Caving in to Big Pharma

File photo: A technician checks capsules leaving the Bosch 3000 Encapsulation machine at the Elan Corporation plant in Westmeath, Ireland, August 16, 2004

The resignation of the chairwoman of the Supreme Committee for Clinical Trials in Humans, Prof. Stavit Alon-Shalev, together with other members of the panel in charge of regulating medical experiments involving human subjects, is commendable. They stepped down to protest the decision by Health Ministry Director General Moshe Bar Siman Tov to strip the so-called Helsinki committee of much of its authority, reducing the medical, scientific and ethical supervision of drug companies seeking to conducted clinical experiments in Israel.

The move had nothing to do with committee members’ personal interests. The panel operates under the Public Health Ordinance; its job is protecting the public interest. It comprises 21 physicians and senior researchers in a variety of scientific fields, experts in law and ethics and representatives of the public and the health system, all working voluntarily. The panel meets monthly to issue opinions on proposed clinical trials, particularly in the sensitive fields of genetics and fertility. It examines the medical logic of the trials, how they are conducted and their ethical aspects.

But Bar Siman Tov has decided that Israel must be “less Bolshevik” and to streamline the approval process for trials in order to increase its market share. Using the capitalist jargon of international competition, aiming for more trials to be conducted in Israel rather than in other countries, the Health Ministry is prepared to ignore international standards of oversight. This isn’t fair competition, but deception.

Committee members warn that Israel will become “the “back alley” for countries with higher ethical standards for clinical. Reducing regulation will allow Israel to host genetics and other clinical trials that have been rejected by other countries for ethical reasons.

Bar Siman Tov wants to vacate the higher committee’s authority to approve such experiments, leaving the decisions to the Helsinki committees that operate in every hospital. He also plans to establish a new “central committee” that will approve research being conducted simultaneously in several Israeli hospitals.

This would leave Israel without a higher authority whose members are not part of any hospital and who thus have no conflicts of interest, and that includes ethics and legal experts as well as public representatives, as is the case in most other countries. It would instead leave decisions on clinical trials to committees comprising hospital physicians and legal advisers who are subject to the influence of money and prestige. There would be no moral oversight and no one to protect the public interest from the interests of the pharmaceutical companies.

It is hoped that this protest will broaden, as planned, and that most of the committee members will resign. The Health Ministry must not be allowed to dismantle the control mechanism on genetics experiments and expose them to destructive market forces.

The above article is Haaretz’s lead editorial, as published in the Hebrew and English newspapers in Israel.