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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
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
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):
PAIN THERAPEUTICS BETTING ON NEXT-GENERATION PAIN KILLERS
By Steve Johnson
The drug industry has come light-years from the days when pain
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
suffering from one hurt or another have shortcomings
that give companies such as Pain Therapeutics a huge opportunity.
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
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
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,
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
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
They say it stimulates nerve cells in a way that makes them more
to pain, so people need larger amounts of the opioid painkiller to
feel its effect. That triggers withdrawal pains if
they quit the drug.
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
withdrawal symptoms than patients on the same opioid
without naltrexone, Pain Therapeutics reported last year.
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.
said the FDA has agreed to let Pain Therapeutics develop
another test where patients won't risk getting such side effects.
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
to addicts who then alter the pills to get euphoric highs.
One drug that has been especially abused this way is OxyContin,
prescribed opioid for moderate-to-severe pain.
About 4.4 million Americans used narcotic pain relievers
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
numbers of opioid abusers are winding up in emergency rooms.
Drug addicts can easily crush or otherwise break down
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.
is counting on doctors taking their patients off other
painkillers and putting them on Remoxy, if the drug is approved
to lessen the likelihood of opioid abuse.
King Pharmaceuticals of Tennessee is betting that will happen,
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
and 20 percent after that. Barbier hopes to win FDA
approval for Remoxy in 2008.
companies, including Progenics Pharmaceuticals of New York,
are developing opioid painkillers with naltrexone to ease
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
that it's going to be approved.''
That was seconded by Dr. George Fulop, vice president of biotechnology
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
assuming what Oxytrex can do.'' He pegged Oxytrex's likely sales at $150
million to $300 million, well below the
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.
done some good science,'' he said.
That's not to say it hasn't been a struggle for the company.
which lost nearly $31 million last year, hasn't been
profitable since it incorporated in May 1998. The company also had
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
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
say, `Oh, I don't want to take the painkiller, because I
don't want to become an addict?' '' Barbier said. ``We thought
to be a better way.''