Hopkins Hospital, is a pediatric dermatologist and advisor to the SJS Foundation, and says, “typically, the reaction begins within the first two weeks of taking the drug.”

Experts usually distinguish between three forms of the disease Dr Cohen explains, “a milder form called Erythema Multiforme Minor, or EM, Stevens Johnson Syndrome, SJS, and TENS, or Toxic Epidermal Necrolysis Syndrome, the most severe form.”

“With EM, which can be recurrent, there will be lesions on the distal extremities [lower legs and arms] and in the mouth; there is little mucous membrane involvement, however.

“With SJS, which is usually not recurrent, there are usually blistering ulcerations of the cornea, mouth, rectum, genitalia, skin, and urethra, usually accompanied by a high fever and generalized weakness.

“TENS involves the entire skin and mucous membrane; the skin literally sloughs off of the person’s body.”

Dr Cohen advises. “Care must be taken to prevent staph infections of the skin from taking hold,” he said. “Intravenous fluids to prevent dehydration are a must, as the person is usually unable to eat or drink due to the mouth blisters,” he notes.

Some of the lasting complications of SJS that have been reported include blindness, dry-eye syndrome, arthritis, lung damage, asthma, photophobia, chronic obstructive pulmonary disease, loss of nail beds, scarring of the esophagus and other mucous membranes, and chronic fatigue syndrome.

As a physician, Susie Orme says she tells anyone who will listen about SJS. “If I prevent one of my colleagues from writing an unnecessary script and prevent one case of SJS it will have been worthwhile,” she notes.

The most frequently implicated drugs with SJS are antibiotics, anti-convulsants, and non-steroidal anti-inflammatory medications. SJS can be caused by these types of drugs:

painkillers
rheumatoid arthritis
antibiotics
drugs for bi-polar disorder
non-steroid anti-inflammatory drugs (NSAIDS)
barbiturates
anticonvulsants
sulfa antibiotics
penicillins

SJS has been reported as caused by these specific medications

Bextra
Arava
Remicade
Ibuprofen
Daypro
Children’s Motrin
Advil
Topamax
Lamictal
Allopurinol
Phenytoin
Carbamazepine

Why certain drugs cause SJS is still not fully understood. However, it is generally accepted that patients with known allergies to sulfa-based drugs have a greater chance of acquiring the conditions. Examples of sulfa-based antibiotics include:

Penicillins
Tetracycline
Doxycycline
Amoxicillin
Ampicillin
Zithromax/azithromycin
Beta-Lactams
Ciprofloxacin

Proper labeling of drugs is crucial to helping medical professionals and consumers recognize and understand adverse reactions such as SJS. Too often, drugs have sulfa components, but are not labeled as sulfa drugs.

Back on December 9, 2004, the FDA ordered new warnings for Pfizer’s Bextra. The warning identified Bextra as containing sulfa, and said that patients taking the drug had reported serious, potentially fatal skin reactions.

As of November 2004, the FDA had received reports of 87 cases of severe skin reactions in association with Bextra. Twenty of the cases involved patients with a known allergy to sulfa and four of the patients died.

The agency noted that Cox-2 inhibitors, such as Celebrex, and other anti-inflammatory drugs, such as naproxen and ibuprofen, also had a risk for serious skin reactions, but said that the reported rate of the side effect was greater with Bextra.

The FDA also told Pfizer to notify doctors of the risk. On October 15, 2004, Pfizer sent a letter to physicians informing them of the SJS risks associated with Bextra and advised that the skin reaction had lead to hospitalizations and deaths.

Five months later, on April 7, 2005, in a startling move, the FDA went against its own advisory committee’s recommendation to allow Bextra to remain on the market and told Pfizer to remove it, in large part due to its associated risks of SJS.

In addition, the agency ordered Black Box warnings about the risk of SJS on over-the-counter NSAID drugs, such as children’s Motrin and Advil. The FDA’s decision to mandate the strongest warning a label can carry, followed two pediatric cases of SJS where one 9-year-old child died, and another 7-year-old girl became blind after using over-the-counter NSAIDs.

Medical professionals advise patients who have suffered a drug-related case of SJS to avoid the offending drug, and all other drugs in the same class. They also recommend that immediate relatives of SJS victims avoid the same drugs as hypersensitivity has been known to be genetically linked.

