BURROUGHS WELLCOME SEEKS PROTOCOL-SECRECY LAW

A proposed Massachusetts law (bill number S. 464), initiated by Burroughs-Wellcome Co., would make it difficult for the public to obtain protocols for clinical trials, including the informed-consent statements which volunteers entering trials are given to sign. While this particular law would only affect Massachusetts, it could be a precedent for similar legislation elsewhere.

The bill, which recently passed one legislative committee despite widespread opposition by AIDS organizations, arose from a dispute between Burroughs Wellcome and ACT UP/Boston over a test of AZT syrup in newborns with HIV-positive mothers. According to Steven Busby of the Community Research Initiative of New England, Burroughs Wellcome had required Boston City Hospital, which conducted the study, not to release any information about it. As a result, even the Massachusetts Department of Public Health (DPH) did not know that the trial was happening, and the study was not listed in the Massachusetts Clinical Trials Registry.

ACT UP learned about the study in April 1989. After it proved to the Department of Public Health that the study existed, the DPH requested a copy of the protocol, to which it was legally entitled. Current Massachusetts public-records law allows the release of the protocol to the public. Burroughs-Wellcome claimed that the protocol contained trade secrets, and obtained a temporary injunction to prevent its release. But ACT UP then obtained a copy from the U. S. National Institutes of Health (NIH), which had determined that the protocol did not contain trade secrets, making the injunction moot. Burroughs Wellcome then went to the legislature to change the law for the future. Meanwhile, ACT UP found both ethical and scientific problems with the protocol, and significant changes were made in the study as a result.

(According to Busby, NIH policy strongly supports the public release of protocols of drug trials using human subjects if the trials receive public funds, and requires it for phase II studies and above. Opponents of S. 464 could find no other case in which a pharmaceutical company strongly objected to such release; certainly there is no other such case in Massachusetts.)

The proposed new law (S. 464) would allow a company required to file a protocol for a clinical trial to claim that the protocol contained trade secrets. If anyone asked for release of the information, a DPH staff person would examine the protocol to decide if there were trade secrets. Either party -- the pharmaceutical company, or the member of the public -- could appeal an unfavorable decision in the courts.

Burroughs Wellcome says that this change in the law would give it due-process protection against public release of its proprietary information. But the likely practical effect would be to make it much harder for the public to obtain in-depth information about clinical trials, even if there was in fact no real issue of trade secrets. Companies could routinely claim trade secrets, requiring court action before protocols are released. Litigation favors the richest party, and pharmaceutical companies are usually far better financed than public-interest groups. The result will be to further remove research from public scrutiny.

Burroughs Wellcome also says that its bill would make Massachusetts law consistent with Federal law, under which the FDA keeps proprietary drug-testing information confidential. But the proper comparison is with NIH, which routinely requires companies to agree to release protocols of clinical trials as a condition for receiving public funds for those trials. The FDA
receives far more detailed and sensitive information from drug companies than ever appears in protocols.

Organizations supporting S. 464 include Burroughs Wellcome Co., Massachusetts Biotechnology Council, Inc., Massachusetts Hospital Association, Massachusetts Medical Society, and the Pharmaceutical Manufacturers Association. Legislators are being told that the biotechnology industry fears that competitors might work backward from a protocol to obtain proprietary information. Because of current economic problems, Massachusetts is especially concerned about being attractive to industry.

The following organizations are opposed to S. 464:


ACT UP/Boston
AIDS Action Committee
AIDS Watchdog Group
Boston AIDS Consortium
Children's Hospital AIDS Program
Community Research Initiative of New England
Dimock Community Health Center
Fenway Community Health Center
Gay and Lesbian Advocates and Defenders
Massachusetts Department of Public Health
Massachusetts Law Reform Institute
Massachusetts Lesbian and Gay Bar Association
Northern Lights Alternative
People With AIDS Coalition of Boston
Roxbury Comprehensive Health Clinic


Note: A December 21 memo from Burroughs Wellcome lists the Massachusetts Department of Public Health as supporting their legislation. In fact the Department opposes the bill, according to Sara Bachrach, it's Director of Government Relations, because it does not want to decrease access by persons with AIDS to information about protocols. A legislative committee ordered the Department to write compromise language for the legislation. The Department did so, but it opposes the bill even with the new language.

What You Can Do

An attorney opposing the bill, Deborah Thompson of the Massachusetts Law Reform Institute, suggested that persons write to Senator William Keating, Chairman, Steering and Policy Committee, State House Room 413-B, Boston, MA 02133. Even

letters from outside Massachusetts, especially from experts, will help show the widespread concern on this issue.

For more information, contact Deborah Thompson, Massachusetts Law Reform Institute, 69 Canal St., Boston MA 02114, 617/742-9250.