Free: I’d like to thank you for your concise and unemotional rebuttal to my post, as I very much appreciate it when someone is willing to debate an issue without resorting to personal attacks. I’d also like to clarify two things. First, I don’t have any special interest per se in the FDA, I simply do not care for demagoguery – I’m referring to the article, not you – in any form. It often causes harm to good people either directly or indirectly, and, if one looks closely enough, it almost always serves no purpose other than to forward the demagogue’s personal and/or financial agenda. Second, no, I don’t expect anyone to conduct intensive research to support their views in the forum, but I would prefer – not demand, just prefer – to see more people provide some substantiation in their posts (well, okay, only in training- and medically-related posts, since I could care less about, for example, someone’s religious views). My entire purpose for participating in this forum is to try to help inexperienced trainees avoid the many mistakes I’ve made over the last 15 years. The internet is a wonderful resource for accomplishing this goal, but, as you well know, it can also be the source of a great deal of confusion and misleading information. Although I firmly believe people should be responsible for their own lives, if I can help a single person take their training and supplementation in the right direction – or, I should say, help them informatively decide for themselves what that direction should be as it applies to him or her – then I feel my time has been well spent. In my opinion – and it is, after all, only my opinion – the article you referenced was misleading, thus I challenged it. I admit I occasionally get a bit “wound up” about things, but I really am only trying to save someone, somewhere, the grief I’ve gone through over the years. Peace, bro, and thanks for the conversation.
Bob: No worries; My posts weren’t a personal
attack on you, and I didn’t percieve your
messages as personal attacks on me. I don’t
think the LEF has ever claimed impartiality.
However the FDA is supposed to be impartial.
And there is evidence that they are clearly
not. Demagoguery used for financial gain?
Sure, happens all the time, no doubt. But the
LEF is a non-profit foundation. They donate
all their profit (after operating expenses) to
medical & life extension research. I’ve never
heard of anyone getting rich from LEF - and
I’ve looked through their financial audits.
(Note: I have nothing agaist the profit
motive.). The motives of the LEF are clearly
stated: they want to develop treatments to
extend lifespan and reverse aging, not to
profit from selling supps. That is just one
way they finance research. A means to an ends.
And those happen to be goals I agree with.
Though I don’t agree with everything LEF says
or does. The thing is, the FDA has done a lot
of abusive things to a lot of different and
unrelated people and organizations. There is
an outcry for FDA reform among a lot of
different people and orgs. I don’t think that
would be happening if there wasn’t a problem.
Anyway, I’ll drop this topic for now. Glad to
see there’s no hard feelings.
I really don’t think it’s pharmaceutical lobbyists behind the FDA. I think the problem we face is that we’re in the minority out here. We care about our health, or we at least care about how we look. The vast majority of the United States does not. Furthermore, those people who end up becoming ill would rather go to a doctor to get a scrip than exercise, eat right, or use effective supplementation. It’s not that the FDA wants us fat and weak, it’s that the American people don’t care that they’re fat and weak. Also, to be honest with you, I don’t care if they continue to stay fat and weak. If everybody trained, ate right, and lived the way T-men do then we wouldn’t be special anymore. So, I don’t care what the FDA does, they’ll never make me look like one of those ordinary people.
I don’t think there is any conspiracy involved.
Just substitute practically any kind of health professional for “FDA” and you can say the same thing… they don’t believe in our nutritional and exercise ideas either.
I think this is just because most people are always going to believe that what they do – in this case, how they eat and exercise – is right, and anyone else saying one needs to do differently is a wacko.
In addition, there’s the mode of thinking where, “I’ve been doing it this way for 30 years, or have had my patients doing it this way for 30 years, so it must be right!”
So why does the FDA buy into arguments made by pharmaceutical manufacturers, but is reluctant to believe claims made by the nutritional supplement industry?
Again, this doesn’t take a conspiracy. The pharmaceutical manufacturers supply literally truckloads of documentation to support their claims. Nutritional supplement manufacturers, for the most part, offer relatively little reason for their claims to be believed.
