Since news of this clinical trial’s success became public, people from all over the U.S. stricken with rheumatoid arthritis have emailed, called and sent letters pressing for their shot at potentially effective—but not yet FDA-approved—treatments. Most wrote that they would gladly travel to Europe if it meant they could get access to the device.
That’s exactly the point: Some patients are very willing to take a calculated risk, but misaligned incentives in the industry are driving potential stakeholders with new solutions out of the business.
Imagine that we had no FDA, but we understood that deceptive advertising and patient ignorance can lead to bad outcomes. It seems to me that principles-based regulation could work.
The basic principle might be: the patient must be capable of understanding and articulating the risks and potential benefits of a proposed treatment. One possible way for a doctor to prove that this principle is satisfied is by recording an interview with a patient in which the patient explains in his own words why he is choosing this particular treatment.
Do you want to hear all the semi-plausible naysayer arguments?
I will like to hear 10. And they can not include arguments about safety which the FDA will never relinquish. Arguments supporting the agency’s sine qua non role on efficacy are fair game.
For the record I suggested informed consent years ago particularly during the aca debatacle.
1. Doctors will talk patients into/out of procedures. Video taping consent addresses thus but not fully nor probably feasibly or ethically. Doctors are too experienced to not be able to win this game on the margin
2. Patients are utterly incapable of being informed. Medicine is way too complex. That is why we have doctors!
3. The medicine should be proven safe and effective AND especially cost effective before general public use (I didn’t say these are my arguments)
4. Drug companies will proliferate minor tweaks of existing drugs to exploit this expanded market.
More later
5. You say these can’t include safety. Well, sorry. When drugs start to get out, the egalitarian impulse will make it REALLY hard to be denied to people. So, when you let the cat out of the bag, there is going to be a lot of pressure to release the drug to the general public. Also, doctors can go “off-label.” Then if the rollout goes to quickly and there is a disaster you have a massive recall.
6. Doctors will complain that patients are coming in because they were told to ask their doctor about an experimental procedure and badgering the doctor into treatment.
7. The patients will start to view denial of experimental treatments as malpractice, further pressuring doctors, partly because they don’t understand how medicine and physiology work and have no…patience. You can get tattoos removed, but you might not get a do-over on a powerful treatment.
8. Experimental treatments will be very expensive. The ones that pass muster will be the ones that get tried a lot. These will be the most profitable ones relative to any other factors like effectiveness.
9. Healthcare costs will rise and outcomes may not improve because even without an FDA we haven’t fixed the fiscal incentives in medicine. For example, I am being nudged toward a vastly inferior treatment because the superior one is still “experimental.” Except it’s not experimental. It is perfect. Cheaper, less morbidity, zero risk of complications (well, almost zero), and no general anaesthetic. It is just not the one that has been common.
10. #9 aside, doctors won’t gain experience from massive repetitions if they are always having to try new procedures. So, all the right procedures are wrong if they are done wrong.
or how about respecting voluntary exchange between adults? really? doctors should be the gate keepers?
If deceptive advertising works, and the deceived patient articulates clearly in his own words why he wants the treatment, is the doctor supposed to say “you don’t understand well enough, no soup for you! “?
Instead, the doctor will seek to correct any false beliefs, and the patient will say, OK, I still want the drug and give my informed consent, but without really changing his mind or the origin of his desire.
In other words, not much of a gateway.
There are two other real problems, which probably apply to more people/drugs than the “new, good, yet unapproved” treatments.
Remember, in a all of these discussions, there are “back stories” and “behind the scenes forces” and it is NOT all about the patient…
1. Everybody knows the treatment works. In fact, it works so well, it’s routinely abused – think Morphine. So how (if at all) do we separate “the informed patient who can articulate what they are risking can have ….” from “the fully informed patient asks for Morphine for their Morphine habit….” Note that we allow people to do great harm to themselves with alcohol or tobacco, but not with say Morphine. Curious, no?
2. There’s a new treatment, it’s getting a lot of advertising, it’s very very costly, and it’s is ever so sligthly less effective than the totally unadvertized generic treatment your doctor would like you to try. So you articulate why you want blood pressure medicine XYZ-DeltaQ (not yet approved by the FDA), but expect somebody else to pay for it even though, well, generic Lisinopril would work just fine for you.
One idea would be to create a list of privileged conditions that could access drugs earlier, such as incurable fatal and/or debilitating conditions. It would be easy to argue that severe case of rheumatoid arthritis would qualify for the second of these if it had any meaning.
I don’t really think this is a good idea and it would be prone to huge amounts of politicking and unfairness, but it would probably be better than what we have, and as someone with medical problems I think the perfect shouldn’t be the enemy of the good.
A lot of our information about whether drugs work comes from the phase II and III clinicial trials that are part of the FDA approval process. These trials are also the major cost of the FDA approval process. If you eliminate these costs, then we’ll know a lot less about which drugs work. So if you weaken the FDA approval process, then the government will need to spend a lot more money on clinical trials instead. I think this could be a fine solution, actually, but I never here anti-FDA economists discuss this issue, which I feel is misleading.
I always think how about we get Government to start prosecuting real fraud.
In other words allow the drugs to go through but prosecute any fraud.I am amazed at the number of fraudulent products that are advertised on TV.
I think a lot recently about how we have two governments. We have the notional government that liberals argue for more of and conservative/libertarians argue for less of.
Then we have actual government in the real world where I can’t get a medical procedure I know is the right one AND safer and less expensive, I can’t get cops to enforce basic laws, court cases take years if not a decade or more, and the like.
I would just like to be able to buy my Claritin-D(R), Sudafed(R), or Zyrtec-D(R) over the counter again with no restrictions. As it has pseudoephedrine (which apparently is one ingredient in meth) we are now limited to one month’s supply at a time (30 tabs) and you have to sign for it each time.
To reduce the meth heads’ access to one ingredient, every allergy sufferer who’d like to take an effective decongestant must be inconvenienced.
Yay. 🙁