Archive for September 26th, 2007

OTC Erectile Drugs Come With Health Risks

Dr. Andrew Kramer recently looked over the medical history of one of
his patients who had been in the emergency department complaining of
chest pains.

Kramer was surprised by what he read: The patient had been taking
three to four dietary supplements for erectile dysfunction — every day.

“I would have never given him Viagra,” said Kramer, a urologist at the
University of Maryland Medical Center. “He was on the cardiac
transplant list.”

Heart patients are potentially at risk for a heart attack and an early
death when they combine erectile dysfunction drugs, such as Viagra,
with heart medications that contain nitrates, like nitroglycerine.

Both drugs lower blood pressure and together can lower it to deadly
levels.

Normally doctors won’t prescribe Viagra or Levitra to these men, but
they can look elsewhere — specifically, the Internet, where herbal
supplements of all sorts are available for sale.

While some of these supplements may contain harmless ingredients, many
are indeed as potent as the real thing.

A recent Food and Drug Administration study showed that some of these
herbal remedies actually contained the active compound in prescription
brands as Viagra, Levitra and Cialis, making them potentially deadly
compounds.

The FDA issued a health advisory last week against these supplements.

“These products are promoted and sold on Web sites as ‘dietary
supplements’ for treating erectile dysfunction and enhancing sexual
performance, but they are in fact illegal drugs that contain
potentially harmful undeclared ingredients.”

“These companies are promoting medications that we would never give to
men with heart disease,” said Dr. Dragan Djordjevic, an internist
specializing in male sexual health at Rush University Medical Center
in Chicago.

The FDA specifically targeted the herbal supplements Zimaxx, Libidus,
Neophase, Nasutra, Vigor -25, Actra-Rx and 4EVERON, all of which do
not list the prescription ingredients on their labels.

For this reason, a patient may not realize the risks.

Erectile Dysfunction Common Among Older Men

“If they are not eligible for one of the classic drugs, they may go to
the supplements, and for this reason, it’s more poignant to let the
patient know that they can be harmful,” said Dr. Yair Lotan, an
assistant professor of urology at the University of Texas Southwestern
Medical Center in Dallas. “They may buy the supplement and not know
they are in danger.”

Doctors can’t estimate how many men have suffered from this drug
interaction because many patients don’t reveal that they are on
supplements.

In many cases, erectile dysfunction and heart disease are linked. Both
are caused by decreased blood flow due to buildup in the arteries.

“A person can come in with severely low blood pressure and die of a
heart attack, and not know they should have reported taking
supplements,” said Dr. Ira Sharlip, a clinical professor of urology at
the University of California at San Francisco and spokesman for the
American Urological Association.

Given that a large majority of Americans have erectile dysfunction,
however, doctors estimate that there are many who have taken or are
using these supplements.

It affects about 30 million U.S. men, including more than half of men
older than 40, according to Dr. Dominic Carbone, assistant professor
of surgery in urology at Wake Forest University Baptist Medical Center
in North Carolina.

May Help Some Men, However

Carbone estimates that he has at least six to 10 patients per month
ask him about supplements for erectile dysfunction.

They wonder whether the supplements are just as good as Viagra, he said.

He also recalls a patient coming in who had erectile dysfunction for
years without treatment and was taking eight to 10 supplements per day.

“The guy buying the supplements in a gas station is probably not
taking the recommended dose,” Carbone said.

Doctors say that some male patients feel forced to turn to the Internet.

Often they are still shy about bringing up the subject with their
doctors and prefer the anonymity of buying online.

Also, at about $10 a pill, Viagra can be too expensive for some men,
whereas supplements can go for a variety of prices, usually for less
than prescription drugs.

That isn’t always a bad thing, one doctor noted.

“The other side of the coin is we have made these drugs unavailable to
the poor. Medicaid does not cover Viagra. If something is off market
and is cheap, it may meet a need,” said Dr. Robert Davis, professor of
urology at the University of Rochester.

Many doctors agree, however, that the advisory is important to public
health.

“Not everyone on nitrates will see the sky fall when they take [these
supplements], but enough will to warrant an advisory,” Davis said.

FDA Warns Consumers about Counterfeit Drugs from Multiple Internet Sellers

The Food and Drug Administration (FDA) is cautioning U.S. consumers
about dangers associated with buying prescription drugs over the
Internet. This alert is being issued based on information the agency
received showing that 24 apparently related Web sites may be involved
in the distribution of counterfeit prescription drugs.

