New Under the Sun:
Volume 4, Issue 6
June can be such a lovely month. The mornings are cool; the days warm and sunny. Life seems full of possibilities, especially for those individuals who are out of school for the summer. This might be the point in time to pick through the plethora of possibilities to find the perfect choice to take your life along a new path.
Money for Nothing?: Last month we talked about the new USDA food pyramid guidelines and how the guidelines are affected by the grain and dairy producers. This month we present another cautionary tale about medical researchers and their sources of funding. One reason to read the original research articles as opposed to just the news releases or popular magazine articles on a particular topic is that the original article is required to publish the funding source(s) for the research. For instance, if the researchers concluded that drinking milk prevented cancer and you saw at the end of the article that the research was funded by a dairy producers organization, it might give you pause and cause you to go back and read the article more carefully. Sometimes, what is written in the abstract or published in the news release does not quite match what the researchers actually found.
In order to prove their worth and obtain tenure, academic physicians/researchers working in medical schools are required to obtain funding to do publishable research. Since government funding is increasingly difficult to obtain, this means that the majority of medical researchers must go to private sources like dairy producers or drug companies. Problems arise when the researchers’ results do not match the expectations of the organization or business providing the funding.
Concerns over this issue led members of the Department of Health Policy and Management at the Harvard School of Public Health to survey the administrators of research at the 122 accredited medical schools in the United States. They received responses from 107 of the schools. Since the drug industry provides funding for about 70% of the clinical drug trials carried out by these medical schools, the degree of contractual control given to the drug company over what the results are and how the results are published is of critical importance.
Interestingly, although the majority of schools would not allow contract provisions that gave the drug company or other sponsor the right to revise the manuscript or prohibit its publication, around 15% of the schools evidently did not have a problem with that concept. More disturbing is that 24% of the schools allowed the drug company or other sponsor to insert their own statistical data into the publication. This number would more than double if the additional 29% who were on the fence about whether or not it was allowable decided to allow it. Strangely, 50% of the schools allowed the sponsor to draft the manuscript, and an additional 11% were on the fence on that issue. How can there be even a pretense to bias-free research if the company whose product is being tested is allowed to draft the manuscript of the trials and insert their own data into the manuscript?
If the sponsors do not like the results of the clinical trials, evidently they frequently refuse to pay the researcher and, on occasion, attempt to prevent publication of the results. Contract disputes over payments were reported by 75% of the schools, while 17% reported that they had difficulty obtaining access to the data. In effect, the sponsor was saying, “We own the data. It doesn’t matter if you actually obtained it for us. We will decide what can be done with it and we’ve decided you cannot have it.” The consequence is that the researcher is prevented from publishing the results of the research. In effect, the sponsor says, “You are not getting money for nothing.”
So, in order to keep the sponsor happy and increase the probability of obtaining future funding, it should not be surprising if some researchers may be prepared to gloss over any problems that occurred during the drug trials and, instead, emphasize any benefits that were found.
Fortunately, the medical community is sufficiently disturbed by this situation that they are planning to institute new guidelines to limit the ability of the drug companies to stifle publication of adverse results of drug trials. In addition, Congress has a bill pending which would require all medical research studies to be registered in a government database. This would make it more difficult to hide adverse results. You can do your part by being a more careful consumer of medical research. Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med. 2005 May 26;352(21):2202-10.
African-American Males, Obesity, and Prostate Cancer: One of the more disturbing health disparities is the extremely high rate of prostate cancer found among African-American males. It is the highest in the world and occurs at much younger ages and in a more aggressive form than is true for males in other populations. Research presented this May at the national conference of the American Urological Association provided a possible clue.
The first research study compared African-American males to European-American males. The men had undergone a retropubic prostatectomy (RRP) between 1988 and 2001. Comparing the men at five and ten years post-surgery, it was found that European-American men had a statistically significant higher probability of remaining disease-free. Further analysis indicated that the majority of this difference could be attributed to the higher body mass index of African-American men relative to European-American men. That is, in any matched pair of men, the African-American man was more likely to have had some disease progression compared to the European-American man and in those cases of disease progression, the African-American man was more likely to be obese.