Filed under: 2006, Bextra, NSAIDs, Scoop, SJS

FDA Runs Protection Racket For Big Pharma

January 7, 2007 Evelyn Pringle

Why would Americans trust the FDA to regulate the pharmaceutical industry? Since the Bush administration took office the FDA has become the industry’s partner in crime.

The most notorious protection scheme put in place by the FDA and Big Pharma is the preemption policy that bans private lawsuits against drug companies in state courts once a drug and its label have been approved by the FDA.

On January 18, 2006, the FDA issued new rules for the labeling of prescription drugs, and in the preamble to the rules on page 43, the FDA says, State law actions “threaten FDA’s statutorily prescribed role as the expert Federal agency responsible for evaluating and regulating drugs,” requiring lay persons to second-guess its expert assessments of a drug’s risks and benefits.

So, after all of the concerns raised about the FDA’s failure to protect consumers against dangerous products over the last several year, by top experts from all over the world, the FDA has hereby declared itself the sole authority on decisions regarding prescription drugs, including whether a drug’s label contains adequate descriptions of indications for use, risks and benefits.

In an October 6, 2006, articled titled, “The Doctrine of Preemption,” Stan Kaufman aptly refers to the new policy as the “Doctrine of Preemptive Crony Capitalism.” When announcing this multi-billion dollar immunization gift 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.”

A statement saying the complete opposite was made in 1996, by the FDA’s Chief Counsel in a speech that 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.”[

The preemption claim reverses a long-standing policy of permitting State actions intended to protect consumers and undermines the States’ ability to protect their citizens, yet State and local entities were given no opportunity to object to it.

Under Executive Order 13132, issued first by President Reagan, and then reissued by President Clinton, the FDA is supposed to consult with State and local authorities about the effects of each regulation it issues that affects the States.

Nowhere in the proposed rule did the FDA provide notice or seek comment on the preemption provisions added to the preamble. In the only proposed rule known to State and local officials, the FDA said that the regulation would not preempt State law. In fact, the language published in the Federal Register on December 22, 2000, explicitly stated that “this proposed rule does not preempt state law.”

The rule requested comment on products liability issues, but only by asking whether the new “Highlights” section raised liability concerns and, if so, how the FDA might alleviate those concerns without eliminating the Highlights section. This request can hardly be called “notice” of the preemption statement that suddenly appeared in the preamble in 2006.

By relying on this false representation, State and local authorities were robbed of any opportunity to object to the preamble. In a January 2006, letter to Michael Leavitt, Secretary of Health and Human Services, the National Conference of State Legislators called the regulation a “thinly veiled attempt on the part of FDA to confer upon itself authority it does not have by statute.”

The NCSL also stated the failure to allow for an appropriate comment period constitutes “an abuse of agency process and complete disregard for dual system of government.”

Ken Suggs, president of the Association of Trial Lawyers of America, was quoted in the January 19, 2006 Washington Post, as saying, 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 the political process.”

Legal experts point out that it was never the intent of Congress to preempt private lawsuits in State courts, and that in fact, when Congress was considering the Food, Drug, and Cosmetic Act of 1938, it specifically rejected a proposal to include a private right of action for damages on the ground that such a right already existed under State common law.

According to Houston attorney, Robert Kwok, who handles complex pharmaceutical litigation involving drugs such Fosamax, Norvasc and SSRI antidepressants like Celexa:

“The real losers from this attempted power grab would be the millions of Americans who depend on safe drugs. Without the protection of state laws Big Pharma can ride shipshod over Americans who are injured by their unsafe drugs. That’s unacceptable and I’m seeing even conservative judges resist it.”

Many members of Congress have also weighed in on the issue and reaffirmed that Congress never intended to preempt State claims in a February 23, 2006, letter to Michael Leavitt, Secretary of Health and Human Services, from Representatives Henry Waxman (D-Calif.), John Dingell (D-Mi.), and Sherrod Brown (D-Ohio).

Rep. Maurice Hinchey (R-NY) and Senator Edward Kennedy (D-MA), have threatened to fight preemption through legislation if necessary. Rep. Hinchey issued a press release on January 18, 2006, immediately after the policy was announced, stating that the “FDA has once again gone to bat for the drug industry by fully endorsing a policy that shelters pharmaceutical companies from Americans who want to file lawsuits because a drug has made them or a loved one seriously ill, or in some cases caused death.”

