The emotional debate over whether companies should allow desperately ill people to have access to experimental drugs was reignited last week after Johnson & Johnson announced the appointment of a panel to arbitrate patient requests.
The move, announced by the company on Thursday, is believed to be the first of its kind in the industry. The panel will be headed by bioethicist Arthur L. Caplan of New York University, who has written extensively about the issue of experimental drug availability, known as “compassionate use.”
“Pharmaceutical companies have long regarded all of their information as propriety data, not to be shared with anyone, but this is starting to change,” Caplan told The Jewish Week via email.
Caplan, himself Jewish, noted that different religious traditions will be heard by the panel. He also noted that his Jewish education plays a role in his deep concern for human life.
Though drug companies have been granting emergency access to their unapproved drugs since the AIDS epidemic of the 1980s, saying yes leads inevitably to anguished decisions over who should be given the medicine. The lens of Jewish medical ethics adds another level of complexity to the already thorny issue of fairness and equal access to care.
“Within Jewish tradition, one of the strongest mandates is to save a person’s life,” said Rabbi Elliot Dorff, professor of bioethics at American Jewish University and author of a book on modern medical ethics. “However, tradition is not blind to the fact that there are scarce resources.”
Rabbi Dorff also raised the question of collective benefit versus personal benefit, one question that arises if a drug is distributed before testing is completed.
“At whose cost do you provide experiment drugs to those who are desperate?” he said. “Delaying the clinical process could delay the drug being made available to everyone.”
Still, he said, nobody should expect the panel to be able to address all the issues connected to compassionate use. “We all want neat and clean guidelines for how to proceed in tricky matters of life and death,” he said. “But that isn’t possible, and can’t be expected.”
Kenneth Feinberg, the attorney best known for serving as the special master of the Federal September 11th Victim Compensation Fund of 2001, reiterated that while there is no easy way to choose one case over another, the law does provide certain guidelines for the ethical prioritization of patients. He mentioned age, pre-existing conditions, strength, contributory negligence (such as smoking), and, the most equivocal, “intrinsic” worth to society, or “communitarian impact.”
“A doctor who practices medicine and assists others in the healing process might be more highly valued than a busboy,” said Feinberg. “It’s a harsh reality, but life is made up of harsh realities.”
He added that a communitarian ethic, stressing the collective responsibility to assist the individual, is consistent with Jewish thought.
“I’ve said it before and I’ll say it again — the community has an obligation to help the individual,” said Feinberg, himself Jewish.
While law may provide certain guidelines for the prioritization of one patient over another, Jewish law adheres to a “first-come, first-serve” methodology, according to Rabbi Moshe Tendler, leading scholar in medical ethics at Yeshiva University’s rabbinical school (RIETS).
“Today, everyone must be treated equally,” he said, noting that evaluating the risks versus the benefits of experimental treatment is a critical first step. “We cannot play God and choose one life over another.”
Though choosing one case over another may be undesirable, the volume of patients seeking compassionate use today makes it necessary, said Rabbi Mark Washofsky, longtime faculty member at Hebrew Union College (HUC-JIR) and author of several responsa, or rabbinic decisions, on Jewish bioethics.
“The panel’s task is reminiscent of the old Jewish discussion: If several people are in the dessert and there’s not enough water to go around, who drinks?” he said. “One school of thought says that we don’t decide, fate must decide. The other way of making the decision is based upon medical effectiveness — who is more likely to benefit?”
Following the Jewish mandate to “heal and be healed,” a decision made on the basis of who will benefit more is a sound decision according to Jewish law, he said. “Most seeking experimental treatments are in an advanced stage of disease,” he said. “If the experts on this panel decide that a particular recipient wouldn’t have a chance of success even if given access to the drug, giving that supply to someone else is an ethically justifiable decision.”
In recent years, families desperate to gain access to unapproved treatments have taken to social media, lobbying for sick loved ones via online campaigns and petitions. Efforts to shame companies into granting their requests have often failed in the past, because drug makers fear that permitting advanced access might interfere with clinical trials.
Still, the question of whether a company is ethically obliged to make such treatments available remains pertinent.
According to Jewish medical ethics expert Rabbi Kenneth Brander, the question of a company’s responsibility to the patient presents conflicting values.
“On the one hand, as long as the drug has been proven by medical experts to be effective and the patient is being encouraged by an expert in the field, then the ‘ill person in front of us’ needs to be our first priority,” said Rabbi Brander, staff adviser of the Medical Ethics Society at Yeshiva University, quoting from a Talmudic discussion about medical precedence.
On the other hand, there is a biblical commandment to heal in a responsible manner, he said.
“One must be guided by both. This means we must insure the efficacy of medicines and leave that process to knowledgeable people with appropriate practice protocols,” he said.
Still, “messing up testing regimes” is a risk that cannot be underestimated, said Rabbi Warshofsky. “If careful and fastidious trials are the best way to advance medicine, intervening with the orderly development of drugs could cause far-reaching problems,” he said. “Jewish ethics wouldn’t object to making trial drugs available, as long as that doesn’t hurt anyone else,” he said, stressing the qualification. “If the general public is denied access to a drug because protocol has been disrupted for one individual, that could very well qualify as hurting others.”
Though a company does take risks by releasing a drug before it has completed clinical trials, in Jewish law it would be a difficult case to make to withhold treatments once they are in the final experimental stage, said Rabbi J. David Bleich, professor of Jewish Law and Ethics at Cardozo Law School.
“Good science doesn’t always means good ethics,” said Bleich, who has represented the Orthodox perspective on bioethics in front of Congress and in several governmental deliberations. “Until now, pharmaceutical companies have largely made decisions based own their own, internal considerations.” The Johnson & Johnson panel, he said, is a significant improvement.
“They will be faced with difficult, and oftentimes painful, dilemmas,” he concluded. “But these cases will be under the eye of ethical scrutiny in a formal setting for the first time. It’s a huge step forward.”