Liberty in America
columnist: rtbohan

Topic: Government Regulation
BPA: Cyclamates Revisited?

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Remember cyclamates? Remember saccharin as a cause of cancer? Rmember "Sugar the Killer"? Here we go again.

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by rtbohan
(Libertarian)
Saturday, April 19, 2008

One of the faults of American politicians is a tendency to overreact to new information. Faced with any real or potential problem, they seem to feel that it is the opportunity to pass a new law and impose new regulations and limit further the choices and the freedomof the American people.

Last week, Health Canada announced that its tests had indicated an increased risk for breast cancer in Bisphenol A (BPA),  a plastic used as a sealant in many products.  The tests on laboratory rats had indicated growth abonormalities in young and pubescent rats which might indicate a greater tendency to cancer later in life.  The report was issued on Monday, with the indication that a summary of the findings would be available within a week, and that the full report of the study will be abailable next month. (www.theglobeandmail.com).  By the end of the week, the Ministry of Health had announced the prohibition of the use of the material in baby bottles and other products  associated with baby food.

In the United States, the FDA had earlier tested the material and concluded that no health risks were associated with its use.  Two Democratic congressmen from Michigan, John Dingell and Bart Stupak, had criticised the report on the grounds that the FDA had relied in part on studies conduct at laboratories associated with industry .  The FDA conducted further studies and reached the conclusion that the product might cause some health risk to infants, but did not recommend that it be banned.

Now Senator Charles Scheumer of New York , claiming  "It's better to be safe than sorry", is introducing in the Senate a bill to ban the use of BPA from dental sealants and containers for food or drink (www.washingtonpost.com).  This seems  like the typical response of a politician and at least premature if not unnecessary

Let me say, first of all, that I am not particularly critical of Representatives Dingell and Stupak and their request for further verification of the FDA's original report.  While industry scientists are competent and usually ethical, it is true that there is a temptation for them to report results in a manner favorable to their employer.  Of course, there is also a tendency of scientists for a regulatory agency to report results in a manner favorable to more regulation, especially when urged by the Congressmen who approve their funding to reach that conclusion.

Senator Scheumer's proposed legislation is certainly premature and could be unnecessary.  At least one manufacturer of BPA has already announced that its production will no longer be used in products connected with child feeding.  Around the world, some retailers have already begun pulling products containing BPA from their shelves.  The proposed law is unnecessary if the market voluntarily limits any dangerous use of the product.

Beyond this, the danger of the product has been announced by scientists, but not scientifically established.  This statement is not at all a criticism of the scientists at Health Canada.  Canadian scientists are as capable as any in the world and their laboratories are up to date.

But science requires certain elements of any conclusion.  The htpothesis tested must be clear and unambiguous, the experiments must be controlled to give certainty that the result achieved was not caused by some factor other than the one being tested for.  The result must be reliable at the 5% or 1% level, and the experiment must be replicable.

It is the last item which concerns me in this case.  Health Canada has conducted its experiment and announced the result.  The Canadaian Ministry of Health has taken what it considers appropriate action in response.  But earlier studies, including the one by the FDA reached a different conclusion.  The question is whether the experiment of Health Canada is replicable.  In other words, will other scientists conducting the same experiment in different laboratories come up with the same results?  I think it is likely they will, but until it can be done it is not certain.  The full report from Health Canada will be out next month. At that point the results can be tested by the FDA and others.  This is an important step.  It was the failure of replication which nipped the Cold Fusion bubble in the 1980s in the bud.

The other question has to do with extrapolation from the results of the actual experiment.  Health Canada reached its conclusions about the dangers of BPA from experiments conducted on laboratory rats.  There is no problem with that;  Nobody would suggest the use of humans to test elements which might cause cancer.  But there is a valid question as to whether the effect of the product on rats will necessarily be reproduced in humans.  BPA has been used in baby bottles long enough by this time that, if the effect shown in rats shows up in human infants there should be clinical evidence of the same change which can be trace to the product.  This is not as reliable as laboratory information, but it would serve to substantiate or cast doubt upon the danger to humans.

In any case, Senator Scheumer's sweeping ban seems premature since the scientific evidence so far indicates only a danger to children. To create an extensive ban without a scientifically verified basis is overkill.

I am a little sensitive to this because I am aware of the strange history of cyclamate.  Cyclamates begam to be used in the 1950s as a ariticial sweetener, and was particularly popular in soft drinks.  The FDA; on the basis of scientific tests showing that consumption of massive amonts of cyclamates increased the incidence of cancer in laboratory rats.  Under the Delaney Amendment to the Pure Food and Drug Act, this led to the prohibition of cyclamates in the United States.  Thd U.K. and a number of other countries followed the U.S. action with bans of their own.

Probably in response to complaints from corporations using cyclamates in their product, the FDA followed a laboratory study showing considerable health risks from the use of saccharin.  The makers of saccharin based products responded to the threat of a possible ban by including a leaflet entitled "Sugar the Killer" listing all the health risks from sugar which could be avoided by using saccharin.  The overall result was that neither sugar nor saccharin was banned from the market, although cyclamates were still prohibited.

In 1980, Abbott Laboratories appealed the ban on cyclamates on the grounds that they were unable to replicate the results of the FDA tests in their laboratory.  Abbott later withdrew its appeal, but the FDA has announced that further tests show no greater risk of cancer in human beings as a result of consumption of cyclamates.  The product remains banned in the United States, although fifty-five countries, including Canada allow its use.

I do not particularly suffer from this ban.  I was never a great drinker of Tab.  My wife is satisfied enough with the saccharin based Sweer &Low avaiable inthe United States that we do not need to have a boot legger bring the cyclamate based Sweet&Low from Canada.  But I am disturbed by the prohibition being maintained after the ostensible reason had been abandoned.  And by the fact that we are eager to follow Canada in banning a product but not in allowing it.  I also have a supicion that the banning and not banning of sweeteners  in the sixties may have been a case of a market struggle in the sweetener industry being carried out through the FDA

I also would like to see more scientific evidence before concluding that a prohibition of BPA is necessary or desireable.  It might be a struggle over the uses of petroleum.

Or it might be the Democrats singing "Ban, Ban, Ban the Product" as a counterweight to the Republicans "Bomb, Bomb, Bomb Iran."

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2008 rtbohan, all rights reserved.
Published: Saturday, April 19, 2008
Last modified: Saturday, April 19, 2008

The views expressed in this article are those of rtbohan only and do not represent the views of Nolan Chart, LLC or its affiliates. rtbohan is solely responsible for the contents of this article and is not an employee or otherwise affiliated with Nolan Chart, LLC in his/her role as a columnist.

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