American Journal of Law & Medicine

Selling stem cell science: how markets drive law along the technological frontier.

I. INTRODUCTION

Since 2001, stem cell science in the United States has been explicitly constrained by federal prohibitions. (1) Under an executive order announced by President George W. Bush on August 9 of that year, U.S. researchers can only receive federal funding for work done on the limited number of embryonic stem cell lines (an estimated sixty to sevent-eight) created prior to the executive order. (2) Continued research on embryonic stem cells (ESCs) is not expressly prohibited. But, under the Bush administration's executive order, no federal funds can be used to develop new embryonic stem cells lines, or even to work on new lines developed after August 2001.

The problems with these restrictions, according to their critics, are threefold. First, they sharply limit the funds available to a high-cost, early-stage endeavor, limiting the pace of scientific discovery in the process. Second, they force stem cell researchers to maintain an administratively absurd line between research conducted in federally-funded laboratories (which include most university facilities) and that conducted in spaces free of federal funds. Third, restrictions push promising scientists to work in the shadow of the law, engaging in cutting-edge research practices that might also be deemed illegal. Embryonic stem cell research received $40 million in federal funds in 2005, a fraction of the total $28 billion the NIH spent on biomedical research in that year. (3)

The Bush administration's prohibitions threaten the state and future of stem cell research in the United States. (4) However, this article posits that breakthrough science can emerge without federal funding, even without the formal sanction of the law. To make this argument, we review the history of two earlier breakthrough technologies, the birth control pill and in vitro fertilization (IVF), both of which developed in the United States without federal funds and in an environment of ambiguous legality. (5)

All three of these technologies, of course, bear an intimate relationship with female reproduction. The birth control pill prevents conception by altering a woman's reproductive hormones; IVF enables otherwise infertile women to conceive outside their wombs; and embryonic stem cell research, at least in its current incarnation, requires the use and manipulation of human eggs and embryos. Currently, moral opposition to this use of reproductive material drives federal restrictions on embryonic stem cell research. Or as President Bush announced in his executive order:

 
   At its core, this issue forces us to confront fundamental questions 
   about the beginnings of life and the ends of science. It lies at a 
   difficult moral intersection, juxtaposing the need to protect life 
   in all its phases with the prospect of saving and improving life 
   in all its stages.... My position on these issues is shaped by 
   deeply held beliefs. (6) 

As we describe below, such opposition is not new. In fact, both the pill and IVF faced similar sentiments at the time of their early development and similar restrictions at both the federal and state levels. (7)

Today, however, the birth control pill and in vitro fertilization are booming businesses, each estimated to generate annual revenues of well over $3 billion. (8) The moral opprobrium that once surrounded them has declined, as have the legal restrictions that once bound them. (9) Federal funds support continued research into contraception and private funds have more than compensated for the lack of federal monies devoted to IVF research. (10) The histories of the pill and IVF, therefore, suggest a pattern that may be highly relevant for embryonic stem cell research. They suggest that science frequently encounters moral opposition at the cutting edge of development, and that this opposition translates easily into legal prohibitions and restrictions on federal funding. In this regard, the current status of U.S. stem cell research is hardly unprecedented. By the same token, though, the legal and commercial evolution of these earlier industries also suggests that prohibitions don't necessarily last forever. When the science is sound and demand deep-seated, markets have a funny way of pushing prohibitions aside, allowing funds to flow to the new science and consumers and patients to eventually reap its rewards.

Thus, this article suggests that, even in areas of strong moral opposition, science can often develop in the shadow of the law, with the market eventually compelling both moral concerns and legal prohibitions to decline. The first section of the article tracks this evolution in the area of birth control, describing early U.S. laws on contraception, the contemporaneous emergence of a black market for contraception, the development of the birth control pill, and the eventual rise of a legal market for contraceptives. The second section considers federal laws relevant to IVF and the emergence, despite these laws, of the IVF industry. Finally, the article explores federal restrictions on the funding of embryonic stem cell research, state level initiatives to both ban and support this research, and the current status of private investment in this field. The Article concludes with a discussion comparing and contrasting the three inventions and exploring how science can drive markets, even in the face of the law.

II. CONTRACEPTION

A. CONTRACEPTION AND THE LAW

Prior to 1873, when it became illegal, the contraception industry flourished in the United States. (11) In that year, however, moral crusader Anthony Comstock convinced Congress to pass the Act of the Suppression of Trade in, and Circulation of, Obscene Literature and Articles of Immoral Use. (12) The bill grouped contraceptives with other "obscene" items, and banned them as such. (13) It outlawed interstate transport of contraceptives and use of the postal system for sending contraceptives and related information. (14) Finally, the bill forbade the importation of contraceptives, (15) stating:

