Pubdate: Sat, 15 Dec 2012
Source: Wall Street Journal (US)
Copyright: 2012 Dow Jones & Company, Inc.
Contact:  http://www.wsj.com/
Details: http://www.mapinc.org/media/487
Authors: Thomas Catan and Evan Perez
Bookmark: http://www.mapinc.org/oxycontin.htm (Oxycontin/Oxycodone)

A PAIN-DRUG CHAMPION HAS SECOND THOUGHTS

It has been his life's work. Now, Russell Portenoy appears to be 
having second thoughts.

Two decades ago, the prominent New York pain-care specialist drove a 
movement to help people with chronic pain. He campaigned to 
rehabilitate a group of painkillers derived from the opium poppy that 
were long shunned by physicians because of their addictiveness.

Dr. Portenoy's message was wildly successful. Today, drugs containing 
opioids like Vicodin, OxyContin and Percocet are among the most 
widely prescribed pharmaceuticals in America.

Opioids are also behind the country's deadliest drug epidemic. More 
than 16,500 people die of overdoses annually, more than all illegal 
drugs combined.

Now, Dr. Portenoy and other pain doctors who promoted the drugs say 
they erred by overstating the drugs' benefits and glossing over 
risks. "Did I teach about pain management, specifically about opioid 
therapy, in a way that reflects misinformation? Well, against the 
standards of 2012, I guess I did," Dr. Portenoy said in an interview 
with The Wall Street Journal. "We didn't know then what we know now."

Recent research suggests a significantly higher risk of addiction 
than previously thought, and questions whether opioids are effective 
against long-term chronic pain.

The change of heart among former champions of opioid use has happened 
quietly, largely beyond the notice of many doctors. New York 
psychiatrist Joseph Carmody said he was "shocked" after attending a 
recent lecture outlining the latest findings on opioid risk.

"It goes in the face of everything you've learned," he said. "You saw 
other doctors come around to it and saying, 'Oh my God, what are we doing?'"

Because doctors feared they were dangerous and addictive, opioids 
were long reserved mainly for cancer patients. But Dr. Portenoy 
argued that they could be also safely be taken for months or years by 
people suffering from chronic pain. Among the assertions he and his 
followers made in the 1990s: Less than 1% of opioid users became 
addicted, the drugs were easy to discontinue and overdoses were 
extremely rare in pain patients.

Many of those experts now say those claims were weren't based on 
sound scientific evidence. "I gave innumerable lectures in the late 
1980s and '90s about addiction that weren't true," Dr. Portenoy said 
in a 2010 videotaped interview with a fellow doctor. The Journal 
reviewed the conversation, much of which is previously unpublished.

In it, Dr. Portenoy said it was "quite scary" to think how the growth 
in opioid prescribing driven by people like him had contributed to 
soaring rates of addiction and overdose deaths. "Clearly, if I had an 
inkling of what I know now then, I wouldn't have spoken in the way 
that I spoke. It was clearly the wrong thing to do," Dr. Portenoy 
said in the recording.

Speaking to the Journal in September, Dr. Portenoy tempered that 
statement with cautions about overturning what he sees as the 
positive change he achieved. He cited his 82-year-old mother, who has 
taken hydrocodone to control arthritis for 15 years. "If you insist 
on regulation, then you're consigning my mother and many millions of 
people like my mother to live in chronic pain," he said.

Virtually no one wants to return to a time when doctors were 
reluctant to use opioids even for cancer patients. All sides also 
agree that there is a group of people who do well on opioids 
long-term, taming their pain while avoiding addiction or excessive 
sedation, although there is no research on how large this group is or 
how to identify them before they begin a treatment. There is also 
widespread agreement that they can be used, with caution, for acute 
pain, such as after an operation.

But some specialists now question whether the drugs should be 
prescribed so freely for months or years to people with chronic pain 
that isn't related to cancer, as Dr. Portenoy proposed 25 years ago. 
"People lost sight of the fact that these are dangerous drugs that 
are highly addictive," said Jane Ballantyne, a pain specialist at the 
University of Washington. She once agreed with Dr. Portenoy and 
proponents of broad opioid use but now believes they need to be used 
more selectively.

Opium-derived painkillers have been around for thousands of years. 
Early in the 20th century, heroin was sold as a cough suppressant. 
Heroin addiction in the U.S. skyrocketed. Congress banned the drug in 
1924 and doctors became deeply wary about using opioids.

