"We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don't have the same scientific knowledge," said Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs.
To soften the blow, the agency's claim of federal preemption was included as a preamble to the long sought after new drug labeling guidelines. In response to the FDA's statement, Senator Edward Kennedy (D-MA) issued a statement of his own that said: "It's a typical abuse by the Bush Administration - take a regulation to improve the information that doctors and patients receive about prescription drugs and turn it into a protection against liability for the drug industry."
The ploy was also readily recognized by state lawmakers and trial lawyers as another attempt to reduce the public's ability to hold Big Pharma accountable. "Eliminating the rights of individuals to hold negligent drug companies accountable puts patients in even more danger than they already are in from drug company executives that put profits before safety," said Ken Suggs, president of the Association of Trial Lawyers of America.
"The fact that the drug industry can get the FDA to rewrite the rules so that CEOs can escape accountability for putting dangerous and deadly drugs on the market is the scariest example yet of how much control these big corporations have over our political process," Mr Suggs told the Washington Post.
According to Attorney Mark Labaton, a partner at the firm Kreindler & Kreindler, LLP, with offices in New York and LA, "the Administration's recent efforts to misuse federal rulemaking in the pharmaceutical and other areas to eviserate consumer rights is a big step backward."
"The new FDA rules to limit consumers' rights," he says, "are part and parcel of a larger effort to deny persons injured by unsafe products - be they drugs, cigarettes or automobiles - any form of redress."
"Clearly," Mr Labaton notes, "this Administration and its supporters want to slam the courthouse doors on working men and women injured by unsafe products.
He says its ironic that "an Administrative that calls itself "compassionate" and "conservative" consistently turns its back on "limited government" and "states rights" when it comes to protecting the rights of seriously injured consumers."
Upon learning of the FDA's power grab, the National Conference of State Legislatures, a bipartisan group that represents state lawmakers, accused the FDA of trying to seize authority that it did not have. The organization bases its opposition, in part on the following:
"FDA has usurped the authority of Congress, state legislatures and state courts. There is no statutory authority in the FDCA for FDA to preempt state product liability laws as they relate to prescription drugs.In an earlier gift delivered to Big Pharma in December 2005, Republican leaders, and specifically Senator Bill Frist (R-TN), attached protective provisions to a Department of Defense appropriations report that gave the industry "unprecedented immunity," according to Democratic lawmakers who described the underhanded move as follows:
"Instead of seeking valid congressional authority, unelected agency officials are seeking to preempt state product liability laws by writing this preemption into a final rule, thereby undermining state policy and judicial decision made in this area.
"State tort laws and civil justice systems serve as an important check on federal standards. Our civil justice system establishes a duty of care that protects citizens when the federal government is too slow to act or when federal standards are insufficient. States have the ability to achieve greater protections for their citizens through successful product liability lawsuits."
"Republican leaders added provisions to the conference report after cutting a back-room deal in the middle of the night. The conference report grants sweeping immunity to drug companies for injuries caused by vaccines and drugs and for the administration of those vaccines and drugs, even if they are made with flagrant disregard for basic safety precautions.Since 2002, Senator Frist had tried numerous times to insert this rider in Homeland Security Bills after thousands of lawsuits were filed by parents who believe the mercury-based preservative thimerosal, contained in childhood vaccines until recently, caused autism and other neurological disorders in their kids.
"Moreover, the compensation program is a sham, leaving people who become injured from a drug or vaccine without recourse."
The rider could save Big Pharma hundreds of millions, if not billions of dollars.
The latest revelation on this little stunt came on May 8, 2006 when the Tennessean reported that vaccine industry officials helped shape legislation behind the scenes that Frist secretly amended into a bill, according to e-mails obtained by Pubic Citizen, a public advocacy group.
The industry group, called the Biotechnology Industry Organization, wanted the vaccine liability language in the bill, the e-mails proves.
"At Senator Frist's staff's request, this morning, BIO (Tom and I) participated in a meeting with three other industry representatives (Sanofi and an outside counsel who works for both Pfizer and Roche, I believe), administration staff (HHS, DoJ and WH Leg Affairs), and Liz Hall to further discuss liability," BIO official Dave Boyer wrote in a November e-mail obtained by Public Citizen.
Other E-mails and documents show that BIO met privately with Frist's staff and the White House to figure out ways to give drug makers protection from people injured by vaccines.
"The lack of any restriction on jury trial is problematic," the BIO analysis said. "Where injured parties have no other avenue for relief, juries are likely to find ways to award damages."
