Envisaging a World Without the FDA
Permalink | View Comments (19) | Post Comment | | Posted by Reason

Incentives matter in all areas of human endeavor. When people gather to develop and deploy new medicines, for example, they are more incentized by the prospect of personal gains - reputation, profit, feeling good by doing good, and so forth - than by the benefits brought to people they have never met. This is simple, hardwired human behavior. Exceptions are few and far between.

That we instinctively work to improve our own lot first is why progress for all happens so much faster in free, open marketplaces under the rule of law. There, everyone can trade to make themselves better off: specialization and comparative advantage means that trade benefits both sides. Trade is not zero-sum; we grow the whole pie by specializing and trading the results of our work. You go off and work to make the medicine I want, and many people like myself give some our our resources to purchase the end result. Both sides benefit, exchanging - what is for them - lesser value to receive greater value.

There is no open marketplace for medical technology in the developed world, however. Instead, we see a very different set of incentives dominating the state of research and development. Regulatory bodies like the FDA have every incentive to stop the release of new medicine: the government employees involved suffer far more from bad press for an approved medical technology than they do from the largely unexamined consequences of heavy regulation. These consequences go far beyond the obvious and announced disapproval of specific medical technologies: the far greater cost lies in all the research, innovation and development that was never undertaken because regulatory burdens ensure there would be no profit for the developer. Personal gain for the regulator is thus to destroy the gains of people they will never meet, the exact opposite of what occurs in an open marketplace.

An article that looks at one small part of the destruction caused by the FDA caught my attention, and particularly these snippets:

Since 2005 the FDA has approved 18 new cancer drugs, many of them breakthrough products. But the pipeline contains hundreds more that will never get to market because corporate developers aren't able, or willing, to come up with the money, time, and patients necessary to establish acceptable data.

...

The clinical trial process now is a three-part, years-long effort that effectively kills off all but a handful of once-promising drugs.

...

It would have been the first new drug for prostate cancer in 20 years

Twenty years! Just stop a moment and think about how far and fast biotechnology and medical science has moved in the past twenty years. Think about what the far less regulated computing industry has achieved in the same timeframe. We live in the early years of the biotechnology revolution, with something amazing and new demonstrated in laboratories every week. Yet the dominant regulatory body for one of the most advanced regions of the world has managed to stop the clock at 1988 for a major disease, the subject of research in a hundred laboratories worldwide.

This sitation exists in every field of medicine, and all participants labor under the crushing burdens imposed by regulators incentivized to stop progress from happening. The same will be true of the future of longevity medicine, unless we do something about it.

The insanity of this all is quite staggering - that people largely accept and defend the need for regulation that achieves this sort of result, that is. I have heard it said that the failure of libertarianism, of the urge to freedom and personal responsibility, is a failure of imagination on the part of those who have been brought up knowing nothing other than government and regulation on a massive scale. The majority cannot make the leap to see an unregulated marketplace for medical development that works in the same way as the unregulated marketplace for computers - enormous choice, low barriers to innovation, efficiency and low cost, competing review organizations, accountable sellers, rapid progress and responsiveness to customers driven by fierce competition, and so forth.

What is, is, and to propose another way is already an uphill battle regardless of merits. That is also hardwired into the human condition. But the present dismal state of affairs must be changed if we are to see the defeat of degenerative aging in our lifetime - nothing short of a revolution is called for, given just how far in the hole we find ourselves. The technologies needed to repair aging will take only a few decades to develop, and indeed some already exist in prototype, but the present regulatory burden placed upon medical technology will ensure we are all dead and buried, that wondrous potential squandered.

Comments

Nice summary of the paralysing effects of over-regulation. You point out the huge problem of younger generations thinking that government has always been this huge and all-encompassing. What to do about it?

The bureaucracies of governments and inter-governments (UN, EU, etc) which administer these debilitating regulations are growth industries. They employ millions, and are powerful political voting blocks, along with their families and associated groups. There is no means of "talking them away", given their economic, political, and regulatory power. Most voters cannot imagine any other system than stifling bureaucracy.

What does that leave? Action outside of the normal political process. Being willing to get down to basics. Supplying for oneself what government claims to provide. A parallel society.

Posted by: Al Fin at May 27, 2008 1:20 PM

Time to put a down payment on a seastead, I guess :)

http://seasteading.org/

Posted by: Michael G.R. at May 28, 2008 4:31 PM

Won't other countries like China or Japan merely bypass these regulations, and move drugs to the marketplace faster? Can't Americans, then, just order them online or through some other means (or, if you are dying of cancer and desperate, simply relocate to a treatment center in China)?

The FDA can stifle the free market in America, but not outside.

Posted by: GK at May 29, 2008 1:42 PM

I once interviewed as an analog electronics engineer at a major cardiac device manufacturer. It was interesting niche work up until I found out that anything I did effectively wouldn't be used for at least 7 years, and more likely 10 or more. Anything I designed would have to go through the FDA and given the requirements and expense it slowed down the development process incredibly, reduced risk taking to an absolute minimum, and slowed down the pace of innovation. It was very discouraging; I chose a different industry and employer where the pace of innovation was a bit faster.

My buddy who took the job there tells me that it's even worse now since there are concerns about "playing doctor" that make it just about impossible to implement even rudimentary changes towards more "intelligent" devices that would improve the life of patients. As such, they haven't changed a thing in the architecture of their devices in over 10 years now. How many fields of electronics have that kind of concern?

Posted by: OldAnalogGeek at May 29, 2008 1:46 PM

The world without an FDA would only last as long as it took one of the new fast-tracked drugs to cause enough adverse events to develop outrage in the population (or the press). You could have a world without an FDA but something would replace it, just like our current world without an INS.

Posted by: HalS at May 29, 2008 1:55 PM

What felt strange about this article is how it assumes that the FDA is stopping every other country in the world from making drugs. Where are the European or Asian drugs? (Forget the Middle Eastern Arabs, the trillions in oil dollars doesn't produce any intelligence) Why doesn't any other country come up with all these amazing drugs the FDA is suppressing?

Posted by: peter at May 29, 2008 2:02 PM

You write: "Regulatory bodies like the FDA have every incentive to stop the release of new medicine: the government employees involved suffer far more from bad press for an approved medical technology than they do from the largely unexamined consequences of heavy regulation."

If there is potential to "suffer" either way -- in one case "more", supposedly "far more" -- than there exists incentive for both cases. Hardly "every incentive," as you suggest.

Nor does the story related by BW effectively call the need for regulation in question. The Oncophage case turns on the reliable interpretation of data produced by a clinical study. The story does suggest a strong case may exist for more flexible interpretation of the data using subset analysis, but as the story itself observes, the scientific community is only "beginning to warm" to the use of subset analysis. Apparently it's not as obviously appropriate as it might seem to you or me.

The author writes, "Some economists worry the health-care system could go bankrupt if subset analysis released a flood of expensive medicines, each tailored to just a few patients. Drugmakers counter that only those patients most likely to respond would be treated, and ideally the medicines would allow them to live long and productive lives." I believe that the qualifier "ideally" is seriously misplaced here, and drugmakers know it. Personalized medicine is the future, but not until diagnostics exist that can match patients with the drugs that will work for them.

Meanwhile, wouldn't it be just as useful for the people with the greatest stake in approval, the companies developing these drugs, to design better clinical trials? The BW piece points to Astra Zeneca as one company taking that approach.

People who are gravely ill are desperate for a solution. They will try anything. It's not like buying a car, where the worst that happens is you're saddled with a lemon; meanwhile the word gets out and other consumers buy something else. No, if something doesn't work, you die, but no one knows why, because you weren't part of a controlled experiment. Someone has to ensure scientific rigor behind the claims drugs make.

Posted by: clazy at May 29, 2008 4:07 PM

You sir, are a lying dick.
http://www.accessdata.fda.gov/scripts/cder/onctools/statistics.cfm

11+28+10, not counting what FDA CBER regulates.

