Big Bravo from Health Lover, Ilena Rosenthal:
http://ilenarose.blogspot.com

http://foodconsumer.org/7777/8888/L_aws_amp_P_olitics_42/041803422008_EPA_Sued_o
ver_Pesticide_Approval.shtml

       
Integrity in Science Watch

Week of 04/14/2008

EPA Sued over Pesticide Approval

A coalition of environmental and farm worker groups sued the
Environmental Protection Agency after the agency approved the sale of
four organophosphate pesticides that the groups say pose unacceptable
risks to the environment and human health. The lawsuit alleged that
the agency violated the Federal Insecticide, Fungicide, and
Rodenticide Act and the Endangered Species Act when it decided in 2006
to allow the continued use of the chemicals, which are sprayed on
fruits and vegetables in California. California has classified one of
the pesticides as a cancer-causing substance, another as an air
pollutant, and a third has been banned or severely restricted in 13
countries. The approval came despite a letter from unions representing
EPA scientists urging Administrator Stephen Johnson to reject the
applications. ?Our colleagues in the Pesticide Program feel besieged
by political pressure exerted by Agency officials closely aligned with
the pesticide industry,? the letter stated. ?We are concerned that the
agency has lost sight of its regulatory responsibility in trying to
reach consensus with those that it regulates, and the result is that
the integrity of the science upon which Agency decisions are based has
been compromised.?

According to Earthjustice the environmental law firm that represents
the coalition, the substances have severe impacts on birds, fish,
honeybees, threatened, and endangered species and have carcinogenic
and neurotoxic effects on human health. The class of organophosphate
pesticides is derived from nerve gas poisons developed during World
War II. Clinton-era efforts to ban the pesticides were reversed by the
Bush Administration. The EPA approved the four substances as part of a
cumulative risk assessment of 20 organophosphate pesticides in 2006,
in which the Agency concluded that with the adoption of risk
mitigation measures, they posed no significant cumulative risk. The
EPA and CropLife America, the trade association representing
manufacturers of organophosphate and other pesticides, could not be
reached for comment on the lawsuit.

FDA Warns GSK on Failure to Report Data

GlaxoSmithKline received a warning from the Food and Drug
Administration last week for failing to file regular reports about
clinical trials on Avandia, a widely prescribed diabetes drug. The FDA
called Glaxo?s failure to provide reports a serious violation and
urged the drug company to take steps to prevent future violations. The
reports, which are required by law and used to catch potential safety
issues, were discovered by the FDA in Glaxo?s records. The FDA
inspection found that between 2001 and 2007, the company did not
inform the agency about the start of nine clinical trials and failed
to provide progress updates on another dozen studies.

Avandia was linked to increased risk of heart attack in a New England
Journal of Medicine study and now carries a ?black-box? warning on its
label. Once the highest-selling diabetes drug in the world, Avandia?s
sales have plummeted since the FDA ordered a warning label on the drug
in November of last year.

UNC Renames Public Health School after CEO Gift

The University of North Carolina School of Public Health will soon be
known as the Dennis and Joan Gillings School of Global Public Health
because of a $50 million donation to the school by Quintiles
Transnational Corp. CEO, Dennis Gillings. Quintiles Transnational, a
research contract and services provider for pharmaceutical companies,
has annual revenue of $2 billion. Gillings, who announced the gift
last year, was a professor in the UNC department of biostatistics for
17 years before he founded Quintiles Transnational in 1982. Currently,
he serves on the advisory council of the school of public health.
Gillings has previously given over $3 million to the university.

While UNC officials have praised the Gillings? charitable gifts, some
local professors have voiced concern. Steve Wing, an associate
professor of epidemiology at the UNC School of Public Health, and Cat
Warren, an associate professor in department of English at North
Carolina State University, wrote in the Raleigh News Observer last
month that the Gillings donation to the school could extend corporate
influence over the school of public health. The editorial also pointed
out that the school has recently developed relationships with
executives of Nestle, McDonald?s, PepsiCo, and Kraft Foods. ?If
universities are skewed more toward the agenda of for-profit
companies, they will be increasingly unable to promote public welfare
when it conflicts with industry?s bottom line,? the professors wrote.

In the week following the professors? editorial, Barbara K. Rimer,
dean of the UNC School of Public Health responded with her own
editorial in the News Observer. ?The Gillingses? gift was subjected to
great scrutiny within the university to assure that it conforms to
university policies and principles, including academic integrity and
autonomy. Their $50 million pledge is a personal not a corporate
gift,? Rimer wrote. The school of public health?s director of
communications, Ramona Dubose, added, ?The university does indeed have
regulations designed to protect the integrity of our research, no
matter what the source of funding. We do this in a variety of ways
through agreements that stipulate our freedom from constraints in
publishing results and disclosure forms that disclose potential
conflicts.? The university?s policy on research relationships between
the school and private entities is also available online.

Study Suggests Ending Cancer Trials Early Could be Unsafe

A study published in the Annals of Oncology suggests new cancer drugs'
effectiveness could be exaggerated when clinical trials are halted
early. Trials are discontinued early if the drug appears to be unsafe,
provides no benefit, or is so beneficial that denying access to the
treatment would be unethical. Giovanni Apolone, author of the study,
told the Guardian that pharmaceutical companies could be ending
successful trials prematurely in order to gain ?quicker access to the
market.? Halting trials too early because of patient benefit could
lead to incomplete and imprecise information about the drug. Potential
adverse (or additional beneficial) impacts of the medications could
also go undetected if the trials are shortened. The authors found that
25 cancer trials were stopped early between 1997 and 2007. For 75
percent of those trials, the data gained from them was used to apply
for FDA or European Medicine Agency approval.

Paul Meuller, an associate professor of medicine at the Mayo Clinic,
warned that such data could be unreliable and lead to dangerous
decisions by government agencies. ?Decisions are being made on some
fairly shaky evidence,? Mueller told the Wall Street Journal Health
Blog. While Mueller noted that halting trials early and bringing drugs
to the market sooner could benefit the industry and patients' health,
he said, ?Trials should be carried out long enough in order to obtain
data about outcomes important to doctors and patients.?

Odds and Ends

House Oversight and Government Reform Committee Chairman Henry Waxman
(D_CA) last week issued a subpoena to the EPA demanding unredacted
copies of documents concerning the agency?s refusal to grant
California a Clean Air Act waiver. The documents pertain to
communications between the agency and the White House prior to the
agency?s decision to deny the waiver, which would have allowed
California to proceed with policies to curb greenhouse gases. . . .
The Food and Drug Administration held two days of hearings last week
on possible agency guidelines designed to regulate embryonic stem-cell
therapies. The FDA continues to face pressure to approve clinical
trials of stem-cell-derived drugs from biotech companies.

Cheers and Jeers

   * Cheer to Lauran Neergaard of the Associated Press for noting
that Andrei Gudkov of the Roswell Park Cancer Institute also founded
Cleveland Biolabs Inc., a drug company currently working on a new
medical treatment that prevents radiation damage during cancer
treatment and biodefense.
   * Jeer to to Barnaby J. Feder of the New York Times for quoting
Mary F. Hazinski, spokesman of the American Heart Association (AHA)
about the benefits of home defibrillators without disclosing that last
year the AHA received money from Zoll Medical, Medtronic, and Philips,
three of the largest manufacturers of home defibrillators. Hazinski
extolled the usefulness of home defibrillators for some consumers
despite the results of a long-awaited, government-supported clinical
trial published this month in the New England Journal of Medicine,
which suggested otherwise.