SACGHS has formed a task force to address the clinical utility of genetic testing—that is,.the usefulness of genetic tests for helping doctors choose more effective interventions for their patients. Assessing clinical utility is an important component of both personalized medicine and comparative effectiveness research, which analyzes interventions head-to-head to see which work better for different patients. The goal is to improve comparative effectiveness research by incorporating genetic tests, which would allow physicians to tailor treatments to individual patients based on their own DNA.

The Personalized Medicine Coalition held a conference last fall to promote the alignment of comparative effectiveness research with personalized medicine. This alignment is also a crucial aspect of the recommendations issued by the Institute of Medicine, which promoted research on both “diseases and conditions with the greatest aggregate effect on the health of the U.S. population, but also less common conditions that severely affect individuals in vulnerable subgroups of the population.”

The Center for American Progress has also recognized the importance of ensuring that CER can “accelerate the discovery of approaches to individualized medicine and help providers cater to the specific needs of patients.”  This will move medicine beyond the “one size fits all” therapies that result from the research provided by pharmaceutical companies to the FDA.  SACGHS is taking an important step forward by identifying ways to assess the clinical utility of genetic tests. This was one of several recommendations CAP has made not just for advancing personalized medicine but also for improving the quality of genetic testing in the report, “Genetic Information Non-Discrimination.”

Genetics education and training will also be a major part of the SACGHS meeting agenda. The task force outlined its action plan in July of 2008 and has since set out to identify the needs of healthcare providers, the public health workforce, and the general public for genetic education. The task force also identified various types of case studies that it will use to analyze the current information gaps in genetic testing. This will require exploring the best way to gather and disseminate information about pharmacogenomic testing, newborn screening, diagnosis of single gene disorders, direct-to-consumer testing, and population genetics. The task force plans to release their report in the coming months.  This is an important step, as the public must be “informed and educated about personalized medicine through outreach efforts, opportunities for public comment or input, and most importantly through transparency.”

Data sharing is also a major component of the agenda.  Representatives from government, academia, health care systems, industry, and consumer groups will present different models for sharing genomic information. This will be followed by a discussion of health information technologies that aim to efficiently connect the data among these multiple sectors.  In “Paving the Way for Personalized Medicine,” my co-author and I addressed both the positive developments as well as the missed opportunities on this front.  In particular, we noted that HHS’s Health IT Standards Committee has not properly collaborated with outside networks that are working to devise consistent nomenclature so that genomic data can be utilized through health IT.  We recommended this kind of collaboration so that HHS can leverage the expert resources available for combining cutting-edge genomic science with health IT.

The face of medicine is changing at a breakneck pace and a forum like the SACGHS meeting allows scientists, policymakers, innovators, service providers, and patients to work together to ensure that this new era of medical innovation serves the common good by being safe, effective, efficient, and equitable.

The rule is pernicious in many ways. It allows all employees, and even volunteers, of most institutions receiving HHS dollars to deny access to a wide variety of medical services. The rule ostensibly protects only employees who object to abortion and sterilization, but it is written so broadly that it could also apply to contraception, fertility treatments, HIV/AIDS services, gender reassignment, end-of-life care, or any other medical practice to which someone might have a personal moral (not even religious) objection.

This rule is not “just a woman’s issue,” though the more than 17 million women who depend on our public health system and who are disproportionately low-income and women of color will certainly bear the largest brunt of this politically-motivated regulation. The rule also provides a striking example of how the stigmatization of one medical service—specifically, abortion—can quickly creep into other areas and erode well-established medical standards of care. Allowing medical services to be ranked on a scale of moral superiority is a public health problem.

The right of conscience is an important and time-honored value in our society and one that should not be tread upon lightly. But it is not only health providers who have rights; so do patients. Standards of care and codes of conduct exist to balance the rights of them both. Instead of pitting the rights of providers and patients against one another, perhaps there are a few tenets upon which we as a society can agree:

• Withholding relevant, medical information from patients is never good medical practice nor ethical;
• In emergency situations, the patient’s medical needs must always come first;
• Providers who are unwilling to provide certain services must give their patients timely notice of their refusal to do so and must refer those patients to a provider who can supply the needed health care.

Despite the fact that professional medical associations have consistently endorsed these precepts, the new HHS rule ignores all three of these basic yet essential codes. Fortunately, it is likely that the new administration and the new Congress will work to reverse this rule as quickly as possible. But this debate will not end with the demise of this rule, and we must not countenance some very dangerous concepts that have been advanced in support of the rule.