Posted by: dustydog at May 29, 2008 5:31 PM

This article was obviously written with little understanding of the nuts and bolts of how a drug comes to market, and what the FDA can and can't do.

First, the FDA did not invent itself; it came into existence in reaction to problems with contaminated, dangerous, or ineffective drugs or biologicals. Every time there is a disaster involving a drug, device, biologic, etc., the American public asks the FDA to do more to prevent this from happening, via regulation, inspection, higher standards for approval, etc.

Although the author is correct that the hidden costs of regulation remain out of sight to most people, the drug companies are pretty good at making a very effective fuss when one of their products seems to be getting short shrift at the FDA (or any other regulatory agency). You do not want to be the FDA regulator called by the ombudsman to explain to Congressman X's staffer why the drug made by company Y in Congressman X's district is not being approved.

Most potential drugs frankly don't work, and of those that do work, the effects are actually small increments of improvement over the current standard of care. The few drugs that actually bring about cures or remissions DO get to market through expedited approval mechanisms. Cases in point: tyrosine kinase inhibitors like Gleevec, or various AIDS drugs or drug combinations that put HIV into prolonged remission make it through the regulatory hurdles in a matter of weeks/months, literally.

As a matter of routine practice (and current law), the FDA gets 30 days to make an exhaustive evaluation of whether a proposed new drug can be studied in humans. That means that a company can hand the FDA a two foot high stack of data on biochemical and physical properities of the drug, pharmacology, animal testing, purity, sterilization procedures, manufacturing process, a complex statistical plan to evaluate the drug, and a team of 5-6 reviewers will have about three weeks to make a determination as to whether the trial can proceed. The only reasons the FDA can say no to an IND is that there is not enough data to satisfy safety concerns, the information presented to the clinical investigators is incorrect/misleading/fraudulent, etc, or that the proposed trial design can't prove that the drug is or isn't safe (for phase I) or effective (for phase II).

The real drug pipeline delays come in getting sufficient data to present ot the FDA that drug X is reasonable to study in humans, and then the actual recruiting of patients into a trial that is designed to prove whether a drug works or not.

Once the data set has been accumulated, at tremendous expense to a (typically large) company, the FDA has to provide timely comments and feedback on the results of the original studies in humans. A LOT of drugs wash out in phase I (safety) or phase II (efficacy) trials. It is a HUGE thing for a drug to make it to phase III (equivalence or superiority to existing treatment), which is why people keep looking for insider knowledge of how a phase III trial is going (remember Martha Stewart and Imclone?).

It is not unusual for the FDA to ask a company to confirm that the apparent benefits in a first phase III trial be confirmed in a second trial. And guess what? More drugs wash out when the confirmatory trial fails to confirm! This week's New England Journal of Medicine has just such a story; you can go look for it.

So, getting a truly beneficial drug into the market is quite rare not because the FDA is arbitrarily throwing spanners in the works, but mainly because the low-hanging fruit has already been harvested. The golden age of antibiotic discovery of truly new and different categories of antibiotics with great new activity against new pathogens has pretty much gone by the wayside as of 30 years ago. Now, we are making little tweaks on the side chain to give it a longer half-life, better tissue penetration, better absorption, less stomach irritation, etc.

It is also the fact that 30-40 years ago, Americans were quite willing to put up with much more risk in their drugs. When there are scourges like polio that paralyze hundreds of thousands of kids, the fact that a new polio vaccine paralyzed hundreds was accepted as the grim cost of eradicating that disease. Now that paralytic polio is something we just don't see anymore, ANY side effects from a vaccine are not accepted. We no longer give the more effective polio vaccines routinely because there are some who will have unacceptable side effect from that vaccine. So, we put up with less effective immunity to polio to protect the handful of people who get the side effects from the vaccine.

Cancer drugs have at least the grim practical advantage that the patients are typically sufficiently desperate that they will take great risks to achieve great benefits. So the FDA allows more risk for a clinical trial of a cancer drug than for, say, a new pill for blood pressure. If you have a chronic condition that won't kill you for 20 years, and there are 25 different meds you can currently take to treat the condition with low risks, then the FDA is not going to be eager to approve a me-too variant of an existing drug if the risk is not low.