Rep. Hinchey also called it “the latest example of the FDA sticking its nose where it does not belong and treating the drug companies as clients rather than regulated entities.”

The FDA’s language on page 38 of the preamble that states “whether it be in the old or new format, the Food, Drug and Cosmetic Act preempts conflicting or contrary state law,” appears to imply that the preemption policy is retroactive.

Part of the language also says that lawsuits against doctors are preempted for failure-to-warn patients of risks associated with a drug, apparently even when a drug is prescribed “off-label,” for a use other than those approved by the FDA.

“Pre-emption would include not only claims against manufacturers,” the FDA states, “but also against health-care practitioners for claims related to dissemination of risk information to patients beyond what is included in the labeling.”

The FDA has never before, in its entire history, claimed that a drug label preempts actions against health care professionals for failure-to-warn patients about risks. In fact, labels carry no information about the risks or benefits of “off-label” uses.

Critics see this language as an attempt to immunize all the doctors who the industry has convinced to over-prescribe drugs to treat conditions or patient populations for which the drugs have never been approved as safe and effective to increase profits.

“Doctors need to be held just as accountable as the drug manufacturers when things go wrong,” attorney Kwok says.

“The profession of medicine is in danger of being totally co-oped by the business of medicine,” he warns, “with more and more of the burden is being placed on the consumer.”

“And with only minimum consumer protection standards set by the FDA, that isn’t very reassuring,” Mr Kwok notes.

“I predict there could be a flood of litigation,” he says, “before FDA policy changes any more.”

In any event, restrictions that the FDA places on drug labeling do not prohibit drug companies from disseminating warnings about a danger by other means. When it originally promulgated these regulations, the FDA made clear that:

These labeling requirements do not prohibit a manufacturer, packer, re-labeler, or
distributor from warning health care professionals whenever possibly harmful adverse effects associated with the use of the drug are discovered. The addition to labeling and advertising of additional warnings, as well as contraindications, adverse reactions, and precautions regarding the drug, or the issuance of letters directed to health care professionals (e.g., “Dear Doctor” letters containing such information) is not prohibited by these regulations. 44 Fed. Reg. 37434, 37447 (June 26, 1979).

One of the main authors of the new labeling rules was the FDA’s Chief Counsel at the time, Daniel Troy, who in previous employment fought the FDA in court to allow drug companies to promote drugs to doctors for “off label” use.

Its now obvious when looking back, that Mr. Troy was appointed by the Bush administration to implement tort reform under the guise of preemption, and under the cover of the Office of Chief Counsel at the FDA.

In the midst of the Vioxx and SSRI antidepressant disasters, instead of going after the drug makers for knowingly injuring hundreds of thousands of consumers with dangerous products, Mr. Troy devoted the majority of his time on the clock to filing five amicus briefs on behalf of Big Pharma to be used against the very citizens who were paying his salary.

In his briefs, Mr. Troy focused his main attention on protecting the profits of the makers of SSRIs, drugs second only to Vioxx when it comes to the concealment of studies and information about harm that if revealed, could have prevented tens of thousands of deaths and injuries over the past 20 years.

And even though there has been an infinite number of reports over the past decade regarding an increased risk of suicide with SSRIs, instead of withdrawing the approval of the drugs, requiring more studies, or demanding a warning be added to their label, Mr. Troy did nothing to protect potential SSRI victims as Chief Counsel of the FDA.

In late 2004, Mr. Troy quit the FDA to go back into private practice to once again represent pharmaceutical companies openly against private citizens, only with the added benefit of using the preemption defense he put in place.

On October 9, 2006, Mr. Troy published an article in the Legal Times, that 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 states in an obvious ad for new clients, “advise and represent companies confronting state-law claims that implicate the pre-emptive effect of FDA requirements.”

In the Times article, Mr. Troy points out the importance of drug companies staying cozy with the FDA to ensure success in future litigation. “Savvy companies,” he wrote, “are recognizing that how they interact with the FDA today may profoundly affect their pre-emption defenses in the future.”

“They are trying to ensure their communications with the agency are as formal as they can be,” he said, “in light of commercial considerations and the need to stay on the FDA’s good side.”

“More formal communications,” he advises, “can help buttress a future case for why a particular state law claim should be pre-empted.”

