WFSTFIELD – Imagine a world in which the clinical research needed to cure disease is free from the restraints of cost and risk.
Imagine a time when it is possible to cure ” or, even better, prevent ” every known disease.
To some, these ideas are far-fetched improbabilities, the material upon which science-ficLion movies and books are based.
However, one local physician not only sees the possibility of a future filled with medical breakthroughs and available treatments, he has figured out a way to make it happen.
Westfield resident Stephen DeFelice’s “prescription” for healing-healthcare innovation calls for the participation of physicians, a segment of the industry vastly underutilized in voluntary clinical trials.
In 1976, Dr. DeFelice established the Foundation for Innovation in Medicine (FIM), a nonprofit organization whose objective, according to its website, is to accelerate medical discovery by creating a more productive clinical research community.
To further FIM’s cause, Dr. DeFelice has written the “Doctornaut Act,” a proposal to step up research by allowing physicians to more freely volunteer for Phase II, early clinical trials, rather than using non-physician volunteers.
He is also backing a book by Michael Mannion, entitled “A Maverick’s Odyssey: One Doctor’s Quest to Conquer Disease,” which tells the story behind the “Doctornaut Act.”
Dr. DeFelice is about to embark on a major effort to educate Congress about the importance of medical innovation and the passing of his “Doctornaut Act.”
“Not only has Congress failed to hold a hearing on medical innovation, until now, no one has made an effort to convince Congress to do so,” said Dr. DeFelice.
“How can Congress deal with health without dealing with the issue of improving medical innovation?” he asked.
According to Dr. DeFelice, there is a cultural “blind spot” to the need for clinical research, and the FDA and medical ethicists have created and long perpetuated the phenomenon, leading to a “culture of safety.”
“The truth is, if we took all medications out of the pharmacy, half the American population would be dead or dying within six months to a year,” said Dr. DeFelice.
Many factors play into Congress’s reticence to explore new treatments and therapies.
“Cost is one factor,” said Dr. DeFelice. “Giving up control is another.”
According to the doctor, patients also have to take some responsibility for the lack of clinical research.
“[They] have to stop being passive and get angry. They have to demand cures for disease,” he said.
“We need to stop living in a culture where our emphasis is on caring for someone after he becomes sick and move into a culture where we support the medical discoveries that prevent people from getting sick in the first place,” he said.
One early supporter of the “Doctornaut Act” was former Tennessee Senator Bill Frist, who left office in January 2007.
More recently, New Jersey Congressman Frank Pallone has expressed an interest in helping Dr. DeFelice introduce his act to Congress.
If passed, Dr. DeFelice’s “Doctornaut Act” will allow studies currently conducted on animals to transfer to humans, namely volunteer physicians.
Dr. DeFelice claimed the long-term results would be a decrease in morbidity and mortality, which will ultimately lead to reduced health costs.
The passing of the “Doctornaut Act” will also, according to Dr. DeFelice, create “a sense of urgency on the part of the patient.”
“Patients, basically, have no rights at the present time,” he continued.
“A diabetic can climb Mt. Everest, but that same person [presently] can’t volunteer for the clinical research that could cure his disease.”
Those physicians who take part in clinical research will also benefit, according to Dr. DeFelice, because “we are all patients,” he explained.
Dr. DeFelice brings a lifetime of medical innovation to the “Doctornaut Act,” including being the first to recognize the therapeutic potential of the combination of the antibiotic Adriamycin and carnitine, a component of muscle and liver, to treat ovarian an cancer and other cancers.
Dr. DeFelice is hopeful that “A Maverick’s Odyssey” will open the eyes of patients and non-patients alike, and motivate them to fight to dismantle the barriers that keep all people from enjoying a life free of disease.
The book’s author, Mr. Mannion, sees another benefit to the “Doctornaut Act.”
“People don’t have the connection with doctors that they once had, This is a good opportunity to build patient doctor partnerships,” he said.
When asked to expand, Mr. Mannion told The Leader/Times in an e-mail that “With Doctornauts, patients will learn that their physicians are volunteering to participate in risky clinical trials that might benefit them as well as possibly the physician ‘ ”
“Patients and physicians will once again have the chance to become partners in healing relationships and no longer be just ‘consumers’ and ‘providers’ in a business transaction,” he added.