Drug trial suspended after 6 become very ill

LONDON — Six men participating in trials of a new drug to treat autoimmune diseases and leukemia became violently ill and were hospitalized in London, in a case raising questions about safeguards for patients when pharmaceutical companies test drugs in healthy volunteers. British regulators ordered immediate suspension of the drug tests.

Ganesh Suntharalingam, clinical director of intensive care at Northwick Park Hospital, said two of the men were in critical condition and four were in serious condition but showing signs of improvement. All six fell ill Tuesday night.

Waltham, Mass.-based research organization Parexel International, which supervised the trial, identified the drug as TGN1412, a monoclonal antibody developed by TeGenero AG of Wuerzburg, Germany, to treat autoimmune and inflammatory diseases and leukemia.

"The drug, which is untested and therefore unused by doctors, has caused an inflammatory response which affects some organs of the body," Suntharalingam said.

The names of the six men were not released. But one woman said her boyfriend, a 28-year-old London bar manager, was among them.

"He's like elephant man," Myfanwy Marshall told the British Broadcasting Corp. after seeing him. "They are saying he could be lying there in six months. He needs a miracle. Those were their words: He needs a miracle."

Marshall told the BBC her boyfriend had decided to participate in the trial for the cash — about $3,500 — to pay bills.

The Medicines and Healthcare Products Regulatory Agency, which ordered the tests suspended, said the six were the only people given the drug in a small trial. Two other subjects received placebos.

Dr. Herman Scholtz, head of Parexel International Clinical Pharmacology, said such adverse drug reactions are extremely rare and that it was an "unfortunate" situation.

Parexel International "adhered to standard clinical-research guidelines," said Dr. Thomas Hanke, the company's chief scientific officer.

Major pharmaceutical companies often farm out drug testing to firms such as Parexel. Universities performed this function in the past, but a whole industry of for-profit companies has sprouted to meet demand. Testing protocols are cleared by oversight committees.

Parexel is part of the $14 billion-a-year contract-research industry that conducts more than 75 percent of the experimental drug trials for the world's largest pharmaceutical companies. Bloomberg News reported last November that more than 15 scientists, doctors and government officials said the industry inadequately protected participants from the risk of injury and death.

SFBC International Inc., the Princeton, N.J.-based operator of the largest drug-testing facility in North America, is at the center of a U.S. Senate probe after at least 20 SFBC employees and participants in a clinical study in Montreal tested positive for latent tuberculosis after exposure to a trial subject with active TB.

The Associated Press, Reuters and Bloomberg News