Thursday, June 13, 2013

CBC News - Can you patent a disease?

The outbreak of a novel coronavirus in the Middle East is not only raising worldwide health concerns but triggering questions about the ability of organizations to patent the genetic sequences of diseases for profit.

The World Health Organization reports that there have been 53 lab-confirmed cases of infection with a new coronavirus called the Middle East Respiratory Syndrome (MERS-CoV). Thirty-one of the people infected with the disease have died.

Saudi Arabia has seen the most cases, but the infection has also been found in countries such as Tunisia, Jordan and Qatar, as well as in Germany and Italy.

The virus was identified in September 2012, three months after the Erasmus Medical Center in Rotterdam, Netherlands, acquired a sample of it. The centre has taken out a patent on the virus's genetic sequence.

While Saudi officials and the WHO have said the patent will impede the process of containing MERS-CoV and developing treatments, Erasmus has defended the move.

Albert Osterhaus, a virologist at Erasmus, told Bloomberg News that patenting the virus was a "normal thing to do."

Indeed, the patenting of genetically modified or isolated viruses is nothing new, says David Schwartz, a patent lawyer and partner at the Canadian intellectual property firm Smart & Biggar.

"You can't patent a disease condition per se, such as cancer or influenza," says Schwartz. "But if you're talking about patenting a lifeform like a bacteria or virus, if altered by man, the answer there is yes."

A patent is a form of intellectual property that allows the patent holder to control the use of a product or method of doing something. That control includes the ability to charge royalties for its use.

Schwartz says that obtaining a patent on a simple mechanical invention, such as a Christmas tree stand, in a single country might cost about $10,000. But getting a patent on a more complex technology - such as one involving chemical synthesis - that also covers multiple countries can run $200,000 or more.

While patent law differs somewhat from country to country, in the area of microorganisms most nations agree on general principles, says Schwartz.

You can't patent something that is naturally occurring, he says, but if an organism is modified in some way, it is patentable.

One of the most famous cases of biological patenting is the so-called "Harvard mouse," a type of laboratory mouse genetically modified by scientists at Harvard University to carry an "oncogene," which makes the animal susceptible to cancer. It was patented in the United States, though not in Canada.

"Ninety-nine point nine per cent of the mouse is God's creation, but in its totality, as you would claim it as the subject for a patent, it's a non-naturally occurring, man-made thing," says Schwartz.

In the case of a gene, modifying its information or removing it from its chromosome typically would be enough to warrant a patent, says Schwartz, because the snippet of chromosome would not appear in nature by itself.

This is a key point in the case of the novel coronavirus. To pinpoint it, Erasmus likely used what is called "deep sequencing," says Earl Brown, executive director of the Emerging Pathogens Research Centre at the University of Ottawa.

In this process, the infected sample would be run against databases of known genes and viruses to determine its genetic composition. Brown says the researchers would then typically remove the sequence from its chromosome and copy it in order to conduct further tests.

The rationale for patenting a genetic sequence such as the novel coronavirus is to be able to develop products, such as diagnostic tests or a vaccine, that could be marketed and sold, says Bernard Dickens, professor emeritus of Health Law and Policy at the University of Toronto.

"Profit is what underlies the whole patent system," he says.

But as the science of biotechnology advances, people are taking a second look at some of the original patent decisions that helped set precedent.

The boom in biological patenting began with the identification of the gene for breast cancer, says Dickens.

In 1994, the University of Utah, National Institute of Environmental Health Sciences (NIEHS) and Myriad Genetics filed a U.S. patent on BRCA1, a gene that indicates a woman's susceptibility to breast and ovarian cancer. The patent was granted in 1997. (In 1995, the same consortium filed a patent on the BRCA2 gene, which was granted in 2000.)

BRCA1 was recently in the news after Hollywood actor Angelina Jolie announced that she had undergone a double mastectomy after learning that she had a "faulty" BRCA1 gene that greatly increased her risk of breast cancer.

The problem with the breast cancer patent, Dickens says, is that Myriad Genetics was charging exorbitant rates for the use of its diagnostic tests.

"They were prohibiting hospitals, including in Canada, from undertaking the test using their technique. They were imposing charges that were really at a prohibitive level," says Dickens.

The dispute over the BRCA1 and BRCA2 patents has sparked a legal challenge that is currently before the Supreme Court in the U.S.

Depending on the court's decision, the case could either strengthen or undermine what can and can't be patented.

Meanwhile, at the World Health Organization's annual conference in Geneva in May, WHO Director General Margaret Chan stressed that countries need to share information on the novel coronavirus.

"Making deals between scientists because they want to take [intellectual property], because they want to be the world's first to publish in scientific journals, these are issues we need to address," she said.

Albert Osterhaus, the virologist at Erasmus, has said that his organization is sharing this coronavirus "with everyone who wants to do public health research."

The aim of patenting, says Dickens, is to encourage organizations to pour investment into solving a specific problem.

"The balance, and it still hasn't been satisfactorily resolved in every case, is giving investigators an incentive to invest in research to produce products, which they can then license and receive results on," says Dickens.

