BRCA Patents Struck Down

Myriad Genetics is a company that owns the patent on the BRCA1 and BRCA2 genes - tumour suppressor genes involved in breast (and other) cancer heredity, and important for genetic testing. This is pretty lucrative for the company since it means they control diagnostic testing based on these genes. As Bayman has written before they've been highly defensive of these patents and restrictive of the tests, threatening to sue provinces that offer BRCA screening other than Myriad's own BRCAnalysis and demanding that patient samples be sent to their Utah headquarters.

Gene patents are great for the companies that own them, but can be problematic for patients who might need these tests and researchers trying to investigate disease. Around 20% of the human genome is 'owned' by some other interest, but the tide is beginning to turn. A ruling yesterday by a New York federal judge has overturned Myriad's BRCA patents, a ruling that will no doubt affect the status of other gene patents.

The key aspects of the ruling is that 1) the patented material - the isolated BRCA1/2 DNA - is "not 'markedly different' from native DNA and is therefore not patentable under US law and 2) the method - BRCA1/2 sequence analysis - is not patentable.

This is good news for consumers (i.e. patients), researchers and a different set of corporate interests (eg. genetic testing services like 23andMe), though there will inevitably be an appeals process before the dust settles and we know for sure where patents like these stand.

Read the full, 156-page, ruling here (there's some interesting stuff in there) and further commentary at The Questionable Authority and Genetic Future.

State of California vs. Personal Genetic Testing

This is a brief follow-up on Rob's 23andMe post. In the comments there, I wondered aloud about counselling services and possible misinterpretation of results.

It turns out the normally progressive State of California is taking those concerns seriously, and recently sent cease and desist orders to 23andMe and 12 other personal genetics companies.

The basis of the order was two-fold. First, the State requires that all such companies must be certified by both the state and federal governments, with the idea being to safeguard privacy and protect consumers from charlatans who might turn around and sell that data to the highest bidder.

Secondly, California law requires that genetic tests be ordered by the patient's doctor. Here, presumably the motivation is make sure someone (the doctor) is going to help properly interpret the results.

[T]he site still provides some probabilities of getting certain diseases. And while none of these sites are going to offer any life-shattering information (e.g. “You will die before you hit 30″), many health care professionals worry that any amount of genetic information could be misinterpreted. What happens when a patient finds out they have a lower-than-average risk of heart failure that leads them to neglect regular checkups? Then again, it’s my information - shouldn’t I be free to (mis)interpret it as I see fit?

23andMe feels they are acting withing current law, and are continuing business as usual, at the risk of a fine of up to $3000 per day.

Is this a case of an over-protective nanny state, or a legitimate consumer protection issue?

Drug Marketing Regulations

Bayman previously touched upon advertising regulation in his comments here. The Globe and Mail has an article about the history of pharmaceutical advertising laws and some of the surrounding issues (sorry, subscription required). Believe it or not, ads for prescription drugs are illegal in Canada (over-the-counter meds can still be marketed). Since 1954, the Food and Drugs Act has banned the advertising of prescription drugs "to protect the purchasing consumer against injury to health, and against deception." CanWest Global is currently launching an assault on these laws in the courts, claiming they violate free speech. So why do we see so many horny elderly couples on TV, sneaking away for some afternoon delight under the shadow of a Cialis or Viagra logo?

The answer lies in a loophole built into the act, also under the guise of consumer protection. An exemption was included to allow pharmacies to post price comparisons, so buyers could get the best deal, but only the name and the price could be included in the ad - no medical conditions or claims of effectiveness. So now, as Canadians, we're treated to two kinds of 'reminder' ads: The Guy Lafleur erectile dysfunction type, that mention a condition but no drug (talk to your doctor about ED) and the Viagra type that mention a drug but no condition (Viagra...ask your doctor) and leave the rest to inference and innuendo. Be careful, though, about running the two too close together: a few years ago, Health Canada cracked down on Wyeth for running acne awareness ads in the same commercial block as their drug Alesse - a birth control and anti-acne drug, using similar themes to link the two in consumers minds.

While Canadian drug marketers have to rely on coy and uninformative (though imaginative) advertising, our neighbours to the south face a different situation. The United States is one of only two nations that allow direct to consumer pharmaceutical advertising (New Zealand is the other). Instead companies can advertise their wares, but must include extensive information about negative side-effects.

Which system is best? That's a tough call. If we must be at the mercy of advertisers, my inclination would be a US system that includes both positive and negative about the drug. It's a rare person that doesn't know what Viagra is for, but probably far fewer are aware of the side-effects. In this sense, the uninformative Canadian ads may be more harmful. However, it's been argued that allowing all-out drug advertising increases the cost of pharmacare since drug companies pass the ad expenses on to consumers. (I fail to see how allowing only Canadian-style ads reduces this expense). Finally, with all drug advertising, there's the issue of mis-prescribing. Studies have shown that if a specific drug is asked for, the chances of it being prescribed increase, regardless of whether they manifest the correct symptoms: "The fact that they asked for the antidepressant was a stronger determinant of treatment than whether they had the conditions the drug was meant to treat."

Engineering the Brain into a Solar-Powered Calculator and Will Biology Ever Be a "Real" Science?

• Engineering the brain is just cool, and this has to be the ultimate example. Groups from Stanford and The Max-Planck have collaborated to create transgenic mice whose neurons can be exquisitely controlled with photons of light. Neurons were engineered to express two types of photoreceptors from algae, one responsive to blue light which creates an action potential, and another responsive to red light which inhibits activity. This highly-specific tool (we're talking lasers) for probing neuronal circuitry will likely replace the far cruder electrode stimulator and undoubtedly open the way to vast new territories of research in neurobiology. Read the original Nature paper here, as well as another concurrently-published PLoS One paper describing a similar system in cultured neurons.

• As a biologist I'm always jealous of physicists, what with the Feynmanian mathematical certainty and Einsteinian grandeur that they wield in their quest to explain the universe. We biologists are are less self-confident bunch, tempered (and tortured) by lives predominated by experimental failures within the lab. Will biology ever join chemistry and physics as a so-called "capital-S Science", with a set of its own all-powerful, generalized and quantitative Laws? (Not to be confused with The Ten Commandments...) MIT biological historian Evelyn Fox Keller argues that biology may never see its Moses descend from the mountain. Instead, she suggests in this Nature essay, that biology is special, and the exceptions more important than the rule. Enquist and Stark, in this response, are more optimistic about the prospects for a quantitative Biology with all-encompassing Laws. Maybe there's hope for biology after all, and there will come a day when we can make predictions that even a VC investor would take to the bank.