No more. Medical research has declined in the United States. It's a win for multiculturalism and a win for globalization but a loss for the U.S. Yet we have no one else to blame. We are not being out-competed by China when it comes to science, we are losing medical research because we have been taught to hate drug companies and that new drugs should be cheap. That has had substantial impact on our policy.
It's rare that a month goes by without mainstream media lamenting some new problem with a product based on suspect epidemiological methods. Then there are cultural pundits who say that American medical research is corrupted by money. To prevent lawsuits and even more media stories, the approval process by the FDA, unless it is for a problem that gets White House attention like Ebola, is more daunting than ever. The cost is billions, the risk of basic research is high, but then everyone wants new drugs to be generic and cheap the moment they are introduced.
It's not a surprise biomedical research is leaving the United States. It is only a surprise it took this long. The writing has been on the wall for decades. Creating small molecule medications across disease areas is now a 14 year endeavor that costs over $2 billion and fails more than 95% of the time, much different than 30 years ago.
A recent paper in JAMA is a hint of what is to come unless we start embracing biomedical science again. The authors found that from 2004 on, the rate of investment in medical research declined - but not worldwide, just in the US. Compare that to the previous 10 years, 1994 and 2004, when investment went up 6 percent each year.
What do people in the US blame for that? Greedy corporations again. If that sounds like steelworkers in the 1970s, it's not a bad analogy, but steel is not a strategic resource and steelworkers seemed to be doing everything they could to drive their employers out of America. Biochemists are not trying to drive pharmaceutical research out of the US, that is instead being done by everyone from patients to the Obama administration, who have found a convenient villain for their culture war.
What is replacing corporate research in the U.S.? Nothing, the National Institutes of Health continue to spend more and more money on HIV and cancer research while the Obama administration has let funding overall stagnate after huge increases in science funding during the Bush years. It wouldn't matter even if the NIH had more money, government is not suited to creative science. I have paraphrased Samuel Broder, former Director of the National Cancer Institute, in the past, who said if it had been up to the NIH to create a centralized program to cure polio, we'd have the best iron lungs in the world but we still wouldn't have the vaccine that eradicated polio.
Government is good at funding incremental science, and I want them to do it for the same reason it has been good for National Public Radio to fund a lesbian music hour - because commercial radio is not going to do it - but big bold medical science is not going to be done when more politicians start choosing what drugs to develop. Creativity in science funding does not get funded the way knowing the system will. As one researcher recently lamented on Twitter:
No one who has straddled the worlds of corporate and government science is surprised by that at all. The NIH will give a politically well-connected company $10 million for a video game about junk food and declare it a success even though it was never completed and no one ever played it. Meanwhile, a company without connections in Washington, D.C. limped along trying to get money from the NIH for clinical trials of its Ebola medication and could not.
Was asked to apply for an “exploratory” grant. Reviewer criticizes grant application as too “exploratory”…. I don’t even...— Bryan William Jones (@BWJones) January 13, 2015
The government can't even build a new telescope on time and budget and those have been under development for 500 years. They sure can't be nimble enough to handle drug discovery. And they aren't. Instead of funding things that make sense they focus on what has political traction. National Institutes of Health (NIH) allocations do not correlate with disease burdens, cancer and HIV/AIDS are funded far, far above necessary levels, with cancer accounting for 16 percent of total NIH funding and 25 percent of all medicines currently in clinical trials.
That's all wrong. But it leads to the first obvious fix:
Stop funding research based on politics and media stories, fund on disease burden
This will have benefits in lots of ways. If we stop funding politics and start funding relevant disease research, it has more value to society. If government-controlled science does discover something new, a company will want to buy it. Then the burden of research and trials is taken on by investors rather than taxpayers and taxpayers can be funding new basic research instead.
Private sector car companies have had plenty of flops but taxpayers did not have to pay for those - that is why they were flops. On the other hand, when governments build cars, we get a Trabant: A two-stroke engine with a body of compressed cardboard and the worst gearshift ever made - along with a 10 year waiting list.
We not do want this to be the future of U.S. biotechnology.
The USSR is a model for how we do not want biomedical research done in the US.
The next thing we need to do is:
Streamline the regulatory process
The United States FDA approval process is far more of a blockade than the two years at the end of clinical trials. The whole process is designed to slow things down in the hopes that problems will be caught by companies long before a politician is blasting a company on the floor of Congress, not to protect patients while still getting new drugs into the marketplace.