In another e-mail, Boyer described a meeting in which Karl Rove said it was "important to the President that a bill move this year," and said "they had invited industry to discuss what they understood to be a few key remaining points" of contention.
Republicans members of Congress had tried on several occasions to enact similar legislation of its own, but with voters already so angry over soaring drug costs, they finally had to back off.
With less than 3 years left in office, and the Democrats positioned to take over Congress in the fall elections, Bush had to find a way to repay Big Pharma so he came up with the bright idea to utilize the FDA and kill 2 birds with one stone.
This route would spare Republicans the task of trying to pass pro-industry legislation in an election year and still reward Big Pharma for the more than $80 million that Republicans received from drug makers over the past decade.
Since 2000, the top drug corporations, their trade group, and their employees gave more than $10 million to 527 organizations, tax-exempt political committees which operate in the grey area between federal and state campaign finance laws, according to Drug Lobby Second to None, July 7, 2005, M. Asif Ismail.
Nearly $87 million of the contributions went to federal politicians, with almost 69% going to Republicans. Top recipients include Bush, with upwards of $1.5 million, and members who sit on committees that have jurisdiction over pharmaceutical issues, reports Drug Lobby Second to None.
During Bush's campaigns, 21 pharmaceutical industry executives and lobbyists achieved "Ranger" or "Pioneer" status, which means they raised at least $200,000 or $100,000, respectively, during the 2000 or 2004 campaigns.
According to Public Citizen, the group included 5 executives from brand-name drug companies, 6 officials from HMOs, the CEO of a pharmacy services company that runs a PBM, the head of a direct-mail pharmacy, and 8 Washington lobbyists who represent drug companies and HMOs.
Frist is never shy when it comes to calling in markers from drug companies. In November 2004, when he wanted to take a victory tour celebrating the newly elected Republican senators, "A Gulfstream corporate jet owned by drug maker Schering-Plough was ready to zip the Senate majority leader to stops in Florida, Georgia and the Carolinas," according to the April 25, 2005 USA Today
Frist's PAC reimbursed Schering $10,809, the equivalent of a commercial first-class fare, but that was only a fraction of the cost of a charter flight, which would have cost 3 times that much. Besides, the cost was almost a wash because Schering had donated $10,000 to Frist's committee in 2003-04, according to USA Today.
Its also worth pointing out that Big Pharma was the largest contributor to the National Republican Senatorial Campaign Committee while Frist chaired the Committee.
The ever-growing number of lawsuits in state courts has created a nagging fear in drug makers. Local juries and elected judges in state courts are much more likely to go against drug giants than juries and appointed judges in federal courts which is a one of the main reasons why Big Pharma wants all cases moved to federal courts.
Vioxx set off the industry's worst nightmare when users or their heirs began filing lawsuits all over the US. According to the January 24, 2006, Associated Press, Merck currently faces 9,200 Vioxx lawsuits, with about 4,050 in federal courts and the rest in state courts.
But Vioxx by far is not the only worry for Big Pharma. These days, every major drug company has litigation problems involving one or more FDA-approved products and a few prominent law firms have taken up the battle for plaintiff's in state courts.
For instance, since 1990, the Los Angeles based Baum Hedlund Law Firm has been handling SSRI (selective serotonin reuptake inhibitor) suicide/violence cases and served on the Plaintiffs' Steering Committee in the first SSRI-suicide litigation involving Prozac, the first SSRI approved by the FDA.
Baum Hedlund partner, Karen Barth Menziess, has been litigating claims involving injuries stemming from SSRIs such as Prozac, Paxil, Zoloft and, more recently, Lexapro/Celexa, for over a decade.
She heads a team of attorneys, who have successfully defeated Pfizer's and the FDA's preemption arguments in a number of cases, including Motus v Pfizer and Witczak v Pfizer.
In addition to her court activities, Ms Menziess has testified about the dangers of SSRIs before the California State Assembly and the FDA's Psychopharmacologic Drugs Advisory Committees and met with members of Congress regarding the risk of antidepressant induced suicidality and preemption issues.
Ms Menziess wrote an article discussing the ill-effects of preemption in Mealey's Emerg. Drugs & Devices 27 (2006), titled, "Preamble To FDA Final Rule: FDA's Latest Effort To Immunize Drug Manufacturers From Tort Liability At The Expense of Consumer Safety," and stated in part:
"Pharmaceutical industry lobbying efforts and zealot tort reformers have sired a new wave of brazen attempts to shield drug manufacturers from tort liability.The Bush administration went up against a tough opponent in Baum Hedlund when it turned to the courts, and had the FDA file amicus briefs hoping the courts would rule in favor of preemption, but those attempts also failed.
