Last month, the FDA revealed its latest protective policy for drug companies in a statement that said people who believe they have been injured by drugs approved by the FDA should not be allowed to sue drug companies in state courts.
"We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don't have the same scientific knowledge," said Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs.
The agency's assertion of "federal preemption" was included as a preamble to its new drug labeling guidelines.
The claim of preemption was quickly attacked by trial lawyers and members of Congress as another effort by the Bush administration to limit the public's ability to bring and win lawsuits, according to the January 19, 2006 Washington Post.
"Eliminating the rights of individuals to hold negligent drug companies accountable puts patients in even more danger than they already are in from drug company executives that put profits before safety," said Ken Suggs, president of the Association of Trial Lawyers of America.
"The fact that the drug industry can get the FDA to rewrite the rules so that CEOs can escape accountability for putting dangerous and deadly drugs on the market is the scariest example yet of how much control these big corporations have over our political process," Mr Suggs told the Post.
In response to the FDA's announcement, Senator Kennedy issued a statement that said: "It's a typical abuse by the Bush Administration - take a regulation to improve the information that doctors and patients receive about prescription drugs and turn it into a protection against liability for the drug industry."
The National Conference of State Legislatures, a bipartisan group that represents state lawmakers, accused the FDA of trying to seize authority that it did not have.
Over the past several years, lawmakers have been turning up the heat on both the FDA and the pharmaceutical industry in response to their combined failure to reveal problems found during studies conducted on top selling drugs like Vioxx.
At one point, Senator Charles Grassley (R-Iowa), Chairman of the Senate Finance Committee, came right out and accused the FDA of suppressing studies in order to protect pharmaceutical industry profits and the careers of certain FDA officials.
"The Vioxx example showed that the FDA and Merck were too close for comfort," Senator Grassely told Health News on March 12, 2005. "Testimony and documents at our Finance Committee hearing showed that the FDA allowed itself to be manipulated by Merck," he said.
Based on a trial that took place in 2000, both the FDA and Merck were aware that heart attacks were five times more likely in patients taking Vioxx than among those taking a similar drug, Sen Grassley pointed out, but the FDA did nothing to change the labeling on the drug for nearly two years, while Merck aggressively marketed its product on nightly TV.
Back on November 18, 2004, he generated enormous media attention when he held hearings on Vioxx, and FDA scientist, Dr David Graham, who works in the FDA Office of Drug Safety, testified that Vioxx may have been responsible for tens of thousands of heart attacks and strokes but that his superiors had pressured him to keep silent about his findings.
"The estimates range from 88,000 to 139,000 Americans," Dr Graham told the committee. "Of these, 30 to 40 percent probably died," he advised.
"For the survivors," he added, "their lives were changed forever."
To put this large number of injuries into perspective, Dr Graham told members of the committee that instead of a serious side-effect of a prescription drug, to think of it as if they were talking about jetliners.
"If there were an average of 150 to 200 people on an aircraft," he said, "this range of 88,000 to 138,000 would be the rough equivalent of 500 to 900 aircraft dropping from the sky."
"This translates to 2-4 aircraft every week," he noted, "week in and week out, for the past 5 years."
"If you were confronted by this situation," Dr Graham asked the committee, "what would be your reaction, what would you want to know and what would you do about it?"
He condemned the FDA's failure to acknowledge the risks that Vioxx posed to millions of people in the 5 years it was allowed to remain on the market. "I strongly believe that this should have been, and largely could have been, avoided," Dr Graham told the committee.
The Vioxx matter caught the attention of the Senate Finance Committee basically because of the Vioxx related costs to government programs like Medicaid and Medicare. The committee is responsible for oversight of the two programs. At the November 18, 2004 hearing, Senator Max Baucus said:
"In the 5 years that Vioxx was on the market, Medicaid spent more than $1 billion on the drug."
"And Medicaid bears the cost of any additional medical care necessary when drugs cause injury," he pointed out.
The hearings followed a study that estimated between 28,000 and 160,000 deaths may have been caused by the Vioxx since it gained FDA approval in 1999.
By far, the Vioxx debacle is the most serious public health failure to occur since the FDA took on the authority for safety oversight of medical products in 1938.
On September 3, 2005, Shane Ellison, M.Sc, a former pharmaceutical chemist turned whistleblower and author of the book, "Health Myths Exposed," gave an interview to Crusador Magazine and discussed Vioxx and some of the problems within the FDA.
His book which was published before Vioxx began making headlines, referred to Vioxx as the "silent killer."
