Supreme Court Rules That Human Genes Cannot Be Patented

This may be best Supreme Court decision in recent years. Human genes may not be patented. Those that have patents on genes no longer have them.

I confess to some surprise at this decision. But my main emotion is elation.

The decision was unanimous.

“A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” Justice Clarence Thomas wrote for a unanimous court. But manipulating a gene to create something not found in nature is an invention eligible for patent protection.

The case concerned patents held by Myriad Genetics, a Utah company, on genes that correlate with increased risk of hereditary breast and ovarian cancer.

The central question for the justices in the case, Association for Molecular Pathology v. Myriad Genetics, No. 12-398, was whether isolated genes are “products of nature” that may not be patented or “human-made inventions” eligible for patent protection.

The patents were challenged by scientists and doctors who said their research and ability to help patients had been frustrated.

The court’s ruling will shape the course of scientific research and medical testing, and it may alter the willingness of businesses to invest in the expensive work of isolating and understanding genetic material.

Obamacare Exchanges in CA, WA, and OR Post Premiums Drastically Lower Than Many Projections

From Sarah Kliff in the Washington Post:

The Congressional Budget Office predicted back in November 2009 that a medium-cost plan on the health exchange – known as a “silver plan” – would have an annual premium of  $5,200. A separate report from actuarial firm Milliman projected that, in California, the average silver plan would have a $450 monthly premium.

Now we have California’s rates, and they appear to be significantly less expensive than what forecasters expected.

On average, the most affordable “silver plan” – which covers 70 percent of the average subscriber’s medical costs – comes with a $276 monthly premium. For the 2.6 million Californians who will receive federal subsidies, the price is a good deal less expensive, the amount noted in green below.

 

This is what is happening in the states whose governors and legislatures are not seeking to sabotage the implementation of the Affordable Care Act. California, Washington, and Oregon are showing similarly low rate offerings on the insurance exchanges, which at the beginning will apply mainly to individuals who were not previously insured.

In other words, the Affordable Care Act is providing affordable insurance to those previously unable to purchase it.

Obamacare Exchanges Already Forcing Private Insurers To Lower Their Premiums

From Oregon, which in many ways is fast becoming a model for how to do health reform right (their recently released low back pain guidelines are also excellent):

In a striking illustration of the promise that the health law holds for consumers, two Oregon private insurers vying to sell coverage on the state’s Obamacare insurance marketplace this October are reevaluating their opening bids for the plans’ monthly premiums. The reason? A side-by-side regional comparison of all proposed 2014 premiums for Oregon marketplace plans became public on Oregon’s marketplace website Thursday, and showed that the two insurers’ planned monthly premiums were far higher than other proposals. That raised fears among the companies’ officials that their plans wouldn’t be competitive on the market later this year, leading them to proactively request a rate reduction — and as more of Obamacare is implemented, state insurance commissioners expect that trend to continue:

“Posting rate comparisons company-by-company is a taste of what is to come,” says Cheryl Martinis of the Oregon Insurance Division.

Judging by the reaction, there’s already an impact.

Providence Health Plan on Wednesday asked to lower its requested rates by 15 percent. Gary Walker, a Providence spokesman, says the “primary driver” was a realization that the plan’s cost projections were incorrect. But he conceded a desire to be competitive was part of it.

A Family Care Health Plans official on Thursday said the insurer will ask the state for even greater decrease in requested rates. CEO Jeff Heatherington says the company realized its analysts were too pessimistic after seeing online that its proposed premiums were the highest.

“That was my question when I saw the rates was, ‘Can we go in and refile these?’” he said. “We’re going to try to get these to a competitive range.”

Although some insurers have been using Obamacare as an excuse to hike premiums despite record profits, such rate hikes have been rarer — and less extreme — since the law’s passage.

 

40% Failure Rate on Hip Transplants: Executives Knew But Hid the Evidence

This level of corruption in the service of corporate profits is no surprise to anyone who follows developments in the drug and medical device industries. Still, if I step back a bit, it is nothing short of breathtaking.

THIS month, Johnson & Johnson is facing more than 10,000 lawsuits over an artificial hip that has been recalled because of a 40 percent failure rate within five years. Mistakes happen in medicine, but internal documents showed that executives had known of flaws with the device for some time, but had failed to make them public.