On three occasions during recent months, FDA received information that
counterfeit versions of Xenical 120 mg capsules, a drug manufactured
by Hoffmann-La Roche Inc. (Roche), were obtained by three consumers
from two different Web sites. Xenical is an FDA-approved drug used to
help obese individuals who meet certain weight and height requirements
lose weight and maintain weight loss.

None of the capsules ordered off the Web sites contained orlistat, the
active ingredient in authentic Xenical. In fact, laboratory analysis
conducted by Roche and submitted to the FDA confirmed that one capsule
contained sibutramine, which is the active ingredient in Meridia, an
FDA-approved prescription drug manufactured by Abbott Laboratories.

While this product is also used to help people lose weight and
maintain that loss, it should not be used in certain patient
populations and therefore is not a substitute for other weight loss
products. In addition the drug interactions profile is different
between Xenical and sibutramine, as is the dosing frequency;
sibutramine is administered once daily while Xenical is dosed three
times a day.

Other samples of drug product obtained from two of the Internet orders
were composed of only talc and starch. According to Roche, these two
samples displayed a valid Roche lot number of B2306 and were labeled
with an expiration date of April 2007. The correct expiration date for
this lot number is actually March 2005. Pictures of the counterfeit
Xenical capsules provided by Roche can be viewed at
http://www.fda.gov/bbs/topics/news/photos/xenical.html.

Roche identified the two Web sites involved in this incident as
brandpills.com and pillspharm.com. Further investigation by FDA
disclosed that these Web sites are two of 24 Web sites that appear on
the pharmacycall365.com home page under the “Our Websites” heading.
Four of these Web sites previously have been identified by FDA’s
Office of Criminal Investigations as being associated with the
distribution of counterfeit Tamiflu and counterfeit Cialis.

At this point, it appears that these Web sites are operated from
outside of the United States. Consumers should be wary, if there is no
way to contact the Web site pharmacy by phone, if prices are
dramatically lower than the competition, or if no prescription from
your doctor is required. As a result, FDA strongly cautions consumers
about purchasing drugs from any of these Web sites which may be
involved in the distribution of counterfeit drugs and reiterates
previous public warnings about buying prescription drugs online.

The Marketing of Drugs - Part III

WITH vast and profitable markets up for grabs, drug companies are
aggressively reaching beyond doctors and taking their marketing
messages directly to consumers.

Some of their promotional strategies have become hard to miss. Nightly
news broadcasts — a beloved habit for aging Americans — are brought
to you by the makers of prescription medications for high cholesterol,
arthritis, Alzheimer’s disease and erectile dysfunction; an Internet
search for a specific symptom, or a visit to any popular health site,
will bring up sponsored links and blinking ads for at least one
prescription medication used to treat that symptom; fans of NASCAR see
Viagra advertised every time No. 6 Mark Martin’s car rounds the track.
And women paging through a magazine for tips on reducing clutter can
scarcely avoid the faces and personal stories of actresses who are
managing their depression, osteoporosis or hot flashes with a
brand-name pill.

In 1997, the FDA loosened regulations governing the advertisement of
prescription medications directly to consumers. The change set off
explosive growth in marketing aimed at a general audience long on
interest and — compared with physicians — short on professional
skepticism. Today, drug makers spend roughly $5 billion a year to run
advertising campaigns that use many of the same appeals that marketers
use to sell breakfast cereal and toothpaste.

A study published in the Annals of Family Medicine’s January-February
issue analyzed the messages of 38 advertisements then running during
prime-time TV and found that 95% used emotional appeals to sell the
medication, often framing prescription-drug use as a means to regain
lost control over some aspect of life. None mentioned lifestyle change
as an alternative to product use, although roughly 1 in 5
advertisements suggested it might be a useful complement to the drug.
One in 4 described the causes of the disease the advertised drug
treats, who is at risk for it or how frequently the condition occurs
in the population. The study’s authors, led by UCLA researcher
Dominick L. Frosh, suggested that without such information, consumers
would have little reason to see prescription medication as a solution
that involves risks as well as possible benefits.

In all, 58% portrayed the advertised drug as a medical breakthrough –
a pharmaceutical twist on Madison Avenue’s “new and improved” message.

