Friday, February 09, 2007

Accusations of disease-mongering and medicalization---are they evidence based?

The pharmaceutical industry has been under fire for its marketing practices. The latest barrage of accusations is about disease-mongering and medicalization. The idea is that the pharmaceutical industry carves out new markets for its products by inventing diseases and inflating the public perception of diseases.

Some of the more shrill industry critics are featured in the documentary “Big Bucks, Big Pharma: Marketing Disease & Pushing Drugs”, which can be viewed from this blogpost by Big Red Pill. The video deals mainly with direct to consumer (DTC) advertising, a major focus of the purported disease-mongering.

I don’t like DTC ads. But drug companies are going to market their products one way or the other. Public pressure may change how they market their drugs, but it isn’t likely to change the amount they spend on marketing. The constant hammering against physician marketing has been effective. It’s led to an increase in DTC advertising. But I digress.

Near the beginning of the video Marcia Angell, author of The Truth About the Drug Companies: How They Deceive Us and What to Do About It accuses drug companies of re-defining what it means to have hypertension and high cholesterol. Wrong, Dr. Angell. Although treatment targets have been lowered no one has “re-defined” hypertension. Hypertension is and always has been defined as blood pressure which exceeds a threshold for cardiovascular risk. Recent evidence suggests that that threshold is much lower than previously believed. An analysis of one million adults in 61 prospective studies demonstrated that the threshold is at least as low as 115/75. These data, rather than any “re-definition of hypertension” by the drug companies, are the basis for the lowering of blood pressure goals in recent guidelines. Over the years we’ve gradually become more aggressive in treating hypertension and data cited in the JNC-7 report suggest that this effort has reduced stroke, coronary events and heart failure. So what are you saying, exactly, Dr. Angell? What fault do you find with these data? You evidently believe we should go back to older, higher BP targets, right? What BP target do you feel would be appropriate and how would such higher targets help patients?

And what about cholesterol? I don’t see anyone defining high cholesterol or making it into a disease. The disease is atherosclerosis. We moved beyond worrying about what’s defined as high or low years ago in favor of setting treatment targets appropriate for the patient’s risk. These treatment targets have been lowered not because of any re-definition of high cholesterol by industry, but because it’s supported by evidence. So, again, Dr. Angell, let’s play fair. You evidently don’t agree with the new treatment targets. What’s wrong with the evidence I’ve cited? What targets do you think would be appropriate and what evidence do you have to support your proposed targets?

The narrator goes on to state that “Big Pharma normalizes even the most obscure health disorders and presents them as common.” Then, as if to illustrate that point, the video cuts to an ad about restless leg syndrome (RLS) which says that nearly 1 in 10 people have the problem. So how does this ad present an obscure health disorder as common? In fact evidence supports the statement in the ad. The figure of 1 in 10 individuals is not in dispute if one checks published research, something the producers of the video didn’t seem to bother to do.

Then Dr. Bob Goodman of No Free Lunch fame weighs in and accuses industry of taking common everyday maladies and “medicalizing” them. He asserts that of all the things they do this is the one thing he would label as “evil.” But he doesn’t really define what he means by medicalization. And while he points out that such “medicalization” might make a person realize that he or she is not healthy or (gasp) end up taking a prescription medication he doesn’t explain what’s really wrong with that. I wish I could pin him down. Is medicalization anything more than defining a problem? The idea that common everyday miseries are defined and characterized is nothing new. Constipation has its own ICD-9 code as does headache. Medicalization?

The video is unconvincing. If accusations of medicalization and disease-mongering are to amount to anything more than half truth and innuendo some questions such as those I have posed here need to be answered.

11 comments:

Anonymous said...

Just let me ask you one thie:Who exactly finances the studies to define the threshold for cardiovascular risk? The drug companies do.Is this not a conflict of intrest and does it not introduce a hefty dose of bias into the supposedly objective scientific basis for the changes in BP and other targets? Not everybody who comments on this phenomenon is a conspiracy theorist.

