George Carlo's Comments on the JAMA (journal of american medical assoc.)
study by Joshua E. Muscat. Below the commentary is a press release from JAMA.
Here is the chronology of the Muscat data shift. Please look at this against the backdrop of what was going on in the book at the time -- spring of 1999. The industry began direct communication with Muscat in March, around me. Up to that point, I handled all of the communication with the WTR's investigators. When the results began to come in, the CTIA cut me out.
9/98 - data collection for the Muscat study is finished. No new patients were entered into the study. Data base for analysis is finalized according to Good Epidemiology Practices. GEP says that once the database is fixed, that is it.
NEUROEPITHELIAL TUMORS:
3/3/99 - Muscat gives us data showing 29 cases of neuroepithelial tumors, with 11 cell phone users among them. That yields a statistically significant risk increase of 2.8.
4/7/99 - Muscat presents these data to the FDA and the governmental Inter Agency Working Group.
5/3/99 - Muscat gives us an updated report that we sent out for peer review to Harvard. Now they have 35 cases of neuroepithelial tumors because they have re-done the pathology. This change was approved according to GEP procedures. 14 of the 35 are cell phone users. Risk is 2.4 and statistically significant. The report withstands peer review. This constitutes final report to WTR. That is what we have in the book.
6/20/99 - Muscat presents the 2.4 risk data to State of Science colloquium in Long Beach.
9/9/99 - Muscat submits paper to New England Journal of Medicine for publication that is rejected -- they say not enough data relevant to cell phone users. Risk presented in that paper is now 1.8 and not statistically significant. This is based on a different statistical analysis with control variable worked in on the same 35 cancer cases, 14 of which are cellular phone users.
6/2000 - Muscat signs off on Chapter in my upcoming State of the Science II book, to be published by Kluwer this spring. In the book, he presents the 2.4 risk data that are statistically significant.
12/19/2000 - in JAMA, Muscat presents yet another analysis of the same 35 cancer cases. The risk presented is 2.1. Even though this is more than a doubling in the risk, the authors dismiss it because it is not statistically significant. The headlines carry this as evidence of no brain cancer risk.
TUMOR LATERALITY:
3/3 - Muscat in report to WTR shows that in 27 instances, the tumor is on the same side of the head as where the person uses the phone; in 15 instances it is not. They give no statistical data on significance.
12/19/2000 - In JAMA article, they report that in 26 instances the tumor is on the same side as where the person used the phone, and in 15 instances it is not. The P value is .06 (.05 is statistically significant). If the original data of 27 is used, the result becomes statistically significant. No mention of where the missing patient is. The authors dismiss the finding of laterality because it is not statistically significant.
As you know, the media have carried this study as reassuring to consumers. In fact, this and the NCI studies are baseline studies against which future observations of cancer among cell phone users can be judged. As I point out in the book, no one could expect epidemiological studies to show much for 15 to 20 years. The fact that we found anything at all is the news. As an epidemologist, the doubling in risk of neuroepithelial tumors, statistical or not, would be a caution for me. Yet in the materials given to the press, this is not even mentioned.
The overinterpretation of the data in the Muscat study is dangerous to consumers. If this leads people to put phones up against the sides of their heads when they otherwise wouldn't, well that is tragic.
The NCI investigators are even handed in how they caveat their study. Note in their study that they say that their study is not adequate to look at rare tumors that would be very close to where the antenna from the phone is. They get it, but nonetheless, their study has been spun by the industry. It is peculiar that the study was made available at 4 p.m. -- many media put it in their stories without even reading it.
I also heard that the pre-release of the NCI study to coincide with the Muscat study was orchestrated by the FDA -- the public pressure that the release of the study cites is actually the FDA. They are now in bed with the CTIA and it appears that these folks are working in concert.
This was a pretty sophisticated media manipulation. How so little data could be used to make such broad assurances of safety is a Houdini trick. And most of the media went for it.
Only in America.
