Integrity in Science Watch....Conflicts of Interest Rampant!!!

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Integrity in Science Watch

February 26, 2007

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Report: FDA Fails to Find Advisers Without Industry Ties

The Food and Drug Administration's latest report on the make-up of its

advisory panels reveals that little has changed in the 15 months since Congress

required the agency to document its efforts to find scientists without ties to

industry. In a report sent to Capitol Hill on Jan. 31, FDA Commissioner

von Eschenbach reported that 24 percent of advisers to the agency’s

seven

centers and offices received conflict-of-interest waivers between November

2005 and January 2007. The Center for Drug Evaluation and Research (CDER) had

the worst performance, with 146 of 417 advisers, or 35 percent, requiring

waivers because they owned stock in, consulted for, or served on the speakers'

bureaus of firms with products up for approval or their competitors.

The agency's ability to identify advisers without conflicts of interest has

not budged since Congress acted. Although the agency says it reviewed the

resumés of 724 candidates to fill the 175 open slots on its committees, its

ratio of waivers per meeting was nearly identical over the period. For instance,

CDER granted 42 waivers for the 8 meetings in the first quarter of last year

compared to 30 waivers for 6 meetings in the fourth quarter. The advisory

committee that met last November to discuss Pfizer's application to use the

painkiller Celebrex for juvenile arthritis was typical. While just 2 of the 8

permanent members required waivers, 4 of the 8 temporary specialists appointed

to the committee for their expertise had conflicts.

When questioned about the agency's failure to reduce its reliance on outside

advisers with ties to industry, acting deputy commissioner Randall Lutter

said that " it is very difficult to get the quality of the expertise we want

without going to people who have some sort of relationship with industry

related

to product development. " But as a _Lancet_

(http://www.thelancet.com/journals/lancet/article/PIIS0140673605665221/fulltext)

(subscription required)

editorial noted in 2005 shortly before Congress passed its law, " it is hard to

believe that in a country with 125 medical schools – not to mention the pool

of

international experts – the FDA cannot find experts who do not have financial

ties with companies whose products are under review. " A New York Times

editorial has pointed out that " unless the FDA makes a more aggressive effort

to

find unbiased experts or medical researchers start severing their ties with

industry, a whiff of bias may taint the verdicts of many advisory panels. "

Lutter said that FDA plans to issue a guidance document aimed at reducing its

reliance on conflicted advisers " very soon. " Former deputy commissioner

Gottlieb promised the new guidance last July at a meeting sponsored by the

Center for Science in the Public Interest.

'State Climatologists' Stripped of False Titles

Delaware Gov. Ruth Ann Minner (D) has become the latest state official to

ask a climate-change skeptic to stop identifying himself as a " state

climatologist. " In a letter to R. Legates sent earlier this month, Minner

asked

him to stop using the title when making public statements about global

warming, noting that his views are contrary to her adminstration's, the

Wilmington,

Del., _News-Journal_

(http://www.delawareonline.com/apps/pbcs.dll/article?AID=2007702220356)

reported. Legates has ties to several groups that have

received funding from ExxonMobil including the Competitive Enterprise Institute

and

the National Center for Policy Analysis.

Virginia and Oregon have also recently asked climate-change skeptics in

their states to stop identifying themselves as state climatologists. The

Portland

_Oregonian_

(http://www.oregonlive.com/news/oregonian/index.ssf?/base/news/1171083308311040.\

xml & coll=7) reported earlier this moth that Oregon Gov. Ted

Kulongoski (D) had asked Oregon State University President Ray to

stop , head of the Oregon Climate Service, from calling himself

the " state climatologist. " And Virginia Gov. Tim Kaine's (D) administration

_told_ (http://www.cspinet.org/integrity/watch/200608281.html#3) global-warming

skeptic J. s last year not to use the title anymore, noting

that there has never been " evidence that any governor since 1980s had made

such an appointment. " However, just last week, an article in _Nature_

(http://www.nature.com/news/2007/070219/full/445806a.html) (subscription

required)

reported that s had been Virginia's state climatologist since 1980 and

failed to note s' numerous ties to the fossil fuels industry.

CDC Vaccine Committee Accused of Whitewashing Thimerosal Dangers

The Centers for Disease Control and Prevention's Advisory Committee for

Immunization Practices (ACIP) last week determined it is safe for pregnant

women,

infants, and children to receive the flu vaccine, despite concerns from some

health advocates about the use of the mercury-containing preservative

thimerosal in the vaccine. The Institute of Medicine has _recommended_

(http://www.nap.edu/catalog/10208.html) since 2001 that mercury not be

injected into

these sensitive populations, but the CDC now recommends flu shots for pregnant

women and children ages six months through 5 years. While most routine

childhood vaccines are currently available in mercury-free or reduced mercury

versions, the majority of flu shots still contain 25 micrograms of mercury. The

Environmental Protection Agency has established _guidelines_

(http://www.fda.gov/cber/vaccine/thimerosal.htm) for safe exposure to mercury

at 1 microgram

per kilogram of body weight per day.

