Drug Company Common Sense
Dean
I have been rather stunned lately that people working on drug research for the National Institutes of Health are allowed to take kickbacks, sometimes in the hundreds of thousands from drug companies, and to learn that FDA panel members that approve drugs often receive money from the drug's manufacturer.
You know, every time I mention the FDA and why I think it's broken, someone brings up thalidomide. I find that interesting because that case was over 50 years ago, and in all that time no one seems able to come up with any other examples of the FDA protecting people in any significant way.
I recently was shocked again to learn that the drug companies are allowed to do research on drugs, and then keep the results of that research secret. Which is stunning; what exactly does the FDA do anyway?
Anyhow, the folks at Consumer's Union have a cute cartoon out that you might like, called The Drugs I Need. Click to view it, and then consider signing the petition urging Congress to mandate that drug companies make their studies available to the public.
That's the sort of thing you'd expect the FDA to already does, isn't it? Wow.
You'd also think such actions would lower drug company liability concerns: if research on negative effects is public, it's harder to justify someone suing saying, "I didn't know this had these side effects!"
(Thanks to Kim Bannon for the link.)
"The unexpected finding that as much as 80 percent of the seeming improprieties were actually the result of errors by government investigators has undermined the rationale behind NIH Director Elias A. Zerhouni's recent decision to impose severe restrictions on the personal activities and finances of all of the agency's more than 5,000 employees..."
Read the whole link.
Drug companies can not keep secret any trial using an approved drug. Period. Not legal. However, chemical compounds that are not yet approved as drugs undergo years of testing before approval. Many of those compounds are rejected in human testing for various reasons, whilst back-ups advance. Requiring drug companies to publish these results would violate their confidentiality agreements with the FDA, and would allow other companies to be able to recreate the innovator's basic chemical and biological research because of the information disclosed. Confidentiality is essential to innovation: drug companies already have to disclose much more intellectual property much earlier in the development process than practically any other industry.
Where is there documented evidence of a company legally witholding information on an approved drug? I'd like to see it.
Jay Wood
Sometimes it takes a long time to find out what the side-effects of a drug are going to be! Much longer than the drug companies (or the patients) want to wait. When you say that they should hurry up and approve something, "and just inform the public" you might as well be asking them to see into the future. I seem to recall you've had a problem with certain chemotherapy drugs being rushed through the approval process in the past. No, the panels who make these sorts of decisions shouldn't get kickbacks. Does that mean we need to blame the entire FDA?
Even the drug-approval process aside, do you know all the other things the FDA does?
Just as a first-hand example, in my line of work, I do Validation work. What does that mean? Well, lets say that 'Anonymous process A' requires 'Anonymous product A' to be heated at 400 degrees C for 2 hours. Take a look at your oven. You set it to a temperature, but how do you know what the temperature really is inside? Is it the same on the top rack as on the bottom rack? What about in the corners? Well, maybe it doesn't matter when you're making meatloaf, but it sure as hell matters when you're making 'Product A'. So they've got a fancy scientific oven. Is it calibrated properly? Is the temperature uniform within the chamber? If you can't prove it, the FDA can shut you down.
Thus, Equipment Validation: I write and then perform tests to demonstrate that the equipment is meeting all process requirements. I document the results in a report that is signed by multiple departments. When the FDA comes to audit the company, they have to be able to demand that report for any and every piece of equipment in the plant, and they can and have shut plants down for not having them.
Then there's process validation and quality control: How do you know what temperature 'Product A' has to be heated at? How do you know for how long? If it's supposed to be heated for 1 hour, is 65 minutes okay? What about 55 minutes? Process Validation and Quality Control determine these parameters and then document that the defined process produces the desired product repeatably and consistently.
Then there's cleaning validation: Say 'Company A' has a big 'ol 3,000 Liter tank that they use to make 'Product A'. Well, one day, they want to use it to make 'Product B'. Only thing is, if any traces of 'A' wind up in 'B', it could result in dead customers. How do they prove that it's clean?
The FDA cares about all this stuff, and they DO CHECK! I know this from first-hand experience. On top of that, there is a lot more stuff that they do that I don't have first-hand experience with, but know about through other sources, but I think I've made my point on that score.
Without the FDA, we're back to the days of Snake Oil Salesmen and miracle tonics. There is no question that the organization has problems. I'll agree fully with you there. But you need to frame your arguments in that context, and not imply that the FDA is somehow bogus or unnecessary. When you say you can't find examples of the FDA protecting the public, you are just demonstrating your ignorance of all that the FDA does.
I'm sorry if any of this sounded hostile. That was not my intention but my job exists pretty much to help pharmaceutical companies comply with FDA regulations, so don't tell me the FDA doesn't do anything.
I thought the cartoon was funny, and I would agree that we should have eliminate kickbacks and make the approval panels as independent as possible. So we're in agreement on that at least. Just try to keep your eye on the prize here and not start curing the disease by killing the patient.
I can think of several reasons why fundamentally overhauling it from top to bottom would improve things for everyone. I think too often they drag their feet on releasing drugs that should be released sooner, and now we see they frequently release drugs that shouldn't. Their way of doing business is outmoded and filled with problems. The agency needs to rethink its mission and its methods from the ground up.
And frankly, don't even get me started on Vioxx. Of course more osteoarthritis patients have heart attack and stroke. They're old, people. That's what happens when you get old: arthritis and CV disease. Also, there's a good reason that vioxx takers have more cardiovascular disease than non-takers: arthritis inflammation affects CV health as well. I haven't yet seen any good evidence that it is the drug specifically causing the heart attack/stroke risk. Which was also MONUMENTALLY small compared to the general risk faced by that population without adding the effects of the drug.....
Sure the FDA has some bad business practices, and some schmucks work there, but it's not ALL their fault. They do a pretty good job. I mean, they pretty much set the standards for the rest of the world. Would you rather take drugs from the US or Mexico?
Food Poisoning Kills 29 Children in Philippenes
Once again, I'll agree that they have problems, but suggesting that the whole organization is fundamentally flawed is too extreme.
This is the unverified part, so if I'm wrong, forgive me. The researcher determined that the birth defects were caused by the drug suppressing the transmission of Vitamin A, I believe it was— and this could be counteracted by the addition of a supplement to the drug. Of course, nobody believed that thalidomide could be made safe, and so it was abandoned entirely...
Neither of these questions is usually answerable "Yes" or "No" without a pile of qualifications.
The FDA, rather than simplifying things to the point that good drugs don't get used, should concentrate on determining whether drug x is safe at dosage y for (young, old, males, females, pregnant females, ... there's a long list) and then publishing that data.
And publishing, as well, a list of dosages and conditions for which drug x is known to be effective, and known to be ineffective. And if there are contradictory data, publish that as well.
While not disagreeing with your point in principle, let me suggest that the reason those questions are hard to answer lies not with the FDA, but within the questions themselves.
How safe is safe? How effective is effective?
Drug: Foo
Harmful to those ...
Harmful to those of any age who ...
Known side effects include ...
Interacts with (list) of drugs.
Shown effective in treating ...
Shown ineffective in treating ...
Some of this is already on the info sheet that's supposed to come with it.
If someone wants to peddle salt tablets as a cure for cancer, and there's no data on the sheet to indicate that they're effective for that, or that it's been shown to be ineffective, to a certain extent we need "buyer beware".