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PORTSIDE  December 2011, Week 4

PORTSIDE December 2011, Week 4

Subject:

How We're Fooled into Using More Medicine than We Need

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Sun, 25 Dec 2011 21:46:54 -0500

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(1)  Disease Creep: How We're Fooled into Using More
Medicine than We Need
(2)  The Champion of Painkillers

(1)
Disease Creep: How We're Fooled into Using More 
Medicine than We Need
by Jeanne Lenzer
submitted to Portside by the author
The New Health Dialogue
A Blog from New America's Health Policy Program
December 22, 2011
http://health.newamerica.net/blogposts/2011/disease_creep_how_were_fooled_into_using_more_medicine_than_we_need-61818

[moderator: go to original source to see tables and graphs
that accompany this article.]

When doctors recommend tests, drugs or surgeries to
prevent bad outcomes (think cholesterol-lowering agents
to prevent strokes or cardiac stents to prevent heart
attacks) they tap into our deepest sense of what
constitutes commonsense: An ounce of prevention. Catch
it early. A stitch in time.

It can't be a bad thing to catch problems early, can it?

Unfortunately, one of the toughest things to explain is
why detecting some illnesses at their earliest stages
can cause more harm than good. Take this example: Since
elevated cholesterol is associated with a higher risk of
cardiovascular disease, doctors often prescribe drugs
known as statins to people with elevated cholesterol
levels in the hopes of reducing their risk of a heart
attack or stroke.

Here comes the part that's tough to explain - because it
is so counterintuitive: Statins only help individuals
who already have had a heart attack or stroke (with a
few exceptions, and more on that later).

Of course, this makes no sense to most people. isn't the
whole point of taking cholesterol-lowering agents to
prevent a heart attack? Why should anyone wait until
after a heart attack or stroke to begin taking a drug
designed to prevent a heart attack or stroke?

The answer rests with disease creep and the simple
statistical quirks that come with it. In the past,
doctors treated diseases that caused symptoms. But now
we have tests and imaging machines that can detect risk
factors and illnesses in their earliest stages. Like
cholesterol. Elevated cholesterol is not a disease. It
doesn't cause symptoms. It is a risk factor. People with
high cholesterol levels are somewhat more likely to
develop a heart attack or stroke, but they are at far
less risk than individuals who already have
cardiovascular disease. This is the definition of
disease creep: when pre-conditions or risk factors are
treated as if they are the same as the actual disease
state.

Here's a thought experiment (with purposefully
exaggerated numbers) to help understand this puzzle:
Imagine a group of people who have the rare but awful
Disease A, which is so terrible that all of its victims
will die. Now imagine the discovery of Wonder Drug X,
which cures half of the patients with Disease A.
Unfortunately, Wonder Drug X does have a pretty bad side
effect profile - it's a very powerful drug, after all -
and 10 percent of people who take it will die from liver
failure. Despite this worrisome side effect, Wonder Drug
X is truly an advance for patients with Disease A: For
every 200 patients with the disease who are treated, 100
will now survive and only 10 of the 100 survivors will
die of the drug's side effects. That means 90 more
people out of 200 will survive thanks to Wonder Drug X.

But now imagine a different group of 200 people, who
don't actually have disease A, but instead have a
genetic marker which "is associated with" Disease A. In
this scenario only 1 in a million people in the general
population will get disease A. If you have the genetic
marker, the risk is much higher, such that 2 of these
200 people will develop the disease at some time in the
future. The genetic test gets highly promoted - "find
out your risk early, because we now have a treatment
that works, and the sooner you're treated, the better!"
There is a tiny grain of truth to this - of the 2 people
identified by the genetic test, 1 (50%) will now be
saved by Wonder Drug A.   This might sound just as good
as before; here's a group of people with 10,000 times
(!) the risk of the general population to develop a
uniformly fatal disease. Surely it's worth taking a drug
that can cure that disease in half the cases, isn't it?