R. W. Donnell said...

To anonymous---
All research is tainted by conflict of interest in one form or another. The fact that a drug company (or any other interested party) pays for a study should cause us to look critically at the results and methods, not reject the conclusions out of hand (the *ad hominem* fallacy of rejection by affiliation). I'd be more than happy for you to challenge the new targets based on analysis of the actual evidence or criticism of the methodology. For that matter can *anyone* mount a better arguement than saying "look who paid for the study"?

Anonymous said...

These treatment targets have been lowered not because of any re-definition of high cholesterol by industry, but because it’s supported by evidence.
Would you care to demonstrate this evidence with regard to primary prevention in women?

R. W. Donnell said...

Primary prevention in women has not been the focus of industry promotion, and the evidence is pretty slim.

Anonymous said...

And what about cholesterol? I don’t see anyone defining high cholesterol or making it into a disease. The disease is atherosclerosis. We moved beyond worrying about what’s defined as high or low years ago in favor of setting treatment targets appropriate for the patient’s risk.
Yes, right... My 10-year risk of heart attack given my age, weight and risk factors (including cholesterol) is under 1%. So, tell me please, how come my doctor wanted to give me statins for LDL 4 points above threshold for my risk factors (btw - my triglicerides were low and my HDL high). He also "forgot" to tell me what my actual risk is, I had to figure it out on my own. I just love it when doctors misuse these meaningless relative risk numbers... "This will reduce your [really small] risk by a whopping X%". Is there something wrong with providing honest information about the potential benefits instead of just citing the guidelines?

As far as lowering the targets -- so how many people do you need to treat whose numbers are above these new targets but below the old ones to prevent one heart attack or stroke? How does the absolute risk reduction in these cases compare to the risk of side effects? What is the time frame before someone can benefit? You reducing small risk of heart attacks in future vs small risk of side effects now. This aspect of quality of life now vs smaller risk of something bad happening some years in future is something doctors tend to forget with primary prevention.

r.w. donnell - it seems this already been done. There was also a recent report in Lancet about the lack of benefit for statins in women.

Also, what is the prevailing belief today may be proven wrong tomorrow. When the guidelines are lowered they affect more and more people at lower risk. They are also likely to be treated for many years. If it turns out tomorrow that whatever you believe in today is wrong, there is much greater probability of harm. Need I remind to you about HRT? Ever read the article on the Arrogance of Preventive Medicine?

R. W. Donnell said...

To anonymous #3---
Concerning "My 10-year risk of heart attack given my age, weight and risk factors (including cholesterol) is under 1%. So, tell me please, how come my doctor wanted to give me statins for LDL 4 points above threshold for my risk factors (btw - my triglicerides were low and my HDL high)."

So you want me to somehow explain why your doctor didn't practice EBM? If you knew my position on woo you'd know I'm not into divination ;) Why not ask your doctor?

Concerning "As far as lowering the targets -- so how many people do you need to treat whose numbers are above these new targets but below the old ones to prevent one heart attack or stroke?" In the study I cited the NNT was 45, over about 5 years. By any reasonable standard of cost effectiveness that's not too shabby. I believe doctors should explain the treatment in terms of ARR and NNT as I once blogged here http://doctorrw.blogspot.com/2005/07/patient-participation-in-medical.html

Faced with that type of information some patients will decline treatment. It doesn't change the fact that new evidence indicates lower targets are optimal for secondary prevention.

And yes I did read the article on the arrogance of preventive medicine. I thought the article was rather arrogant, myself. So did CMAJ. They had to issue a public apology.

R. W. Donnell said...

To anonymous #3---
Concerning "My 10-year risk of heart attack given my age, weight and risk factors (including cholesterol) is under 1%. So, tell me please, how come my doctor wanted to give me statins for LDL 4 points above threshold for my risk factors (btw - my triglicerides were low and my HDL high)."

