Archive for the ‘Public Policy’ Category

July 28, 2010

Live in Massachusetts? Support Midwives? Call Your Legislator Today

If you’re in Massachusetts, please ask your state representative to urge House Speaker Robert DeLeo to bring an important midwifery bill to a vote. Text of the bill — House 4810: An Act Relative to Certified Professional Midwives and Enhancing the Practice of Nurse-Midwives – can be found here.

The bill was just released from the House Policy and Steering Committee and is now in Third Reading, chaired by Rep. Vincent Pedone of Worcester.  The legislative session closes on Saturday, July 31. If it’s not voted on by then, the bill would die and have to be reintroduced in the next legislative session.

If you’re able to discuss the bill with your legislator or a staff member, please be aware that some legislators have misinformation about the midwifery bill’s content, especially regarding the items below. Here’s some background:

1. The Massachusetts Medical Society strongly objects to CNMs functioning without direct MD supervision, yet has articulated no sound basis for this objection. Nationally, ACOG already supports the elimination of direct supervision of CNMs by physicians, acknowledging that it is not required for safe practice, and 44 other states no longer have such requirements.

2. Some legislators incorrectly think that the bill would provide new prescription-writing privileges for nurse-midwives — this is not really the case. Nurse-midwives already have prescription-writing privileges but can now exercise these privileges only if an MD is technically providing supervision, which amounts merely to a review of sample prescriptions on a quarterly basis.

Because of hospital accrediting rules, this clause prevents CNMs from admitting patients in labor under the midwives’ own names; prevents CNMs from serving on hospital committees that determine maternity care policies; and bars them from control of their own practice environment. This undermines the ability of CNMs to provide the most effective care. (CNMs already have independent prescription authority in most other states, including New Mexico, New Hampshire, Washington, Arkansas and Oregon, and the District of Washington.)

3. Although the legislation has already been rewritten to accommodate concerns about the age at which a midwife could begin training (it was changed from 18 to 21), legislators are still being misled about this fact. There are, by the way, no such age requirements that we have been able to find in the Massachusetts statutes with respect to the education of nurses.

4. Another objection is that the bill does not require a midwife to carry malpractice insurance. In almost all states, malpractice insurance is not required by statute, and it would be unfair to single out one professional group in this regard. Some would argue that such a requirement would violate equal protection clauses.

Because the “risk pool” of homebirth midwives across the country is small, malpractice insurance has never been available for homebirth midwives, despite the concerted efforts of national and local organizations over several decades. Requiring CPMs to adhere to a standard that is impossible is another mechanism to restrain trade and prevent access to home birth midwives.

Childbearing women who want to be protected by malpractice insurance have the option of delivery in facilities, where such insurance coverage is required. Moreover, the Massachusetts legislature could follow a few other states in making disclosure of this absence of malpractice insurance coverage part of a required informed consent procedure. The malpractice insurance issue is not a credible objection to this bill.

Please share this news, and thanks for taking the time to take action on this important piece of legislation!


July 12, 2010

Health Care Reform and Family Planning

Two aspects of recent health reform legislation may help expand access to affordable contraception and family planning services. The first of these is a provision that allows states – through their Medicaid programs – to receive federal funding to cover family planning and related services and supplies for individuals not otherwise eligible for Medicaid.

This coverage would be available to individuals (women and men) who are not currently pregnant and whose income does not exceed an income eligibility level established by the state (similar to special eligibility rules for pregnant women who wouldn’t otherwise quality for Medicaid). Family planning-related services that may be covered include STI diagnosis and treatment, treatment of urinary tract infections, treatment of major complications from family planning procedures such as IUD insertion, and vaccines and other preventive services when provided as part of routine family planning visits.

States will basically have to opt in to this coverage by submitting some paperwork to the Centers for Medicare & Medicaid Services (CMS), the federal agency that oversees Medicaid. States will also set the eligibility guidelines for coverage up to a certain threshold. It is not yet clear how many or which states will be offering this coverage, which will expand access to family planning services for people who earn to much to qualify for Medicaid but who are having difficulty affording this care.