“It is time to ban direct-to-consumer advertising of prescription
drugs,” wrote Dr. Kurt Stange, editor of the Annals, in an
accompanying editorial. The advertisements consumers see “distort the
relationship between patients and clinicians. [They] manipulate a
patient’s agenda and steal precious time away from an evidence-based
primary care clinician agenda that is attempting to promote healthy
behavior, screen for early-stage treatable disease and address mental
health.”

Even after 23 major pharmaceutical companies agreed to a new slate of
voluntary guidelines limiting their advertising, Stange wasn’t buying
it. Self-monitoring, he wrote, “is not working . . . and cannot
realistically be expected to work.”

PhRMA, the drug manufacturers’ industry group, says direct-to-consumer
advertising empowers patients to take an active role in their
healthcare and spurs them to discuss symptoms, diseases and treatment
options with their doctors that might otherwise go unraised. The
industry group frequently cites a 2002 survey of consumers that found
that 43% were spurred by a prescription-drug ad to look for more
information about the drug or their health.

Although direct-to-consumer advertising has spurred the most political
and professional debate, it is only the most visible means of
prescription-drug marketing aimed at the consumer. To build markets
and encourage consumer loyalty to their products, drug makers have
invested heavily in a tactic known to public relations professionals
as “third-party marketing.” Through voices, groups and activities that
seem independent of them — but frequently are not — drug companies
have found another way to get their messages to consumers.

‘Third-party’ approach
ACCORDING to an article published in the British Medical Journal in
2003, the top five public relations firms specializing in healthcare
earned $300 million in 2002. These firms “are expert at ‘third-party
technique’ — helping the drug industry separate the message from what
could be seen as a self-interested messenger,” wrote authors Bob
Burton and Andy Rowell.

Last October, a commentary in the New England Journal of Medicine
detailed one little-noticed third-party marketing venture.
Underwritten by Eli Lilly, the campaign was designed to increase the
use in hospitals of a drug commercially known as Xigris, for the
treatment of sepsis, or blood poisoning. A preliminary study had
suggested some safety concerns with Xigris, and an FDA advisory panel
had urged more thorough study of the drug before its approval. But in
2001, the FDA approved its entry into the market. The controversy
appeared to sap first-year sales of Xigris, which fell short of
Lilly’s expectations.

Lilly’s response was to secure the services of a small public
relations firm, New York-based Belsito and Co. Belsito would begin
spreading the word to physicians and media outlets specializing in
medical news that Xigris was being rationed and that physicians were
being “systematically forced,” because of the drug’s high cost, to
decide which patients would live and which would die. A $1.8-million
educational grant from Lilly would fund the creation of a group of
physicians and bioethicists — named the “Values, Ethics and Rationing
of Care Task Force” — to study this rationing and its ethical
implications. And a Surviving Sepsis campaign was launched “in theory
to raise awareness of severe sepsis and generate momentum toward the
development of treatment guidelines,” wrote Dr. Peter Q. Eichacker and
two fellow investigators based at the National Institutes of Health,
in the NEJM.

Lilly’s financial inspiration of the campaign aimed at physicians,
patients groups and the media was not apparent to many of the
audiences reached. But its effect was quite clear, concluded a case
study of the campaign done by the Council of Public Relations Firms:
Sales of Xigris “have begun to trend upwards. Through the first
quarter of 2004, Xigris sales were up 36%.”

In such campaigns, public relations companies operate as off-site
extensions of a drug company’s marketing department. But sometimes,
the relationship of a drug company and a third-party voice is more
complex. The tie between patient-advocacy groups and drug companies is
a good example.

Drug makers richly support the nation’s proliferating patient-advocacy
groups, and only a handful of the charitable organizations refuse the
sponsorship of pharmaceutical firms, says Georgetown University’s Dr.
Adriane Fugh-Berman, who has studied these ties. That link presents
rich marketing opportunities for corporate sponsors with an interest
in reaching the patients the organizations advise and represent,
Fugh-Berman says. But it also raises real questions about the
independence of patients groups, she adds.

In marketing trade publications, the value of patients’ groups is
widely touted. As friends and allies to potential customers, groups
dedicated to patients who suffer from a specific condition can be
powerful marketing tools. Patients seek information and emotional
support from these groups, and trust them as an unbiased source of
advice. Groups that empower patients to seek treatment are eager to
foster awareness of their disease and, in the process, expand their
membership. When they are successful, patients groups have a natural
market-building effect.

But drug makers have the deep pockets, and patients groups — until
they’re very large and well-established — are constantly scrambling
for money. As a result, according to those calling for reform, the
relationship is not always an alliance of equals.