As the number of drugs for a particular disease increases, the bar is raised by the fact that the FDA has little incentive to approve something that is inferior to what is already available. The fact that a company wants to be able to make money from a market that they think is lucrative is of no interest to the FDA. The FDA is not permitted to factor cost into any of its decision making. It doees not matter that a new drug is expensive to the bureaucrat that approves or does not approve it. There is no official policy on that, and the FDA does not set prices. You wouldn't want the FDA to care about the profit or failure of the company, and you have elected representives who have legislated to that effect.

It is also amusing to see people complain about the FDA being obstructionist, when drugs like Vioxx are taken off the market by the legal department of the manufacturer when they saw the adverse events mounting up. Then, everyone says "why did the FDA ever let this get approved?!". And of course, as is always the case, there is a dissenter within the FDA for just about every approval, so when things go wrong after an approval, he/she is cited as the wise sage who was ignored to the detriment of the consumer.

The one not-so-obvious fact is that most drugs that are approved have only a slight benefit over the drugs already out there. So, manufacturers spend a lot of time and effort and money to make sure that they make back their substantial investment by convincing as many people to take the drug as possible, whether it is a wise thing or not. So, when a trial of a drug looks good with 4000 study subjects, and the ad team convinces 4,000,000 people to take the little blue pill, the inevitable side effects and problems mount up to the point that someone in Legal says, pull the drug, the profits are going to be taken away by the civil lawsuits. Think diet drugs (Phen-fen), Vioxx, vaccines, whatever.

So, get rid of the FDA and go back to the good old days when you could do what you want. Then, when it goes wrong, you will re-invent the FDA and call it something else, but it will be the FDA.

By the way, it is telling that there is no real drug development of significance outside the US/EU regulated markets, unless you think laetrile equivalents or coffee enemas are the next big thing. If it were a matter of getting rid of regulations would bring breakthroughs, then we would really have a lot of novel, effective drugs from China, India, Brazil, or maybe Mexico. However, what you see from these countries are knock-off derivative drugs that can be made cheaply because all the true R&D has been done in the US or EU, or maybe Japan at a high price. Or you see the production of raw materials for drugs like heparin moved to China, with little regulation and then shock to find out that they just might put dangerous crap in the product to fool the US company into paying them money for garbage. Same for pet food.

The fact of the matter is that the deveolped countries pay the price of drug development for the world, both in public funding of basic research, and the cost/burden of costly ethical trials that have to satisfy our innate need to feel that drugs are as "safe" as they can be, based on the circumstance.

We also set the tone for the amount of risk that can be taken in drug development, which is not unlike any other aspect of our lives. As we become richer, healthier, and think ourselves to be "safer", we demand more safety in every aspect of our lives. How many of you put your kids in car seats and make them wear helmets when they ride their bikes? What about when you were a kid? Didn't you roam the back seat of the family car, sit in the front, ride your bike without a helmet on a daily basis? How many of you would let your kids siphon gas out of a gas can as some of us did routinely to get gas for the lawn mower each week? I did, but would never let my kids do that. Likewise fire works, making gunpowder, etc. As a civilization we set the bar higher and higher in every aspect of life. It may be too much, but it is in the nature of social evolution.

Posted by: jnl at May 29, 2008 8:45 PM

I'm hard pressed to understand why "equivalence or superiority" to existing treatment should matter, or why the FDA's regulation of drugs should also extend to biomedical devices or various treatments which should not be its purview.

I get the importance of a drug or food additive passing safety tests. I also believe efficacy tests are mostly a good thing. But explain to me why a new drug has to be an improvement on most or all existing choices to work. If a drug is found to be not quite as helpful for a lot of the people in the study, but a precious few find even more benefit from it than other medicines, then what's to stop the drug from going to market? Antihistamines are known to work well for some people and not for others, and it's different for each one--how many promising antihistamines have died in Phase III?

But while I understand the FDA getting finicky about drug development, I don't see why it should have authority over non-drug medical treatment. Shouldn't the AMA and similar groups handle for themselves what they think are reasonable procedures and risks? There is precious little reason for regulators to have exerted any control in this area, to no apparent benefit and much known harm.