The second study was done to determine whether, with newer detection and treatment modalities, obesity was still a risk factor in the occurrence of aggressive prostate cancers. This study examined the patients of one surgeon: men who’d undergone retropubic prostatectomy (RRP) between 1985 and 2004. Somewhat surprisingly, given the increased awareness and utilization of prostate screening methods, the correlation between obesity and aggressive prostate cancer increased rather than decreased over the past twenty years. The authors of the study were not sure why this would be, but speculated that for some reason the prostate screening assay was more likely to appear normal when there was actually cancer present in obese than non-obese men. Matthew E. Nielsen, Baltimore, MD; Misop Han, Chicago, IL; Patrick C. Walsh, Alan W. Partin, Stephen J. Freedland*, Baltimore, MD. Body Mass Index And Outcomes In African-American And Caucasian Men Following Radical Prostatectomy For Clinically Localized Prostate Cancer. #675 American Urological Association Annual Meeting May 21 - 26, 2005 San Antonio, Texas, USA. Stephen J Freedland*, William B Isaacs, Leslie A Mangold, Sindy K Yiu, Kelly A Grubb, Alan W Partin, Jonathan I Epstein, Patrick C Walsh, Elizabeth A Platz, Baltimore, MD. Stronger Association between Obesity and Biochemical Progression Following Radical Prostatectomy over Time. #257 American Urological Association Annual Meeting May 21 - 26, 2005 San Antonio, Texas, USA.
Comment: A good reason for presenting research at national meetings is to obtain feedback from other researchers. Let us hope that the researchers in these studies were able to chat with researchers examining the association between vitamin D deprivation and prostate cancer. It should be well-known in the field of prostate cancer research and treatment that vitamin D analogs (safer versions of the hormonal form of vitamin D) are being successfully used in the treatment of prostate cancer. It should also be well-known that there is a latitudinal gradient associated with prostate cancer: the highest incidence levels occur at the highest latitudes. Since high latitude and dark skin color are associated with vitamin D deprivation, and since vitamin D deprivation is a factor in prostate cancer, one would think that this may have occurred to the researchers as a reason for the higher rates of poorer outcomes among their African-American patients. However, it may not be as well-known that obesity is linked with vitamin D deprivation. Vitamin D is fat-soluble. It appears that the fat cells of obese individuals “soak up” the serum vitamin D causing vitamin D deficiencies throughout the body and setting the stage in some individuals for the onset of early and aggressive cancers that would otherwise have been ameliorated by the tumor suppressant properties of vitamin D. My conclusion is that to be both obese and darkly-pigmented is to significantly increase your probability of developing cancers if you do not take countermeasures to ensure adequate levels of serum vitamin D. And given the effect of obesity on vitamin D levels, one of those countermeasures must be weight reduction.
Another countermeasure is to increase your dietary intake of vitamin D. However, this is currently quite difficult since the best, safest source is sardines which are not a particularly popular food item, for some reason I fail to fathom. The majority of African Americans are lactose intolerant, which means they are unlikely to drink whole milk. This is not a good option anyway since whole milk is thick with saturated fat, a cause of obesity. Other food sources currently provide minimal, if any, amounts of vitamin D.
But there is a company attempting to change this. The Natural Ovens Bakery in Wisconsin [http://www.naturalovens.com/] is developing a whole-grain (good!) bread that outdoes a can of sardines by providing 1600 IU of vitamin D per slice. I looked at their website, but could not find this product listed, so it is possible that they are having trouble getting government approval because the government would fear that someone eating two slices of bread would overdose on vitamin D since they put the safe limit at below 2000 IU/day, a limit which ignores all recent research studies on vitamin D safety. Unfortunately, even if the government did approve the bread, the type of vitamin D used at the bakery in their other products is D2 which is not as effective or appropriate for human use as is D3, the type found in sardines and the type we manufacture in our skin.
This leaves vitamin D supplementation in pill form. The vitamin D should be cholecalciferol (D3) and not bound to anything else, such as vitamin A or calcium in order to avoid overdose problems with the other vitamins and/or minerals. Unfortunately, such pills are also difficult to obtain. This leaves exposing unprotected skin to UVB radiation. However, this option is not particularly good for those who are heavily-pigmented since the amount of time required for exposure, depending on latitude, could be up to several hours per day, something few have the time to achieve.
Perhaps the reseachers discussed above were approached at the conference by other researchers examining the vitamin D connection. Maybe they will collaborate on a study which will more definitively link the prostate cancer disparity with vitamin D deprivation. Perhaps then the government will be more willing to support efforts to find methods to optimize serum vitamin D levels in all Americans. Perhaps…
AnthroHealth Tip of the Month: Laugh heartily every day. Sometimes we get so caught up in our daily activities that we forget to laugh. Or life seems so stressful that there seems no reason to laugh. But it is at those points where stress or depression or just the general busyness of life seems overwhelming that a good belly laugh is in order. I was reminded of this the other day after viewing The Hitchhiker’s Guide to the Galaxy. The movie was just as funny as I remember the book being. Of course, it might not be to everyone’s taste. But that is not the point. The point is to find something to view or read that makes you really laugh. So, when you feel stressed out, Don’t Panic! Grab your towel, hit the funny button, and get a dose of rejuvenation.
© 2001-2009 Kathleen Fuller. All rights reserved.