According to Mr Ellison, the FDA and Merck knew about the dangers associated with Vioxx for at least 4 years before it was taken off the market. "Instead of removing the drug immediately," he said, "they kept it on the drug market for matters of wealth not health."
Mr Ellison says pharmaceutically compliant politicians have "democratized" the drug industry. "This means that drug approval is a matter of 51% telling the other 49% that deadly drugs are safe and necessary," he reports. "Science and choice no longer prevail at the FDA or at pharmaceutical companies," he added.
"To go against the 51% means losing your career," Mr Ellison said. "Therefore, the majority of scientists choose to please drug companies, not the general public."
To substantiate this claim, Dr Ellison pointed to Dr Curt Furberg, a member of the FDA's drug safety advisory committee.
In the wake of the Vioxx revelations, Dr Furberg went public with findings that Pfizer's drug Bextra also caused heart attacks and strokes and said studies "showed that Bextra is no different than Vioxx, and Pfizer is trying to suppress that information," in the British Medical Journal.
"Immediately thereafter," Mr Ellison said, "Dr. Furberg was barred from serving on the panel that was responsible for considering the safety of cyclo-oxygenase-2 (COX 2) inhibitors."
"The end result being more votes in favor of COX 2 inhibitors, the drug company wins by votes - not science," he told Crusador.
A little-mentioned fact is that many FDA employees end up working for the pharmaceutical industry. "The old joke is that the FDA is sort of like a showcase for a future job in the drug industry," Robert Whitaker, author of Mad In America, said in an August 2005 interview with Street Spirit.
"You go there, you work awhile, then you go off into the drug industry," he said, "the progression that people make, in essence they're making good old boy network connections, so they're not going to be so harsh on the drug companies."
Critic say the passage of the Prescription Drug User Fee Act in 1992 contributed to the current problems within the FDA. The Act allows the agency to collect a fee from a drug company seeking approval for a new drug. In return, the FDA is expected complete the review process within 12 months.
User fees now account for about 40% of the approval process, which means the FDA is dependent on drug companies for nearly half of its funding.
This situation is the root of a major conflict of interest according to Dr Graham: "This culture (at the FDA) views the pharmaceutical industry it is supposed to regulate as its client. It overvalues the benefits of the drugs it approves, and seriously undervalues, disregards and disrespects drug safety," he told members of Congress.
Another problem he cited is that even when the FDA does try to take measures to limit harm, the agency lacks the enforcement authority to force drug companies to comply. In the case of Vioxx, Dr Graham said it took more than 2 years to get Merck to add the increased risk of heart attack and stroke to its label.
Then there are the conflicts of interests involving the FDA panels that advise the agency on matters such as which drugs should be approved, what their warning labels should say, and how studies should be conducted.
The 300 experts on the 18 committees make decisions that affect billions of dollars in sales and with few exceptions the FDA follows their recommendations.
Members of the panels are supposed to be free of conflicts of interest relating to products they consider. But the FDA can grant a waiver if a member's expertise is deemed to outweigh the risk of a conflict or if the financial interest is minimal. Waivers are liberally granted all the time.
For instance, in February 2005, when the highly publicized hearings were held to determine whether the COX-2 inhibitors, manufactured by Merck and Pfizer, should be permitted to remain on the market, an advisory committee that was mired with conflicts of interest was exposed. Out of the 32 advisers voting on the issue, ten had served as consultants to Merck and Pfizer in recent years.
This revelation prompted Senator Mike Enzi, (R-WY), the chairman of the Health, Education, Labor and Pensions Committee, along with Senators, Edward Kennedy (D-MA), and Richard Durbin (D-IL), to ask the General Accounting Office to look into the FDA's practice of letting scientists serve on panels when they have conflicts of interest.
"We are concerned about the process that supports FDA's decisions to waive conflicts of interest rules for scientists with financial ties to the manufacturers of the products under consideration, or their competitors," said a letter to the GAO, signed by Senators in September 2005.
"These practices appear to have undermined the public's faith in the objectivity and fairness of FDA's advisory committees," they wrote. The Senators specifically noted the conflicts among the panels that studied the Cox-2 inhibitors like Vioxx.
According to the Associated Press on January 24, 2006, Merck currently faces 9,200 Vioxx lawsuits, with about 4,050 in federal courts and the rest in state courts. Without state product liability laws, drug companies like Merck will be able to escape liability for injuries and deaths caused by drugs like Vioxx.
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