A series of articles in the LATimes By Melissa Healy
 
Date: Wed, 8 Aug 2007 18:08:33 -0500 (CDT)


ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) 
Promoting Openness, Full Disclosure, and Accountability 
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FYI
A must read, six-part report by Melissa Healy of the Los Angeles Times
(excerpts below) lays out the pharmaceutical industry's masterful
manipulation of America's healthcare system succeeding to divert healthcare
budgets for patented, expensive drugs whose benefits are uncertain at best.

The pharmaceutical industry has undermined the integrity of medicine by
rendering healthcare providers, academic institutions, journals, government
healthcare agencies, patient advocacy groups, and the media financially
dependent on its largesse. This industry has bypassed the inconvenient
scientific evidence of its products' failure to show a positive benefit/
risk ratio by use of fictitious "evidence" fashioned by sophisticated public
relations firms. PR firms have also manufactured buzz about the latest
"under diagnosed condition" (e.g. "female sexual dysfunction" "juvenile
bipolar disorder" "restless leg syndrome") for which there just happens to
be a newly marketed drug available. 

To create demand, industry has recruited influential professionals and
professional associations and it has sent an army of attractive sales reps
"sex icons" to woo doctors into prescribing. 
http://www.latimes.com/services/site/premium/access-registered.intercept 
Industry has also recruited patient advocacy groups who can be relied on to
bully third party payers to pay for the latest, most expensive drugs which
are promoted as "breakthrough" therapies despite the lack of scientific
evidence to back up such claims.
  
Drug makers are driving sales from both ends: since consumers cannot
purchase drugs without a physician's prescription, advertisements directed
at consumers prod consumers to prod their doctor ( "ask your doctor") for a
specific brand of prescription drug. Companies simultaneously pitch the drug
to doctors personally through an army of company detailers (sales reps), in
separate ads, in ghostwritten journal articles, and by controlling  the
content of continuing medical education courses. To ensure that physicians
write brand name prescription drugs manufacturers offer prescribing
physicians gifts and financial enticements (bribes). The medical profession
has accepted industry's 'free handouts' and 'fee for service' arrangement by
offering the untenable argument that physicians are incorruptible.  On the
contrary, several studies have found that physicians who accept and dispense
free samples to their patients are far more likely to prescribe those drugs
than those who don't take or have no access to samples.

However, the most effective drug marketing is indirect but shaped by
industry--as when influential "authorities" pen their names to ghostwritten
journal articles and render their opinions in the media. Industry-influenced
patient groups 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.

Healy reports: "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." 

Industry's successful marketing strategy is measureable in increased number
of prescriptions, increased sales, and : 
In a nation that consumed $279-billion worth of prescription medications in
2006 -- spending 80% of that on brand-name products that are advertised--
their efforts appear to be paying off.  The number of individual
prescriptions filled in the US rose from 2.9 billion in 1999 to 3.7 billion
in 2006; in 1994, Kaiser calculated that each American filled on average 7.9
prescriptions per year; by 2005, that number had risen to 12.4. Does that
mean Americans are sicker now than in 1994, or just popping more pills?  And
what about the adverse effects of these pills, are they creating chronic
disease in previously healthy people??

Healy suggests that there is a push for change; that doctors are rethinking,
or at least disclosing, their ties to drug companies; and that legislators
are drafting and passing bills aimed at blunting the effects of
prescription-drug marketing. Citing a 2004 meeting of the American College
of Rheumatology, she reports that physicians reeling from public outcry over
the market withdrawal of the arthritis drugs Vioxx and Bextra vowed to wean
their organization from its heavy dependence on pharmaceutical funding,
setting off similar self-examination among other medical societies.
 
Unfortunately legislators are also "on the take" relying on industry's
campaign contributions. Thus, the disengagement process is painfully snail
paced.
There will, no doubt, be more scandals, and more preventable deaths before
real changes are put in place.

Contact: Vera Hassner Sharav 
212-595-8974 
veracare@ahrp.org <mailto:veracare@ahrp.org>  
  

http://www.latimes.com/features/health/la-he-drugintro6aug06,1,6647049.story

The Los Angeles Times
SOLD ON DRUGS Under the influence
Savvy marketing whets our appetite for prescription pharmaceuticals.
Consumers, doctors, researchers -- no one is immune
By Melissa Healy
August 6, 2007
	
FOR many Americans, a doctor's decision to prescribe medication is something
of a sacred transaction. A physician considers the patient and symptoms and
chooses the best drug for the job, drawing upon years of training and
clinical experience. It is an exchange conducted in a hushed sanctuary, far
from the heat and noise of the marketplace -- a place where cool judgment
reigns. 

That sanctuary has been breached. Today, drug manufacturers do everything in
their considerable power to ensure that their brand-name prescription
medications are on the lips of patients and in the minds of physicians every
time the two meet across an exam table. A growing chorus of critics says
their efforts have begun to rewrite the dialogue between patient and doctor,
influence physicians' judgments and open the act of prescribing to forces
more profit-minded than sacred. 

