The Nation's Pulse / Regulatory Practices

...This scientific and entrepreneurial tour-deforce has been virtually quashed by the EPA's dilatoriness and excessive safety requirements, a tale elegantly recounted by William Tucker in the August 1978 issue of Harper's...

...The far more reliable index of what a person thinks will be found in the individual's legal opinions or public writings, a large and useful deposit of which, in the case of O'Connor, we simply do not have...

...0 There is 01)1) or•tunity in America...

...It advocates deferral by the federal judiciary to the judgments of state courts on federal constitutional questions...

...This, then, is a riveting tale of entrepreneurship, but it has a sobering side as well which is at the core of the hook...

...Djerassi's tunnel focus is so complete that on at least one critical topic-the use of animal models as proxies for humans-he appears wholly oblivious to the battle currently being fought in the testing of food additives and chemicals for cancer...

...This insight led to the establishment of a laboratory in Mexico City which became the progenitor of the now-large drug firm, Syntex...

...Djerassi is one of the scientific fathers of "The Pill,'' a discovery which has not only advanced the capability of people to lead self-determined lives, but which has also supplied an essential means (if not, alas, the incentive) for bringing the growth of world population into step with the inevitably low levels of economic growth obtainable under current political arrangements...

...In short, for over half a decade millions of American women were being needlessly overdosed as a direct consequence of the FDA's dilatoriness...

...Did you know, for instance, that sand-filled bean bags are banned because kids might eat the sand...

...In this vein, Djerassi relates a positively astonishing episode whereby the FDA, in its zeal to eliminate risk, actually raised it instead...

...Pasteur rightly observed: ''Chance visits the prepared mind...

...2) the mandating of excessively long and large human trials before the new contraceptive can be marketed...

...the Court in Roe also said abortions occurring in the second and third trimesters of pregnancies could be regulated by the states...

...The next major step was the daring move of a young chemistDjerassi-to the then still obscure lab, which meant foregoing the established paths to a career in American academia...

...Thus when rare side effects among Pill users began to appear in the sixties from the daily dose then recommended, no reduction was possible until the FDA completed its review, and it was not until 1974 that the FDA began approving lower dose formulations-some five to six years after women in Communist China, of all places, had switched to the routine use of low-dose pills...

...But I was wrong...

...The problem is that O'Connor's views on the Constitution and her understanding of judicial review are largely unknown...

...D jerassi, unfortunately, is reluctant to draw any larger conclusions from his material...

...Movement in these directions has been hampered by the high costs and long delays entailed in the FDA's testing requirements...

...And the winemaker, in recounting his efforts to get his new and innovative winery off the ground, referred time and again to the regulatory hindrances placed in his way, ranging from the design of his wine labels and the monitoring of every last drop of taxable alcohol to the working conditions of his few employees and the variant (though always costly) licensing requirements of each state in which he wanted to market a few cases of his small, boutique output...

...10.95...

...with the Justice Department or, as it happened, in a 48-minute chat with the president...

...And those thoughts cannot be reliably disclosed in interviews turned out that each of us had in common some fearful encounter of the regulatory kind...

...The toy manufacturer, in response to some pre-Christmas burbling about the virtues of toys for r William Havender is a research bio chemist at the University of California at Berkeley...

...What is important is that document and what O'Connor believes about it...

...Thus, though we had been invited to the show for different reasons, it nominee...

...And with five aging justices (they are 72 or older), Reagan, one hopes...

...Djerassi advises that rather than mandating testing with dogs, as at present, discretion in the choice of appropriate test species should be left to the experimenters...

...The Delaney clause, for example, allows no scope for consideration of the "appropriateness" of the animal model...

...Yes, as George Will correctly noted, Reagan "dug about as deep as any president ever has into the state judiciary for a "children" of "any" age, chimed in with unkind words about the Consumer Product Safety Commission's pointless safety commands...

...Bearing this in mind, Djerassi's plea that dogs not be used in the cancer testing of oral contraceptives precisely because they do get cancer from these agents makes no sense...

...Obviously, there is more at stake here than the simple matter of better contraceptives or a new bugkiller...

...Or consider Djerassi's description of the package inserts required by the FDA since 1970...

...And so far, the score is Lions, a gross, Christians, null...