In the article, Mr. Troy brags that his filing of FDA briefs on behalf of Big Pharma “has reduced the negative consequences of the current pharmaceutical-liability regime.”

But for once, he at least mentions that it cost the tax payers plenty. “FDA involvement in state-law cases is not an ideal solution,” he writes, “not least because each instance of such involvement involves the costly investment of substantial agency resources.”

It should be noted that two years before Mr. Troy filed his first brief as a kick-off for the preemption policy, the “costly investment of substantial agency resources” went for an FDA brief, in which the FDA acknowledged “the historic primacy of state regulation of matters of health and safety” and the appropriateness of a presumption against preemption where the state-law claims allege defective design, negligent manufacturing, or failure-to-warn in, Buckman v. Plaintiffs’ Legal Committee, 531 US 341 (2001).

In the Legal Times, Mr. Troy goes on to explain that the new labeling rule is intended to limit the direct involvement of the FDA in lawsuits. “The preamble to that rule,” he says, “makes an official statement of FDA’s views on preemption easily available to courts hearing state-law tort cases.”

“If courts give appropriate deference to this statement of FDA’s considered judgment,” he notes, “FDA will not be forced to file briefs in individual cases.”

Until reading this article, its likely that most people had never realized that Mr. Troy was “forced” to file briefs on behalf of Big Pharma while he worked at the FDA.

In a March 31, 2006 paper, titled, State-Level Protection for Good-Faith Pharmaceutical Manufacturers, Mr. Troy can be found advising State lawmakers to pass shield laws for Big Pharma based on a Michigan model, to “help to reduce the negative consequences of the current pharmaceutical-liability regime,” he says.

“In so doing,” he states, “they would help to encourage the development of new drugs, preserve the availability of existing drugs, reduce upward pressure on drug prices, and assure rational prescribing.”

Such a statement might be a wee bit credible if it also included a suggestion for the lowering of the multi-million dollar annual salary and benefit packages enjoyed by Big Pharma CEOs or a reduction in the billions of dollars that are spent each year on illegal off-label promotion and marketing schemes.

For all the whining he does about litigation keeping products off the market, Mr. Troy cannot cite a single case in which a failure-to-warn claim interfered with the FDA’s federal regulatory authority or kept a drug off the market. In fact, in a lecture to Big Pharma attorneys in December 2003, on how to use the preemption defense, Mr. Troy told the attorneys that the FDA had “no good evidence” showing product liability concerns “keep good products off the market,” even though he had “combed the literature” to find such evidence.

Apparently to help resolve this nagging little problem, Mr. Troy told the defense attorneys to pay for research to find some evidence to back this claim even if it was 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.”

Mr. Troy filed the FDA’s first brief in support of Big Pharma in September 2002, in the California Zoloft case titled Motus v. Pfizer, after he was contacted by Pfizer attorney, Malcolm Wheeler, in the summer of 2002, requesting that he get the government involved to help Pfizer win the preemption argument.

Despite the fact that Pfizer had paid Mr. Troy’s law firm over $358,000 in the year before he became Chief Counsel, Mr. Troy argued later that he did not become involved in the case until after the 1-year grace period in which employees may not participate in activities involving former clients. From all public accounts, the time period elapsed less then a month before he entered the case.

In the brief, Mr. Troy argued that any warning that suggested a link between Zoloft and suicidality would have been false and misleading, and the FDA would have rejected any effort to add such a warning. However, that argument contradicts 21 CFR § 314.126(b), which requires warnings to be added based on reasonable evidence of an association, even absent proof of a causal relationship. The preemption issue was never decided in Motus because the case was concluded on unrelated grounds.

Legal experts say the preemption defense will not only be used in SSRI-related suicide cases, it will be applied in SSRI cases involving the failure-to-warn about other types of injuries and deaths caused by these drugs as well.

For instance, Big Pharma will no doubt attempt to preempt cases filed on behalf of infants born with birth defects to mothers who unwittingly took the drugs during pregnancy, such as with Lacee Shore, who was prescribed Celexa during her first trimester of pregnancy and as a result, her baby, Gavin Shore, was born with serious heart birth defects and diagnosed with Shone’s Complex, which can lead to the obstruction of blood flowing to the body from the left side of the heart.

Gavin has already gone through several surgeries in attempt to correct the heart defects and will have to undergo more in the future.

