TCS Daily

The Lancet Pricks Itself

By Henry I. Miller - March 3, 2006 12:00 AM

The term "medical journals" elicits automatic respect from most people. Not from me: I read them. I've found the editors to be increasingly hubristic and anti-business; and even worse, not to know what they don't know.

The British journal The Lancet is a case in point. Having previously erred by publishing an obviously flawed paper purportedly showing toxicity of gene-spliced potatoes, another containing wild and irresponsible (but damaging) speculation about the possible dangers of the insecticide DDT, and a commentary about a link between autism and vaccines that contain the preservative thimerosal, The Lancet again has gone off the deep end. This time the issue is the regulation of chemicals in Europe. (What this has to do with medicine isn't entirely clear, but it illustrates the expansive, do-gooder mindset of the editors.)

The Lancet's biases are unmistakable: Chemicals bad, regulation good. Therefore, REACH (Registration, Evaluation, and Authorization of Chemicals), the EU's sweeping plan, which The Lancet believes is "designed to reign in an industry that for decades had placed chemicals on the market with, at best, only irregular government oversight," is laudable; while any attempts to introduce rigorous scientific and economic analysis into regulation can only be the product of cynical, self-serving interference.

According to The Lancet, REACH was right on track until "European lawmakers met The Lobby. In what some European Commissioners say is the largest lobbying effort in the modern history of the EU, European and American chemical manufacturers orchestrated a multilayered and multipronged lobbying campaign that encompassed all the original 15 EU member states plus the 10 new ones, as well as countries outside the continent such as Japan, Mexico, and the USA."

In spite of the bad rap that lobbying has gotten recently on this side of the pond, however, all lobbying is neither negative nor motivated by special pleading. At its best, it is a means to educate policymakers about important and sometimes arcane issues.

The Lancet's sanguine view of REACH is demolished by the meticulously argued, "Europe's Global REACH," released last November by the Hayek Institute in Brussels. It concludes that REACH will harm Europe and its trade partners economically - without any convincing evidence of health or environmental benefits.

REACH would extend to all chemicals produced in or imported into Europe the bogus "precautionary principle," which holds that if the evidence about a product, technology or activity is any way incomplete, it should be prohibited or at least stringently regulated.

Potential risks should be taken into consideration before proceeding with any new activity or product, to be sure, whether it is the siting of a power station or the introduction of a new flame retardant. But what is missing from precautionary calculus is an acknowledgment that even when technologies and products introduce new risks, most confer net benefits -- that is, their use reduces other, far more serious hazards. Vaccines have occasional side effects, for example, but they confer net benefits. The danger in the precautionary principle — which in concept is centuries old — is that it focuses exclusively on the risks - often purely hypothetical ones, at that - and diverts consumers and policymakers from seeking possible solutions to known, significant threats to human health. Its overall impacts may be overwhelmingly net-negative.

The costs of REACH's precautionary approach will be prodigious. The European Commission's own estimates range up to €5.2 billion, but according to a study produced by the Nordic Council, the price tag could be as much as €28 billion. This higher estimate includes both direct and indirect costs, and assumes that the latter may amount to as much as 2.5 times the former.

REACH's supporters maintain that businesses can absorb this high price tag easily, but the Hayek Institute analysis offers a very different view. Its author, public policy scholar Angela Logomasini, points out that cost estimates that are favorable to REACH are incomplete, fail to consider a host of direct costs, and often completely neglect the indirect costs.

Moreover, REACH's advocates ignore its disproportionately harsh impact on small businesses and businesses in the newer EU member nations. A study conducted by consulting firm KPMG on behalf of the European Commission concludes: "The heaviest burden will be on SMEs [small and mid-sized enterprises] which cannot consistently fulfill the REACH requirements and so it is predicted that most of them may face financial troubles, may be taken over by bigger ones, or even shut down."

These prospects should raise serious concerns for Europeans. Small and mid-sized firms represent more than 99 percent of EU businesses, and account for two-thirds of the jobs. The imposition of REACH will increase unemployment and diminish competition -- which will lead to less innovation and higher prices.

The Lancet's take on these monumental costs? "While EU regulation involves unpleasant upfront costs, it also provides predictability and efficiency." The Hayek Institute's analysis suggests that REACH will offer few predictable benefits to offset the potentially devastating costs. In a review of the benefits claimed for REACH, Logomasini shows that the "studies" that purport to demonstrate benefits depend more on unsupported assumptions and wishful thinking than on science or logic. The European Commission's only study of likely benefits from REACH, conducted by Risk and Policy Analysis Limited (RPA) in 2003, addresses occupational exposure to chemicals and attempts to estimate the extent to which REACH would reduce health problems among workers. However, it is based on sketchy, incomplete, and inconsistently collected data assembled from a handful of member governments that is of questionable relevance to REACH.

The RPA report explicitly assumes that problems related to currently known chemical causes will be addressed by existing laws, while REACH will prevent currently unknown health problems from chemicals. But if these cases are unknown, how can we know they are caused by chemicals or are even work-related? Obvious errors and insufficient documentation in the report only compound problems with the study, which makes no mention of having been peer reviewed.

REACH's presumed benefits are based on the assumption that testing chemicals, filing paperwork, and pursuing politically correct product bans will somehow reduce cancer rates. But as the Hayek Institute analysis makes clear, the vast majority of cancers are not related to chemicals. According to the World Health Organization, the major preventable causes are tobacco use, diet, and infections, which account for 75 percent of cancer cases worldwide. WHO bases these findings on a landmark study conducted by scientists Sir Richard Doll and Richard Peto, which concluded that all environmental pollution might amount to only as much as two percent of cancers.