I'm no booster for alternative medicine but if the FDA is really concerned about the level of quackery out there, they should loosen or cut a lot of their strings so the market can move forward quicker with things that work. Quackery thrives because of the public perception that there are miracle treatments tied up in regulatory hell or even abandoned entirely due to profit/loss calculations. That perception is somewhat accurate; the solution to their particular problem may not be out there but the solutions to others surely are.

Finally I leave you with one recent example of the FDA creating too high a barrier: Dichloroacetate. It surfaced as a promising cancer treatment that no drug company would touch because they couldn't make money on it (it's not under patent) and finding out if it's effective against cancer would involve costly FDA trials (in this case, at least a Phase II for efficacy, since it's already considered safe). No company would run such a study for a drug they could never make money on. But some desperate people started making it, taking it, and analyzing their results, until the FDA shut down the central website that organized them. The people who took the drug discovered that in some cases it did nothing, and in others it helped; but the lack of research up to that point would have kept even that much knowledge from getting out. I'm not a fan of self-medicating, but if I had an untreatable or difficult-to-treat cancer, I'd be on board. Drugs like this shouldn't fall through the cracks.

Posted by: Lummox JR at May 30, 2008 7:29 AM

Comparing medical research under the FDA with the computer industry isn't quite fair: If your new PC crashes you can reboot, if your new gout drug instead kills people you can't. In 1905 the FDA determined to drive the hucksterism out of medicine and I don't think we've really suffered as a result.

On the flip side there are certainly bureaucratic hangups which the FDA could do more to resolve. Reviews of trials could move faster and unnecessary hoops be removed from the arena. Better computer simulation and modeling of the effects of new medicines and technologies on the human body would help. With human life, though, you really do need to take care and go slow.

Posted by: Orion at May 30, 2008 2:12 PM

The reason that the FDA has any authority over anything at all is that the Congress gave it that authority by statute, and delegated to it the power to enact regulations that help it enforce the law.

There is an act of Congress that gave the FDA authority over medical devices. I can't cite the statute, but it is there.

On the other hand, Congress very specifically has forbidden the FDA from regulating "nutritional supplements" because it was/is a grey area with powerful Congressional patrons (Harkin and Hatch) who didn't want the FDA mucking up constituents businesses with requirements that they be shown to work or regulations on how they are made, etc.

So far, this has worked ok. There is a lot of hucksterism in this area ("Is there anything vitamins/supplements/health foods can't cure?") but it is merely harmless or a waste of some people's money, for the most part.

Food is treated differently than medicines from the FDA perspective. Anyone can make/sell/distribute food, and the presumption is that it need not prove that it is good, unless there is a problem. Meds/devices have to prove that they do some good and are "safe" (whatever that means) before being entered into interstate commerce.

As for the AMA regulating anything, that would be a laugh. The AMA is a special interest group that represents the interests of doctors. The technical expertise is possiby there in some areas, and possibly not there in other areas. No doubt there is going to be a lot of conflict of interest for a lot of devices that are invented by doctors. One salutary thing about the FDA is that there is every effort to eliminate conflicts of interest. You could even say that the quest to eliminate conflict of interest keeps some talented people out of the decision making process, but that is a different argument.

Devices, by the way, are stratified into classes based on their potential for harm, and the devices that have minimal potential for causing damage to patients do not get the same level of scrutiny as complicated devices that are potentially dangerous. Crutch versus lasik machine, different burdens of proof.

Finally, I may have misled you to think that new drugs have to be "better" than what is out there. They can be simply better than placebo, and this works fine if there is no good treatement for a problem. It is usually considered to be unethical to test a new drug against placebo for a significant medical condition if there is something that is considered to be safe and effective that is already available. Think Tuskegee study, which became unethical once penicillin was shown to cure syphyllis. So, if there is a disease for which there is no treatment, a placebo-controlled trial is fine, and an increment of benefit over placebo will be enought for approval. At this time in medical history, most medical conditions have some accepted treatment or intervention, so that is rare. If the condition is not very serious, and a placebo-controlled trial is considered to be ethical, then such a trial can be done.

