GELFAND’S WORLD-Here are two seemingly unrelated stories that nevertheless intersect. The first involves a scientific lecture I heard the other day. Without going into details, the story involves the discovery of a naturally occurring small protein that treats some of the symptoms of diabetes when injected into rodents, and also slows the growth of cancer cells grown in culture. It is a marvelous discovery and is supported by numerous control experiments that are very convincing.
The scientist, in a later conversation, explained that the patent on this discovery had already been submitted, even though the scientific papers had not all been written and submitted to journals.
In another lecture a few weeks earlier, but at the same institution, we heard from a venture capitalist. He explained that the pharmaceutical companies are only interested in developments that promise to show a billion dollars in sales.
In yet a third talk by an administrator, the resident scientists and physicians were encouraged to work with the institution's patent office as early as possible on any patentable application.
The subject of this discussion is the monetization of science and its application to pharmaceutical research. It was not always so. In some ways this is a bad thing, and in other ways it is not.
The great counterargument to the direct monetization of scientific discovery is the story of the polio vaccine. Jonas Salk and his financial supporters made no attempt to patent the Salk vaccine. There are competing stories as to the motives and law that led to this decision. One argument is that the research had been paid for by tens of millions of donations through organizations such as the March of Dimes. Another argument is that the lawyers did not believe that a patent application would be upheld. Salk famously stated that the vaccine presumably belonged to the people, perhaps implying that the mass of Americans through their donations had already earned the right to the vaccine.
In any case, the polio vaccine process was offered to several pharmaceutical companies for production and sales.
Another famous scientist who developed the test known as the radioimmune assay (RIA for short) pointed out that in her day, they didn't patent, they published.
(By the way, all of the above information about the polio vaccine and the RIA are general public knowledge and can be reviewed by a quick internet search.)
Times have changed. I think there is a rational historical explanation for the big switch from the earlier culture of scientific openness to the modern culture which reveres intellectual property rights.
The major change of direction seems to have occurred with the advent of genetic cloning. The concept of "biotechnology" was new when Genentech was founded. The idea that private corporations could profit from the output of scientific research was nothing new to the big pharmaceutical companies. That is what they already did. But the new group of companies made use of new technologies that seemed to change almost from one month to the next, and promised a whole new range of drugs that would otherwise have been impossible to make.
One such drug was human insulin. In previous decades, the pharmaceutical companies had extracted insulin from pigs. The porcine insulin was pretty close to human insulin in sequence and structure, and most diabetics who needed insulin injections did pretty well on it. But there were always questions about humans developing an immune response to the foreign product. The production of insulin that has exactly the same amino acid sequence as what we make in our own bodies, but grown in vats, allowed for the replacement of the porcine product in medical care.
Other successful products coming out of the new biotechnology allowed for the stimulation of immune cells in otherwise immune-impoverished chemotherapy patients. Another drug allowed for stimulation of the production of red blood cells, useful in some medical conditions and in the world of high stakes bicycle racing.
Yet another class of drugs referred to as "clot busters" allowed emergency rooms to dissolve the clots in coronary arteries, the ones that cause heart attacks.
Discovery and production of these products didn't come cheap, and the financial markets bid up the stock prices of companies such as Amgen accordingly.
While all of this has been going on, the situation with regard to funding of basic science has gotten worse and worse. Most funding of basic research comes from governments. That's partly because this is what governments do, and partly because venture capitalists are loathe to fund basic research. They like to put their money into items and processes that are already shown to work, and strongly likely to make a profit.
It's therefore no big surprise that research organizations, heavily squeezed financially, see an opportunity in the discoveries made by their scientists. There is little official resistance. The U.S. government has encouraged the development of the biotech industry as a growth sector in the U.S. economy, much as Swiss and English companies have contributed to their own national GDPs.
There are a couple of issues here. Some new drugs come with horrendous price tags. It's not terribly uncommon to find that a new treatment has a lifetime cost approaching a hundred thousand dollars. This is a huge contrast with the few dollars we remember paying for a bottle of pills at the corner drug store.
It's not entirely unwarranted in every case. Some of the more expensive drugs involve the painstaking development of particular monoclonal antibodies, a process that is not guaranteed of success, and involves expensive production processes.
Still, it's not too much of a stretch to argue that the pharmaceutical giants are taking advantage of their intellectual property rights to squeeze the consumer dry.
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When we look back on Jonas Salk and his unpatented vaccine, we are entitled to wonder. Perhaps if government funding of basic science had been allowed to keep up with inflation, there wouldn't be as much pressure on academics to act like inventors in terms of patenting everything in sight. Perhaps we could go back to the culture where we published rather than patented.
Or maybe not. Maybe this cat is too far out of the bag. The money -- and therefore the temptation -- is just too much.
Or then again, maybe so. The price of new drugs, some not really miracles at all, but incredibly expensive, may eventually cause a reaction even on this side of the Atlantic, even as it has already done in the UK.
Whatever the future, it is a little surprising to those of us raised in a different era to see financial gain through intellectual property rights as a major movement in modern academic research. After all, that is not really why people go into science as a career. At least it wasn't.
The chance to take advantage of the patent system is just something that drops into the laps of some lucky people. At least that's the way it once was.
The American people might also take notice that they are actually paying for much of the basic research through governmental agencies such as the National Institutes of Health, much as their parents contributed to the March of Dimes. Just as Jonas Salk said that the polio vaccine belonged to the people, perhaps the current day American taxpayer ought to demand a cut of the profits from these modern day discoveries.
(Bob Gelfand writes on culture and politics for CityWatch. He can be reached at [email protected])
-cw
