http://www.latimes.com/news/nationworld/nation/la-na-diet-pill-recall2-2009may02,0,5931665.story

In a completely free market, how exactly would this be handled? If there were no government agency looking over this, wouldn't it be very, very difficult for them to show a correlation between the liver damage and the product? And wouldn't it be easy for the company, once they got enough money, to suppress that type of information leaking out?

5/1/2009 1:27:37 PM

not really. we could just have a UL-type organization or two that did the testing for us.

5/1/2009 1:29:00 PM

You mean companies would have to voluntarily seek out this rating? I somehow don't see that stopping something like this.

The only thing that I could see working without a gov. regulation of some sort is if someone who was very wealthy were affected by the product and sued the company amidst a media frenzy, causing them to be discredited.

5/1/2009 1:33:17 PM

Well, the reason that UL works is because people look for the UL label when buying products.

Presumably, if we had a purely free market system with a private company which tested and independently verified the safety of supplements/medications, we would look for that company's logo on products before deciding whether or not to buy them.

There are always idiots who will take medicine/pills which aren't reviewed by anyone based on some vain hope that they can lose weight without actually doing anything. Shoot, on the man show (awful reference to make, but SPEAKING of diet plans) they convinced a bunch of idiots in a mall to go on "the chocolate diet", which supposedly works because you burn more calories while chewing than you gain from eating the chocolate. It was a hilarious scheme that pointed out how stupid people are and how far they are willing to go to for the promise of a magic weight loss solution. One lady shoved a chocolate bullet smothered in chocolate sauce up her butt to lose weight (The chocolate suppository!).

Also, as for how this would be settled, you'd be looking at a class action lawsuit. Wasn't that how they settled all that BS with the Airborne! cold remedy stuff?

5/1/2009 1:57:46 PM

Re: the OP: Read the original article. The FDA never approved Hydroxycut in the first place - it was a "supplement." So you're about as close to how things would work without an FDA in the first place; in this instance, like in the case of any drug not approved by the FDA, they simply acted in the capacity of an information clearinghouse.

Quote :

"Dietary supplements aren't as tightly regulated by the government as medications. Manufacturers don't need to prove to the FDA that their products are safe and effective before they can sell them to consumers. But regulators monitor aftermarket reports for signs of trouble, and in recent years companies have been put under stricter requirements to alert the FDA when they learn of problems."

Quote :

"The FDA relies on voluntary reports to detect such problems, and many cases are never reported, officials acknowledge."

So, how would it work without an FDA? Well, in this case, about the same as with an FDA.

[Edited on May 1, 2009 at 2:09 PM. Reason : .]

5/1/2009 2:04:45 PM

Quote :

"The FDA never approved Hydroxycut in the first place - it was a "supplement.""

well you can probably thank the Dietary Supplement Health and Education Act of 1994 for that, which completely gutted regulation for health products like supplements, vitamins, herbs, "alternative medicine", etc. That's what we get when Congress is full of science-ignorant ideologues in the pocket of big corporations.

5/1/2009 2:33:41 PM

^ Sure 'nuff.

Quote :

"Dietary Supplement Health and Education Act of 1994 Public Law 103-417 103rd Congress"

Quote :

"The One Hundred Third United States Congress was a meeting of the legislative branch of the United States federal government, composed of the United States Senate and the United States House of Representatives. It met in Washington, DC from January 3, 1993 to January 3, 1995, during the first two years of Bill Clinton's presidency. The apportionment of seats in the House of Representatives was based on the Twenty-first Census of the United States in 1990. Both chambers had a Democratic majority."

You mean the Democrats don't always look out for our best interests? Shocking.

5/1/2009 2:39:45 PM

Do most consumers actually look for a UL tag when they buy electronic goods? Me personally, I tend to assume that the people I give my money to are somewhat competent enough to stock goods that aren't going to electrocute me or break down too soon.

5/1/2009 4:01:08 PM

Quote :

"Re: the OP: Read the original article. The FDA never approved Hydroxycut in the first place - it was a "supplement." So you're about as close to how things would work without an FDA in the first place; in this instance, like in the case of any drug not approved by the FDA, they simply acted in the capacity of an information clearinghouse."

Yeah, the FDA has been specifically designed, wrt diet pills, to take a laissez faire approach. I'm wondering that if everything were done this way, what would the corrective mechanism be?

With drugs, it's not as clear cut as with, say, mp3 players, in how the market can control it.

But, if i am reading your post correctly, you're saying that we'd have more incidents of drug companies pushing potentially harmful drugs, if someone wasn't looking over their shoulder?

5/1/2009 4:27:19 PM

Look, even with the FDA looking over their shoulder (which is the understatement of the year, easily), drug companies later discover inadvertant side effects all the time. Drug recalls of drugs approved by the FDA still happen.