Some universities patent particular inventions for the purpose of preventing commercial exploitation, Dickens says. They get the patent and then publish it widely, so it's available to all researchers.

"That's part of the mission of universities, of course: to make investments for the public good," says Dickens. "So it doesn't follow that [a patent] is necessarily going to be exploited for profit."

Schwartz says that while some may see biological patents like a hindrance to gaining a handle on potentially lethal organisms such as a coronavirus, they are ultimately intended as an incentive for researchers to find solutions.

"Perhaps there are also other ways of advancing industry and science, but this is the globally accepted system," he says.

Wednesday, June 12, 2013

Healing the Overwhelmed Physician -

BOSTON — DURING an 1817 visit to Florence, the French author Marie-Henri Beyle, known by the pen name Stendhal, was seized by palpitations, dizziness and a feeling of being overwhelmed by the abundance of great art surrounding him; an Italian psychiatrist later coined the termStendhal syndrome to describe this phenomenon.

We physicians are susceptible to a kind of medical Stendhal syndrome as we confront the voluminous evidence about the clinical choices we face every day. It would take dozens of hours each week for a conscientious primary care doctor to read everything he or she needed in order to stay current — a dizzying and impractical prospect.

To remedy the problem, many medical groups issue clinical-practice guidelines: experts in a field sort through the reams of clinical research on a medical condition and pore over drug studies, then publish summaries about what treatments work best so that physicians everywhere can offer the most appropriate, up-to-date care to their patients.

While this sounds straightforward, the process can go astray. Take, for example, the recommendations issued recently by the American Association of Clinical Endocrinologists on caring for patients with diabetes. The A.A.C.E.'s latestguidelines elevate many second- or third-line drugs to more prominent positions in the prescribing hierarchy, rivaling once uncontested go-to medications like metformin, an inexpensive generic. They also emphasize the riskiness of established treatments like insulin and glipizide, which now carry yellow warning labels in the A.A.C.E. summary.

We've been here before. Several years ago, another set of practice guidelines recommended the aggressive treatment of anemia in kidney-disease patients with the drug erythropoietin, though the higher doses substantially increased the risk of heart attack, stroke and death, with little countervailing benefit. Here, too, the professional society that issued the guidelines, as well as many of the doctors who formulated them, received funding from companies marketing the drug.Several of the now promoted drugs are expensive newcomers that lack the track records of clinical effectiveness and safety held by the older, potentially displaced treatments. The changes were made, ostensibly, to give physicians more treatment choices for their patients. But there is also concern that they could have been influenced by another factor: the manufacturers of some of these new drugs financially supported the development of the guidelines, and many of the authors are paid consultants to some of those companies.

The nation's $325 billion prescription-drug market offers an enormous incentive to develop and disseminate information lauding the presumed virtues of costly new medications, but there is much less muscle behind efforts to encourage the use of established, off-patent drugs, even when the weight of evidence and experience recommends them.

At the same time, the medical literature is rich with superbly conducted trials and thoughtful, balanced clinical guidelines. For a physician, trying to process this rush of inputs can feel like drinking from a fire hose into which someone occasionally squirts a stream of arsenic. Imagine Stendhal on acid.

To address this problem, which affects the care of every patient in the nation, several groups — including the Institute of Medicine, the American College of Physicians and the Cochrane Collaboration, an international network of experts that evaluates clinical research — serve a "curation" role for medical knowledge. As the evidence base becomes ever larger and more contentious, this honest-broker synthesizing function becomes increasingly important.

A 2011 report I helped write for the Institute of Medicine sought to establish guidelines for guidelines — standards to ensure that these recommendations rigorously and fairly depict the best available knowledge and are not tainted by financial ties to the companies that could win or lose based on their content.

Beyond such standards, though, another critical step is needed. That's because even the most superbly assembled evidence doesn't disseminate itself. Like Stendhal, doctors also need a skilled docent to help walk them through all that curated data.

The pharmaceutical industry figured that out decades ago, deploying tens of thousands of sales representatives, or "detailers," to promote their products directly to doctors in their offices. For years, my colleagues and I have been using a similar approach through the nonprofit Independent Drug Information Service, now financed by the governments of Pennsylvania and the District of Columbia. Our "academic detailing" program assesses the medical literature in a non-product-driven way and then deploys a "docent service" of pharmacists and nurses to visit doctors in their own offices and guide them through the resulting therapy recommendations.

A few large health systems, including Kaiser Permanente and the nation of Australia, have adopted this curator-docent approach, which has been shown to improve doctors' clinical decision making. The programs can also control costs over time, as they counter the influence of drug companies promoting the most expensive new drugs, whether or not they're an improvement. But to make a significant difference, many more health care systems, both private and public, must adopt them.

Back from Florence, Stendhal ended his life racked by disabilities attributed to his syphilis. It now appears that many of his symptoms were probably adverse effects of the drugs his doctors were using to treat him, following the not-so-scientific treatment guidelines of their time.

Jerry Avorn, a professor of medicine at Harvard, is an internist at Brigham and Women's Hospital and the author of "Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs."