Monday, May 16, 2011

Regulation Cannot Control Malignant Melanoma

As we move into the summer season, not only do temperatures increase, so do exposure to the Sun, sunburns, and concern about the ozone layer and skin cancer. But there are also some important policy issues to think about.

Malignant melanoma is the most-feared type of skin cancer and has been discussed widely in the (non-medical) scientific literature dealing with the stratospheric ozone layer. It turns out, however, that melanoma may have nothing to do with the alleged depletion of the ozone layer or with the Antarctic Ozone Hole (AOH). Melanoma shows distinct differences from the more common and less dangerous forms of skin cancer, Basal-cell and Squamous-cell carcinomas. As a consequence, EPA regulations can do little to stem the growing incidence of this malignant skin cancer—even though EPA regularly (mis)uses "lives saved from melanoma" in the benefit-cost data it presents to Congress.

First, there is no doubt that CFCs ("Freons") can deplete the stratospheric ozone layer. However, they are most effective at altitudes above 40 km, where there is little ozone; so that they have little influence on the total column amount of ozone and therefore on the amounts of cancer-causing solar ultra-violet radiation. At the 20 to 25 km level, where most of the stratospheric ozone is located, there are also other chemical species that deplete ozone, derived from water vapor (WV) and from nitrogen oxides [see Ravishankara et al in Science 2005].

Such depletions had been under discussion since about 1970, in connection with planning for a Supersonic Transport (SST) aircraft. Long before there was any mention of Freons, the National Academy was publishing depletion estimates that ranged all the way up to 70 percent! It came as a great shock, therefore, when published calculations showed that cattle raising and rice growing agriculture already generate large amounts of atmospheric methane that eventually lead to as much stratospheric WV as a fleet of 500 SSTs.

In fact, to become important for ozone destruction, the chlorine atoms released from CFCs require the presence of particles (for so-called heterogeneous reactions) and therefore are most effective following volcanic eruptions—or as is the case in the Antarctic Ozone Hole (AOH), when stratospheric temperatures become cold enough to form ice particles, called polar stratospheric clouds.

Chlorine is a natural constituent of the stratosphere, injected by volcanoes and likely also by the dissociation of salt particles convected upward from the ocean. Up until 1988, a year after the Montreal Protocol was ratified, the published data still showed no increasing trend of stratospheric chlorine compounds. This would indicate that the human contribution from CFCs was negligible. However, the data changed after 1988 and so did even skeptical scientific opinion about the contribution from CFCs.

We know from many lines of evidence that Basal-cell and Squamous-cell cancers are produced by UV-B, the region of the sun's ultraviolet spectrum between 280 and 320 nanometers. This is also the region in which ozone absorbs strongly. As a result, the incidence of those cancers increases greatly in going from the pole to the equator—not only because of changes in the ozone layer but because of the change in the solar zenith angle. As it becomes steeper, it traverses less stratospheric ozone, and therefore the UV-B intensity at the surface should be greatest around local noon at low latitudes.

It is interesting to note that there have been no observations in the last 40 years that would demonstrate an actually increasing trend in UV-B at the surface. This may be due to various atmospheric interferences or even the presence of ozone pollution in most areas. It has been hypothesized that if all of the smog over Los Angeles were to disappear, skin cancer rates there would approach those seen in El Paso, TX.

At US latitudes, the average UV-B is calculated to increase by 5% to 10% for every 60 miles (100 km) move to the south—and so does the observed skin cancer rate. Note, however, that these skin cancers affect primarily Caucasians and other fair-skinned individuals and that the incidence may be increased by the fact that people dress more lightly in warmer climates.

Melanoma is a very different beast. First, laboratory studies by Dr. Richard Setlow at Brookhaven National Laboratory have shown that UV-A is much more important than UV-B in initiating melanoma. UV-A covers the region from 320 to 400 nanometers of the solar spectrum, where ozone does not absorb.

Medically, it has been observed, that melanoma can occur on many parts of the body that are not exposed to solar radiation at all. It does not show the strong preference for Caucasians of other forms of skin cancer. It seems that there is an association between melanoma and childhood exposure to solar UV causing sunburn; but this association is not certain.

