Red tape and scientific discourse: a match not made in heaven...

So Science magazine had an article 2 weeks ago describing an interesting conflict in government science.  To give a brief history, last year a group of European researcher's published a paper that a murine (aka mouse) retrovirus was found in about 70% of people diagnosed with chronic fatigue syndrome.  This was a major publication as the cause of chronic fatigue has been quite elusive and, if true, discovery of the agent could lead to potential preventative measures and/or treatments down the road.  Since that publication, several labs have tried to reproduce the studies findings with mixed results.  Two notable groups working on this are one at the CDC in atlanta and a collaboration between the NIH and FDA, all of which are government research labs.  Now, the CDC and the NIH/FDA labs both did their own experiments with their own cohort of patients and found exactly oposite results.  The labs tried to publish the results and both were accepted by peer review, one to PNAS and one to Retrovirology. Now normally, this is sorta where the story ends.  The data would be published and the scientific community would then hash out which data was correct.  It might take years, but this is really how a consensus can be built.  Unfortuantely, the umbrella overseer of both the NIH/FDA and the CDC, HHS, stepped in and blocked publication of the two manuscripts.  Their rationale being that 2 government labs should report the same findings.  Sadly, that is not how science has worked in our country.  In fact, it actually implies that our government is not transparent in its treatment of scientific data.  Hopefully this is a one time incident and the offices of HHS will learn that only through analysis of all data in front of us can the scientific community truly understand the principles governing our lives.

The fate of Avandia

So the FDA has a great opportunity in front of it.  As some of you might have read, the safety of the drug Avandia has been brought into question.  It is now well established that, while the drug does provide some benefits to diabetics, it comes with cardiovascular risks.  Recent studies highlight these findings and also show that the drug is no more effective than its competitors.  While this alone should be sufficient to pull the drug from the shelf, the controversy goes much deeper.  Glasko Smith Klein, the maker of Avandia, had evidence as early at 1999 that there was significant cardiovascular risks for patients on the drug, but decided to hide that evidence from the public and the FDA.  They continued to hide increasing amounts of internal data for years in order to keep the money coming in (an internal memo from the company estimated that releasing the negative data could result in hundreds of millions of dollars lost), before the courts finally forced their hand. 

To me, and maybe to many of you, it seems logical that the drug be pulled from the shelf and huge penalties be thrown at GSK, however, I'm not to confident that will happen.  When a member of the review committee for Avandia suggested the drug not go to market over concerns about cardiovascular risks she was kindly asked to leave.  Hopefully the increased public awareness and mounting evidence will sway the upper echelon of the FDA towards the correct, ethical decision.

On the patenting of genes...

First off, my apologies to those who read this blog regularly for my delay in posting.  I'm actually doing some writing at work at the moment and I find my neurons can't write at home and at work without severe consequences involving bruised knees and lots of drool.  In any case, I had hoped to post today's topic immediately following the review of "The immortal life of Henrietta Lacks," but I found it quite difficult to maintain a neutral stance on the issue of patenting genes (which was the original goal, but to hell with that).

I'd like to start by simplying a very long story that I think many of us can relate to in some way.  For hundreds of years, one of the leading killers of moms and grandmas has been breast cancer.  I'd be surprised if I could find anyone that has not known some one that has dealt with this terrible disease.  For years, researchers wed themselves to the bench trying to find genes that might predict women who were at high risk for the disease, and thus more aggressive preventative care could be administered.  Finding these genes proved challenging and it wasn't until about a decade ago that a university lab made a very important observation that the risk of developing breast cancer was linked to a region of a specific chromosome, but they did not identify the exact gene.  Nonetheless, this discovery was a huge step forward and caught the eye of quite a few people, including a start up biotech company.  This company and the acedemic lab would compete to find the gene.  It was a grueling race for everyone involved, but, in the end, the resources of privatized research overwhelmed the acedmic lab and they found the gene first:  BRCA, four letters that have become part of many women's everyday lexicon.  Before publishing they had found the gene, the company applied, and was approved, for a patent on all things related to BRCA and not too long later, tests for mutations in BRCA became available.  Note: the patent issued was for all things related to BRCA and not just the test for the mutations found in many breast cancer patients.

While the identification of BRCA was a HUGE step forward for detection of women at risk for breast cancer, and the company that developed the test praised for their work, problems started to arrise....many of which are directly related to the patent.  First, the test administered by the company is very expensive (in price, but estimates on the actual cost of the test suggest a very nice profit margin) and not all insurance plans will cover the cost.  Second, the test doesn't screen for all the mutations that are known to be markers for increased risk of breast cancer, meaning you could get the test, be told you were not at risk, and choose to not to undergo more frequent screening for breast cancer, all the  while, you actually are at high risk.  So the result is we have women who can't get tested for economic reasons or were tested but markers that should be screened for weren't because the only test available doesn't screen for them.  Why doesn't some one else make a test for the new mutations?  well they can't, at least, not without permission from the patent holder whom seems more interested in the bottom line and less in good medicine.  As of writing this, there is one BRCA test available.

So how did the law get this way?  Patent law has always held that patentable items must be inventions and not something found in nature.  For example, if you found a new element in your backyard you would likely be heralded in all the scientific journals but you would not be able to patent it.  Why not? because you didn't make it.  So why can some one patent a gene?  did they invent it? ummm, no, millions and millions of years of natural selection did.  Then how did this gene get patented?  The answer can be traced  back to the last major oil disaster that struck the US (Exon Valdeez).  At that time, a quite inventive biotech company constructed a strain of bacteria in the lab that liked to eat oil.  In order to not lose all the money from their invention, they patented it and that patent was upheld all the way to the Supreme Court.  The basic idea being that the company had made a new tool that was not found in nature and thus could be patented.  This decision, however, has been used to support the patenting of genes.  Is it the same thing? In my opinion, not in a million years...making a tool in the lab is not the same as identifying a gene.  Nonetheless, tens of thousands of genes have now been patented.  Its rather insane and has huge consequences on scientific research (patents can be used to decide what other scientists can and can not work on), market competition and most importantly, providing good medicine. 

Now, as you can tell, I loath the patenting of genes and would like to see an end put to the practice.  Will that happen? possibly as there are a myriad of cases making their way up the courtroom ladder, including challenges to the BRCA patent.  The hope is that some of these cases will make it to the Supreme Court and they will clarify what can and can not constitute a biological patent.  Here's hoping.