BioCentury reports that Senator Ron Wyden (D-OR.) sent a letter to NIH requesting a list of medicines that have reached the market as result of NIH research since 1995 -- when the agency removed the reasonable pricing clause from cooperative research and development agreements (CRADAs).
Wyden also asked NIH to convene a panel to reexamine the pricing of medicines and treatments that are developed with public funding.
Assuming (and it is not a big assumption) that Senator Wyden wants to show that it’s public money responsible for new drugs – he needs better staff work.
This question has been asked and answered a number of times from a number of different angles. And, at the end of the day, the answer is that NIH-funded research grants are rarely responsible for pharmaceutical breakthroughs – and are never responsible for the complicated and expensive research behind the development phase of drug programs.
Does Senator Wyden even understand the difference?
As the New York Times reported in January 2011, “The National Institutes of Health has traditionally focused on basic research, such as describing the structure of proteins, leaving industry to create drugs using those compounds.”
A quick look at the grants given out by NIH to investigators in academic research demonstrates that taxpayer money is given to pre-clinical activities. The track record of academics moving something into the clinic is quite poor for a variety of reasons. That's where venture capital, biotech, and pharma come in. Indeed without such investment -- which comes earlier than ever before in the discovery process -- taxpayer support for NIH would not be worth the effort. It's the private investment -- which by the way is now increasingly translational in nature and now involves the development of new drug development tools -- that enhances the NIH investment.
Indeed, without contracts and contracting out in key areas such as genomics, proteomics, high throughput screening, biomarker development, the NIH would not be relevant. It relies upon constant collaboration with the private sector at all levels. In fact, efforts to bar NIH scientists from consulting and working with private companies have lead to a massive exodus of key researchers to for profit companies where there is more freedom and resources.
Wyden also requested information about a CRADA covering research on JAK-3 that he said helped lead to the development of rheumatoid arthritis drug Xeljanz tofacitinib from Pfizer. According to Wyden, "taxpayer-funded research was foundational" to the development of the oral pan-Janus kinase (JAK) inhibitor, though he acknowledged Pfizer funded all drug discovery, preclinical and clinical development expenses.
Um, not so fast. In response, Pfizer said it has invested over $1 billion over the past 20 years for the discovery, development and commercialization of Xeljanz. Pfizer also said the CRADA did not yield any compounds or patentable IP.
Wyden made similar requests in the early 90s seeking to regulate prices on drugs developed with the aid of federal resources.
The definition of insanity, said Professor Einstein, “is doing the same thing over and over again and expecting different results.”
Words to the Wyden.