According to Attorney, Karen Barth Menzies, a partner in the Los Angeles based Baum Hedlund law firm, "the Vioxx public health debacle, has served to highlight deep-seeded problems within the FDA."
She says, "drug companies are profit-driven and are loath to issue warnings about risks associated with their drugs, even those that become quite clear."
"And it is precisely for this reason," Ms Menzies says, "that the public is in such desperate need for an agency that advocates for them, rather than the drug industry."
The FDA played a big part in the Vioxx disaster and allowed Merck to get away with murder. A new report released on April 24, 2006, by the Government Accountability Office is deeply critical of the FDA's approach to drug safety and specifically Vioxx, and lists organizational dysfunction, bureaucratic politics, and ineffective enforcement over drug companies as factors compromising drug safety.
The report was commissioned by Senator Charles Grassley (R-Iowa), in response to findings at a November 18, 2004, Senate Finance Committee hearing titled, "FDA, Merck and Vioxx: Putting Patient Safety First," where reports of mismanagement surfaced regarding the FDA's failure to implement safety measures to protect the public against the dangers of Vioxx.
Citing "recent controversy about drug safety," the report illuminates the weaknesses of the FDA in monitoring the safety of drugs once they are approved.
The report states that the FDA "lacks a clear and effective process for making decisions about, and providing management oversight of, postmarket drug safety issues."
It highlights the communication problems between the two FDA offices that handle postmarket safety concerns and advises that "insufficient communication" between the Office of Drug Safety and the Office of New Drugs "has hindered the decision-making process."
"Specifically," the GAO wrote, "ODS management does not always know how OND has responded to ODS's safety analyses and recommendations."
Ms Menzies says the FDA has sided with industry for years. "The recent GAO report," she says, "confirms many of the problems that we have been shouting about for years and illustrates that, contrary to FDA's preemption arguments, FDA's decisions must be second-guessed for the safety of the public."
The report comes almost two years after the hearing that revealed the FDA had not acted promptly to protect the public when it first became aware of information that Vioxx might pose risks to cardiovascular health.
The Senate Finance Committee got involved in the Vioxx matter because it has jurisdiction over the Medicare and Medicaid programs. "Accordingly," Senator Grassley informed the audience at the start of the November 18, 2004 hearing, "the committee has a responsibility to the more than 80 million Americans who receive health care coverage — including prescription drugs — under these programs."
"Of the 20 million Americans who reportedly took Vioxx, an untold number are Medicare and Medicaid beneficiaries," he advised. "I was told that the Medicaid program paid in excess of $1 billion for Vioxx while Vioxx was on the market," he said.
To demonstrate the value of government payments to Merck, at the beginning of the hearing, Senator Grassley described a June 4, 1999 Merck document titled "IN IT TO WIN IT” that said: “As of yesterday, Vioxx became reimbursable on Medicaid in 42 states with the other 8 states close behind."
"The Medicaid market was clearly going to be a money maker for Merck," he said, "and Medicaid has paid Merck well for Vioxx."
When the FDA approves a drug, Senator Grassley said, it’s considered a “Good Housekeeping Seal of Approval.”
