Maybe SOME Good News from the FDA

Outstanding post top to bottom and I was in full agreement with your previous post on your criticisms of “Big Pharma” as well. I wish I could give the whole thing a gold star or something.

I just wanted to quote this part because I feel you have hit the nail on the head, but also feel that there needs to be a caveat here–physicians often do not have a clue about how to read research or stats. Clinicians and general practice docs really don’t! The reason these “education” dinners are successful is in part because doctors are not freaking chemists or statisticians and if you throw up academic words and graphs they mostly nod their heads in agreement without understanding the real “why” of the chemistry or what is exactly happening on a molecular level…because they can’t.

This leads to a problem down the road because a doctor’s job is to diagnose an illness or disease accurately and determine appropriate treatment for it, but they did not study to become chemists, nor should they. The encyclopedic knowledge required to sniff out differential diagnoses and look at tests and interpret tests and all the rest does not leave time or brain power to be stats people or molecular mechanists. There simply isn’t enough time in school, or in the day.

Two of my clients are physicians, and one is a nurse. They do not know things about chemistry or drug metabolism that I learned years ago in school. It’s kind of depressing really, but frankly the scope of practice for a general MD or even a specialist deals with so much that they simply don’t have time. They see about 40 patients a day. After that they do paper work and continuing education, and they run staff meetings and do surgery. There’s no way in hell they can come up with the time to become chemists.

So the problem is that doctors often see things the same way a patient does “take this drug because it will prevent heart attack”. Therefore in good faith that is what they tell their patients. This means that I agree with you all the more about how to distance Pharma from consumers and from MDs, but there is a series of practical problems that need to be addressed in that process as well.

Setting aside the First Amendment issues…I am sympathetic to this idea, because DtC advertising makes doctors’ lives difficult. But wouldn’t this detract from your goal of a better-informed healthcare consumer?

Meh. It takes more than a dinner to sway us. And having attended a few of these, I can tell you there’s an awareness shared by the physician-speaker and the audience of the fact that the speaker’s remarks have been designed to put the sponsor’s product in the best possible light. (Unnecessary disclosure: I haven’t attended one of these dinners in many years.)

As an aside, I will point out that certain states do prohibit this sort of thing. Some go so far as to forbid their physicians from accepting a cold bagel at an 8 AM conference talk if the bagel is ‘sponsored’ by a drug company. Mind you, neither the conference nor the speaker are sponsored by the drug company–just the bagel. I don’t know if you could be bought off with a bagel, but my price is somewhat higher than that. (Aside to the aside: It’s amusing and irritating to think of legislators–who are not only allowed to accept thousands of dollars from Pharma, they’re allowed to solicit them–telling us that we can’t accept a bagel because it might cloud our judgment.)

This is because the vast majority of pts do not possess the requisite fund of knowledge and or critical-thinking skills to process the ‘true risks and benefits.’

Small quibble: No physician (in her right mind) would say a therapy would prevent a heart attack, as to say this would be to expose oneself medicolegally. Rather, we say ‘you should take this drug because it will reduce your risk of a heart attack.’

You have to believe me when I say that, for most pts, you would not be doing them a favor by presenting the decision in this manner (although there are certain select circumstances in which I do precisely this). Further, in my experience most pts do not want to try and make such decisions. Rather, pts expect their doctor to have ‘crunched the numbers’ on their behalf, and to make the appropriate recommendation based thereupon.

I can’t even begin to estimate how many treatment-related discussions I have had with pts, but I can tell you how 99.99% of them ended: With the pt saying ‘Whatever you think is best, doc.’

For a very few select pts, this would be true. But for the rest, it would lead to confusion and doubt, both of which can undermine the pt-doctor therapeutic alliance.

It is indeed. But it is also our responsibility to convey those risks and benefits in a manner tailored to the intellectual abilities and emotional needs of the pt. Doing so is part of the art of medicine.

I think–I know–this underestimates the sophistication of most physician’s understanding of the data. (If it accurately describes your doctor’s level of understanding, you need to get a new doctor.) It’s true, most of us have forgotten the aspects of pharmacology that are no longer relevant to clinical practice–those synapses got pruned for lack of use. But most of us have a pretty good handle on the clinical-trial-level data, at least so far as new drugs are concerned.