“There’s an inherent conflict of interest,” says Merrill Goozner,
editor of Integrity in Science, a publication of the Washington-based
watchdog group the Center for Science in the Public Interest. “The
question becomes, ‘Are you doing the best for the patients you
represent, or are you doing the best for your sponsors?’ ”

Goozner says that patient-advocacy groups are especially vulnerable to
carrying drug companies’ messages, untempered by skepticism, directly
to their members. “They’re desperate” for a cure or treatment, he
says. “And no one likes to be told that this latest breakthrough is
not all it’s been cracked up to be,” especially when it’s being pushed
by a company that’s been generous with funding, he adds.

Last October, the magazine New Scientist published a survey gauging
the dependence of randomly selected U.S. patients’ groups on drug
manufacturers. Combing through the tax returns, annual reports and
voluntary disclosures of 29 nonprofit patient-advocacy groups, the
publication found that most accepted financial backing by companies
developing or producing drugs used to treat patients supported by the
group. In some groups, such as the American Heart Assn., the drug
makers’ financial backing was huge ($23 million in 2005) but
represented a small portion (4%) of revenue. For seven groups,
donations from interested drug companies represented more than
one-fifth of revenue. The Depression and Bipolar Support Alliance said
it received more than half of its 2005 funding from the drug industry,
and the Colorectal Cancer Coalition got 81% of its funding from drug
makers.

New Scientist’s probe found that some donations appeared directly tied
to marketing interests. In 2003 and 2004, when the drug giant Pfizer
was developing a drug to treat restless leg syndrome, it was a major
donor to the Restless Legs Syndrome Foundation. But in 2005, after
Pfizer announced it had abandoned development of the potential drug,
its donations to the patient group dried up.

Many of the best-known groups, including the Alzheimer’s Assn.,
American Cancer Society and American Diabetes Assn., typically have a
board of physicians who vet the scientific accuracy of the information
they provide to patients. And most solicit “unrestricted” grants that
allow them freedom to use the drug makers’ donations as they see fit.

But even large groups often provide a gateway to the products of
corporate sponsors, say those who have surveyed them. Many list
FDA-approved medicines available to treat the disorder that is their
focus and provide Web links that lead patients directly to marketing
sites. And many offer their corporate sponsors access to their
members, a potential gold mine of direct-marketing opportunity.

The corporate-donor pitch posted on the website of the national
infertility patient group, Resolve, is typical of many patient groups.
“Whether you become a site sponsor, a resource partner, or a sponsor
of Resolve’s chats, [the group’s website] is the ideal place for your
company to market its products and services to thousands of men and
women across the country,” the appeal states. Among the benefits the
group lists for becoming a member of the group’s “Corporate Council”
are access to data on utilization of the group’s programs and services
and “the opportunity to establish topics and sponsor special briefings
for patients, the medical community and public policy makers.” Serono
and Organon, both makers of prescription medication used to treat
infertility, are among the group’s corporate sponsors.

Patient groups also mobilize patients — sometimes armies of them –
to push for coverage of prescription drugs by insurance companies and
states’ Medicare and Medicaid agencies. To pharmaceutical companies,
this can make or break the market prospects for a new drug because 80
million Americans — among them, the heaviest prescription-drug users
– receive healthcare coverage through Medicare and Medicaid, and
roughly 155 million have prescription drug coverage through private
insurance companies.

Strength in numbers

WHEN insurers balk at reimbursing patients for new prescription
medications, these groups typically swing into action, rallying
sufferers to appear before public and consumer panels, contact
lawmakers, and provide media outlets a human face to attach to a
cause. Infertility patients mobilized by Resolve, for instance, have
been extremely effective in extending states’ insurance coverage of
infertility treatments. Groups such as the Depression and Bipolar
Support Alliance have fielded experts and patients who have done the
same for psychiatric conditions. And a wide range of patient groups,
most with substantial backing from the makers of erectile dysfunction
drugs, have mounted successful campaigns to get wary insurers to cover
drugs such as Levitra, Viagra and Cialis.

The Marketing of Drugs - Part II

AS guardians of the nation’s prescription pads, doctors are the
gatekeepers that stand between American patients and the
pharmaceutical companies that have drugs to sell them.

