In a nutshell, the FDA's position on preemption means that states cannot force drug companies to warn consumers about any safety risks associated with a drug other than what the FDA says is required.
In the case of Vioxx, under the Texas statute cited by the judge, all the FDA would have to do to stop the dismissal of the lawsuits filed by citizens in state courts is acknowledge that Merck withheld or misrepresented safety information about the drug to the FDA.As the judge said in his April 19, 2007, opinion, "plaintiffs can still avail themselves ... if the FDA determines that required information was withheld."
In the end, the judge granted Merck's motion to dismiss the failure-to-warn claims because "someone other than the FDA is being asked to make the determination," and plaintiffs cannot rebut the presumption of preemption "unless and until the FDA makes the required findings."
The proof for these finding can easily be found in the agency's own actions against Merck for making misleading statements about the safety and efficacy of Vioxx. For example, on September 17, 2001, the FDA sent Merck a Warning Letter about its promotion of Vioxx and described numerous instances where Merck lied about the risks associated with the drug and specifically the heart attack risks.
The letter said Merck was misrepresenting the risks of Vioxx to both the public and doctors. "Your minimizing these potential risks and misrepresenting the safety profile of Vioxx raise significant public health and safety concerns," the FDA said.
And this was not the first time Merck was warned about making misleading claims in promoting Vioxx. "Your misrepresentation of the safety profile of Vioxx," the FDA letter said, "is particularly troublesome because we have previously, in an untitled letter, objected to promotional materials that also minimized Vioxx's safety profile."
The promotional activities described in the letter included audio conferences, events in which a doctor gave a Merck-sponsored presentation to other doctors, statements made by sales representatives at professional conferences and a press release.
The press release, in fact, claimed that Vioxx had "a favorable cardiovascular safety profile," a claim that the FDA called "simply incomprehensible."
Company documents that surfaced in litigation prove that Merck intentionally concealed the heart risks of Vioxx from prescribers, with a specific sales training manual that instructed sales representatives to "dodge" if doctors asked about the cardiovascular risks of Vioxx.
The company's illegal promotional activities were extremely profitable for Merck but lethal for consumers. According to the May 13, 2006, New York Times, twenty million Americans took Vioxx between 1999 to 2004, and epidemiologists "estimate that the drug may have caused 100,000 heart attacks during the five years it was on the market."
The Bush-appointed FDA officials' preemption position reverses a long-standing policy of allowing states to provide additional remedies for citizens against the marketers of unsafe drugs, over and above the minimal protection afforded by the FDA.
"The FDA admittedly does not have the resources or manpower to achieve a perfect record," says Baum Hedlund attorney Karen Barth Menzies, "nor does it provide remedies to the victims when it fails."
"State product liability laws," she notes, "provide remedies and an invaluable safeguard."
In addition, she says, preemption eliminates one of the few methods available to obtain safety and efficacy information about a drug that companies do not publish and often hide from the FDA. "Civil lawsuits," Ms Menzies points out, "have uncovered internal company documents to which not even FDA is privy."
According to Pennsylvania Attorney Derek Braslow, state tort claims do not force a drug company to take any action that is not permitted by FDA regulations. "Federal regulations," he says, "specifically mandate drug companies to strengthen their drug's label as soon as there is reasonable evidence of an association of a serious hazard with their drug."
"The reality of preemption," he says, "allows drug makers to peddle unsafe products and avoid being sued for deceiving consumers about the safety and effectiveness of the drugs."
"The position on preemption taken by the Bush-era FDA," Mr Braslow says, "is an attempt to achieve tort reform for the benefit of the pharmaceutical industry without the consent of Congress."
Other legal experts view the actions of the current FDA the same way. "The fact that the leaders of the FDA have taken the extraordinary step of interjecting the agency into private lawsuits and arguing preemption," says Alaska Attorney Jim Gottstein, "leaves no doubt that the FDA has abdicated its duty to protect the public in favor of protecting pharmaceutical profits."
The FDA's past collusion with Merck to keep Vioxx on the market to increase profits is no secret. In the December 2004 British medical journal Lancet, a team of scientists from the University of Berne, Switzerland, reported: "Our findings indicate that Vioxx should have been withdrawn several years earlier."
The study pooled data from 5,273 patients who participated in 18 clinical trials conducted before 2001 and found that Vioxx patients had 2.3 times the risk of heart attacks as patients taking placebos or other pain medications.
"The reasons why manufacturer and drug licensing authorities did not continuously monitor and summarize the accumulating evidence needs to be clarified," the authors stated.
Dr Richard Horton, editor-in-chief of Lancet, wrote: "With Vioxx, Merck and the F.D.A. acted out of ruthless, short-sighted, and irresponsible self-interest."
Also, it's a matter of public record that Merck concealed safety information from the FDA. In a November 18, 2004, hearing before the Senate Finance Committee to evaluate the FDA's handling of the Vioxx disaster, Dr Gurkirpal Singh, Adjunct Clinical Professor of Medicine Department of Medicine, Division of Gastroenterology and Hepatology at Stanford University, testified by video conference and said Merck knew all about the health risks of Vioxx long before the drug was approved.
"We now know that by November of 1996," he told the panel, "Merck scientists were seriously discussing a potential risk of Vioxx - association with heart attacks."
At that time, he said, it was not known that Vioxx itself caused heart attacks, but the discussion focused on the issue that by inhibiting platelets, other painkillers might protect against heart attacks while Vioxx had no effect on platelets.
