Living With Endometriosis

ATTENTION! Please sign the petition to stop the FDA from further restrictions on pain medication.

Thank you.

F.D.A. to Place New Limits on Prescriptions of Narcotics
By GARDINER HARRIS
Published: February 9, 2009

WASHINGTON — Many doctors may lose their ability to prescribe 24 popular narcotics as part of a new effort to reduce the deaths and injuries that result from these medicines’ inappropriate use, federal drug officials announced Monday.

A new control program will result in further restrictions on the prescribing, dispensing and distribution of extended-release opioids like OxyContin, fentanyl patches, methadone tablets and some morphine tablets.

These products are classified as Schedule II narcotics and already are restricted according to rules jointly administered by the Food and Drug Administration and the Drug Enforcement Agency. But the current restrictions have failed to “fully meet the goals we want to achieve,” said Dr. John K. Jenkins, director of the F.D.A.’s new drug center.

“What we’re talking about is putting in place a program to try to ensure that physicians prescribing these products are properly trained in their safe use, and that only those physicians are prescribing those products,” Dr. Jenkins said in a news conference on Monday. “This is going to be a massive program.”

Hundreds of patients die and thousands are injured every year in the United States because they were inappropriately prescribed drugs like OxyContin or Duragesic or they took the medicines when they should not have or in ways that made the drugs dangerous. The agency has issued increasingly urgent warnings about the risks, but the toll has only worsened in recent years.

The blame for this is shared among doctors who prescribe poorly, patients who pay little attention to instructions or get access to the medicines inappropriately, and companies that have marketed their products illegally.

The F.D.A. this year will hold meetings with manufacturers, patient and consumer advocates, and the public to ask for advice on how to carry out the new control program, officials announced. The first meeting will be on March 3, and no immediate changes in access to the drugs is planned.
(A complete list of the drugs is at www.fda.gov/cder.)

But many doctors prescribe the drugs far too cavalierly, Dr. Jenkins said. The F.D.A. has received reports of patients’ being prescribed such medicines to treat something as simple as a sprained ankle, he said. In such patients, the medicines can be dangerous.

Part of the problem is marketing. Several reports, for instance, have suggested that Purdue Pharma, the maker of OxyContin, helped fuel widespread abuse of the drug by aggressively promoting it to general practitioners not skilled in either pain treatment or in recognizing drug abuse.

The company has denied such a connection, but a holding company connected with Purdue and three top Purdue executives pleaded guilty last year to criminal charges that the company had misled doctors and patients by claiming for five years that OxyContin was less prone to abuse because it was a long-acting narcotic.

Doctors are also to blame. A common reason for disciplinary actions at state medical boards is the use of narcotics in patients who show clear signs of addiction or for whom the drugs are obviously inappropriate.

The F.D.A. generally avoids interfering with the practice of medicine because doctor behavior is governed by state medical boards. Instead, the agency usually tries to provide doctors with the best and most current information, and then allows them to decide how to use it.

Most of the drugs withdrawn over the last 20 years, however, were taken off the market because doctors continued to use the medicines in ways that the F.D.A. warned against.

For decades, the agency’s armory in these battles held only a popgun and a cannon — the popgun being the issuance of widely ignored warnings; the cannon being its ability to force a medicine’s withdrawal. But a law passed in 2007 gave the agency a new, intermediate weapon — Risk Evaluation and Mitigation Strategies. Known as REMS, these programs allow the agency to place strong restrictions on the distribution of certain drugs.

Judge asked to lower award
Government questioning future costs
Saturday, Dec. 13, 2008
BY JIM SUHR - Associated Press

EAST ST. LOUIS — The U.S. government is asking a federal judge to trim an $8.6 million judgment over an Air Force base doctor’s mistreatment of a case of flesh-eating bacteria that cost a woman use of an arm.

Federal prosecutors this week asked federal Magistrate Judge Philip Frazier to reconsider his ruling favoring Jean Phillips, an Air Force captain’s former wife, who the judge concluded was left with a right arm that’s been “withered, lifeless and useless” since 2002.

Frazier, after an August bench trial, found that Dr. Dan MacAlpine was stationed at Scott Air Force Base just east of St. Louis when he failed to notice or heed Phillips’ rash on her right arm in 2002, assuming she was an addict looking for prescription drugs. MacAlpine told her to go home and take Motrin, a popular over-the-counter pain medication.

But the rash turned out to be necrotizing fasciitis, commonly known as flesh-eating bacteria, that Frazier says eventually cost Phillips use of her right arm.

“This is a sad story,” Frazier wrote in his 13-page ruling Nov. 25. With a useless arm that causes her continuous, extreme pain and likely hooked on prescription drugs, the judge added, the now-divorced Phillips “faces the future with no reason to be optimistic that things will improve.”

Frazier awarded $2.5 million each for future pain and suffering and for future disability, as well as $1.5 million for past pain and suffering. The judge also said Phillips should get $500,000 apiece for past disability and disfigurement, $495,169 for past and future lost earnings, $421,581 for past medical costs and $215,040 for future ones.

Frazier credited the government for $110,748 in medical services already rendered.

“Granted, there are more dramatic injuries out there involving multiple amputations and the like,” Frazier wrote. “But (Phillips’) situation is about as bad as it gets when one considers the impact on her work and personal life.”

The judge acknowledged Phillips’ life already “was on a downward arc” when she contracted the flesh-eating bacteria, noting she had poor health including issues with abnormal uterine tissue growth called endometriosis, hypothyroidism, insomnia, headaches and anxiety. Frazier said she also had emotional troubles and perhaps drug addiction.

But “she had one other thing that she does not have today. She had a chance,” the judge wrote. “The cruel reality is that her life would probably improve if the arm were taken” — amputated to make way for a prosthetic arm she actually could use.

In its motion Wednesday, the U.S. government, which operates Scott Air Force Base through the Defense Department, asked Frazier to lower the damages he assessed for Phillips’ past and future medical expenses and her lost wages. Those damages total $1,131,790.

According to the government, Phillips’ future medical expenses beyond 10 years from now required speculation, perhaps making her eligible for $48,000 — not $215,040 as Frazier ruled. And “there is simply no evidence in the record that (Phillips) was willing or able to work even prior to her necrotizing fasciitis,” Wednesday’s motion read in questioning the woman’s eligibility for lost earnings.

Phillips’ attorney, Thomas Keefe Jr., was out of the office Friday and unavailable until next week, according to his office, which declined to disclose where Phillips now lives. A published telephone listing could not be found.

MacAlpine now lives in Iowa, where a woman who answered his home telephone Friday said the 39-year-old doctor had no comment. The AP left a message.

Randy Massey, a spokesman for Southern Illinois’ U.S. attorney’s office representing the federal government in the case, declined comment Friday.