CLEVELAND, Ohio — The medical profession should get behind “innovative” federal regulations that will help win back a skeptical public, and better navigateÂ tougher and tenuous drug pipelines, Cleveland Clinic‘s Dr. Steven Nissen told his peers Thursday.
Nissen is a bitÂ fire-and-brimstone when speaking to the public about the U.S. Food and Drug Administration. But Thursday afternoon, he was standing in front of fellow cardiologists — as well as drug and medical device companies — during a lunch speech at the Clinic’s three-day symposium on cardiovascular disease.
Nissen proclaimed dead the concept of the blockbuster drug — the statin that would work for tens of millions, for example. The “low-hanging fruit” in drug development is gone, and harder-to-develop, targeted therapies will be part of the next wave in care.
There are too many drugs that incrementally improve on existing drugs, he said. The federal government can turn companies back toward creating novel treatments — and developing them quickly — in areas like Alzheimer’s, obesity and drug-resistant tuberculosis, Nissen said.
The government should create incentives to develop drugs for such treatments, including extended patent rights for innovative medications, as well as FDA approvals that expire after five years if outcome trials have not been performed in that time.
“If we encourage that kind of regulation ,then regulation becomes our friend rather than our enemy,” he said.
There were no questions at this talk, and the crowd applauded politely.
Nissen also said physicians and the medical industry have played roles in the erosion of public trust that’s gripping health care and the FDA. Nissen said the industry has reacted cynically to calls to disclose doctors’ ties to the medical industry, and the practice of non-disclosure ofÂ clinical studies has helped poison the public against health care.
He decried the marketing of drugs for off-label use — usingÂ drugsÂ for other than theirÂ approved purposes. ButÂ heÂ also said physicians should be allowed to useÂ drugs and devices in the best way they see fit. He showed data that says nearly half ofÂ cardiovascular drugs are being used inÂ ways for which they are not approved.
“I personally think that physicians should be allowed to prescribe or use devices for whatever indications they think are in the best interest of patients,” he told the audience.Â “I’m not interested in taking away physician prerogatives. I am interested in preventing inappropriate marketing of devices and drugs for things they are not tested for.”
BRAVO, Dr. Nissen!! Finally, a physician who believes there is intelligence beyond the Pharmaceutical sphere. There MUST be varied and/or better solutions to patient care than chemical intervention. In many cases it would seem that we should have been born with this plethora of chemicals innate; why else would we need Statins for example. And WHY is our body raising our cholesterol levels in the first place if the increase is not due to familial cholesteremia? Chemicals are too easy a solution (treat the symptom). We need to broaden our theater of treatment possibilities and encourage the FDA to do the job we expect THEM, not the pharmaceutical industry, to do. BRAVO!!