The Biotech Valley of Death

“According to [an American Association for Cancer Research] report, the amount of annual funding for [the National Institutes of Health] has been less than what is needed to keep pace with biomedical inflation. In the late 1990s, following a period of stagnant budgets, Congress ramped up medical research funding for 5 years. But in the 10 years since the doubling ended in 2003, the NIH budget has been steadily shrinking… On top of that, the sequester cuts rolled out in March 2013 slashed the NIH budget by $1.6 billion, just over 5%. The impact to the National Cancer Institute was a cutback of $239 million, according to the AACR report, which was presented to Congress March 13.” FierceBiotechResearch.com, March 15th.

That’s just the tip of the iceberg, since federal budget cuts, accelerated by the Sequester (even with some cuts restored), have sliced and diced university and foundation research grants and even reduced direct government work as well. The result has been a shift to the private sector for that research money, but the notion of pure research or niched research (that often produces serendipitous benefits well beyond the initial focus) has vaporized in an increasingly-private sector mandate: direct and clear linkage between research and significant profitability. Woe to those with rare diseases or global regions with problems but no real masses of solvent buyers.

Ebola is just one of those diseases, mostly impacting poor regions, with no money to pay for the profitable business of massive inoculations, that just slipped between the cracks in a world of research funding cutbacks. With NIH research priorities now limited by reason of an impaired budget and no real private sector upside in catering to poor people, promising research to contain this deadly virus – now infecting people on our own shores – just didn’t pass the profitability test for further work.

Indeed, it seems that there was a promising vaccine to prevent Ebola developed in the U.S. and, more recently, Canada to a preliminary stage almost a decade ago… but that research was shelved. “‘There’s never been a big market for Ebola vaccines,’ said Thomas W. Geisbert, an Ebola expert here at the University of Texas Medical Branch in Galveston, and one of the developers of the vaccine that worked so well in monkeys. ‘So big pharma, who are they going to sell it to?’ Dr. Geisbert added: ‘It takes a crisis sometimes to get people talking. ‘O.K. We’ve got to do something here.’ ‘
 “Dr. James E. Crowe Jr., the director of a vaccine research center at Vanderbilt University, said that academic researchers who developed a prototype drug or vaccine that worked in animals often encountered a ‘biotech valley of death’ in which no drug company would help them cross the finish line… To that point, the research may have cost a few million dollars, but tests in humans and scaling up production can cost hundreds of millions, and bringing a new vaccine all the way to market typically costs $1 billion to $1.5 billion, Dr. Crowe said. ‘Who’s going to pay for that?’ he asked. ‘People invest in order to get money back.’” New York Times, October 23rd.

 With Ebola raising its threat level, experts are scrambling for both an effective treatment and a functional preventative inoculation. “Now, as the growing epidemic devastates West Africa and is seen as a potential threat to other regions as well, governments and aid groups have begun to open their wallets. A flurry of research to test drugs and vaccines is underway, with studies starting for several candidates, including the vaccine produced nearly a decade ago.

“A federal official said in an interview on [October 23rd] that two large studies involving thousands of patients were planned to begin soon in West Africa… With no vaccines or proven drugs available, the stepped-up efforts are a desperate measure to stop a disease that has defied traditional means of containing it.” NY Times.

The panic has resulted in a stepped-up response by the World Health Organization (with U.S. support), but is this effort too little, too late? “Millions of doses of experimental Ebola vaccines will be produced by the end of 2015, the World Health Organization has announced… It said ‘several hundred thousand’ would be produced in the first half of the year.

“And vaccines could be offered to health workers on the frontline in West Africa as soon as December 2014… However, the WHO cautioned that vaccines would not be a ‘magic bullet’ for ending the outbreak… There is no proven cure or vaccine for Ebola.” BBC.com, October 24th. How many will perish in the meantime? And it is WHO that is leading the charge… not the United States anymore.

There is a more basic question here. If the United States has the slightest hope of maintaining its economic position in a globally-competitive universe, side-stepping what appears to be a precipitous slide into a “formerly great and powerful international force,” does it have the remotest chance of sustaining that desire if cutbacks to education, infrastructure and research remain the primary philosophy of American leadership on both sides of the aisle?

Why are we restructuring our spending priorities and tax codes for short term “bandages” and “catering to disproven sloganeering” (like “tax cuts for the ‘job creators’”) at what appears a complete lack of concern for our future? And exactly how weak does that made us appear to the rest of the world? How may will die or face truly hard downward adjustments in their quality of life based on these short term missteps? Time for a ground-up reprioritization of our spending and taxing habits.

I’m Peter Dekom, and being on top requires continuing effort… not relying on fading memories of past glory and accomplishment.