November 1995 (vol. 12, #1) 1601 N Tucson Blvd #9, Tucson AZ 85716 c 1995 Physicians for Civil Defense




Although one would never guess it from reports in the mainstream press or the Women's Studies Department at your local college (which seem to suggest that male aggressiveness and oppressiveness are unabated), America is said to be losing its virility. And so is the rest of the world.

The alarms are not sounding about atrophy of the military virtues, or a decline in male commitment to the family, or a birth dearth-though they probably should.

And the cause of the problem is not identified as a moral decline, a loss of faith, the welfare state, or socialized education-though these can cause the manifestations listed above.

No, the concern is focused on DDT, which was banned by the EPA in 1972. Along with other chemicals such as dioxin and polychlorinated biphenyls (PCBs), DDT breakdown products are said to be causing ``Havoc in the Hormones.''

``A chill went up my spine,'' reported alligator endocrinologist Louis Guillette, when he looked at slides of the ovaries of laboratory mice exposed to diethylstilbestrol (DES). He reported similar observations in alligators born on Lake Apopka in Florida, site of a pesticide spill.

Of even greater interest to television documentaries is Guillette's finding that the male alligators have a smaller penis than normal. This and other anomalies in certain wildlife populations are all linked together in the July/August, 1995, issue of Audubon.

Guillette reportedly thinks that we should all ``be screaming in the streets'' because every man today is ``half the man his grandfather was'' (National Review 6/26/95). Guillette is not speaking of the ability to shoot straight, fell timber, or blaze trails. Rather, he refers to the claims that ``male sperm counts [sic.] in the industrialized world have plummeted by a startling 50 percent since the dawn of the `chemical revolution' that began after World War II.''

Audubon also queries whether the hormone-like effects of organochlorines might be responsible for increasing rates of breast and testicular cancer.

In an editorial entitled ``Masculinity at risk,'' Nature (6/15/95) opined that ``it would be a cruel irony if the introduction of DDT half a century ago turned out to have been responsible for a decline of male fertility worldwide.''

The same issue carried an article showing that a DDT metabolite (p,p'-DDE) inhibits androgen binding to the androgen receptor. Studies were done in tissue culture and by gavaging rats with 100 mg/kg/day of the compound. A second article by Richard Sharpe (``Another DDT connection'') referenced a study of sperm donors in Paris. It queries whether the concern is ``a remarkable coincidence.'' Sharpe presents no data; rather he notes that ``we lack accurate data on the levels and routes of human exposure and on whether, and at what levels, adverse reproductive changes can be induced (in animals).''

The editorialist doesn't quite believe his own headline. He cites the ``need for a certain calm.'' After all, ``panic does not make DDT disappear from the environment. Moreover, this will not be the first occasion when a presumed link between an environmental contaminant and a risk to health has melted away on close examination'' [emphasis added].

Already, the evidence against the link is accumulating, and the risk itself may be melting away. An article in Science (3/24/95) referred to a global decline in human sperm count over the past 50 years but cited a study in which PCBs fed to newborn rats actually boosted their sperm production and testes size. There is no evidence of decreased human fertility, and reports of the falling sperm count are suspect.

The study from the Paris sperm bank (Auger, et al., New Engl J Med 1995;332:281-5) concluded that there had been a significant decline in the concentration and quality of semen over a 20-year period and suggested that this could ``implicate factors affecting all the inhabitants of an area, such as the water supply or environmental pollution.'' The study design and statistical analysis were criticized by Richard Sherins in the same issue. In particular, Sherins pointed out that concentration of sperm from one individual can vary two- to four-fold. Furthermore, a reanalysis of the data from 48 previous studies showed a statistically significant increase in sperm concentration over the past two decades.

Writing in the British Medical Journal (7/2/94), Stephen Farrow noted that the finding of a decrease in sperm concentration ``led to much speculation about the cause: oestrogen or pesticides in meat or water were the popular culprits,'' as in a BBC special entitled ``Assault on the male.'' Farrow thought the first question to ask was whether the decline was fact or fiction; his answer is that it is an artefact due to misapplication of sophisticated statistics such as regression analysis.

As to the cancer fears, the late William Hazeltine, Ph.D., presented an analysis at a seminar sponsored by the International Center for Scientific Ecology on May 10, 1993. In his assessment, evidence for the carcinogenicity of DDT is limited and weak. Nonmalignant hepatomas were induced in mice fed maximum tolerated doses of DDT for their entire life. Hazeltine was skeptical of a study by Wolff et al. (JNCI 1993;85:648-652) purporting to show higher levels of organochlorine residues in women with breast cancer. The levels were at the limit of detection of the gas chromatography system used.

He noted some surprising beneficial effects. In a three-generational study that dosed Beagle dogs with 10 ppm DDT in their feed, the technicians began to refer to the untreated controls as the ``DDT deficient animals,'' because the treated animals seemed to do noticeably better (and autopsy revealed no adverse effects). Dosing rats with DDT before feeding them the known carcinogen dimethylbenzanthracene (DMBA) reduced the incidence of leukemia and mammary tumors.

Hazeltine thought that increased levels of DDT in the tissues of people in agricultural areas might account for a decreased incidence of infant jaundice. One paper reported the use of DDT in place of phenobarbital in a 17-year-old boy with juvenile jaundice; the bilirubin remained low for seven months after the end of DDT therapy (Lancet II(7161):4-6, 7/5/69).

