A Baltimore medical equipment company that wants to market an innovative vest for reviving heart attack victims hopes to begin testing it on people by early next year.
The testing would be made possible by federal regulators, who have proposed allowing doctors to test such innovations on emergency patients without first getting their consent.
The proposed change to the so-called "informed-consent provision" -- published in yesterday's Federal Register -- could have implications nationwide for dozens of medical companies and researchers who are developing new drugs and devices for emergency care, said medical experts.
Among them is Cardiologic Systems Inc., a venture capital-backed Baltimore firm that wants to test and market a "cardio-vest" developed by a bio-engineering team at the Johns Hopkins School of Medicine. Cardiologic officials believe there is a $1.6 billion market for the device in the United States alone, and perhaps an $800 million market in Europe.
The proposal "is very significant" because "it affects all innovations in catastrophic illness and injury," from brain trauma to shock and cardiac care, said Dr. Michelle Biros, a Minnesota emergency physician and leader of the Coalition for Acute Resuscitation and Cardiac Care Researchers, one of numerous medical groups lobbying for the change.
Such research has been at a standstill for about two years, since the government tightened its interpretation of the rule after revelations of Cold War radiation experiments on unwitting subjects.
But the Food and Drug Administration yesterday proposed changing a regulation that prevents testing experimental drugs and medical equipment on patients without first telling them about the therapy and its potential drawbacks and getting their consent to use it on them.
Cardiologic -- and other medical companies and a coalition of emergency care experts -- have been arguing that this informed-consent provision is impractical in life-threatening situations, particularly in cases of heart attack and brain trauma when victims often are unconscious and medical treatment must be administered too quickly to allow contacting the family.
The proposal, which the FDA wants to enact by early next year, would allow doctors to test drugs and devices that are not yet approved by the FDA in life-threatening situations without first getting the consent of the patient or a family member.
The proposal says that hospitals and other health care centers where testing occurs would be required to have independent oversight boards to ensure that emergency care devices and medicines being studied would be used only in life-threatening situations in which other treatments had poor chance for success.
Arthur Caplan, a bioethicist at the University of Pennsylvania, said the government's decision to propose the informed-consent change is wise. But he cautioned that the FDA needs new, clear guidelines regarding informed consent that meet the challenge of today's rapid advancements in medical technology.
"Medical research is always risky," said Mr. Caplan. "It's reasonable to let this trial proceed, but I still don't think the FDA has solved the larger problem."
Most medical experts believe that the proposed rule change should take effect early next year, to allow dozens of stymied research projects to proceed.
"I'm very excited about the news," said Jeffrey Koepsell, president of Cardiologic Systems. "It's a glimmer of hope for businesses engaged in expensive medical research."
He said he believes that the device holds huge profit potential if it is proved effective in saving lives.
The vest's chief inventor, Dr. Henry Halperin, says the device holds promise for improving the survival rate for people who go into cardiac arrest.
About 300,000 Americans a year have such attacks, but only about 15 percent of those who receive cardiopulmonary resuscitation live.
"If we can improve those odds of surviving with the vest by just 5 percent, than we save an additional 20,000 people a year. We may be able to save as many as 50,000 lives a year," said Dr. Halperin, a Hopkins associate professor of medicine and biomedical engineering.
The vest increases blood flow to the brain and heart, and stabilizes blood pressure to near normal within minutes. Dr. Halperin says research has shown that improved flood flow to the heart and brain improves survival, but the device must be used within about 10 minutes of a cardiac arrest.
The vest, if approved by the FDA, primarily would be used by paramedics and emergency room physicians.
They also would use the vest if Cardiologic gets the green light to begin testing its effectiveness on heart attack victims.
The public has 45 days to send the FDA its comments on the proposal. Glen Drew, of the FDA's Office of Health Affairs, said the agency does not expect a protracted review of the comments and should issue a final version of the rule early next year.
Mr. Koepsell said Cardiologic has agreements with 10 hospitals and acute care centers nationwide to begin using the cardio-vest in trials after the rule change.