U.S. Drug Safety Laws Must Be Tougher, Families Say

U.S. Drug Safety Laws Must Be Tougher, Families Say

(March 8, 2007) -- Cathy Harter will tell lawmakers how her 19-year-old son committed suicide after taking an antidepressant. Francine Esposito, who took a painkiller, will describe her congestive heart failure. And Kristine McCown will say she had three strokes while using the same pain medication.

The three are among more than a dozen families who have come to Washington to lobby Congress today and tomorrow for tougher U.S. drug safety laws.

The families, organized by the advocacy group Consumers Union, are using their experiences to make the case for measures now being considered in Congress, such as mandating disclosure of clinical trial results, requiring studies after medications are sold and imposing limits on consumer drug advertising.

``Our son's death was unnecessary and preventable and nobody that has ever experienced the death of a child could even imagine what you go through,'' said Harter, 45, of Troy, Ohio, in an interview. ``How long is Congress going to wait around to do something?''

The Food and Drug Administration's oversight of drug safety has come under scrutiny in the last three years after studies linked antidepressants to suicide risk for children and Merck & Co.'s Vioxx painkiller to elevated chances of heart attack and stroke.

Family members are visiting the offices of Senate and House members who represent their states and home towns, along with those sponsoring legislation on drug safety. Lawmakers have said they may consider the safety measures in coming months as part of legislation that would increase fees drugmakers pay to speed the FDA's approval process.

Sponsors in Congress

Congress is considering competing versions of drug safety legislation, which include many of the provisions being sought by the families. One measure was proposed by Senator Charles Grassley, a Republican from Iowa, and Senator Christopher Dodd, a Democrat from Connecticut. Another is sponsored by Senator Edward Kennedy, a Massachusetts Democrat, and Senator Michael Enzi, a Republican from Wyoming.

Most medications are safe, and drugmakers and regulators do a good job at providing information to the public to evaluate risks and benefits, said Alan Goldhammer, deputy vice president for regulatory affairs of the Pharmaceutical Research and Manufacturers of America, the industry's trade group in Washington.

``The vast majority of people get positive therapeutic results from the medicines that the pharmaceutical industry produces,'' Goldhammer said in an interview. ``When we're confronted with treating serious diseases and medical conditions, there's always going to be a benefit-risk decision.''

A Distraught Son

Harter and her husband, Daniel, want lawmakers to know about their son, Stephen. In 2004, his family physician prescribed the drug Paxil CR, made by GlaxoSmithKline Plc, to treat mild anxiety and depression.

One day, about two weeks after starting the medication, Stephen became distraught, cried and couldn't sit still. Later that day, Daniel Harter discovered that Stephen hanged himself in the garage.

Harter said she learned only after her son's death that the drug had been linked to a risk of suicide. Stephen hadn't previously been suicidal, and the family attributed the death to the drug.

Boldfaced Warnings

Glaxo and other makers of antidepressants later added boldfaced warnings to their labels describing suicide risks in children and adolescents.

The Harters, who filed a lawsuit against Glaxo, have set up meetings with five lawmakers or their staff members to outline safety measures that they say are needed, including public disclosure of studies about risks. They also plan to speak at a news conference organized by Consumers Union, the nonprofit organization that publishes Consumer Reports magazine and is based in Yonkers, New York.

``My husband and I wanted to do everything we could to prevent this from happening to someone else,'' Harter said.

Glaxo, based in London, had provided information to the public at the time of Stephen's death about suicide risks and had posted data from clinical trials on its Web site, said company spokeswoman Mary Anne Rhyne, in an interview. She declined to comment on the family's lobbying effort.

A Volleyball Injury

McCown, 32, said that in 2002, she suffered a shoulder injury playing volleyball.

Her doctor prescribed Vioxx, she said in an interview. Within several months, she woke up unable to walk or speak properly. Her doctor later told her she had three strokes, the result of Vioxx, she said.

McCown, of Fairbury, Nebraska, still has trouble with her short-term memory and keeping her balance. Once a social worker, she is on disability and said she has a permanent migraine headache.

``I want them to make tougher laws against these drug companies,'' she said. ``We want them to do more research after the drug is out on the market.''

Francine Esposito, 55, of Ashtabula, Ohio, said in an interview that she suffered a different problem after taking Vioxx. Her doctor gave her the drug in 1999 to treat Bartter Syndrome, a rare group of conditions affecting the kidneys.

Heart Failure

In 2004, Esposito went into congestive heart failure, she said.

``I hope that in the future when the FDA approves a drug that everything is told -- the good and the bad,'' she said.

Merck, based in Whitehouse Station, New Jersey, pulled Vioxx from the market in 2004 after a company study showed increased heart risks.

Merck is ``committed to patient safety,'' said Casey Stavropoulos, a company spokeswoman, in an e-mail statement. ``We support the indispensable role of the FDA in evaluating the risks and benefits of medicine -- not only before FDA approves a new medicine -- but throughout the time the medicines are available to patients.''

More than 27,000 lawsuits have been filed against Merck regarding Vioxx. Of cases that have gone to trial, the company has won eight and lost four.

To contact the reporter on this story: Justin Blum in Washington at jblum4@bloomberg.net .

By: Justin Blum
Source: Bloomberg

Last updated: 03/07

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U.S. Drug Safety Laws Must Be Tougher, Families Say