FDA Staff Travels on Drug Industry Dollars

April 12, 2006

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

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

FYI

The Center for Public Integrity reports that FDA officials circumvent

the prohibition on accepting trips from drug and medical device

manufacturers.

They accept trips from nonprofit associations " that draw their

members, their boards and even some of their funding from medical and

pharmaceutical-related companies paying for the travel of hundreds of

FDA employees. "

The major sponsor of FDA staff travel expenditures was the Drug

Information Association which paid for more than 600 trips of FDA

employees.

Encapsulating the arrogance of power and the disdain for public

accountability, Dr. Temple " denied that his policy decisions

and those of the agency had been influenced because of the trips he

took: " I don't pay attention [to who pays]. We don't get any more

money or more attention if somebody else pays. "

The agency is as corrupt as the industry it shields, whose financial

interests it promotes by sacrificing the safety of the Amrican public.

Millions of children are being pumped with psychosis-inducing drugs

whose toxic effects destroy their physical and mental health.

Antipsychotics prescribed off-label for children are damaging their

brains and cutting short their lives.

Travel expenses may not be the only percs FDA officials accept from

industry-sponsored front organizations.

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

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http://www.publicintegrity.org/rx/printer-friendly.aspx?aid=792

FDA Staff Travels on Drug Industry Dollars

Groups tied to FDA-regulated industry paying for agency officials'

trips

By Cohen

WASHINGTON, March 30, 2006 — Through an apparent loophole in agency

rules the Food and Drug Administration has allowed its employees to

receive more than $1.3 million in sponsored travel since 1999 from

groups closely tied to pharmaceutical and medical device companies.

FDA policy bars employees from taking trips paid for by the drug,

medical device and other companies the agency regulates or by their

trade groups. But the Center for Public Integrity has found nonprofit

associations that draw their members, their boards and even some of

their funding from medical and pharmaceutical-related companies

paying for the travel of hundreds of FDA employees.

The sponsor of the most trips was the Drug Information Association,

which footed the bill for more than 600 trips taken by FDA employees.

The nonprofit group made up of pharmaceutical and medical device

employees, academics and government regulators boasts 13 members on

its board of directors who work or have worked for the industry or

its consulting groups.

Story section links

Substantial corporate ties

Research universities in the mix

Travelers move on to industry jobs

Potential for a hand in shaping policy

Tighter budgets, looser restrictions

A neutral, educational role

The FDA has come under heavy criticism since Vioxx and other widely

prescribed drugs were recalled for safety reasons. Members of

Congress and government watchdog groups have charged that the

regulatory agency is too close to the industry it oversees to

impartially and effectively police the roughly 10,000 drugs on the

market.

At the behest of Congress, the Inspector General of the Department of

Health and Human Services has investigated ties between the industry

and the agencies that oversee it. Many of the top sponsors have

membership or financial ties to medical and pharmaceutical-related

companies. Nonprofit groups and universities with such ties paid for

roughly a third of the more than 3,600 trips taken by agency

officials, suggesting that the industry is indirectly subsidizing the

travel taken by employees of the FDA.

The Center for Public Integrity analyzed all of the FDA's available

reports of privately sponsored trips taken by agency officials

between October 1999 and September 2005 that cost more than $250. The

traveler ranks included many division and department directors.

The Center identified 10 officials who took more than 25 trips each,

often serving as speakers at the events they attended. Two of those

officials are also members of the agency's new Drug Safety Oversight

Board. After the recall pileup of Vioxx and other potentially

dangerous medications, the safety board was established last year to

independently monitor approved drugs. Seventeen of the board's 29

members have taken more than a combined 160 privately sponsored

trips, at a total cost of more than $220,000.

Substantial corporate ties

More than a quarter of all of the trips reported were sponsored by

five groups with ties to the pharmaceutical, biologic and medical

device industries:

the Drug Information Association, the American Association of

Pharmaceutical Scientists, the Parenteral Drug Association, the

International Society for Pharmaceutical Engineering, and the

Regulatory Affairs Professionals Society. They were responsible for

close to 1,000 excursions, spending more than $1.3 million to fly and

host agency employees.

