Ct. Attorney General Files Petition with FDA Seeking Warning on Drug – NYT

Sat, 7 May 2005

Connecticut’s Attorney General, Richard Blumenthal, is to be commended for filing a citizen’s petition that essentially asks the FDA to do its job of protecting the public by issuing warnings about the potentially lethal hazards of drugs the agency approves for marketing.

The drug, In this case, is an anticancer drug, Thalomid–it causes blood clots, but that risk is not adequately disclosed to physicians and patients.

Blumenthal said he took the unusual action because “it’s vitally important in light of F.D.A.’s ignoring a critical responsibility to mandate adequate warnings and labeling.”

Blumenthal’s petition says that there should be explicit warnings about blood clots “and that physicians should consider giving patients other drugs to guard against the problem.”

Blumenthal’s petition notes that “failure to require a similar warning here “has not worked well for patients, leaving them unnecessarily vulnerable to potentially fatal and possibly preventable side effects.”

The Hebrew sages of old encouraged taking responsibility: In circumstances where there is no leader at the helm–you, be that leader. Richard Blumenthal filled the vacum.

Contact: Vera Hassner Sharav
212-595-8974

http://www.nytimes.com/2005/05/04/health/04drug.html?

THE NEW YORK TIMES
May 4, 2005
Petition Seeks Warning on Anticancer Medication
By GARDINER HARRIS

WASHINGTON, May 3 – Drug regulators have failed to warn patients that a popular anticancer drug, Thalomid, can cause fatal blood clots, according to a petition filed on Tuesday by the attorney general of Connecticut, Richard Blumenthal.

In the petition, Mr. Blumenthal also said Celgene, the maker of Thalomid, had increased its price so many times that patients had to find supplies overseas, where prices are lower. The increases are undermining a safety program mandated by the Food and Drug Administration, Mr. Blumenthal said, and the F.D.A. should prevent Celgene from further increases.

“At least one Connecticut patient almost died as a result of a blood clot while taking Thalomid,” Mr. Blumenthal said.

A spokeswoman for Celgene would not comment.

A spokeswoman for the drug agency said it would examine the petition.

Mr. Blumenthal said he believed that he was the first state attorney general to file a citizen petition, a method by which anyone can request a specific action by the drug agency.

Although the New York State attorney general, Eliot Spitzer, has helped expand the job description of attorneys general beyond arrests in criminal cases and consumer protection actions, he has not delved into drug labeling.

Suggesting that the drug agency should regulate drug prices is perhaps even more unusual.

“Yes, it’s a new arena,” Mr. Blumenthal said, “but one that’s vitally important in light of F.D.A.’s ignoring a critical responsibility to mandate adequate warnings and labeling.”

The chairman of the International Myeloma Foundation, Dr. Brian G. M. Durie, said he thought that most physicians were well aware of the clotting risks. Dr. Durie said that he had not heard of any patients going abroad to buy Thalomid.

Thalomid is an unusual medicine. Known generically as thalidomide, it became infamous in the 1950’s and 60’s for causing thousands of horrific birth defects in babies in Europe, where the drug was approved for use as a sedative. Most of the affected fetuses died, but some children were born with arms and legs that resembled flippers.

The drug was not approved in the United States, so American women were spared its effects.

Celgene, based in Summit, N.J., initially sought approval for thalidomide in the 90’s to help treat the wasting disease associated with AIDS. The drug caused an unusual complication in AIDS patients, and the company was eventually able to have the drug approved to treat just leprosy, an extremely rare condition. As a result, its sales potential was limited.

After Thalomid was on the market, Celgene found that it was effective in treating multiple myeloma, a cancer of the plasma cells in bone marrow that affects 50,000 patients a year in the United States. Sales soared.

More than 90 percent of its sales are to cancer patients, a use for which the Food and Drug Administration has never granted formal approval. Still, such “off label” uses of drugs are common.

As Thalomid became an accepted cancer treatment, Celgene increased the price roughly fivefold in six years. The company sells a 100-milligram capsule for $70.47 in the United States, according to Mr. Blumenthal’s petition.

A recent article in The Wall Street Journal found that a laboratory in Brazil sold 100-milligram capsules of thalidomide to the Brazilian government for 7 cents, or one-thousandth of the American price.

To gain approval here, the drug agency required Celgene to create an elaborate distribution system that involved physician training and patient education.

Patients have to comply with mandatory contraceptive measures.

The price increases undermine those controls, Mr. Blumenthal said. As a result, the F.D.A. should prohibit Celgene from raising the price of the medicine further, he added.

“Excessive prices cause people to go to illicit means of obtaining the drug, and that thereby undermines the safety programs that are so powerful,” Mr. Blumenthal said.

The drug label says patients “may have an increased incidence” of serious clots.

Mr. Blumenthal’s petition says the risk of such clots is well characterized. It says that there should be explicit warnings and that physicians should consider giving patients other drugs to guard against the problem.

The petition says the Australian label has a far stronger warning about clots.

The failure to require a similar warning here “has not worked well for patients,” the petition says, “leaving them unnecessarily vulnerable to potentially fatal and possibly preventable side effects.”

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