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Viewing by month: July 2012
July 6, 2012 | Posted By John Kaplan, PhD

In an opinion piece by Thomas Stossel, the Harvard physician and researcher argues that financial conflicts of interest between academic research investigators and industry are “unequivocally beneficial” and that the concern that these may cause bias is a “mania”.  Dr. Stossel seems to be on a crusade in this regard having written numerous similar opinion pieces published in industry supported blogs, Forbes, and the Wall Street Journal and has even started an organization (Association of Clinical Research and Educators) for the purpose of advancing his viewpoint. Dr. Stossel is the brother of well known libertarian and Fox News commentator John Stossel and seems to be expressing a similar libertarian view on biomedical research. Especially interesting considering the apparent strength of his beliefs is his recent publication in Nature Biotechnology in which he claims to prove that those who hold an opposing point of view are biased.

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

July 5, 2012 | Posted By Bruce D. White, DO, JD

The Wednesday, June 27, issue of the Washington Post reported that the U.S. Senate passed a bill empowering the Food and Drug Administration (FDA) to collect about $6 billion over the next five years in new “user fees.” The bill passed the Senate 92 to 4 and now goes to the White House for President Obama’s signature.

The bill for the first time requires generic drug manufacturers to make payments to the FDA as part of the drug approval, manufacturing, and marketing process. “Innovator” (or what old-timers might recall as “ethical” or “brand name”) pharmaceutical manufacturers have been paying similar user fees since the passage of the Prescription Drug User Fee Act (PDUFA) of 1992. The user fees were seen as a “private industry” approach with manufacturers being required to shoulder some of the drug regulatory and safety processes costs. Generic manufacturers will contribute about $300 million annually. In return, the FDA has agreed to help speed the approval process for generics.

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

 

July 2, 2012 | Posted By Wayne Shelton, PhD

The decision by the Supreme Court affirming the Patient Protection and Affordable Care Act (ACA) caused many who follow health care closely to breathe a sigh of relief. About 32 million more Americans will now have access to health care insurance. One sticking point that worried many of us was the mandate in the bill requiring everyone to purchase health care. It was frustrating this past March to hear in the oral arguments comparing a requirement for citizens to buy broccoli to a requirement to buy health care, as though both are the same type of market commodities. Many on the right, such as Judges Scalia, Thomas and Alito, expressed concerns that the mandate to require everyone to buy health care was a unconstitutional, a violation of the commerce clause; whereas, many others see health care as a basic public good, which unlike broccoli, everyone requires or will require sooner or later. Fortunately, a legal consensus was reached in the ruling, with Chief Justice John Roberts moving over into the majority in the 5-4 vote. In their ruling, the mandate was not viewed as an expansion of the commerce clause, but rather as a tax, which congress has a right to impose. Regardless of the final legal justification of the ruling, many of us are pleased that the most important piece of health care legislation since Medicare and Medicaid in 1965 is now the law of the land.

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.
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