[Congressional Record (Bound Edition), Volume 150 (2004), Part 15]
[House]
[Pages 19975-19976]
[From the U.S. Government Publishing Office, www.gpo.gov]




     THE NEED FOR MORE RESEARCH AND MANAGEMENT OF RISK OF ACCUTANE

  The SPEAKER pro tempore. Under a previous order of the House, the 
gentleman from Michigan (Mr. Stupak) is recognized for 5 minutes.
  Mr. STUPAK. Madam Speaker, I rise tonight to inform the American 
public on the safety concerns of Accutane. Accutane is a dangerous, 
powerful prescription drug approved by the Food and Drug Administration 
in 1982 to treat severe, recalcitrant, nodular acne that is 
unresponsive to conventional treatments, including antibiotics. Today, 
approximately 1.5 million prescriptions are written each year to 
hundreds of thousands of young people.
  The horrific birth defects associated with Accutane are well-known 
and understood. The psychiatric effects associated with the drug, 
including depression, suicidal thoughts and behavior, suicide and 
aggression are less known and are denied by its manufacturer, drug 
company giant Hoffman-LaRoche.
  Tonight, I want to share the results of a study that sheds light on 
these psychiatric effects. Dr. J.D. Bremner of Emory University 
recently completed a study which demonstrated that Accutane affects the 
metabolism of the orbitofrontal cortex, a brain area known to mediate 
symptoms of depression. If you look at this chart, Dr. Bremner had two 
PET scans, the baseline PET scan before the patient began Accutane 
therapy and 4 months into the Accutane therapy. Even my inexpert eyes 
can tell the difference, and Dr. Bremner will present his findings in 
November to a convention of psychiatrists studying this issue.
  For every question Dr. Bremner's work may answer, there are other 
questions that need to be answered about the psychiatric effects of 
these drugs. These scans show the promise more research can hold.
  If you take a look at these, you can see there is a 21 percent change 
in the metabolism of the front orbitofrontal cortex. These scans show 
the promise of more research, and Hoffman-LaRoche has always denied 
that Accutane affects the brain. We know this is not true, as the PET 
scans show. This person had a 21 percent change in their orbitofrontal 
cortex of the brain. Is this damage to the brain permanent? Only more 
research will answer this question.
  I do not know why the FDA and Hoffman-LaRoche seem reluctant to look 
for these answers. The FDA has already determined that the link between 
Accutane and psychiatric events is strong enough to require a bold 
warning on the physician label and the packaging label for this drug.
  The FDA should also re-examine previous studies submitted on 
Accutane. A 2001 review of three studies that were not disclosed by the 
drug company found the drug to cause an excessive serotonergic response 
and concludes that it should be noted that increased serotonergic 
function is presumed to be the mechanism of action of a major class of 
antidepressants or SSRIs, or selective serotonin re-uptake inhibitors. 
In other words, Accutane acts like antidepressants in the brain so it 
couldn't possibly cause psychiatric effects.
  We all realize the uproar that has been caused by the FDA when they 
would not allow their own expert to testify that antidepressants used 
in young people were ineffective and increased suicidality. The British 
came to the same conclusion, and they banned the use of antidepressants 
in people under the age of 18.
  Just 2 weeks ago, the FDA finally declared that there is an increased 
risk in suicidality in children who take SSRIs. It has created a 
firestorm of debate about how safe these drugs are and how they affect 
kids.
  Yesterday's Wall Street Journal had a story about the possible 
reasons why there is an increase of suicidality of children who take 
antidepressants. The story says, ``One hypothesis is that, in some 
patients, these drugs have a disinhibiting effect,'' says one Wayne 
Goodman, chairman of the FDA panel that examined the issue in young 
people. ``Children are already a bit disinhibited because their brains 
aren't fully developed.'' Remember, in 2001, Accutane studies that the 
FDA reviewed concluded that Accutane was like the antidepressants with 
its SSRI function.
  The FDA must demand a full accounting of how these drugs, both 
Accutane and antidepressants, affect our children and their developing 
brains.
  There is no excuse for allowing Accutane to be prescribed to hundreds 
of thousands of kids without, at the very least, continuing to demand 
answers as to the effect of this drug on the brain.
  At the very least, FDA can begin to address the ``off label'' use of 
this drug, but yet the FDA estimated in 2002 that 90 percent of the 
prescriptions were written for ``off label,'' meaning they were not 
written to treat severe acne unresponsive to other antibiotics.
  At the very least, FDA can finally approve a mandatory risk 
management plan to track Accutane's side effects and prevent thousands 
of pregnancy exposures, miscarriages and abortions

[[Page 19976]]

each year. FDA advisory committees have called for stricter 
distribution of the drug and a registry of the patients to control the 
use of this drug. They have called for this twice in the last 4 years. 
Unfortunately, the FDA has ignored these recommendations, and the same 
failed policy and system is in place with this drug.
  Last week, I and a few of my colleagues shared our concerns with the 
Secretary of Health and Human Services Tommy Thompson about the lack of 
action on implementing these advisory committee recommendations.
  The birth defects caused by Accutane are similar to those of 
thalidomide. People of my generation and older remember vividly the 
thalidomide babies of the 1960s.
  Over 1.5 million prescriptions for Accutane and its generics were 
written in 2003, and clearly, Accutane has the potential to do greater 
damage, so why do we not have the same controls as we do on 
thalidomide?
  Madam Speaker, my time has expired, and I will insert the rest of my 
remarks at this point in the Record.
  It's no secret that I am no fan of the FDA's handling of Accutane or 
the drug company, HLR's, constant denial that Accutane does not cause 
depression or affect the brain--we know with this PET Scan their 
denials are baseless! However, I am appalled at the FDA's inaction on 
this registry. That's why in June, I joined with colleagues on both 
sides of the aisle and introduced the Accutane Safety and Risk 
Management Act (H.R. 4598). The legislation would create a mandatory 
program to manage the drug, and includes provisions to protect the 
health of patients and their children. To make sure we do not allow our 
children and their developing brains to be destroyed.
  History suggests that unless there is strong leadership from Congress 
on this issue, the Advisory recommendations to the FDA will end up 
collecting dust on a shelf.
  I hope my colleagues on both sides of the aisle will join me in 
cosponsoring this important legislation to send a strong message to the 
FDA and HLR that we will not accept their inaction any longer.

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