Another provision of the health care reform legislation that will take effect in late September, often referred to as the “Mikulski amendment,” requires that health plans cover preventive care and screenings (at no cost to the individual) for women. The coverage must be based on current evidence-based recommendations of the United States Preventive Services Task Force, and must includevaccines recommended by the CDC, and other care and services “as provided for in comprehensive guidelines supported by the Health Resources and Services Administration [HRSA]for purposes of this paragraph.”

What’s not clear is what guidelines the HRSA will support. Some have suggested that because HRSA doesn’t seem to have its own set of guidelines now, these will need to be created. I think another possible interpretation is that HRSA will identify an existing set of guidelines to support (such as from ACOG or another professional or governmental health organization). Whether new standards have to be created or HRSA simply designates some existing guidelines to support will determine how much room there is to advocate for services, but what will happen is not entirely clear at the moment.

A recent Guttmacher policy review has more on this issue, specifically on whether contraception might be included as preventive care. Guttmacher’s Adam Sonfield has also written about the issue for CNN, concluding:

In short, the case for ensuring family planning services are comprehensively integrated into women’s preventive care and insurance coverage is compelling. More and better contraceptive use will lead to more pregnancies that are planned and wanted, which will lead to more women who are healthy during their pregnancies and whose babies are born healthy. Who could argue with that?

The National Latina Institute for Reproductive Health is planning a “virtual cafecito” to discuss the issue of whether family planning will be included as a preventive service and to discuss strategies for ensuring that Latinas and other women have access birth control options as a preventive service. The call-in discussion will occur Wednesday, July 4 at 1pm EST; register online to participate.


July 7, 2010

Quick Hit: Public Comment Open on Hospital Visitation Rule Change

We recently wrote about a proposed rule change that would protect patients’ rights to choose and designate their own visitors during a hospital stay. The change would make hospital visitation much easier for LGBTQ patients and their partners. At the time, we indicated that while public comment would be open for 60 days before the rule could be made official, the proposal hadn’t been posted yet for comment.

The proposed rule is now posted for public comment at Regulations.gov. Comments are being accepted until 11:59 pm Eastern time on August 27, 2010. Click on “Submit Comment” at the top of the page to weigh in on the proposed rule.

Once comments are submitted and uploaded, you’ll be able to view them here. (You won’t see any just yet, as none have been uploaded as of this writing.) You can also sign up for email alerts on this item and use the “Share” options to post to Twitter, Facebook, and other services.


July 7, 2010

HealthCare.gov Provides Tools for Understanding Health Care Options

Last month, Christine posted some resources for shopping for health insurance in light of the Patient Protection and Affordable Care Act, which institutes a number of changes in health insurance availability and coverage.

This month, one of the provisions of that Act was enacted to further aid in insurance shopping. The government is now offering a website where residents of any state can identify affordable health insurance coverage options in their state.

The website, HealthCare.gov, provides an online tool individuals and families can use to search for insurance and healthcare options. Under the “Find Insurance Options” section, you can put in information about your state, status (healthy individual, senior, young adult, etc.), age, and other non-personal details to find information about available plans in your area for individuals and families, including those considered “high risk” because they have a pre-existing health condition.

You can also find out if there are health care facilities near you that provide free or low-cost care.

The “Understand the New Law” section provides information on the Act and a timeline of when the various provisions will be implemented, and the “Information for You” section provides details specifically for families with children, individuals, people with disabilities, seniors, young adults, and employers.

The site also links to other federal sources of information, like Hospital Compare for healthcare quality data by hospital/location, and healthfinder for disease prevention information.


June 17, 2010

The Politics of Fathering

Nancy Chodorow’s “The Reproduction of Mothering” was an instant feminist classic when it was published in 1978. One of the most visionary conclusions was her call for men to take an equal role in the caretaking of children. If they don’t, she argued, women would grow up with a distorted perspective on their own relationships with men.