The upshot: Melanoma has little to do with ozone or Freons. The Montreal Protocol will do nothing to stop the rise in melanoma cases. EPA's benefit-cost calculations, used to support the regulation of important chemicals, like methyl bromide (MeBr), are essentially fraudulent if they include avoidance of melanoma cases.

And some personal advice: Exposure to the sun without proper protection is unwise, particularly when the sun is near the zenith, around 2 to 4 PM. Sun creams can help but they should also screen against UV-A and not just UV-B. Remember Noel Coward's cabaret song "Mad dogs and Englishmen go out in the midday sun."


FDA bureaucracy caused the “American thalidomide” tragedy

Enforcement of the deadly 1962 Kefauver-Harris amendments, in particular

In the early 1980s, several reports in medical journals indicated that folic acid taken early in pregnancy could prevent a number of birth defects. Naturally, folic acid manufacturers wished to advertise the benefit of this vitamin. However, to be consistent, the FDA could not allow them to make an efficacy claim without going through the expensive development process.

In 1992, the Center for Disease Control, another government agency, began recommending that all women of childbearing age take folic acid supplements, as they worked best early in pregnancy, when a young woman might not be aware of her condition. The FDA warned folic acid manufacturers not to refer to the Center’s recommendation, as this would be considered a form of advertising a drug for effectiveness against disease. Such advertising was not permitted under the amendment-driven FDA regulations.

Consequently, over a decade past before most young American women were made aware of folic acid’s benefits. About 4,000 babies are conceived each year with these birth defects; folic acid would prevent about 85% of them. Thus, in the years during which manufacturers were forbidden to educate the public, thousands of children, perhaps tens of thousands, were born deformed or unnecessarily aborted. Ironically, the amendments, which were passed to protect the public from thalidomide-like tragedies, created an American equivalent of the thalidomide tragedy which probably harmed more children than the 10,000 affected by its European counterpart!

The cost of keeping life-saving information from the public falls primarily on the poor. Advertising is the primary way by which many people, especially the poor, get new medical information. Educated and affluent individuals visit and converse with doctors, read health-related magazines, and spend more time tracking down life-saving information. The poor, on the other hand, see their doctors sporadically, read less, and often depend upon television news and advertising to inform them of new medical findings. Had folic acid manufacturers been permitted to advertise the health benefits of this vitamin, many more young women, especially among the disadvantaged, would have known about this inexpensive way to protect their unborn children.


In conclusion, the 1962 Kefauver-Harris amendments are the deadly secret behind soaring pharmaceutical prices. Most industry insiders are well aware that the “regulatory creep” stemming from the amendments has greatly increased new drug R&D, manufacturing, and advertising costs.

As a result of these regulation-driven factors, the rate at which pharmaceutical prices rise increased by a factor of 13 after the passage of the 1962 amendments. Consumers pay 700% more for their new drugs than they would in the absence of the amendments.

Because companies must spend more on development, they spend less on research. Consequently, we have only half as many innovations as we otherwise would. Instead, we must turn to more expensive forms of health care (e.g., surgery), adding further to our monetary burden.

The costs of the amendments are measured in lives as well as money. The amendments have tripled the time needed to develop a new drug. Millions of terminally-ill patients have died while the drug which could have saved them languished in regulation-mandated testing.

An equal or greater number of people have died because the drug that would have saved their lives is never developed and marketed. The amendments have made development so expensive that only about 50% of new, innovative drugs can be developed.

As many as 1 out of 3 individuals who have died from disease since
1962 were victims of the Kefauver-Harris amendments. They died waiting for a cure that was held up by regulatory testing or never reached the pharmacy shelves.

Without the 1962 Kefauver-Harris Amendments, we would have likely enjoyed longer and healthier lives, with more emphasis on prevention and natural products. We would have used drugs with a known safety profile for multiple uses, rather than wastefully developing new drugs for secondary indications. We would have had twice as many drugs, some of which would treat diseases that we currently think of as incurable. We would have emphasized prevention instead of treatment. We would have all this for a fraction of what we pay today for pharmaceuticals. Health care costs would be greatly lower too.

In 1962, we lost a golden opportunity to take a quantum leap in our health and well-being. It’s not yet too late to regain that opportunity. We can repeal the 1962 amendments and the excess regulations that they spawned. The first step in changing the law is changing our minds. Share this Special Report with your friends, your family and congressional representatives. The life you save may be your own!


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