But it really isn't the same. Because saving that one
life isn't remotely worth the harm caused by Wonder Drug
X in these 200 people. For while each individual is at a
10,000 fold risk of the disease, only 2 are destined to
die from it. On the other hand, if they take Wonder Drug
X, roughly 20 (10 percent of the 199 survivors) will die
unnecessarily of liver failure.

In the group who already have Disease A, Wonder Drug X
is great, saving 100 lives and killing 10, for a net
benefit of 90 lives saved. But this contrasts with those
who are "caught early" and treated because of a risk
factor (before they actually have the disease); in this
instance, Wonder Drug X is a disaster, saving 1 life and
killing 20, for a net harm of 19 extra deaths.

Most people with high cholesterol are like our fictional
group of people with the genetic marker for Disease A;
they have a risk factor for a disease, but not the
disease itself. Most individuals with high cholesterol
but without known heart disease will not die of an early
heart attack or stroke. As with Disease A and Wonder
Drug X, the ratio of benefit to harm that will result
from treatment, is (ironically) much less favorable in
these people (not yet "patients") who are simply "at
risk of getting the disease" than it is among people who
actually already have it.

The big difference between Wonder Drug X and statins is
that cholesterol-lowering drugs are neither as
beneficial, nor as harmful as Wonder Drug X; for low-
risk individuals, the harms of statins appear simply to
balance their benefits. The primary downside is the
billions of dollars, lost time and inconvenience caused
by the attempt to treat disease before it happens. Of
course there's one other harm: our misdirected
attention. It turns out that compared to taking a
statin, simply eating a Mediterranean-style diet and
exercising at least 3 and preferably 5 times each week
is nearly three times more effective at preventing heart
disease and death in patients who have already had a
heart attack - and it comes without nearly the same
cost, or the same adverse side effects.

In 2003 and 2010 the widely respected and independent
group Therapeutics Initiative, published in-depth
analyses of randomized controlled trials of statins for
low-risk individuals (called primary prevention) and
concluded that for this population, "Statins do not have
a proven net health benefit." Yet despite the lack of
proven benefit, the overwhelming majority (up to three
quarters ) of people taking the drugs are low risk. In
other words, "statins do not have a proven net health
benefit" for most of the people who are taking them.

Using the National Cholesterol Education Project
guidelines, researchers determined that vast numbers of
people on statins are overtreated. (What's really crazy
is that among the far smaller group of high-risk
patients, most were undertreated.) For an incisive
analysis of the studies and how the majority of patients
on statins are overtreated, a review in the Lancet is
illuminating. (Even worse than our overtreatment of
adults with high cholesterol is the new evidence-free
movement to start trying to lower cholesterol levels in
kids. Christie Aschwanden deconstructs that idea and the
conflicts of interest behind it in her recent piece at
Slate.)

Disease creep, or our drive to catch disease early, and
the counterintuitive nature of waiting for symptoms, are
pushing more and more of us onto medicines we may not
need. In addition to "pre-heart disease," which is in
effect what having elevated cholesterol amounts to, we
now have pre-hypertension and pre-diabetes. We catch
cancers too early to know if they are ever going to
cause a problem. And we put a million stents a year in
people's hearts - yet elective stent placement offers no
benefit at all in terms of reduced heart attacks or
deaths. Nearly half the population in the U.S. is taking
at least one prescribed drug, according to the Centers
for Disease Control and Prevention. More than one in ten
is taking five or more medicines. Yet we are sicker and
don't live as long as people in Canada or England - or
35 other nations where they generally take fewer
medicines and undergo fewer tests.

Now that the top-selling drug in the world, Lipitor, is
going off patent after 17 years on the market, its
manufacturer is already poised to keeps its sales high
by promoting its drug directly to you, the consumer.

