Drug Treatment Network Told to Halt New Federal Research

U.S. authorities have ordered a network of renowned drug addiction treatment centers in the Los Angeles area to stop doing federally funded clinical research on new patients because vulnerable people taking part in studies were not adequately safeguarded, according to documents obtained by The Times.

The Office for Protection From Research Risks restricted research at the clinics in late February after an ethics probe surrounding one of the nation’s leading addiction specialists, Dr. Walter Ling, who runs overlapping research enterprises in Southern California that have received tens of millions of dollars in government funds.

The investigation found numerous violations of federal regulations and policies in the management of dozens of studies run by Friends Research Institute, a private nonprofit organization in which Ling plays a prominent research role.

Doctors working with drug addicts predicted that suspending research administered by the Friends group will hobble several of the area’s busiest drug treatment centers, which have turned away hundreds of addicts in the two months since research efforts were put in limbo. Street addicts and lower-income people have often been attracted to the studies because they offer free medical treatment.

The suspension order covers research--but not standard medical care--at the Pizarro Treatment Center in Los Angeles, the Friends Health Center in Hollywood and Matrix Institute sites in West Los Angeles and Rancho Cucamonga.

Patients already taking part in research can remain in the studies, which range from special counseling sessions to tests of experimental medications intended to ease cravings for heroin, cocaine and methamphetamine.

The move is the second strong statement in recent months from government regulators suggesting that perhaps thousands of Los Angeles-area people have been subjected to biomedical studies that did not meet federal ethics standards. Last month, the Department of Veterans Affairs and the risk office suspended research activities at the Veterans Affairs hospital in West Los Angeles.

The recent actions represent a growing awareness that “researchers working with vulnerable populations do not always adhere to requirements for overseeing the well-being of human subjects,” said Vera Hassner Sharav, head of Citizens for Responsible Care and Research, a New York City-based advocacy group. “Vulnerable populations are at risk of having their conditions worsened in order to afford researchers the opportunity to study their illnesses.”

The sanction shines a harsh light on Ling, who was head scientist of the studies that the risk office says were problematic.

Ling played an indirect role in the abrupt suspension last month of research at the VA hospital in West Los Angeles. He was running the hospital’s drug addiction center in 1997 when VA officials in Washington audited the center’s finances because of disputes between Ling and the research chief. VA officials put the research service on probation, culminating in the sweeping research stoppage in March, sources say.

Ling, who last year relocated his VA addiction program to the VA medical center in Long Beach, is also a psychiatry professor at the UCLA School of Medicine and director of a network of eight drug addiction clinics, including the three affected by the suspension order, known as the Los Angeles Addiction Research Consortium.

He said in an interview that the deficiencies in the Friends operation cited by the risk office pertained to administrative procedures and did not harm patients. Also, he said the West Coast office of Friends had hired two UCLA consultants to improve its management of clinical research.

Ling suggested that many of the findings were nitpicking, and he said it was unfair that the risk office was holding up current research, which was not being question, for problems identified in studies done years ago.

Ling’s work has garnered high praise. Among his supporters are U.S. drug czar Barry McCaffrey, who recently awarded Ling a presidential citation, and the director of the National Institute on Drug Abuse, Alan Leshner, who praised him in an interview last week as an “internationally recognized” scientist who “gets things done.” The drug institute provided $4.3 million in research funds to the West Coast office of Friends in fiscal year 1998, an institute spokeswoman said.

At the same time, some physicians and nurses familiar with Ling’s work say his interlocking research operations are beset by conflicts of interests and other ethical problems. A physician who did drug addiction research under Ling at the VA hospital in West Los Angeles resigned because he believed a study of an experimental medication involved too few nurses and endangered research subjects, sources say.

Critics point to Ling’s potentially conflicting roles at Friends, where until recent weeks he chaired the ethics committee that was supposed to regulate the very studies he and his co-workers were conducting.

In its 14-page letter disciplining the Friends organization, the risk office specified 16 overall violations of federal policies and regulations from 1991 to 1996 in studies overseen by Ling. It said it was taking the action to “ensure adequate protections for human subjects.”

Perhaps most significant, a Friends committee that was supposed to safeguard patient welfare by evaluating study proposals repeatedly made crucial medical research decisions without a physician present, contrary to the government research contract, according to the federal agency.

The violations occurred when Ling recused himself from the committee meetings because his work was being evaluated. That created a deficit of medical expertise, and more than a dozen research decisions were left to a businessman, a nurse, a lawyer and a statistician.

Also, the letter said, many consent forms exaggerated the potential benefits of studies while understating the risks. Others misled patients about the right to withdraw from studies or failed to discuss existing treatments they could use instead of experimental ones.

Further, the risk office cited a 1996 audit of the Pizarro Treatment Center by the National Institute on Drug Abuse. The audit found poor record-keeping in a study of an experimental medication. The risk office investigation yielded no evidence that the violations caused physical harm to patients, and the risk office acknowledged that Friends had recently taken steps to correct the problems.

But a risk official said that the procedural shortcomings were severe and systematic, undermining confidence in the group’s ability to protect its subjects.

The Friends Research Institute is based in Maryland. The risk office sanction applies only to research overseen by the West Coast office, according to the risk office letter, which was obtained by The Times through the Freedom of Information Act.