August may be a slow news month, but not for stories about what's wrong with the drug industry. In just one recent week, the New York Times published three articles that exposed what we're up against with Big Pharma--and the weakness of the agency that's supposed to regulate it.
On August 6, "At Midpoint of Vioxx Trial, Merck Looks Battered" explained how the drug company Merck "appears to be in a deep hole" in its court case in Texas, where it was being sued by the family of a Wal-Mart employee, Robert Ernst. The family charged that Ernst died from an arrhythmia caused by the painkiller Vioxx after taking the medicine for eight months. The coroner who did the autopsy on Ernst told the jury that "Vioxx was probably responsible for Mr. Ernst's death," the Times reported. And the jury agreed this afternoon as it found Merck liable in Ernst's death and awarded his widow a settlement of $253 million.
And this is just the first of more than 4,000 other lawsuits in which the company is being sued over Vioxx in state courts in California, Texas and New Jersey and in US federal court, with liabilities for the company potentially running as high as $30 billion.
The second article ran three days later. "Today's Insider Trading Suspect May Wear a Lab Coat" exposes another problem that has led to our unsafe market for prescription drugs. Doctors and scientists are now joining forces with the big drug companies to promote their products and are increasingly "working as consultants to investors, especially hedge funds," the Times reported.
Most important, though, the SEC is "taking a closer look at whether doctors, participating in criminal trials with drug companies, are accepting money to talk to analysts and investors about the confidential results of a trial." (Another piece in the Times from August 16 reported that "nearly 10 percent of the nation's 700,000 doctors have signed up as consultants" on investment deals. And, according to a Times editorial, doctors make anywhere from $200 to $1,000 an hour on consulting.)
The Seattle Times reported, after completing its own investigation, that it found "at least 26 cases in which doctors have leaked confidential and critical details of their ongoing drug research to Wall Street firms." Doctors who did the leaking were affiliated with top universities like UCLA and the University of Pennsylvania as well as companies like Citigroup, Smith Barney and Wachovia.
That's shameful, but it's not shocking. After all, doctors have gotten dinners, vacations and even thousands of dollars in fees from drug companies to attend "conferences" and "summits," where they are informed of the benefits of the wonder drug du jour. In 2002, one cardiologist told the Washington Post that Merck sent a limo to pick him up, take him to dinner and included a bottle of champagne for kicks.
The third article that I found really disturbing, "FDA Will Not Release Some Data on Heart Devices" (August 6), illustrates why these abuses have become so rampant: The FDA has abandoned its responsibility to oversee and regulate the drug industry.
As the story puts it: "The Food and Drug Administration said yesterday that it would not release information that it receives annually from the makers of heart devices detailing how often and why products fail." Protecting such data by calling it a corporate "trade secret," the FDA was pulling the plug on the public's right to information.
The Director of Public Citizen's Health Research Group, Dr. Sidney Wolfe, argued in a recent interview that the FDA has become a "formal partner" to drug manufacturers for at least two reasons. First, in 1992, Congress decided that drug companies, not taxpayers, should have to fund the drug review and approval process at the FDA. And so the industry is spending an estimated $350 million this year alone to get its drugs approved, Dr. Wolfe says. Consequently, "Approve now, test later" is the FDA's attitude, Wolfe explained.
The second factor is that Congress has almost totally failed in its responsibility to police the Food and Drug Administration. Committees in Congress used to hold many hearings looking at the FDA's performance, but those days are over. Now, it is up to lone Senators like Chuck Grassley of Iowa to hold the agency's feet to the fire. In a recent floor debate, Grassley said that the agency "is plagued by structural, personnel, cultural and scientific problems." But a lone Senator's voice isn't enough.
In a recent article in the Columbia Journalism Review, investigative journalist Trudy Lieberman argued that the FDA views the companies it regulates "as clients." That's a fair description. After all, The New England Journal of Medicine reported as early as 2000 that Cox 2 drugs like Vioxx could cause patients to suffer heart attacks, but the FDA refused to force the industry to warn consumers at that time. Similarly, when one safety officer told the FDA's higher-ups that reports had shown that Viagra could lead to the onset of blindness in men, the FDA remained silent. (Thirteen months later, a scientific journal published an article that revealed the problem.)
The FDA also recently rejected the advice of its own advisory panel--which has happened only twice in five decades--that the emergency contraception known as Plan B should be made available to women over the counter. Moreover, the agency failed to warn parents in a timely manner that antidepressants could make kids more likely to commit suicide.
So, what should be done? Dr. Wolfe says that at least four reforms would amount to a good start.
First, he argues that Congress should repeal the 1992 Prescription Drug User Fee Act that "demolished" much of the vigilance that the FDA exerted over the drug industry in previous years. Second, Congress should pass legislation that is being sponsored by senators Dodd and Grassley that will free the Office of Drug Safety from the FDA's Center for Drug Evaluation and Research. (The FDA has been reluctant to admit problems with medicines once drugs have reached the market. By liberating the Office of Drug Safety from the office that handles the review process, Drug Safety would gain independence, and the FDA might finally begin to warn consumers about drugs that turn out to be unsafe after they've gone on the market.)
Third, more generally, the FDA needs to do a better job of enforcing the law, says Wolfe. In 1998 the FDA stopped 157 illegal prescription drug ads, while in 2004 it stopped only twenty-four illegal ads--an 85 percent decrease in the number of FDA enforcement actions.
Finally, Wolfe believes that if Congress increased the number of hearings it held looking into how the FDA is performing, the FDA would face greater scrutiny and be more likely to protect consumers' health, not the drug industry's profits. Here's hoping Wolfe's sensible ideas take hold.