A provocative debate in this week’s PLoS Medicine examines whether it
would be legitimate to stop a clinical trial of a global health tool early
in
order to reallocate the resources to testing newer products.

After the failure of three large clinical trials of vaginal microbicide
candidates (chemical agents aimed at preventing HIV infection), a 2007
editorial in Nature stated that the microbicide field “requires a
mechanism to help it make rational choices about the best candidates to
move
through trials.” In the PLoS Medicine debate, James Lavery (University of
Toronto, Canada) and colleagues propose one such mechanism, based on
stopping trials early for “opportunity costs.” They argue that microbicide
trial sites could have been saturated with trials of scientifically
less advanced products, while newer, and potentially more promising,
products were being developed. They propose a mechanism to reallocate
resources
invested in existing trials of older products that might be better
invested in more scientifically advanced products that are awaiting
clinical
testing.

But countering Lavery and colleagues’ proposal, David Buchanan (University
of Massachusetts, Amherst, USA) argues that stopping trials early for
such opportunity costs would pose insurmountable practical barriers, and
would risk causing harm to the participants in the trial that was stopped.
Funding: James Lavery and colleagues’ article was funded by a grant from
the Bill & Melinda Gates Foundation (BMGF) to Drs. Singer and Lavery.
Lavery and colleagues presented an earlier version of their ideas at the
BMGF, and feedback was taken into consideration in revisions of their
paper.
Peter Singer is also Sun Life Financial Chair in Bioethics at University
of Toronto. The funders had no role in the decision to submit the
manuscript
or in its preparation. David Buchanan received no specific funding for his
article.

Citation:
“In Global Health Research, Is It Legitimate To Stop Clinical Trials Early on Account of Their Opportunity Costs?”
Lavery JV, Ridzon R, Singh JA, Slutsky AS, Anisko JJ, et al. (2009)
doi:10.1371/journal.pmed.1000071

Source
Plos Medicine

The announcement of the establishment of a new Indigenous Health, Rural and
Regional Health and Regional Services Delivery portfolio has been welcomed by the
Pharmaceutical Society of Australia.

President of the PSA, Warwick Plunkett, said the establishment of the new portfolio was
recognition of the unique and challenging issues faced by indigenous health consumers
as well as those living in non-urban areas of Australia.

“Often people living in rural, regional and remote areas of Australia face enormous
difficulties when it comes to their health-care needs,” Mr Plunkett said.
“In addition, indigenous health has its own unique challenges which the establishment of
this portfolio will go a long way towards addressing.

“The PSA, as the organisation that represents the professional interests of pharmacists
across the nation, is well aware of these difficulties and has long advocated policies and
programs to help address them.

“The establishment the Indigenous Health, Rural and Regional Health and Regional
Services Delivery portfolio gives the Government and health-care professionals in
Australia a vehicle from which to work to improve the health needs and outcomes of
indigenous Australians and those living in non-urban areas.”

Mr Plunkett said the appointment of Mr Warren Snowdon as Minister for Indigenous
Health, Rural and Regional Health and Regional Services Delivery underscored the
importance of the portfolio.

“Mr Snowdon is a widely experienced politician and as a member for a rural area has
first-hand knowledge and experience of some of the issues and difficulties faced by
consumers in these areas,” Mr Plunkett said.

“On behalf of the PSA, I congratulate Mr Snowdon on his appointment and look forward
to working closely with him and his new department to help achieve the outcomes that
people in these areas so demonstrably need.”

Source
Pharmaceutical Society of Australia

WASHINGTON, June 10 — A line of skin care products — including some hand sanitizers — was voluntarily recalled after FDA inspectors discovered high levels of disease-causing bacteria in them, according to the agency.

Clarcon Biological Chemistry Laboratory, based in Roy, Utah, said the recall covers all Clarcon products.

The FDA said its analyses of several samples of over-the-counter topical antimicrobial skin sanitizer and skin protectant products revealed high levels of various bacteria, including some associated with unsanitary conditions.

According to the FDA warning, some of the bacteria identified in the products can “cause opportunistic infections of the skin and underlying tissues. Such infections may need medical or surgical attention, and may result in permanent damage.”

The inspection findings, the FDA said, were “particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds, damaged skin, and protect against various infectious diseases.”

The agency said the inspection also uncovered serious deviations from current Good Manufacturing Practice requirements.

The FDA released this list of products covered by the recall:

• Citrushield Lotion
• Dermassentials DermaBarrier
• Dermassentials by Clarcon Antimicrobial Hand Sanitizer
• Iron Fist Barrier Hand Treatment
• Skin Shield Restaurant
• Skin Shield Industrial
• Skin Shield Beauty Salon Lotion
• Total Skin Care Beauty
• Total Skin Care Work