Eleven drug safety board members were among the travelers sponsored

by those groups. They took 55 trips costing approximately $75,000.

These groups do not describe themselves as trade associations.

Instead, they promote themselves as scientific associations of

individuals, apparently thereby skirting FDA travel sponsorship

prohibitions.

Each of the five groups boasts board members with ties to medical and

pharmaceutical-related firms, including current and former employees,

contract workers and consultants. Many of the groups' members have

similar connections.

For example, Nikki Mehringer, an Eli Lilly quality control manager,

was PDA's treasurer in 2000. She also testified before Congress that

year on the subject of drug importation, promoting the industry

argument that drugs from other countries might not be safe.

All of the organizations appear to draw at least some funding from

corporations and individuals with business before the FDA:

The American Association of Pharmaceutical Scientists' " Loyal

Supporters " brochure lists Pfizer, Eli Lilly, Sanofi-Aventis and

GlaxoKline among companies funding some of its programs and

events.

Amgen and Bristol-Myers Squibb were among the sponsors of the

Regulatory Affairs Professionals Society annual conference in 2005.

RAPS promoted the expected attendance of " more than 1,000 regulatory

affairs professionals from around the globe — including the decision

makers, senior- and mid-level executives you want to reach. "

The International Society for Pharmaceutical Engineering's 25th

anniversary gala last year listed sponsors that included AstraZeneca

and Wyeth.

The Parenteral Drug Association is offering exhibit and sponsor

opportunities for its upcoming annual meeting in April; exhibitors

signed up so far include subsidiaries of pharmaceutical manufacturers

Dupont, Eisai, and Baxter.

DIA, which has a policy prohibiting corporate sponsorship of

programs and events, allows exhibits by companies such as AstraZeneca

and Bristol-Myers Squibb at its meetings and conferences.

Independent consulting firm the Weinberg Group frequently assists

companies with applications before the FDA. It boasts employees tied

to the top travel sponsor, DIA, including DIA's last former

president. At last year's DIA annual meeting, a Weinberg Group

employee delivered one of its many tutorials; the topic: " FDA

Enforcement: What You Need to Know to Avoid or Respond to the FDA. "

Theresa Musser, president of DIA and executive director of Rigel

Pharmaceuticals, defended the presentation. " When you're looking at a

neutral forum, the bias would be if we didn't allow that to go on, "

she said.

Research universities in the mix

Universities and multilateral organizations were also among the major

trip sponsors. One of the largest patrons was the University of Rhode

Island, which spent $275,000 underwriting the travel of FDA

employees, some of whom were entertained at annual conferences

sponsored by the school's College of Pharmacy that were held at

Chesapeake Bay and Hilton Head, S.C., resorts.

URI's College of Pharmacy itself has strong ties to the drug

industry. The school has adjunct professors hailing from just about

every major drug company, including Schering-Plough, Novartis,

Hoffman-La Roche and Pfizer. The university is currently conducting

clinical trials for vaccines with drug giants GlaxoKline and

Merck.

Simeone, the pharmacy school's director of continuing

education, acknowledged that the school's close relationship with the

industry could appear to be a conflict of interest.

" There's definitely going to be some interaction whenever you have an

exchange of ideas, " Simeone said. By footing the bill for the FDA to

educate members of the industry, " we're helping stretch the limited

resources that the FDA has — I don't know if that's proper. "

Two other universities with ties to the pharmaceutical industry

together sponsored more than 100 trips costing roughly $98,000. The

University of Texas conducts clinical trials for drug companies,

including AstraZeneca and TAP Pharmaceuticals, while the University

of Wisconsin is a major research center that has conducted clinical

trials for Pfizer, GlaxoKline and other companies.

Consumer and government watchdogs worry that trips sponsored by those

with financial ties to regulated companies provide opportunities for

pharmaceutical, medical device and other related industries to set

the agenda for the FDA.

" There is no countervailing perspective, " said Dr. Lurie,

deputy director of Public Citizen's Health Research Group, which

monitors the FDA and the health industry. " They mostly become

schmooze-fests for people from industry. "

" We strongly think it's a problem, " said Bill Vaughan, senior health

policy analyst with Consumers Union. " It contributes to the revolving

door. "

Travelers move on to industry jobs

Several former FDA officials now work for the industry they policed.

