[Ip-health] Philadelphia Inquirer:Donations tie drug firms and nonprofits - Many patient groups reveal few, if any, details on relationships with pharmaceutical donors.

[James Love]

This is the story John Mack was referring to, and a few more
highlights...

* Ties between drug marketers and patient groups appear closest on so-
called 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
coalition 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 positions 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 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.

* In 2000-2001, the American Diabetes Association did not disclose an
unusual 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."

* 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.

* The Gaucher group, according to tax returns, received $1.77 million
of its $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.



http://www.philly.com/mld/philly/living/health/14687073.htm

Posted on 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
Inquirer Staff Writer

The American Diabetes Association, a leading patient health group,
privately 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
patients 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.

They also try to police themselves. For example, each declares it
does not 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
calling 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,"
said 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 have trouble raising money themselves," Kassirer said.

But not all nonprofits are alike, said Marc Boutin, executive vice
president 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
internal 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. But 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
unusual 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 did 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 and $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
nonprofits 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
advisory 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
typically 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 so-
called 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
coalition 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
positions 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 its $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 a dominant position," said Matt Cabrey, a Shire spokesman in Wayne.

David Meeker, president of Genzyme's lysosomal business unit, said
Genzyme 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 $932 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
without 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
tginsberg@phillynews.com.

---------------------------------
James Love, CPTech / www.cptech.org / mailto:james.love@cptech.org /
tel. +1.202.332.2670 / mobile +1.202.361.3040

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