[Congressional Record (Bound Edition), Volume 150 (2004), Part 18]
[House]
[Pages 24064-24066]
[From the U.S. Government Publishing Office, www.gpo.gov]




                          PUTTING PEOPLE FIRST

  The SPEAKER pro tempore. Under a previous order of the House, the 
gentleman from Michigan (Mr. Stupak) is recognized for 5 minutes.
  Mr. STUPAK. Mr. Speaker, it was an honor and a privilege to join with 
over 100 of my colleagues, Democrats and Republicans, and four U.S. 
presidents to dedicate the William J. Clinton Library in Little Rock, 
Arkansas. All of the four presidents spoke eloquently. I was especially 
moved by the words of former President George W. Bush when he said it 
not a Democrat or Republican day, but it was a great day for all 
Americans.

[[Page 24065]]

  I joined President Clinton in the 1992 election here in Washington to 
represent northern Michigan to do, as President Clinton challenged us 
then, to put people first. I have learned and tried to do that each day 
as a Congressman. I learned this not just from President Clinton but 
from my own father who was a local elected official in Delta County, 
Michigan.
  I come tonight to put people first, to put our children first as I 
continue to speak out against the acne drug Accutane. As a legislator, 
I have called for more restrictions on the distribution and use of this 
drug, which is known to cause severe birth defects and a form of 
impulsive behavior and depression in young people taking this drug.
  This drug has devastated my family with the loss of our son BJ and 
more than 250 other families who have lost their young son or daughter 
across this Nation who have lost them while they were taking Accutane.
  As we were flying back from Little Rock, Arkansas, CBS news ran a 
story tonight, and I quote an FDA safety reviewer, Dr. David Graham, 
when he spoke to the Senate Finance Committee. Dr. Graham said, ``I 
would argue that the FDA as currently configured is incapable of 
protecting America against another Vioxx.'' He told the Senate Finance 
Committee that ``there are at least five other drugs on the market 
today that should be looked at seriously to see whether they should 
remain on the market.'' He cited the acne drug Accutane.
  Why Accutane? Because of the horrendous birth defects, but also 
because of a recent study by Dr. J. Douglas Bremner. He has 
demonstrated how Accutane mediates depression, causes impulsive 
behavior due to changes in the orbito frontal cortex in the front part 
of the brain. That mediates depression. Depression is found in this 
part of the brain.
  Over the course of our investigation of the Committee on Energy and 
Commerce research, it has indicated that the current formula of 
Accutane may be about 240 times greater than what is necessary to be 
effective. Too much Accutane, a synthetic vitamin A, causes cerebri 
tumor or a pseudo tumor in some patients. This pseudo tumor is a 
warning that is found on the packaging, but what does it really mean? 
It means severe headaches. And while it acts like a tumor in the brain, 
it cannot be discovered. CAT scans will not show it. There is no 
evidence of a tumor. So what happens?
  As Dr. Bremner showed us here in a study of the orbito frontal 
cortex, there is a decrease in the metabolism of the brain. This is the 
baseline of a person before they started Accutane. This is post 
Accutane, or 4 months on Accutane. Notice the red brain activity in the 
front part of the brain. Notice very little red after 4 months on 
Accutane. It neutralizes or decreases the metabolism in this part of 
the brain.
  In this one slide that Dr. Bremner has shared with us, there is a 21 
percent decrease in brain metabolism with this patient. This only 
occurred in Accutane patients. Dr. Bremner did the same thing with 
other patients on oral antibiotics. And it was not all Accutane 
patients, just those who complained of severe headaches. Is this 
excessive dosage found in the current formula of Accutane that is being 
given to patients, is this the cause in the change that we see?
  The medical evidence is clear that Accutane causes changes in the 
brain, which leads some young people to take their own life through 
impulsive behavior.
  Putting people first. Let us put children first. Let us join with the 
FDA drug safety reviewer and pull this drug from the market or, at a 
minimum, severely restrict the use and distribution of Accutane until 
we have all the answers about this powerful, dangerous drug.
  Is a decreased metabolism that we see here, is this reversible? Will 
the brain repair itself? How much Accutane is safe? What should the 
real dose be so we do not hurt the developing young brains of our 
children? Has the FDA done enough to protect our children? Has the FDA 
seriously looked at this study and similar studies in animal testing, 
which also demonstrate Accutane harms the brain?
  It is time to put our children first. It is time to pull this drug 
off the market until all of our questions are seriously answered. Put 
our children first.
  Mr. Speaker, I will submit for the Record the CBS news report and 
also a photocopy of the CAT scan from Dr. Bremner.