Physicians’ choices — whether to medicate, with which medication,
generic vs. brand-name drug, and for how long — profoundly affect
sales of a drug company’s products. So pharmaceutical manufacturers
focus the bulk of their marketing budgets to influence those choices.
The drug companies’ promotional efforts reach into physicians’
offices, pervade their medical specialty organizations and often shape
the messages that doctors receive in educational settings.

“There is a big bucket of money sitting in every office” a drug
representative visits, said an AstraZeneca marketing director in a
widely circulated newsletter interview. “Every time you go in, you
reach your hand in the bucket and grab a handful,” said Mike
Zubillaga, who was fired after his blunt comments made their way onto
the Internet last April.

Each day in the United States, an army of roughly 100,000
pharmaceutical company sales reps storms the waiting rooms and offices
of the nation’s 311,000 office-based physicians. Called “detailers” –
and earning, on average, $81,700 per year — they are the smiling,
well-dressed men and women often seen in a physicians’ waiting room
toting a cavernous briefcase and making small-talk with the
receptionists. Their ranks have more than doubled in the last 10 years.

Sales reps say they want nothing more than to drop off drug samples
that doctors can dispense at no cost to their patients, and to brief
physicians on the FDA-approved benefits and risks of the prescription
drugs their companies make. That’s an accurate job description. But it
doesn’t nearly capture the sophistication of their efforts or the
complex web of relationships that marketing departments cultivate with
physicians. In recent years, drug-company insiders have come forward
to detail the enticements, persuasive techniques and market-tracking
systems that their organizations use to nudge doctors’ prescribing
decisions to boost sales. The picture they provide is of an industry
in hot pursuit of physicians’ hearts and minds.

Relationships with drug reps
THE inducements that doctors accept are more than just pads, pens and
gadgets such as the Viagra calculator that stands up on its base when
the “on” button is pushed. A national survey of doctors published in
the April 2007 New England Journal of Medicine found that 94% of
physicians in the six specialties studied reported some type of
relationship with pharmaceutical companies’ representatives. Most
(83%) received food in their workplace, or accepted drug samples (78%)
proffered by visiting representatives. Thirty-five percent reported
that drug companies had reimbursed them for the cost of attending
professional meetings or company-sponsored sessions that satisfied a
physician’s “continuing medical education” requirement. And 28%
received payments for consulting with a drug company, giving lectures
or enrolling patients in trials.

The American Medical Assn. and the pharmaceutical industry group PhRMA
adopted non-mandatory codes of conduct in 2002 that discourage the
offering or acceptance of items that bring only “personal benefit” to
a physician. Shahram Ahari, a former drug rep with Eli Lilly, says
that in many cases, those guidelines have given the practice of
gift-giving “a nice veneer of respectability.”

But the practice’s impact is often unaltered — and may even be
greater than when drug reps were permitted to offer extravagant gifts
such as theater tickets and golf bags. That is because psychologists
have shown consistently that a small token or gesture of friendship
often inspires a sharper sense of obligation in the recipient than
does a showy gift, for which reciprocation is impossible.

Moreover, Ahari says, “the amount of money invested in gifts hasn’t
changed. In the past, I could spend $100 on a golf club and give it to
you. Now, I can spend $100 on a textbook you need so you can spend
your own $100 on that golf club.”

Sales reps bear many gifts, but none is more important than the
prescription drug samples they bring to doctors. In 2003, the
pharmaceutical industry distributed $16.4 million worth of them to
doctors, according to PhRMA, the industry’s most important trade group.

“For me, that’s access,” Ahari says. “The doctors are first grateful
that you’re giving them samples, because it makes them seem like a
hero to patients . . . and when they feel that sense of gratitude,
they feel obliged to spend some time with the drug rep delivering
them.” But in the end, it is the patient who often will pay more,
because even a short course of sample use builds customer loyalty to a
brand-name drug, even when a generic or a cheaper, older drug might be
just as effective.

Among the not-so-well-kept secrets of the medical world is the
physical attractiveness of the men and women who make up the
pharmaceutical sales-rep force. “It seems pretty cynical,” says UCLA
internist Dr. Martin Shapiro. “I mean, the people that do the
detailing aren’t your average-looking individuals.”

Ahari laughs at the description. Pharmaceuticals’ marketing
departments look to hire “young, attractive people, quite charismatic”
– and scientific training is completely optional, says Ahari, now a
researcher at the UC San Francisco’s School of Pharmacy, who describes
his former profession on a website ( www.Pharmedout.org) devoted to
exposing drug company marketing practices.

