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The New Gold Rush
by Linda P. Beckerman, Ph.D.
lbeckerman@cfl.rr.com
Suppose you woke up one morning and discovered a pharmaceutical company had patented your DNA. Would you mind? You would if a competing pharmaceutical company couldn't develop a medicine that might save your life unless it paid the patent holder a royalty. Now picture the price of your medicine going up.
As outrageous as the idea of patenting an individual person's DNA may seem, it has already happened to John Moore. While being treated for leukemia at UCLA, he became suspicious because of all the "samples" of him that the doctors were taking without telling him why. So he asked a few questions and the next thing he knew, his cell line had become U.S. Patent Number 4,438,032. John didn't like the idea of his cell line being treated like a salad spinner or can of spray paint. And he especially didn't like the way UCLA and its partners, who included a pharmaceutical company, were making money hand over fist by commercially marketing pharmaceuticals based on his cell line. John Moore then sued for property theft. The case went all the way to the California Supreme Court. They sided with UCLA and said they did not want to “hinder research by restricting access to the necessary raw materials". John lost the case.
Now universities and pharmaceutical companies apply for patents on “the necessary raw materials”, in the thousands. So if the seams in the gold mine are being tapped at a frantic pace, how did this all begin? The answer lies with the progenitors of the hunt for the mother lode, the Human Genome Project.
In The Beginning - Fool‘s Gold
When the Human Genome Project was founded, one of the big hopes was the idea of marketing and developing drugs for each of the specific races. This was based on clinical observations that some races seemed more predisposed to certain medical diseases than others. Then they succeeding in mapping the Human Genome and discovered there is no genetic basis whatsoever for the concept of race. Associated geneticists confirmed and reconfirmed their discovery of only one race on Planet Earth.
The inability to cash in big on drugs for the different races was initially a big disappointment. But the project disclosed that what we do have instead of races is ethnic lineages. In each ethnic lineage, one or several gene mutations are passed down through all succeeding generations. If the gene hunters could identify within these ethnic lineages the portion of their DNA that is responsible for a particular disease or how they respond to a medication, then they were still in the game.
There Really is Gold in Them There Hills
The big breakthrough came when geneticists determined that the way to unlock the code for ethnic lineages was via single nucleotide polymorphisms (SNPs - pronounced snips). Each SNP is a mutation, or variation in the DNA sequence that changes the way essential proteins are made. For example a SNP might change a DNA sequence, which is comprised of some combination of the four chemical bases A, C, T, and G, from AAGG to ATGG. From such variations comes the color of your hair, a body builds that favor Olympic class athletic sprinters, a predisposition to a disease, or a specific response to a medication.
The start of the all out Gold Rush
Among the groups that first set out to map the SNPs, were the Human Genome Project, independent entities such as Celera, and the SNP consortium, which is composed of at least ten heavy hitter pharmaceutical companies. Given the large number of SNPs, temporary collaboration provided distinct advantages in being able to speed up the SNP mapping process. When the count on SNPs began to rise, this led to further collaboration between the Human Genome Project and the SNP Consortium. In a further collaboration spasm, HapMap brought other countries like China, Japan, and Canada into the fold. And several countries, such as Japan and Israel, have launched their own independent efforts.
Even Iceland jumped into the fray with an effort to map the genome of every single Icelander. Since the population makeup of Iceland has not changed much since the arrival of the Vikings, the genetic pool is very homogenous. The company deCode Genetics has mapped both the genome of those currently living and entire genetic genealogical trees. Recently the Icelandic Government passed a law for creation of a national health database that would include everyone’s DNA along with their medical histories. In spite of an outcry from some Icelandic citizens about their right to medical privacy, the Government has provided deCODE direct access to the database. Thus deCODE has the potential to reap huge financial windfalls, as researchers pay a fee for a map of the Human Genome that is not only more free from the taint of mutational diversity, but tied to genealogical and medical histories as well. Such is the potential financial value of getting there “fustest with the mostest“.
Panning for the Gold
Back in the more heterogeneous population, the original goal of the SNP Consortium was to map the 300,000 SNPs they believed were common to most of the population. They then proceeded to gather together genetic samples from 24 anonymous, unrelated donors of diverse geographic origin, which they believed would be sufficient to represent a significant section of the world population. Then the number of SNPs grew from 300,000 to exceed 1.5 million.
To cope with the burgeoning SNP population and the burden of making any sense of them all, an additional group, the Allele Frequency Project was been spawned off to determine how frequent some 60,000 SNPs appear in various populations. However, some geneticists believe that the SNP approach is too unwieldy to work because there may actually be over 10 million SNPs. They choose instead to focus on haplotypes, which are chunks of SNPs that lie close to each other on the DNA strand and are thought to be inherited together. Researchers believe these confer a research advantage since they may be common to large groups in the population.
Given huge monetary payoffs, there is a substantial pressure to group enough of the ethnic lineages together so that there are only four or five main groups, thereby getting around the problem of not being able to market drugs to different races. Ironically, this effort is pushing the entire genetic effort towards recreating the concept of race under a whole new set of group names.
Standing in Line at the Patent Office
In a seemingly altruistic move, the SNP consortium and other collaborative efforts are making the data freely available under certain conditions. But once they all learn from their pooled efforts, then the hardcore independent, proprietary profit generating efforts will follow.
In the meantime, the gold rush by the independents proceeds unabated. Pharmaceutical companies and universities continue to file for patents on genetic material and the patent office has now issued patents on thousands of human genes or gene fragments. Private corporations continue to file for patents with at least one company filing some 16,000 patent applications.
But in a bizarre twist, patents are being granted for bits of genetic material when there is no clear evidence that the applicant knows what the function of the genetic material is. This violates one of the rules of Patent Law, which requires a definition of the invention‘s usefulness. Aside from the absurdity of calling a gene or SNP an invention, the rate of patent applications continues to bore forward at breakneck pace. While ethics activists are exerting some pressure on the Patent Office, they mostly look the other way. And corporations look gleefully towards a future where they are able to hold a monopoly on the genetic data and charge the highest prices they can for access to it.
Muddy Streets Run Through Gold Rush Town
Of course we all stand to benefit from medical breakthroughs in testing and the development of new medical treatments. But consider this. The pharmaceutical companies want to avoid selling you a drug that results in a lawsuit, lest you die or suffer irremediable damage. In addition, they want to bring back drugs whose side effects once killed people. The presumption is that those people died because their SNPs were incompatible and if we could identify those people the drugs can be brought back into the marketplace.
Therefore, in order for you to be a candidate for one of these new or old recycled drugs you will need to have your DNA tested. So ask yourself this - who owns the data on your DNA test results? If your HMO pays for the test, do they own the data? If your employer pays the premium on your HMO, do they have the right to demand access to the data? What if your DNA shows you carry a gene that indicates predisposition for a certain disease? Can your HMO refuse to cover you should such a disease actually occur? Can an employer decide it doesn’t want to risk hiring you? Or can your life insurance carrier pay a fee for access to the data and then decide that you should be in a higher risk category on your premiums?
Finally there is the possibility of a genetic underclass who are denied the benefits of this marvelous panoply of new tests and medical remedies simply because their ethnic lineage does not fit into one of the large genetic groupings where the big bucks lie.
None of this means that the race for the gold should be stopped. We still hope that good will conquer evil. But who’s really watching? We don’t see this in our local newspaper or hear it on the national news. For now, the only ones watching the winners sprint across the finish line are the lawyers.
Copyright by Linda P. Beckerman, Ph.D. January 2003 All rights reserved.
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