It would be nice to imagine that this kind of behavior is exceptional, but in reality, the entire evidence base for medicine has been undermined by a casual lack of transparency. Sometimes this is through a failure to report concerns raised by doctors and internal analyses, as was the case with Johnson & Johnson. More commonly, it involves the suppression of clinical trial results, especially when they show a drug is no good. These problems would be bad enough on their own, but they are compounded by a generation of “fake fixes” that have delivered false reassurance, and so prevent realistic public discussion.

The best evidence shows that half of all the clinical trials ever conducted and completed on the treatments in use today have never been published in academic journals. Trials with positive or flattering results, unsurprisingly, are about twice as likely to be published — and this is true for both academic research and industry studies.

Read the rest of the article. It actually gets worse.

 

 

U.S. Allows Chemicals in Food That Are Illegal Elsewhere

One more reason to read ingredient lists and not to trust the safety of listed items that aren’t actually recognizable foods.

Why the difference? The U.S. Food and Drug Administration would not provide a representative for an interview, but in past statements to the media and on its website the agency has presented a variety of reasons for allowing controversial chemicals in food, ranging from a lack of resources for research to assurances that the substances are safe in small doses.

In the case of BVO, the agency has allowed “interim” use of the ingredient since 1970, pending additional toxicological tests. Asked why it has not addressed the interim status in more than 40 years, the agency cited a need to “maximize its resources” and said addressing the issue is “not a priority for the agency at this time.”

“FDA’s mission is first and foremost to protect public health by ensuring that foods are safe and properly labeled,” the agency said in a statement, contending that science-based implementation of federal law has helped make the U.S. food supply “the safest in the world.”

Unsatisfied with these kinds of answers, activists and public health watchdogs have urged the FDA and food makers to halt the use of various chemicals until safety can be fully determined. Food companies, they note, have reformulated their products for other countries — including members of the European Union, China, Australia, Japan and India — but seem reluctant to change their products in the U.S. until they must.”

Oregon’s Major Medicaid Experiment

As the reporters in this Washington Post article explain, the effort to get more effective health care while controlling costs is the goal of many of the health reform efforts now underway. This Oregon project may be the most of all. If it works, it can create a model for others to emulate.

So Kitzhaber did something that many before him have done in desperate times. The governor who favors cowboy boots over dress shoes made a bet that Oregon could not afford to lose.

The deal Kitzhaber struck was this: The Obama administration would give the state $1.9 billion over five years, enough to patch the budget hole. The catch: To secure that, Oregon’s Medicaid program must grow at a rate that is 2 percent slower than the rest of the country, ultimately generating $11 billion savings over the next decade. If it fails, those federal dollars disappear.

Oregon is pursuing the Holy Grail in health-care policy: slower cost growth. If it succeeds, it could set a course for the rest of the country at a pivotal moment for the Affordable Care Act. Under the law, many states will expand Medicaid programs to cover everyone below 133 percent of the federal poverty line, adding 7 million Americans to the program in 2014 and leaving states looking for the most cost-effective way to cover that influx of patients.

In Oregon alone, Medicaid is expected to enroll 400,000 new patients by 2022, nearly doubling its current numbers, according to an Urban Institute analysis.

As Oregon’s population grows, the state has come to realize that Medicaid is not a bottomless bucket of money. The state’s budget cannot sustain that. Instead, it strives to deliver what health policy experts call “the triple aim”: higher-quality care that leads to better outcomes, all delivered at a lower cost.

 

Provider Nondiscrimination Update

My editorial on the Affordable Care Act’s section that prohibits insurance companies from discriminating against classes of health care providers is now posted at Health Insights Today.

When fully implemented, this federal nondiscrimination policy will for the first time forbid any American health insurance company from refusing to cover services legally provided by a class of licensed health care practitioners (e.g., chiropractors, acupuncturists or clinical social workers) acting within the scope of their state licenses, if it covers those services when provided by a different class of practitioners (e.g., medical or osteopathic physicians). While the Affordable Care Act does not mandate equal payment for equal work (i.e., paying a chiropractor providing a service the same rate as an MD providing the same service), friend and foe alike understand that Section 2706 would make it illegal for insurers to cover any health service for one class of providers licensed to perform it while rejecting coverage for another also licensed to do so. (This nondiscrimination policy does not apply to the two largest government insurance plans—Medicare, which offers partial chiropractic coverage nationwide, and Medicaid, where coverage varies from state to state.)