Chew on this! Little known fact,the FDA gets more complaints filed on aspertame than anything else since 1986. Nearly 80% of the complaints they receive are about aspertame.
Here is evidence that I am not the only one
who thinks people at the FDA are corrupt.
So does Richard Horton, the editor of the
prestigious UK medical journal The
Lancet. In a current editorial he states:
"This story reveals not only dangerous
failings in a single drug's approval and
review process but also the extent to which
the FDA, its Center for Drug Evaluation and
Research (CDER) in particular, has become a
servant of the [pharmaceutical] industry,"
In the editorial he slammed the FDA for its handling of GlaxoSmithKline Plc's controversial bowel drug Lotronex.
The FDA approved Lotronex in February 2000, but the company voluntarily withdrew it from the market nine months later after the deaths of five patients who had been taking it.
The Lancet said scientists within the FDA who raised concerns about the drug's safety were sidelined and excluded from future discussions. An independent review of research found serious flaws but calls for more studies were ignored.
"The FDA is not only compromised because it receives so much funding from industry, but because it comes under incredible congressional pressure to be favorable to industry. That has led to deaths," he added.
"It is an impossible conflict for safety issues to be overseen by a center that receives funding from industry to review and approve new drugs," Horton added.
For the full story you can go here:
http://www.wired.com/news/medtech/0,1286,43891,00.html
So, do you still think there is no conflict of interest at the FDA? Do you still think the FDA bureaucrats are operating to "protect" you and look out for your interests? (And this is just ONE of MANY examples of this kind of behaviour.)
If people think that the FDA is powered by the pharmacuetical companies, then why doesn’t the nutritional supplement companies put their money together and lobby in their favor?
Jerry Pournelle (science finction writer and computer guru) has a saying which might be applicable: Do not ascribe to malice that which is adequately explained by incompetence
The problem is rooted in the fact that Americans are WILL pay outrageous prices for drugs as a quick fix to problems incurred by poor diet, lack of excercise, and poor lifestyle choices. The pharmaceutical companies are now so rich (BTW, if you have extra cash around pharmaceutics makes a great investment) that their fingers are in everything. The FDA gets bombarded until money makers get passed by shear name recognition (exactly the same reason people keep going to McDonald’s even though the shit they peddle barely passes for food).
Its to the point now that I almost wish the FDA would be disbanded totally. Give everyone access to what ever they want and let those who are too lazy or careless to educate themselves properly get sick or die. More people in this country die now from doctor sanctioned use of prescription drugs than from all the use of illegal drugs combined(at least that’s what Michael Colgan said in one of his books). Its a very sad statistic.
As long as the market continues to support drugs sales like this nothing will change.
I think there is probably plenty of corruption in the FDA but it is not anymore than what you would find in any large organization anywhere. I guess what I’m saying is the FDA is not the problem with drug dynamics, it is merely a symptom.
I really don’t mean to harp on this subject.
But you guys challenged me to provide evidence
of corruption of the FDA. And it bothers me
when I don’t have factual evidence to back up
my points. So here is some more evidence.
There was an article published in the LA Times on March 11, 2001, written by David Willman. His investigative reporting discovered that a drug Rezulin, for Type II diabetes, was approved by the FDA even though both high level FDA bureaucrats and the company developing it knew that it would cause deaths due to liver failure. Lower level bureaucrats at the FDA who opposed approval were removed from the drugs evaluation. The reason the FDA approved the drug is because information on the drugs dangerous side effects was withheld from the approval committee by certain FDA bureaucrats who apparently have too cozy a relationship with the pharmco developing the drug.
You can see a link to the story here:
http://www.latimes.com/cgi-bin/archsearch-cgi?DBQUERY=Rezulin&DATE=Last+6+months&SECT=&TYPE=&SORT=d%3Ah&NITEMS=25&x=50&y=4
The story is item number 6 in the search result list. I can't provide a direct link because the LA Times requires payment for the story. By the way, if you look at item 1 in the search result list, you will see that David Willman won a Pulitzer Prize for his investigation into corruption at the FDA. Not just for this drug, but for investigation into 7 questionable drugs approved by the FDA which have caused thousands of deaths.