If you want to know your cardiac risk, go to this
calculator at the National Institutes of Health:
http://hp2010.nhlbihin.net/atpiii/calculator.asp and
then talk to your doctor about whether you meet the
criteria.  But beware of other calculators and newer
criteria that have been altered in ways that inflate the
number of patients who should be on cholesterol-lowering
drugs. And don't be distracted by all the drug ads and
medical news: by far the most effective way to prevent
heart disease (as well as diabetes, stroke,
hypertension, etc.) is to eat a healthy Mediterranean-
style diet, exercise routinely, and don't smoke.  That's
a prescription for health that won't cause fatigue,
nausea or death from liver failure.

[This is a guest post from independent medical
investigative journalist Jeanne Lenzer. She is a former
Knight Science Journalism Fellow and a frequent
contributor to BMJ, and has published works in  The
Atlantic, The New York Times Magazine, Discover, The New
Republic, and other outlets.]

(2)
The Champion of Painkillers
by Charles Ornstein and Tracy Weber
ProPublica
December 23, 2011
http://www.propublica.org/article/the-champion-of-painkillers

A version of this story ran in the Washington Post.

The news about narcotic painkillers is increasingly
dire: Overdoses now kill nearly 15,000 people a year --
more than heroin and cocaine combined. In some states,
the painkiller death toll exceeds that of car crashes.
How Does the Medical Industry Influence Patient Care?

The head of the Centers for Disease Control and
Prevention has declared the overdoses from opioid drugs
like OxyContin an "epidemic." And a growing group of
experts doubts that they work for long-term pain.

But the pills continue to have an influential champion
in the American Pain Foundation, which describes itself
as the nation's largest advocacy group for pain
patients. Its message: The risk of addiction is
overblown, and the drugs are underused.

What the nonprofit doesn't highlight is the money behind
that message.

The foundation collected nearly 90 percent of its $5
million funding last year from the drug and medical-
device industry -- and closely mirrors its positions, an
examination by ProPublica found.

Although the foundation maintains it is sticking up for
the needs of millions of suffering patients, records and
interviews show that it favors those who want to
preserve access to the drugs over those who worry about
their risks.

Some of the foundation's board members have extensive
financial ties to drugmakers, ProPublica found, and the
group has lobbied against federal and state proposals to
limit opioid use. Painkiller sales have increased
fourfold since 1999, but the foundation argues that pain
remains widely undertreated.

The group says industry money has had no effect on its
advocacy.

"I'm convinced with every shred of my body that our
interest is improving the lives of people affected by
pain," said Will Rowe, the foundation's chief executive,
"and we want to do that the best way we can."

The problem isn't opioids, Rowe and other group leaders
say. It's poorly trained doctors who prescribe them too
easily or in excess.

Yet, critics say the Baltimore-based foundation is
making it harder to address a major public-health
problem.

"If you were a drug company, wouldn't it be smart to
make it look like you had a patient-oriented group?"
said Dr. Gary Franklin, a Washington state official who
tussled with the foundation over new restrictions on
high-dose painkillers.

Its funding makes the group "one and the same" with the
pain industry, Franklin said.

In stories this year, ProPublica has detailed the close
entanglements between pharmaceutical companies and
groups representing doctors. Reporting showed that the
positions of societies representing specialty physicians
often reflected the views of their major funders.

The American Pain Foundation falls into a different
category -- health advocacy. It harnesses the power of
patient stories to sway politicians, state medical
boards, judges and government health regulators,
emphasizing that it represents grassroots voices.

ProPublica's review found that the foundation's guides
for patients, journalists and policymakers play down the
risks associated with opioids and exaggerate their
benefits. Some of the foundation's materials on the
drugs include statements that are misleading or based on
scant or disputed research.

The group has intervened in court cases in ways that
appear to counter its stated mission. In one example, it
sided with Purdue Pharma, its longtime funder, to block
a 2001 class-action case filed by Ohio patients who had
become addicted to or dependent on the company's
blockbuster painkiller, OxyContin.