1. Requiring a health care provider to do his or her job is not discrimination. Employers are required to accommodate an employee’s religious beliefs when doing so does not present an undue hardship on the employer. However, refusal or withdrawal of health care in a manner that neglects a patient’s needs is an undue hardship and should not be entitled to accommodation.
2. Providing a referral for a service is not morally equivalent to providing that service yourself. There are varying degrees to which one’s conscience may be burdened by certain actions. Supplying information about where to find appropriate medical care ought not to tax one’s conscience to the same extent as performing a procedure or dispensing medication. Moral beliefs exist along a continuum and the protections afforded for such beliefs must be proportionate as well.
3. A refusal to provide care can harm patients. In our current health care system, we face a shortage of primary care physicians, a nursing shortage, a vast population of uninsured and underinsured patients, hospitals that cannot afford to stay open, and rural communities with few health care resources like clinics and pharmacies. Health care providers should not assume that just because they say no, a patient will be able to find another provider who will say yes who is also affordable and accessible.

The so-called “provider conscience” rule disrupts the careful balance established by medical codes of conduct and standards of care, placing the health, well-being, and dignity of patients at risk. We must work to ensure the proper balance is restored quickly, so that we can continue to protect the right of conscience while also protecting access to all health care services for every patient who needs them.
Jessica Arons is the Director of the Women’s Health & Rights Program and a member of the Faith and Progressive Policy Initiative at the Center for American Progress.

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In the final year of the Bush administration, social conservatives have successfully pressured the Department of Health and Human Services to propose a rule that would ostensibly protect health care workers who object to performing abortion and sterilization procedures. The catch is that there are already federal laws in place that do just that. The regulation would instead open the door to denying patients access to all sorts of potentially controversial health care services. (For a look at an earlier draft of this rule, see Jessica Arons’s Science Progress article, “Contraception is the New Abortion.”)

The rule could have a variety of sweeping effects. Among them, it could:

1. Potentially allow providers to deny patients access to contraception, end-of-life care, and fertility treatments, among other forms of treatment
2. Allow providers to withhold information essential to informed consent and to refuse to provide referrals for patients
3. Extend beyond doctors and nurses to virtually anyone in the health care system, including ambulance drivers, receptionists, claims adjusters, and custodians.

But that’s not all. The rule is indeed written so broadly that it might also protect individuals who refuse to assist with research to which they object, which could include work on stem cells funded by National Institutes of Health. The proposed rule includes this language:

Entities to whom this subsection 88.4(d) applies shall not require any individual to perform or assist in the performance of any part of a health service program or research activity funded by the Department if such service or activity would be contrary to his religious beliefs or moral convictions.

The potential for interpretations of “health service program” include the effects mentioned above, but the implications of the “research activity” have been less-discussed. Needless to say, the rule is unnecessary and poorly crafted from either perspective.

The deadline for public comments is this tomorrow, Thursday, September 25th, and they can be submitted to regulations.gov or via email to consciencecomment@hhs.gov. Let the HHS know that this is one regulation health care workers and scientists alike can do without.

Dr. Orr does not have a medical degree and has no direct experience in family planning. Her public statements indicate a lack of experience and an ideologically-based commitment to extreme points of view that bring into question her qualifications for the job and her ability to objectively assess and apply accepted best practices in health care to Federal policy.

Americans value their right to decide when and whether to have children, and sound public policy supports their ability to make those decisions.

What’s worse, this is the second time in a year that the administration has appointed an anti-contraception activist to the position. In November 2006, the administration appointed Dr. Eric Keroack, a non-board certified gynecologist, who received “two formal warnings from the Massachusetts board of medicine ordering him to refrain from prescribing drugs to people who are not his patients and from providing mental health counseling without proper training,” just before he resigned in March amid Medicaid fraud allegations.

Dr. Orr’s appointment is only the most recent example of a trend that will take years to repair. The administration’s unapologetic long-term political strategy of diminishing the value of scientific integrity to create doubt and achieve ideologically-driven political goals is becoming more widely recognized. Unfortunately this appointment is another clear-cut example of an administration appointee whose background and ideology are at odds with the majority of reproductive health professionals.

In Title Only

Dr. Orr’s appointment highlights some particularly difficult challenges that will likely have negative implications for people in America who don’t have full access to health care. Her position oversees Title X, the federal family planning program that serves more than 5 million low-income Americans annually through more than 4,400 community-based clinics. Seventy-five percent of U.S. counties have at least one clinic that receives Title X funds, and it is estimated that over 1 million unintended pregnancies are prevented each year through contraceptives made available for low income Americans by Title X services each year.

Application of Dr. Orr’s position on family planning places undo hardship on those least able to pay for contraception.