Some are involved with groups that formerly funded their travel; the

Center identified 20 former FDA officials who took trips sponsored by

one of the five associations that went on to work for medical and

pharmaceutical-related companies.

Hoiberg, former deputy director of the FDA's Office of New

Drug Chemistry, now works for Pfizer. Hoiberg is a board member of

the International Society for Pharmaceutical Engineering, a group

that paid more than $15,000 for his travel to Milan, Tokyo,

Singapore, Zurich and Dublin while he was with the FDA.

Hoiberg declined to comment on his connection to ISPE, but said that

he received no money from any of the organizations that sponsored his

travel. Travelers are repaid indirectly — the FDA receives funds from

the sponsoring organization and passes on the travel reimbursement to

the FDA staffer.

Ajaz Hussain, former deputy director of the FDA's Office of

Pharmaceutical Science, took more than 35 privately sponsored trips

costing more than $68,000 before leaving the agency last fall to work

for Sandoz, a manufacturer of generic drugs owned by pharmaceutical

giant Novartis.

" You utilize the resources you have, " Hussain said, citing the

limitations in the FDA's travel budget as a reason for accepting

outside sponsored travel. " You have to fulfill your responsibility of

realizing the agency's public health objective. "

Potential for a hand in shaping policy

While many of the meetings held by groups such as DIA involve

discussions of highly technical topics, sometimes important policy

considerations are in play as well.

At DIA's 2002 annual meeting in Chicago, a panel on amendments to the

Declaration of Helsinki, the world's main statement of ethics

regarding medical research, included both director for medical policy

at the FDA's drug unit Temple and Bert Spilker, then-senior

vice president for scientific and regulatory affairs of the

Pharmaceutical Researchers and Manufacturers of America — the drug

industry's main trade lobby.

The panel addressed amendments that would limit the use of placebos

in clinical trials and require that patients have access to

treatments after a trial ended. Industry has opposed those changes

and the FDA has backed the industry position. In a 2004 letter

addressed to Dr. Lepay, who oversees clinical regulation at the

FDA, the watchdog group Public Citizen charged that the ultimate goal

of Temple and the FDA was the " undermining " of the declaration.

Temple said that he opposed giving the Declaration of Helsinki the

force of law because " you don't want to be relying on anybody who's

not sending you drafts. "

He also denied that his policy decisions and those of the agency had

been influenced because of the trips he took. " I don't pay attention

[to who pays], " Temple said. " We don't get any more money or more

attention if somebody else pays. "

In 2004, Congress examined the National Institutes of Health ethics

programs after news reports documented that NIH and FDA employees

engaged in outside consulting work. The Inspector General of the

Department of Health and Human Services — of which the FDA is a part —

reviewed similar conflicts at the agency. But references to some top

officials were noticeably absent.

Troy, the FDA's former chief counsel, is mentioned only once

among the reports. During his tenure, Troy attracted many critics who

accused him of creating or modifying policies favorable to the same

pharmaceutical companies he once represented. And in September 2005,

Legal Times reported that between August 2001 and November 2004 he

met dozens of times with industry representatives and gave almost 80

speeches.

According to the records, Troy disclosed only one of those trips as

having been sponsored by a third party. On Feb. 21, 2002, he traveled

to New York to address the DIA on the subject " Marketing of

Pharmaceuticals: How to be Aggressive and in Compliance. " The DIA

billed it as Troy's " first public speech " in his new position. When

questioned, he said that he did not specifically recall the trip or

being reimbursed for it, something he said his assistant would have

handled.

" I basically took the position that if I was traveling on the

government's time, I should use the government's money, " Troy said.

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group,

was critical of the FDA's reliance on travel sponsorship by DIA and

other nonprofits.

" It sounds like they're violating the spirit of the law, if not the

letter of the law, " Wolfe said.

Tighter budgets, looser restrictions

The organizations sponsoring travel have grown quite a bit in the

past few decades. For example, DIA's Web site says that it had only

300 members in 1979, compared with 27,000 in 2001.

