Healthy Skepticism Library item: 1000

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Holland J.
MedicAlert lifeline lent to patients in drug trials
2003 Jan 5

Full text:

Turlock — MedicAlert, which provides quick access to medical records in emergencies, is taking on a role in clinical drug trials.

The Turlock organization is working with a company in Pennsylvania to sign up people who take experimental medicines under the supervision of researchers.

If a trial participant has a bad reaction or other medical emergency, a paramedic or physician could tap into MedicAlert’s electronic records and see what the person was taking. The information could aid in emergency treatment.

In turn, researchers would promptly learn about a drug reaction — information that could help refine testing.

“There seems to be increased awareness among (drug trial) sponsors to provide additional safety precautions for the participants while they conduct the studies,” said Ramesh Srinivasan. Srinivasan is director of marketing and business development for MedicAlert Foundation International.

The arrangement is with Physicians Clinical Research Solutions Inc. of Wayne, Pa., which helps plan and conduct drug testing with the goal of speeding approval by the federal Food and Drug Administration.

Srinivasan said the arrangement could add 60,000 to 80,000 U.S. members to MedicAlert over five years. The organization has about 2.3 million in the United States and about 1.7 million in other nations, all of them issued bracelets or pendants that identify them to emergency workers.

Tracy Blumenfeld, president and chief executive officer of PCRS, said MedicAlert membership could be provided to 1.5 million or so Americans who take part in drug trials each year.

“Since there’s nothing out there now that has these benefits that we know of, we hope we can get every clinical trial participant using the MedicAlert service,” she said.

Srinivasan said the program eventually could be expanded to drug trials in other countries.

Blumenfeld said trial participants sometimes do not let researchers know of medical problems that happen after the trials begin. The communication with MedicAlert will be “instant and confidential,” she said.

Another goal is preventing emergency workers from administering drugs that, in combination with the trial drugs, could harm the participants.

Drug makers and other sponsors of the trials will cover trial participants’ MedicAlert membership fees while the research is taking place. The aparticipants could remain enrolled at their own expense.