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Pain Doctors Denounce DEA

A leading pain-medication expert says the Drug Enforcement
Administration (DEA) is failing to strike a proper balance between preventing illicit diversion of pain drugs and ensuring that patients get the medicine they need, Medical News Today reported March 21.
"It is now apparent to me that the spirit of cooperation that existed
between the DEA and the pain community to achieve the goal of balance has broken down," said Howard A. Heit, M.D., a pain doctor who previously had collaborated with the agency in an aborted effort to provide guidance to physicians on prescribing pain medication. "The DEA seems to have ignored the input and needs of the healthcare professionals and pain patients who actually prescribe, dispense and use controlled substances."
Heit wrote one of seven commentaries on the subject in the February
2006 issue of the journal Pain Medicine, published by the American Academy of Pain Medicine (AAPM). Doctors charge that the DEA has used the courts to bypass state medical boards and go after doctors who prescribe pain medications. AAPM President Scott M. Fishman, M.D. worries that a recently passed law requiring states to track prescriptions of controlled substances "may be intended less as a clinical tool than as a physician mouse trap." "Healthcare decisions, including those involving legitimate use of analgesics, must remain in the hands of healthcare professionals," wrote Fishman. The DEA should be required to work with health agencies and healthcare professionals in finding common ground and reaching the rational position of balance that is in the public's best interest, Healthcare oversight must remain within agencies whose primary responsibility is
to improve public health. Contrary to recent events in Washington, we must continue to insist that drug abuse can be curbed without
undermining patients in pain and striving for such policies is in the best interest of society. The least we can do is to make sure that the casualties of the war on drugs are not suffering patients who legitimately deserve relief."

Medicaid/Medicare Exceptions for RSD
Background:   Section 4541 of the Balanced Budget Act of 1997 (BBA) required the Centers for Medicare & Medicaid Services (CMS) to impose financial limitations or caps on outpatient physical, speech-language and occupational therapy services by all providers, other than hospital outpatient departments. The law required a combined cap for physical therapy and speech-language pathology, and a separate cap for occupational
therapy. Due to a series of moratoria enacted subsequently to the BBA, the caps were only in effect in 1999 and for a few months in 2003. 
With the expiration of the most recent moratorium, the caps were reinstated on January 1, 2006 at $1,740 for each cap.

RSD has been granted an automatic exception to the above limitation.

Go to this URL for more information (cut & paste in your browser):

By Steve Johnson
Mercury News
March 2006 

The drug industry has come light-years from the days when pain was
regarded as something to be grimly endured, rather than overcome.

Treating everything from headaches to the agony of cancer has become a
multibillion-dollar business. Yet many medicines sold to help the 50
million Americans suffering from one hurt or another have shortcomings
that give companies such as Pain Therapeutics a huge opportunity.

The South San Francisco company has two pain drugs in late-stage tests
that could prove highly profitable if they get approval from the U.S.
Food and Drug Administration. And they could give people relief from
pain without having to worry about becoming addicted.

Although some analysts are skeptical about one of the drugs, Oxytrex,
Pain Therapeutic's founder and chief executive, Remi Barbier, is
undeterred. He believes annual sales of the drug, which is formulated to
eliminate the addictive qualities and withdrawal effects of opiate
painkillers, could hit $1.5 billion.

``What Vioxx and Celebrex did for mild painkillers, that's exactly what
we think Oxytrex can do for severe pain,'' Barbier said. He added, ``Of
course, we're going to do it right, without all the mistakes of Vioxx
and Celebrex,'' which have triggered hundreds of lawsuits over their
alleged side effects.

Opioids, such as morphine, long have been known to block the
transmission of pain signals by nerve cells so the brain, in effect, doesn't
sense pain. But scientists say repeated opioid use also can have a
contradictory effect.

They say it stimulates nerve cells in a way that makes them more
sensitive to pain, so people need larger amounts of the opioid painkiller to
feel its effect. That triggers withdrawal pains if they quit the drug.

Boosting potency

Based on work by researchers at Albert Einstein College of Medicine in
New York, Pain Therapeutics claims adding a second ingredient, a
so-called antagonist named naltrexone, avoids stimulating these nerve cells.
This boosts the painkiller's potency, while lessening the patient's
drug tolerance and withdrawal symptoms, the company says.

