Connected Health: FDA inaction may do more harm than good

BOSTON—Pharmaceutical companies don’t make drugs like they used to. The FDA should let them, according to Juan Enriquez, MBA, managing director of Excel Venture Management and former founding director of the Harvard Business School Life Sciences Project, who spoke Oct. 25 at the ninth annual Connected Health Symposium, hosted by Partners HealthCare.

Over the past several decades, pharmaceutical companies’ spending on research and development has gone up, even as output has gone down and organizational focus has shifted from research and development to marketing and mergers. Many drugs are delayed or never even tested. Over the last 60 years, new drugs developed per billion dollars invested have dropped by a factor of 100, according to Enriquez. The primary purpose of pharmaceutical companies was to investigate life-saving molecules, but most of the science it sells is now acquired outside the industry.

Why is that? “If you raise the hurdle in terms of cost, time and complexity, it’s not surprising that the pharmaceutical companies will turn primarily to sales and not discovery,” Enriquez said.

Enriquez pointed to the course of vaccine development over 20 years as evidence of a disturbing trend. Despite a high societal return on investment in vaccines, 26 were brought to the market in 1967 compared to only three in 1986. “Vaccines are not the sexiest of programs for a pharmaceutical company,” Enriquez said. “What would they rather do: sell a pill that patients will take every day for the next decade or one jab of a vaccine?”   

He had two suggestions to help the situation. First, take action to encourage the government to adjust regulatory structures to accommodate the development of effective drugs that make sense for society.  Second, call for a measurement of lives lost for drugs not brought to market due to the costs of having them approved. “Maybe by being too careful and by making it too expensive, we’re hurting more people than we’re saving,” he said. “I’m not asserting that’s true, but it’s a possibility.”

Enriquez illustrated his point with an anecdote about John Nestor, MD, a former FDA medical officer who never approved a new drug during his career. “The irony of his obituary, of course, is he died of renal failure because the renal drugs weren’t approved. There were even personal consequences to not acting.”