gene patenting

This week's Science Friday focused on gene patenting.  Specifically, a case that has been in court since May of 2009: the American Civil Liberties Union (ACLU) -- along with several cancer patients and organizations of pathologists -- has raised a lawsuit against Myriad Genetics' patenting of the two genes BRCA1 and BRCA2.  Mutations of these genes are indicative of increased risk of breast and ovarian cancer.

The ACLU claims that Myriad's 1994 patent on the genes is illegal, unconstitutional and should be thrown out.  The issue of importance to the cancer patients involved is that Myriad's monopoly on the tests for mutated BRCA1 and 2 prevents patients from getting a second opinion on the results of their tests, and from obtaining a more affordable version of the test.

In my mind, patenting genes is like patenting anything else in medicine.  By invoking a 20-year period of exclusive rights, development of the patented technology or drug is inhibited.  This is the way it has worked with pharmaceuticals for eons: drugs remain produced, distributed and exorbitantly priced by the pharmaceutical companies who patent them, and become eligible for other companies to optimize and distribute generically when that 20-year period is up.

The opposition to this argument is that patenting genes causes more stunting to medical innovation -- and, by default, medical cures -- than does patenting of drugs and other medical technology.  By patenting genes and the single test that has been developed to identify them, patients interested in the risk those genes may pose to them are forced to rely on the interpretation of the patenting company.  In the case of BRCA1 and 2, patients cannot get a second opinion outside of Myriad Genetics; they are forced to rely on the results obtained from Myriad's test and on the interpretation of Myriad's doctors.

My response to this opposition is as follows:

Genes are only a single indication of disease.  It has been reported that  "inherited BRCA1 and BRCA2 mutations account for 5 to 10 percent of breast cancers and 10 to 15 percent of ovarian cancers among white women in the United States" (Campeau et al 2008) -- having the mutations is not a definitive diagnosis of cancer.  It has also been reported that this percentage is even smaller: "[a]pproximately 5-10% of breast carcinomas and 10% of ovarian carcinomas are ascribable to a genetic susceptibility. Of these, about 40% are related to genetic mutations in the genes BRCA1 and BRCA2" (Palma et al 2006).  Take from that statistical discrepancy what you will -- I guarantee there was not a new census taken between 2006 and 2008.

If patenting of genes inhibits patients from getting a second opinion on their genetic tests, it seems that seeking a verification through other diagnostic methods is not only an acceptable option, but a preferable one.  Treatment of breast/ovarian cancers in particular are radically invasive and life-altering; until the BRCA gene identification tests are available "generically", mammograms,  MRI and screenings for other genetic markers of breast/ovarian cancers are not only options but -- in my very humble opinion -- an incredibly good idea before making decisions about radical mastectomy and chemo:

"Clinical testing options for BRCA1 and BRCA2 are limited in the United States. In contrast to genetic testing for BRCA1 and BRCA2, genetic testing for other cancer susceptibility genes (MSH2, MLH1, PTEN, TP53, etc) is available from numerous profit and notfor- profit laboratories, with a range of testing options and prices."

"In addition to DNA sequencing of BRCA1 and BRCA2, genetic testing for other major breast cancer susceptibility genes including CHEK2, PTEN, and TP53 is clinically available in the United States." (Walsh et al 2008)

 Patients at risk for cancer should not limit their diagnosis to the outcome of a single kind of test when there are several out there, and certainly not to a single genetic test which measures only susceptibility.  I do not argue against the legitimacy of a patient's concern, I just don't think that this particular argument is reasonable ground to make illegal the patenting of genes by their discoverers.

I am not sure I agree with the ACLU's argument either:

“What they have really patented,” says Chris Hansen of the ACLU to the New York Times, “is knowledge.” 

Really?  If that is a legitimate statement, then every biomedical patent in the world is a blockade against knowledge, and they should all be overturned.  Patenting is a measure taken to protect and honor the discoveries of researchers.  It gives them the opportunity to make advancements on their own discoveries before the whole world is allowed to take a crack at them.

"Genes are informational. [By] allowing a company to have a patent on the actual sequence you are restricting the free flow of information," Tania Simoncelli, ACLU's science advisor, told Pharmacogenomics Reporter back in May.  Simoncelli's colorful expatiation of this comment can be found here.

THE POINT OF PATENTS IS TO TEMPORARILY RESTRICT THE FLOW OF INFORMATION.  IF YOU WANT TO BRING THE FIRST AMENDMENT INTO THIS, YOU HAVE TO FIGHT ALL PATENTING OF ALL DISCOVERIES EVER.