Asked about the activities of such groups during his 1977 to 1979

tenure as FDA commissioner, Kennedy said that he

doesn't " remember that there were these types of associations. "

Gerald Meyer, a former FDA associate commissioner for management and

operations, said that the agency allowed travel paid by trade

associations until the late 1970s, but " there was a perception that

it was a cozy relationship. "

Meyer, whose office oversaw conflict of interest questions, said that

although he believes that lavish accommodations posing an actual

problem was a rare event, " we made a decision. If someone needed to

attend something, we'd pay for it ourselves. "

The rules were further toughened in 1988, after several FDA employees

were caught taking payoffs, expensive trips and pricey meals from

generic drug companies. As a result, outside groups were barred from

sponsoring travel. But the tide turned in 1992, when Congress passed

the Prescription Drug User Fee Act, which billed drug companies to

fund the drug approval process. DIA was again permitted to sponsor

travel around that time.

Restrictions on travel sponsorship by several other groups were also

relaxed after passage of the PDUFA legislation. Sherry Keramidas,

executive director of the Regulatory Affairs Professionals Society,

said that sometime around 1995, the FDA first made " some requests "

that they support travel to critical meetings. But lack of funds has

left the regulatory agency's officials dependent on organizations

whose members have significant business interests before it.

Alan Andersen, who was associate director of the Office of Device

Evaluation when he left the agency in 1993, said the travel policy

changed " because of budget constraints. " Andersen said that the

roughly $1 million supplement to the agency's annual travel

expenditure of $28 million is " significant. "

" It's a 5 percent increase in what you're able to do, " he said.

Ellenberg, a former director of FDA's Office of Biostatistics

and Epidemiology, said she could not have attended conferences

without private groups' support. " Our budget is very limited, " she

said.

Sharon Holston, who oversaw FDA's conflict of interest

questions after Meyer, accounted for the decision by characterizing

DIA's role as educational. Ellenberg, Meyer and other former FDA

employees agreed and referred to DIA not as a trade association, but

as a professional association.

" The public doesn't gain anything from not having anyone at these

presentations, " Meyer said.

All current and former FDA officials interviewed for the Center's

report defended FDA's oversight of travel sponsorship.

" We have very tight travel restrictions, " said , a

deputy director with the agency's drug unit. " It's not like we're

going off to Hawaii. "

Ellenberg agreed with , adding that FDA officials " police it

very tightly. "

FDA's policy manual states that " if an employee's participation

warrants the expenditure of official time, it also warrants the

expenditure of [government] travel funds. " However, according to

Meyer, funds aren't always available.

" Getting money for that kind of thing is not in the cards, " Meyer

told the Center. " That's the right answer, no question — have FDA pay

for all their travel. "

A neutral, educational role

Many of the private organizations sponsoring FDA employees' trips

defend the practice, saying that they help provide a forum for

learning about policies.

" To get all those parties into discussions will lead to greater

productivity, " said Best, president of the International

Society for Pharmaceutical Engineering.

Representatives of several organizations said they saw no conflict of

interest in sponsoring the travel, and most stressed their groups'

neutrality.

" We have absolutely no bearing and no influence on what [the industry

is] saying, " said , director of marketing services for

the Parenteral Drug Association.

Other organizations also stressed their independence from the

industry, noting that most of their funding comes from individual

membership dues and program activities. Stacey May, the public

affairs director of the American Association of Pharmaceutical

Scientists, said that her group does not lobby.

" We really view ourselves as a scientific organization. We support

science only, " May said, citing the association's written policy.

ISPE's Best said that while his group's funding comes from

individuals, " probably the vast majority " of those dues were

underwritten by the members' employers. Musser of DIA said she

believes its dues and program fees are paid in part by both members

and their employers, but that she did not know the details.

RAPS executive director Keramidas told the Center that who pays a

member's dues has no bearing on the group itself.

" Many of our members work for corporations and they may be paying

their dues. It's not as if corporations are driving our agenda, " she

said.

Kreha and Brodsky contributed to this report.

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April 12, 2006