And the foundation mobilizes patients to send "outraged"
email messages to news organizations that run stories it
believes reinforce "stigmas and stereotypes" about the
risks of pain medication.

The group's board includes some patients but also
doctors who are paid to speak and consult for drug
companies, a researcher whose clinic has relied on their
funding for survival and a public-relations executive
whose firm represents them.

Last year, one board member was the lead author of a
study about a Cephalon drug. Cephalon sponsored the
study, and its employees were co-authors. The study
found that the drug, Fentora, was "generally safe and
well-tolerated" in non-cancer patients even though it is
only approved for severe cancer pain.

Dr. Andrew Kolodny, a New York psychiatrist who heads
Physicians for Responsible Opioid Prescribing, said the
foundation has built credibility with politicians and
regulators who may not be aware of the extensive
industry ties.

"I don't think they realize that in many ways the
American Pain Foundation is a front for opioid
manufacturers," Kolodny said.

Rowe, however, said it can be hard for critics to
understand the mindset of patients whose pain is so
severe they are willing to risk serious side effects to
gain relief.

"Policymakers can go to bed at night and say, 'Well, I
protected society,'" by restricting access to a risky
painkiller," he said. "The person with pain or the
person with cancer could say, 'You know, I'm sorry. I'm
living with this, and I want to take this chance.'"

'The System Is Awash in Opioids'

In the late 1980s and early '90s, physicians who cared
for pain patients excitedly embraced opioids as a low-
risk treatment for suffering.

Derived from the opium plant, opioids reduce the
perception of pain by attaching to opioid receptors in
the brain, spinal cord and elsewhere in the body.

"We bought into this idea that opioids would be
effective and that the risk of addiction would be low,"
said Dr. Jane Ballantyne, a longtime pain expert and a
professor at the University of Washington.

But along the way, pain doctors split. Some, like
Ballantyne, began decrying the increasingly widespread
use of opioids and questioned whether the drugs worked.
Others, like the foundation's leaders, said the drugs
were being unfairly maligned, making pain patients feel
like criminals and discouraging doctors from prescribing
them.

Despite the debate, sales of the drugs have skyrocketed.

Last year, $8.5 billion worth of narcotic painkillers
were sold in the United States, according to the
prescription-tracking company IMS Health. Enough of the
drugs were prescribed last year to "medicate every
American adult around the clock for a month," the CDC
said.

"Right now, the system is awash in opioids, dangerous
drugs that got people hooked and keep them hooked," said
CDC Director Thomas Frieden in a recent news briefing.

Some of the pills have become household names: Vicodin,
Percocet, OxyContin. On its own, OxyContin, an extended-
release painkiller, accounted for $3.1 billion in sales
last year, up from $752 million in 2006, according to
IMS Health.

There's little dispute that many people endure chronic
pain. In the past, many doctors, especially those
providing primary care, ignored pain as a condition that
warranted its own treatment.

A report from the prestigious Institute of Medicine last
summer said 116 million American adults suffer from
chronic pain. The report also cited legal and regulatory
barriers to opioids, especially for cancer and end-of-
life pain. The findings are lauded by the foundation as
underscoring the concern about undertreatment.

In an email to ProPublica, however, the report's
chairman said the study panel took a broad look at
chronic pain and didn't examine the use of opioids with
"rigor or detail."

"It does seem like the issue of opioid use is worthy of
a separate study," wrote Dr. Philip A. Pizzo, dean of
Stanford University's medical school.

Guides Offer Reassurance About Pain Drugs

The American Pain Foundation's website offers
publications for patients, policymakers and even
journalists. Each depicts the benefits of opioids, and
each is underwritten by the makers of those drugs.

Its patient guide, paid for by four companies, discusses
several treatments for pain. It says such pain relievers
as aspirin, ibuprofen and naproxen commonly cause
gastrointestinal bleeding or ulcers, delay blood
clotting, decrease kidney function and may increase the
risk of stroke or heart attack. And it warns patients to
use these pain pills at the lowest dose and stop them
unless clearly needed.

