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.

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. “

A review of Chasing Medical Miracles in the latest issue of New Scientist magazine is below. I am proud of the fact that the book holds up under scrutiny from such a well-respected publication.

Despite economic hard times more clinical trials were initiated in 2008 than the previous year, boding well for the industry to weather the recession. Perhaps helping keep the industry active in the coming months and years is an increase in stem cell trials overseas after the U.S. government changed policy and allowed federal fund to be used for the research. All this and a look at how trials results from China are being called into question plus lots more in today’s news…

Clinical research activity up significantly in 2008 – WTN News – Madison,WI,USA – Despite cutbacks in the international biopharma industry, clinical trial activity was up in 2008. Overall, 795 new clinical trials were launched in 2008 … See all stories on this topic

Policy Shift On Stem Cell Research May Produce Effect Overseas – Life Science Leader Magazine – Erie, PA, USA – A total of 2147 clinical trials (Phase I-IV) for stem cell therapies overall were listed, as of June, on NIH’s website: www.ClinicalTrials.gov … See all stories on this topic

Randomized trials published in some Chinese journals: how many are …

The Good News: The first clinical trial for healing an injured heart by using a subject’s own stem cells is underway. Pfizer proactively and voluntarily halted a trial after results showed it was to likely to be successful.

The Bad News: The validity of clinical trials conducted China is under scrutiny because of too many positive results. A columnist says some trials may be rushed and done poorly to get drugs to market quickly.

All in all, another normal day of mixed news about whether trials are mostly helping or harming. Here’s to hoping that on this July 4 eve we start moving in a direction where there’s more good news than bad news for the American people and the global community.

Doubts Cast On Credibility Of Some Published Clinical Trials – Science Daily (press release) – USA- However, all RCTs of pre-market drug clinical trial were authentic, and RCTs conducted at hospitals affiliated with medical universities were more likely to …