...and we shall not have the justice we need if O'Connor turns out to be simply a deferring justice who neglects to speak, as Lincoln also said the Court must do, to "the better angels of our nature...

...Thus, although not quite radiant, Djerassi is a splendid conductor of light...

...So it was with a sense of deja vu that I read an extraordinary contribution to this scholarship, The Politics of Contraception* by the justly honored Stanford University chemist, \oriun...

...A good argument can of course be made in support of a nominee who is intellectually disposed to defer to the judgments of lower courts and legislatures, state and federal, and to resist the temptation to make law-that is, a judicial conservative...

...I was there to talk about saccharin, cancer, and the folly of the Food and Drug Administration's pending ban...

...This chance meeting instructed me on the sheer breadth and pervasiveness of government regulations and their stultifying effects on the productivity of the small entrepreneur...

...Alexander Bickel once said that appointing a justice is like shooting an arrow into the air and not knowing where it will come to rest...

...One should not mistakenly believe that the adoption of Djerassi's suggestions would necessarily increase the level of risk to the public, however minutely...

...She finished in the top ten percent at the Stanford Law School and is intellectually quite capable, yet I sense she will probably he on this Court what her predecessor was-one of those justices in the "center," who are moved by others and move it nowhere themselves...

...This was not without adverse public health sequelae since virtually all the risks associated with oral contraceptives have stemmed from the early, high-dose pill...

...She became a trial judge in Arizona in 1975, and went to the court of appeals in 1979...

...Lasagna has also described how some drugs intended for small and specialized markets never get developed at all because of inflated development costs...

...The Supreme Court, as Lincoln once said, must decide the cases that are properly brought before it...

...Orphan drugs" is another term that goes unmentioned...

...The opening step was the revolutionary inspiration of a maverick chemist Russell Marker in the late thirties and early forties that animal hormones of the steroid family Ouch as the sex hormones and cortisone) :S REGULATORY PRACTICES THE AMERICAN SPI'(I Al OR SEPTEMBER 1981 could be synthesized by using certain common Mexican plants as starting materials...

...In a pleasant coincidence for O'Connor, her one law review piece-she has written no books or articles for popular or intellectual journals-was published this past summer, in the William and Mary Law Review...

...What makes this development an enthralling chapter in intellectual history is the fact that it was not merely a serendipitous occurence, but the outcome of far-sighted, purposeful, and risky initiatives...

...It also caused me to reflect on how much easier it would be to resist regulatory intrusiveness if chaps like these would strike alliances with one another, and if they were also acquainted with the wide body of anti-regulatory scholarship which has matured so vigorously in the last decade...

...Such a philosophy of jurisprudence will cause a jurist to refrain from making law, but it will also enable a jurist to know when not to defer to the judgments of others...

...Meanwhile, the portrayal of O'Connor as a judicial conservative, while soothing many conservatives and fulfilling Reagan's promise to appoint such a justice, revealed little about O'Connor's views on the Constitution...

...Her 29 written opinions mainly covered criminal convictions, workmen's and unemployment compensation cases, divorces, and bankruptcies...

...she did not have to rule on the federal civil rights laws, nor pronounce on other weightier matters...

...There is no virtue in deferring to a lower court's judgment, or to Congress, if its reading of the Constitution is wrong...

...v Sarkes Tarz,an Inc Bloomington, Indiana 26 THE AMERICAN SPECTATOR SEPTEMBER 1981...

...Now a package insert that details for consumers the known risks and benefits associated with the use of a given drug may sound innocent enough...

...will still have many opportunities to leave a more clearly defined mark on the Supreme Court...

...This is not merely a historical observation, for there are good reasons for desiring improvements in oral contraceptives: to develop an even safer methodology (such as a monthly pill which would free women from chronic doses of hormones), to discover a method convenient even for peasant women in the Third World, and to develop a male pill...

...For under the present scheme we would be marking time pending assurance of the total safety of a new contraceptive, while continuing to use an older method whose safety-with regard to the risks of blood clots, endometrial (uterine) cancer, etc.-is precisely in doubt...

...Indeed, the regulatory climate surrounding the introduction of new drugs has so changed in the two decades since the introduction of oral contraceptives that these same drugs could not now win acceptance...