Central to the health advocates' concerns about CDC's recommendations are

conflict-of-interest accusations surrounding the doctor who presented the

committee with a review of the evidence on the dangers of thimerosal. Dr. Jay

Lieberman has been a _consultant_

(http://cme-online.med.upenn.edu/index.pl?iid=313183;op=show;isa=Course) to

Merck, GlaxoKline, and Sanofi-Pasteur and

is on the speakers' bureaus for all three vaccine-makers, which use thimerosal

in their products. " It's obvious this committee's ties to the drug companies

are dictating what will come to light regarding the use of mercury in

vaccines, " said Bothwell, board chairwoman of the National Autism

Association, in a _statement_

(http://www.nationalautismassociation.org/press022307.php)

..

Positive Results More Likely in Breast Cancer Trials Involving Drugmakers

Studies of breast cancer medicines that involve drug manufacturers are more

likely to show positive results than those without their involvement,

according to a study to be published in the April 1 edition of the journal

Cancer.

The study, led by Dr. Peppercorn of the University of North Carolina

School of Medicine in Chapel Hill, analyzed 140 trials reporting breast cancer

therapy results over the past decade in select journals at five-year

intervals. Of the 140 trials, 67, or 48 percent, reported some form of drug

company

involvement, meaning the studies had received funding or drugs from a

manufacturer or at least one of the study's authors worked for a drug company.

Drug

company participation increased from 44 percent in 1993 to 58 percent in

2003. Besides the increased likelihood of reporting results that favoring the

experimental therapy, industry-funded studies also were significantly more

likely to use " single arm " designs – that is, a study whose patients get the

same

treatment with no control group to compare efficacy. Drug company-sponsored

trials also tended to target patients with advanced disease. Three of the four

authors of Cancer study, including Peppercorn, had financial ties to

manufacturers of anti-cancer drugs.

Cheers and Jeers

· Jeers: A recent _Reuters_

(http://www.alertnet.org/thenews/newsdesk/N21306990.htm) article about a new

study of the GlaxoKline herpes medication

Valtrax (valacyclovir) did not disclose that Dr. Philip Keiser, who lauded

the medication, has conducted _research_

(http://www.medscape.com/viewprogram/6288_authors) for GlaxoKline and is

on the company's speakers' bureau.

· Cheers: An op-ed in the _Washington Times_

(http://www.washtimes.com/commentary/20070219-102043-5765r.htm) identified

Driessen as " senior

policy adviser for the Congress of Racial Equality and Center for the Defense

of

Free Enterprise, two groups that have received some ExxonMobil support for

work by him and others on malaria, Third World agriculture and economics,

climate change, and other issues. "

· Jeers: The _Chattanooga Times Free Press_

(http://www.msnbc.msn.com/id/17290669/) quoted global warming skeptic

Christy without noting Christy's

_affiliation_ (http://www.exxonsecrets.org/html/personfactsheet.php?id=903)

with several organizations that have received funding from ExxonMobil

including the Competitive Enterprise Institute and Cato Institute. Christy was

also

cited last week in an _Arizona Daily Star_

(http://www.azstarnet.com/metro/170549) article on global warming.

Odds and Ends

Richmond, Va.-based tobacco giant Philip USA is donating $25 million

to the University of Virginia, primarily for research " to help prevent youth

smoking, improve the effectiveness of smoking-cessation efforts and reduce

the harm caused by smoking, " the university said in a _press release_

(http://www.virginia.edu/uvatoday/newsRelease.php?id=1469) . … The House

Oversight and

Government Reform Committee is holding a follow-up hearing Thursday to

examine political interference in federal climate science. … Merck & Co.

announced

last week that it is suspending its campaign to get state legislatures to

require pre-teen girls to receive a vaccine for human papillomavirus, the _Wall

Street Journal_

(http://online.wsj.com/article/SB117200727319814015-search.html) (subscription

required) reported. Merck is the manufacturer of the only

vaccine currently on the market. … Michigan's Henry Ford Health System last

month became the first health care system in the country to require drug

companies to acquire certification before conducting business there, as part of

an

overall strategy to reduce drug reps' influence that also included bans on

free lunches, gifts, and other perks, the _Detroit News_

(http://www.detnews.com/apps/pbcs.dll/article?AID=2007702210341) reported.

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