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If you’ll forgive the oversimplification and slight misstatement (“reduce your risk” vs “prevent”, although I think the overall thrust of the hypothetical quote was clear), I was speaking in a general way in order to make a larger point about the scope of practice and the vast knowledge base required to be good at general medicine vs drug mechanisms and specifics. I’m quite sure you specifically have a good grasp of research and clinical trial data analysis, but a lot of general practitioners I don’t feel do have your same grasp. I feel this is probably particularly true due to your MD/PhD and research experience.

In general I would surmise it is probably inversely related to scope of practice: the more specialized one is the more one is current on clinical trials and new drugs. On the other hand if you’re a general family doctor, your scope is quite wide and I would not expect them to be up on most new drugs as much.

Also keep in mind you’re in a major metro area–there are tons of doctors out in smaller towns across the country that don’t routinely go to conferences and serve people. I live in one such town, and although the doctors who are clients of mine do (or have, one of them is retired) make it a point to attend conferences this is not universal in the less urban areas.

I suppose it is relative, but I’m pretty sure most people wouldn’t consider the town of my residence a “major metro area.” My ‘city’ pop is about 60,000 people, and the local news routinely includes a farm report.

But the next time I see him, I’ll pass along your compliment to the mayor. :wink:

In fairness, my view of doctors’ degree of sophistication could be skewed by the fact that I work in a teaching hospital, and thus like me, most of my colleagues are university-affiliated.

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Excellent stuff, as always. A few thoughts:

In theory, yes.

In practice, I don’t think so. In my (not very humble) opinion, the current state of DtC advertising does not inform a consumer of anything useful other than “I see good-looking people walking through a field with music playing, maybe that erectile-dysfunction drug will help me do the same thing!”

Agree-ish. I believe you (and believe that this would hold true for many of my colleagues as well - most of the “old dogs” have seen all the tricks and typically remain skeptical of almost any new treatment, or at least, any new drug).

Completely agreed with that part, lol.

And now we come to the real meat for me…

This is a valid counterpoint. I’m a stats guy; I spend all day working with numbers. Most people do not, and as you correctly surmise…well, hold this thought for a moment.

I completely agree that is what should be said.

But I have directly heard cardiologists say things like “We know statins prevent heart attacks” (in our journal clubs, anyway; I sincerely hope that they are not saying that to patients).

OK, back to that thought you’re holding:

I will, somewhat reluctantly, admit that you are right. Back to that thought I asked you to hold earlier - most people are not comfortable with things like probability and uncertainty, and I admit that many patients do not care to hear that this drug might reduce their five-year risk of heart attack from 11% to 8% while introducing the possibility for bleeding in 5% of patients, trouble sleeping in 10%, frequent urination in 25%, etc.

I don’t doubt that you personally have a good understanding of such matters (as Aragorn noted, I suspect that your MD/PhD and research background gives you a leg up in that regard on many practicing MD’s) and maybe that’s even typical amongst your institutional colleagues.

But just as you have countless experiences relevant to the points above, in four years “working” with MD’s, I’ve already amassed a long list of “I can’t believe that I had to explain (insert basic study design concept here)” stories. I do not expect all or even most MD’s to be statistical experts (that’s why I have a job) but I have plenty of anecdotes suggesting that many of them display an unfortunately mediocre understanding of how to interpret the results of clinical trials.

One point from Aragorn’s last post:

This is more than likely true, and there is no solution to this. General practitioners are, in my mind, some of the most under-appreciated, under-paid, under-everything resources we have in medicine. They’re also a frequent target of jokes from my colleagues who scoff when they hear that a community GP started Mr. A on Drug X when there was no indication for doing so, and then Mr. A ended up at our ED for chest pain.

On paper, it seems a sensible model: GP’s monitor patients, handle primary care on basic issues, but kick things to a specialist if they feel it is warranted. In that model, GP’s don’t have to be well-versed in the latest clinical-trial data for every drug; what they must be good at (and this is a tremendously difficult chore) is determining when a patient has a real problem that needs to be kicked to a specialist vs. when they have something that can be treated with the old chicken-soup-and-more-sleep routine.

