$29 Million Donations Tie Drug Firms and Nonprofits_Philadelphia Inquirer

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$29 Million Donations Tie Drug Firms and Nonprofits_Philadelphia

Inquirer

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and

Accountability

http://www.ahrp.org/cms/

An investigative report in The Philadelphia

Inquirer examined pharmaceutical

company ties to six, tax exempt organziations

that identify themselves as

" patient advocacy " groups, " Each a leading

advocate for patients in a

disease area. "

The conflicts of interest are covert: the

reporter notes that " 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....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. "

The following six organizations took in $29

million in drug company

donations last year: American Diabetes

Association (ADA); National Alliance

on Mental Illness (NAMI); National Gaucher

Foundation; Children & Adults

with Attention Deficit/Hyperactivity Disorder

(CHADD); Arthritis Foundation

(AF); National Organization on Rare Diseases

(NORD).

" For drug companies, patient groups carry

credibility that the industry

sometimes lacks to target patients and " opinion

leaders " who drive

prescriptions, and hence, sales. " However, such

coziness " raises questions

about the impartiality of groups that patients

trust for unbiased

information. "

The Inquirer describes some of the insidious ways

that these groups work

covertly hand in glove with their pharmaceutical

corporate benefactors:

" Merck explicitly wove the [Arthritis 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. "

" 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. " However when safety concerns

emerged sales of these hazardous

drugs flattened, and the donations fell below

$375,000 by 2004.

The National Gaucher Foundation, a supporter of

people suffering from a

horrific rare disease, is reported to get " nearly

all its revenue from one

drugmaker, Genzyme Corp. " The foundation is

criticized for promoting only

this company's product.

These covert financial ties bind these groups to

pharmaceutical companies,

securing their help in promoting particular

" diseases " to increase demand

for treatment-thereby expanding the market for

their drugs. [1]

However, the most damning aspect about these

collaborating " advocacy "

groups' is their withholding of vital safety

information from their

membership: information about evidence of these

drugs' hazardous-even

lethal-effects. Some would consider this a

partnership in deception.

Surely, this is the ultimate betrayal of trust by

organizations claiming

that their raison d'etre is to educate and

advocate for the best interest of

their constituency--patients and families.

The Inquirer reports that The American Diabetes

Association privately

enlisted an Eli Lilly & Co. executive to chart

its growth strategy and write

its slogan. It received at least $2.5 million

between 2003-2005. And the

Inquirer reports that " 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. "

Lilly donated at least $3 million to NAMI. For

its part, NAMI promotes the

increased use of psychotropic drugs, lobbies

against any cost-saving

restrictions on number of psychotropic drugs

prescribed for one patient

under Medicaid, and even lobbies for laws

allowing mental patients to be

forced to take antipsychotic drugs. The drugs

most often prescribed for

involuntary patients-Janssen's Risperdal

(risperidone) and Lilly's Zyprexa

(olanzapine)-cause debilitating, indeed, lethal

effects. . NAMI's failure to

inform its constituents about the danger these

drugs pose for patients, and

its continued aggressive promotion of these drugs

despite the evidence, may

be viewed as confirmation that NAMI is an

extension of Lilly's marketing

department.

The documented hazards:

1. During pre-marketing trials 2/3 of patients on

Zyprexa dropped out and 1

in 145 died-some committed suicide.

http://www.ahrp.org/infomail/0702/12b.php]

2. In 2002, Duke University's analysis of FDA

MedWatch reports identified

289 cases of treatment-emergent diabetes in

patients who had been prescribed

Zyprexa for less than six months. In addition,

the researchers found 100

cases of ketoacidosis (diabetic coma potentially,

death) as a result of

Zyprexa use, 22 cases of Zyprexa-related

pancreatitis, and twenty three

patients who died as a result of Zyprexa side

effects.

http://www.ahrp.org/infomail/0702/12b.php

3. Dr. Arif Khan's independent analysis of FDA

data found the suicide rate

in clinical trials to be 752 per 100,000 persons

for those treated with an

atypical antipsychotics--risperidone, olanzapine,

and quetiapine.

4. The government-sponsored, CATIE study

findings: " Patients in the

olanzapine group gained more weight than patients

in any other group, with

an average weight gain of 2 lb (0.9 kg) per

month. A larger proportion of

patients in the olanzapine group than in the

other groups gained 7 percent

or more of their baseline body weight. Olanzapine

had effects consistent

with the potential development of the metabolic

syndrome and was associated

with greater increases in glycosylated

hemoglobin, total cholesterol, and

triglycerides after randomization than the other

study drugs, even after

adjustment for the duration of treatment. " See:

http://www.ahrp.org/infomail/05/09/20.php

5. Yale investigators reported earlier this month

that 2/3 of the children /

adolescents in its speculative " schizophrenia

prevention " experiment

conducted on healthy adolescents, dropped out.

The investigators have yet

to report the adverse events suffered by the

otherwise healthy youth during

the experiment.

Diabetes is by far the most prevalent serious

risk linked to Zyprexa.

The fact that NAMI lobbies for laws facilitating

involuntary

treatment-despite scientific evidence linking the

drugs most often used on

involuntary patients-is a measure of this

organization's duplicity and

betrayal of its mission.

The high incidence of diabetes among patients

exposed to Lilly's

antipsychotic drug, Zyprexa, undoubtedly provides

the company an opportunity

for huge increased profit margins. Lilly is the

foremost producer of

treatments for diabetes.

The revelation, discovered during court

procedures, that Eli Lilly's

marketing manager, Gerald Radke, actually ran

NAMI takes on significance far

beyond mere corporate " donations. " Such dubious

direct intermingling

between the company marketing manager and a tax

exempt organization requires

a full investigation by the Inspector General.

Reference

1. For additional examples of the role played by

nonprofits " on the take " to

expand the market for drug companies, See: Ray

Moynihan and Alan Cassels,

Selling Sickness: How drug companies are turning

us all into patients. Crows

Nest: & Unwin; 2005.

See also, Disease Mongering, special issue, PLoS

Medicine

http://collections.plos.org/diseasemongering-2006.php

Contact: Vera Hassner Sharav

212-595-8974

veracare@... <mailto:veracare@...>

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

template=conte

ntModules/printstory.jsp

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

PHILADELPHIA INQUIRER

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 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.

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 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@....

C 2006 Philadelphia Inquirer and wire service

sources. .

http://www.philly.com

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FAIR USE NOTICE: This may contain copyrighted (C

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has not always been specifically authorized by

the copyright owner. Such

material is made available for educational

purposes, to advance

understanding of human rights, democracy,

scientific, moral, ethical, and

social justice issues, etc. It is believed that

this constitutes a 'fair

use' of any such copyrighted material as provided

for in Title 17 U.S.C.

section 107 of the US Copyright Law. This

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profit.