"The preemption language in the preamble to the Final Rule is but the latest attempt. Preemption has become the argument du jour and politically appointed regulatory officials the mouthpieces. The crafty messages sound of consumer protection, but are just the opposite. Limiting the liability of drug companies will not improve public safety.
"The FDA s purported position on preemption assumes that the FDA is infallible and that negligent misconduct by pharmaceutical companies should be the sole purview of FDA. Recent regulatory failures demonstrate that FDA is neither infallible nor does it have the capability of policing drug manufacturers negligent misconduct."
Ms Menziess explains some of the history of the FDA's intervention into lawsuits she was involved in stating: "Until his resignation in late 2004, FDA Chief Counsel, Daniel Troy, was the pharmaceutical industry's 'inside man,' filing legal briefs on behalf of former clients such as Pfizer (the maker of Zoloft) and soliciting defense attorneys to submit their cases for government amicus brief consideration."
"Although the newly appointed Chief Counsel, Sheldon Bradshaw, lacks the blatant pharmaceutical industry ties that Troy had," she advises, "he clearly was not selected to his position because of a sudden change-of-heart in the political leadership or direction of the FDA."
"In fact," Ms Meziess says, "following in his predecessor's footsteps, Bradshaw submitted a legal brief in support of Pfizer's federal preemption arguments."
The FDA filed its first brief in favor of a manufacturer of SSRIs in September 2002 in Motus v Pfizer, one of Baum Hedlund's cases in California, which was pending in the 9th Circuit Court of Appeals.
Daniel Troy, who was the FDA's Chief Counsel at the time, was contacted by Pfizer's national counsel, Malcolm Wheeler, in the summer of 2002 requesting that the government get involved in this private lawsuit to help Pfizer with its preemption argument related to Zoloft-induced suicidality.
Despite the fact that Pfizer had been one of his clients and Troy was paid over $358,000 for work he had conducted for Pfizer in the year he took office, Troy acquiesced, arguing that there was no impropriety in doing so because he did not become involved until after the required 1-year period in which government employees may not participate in official activities involving former clients.
From public accounts, it appears that the 1-year "grace period" elapsed less then a month before Troy entered the fray.
Troy argued in the FDA brief that, even though Pfizer never sought to strengthen Zoloft's warning label concerning suicidality, any warning, no matter how worded, that suggested a link between Zoloft and suicidality would have been false and misleading, would have misbranded the drug, and the FDA would have rejected any effort by Pfizer to use such a warning.
The 9th Circuit never decided the preemption issue, instead ruling on another appellate issue, which concluded the case on unrelated grounds.
Nevertheless, Menzies said that Pfizer has continued to use the brief in its battle against Zoloft-induced suicide cases, arguing that the lawsuits are federally preempted and should be dismissed.
But Judges across the US have been rejecting Pfizer's arguments, as well as the FDA brief itself. A federal judge in Texas pointed out that the law "allows, even encourages, manufacturers to be proactive when learning of new safety information related to their drug."
"Manufacturers, not the FDA, are tasked with the responsibility of taking proactive steps once a manufacturer learns of 'reasonable evidence of an association of a serious hazard with a drug,'" the judge stated.
A state court judge in California ordered the FDA brief stricken from the record, calling it "hearsay and irrelevant."
In an Illinois case, the judge said the brief "contains nothing more than legal argument by [FDA] counsel."
In a Zoloft suicide case in Minnesota, the court rejected Pfizer's arguments, stating that it "declines to treat statements from a single FDA legal brief as declarations afforded the preemptive force of law." The same judge also called Pfizer's arguments "perverse" and a "public policy argument gone awry."
Ms Menziess notes that the FDA's legal stance on preemption is "particularly egregious in the wake of congressional investigations involving FDA failures to protect the public health, in particular related to antidepressants."
Without state liability laws, she says, drug companies will be able to escape liability for injuries and deaths caused by drugs like SSRIs and Vioxx.
Baum Hedlund currently represents approximately 50 victims and their families in cases involving alleged antidepressant-induced suicide and suicide attempts, over one third of whom are children and adolescents.
As with Vioxx, the risks associated with SSRIs were also kept hidden. Ms. Menziess' litigation has evidence from as far back as the 1980's that people taking SSRIs were at a heightened risk of suicidality, and not just children, she notes.