However, most companies want to be able to say "our drug is better than any other drug for this condition" or they really won't be able to convince people to take it (and therefore won't make money). Market forces and the ethical considerations for clinical trials that have evolved over that last 30-40 years have as much veto or influence over what gets developed as the regulatory authority of the FDA.

The point about dichloroacetate more or less makes the point. No company wants to spend time and effort to do the required clinical trials to prove that it works, if they can't make a buck at the end of the process (if it works). You could go out and buy it and take it on your own, if you had cancer, but wouldn't you want to know that it had actually been systematically studied in cancer patients before taking it yourself? Or wouldn't you want to know that your use of it would be studied carefully to help figure that out? That is the way that new drugs are developed.

Posted by: jnl at May 31, 2008 10:30 PM

Very interesting real JNL. It made me rethink the FDA a bit since I was sort of going along with what the article was presenting. I tend to do that with stuff I've little experience with.

Posted by: Tyciol at June 15, 2008 4:21 PM

There's no need to "envisage a world without the FDA" you simply need to look around 100 years ago, when people sold tapeworms as diet pills, breakthrough medicines at jacked up prices were snake oil, no tamper-evident packaging (see Tylenol killings in the 70's), and drugs were of unknown purity strength and efficacy.

The free market makes a good servant, but a worse master and a terrible religion.

Posted by: Pibbly at July 14, 2010 12:58 PM

Bravo, JNL!

American politics at the moment is being poisoned by the whining, puking and mewling of a bunch of very well financed ignoramuses bitching that government -- that's all of us doing our best to create a civilization -- is The Problem.

The mean little facts are that even the most honest researchers are prone to enthusiasms, while corporate marketers have not a shred of conscience if left to their own devices. In medicine of the past the only thing wrong with the term "snake oil salesman" is that it was unfair to snakes.

You need the FDA -- and the Pure Food and Drug laws in general, because marketers left alone are liars. In unregulated markets the dominant wisdom is that the cure for AIDS is to sleep with a virgin, and I just happen to have one handy for a certain fee.

Americans live as long as they do in large part because of government funded research -- though government funded sewage and garbage removal are probably just as responsible.

Americans don't live as long as Canadians, Australians, or the people in maybe a dozen other advanced countries, because only in America do you let private investors run your health care system.

If you are to live long and prosper, it's time to stop the whining and pay attention to what serious policy thought and debate look like. Any place in the English-speaking, or European, world -- except whiney Washington, would be a good place to look.

-dlj.

Posted by: David Lloyd-Jones at July 18, 2011 9:53 AM

I believe Elon Musk is entertaining the idea of an off-shore project to create a truly free society. Lets wish him success and if possible contribute to it.

Posted by: jerry t. searcy at September 19, 2011 12:01 PM

Dlj/jnl I believe your opinions are well placed but your wisdom is a bit outdated. The FDA has and is actively suppressing drugs, devices, substances and technology that can and do improve and save lives. Period.

Although there is a need for a regulating agency to keep food and drugs as safe as is possible and the original idea behind the creation of the FDA is sound, the FDA that exists today has become an oversized government agency that is driven to perpetual expansion far beyond the boundries originally set by congress. The reason behind this is exactly what is stated in the original article here - human instinct. The FDA is so inextricably intertwined with government legislative bodies and large pharmaceutical corporations that it is these forces that pick, choose and drive FDA policy and expand its power. The FDA has really become a government/corporate front that is used as a tool to obtain the desired results of the powers behind the FDA that drive it's policies.
Anyone, who undertakes serious research of the FDA history of legal actions will quickly find that the FDA is best at looking out for its own vested interests. Those interests have become more aligned with keeping the current US and world healthcare pipeline status quo operating at peak efficiency. What that boils down to is special interest groups such as Pfizer and the rest of the pharmaceutical industry have their operation and thereby their profits protected by the FDA due to the disproportionate level of infuence upon the FDA - Read, lot's of money and lot's of power are very condusive to helping biasing desired outcomes in your favor. And what that means to a small research lab or company that may come up with a revolutionary product or treatment is it has no chance whatsoever against huge billion dollar companies.