                   Insider: FDA Can't Protect Public

       The American public is ``virtually defenseless'' if another 
     medication such as Vioxx proves to be unsafe after it is 
     approved for sale, a government drug safety reviewer told a 
     congressional committee Thursday.
       ``I would argue that the FDA as currently configured is 
     incapable of protecting America against another Vioxx,'' said 
     David Graham, who warned that the arthritis drug had been 
     linked to an increased risk of heart attack and stroke.
       He told the Senate Finance Committee that there were at 
     least five other drugs on the market today that should be 
     looked at seriously to see whether they should remain there. 
     He cited the acne drug Accutane, the weight loss drug 
     Meridia, the anti-cholesterol drug Crestor, the pain reliever 
     Bextra, and the asthma drug Serevent.
       Vioxx's maker, Merck & Co. pulled the drug from the market 
     on Sept. 30 after a study indicated the popular painkiller 
     doubled the risk of heart attacks and stroke when taken for 
     longer than 18 months.
       Raymond V. Gilimartin, the company president, said in 
     prepared testimony that Merck acted within four days of 
     learning about the risk.
       ``Given the availability of alternative therapies and the 
     questions raised by the data withdrawing Vioxx was consistent 
     with an ethic that has driven Merck actions and decisions for 
     more than 100 years,'' he said.
       Gilimartin also said the company was surprised by the 
     cardiovascular risk because it differed from past clinical 
     trials. ``My wife was a user of Vioxx until the day we 
     withdrew it from the marketplace,'' he said.
       The Food and Drug Administration has defended its actions 
     regarding Vioxx. In a statement issued late Wednesday, the 
     agency cited its ``well-documented and long-standing 
     commitment to openness and transparency in its review of 
     marketed drugs.''
       ``What's come to light about Vioxx since Sept. 30 makes 
     people wonder if the FDA has lost its way when it comes to 
     making sure that drugs are safe,'' said Senate Finance 
     Committee Chairman Charles Grassley, R-Iowa, as the hearing 
     opened.
       Grassley suggested that an independent board of drug safety 
     might be needed to ensure the safety of medications after 
     they're approved for the market.
       ``Consumers should not have to second-guess the safety of 
     what's in their medicine cabinet,'' he said.
       Graham told the committee that research indicated that 
     Vioxx caused up to 160,000 heart attacks and strokes.
       ``If we were talking about Florida or Pennsylvania, 1 
     percent of the entire state population would have been 
     affected,'' he said. ``I'm sorry to say Sen. Grassley, but 67 
     percent of the citizens of Des Moines would be affected and, 
     what's worse--the entire population of every other city in 
     the state of Iowa.''
       Graham said his research helped to coax the FDA to withdraw 
     a number of drugs including Fen-phen, a weight loss drug, 
     Lotronex, Baycol and Rezulin. ``During my career I have 
     recommended the market withdrawal of 12 drugs,'' he said. 
     ``Only two of these remain on the market today.''
       At the same time, though, he questioned the agency's 
     commitment to removing unsafe drugs from the market, since it 
     would call into question their earlier approval.
       Sen. Jeff Bingman, D-New Mexico, said the problem was 
     within the FDA's own culture.
       ``The culture within the FDA, being one where the 
     pharmaceutical industry, which the FDA is supposed to 
     regulate, is seen by the FDA as its client instead,'' he 
     said.
       He called on President Bush to appoint a new head for the 
     agency. Lester Crawford has been acting commissioner of the 
     agency.
       Lester Crawford's statement, sent by e-mail to reporters 
     about 16 hours before the Senate Finance Committee's 
     scheduled hearing on Vioxx, said the FDA initiated and paid 
     for reviews of Vioxx and antidepressants after those drugs 
     had hit the market. ``That is evidence the system is 
     working,'' Crawford said.
       ``It's not working good for them to have a drug to be out 
     on the market this long . . . and never really announcing 
     that it was causing strokes and heart attacks,'' John Byrd of 
     Coats, N.C., told CBS Radio News Thursday morning. He's a 47-
     year-old who had a heart attack last spring and is now suing 
     the maker of Vioxx.
       Critics contend the agency ignored risks in both instances, 
     then intimidated its own reviewers when they pointed to 
     safety concerns.
       In October, the FDA ordered that all antidepressants carry 
     warnings that they ``increase the risk of suicidal thinking 
     and behavior'' in children who take them.

[[Page 24066]]

     Vioxx's maker, Merck & Co. pulled the drug from the market on 
     Sept. 30 after a study indicated the popular painkiller 
     doubled the risk of heart attacks and stroke when taken for 
     longer than 18 months.
       ``I've never had any knowledge that it could cause a heart 
     attack or blood clots or stroke. That's where I find a little 
     shadiness in this recall,'' said Byrd, a Goodyear employee, 
     who added the Vioxx paperwork only warned that it could upset 
     his stomach.
       The FDA's statement disturbed lawyer Andy Birchfield, who 
     is evaluating thousands of potential cases against Merck on 
     behalf of injured patients.
       ``How can they see that type of problem and look back and 
     say `We did everything right'?'' Birchfield said. ``When 
     they're not willing to recognize mistakes, we have no hope 
     for them voluntarily taking measures to correct the 
     situation.''
       Crawford's statement did not mention Graham by name, but 
     suggested that the reviewer was a maverick who did not follow 
     agency protocol.
       Graham was lead author on a research project that studied 
     the records of almost 1.4 million Kaiser Permanente patients, 
     including 40,405 treated with Pfizer's Celebrex and 26,748 
     treated with Vioxx. The study found that high doses of Vioxx 
     tripled risks of heart attacks and sudden cardiac death.
       Vioxx was responsible for an additional 27,785 deaths from 
     heart ailments from 1999 to 2003, Graham concluded.
       He has told congressional investigators that, superiors 
     pressured him to soften his conclusions.
       Crawford said in his statement that the reviewer 
     voluntarily chose to revise his conclusions, and he did so, 
     in his own words, ``without compromising my deeply held 
     convictions.''

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