Floor Statements

Mr. Speaker, this week marks the 2-year anniversary of the strike of the nurses at Northern Michigan Hospital in Petoskey, MI, which began on November 14, 2002. This strike is now the longest nurses' strike in our nation's history.

Sadly, today many of these nurses have to travel to different communities to work. This strike has impacted local health care, and left a community divided. It needs to be resolved soon. This strike is even costing the hospital. NMH had an operating loss of over $11 million dollars, largely because of $14 million spent on replacement nurses.

Over the past 2 years, the hospital administration has shown clearly that its objection to bargaining demands by the striking nurses is not a matter of cost, but of opposition to union representation. The bottom line is these nurses have voted twice for union representation, and they have a legal right to a contract. I will always support the right of employees to organize and to collectively bargain with their employers.

Since the beginning of this strike, I have visited the nurses on the picket lines, met with the hospital administration, and held a town hall meeting in Petoskey.

I have worked well with NMH over my 12 years in office and I have visited their facilities numerous times. It is time to bring back the experienced nurses who provided quality care at NMH for so long, and I urge the NMH administration to join the nurses and agree to binding arbitration or any other independent means so the community can move forward and heal.

Every employee has the right to collectively come together, to unionize if they choose, and to address employment concerns with their employer. When labor disputes polarize the parties and negotiations break down, it is the responsibility of community residents and leaders to let each side know how they feel and to encourage both sides to stay engaged in meaningful discussions to resolve their differences. Any strike, any disruption of employment of any industry, divides and hurts the very fabric that composes any community. The NMH strike has torn at the very heart of the Petoskey area. It is time to end the division and reconcile the community, beginning with NMH.

Mr. Speaker, Dr. Graham, medical review officer of the FDA, told the Senate that there are a number of drugs that should be pulled from the market. One of the drugs that should be pulled from the market is the drug Accutane. This devastating drug has crippled America for some time and its youth. Not only has Dr. Graham called for the pulling of Accutane, but Dr. Huene, one of the first medical review officers to look at Accutane when it first came on the market, found serious problems with Accutane and asked for help and was ignored by the FDA. Dr. O'Connell, who suggested severe restrictions of the use of the drug Accutane, again was ignored by the FDA management. Dr. Graham has now come out against this drug, again being ignored by FDA management.

Not only are these three medical review officers in the FDA calling for severe restrictions or pulling the drug from the market, but also the CDC backed in 1990 because of birth defects said this drug should be pulled from the market. The March of Dimes has said this drug should be severely restricted when used because of birth defects. Two FDA panels have come out and told the FDA, their own advisery panels, to severely restrict the use and distribution of this drug. Again they were ignored.

It is time we pulled this drug Accutane from the market.

Mr. Speaker, I ask unanimous consent to take my special order at this time.

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.

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. 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.''

Mr. Speaker, I rise today to commemorate the 130th anniversary of the creation of life-saving stations on the Great Lakes.

Congressman McCotter and I recently introduced House resolution 750 to recognize the heroes who paved the way in improving modern maritime safety and enabling the Great Lakes shipping industry to take hold and expand in the early part of the 20th century.

Despite facing long hours and low pay, these individuals risked their lives--tackling giant squalls and wrecked vessels to ensure the safety of individuals and property traveling on the Great Lakes. In all, the Great Lakes Life-Saving Service saved over 55,000 people and $110 million in property.

In the late 1870s while Chief of the Revenue Marine Division of the Department of Treasury, Sumner Increase Kimball played a key role in redesigning the network of life-saving stations around the country and championed the idea of establishing stations on the Great Lakes.

These life-saving stations, which became part of the United States Life-Saving Service, combined with the Revenue Cutter Service in 1915 to form the United States Coast Guard.

The organization provided in these units serving the Great Lakes provided a basis for the new United States Coast Guard's search and rescue organization for years to come.

I would like to thank Congressman McCotter for his efforts to acknowledge the heroic performance of the Life-Saving Service on the Great Lakes.