The successful use of the preemption argument in a case such as this, where the drug maker, Forest Laboratories, could and should have warned doctors and pregnant women about the possibility of birth defects associated with Celexa, would leave the Shore family strapped with the burden of life-long medical costs related to Gavin’s condition.

According to attorney Kwok, who is handling the Shore case, the birth defect situation is even more devastating than with patients harmed by Vioxx because the Celexa victims are so young. “Their whole lives,” he says, “if they survive, will be under the threat of illness and additional surgery, with a very poor prognosis.”

Mr. Kwok points to a 1990 study conducted at the University of Michigan that shows the outlook for infants born with heart defects like Gavin is very poor. “One quarter of patients die after their second operation,” he says.

“The second operations are very often necessary,” he explains, “because of the complexity of the heart problem.”

Forest Labs knew about the potential for birth defects caused by Celexa because more than two years before Gavin was born, on June 9, 2004, Web MD reported that the FDA was concerned about reports that SSRIs may cause adverse effects to babies born to mothers taking the drugs late in pregnancy.

According to Web MD, the FDA had been receiving reports for 10 years. In fact, it said that hundreds of reports on adverse effects in babies were received involving all the SSRIs sold in the US, which would include Prozac, Paxil, Luvox, Zoloft, and Celexa.

In July 2004, the FDA finally asked the SSRI makers to change the labels, warning that some infants had developed problems requiring tube feeding, respiratory support, and prolonged hospitalizations.

On September 1, 2005, the BBC reported that Danish and U.S. scientists found that cardiac birth defects appeared to be 60% more likely in newborns when women used SSRIs.

Studies show that women are prescribed SSRIs twice as often as men and yet the drug makers have made no effort to evaluate the use of these drugs with pregnant women. And as a result, Mr. Kwok says, “new moms are finding out too late that the Celexa they took was putting their unborn baby in grave danger.”

A successful preemption ruling would go a long way as far as protecting profits against damage awards based birth defects, because pregnant women represent a major share of the market. According to a May 2005, study in the Journal of American Medical Association, 80,000 pregnant women are prescribed SSRIs in any given year in the U.S., which means there are bound to be many cases where babies were born with birth defects.

The majority of courts that have addressed the preemption argument have ruled against it. One of the first federal courts to specifically rule against the FDA’s preamble position was a Nebraska District Court on May 31, 2006, in Jackson v. Pfizer, where the plaintiffs’ son took both Zoloft and Effexor and then committed suicide.

The parents alleged that the drugs caused their son to commit suicide and Nebraska law required additional warnings about the suicide risk. The drug maker defendants moved for summary judgment claiming that the State law claims were preempted by the FDA.

The court said that the claims were not preempted because the federal regulations did not conflict with State law and specifically held that there was no Congressional directive that the field was preempted.

The court stated the FDA preamble was not persuasive and pointed out that the Eighth Circuit had adopted the proposition that the FDA prescribes only minimum standards and the Fourth Circuit had declared that complying with federal regulations does not release a manufacturer from liability.

The court also noted that the FDA “failed . . . to allow the states an opportunity to participate in the proceedings prior to a preemption decision,” and dismissed the FDA’s brief stating that it “will not treat amicus briefs as the force of law.”

On May 25, 2006, a federal court in Pennsylvania was the first to grant the FDA’s preemption rule full deference in a wrongful death and survival action, with 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 (E.D. Pa. May 26, 2006).

In this case, the plaintiff alleged that his wife’s suicide resulted from the drug makers’ failure-to-warn of the increased risk of suicide linked to Paxil and its generic equivalent.

The judge on his own initiative, invited the FDA to file a brief. The current Chief Counsel, Sheldon Bradshaw, went to bat for the drug makers and filed a brief at record speed within 20 days, urging the court to dismiss the lawsuit on the basis of preemption, stating 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.”

The FDA argued that any such warning regarding an association between Paxil and suicide would have been false or misleading, and thus would have constituted misbranding under the FDCA.

The plaintiff responded by arguing that the court should not afford deference to the brief because 21 C.F.R. § 314.70, does permit manufacturers to strengthen labels without FDA approval and the FDA has no authority to simply declare that a drug is misbranded.

The court disagreed and determined that it was to give significant deference to the amicus brief based on the U.S. Supreme Court’s decisions in Chevron, Medtronic, and Geier which state that an amicus brief is an appropriate form to express preemptive intent and held that the principles of deference do not permit a court to question the FDA’s interpretation of its own regulations.

