Author: Katherine Hobson

The controversy over gene patents is not going away anytime soon. As the WSJ reports, a Duke University study concludes that exclusive licensing of gene-based diagnostic tests can keep patients from benefiting from genetic discoveries and often leads to legal wrangling.

And current disagreements surrounding gene patents –- such as the recent federal court decision to invalidate seven patents covering the BRCA1 and BRCA2 genes licensed solely to Myriad Genetics –- may be small potatoes compared with what lies ahead. If the price of mapping a person’s entire genome continues to fall, what are the consequences of the “hundreds or thousands of patents already issued and exclusively licensed gene by gene?” Robert Cook-Deegan, head of the Duke Institute for Genome Sciences & Policy, who led the study, asks in an interview with the WSJ. “How will you offer full gene sequencing without getting sued?”

Of course, the $1,000 genome is likely years away, and those who favor exclusive patents on diagnostics say they’re necessary for companies to make their money back on research and development.

But exclusive patents may already be keeping some patients in the dark, the WSJ article says. It describes a new method of genetic testing called chromosomal microarrays that can pick up chromosomal abnormalities in the genome. What’s a doctor to do if that kind of analysis encompasses a gene that’s already patented — tell the patient or stick to the letter of the law?

Image: Wikimedia Commons

Drugstores are trying to bolster their presence in the in-store clinic market, even though the concept has thus far not been a particularly profitable one. The WSJ reports that CVS Caremark may double its number of MinuteClinic retail operations over the next five years.

The company has no plans to forge financial partnerships with medical providers, but instead prefers “collaborative” non-financial ties, MinuteClinic President Andrew Sussman tells the paper. Bloomberg quotes Gabelli analyst Jeff Jonas as saying that CVS has trimmed its losses on its MinuteClinics from the five cents a share that they were costing the chain two yeas ago.

Meantime, Walgreens’ Take Care Clinic has recently said it’s in “deep discussions” with possible hospital system partners. Joint ventures, franchises and other business models are all on the table, as long as the arrangement is a “winning situation” for both sides, Take Care Chief Executive Peter Miller tells the WSJ.

CVS and Walgreens dominate the in-clinic market, with a 72% share of the business, according to a report released last year. The WSJ says operators are attempting to find a way to “overcome the seasonal nature of the business, which has caused some companies to shut clinics outside of flu season.”

Nebraska became the first state in the nation to enact restrictions on abortion based on the concept of fetal pain, the New York Times reports.

The new law, signed on Tuesday, bans abortions after 20 weeks’ gestation, a point at which some argue the fetus feels pain. Previously the state forbade abortion based on the ability of the fetus to live outside the womb, which is considered to begin no earlier than at 22 weeks, according to the Times. Abortions after 20 weeks are now permitted only in an emergency or when the mother’s life or physical health are at serious risk.

Fetal pain is a highly controversial topic that has implications for the increasingly intricate surgical procedures performed on fetuses in utero as well as abortion. A JAMA review published in 2005 concluded that while evidence “regarding the capacity for fetal pain is limited,” it’s “unlikely before the third trimester.” Other researchers, however, studying responses during fetal surgery, say they’ve observed flinching or physiological changes like an increase in stress hormones in fetuses even at 18 weeks’ gestation.

The focus on fetal pain may open a new front in the abortion wars. “If some of these other anti-abortion bills have been chipping away at Roe v. Wade, this takes an ax to it,” Nancy Northrup, president of the Center for Reproductive Rights, told the NYT.

Image: iStockphoto

UnitedHealth Group and Walgreens say they’re teaming up with the YMCA on a program that will reimburse pharmacists and lifestyle coaches to help insured patients prevent and control diabetes.

The program, which will be announced Wednesday at the CDC Diabetes Conference in Kansas City, Mo., will have two parts, says Tom Beauregard, executive vice president of UnitedHealth and executive director of the UnitedHealth Center for Health Reform and Modernization. The prevention arm will use UnitedHealth claims data and other demographic information to flag people at risk of developing diabetes and invite them to a free, 16-session exercise and nutrition class at a local YMCA. They’ll have monthly follow-up after the class is over, and instructors will be paid bonuses if participants meet certain modest weight-loss goals.

The control part of the program will be administered with Walgreens. Participants who already have diabetes will receive a 45-minute assessment and then other health-care coaching sessions, covering both medical and lifestyle management, says Colin Watts, chief innovation officer at Walgreens.

Beauregard notes that the Diabetes Prevention Program is based on an NIH- and CDC-funded efforts that showed a 5% weight loss translated into a 58% reduction in the likelihood of the development or progression of diabetes. He said UnitedHealth would pay the YMCA around $300 for someone who completed the program and it could rise to $500 for someone who met weight-loss goals. Neither he nor Watts would disclose the reimbursements to Walgreens, but Watts says it includes a strong pay-for-performance element.

