Don't Take That Pill!

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Vance917

I teach a class on clinical trial design and analysis, and the theme is mostly about all the biases that plague clinical trials, and how these biases are wonderful for selling drugs, but horrible for the patients taking them.  Does anybody here on Chess.com care?  Well, maybe.  Maybe not.  But let me put it this way -- do any of you take any medications?  Do any of you have loved ones who do?  Would any of you ever consider the possibility of getting sick and taking a medication?

Trace the chord back to the wall and see how weak the chain is not only at its weakest link, but in fact at just about every link.  Your physician prescribes a medication because the manufacturer sent him to Hawaii or Tahiti for propoganda dressed up as "medical education".  Yeah, right.  But of course he will not offer this as the reason.  No, he will point to the article in the prestigious medical journal, and the implicit FDA endorsement that can be inferred from approval of this drug to be sold.

How can a useless, even harmful, drug be studied by the "best" methods available, in a study funded by the most prestigious funding agencies, result in publications in the most prestigious medical journals which conclude that the drug is safe and effective?  How can such a study, or series of studies, form the basis for regulatory approval?  My class discusses the "tricks of the trade" that make it possible to defend the indefensible and support the unsupportable.

The bottom line is that drugs which are advertised as being safe and effective are quite often neither.  Again, I have no idea how much or how little anybody here cares, but if there is sufficient interest, then I will expand on these ideas, and summarize some of the tricks that are used, and how these tricks result in the appearance of safety and efficacy when in fact none exists.

RyanMK

So we shouldn't take medicine if we have a disease or illness? Are you against penicillan as well? Or flu vaccines?

Vance917

That is not what I said.  What I am against is the flawed methodology used to study medicines, and the uncritical acceptance of trial results.  Bad studies do not prove that the medicine is bad.  But certainly we cannot take at face value the claims that they are good.  In the case of penicillin, there is quite a track record, and that speaks for itself.

mowque

i trust alot of speicalists in my daily life, i can;t know everything. Health care...well, i have to put my faith in FDA, just like the USDA with meat

Vance917

You're right -- it is not practical for each of us to become encyclopedic in our knowledge of the methods and results of the studies of all drugs.  Yet this is also quite scary for someone who knows the system like I do.  My hope is that another Upton Sinclair will come along and expose just what is going on so that the public can demand reforms.

freetofly33

I agree with you Vance 917. I have also taken statistics courses and have been involved in conducting research in the past. The bottom line is that you can spin research results to say anything you want them to say-- ANYTHING. I do think it is important sometimes to take medications, if you really need them. But, I also believe that it is important to take what people (all people) say with a grain of salt... research studies are not unbiased just because they claim to be.

Vance917

Well said!  So what do you do for a living?  Or are you a student?  Sorry if I already asked you this, but my memory is not what it ... never was!

Ritadhooge

What will happen to me if I mix Finecol and Medlemon?Frown

Vance917

Good question!  Let us know once you do!

ButterflyBliss

The pharm business is really out of hand. I was dating a doctor that had the very same thing like you are saying. He'd go to luncheons every week at a very fancy place all on the pharma companies just for writing prescriptions!

Most of the pills I see on TV cause more side effects than the actual cure is even worth. I wouldn't doubt that most of them are dangerous. But drugs are dangerous anyway when it all comes down to it.

The biggest thing I find appauling is the lobbyists trying to get the FDA to disapprove of safe (yet dangerous) compounded drugs so that the patient is forced to buy the expensive name brand drug and not the more affordable generic compounded one.

It seems to be a never ending battle with not enough people to care enough to fight.

Protego

A drug can be used in diseases in a cause for treatment. It appears to be effective only in one way. On the other hand it may cause other problems in the self defence of a patient, as a resault the  "cure" only has  a relevant meaning.

However in every medical description there is a piece of paper with tiny letters that describes the statistics of "what it might happened" to the health when taking those medications.

So the doctors don't have to worry that they did something wrong or cause any damage, and the patients are getting sleepy happily ever after.

Vance917

Thank you both -- everything you say is true.  But there is more than even you know (or at least more than you wrote here).  Because the common perception is, as Dina said, that they work in one way but may cause harm in another.  What I am saying is that they may not even work in the way you think they do.  So you are trying to balance the good against the bad, except that the good you are trying to balance is, in many cases, an illusion.

One example is carvedilol.  The pivotal trial used an active run-in period, meaning that all patients received carvedilol BEFORE being randomized to the same carvedilol or a control.  But here's the catch.  Only those who did well during this run-in period were randomized.  The others were excluded.  Among these others were seven deaths and 17 serious cardiac events.  But as far as the report goes, it never happened.

Want a chess analogy?  Who would like to play 100 games of chess against me, not for fun, not for chatting, not for improving our respective games, not for any other purpose but seeing who is the better player, but with a catch.  In any game in which you get my queen first, before I get yours, I dit the "do over" or "reset" button, and the game never happened.  This is not me resigning.  It just never happened.  So suppose that you get my queen first in 80 games, and in the remaining 20 I win 15.  Now I claim to be the better player, as I won 15 of 20 games (75%).  Are you happy with this arrangement?  Oh, and did I mention that for "winning" I get a huge prize that could have instead been yours?

celiarose

Glad my dad took his chemo pill, now he is cancer free. Talk about toxic side effects but well worth the alternative. I'll never take for granted the benefits of modern medicine and the brilliant dedicated doctors who saved his life. Don't be fooled, there are good honest medical professionals all around, you just have to find them. Its just a matter of time, we all will need their assistance. 

Vance917

I am glad that your dad is OK, and I agree that there are good doctors out there.  In no way does this contradict my statement.

Vance917

Tip of the iceburg.  When I have time I will write more.

Theoryful

Isn't the FDA mostly funded by pharma companies? That about sums it up.

Vance917

Yes, the Prescription Drug User Fee Act (PDUFA) of 1992.  But I do not think that this act necessarily ensures the problems we have (although it certainly has turned out that way).  The money could be "laundered" or "sanitized" so that it does not pay for results, but unfortunately it does not.  I used to work at the FDA, and I can tell you some stories.  Well, no, I can't, actually, not without fear of a law suit.  But what I can tell you is that the regulations are written so that a drug is approved unless a compelling reason is given not to.  And what is a compelling reason?  Ever read "Catch-22"?  Often in meetings I heard these exact words from a higher up:  "Let's find a way to approve this drug".

Theoryful

Catch-22, one of my favorites. Yossarian, what a character. I know, it's off tangent but hey, you brought it up. lol

Vance917

Great, great book!  But the point was the carrot you pursue that moves with you -- like trying to catch your own shadow.  This evidence is not quite enough to render the drug unapprovable -- we need a bit more.  OK, we still need more.  Still more.  More again.  Moving target.

OgreVI

Vance:  Don't wait for another Upton Sinclair.  Be one.