The protective effects were attributed to the induction of liver enzymes that metabolize toxins (and hormones), whether from external sources or the body's own metabolism.

The assault on the male may be a fact; but the ban on DDT and other organochlorines is a symptom, not a cure.

Drug Component Manufacture Exported to China

Drug Component Manufacture Exported to China 


A ``burgeoning scandal'' concerning Chinese manufacture of bulk drug components for U.S. firms may soon emerge, according to Congressman Joe Barton (R-TX). Traditional sources of bulk components (of which 70% are now manufactured overseas) have been Italy, Germany, and Switzerland, but imports from China and India are increasing, perhaps due to heightened pollution laws or higher costs in more industrialized nations. The FDA conducts regular inspections, and random, unannounced visits of plants about every two years. The Chinese government, however, requires a month's notice prior to an official visit, eliminating the potential for surprise (BNA's Health Care Policy Report 10/16/95).

Rep. Barton favors FDA reforms, and wants to consider having drug efficacy determined by market forces, with the FDA concentrating on safety issues. His concerns include timely consumer access to new drugs and devices; an appeals mechanism that prevents retaliation by the FDA against small-and medium-size applicants; external review and comment for internal FDA guidance documents; reducing documentation requirements; and eliminating FDA oversight on the design and layout of manufacturing plants, product warehousing facilities, and production lines (ibid.)


Unannounced Inspections


While the Chinese may be immune from unannounced inspections, American physicians are not.

A dermatologist reports that he received a surprise visit from an FDA representative. ``My office manager was immediately intimidated and suffered chest pains the rest of the day. The FDA is such a large, powerful arm of the federal government that its intimidation factor is tremendous, and someone with true angina might well incur an actual heart attack under such circumstances. It was not until one full hour later that any of us learned that a pharmacy was under investigation, not our office.''

Instead of informing the doctor of the reason for the visit, the investigator immediately began grilling him about the prescription generics that he dispenses, where he purchases them, whether he orders them by phone or by mail, whether he charges patients for them, etc., etc. He also asked to inspect the doctor's supply of these generics.

``Although I knew I had done no wrong, I felt as if I were a criminal,'' the doctor stated.

Because the doctor questioned his own examiner, he discovered that the FDA was pursuing pharmacies that it views as ``manufacturers'' rather than ``compounders'' of prescriptions. If the pharmacist mixes two agents after receipt of a prescription, the FDA regards this as compounding; but if he does so beforehand, the FDA contends that he is ``manufacturing,'' and that the compound may actually be a ``new drug,'' requiring FDA approval before dispensing.

Approval costs are estimated to be $125 million, and approval time is about ten years.

According to Professionals and Patients for Customized Care, the ``FDA's threats to make compounding illegal had such a chilling effect on pharmacists that when an infant in Georgia was facing death if she did not receive pyrimethamine and sulfadiazine in an oral suspension compounded weekly, none of the 3,600 pharmacists in the state was willing to make the medication for her. Finally, a pharmacist came forward and saved the child's life.''

``Let the FDA figure out who I am,'' he said.

The dermatologist now has in his office manual a memorandum quoting advice from Mr. Roger Thies (tel. 202-737-4285), an attorney specializing in laws pertaining to the FDA. An FDA representative has the authority to visit the office only during regular business hours and only if he presents his badge and FDA form 482. No one is obligated to answer any questions, and if he shows an affidavit, no one is obligated to sign it. ``Do not even verbally acknowledge the accuracy or inaccuracy of such an affidavit,'' Thies advises.

The physician or his staff must allow the representative to inspect supplies or the physical structure, but he is not permitted to see any patient records, computer records, or other written records such as purchase orders or invoices.


Peace After Rabin


Some notes on the Middle East by Joseph de Courcy, editor of Intelligence Digest, the Stoneyhill Centre, Brimpsfield, Gloucester, GL4 8LF, UK:

October 6, 1995: ``Peace is kept by a balance of power, not fine words. The latest accord between the PLO and Israel will be no exception....The romantics should reread the history of the Locarno Pact,...signed in London on 1 December 1925 ....Germany, Belgium, and France bound themselves to recognize as inviolable their existing mutual frontiers and the demilitarization of the Rhineland....''

October 13, 1995: ``Israel's Labour government has to all intents and purposes conceded a return to the pre-1967 borders....All of our best military sources say that with the development of weaponry since 1967, pre-1967 Israel is no longer defensible by conventional means.

``Only an Israeli conventional first strike or reliance on nuclear weapons to defend against an Arab conventional attack will be able to prevent defeat. Both military doctrines are incredibly destabilizing during times of tension as they put such a premium on making the first move....''

November 10, 1995: ``The killing of Israeli Prime Minister Yitzhak Rabin by a Jew opposed to the peace process was both predictable and predicted....''

``The public perception is that he was a military hero of iron will and determination: that he could be trusted like no other Israeli with negotiating peace treaties with the Arabs. But the reality is not so noble....At critical moments in his military career, Rabin cracked under pressure....

``We thought hard about republishing these facts so shortly after Rabin's assassination, but they are the key to understanding his character and why he was unable to stand up to the internal pressures from doves such as Peres and the external pressures from the United States when his own military instincts told him that a retreat to the 1967 borders would be suicidal for Israel.

``He was the ideal front man for the doves because the Israeli's public perception of Rabin was of a fearless and successful fighter. That image was not supported by the facts.''


High Level Gamma Rays are used for sterilizing. Thanks to D.C. Dickson for noticing the glitch in the July issue.