“They’re looking for gender icons — cheerleaders and ex-military
types — fun to be with, someone with whom you’d like to have a beer
or watch a game,” Ahari says. To establish friendship and assure
access to a physician, a detailer “will scour a doctor’s office for
objects — a tennis racquet, Russian novels, ’70s rock music,” wrote
Ahari and Adriane Fugh-Berman, a Georgetown University physician, in
an article published by the Public Library of Medicine in April.

Small practices and family physicians are most intensively courted.
And doctors whose prescribing practices are not circumscribed by
healthcare companies or hospital formularies get extra attention as
well. According to the New England Journal of Medicine survey
published last April, family practitioners reported they met with
pharmaceutical-company detailers, on average, 18 times per month, more
than four times the average for all doctors that was reported in a
2000 study. Trailing not far behind them were internists (10 meetings
per month), cardiologists (nine) and pediatricians (eight).

Outside the confines of a doctor’s office, pharmaceutical marketing
efforts become more extravagant.

At physicians’ association meetings and at conferences and seminars
that provide “continuing medical education” for doctors, drug-company
sponsorship is substantial. Both have become important venues for
courting physicians over meals and in appealing venues. Both provide
opportunities for drug companies, indirectly, to pay speaking fees to
favored physicians. And a recent Senate Finance Committee report
concluded that, in spite of efforts to stem the practice, both are
used by pharmaceutical companies to boost physicians’ prescribing of
their products.

Sponsorship of seminars
AT a recent hearing of the Senate Committee on Aging, Dr. Jerome
Kassirer of Tufts University School of Medicine described meetings of
medical societies and associations as “mini-circuses, replete with
enormous glittering displays and hovering attractive personnel.
Although couched as education,” he added, “these marketing efforts are
thinly disguised bribes.”

UCLA internist Shapiro, who as president of the Society for General
Internal Medicine in 2002 sought to limit drug company sponsorship,
calls it “the walk of shame.” At almost every major medical meeting he
attends, he said, “there are these opportunities to get free things
that are questionable — and that clearly are not intended to sharpen
the rational decision-making skills of a physician, but to have an
impact . . . on how they prescribe medications.” It’s not enough, he
added, to close your eyes and walk past them: Pharmaceutical company
money has largely underwritten the programs doctors will attend and
the administration of the professional association that organizes the
event.

Medical societies “have become dependent on the infamous ‘unrestricted
grant’ from numerous pharmaceutical companies,” Dr. J. Gregory
Rosenthal, a Toledo, Ohio-based retinal surgeon, told the Senate
Committee on Aging in June. “In this context, ‘unrestricted’ means,
‘Use this for whatever you want, but if you ever want another, don’t
displease us.’ ”

Physicians’ “continuing medical education” requirements also have
provided drug companies ripe marketing opportunities, experts say. In
2005, drug companies spent $1.12 billion to fund sessions that
physicians attend to maintain their license to practice.

In recent years, new guidelines have sought to distance those grants
from companies’ marketing departments. Still, the Senate report noted,
“drug companies routinely fund educational grants to support programs
that favorably discuss the companies’ newer and more lucrative
products, thereby encouraging physicians to prescribe these products
and, ultimately, driving sales.” Where doctors are typically a
skeptical audience for direct pitches, “when the favorable message is
delivered in the context of education — even if corporate sponsorship
is disclosed — there is an imprimatur ofcredibility and
independence,” investigators noted.

Some of those programs appear to have been forums for pushing
“off-label” uses for prescription drugs, a back-door means of
expanding its market. About one-fifth of prescriptions that doctors
write are for off-label uses — to treat a condition other than that
for which FDA has found a drug safe and effective. Although it’s legal
for doctors to write off-label prescriptions, it is illegal for a drug
manufacturer to market its drugs for off-label uses.

In 2004, Warner-Lambert (now a division of Pfizer Inc.) paid $430
million to settle claims that it was using continuing education grants
to promote off-label uses of Neurontin, an epilepsy drug. In 2005,
Serono Laboratories paid $704 million to settle claims in a case that
alleged it was using educational programs to boost sales of the AIDS
drug Serostim for off-label uses.

The 50 state attorneys general who accepted the settlement of the
Neurontin case have used $21 million to establish the Consumer and
Prescriber Grant Program, www.ohsu.edu/cpgp/, designed to provide
healthcare professionals and consumers information related to
prescription drugs and their marketing.

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