GC
(By the way- GC= George Carlo the former Director of the WTR)
Reprinted below is the press release issued by the Journal of the American Medical Association, The Muscat study appears in the Journal's December 20th issue.
HANDHELD CELLULAR TELEPHONE USE NOT ASSOCIATED WITH RISK OF BRAIN CANCER
Study suggests risk not increased with short-term cell phone use
CHICAGO - The use of handheld cellular telephones does not appear to be associated with the risk of brain cancer, but further studies are needed to account for longer induction periods, especially for slow-growing tumors, according to an article in the December 20 issue of The Journal of the American Medical Association (JAMA).
Joshua E. Muscat, M.P.H., of the American Health Foundation, Valhalla, N.Y., and colleagues conducted a case-control study from 1994 to 1998 to test the hypothesis that using handheld cellular telephones is related to the risk of primary brain cancer. A total of 469 men and women aged 18 to 80 with primary brain cancer and 422 matched controls without brain cancer took part in the study. Patients were interviewed at Memorial Sloan-Kettering Cancer Center, New York University Medical Center, and Columbia Presbyterian Hospital in New York; Rhode Island Hospital in Providence, R.I.; and Massachusetts General Hospital in Boston.
According to background information cited in the study, there were more than 86 million cellular phone users by the end of 1999. The use of cellular telephones is one of several suspected risk factors for brain cancer, although the causes of this disease remain poorly understood. The health effects due to using cellular telephones are currently being studied in a number of populations. In preliminary reports of a case-control study conducted in Sweden, the risk of brain cancer was unrelated to using a handheld cellular telephone.
Cellular telephones include handheld or mobile telephones, car telephones, and portable or bag telephones that operate on radiofrequency (RF) signals in the 800- to 900-MHz range. Concerns have been raised about possible adverse health effects due to exposure to these signals. In particular, the concern that the use of handheld cellular telephones causes brain cancer is based on the close proximity of the antenna, which is incorporated into the telephone receiver, to the head of the user.
The authors used a structured questionnaire to interview patients. The patients were asked if they had ever used a handheld cellular telephone on a regular basis. "Regular" was defined as having had a subscription to cellular telephone service. Information was obtained on the number of years of use, minutes/hours used per month, year of first use, manufacturer, and reported average monthly bill. Information on which hand was used to hold the cellular telephone was collected from 700 (78.6 percent) of the 891 patients.
"The use of handheld cellular telephones was unrelated to the risk of brain cancer in the current study," the authors write.
"The median monthly hours of use were 2.5 for cases and 2.2 for controls," they report. "Compared with patients who never used handheld cellular telephones, the multivariate odds ratio (OR) associated with regular past or current use was 0.85. The OR for infrequent users (less than 0.72 hours per month) was 1.0 and for frequent users (more than 10.1 hours per month) was 0.7."
"The mean duration of use was 2.8 years for cases and 2.7 years for controls; no association with brain cancer was observed according to duration of use," they continue.
The study found that among brain cancer cases, cerebral tumors occurred more frequently on the same side of the head where cellular telephones had been used (26 vs. 15 cases). But in cases of temporal lobe cancer, a greater proportion of tumors occurred in the opposite side of the head (9 vs. 5 cases).
The authors report the odds ratio was less than 1.0 (i.e., no increase in risk) for all histologic categories of brain cancer except for an uncommon type of brain cancer called neuroepitheliomatous.
"The current study shows no effect with short-term exposure to cellular telephones that operate on (primarily) analog signals," the authors conclude. "Further studies are needed to account for longer induction periods, especially for slow-growing tumors. The RF fields emitted from digital cellular telephones might have different effects on biological tissue than analog telephones, and studies are under way in several European countries that use primarily digital telecommunication networks."
(JAMA. 2000; 284:3001-3007)
Note: This work was supported by a contract from Wireless Technology Research LLC and by grants from the Public Health Service.
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an excellent overview of the current political/scientific
cellular phone situation by B. Blake Levitt, an expert in the field.
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