"This was a serious concern because the entire reason for the development of Vioxx was safety," Dr Singh explained.
He noted that Vioxx was no more effective than older NSAID's, and if the improved stomach safety of the drug was negated by a risk of heart attacks, patients might not have been willing to make the trade-off.
"It appears from the internal Merck e-mails provided to me," he testified, "that in early 1997, Merck scientists were exploring study designs that would exclude people who may have a weak heart so that the heart attack problem would not be evident."
"Clinical trials should be designed to test a drug under 'real world' circumstances - on patients who are most likely to use the drug," Dr Singh told the panel.
"Clinical trials should not be designed," he said, "to selectively favor one outcome over another by excluding people similar to those who would take the drug after its approval."
"Certainly," he continued, "clinical trials should not be designed to put marketing needs in front of patient safety - we need to know how a drug behaves in people who are going to take it, even if it 'kills the drug'".
Citing Merck internal documents provided to him by the Committee, he said, "there were many other internal discussions within Merck on these concerns of heart attack-stomach bleed trade-offs, although the practicing physician did not learn of any of this till many years later."
For instance, one 1998 document by Merck scientist Dr Doug Watson presented an analysis of serious heart problems with Vioxx compared to patients enrolled in studies of other Merck drugs and concluded that, in women, the risk of heart problems was more than double compared to people not taking any drug in other studies.
"To the best of my knowledge," Dr Singh said, "these data were never made public."
"This is when a public scientific discussion of the pros and cons of the medication should have started," he told the committee.
He said larger, definitive studies should have been conducted before the drug was approved. "After all," he noted, "the drug was no more effective than any other available pain-killer - and there were nearly 30 such drugs available in the US."
Instead, Dr Singh told the panel, the drug was approved in a priority review within 6 months - with no discussion of the heart attack trade-off. "The prescribing physicians," he said, "remained unaware of any of these data or discussions, till much later - with the new label change in April 2002."
Dr Singh also described a pattern of intimidation by Merck, similar to what the Committee heard about from other experts who dared to speak out on Vioxx. He said he persisted in his inquiries about Vioxx and "was warned that if I continued in this fashion, there would be serious consequences for me."
"I was told that Dr Louis Sherwood, a Merck senior vice-president, and a former Chief of Medicine at a medical school," he told the Committee, "had extensive contacts within the academia and could make life 'very difficult' for me at Stanford and outside."
"But as a research scientist," he testified, "I felt that it was unethical for me not to discuss my concerns in public."
Dr Singh said, "Dr Sherwood called several of my superiors at Stanford to complain."
"Subsequently," he said, "I learnt that this was a persistent pattern of intimidation by Dr Sherwood."
"The failure to conduct large long-term safety studies," Dr Singh told the panel, "subjected millions of patients over 4 years to a drug whose safety had been questioned by the FDA even before its approval."
"This is not the proudest chapter in drug approval in the US," he added.
Another expert, Dr Bruce Psaty, Professor of Medicine at the Cardiovascular Health Research Unit at the University of Washington, also testified at that hearing and delivered a summary of Vioxx's history that underscored the conflict of interest between the FDA and Merck and offered recommendations to avoid similar fiascoes in the future.
He also testified that the "failure to conduct large long-term randomized trials in a more timely fashion permitted millions of Americans to use a drug whose cardiovascular safety profile was in question."
Overall, Dr Psaty said, Merck intentionally designed studies to only bring out the positives. "If I were to give a test to my students and ask what thing could you do to design a study to not find harm, and to find benefits," he noted, "Merck would have gotten an A-plus."
He also pointed out that the FDA's review of the VIGOR study occurred in February 2001, but the revisions to the Vioxx label were not completed until April 11, 2002.
At a November 17, 2006, hearing by the Senate Committee on Health, Education, Labor, and Pensions, to advocate for FDA reform legislation, the "Enhancing Drug Safe and Innovation Act of 2006," prominent cardiologist, Dr Steven Nissen of the Cleveland Clinic described "a crisis in public confidence in the FDA following an unprecedented series of revelations about drug and device safety."
"I served on a 2001 Advisory Panel that recommended a warning label for Vioxx," he told the panel, "but it took 14 months before the FDA could secure agreement from the company to accept a weakly written warning."
Merck has continued to mislead doctors and former Vioxx users about the risks of the drug. On May 12, 2006, Reuters reported that Dr Nissen said Merck misrepresented an analysis of data from a follow-up review of patients involved in the trial that led to Vioxx being pulled off the market and that patients were at a high risk of heart attacks and stroke long after they stopped taking the drug.
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"It's important that we inform people about this because patients who have taken the drug will need increased surveillance by their physicians and increased awareness of their risks in the year subsequent to stopping the drug," Dr Nissen told Reuters in a telephone interview."And that risk may extend beyond a year;" he added, "we simply don't know."
"In the one year after Vioxx was stopped there was a 75 percent greater risk of having an adverse event," Dr Nissen told Reuters.
Speaking to the Consumer Federation of America in March 2005, Senator Grassley basically said that the FDA cannot be trusted to protect Americans against drugs like Vioxx because the agency is too "cozy" with the drug makers like Merck. "The very same month that Dr. Graham warned the FDA of the cardiovascular risks of Vioxx," he pointed out, "the FDA approved the use of Vioxx for children."
Also see Part I: FDA Colludes With Merck To Avoid Vioxx Liability - Part I
