Non Profit Fronts for Drug Companies

[Guest guest]

repeated from 2006

E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

Vienna, Virginia http://www.nvic.org

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UNITED WAY/COMBINED FEDERAL CAMPAIGN

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

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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,

GlaxoKline, Chiron Vaccines, Bristol-Myers Squibb Co,, and MedImmune,

Inc.

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

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 Ginsberg

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.

T hey 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 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 , president of Langhorne-based

Viewpoint Consulting Inc. and veteran marketer for Merck & Co. Inc.,

& 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 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. 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 andria, Va., headquarters and coached it on growth strategies, all

paid by Lilly.

Vaneeda , 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, " 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 burg, 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, 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 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.

h, 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. e 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, 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 ovitz. 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.

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 Ginsberg at 215-854-4177 or

tginsberg@....

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