Accutane
For Immediate Release
December 19, 2002
Contact: Dave Sauceda (202) 225-4735
E-mail: dave.sauceda@mail.house.gov
HOUSE OVERSIGHT AND INVESTIGATION SUBCOMMITTEE HEARING ON SAFETY ISSUES RELATING TO ACCUTANE TO AIR ON C-SPAN
WASHINGTON DC The U.S. House of Representatives Energy and Commerce Committee Oversight and Investigation Subcommittee's December 11, 2002 hearing on issues relating to the safety of Accutane will air in its entirety over the next few days or weeks, Congressman Bart Stupak, D-Menominee, announced today. Interested viewers should check their local C-Span and C-Span 2 programming for the exact time and date of the broadcast of the Accutane hearing. Persons may also check C-Span program scheduling at http://www.c-span.org/ and click on ATV Schedule."
The entire hearing can also be viewed by connecting to the House Energy and Commerce Committee web-site at http://energycommerce.house.gov/ and click on "Issues Relating to the Safety of Accutane" or by using the C-Span web-site and click on "107th Congress" and then looking under "Recent Programs." A full copy of Stupak's opening statement to the subcommittee is attached.
"Accutane is a dangerous drug that causes birth defects and adverse psychiatric reactions," Stupak said. AThe U.S. Food and Drug Administration (FDA) is unwilling or unable to adequately protect the public from the dangers of Accutane. The hearing established a record that makes a strong argument for an increased FDA role in managing the risks associated with Accutane use, such as profound birth defects and harmful psychiatric reactions."
Accutane, isotretinoin, manufactured by Hoffman-LaRoche (Roche), is a prescription drug used to treat severe acne. Accutane went on the market in 1982 and has been at the center of safety concerns ever since.
By July 1983, Roche reported to the FDA that it had received three reports of birth defects attributed to Accutane use. In 1985, Accutane's package insert for physicians first mentioned receiving reports of depression in patients being treated with Accutane. In 1986, the physicians were again notified that Accutane users who became depressed saw their depression go away when they discontinued their use of Accutane. The depression came back when Accutane users were placed back on the medication. Physicians were also informed that simply removing the patient from Accutane therapy may not be sufficient to treat the depression and that a follow up for their depression may be necessary.
In 1998, the FDA notified doctors that Accutane, "may cause depression, psychosis, and rarely, suicidal ideation, suicide attempts and suicide."
At the December 11th hearing the Oversight and Investigations subcommittee placed documents into the record that indicate that some public health officials have serious concerns about the dangers of Accutane. A 1998 letter to the FDA from a Centers For Disease Control and Prevention official, compares Accutane to the infamous cancer and leprosy drug Thalidomide, a well known cause of birth defects, stating, Awe simply need to remove the drug (Accutane) from the market." Another document, a 1990 internal FDA memo states, "Accutane poses an imminent hazard to public health, and as such should be withdrawn immediately from the market." Despite the urging to remove the drug, Accutane remains on the market.
The December 11th hearing focused on Accutane's link to birth defects, depression and 173 suicides associated with Accutane use. The investigative committee also explored Accutane's Aoff-label" use by health care providers for individuals without severe recalcitrant cystic acne, the illegal importation of Accutane, and the uncontrolled Internet sales of the drug.
Accutane is a teratogen. More simply put, Accutane causes birth defects. The FDA and Roche claimed to have designed a program intended to prevent pregnancies while women use Accutane. The System to Manage Accutane Related Teratogenicity, or SMART program, started in April, requires women to get a pregnancy test each month, receive counseling on birth defects, and agree to use two forms of birth control during their use of Accutane. Dr. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research, testified that the SMART program will help keep women from becoming pregnant during Accutane use, thereby decreasing birth defects.