I first became personally aware of the FDA insanity and the tactics they will use and the way that they 'play to win' when I quit smoking cigarettes using electronic cigarettes. I smoked 37 years and could not quit until switching over to the electronic cigarettes that make a vapor instead of smoke, which makes ecigarettes at least an order of magnitude less harmfull than smoking burning tobacco. There are no carcinagens in any harmful amount present in ecigarettes because most of those compounds are only created when tobacco (or many other materials) is combusted (burned). So, I think these ecigs are the best thing since sliced bread and I start learning more about them and then find out that...the FDA is vigoroulsy attempting to ban them and classify them as a drug which for all intents and purposes remove my and any citizens access to this product - which is not illegal under any existing law. The entire point of electronic cigarettes, which is backed by some large professional medical organizations such as the AAPHP is that electronic cigarettes can (and will) save literally 10's of millions of lives if allowed to be used freely by those over 18 years of age. That...is none other than a huge, revolutionary health benefit from a very simple technology introduction. Kind of like the laptop versus the mainframe although I agree that does not translate as a perfect analogy. Well, the FDA did not aggree and claimed that they had the authority to regulate (and remove) ecigarettes from the market. The FDA in fact, began seizing millions upon millions of dollars of product inventory such as batteries at point of entry to US and not returning or compensating those businesses loss in any way whatsoever. One company courageously filed suit against the FDA and The FDA lost in court 3 seperate times before giving up and saying they would regulate ecigarettes as a tobacco product - an authority they possesed from the very begining but that did not give FDA the level of control over this product that it desired. A link to that years long court battle fought and funded entirely at US tax payer expense is here:

http://www.bizmology.com/2011/05/10/e-cigarette-legal-battle-comes-to-close/

Now, please this is by no means marketing as I see the FDA is using the same exact methods to gain control of regulation over supplements. So whoever was saying the FDA cant regulate supplements must not be aware of the bill in legaslature right now that if passed, will give the FDA much greater power to regulate supplements - even though the fact is the FDA already has all the legal authority it will ever need to deal with removing potentially unsafe substances from the market. I draw your attention to proposed legaslation S.1310 Dietary Supplement Labeling Act of 2011. Here is a small quote from the bill S.1310 "A bill to improve the safety of dietary supplements by amending the Federal Food, Drug, and Cosmetic Act to require manufacturers of dietary supplements to register dietary supplement products with the Food and Drug Administration and to amend labeling requirements with respect to dietary supplements."

Sounds sensible enough right? wrong! What is happening here is pharma companies are coming out with actual 'drugs' that are based on 'supplements'. Just a few of these are rozerem, which is melatonin, lovasa which is fish oil, niaspan which is merely Niacin, also known as vitamin B3. Being that the drugs will cost at least 10 times what the supplements do, it behoves the companies selling the drugs IE Pfizer, Norvartis, Johnson and Johnson, Roche, Glaxo-Smithkline, Astrazeneca, Abbot, Bayer...the list goes on... to remove the lower priced supplements from the market. And please make no mistake, this bill is a crucial part of pharmaceutical companies acheiving that end, and continuing to reap massive profits. What the FDA will do, when they have the 'legal authority' in place is demand very high cost review and studies to be provided at the supplement companies expense. If the company does not then comply with the FDA, then that company will be informed to cease and desist all manufacture, import, distribution and sale of it's products. If the supplement company then ignores that, the owners will have any company facilities forcibly shut down by armed government employees and or law enforcement special agencies contracted to do that. The owners will likely then face the threat or actual incarceration, substantial fines and huge legal costs. This has already happened mutiple times to supplement suppliers already and will only give the FDA more power to conduct business in this fashion in the future.

