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F.D.A. Weighs Training to Dispense Narcotics

From The New York Times:

Should doctors be required to undergo special education in order to prescribe powerful narcotics? The Food and Drug Administration may soon recommend that they do so, though such a move would most likely prove controversial.

“I think it is a good idea, and it is something we are considering,” said Dr. Bob Rappaport, the director of the division of Anesthesia, Analgesia and Rheumatology Products at the F.D.A. But the agency itself does not have the authority to take such a step, Dr. Rappaport said.

Typically, state medical boards, rather than the federal government, impose licensing requirements on doctors, including the type of continuing education they must receive. A few states, including California, now provide doctors with education about the treatment of pain patients. But nationally, state medical boards have shown little interest in mandating added training in the use of potent pain medications or in screening patients for those prone to drug abuse.

Pain experts say they support increased education for doctors, but some fear that mandatory training may harm pain patients by limiting the number of doctors prescribing such drugs.

Under current federal law, doctors need only show they are licensed to practice medicine in order to register with the Drug Enforcement Administration, which will permit them to prescribe narcotics.

An exception is if a doctor wants to prescribe the drug buprenorphine as in-office treatment for narcotics addiction; federal rules require eight hours of specialized training first. Prescribing that same drug for pain treatment, however, does not require such training.

Dr. Rappaport said the F.D.A. was most concerned about potent and longer-acting narcotics like methadone, fentanyl and certain formulations of the drug oxycodone, the active ingredient in OxyContin.

With methadone, fentanyl, which is available in patches, has been associated with patient deaths and injuries resulting from physician misprescribing or inadvertent patient misuse.

In recent years, the F.D.A. has faced pressure to take added steps on such drugs. Dr. Rappaport said recommending additional education was one of the responses the agency might unveil by early next year.

He said the F.D.A. would probably require that makers of such drugs develop programs to monitor how they are prescribed.

In the last two years, the agency has sent out alerts to doctors about both methadone and fentanyl, but officials acknowledged that preventable patient deaths were continuing.

“We are putting out communications,” said Dr. Gerald Dal Pan, who directs the F.D.A.’s office of surveillance and epidemiology. “We don’t know why they are failing.”

Posted: 8/19/2008 9:10:00 AM

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Parkinson's case offers glimmer of hope for future research

From The Dallas Morning News:

Matthew Greenstein is living a story about illness, failure and a chance at redemption. He’s also an example of how, in an era when medical research is mostly about crowds of scientists and millions of dollars, a little luck might still make a difference.

Some of the details of his life are like an anti-lottery ticket: Matt has Parkinson’s disease at an age — 32 —when almost nobody has it. He has psychological issues that require medication — but most of the medicines are either bad for people with Parkinson’s or not strong enough to treat Matt’s problem.

But here’s the kicker: A couple of months ago, right after his Dallas psychiatrist prescribed his one remaining choice of medication, Matt’s Parkinson’s got a lot better.

And while nobody knows if one is related to the other, a top Parkinson’s researcher is interested and wants to find out if there’s a connection.

Parkinson’s is a degenerative disease that seems to be related to the unexplained death of brain cells and the loss of an important chemical called dopamine. Doctors don’t know the cause, but genetics, prior infections and other environmental factors may all play some role.

And while there are medications that help relieve symptoms in many people, there is no cure.

Matt had been hitting the New Jersey casinos since he was 21. What had been a gambler’s itch became a serious psychological addiction — and a way to escape his PD.

It was also a side of his life that he kept hidden. These days, Matt uses words like “betrayal” to describe how he treated his friends and family.

Last year, Rachel found out about the gambling and Matt stopped for a while. Nine months later, he fell off the wagon and had what he calls “a 10-day manic episode.” His family convinced him to see a Dallas psychiatrist, Dr. Robert Schwartz.

Dr. Schwartz quickly diagnosed him with moderate to severe manic symptoms, which seemed at the time like another piece of particularly bad luck:  Some newer medications used to treat manic symptoms can make PD symptoms worse, others aren’t strong enough to help Matt. That left one older drug, lithium, that also has some potentially severe side effects — including Parkinson’s-like symptoms in some people who don’t have PD.

Psychological relief from the drug started after a day or two. But the medical mystery began after a week: Matt’s PD symptoms suddenly got better.

“I got out of bed in the morning and started to walk, normally, to the bathroom,” Matt said.

Mornings, before his PD pills kicked in, had been very bad. And yet, that morning, he was more fluid, more normal. Ditto for that night, long after the day’s PD pills should have worn off. And so on. For the past two months.

Someone who meets Matt in the morning these days sees a soft-spoken man who walks with only the slightest hint of a limp and who lifts his daughter over his head with only a slight tremor.

Could it have been the standard cocktail of medications suddenly working better? Could it have been a spontaneous remission – doctorspeak for “We don’t know why you got better”? Or maybe, just maybe, the lithium had something to do with it?

“It isn’t crazy,” Dr. Bressman said. “We don’t know everything about Parkinson’s disease, and we don’t know everything about how lithium works.”

And Matt’s particular run of medical bad luck — PD plus severe manic symptoms requiring lithium — is very unusual, she said. Unusual enough that a beneficial effect on Parkinson’s from lithium may have been missed until now.

But there may not be anything useful to others in Matt’s case, she warned.

There are at least two tantalizing hints about lithium and PD in the medical literature:   Dr. De-Maw Chuang is a researcher with the National Institutes of Health who has published reports that lithium protects and even contributes to regeneration of mouse brain cells afflicted with conditions that look something like Parkinson’s.

And earlier this year, Italian researchers reported remarkable results in a small study of lithium of patients with ALS, better known as Lou Gehrig’s disease. The researchers said they’d like to try the drug on PD, if they could get the money.

Dr. Bressman is in the middle of a research study about PD and mood disorders – such as Matt’s manic symptoms. His case is prompting her to go back into the data looking for any cases similar to Matt’s. And to informally ask her colleagues if they’ve heard of similar cases. But whether Matt’s case turns out to be a trigger for productive treatment or just another blind alley will take years to answer.

Posted: 8/19/2008 9:00:00 AM

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