So this would not a trade-off of perfect scrutiny vs. anarchy.

The other side of this is the fact that the FDA can potentially hold back proven, life-saving treatments which are both necessary and vetted in other countries. Ergo, the other side of it - having an FDA is not costless, even in terms of human lives. FDA regulation will inherently cost lives too - every year a lifesaving drug gets held back, more people die.

There's no free lunch, here.

5/1/2009 4:31:18 PM

I'm not here to defend the FDA, i didn't specifically bring the FDA up. I don't care about the FDA.

I'm wondering how would a recall process work, without an agency similar to the FDA? Even in this case, the mere existence of an overarching entity, that wasn't specifically regulating the drug, fomented the recall process in this case.

5/1/2009 4:40:17 PM

Wouldn't happen

people would die from the drugs until they learned that there were terrible side effects.

After that more informed people would stop taking the drugs, while less informed people would continue to die.

[Edited on May 1, 2009 at 5:04 PM. Reason : ]

5/1/2009 5:04:21 PM

Quote :

"I'm wondering how would a recall process work, without an agency similar to the FDA? Even in this case, the mere existence of an overarching entity, that wasn't specifically regulating the drug, fomented the recall process in this case."

Again, though the only the thing the FDA did here was compile independent reports. Any recall will be by the makers of the supplement. There's nothing to indicate this wouldn't happen otherwise - Consumers Union and Underwriters Laboratories are two examples.

So, if you're looking for your example, this is pretty much it.

5/1/2009 5:14:43 PM

Quote :

"people would die from the drugs until they learned that there were terrible side effects. After that more informed people would stop taking the drugs, while less informed people would continue to die."

This possibly overstates the case as it ignores the role of intermediaries. Walgreens, for example, would cease selling a drug it deems unsafe for fear of losing current and prospective customers.

5/1/2009 6:39:05 PM

You're saying that vendors wouldn't sell a harmful product even if consumers wanted it?

5/1/2009 10:20:15 PM

Not ones with plans to run a sustainable business.

[Edited on May 1, 2009 at 10:42 PM. Reason : .]

5/1/2009 10:27:48 PM

Not if they were risking lawsuits by selling a dangerous product.

Although the product maker would likely pull it first in order to avoid costly litigation.

Sucks that some people had to get liver damage before this product was pulled. But its not like the FDA did anything in this case other than repeating alarm bells that were already going off. The product would have been pulled anyway.

[quote]Iovate Health Sciences, which makes the diet pills, said it agreed to the recall out of "an abundance of caution." The company is based in Canada and its U.S. distributor is headquartered near Buffalo, N.Y.

"While this is a small number of reports relative to the many millions of people who have used Hydroxycut products over the years, out of an abundance of caution and because consumer safety is our top priority, we are voluntarily recalling these Hydroxycut-branded products," the company said in a statement on its Web site. Consumers can get a refund by returning the pills to the store they purchased them from, the company said.

5/1/2009 10:28:30 PM

Quote :

"Walgreens, for example, would cease selling a drug it deems unsafe for fear of losing current and prospective customers."

yeah, that's more Libertarian fantasy-talk. Walgreens sells plenty of useless, at best, and harmful, at worst, products because they don't care - it's not their ass on the line. Walgreens (or Rite-Aid or CVS) will just shift blame to the manufactures and the gov't.

It's like the Airborne shit that went down last year. Every drug store in the country was happy to sell a "supplement" that explicitly made medicinal claims. When Airborne was sued and lost to the FTC, they just changed the box, and every store went right on selling it, without a care at all of the effectiveness, or side effects or problems with the product.

[Edited on May 1, 2009 at 10:30 PM. Reason : .]

5/1/2009 10:29:57 PM

Quote :

"Not if they were risking lawsuits by selling a dangerous product."

Maybe they'd just slap a warning label on it.

5/1/2009 10:31:41 PM

^^ How many people died from taking Airborne?

5/1/2009 11:04:12 PM

Probably a lot less than die from smoking cigarettes.

5/1/2009 11:10:10 PM

i always wished hydroxycut woulda died off after ephedra was banned

[Edited on May 2, 2009 at 1:07 AM. Reason : ^are you saying people were addicted to hydroxycut or something?]

5/2/2009 1:06:21 AM

Quote :

"Maybe they'd just slap a warning label on it."

What's wrong w/that? If the company gives you accurate info about the risks of its product, like they do with cigs, shouldn't we allow people to make their own choices???


nahhhhhhhhhhh. need the gov to protect us from ourselves too.

5/2/2009 2:38:41 AM

why would they need to have warning labels without regulation?

