10/22-10-28: FDA on the Prowl

By law, the FDA can regulate how manufacturers of drugs and medical devices promote their therapies; now it must decide how to enforce this policy online. Should the Internet receive the same FDA vigilance as the real world, or will this stifle a growing network of information on experimental drugs, personal experiences and counseling? If this is not the FDA's turf, what should be done about dangerous or misleading medical information online? Do we need help telling science from quackery when it comes to health information online?

Here's what Tripod members had to say:

rjnerd: As far as the net is concerned, FDA regulations count as local ordances. They may try, but any actions may be empty ones.

I also question how succesfull they are at local regulation. There is a huge commercial presence by "quacks" making medical claims, that the FDA may well be completely powerless (by law unfortunately) to do anything about.

On more interactive forums (newsgroups) the MLM powered quacks get shouted at whenever they pop their slimy heads up. They are free to put up Web pages however, and those will be immune to dissenting views.

I suffer from two chronic conditions for which western medicine has at best imperfect treatments. The newsgroups in support of the conditions regularly get hordes of people proclaiming that their pond scum or "magic" vitamin is a real cure. (It's a cure all right, of their wallet's cash deficiency syndrome).

There even seems to be some sort of reality distortion field in action. On of the things I have wrong with me is overuse tendonitis in both arms, a legacy of 25 years of intense hacking. I went into a bike shop to try the recumbent bicycle that they sold, as those don't put the huge stresses on my arms that a regular bike would. I started talking to the shops owner about the bike, and at one point, asked me why I was considering a recumbent. I told him I had RSI, and he immediately (without knowing or asking which set of the 30 or so injuries that fall under that designation) launched into a spiel about how the pond scum he sold would cure me. It took about 10 minutes to turn the conversation back to the bicycle. The bike was $2000. The scum, $15. Only some sort of brainwashing could explain the interest bias.

Style: I think any medical information or advice on the Internet should be clearly labeled as what it is: friendly advice, advertisement for a new drug, researched scientific information. But I don't know how on earth the FDA would be able to enforce that. How much is it the FDA's responsiblity and how much is it ours for having enough common sense to take medical advice from some random Web site?

feminoogie: We wouldn't have the explosion in the self-medicating business if people could tell the difference. The Net makes for a fertile environment for all sorts of constructive and useful discussions, and that is the key to its thriving. That said, it's also a place where people can make claims with relative impugnity and sometimes no accountability. It's one thing if it's a used car dealer. It's quite another if it's your health. I think the same care we must use when reading print collateral has to apply.

sotterso: The Internet is the only free forum for the sharing of information on alterative therapies. The pharmaceutical companies are pushing the FDA to keep people from hearing about legitimate nutritional therapies that work. They have a lot to lose, since vitamins and minerals cannot be patented. Your doctor probably didn't learn about nutrition in med school, since it is only offered as an elective course. The only recourse the average person has is to read everything available and make up their own mind. The ultimate responsibility resides with the individual.

abutler: If you called a friend and asked for medical advice, who would regulate what your friend was telling you? Nobody but yourself. So too, on the Net, people have to be smart enough to only trust responses from people who are trustworthy. Do we need the government to tell us not to take advice from strangers? Real life on the Net is not an AOL kids-chat-room, with its safety police making sure no kid calls another 2 kids "gay lovers," and then kicking the rude kid off AOL with that annoying "GOODBYE" voice. (true story, by the way...) So, be mature. Don't take candy from strangers, and if you do -- own up to the responsibility that goes with it.

betho: At its best, the FDA has saved some lives by blowing the whistle on products such as Thalidomide. The FDA has become, however, an intensely political, government entity that too often approves products that have not been proven to be safe, and denied approval to products that will save lives. The goverment already has too much control, so let's keep Big Brother from controlling which alternative products can be discussed on the Net.

rjnerd: Herbal treatments have been shown to cure cash defficency syndrome in their promoters. They haven't been reliably demonstrated to be useful in treating other conditions. If they were, some pharmaceutical company would be selling a synthetic version of the useful part. Many of the medications we take are derived from compounds that are an adjunct to some other organism's metabolisim.

Yes, the "evil" drug company has looked at the plant the promoter is trying to get you to buy. They have much greater resources than the average herbal product company (after all they can afford the FDA approval testing), and have "ethnobotanists" following all the "shamen" around, collecting plants that have been discovered by centuries of trial and error to have theraputic uses.

The problem with most herbal preparations is the baggage that comes along with the good bits. Take Taxol, a promising anti-cancer drug. If you took "natural" yew, the assorted other chemicals would kill you long before you accumulated a theraputic dose of the good bit.

Even if the other components are benign, the dosage of most "natural" products is often quite erratic, depending a great deal on how stressed the plant was while grown, and how the material was handled. If you are taking a drug with a narrow effective range of doses, you will find yourself on a roller coaster -- hopefully the toxic dose is a large multiple of the theraputic dose, otherwise (like some "natural" ephedra users) you could wind up very dead.

stoddard: It is a sad commentary of our society that quackery flourishes to such a wide extent that it does. I'm not sure who said first, "A fool and his money are soon parted," but I think it was Barnum who added the corollary, "A fool and his money should have never gotten together in the first place."

People are drawn into these scams, whether it is maintenance Chiropractic adjustments which have no basis in physiology, or multi-level marketing nutrition, and it takes on a religious fervor. No one can discuss with these people scientific method, and I've tried. I read about it in my son's seventh-grade text book. You, know, the part about there being a control sample, then a sample where the only difference is the variable being tested. And, then that the experiment be completely and accurately reported and peer-reviewed, so that an independent person can duplicate the experiment and get replicate the results. These are standards of truth.