Dr. Portenoy set out to change that. As a young doctor at Memorial 
Sloan-Kettering hospital in New York, he noticed that opioids were 
effective in cancer patients with terrible pain.

In 1986, at the age of 31, he co-wrote a seminal paper arguing that 
opioids could also be used in the much larger group of people without 
cancer who suffered chronic pain. The paper was based on just 38 
cases and included several caveats. Nevertheless, it opened the door 
to much broader prescribing of the drugs for more common complaints 
such as nerve or back pain.

Charming and articulate, he became a sought-after public speaker. He 
argued that opioids are a "gift from nature" that were being forsaken 
because of "opiophobia" among doctors. "We had to destigmatize these 
drugs," said Dr. Portenoy.

He rose to chairman of pain medicine and palliative care at Beth 
Israel Medical Center in New York. His small office is studded with 
awards and evidence of his offbeat sense of humor. He prominently 
displays a magazine mock-up that jokingly dubs him "The King of Pain."

At medical conferences, his confident, knowing manner helped smooth 
the way for his message. Before an audience of government regulators, 
he once joked that he might tell a patient at low risk of abuse: 
"Here, [have] six months of drugs. See you later," he said, according 
to a Food and Drug Administration transcript. Amid laughter, he 
added, "It's just hyperbole. I don't actually do that."

Steven Passik, a psychologist who once worked closely with Dr. 
Portenoy and describes him as his mentor, says their message wasn't 
based on scientific evidence so much as a zeal to improve patients' 
lives. "It had all the makings of a religious movement at the time," 
he says. "It had that kind of a spirit to it."

Drug companies took notice. In 1996, Purdue Pharma LP released 
OxyContin, a form of oxycodone in a patented, time-release form, and 
rivals followed suit. Today, sales of opioid painkillers total more 
than $9 billion a year, according to IMS Health, which tracks sales 
for drug companies.

In 2007, Purdue Pharma and three executives pleaded guilty to 
"misbranding" of the drug as less addictive and less subject to abuse 
than other pain medicines and paid $635 million in fines.

Purdue Pharma says it has worked to discourage abuse of its drugs, 
adding that OxyContin is safe and effective when used properly.

In the late 1990s, groups such as the American Pain Foundation, of 
which Dr. Portenoy was a director, urged tackling what they called an 
epidemic of untreated pain. The American Pain Society, of which he 
was president, campaigned to make pain what it called the "fifth 
vital sign" that doctors should monitor, alongside blood pressure, 
temperature, heartbeat and breathing.

Dr. Portenoy helped write a landmark 1996 consensus statement by two 
professional pain societies that said there was little risk of 
addiction or overdose among pain patients. In lectures he cited the 
statistic that less than 1% of opioid users became addicted.

Today, even proponents of opioid use say that figure was wrong. "It's 
obviously crazy to think that only 1% of the population is at risk 
for opioid addiction," said Lynn Webster, president-elect of the 
American Academy of Pain Medicine, one of the publishers of the 1996 
statement. "It's just not true."

The figure came from a single-paragraph report in the New England 
Journal of Medicine in 1980 describing hospitalized patients briefly 
given opioids. Dr. Portenoy now says he shouldn't have used the 
information in lectures because it wasn't relevant for patients with 
chronic noncancer pain.

For such a widely used therapy, there is relatively little scientific 
evidence that opioid drugs are safe and effective for long-term use. 
"Data about the effectiveness of opioids does not exist," Dr. 
Portenoy said in his recent Journal interview. To get a painkiller 
approved, companies must prove that it is better at reducing pain 
than a sugar pill during short trials often lasting less than 12 weeks.

"Do they work for five years, 10 years, 20 years?" Dr. Portenoy said 
in the Journal interview. "We're at the level of anecdote." Even so, 
he says, the drugs can still benefit carefully selected patients.

Dr. Portenoy's ideas about opioids reached into mainstream medicine 
and attracted outspoken advocates. In a 1998 talk in Houston, Alan 
Spanos, a South Carolina pain specialist, said patients with chronic 
noncancer pain could be trusted to decide themselves how many 
painkillers to take without risk of overdose. According to a 
recording, Dr. Spanos said he understood that a patient would simply 
"go to sleep" before stopping breathing. While asleep, he said, the 
patient "can't take a dangerous dose. It sounds scary, but as far as 
I know, nobody anywhere is getting burned by doing it this way."