Occasional fuckups would more likely be attributable to gross incompetence. Observe a behaviour pattern repeatedly and consistently and it is more likely intentional, not accidental.
Still think that the bureaucrats at the FDA are "protecting" you?
Free: While Willman’s work is indeed interesting, it doesn’t in any way prove the existence of an FDA/pharmaceutical conspiracy. The majority of people – including many of the FDA’s most vocal critics – attribute the FDA’s current sloppiness to political and not industry pressures. For instance, a December 20, 2000 LA Times article states: “In 1992, Kessler issued regulations giving the FDA discretion to ‘accelerate approval of certain new drugs’ for serious or life-threatening conditions. That same year a Democrat-controlled Congress approved and President Bush signed the Prescription Drug User Fee Act. It established goals that call for the FDA to review drugs within six months or a year; the pharmaceutical companies pay a user fee to the FDA, now $309,647, with the filing of each new drug application. The newly elected Clinton administration climbed aboard with its ‘reinventing government’ project. Headed by Vice President Al Gore, the project called for the FDA, by January 2000, to reduce ‘by an average of one year the time required to bring important new drugs to the American public.’ As Clinton put it in a speech on March 16, 1995, the objective was to ‘get rid of yesterday’s government.’” As I indicated much earlier in this thread, I firmly believe that this problem is political in nature and not borne of duplicity.
I don’t know. Maybe you are right, Bob, in
that it is a “political” problem. I don’t
have enough information either way. From your
description, I’m not quite sure what you mean
by a “political problem.” Proving corruption
at the FDA was not my main purpose here. My
main point here is this: the results the
FDA produces are horribly, fundamentally
broken, couterproductive, dangerous and
IMHO, immoral. The specifics of why this
is the case are less important to me. So I
think the FDA should either be replaced, or
better yet eliminated completely. “Free market
regulation” could work wonders.
Free: First off, how the heck do you do the italics? That’s pretty cool… Second, the whole “what to do about the FDA” thing is a tough call. I agree with you that the agency has made some horrifically stupid decisions over the past few years, but I shy away from taking the “let the industry regulate itself” approach. The fact of the matter – and I doubt you’ll disagree here – is that most people are phenomonally ignorant when it comes to drugs and self-treatment. My concern is that the industry couldn’t resist the urge to take advantage of such a situation, and thus the overall result would be worse than it is now. (Oddly enough, I have some direct experience in this matter in another industry related to one of California’s current problems.) Comments?
Bob: You do italics by using the HTML tag
before the text you want in italics, and then
you have to put at the end of the text
you want in italics - to turn off the italics.
Except you use the arrow brackets around the i
instead of the square brackets.
I understand your concern about a purely market driven model. But it depends on what exactly you mean by "let the industry regulate itself". There are a lot of potential options. One thing I want to point out is that the FDA is a political institution, not a scientific one. One option would be to have independent scientists (in other words, independent researchers, who are not part of any organization, drug company, or political body like the FDA) review drug studies for safety and possibly efficacy. Although I would prefer the latter decision to be left up to doctors and individuals. This is sort of like the peer review process in science research papers. A second possibility is to have independent non-profit or for-profit "review companies" similar the the Consumer Reports model. Their reputation for reliability is dependent upon the accurate and unbiased nature of their reviews. If they become biased, they will lose their rep and will lose business or go out of business. A third possibility would be to strip Pharmcos of their corporate limited liability protection and hold executives and shareholders legally liable for the consequences of their actions. Both the corporations and the individuals could have class action lawsuits brought against them when they irresponsibly introduce overly dangerous drugs. (What I mean by that is they could be sued only if the drugs were used properly according to instructions and harm still occurred even though they said it would not. Drug or supplement companies should not be held liable due to improper use/abuse or user stupidity.) I think the fear of this alone would be very effective at keeping overly dangerous drugs off the market. These are just a few possible options out of many. I'm sure I, as well as others, could come up with other possibly good alternatives. There are almost always much better creative solutions to problems that are often framed very narrowly by politicians.