More than 30 years later, Chodorow’s call appears as challenging as ever — at least in the United States, where parental leave is still unpaid (putting us behind 177 nations, including Haiti and Afghanistan, that provide all women, and in some cases men, income and time off after the birth of a child) and only 12 weeks long, which discourages even willing men from taking over child-rearing duties.

Four years before the publication of Chodorow’s landmark text, however, Sweden had already become the first country to replace maternal leave with parental leave, and Sweden has continued to break new ground by spurring a revolution in male attitudes toward and male participation in childcare. Katrin Bennhold of The New York Times writes:

85 percent of Swedish fathers take parental leave. Those who don’t face questions from family, friends and colleagues. As other countries still tinker with maternity leave and women’s rights, Sweden may be a glimpse of the future.

In this land of Viking lore, men are at the heart of the gender-equality debate. The ponytailed center-right finance minister calls himself a feminist, ads for cleaning products rarely feature women as homemakers, and preschools vet books for gender stereotypes in animal characters. For nearly four decades, governments of all political hues have legislated to give women equal rights at work — and men equal rights at home.

Swedish mothers still take more time off with children — almost four times as much. And some who thought they wanted their men to help raise baby now find themselves coveting more time at home.

But laws reserving at least two months of the generously paid, 13-month parental leave exclusively for fathers — a quota that could well double after the September election — have set off profound social change.

Bennhold goes on to describe the positive effects of this change, such as a lowering of divorce rates and an increase in shared custody when a divorce does occur. It has undeniably transformed what it means to be a man.

Birgitta Ohlsson, European affairs minister, puts it in the terms of an old feminist maxim: “Now men can have it all — a successful career and being a responsible daddy. It’s a new kind of manly. It’s more wholesome.”

For more on how father’s leave in Sweden came to be so popular, read this side piece on politician Bengt Westerberg, who in the 1990s “championed the introduction of the first dedicated father month — 30 days of paid parental leave that could not be transferred to the mother — to encourage reluctant men like himself to do their bit and overhaul Swedish society in the process.”

Despite the fact that Sweden and other countries are far ahead of the United States when it comes to supporting fair and equitable childcare, it’s important to remember that progressives in the United States have been fighting for some form of paid parental leave for almost 100 years.

Yes, 100 years. As Sharon Lerner reminds us in the Washington Post:

As far back as 1919, when the Model T was switching from a crank to an electric starter, the U.S. government came close to signing on to an International Labor Organization agreement, supported by 33 countries, that said women workers should receive cash benefits in addition to job-protected leave for 12 weeks in the period surrounding childbirth. That same year, Julia Lathrop, the chief of the Labor Department’s children’s bureau, issued a report on international maternity leave policy in which she decried the United States as “one of the few great countries which as yet have no system of State or national assistance in maternity.” She had recently returned from Europe, where Germany and France had paid-leave laws that had been in place for decades.

The entire article is a very enlightening history lesson — revealing the twisted politics that have held back justice and common sense for far too long. For more on that subject, check out Lerner’s new book, “The War on Moms: On Life in a Family-Unfriendly Nation.”


June 1, 2010

Quick Hit: Defense Authorization Would Repeal DADT, Prohibitions Against Abortions in DoD Facilities

According to this release [PDF] on May 28 from the U.S. Senate Armed Services Committee, the proposed National Defense Authorization Act (NDAA) for 2011 includes provisions both to repeal the “Don’t Ask, Don’t Tell” policy and the prohibition on performing legal abortions in Department of Defense medical facilities.

The ACLU and Planned Parenthood have further commentary.


May 24, 2010

OBOS’s Judy Norsigian on Health Care Reform at Salon

Our own Judy Norsigian – along with Ellen Shaffer of the Center for Policy Analysis – has a new piece up at Salon.  A practical guide forward for progressives on healthcare looks at the myths that have undermined  enthusiasm for the new health care reform package and encourages people to build upon its successes.

Norsigian and Shaffer also propose next steps for progressives who share the goal of affordable universal health care. Check it out, and let us know what you think in the comments!