Roche claims that only 2,300 pregnancies have occurred among Accutane users since its introduction twenty years ago. Stupak refuted such an assertion, citing a 1999 Roche report indicating that in a single three month period that year, 93 unwanted pregnancies were reported and 42 abortions occurred. A 1990 report by the FDA stated that, "the magnitude of fetal injury and death has been great and permanent, with 11,000 to 13,000 Accutane-related abortions and 900 to 1,100 Accutane birth defects." A representative of the Organization of Teratology Information Services, a national group that tracks prenatal birth defects exposures, said her organization is still receiving reports from women who have become pregnant while taking Accutane, despite the SMART program. Congressional members, Stupak, and some experts testifying, called for a mandatory registration and certification of health care providers prescribing Accutane, similar to the system used when a person uses Thalidomide.
Roche denies that there is any scientific proof that Accutane causes depression or suicide. However, a 1997 FDA memo detailing a teleconference call with Roche, indicates that Roche agreed with the FDA that there does appear to be a problem with Accutane and depression and suicide. George B. Abercrombie, Roche North American president and CEO, denied any knowledge of the phone call or the memo.
The FDA has confirmed 173 cases of suicide among persons taking Accutane since its introduction in 1982. Because the suicide figures are based on self reporting, that figure is suspect. According to an FDA official only 1% of the suicide adverse events are reported and that the actual figure could be as high as 20,000. "Given the widespread nature of psychiatric events, including suicide, it is unfortunately not surprising to find deaths by suicide in the Accutane patient population," Abercrombie said in a written statement. Still, a 1998 memo from the FDA's medical officer in charge of Accutane stated, AGiven all the pieces of evidence available, it is difficult to avoid the conclusion that Accutane can adversely affect the adult human brain in clinically significant ways and that Accutane use is associated with severe psychiatric disease in some patients."
Two couples testified that their sons, neither of whom had a history of depression, inexplicably and suddenly committed suicide while taking Accutane. The spontaneity of these suicides was the center of discussion between committee members and witnesses throughout the hearing. AI know of no clinical concept of depression that has an instantaneous onset and what we've heard described are people who are emotionally, psychologically healthy with none of the clinical signs of depression spontaneously doing something to themselves. So I'm wondering if we are dealing here with something other than depression, and that we ought to recognize that. Is it possible that this medication has an effect, an action that results in spontaneous, impulsive, self destructive behavior that is different from that which occurs from a clinical depression?," Congressman Ted Strickland, D-OH, a Ph.D in psychology, asked.
Roche will now include in the Accutane packaging a MedGuide that warns that, "Some patients taking Accutane have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives. And some people have ended their own lives. There were reports that some of these people did not appear depressed. There have been reports of patients on Accutane becoming aggressive or violent." Testimony established that medical care providers hold an important position in appraising Accutane users of the dangers of the drug. However, a mandatory informed consent for all patients has been rejected by the FDA and the manufacturer.
Improper use of Accutane is also a serious concern. AA proportion of people treated with this drug in the last decade had mild acne and should've been treated with other drugs," Woodcock said. So called "off-label" use is prevalent, with some experts putting the improper use of Accutane at almost 90% among women.
Abercrombie denied that Roche markets Accutane to individuals not suffering from severe acne. When shown a number of Roche print advertisements for Accutane that featured teenage models with little or no visible acne, Abercrombie contended that the advertisements do not mention Accutane specifically and are intended to make consumers aware that there were treatments for severe acne. "What you just said is not a truthful statement," Congressman Peter Deutsch, D-FL, said. "You're beyond the straight-face test, I'm sorry."
Other problems with Accutane, illuminated at the December 11th hearing, are the increasing dangers of illegal importation of Accutane and Internet sales of the acne drug. Procuring Accutane, in any way besides through a health care provider, renders the safeguards already in place worthless. Neither psychiatric warnings nor the SMART program are provided to Accutane users who get their pills through illegal importation or via the Internet.
"If the FDA cannot or will not regulate Accutane then it is imperative for the U.S. Congress to act to protect the American people," Stupak said. "If the FDA does not act appropriately, Congress could pass legislation prohibiting Internet sales of Accutane, mandating the FDA to require every Accutane user to sign an Informed Consent, and requiring the manufacturer to stop selling Accutane to countries like Mexico which is adjacent to the U.S. border and has no regulatory system for pharmaceutical sales."
