Sting Operation Exposes Gaps in Oversight of Human Experiments

Thousands of medical research groups that monitor clinical trials on behalf of the drug industry may face tougher regulations in the wake of a congressional sting operation that found gaps in the nation's oversight of experiments on humans.
The sting, detailed at a House Energy and Commerce Committee hearing Thursday, involved the creation of a fictitious company and a fake medical device, a surgical adhesive gel. The sham firm then applied to three for-profit oversight groups -- called institutional review boards, or IRBs -- for approval to begin a clinical trial using their adhesive on human subjects.
Two IRBs contacted by the GAO's sting operators -- Argus IRB of Arizona and Fox IRB of Illinois -- rejected the Adhesiabloc proposal because of unanswered safety questions.

Coast IRB LLC of Colorado Springs, Colo., did approve a study for the fictitious adhesive gel, "Adhesiabloc." Five months after approving the study for abdominal surgery patients, Coast learned that neither Adhesiabloc nor its maker, Device Med-Systems of Virginia, existed.

Coast CEO Dan Dueber said in an interview that the congressional case was illegal entrapment. At the hearing, Mr. Dueber testified, "The GAO perpetrated an extensive fraud against my company. You pulled the wool over our eyes -- congratulations." Because the product was fake, it was never used.
As part of the sting, the committee also created a sham IRB to see whether the Department of Health and Human Services, which registers IRBs, would certify their fictitious group.

The committee, working with the Government Accountability Office, Congress's investigatory arm, named the CEO of the fake IRB Truper Dawg, after a staffer's three-legged dog, now deceased. Other fake names included "April Phuls" and "Timothy Wittless," which lawmakers said should have signaled irregularities to HHS. The department registered the IRB.
http://online.wsj.com/article/SB123811179572353181.html

How Does the FDA Monitor Your Medical Implants? It Doesn’t, Really

http://www.propublica.org/article/how-does-the-fda-monitor-your-medical-implants

it is now Dr. Wakefield's turn to be exonerated

Mr. Justice Mitting's scathing indictment of GMC's unprofessional and dishonest handling of the Dr. Wakefield case is telling, as it once again calls into question the legitimacy of any of the claims made against Dr. Wakefield and his colleagues concerning their observational, peer-reviewed study. It only further reinforces what has already come to light about the blatant fraud that is the continued witch hunt against Dr. Wakefield for his independent work.

"The welcome decision to exonerate Prof. Walker-Smith is a clear indication that the GMC's case against the Royal Free doctors was manufactured to discredit any association between bowel disease, autism conditions and some of the parents' reported link to the MMR vaccine," writes Age of Autism. "The allegations leveled at Prof. Walker-Smith and the Royal Free team now have to be viewed with total skepticism as nothing more than a witch hunt by vested interests at the highest levels in government, media and the pharmaceutical industry."

This ruling will clearly bolster the efforts of Dr. Wakefield to vindicate his own reputation and career, including his recent lawsuit against Brian Deer, BMJ, and BMJ editor Fiona Godlee, all of which have repeatedly spread lies and slander about Dr. Wakefield and his paper (http://www.naturalnews.com/034974_Andrew_Wakefield_BMJ_lawsuit.html).

Learn more: http://www.naturalnews.com/035256_Professor_Walker-Smith_MMR_vaccines_High_Court.html#ixzz1uFbANzgz

The participation of physicians in torture and murder both before and after World War II is a disturbing legacy

More than 7% of all German physicians became members of the Nazi SS during World War II, compared with less than 1% of the general population. In so doing, these doctors willingly participated in genocide, something that should have been antithetical to the values of their chosen profession. The participation of physicians in torture and murder both before and after World War II is a disturbing legacy seldom discussed in medical school, and underrecognised in contemporary medicine. Is there something inherent in being a physician that promotes a transition from healer to murderer? With this historical background in mind, the author, a medical student, defines and reflects upon moral vulnerabilities still endemic to contemporary medical culture.
http://jme.bmj.com/content/early/2012/05/02/medethics-2011-100372.abstract

Alessandra Colaianni, of Johns Hopkins Medical School, asks the unsettling question: "Is there something inherent in being a physician that promotes a transition from healer to murderer?" Some recent situations in the United States suggest that this is possible: allegations of euthanasia in the wake of Hurricane Katrina, torture of Guantanamo detainees, and the participation of doctors in capital punishment. Colaianni suggests that there are illuminating parallels between medical training and the work of doctors in Auschwitz.
Socialisation and hierarchy: doctors are pressured to conform to group norms, often with techniques like "Sleep deprivation, heightened stress levels and fear of failure". Ambition: just as Nazi doctors participated in the T4 euthanasia program to advance their careers, today's doctors are pressured to succeed even at the risk of losing their integrity. Doctors have a "licence to sin" which can easily be perverted: some "actions are allowed when they are performed by physicians, but are the stuff of horror films and criminal cases when non-licensed personnel attempt them."
Detachment was also a characteristic of Nazi doctors. They could select prisoners by day and dine with their colleagues by night: "the medical profession requires unflappability in the face of things that others would consider disgusting, horrific, or otherwise overwhelming".
Colaianni concludes that medical students need to realise how vulnerable they are to being seduced by the special privileges of their profession. "It is for this reason that a solid grounding in principles of ethics, individualism and human rights is so crucial for physicians and others in positions of power or trust."
http://www.bioedge.org/index.php/bioethics/bioethics_article/10042