May 21, 2010

Plan Outline Released to Shape Public Health Approaches to Infertility

In 2007, the CDC formed a working group to coordinate public health-related infertility activities, and identified opportunities for improvement in public health activities to understand and address preventable causes of infertility. The group subsequently published a white paper in 2008 on infertility prevention, detection and management, which included a call for the development of a national plan of action to address infertility issues.

A CDC representative from the Women’s Health and Fertility Branch of the agency’s Division of Reproductive Health has now informed us that the resulting outline for an action plan – “Outline for a National Action Plan for the Prevention, Detection, and Management of Infertility” [PDF] – can now be circulated. Our Bodies Ourselves is one of many organizations engaged in the review of the document, alongside other professional, advocacy, consumer health, and educational organizations and institutions.

As the background section explains, some infertility may be preventable through public health approaches:

Known or potential causes of infertility include genetic abnormalities, environmental, occupational, and infectious agents, certain diseases, delayed childbearing, and behavioral risk factors. We do not know what proportion of the infertility burden can be prevented, but it may be substantial.

The authors provide examples such as effects of sexually transmitted infections, as well as environmental and occupational hazards, and concerns that some risk factors for infertility may disproportionately affect those experiencing “social and racial disparities in health status.”

The plan includes four main goals:

1) To reduce the burden of infertility and impaired fecundity in the United States by promoting behaviors that maintain fertility, by promoting prevention, early detection, and treatment of infections (such as chlamydia) and other medical conditions that lead to infertility, and by removing or reducing environmental and occupational threats to fertility;
2) To improve access to the diagnosis and treatment of infertility and eliminate disparities in infertility care;
3) To improve the efficacy and safety of infertility treatment; and
4) To improve the quality of life of people who live with infertility in the US.

The plan outline document lists numerous strategies for surveillance, prevention research, policy development, evidence-based patient care guidelines, public education, expanded prevention and infertility care services, and other approaches, which should form the basis of a more detailed full action plan.

Download the Plan Outline


May 20, 2010

FDA Unveils Next Steps in Transparency Initiative, Public Comment Requested

The U.S. Food and Drug Administration last year formed a task force to increase the agency’s transparency to the public, with a goal to “develop recommendations for making useful and understandable information about FDA activities and decision making more readily available to the public in a timely manner and in a user-friendly format.” This effort stems from the Obama administration’s goal of increasing the transparency of government agencies in general.

In a newly published perspective piece for the New England Journal of Medicine, representatives of the FDA’s transparency initiative describe the task force’s work to date, including release of a website, FDA Basics, “to answer fundamental questions about how the agency does its work.”

Today, the agency has released a report [PDF] from the task force outlining draft proposals “for expanding the disclosure of information by the agency while maintaining confidentiality for trade secrets and individually identifiable patient information.”

The proposal document is fairly technical and seems to assume a fair bit of background knowledge of FDA procedures and policies, but it includes proposals such as disclosing information about commonly observed violations associated with FDA-regulated products, the status of terminated and withdrawn new drug and device applications, and summary safety and efficacy information related to investigational new drug applications (data that may not have been published in the medical literature) when the agency determines the information is necessary to protect the public health

The agency will be accepting public comment on the proposal, including which draft proposals should be given priority, until July 20, 2010 via regulations.gov (direct link for comments not yet available). The FDA has also set up a transparency-related blog for updates on these efforts.

Added: you can now go here at Regulations.gov to submit comment, due by July 20, 2010.


May 18, 2010

President’s Cancer Panel Reports on Environmental Causes of Cancer

The President’s Cancer Panel, created in 1971 to monitor the National Cancer Program, provides reports to each sitting President on the nation’s cancer programs and priorities. Previous reports have covered topics such as health disparities, translational research, cancer survivorship, barriers to care, and cancer among Native American populations.

