A gangbusters investigative report by Science Magazine (July 2018) documents FDA’s disregard of substantial financial conflicts of interest by the advisory panel members that FDA selects. What’s more, the reporters uncovered a previously overlooked stream of company kickbacks to doctors on FDA advisory . . . Continue reading →
“Cochrane Announces Support of New Donor” This may be the last straw in dissolving the illusion of scientific integrity i n reviews published by the Cochrane Collaboration group. With a $1.15 million “donation” – chicken feed for the Bill and Melinda Gates . . . Continue reading →
The difficulty of identifying academic experts who have not crossed over to the commercially funded research was acknowledged by Dr. Marcia Angell, just before she relinquished her position as editor of The New England Journal of Medicine (“Is Academic Medicine for Sale?” . . . Continue reading →
Lots of babies get measles in Africa and India, and it is a significant cause of death there. A great deal of work has gone into developing measles vaccines that can be given to children at younger and younger ages, especially in . . . Continue reading →
Posted by Meryl Nass, MD Swine flu vaccine-induced narcolepsy is costing European governments over $1 Billion due to liability waivers for manufacturers; and the same waivers were just issued for Ebola vaccines. The UK is paying out about $1.7 million dollars per . . . Continue reading →
Anthrax Vaccine: Its checkered history, excessive stockpile and the human and financial costs By Meryl Nass, MD* The current vaccine (Biothrax, manufactured by Emergent Biosolutions or EBS) has never been proved effective in humans. One human trial took place in the 1950s . . . Continue reading →
Part III. The Untouchable Third Rail in Healthcare—The Vaccine Controversy: Core Issues Continue reading →
America’s healthcare system is riddled with financial conflicts of interest. Business interests and commercial priorities undermine the precautionary principle of Medicine, the therapeutic mission of Medicine, the scientific integrity of Medicine. Government oversight agencies and Congress have subordinated the public interest for $$$. As a result, America’s healthcare delivery system is the third leading cause of death.
The decision to suspend the trial is viewed as highly questionable, raising disturbing questions about the role that marketing played–especially in light of the fact that Zytiga’s patent is due to expire in 2017.
The latest area of controversy focuses on the proposed revision of the definition "behavioral addiction disorder" extending the addiction diagnosis to include drug, alcohol and gambling. It is estimated that the change would expand the number of people labeled as "addicts" by 20 to 30 million who would be entitled to treatment and disability payments costing taxpayers many hundreds of millions of dollars. Continue reading →
Even if retracted, published clinical trial reports that misrepresent findings, withhold negative data, or make false, or unsubstantiated claims have done irreparable damage. AHRP calls upon all medical journals to adopt a publication policy requiring submission of the sponsor’s formal Clinical Study Report to accompany articles about clinical trial findings.
News and Analysis for Colleges, Universities and Teaching Hospitals
Big Drop in OHRP Letters, Open Cases Raise Questions of Agency Commitment
In 2010, the Office for Human Research Protections issued and posted 16 determination letters, the lowest number in its 11-year history and less than half the number issued in each of the previous five years. Since 2007, the office has averaged 35 letters a year, down from a peak of 146 in 2002 and another high of 86 in 2006.
The number of determination letters is tied to the number of cases OHRP opens, and during the recent past, that number has also declined, RRC has learned, tumbling to an all-time low of six in 2009. Some tie the decline in activity to the arrival of Jerry Menikoff, whose tenure as OHRP director began in the late fall of 2008.
