[NVIC June 2006] Non Profit Fronts for Drug Companies

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"Protecting the health and informed consent rights of children since 1982."

BL Fisher Note:

   Non-profit organizations promoting mandatory vaccination with multiple
vaccines often are funded by drug companies marketing vaccines. For example,
the Immunization Action Coalition (IAC) and Hepatitis B Coalition,
registered as a 501C(3) non-profit organization, is funded by the CDC as
well as Merck & Co., Inc., Wyeth Pharmaceuticals, Sanofi Pasteur,
GlaxoSmithKline, Chiron Vaccines, Bristol-Myers Squibb Co,, and MedImmune,

Philadelphia Inquirer
Sun, May. 28, 2006

Donations tie drug firms and nonprofits
Many patient groups reveal few, if any, details on
relationships with pharmaceutical donors.

by Thomas Ginsberg

   The American Diabetes Association, a leading patient health group,
enlisted an Eli Lilly & Co. executive to chart its growth strategy and write
its slogan.

   The National Alliance on Mental Illness, an outspoken patient advocate,
lobbies for treatment programs that also benefit its drug-company donors.

   The National Gaucher Foundation, a supporter of people suffering from a
horrific rare disease, gets nearly all its revenue from one drugmaker,
Genzyme Corp.

   Although patients seldom know it, many patient groups and drug companies
maintain close, multimillion-dollar relationships while disclosing limited
or no details about the ties.

   At a time when people are making more of their own health-care decisions,
such coziness raises questions about the impartiality of groups that
patients trust for unbiased information. It also poses a challenge for
groups trying to hold patients' trust and still raise money to serve them.

   An Inquirer examination of six groups, each a leading advocate for
in a disease area, found that the groups rarely disclose such ties when
commenting or lobbying about donors' drugs. They also tend to be slower to
publicize treatment problems than breakthroughs. And few openly questioned
drug prices.

   At the same time, the groups perform an important function by providing
services unavailable elsewhere, such as patient education and help in
obtaining medications or affording insurance.

T   hey also try to police themselves. For example, each declares it does
endorse or reject products. All formally require that industry grants be
"unrestricted," meaning that there are no strings attached. One of them,
Children & Adults with Attention Deficit/Hyperactivity Disorder, or CHADD,
formally caps pharmaceutical donations.

   Combined, the six received at least $29 million from drug companies last
year, according to tax returns and annual reports. The amount ranged from 2
percent to 7 percent of revenue at the Arthritis Foundation, to 89 percent
to 91 percent at the much smaller National Gaucher Foundation.

   Some health-care experts, although applauding the groups' work, are
for greater disclosure. And many patients expressed surprise at the ties.

   "I don't think that would make a difference as far as taking a drug,"
Gloria Antonucci, 65, leader of a Montgomery County pain-support group that
relies on Arthritis Foundation advice. "But I think it would make me, maybe,
250 percent more skeptical about what the group is saying."

   Jerome Kassirer, a Tufts University and Yale University medical school
professor and author of On the Take: How Medicine's Complicity With Big
Business Can Endanger Your Health, said better disclosure would guard
against abuse.

   "These organizations are susceptible to industry influence because they
trouble raising money themselves," Kassirer said.

   But not all nonprofits are alike, said Marc Boutin, executive vice
of the National Health Council, a standard-setting coalition funded by
nonprofits and drug companies. He said leading nonprofits with "fire walls"
against donor influence were worlds apart from questionable organizations.

   "We are controlled by volunteers who are living with a condition and the
drugs they take, and I guarantee these people would not be influenced by a
donor," Boutin said.

Matter of credibility

For drug companies, patient groups carry credibility that the industry
sometimes lacks to target patients and "opinion leaders" who drive
prescriptions, and hence, sales. Nonprofits also help patients stay on the
medicine and push insurers to pay for it.

   "Does it help us? Sure," said Matthew Emmens, Wayne-based chief executive
officer of Shire PLC, the No. 1 ADHD drugmaker and a major donor to CHADD.

   "In the industry, we feel we're doing a pretty good thing while making
money, which is even better," said Norm Smith, president of Langhorne-based
Viewpoint Consulting Inc. and veteran marketer for Merck & Co. Inc., Johnson
& Johnson and others.

   The donations are sometimes portrayed by the companies and nonprofits as
"giving back" to patients. But the funding usually comes from the companies'
marketing or sales divisions, not charity offices, company and nonprofit
officials said. Grants often rise with promotional spending as a drug hits
the market and fall when sales ebb.

