BUSINESS AND REGULATORY NEWS

http://biotech.nature.com • MARCH 2002 • VOLUME 20 • nature biotechnology 207

try, says Powell,“spent too much time creatingbetter and better versions of the same olddrugs rather than looking for new targets.”)According to UBS Warburg (New York), anti-infectives are the fourth-largest therapeuticcategory after cardiovascular, CNS andinflammatory diseases, generating $22 billionin sales during 2000. Biotechnology startupsare gearing up to capture some of this market.Powell says that the number of anti-infectivestartups has doubled in the past few years, andthat there is “plenty of space” for new compa-nies (see Table). However, there could beproblems ahead says Shlaes: “For small com-panies, an increased stringency for trials willmake them more dependent on pharma [forfunding clinical development] at a time when

The US Senate is set to review new legisla-tive proposals and to resume a postponed

debate on human cloning, including whethernuclear transplants should be permitted tofurther stem cell research. Many elements ofthis debate also are central to the agenda of thenewly formed President’s Council onBioethics, whose members convened for thefirst time in mid January.

Amid such meetings and hearings with stillothers being scheduled, a panel from the USNational Academy of Sciences (NAS;Washington, DC) weighed in on these mattersduring January. They called for legal sanctionsagainst human cloning for reproductive pur-poses, but reiterated an NAS endorsement ofcloning to produce stem cells for research pur-poses, a process it prefers to call nuclear trans-plantation. In its final report, this NASpanel—which met publicly in mid-2001 (Nat.Biotechnol. 19, 791, 2001) and was chaired byIrving Weissman of Stanford University(Stanford, CA)—is now calling for a “legallyenforceable” ban on human reproductivecloning, one that would carry “substantialpenalties” and would apply to clinics in theprivate sector to which other federal regula-tions have not applied.

“The proposed ban … should be reviewedwithin five years, but it should be reconsideredonly if a new scientific review indicates thatthe procedures are likely to be safe and effec-tive, and if a broad national dialogue on soci-etal, religious, and ethical issues suggests thatreconsideration is warranted,” Weissman says.He and other members of the NAS panel tookcare to distinguish reproductive cloning fromnuclear transplantation as a means for pro-ducing stem cells, a procedure that would also

use blastocyst cells from very early-stagehuman embryos but would not involveimplanting them into a woman’s uterus forfurther development.

The kind of dialogue alluded to byWeissman is very much the sort of national-level discussion that the members of thePresident’s Council on Bioethics are seekingto lead, according to council chair LeonKass, a bioethicist from the University ofChicago (Chicago, IL). He calls the 18 mem-bers of the council, including himself andseveral additional bioethicists, five biomed-ical researchers, four lawyers, severalphilosophers and social scientists, and ajournalist, “intellectually diverse” and saysthat they are “liberated” from a need to seekconsensus on issues that they consider.Although the first meeting of the councilmembers in mid-January was abbreviated,there is no doubt that human cloning is thenear-term issue on which they intend tofocus. The council, which was establishedlast November for a two-year (renewable)term by an executive order of President

Bush, plans to meet six to eight times peryear (Nat. Biotechnol. 19, 791, 2001).

One practical issue is whether the Councilon Bioethics will discuss that first agenda itemin time to influence a heated congressionaldebate over human cloning, scheduled toresume in earnest this month. A recent legisla-tive addition to this debate is a bill co-sponsored by Senator Tom Harkin (D-IA) andSenator Arlen Specter (R-PA), “The HumanCloning Ban and Stem Cell ResearchProtection Act.” If enacted, this bill effectivelywould codify many recommendations in therecent NAS report, permitting cloning for var-ious research purposes—particularly studiesof embryonic stem cells—but imposing bothcriminal and civil penalties on anyone usingcloning techniques for the purpose of repro-ducing a human.

However, last year the House ofRepresentatives passed a bill that wouldbroadly prohibit such research along withreproductive cloning. Moreover, SenatorSam Brownback (R-KS) has already provenhimself an outspoken proponent of thosesweeping restrictions, offering similar legis-lation in the Senate and, late last year,maneuvering to attach its restrictive provi-sions to an essential appropriations bill. Herelented only on the promise that the debatewould be rejoined this year.

Representatives of the biotechnologyindustry and also the academic research com-munity are endorsing the NAS report and theHarkin-Specter legislative approach thatwould permit cloning of human embryonicstem cells for research purposes, but ban theiruse for reproductive purposes. For example,the US Biotechnology Industry Organization(BIO; Washington, DC) views reproductivecloning as “dangerous and fraught with ethicalconcerns” and thus “supports a legallyenforceable ban on [its] practice,”according toMichael Werner, vice president of bioethics atBIO. Like NAS, BIO supports research onhuman cells “using nuclear transplantationtechnology, especially as applied to stem cellresearch,” noting its “potential to provide newtherapies and cures …”

Jeffrey L. Fox, Washington, DC

the large companies may be dissuaded fromcontinuing in the area.”

Meanwhile, Cubist is deliberatingwhether or not to submit a filing forCidecin for cSST alone, and Shlaes pointsout that the FDA is backpedaling, searchingfor ways to ensure the safety and efficacy ofnew antibiotics, without “driving theindustry out of the business.” Indeed, theFDA was to hold a public meeting of itsanti-infectives advisory committee onFebruary 19–20 (after Nature Biotechnologywent to press), and the FDA plans to pub-lish a response to Shlaes and Moellering’sletter in the March 15 issue of ClinicalInfectious Diseases.

Liz Fletcher, London

Panels jockey for position in US debate on cloning

The already murky outlook for medicalbiotechnology in the US is being fur-

ther clouded this year by big pharma’sfinancial woes and productivity slump. Fornow, biotechnology companies can’t counton the large-cap pharmaceutical industryto provide timely acquisitions or evenmajor capital for any but the most promis-ing and risk-free products. And the

ImClone (New York) debacle surroundingErbitex is expected to further freeze thealready chilly investment climate.

Big drug makers have not done wellrecently. Merck (Whitehouse Station, NJ)and Schering-Plough (Madison, NJ)shares, for instance, suffered a punishing37% decline during 2001, while Bristol-Myers Squibb (BMS; New York) stock fell

Troubled big pharma turns away from biotech

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