Drug industry needs revolution to streamline pricey research

Pundits have been weighing in on Big Pharma’s innovation drought for years, but recently Silicon Valley gurus like Intel’s Andy Grove and Microsoft’s Bill Gates have gotten into the act.

Gates’ interest stems from his support for the Gates Foundation, which has made a tremendous commitment to vaccine development for “neglected” diseases in the developing world, like malaria.

Unlike other tech honchos who merely offer advice to their drug company colleagues, Gates’ work with companies like GlaxoSmithKline has given him an insider’s perspective. He has made a real contribution here.

Still, as recounted in a recent Forbes article, Gates’ views on the drug industry as a whole don’t stray too far from conventional wisdom. Like many critics, Gates believes that the drug industry has misplayed its hand over the past decade by devoting too much attention to expensive drugs for niche diseases or “blockbusters,” and too little attention to treatments for chronic illnesses that could save the most lives.

Even drugs like Gleevec, a lifesaving treatment for leukemia, have only a modest effect on population health, Gates says, compared with “preventing Parkinson’s or preventing Alzheimer’s.”

But Gates’ criticism is off target. Unlike tech companies, drug companies face stringent pre-market review from the U.S. Food and Drug Administration.

Generating safety and efficacy data for FDA approval of a single new medicine can take upward of $1 billion and a decade of arduous clinical trials.

The extraordinary risk and expense associated with drug development severely limits what products companies can pursue. If it takes hundreds of millions of dollars to make a drug, you’d better be able to earn at least that much back.

And public and private insurers are much more likely to grant premium reimbursements for drugs that treat serious and life-threatening diseases, even for small populations, when there aren’t other good therapies available.

Also, cancer drugs and other medicines that treat small populations benefit from several accelerated regulatory processes that make it easier for companies to navigate FDA requirements. In short, the market follows the regulatory path of least resistance.

Gates is right that there is tremendous unmet medical need for many widespread and devastating chronic illnesses, like Alzheimer’s. But diseases that develop over years or even decades (as Alzheimer’s probably does) also present costly regulatory and scientific hurdles that slow research into new cures, or even make them prohibitively expensive.

Streamlining research into new cures will entail something analogous to an Apollo “moon shot” for drug development, starting with setting ambitious goals and leading a collaborative effort between the FDA and the industry to rethink our 50-year-old paradigm for making and approving new medicines.

In 1960, John F. Kennedy didn’t know exactly how we’d get to the moon, because some of the technologies didn’t yet exist. By 1969, Neil Armstrong took his first steps there.

Today, we don’t know exactly how we’d make a quantum leap in drug development — like developing and approving a groundbreaking Alzheimer’s drug in five years — but we know that we need to do it.

Strategies that work in Silicon Valley don’t always apply to fields like biotechnology, where the scientific and regulatory challenges are very different.

But Gates’ leadership and his willingness to challenge the status quo for vaccine development is exactly the kind of vision and dedication the field needs to rally stakeholders in other areas, especially for drug development.

Paul Howard, Ph.D., is director of the Manhattan Institute’s Center for Medical Progress and the managing editor of Medical Progress Today, from which this excerpt was taken.

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