5/2/2009 4:45:22 AM

Wasn't the reason the FDA was created to begin with was to deal with all the snake oil being sold back in the day?

5/2/2009 5:13:57 AM

Andy,

One could argue that no fully advising the customer to the risks of the product could bring liability suits against the company if the customer is injured (kinda like what's happened with cig companies, even though they had labels for decades).

Though even if one didn't want to make that argument, its beside the point. Given that a company informs the customer about the risks involved with using their product (to either meet a regulatory or legal obligation), I don't see why it shouldn't be up to individuals to decide if they want to take that risk. That was the point I was making to spooky.

5/2/2009 5:25:10 AM

Quote :

"Last week brought hopeful news for prostate cancer patients, with the biotech company Dendreon announcing that its cancer treatment Provenge improved survival and prolonged life in an important study. That may finally be enough for Provenge to win Food and Drug Administration approval, but the tragedy is that it wasn't approved years ago. Provenge is an advanced cancer "vaccine," which stimulates the body's immune system to attack tumor cells and thereby fight off cancer on its own, instead of using chemotherapy or surgery. In an earlier placebo-controlled Phase III trial (the most rigorous kind), men with late-stage cancer who received Provenge lived a median of 25.9 months, compared with 21.4 months otherwise. After three years, 34% were alive, compared to only 11% for the control group. In March 2007, an FDA advisory panel voted 13 to 4 that there was "substantial evidence" the drug worked, and 17-0 that it was safe. But later that year, the FDA delayed approval, ruling that the trial did not meet its criteria for statistical significance and that the patient sample was too small. So Dendreon agreed to complete another double-blind trial to FDA specifications, and Dendreon officials say the results have now met those benchmarks. The detailed results will be presented later this month. The larger question is why Provenge wasn't made available sooner to the 30,000 American men who die each year from prostate cancer. The FDA regularly -- and pointlessly -- slow-walks potentially revolutionary therapies, relying on overly simplistic and unscientific statistical models that don't take into account the fact that some drugs may work better in certain subgroups than in others. Its regulatory blockade is especially cruel to terminally ill patients for whom drugs like Provenge may mean extra months or years of life. These corroborating data should lead to a shift in the way the FDA evaluates innovative oncology medicines. But they almost surely won't, since the demands of bureaucratic politics to play it safe nearly always trump the needs of patients."

http://online.wsj.com/article/SB124018504363133253.html

We shouldn't expect much else given the incentives in place. Imagine if you worked at the FDA. If you reject a potentially harmful drug, you are commended for ability to save lives. If you reject a drug that potentially saves thousands of lives, the result is not visible and thus not condoned. Your incentive, then, is to err far too much on the side of caution as that is how you are rewarded. While we may think the FDA has done a tremendous job watching out for our best interests, we forget about the lives lost or harmed from drugs rejected by the FDA or drugs that never make it to market given the prohibitively expensive process mandated by the FDA.

5/2/2009 10:37:18 AM

Quote :

"If there were no government agency looking over this, wouldn't it be very, very difficult for them to show a correlation between the liver damage and the product? And wouldn't it be easy for the company, once they got enough money, to suppress that type of information leaking out? "

Considering that the FDA banned the original drug in Hydroxycut - ephedrine - for bullshit reasons, I'd say that they partially caused the problem with the revised hydroxycut in the first place.

5/3/2009 12:28:52 AM

gtfo with this "bullshit reasons" bologna

5/3/2009 12:40:29 AM

they banned ephedrine for claiming that it posed health risks, but didn't mention that all the people who died from ephedrine were taking multiple doses and then dehydrating themselves during strenuous exercise. The real reason they banned it was because they wanted to curtail the methamphetamine epidemic in this country, reasoning that most meth is made from ephedrine and pseudoephedrine (which was also moved behind the counter of the pharmacy and tracked at the same time.)

I want you to find an example of where any other drug as popular as ephedrine has been banned after only causing about 150 deaths in the history of its use. The only other compound I can even think of that falls into that category is another FDA conspiracy, tryptophan. The reason I say conspiracy with tryptophan is that the FDA banned an essential amino acid touted for its depression fighting capabilities about a week before Prozac made mainstream American headlines. The reason for the ban is because they claimed tryptophan could cause a deadly flu-like condition, yet about 3 years after the ban a company filed a patent for pharmaceutical tryptophan to fight said condition. It turns out the few tryptophan deaths were caused by a contaminant in tryptophan coming from one Japanese manufacturer, yet the ban still continues today despite no other health problems occuring from tryptophan use in the rest of the world. Tryptophan is naturally in the foods we eat in considerable quantities and is necessary for optimum health.

5/3/2009 10:40:30 AM