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FDA Scientists To Obama: Agency Is ‘Fundamentally Broken’

fda-logo.jpgNine Food And Drug Administration (FDA) scientists have sent a letter to President-elect Barack Obama’s transition team, urging the incoming administration to reform the “fundamentally broken” agency. The letter’s authors revealed that President Bush’s FDA managers “ordered, intimidated and coerced scientists to manipulate their research results in violation of federal law.” Scientists who did not comply with managers faced “the threat of disciplinary action”:

The scientists wrote that they have raised their concerns with FDA Commissioner Andrew von Eschenbach and Bill McConagha, an attorney and the assistant commissioner for accountability and integrity at the agency, but added that the agency has taken no action to address the issues. In addition, they wrote that FDA has promoted and rewarded some of the managers involved with the inappropriate practices.

Indeed, in 2005, a Government Accountability Report (GAO) concluded that “political pressure led to the Food and Drug Administration’s 2004 decision to deny over-the-counter (OTC) status to Plan B, an emergency contraceptive.”

The FDA Commissioner’s denial “overruled the FDA’s expert advisory panel, FDA scientists in charge of over-the-counter and reproductive drugs, and the director of the Office of New Drugs, all of whom recommended approving Plan B for OTC use,” the report concluded.

Political interference led Susan F. Wood, the top Food and Drug Administration official in charge of women’s health issues, and Frank Davidoff, an FDA consultant to an advisory panel that voted to approve Plan B, to resign in protest. “I can no longer serve … when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled,” Wood explained.

Earlier today, during his confirmation hearings, Health and Human Services nominee Sen. Tom Daschle (D-SD) emphasized, “as Secretary, I will work to ensure that trust in FDA is restored as the leading science based regulatory agency in the world.” “I will send a clear message from the top that the President and I expect key decisions at the FDA to be made on the basis of science – period,” Daschle said.

Daschle: ‘Wellness Has To Be Cool And Prevention Has To Be A Hot Thing’

During his confirmation hearing before the Senate Committee on Health, Education, Labor, and Pensions, Health and Human Services (HHS) nominee Sen. Tom Daschle (D-SD) reiterated his commitment to investing in wellness and prevention and changing the “paradigm from illness to wellness.” “Wellness has to be cool and prevention has to be a hot thing,” Dashle said.

Watch it:

Indeed, compared to scientific recommendations, “too few Americans receive preventive services.” According to one study, for instance, “only half of recommended clinical preventive services are provided to adults.” In 2002, the United States spent $132 billion treating Americans with diabetes, but just $70 billion on the prevention of all diseases.

Correcting this imbalance could build a healthier nation and save health care dollars. In fact, experts estimate that just ensuring that every child receives every routine vaccination could reduce direct and indirect health care costs by up to $40 billion over time.

Luckily, Daschle’s deputy at the HHS, former CAPAF Senior Fellow Jeanne Lambrew, has promoted the idea of a Wellness Trust, a concept premised on the notion that “disease prevention is more like homeland security than health insurance: everyone needs it, no one notices if it works, and it depends on persistent, strong leadership and systems“:

The proposed Wellness Trust would dramatically increase the nation’s emphasis on prevention. It would create a broad-based, 21 st century system, including population-based interventions outside of the traditional bounds of the health care system. It would use consolidated financing and information technology to expand and coordinate services over a lifetime and across care settings. While elements of the Wellness Trust could be implemented immediately, it should be an essential component of any effort to reform the U.S. health care system.

Sen. Hillary Clinton (D-NY) and Rep. Doris Matsui (D-CA) introduced Lambrew’s Wellness Trust in legislation. To read more about the Wellness Trust, click here.

‘Balanced’ C-SPAN Promotes Heritage’s Questions And Answers On Stream Page For Daschle Hearings

Yesterday, the Heritage Foundation published a WebMemo, ‘Key Questions for Senator Tom Daschle, Nominee for Secretary of Health and Human Services.’ The document both asks and answers the questions, effectively twisting Daschle’s quotes into standard conservative attacks.

The document reads like a copy-paste job of Heritage’s 1994 talking points on health reform — in which the Foundation argued that Clinton’s reform efforts would result in a “top down, command-and-control system.” This latest incarnation suggests that Daschle’s reforms violate the Hippocratic Oath, undermine “Americans’ personal liberty,” and ration care.

Yet despite the predictable smear tactics, C-SPAN linked to the Heritage questions — and to Heritage alone — from its stream page for Daschle’s confirmation hearing:

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C-SPAN’s ‘About’ page tasks the network with providing coverage “without editing, commentary or analysis and with a balanced presentation of points of view.” Perhaps the network can then link to the Wonk Room’s new report, Ten Myths About Health Care Reform?

Debunking Conservative Health Reform Myths

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Today, the Senate Committee on Health, Education, Labor, and Pensions will hold confirmation hearings for former Sen. Tom Daschle (D-SD), President-elect Barack Obama’s nominee to head the Department of Health and Human Services.

In advance of the confirmation, conservatives have been actively filling the nation’s leading newspapers with editorials attacking Daschle and misrepresenting the consequences and implications of expanding access to affordable health care coverage.

In a recent op-ed in the Wall Street Journal, for instance, Karl Rove warned that Obama’s health care appointments suggested that he would “run to the extremes with government-run health care.” Other conservatives have falsely suggested that Obama’s health reforms would “build more federal bureaucracy, impose price controls, restrict medicines and technology, boost taxes, mandate the purchase of health insurance, and expand government health care.”

In a new report released today, the Wonk Room identifies and debunks the right-wing’s most widely circulated myths about reform. Here is a sampling:

- MYTH: “The Left’s idea of limiting Medicare spending is to have bureaucrats tell Mom she cannot have the cancer treatment she wants.” [Washington Times, 12/28/2008]

REALITY: Research into the comparative effectiveness of treatments can identify the procedures that provide the best results at the lowest cost. Currently, at least one-third of medical procedures have questionable benefits, according to the Rand Corporation. [Rand Corporation, 1998]

- MYTH: Affordable health reform would “cancel private coverage and care.” [Heritage Foundation, 12/04/2008]

REALITY: According to the Urban Institute, private insurers who “offer a superior product through high levels of efficiency, satisfaction in consumer preferences and ease of access to quality medical services” will thrive in a reformed market. The presence of a well-run and effective public plan will incentivize innovation in cost containment and service delivery. [Urban Institute, 10/03/2008]

Read the full report here.

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