This blog began in 2007, focusing on anthrax vaccine, and later expanded to other public health and political issues. The blog links to media reports, medical literature, official documents and other materials.
Re: Clinical trial data for all drugs in current use
31 October 2012
Dr. Godlee's editorial (BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e7304) underscores the importance of the GlaxoSmithKline decision to allow access to anonymized patient level data from its clinical trials. Meta-analysts can now work more efficiently in summarizing knowledge relating to the benefits and risks of drugs and other medical interventions. As a result, the pace of evidence-based medical practice should pick up.
Open availability of data on which journal and other publications are based is wise public policy and one that is consistent with the replicability tenet of empirical science. Now selective reporting of findings by researchers should not go unnoticed for so long and thus draw swift deserved criticism and reprimand.
Yet the hold-outs may well be government agencies when their interests are threatened. My correspondence via registered mail to US Center for Disease Control (CDC) co-authors of an anthrax safety report that they had published in Vaccine (1) has gone ignored for almost 8 months--despite citation of the CDC policy relating to data release and copying my concerns to Dr. Thomas Freiden, CDC Director. The US Department of Health and Human Services, of which the CDC is a part, has been advocating a test of the anthrax vaccine in children in face of substantial doubt about the safety of the anthrax vaccine in adults. (2)
John H Noble Jr, Emeritus Professor
State University of New York at Buffalo, 508 Rio Grande Loop, Georgetown, TX 78633, USA
(1) Stewart B, Zhang Y, Rose Jr CE, Tokars JI, Martin SM, Franzke LH, McNeil MM. Health-related quality of life in the Anthrax Vaccination Program for workers in the Laboratory Response Network. Vaccine 2012;30 (10): 1841-1846. (2) Alliance for Human Research Protection (AHRP), 18 May 2012. Anthrax vaccine trial ethics? Science? See: www.ahrp.org/cms/content/view/851/9.
Meryl, enjoying spotting animals in the Thai jungle
Visiting tigers (inside the cages) in Chiang Mai
I think I'm in the wrong cage...
Night shot of a wild elephant
Canoodling at Elephant Nature Camp, Thailand
5 and 7 month olds playing
Mum and her 5 month old infant
Dusky Langur, curious about us humans in his territory
Self-satisfied Dusky Langur, after he relieved himself on me
Rhesus macaque: "I need three hands for this meal"
After swimming with dolphins at Key Largo, they checked me out at the edge of the pool
Visiting a Bhutanese Dzong, the regional seat of both government and religion (and a fort for good measure)
Why am I blogging?
Because life is meant to be lived! The left side of this blog has photos of some peak experiences. And the right side contains information about which I am passionate.
Too many peoples' lives are characterized by lack of authenticity, and fear of acknowledging and expressing their true nature. Employees cannot say what they think at work, and in the corporate system we must squish ourselves into square holes when we are round pegs. We thus lose touch with our souls, becoming cogs in a soulless, profit-driven machine.
The culture of political correctness has meant, in medicine, that we ignore how the foundations of our science are being undermined by commercialism. Clinical data generated or presented by the manufacturers of drugs, vaccines and devices cannot be trusted: there are hundreds of studies proving this. But this fraudulent information continues to be the only data informing the approval and use of vaccines, drugs and devices.
Unless scrupulous ethical conduct is demanded of physicians and biological scientists, our lack of meaningful standards will carry the medical-pharmaceutical system down the path of increasing irrelevance.
Medicine and its tools need to be affordable. The current medical-industrial milieu, characterized by contempt for science, countless ways for insiders to achieve wealth due to failure of good governance, and regulatory agency-to-industry revolving doors, has ushered in stratospheric pricing... further kicking us down that path to irrelevance.
Why is our new health care plan a giveaway to health industries instead of to health consumers? Wha won't it cover all Americans? Why was the "public option" never an option for the Obama administration?
So many of our leaders carry a heavy burden of mendacity and avarice. If they instead got in touch with their own souls (perhaps by exposure to the natural world), or made their decisions by maximizing the amount of good that results, our leaders might find real meaning and value in their lives.
Until that happens, the only way to straighten out the current mess is to demand accountability and impose penalties on unethical/dishonest leaders. Both political parties enjoy bounteous hors d'oeuvres from Pharma's table, making it unlikely the existing political "process" will provide relief--as we've seen in the demoralizing healthcare reform drama.
Until then, I'll continue to "call it as I see it" in this blog -- working and living the way life should be, in rural Maine, far from the centers of power.
Ellen Byrne has created several designs encapsulating aspects of the FBI's ridiculous case against Bruce Ivins. They can be purchased on T-shirts and coffee mugs. All proceeds will be donated to the the Frederick County chapter of the American Red Cross, a favored charity of Dr. Bruce Ivins.