The Panel’s recently released report, “Reducing Environmental Cancer Risk: What We Can Do Now,” [PDF] focuses on potential risks posed by contaminants in the environment from industrial, manufacturing, agricultural, medical, military, natural, and other sources, and provides recommendations for reducing environmental cancer risks. For example, the report discusses the radiation exposure from medical CT scans, mercury emissions from coal-fired power plants, and pesticide exposures.

The Panel’s report calls for further research into environmental causes of and contributors to cancer, stronger regulation and enforcement related to hazardous substances, better disclosure to the public of potential hazards created, inclusion of environmental and public health advocates in developing research and policy agendas and information dissemination, minimization of radiation exposure from medical sources, attention to the unequal burden of exposure, and increased use of safer alternatives.

It also calls for a move away from “current reactionary approaches to environmental contaminants in which human harm must be proven before action is taken to reduce or eliminate exposure” to a more “precautionary, prevention-oriented approach.” (For more information on what such an approach would look like, see The Precautionary Principle on the OBOS website.)

The free report also includes a number of recommendations for individuals to reduce their exposure to potentially harmful chemicals.

A representative of the American Cancer Society has criticized the report, arguing that “the report is unbalanced by its implication that pollution is the major cause of cancer…its conclusion that ‘the true burden of environmentally (i.e. pollution) induced cancer has been grossly underestimated’ does not represent scientific consensus. Rather, it reflects one side of a scientific debate that has continued for almost 30 years.”

The chairman of the panel has reportedly responded, “This is an evenhanded approach, and an evenhanded report. We didn’t make statements that should not be made.” A representative of Utah Physicians for a Healthy Environment, in a commentary for The Salt Lake Tribune, further criticized the ACS’s response, commenting that the ACS’s focus on “lifestyle factors” such as diet and exercise reflects a “blame the victim” philosophy that trivializes environmental risks. He also questions the ACS’s relationship with corporate donors who could possibly be affected by increased regulation and enforcement.

Orac at Respectful Insolence (ScienceBlogs) has detailed commentary on the report, including discussion of the ACS’s reaction – the full post is well worth a read.


May 10, 2010

Campaign to End Chronic Pain in Women Launches May 19

We have written previously about the Overlapping Conditions Alliance, a group of nonprofit organizations “seeking to advance the scientific, medical and policy needs of individuals affected by medical conditions that frequently overlap.”

On May 19, the Alliance will launch the Campaign to End Chronic Pain In Women with a goal “to improve the quality of women’s lives by raising awareness of chronic pain conditions that disproportionately impact women, as well as the neglect, dismissal and discrimination faced by women suffering from chronic pain. ”

As a campaign alert explains:

Chronic fatigue syndrome (CFS), endometriosis, fibromyalgia, interstitial cystitis (IC), irritable bowel syndrome (IBS), temporomandibular (TMJ) disorders and vulvodynia are just some of the conditions that have sidelined as many as 50 million lives and cost up to $80 billion each year. These four either solely affect women, or target women at least four times more often than men.

At a congressional briefing on the 19th, the Campaign will release a report on chronic pain in women. The briefing will be hosted by by Representatives Lois Capps (D-CA), Tammy Baldwin (D-WI), Janice Schakowsky (D-IL), and will feature representatives of the four organizations of the Overlapping Conditions Alliance. A website for the campaign will also become available on that date; we’ll update with the link.


May 5, 2010

Campaign Asks for Creation of Office of Maternal Health

Amnesty International, which recently released a report on maternal health in the United States, is asking supporters to contact Kathleen Sebelius, Secretary of Health and Human Services, to ask for the creation of an Office of Maternal Health to “ensure that the country’s maternal health care crisis is addressed in a comprehensive manner.”

In the provided letter, the organization asks for such an Office to work on the following priorities:

  • gathering comprehensive data on deaths, complications and performance measures along with an effective nationwide review process;
  • ensuring access to timely prenatal care;
  • issuing evidence-based protocols for health care providers to prevent, recognize and respond to the leading complications that cause pregnancy-related deaths;
  • encouraging home visits in the days following childbirth; and
  • vigorous enforcement of federal nondiscrimination laws;
  • recommending the necessary regulatory and legislative changes to ensure that all women receive the quality maternal care necessary to reduce maternal deaths in the United States.