 
   [W]hoever ... shall sell, or lend, or give away, or in any manner 
   exhibit, or shall offer to sell, or to lend, to give away, or in any 
   manner to exhibit, or shall otherwise publish or offer to publish 
   in any manner, or shall have in his possession, for any such 
   purpose or purposes, any obscene book, pamphlet, paper, writing, 
   advertisement, circular, print, picture, drawing or other 
   representation, figure, or image on or of paper or other material, 
   or any cast, instrument or other article of immoral nature, or any 
   drug or medicine, or any article whatever, for the prevention of 
   conception, or for causing unlawful abortion, or shall advertize 
   the same for sale, or shall write or print or cause to be written or 
   printed, any card, circular, book, pamphlet, advertisement, or 
   notice of any kind, stating when, where, how, or of whom, or by 
   what means, any of the articles in this section hereinbefore 
   mention, can be purchased or obtained, or shall manufacture, 
   draw, or print, or in any wise make any such articles, shall be 
   deemed guilty of a misdemeanor. (16) 

Each offense could result in a sentence of six months to five years of hard labor and a fine between $100 and $2,000. (17)

In the wake of what became known as the "Comstock law," most U.S. states adopted their own "mini" or "little" Comstock laws. (18) Twenty-two states, for example, passed local obscenity laws that theoretically made birth control illegal, although the precise determination of illegality was left to the courts (19) Twenty-four states explicitly passed laws forbidding contraception and advertising or information related to birth control. (20) Connecticut went the farthest of them all, outlawing the actual use of contraception. (21) The terms of its 1878 statute read: "Every person who shall use any drug, medicinal article or instrument for the purpose of preventing conception, shall be fined not less than $50.00 or imprisoned not less than 60 days nor more than one year or be both fined and imprisoned." (22) In a 1940 case, a Connecticut court interpreted the statute not to exempt doctors. (23) In 1942, a state court likewise ruled that there was no exception when the life of a woman was at risk. (24)

Massachusetts law is of particular interest because researchers in that state began to design the birth control pill in the 1950s. In 1879, Massachusetts passed An Act Concerning Offences against Chastity, Morality and Decency, outlawing information about contraception and the distribution of contraception. (25) Its purpose, the Supreme Judicial Court wrote in a subsequent defense of the statute, was to "to protect purity, to preserve chastity, to encourage continence and self restraint, to defend the sanctity of the home, and thus to engender in the state and nation a virile and virtuous race of men and women." (26) As in Connecticut, Massachusetts state courts determined that the law made no exception for physicians. (27)

By the 1910s, activists at both the state and federal level were fighting for repeal of the Comstock statutes. Mary Dennett Ware, for example, a middle-aged activist and grandmother, tried to get the Comstock laws revoked by striking "for the prevention of conception" from Section 1142 of the New York Penal Law, which made it a misdemeanor for "a person to sell, or give away, or to advertise or offer for sale, any instrument or article, drug or medicine, for the prevention of conception." (28) She failed, and was instead convicted in 1929 of sending obscene material through the mail. (29) Margaret Sanger, by contrast, had slightly greater success in arguing that physicians should be exempted from the Comstock laws if they were using contraceptives to cure or prevent disease. (30) In 1918, while upholding Sanger's own conviction for distributing contraceptives because she was not a physician, the New York Court of Appeals explicitly accepted her basic argument, agreeing that physicians were indeed exempt from the Comstock provisions of New York law and defining disease to mean "an alteration in the state of the body, or of some of its organs, interrupting or disturbing the performance of the vital functions, and causing or threatening pain and sickness; illness; sickness; disorder. (31) In reinterpreting this definition, the Court expanded it critically to include pregnancy. (32) The Court also read the exception to include "the druggist, or vendor, acting upon the physician's prescription order." (33)

In 1930, a condom manufacturer sued another company for trademark infringement. (34) The defense argued that since condoms were illegal, the plaintiffs trademark was not protected. (35) The Court, however, interpreted the Comstock laws to apply to intent rather than the product itself, writing: "There is no federal statute forbidding the manufacture or sale of contraceptives. The articles which the plaintiff sells may be used for either legal or illegal purposes." (36) The Court continued: "The intention to prevent a proper medical use of drugs or other articles merely because they are capable of illegal uses is not lightly to be ascribed to Congress." (37)

Three years later, in Davis v. United States, the Sixth Circuit Court of Appeals considered violations of 18 U.S.C. [sections] 334 and 18 U.S.C. [sections] 396, statutes concerning, respectively, the use of the mail system and interstate commerce for distributing information regarding the prevention of conception. (38) The defendants, who operated a wholesale business that sold rubber goods to druggists, defended on the grounds that their products could be used for the "legitimate medical and surgical use in treatment and prevention of disease." (39) The Court agreed, stating that conviction required "intent that the articles described in the circular or shipped in interstate commerce were to be used for condemned purposes." (40) Davis thus confirmed that the sale or advertisement of contraceptive materials was not necessarily illegal. Instead, illegality required proof that the contraceptives would be used to prevent pregnancy rather than to combat disease. (41)

Perhaps the most important case limiting the impact of the Federal Comstock laws was United States v. One Package. (42) There, the Second Circuit Court of Appeals ruled that physicians could legally import and prescribe birth control and thus were exempt from the Tariff Act of 1930 and Comstock laws. (43) In One Package, the Court considered whether the importation of vaginal pessaries for contraception violated Section 305(a) of the Tariff Act of 1930 and the Comstock laws. …

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