The side effects of opioids, on the other hand, are
minor, and most go away "after a few days," the
foundation's guide says. The underuse of opioids, it
says, "has been responsible for much unnecessary
suffering."

Patients, it says, shouldn't worry if they need more of
a drug. They are not developing an addiction.

"Many times when a person needs a larger dose of a
drug," the guide says, "it's because their pain is worse
or the problem causing their pain has changed."

Another guide, written for journalists and supported by
Alpharma Pharmaceuticals, likewise is reassuring. It
notes in at least five places that the risk of opioid
addiction is low, and it references a 1996 article in
Scientific American, saying fewer than 1 percent of
children treated with opioids become addicted.

But the cited article does not include this statistic or
deal with addiction in children.

"I would much prefer that they would put in there
something that could be substantiated by a real
reference," said Dr. Leonard Paulozzi, a CDC medical
epidemiologist specializing in drug overdoses. "That
would present a much less rosy picture of the risk."

A recent report by the National Institute on Drug Abuse
said estimates of addiction among chronic pain patients
using opioids range from 3 percent to as high as 40
percent.

One Foundation-related publication this year provided a
case study of how physicians could convince patients
that the drugs are not addictive.

In an e-newsletter paid for by a drug company, Florida
family physician Louis Kuritzky summed up the advice
he'd give to a patient with knee pain: "We have learned
that when patients have important pain problems like you
do, they can use such medications successfully over the
long term without any major risk of addiction."

This advice is contradicted by a respected medical
review organization that looked at research on the use
of opioids for osteoarthritis of the knee or hip. The
Cochrane Collaboration concluded that "the small to
moderate" benefits of opioids "are outweighed by large
increases in the risk of adverse events" and the drugs
should not be routinely used.

Kuritzky said he had not read the Cochrane review but
believes that the downside of opioids is "very, very
small" based on his experience with his patients.

"There are many issues where you will see wise men and
women differ about the right answer to a difficult and
important question," he said.

Rowe, the foundation's chief executive, acknowledged
that some of its publications need updating. He pointed
to additional materials on the group's new PainSAFE
website, which include a broader description of the
risks. But the foundation continues to post outdated
guides and even refers to them in newer materials.

And while the PainSAFE site discusses the risks more
completely, it is based on the assumption that the drugs
have proven to work well for chronic pain sufferers. The
site says studies have shown opioids improve daily
function and quality of life for such patients. In
contrast, a new guide by New York City's Department of
Health and Mental Hygiene says there is "insufficient
evidence" that "pain relief is sustained or function
improves."

Dr. Lewis Nelson, chairman of the federal Food and Drug
Administration's Drug Safety and Risk Management
Advisory Committee, said he believes the foundation's
guides can't help but be biased.

"If you're taking drug-company money and you're working
as an advocacy group for patients, I think by definition
you're biased," said Nelson, an emergency room physician
in New York. "I take everything they say with a grain of
salt."

Fighting in Court for Painkiller Access

The foundation doesn't just offer advice about opioids;
it takes its arguments into court.

In 2005, it filed a friend-of-the-court brief in the
U.S. Fourth Circuit Court of Appeals in support of Dr.
William Hurwitz, a pain doctor in Virginia who had been
convicted on 50 counts of drug trafficking.

The doctor had been accused of prescribing a single
patient as many as 1,600 Roxicodone pain pills in one
day. Hurwitz allegedly had prescribed that patient alone
more than 500,000 pills between July 1999 and October
2002.

The pain foundation and its allies argued that the jury
instructions in the case didn't distinguish between
criminal behavior and mistakes by a well-intentioned
physician. "It is not drug dealing to prescribe opioids
to patients that might be 'suspected' addicts or
substance abusers," the foundation and two other groups
wrote in a brief.

Rowe said the foundation intervened in the case on
principle, fearing the drugs would be "demonized." The
appeals court threw out the conviction, but Hurwitz was
retried and convicted on 16 counts of trafficking.

