CLEVELAND, Ohio — The medical profession should get behind “innovative” federal regulations that will help win back a skeptical public, and better navigate tougher and tenuous drug pipelines, Cleveland Clinic‘s Dr. Steven Nissen told his peers Thursday.
Nissen is a bit 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.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
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 of clinical studies has helped poison the public against health care.
He decried the marketing of drugs for off-label use — using drugs for other than their approved purposes. But he also said physicians should be allowed to use drugs and devices in the best way they see fit. He showed data that says nearly half of cardiovascular drugs are being used in 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. “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.”