BIOMEDICAL RESEARCH HAS BEEN PATENTING GENES SINCE THE 1980's AND DOCTORS HAVE BEEN PISSED OFF ABOUT IT SINCE THE 1980's.  IF THE PATENT OFFICE WAS WORRIED ABOUT GENE PATENTING BEING CONTRARY TO THE PUBLIC INTEREST, THEY WOULD NOT ISSUE THEM.

In short, I have yet to find a legitimate argument made by the ACLU against patenting the BRCA1 and 2 genes, much less any gene.  I'm not saying that genes should or should not be patentable; what I'm saying is that the ACLU is making a poor argument, and needs to approach this from more of a patient access angle.

Maybe what needs to happen here is for gene patenting to selectively be restricted to 5 years instead of 20.  Five years is nothing from a scientific standpoint, and wouldn't actually allow researchers the opportunity to make significant headway before the rest of the world chimed in, but it would at least give them a head start without making prospective patients wait an inordinate amount of time for reasonable diagnosis or treatment.  And five years of profit from over-priced tests certainly ain't bad.

in vitro meat and the de-evolution of homo sapiens

Homo sapiens is Latin for wise or knowing man.  I would like to strike "sapiens" from our evolutionary title and replace it with "homo follis", which is Latin for windbag or foolish man.  Can I do that?

Normally, I love technology and am all for its advancement as long as there is an antidote should it prove to be physically or ethically harmful.  There is a line, however, over which technological advancement frequently crosses into the world of promulgating sheer gluttonous sloth.  The antedote in the case of modern animal farming is to change human behavior.  If we consume less meat, farmers aren't pressured to over-produce massive qunatities in order to stay economically competitive.  Less pressure to over-produce means less incentive to abuse farmed animals with antibiotics, hormones, extremely unhealthy food and other revolting living conditions.

But is the American populous ready to make that sacrifice for the sake of being humane?  You bet your ass we're not.  Instead, commercial science has discovered a much more attractive antidote to modern animal farming -- one that requires significantly less effort on the part of the consumer than reducing meat consumption.  For the last decade or so, scientists have been learning how to culture "meat" in a petri dish (Datar & Betti 2009; Edelman et al 2005).  We (the people) are so lazy and so addicted to meat that scientists and economists have fleshed out an analysis of the viability of in vitro meat culturing as a "replacement" for meat farming (In Vitro Meat Consortium 2008).

Is it less of a personal burden to adjust to the taste of stem cell meat than to eat less meat and/or eat more local/grassfed/humanely farmed meat?  The In Vitro Meat Consortium seems to think so, as does PETA:

"As far as we’re concerned, if meat is no longer a piece of a dead animal there’s no ethical objection." 

Really?  Because I'm pretty sure that teaching humanity survival through relying on technology to save us from having to make proactive changes in our behavior has negative ethical implications.  For instance, the backward evolution of our species. 

"Lab-grown meat isn't an easy sell, but there could be benefits. Designer meat would theoretically be free of hormones, antibiotics, and the threat of mad cow disease or bird flu. Omega-3 fatty acids and vitamins could be blasted into the mixture ", says Ian Christe in his article in Popular Mechanics on the subject.

Yes, Ian, you are absolutely correct.  However, HUMANELY FARMED ANIMALS WOULD ALSO BE THEORETICALLY FREE OF HORMONES, ANTIBIOTICS AND THE THREAT OF MAD COW DISEASE OR BIRD FLU.  Additionally, OMEGA-3 FATTY ACIDS AND VITAMINS ARE PRESENT IN FREE-ROAMING UNGULATES WHO ARE NOT PUMPED FULL OF GRAIN-BASED SLOP TO FATTEN THEM UP ALL YEAR ROUND.  And further, WHAT ABOUT ALL THE OTHER SUBSTANCES THAT ARE USED IN THE CULTURING OF THE MEAT; MUST WE ASSUME (like idiots) THEY WILL BE TOTALLY HARMLESS?

So, I must pose the final question: will humanity prefer the financial burden of commercial in vitro meat production, or the burden of changing their consumptive behavior in order to promote humane animal farming?  Unfortunately, I fear the former may win out. 

Lastly, a warm thank you to PETA for supporting the de-evolution of humanity (not that I'm surprised), as well as an alternative to industrially farmed meat that wont actually stop anyone who wants to taste real meat from doing so (tofu dogs have already made this attempt).