So you’d rather have an underfunded and slow FDA prove things which are meant to be consumed are poison after the fact, than make corporations prove they’re safe before they get to sell them to consumers who assume the product is safe?
Yes, I believe it is appropriate to punish only crimes that have occurred and not impede all actors in a futile attempt to prevent every imaginable or accidental evil.
You sound like you want to keep corporations honest and I do too.
Unfortunately raising the barriers to entry will also reduce competition, leaving only those that can afford to do exhaustive testing of things as simple as nutmeg and oregano in the game (large corporations, who’s studies are already dubious). I would rather assume individuals are capable of choosing for themselves than ruin a good thing (the ability to innovate) by trying to save everyone from themselves. It’s an admirable sentiment, but placing the responsibility in the wrong place creates numerous conflicts of interest later. “Guilty until proven innocent” only helps those who don’t need it (if you weren’t guilty, well, you wouldn’t be on the witness stand…).
Don’t get me wrong though, there’s no reason problematic cases can’t be prosecuted fully to set a punitive example.
Furthermore, labeling would go a long way to supporting and informing consumer choice. But ultimately that choice resides with the consumer, who is not a passive agent by any means.
By that logic we shouldn’t hold restaurants to strict standards of cleanliness because it cuts into their bottom lines and creates a barrier to entry as well. Also, automakers shouldn’t be held to safety standards like requiring vehicles have seat belts, headlights and windshield wipers.
Proving that your dietary supplement isn’t poisonous should absolutely be a barrier to entry, since they’re marketed as if they’re drugs. They’re technically treated like foods, but let’s be serious here, they’re filling the same market niches as drugs, and people assume they’re held to standards of purity, safety and effectiveness because of that association. If the producers want their supplements treated in a regulatory sense as foods, then they shouldn’t be allowed to turn around and market them as drugs. It’s deceptive and is harmful to the public who trusts that drugs are held to a high standard.
“On September 30, 2004, Merck withdrew rofecoxib from the market because of concerns about increased risk of heart attack and stroke associated with long-term, high-dosage use. Merck withdrew the drug after disclosures that it withheld information about rofecoxib’s risks from doctors and patients for over five years, resulting in between 88,000 and 140,000 cases of serious heart disease [2] of which roughly half died. [citation needed] Rofecoxib was one of the most widely used drugs ever to be withdrawn from the market. In the year before withdrawal, Merck had sales revenue of US$2.5 billion from Vioxx.”
It was that, or the FDA would have done it for them. By my count:
Here is the link to the Wikipedia article that I think you are quoting: Rofecoxib - Wikipedia It seems to be saying that somewhere between 26,400 (30% of 88,000) and 55,600 (40% of 139,000) people died as a result of this drug (this paper?). Wikipedia also mentions another study which seems to get different results for the risk, but I do not know how those numbers translate into American deaths (this paper?):
Several very large observational studies have also found elevated risk of heart attack from rofecoxib. For example, a recent retrospective study of 113,000 elderly Canadians suggested a borderline statistically significant increased relative risk of heart attacks of 1.24 from Vioxx usage, with a relative risk of 1.73 for higher-dose Vioxx usage. (Levesque, 2005). Another study, using Kaiser Permanente data, found a 1.47 relative risk for low-dose Vioxx usage and 3.58 for high-dose Vioxx usage compared to current use of celecoxib, though the smaller number was not statistically significant, and relative risk compared to other populations was not statistically significant. (Graham, 2005).
The numbers for DMAA appear to be based mostly on voluntary reports:
As of April 11, 2013, FDA had received 86 reports of illnesses and death associated with supplements containing DMAA. The majority are voluntary reports from consumers and healthcare practitioners. The illnesses reported include heart problems and nervous system or psychiatric disorders. Note, however, that a report is not proof that the product actually caused the problem.
As of October, Hawaii reports 41 cases of liver problems, two liver transplants, and one death due to liver failure.
So, I do not think it is entirely useful to compare the numbers from one study (which may or may not be statistically consistent with another study) for a drug to the voluntarily reported numbers for a dietary supplement. I would also think that the number of people taking rofecoxib versus the number taking DMAA would need to be known for a comparison to be at all useful.
You got me. I don’t eat out much since I don’t generally like or trust what’s being offered and, despite the laws, I am pretty sure my food gets spat in and dropped on the floor far more than it would if I made it myself. I must be an exception for questioning the reliability and cleanliness of teenagers making minimum wage. (But I’m not wanting to impose my choice on others…)
As for headlights, seat-belts, and windshield wipers, I don’t see how that compares to proving, ab initio, a food’s safety. The costs are on completely different scales. Studies around un-established products cost overwhelmingly more and often advance (we’d starve if we were talking about food) whereas adding windshield washers and seat-belts to pre-existing products that benefited significantly during their developmental years from the lack of regulation, are two very different things.
More importantly and directly relevant however: I reserve the right to put anything I want in my body. I want the choice, and won’t part with it.
To be clear, I don’t think automakers should be forced to include any of those things either since it has become virtually impossible to build or import a kit to build your own car, basically creating a situation where only SUVs (the processed chicken fingers of existing designs) and similar designs, and the manufacturers that can afford to produce them, do high volumes of business. If we ever want flying cars we’ll need to clear out the legal brush there too - but due to the differences in scale, I’m less likely to focus on the latter.
We can agree on that: deception is wrong. How about a label that reads “this is not a drug”? (I’d also be more than happy to see the “good name” of drugs, which I do not believe are being held to high standards, corrected in the public’s mind.) I think a moral is that skepticism is something we could all use more of…
The gold standard for justice however is still “innocent until proven guilty” even when it means some choices contain risk. We cannot eliminate risk, or terror for that matter, or papercuts, by eliminating freedom or paper; I am not afraid of freedom or paper.
A) The sheer amount of damage done by FDA-approved pharmaceuticals makes the 2,000 number given in the BB article look miniscule.
B) FDA approval does not necessarily result in safety, and often results in state-sanctioned damage to .tens of thousands. (I didn’t bother to add all the estimates up, but since you’re so into the numbers, maybe you’d like to.)
If you don’t like the Vioxx example, just go pick another drug - thalidomide, for example. There are plenty to choose from.
I can see now that we simply won’t come to much of a consensus on this.
I’m glad we can agree that deception is unacceptable.
You seem to be concerned with the economic consequences of regulating supplement makers. While I simply don’t care that holding them to standards of purity is expensive. People pay a lot of money for snake oil, and I’m feeling generous enough to allow for it to be sold as long as what’s in the bottle is what it says on the label, and not something else like strychnine or used engine coolant.
If I had my way anything used to treat medical conditions would be regarded as medicine and be held to medical standards of purity and effectiveness, which includes most dietary supplements.
