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FTC to FDA: Do Your Job So We Can Do Ours
Regulation is a tricky matter, filled with tension. Too little and you end up with fraud and harm; too much and you stifle innovation. Too little input from industry and you get decisions ignorant of conditions on the ground; too much and you have regulatory capture. When it comes to homeopathy, the Food and Drug Administration seems to have managed to make all of these errors at once — including ones that should be mutually exclusive.
A few months back, the FDA sought public comment on its regulatory regime for homeopathy. Both homeopaths and science-based activists flooded them with material. The most surprising comment, however, came from another organ of the government: a pointed and bitter memorandum from the Federal Trade Commission, essentially telling its fellow regulators to stop making the FTC’s job impossible by abdicating the FDA’s duty to evaluate homeopathic products’ efficacy and safety in the same way they do normal drugs.
As described by the blog Science-Based Medicine, who — rightly, I think — consider homeopathy a fraud:
In 1972, the FDA undertook a massive review of all OTC drugs (and an estimated 100,000 to 500,000 separate ingredients) to determine which could be classified as safe and effective and not misbranded. In accordance with amendments to the FD&C, the FDA was to determine which OTC drugs are generally recognized among qualified experts as safe and effective and not misbranded under prescribed, recommended, or suggested conditions.
However, at the request of homeopathic trade groups, homeopathic remedies were deferred from review. The FDA never returned to the task and OTC homeopathic drugs have never been reviewed by the FDA for safety and efficacy.
Homeopathy is based on the principle that symptoms can be cured by ingesting dilutions of substances that cause similar effects. Put a certain way, it sounds intuitive and appealing, but its implausibility becomes more apparent with a bit of dramatic heightening. More importantly, no credible study has found homeopathy more effective than a placebo, largely because — if practiced as advertised — it is a placebo. Regardless, it’s big business, to the tune of $2.9 billion annually in the United States.
Under the current system, the FDA is specifically charged with regulating homeopathic products, but, for a variety of historical reasons, it has almost wholly farmed out that responsibility to the industry. Essentially, if your homeopathic product has a label on it that gives an indication for use, it counts as FDA-approved; it doesn’t matter how implausible the claims are, and there’s no control on what’s in there. That’s the basis for the FTC’s complaint: that they cannot evaluate claims of fraud or false advertising when the regulatory agency assigned that duty is refusing to do its job.
The FDA is one of those agencies that probably shouldn’t have to exist as a part of the government, though it’s also clear that it’s presided over a period of unprecedented explosion in new drugs that are overwhelmingly safe and effective (whether the the agency has hit the right balance between safety and innovation is a matter for another time). But it’s hard to find an argument against the existence of the Federal Trade Commission — at least in its capacity as a prosecutor of fraud — that’s this side of anarcho-capitalism. So long as we have the two, the FDA should do its job and treat all purported remedies and cures the same, without the special pleading.
Published in Domestic Policy
Tuck did say “most of the time”. And yeah, it’s surprising how often watchful waiting, even for acute conditions, ends up being a reasonable treatment. I’ve now lost track of the number of times something acutely painful but evidently not life-threatening didn’t send me to the ER.
Of course, the miracle of Google enables this reduction of pointless ER visits, since you can instantly find out info like whether that acute abdominal pain is in the proper quadrant to be appendicitis, and if it’s not, save yourself an emergency trip where all that happens is you wait around for six hours and then get sent home with a flier on home care of abdominal pain :-)
Homeopathic medicines can certainly hurt you, and not because they delay “real medicine,” which, by the way, certainly can hurt you. I can see you are unlikely to believe this, but if you take a homeopathic remedy beyond the point you should, you can exacerbate your symptoms, and that can be quite nasty. The characteristics of the hundreds of homeopathic remedies in the pharmacopeia were discovered mainly by physicians who took them until they became ill, writing down the symptoms they developed.
People give their children ordinary painkillers when they shouldn’t, too. Would you ban them?
My 37 years experience with this form of medicine, and the experience of my children and grandchildren, to say nothing of millions around the world, is quite different from yours. I only want the right to decide what is in my own best interest, and I’m sure you want that for yourself, too.
I see. Well, maybe they shouldn’t sell them over the counter, then.
