Researchers involved in clinical trials are being so choked by bureaucratic red tape that their research is suffering, according to Sally Satel, a scholar at the American Enterprise Institute in an op-ed piece in Friday’s New York Times. Satel’s insights are valuable because they point out that thickets of regulations often don’t protect subjects. She however misses the larger point that the red tape and lack of subject protection in what she in the article refers to as the “dysfunctional system” of clinical trials is due mostly to their explosive growth and commodification in the last decade.

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.

The New York Times has a story about cancer trials that subtly urges patients to enroll as subjects. There is also a sidebar about how to make the decision to enroll. Al in all, a pro-trials approach, which is becoming all too common in most media coverage of trials at the same time that corporate interests assert themselves … Also, a story from a recent Parade magazine urging people to, you guessed, it, enroll in trials. This one is done is such a strenuously blatantly fashion that the subhead is: “Sometimes it take an experiment to make you well.”

Forty Years’ War Lack of Study Participants Said to Hobble Fight … New York Times – Of course, there have been highly successful clinical trials…

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.

The research community and clinical trials industry is reacting quickly and efficiently to formulate a swine flue vaccine, as proven by the number of trials set to begin or that have already started throughout the country. It is very impressive… Also, a nice story from the Examiner about the phases of clinical trials. Good refresher…
H1N1 Vaccines To Undergo Clinical Trials – NY1 – NY, USA – Government affiliated scientists will hold a series of clinical trials to gather information about possible vaccines. The vaccine will be given to adult … See all stories on this topic

Clinical Trials for Swine Flu Vaccine to Begin Soon – New York Times – United States … ready 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 …

A vaccine for swine flu is nearing clinical trials testing while at the same time the U.S. is pumping another $1 billion into the vaccine to get it to trials, perhaps this month… A Denver television news station (of all places) has a very interesting story on a report released from watchdog organization Public Citizen saying that a large number of clinical trials results are not accurate because money plays to big an influence in trials… An examination of cancer trials reveals that race plays a part in the rates among African Americans in some significant cancers… all in all, interesting reading for a beautiful Wednesday…

Labs say swine flu vaccine is close to clinical trials – guardian.co.uk – UK – Some are in the experimental stages, while others are approaching the need for clinical trials. However they are “by no means” ready yet, according to the …

Dr. Scott Gottleib, a former deputy commissioner at the FDA, reviewed Chasing Medical Miracles favorably in today’s Wall Street Journal…

“Mr. O’Meara is adept at portraying clinical trials and in discussing ethical concerns — about CROs possibly skewing results to favor the interests of the drug companies that hire them, and about the financial incentive for clinical-trial applicants to lie about their medical history. “

An excellent article in the New York Times by the always astute and well-informed medical and health writer Gina Kolata sheds light on how cancer research is driven by a grant system that rewards cautious thinking more than promoting bold ideas of how to cure and treat cancer. The article is a nice look at a portion of the “medical industrial complex” that appears to be a self-sustaining enterprise and an embedded part of how health care and research are conducted in the United States.

In a related story …

The death of Michael Jackson from what appears to be sudden cardiac arrest could probably not have not been prevented if a home automated external defibrillator (AED) had been applied to revive his heart rather than simply receiving CPR. Keep this in mind in the next few days as you hear more and more medical professionals give opinions about how his death might have been prevented: A home defibrillator in all likelihood would not have saved Michael Jackson if he suffered from sudden cardiac arrest.