A Medical Device Daily

The National Patient Advocate Foundation (NPAF; Washington) and the Prostate Cancer Foundation (PCF; Santa Monica, California) have praised Sens. Ted Kennedy (D-Massachusetts) and Kay Bailey Hutchinson (R-Texas) for introducing the 21st Century Cancer Access to Life-Saving Early detection, Research and Treatment (ALERT) Act.

The legislation, introduced late last week, offers what the NPAF characterized as "a comprehensive approach to combating cancer in America through improved cancer prevention, early detection, research and treatment."

The PCF said the bill "comprehensively addresses the challenges our nation faces in battling this disease and is the first sweeping cancer legislation introduced since the National Cancer Act in 1971, authored by Kennedy."

NPAF describes itself as "a national, non-profit organization dedicated to the mission of creating avenues of improved patient access to health care through public policy reform at the state and federal levels."

Its founder and CEO, Nancy Davenport-Ennis, said, "The National Patient Advocate Foundation commends Senators Kennedy and Hutchinson for renewing their commitment to the war on cancer and introducing this historic piece of legislation. We at NPAF consider it a . . . privilege to participate with our colleagues in the non-profit community and Sens. Kennedy and Hutchinson's health policy teams in the development of this bill and we look forward to working with them to ensure this legislation is signed into law."

The advocacy groups said the 21st Century Cancer ALERT Act would provide greater access to cancer care for all Americans, as well as increase funding for preventive treatments and screenings.

"Among other provisions that aim to improve care," said NPAF in a statement, "are greater coordination among existing resources through the linking of cancer registries and federal data sources; increased access to responsible research through improved privacy standards in clinical research; increased access to early detection and cancer prevention through state grant programs for screening and education; and improved coverage of cancer services under the Medicare and Medicaid programs."

It added: "By increasing disease prevention programs and breaking down barriers to patient participation in clinical trials, the legislation would not only improve access to underserved populations, it would help reduce the nation's growing healthcare costs."

Jonathan Simons, MD, president/CEO of the PCF, said, "This is milestone legislation for cancer research and patient treatment. The PCF is proud to have worked closely with congressional staffers, providing strategic input for crafting the bill."

PCF said the bill places an emphasis on strengthening cancer research and "the urgent need for resources to both prevent and detect cancers at an early stage. The bill strives to give scientists the tools they need to fight cancer and to understand more thoroughly how the disease works."

Bioethicists take issue with Obama

In a commentary in the Hastings Center's (Garrison, New York) Bioethics Forum, President's Council on Bioethics members Gilbert Meilaender, Ph.D., and Paul McHugh, M.D., and eight of the other 18 council members take issue with President Barack Obama's recent executive order removing restrictions on federal funding of research on embryonic stem cell lines (Medical Device Daily, March 10, 2009).

The group raises three concerns in the commentary:

The policy under President George Bush was inaccurately characterized. While President Obama characterized his action as "'lift[ing] the ban on federal funding for promising embryonic stem cell research'," the authors write, the policy under President Bush "did not ban federal funding of embryonic stem cell research; rather, for the first time, it provided and endorsed such funding (as long as the stem cell lines had been derived prior to that date). The aim of this policy was not to shackle scientific research but to find a way to reconcile the need for research with the moral concerns people have."

President Bush's policy was advancing research within ethical norms more effectively than President Obama's will. The commentary asserts that the policy under President Bush was well on its way to "advancing biomedical science and upholding ethical norms," two goals outlined in the 2005 Council on Bioethics white paper titled Alternative Sources of Human Pluripotent Stem Cells. Since then, researchers have made progress on alternative methods of obtaining stem cells, particularly in reprogramming somatic cells in order to restore them to a pluripotent condition. "With respect to the progress that had been made in reconciling the needs of research and the moral concerns of many Americans, we can only judge, therefore, that the president's action has taken a step backward, and we regret that," they write.

The risk of reproductive cloning still must be addressed. The authors offer what they say is needed clarification on President Obama's promise to "ensure that our government never opens the door to the use of cloning for human reproduction." They write that the president's announced policy would permit federal funding of research not only on stem cell lines derived from IVF embryos, "but also on lines derived from created and/or cloned embryos. In the latter two cases, we would be producing embryos simply in order to use them for our purposes." Furthermore, to prevent such cloned embryos from being used reproductively, "the government would find itself in the unsavory position of designating a class of embryos that it would be a felony not to destroy," they conclude.

Lautenberg pushes for removal of 'e-cigarettes'

Sen. Frank Lautenberg (D-New Jersey) has urged the FDA to take electronic cigarettes, or 'e-cigarettes,' off the market until they are proven safe by the federal agency.

Electronic cigarettes, alternatives to cigarettes and other tobacco products, are battery-powered devices that use a vapor to deliver nicotine to smokers. When the smoker inhales through the device, airflow is detected by a sensor, which activates a heating element that vaporizes a nicotine solution stored in the mouthpiece.

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