A Medical Device Daily
The Bush administration has granted sweeping new protections to health workers who refuse to provide care that violates their personal beliefs, setting off an intense battle over opponents' plans to try to repeal the measure. Critics began consulting with the incoming Obama administration on strategies to reverse the regulation as quickly as possible while supporters started mobilizing to fight such efforts. The regulation cuts off federal funding for any state or local government, hospital, health plan, clinic or other entity that does not accommodate doctors, nurses, pharmacists and other employees who refuse to participate in care they find ethically, morally or religiously objectionable. It was sought by conservative groups, abortion opponents and others to safeguard workers from being fired, disciplined or penalized in other ways. But women's health advocates, family planning proponents, abortion rights activists and some members of Congress condemned the regulation, saying it will be a major obstacle to providing many health services, including abortion, family planning, infertility treatment, and end-of-life care, as well as possibly a wide range of scientific research.
The 127-page rule, which was issued just in time to take effect in the 30 days before the change in administrations, is the latest that the administration is implementing before President Bush's term ends.
The "right of conscience" rule could become one of the first contentious tests for the Obama administration, which could seek to reverse the rule either by initiating a lengthy new rulemaking process or by supporting legislation already pending in Congress.
Sen. Patty Murray (D-Washington), who with Sen. Hillary Clinton (D-New York) introduced a bill last month to repeal the rule, said: "We will not allow this rule to stand. It threatens the health and well-being of women and the rights of patients across the country." Similar legislation is pending in the House.
The rule comes at a time of increasingly frequent reports of conflicts between healthcare workers and patients. Pharmacists have turned away women seeking birth control and morning-after emergency contraception pills. Fertility doctors have refused to help unmarried women and lesbians conceive by artificial insemination. Catholic hospitals refuse to provide the morning-after pill and to perform abortions and sterilizations.
"Doctors and other healthcare providers should not be forced to choose between good professional standing and violating their conscience," said Mike Leavitt, secretary of the Department Health and Human Services, which issued the regulation.
The rule, which will cost more than $44 million to implement, gives more than 584,000 healthcare organizations until Oct. 1, 2009 to provide written certification of their compliance. Those that do not comply face having their funding cut off or being required to return funding they have received.
Officials at hospitals and clinics are predicting the regulation will cause widespread disruptions, forcing family planning centers and fertility clinics, for example, to hire employees even if they oppose abortions or in vitro fertilization procedures that can destroy embryos.
The regulation could also make it difficult for states to enforce laws such as those requiring hospitals to offer rape victims the morning-after pill.
Because of such concerns, 28 senators, more than 110 House members and more than a dozen state attorneys general opposed the regulation, along with medical organizations including the American Medical Association (Chicago), the American College of Obstetricians and Gynecologists (Washington) and the American Hospital Association (Chicago).
The language of the rule stresses that it is designed to make sure federal laws on the books since the 1970s are enforced, and that nothing in the regulation will prevent an organization from providing any type of care.
Leavitt initially said the regulation was intended primarily to protect workers who object to abortion. The final rule, however, affects a far broader array of services, protecting workers who do not wish to dispense birth control pills, Plan B emergency contraceptives and other forms of contraception they consider equivalent to abortion, or to inform patients where they might obtain such care. The rule could also protect workers who object to certain types of end-of-life care or to withdrawing care, or even perhaps providing care to unmarried people or gay men and lesbians.
While primarily aimed at doctors and nurses, it offers protection to anyone with a "reasonable" connection to objectionable care – including ultrasound technicians, nurses aides, secretaries and even janitors who might have to clean equipment used in procedures they deem objectionable.
NIH expands dataset to include asthma
The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has expanded its collection of genetic and clinical data first made freely available to researchers worldwide last year, to include clinical and genetic information collected from three asthma research networks.
In 2007, the NHLBI initiated SHARe, (SNP Health Association Resource), a web-based dataset which provides qualified researchers with free access to a wealth of data from multiple large population-based studies, starting with the Framingham Heart Study. This new expansion of the project, called SHARe-Asthma Resource Project (SHARP) is also funded by the NHLBI.
SHARP includes data on 2,332 people with asthma and 805 families whose DNA was tested for 1 million genetic variations. In addition, clinical data gathered during asthma clinical trials, such as lung function, allergy status, and respiratory symptoms are included in the database. In this way, SHARP will permit researchers to relate study participants' genetic variations to their clinical and laboratory test results, thereby enabling future discoveries of links between genes and health for asthma and other airway diseases. To protect the confidentiality of study participants who agreed to share their medical data, the database does not include any personal information.
"The NIH is committed to both broadly sharing research information while also providing maximum safeguards to the privacy and confidentiality of our valued study volunteers," said NHLBI Director Elizabeth Nabel, MD. "Expanding the SHARe program to include asthma through the SHARP initiative will greatly expand our understanding of lung disease biology using genetic and genomic technologies."
The three asthma clinical research networks providing data are the Childhood Asthma Management Program (CAMP), the Childhood Asthma Research and Education Network (CARE), and the Asthma Clinical Research Network (ACRN) –all funded by NHLBI. For more than 10 years, these networks have been major sources of information about the best practices in asthma care, translating and developing new knowledge for patients and physicians.
"The clinical asthma networks have been the backbone of our translational research program at NHLBI for many years," said NHLBI Division of Lung Diseases Director James Kiley, PhD. "Creating this new resource not only provides a new opportunity for our own network investigators to use this unique data, but opens it up to the broader scientific community as well."
Genotyping information, including data from a 1 million SNP mapping array, was generated for SHARP by Affymetrix (Santa Clara, California), through a contract with NHLBI. Summary data and analyses are available to researchers with appropriate approvals. Individual-level data can be used only by authorized investigators who meet requirements for access outlined in the NIH GWAS policy. Researchers are prohibited from redistributing data or trying to determine the identity of participants.