The investigation also made public an internal FDA memo from 1998 recommending the drug be taken off the market due to its potential to cause birth defects.
Staffers on the House Energy and Commerce subcommittee on oversight and investigations spent hundreds of hours culling internal memos, reports and e-mails obtained from the Food and Drug Administration and the Centers for Disease Control and Prevention, as well as from Accutane's manufacturer, Roche U.S. Pharmaceuticals, part of Hoffmann-La Roche Inc., of Nutley, N.J.
More than 200 people have taken their lives while taking Accutane -- and perhaps many more -- but neither the FDA nor Roche has ever publicly admitted the suicides were due to the drug.
"This investigation leads to one conclusion: In some cases ... Accutane results in severe cases of depression, suicide ideation, suicide attempts and suicide," said Bart Stupak, R-Mich. Stupak's son, B.J., died in 2000 from a self-inflicted gunshot wound while taking Accutane.
"If the FDA cannot or will not regulate Accutane, ... then it is imperative for the U.S. Congress to act to protect the American public," Stupak said.
Committee members grilled representatives from FDA and Roche on the findings of their investigation, charging both have failed to protect the public from the known risks of Accutane. Both denied the suicide link and said a new plan instituted earlier this year will lower the incidence of birth defects.
Accutane, first approved in 1982, is intended to be used as a last resort to treat severe forms of acne that cause scarring and cysts. It often works miracles, as patients have attested, because it can clear up their skin in a matter of months. However, the drug carries serious side effects. It is known to cause birth defects and an unknown percentage of people using the drug have developed depression and committed suicide.
The FDA and Roche maintained there is no scientific proof the drug caused the depression or suicide cases -- although the labeling on the drug specifically warns of both possibilities. The FDA has confirmed 167 cases of suicide in people taking Accutane. Stupak said his office sent 37 more cases to the agency last week. He said, however, internal FDA documents suggested this was less than 1 percent of the total number of suicides by people on Accutane, indicating the real number could range from 2,000 to as high as 20,000.
Stupak also cited a 1994 FDA memo discussing a teleconference call with Roche. It said Roche concurred with the agency that there does appear to be a problem with Accutane and depression and suicide.
Roche's president and CEO George Abercrombie said he was not familiar with the memo or the teleconference call.
Accutane also is known to cause birth defects, such as ear deformities -- including a lack of an inner and outer ear -- fatal heart defects and mental retardation. The committee obtained internal memos from the CDC and FDA that said risk of birth defects is so dangerous the drug should not be allowed to be sold. A CDC official wrote in a 1998 letter to the FDA that Accutane is just as serious a cause of birth defects as the cancer and leprosy drug thalidomide, and "we simply need to remove the drug from the market."
Another FDA internal memo, written in 1998, said, "Accutane poses a significant public health threat and as such should be withdrawn from the market."
The memos notwithstanding, the FDA has attempted to put provisions in place to inform women of this risk and warn them not to become pregnant while taking the drug. Despite these efforts, and warnings to physicians to prescribe the drug only for the most serious form of acne, the investigation found 90 percent of women who received the drug suffered only mild acne and nearly half of all prescriptions went to teens with mild cases of acne.
Pressed by committee members on this, FDA's Janet Woodcock, director of the agency's Center for Drug Evaluation and Research, said, "A proportion of people treated with this drug in the last decade had mild acne and should've been treated with other drugs."
Roche's Abercrombie disagreed, saying, "we believe the vast majority of use is" appropriate and in people who have severe acne.
The FDA has no control over how a drug is prescribed and physicians are essentially left to their own discretion to decide whether to limit a drug to the use for which it is approved.
Stupak noted although thalidomide is not used by women likely to have children, it is tightly controlled and regulated with a system that requires the physician, the pharmacist and the patient to be registered. "Yet, Accutane is not tightly controlled like thalidomide, and Accutane is marketed to women of child-bearing years despite its horrendous record of causing birth defects," he said.
The FDA estimated about 2,000 pregnancies per year occur in women taking Accutane. Roche disputed that number, saying only about 2,300 pregnancies have occurred, in total, since the drug first became available 20 years ago.
"Roche isn't telling the truth on that," Stupak told United Press Interational. During the hearing, he cited a 1999 report from Roche that mentioned 93 pregnancies affected and 42 abortions in women taking the drug during only one-quarter of that year.
The FDA has worked with Roche to develop a new plan called the System to Manage Accutane Related Teratogenicity, or SMART, that began in April. This requires women to get a pregnancy test each month, receive repeat counseling about birth defects, and agree to use two forms of contraception while on Accutane. This new program will help curtail pregnancies in women on the drug and, therefore, birth defects, Woodcock said.
However, Lynn Martinez of the birth defects program at the Organization of Teratology Information Services, a national group that tracks prenatal exposures, said her organization is still getting calls from women who have become pregnant while taking Accutane even after the SMART program has gone into effect.
Many experts testifying before the subcommittee called for a mandatory registration similar to the thalidomide system. They urged that doctors, pharmacists and individuals taking the drug be required to register. This has been employed in Europe for Accutane and there are nearly no birth defects associated with the drug in that region, Stupak said.
FDA's Woodcock said such requirements would violate patient confidentiality and, by making the drug harder to get, would only create a black market. Pressed on this by the subcommittee, she admitted there was no evidence tighter restrictions would lead to a black market.
The investigation also found Accutane is being purchased in Mexico and brought illegally into the United States, and it is available on approximately 40 Internet Web sites, where individuals can order it without a prescription or being informed of the risks, Stupak said.
Roche could help crack down on these illegally sold products simply by purchasing some of them and using the tracking codes on packaging to determine where they originated, Stupak told UPI. He noted Pfizer did something similar with its drug Viagra to curtail illicit sales.
Roche relies on regulatory and law enforcement agencies to control the illegal sales of Accutane, Abercrombie said. "As soon as we are made aware of illegal distribution, ... we immediately turn that information over to the appropriate authorities," he said.
The committee also faulted Roche for its ads targeting consumers, given the serious consequences that can result from the drug and the assumption by the medical community that patients should be strictly warned of the side effects.
Although the ads do not mention Accutane specifically, the purpose of the ads was to make consumers aware there were treatments for severe acne, Abercrombie said.
"What you just said is not a truthful statement," said Peter Deutsch, D-Fla. He held up a Roche ad depicting a teenage male who did not appear to have acne. "You're beyond the straight-face test, I'm sorry," he added.
If FDA fails to regulate Accutane adequately, Congress could pass legislation regulating Internet sales of pharmaceuticals, requiring the FDA to more closely monitor people taking this drug and requiring the FDA to do a better job of controlling illegal importation of drugs, Stupak told UPI.
In response to the committee's investigation, the FDA announced this week that it was placing importation restrictions on Accutane and warned consumers not to buy it over the Internet.
To add to the list of problems associated with Accutane, the FDA recently made the decision to include the risk of violent and aggressive behavior on the list of warnings on labeling.
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