The plaintiff argued that the preamble which was promulgated in 2006 could not be retroactively applied to the October 2003, death of his wife. However, the Court said that preemption could be applied retroactively because the preamble simply clarified the FDA’s “longstanding views on preemption,” and characterized the preamble as an “interpretive rule,” rendering retroactivity concerns “irrelevant.”

The Court went on to say that even if the preamble did not apply retroactively, it would have found preemption anyway based on the views previously expressed in amicus briefs by the FDA.

An appeal is pending on the Colacicco decision, and the case has drawn amicus support from a dozen scientists and doctors who contend that preemption “would threaten the public health and eliminate an important counterpart to the public health objectives of the FDA.”

The national non-profit consumer advocacy organization, Public Citizen, the Trial Lawyers for Public Justice, a national public interest law firm, and the Association of Trial Lawyers of America, an international coalition of attorneys, law professors, paralegals, and law students, have together filed an amicus brief supporting Mr Colacicco, stating:

“Products liability lawsuits help to protect patients from drugs with undisclosed risks because the potential for being held liable for harm caused by their products provides a powerful incentive for drug companies to make their products as safe and effective as possible and to revise labels as soon as new risks become apparent.

“Furthermore, because FDA lacks authority to subpoena documents from the companies it regulates, products liability lawsuits help to uncover information that can lead to safer products.”

In fact, the group points out, since at least several months before the victim’s suicide, the FDA had been reviewing data about a possible link between SSRIs and suicidality, and the agency issued a Public Health Advisory on the topic in October 2003, the same month that Mrs. Colacicco died.

The amicus brief also notes that the FDA’s preemption statement lacks the “consistency” needed to warrant any degree of deference because prior to 2002, the FDA’s consistent view was that State common law was not preempted by federal drug regulation. “For example,” the brief wrote, “in both 1979 and 1998, in preambles accompanying various drug regulations, FDA stated that state tort law did not interfere with federal regulation.”

In 1998, when addressing pharmacists’ provision of written patient information for “Medication Guides,” when issuing the final rule, the FDA rejected calls for the agency to express an intent to preempt State regulation of labeling requirements stating:

“FDA regulations establish minimal standards necessary, but were not intended to preclude states from imposing additional labeling requirements. States may authorize additional labeling but they cannot reduce, alter, or eliminate FDA-required labeling.” 63 Fed. Reg. at 66384.

According to the amicus brief, “The authority to regulate drug labeling may carry with it the authority to address state drug labeling regulations, but it does not carry with it authority to determine the preemptive effect of federal regulation on state common-law compensation systems.”

It appears that the FDA’s own regulations acknowledge that preambles are not statements of law and that they should not be presented as such in legal proceedings.

The amicus group states that the preamble is not part of the regulation, will not appear in the Code of Federal Regulations, and does not have the force of law. “In fact,” the brief notes citing FDA regulations, “a longstanding FDA regulation provides that a statement in a regulatory preamble constitutes only an “advisory opinion.”

The FDA recognizes that an advisory opinion may be used to “illustrate acceptable . . . procedures or standard, but not as a legal requirement,” the brief points out.

“Having made no effort to legislate on the topic of drug-related damages remedies,” the brief concludes, “Congress can hardly be said to have authorized FDA to supersede the damages remedies traditionally provided by the states.”

There was an extremely important preemption ruling handed down on June 9, 2006, in the Vioxx case of Doherty v. Merck prior to the beginning of the actual jury trial. Merck moved to dismiss the failure-to-warn claim arguing that the preamble barred claims with respect to FDA approved drugs.

The June 9, ruling from the bench, drew massive attention to the case when New Jersey Superior Court Judge, Carol Higbee, refused to exclude the claims.

“The preamble, as I see it, is a political statement by the FDA,” she said.

“The primary purpose of it,” she stated, “is to criticize state courts and to set forth the FDA’s position, not to criticize state courts so much as to set forth the FDA’s position that they believe there should be federal preemption of all tort actions.”

“What the preamble is saying,” Judge Higbee noted, “is the FDA should be the final word.”