Dr. Spanos declined to say whether he still agreed with his previous 
statements. He said opioids can be helpful and safe with proper use.

One of Dr. Portenoy's chief complaints was that doctors were 
reluctant to prescribe opioids because they feared scrutiny by 
regulators or law enforcement. In the second half of the 1990s, he 
and his followers campaigned successfully for policies to change that.

In 1998, the Federation of State Medical Boards released a 
recommended policy reassuring doctors that they wouldn't face 
regulatory action for prescribing even large amounts of narcotics, as 
long as it was in the course of medical treatment. In 2004 the group 
called on state medical boards to make undertreatment of pain 
punishable for the first time.

That policy was drawn up with the help of several people with links 
to opioid makers, including David Haddox, a senior Purdue Pharma 
executive then and now. The federation said it received nearly $2 
million from opioid makers since 1997. The federation says it derives 
the majority of its funding from administering medical licensing 
exams, credential verification, and data services.

A federation-published book outlining the opioid policy was funded by 
opioid makers including Purdue Pharma, Endo Health Solutions Inc. and 
others, with proceeds totaling $280,000 going to the federation. Endo 
declined to comment.

Purdue Pharma said, "Dr. Haddox was recruited by the FSMB, so he did 
not have undue or inappropriate influence" on the federation's 
output. Purdue declined to make Dr. Haddox available to comment.

The federation said it didn't believe its model policy contributed to 
increased prescriptions and said drug makers didn't influence its guidelines.

In 2001, the Joint Commission, which accredits U.S. hospitals, issued 
new standards telling hospitals to regularly ask patients about pain 
and to make treating it a priority. The now-familiar pain scale was 
introduced in many hospitals, with patients being asked to rate their 
pain from one to 10 and circle a smiling or frowning face.

The Joint Commission published a guide sponsored by Purdue Pharma. 
"Some clinicians have inaccurate and exaggerated concerns" about 
addiction, tolerance and risk of death, the guide said. "This 
attitude prevails despite the fact there is no evidence that 
addiction is a significant issue when persons are given opioids for 
pain control."

Purdue said the booklet emerged from a process that "represented the 
consensus of a broad range of interested stakeholders." Drug makers 
regularly pay for educational materials for physicians as an element 
of their marketing.

The Joint Commission said its standards didn't encourage physicians 
and hospitals to increase prescriptions. "I think that's a very 
distorted and not helpful explanation of what's going on," said Ana 
McKee, the Joint Commission's chief medical officer.

Over his career, Dr. Portenoy has disclosed relationships with more 
than a dozen companies, most of which produce opioid painkillers. "My 
viewpoint is that I can have those relationships, they would benefit 
my educational mission, they benefit in my research mission, and to 
some extent, they can benefit my own pocketbook, without producing in 
me any tendency to engage in undue influence or misinformation," he said.

Dr. Portenoy and Beth Israel declined to provide details of their 
funding by drug companies. A 2007 fundraising prospectus from Dr. 
Portenoy's program shows that his program received millions of 
dollars over the preceding decade in funding from opioid makers 
including Endo, Abbott Laboratories, Cephalon, Purdue Pharma and 
Johnson & Johnson .

Endo, Abbott, Janssen and Purdue declined to comment. Cephalon's 
current owner, Teva Pharmaceutical Industries Ltd., didn't 
immediately have a comment.

In May of this year, the Senate Finance Committee opened an 
investigation into the financial ties between the pharmaceutical 
makers and the doctors and groups that advocated broader use of 
opioids. It asked opioid makers to disclose how much they had paid 
Dr. Portenoy, his program and several organizations he was involved with.

After spending most of his professional life advocating greater use 
of the drugs, Dr. Portenoy said there is still little research to 
show whether patients who embark on long-term opioid therapy will 
ever be able to stop.

Earlier this year, he said, he asked his mother whether she would 
stop taking her hydrocodone as part of a scientific study. She said no.

"How difficult is it for her to get off these drugs?" Dr. Portenoy 
asked. "You have no idea and neither do I, because no one knows."

""Devlin Barrett contributed to this article.

A version of this article appeared Dec. 15, 2012, on page A1 in some 
U.S. editions of The Wall Street Journal, with the headline: A 
Pain-Drug Champion Has Second Thoughts
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