U.S. comes down against gene patents

In a surprising move, the U.S. Justice Department filed a brief last Friday that declared, for the first time, that the U.S. government does not support the patenting of naturally occurring human genes. This new position is contained in a document filed as part of the ongoing legal challenge to the gene patents on the human breast cancer genes, BRCA1 and BRCA2.

As background: a company called Myriad Genetics has held the patents on these two genes since the late 1990s. They sell diagnostic tests that cost nearly $4,000, and if a woman wants to test her own DNA for any mutations in the BRCA genes, they are required to pay for this very expensive test. The gene patents prevent any competitors from offering the same test without paying Myriad a license fee. Earlier this year, the ACLU challenged these patents in federal court, and the initial court ruling, which came as a surprise to many, invalidated the patents. Myriad appealed, and it seems likely this will end up in the Supreme Court before it is finally settled.

I have a scientific interest in this case, having just published a paper that directly challenges gene patents by providing free software that allows anyone to test their own DNA for mutations in the BRCA genes. Our software requires that you first have your genome sequenced, which (of course) is not feasible for most people today, but which I think will be routine in the not-too-distant future.

It seems absurd that, having your own DNA in hand (on a flash drive, perhaps), you wouldn’t be allowed to check your own genes for mutations without first paying a license fee to a company. Actually, under current law you might have to pay hundreds of license fees, because thousands of human genes have already been patented.

The same government that issued these patents has finally woken up to this absurdity. In their amicus brief, the Justice Department wrote:

“the unique chain of chemical base pairs that induces a human cell to express a BRCA protein is not a ‘human-made invention.’ Nor is the fact that particular natural mutations in that unique chain increase a woman’s chance of contracting breast or ovarian cancer. Indeed, the relationship between a naturally occurring nucleotide sequence and the molecule it expresses in a human cell – that is, the relationship between genotype and phenotype – is simply a law of nature. The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is ‘isolated’ from its natural environment than are cotton fibers that have been separated from cotton seeds.”

Rarely have I seen such sensible scientific reasoning from lawyers, and I must say it is very refreshing. Just in case the text quoted above is isn’t clear enough, the brief goes on to point out that “the patent laws do not, however, embrace the products and processes of nature itself.” The reason for the bit about “isolated” DNA is that Myriad’s patents cover DNA that has been “isolated” from the cell, and the Justice Department wanted to make it clear that this distinction should not somehow make the DNA patentable.

The legal implications of my own challenge to the BRCA gene patents were discussed at length at Genomics Law Report, and by Forbes blogger Robert Langreth. It will be interesting to see how this latest filing by the Justice Department changes the picture. The implications go far beyond the BRCA gene patents: if the initial court ruling and the Justice Department’s position hold up, then virtually all gene patents, on human genes and on many other species’ genes, will become invalid.

It’s about time. New genes have been the basis of many exciting discoveries, but they are not inventions. No one should have exclusive rights to a gene that occurs naturally in a human, another animal, a plant, or any other living species.

Osteopathic medicine redux

Some of you may have noticed that I removed my blog post on osteopathic medicine. Over at Forbes there is a fierce debate in the comments section, and I've put up a new post there, at this link, correcting what may have been a too-harsh commentary, if anyone wants to follow this discussion further.

Whooping cough in California: deaths caused by the anti-vaccination movement

California is suffering the worst epidemic of pertussis, or whooping cough, in 60 years, with over 5,200 cases already, the most since 1950. Nine babies have died, all of them too young to receive the vaccine. Michigan is also reporting a serious outbreak, with over 600 cases so far this year. The deaths of the infants in California are tragic, and what’s more tragic is that some of them almost certainly could have been prevented if more people had been vaccinated.

The pertussis vaccine, called DTaP (diphtheria, tetanus, and pertussis) has been responsible for a dramatic drop in whooping cough in recent decades. It isn't 100% effective, but its effectiveness relies in part on “herd immunity”: if enough people are immune to the bacteria, then even if someone gets sick, the disease cannot easily spread through the community. This is especially true for very young infants, who are too young to be vaccinated and whose immune systems are not yet strong enough to defeat the bacteria on their own.

Unfortunately, it’s not a coincidence that California is the center of the new pertussis epidemic. Vaccination rates among adults in California have been dropping in recent years, largely due to the influence of anti-vaccination zealots such as Jenny McCarthy and groups such as Age of Autism. Anti-vaccination sentiments seem to strike a chord with relatively well-educated segments of the population – the same people who favor organic food and want to use “natural” products as much as possible. Anti-vaxers appeal to this group by arguing that vaccines are unnatural, and that the body’s own immune system can be “boosted” by various natural treatments. Appealing though this may sound, it has no basis in science. California makes it easy for parents to claim exemptions from the required vaccinations for their children, and exemptions have more than doubled since 1997, according to the L.A. Times.

Among the anti-vaccinationists who deserve blame for the current pertussis outbreak is “Dr. Bob” Sears, a kindler, gentler anti-vaxer who claims (like many of them) to be in favor of vaccines, but only under his own, unscientific terms. He stated flatly in the Huffington Post (a hotbed of medical misinformation) recently that pregnant women should not get the DTaP vaccine. But as Dr. Paul Offit tells us in a tragic story, refusing the vaccine can lead directly to the death of an infant. Dr. Bob is just wrong. I should add that Sears has written two books on vaccines and autism, promoting his misguided “alternative” vaccine schedule (see this article in Pediatrics about that) and his rather naive theories about the rise in autism diagnoses.

Everyone should have their children vaccinated. On top of that, in order to maintain herd immunity, most of us should get the pertussis booster shot if we haven’t had one in the last ten years. That’s what vaccine expert Paul Offit recommends, and I’m planning to follow his advice myself. It won’t take long, and it might save a life.