Organizations can also sign onto a letter to be delivered to Secretary Sebelius tomorrow by contacting demanddignity@aiusa.org.


April 26, 2010

New Jersey Budget Plan Mixed Bag for Health, Eliminates Family Planning Funds

In this difficult economy, many states are struggling to balance their budgets, often resulting in controversial decisions and cuts. Last month, New Jersey Governor Chris Christie (R) released a 2011 budget plan for the state which continues to generate considerable discussion. An astute reader brought one line in particular to our attention from the proposed budget: “Funding for grants to support clinical family planning and related services is eliminated.”

A representative of the ACLU of New Jersey writes:

Without state funding next year, the centers would serve 40,000 fewer patients, leaving an already vulnerable population with even less. In the midst of a recession, these services are more critical than ever. The recently passed health care legislation may offer some assistance in the coming years, but it won’t keep the lights on in the only medical centers serving neighborhoods that need them the most.

A piece in the Daily Princetonian urges students to contact Christie about the proposed cuts, arguing that the cuts will lead to poorer health for both men and women, and already vulnerable populations, ultimately costing the state more: “These cuts are not just shortsighted, misogynistic and classist — they’re completely nonsensical. And they will result in devastating consequences for public health.”

What’s going on in your state’s budget related to women’s health? Let us know in the comments.


April 8, 2010

Two Weeks into Health Care Reform: Answers to Questions, Concerns Over Costs and What’s in it for Me

Wondering what health care reform means for you and your family? You may want to invite Raising Women’s Voices to your community for a special education session. From RWV:

We are bringing groups of experts into the community to meet with women, who often are the key health decision-makers for their families. Our aims are to explain the many ways in which health reform will help families — such as providing coverage for 32 million uninsured Americans — and to note the ways in which the law fell short, such as in covering abortion services and including undocumented immigrants.

Check out the list of available experts and topics to be covered. It seems like a wonderful opportunity to hear directly from women who can discuss individual and community-wide benefits and the nuances of the new law.  To learn more, email info [at] raisingwomensvoices.net

* * * * *

Last week, The New York Times Science section published an informative special issue on health care reform. The lead story, “What You Need to Know in the First Year” has an alternative title online that cuts to the chase: “What’s in it for Me?”

“The basic thrust of this law is that all of these nooks and crannies, all these gaps where private insurance has left you without any option, those are going to be taken away,” said DeAnn Friedholm, campaign director of health reform for Consumers Union, the nonprofit publisher of Consumer Reports. “It’s complicated, but it does establish a very key, important policy that you’re going to have options, regardless of your health situation or your employment situation.”

More specific to women’s health is an article by Denise Grady that looks at how health care reform will reduce costs associated with having double X chromosomes.

Among the major changes: Gender rating, the act of charging women more than men for the same insurance policy, even when maternity care is not included, is no longer allowed, and maternity coverage is now considered “an essential health benefit.”

“It has to be a part of the premium just like heart attacks, prostate cancer or any other condition,” said Marcia D. Greenberger, co-president of the National Women’s Law Center. The story continues:

Despite her enthusiasm for many aspects of the new law, Ms. Greenberger said she was profoundly disappointed in provisions that she thought would limit women’s access to abortion services.

Advocates for women’s health said one of the new law’s benefits would be to ban the denial of health coverage to women who have had a prior Caesarean section or been victims of domestic violence. Some companies providing individual policies have refused coverage in those circumstances, regarding Caesareans or beatings as pre-existing conditions that were likely to be predictors of higher expenses in the future.

In a statement issued Thursday, Senator Mikulski said: “One of my hearings revealed that a woman was denied coverage because she had a baby with a medically mandated C-section. When she tried to get insurance coverage with another company, she was told she had to be sterilized in order to get health insurance. That will never, ever happen again because of what we did here with health care reform.”