Modern contempt for drug companies - and science itself - is rampant. It is okay for the public to dismiss the ethics of drug companies because too many people in the current administration also believe corporations are bad and only government is good. It's little wonder that an anti-vaccine mentality has taken hold of so many Democratic voters, vaccines are made by drug companies. As a result of an onerous approval process, increased costs and court judgments sure to be substantial just by mentioning a drug company, the U.S. share of life science patents has been in steady decline - and not just during the Obama years. America had 57 percent of medical patents in 1981 and that went down to 51 percent by 2011. The most valuable ones really dropped, from 73 percent to 59 percent in the same period.
What changed? In 1981, the typical drug underwent 30 clinical trials involving about 1,500 patients. A decade later that had ballooned to more than 60 clinical trials and 5,000 patients.
We are regulating biotechnology out of the country. To gain our edge back the next things we need to do is to
Extend patent life
If we want investors to be interested in medicine - and we do unless we want new iron lungs or 40 year, $40 billion drugs with a 10-year waiting list to get them - we have to make it worthwhile again.
Right now it takes about 14 years to go from research to market. Only 5 out of 5,000 drugs that enter pre-clinical testing ever get to human testing and 1 of those 5 will survive clinical trials and then get approved. That means the chance to make it to market is only 1 in 5,000. How long does a company get a patent? 20 years. If one company did all those attempts at basic research, they have to make back the cost of their one successful effort and 4,999 failed ones in just a few years.
Drug prices make for good outrage journalism but high prices for early adopters have always been the case - like any other technology, in order for it to get cheap enough to be popular for all, it first has to have uptake among the rich. Sorry, you don't get an Apple iPhone for free the day it ships and cutting-edge drugs are going to cost money - but if they really work, the price comes down fast. Generics have not led to all that savings we were supposed to get.
In our rush to think that a low prescription cost is a right, we do nothing but make generic drug manufacturers - who do no research - rich, and we mortgage our research future.
Maybe sharing the burden with the world is a good thing
Contempt for drug companies is a Western problem; people in Asia are not embarrassed to admit they work for a pharmaceutical company and that is a big part of the reason why so much of development is moving there - the best people want to work in the field and Asian governments do not spend billions convincing graduate students that only government-funded academia is real science. Plus, a lot of entry-level research is shotgun-type stuff, we don't need to give Johns Hopkins $600 million a year in taxpayer money for that.
Asian governments are not looking for reasons to hate medicine the way the Obama administration is now telling drug companies, insurance companies and doctors they are the problem in American health care.
We're still going to get new drugs, so perhaps American "leadership" is unimportant in the long run - that is a win for progressives who hate the idea of American exceptionalism. The government created a complete fiasco the last time we tried to build a large physics experiment, the Superconducting Supercollider, but physics did not end because America over 20 years ago America gave up on a specification that might still not be built even today.
The free market can be efficient and still be in the U.S. but first we need to recognize the problem, then we need to allow regulators to fix it. The problem won't be fixed by meaningless jargon drafted by insiders. In an editorial in the same issue of JAMA (doi:10.1001/jama.2014.17660), we get a glimpse of how American government and academia is not yet ready to make the necessary changes to keep actual science going, they just want to lobby for more money:
"To achieve a new strategic vision for research, the United States will need a roadmap that sets priorities, describes needed structural and organizational changes, and creates an environment that enables innovation," write Victor J. Dzau, M.D., of the Institute of Medicine, Washington, D.C., and Harvey V. Fineberg, M.D., Ph.D., of the University of California, San Francisco. "The needed changes include better coordination across funders and research institutions, development of new funding sources, improved grant evaluation processes, changes in education and training, rationalization of capital investments, and improved operational efficiencies. By taking the necessary political and institutional steps to ensure commitment of adequate resources over time, adopting a comprehensive research strategy, and attaining greater coordination and efficiency, the United States can retain its leadership position in biomedical research."
What does all of that even mean? Absolutely nothing. When a crime has been committed, asking the criminal what happened is not how the case gets solved.
Citation: Moses H, III, Matheson DM, Cairns-Smith S, George BP, Palisch C, Dorsey E. The Anatomy of Medical Research: US and International Comparisons. JAMA. 2015;313(2):174-189. doi:10.1001/jama.2014.15939