What an offensive, ignorant statement. The PCPs I know (including Mrs. Doctor Robert) treat hypertension, depression, sprains, burns, diabetes, chronic pain, smoking, asthma, COPD and general ennui every day. Sometimes I’d like to see them use specialists more (I’m an endocrinologist), but patients object to the extra visits and extra co-pays for, say, high level diabetes care, when Dr Karen has taken care of it all these years.
The problem? Our current system obliges PCPs to see far too many patients to satisfy their corporate employers. The Docs working for a local hospital, for example, see 40 patients/day. Twenty in the morning, 20 in the afternoon. Med Assistant takes the history, Doc has 12 minutes to diagnose, prescribe, explain and chart. I draw the line at 20 a day and I struggle to stay afloat despite 10-12 hour days.
This, of course, is because Joseph and everyone else expects free, or nearly free, care.
Navigating insurance issues is not the PCP’s job nor mine. It’s yours. We can help, but it’s hard enough to keep up with the medicine.
I’m not sure all of us do. I pay up-front wherever possible. Sometimes the full amount, if it seems cheap enough. Sometimes an estimate (later adjusted or written off) based on what the doctor’s office guesses my benefits will me. I’ve come to like it when medical payment is done up-front whenever possible. It saves nasty surprises later.
It’s amazing, though, how many doctor’s offices aren’t set up to do up-front payment effectively (or at all). Moreover, since we do also pay for a health plan, it would be stupid to never get benefits from it (though at this point we often forego full benefits from our plan because those are like getting blood from a stone). So yeah, a doctor’s office that utterly refuses to cooperate with our health plan is not going to get our business anymore.
Realistically, it gets to a point where it ceases to be the patient’s either. I cannot authorize myself for a prior approval, for example – and some important treatments are prohibitively expensive without it. While I’m happy to help doctors’ offices as much as I can in these matters, there’s a limit to how much reliable knowledge I as a health plan client can get my hands on, too. Often, doctors have an “in” I don’t have.
About five years ago, our health plan was one I could manage myself: the explanation of benefits booklet was clear, it was easy to reach a representative, the health plan processed and reimbursed relatively quickly. I as a patient could see (and pre-fill, if necessary) any forms that my doctor’s office needed to approve. We’ve changed plans five times since then, though, and I swear they get less transparent every time.
At this point, I effectively have two primary-care physicians. One, who sees fewer patients per day and is often booked two months in advance, is the guy who actually takes care of any long-term medical mysteries. The other is an old family friend whose office has offered to take on the burden of coordinating all my medical records (the medical mystery guy can’t do that anymore) and has an easier time scheduling for minor urgencies. It sort of works.
Actually, we kind of love docs who don’t take any insurance and only accept payment from the patient. Or am I misreading you?
Also to be clear, although I think people should be able to spend their money on homeopathy or reiki any other form of treatment they choose, I don’t personally go that route.
In spite of many many various horrible experiences with standard medical practitioners, and in full awareness of medicine’s limitations, I continue to be deeply grateful for the medical care I have received in my life. I feel so fortunate to live in such a medically advanced society.
Maybe aspirin shouldn’t be sold OTC either, since it can kill you. This argument is a bit silly, no?
Up-front payment is a huge plus for me. Not cooperating at all with my plan is not, though. Often, paying for a visit, even completely out of pocket, is a relatively small expense. The stuff recommended during the doctor’s visit, though – labs, medications, etc – are usually our biggest expense. And many plans will offer the patient some discount on these things – but only if the doctor affirms to the plan that the patient “really needs” it.
It’s a huge hassle for the doctor, of course, and insulting to boot – it seems to assume he regularly prescribes his patients unnecessary stuff. When I know what my plan needs to hear, I’ll do as much of the paperwork for the doctor as I can short of committing fraud (like forging his signature, though sometimes I am tempted). If his office can’t follow through on what remains, though, it’s usually not worth it.
I’m unaware of a huge spate of people people being harmed by homeopathy. What is the reason again to increase regulations on it?
I don’t know who is pushing this, but I do know that when Harvard’s Dr. David Eisenberg discovered in a 1990 survey that patients were spending enormous sums out-of-pocket on “complementary and alternative medicine,” a lot of people sat up and took notice. Some of them are probably still in shock. As this article from Harvard Magazine explains, this was a bottom-up, consumer movement. Is all this money spent wisely? Of course not. Do people spend their money wisely on conventional medicine? This was and is the market speaking, or maybe shouting. Here is exactly how loud, and note, this was published in 1993:
The article reported a 1990 national survey (“a way to biopsy what is happening in the marketplace,” Eisenberg says) showing that 34 percent of American adults had used at least one unconventional therapy in the previous year, and estimated that Americans made 425 million visits to providers of such therapies–exceeding the number to primary care physicians (388 million) [emphasis added]. This, despite the fact that 75 percent of CAM therapy expenditures were paid out of pocket–for a total annual out-of-pocket expense approximating the comparable figure for all hospitalizations in the United States.