In the interest of free markets and economic growth, we need global regulatory policies that make scientific sense and that encourage innovative research and development. But by promoting the precautionary principle, EU politicians are performing a disservice. The only winners will be the European regulators, who will enjoy additional power, and the anti-science activists who will have succeeded in erecting yet more barriers to the use of superior technologies and useful products.

The Lancet should narrow its focus and stick to what it does well, assuming that something in that category can be identified.

Henry I. Miller, M.D., is a fellow at Stanford University's Hoover Institution and a former official at the FDA, 1979-1994. Barron's selected his most recent book, "The Frankenfood Myth..." one of the 25 Best Books of 2004.


"we need global regulatory policies"
Decidely not.

Risk assessment
"Potential risks should be taken into consideration before proceeding with any new activity or product, to be sure, whether it is the siting of a power station or the introduction of a new flame retardant."

I would urge a new math class be started at the earliest level teaching how to quantify risk.
If risk was of most concern to Lancet, they would urge the world to stop driving automobiles.

Precautionary Principle?
"REACH would extend to all chemicals produced in or imported into Europe the bogus "precautionary principle," which holds that if the evidence about a product, technology or activity is any way incomplete, it should be prohibited or at least stringently regulated."

Hmmm. How about applying that principle to potentially hazardous legislation? If there is any product about which the evidence of its potential harm is incomplete, it is REACH itself. Therefore, it should be prohibited.

(Actually, the evidence of its potential harm is quite clear. The evidence of its potential benefits, however, is scarce. BUT, even if the evidence were balanced, so that the expected benefits matched the expected risks, this principle would demand that REACH itself be rejected.)

Unfortunately, my argument is useless, because it is based on logic, and Eurocrats are not easily swayed by such trivialities.

Regulators with blinders on
All of the regulators feel that their regulations do not put an undue burden on anyone. What they all fail to recognize is that the sum total of ALL the regulative bodies can be stifling.

I got out of Radiation Therapy when I counted up the regulators I had to deal with. NRC, AEC, OSHA, FDA, IDNS, JCAHO, City, County, NIST, NCRP, and I know I've blissfully forgotten a few.

The one that still boggles the mind is that the Food and Drug Administration was given charge of our Cobalt Therapy Machine. (That administrator didn't know what a gurney was, and visited Diagnostic Radiology looking for the cobalt60 machine.)

The almost universal problem was too many bureaucrats with dismal grasp of the science behind what they were regulating.

Scurrilous sniping
The author mentions in passing that it should be okay to introduce toxins-- I'm thinking carcinogens and endocrine disruptors-- into our environment, so long as the products they contain confer some benefit. Thus a flame retardant spray for infant pajamas that increased the tot's risk of liver or thyroid damage should be acceptable? Such risks are just part of growing up in an advanced society, I suppose.

Taking thimerosal preservatives as the example, I would note that the health-protective component of childrens' vaccines is not the thimerosal. This compound is merely the preservative. The reason there has been such adamant resistance to discontinuing its use has been because other, equally efficacious preservatives would add as much as one dollar ($1.00) to the cost of a dose.

The extensive research into whether there exists a link between thimerosal exposure and the concomitant upsurge in child autism has been ambiguous. We don't know if there is or is not a definite link. In that instance, of course the most prudent practise is to continue using it.

Pattern extends broadly
The Lancet and most "respected" medical journals in the US accept "evolution" as fact, in the absence of supportive scientific data. Like the REACH program in Europe, many false assumptions are followed in interest of a particular philosophical agenda or political outcome. "Political correctness" deeply corrupts science, as well as society at large. /J M Long, MD, Birmingham, AL

Accepting evolution
As a physician, are you saying that the evidence of our genetic similarities and differences does not imply an evolution of later forms from earlier forms, and that the evidence for a 4-1/2 billion year history of a relatively stable surface on the earth does not give ample time for evolution to proceed from the simplest life forms to humans?

Can a more grandiose stage be imagined on which the works of a Creator (if you believe in one) might unfold than this? I would offer that today we can not only admire such a Creator's works, but we can begin to understand how they were constructed.

Or were we put down here in 4004 BC, with a body plan only coincidentally identical to that of the other mammals?

Roy Bean northernguy
Roy Bean writes that since he feels there might possibly be a thimerisol connection to the collection of symptoms currently called autism that an extra dollar a shot for vaccinations is a small price to pay.

Currently hundreds of million of people are unable to receive vaccinations of any kind because of the excessive cost. Adding a dollar cost for each injection can reasonably be supposed to increase that number by another hundred million or so. Given the real environmental threats that these people are exposed to one can expect that at least ten per cent of them will die or experience horrible diseases because of their inability to get even the most basic vaccinations. Yet Roy Bean says let them die.

Why? Because the presence of themerisol in the vaccination _may_ have a barely measurable contributory impact on the miniscule number of people who are afflicted with some degree of what has been labeled autism.

Better yet let ten thousand babies burn to death rather than one of them should die of thyroid cancer (assuming that there actually is any _real_ evidence that flame retardants are directly connected to any form of cancer).

Meanwhile Roy Bean continues to denounce the corporate mentality because of its harmful actions.

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