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The FDA is a Destructive Force

The employees and appointees of the US Food and Drug Administration have caused an incredible destruction of value and progress over the time that the agency has existed. Their regulatory policies become ever more onerous with each passing year, as unaccountable bureaucrats follow their incentives: nothing good can happen to their careers as a result of approving new technologies, and nothing bad tends to happen to their careers as a result of making it really, really hard to bring new medicine to the clinic. So of course you wind up with an organization whose members collectively pay nothing more than lip service to their declared mission, while working to make sure that medicine stays moribund in a slow-motion stasis. This is most evident in the cancer research community, largely because of its size, but it applies just as evenly across all forms of medicine:

A 2010 study in the Journal of Clinical Oncology by researchers from the M.D. Anderson Cancer Center in Houston, Texas found that the time from drug discovery to marketing increased from eight years in 1960 to 12 to 15 years in 2010. Five years of this increase results from new regulations boosting the lengths and costs of clinical trials. The regulators aim to prevent cancer patients from dying from toxic new drugs. However, the cancer researchers calculate that the delays caused by requirements for lengthier trials have instead resulted in the loss of 300,000 patient life-years while saving only 16 life-years.

To add to this picture, you must also see incumbent Big Pharma entities and their executives and lobbyists - a deeply enmeshed network of regulatory capture. They are far more willing to use the current system as a weapon to suppress disruptive innovation in their industry than to be a source of innovation themselves. So it goes, just as in any other heavily regulated market. The strategic goals of the major players wind up having very little to do with creating beneficial change, and everything to do with keeping things the same as they are now.

As I've said in the past, it is a waste of energy to fight this. That's a money pit, and resources are better spent on creating actual progress than lining the pockets of politicians, their lackeys, and other corrupt cogs in the system. Work around the roadblock instead: start companies and partner for research development outside the US. Deliver services in Asia and take advantage of cheap flights and the growing medical tourism industry. The only way that the FDA will whither away is to make it entirely irrelevant - and as the bureaucrats keep piling on the costs, erecting an ever higher barrier to actually developing any new medicine in the US, that will become a more popular option. You can be sure that the wealthier and more connected individuals who make regulations and advocate for ever greater powers to accrue to the FDA will be amongst the first flying beyond the US to undergo newer therapies - treatments that they have managed to make illegal or too expensive to exist in their own country.

Some more on this topic:

Though the United States urgently needs new treatments for common illnesses such as heart disease, stroke, and diabetes, the nation's system for drug approval discourages innovation and investment, especially for our most pressing public health challenges. In this paper, we find that the main culprit is the high cost of Phase III clinical trials, which are required for FDA approval of most drugs. We examined drug development in four major public health areas and discovered that for any given drug on the market, typically 90 percent or more of that drug's development costs are incurred in Phase III trials. These costs have skyrocketed in recent years, exacerbating an already serious problem.

The enormous cost and risk of Phase III trials create incentives for researchers and investors to avoid work on medications for the chronic conditions and illnesses that pose the greatest threat to Americans, in terms of health spending and in terms of the number of people affected. This avoidance, in turn, harms overall U.S. health outcomes and drives up the cost of health care.

Comments

Totally agree. I've lived in Asia for 12 years now, and I can report life is perfectly livable and comfortable in places outside the U.S. :)

Research is already happening in places like China and Thailand at a quickening pace. As Asia gets richer, I think we'll find companies will not need persuading to aim their research and marketing at Asia. The effect will snowball, and pretty soon millions will be coming to Asia for treatment every year.

I used to get anxious when I thought about how America was losing its edge in things like medical research as a result of excessive law and caution and a calcifying political system. But these days I think it is OK. A country can't remain number one at everything forever, and America still has things like Silicon Valley and the best agriculture in the world.

You are right that trying to change the FDA is a waste of energy and resources. It may change, but not for the better. The main services the FDA provided the country (and the world) of protection from snake oil, elimination of quackery, and the application of rigorous testing were accomplished decades ago. These days, the agency does FAR more harm than good.

Focus outside of the U.S. and you'll find that it is full of customers who have needs to meet and money to spend. It's a big world!

Posted by: Paul at April 25th, 2012 10:00 PM

Yes I agree, and this is what we are trying to do now, to take promising therapies from the US or other places and bring them to Asia, bringing therapies to the market in a much faster and cheaper way.

Feel free to suggest any promising therapies that may be ready for the market but lack the resources to undergo the FDA trials.
Can always email us at biovax.sb@gmail.com to see how we can push the therapies sooner. This is how we would like to contribute to defeat aging.

Posted by: Jason at April 25th, 2012 10:06 PM

There are still problems with drugs of Chinese manufacture. There was a report on the BBC of malaria resistance due to the manufacture and dumping for over-the-counter sale of products sub-potent in artemisin, capsules made from industrial grade gelatin containing high levels of heavy metal contamination, and I am sure many people would be horrified to learn that a Chinese pharmaceutical company has applied to farm bears in cages for their bile. The world's wildlife will not support much more tiger cub jelly, rhinocerous horn, sea horse and other products of dubious therapeutic value.

I have worked in drug regulatory affairs on both sides of the fence, and I am not so ready to abandon drug regulation. Customers of overseas medical services at least should be prepared to pay for therapy in the country of origin of those services should their health worsen as a result.

My husband had a brain tumour and took melatonin. It gave him diarrhoea so badly his oncologist took him off his chemotherapy thinking that this was causing these effects, not melatonin, with the consequence the tumour grew back readily.
I have encountered deadly contamination of erythromycin by penicillin and other reasons to not so readily discard regulation. I agree it can be too slow to approve some products, but I am old enough to remember thalidomide, and young enough to remember the professionalism of the regulatory affairs people at Merrill Dow that the horror of this situation brought about compared with some of the cowboy attitudes of other pharmaceutical teams.

Posted by: catherine donaldson at April 30th, 2012 11:42 AM

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