Integrity in Science Watch

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September 4, 2007:

Conflicted Docs to Consider EPO Safety

Voluntary Toxics Testing Falls Short

MN Psych Docs Get the Most Payouts

NIH Director Charged with Bungling Ethics Probe

and more ...

FDA Waives Three Conflicted Docs onto EPO Safety Panel

The Food and Drug Administration revealed late last week that three

_physicians_

(http://www.fda.gov/ohrms/dockets/ac/07/waivers/2007-4315W1-00-index.htm)

participating in the September 11 advisory committee meeting that will

evaluate the safety of red blood cell stimulating agents used in dialysis have

financial conflicts of interest. A joint meeting of the Cardiovascular and

Renal Drugs and Drug Safety advisory committees will review new clinical trial

data that led the FDA last March to slap a black box _warning_

(http://www.fda.gov/cder/foi/label/2007/103234s5122lbl.pdf) on Amgen’s

Aranesp and Epogen and

& ’s Procrit, known collectively as EPO. The trials, reviewed

in this Journal of the American Medical Association _editorial_

(http://jama.ama-assn.org/cgi/content/full/297/15/1713) , showed excessive EPO

use

increases the risk of heart attack, stroke and premature death.

After the FDA issued its warning, the Center for Medicare and Medicaid

Services, which pays for most dialysis patients in the U.S., instituted a

monitoring and payment _policy_

(http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=11) that will cut EPO

use. Amgen, whose stock price fell 25 percent since

March, spent over $9 million on lobbyists in the first half of 2007 – nearly

as

much as it spent in all of 2006. The National Kidney Foundation’s anemia

management _committee_

(http://www.kidney.org/professionals/kdoqi/guidelines_anemia/bios.htm) , the

president of the _Renal Physicians Association_

(http://waysandmeans.house.gov/hearings.asp?formmode=view & id=6177) , and the

_American

Association of Kidney Patients_ (http://www.aakp.org/message/) – which all

have extensive _financial ties_

(http://jama.ama-assn.org/cgi/content/full/298/8/861) to Amgen or J & J – have

issued guidelines and lobbied for measures

that could lead to EPO use at or above the maximum level suggested on the FDA

label. A provision in the House version of the Children’s Health Insurance

Program bill would grant $300 million in incentive payments to dialysis clinics

over the next three years if they maintained relatively high levels of EPO

use. A provision in the House version of the Prescription Drug User Fee Act

renewal would limit conflicts of interest to one per committee.

Voluntary Industry-Government Toxics Testing Program Falls Short

The chemical industry fell far short of its promise to produce data on the

toxic properties of widely-used chemicals, a new _report_

(http://www.environmentaldefense.org/hpvreportcard) from Environmental Defense

showed. The

Environmental Protection Agency established the _voluntary testing program_

(http://www.epa.gov/chemrtk/) in 1998 in collaboration with the American

Chemistry

Council and Environmental Defense. The idea was to generate voluntary data

disclosure for regulatory actions under the federal Toxic Substances Control

Act (TSCA) since the law limited the EPA’s ability to demand hazards data to

just 200 of the 80,000 chemicals on the TSCA inventory list. The industry’s

self-imposed deadline for producing toxics data for an additional 2,200

chemicals on the inventory was 2004. To date, industry has produced data for

less

than half that number. The U.S. lags far behind the regulatory toxics testing

programs in the European Union and Canada.

Psychiatrists Lead Buck-raking Pack in Minnesota

Drug manufacturers paid Minnesota physicians over $73 million between 2002

and 2006 with psychiatrists receiving over 10 percent of the payouts, more

than twice any other specialty, a new report shows. Minnesota requires drug

companies disclose their payments to doctors, which often involves their

speaking

at sessions promoting the companies' drugs. An analysis of the latest data

by the _St. Pioneer Press_

(http://www.twincities.com/allheadlines/ci_6728068?nclick_check=1) showed that

disclosure has failed to stem the tide of

industry grants. Psychiatrists, for instance, collected $2.1 million in 2006, a

50 percent jump over the year before. Eli Lilly, whose best-selling drug is

the atypical anti-psychotic Zyprexa, led the pack among corporate donors with

over $11 million in payouts over the five-year period. One psychiatrist,

Simon, who sits on the state’s Medicaid formulary committee, received

$570,000, most of that from Eli Lilly, according to the report. " Most of the

psychiatrists who are really good have ties to industry, " Simon told the paper.

Meanwhile, Representative Henry Waxman (D-CA) _told_

(http://oversight.house.gov/documents/20070829105649.pdf) the head of the

National Toxicology

Program (NTP) at NIEHS that its internal study of conflicts of interest among

contractors is invalid because it was based on the contractors' own

self-assessments. “The working group's reliance on contractor reports is a

questionable way

to assess conflicts of interest,†the letter charged. The internal review

was prompted by _revelations_

(http://www.cspinet.org/integrity/watch/200704092.html#1) in March that NTP’s

review of the carcinogenic compound bisphenol A

had been run by a consulting firm with financial ties to the company that

makes the chemical.

Cheer: to the Washington Post for _exposing_

(http://www.washingtonpost.com/wp-dyn/content/article/2007/08/30/AR2007083002198\

..html) the infant formula

industry’s successful campaign to pressure the Health and Human Services

Department to tone down ads promoting the health benefits of breast feeding.

According to the report, Rep. Henry Waxman is investigating allegations that

former Surgeon General Carmona was blocked by political appointees at

HHS,

including a former drug industry lobbyist, from participating in the

breast-feeding advocacy effort.

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