So you want me to somehow explain why your doctor didn't practice EBM? If you knew my position on woo you'd know I'm not into divination ;) Why not ask your doctor?

Concerning "As far as lowering the targets -- so how many people do you need to treat whose numbers are above these new targets but below the old ones to prevent one heart attack or stroke?" In the study I cited the NNT was 45, over about 5 years. By any reasonable standard of cost effectiveness that's not too shabby. I believe doctors should explain the treatment in terms of ARR and NNT as I once blogged here http://doctorrw.blogspot.com/2005/07/patient-participation-in-medical.html

Faced with that type of information some patients will decline treatment. It doesn't change the fact that new evidence indicates lower targets are optimal for secondary prevention.

And yes I did read the article on the arrogance of preventive medicine. I thought the article was rather arrogant, myself. So did CMAJ. They had to issue a public apology.

Anonymous said...

Primary prevention in women has not been the focus of industry promotion, and the evidence is pretty slim.
Is this reflected in the guidelines?

Anonymous said...

Concerning "As far as lowering the targets -- so how many people do you need to treat whose numbers are above these new targets but below the old ones to prevent one heart attack or stroke?" In the converting healthy people as sick, i.e. primary study I cited the NNT was 45, over about 5 years.
Please correct me if I am wrong, but this was the study of secondary prevention for the people who already have heart desease.

In my understanding, the accusations disease-mongering usually apply to primary prevention i.e. labelling people who were considered "healthy" yesterday as "sick" today because of the lowered guidelines and thus increasing the number of people who are considered to have a disease. So the study of secondary prevention.

Now the NNT for treating people with hypertension over 115/75 as opposed to current guidelines would be relevant to the subject. Are you aware of any RCTs that show a reduction in strokes for these people and what is the magnitude of this reduction?
Your link is a meta analysis showing death rates, it is not an R CT that shows treatment of pre-hypertension significantly decreases the number of strokes (compared to starting treatment later), the magnitude of this decrease and side effects?

R. W. Donnell said...

Anonymous said "In my understanding, the accusations disease-mongering usually apply to primary prevention i.e. labelling people who were considered 'healthy' yesterday as 'sick' today because of the lowered guidelines and thus increasing the number of people who are considered to have a disease."

That's what the video implied, and that's what everybody is screaming about, and it's not true. The guidelines everybody's concerned about (NCEP ATP-3)do *not* advocate aggressive drug treatment or low targets for primary prevention. For people with 0-1 risk factors (see table VI.1-3 of ATP-3)the guidelines recommend an LDL threshold of 190 for *consideration* of drug treatment. Note the term *consider* which means, as explained in the text of the full report, don't try drug therapy at all until diet and exercise (total lifestyle change) have been tried.

The only patients who are being recommended for the new low targets are folks who already *are sick* with atherosclerosis or diabetes!

This has become a widespread misconception, and I will consider this very point for a follow up post.

As far as hypertension you said "Now the NNT for treating people with hypertension over 115/75 as opposed to current guidelines would be relevant to the subject. Are you aware of any RCTs that show a reduction in strokes for these people and what is the magnitude of this reduction?" No. And no one's advocating treatment to that level. JNC-7 treament targets for the general population are 140/90, and that's only after trying lifestyle changes. I wouldn't call that disease mongering, would you? The somewhat lower targets for people with diabetes and kidney disease (not 115/75) are based on the HOT study and the UKPD study. I don't know the NNTs.

Anonymous said...

THE OLD SYSTEM IS COMING DOWN. I can hear the Drums beating. Bugs are outpacing Drugs. The next epidemic is here. Go to www.wsvn.com and Look at the Brilliant, Patrick Frazier (great journalist) he wrote a segment called: "Body Bugs" this says a lot and also look at the video.
www.wsvn.com scroll to "Body Bugs".
We have all been delusional and people are now screaming loudly. They want their HEALTHCARE and
GOVERNMENT BACK.
no more secrets.
Trisha R. Springstead RN
Florida
trishaspring50@bellsouth.net