Healthy Skepticism Library item: 6464
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Publication type: news
Carreyrou J.
Cephalon Used Improper Tactics To Sell Drug, Probe Finds
Wall St Journal 2006 Nov 21
http://online.wsj.com/article/SB116407880059829145.html
Full text:
http://online.wsj.com/article/SB116407880059829145.html
THE WALL STREET JOURNAL
Cephalon Used Improper Tactics To Sell Drug, Probe Finds
By JOHN CARREYROU
November 21, 2006; Page B1
>From setting unrealistically high sales quotas to pushing larger
prescriptions at higher doses, drug maker Cephalon Inc. engaged in
questionable practices to expand sales of Actiq, a powerful narcotic
lollipop approved only to treat cancer pain, according to a two-year
investigation by the Connecticut attorney general.
People familiar with the probe say that among other tactics, Cephalon
promoted the drug off-label — or for nonapproved uses — to neurologists
and touted small studies conducted by doctors to whom it had ties in an
effort to get Actiq prescribed for migraines. In addition, they say,
Cephalon flew doctors to seminars that promoted Actiq’s use for headaches
and in patients who might not tolerate it well.
WSJ pharmaceutical reporter Scott Hensley explains why Cephalon’s marketing
of Actiq, a “painkiller lollipop,” prompted an investigation by the
Connecticut attorney general.
Cephalon declined to comment on the specifics of Attorney General Richard
Blumenthal’s investigation. Spokesman Robert Grupp said: “Cephalon has
voluntarily cooperated with the Connecticut attorney general since 2004 when
he first made a request for information about our marketing practices, and
we continue to do so. Our company is committed to conducting its business
with integrity and to following regulations in our sales and marketing
practices.”
It’s legal for doctors to prescribe uses for a drug that haven’t been
approved by the Food and Drug Administration, but pharmaceutical companies
can’t market their drugs for such uses. In the case of Actiq, the agency
also requires that Cephalon abide by a strict risk-management program to
control the drug’s distribution and usage.
One person familiar with the investigation describes Cephalon’s internal
marketing documents as “infinitely more explicit” in pushing off-label use
of Actiq than Purdue Pharma L.P. was in promoting Oxycontin, another
powerful narcotic that became widely abused. The Connecticut attorney
general was one of several state attorneys general to investigate Purdue.
Mr. Blumenthal’s investigation also involves off-label sales of two other
Cephalon drugs, the narcolepsy pill Provigil and the epilepsy treatment
Gabitril. Cephalon is also being investigated by the U.S. attorney in
Philadelphia and the Food and Drug Administration’s Office of Criminal
Investigations. Like Mr. Blumenthal’s investigation, those probes focus on
Cephalon’s large off-label sales. The U.S. attorney and the FDA declined to
comment.
Mr. Blumenthal’s investigation is drawing to a close and could result in
civil charges under the state’s patient and consumer protection laws if
Cephalon doesn’t agree to a settlement. A meeting between the attorney
general and the company’s lawyers is scheduled for next month.
If Cephalon opts to settle the case out of court, Mr. Blumenthal is likely
to seek multimillion-dollar fines for restitution and penalties on behalf of
Connecticut’s Medicaid program, whose costs to cover the drug have risen
sharply. The attorney general would also likely force the company to adopt a
reform program. “We want them to change the way they do business,” Mr.
Blumenthal says.
Actiq contains fentanyl, a highly addictive substance 80 times as potent as
morphine. Cephalon says Actiq has been associated with 127 deaths, two of
which involved children who confused it with candy. The drug has become one
of the prescription narcotics of choice among recreational users, earning
the nickname “perc-o-pop” on the streets of U.S. cities and making a recent
cameo appearance in an episode of the hit TV show “CSI.” In the first nine
months of this year, Actiq sales reached $471 million.
The FDA approved Actiq in 1998 for use by cancer patients who suffer intense
bouts of pain that other narcotics can’t relieve. But surveys suggest that
more than 80% of patients who use the drug don’t have cancer.
The trigger for Mr. Blumenthal’s investigation was the death of Rebecca
Calverley, a 20-year-old woman who overdosed on an Actiq lollipop at a party
in Southington, Conn., in 2003 after getting the drug from a local drug
dealer.
Mr. Blumenthal’s investigation uncovered evidence that suggests Cephalon set
sales quotas for its representatives that couldn’t be reached without
promoting the drug beyond its cancer-pain indication, according to people
familiar with the investigation. Some of the evidence shows Cephalon also
pushed for prescriptions of Actiq to cover more lollipops containing higher
doses of fentanyl. Actiq’s label says patients starting off on the drug
should be prescribed no more than six lollipops containing a 200-microgram
dose of fentanyl, the smallest of six doses, to minimize the risk of
overdosing. Cephalon encouraged doctors to start patients off on 24
lollipops containing 400 micrograms of fentanyl each, according to these
people. The higher dose costs more and brings in more revenue.
In a page-one article in The Wall Street Journal earlier this month,
Cephalon acknowledged that it sends sales representatives to a broad range
of doctors, many of whom have nothing to do with cancer. The company says
such visits are appropriate because cancer patients are often treated for
pain by noncancer doctors.
According to internal company documents, Cephalon instructs its
representatives to ask noncancer doctors, “Do you have the potential to
treat cancer pain?” Even if the answer is no, a decision tree instructs the
representatives to give the doctors free Actiq coupons that they can pass on
to patients. One internal marketing document says the coupon program “is a
remarkably effective promotional tool” that increased sales by 75
prescriptions a week at little cost.
