Is the FDA in Bed With Industry? asks MedPage today, in a world where there are no such thing as wealthy virgins.
Our chums on MedPage Today reviewed JAMA: Ehrhardt S, et al “Trends in national institutes of health funding for clinical trails registered in clinicaltrials.gov” JAMA 2015; 314(23): 2566-2567
Excerpted from MedPage:
From 2006 to 2014, the number of trials funded by the NIH dropped by nearly one-quarter, while the number of trials funded by industry spiked more than 40% and trials funded by “other” sources more than tripled, according to Stephen Ehrhardt, MD, MPH, of Johns Hopkins Bloomberg School of Public Health in Baltimore, and colleagues, writing in a research letter in the Journal of the American Medical Association.
“I was surprised to find that the industry-funded trials have increased by more than 40% over the years, and the NIH-funded trials have decreased quite so dramatically,” Ehrhardt said in a phone interview with MedPage Today. “We suspected a decrease, but we didn’t expect to see it to such a large extent.”
“What we should look at is who is funding the trials here. The two of them [industry and NIH] are funding very, very different trials,” Ehrhardt said. “You could ask, ‘So what?’ But it brings some imbalance to the type of trials being funded.”
Ehrhardt argued that industry players use resources to fund trials that will support their own drugs. “I’m not blaming them,” he stated. “They have to watch their bottom line.”
But as a physician who must do what is best in the interest of public health, Ehrhardt said he has to ask himself “What should I actually prescribe to my patients, or is a lifestyle intervention better?”
“For public health, we need someone looking at comparative interventions. These are the trials that the NIH is funding,” he stated. “It might not always be drugs — it might be lifestyle.”
Can’t see the forest for the trees, here. There has been a decades-long shift in the American culture in general from the identity of America being the individual person, to the collection of interweaving, clashing gears that compose a society of entities, conglomerates, institutes and corporations. People aren’t really considered. Of course, they fit into the economy – so does the purchase of things for pets, for example – but people are merely enumerated widgets that make up the machine.
I wanted long ago to be a medical scientist – and I long ago threw cards and walked away. I could see this coming.
From Jefferson’s days to recently, it was thought to be the people’s interest to further the sciences and public knowledge. Even the Constitution stated, somewhat obliquely:
To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries;
In the last quarter-century or two, we agreed to take the business of American science and medicine away from the public funding of university researchers, and give it to corporations exclusively.
The NIH had a researcher at Harvard who was hot on the trail of the Huntington’s Disease gene. Before he found it, he lost his NIH funding. That’s when the worm turned, in my thoughts.
The competition for NIH and NSF funding before the defunding was pretty damn competitive. The grants were peer reviewed, the articles also. The modern habit of churning out McPapers in the university was laughed at.
Ever notice how many medical papers that you read end up with your conclusion – “Well, DUH!” That’s because the deal is to get peripheral McPapers out for the resumes of the MD/PhD clones, so that they can get lucrative jobs in Private Industry.
Industry thinks of how to bring things to market, new and big, expensive things. Basic research looks at simple stuff as well.
For instance, one orphan idea I’ve offered around is – why not administer a fixed ratio of Vitamin K/warfarin for anticoagulation? Our current system is one of balancing a known warfarin dose, against a patient’s unknown Vitamin K consumption in foods and enteric bacteria, etc. The ratio determines the INR/PT.
The reason it’s an orphan, is it consists of mixing an off-patent drug that costs perhaps 10¢, and a never-patented vitamin costing less than 1¢, to make a daily dose of a medicine that might well dispense with INR testing, unwanted haemorrhaging and clotting. Improved warfarin, that costs about 15¢ a daily dose, would wreck the market for GumbyTran and all the other coagulation blockers that are invented (and patented.)
What is more beneficial for industry? GumbyTran, of course – it is very biochemically slick and pretty. Vitamin K/warfarin is clunky and missionary-position, and something that could have been tried fifty years ago, but wasn’t. Big profits vs. no profits.
What is better for the patient? It’s kinda obvious. Cheap warfarin – especially if it didn’t need INR checking – could be sold world-wide. The measurement would be in the millions of lives, not millions of dollars.
We have bought into cost-no-object pharmaceuticals, and are seeing the effect. Tomorrow, I’ll write a little about how the Universities ride in on the scam.