  Donations from Merck and Pfizer Inc. to the Arthritis Foundation more than
doubled, to at least $1.65 million combined, in 2000 as they launched Vioxx
and Celebrex. The donations fell below $375,000 by 2004, when safety fears
had flattened sales, foundation reports show.

  Merck explicitly wove the foundation into sales strategies. A 2001
memo, disclosed in product-liability trials, shows that Merck sought to use
the foundation's pain-management program to "demonstrate additional
benefits" of its products.

   Foundation president John Klippel said he was unaware of Merck's plan.
he dismissed it as an example of mutual interests in treatment, not profits.
"We envision that as an educational program," he said. "Their marketing
folks envision it as marketing."

   When interests diverge, however, groups must be ready to face donor
pressure. Michael J. Fitzpatrick, president of the National Alliance on
Mental Illness, or NAMI, said one donor recently demanded that, in return
for funding a TV public-service announcement, the ad include the company's
direct contact information. Fitzpatrick said NAMI refused.

   The industry also benefits in Washington and state capitals, where
nonprofits lobby for issues such as expanded Medicaid drug coverage or
treatment programs. That can boost sales.

   All six groups are active lobbyists. NAMI, for example, urges and helps
states and localities to create special one-on-one "assertive" treatment
programs, which include making patients take their medicine. It acknowledged
that drug-company donors may benefit but insisted that's not the goal.
"Nobody from the pharmaceutical industry tells us what to do," NAMI
president Fitzpatrick said.

Unusual corporate gift

   In 2000-2001, the American Diabetes Association did not disclose an
gift from Lilly: a lent executive, Emerson "Randy" Hall Jr., who moved into
its Alexandria, Va., headquarters and coached it on growth strategies, all
paid by Lilly.

   Vaneeda Bennett, the ADA vice president for development, denied that the
gift compromised the group but conceded that it might look bad. "We always
walk a fine line on showing favoritism to one company or another. I would
imagine other corporate donors would look askance at it," Bennett said,
adding that, if it were offered again, "we'd ask for money."

   Hall, a Philadelphia native now retired and living in Princeton, said he
never tried to influence the group and merely helped it market itself,
including writing its slogan, "Cure. Care. Commitment." He estimated that
his work, including diabetes patient research he subsequently shared with
Lilly, would have cost "hundreds of thousands" from a contractor.

   Asked why it did not cite Hall on its tax returns or annual report, ADA
spokeswoman Diane Tuncer said: "There is not a requirement to do so."

  Nonprofit experts laud such executive "loans," as long as groups disclose
them and limit their authority.

   Another group, NAMI, did not disclose that Lilly marketing manager Gerald
Radke briefly ran its entire operation. Radke began in 1999 as a Lilly-paid
"management consultant," then left Lilly and served as NAMI's paid "interim
executive director" until mid-2001. The group acknowledged this only after
being shown Radke's resume listing the job.

   NAMI's president, Fitzpatrick, said he did not know why his predecessors
not disclose Radke's work. He said using Radke "was a reasonable move to try
to increase capacity." "But there is a perception issue," he said. "So that
makes it, in hindsight, a difficult choice."

   Radke, of Harrisburg, declined to comment. After NAMI, he ran the
Pennsylvania Office of Mental Health and Substance Abuse, and now serves in
the state Health Department.

   Indianapolis-based Lilly, which donated at least $2.5 million to the ADA
$3 million to NAMI between 2003 and 2005, called its executive loans
mutually beneficial. "The primary goal is to assist that organization in
developing a needed capacity or function, but it also often serves to assist
in the career development of the employee," a Lilly spokesman, Edward G.
Sagebiel, said.

Avoiding favoritism

   Drug marketers battle hardest over safety and effectiveness, and
say they strive to avoid favoring one product over another. The six appeared
to be cautious on safety scares and rarely took the lead sounding
drug-safety alerts, even as they highlighted news of drug breakthroughs and
approvals they say members demand, their materials show.

   "We don't position ourselves as a watchdog," said Bennett of the ADA.

   The ADA, which received 5 percent to 10 percent of its revenue last year
from drug companies, reported little initially in 2004 about suspected
diabetes risks from antidepressants. Instead, Tuncer, its spokeswoman, said
it convened an expert conference - funded by drug companies - and ended up
echoing the concerns.

   The Arthritis Foundation, which received 2 percent to 7 percent from drug
companies, said little in 2000 about early studies raising questions about
Vioxx. But when follow-up studies confirmed the concerns in 2001 and 2002,
the group highlighted the problems and called for more safety research. A
year later, Merck cut off all donations.