Please join me in recognizing the personnel of the United States Life-Saving Service, especially the 20 brave rescuers who gave their lives in duty during the Services' existence, and Mr. Kimball for his commitment to marine safety on the Great Lakes, by supporting this resolution.

Mr. Speaker, I rise today to recognize that October is National Spina Bifida Awareness Month and to pay tribute to the more than 70,000 Americans--and their family members--who are currently affected by Spina Bifida--the nation's most common, permanently disabling birth defect. The Spina Bifida Association of America (SBAA), an organization that has helped people with Spina Bifida and their families for over 30 years, works every day to prevent and reduce suffering from this devastating birth defect.

The SBAA was founded in 1973 to address the needs of the individuals and families affected by this disease and is currently the only national organization solely dedicated to advocating on behalf of the Spina Bifida community. As part of its service through almost 60 chapters in more than 125 communities across the country, the SBAA puts expecting parents in touch with families who have a child with Spina Bifida. These families answer questions and concerns and help guide expecting parents. The SBAA then works to provide lifelong support and assistance for affected children and their families.

Together the SBAA and the West Michigan Spina Bifida Association, the Spina Bifida Association of Southeastern Michigan, the Spina Bifida Association of Upper Michigan, and the Southwest Michigan Spina Bifida & Hydrocephalus Association work tirelessly to help families meet the challenges and enjoy the rewards of raising their child. I would like to acknowledge and thank SBAA and these local Spina Bifida organizations in Michigan for all that they have done for the families affected by this birth defect, especially those living in my state.

Spina Bifida is a neural tube defect that occurs when the central nervous system does not properly close during the early stages of pregnancy. Over 1,500 babies are born with Spina Bifida each year. There are three different forms of Spina Bifida with the most severe being Myelomeningocele Spina Bifida, which causes nerve damage and severe disabilities. This severe form of Spina Bifida is diagnosed in 96 percent of children born with this condition. Between 70 to 90 percent of the children born with Spina Bifida are at risk of mental retardation when spinal fluid collects around the brain.

The exact cause of Spina Bifida is not known, but researchers have concluded that women of childbearing age who take daily folic acid supplements reduce their chances of having a Spina Bifida pregnancy by up to 75 percent. Progress has been made in educating women on the importance of consuming folic acid supplements and maintaining diets rich in folic acid. Recent data from the Centers for Disease Control shows an increase in consumption of vitamins with folic acid by 8 percent over 2003. Since the Food and Drug Administration decision to fortify enriched grains with folic acid, CDC has documented a 26 percent decline in these birth defects.

Although this is good news, we will still have babies born with Spina Bifida who need intensive care and families that need guidance and support in caring for and raising these children. The result of this neural tube defect is that most babies suffer from a host of physical, psychological, and educational challenges, including paralysis, developmental delay, numerous surgeries, and living with a shunt in their skulls in an attempt to ease their condition. Today, approximately 90 percent of all babies diagnosed with Spina Bifida live into adulthood, approximately 80 percent have normal IQs, and approximately 75 percent participate in sports and other recreational activities. With proper medical care, people who suffer from Spina Bifida can lead full and productive lives. However, they must learn how to move around using braces, crutches or wheelchairs, and how to function independently. They also

must be careful to avoid a host of secondary health problems ranging from depression and learning disabilities to skin problems and latex allergies.

After decades of poor prognosis and short life expectancy, breakthroughs in research combined with improvements in health care and treatment children with Spina Bifida are now living long enough to become adults with this condition. However, with this extended life expectancy people with Spina Bifida now face new challenges in the fields of education, job training, independent living, health care for secondary conditions, aging concerns, and other related issues.

I am proud to cochair the Congressional Spina Bifida Caucus with my colleague Representative Christopher Smith. The Congressional Spina Bifida Caucus brings increased attention to this condition and advances initiatives that will improve the quality of life for those individuals and their families living with Spina Bifida. So far we have 43 members, and I encourage my colleagues to join the Caucus.

