A story headlined “Cutting-edge therapy is one reason why many participate in clinical trials” in the Indianapolis Star by Barb Berggoetz about why people enroll in clinical trials is indicative of an overall bias on behalf of the media toward encouraging participation in trials. Most stories about trials stress the positive outcomes. Some are so blatant as to almost seem like a public service announcement for the institution or business conducting the trial. The articles, like the one below, always mention risks. But, like I wrote in Chasing Medical Miracles about my own experience becoming aware of the real risks of any trial: “The trial up until now had been like taking a trip to Disney World. Before your plane takes off they tell you in detail what to do if it becomes a fireball of screaming death and dives nose first into the ground. But you don’t hear that part. You’re too busy thinking about shaking hands with Goofy.”

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 …

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 ,,,

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 …

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 ..

An article in Scientific American states that “patients” in clinical trials would prefer to be informed if researchers in their clinical trial have a financial conflict of interest in the outcome of the research. The premise, however, that subjects are eager for such disclosure, is not necssarily true and might actually be false.

Some really fascinating stories get us going into the weekend. Interesting and heartfelt responses to NYT article about cancer trials and why people don’t volunteer for trials… although I’m not convinced of their necessity at all, very cool story about iphone and Windows apps for clinical trials … and an update on efforts in the U.S. and abroad about progress on trials for a swine flu vaccine…

Why Patients Turn Down Clinical Trials – New York Times – I read with interest your article about the chilling effect that low recruitment for clinical trials has had on the search for meaningful treatments.

I was on the Diane Rehm Show, out of WAMU in Washington DC, yesterday, July 29 to discuss Chasing Medical Miracles and clinical trials in general. Susan Page, the Washington bureau chief for USA Today was the guest host for Diane. I thought the hour was interesting and wide-ranging but you can listen and decide for yourself by clicking on “More” then clicking the link there to access a Real Player and a Windows Media version of the interview.

More than 2,000 volunteers will be recruited for clinical trials to test potential swine flu vaccines at eight locations in the United States. The trials will move quickly over two months to develop a vaccine to combat the flu before another outbreak can occur in the Fall. Volunteers, apparently, are already asking to sign up to be vaccinated. The fascinating part of this effort will be to see how such a crash program goes. The New York Times story is below. For all aspects on the progress of this program in the next two months, check back…

Clinical Trials for Flu Vaccine Are to Begin Soon
By DONALD G. McNEIL Jr.

With pharmaceutical companies racing to have a swine flu vaccineready for the fall flu season, the federal government announced Wednesday that the first clinical trials of vaccine candidates would start shortly.

A story out of Pennsylvania on clinical trials subjects is insightful except for how it pushes pushing people to volunteer, which is too often typical of media coverage about trials … The clinical trials market tops $50 billion a year. That. Is. Amazing. Talk about growth in a shrinking economy… The Office for Human Research Protection slapped a hospital in Illinois for documentation errors and oversights in 11 clinical trials – all too common an occurrence I’m afraid …

Clinical research study participants share experiences – PennLive.com – Harrisburg, PA, USA – However, Dwyer-Jones said only 3 percent of all cancer patients are enrolled in clinical trials. “That’s a pretty small group of people for a really big job …