A good example of this is the actual case of the Life Extention Foundation in which the owners were being faced with life in prison for vitamins that the FDA thought should not be imported and used in the USA. These guys now run one of the most successfull vitamin and supplemment companies in the US but there story is one of harrowing drama at the hands of the FDA. Here is a link for further reading.

http://articles.sun-sentinel.com/1992-12-06/features/9203040859_1_pharmaceutical-drugs-counts-saul-kent

There are hundreds of instances of the FDA raiding, seizing, closing down and otherwise obliterating any new invention that FDA does not want to approve or interefering with the 'main' customers of the FDA - the huge medical companies. By admission in it's own press releases and recent government legislation signed by a US president fond of granting regulatory powers, the FDA makes no secret of it's desire to expand it's reach and scope until has has some kind of control over every aspect of any product a US citizen may purchase and even more control over every aspect of any company manufacturing those products. A final link with the very bold 'expansionist' wording is on the ammended FDA regulatory power over grocery markets:

http://www.fdalawblog.com/2011/01/articles/legislation/president-obama-signs-new-expansive-food-safety-law/

With some research of FDA history one will findn an organization created by good intentions that is expanding unchecked. The US does need safety but above all the US need Freedom. The current FDA seems to disregard that all impotant distinction.

The FDA will hold back medical progress for the sake of safety to a slow, evolutionary crawl. Less regulation and smarter focus on potentially beneficial research and developement is the only way to allow for the revolutionary advances to be made and then be made available to the people that make up our society.

Posted by: Ralph Woodin at October 18, 2011 2:03 AM

I agree with Mr. Woods comments 110%

FDA regulations are stifling medical breakthroughs from reaching the people who really who need it. Not only does it take millions of dollars to get anything through the FDA drug approval process, it takes a decade or more to run all the trials. There are many promising nutriceuticals which can help people with severe medical conditions; bowever, the companies who make them can't say anything about what they can do even though they may have data to back up claims. Supplements, even if safely used for decades or 100s of years can't run clinical trials or publish such data, merely because supplements cannot make medical claims under the current FDA guidelines. Any hint or implication that a supplement can cure or treat a medical condition, will get your business immediately shut down with armed FDA agents pilfering and taking away all your files and equipment. They don't even have to warn you upfront. It's frustrating as hell for these small companies, but what can they do. They don't have the money or time to go through the laborious FDA drug process. Only Big Pharma can. Ultimately, in the end, it's the consumer who pays, with higher drug prices, and even then they are not guaranteed safe (Vioxx, Fen-Phen). I believe Big Pharma lobbyists are behind this movement to regulate supplements even more. In the past, nutriceuticals could run clinical trials for medicinal benefits, but now even that is prohibited. Basically, if you market your substance as a nutriceutical, you can't say anything more than it's good stuff, trust us, it works. Can't say what it works on. Can't provide any data (even though it exists), you just gotta trust us, it's good for you. Who is going to buy any nutriceutical for medicinal purposes without some kind of data? Nobody. So the only thing not banned yet is public opinion. If you give a testimonial about a supplement that miraculously cures your cancer, you can say that because you are not selling it. But the company can't publish your testimonial on their website. It's ridiculous. Big Pharma has nothing innovative in the pipeline, so they have an incentive to shut down all the little biotech companies that come up the newest and safest therapies or buy them out. It all comes down to profit. It comes under the guise of protecting the public, but the FDA is actually preventing people from getting info about the most promising and safest treatments.

Posted by: NGP at May 29, 2012 12:31 PM

Pibbley,

You are incredibly naive! Are you not aware that those that run the FDA are former executives and chairmen of the pharma companies? The FDA is in bed with big pharma and FDA people get cushy positions in big pharma and vice versa. Have you not seen the quote by the former FDA commissioner where he says that people are deceived if they think the FDA is to protect the public because its real purpose is to serve the interests of pharma companies? I don't remember his name but you shouldn't have trouble finding it if you google FDA commissioner exposes FDA or something like that. You seem to have the naive idea that government is beyond corruption and can be trusted. In truth it is riddled with corruption and acts as a protector and strong arm for business. Conflict of interest is rampant.

Posted by: Lisa truitt at June 17, 2013 11:05 AM
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