But the controversy of her appointment is about more than the possible subversion of policies that have proven effective for preventing unintended pregnancies and abortions. Few would question that the person filling this position should have a commitment to evidence-based science and to all aspects of reproductive health care including disease prevention and family planning. Title X-supported clinics provide patient education and counseling; breast and pelvic examinations; breast and cervical cancer screening; sexually transmitted disease (STD) and Human Immunodeficiency Virus (HIV) prevention education, counseling, testing and referral; and pregnancy diagnosis and counseling.

Steering the ship responsible for funding such services requires respect for the value of providing people with informed options for their health care. Americans value their right to decide when and whether to have children, and sound public policy supports their ability to make those decisions. The Centers for Disease Control and Prevention included family planning in its list of the “Ten Great Public Health Achievements in the 20th Century,” yet Title X funding has declined by 60 percent since 1980, when adjusted for inflation, even though 17 million U.S. women rely on public funding to obtain contraception.

With almost half of all pregnancies in the United States being unintended—80 percent of teen pregnancies fall in this category—any neglect of basic services can be directly linked to failures in education and public policy. The American public will benefit from a significant increase in funding to make all methods of contraception available to all who want and need them, to research new approaches to family planning, and to provide comprehensive, evidence-based reproductive health and sexuality education in schools and communities.

Steering the ship responsible for funding such services requires respect for the value of providing people with informed options for their health care.

Application of Dr. Orr’s position on family planning places undo hardship on those least able to pay for contraception. Further restriction on these funds will inevitably result in more unintended pregnancies and more abortions, an outcome that runs directly counter to the stated goals of the program she is supposed to be directing.

While most private insurers cover contraception, it is ethically and fiscally sound public policy to ensure that all Americans have equal ability to decide what is best for them and their families. Dr. Orr’s position as senior director for marriage and family care at the Family Research Council, an organization that advocates restricting access to family planning, makes her entirely unsuitable to run the agency whose mandate is to provide access to needed family planning care for our nation’s men and women.

One Tired Finger

Americans deserve a deputy assistant secretary for population affairs who will advocate for increased access to contraception for all who need and want it, and for the full range of reproductive health services that enhance quality of life. We believe that we must communicate the value of reproductive health services to individuals first and, second, to society as a whole.

Simply put, we are advocating for reproductive health professionals to compensate for the inability of Dr. Orr, her predecessors, and this administration to achieve those goals. As scientists, we must learn to appeal to the positive aspects of belief systems outside of our experience to communicate scientific values, to change minds and to affect public policies.

But it is insufficient to simply point our finger at the administration and Dr. Orr. We also must accept responsibility for failing to effectively communicate with the public and policymakers.

It isn’t completely clear why it’s been so easy to take anti-science policy positions in the United States in the last decade. One answer lies in the U.S. public’s ambiguity about science and the role it plays in their lives. In the most recent survey of public perceptions about science by the National Science Foundation, 55 percent of the respondents agreed that “we depend too much on science and not enough on faith,” and 70 percent agreed that “scientific research these days doesn’t pay enough attention to the moral values of society” and that “scientific research has created as many problems for society as it has solutions.”

These findings indicate that the anti-science faction that has taken root in Washington of late has reason to cheer. This unfortunate trend is not merely the result of overzealous ideologues; there seems to be a level of indifference among much of the lay public to the importance of science and the policies that directly affect them. For many, “science” is a necessary but somewhat remote, dusty, and godless venture that has no direct impact on their everyday lives. These findings should also serve as a warning that regime change in Washington 15 months from now will not be enough to turn the tide of public sentiment.

We also know that lecturing the public about scientific principles and research outcomes in the desire to convince them about our correctness is oftentimes a wasted effort; our intended audiences often consider this approach condescending and patriarchal, despite our opposite intention. If our goal is to change minds, this approach just does not work and should be abandoned as a primary course of action.

Behavioral science theory tells us that most people operate from the screens of their own interests and beliefs; they are not going to listen to or be swayed by data that contradict their belief systems, regardless of accuracy. Without getting overly academic (we tried that), we have to reinvent the way we communicate the value of applying science to health policy in the context of the values that we share with an angry and doubting but concerned public.

The scientific community and the general public have a lot more in common than not. That’s why we as scientists must be prepared to channel the public’s skepticism of science toward a broader understanding of the progressive values that should always underpin scientific inquiry and public policymaking.

Wayne C. Shields is the President and CEO, Association of Reproductive Health Professionals. Rivka Gordon is the Director of Strategic Initiatives, Association of Reproductive Health Professionals.