I again wish to thank the SBAA and its chapters for all of their hard work to prevent and reduce suffering from this birth defect and for their commitment to improve the lives of those 70,000 individuals living with Spina Bifida throughout our nation. The Spina Bifida community and our nation owe a tremendous debt to the SBAA for its work over the past three decades. Much more work still needs to be done, and I am confident this fine organization and its chapters will lead the effort for decades to come. I wish the Spina Bifida Association of America the best of luck in its endeavors and urge all of my colleagues and all Americans to support its important efforts.

Mr. Speaker, I rise today in recognition of a hospital in my district that has recently passed a remarkable milestone. On October 25, the board of trustees and members of the staff at the West Branch Regional Medical Center, formerly known as the Tolfree Memorial Hospital in West Branch, MI, will celebrate their 75th anniversary. For the past 75 years, the West Branch Regional Medical Center has provided service and care to patients in West Branch area.

The original Tolfree Memorial Hospital was built in West Branch in 1929, through the generosity and vision of local farmer, lumberman and banker John Tolfree. Over the years, as the community grew and the hospital became more regional in scope, several additions were constructed.

In 1991, it was determined by the Tolfree Memorial Hospital's Board of Trustees that the region had outgrown the facility. After careful financial planning which included fundraising, ground was broken for what is now known as the West Branch Regional Medical Center in 1996. The center was dedicated in 1999 and has been successfully serving Ogemaw County and the surrounding counties ever since. Patients no longer have to travel to Saginaw, MI, which is over an hour away.

West Branch Regional Medical Center is the result of many dedicated people who from the beginning had the foresight and the dedication to see this hospital grow with the community and become a regional medical facility.

In the tradition of the past administration, the current board of trustees for the West Branch Regional Medical Center have also recognized they could offer more services to the community. Along with celebrating their 75 years of service, on October 25, the West Branch Regional Medical Center will also unveil its plan for the next 3 to 5 years which includes the construction of an Ambulatory Care Center.

Mr. Speaker, I ask the U.S. House of Representatives to join me in congratulating the West Branch Regional Medical Center and its staff on their first 75 years of service and wishing them well in their next 75 years.

Mr. Speaker, I rise today to honor a community in my district that is celebrating its 100th anniversary as a city. Last weekend, I joined the residents of Standish, Michigan as they marked this great milestone.

The land that is now Standish was originally surveyed and mapped in 1871 by P.M. Angus, who had to travel there on foot since the railroad had not yet been extended to the area. Mr. Angus was hired by John D. Standish, who owned most of the land, and whose saw mill was the first industry in the new settlement. The first official name of the settlement was Granton, but in 1884, the Village of Granton changed its name to the Village of Standish.

The same year that Standish was founded, the community built its first school, and the railroad was eventually extended to the area. The residents of Standish have a strong sense of their history, and the current Standish Elementary School stands at the same location as that original school. Also, the original railroad depot for the town is still in use, thanks to the local fundraising and restoration efforts of the community.

In 1904, Standish was first incorporated as a city. Over the following years and decades, the community grew and marked a series of firsts along with the rest of our nation. By 1938, it had 913 residents, and today its population is 2,091. The first cars came in 1907 with the arrival of a Buick dealership. Next came commercial electricity, speed limits, the first Prohibition arrests, battery operated radios, and city water and trash removal services. The story of growth and development in Standish is the story of small town America.

Mr. Speaker, Standish is a warm, welcoming community, and I can personally attest to that. The city was part of the area added to my district after the 2000 census, and I held a town hall meeting at Standish-Sterling High School in February of 2003 in order to get to know my new constituents. I was impressed by their thoughtful questions and touched by their welcome to me as their new Representative. I was, and continue to be, very proud to represent this fine community in Congress.

Mr. Speaker, I ask the United States House of Representatives to join me in congratulating the City of Standish and its residents on their first 100 years and in wishing them well through the next century.