   Patrick Davish, a Merck spokesman, denied any link between the donation
cutoff and criticism, calling it just a "change in funding priorities."
Klippel, the group's president, said he doubted there was a link but said it
would not matter anyway. "It's not to say they've not been unhappy with us
from time to time," he said. "But it would not influence me."

   The ADHD group, while calling itself a science-based information
clearinghouse, has not published some critical information about ADHD drugs,
including an FDA warning last September about suicide risk from Strattera,
made by one of its biggest donors, Lilly.

   Its chief executive, E. Clarke Ross, said the group's professional
board took time to review all information before posting it. Although the
group is an outspoken proponent of ADHD drugs, he said, it has strict fire
walls against corporate influence. Indeed, it was alone among the six in
publishing an easy-to-find figure on pharmaceutical donations: 22 percent
last year, or $1.01 million.

  "We have a number of conflict-of-interest practices that meet industry
standards," he said.

   NAMI, like most groups, lists only FDA-confirmed side effects and
refers people with any questions to the drugmaker.

   One outspoken NAMI critic, David Oaks of the support group MindFreedom,
described the group as an independent but willing pawn of industry.
"We're not saying there is some conspiracy in a skyscraper by a
pharmaceutical executive rubbing his hands together," Oaks said. "It's that
the entire paradigm is owned by the drug companies, and that the hazards of
the drugs, like brain damage, are not discussed."

   NAMI's Fitzpatrick defended its information, but acknowledged that groups
were facing demands for fuller drug information. "I think we should be much
more like Consumer Reports. We should have transparency on both side effects
and benefits," he said.

Close ties on orphan drugs

   Ties between drug marketers and patient groups appear closest on
orphan diseases, which involve relatively few patients, experts and
drugmakers. Financial disclosures by two groups show they used most of the
deductible donations to pay the medical bills and insurance premiums of
patients using donors' products. That, in effect, spreads around costs while
leaving pharmaceutical prices unchanged.

   The National Organization for Rare Disorders, a Connecticut-based
that tries to spur development of orphan drugs, got $10.5 million - 68
percent of its revenue - from drug companies last year. It helps pay
patients' premiums and bills, administers companies' free-drug programs and
helps recruit patients for their clinical trials.

   Founder Abbey S. Meyers said that donors did not shape her group's
and noted that the industry needed the groups as much as they needed it: "I
criticize them [donors] all the time. It has never come back to hurt us."

   The Gaucher group, according to tax returns, received $1.77 million of
$2 million in revenue last year from Boston-based Genzyme, and spent $1.69
million on medical bills and insurance premiums of patients taking Genzyme's
enzyme therapy Cerezyme, which cost insurers as much as $350,000 a year.

   In contrast, the foundation took nothing from Actelion Pharmaceuticals US
Inc., of San Francisco, maker of a second-line treatment, Zavesca, to be
used when Cerezyme doesn't work. Actelion said the foundation rejected its
no-strings grants and gave little or only critical Zavesca information.

   "I don't want to say anything nefarious is going on. But it doesn't pass
scrutiny," said Actelion's president, Shal Jacobovitz. He portrayed the
foundation "almost as a commercial arm" of Genzyme.  Ronda P. Buyers,
executive director, denied that the group is biased toward Genzyme. "We're
two different organizations. We do get its money, which allows us to do what
we do," she said.

   Another company, Shire Human Genetic Therapies, formerly Transkaryotic
Therapies Inc., which is developing an alternative to Cerezyme, also called
the foundation unusually close with Genzyme, even though it had accepted
Shire's small donations.

   Genzyme "is aggressive, and it's all part of their marketing plan to have
dominant position," said Matt Cabrey, a Shire spokesman in Wayne.

   David Meeker, president of Genzyme's lysosomal business unit, said
had no control over the foundation. He acknowledged that the group was so
important for Cerezyme marketing that if it didn't exist, Genzyme would have
looked for another.

   "This is how we built our business," said Meeker, whose company took in
million last year from Cerezyme, high for an orphan drug. "It's also
building a community where patients can get the help they need. It's the
ultimate win-win."

   Buyers, who did not respond to repeated follow-up calls after an initial
interview, said:

   "We cannot make them bring the price down. They do make a lot. But
the drug, there would be all these people who would be in such horrible
positions. More people would die."

Contact staff writer Thomas Ginsberg at 215-854-4177 or

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