In fact, in the early 1990s, it was the FDA safety officer Dr David Graham, of recent Vioxx fame, who raised concerns about the risk between antidepressants and suicidality, but no one listened, Ms Menziess says.
Fourteen years later, the FDA finally ordered black box warnings labels on SSRIs alerting physicians about the increased risk of suicidality. Ms Menziess describes the FDA during these years as "complacent, ignoring its own internal scientist when they raise concerns, and in the pocket of industry."
She believes that the FDA would never have confronted the issue had it not been for the public outcry from victims, consumer groups, courageous experts willing to place their careers on the line, investigative reporters and pressure from certain members of Congress; and yes, she says, "lawyers uncovering the drug industry's dirty little secrets through legal discovery and speaking out about the dangers."
Ms Menziess points out that "the antidepressant controversy and resultant congressional investigations, and later, the Vioxx public health debacle, have served to highlight deep-seeded problems within the FDA."
Over the past couple of years, a growing number of lawmakers have been turning up the heat on both the FDA and the industry in response to their combined failure to reveal the problems found in studies conducted on drugs like SSRIs and Vioxx.
At one point, Senator Charles Grassley (R-IA), Chairman of the Senate Finance Committee, came right out and accused the FDA of suppressing studies in order to protect industry profits and the careers of certain FDA officials.
"The Vioxx example showed that the FDA and Merck were too close for comfort," Senator Grassely told Health News on March 12, 2005. "Testimony and documents at our Finance Committee hearing showed that the FDA allowed itself to be manipulated by Merck," he said.
The results of a trial that took place in 2000, surfaced that showed that the FDA and Merck were aware that heart attacks were 5 times more likely in patients taking Vioxx than among those taking a similar drug, Senator Grassley pointed out, but the FDA did nothing to change the labeling for nearly 2 years, he said, while Merck marketed its product on nightly TV.
On November 18, 2004, Senator Grassley drew enormous media attention when he held hearings on Vioxx, and FDA scientist, Dr Graham, testified that he determined that Vioxx may have caused tens of thousands of heart attacks and strokes but that his superiors at the FDA pressured him to keep quiet.
"The estimates range from 88,000 to 139,000 Americans," Dr Graham told the committee. "Of these, 30 to 40 percent probably died," he advised. "For the survivors," he added, "their lives were changed forever."
To put the number of injuries into perspective, Dr Graham told members of the committee that instead of side-effects from a drug, to think of it as if they were talking about jetliners.
"If there were an average of 150 to 200 people on an aircraft," he said, "this range of 88,000 to 138,000 would be the rough equivalent of 500 to 900 aircraft dropping from the sky."
"This translates to 2-4 aircraft every week," he advised, "week in and week out, for the past 5 years."
"If you were confronted by this situation," Dr Graham asked the panel, "what would be your reaction, what would you want to know and what would you do about it?"
He noted the problems with the FDA's reliance on a 95% paradigm. In other words, he said, a drug is considered safe "until you can show with 95% or greater certainty that it is not safe."
The scientist condemned the FDA's failure to acknowledge the Vioxx risks sooner. "I strongly believe that this should have been, and largely could have been, avoided," Dr Graham told the committee.
Ms Menziess often cites his testimony to demonstrate that the FDA's position on preemption is wrong and states: "Dr. Graham's testimony illustrates why FDA approval and subsequent post-marketing acquiescence should have no preemptive effect."
The Vioxx matter caught the attention of the Senate Finance Committee basically because of the drug's cost to government programs like Medicaid and Medicare. The committee is responsible for oversight of the two programs.
At the November 18, 2004 hearing, Senator Max Baucus discussed the high-costs related to the drug: "In the 5 years that Vioxx was on the market, Medicaid spent more than $1 billion on the drug," he said.
In addition to the prescription costs, government programs are now paying for the damage caused by Vioxx. "Medicaid bears the cost of any additional medical care necessary when drugs cause injury," Senator Baucus pointed out.
By far, the Vioxx debacle is the most serious public health failure to occur since the FDA took on the authority for safety oversight of medical products in 1938.
On September 3, 2005, Shane Ellison, a former pharmaceutical chemist turned whistleblower and author of the book, "Health Myths Exposed," gave an interview to Crusador Magazine and discussed Vioxx and the problems within the FDA.