The success of health care reform will depend on the ability to control soaring health care costs, many experts have argued. Another story in the package looks at how the law will do little to curb unnecessary care, a subject that is also the focus of a piece published this week in the business section. David Leonhardt offers a concise explanation of a major obstacle: Convincing the public — and the medical community — that more care does not necessarily mean better care.

Managed care became loathed in the 1990s. The recent recommendation to reduce breast cancer screening set off a firestorm. On a personal level, anyone who has made a decision about his or her own care knows the nagging worry that comes from not choosing the most aggressive treatment.

This try-anything-and-everything instinct is ingrained in our culture, and it has some big benefits. But it also has big downsides, including the side effects and risks that come with unnecessary treatment. Consider that a recent study found that 15,000 people were projected to die eventually from the radiation they received from CT scans given in just a single year — and that there was “significant overuse” of such scans.

From an economic perspective, health reform will fail if we can’t sometimes push back against the try-anything instinct. The new agencies will be hounded by accusations of rationing, and Medicare’s long-term budget deficit will grow.

So figuring out how we can say no may be the single toughest and most important task facing the people who will be in charge of carrying out reform. “Being able to say no,” Dr. Alan Garber of Stanford says, “is the heart of the issue.”

Here’s what I wrote last year on guidelines to reduce routine breast cancer screenings.

For more on the economics of health care (and resistance to reform), read Atul Gawande’s piece in The New Yorker, which includes an excellent example of the effectiveness of preventative and comprehensive care — and the conundrum of costs.

Plus: Kaiser Family Foundation has published online a handy health reform implementation timeline that looks at when specific provisions of the legislation are scheduled to take effect. KFF also provides a summary of the new health reform law, breaking out key provisions by topic.

And Health and Human Services Secretary Kathleen Sebelius this week announced the appointment of five new HHS regional directors who will work with the states on implementing the Patient Protection and Affordable Care Act.


April 5, 2010

Breast Cancer Gene Patents Invalidated

Last summer, we shared that OBOS had joined an ACLU lawsuit challenging breast and ovarian cancer gene patents.

Briefly, the ACLU and the Public Patent Foundation (with plaintiffs including OBOS, pathology associations, and individuals) filed a lawsuit against the U.S Patent and Trademark Office, Myriad Genetics and the University of Utah Research Foundation, “charging that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid.” The suit focused on the BRCA1 and BRCA2 genes, mutations of which are related to increased risk of breast and/or ovarian cancers, and for which Myriad Genetics controlled the patents (effectively controlling the available testing for important mutations).

As Breast Cancer Action explained, “When one company controls all the testing, less information and resources are available to both patients and researchers.” The New York Times story on the ruling also explains that “Some doctors and researchers contend that this monopoly has long held up not only competing, cheaper tests but has also hindered gene-based research.”

Last Monday, a U.S. judge ruling in the case invalidated the patents, arguing that “the company deserved praise for what is ‘unquestionably a valuable scientific achievement,’ but not a patent because the ‘isolated DNA is not markedly different from native DNA as it exists in nature.’” Essentially, the relevant genes are found in nature and thus aren’t novel enough to qualify for patent protection.

The judge dismissed the claim that the U.S. Patent and Trademark Office’s issuing of the patents was unconstitutional. The complete ruling can be found here [PDF]. The ruling has the potential to make the study of and testing for important genetic variations cheaper and more readily available.

Genomics Law Report has a good overview of the ruling, and several ScienceBlogs authors are also talking about the case, with one calling the ruling “a monumental step towards bringing sanity to biotech patents.”

This Sunday, CBS aired an episode of 60 Minutes that prominently featured the case. As OBOS was a plaintiff to the suit, we also got a chuckle out of the title of this editorial at the NYDailyTimes: Our bodies, ourselves: Judge rightly rules that no one can patent human genes

The ACLU itself also has commentary on the ruling, calling it “a huge victory for women’s health and scientific freedom,” and NPR’s Richard Knox has an interview with an attorney who explains the ruling and its implications.