When 719 patients with severe back pain took Oxytrex, half had less
dependence and withdrawal symptoms than patients on the same opioid
without naltrexone, Pain Therapeutics reported last year.

But a second test of Oxytrex had to be suspended, the company said in
November. In that test, Barbier said the FDA required patients be given
a large dose of Oxytrex, without letting them gradually become
accustomed to the drug. Consequently, many of the patients developed nausea or
other unpleasant side effects that prompted them to quit the study.

Barbier said the FDA has agreed to let Pain Therapeutics develop
another test where patients won't risk getting such side effects.

The company's other drug, Remoxy, has won enthusiastic reviews from
some analysts and the company estimates its potential annual sales at $1

It is designed to combat the growing problem of prescription drugs
being diverted to addicts who then alter the pills to get euphoric highs.
One drug that has been especially abused this way is OxyContin, a widely
prescribed opioid for moderate-to-severe pain.

About 4.4 million Americans used narcotic pain relievers for
non-medical uses in 2004, the most recent data available, according to Leah
Young, spokeswoman for the federal Substance Abuse and Mental Health
Services Administration. Of those, 325,000 used OxyContin, she said, and
growing numbers of opioid abusers are winding up in emergency rooms.

Drug addicts can easily crush or otherwise break down time-release
tablets of OxyContin into a form that can be snorted or injected for an
intense high. But Remoxy, which contains the same opioid as OxyContin, has
a sticky composition that resists injecting or snorting.

The company is counting on doctors taking their patients off other
painkillers and putting them on Remoxy, if the drug is approved for sale,
to lessen the likelihood of opioid abuse.

King Pharmaceuticals of Tennessee is betting that will happen, too. It
announced in November that it will kick in $400 million to help Pain
Therapeutics develop Remoxy and other abuse-resistant painkillers. Under
the deal, Pain Therapeutics gets 15 percent of the first $1 billion in
Remoxy sales and 20 percent after that. Barbier hopes to win FDA
approval for Remoxy in 2008.

Few competitors

Some other companies, including Progenics Pharmaceuticals of New York,
are developing opioid painkillers with naltrexone to ease constipation,
another common side effect. But Pain Therapeutics seems to have few
direct competitors, which is a plus with some analysts, though they tend
to be more excited about Remoxy than Oxytrex.

``I'm less confident about Oxytrex,'' said Kate Winkler, of Global
Crown Capital, who said she owns no Pain Therapeutics stock. ``I'm not
altogether optimistic that it's going to be approved.''

That was seconded by Dr. George Fulop, vice president of biotechnology
and life sciences equity research for Needham & Company, who also owns
no Pain Therapeutics stock.

While agreeing with Pain Therapeutics that Remoxy ``is a billion-dollar
potential drug,'' Fulop added, ``I'm more conservative with regard to
assuming what Oxytrex can do.'' He pegged Oxytrex's likely sales at $150
million to $300 million, well below the company's estimate.

However, Dr. Raymond Gaeta, director of Stanford Medical Center's pain
management unit, sees a big need for Oxytrex and he praised Pain
Therapeutics for the way the company developed it.

``They've really done some good science,'' he said.

That's not to say it hasn't been a struggle for the company.

Pain Therapeutics, which lost nearly $31 million last year, hasn't been
profitable since it incorporated in May 1998. The company also had to
discontinue work in December on another drug it developed for treating
irritable bowel syndrome after the medicine failed to show enough
benefit in a clinical test.

Reason for optimism

But Barbier, who has worked at several other biotech companies,
including Exelixis of South San Francisco, where he was chief operating
officer, doesn't sound concerned.

He said failure is to be expected in drug development, which he likened
to ``looking for oil.'' He's already on the prowl for other products
Pain Therapeutics can develop, including possible cancer treatments, and
plans to add up to 10 people this year, bringing the company's
workforce to about 50.

But pain relief is the company's major focus for now.

``How many times have we heard patients who have a legitimate need for
painkillers say, `Oh, I don't want to take the painkiller, because I
don't want to become an addict?' '' Barbier said. ``We thought there had
to be a better way.''


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Copyright 2006 RSD Angels