October 25, 2012

Drug R & D: Less Money, Fewer Products

Like most of my contemporaries, I'd like to see lots of new pharmaceuticals that might treat my afflictions... and I want to see them soon. But research and development (R&D) seems to have stalled, with billions of dollars yielding only a trickle of drugs. Many of the new products are just attempts to improve existing drugs, and show few advantages, if any. Meanwhile, Big Pharma's patents on blockbuster drugs (like the No. 1 bestseller Lipitor) are expiring. 

Some blame excessive regulation by the Food and Drug Administration (FDA). Others complain that players in Big Pharma are too bureaucratic. Developing a new drug in America requires lots of money (over $1 billion) and time (over ten years). I can't wait that long.

So, what happens between the researcher's "ah-HA!" moment and the product's appearance on the shelf of my local CVS? The Michael J. Fox Foundation for Parkinson's Research produced this video explanation that's informative and fun:

The Role of Governments
The video's example showed the government, primarily through the National Institutes of Health (NIH), investing $30 billion in research, and private enterprise investing $70 billion in development. NIH is the world's biggest supporter of medical research. Last December, it created a National Center for Advancing Transactional Sciences (NCATS) to hasten the development of new drugs. NIH Director Dr. Francis Collins said:
Patients suffering from debilitating and life threatening diseases do not have the  luxury to wait the 13 years it now takes to translate new scientific discoveries into treatments that could save or improve the quality of their lives. The entire community must work together to forge a new paradigm and NCATS aims to catalyze this effort.
Similarly, in 2007 the European Union announced a ten-year, €2 billion ($2.6 billion) effort to improve collaboration in early research. 

During this presidential campaign, we've heard a lot about the Obama administration's $500 million loan to the solar panel developer Solyndra, which was a bust. We didn't hear about the Human Genome Project. The federal government funded this project to map the human genome at a whopping cost of $3.8 billion over a 15-year period. 

But the payback has been huge. One study estimated that the project has helped drive $796 billion in economic activity, raised $244 billion in personal income, and supported 310,000 jobs in 2010 alone. The study was funded by the industry, so those numbers may well be exaggerated. But the impact is considerable in agriculture and medicine, and in new areas like gene therapy.

I'm intrigued by reports that genome-based medicine, frequently called personalized medicine, might lead to individualized risk predictions and treatment decisions.

But federal funding for research and development -- a drop in the bucket compared with farm subsidies, and infinitesimal compared with military weapons research -- has long been in decline. In today's knowledge economy, American jobs will depend more on scientific research than they did in the 1950s, and yet we spend much less on it as a percent of GDP. The benefits of hefty increases to support medical and scientific research are clear. As usual, the problem is politics.

The Role of Private Industry 
Companies, beholden to shareholders, are reluctant to risk losing money. After decades of steady increases, the global drug industry cut research spending for the first time ever in 2010. It appears that the diminishing trend will continue.

That decline reflects a growing disillusionment with poor returns on pharmaceutical R&D. Since 2000, research investment by drug companies has increased by more than 50%, but the development of new medicines has actually decreased. Between 2008 and 2010, there were 55 terminations of projects that had already reached the final phase III stage of clinical testing, more than double the level of 2005-2007. Companies have been hard pressed to develop new drugs that are better than existing ones.

Aware of their own limits, big drug companies are adjusting and experimenting with new ways of encouraging new ideas.

Emerging Role for Charities
The shortfall in drug R&D has inspired a flood of new partnerships. Charities have been particularly bold, according to The Economist. It reports:
The leading "venture philanthropist" is the Cystic Fibrosis Foundation.  It has supported early research and clinical trials, small biotech firms and the biggest of Big Pharma companies, Pfizer. The foundation spent $75m on early research for Kalydeco, which in January became the first approved drug to target the mutated gene that causes cystic fibrosis.  Kalydeco is owned by Vertex, a firm based in Massachusetts, but the foundation will get royalties from the drugs sales, which will then support further research.  Other charities have followed the Cystic Fibrosis Foundation's lead.  The Fox Foundation, for example, has spent $289m on research.
The Economist says the trend is clear: "Big Pharma now needs a lot of smaller partner."

So How Should I Vote on Nov. 6
Should I vote for Romney who says we should give more money to the military to fight more wars and give less money to government agencies like NIH that are fighting to develop drugs that might extend or improve the quality of my life?  Or for Obama who wants to expand government investment in R&D?

1 comment:

Anne Goodwin said...

Obama. We have lost so much in these two stupid wars.