In 2006, drug-makers spent almost $5 billion to reach out to consumers with
direct advertising. But the glossy magazine ads and buzz-generating TV spots
are just the most visible parts of a campaign to build and nourish markets
for brand-name prescription products. The world's pharmaceutical companies
spend an estimated $19 billion annually to woo doctors. They sponsor
teaching programs and research at universities across the country, gaining
goodwill along the way. They give money to patient groups. They hire public
relations firms to share patient stories of illness and triumph.

In a nation that consumed $279-billion worth of prescription medications in
2006 -- spending 80% of that on brand-name products -- their efforts appear
to be paying off. Americans filling a prescription choose brand-name
products 37% of the time, even though three-quarters of all prescription
drugs in the U.S. are available in cheaper generics. 

"The most effective marketing is the marketing you're not aware of," says
Dr. Peter Rost, a one-time pharmaceutical company marketing executive who
has become an Internet-based industry watchdog. "If you see an ad, you know
it's marketing. But if a friend or your doctor talks to you about a drug,
you don't."

Now the size, scope and apparent effectiveness of drug companies' marketing
efforts has begun to prompt cries of foul even from within the medical
establishment, which has long been silent about its growth. In a handful of
state legislatures across the country, lawmakers already have acted to blunt
drug-company marketing, and many more are considering similar measures.
Lawmakers on Capitol Hill have suggested that federal legislation may come
next. 

At stake, critics say, are patients' health, the nation's healthcare budget
and, ultimately, the trust and esteem in which Americans hold their
physicians. Costs rise as more doctors prescribe brand-name drugs when
cheaper, older or more effective drugs might be available. 

Under-treated conditions that threaten the lives and wellness of large
swaths of the population -- illnesses such as diabetes and high blood
pressure -- may get less attention than conditions such as erectile
dysfunction or insomnia, for which pharmaceutical firms have new and
potentially more profitable offerings. And patients may be steered toward
newer drugs with risks and side effects that are less well-known, in lieu of
medications with a longer history of safe use.

"There is nothing fundamentally wrong with advertising products," Dr. Jerome
P. Kassirer, a former editor of the New England Journal of Medicine, told a
Senate committee recently. "But when financial incentives yield
inappropriate or dangerous care, when they inordinately raise the cost of
care, when they risk patients' lives in clinical trials, and when they
damage the profession, they have gone too far."

The pharmaceutical industry counters by arguing that its marketing efforts
are needed to recoup the cost of drug development and that they introduce
Americans to medicines that can save lives and improve well-being. The
industry's sponsorship of research and education pushes the process of drug
discovery and development forward, drug-makers say. Companies' marketing to
physicians keeps busy clinicians abreast of new therapies and scientific
advances in a fast-changing landscape. And their advertising of drugs in
mass-media outlets educates patients and improves their communication with
doctors, they add.

And drug marketing improves the economic vitality of the nation, a
representative of the drug industry's largest trade group, PhRMA, said at a
recent Senate hearing. Prompted by drug industry marketing, more patients in
recent years have sought out a doctor, and more doctors have looked for
signs of under-treated conditions such as depression, diabetes and asthma
among patients, Marjorie E. Powell, an attorney for PhRMA, said to the
Senate Select Committee on Aging in late June. Citing a pair of studies
published in 2003, Powell said that in the long run, increasing treatment of
such chronic conditions should drive down the nation's healthcare bill. 

As the debate rages -- among doctors, within universities, in statehouses
across the nation and in the halls of Congress -- here is a look at a wide
range of marketing efforts that has touched it off.
~~~~~~~~~~~~ 
http://www.latimes.com/features/health/la-he-sellingthepatient6aug06,1,31300
43.story?coll=la-headlines-health 
SELLING THE PATIENT Next step: Create the demand
Direct, emotional ads for prescription drugs are everywhere. But they're
just one way to get to the consumer.
By Melissa Healy
August 6, 2007

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. 

~~~~~~~~~~~~
See also: Melissa Healy. 
THE PAYOFF In short, marketing works Why argue with success? The Los Angeles
Times.
http://www.latimes.com/features/health/la-he-effectiveness6aug06,1,4029145.s
tory

SOLD ON DRUGS And now, a push for change
http://www.latimes.com/features/health/la-he-reforms6aug06,1,2797596.story  

BUILDING THE MARKET From funding to findings
http://www.latimes.com/features/health/la-he-buildingthemarket6aug06,1,12457
2.story  

WOOING THE GATEKEEPER Doctor, just a little something for you
Complex sales strategies go way beyond freebies.
http://www.latimes.com/services/site/premium/access-registered.intercept 
And now, a push for change Legislators have begun to question the drug
industry's pervasive influence in healthcare. Some doctors are backing them
up.
http://www.latimes.com/features/health/la-he-reforms6aug06,1,2797596.story 

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