Yes, being a GP is a whole lot more complicated than that, but my point is that I don’t care if my local GP has read the latest trial on Glitipromazoleabride. I do care if my cardiologist has read that trial, though, and if they have, I’d like them to understand it better than merely reading the first paragraph of the Discussion and “OK, looks like this Glitipromazoleabride is ready for prime time.”

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Fair. And your posts are excellent on this topic (I never expected to have anything resembling an actual conversation in a Zep thread).

To be honest I wish most doctors were affiliated with teaching hospitals. I feel such doctors have a much greater awareness outside of immediate practice areas compared to others, and that is a great thing.

This is true for me as well. Obviously the plural of “anecdote” is not “statistical significance” but quite enough for me to come to the same conclusions as yourself. I in fact believe that many of them are only slightly less guilty of the “abstract highlighting” when talking about studies as non-medical pros (or as you note, the first Discussion paragraph). That may be a bit cynical and ungenerous, but it does jive with my experiences better than the notion that most of them are adept at parsing trial data and methods/interpretation. And it’s important to say that this isn’t due to a deliberate slacking off on their part of course.

Agree, and I’ve even been guilty of making jokes as well. But they have an extremely hard chore and are very underappreciated.

Well, the cardiologists are almost certainly correct–statins probably do prevent heart attacks. What I mean is, there is a cohort of pts out there for whom statin usage played a causal role in preventing them from having an MI they otherwise would have had. So like I said, the cardiologists are right in that sense.

The issue is, there is a (probably much larger) cohort of statin pts who don’t have an MI, but they wouldn’t have had one even without the statin. And finally, there is a cohort of statin pts who do have an MI–pts for whom the statin did not work (‘work’ here meaning ‘prevent an MI;’ note that the statin might have delayed the MI, or reduced its severity). And at this point in time, we do not have the ability to determine a priori into which of these cohorts a given potential statin pt would fall.

tl;dr It is probably technically correct for a cardiologist to assert ‘we know statins prevent heart attacks.’ What would be an incorrect extrapolation on the part of said cardiologist would be to say, to a specific individual pt, ‘we know statins will prevent a heart attack in you.’

All those things you think ought to be stopped won’t because it could dent their profits. Like I said, the system sucks and Big Pharma owns the FDA. Completely corrupt.

Who is advocating a total dismissal of the FDA process?

A flaw in the system. Who has a incentive to keep this going?

DtC marketing will most likely never be stopped, as it is too lucrative for Big Pharma. And they ow the system.

[quote=“EyeDentist, post:403, topic:224450”]
This is because the vast majority of pts do not possess the requisite fund of knowledge and or critical-thinking skills to process the ‘true risks and benefits.’[/quote]

Agreed, and this is why things are phrased as carefully and purposefully as they are in (the better) ICFs.

Participants typically don’t sign a form stating they understand the risks/benefits of the study, or that they understand the study, or that the study has been fully explained to them… because they aren’t in a position to really say that.

So, they usually sign forms stating that they understand the information presented in the consent form/consent process. From one I have most readily available: “I understand the information in this form, I have been able to ask questions, and I have had my questions answered.”

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What if the clinical-trial level data has been manipulated to favor the outcomes? Which benefit the profits for Big Pharma.

Eventually, the manipulation will come to light. The investigators will lose their credibility (and perhaps their jobs), and the pharma corp will be subject to stiff fines, and perhaps civil action.

If fines are given it won’t compare to the profits already made and future profits made on the specific drug. Job loss will only occur if the person is not protected by Big Pharma. Loss of credibility implies that the group responsible for the manipulated data won’t be able to do it again. Highly doubtful as Big Pharma owns the system.

Academic physicians conduct the lion’s share of RCTs, at least at the Phase III level. If found to have manipulated data, they will lose their jobs, and their standing in the academic community. If being ethical is not motivation enough, the prospect of such losses are enough to deter most clinician-researchers from knowingly misrepresenting their research.

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:areyoukiddingme:

Really? Then why does it happen at all?

My sentiments exactly. Pharmaceutical companies worry as medical marijuana use increases