Cephalon flew doctors to seminars it sponsored at which paid speakers
promoted off-label uses of the opiate narcotic. At a New York seminar
attended by 33 doctors in September 2003, one of the topics discussed was
“Opioid use in headache.” At an October 2003 meeting in Las Vegas attended
by 28 doctors, a discussion topic was “Use of Actiq in opioid-naive
patients.” Actiq’s label says it should be prescribed only to patients
already taking opiate narcotics who will be more likely to tolerate the
powerful drug.
Mr. Grupp declined to comment on the seminars. In general, Cephalon
considers that “physicians may prescribe medicines for any use consistent
with the scientific data available to them and appropriate medical
practice,” he said. “The decision to prescribe ‘off label’ is theirs and
theirs alone.”
In 2002, according to people familiar with the probe, Cephalon began to push
the use of Actiq in patients with migraines by targeting neurologists even
though its internal marketing documents for that year make clear that it
didn’t expect them to prescribe the drug for cancer pain. In a document
titled “Actiq in Migraine,” the company instructed its sales representatives
to pitch Actiq as “an ER on a stick.”
Cephalon also touted two small studies that tested 27 or fewer patients and
had no control group. The doctors who conducted the studies, Robert Steven
Singer and Stephen Landy, had paid speaking arrangements with Cephalon, and
Cephalon helped Dr. Landy with the study he conducted, according to the
people close to Mr. Blumenthal’s probe.
Dr. Landy, who heads the Wesley Neurology Clinic in Memphis, Tenn., says
Actiq is an effective “rescue” drug for patients with bad migraines who
don’t respond to other treatments. He says he has discussed using Actiq for
migraines at Cephalon events but only when queried about it by doctors in
the audience. Dr. Landy won’t say how much Cephalon paid him for speaking.
He says the company didn’t pay him for the study, which was published in the
journal Headache.
Dr. Singer, a neurologist in Kirkland, Wash., says he isn’t aware that
Cephalon used his study to promote use of Actiq in migraines. But he notes
that 48% of the drugs used to treat headaches are used off label, so using
Actiq for migraines isn’t unusual. He declines to say how much Cephalon paid
him to speak.
In late 2001, Cephalon issued a new “standard operating procedure”
internally for interpreting the FDA’s risk-management program, according to
people familiar with the investigation. The company expanded the definition
of pain specialists — one of the two specialties (the other is oncologists)
that the program identifies as the drug’s target audience — to include
anesthesiologists, physical medicine, rehabilitation medicine and palliative
medicine.
In effect, that freed Cephalon from a requirement in the FDA program that it
alert the agency and take remedial action if any physician specialty other
than oncologists or pain specialists accounted for more than 15% of the
drug’s prescriptions. Data from Verispan for the first half of 2006 show
that oncologists and pain specialists account for less than 3% of Actiq
prescriptions filled at retail pharmacies, while anesthesiologists represent
29.5% of prescriptions.
Write to John Carreyrou at john.carreyrou@wsj.com
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Looking at the numbers, I would say that American consumers are confused
rather than divided.
Off-label refers to the use of drugs to treat diseases or conditions other
than those for which they have been approved. Off-label prescribing is legal
in the U.S. However, there are strict rules governing the marketing of a
drug for treatment of a disease for which it hasn’t been approved and
several pharmaceutical companies have been caught aggressively promoting
off-label use of their products (see, for example, “Why Drug Companies
Promote Off-Label
Some Fun Off-Label Facts
A 1992 American Medical Association study estimated that 40 to 60
percent of prescription drugs were given for unapproved uses.
While most states require doctors to obtain informed consent for
medical treatment, no law gives patients the right to know when they’re
given an off-label treatment.
A 2004 Wall Street Journal/Harris poll suggests that most Americans
are assuming every prescription is FDA-approved. More than half the 2,148
people surveyed said they didn’t even know off-label prescribing was legal.
Another 17 percent weren’t sure.
Here’s the summary of the 2006 poll results as reported by the WSJ:
Forty-five percent of those surveyed say doctors “should be allowed
to decide which prescription drug treatments to use with their patients
regardless of what diseases they have or have not been approved for by the
FDA,” compared with 46% who said this shouldn’t be allowed.
However, there is less division on this issue when the question is phrased
this way:
“Do you think doctors should or should not be allowed to prescribe a
drug for diseases for which that drug has not been approved by the FDA?”
In this case, only 27% answered “Should be allowed” vs. 48% who answered
“Should not be allowed.”
I’m confused. Is it 45% or 27% who agree that off-label prescribing is OK?
Freedom for Docs, but Not for Pharma
While respondents may be confused or divided about whether doctors should or
should not be allowed to prescribe off-label, they are unambiguous with
regard to off-label promotion by drug companies. First amendment or no, they
are agin’ it!
Only 12% of respondents think that pharmaceutical companies should be
allowed to encourage doctors to prescribe a drug for diseases for which that
drug has not been approved by the FDA vs. 69% who say no way!
Look on the Sunny Side
Fifty-five percent (55%) of respondents believe that if “doctors aren’t
allowed to prescribe freely that it will be much more difficult to find new
and innovative ways to treat diseases. Thirty-five percent (35%) disagree.”
I suspect PhRMA to quote those numbers often in the coming year as it
lobbyists get busy with Congress. (I don’t think they’ll talk much about the
12% or 27% numbers, though.)
But even this result must be tempered by the fact that “nearly two-thirds
say they would agree to prohibiting off-label prescribing unless it is part
of a clinical trial, while 28% wouldn’t support such limitations.” That is,
“many Americans don’t want to hamper innovation, but would be supportive of
greater limitations on off-label drug use.”
Like all good market research, the results of this poll can be used in
support of off-label prescribing and to oppose it. Just cherry pick the
results you wish to quote and Bob’s your uncle!
Labels: Drug Safety
Legal/Regulatory
Physician Marketing
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