She refused to dismiss the claims based on the preamble she said, because it “has nothing to do with science.” In conclusion, she told Merck defense attorneys:

“It has nothing to do with what happened back in 2000, 2001, 2002, when these issues were being debated. It is contrary to the U.S. Supreme Court’s decisions. It is contrary to all the law on preemption.

“And I am not going to allow you to use it.”

Merck later enjoyed a victory at trial when a jury decided that Vioxx was not the main cause of Elaine Doherty’s heart attack, but a favorable ruling on the preemption issue prior to trial could have potentially saved the company billions of dollars. According to the company’s SEC filings, as of October 9, 2006, Merck is a named defendant in about 13,850 Vioxx cases in the New Jersey State court coordinated litigation.

The next victory using the preemption argument was a major win in August, 2006, when a California court dismissed the Celebrex failure-to-warn claims against Pfizer, In re Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, No M: 05-1699 CRB, 2006 WL 2374742 (N.D. CA, August 16, 2006).

In opposing the motion, the plaintiffs argued that because the FDCA does not provide a monetary remedy, Congress must not have intended the FDA to have authority over damage claims and that the FDA’s position on preemption was not entitled to deference because it was clearly erroneous and inconsistent with the regulations.

Saying the FDA specifically considered the safety risks about Celebrex 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.”

But the judge refused to dismiss the false advertising claims. The plaintiffs argued that the Celebrex ads were false and misleading because they exceeded the labeled and approved gastrointestinal benefits and also minimized the established risks of the drug.

Pfizer claimed that because it submitted the ads for FDA approval, and the FDA did not object, the FDA had determined that the ads were accurate and struck a fair balance of the risks and the benefits of Celebrex.

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

A little over a month later, on September 29, 2006, across the country in New Jersey, the court in McNellis v. Pfizer, refused to allow the preemption defense based in part on the fact that the text of FDA regulations had remained unchanged for years, and the regulations did not conflict with New Jersey’s failure-to-warn laws.

The McNellis Zoloft-suicide case comes with a history. On December 29, 2005, the U.S. District Court for the District of New Jersey had also denied Pfizer’s original motion for summary judgment. The court reasoned that the FDA’s approval of a label creates only a minimum standard and that the drug maker may strengthen the warnings as long as the new warning is not false or misleading.

After the FDA published the new rule and preamble with the preemptive language in January 2006, Pfizer filed another motion asking the court to vacate the order denying summary judgment, or to certify the question for interlocutory appeal

In opposing the motion, Ms. McNellis said that the preamble amounted to nothing more than the FDA’s opinion on preemption; the same opinion expressed previously by the FDA in amicus briefs, and the same opinion already rejected by the court. It is irrelevant that this opinion now comes in the form of a preamble to a regulation rather than an amicus brief, she said.

In her brief filed on March 2, 2006, Ms. McNellis argued that the FDA had also exceeded its authority, stating:

“In this instance, an executive agency, the FDA, has expressed an opinion that Congress has never agreed to. Without notice or comment, the FDA found it within its jurisdiction to go against the wishes of Congress as well as the wishes of those states which have product liability failure-to-warn statutes.”

Ms. McNellis also pointed out that the last six courts to decide the issue “have found, consistent with this Court’s finding, that the FDA regulations establish minimum requirements such that they do not preempt state tort laws.”

She also noted that the preamble was not in effect at the time that her father committed suicide as a result of taking Zoloft.

The court held that regulations allow a drug company to increase warnings when new risks emerge, that the Food, Drug and Cosmetic Act does not contain a preemption clause, and that Congress gave no implicit empowerment to the FDA to preempt State law.

Following the McNellis decision, on October 16, 2006, a federal court in Pennsylvania refused to grant the drug maker’s preemption motion on the failure-to-warn claims in Perry v. Novartis Pharma Corp, — F Supp 2d —-, 2006 WL 2979388.

This case involved Elidel, a drug used to treat eczema, prescribed to Andreas Perry when he was 2-years-old. Six months after he began using the cream, in October, 2003, Andreas was diagnosed with a form of cancer known as lymphoblastic lymphoma.

Elidel belongs to a class of drugs known as calcineurin inhibitors, so called because they reduce immune activity by inhibiting the activity of the enzyme calcineurin. Prior to the approval of Elidel for treating skin conditions in children over 2 years of age, calcineurin inhibitors were used as systemic immunosuppressants in organ transplant patients.