I will add that when one spends one’s own money on a treatment, one tends to be particular.
It’s fraud. You’re harmed because you have to pay for something that can’t work.
Have to pay? I suppose, if homeopathy receives government money, or if government mandates that health coverage include it. But otherwise, why “have to pay”?
I’ve seen and used homeopathic balms or creams at the strong recommendations of my accordion teacher. It seems to work for me well enough that I don’t need repeat applications over time, but I am using it for something specific. I see homeopathic medicine or the standard little jars containing this or that in solution is big business as evidenced by big displays and the prices being charged in the health food cooperatives. I just wanted to make the point that it’s not all the same, there’s more than just the little jars out there (which I confess I’ve tried without noticing any benefit). Topicals, depending on the brand and the age of the product, do seem to be doing something.
Since it is not the consumers of homeopathy who are complaining, one becomes suspicious that there are other matters at issue. That it doesn’t make sense to you, or is contradicted by various rules of chemistry and physics, does not necessarily mean that it is a fraud. It might mean only that there are still a lot of things we don’t understand.
As someone who has used homeopathy successfully for many years, of course I’m annoyed by the possibility that I might not have unfettered access to something that works for me and my family, but what really annoys me is the nanny-statism here, and I find conservative support for this to be especially grating.
One reason you may have more success with the topicals is that most of them are made of combinations of remedies, with the idea that there is a decent chance that one of the remedies in the combination will be right for you, the remainder being useless. Choosing that one remedy takes time and knowledge that not everyone has, so the combinations are a practical solution.
Because you’ve been convinced by a con man that it does work.
We’ve got three issues, that you’re conflating here.
1. Should the FTC be policing fraud? If you think not, then the next two don’t matter.
2. Does the FTC currently have a mandate to police fraud? Yes, and given that, I’d like to either see them do it, or revert to #1 above and at least save me the tax money.
3. Is homeopathy fraud? Placebos have great healing power. Lots of studies have shown this. Of course, what those studies are actually showing is that our bodies have great healing power, and people heal at different rates. Homeopathy isn’t some new principle of nature that we don’t yet understand, it’s an old one that we understand very well.
Even when I’m convinced treatments do work, I don’t seek out every treatment that could conceivably work because of the costs. In my case, I’m not convinced that homeopathy works. Who are these people who, after being convinced homeopathy works, are powerless to resist the urge to spend money on it? Even people who believe a treatment works are not compelled to spend money on it.
This all hangs on #3, and clearly we don’t agree.
I don’t think you get the crime of fraud. If you’re told that a treatment is going to cure your child, aren’t you compelled to use it? If it’s really a cure, and you don’t use it, you may well be guilty of a crime, if being a bad parent weren’t enough.
If the cure is a lie, you’ve been defrauded.
No, it hangs on #1. If you don’t think the FTC should be policing fraud, then your views on #3 are irrelevant. If you do, only then does it become important if #3 is a fraud.
As am I, but I think it’s important to be aware of its limitations, as it’s ripe for abuse if you’re not.
Of the three examples you gave, I’d argue the first was a case of doctors attempting to aid the body to heal. Sadly, there’s no evidence that steroids aid in preventing death in pneumonia…
The second two were palliative care, as the underlying cause remained, it was just suppressed or dealt with.
That doesn’t meet my definition of healed… Although I’ll agree that your husband’s far better off with his fake hip, and your friend with the meds!
In comment #43, you specifically framed it as being forced (“have to”) to do something. Theft by deception is also wrong, but it’s different from theft by force. That is all.
No.
Even among well-educated, responsible families, I have known several children whose parents decided to deny them one cure or another. Nearly all of these kids have turned out OK. And even when the kids don’t turn out OK, sorry, being under the authority of one’s parents is just part of being a kid.
That is a problem with child-welfare laws, though, not with parents’ natural right to preside over their children’s medical care, even in ways outsiders would deride as rather dumb.