Friday, September 27, 2013

AHRP- Beware of Comparative Effectiveness Research--a Major Government /PhRMA Initiative

Advancing Honest and Ethical Medical Research


OBAMACARE includes a major initiative which needs close public scrutiny otherwise unsuspecting patients--in particular, patients whose medical bills are paid for by Medicare and Medicaid--will become human guinea pigs in medical experiments without their knowledge or consent.

A PhRMA-Merck sponsored Roundtable on "Comparative Effectiveness Research" is being held at the National Press Club in Washington, DC on October 29th.

The participants represent the federal government--officials from the so-called, Patient Centered Outcomes Research Institute (PCORI), the Executive Vice President & Chief Medical Officer of Merck, the President & Chief Executive Officer of PhRMA, and Academy Health--representing the major medical research centers such as Harvard, the Association of American Medical Colleges. 

No one involved in formulating plans for "comparative effectiveness research" and no one at this Roundtable represents the interest of ordinary citizens who will be sought as human subjects of potentially dangerous experiments.

The prototype for such "comparative effectiveness research" is the controversial, unethical oxygen-restricted SUPPORT experiment that was conducted on 1,316 extremely vulnerable, premature babies.  A two-year investigation by the federal oversight agency (OHRP) determined that SUPPORT was conducted in violation of federal informed consent requirements. 

In fact, parents were deceived--just as as parents had been deceived about the unethical radiation experiments conducted on their children in the 1950s, 1960s and 1970s before there were federal regulations requiring full disclosure of the foreseeable risks.

Neither parents were  informed about the nature of the experiment and the risks involved for their babies. The babies were randomized--without regard for their physical condition or oxygen need--to receive either high or low oxygen supplements.  The deceptive consent documents stated: "because all the treatments proposed...are standard of care, there is no predictable increase risk for the babies." But in fact, NONE of the babies in SUPPORT received standard of care.

The SUPPORT death toll: 
130 babies who were randomized to the restricted low oxygen group died (20%); and 107 babies randomized to the high oxygen group died (16%).

SUPPORT researchers complained that it takes "too much effort" to obtain consent; some mothers were approached up to 11 times to give their consent, yet, 47% refused. The researchers urged that informed consent be waived for similar trials.

The promoters of "comparative effectiveness research" would have you believe that there are no risks from "CER" research--they seek waivers from federal informed consent and disclosure requirements.  They would revert medical research to the pre-Nuremberg  Code  "good old days."

See detailed, documented evidence--from HHS sources--that back up our claim:!documentDetail;D=HHS-OPHS-2013-0004-0033 
(it takes several clicks on the government website)

(AHRP will re-post several submissions to 
HHS  Docket 2013-0004)

Vera Sharav


PRESS RELEASE: Comparative Effectiveness Research: Where Are We and Where Are We Going?
An expert roundtable on the impact of expanded comparative effectiveness research on innovation.
October 29, 2013  12:30 - 4:30 PM
l2:30 PM: Registration
1:00 - 4:30 PM: Roundtable Discussion

Phone: (617) 225-0857
WASHINGTON DC, USA -- HEALTHCARE UPDATE NEWS SERVICE™ -- SEPTEMBER 27, 2013: Join NEHI and the California Healthcare Institute for a half-day conference focusing on the current state of CER and innovation. Experts will assess how the landscape has evolved and discuss emerging trends such as Big Data, HIT, personalized medicine, and their impact on the future of CER.
LOCATION The National Press Club, Holeman Lounge
529 l4th St NW  Washington, DC 

Featured Participants:
Cliff Goodman, PhD   Senior Vice President and Director, Center for Comparative Effectiveness Research, Lewin Group, Moderator
Anne Beal, MD  Deputy Executive Director & Chief Officer for Engagement, PCORI

John Castellani 
President & Chief Executive Officer, PhRMA
Erin Holve, PhD  Senior Director, Academy Health
Eric Perakslis, PhD  Executive Director, Center for Biomedical Informatics & the Countway Library of Medicine, Harvard Medical School
Alan Rosenberg, MD  Vice President of Clinical Pharmacy & Medical Policy Programs, WellPoint, Inc.; Advisory Panel, PCORI
Michael Rosenblatt, MD  Executive Vice President & Chief Medical Officer, Merck
Jean Slutsky  Director, Center for Outcomes and Evidence, AHRQ


MERCK            PhRMA

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