Mr. Speaker, as an original co-sponsor of the National All Schedules Prescription Electronic Reporting, or NASPER, Act of 2003, I rise today in strong support of its passage. The prescription drug abuse problem in our country has been well documented, and by passing the NASPER Act (H.R. 3015), Congress will take one step towards addressing the problem.

The NASPER Act will help ensure that Schedule II, and III, and IV controlled substances are used and prescribed safely and responsibly. The legislation will help States create electronic monitoring systems that will allow physicians and pharmacists to ensure that their patients are not being over-prescribed these powerful, yet potentially dangerous drugs. The legislation builds upon proven programs already started in 15 States, including Michigan. The Government Accounting Office (GAO) found in 2002 that these State programs are useful tools to help prevent the illegal distribution of these drugs.

However, the GAO also found a loophole that is often exploited. The States with electronic monitoring systems are often undermined by neighbor States who lack monitoring systems. The NASPER Act addresses this problem by allowing States to contact each other so that practitioners in one State can ensure that their patients are not receiving medications in another State.

I am proud to join with Congressmen Pallone, Whitfield, Strickland, and Norwood in providing leadership on this issue. I also applaud the tireless work of the American Society of Interventional Pain Physicians to combat the illegal use and inadvertent over-precribing of controlled substances and promote this legislation.

Mr. Speaker, I rise today to honor a community in my district that is celebrating its 100th anniversary as a city. This weekend, I will join the residents of Standish, Michigan as they mark this great milestone.

The land that is now Standish was originally surveyed and mapped in 1871 by P.M. Angus, who had to travel there on foot since the railroad had not yet been extended to the area. Mr. Angus was hired by John D. Standish, who owned most of the land, and whose saw mill was the first industry in the new settlement. The first official name of the settlement was Granton, but in 1884, the Village of Granton changed its name to the Village of Standish.

The same year that Standish was founded, the community built its first school, and the railroad was eventually extended to the area. The residents of Standish have a strong sense of their history, and the current Standish Elementary School stands at the same location as that original school. Also, the original railroad depot for the town is still in use, thanks to the local fundraising and restoration efforts of the community.

In 1904, Standish was first incorporated as a city. Over the following years and decades, the community grew and marked a series of firsts along with the rest of our nation. By 1938, it had 913 residents, and today its population is 2,091. The first cars came in 1907 with the arrival of a Buick dealership. Next came commercial electricity, speed limits, the first Prohibition arrests, battery operated radios, and city water and trash removal services. The story of growth and development in Standish is the story of small town America.

Mr. Speaker, I said that Standish is a warm community, and I can personally attest to that. The city was part of the area added to my district after the 2000 census, and I held a town hall meeting at Standish-Sterling High School in February of 2003 in order to get to know my new constituents. I was impressed by their thoughtful questions and touched by their welcome to me as their new Representative. I was, and continue to be, very proud to represent this fine community in Congress.

Mr. Speaker, I ask the United States House of Representatives to join me in congratulating the City of Standish and its residents on their first 100 years and in wishing them well through the next century.

Madam Speaker, I ask to proceed out of order and take the time of my Special Order at this time.

Madam Speaker, last night I spoke on the floor about the troubling new information about the effects of Accutane. I will continue to speak out and advise Americans about the dangers of Accutane until the FDA does its job.

Next to me is a PET scan taken from a study completed by Dr. J.D. Bremner from Emory University. It is a brain scan of a patient who took Accutane. The first scan on the far right is the baseline scan before the patient even began Accutane. On my left here is a scan after 4 months of Accutane treatment. Dr. Bremner studied 30 patients, 15 on Accutane and 15 on antibiotics.

His research found that Accutane affects the metabolism of the orbitofrontal cortex, a brain area known to mediate depression in the front part of the brain. Four months after the baseline PET scan was taken, he found that with antibiotics, they had no changes in the brain. Accutane patients, those who complained of headaches, had a change in the front of the brain.