Systemic use of the drugs has long been known to increase the risk of cancer and the labels on the drugs prescribed to organ transplant patients say so. But because Elidel is applied topically for eczema, it was not known at the time of approval in December 2001, whether long-term use posed a risk of cancer.

This case illustrates why drug companies must be made to alert the public of known dangers as soon as they are known. On February 15, 2005, an FDA advisory committee met to discuss calcineurin inhibitors. In particular, reports of “off label” use of the drugs in children under two caused concern for some members of the committee.

At the meeting, the committee voted to add a “Black Box” warning about the possible increased risk of cancer associated with the topical use of Elidel, and the lack of long-term safety data on the use of the drug.

On March 10, 2005, the FDA told the drug maker to add a “Black Box” warning and issued a public health advisory about the possible cancer risk. However, it was nearly a year later when Novartis finally got around to adding a “Black Box” warning to Elidel’s label on January 19, 2006.

In their brief in opposition to the preemption motion to dismiss, the plaintiffs said that the FDA’s broad claim of preemption is not entitled to deference, “whether it is expressed in the January 2006 Preamble to the Final Rule,” or “in amicus curiae briefs filed by the agency in support of drug manufacturers.”

“The FDA’s claims,” the brief wrote, “which are tantamount to an advisory opinion, lack the force of law and contradict the FDA’s governing statute, its regulations, and its regulatory purpose.”

It also noted that the FDA’s current opinion directly opposes the FDA’s longstanding views on preemption. “For these reasons,” the brief pointed out, “a majority of courts that have considered this issue, both before and after the FDA issued the Preamble, have held that FDA approval of labeling does not preempt state failure-to-warn claims.”

In denying Novartis’ preemption motion, U.S. District Court Judge, Stewart Dalzell, of the Eastern District of Pennsylvania, wrote in the decision that the FDA’s new “Preamble is not entitled to any special consideration in our analysis.”

Where the agency attempts to “supply, on Congress’s behalf, the clear legislative statement of intent required to overcome the presumption against preemption,” no deference is warranted, he noted.

In reaching its decision, the court said preemption would only apply if a specific warning about Elidel and pediatric cancer had been considered by the FDA and found to be unnecessary and that had not happened in this case.

In discussing the FDA’s assertions in its amicus brief, the court stated, “To be sure, because of its expertise in the area, the FDA’s construction of its own regulations is likely to carry great weight.”

“But where an interpretation has changed frequently in significant respects,” it wrote, “the persuasive force of the argument diminishes.”

The court also said that even if the Preamble represents a change of policy with the force of law, it would not apply to this case. “The FDA cannot retroactively absolve Novartis of a duty it may have owed the Perrys in 2003,” it wrote.

The court also noted that the FDCA provides no remedy for an injured consumer and said, “a finding of preemption here will foreclose a remedy that was traditionally available and for which federal law provides no substitute.”

In its decision, the court made an interesting observation about the viability of the preemption defense on failure-to-warn claims based on other available methods of warning the public about the dangers of a drug, stating:

“It is worth noting that, even where FDA regulations or other federal law prevent a manufacturer from modifying the approved labeling, a modification of the label is not the only form that a warning could take.

“If, for example, a plaintiff claimed that a manufacturer was negligent in not sending a letter to prescribing physicians or other health care professionals, that might present a different case, even if modification of the approved labeling were prohibited.”

In conclusion, citing a September 23, 2006, New York Times report by Gardiner Harris, the court said, “given the recent concerns about the effectiveness of the FDA’s safety monitoring of recently approved drugs, . . . the availability of state law tort suits provides an important backstop to the federal regulatory scheme,” and further stated:

“If, at some future date, Congress determines that FDA monitoring is sufficiently effective on its own to warrant the elimination of state law incentives for manufacturers to provide adequate warnings, it also has the authority to declare that failure-to-warn suits, like the Perrys’ action, are preempted.”

“Until it does so, however,” the court said, “in the absence of a specific FDA safety determination, such suits can go forward.”

(This article is written as part of a series on pharmaceutical litigation and is sponsored by Robert Kwok & Associated, LLP)

Filed under: 2007, Bextra, Birth Defects, Bush, Celexa, Colacicco, Elidel, FDA, Glaxo, Kwok, McNellis, Novartis, Paxil, Perry, Preemption, SSRIs, Troy, Vioxx

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