Guest-blogging today is my partner, Barbara Adams. She and Jim Sinunu head our firm’s toxic tort practice, and she’s expanding on a couple of recent posts relating to the effect of the litigation process on the course of scientific discourse. The following is her post:
In two linked posts, Blog 702 and Drug and Device Law the bloggers write about, and agree with, the thesis of a recent article in Neurology (Subscription) that “Modern litigation does exert a biasing effect on some published, peer-reviewed research”. Blog 702 notes, however, that
"the Neurology article fails to make a convincing case that the state or progress of neurological or other medical research have suffered, or will suffer, at the hands of the litigation system.”
While I can't attest to the effects of litigation on neurological research, I have some familiarity with asbestos litigation. In one aspect in particular, the existence of and profits derived from asbestos litigation appear to have had a significant impact on medical research.
There's more after the jump.
Asbestos litigation may be the costliest litigation in U.S. history. As of 2004, over 700,000 claims had been filed against corporate defendants, at a cost of $70 billion dollars. 2003 represented the largest number of claims filed in one year - 110,000.
That claims for asbestos-related injury continue to be made in these large numbers at this late date is certainly puzzling. The U.S. and Britain had recognized that asbestos caused the lung disease “asbestosis” in the 1930's, and started to implement (inadequate, but progressive) controls at that time. In World War II, thousands of individuals were exposed to levels of asbestos higher than those allowed in factories, during the construction of ships for the Navy. While it resulted in exposures at a much lower level than ship construction, asbestos was a popular additive to products for housing construction, such as insulation, wall board and joint compounds for decades thereafter. Thanks in part to OSHA, however, as well as EPA regulation, the use of asbestos was virtually eliminated by the mid-1970's. Given an average latency period of 20 to 30 years for the appearance of asbestos-related disease, why have the number of claimants increased in recent years?
One of the insidious diseases caused by asbestos is a malignancy called “mesothelioma”. Asbestos is a recognized cause of this disease. Some 70% to 80% of the individuals who develop mesothelioma were exposed to asbestos in the work place.
Some researchers and most experts who testify on behalf of plaintiffs contend that asbestos is the “only known cause” of mesothelioma.
The existence of a fatal disease with only one “known cause,” and an ability to tie that cause to industries (and insurance money) represents, of course, a substantial source of income to both attorneys representing individuals who have developed the condition, and to the expert witnesses who repeatedly testify for those attorneys. The existence of another cause - particularly a cause that can't be sued - would present a threat to what has become somewhat more than a cottage industry.
Is there another and wide spread cause of mesothelioma? In the 1990's, it looked as though there might be, and therein hangs the tale of what may be a suppression of good medical research.
Until the 1950's, polio was a major threat in the US and world wide, striking tens of thousands of children, often resulting in paralysis or death. In 1955, Dr. Salk discovered a vaccine, which saved tens of thousands of lives.
Unfortunately, from 1955 to at least 1961, the polio vaccine was cultivated on monkey kidneys, mostly on the kidneys of rhesus monkeys. In 1960, some of those kidneys were found to be infected with a virus known as “simian virus 40", or SV-40, for short. In 1960, it was discovered that SV 40, while not directly causing illness in humans, induced cancers in hamsters. In 1961, the US Government started testing for SV 40, and instituted controls that resulted in the virus being eliminated from all vaccines given after 1963.
Fast forward three decades, and Dr. Michele Carbone of Loyola University in Chicago published a paper in which he revealed that his laboratory had discovered SV 40 in the tumors of people who had several types of cancers, including bone cancer and mesothelioma. (Carbone, M. et al. Simian virus 40-like sequences in human pleural mesothelioma. Oncogene 9, 1781-1790 (1994). | PubMed | ISI | ChemPort). In 1997, Dr. Carbone made the link between the appearance of the virus and the causation of mesothelioma, noting,
“...at least 20% of mesotheliomas in the United States are not associated with asbestos exposure, and only a minority of people exposed to high concentrations of asbestos develop mesothelioma. Thus, other carcinogens may induce mesothelioma in individuals not exposed to asbestos, and/or may render particular individuals more susceptible to the carcinogenic effect of asbestos....Our findings do not establish a cause-and-effect relation, but indicate that the possibility that SV40 contributes to the development of human mesotheliomas should be carefully investigated.”
In 1997, as well, the NIH hosted a conference to look at precisely this issue, and suggested additional research.
In fact, Dr. Carbone and others have noted that SV 40 is an almost “perfect” cancer causing agent, in that it both promotes cancers into development, and impedes the human tumor suppressor cells that could fight those tumors.
What’s more, the virus is present in the children of individuals who were inoculated with the contaminated vaccines.
By 2000, however, the published research, including that of Dr. Carbone, had shifted from SV 40 as a cause of mesothelioma, to merely something that worked with asbestos to cause mesothelioma.
In 2003, Dr. James Goedert, Chief, Viral Epidemiology Branch, Division of Cancer Epidemiology of the National Cancer Institute attempted to put to rest any notion that SV 40 was a cause of mesothelioma. He noted that not all mesothelioma tumors contain the virus and that some tissues that contain the virus do not develop cancer. Of course, since asbestos certainly does cause mesothelioma in some people, the fact that some mesothelioma patients don't have the virus doesn't prove the virus doesn't cause the disease. Nor does the fact that some patients have the virus but not the cancer prove anything, as nothing causes cancer 100% of the time! Moreover, Dr. Goedert stated that,
“U.S. cancer incidence data have not shown an increased incidence of pleural mesothelioma among the age groups that were exposed to SV40-contaminated poliovirus vaccine.”
This, however, doesn't explain the 20% of mesotheliomas that occur without known asbestos exposure, as referenced by Dr. Carbone (and others).
All of this could appear to be nothing more than investigative science, were it not for the admitted anecdotal evidence that the insistence that asbestos be the “only known” cause of mesothelioma is affecting both the research and scientific publication on the subject. One example I have personal knowledge of is a study conducted in a hospital with strong historic connections to asbestos research. A pathologist at this hospital authored a study that demonstrated that in each and every case in which there was no historical exposure to asbestos in an individual with mesothelioma, SV 40 was present in the tumors. On the flip side, each individual but one in the study who had known exposure to asbestos lacked the SV 40 in the tissue of their tumors.
I’d link you to the study - but no one will publish these potentially explosive results. The pathologist in question told me that the obstacle is the lack of exposure to asbestos – something that has scarcely hindered publications that implicate asbestos as a cause of disease!
Finding that SV 40 “combined with” little asbestos exposure causes mesothelioma, as opposed to finding that SV 40 is an independent cause of the disease is just what plaintiffs attorneys want to see – not an alternate cause, but something to bootstrap any marginal asbestos exposure into something for which liability can be imposed.
Thus, the asbestos litigation machine grinds onward.
--- Barbara Adams
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Posted by: iknowall | June 01, 2007 at 06:25 AM
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