Years earlier, the foundation opposed several pain
patients who had sued Purdue Pharma in an Ohio county
court for allegedly obscuring the risks of OxyContin.

The foundation filed a friend-of-the-court brief backing
Purdue, arguing that the health of all pain patients
would be harmed if the class-action lawsuit went forward
because doctors would become fearful of prescribing
opioids.

Ohio was plagued by "opiophobia" according to a brief
co-authored by the foundation and two smaller pain
nonprofits. "Consequently many, if not most, of the
state's residents had been deprived of adequate pain
care," it said.

The Ohio Supreme Court decided in 2004 not to allow a
class action.

In a separate federal case in 2007, Purdue pleaded
guilty to misbranding OxyContin "in an effort to mislead
and defraud physicians and consumers," according to a
statement from prosecutors. The company agreed to pay
$600 million in penalties. Three top officials also
pleaded guilty to misdemeanors and agreed to pay $34.5
million.

Two months after the conviction, however, then-
foundation chairman Dr. James Campbell praised Purdue in
a statement to a U.S. Senate committee.

"I believe Purdue and its management deserve recognition
for their contribution to the welfare of these many
patients," Campbell wrote. Prosecuting the executives,
he wrote, sent a "chilling message to those who dare to
develop high-risk drugs for important diseases."

Campbell mentioned his foundation role in his remarks.
Rowe said the former board chairman was not speaking for
the group, and stressed that strict rules keep funders
from influencing its work. The foundation is working to
diversify its support, Rowe and others said.

Nevertheless, the group often finds itself on the same
side as drugmakers in state and federal debates over how
to regulate painkillers.

In 2009, the FDA suggested changes to address concerns
about the risks of long-acting opioids, recommending
that physicians and pharmacists be certified to ensure
they had been educated about those risks.

Although foundation officials blame poorly educated
physicians for the growing problems with opioids, the
officials joined with other pain groups and drugmakers
to assail the plan.

The FDA backed off key elements of its proposal last
year and said doctors could voluntarily attend courses
about the risks.

That move was criticized by an FDA advisory committee,
which voted overwhelmingly that it wasn't enough to stem
the tide of overdose deaths.

"When you look at 14,000 people dying on an annual
basis, that's more than we've lost in Iraq and
Afghanistan since 2001 in active duty," Dr. Mori Krantz,
an advisory panel member and director of the prevention
center at the University of Colorado in Denver, said
during the meeting.

Little Evidence That Narcotics Work for Chronic Pain

Missing from the American Pain Foundation literature is
any suggestion that the drugs don't work for many
chronic pain sufferers.

Recent editorials in medical journals and scientific
reviews cite little evidence of long-term benefit.

Most of the clinical trials for opioids to treat chronic
pain "were small, lasted less than 16 weeks and excluded
patients with a history of substance abuse, psychiatric
illness and depression, who are at increased risk for
opioid misuse and abuse," three physicians wrote in an
editorial this year in the Archives of Internal
Medicine.

"How can a therapy be considered if there's no evidence
that it works and there's evidence of lots of side
effects?" Dr. Mitchell Katz, one of the authors and
director of the Los Angeles County Department of Health
Services, said in an interview.

Rowe said he knows plenty of patients for whom the drugs
work, "and their lives are together because they use
them."

The foundation board's chairman and president, Dr. Scott
Fishman, is stepping down at the end of the month. In a
statement to ProPublica, he said his views have evolved
and that he now believes opioids are both overused and
addictive. But he defended the group.

"I have not always agreed with APF positions and have
had disagreements with some APF leaders and patient
advocates about many issues in pain management,
including the appropriate place of chronic opioid
therapy," wrote Fishman, chief of pain medicine at
University of California, Davis.

"Nonetheless, I have always believed that patients in
pain in the United States need strong patient advocacy,
which APF has offered."

___________________________________________

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