According to Mr Ellison, the FDA and Merck knew about the dangers of Vioxx for at least 4 years before it was pulled off the market. "Instead of removing the drug immediately," he said, "they kept it on the drug market for matters of wealth not health."
Mr Ellison says compliant politicians have "democratized" the industry. "This means that drug approval is a matter of 51% telling the other 49% that deadly drugs are safe and necessary," he reports. "Science and choice no longer prevail at the FDA or at pharmaceutical companies," he added.
"To go against the 51% means losing your career," Mr Ellison explains. "Therefore, the majority of scientists choose to please drug companies, not the general public."
To substantiate this allegation, Dr Ellison points to Dr Curt Furberg, a member of the FDA's drug safety advisory committee. Dr Furberg went public with findings that Bextra also caused heart attacks and strokes and said studies "showed that Bextra is no different than Vioxx, and Pfizer is trying to suppress that information," in the British Medical Journal.
"Immediately thereafter," Mr Ellison said, "Dr. Furberg was barred from serving on the panel that was responsible for considering the safety of cyclo-oxygenase-2 (COX 2) inhibitors."
"The end result being more votes in favor of COX 2 inhibitors, the drug company wins by votes - not science," he told Crusador.
Another relevant, but little-mentioned fact, is that many FDA officials end up working for Big Pharma. "The old joke is that the FDA is sort of like a showcase for a future job in the drug industry," Robert Whitaker, author of Mad In America, said in an August 2005 interview with Street Spirit.
"You go there, you work awhile, then you go off into the drug industry," he said, "the progression that people make, in essence they're making good old boy network connections, so they're not going to be so harsh on the drug companies."
In addition, when leaving office many federal employees and members of Congress go to work for Big Pharma in one area or another. For instance, of the 1,274 people registered to lobby in Washington for drug companies in 2003, according to an April 2005 report by the Center for Public Integrity, 476 are former federal officials, including 40 former members of Congress.
Critics say the Prescription Drug User Fee Act, is in large part to blame, for the current problems within the FDA. The Act allows the agency to collect a fee from a drug company seeking approval for a new drug. In return, the FDA is expected complete the review process within 12 months.
User fees now account for about 40% of the approval process, which means the FDA is dependent on drug companies for nearly half of its funding. This situation creates a major conflict of interest according to Dr Graham: "This culture views the pharmaceutical industry it is supposed to regulate as its client. It overvalues the benefits of the drugs it approves, and seriously undervalues, disregards and disrespects drug safety," he told members of Congress.
Another problem he said is that even when the FDA does try to take measures to limit harm, the agency lacks the authority to force drug companies to comply. For example with Vioxx, he said, it took more than 2 years to get Merck to add the increased risk of heart attack and stroke on the label.
Then there is the matter of the conflicts of interests involving the FDA panels that advise the agency on which drugs should be approved, what their warning labels should say, and how studies should be conducted.
The approximately 300 experts on the 18 committees make decisions that affect billions of dollars in sales and with very few exceptions the FDA follows their advice.
Members of the panels are supposed to be free of conflicts of interest relating to products they consider but they rarely are. For example, in February 2005, when the hearings were held to determine whether the COX-2 inhibitors should be allowed to remain on the market, a panel mired with conflicts was exposed. Out of the 32 voting members, ten had served as consultants to Merck and Pfizer in recent years.
This revelation prompted Senator Mike Enzi, (R-WY), the chairman of the Health, Education, Labor and Pensions Committee, along with Senators, Edward Kennedy (D-MA), and Richard Durbin (D-IL), to ask the General Accounting Office to look into the FDA's practice of letting scientists serve on panels when they have conflicts of interest.
"We are concerned about the process that supports FDA's decisions to waive conflicts of interest rules for scientists with financial ties to the manufacturers of the products under consideration, or their competitors," said their letter to the GAO in September 2005.
"These practices appear to have undermined the public's faith in the objectivity and fairness of FDA's advisory committees," they wrote. The Senators specifically referred to the conflicts among the panels that studied the Cox-2 inhibitors like Vioxx.
According to Ms Menziess, "The FDA's preemption argument, if successful, would take away the sole means by which American consumers may obtain compensation for drug-induced injuries caused by a drug company's failure to warn."
"Civil lawsuits uncover internal company documents to which not even the FDA has access," she explains.
"The tort system provides an important check on the regulatory process and on drug companies' compliance with law."
"Preemption," Ms Menziess warns, "would close off one of the few avenues by which we learn of safety and efficacy information that pharmaceutical companies do not publish or hide from FDA."