My wife brings home these pamphlets claiming the "research" behind these things. I ask "What research? Show me. Let me know how many years are added to a person's life from geting 'adjusted' weekly. What diseases have been shown to occur a certain percentage less frequently in those persons taking those herbs (compared to a control sample of 500 or 1000 persons not taking them)?" Some persons wouldn't know science if it were to rise up and bite 'em in the butt. Yet, they want to believe, and will assert it's been "shown" because some testimonial is offered. This is religion. It is belief. It is not science or establishing truth.

Yes, the FDA should take an active role in the Internet offers for medical therapies. More importantly, though, maybe the FCC should be the one who takes the lead on this. After all, doesn't the FCC have regulations already in place dealing with false advertising? This is where I see the jurisdiction occurring. Unless something is demonstrated as a valid claim (safe and effective), then we must regard it skeptically, and require that it be lathered up with sufficient disclaimers. People can still exercise freedom in partaking (pitiably) or disregarding (hopefully), but at least there will not be false representations of "research" which is dubious, phony, or non-existent. I expect government agencies to uphold such a standard based on scientific method.

JLawrence: The Internet is no place for the FDA. What do they do about TV, zine, and radio ads? Nothing. Our government is intent on taking away our freedoms.

Loron: Like beauty is in the eye of the beholder -- so is the outlook on quackery. Give me a quack anyday FIRST before I try medication from an allopath. I think,like some of your staff members who have voiced an opinion, that minds are not being left open -- and that the great sell out and buy-in to the great AMA authority has finally got its tentacles slithering through sludged brains.

If anyone offers you a quack cure -- try it before denouncing it -- it JUST MIGHT WORK. You know, not every single cure works the same delightful cure on everyone with the same illness. We are all different. Our chemical makeup is unique, and you may just be passing up the holy grail of cures for you.

Re: the person who has the muscular inflamation and tissue inflamation (damned painful) I have tried every quack treatment I could lay my hands on, but FINALLY found a dr (medical) who put me on tylenol-3. I take 8 a day -- for the past 25 years, and manage to function quite normally. My liver has not been damaged -- because I also take a herb to flush the toxins left by the tylenol 3. This herb is psillymarin.

Sometime it is the use of a combination of alternate therapies which give relief. I didn't realize there were still people out there who close their minds to our great cornucopeia of healing herbs -- vitamins and drugs.

No one like to admit they are wrong - thus medical men hate to admit that other therapies WORK. Look how long it took them to admit Chiropractic and acupuncture had their place in relieving pain and illness. I have even met people who are so conditioned to the healthy way of living that they would rather do without taking the very drug which would relieve their suffering. So it works both ways. I say, leave yourself open -- try everything until you beat the problem. There is no reason why that person can't ride an ordinary bycicle.

hwealth: Whether it is the FDA, or another entity -- they all should be allowed to state their claims as long as they are accountable to the end users of their cures, medicine, whatever. That is to say, if they report that this works, or this doesn't work, and if later it is found that it didn't work or did work (respectively), financial liability for damages because of their pontifications would really help to prevent hype versus verifiable criteria/data for what they are talking about as a cure/remedy or else they'd be out of business in short order. Let them bear the potential costs of being the experts, without the excuse of oops! Note, that this places the burden of proof squarely where it belongs. The current situation is a shield (FDA) that protects the pontificators and not the consumer, claims being made, all the while money is sucked out of the pockets of those that are truly victimized twice.

tmh: FDA probably doesn't have jurisdiction on the Internet. It is even less regulated than is real life. We are, to a large degree, brought up to believe in quacks, medicine doctors, voodoo economists, and philosophies of the virtues of being slaves, and the chances of any improvement through regulation of the Internet are less than are the chances of any improvement through the regulation of the marketplace. People believe that "it would be on the market unless the government approved it," then complain about too much government, ignorant of the fact that their government, even now, can't afford to provide them decent protection. So for a conclusion: Let's reform the world beginning with ourselves. Internet astronauts can fend for themselves; let's improve our regulatory system that is supposedly in place on the ground.

VLemley: No! Neither the FDA, nor any other government agency should be allowed to regulate what is or is not on the NET. The next thing would be someone listening in on your private telephone conversations and censoring them.

The same types of argument about misleading or dangerous information was used in the 60s, first to kill the tobacco advertisements and then eventually any program or advertisement that the government wanted quashed. Why do you think messages and advertisements for alternative medicines are not on the TV or radio?

When you need medical information from the NET do you go to a quack site or an AMA site? The quack sites are easy to find. They tell of amazing cures for just about any medical condition, for a price. And they give testimonials from people no one ever heard of or tell of fantastic discoveries in some little known research lab in Cuba or some such. The real medical sites are run by universities and professional medical associations of many nations, such as the American Medical Association or the Canadian Medical Society. You can even find such publicatins as the Journal of the American Medical Association and The Lancet on line.

Dragon27: I think the Gov disrespects the general population enough already as it is. We are completely removing any responsibility for our own actions from society. I feel this is wrong. When I was a teen I couldn't wait to get away from my parents and become responsible for myself. Then in my mid 20s I found the government being more of a mother to many than any biological parent could be. Now that I'm 30-something my opinion hasn't changed. People should be responsible for themselves first and formost. The government is at best a safety net when all else breaks down. Well that's my 2 cents.