This part of  the law goes into effect on January 1, 2014. Because it applies to all services that a practitioner is licensed to provide under state law, the implications are quite broad. I’ll be writing more about this in the near future, and presenting on the prevention and health promotion part of this equation at the March ACC-RAC conference in Washington, DC. (ACC-RAC is the annual Association of Chiropractic Colleges Research Agenda Conference).

States Spend Less Than 2% of Tobacco Settlement Money on Anti-Smoking Campaigns

This qualifies for placement in the Public Health Hall of Infamy.

The report blasted states for failing to reverse the budget cuts to tobacco prevention programs that occurred after that time, calling them even more problematic in light of recent surveys that show smoking declines in the U.S. have slowed.

Across the country, 19% of adults and 18% of high school students still smoke, those surveys show.

The $460 million being spent this year amounts to just 12.4% of the $3.7 billion that the CDC recommends on tobacco prevention spending for all states combined.

It would take less than 15% of total state tobacco revenues to fund programs at CDC-recommended levels, according to the report.

Only two states – Alaska and North Dakota – will fund tobacco prevention programs at CDC-recommended levels, while only three – Delaware, Wyoming, and Hawaii – will spend at half the recommended level, the report said.

Four states — New Hampshire, New Jersey, North Carolina, and Ohio — have allotted no state funds for tobacco prevention programs next year.

CFO Magazine Urges Fortune 500 Firms to Explore Cost Savings Via Alternative and Integrative Medicine

A fine article by John Weeks at Huffington Post, well worth reading in its entirety.

CFO Magazine would seem an unlikely source of cheerleading for more inclusion of complementary and integrative medicine practices and providers into U.S. health care delivery. Yet the magazine that targets chief financial officers (CFOs) of Fortune 500 firms has been shaking those pom poms in recent months.

There is a smart economic alignment that connects these stakeholders at the economic hip. They may even be a perfect marriage, as one writer recently put it.

An October CFO Playbook on Health Care Cost Management webinar featured the medical doctor who chairs the most significant lobbying group for integrative health care, the Integrative Healthcare Policy Consortium. The presentation from Leonard Wisneski, M.D., was assertively titled “Integrative Medicine: The Future of Health Care Delivery.” Wisneski, a former medical officer for a large employer, urged extensive piloting of integrative approaches for their cost-saving possibilities.

Early efforts to integrate complementary and alternative medicine therapies and practitioners with conventional delivery — later called integrative medicine — taught us a hard lesson. Hospitals weren’t going to make money with “CAM” the way they do with high-priced services like interventional cardiology.

Rather, the big money in complementary and integrative medicine fields and their preventive and health promoting focus that CFO Magazine’s McCann notes is not in churning services. It is in saving money by limiting services. Use of lucrative interventional cardiology services may be reduced. Hospital business models typically don’t like this. Employer business models do.

Supreme Court Accepts Gene Patenting Case

In the long run, this case may have greater influence than many of the higher profile cases on which the Court decides.

The U.S. Supreme Court on Friday agreed to decide whether human genes can be patented, a hotly contested issue with broad practical and ethical consequences for the future of gene-based medicine for millions of people worldwide.

The nation’s highest court in a brief order agreed to review a case over whether Myriad Genetics Inc may patent two genes linked to hereditary breast and ovarian cancer.

In a 2-1 ruling on Aug. 16, a panel of the U.S. Federal Circuit Court of Appeals in Washington, D.C., upheld the biotechnology company’s right to patent “isolated” genes that account for most inherited forms of the two cancers.

That ruling also denied Myriad’s effort to patent methods of “comparing” or “analyzing” DNA sequences.

The appeal against Myriad and the University of Utah Research Foundation was being pursued by a variety of medical associations and doctors, led by the Association for Molecular Pathology. Their case is being handled by lawyers for the American Civil Liberties Union.

There are many issues at play here. Consider this one: gene patents like these held by Myriad can be used (and are used) to deny researchers the right to conduct research related to the patented genes (i.e., breast cancer research) unless they pay the patent holder whatever fee the corporation wishes to charge.

From both ethical and economic perspectives, this is a most controversial topic. I hope the Court decides that genes are the common heritage of all humanity and are not patentable under any circumstances.