The Diabetes Prevention and Control Alliance will be rolled out first in six markets in four states, and will be expanded nationwide through 2012, says Beauregard.

Photo: Bloomberg News

During the health-care debate, the impact of medical malpractice suits was controversial, with the Republicans saying it was a key part of the escalating cost issue and the Democrats saying, not so much. For its part, the CBO estimated tort-law changes would cut only about 0.5% from U.S. health-care spending.

A study now reinforces the long-held belief of many doctors that malpractice -– or fear of same — is really pretty important on the cost front after all. Researchers wanted to know if physicians’ behavior and attitudes explain some of the regional variations in the number of intensive procedures. (Citing the Dartmouth Atlas of Health Care, they said the rate of a given cardiac procedure might be three to eight times higher in one area of the country than another, depending on the procedure.) The researchers surveyed 598 cardiologists across the U.S. about what non-clinical reasons might lead them to recommend cardiac catheterization. They also calculated a doctor’s “cardiac intensity score” — a quantitative measure of his or her propensity to test and treat, based on his or her response to hypothetical patient scenarios.

The study, published online in Circulation: Cardiovascular Quality and Outcomes, found that nearly 24% of those surveyed reported that fear of malpractice was a non-clinical factor in their decision to recommend catheterization; docs with high intensity scores were more likely to say that legal fears influenced their recommendation. And 27% said if they thought their colleagues were likely to order the procedure, they would too. Researchers also asked doctors if they’d recommend the test because “the patient expects it,” “to satisfy the expectations of the referring physician,” or to enhance “the financial stability” of a medical practice. (Surprisingly, five doctors actually admitted they frequently or sometimes recommended catheterization for that last reason.)

Only the fear of malpractice, however, was significantly associated with regional differences in the level of health-care services used. “I think this study provides enough evidence to think it’s maybe a target for intervention,” says F. Lee Lucas, lead author of the study and associate director of the Center for Outcomes Research and Evaluation at Maine Medical Center, who found the malpractice findings surprising. “It seemed to be, for a fair number of physicians, to be a clear motivation for doing something potentially unnecessary.”

Even for doctors who aren’t directly affected by malpractice suits, the fear of being sued may lead them to order more tests than they otherwise might have – that’s so-called defensive medicine.

Image: iStockphoto

Patients already lie to their doctors. And almost half of respondents in a new survey said if there was any hint their health information — even stripped of identifying details like name or date of birth — would be shared with outside organizations, they might be even less forthcoming.

A study on electronic medical records use by the California HealthCare Foundation, a philanthropic group, found that 15% of the 1,849 adults surveyed said they’d conceal information from a physician if “the doctor had an electronic medical record system” that could share that info with other groups. Another 33% would “consider hiding information.”

Privacy concerns still hover around EMRs, with 68% of survey respondents reporting some degree of worry about what happens to their personal information once it’s stored in a doctor’s computer. EMR use by consumers is rising, though, with 7% of Americans reporting having used one, compared with 2.7% in a 2008 survey conducted by another organization. (Those that did use EMRs said they were helpful, and a significant number of them said the electronic records prompted them to ask questions about or take steps towards improving their health.)

Of course, not being completely honest with doctors is practically an American tradition, with or without EMRs. Another study out earlier this year, conducted by General Electric, the Cleveland Clinic and Ochsner Health System, broke down what patients generally lie about. Lack of exercise led the pack, with 13% of respondents, followed by compliance with medication instructions (9%), dietary habits (9%), drinking (7%), smoking (7%), use of illegal drugs (4%) and unprotected sex (4%).

Image: iStockphoto

Starting today, you’ll see a new byline on the Health Blog. I’ve long been a fan of The Wall Street Journal’s health and health-business coverage, and I’m looking forward to being a part of it by continuing the strong three-year tradition of this blog. Whether delivering the latest breaking news, bringing you expert insights or digging up tidbits you won’t find anywhere else, the goal is to keep the Health Blog your first and most trusted source of health-related news. I’ll be helped out by plenty of contributions from staffers at the Journal, WSJ.com and Dow Jones Newswires. We also hope to expand the blog’s scope even more to appeal not just to those in medical-related industries, but to anyone who is interested in his or her own health.

I joined the Journal from U.S. News & World Report, where I covered health and medicine for many years. Before that, I wrote about business for USN&WR, TheStreet.com and Bloomberg News. I’ve had the chance to write about the science of cancer metastasis, why the notion of “superfoods” is silly, medical fraudster John Brinkley (Google his name and “goat” for some entertainment on your lunch break) and London casinos. I hope to bring the same eclecticism to this blog in pursuit of making the Health Blog uniquely informative and interesting.

And there’s plenty of raw material ahead: the effects of health-care overhaul, the often-contentious debate on the effectiveness of screenings and new drugs and how information technology is changing the business — just to name a few looming issues. I’m thrilled to start the conversation today, and I hope you’ll be vocal with your input in comments and emails to [email protected].