More Reasons not to trust the FDA

[Shandi]

This was posted in Quora to answer the question "Is the FDA Killing Us? : Mike S. Goodman's answer:

Is the FDA killing us?

4 Answers

Steve Harris, Physician who used to do animal and human nutrition studies1.4k Views • Steve is a Most Viewed Writer in US Food and Drug Administration (USFDA).

Yes, in some ways. We need an FDA, but what we need is the old 1961 FDA.

See Eroom's law. That's "Moore" as in Moore's law spelled backwards. The number of new drugs coming out each year DECREASES.

Nature Reviews Drug Discovery

Now, in case you are wondering if this is because we've already invented all the easy drugs, or maybe run out of drugs to invent because we mostly understand biology, let me just stop you right there and say: "NO". That's ridiculous.

The slowdown is caused by regulatory burdens such as the 1962 addition to the Food and Drug Act that new drugs had to show "efficacy" not just be safe. Dietary supplements and homeopathics are exempted from this (due to politics, not science), but the drugs that really matter have to have developers pay the FDA a large fee (millions ) just to look at the efficacy data-- which costs many millions more (average $50 million per drug) to produce.

All of this is constrained by drug patents which are only 20 years, and 14 by the time the FDA and patent office delays get done with them. The FDA doesn't care about this, because as an institution it is functionally immortal. It doesn't get cancer. It doesn't age. It feels no pain. The nearest human emotions it has are greed and a sense of political embarrassment when a drug it approves turns out to have some side effect. But note that it doesn't go the other way: the FDA is never embarrassed about a death caused by lack of a drug, because that's not a formal cause of death. No doctor writes: "Sclerosis of the FDA" on a death certificate. Even if one did, the state recorder would reject it.

See my answer to:

Is the FDA an example of Big Bad Government?

My answer was:

The FDA has certainly grown as a result of drug company shortcuts, from elixer of sulfonilamide in 1937, to thalidomide in 1960. Alas, the FDA had no role in protecting the US from thalidomide other than a bureaucratic holdup while it showed side effects in Europe. The FDA didn't require testing for teratogenic effects in 1960.

The fact that some FDA-like thing is needed, does NOT imply that today's FDA does a good job. They don't. They are 13,000 underpaid people with a total budget of less than $5 billion, trying to police a US drug industry with revenues of $400 billion or so-- 80 times more than FDA. And that employs roughly 270,000 people, 20 times more than the FDA. Just lobbying by pharma to congress is about 10% as much as the whole FDA budget. That's a lot of lobbying (more than nearly all other industries).

Worse still, pharma pays the FDA "user fees" (PDUFAs) of $500 million a year, which is also about 10% of the FDA budget. It costs a drug company $900,000 to apply for a drug that requires no clinical trials, and twice that much for one that does. This fee is non-refundable, and both sides know it. So guess how much influence it has? In total, the PDUFAs (which go up like the price of postage stamps) is as much money as pharma spends to lobby congress, but it goes into a little regulatory agency with a budget only 10 times larger than the fees, and a discretionary budget far less. Why? Because congress under-funds the FDA. Why? Because they can.

Remember all that pharma lobbying money? Congress does what the pharmaceutical industry wants, and the industry is only too happy to pay for the analysis of their own drugs. Why wouldn't they be? They get it back, and more, in Medicare part D taxpayer dollars that pay for prescription drug benefits for seniors.

The US has the highest drug prices for drugs (the same drugs) of any place in the world. Laws against imports of tablets (but not the powder that is turned into tablets) insures that huge prices for drugs in the US can be sustained for the very same drugs by the very same companies that cost a fraction in other countries. Isn't it crazy to worry about counterfeit pills, but not counterfeit or adulterated drugs and that go into pills? Of course it is. But pharma advertising and lobbying has made sure that counterfeit pills are what people worry about.

I enjoy learning from the Quora questions and answers. It's a community of thinkers, although everyone isn't brilliant or highly conscious, the questions make me think and question, which seems to be part of a drive to evolve my conscious awareness.

I can no longer blindly trust that anyone is looking out for me, and I accept that it's my responsibility.
When I become unable to do that, I will have to reluctantly surrender, and just hope it's over soon. To give up my power to someone with no conscience or compassion would be my worst nightmare.