Manhattan Institute for Policy Research.
search  
 
Subscribe   Subscribe   MI on Facebook Find us on Twitter Find us on Instagram      
 
 
   
 
     
 

Washington Examiner

 

Gates Invests Time, Cash Into Drug Research

November 25, 2011

By Paul Howard

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 last 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 life-saving treatment for leukemia, have only a modest effect on population health, Gates says, compared with “preventing Parkinson’s or preventing Alzheimer’s.”

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.

If the research costs and time required to develop new medicines could be significantly reduced using tools like biomarkers -- biological indications showing rapid response to promising therapies -- we might see an explosion of private investment not only for costly chronic illnesses, but also for the “neglected” diseases that the Gates Foundation focuses on.

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 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.

If Gates wanted to leverage his own bet on vaccines, this is exactly the kind of project he should embrace.

Original Source: http://washingtonexaminer.com/opinion/columnists/2011/11/manhattan-moment-gates-invests-time-cash-drug-research#ixzz1f0aOBw00

 

 
PRINTER FRIENDLY
 
LATEST FROM OUR SCHOLARS

5 Reasons Janet Yellen Shouldn’t Focus On Income Inequality
Diana Furchtgott-Roth, 10-20-14

Why The Comptroller Race Matters
Nicole Gelinas, 10-20-14

Obama Should Have Picked “Ebola Czar” With Public-Health Experience
Paul Howard, 10-18-14

Success Of Parent Trigger Is Unclear­—Just As Foes Want
Ben Boychuk, 10-18-14

On Obamacare's Second Birthday, Whither The HSA?
Paul Howard, 10-16-14

You Can Repeal Obamacare And Keep Kentucky's Insurance Exchange
Avik Roy, 10-15-14

Are Private Exchanges The Future Of Health Insurance?
Yevgeniy Feyman, 10-15-14

This Nobel Prize-Worthy Economist Figured Out How To Destroy Terrorism
Diana Furchtgott-Roth, 10-15-14

 
 
 

The Manhattan Institute, a 501(c)(3), is a think tank whose mission is to develop and disseminate new ideas
that foster greater economic choice and individual responsibility.

Copyright © 2014 Manhattan Institute for Policy Research, Inc. All rights reserved.

52 Vanderbilt Avenue, New York, N.Y. 10017
phone (212) 599-7000 / fax (212) 599-3494