...ingestion of a chemical used as a food additive in any species that is found to cause a statistically significant increase in the incidence of tumors (no matter how benign) automatically forces that additive off the market...

...Even so, given the chance to know more or less about a person's thoughts on jurisprudence, a president, obviously, should know more, not less...

...And OSHA's newly promulgated "generic" carcinogen policy, detailed in some 300 sparkling pages of the Federal Regis...

...O'Connor's remark that abortion is a suitable subject for legislation is no clue as to what she thinks...

...The problem, unfortunately, is that such inserts are not devised by medical personnel intent on presenting a balanced picture of risks and benefits, but by lawyers determined to protect their client from future liability...

...Djerassi's indictment is doubly powerful, moreover, when we recall that this same scientist has also been involved in bringing to market a new generation of safe, selective, non-bioaccumulating, noneggshell-depleting, and non-immunity-building insecticides which are based on turning an insect's own hormones against itself...

...But there is a better argument for appointing someone who not only respects the decisions of other courts and the judgments of legislatures, but also believes that the Constitution does contain certain A s a cancer researcher at Berkeley, I was recently a guest on a local radio talk show, together with a builder of low-cost homes, a toy manufacturer, and a winemaker in tent on making California's finest Pinot Noir...

...If no one can say where O'Connor, about to go in flight, will come to rest, it is also true that no one can much say what kind of arrow we are watching being lifted to the bow...

...C by William Havender Carl Djerassi...

...This is somewhat reassuring, but it pales beside what we don't know about O'Connor...

...Sam Peltzman, Bill Wardell, and Lou Lasagna, for example, have already documented how FDA requirements governing the introduction of new drug laws cause substantial delays (symptomatically, the term ''drug lag'' does not appear in the book...

...Because oral contraceptives are intended for use by healthy women and will affect millions of users over periods of many years, these requirements are far more stringent than for any ordinary medicinal drug...

...Djerassi notes that bitches, with their semi-annual heat cycle, have little physiologically in common with human females, and on top of that are notoriously sensitive to sex hormones, so much so that beagles develop breast nodules (a mild form of cancer) in response to their own progesterone when administered in high doses...

...Thus when it is said that O'Connor is a judicial conservative, we do not have the whole picture...

...ter a year and a half ago, reflects the same consensus...

...The central problems he cites are: 1) the mandating of long-term toxicity and cancer bioassays not only in rodents and monkeys but in a wildly inappropriate species-the dog...

...An odder mix of company would be hard to imagine, and that a theme of common enthusiasm would emerge seemed unlikely...

...The builder, when asked about the astonishing cost of California housing, couldn't refrain from describing the impact of no-growth zoning and building regulations on raw costs (an estimated 20 percent higher on the typical new home, according to a recent Rutgers University study...

...This critical discovery remains the basis of all oral contraceptives...

...Whether because of a conscious tactical choice or of a simple unawareness of any parallels and related scholarship, the result time and again is Djerassi's laborious rediscovery of the wheel...

...And so, risks and side effects are exaggerated and benefits understated, frightening women who could use the drug safely into choosing less safe and effective contraceptive methods, including abortion...

...This of course will still be far better than a ''mover" who moves in the wrong direction...

...His book is a jewel for scholars of regulatory questions because it adds yet another well-documented chapter to the dreary recital of regulatory horrors...

...As for the required lengthy pre-market clinical trials which involve thousands of women, they' should be replaced by a system of conditional approval and phased market introduction with careful monitoring for side effects, as currently practiced in England...

...The result was not only the first synthesis from cheap and abundant plantstuffs of the medically important hormones-cortisone, testosterone (the male hormone), and progesterone (the natural ovulationregulating hormone in women)-but also of a derivative of the latter which rendered it orally effective...

...It is said in apology for O'Connor's lack of a more substantial record that there have been previous court nominees about whom little was known, and that anyway how the nominee performs is often unrelated to what he thought before going to the Court...

...It so happens that FDA review is required even to lower the dosage in a drug formula (since the lowered dose must be shown still to be effective), causing substantial delays even for this modest step...

...Although a measure of added caution is justified, in Djerassi's view the FDA has gone overboard...

...principles-such as that racial discrimination of any kind is forbidden...