Even an untrained eye can see there is a difference in this PET scan. There is a 21 percent difference in the brain after 4 months of Accutane.

Dr. Bremner will present the findings of his study in November at a neuroscience conference. I will share those complete findings at that time. For now, his abstract is found on the Internet and we can see that Accutane causes changes in brain function.

Why is this important? Here is an e-mail I received from a family in North Carolina. ``On July 12, 2004, our precious 17-year-old son, Nicholas, took his life by a gunshot to his head. He had been taking the drug Accutane. I have read about what happened with your son, and certainly understand what you and your family are feeling. Like your son, Nicholas was a star athlete and honor student. Please send us any information you think would be of help. We are overcome with grief and still have a hard time realizing that he could take himself away from us and his four siblings.''

I receive an e-mail like this on average once a week or so. As of 2004, according to reports received by the FDA, there have been 235 suicides associated with Accutane. The FDA admits they are receiving only 1 of 10 percent of the actual events being reported. If 235 suicides represents 10 percent of the total, that would mean there are actually 2,350 suicides associated with this drug. If 235 suicides have been reported and it represents 1 percent of the total, that would mean there are actually 23,500 suicides associated with this drug.

Still, the drug manufacturer, Hoffmann-LaRoche, Roche Pharmaceuticals, continues to deny that Accutane affects the brain. Just look at this scan. It does. FDA believes there is a link. That is why there is a bold warning on its label, ``Accutane may cause depression, psychosis, and, rarely, suicide ideation, suicide attempts, suicide, and aggressive and/or violent behaviors.''

However, the FDA says they do not know the reason for this link. They need to look at these PET scans. They need to demand research, they need to demand answers. The bottom line, 235 young people have taken their life while on Accutane, including our son, B.J., who died in May of 2000.

Some patients never recover from their adverse effects to the drug. There is damage to the brain. I am constantly receiving e-mails like this one from Michigan. ``Dear Congressman, Just a note to thank you for your ongoing effort to educate the public about the dangers of Accutane. I am a psychiatric social worker in a hospital emergency room, and whenever I meet an adolescent patient who is depressed and taking Accutane, it raises a red flag. I make sure that the other social workers are informed about its link with depression and suicide, as I have a personal connection with it.

``My son Eric was an outgoing, happy kid and a respected leader in his school. He began taking Accutane at age 16 and, a few months later, began having difficulty keeping up in school. He failed to turn in homework and his grades took a nose-dive. To make a long story short, he became deeply depressed and he began talking about ending his life. That is when we knew this was not the run-of-the-mill ups and downs that teenagers sometimes have. We did manage to get help for him, but it was a long journey through a dark tunnel of despair. He is now 23 and still has a bright, articulate mind, but he is forever marked by the depression that stole his joy during adolescence. It is because of his journey that I have added an MSW degree to my high school teaching credentials, so I can be more educated to help young people who are at risk.''

As we can see, there is damage done to the brain. Why the FDA allows Roche to continue to market this drug is beyond me. We should not leave this drug out there until these questions are answered. Questions such as, is this damage to the brain permanent? For more than 20 years, the FDA has done little to address the adverse effects caused by Accutane. We know Accutane affects the brain. It is time for the FDA to pull this drug from the market until all of the questions surrounding Accutane are fully addressed.

Mr. Speaker, I wanted to take a moment to discuss today's floor vote on H.R. 3193, to repeal the DC gun ban. I voted in favor of this bill. However, I am concerned with how this legislation came to the floor--without a hearing and without the opportunity to offer amendments. In addition, I am a strong supporter of local rule and this legislation, although I agree with the principle, blocks the local District of Columbia government from having any authority over the matter. Again, I support the legislation in general, I just don't believe appropriate procedure was followed on such a controversial issue.

Madam Speaker, I ask unanimous consent to proceed out of order and address the House for 5 minutes.

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 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.