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Archive for September, 2009

AIDS/HIV Vaccine Breakthrough Announced

Icon Written by Alex on September 24, 2009 – 10:16 am

Amazing. Truly amazing. The news today is that an AIDS vaccine has shown remarkable progress in clinical trials in Thailand. (Read AP story here.) There have been more than 100 AIDS vaccine trials in the last 20 years and none of them have gotten close to showing the kind of promise this one is showing. However, as we all know, it is only promise – not a cure or preventative. Much can go wrong. As one scientist soberly said about the findings of the trial: Now the work begins.

Having travelled to and spent time in eastern Africa to research Chasing Medical Miracles …

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Medical Journal Ghostwriting Crackdown … Maybe

Icon Written by Alex on September 18, 2009 – 10:27 am

Sen. Chuck Grassley (R-Iowa) and others, including some editors of medical journals are saying they will work to curtail ghostwriting in medical journals. This self-regulated practice of allowing journals and the scientific community to police itself is apparently not working because now up to 11 percent of articles in medical journals are ghostwritten, according to an article in todays New York Times which you can read here.

Of course everyone would agree it is long past time this issue was resolved ,,,



H1N1/Swine Flu Vaccine Approved Amid New Dire Predictions

Icon Written by Alex on September 16, 2009 – 10:53 am

A vaccine against the H1N1 viral strain – or swine flu – was approved yesterday by the FDA after a lightening round of clinical trials that are still, in fact, continuing to be conducted on some populations, including children and pregnant women. In the shadow of this good news however comes news that the vaccine might arrive too late to address the peak of the expected flu season …



So far better than so good on swine flu – H1N1 – clinical trials

Icon Written by Alex on September 15, 2009 – 9:06 am

Published results of clinical trials so far indicate one dose of the vaccine being tested could be enough to inoculate the more than 159 million people in the U.S. who are expected to be at risk to contract the flu this season. That’s good news but – and this is big – these trials are being hurried along. The process as much as the vaccine is a test and the results could be surprising in unanticipated ways. I am loathe to be a downer about this (although I appear to one of the only ones who is not doing backflips over the apparent success so far of all efforts in HINI clinical trials) because the effort to test the vaccine is impressive, appropriate, and in the best interest of the public health. But, as always, stay tuned for all shoes to hit the ground.

In other news, the American Medical News examines the ethical considerations of outsourcing pharmaceutical clinical trials to developing countries, a topic close to my heart since my trip to Uganda to see the unfortunate exploitation of people there ..



Preregistration and Swine Flu Clinical Trials

Icon Written by Alex on September 9, 2009 – 3:20 pm

This is definitely a glass half empty/glass half full thing. A report in the Chronicle of Higher Education reveals that five years after a consortium of medical journal editors asked for the pre-registration of clinical trials at their outset less than 50 percent of trials are registering properly so that they can be reviewed and their results scrutinized and journals are lax in insisting upon the practice. Now comes the glass half full part: The editor in chief of the Journal of the American Medical Association says that before the request for registration the number of trials that would have registered would have been “zero.” The editor sites the study results as real progress in getting compliance and full disclosure in trials results. There’s no word on what if any steps will be taken to ensure a higher or increased rate of compliance in the future… in other news, the swine flu vaccine keeps marching on and the number of trial in India grows by huge rates…