In 1998, Lazarou, Pomeranz and Corey published, in JAMA, what is still (in 'ole Hank's humble opine)
one of the most important papers in the medical literature.
The authors looked at 30 years of data between 1966-1996 on the incidence of hospital related deaths due to unfortunate adverse reactions to one or another drug that was administered. They found that about 106,000 patients die each year from drugs -- not overdoses, mind you, but from the "properly" prescribed doses. That makes it the 4th biggest killer after heart attack, cancer and stroke.
Of course, these deaths were not intended, but neither were they counted. Just blips on the screen to the medical establishment, the cost of doing business. But the "times they are a-changin" (at least a little).
Everybody knows that Merck has been in a world of hurt over Vioxx. Now, we see that Wyeth just got nailed for some decent shekels in a Pennsylvania court room.
A jury awarded a woman $1 million and her husband $500,000 in compensatory damages after finding that Wyeth's hormone replacement drug, Prempro, caused a poor woman to get breast cancer. Punitive damages to follow.
The learned commentator in one of our threads, who asserted: "It is not possible to follow the tenet 'First, do no harm", needs to read Stephen Davis' Wrongful Death. He just might see the writing on the wall.
Right along with that 1998 paper, you should definitely mention the 2000 paper by Starfield, "Is US Health Really the Best in the World?" (JAMA 2000 July 26; 284(4): 483-5).
This article adds, to the normal prescription deaths mentioned above, deaths caused by unnecessary surgery, infections, medication errors, and "other" errors, to arrive at a total iatrogenic death count of 225,000 per year in the U.S.A. Almost a quarter of a million, which puts this category in the THIRD leading cause-of-death position, behind heart disease and cancer. Third!!
So if you aren't in the process of actually dying from either heart disease or cancer, statistically your best bet is to stay away from those doctors at all costs!
Posted by: Steve | October 06, 2006 at 08:01 AM
I predicted my comments about "First do no harm" would be quoted out of context, despite my request that they were not.
Here it comes again: "It is not possible to follow the tenet "First, do no harm." Since ALL drugs have side effects, their use is a trade off between risk and benefit. If doctors decided to never do harm, they would never do anything."
I repeat, since all drugs have side effects, the only way to never do harm would be to do nothing, and never give anyone a drug, ever.
I can see the emergency room doctor now: "Your daughter has meningococcal meningitis, Mrs Jones? I'm sorry, but I cannot possibly give her antibiotics to cure her, since she might get a rash." Yeah,.... Very logical.
Posted by: DT | October 06, 2006 at 08:14 AM
DT, you are carrying the statement to the extremes. Of course there are risks involved with any drug. Life is all about taking risks. We are looking at the larger picture here. When drugs are having more and more dangerous effects which seem to be more than the original problem, does this make sense to you?
There are many routes to treatment. However thanks to the Flexnor report and to the powerful powers that be, we are mostly in this prescription boat of treating ailments.
Posted by: noreen martin | October 06, 2006 at 09:13 AM
Hey DT!
There is no contest between you and Dr. Knobless as profs. He wins hands down and I am sorry that I seeemed to favor your repetetive bluster when I first read your writing here that now reminds me a lot of my prof in the middle of nowhere USofA so maybe you use the same secret website.
Anyway I did not come here now to diss you (or as you would say "spew abusive ad hominems even if you don't exactly know what those words mean either. I do because they made me take Latin in catholic school for a year and that's one of the things I remember because like a lot of people use it to sound smart but don't really do so correctly if ya get my drift maybe Dr. DT).
No. I came to point out that even to a dummy like me there is no difference at all in meaning or intent between the short and long versions of your self-serving (if you ARE a doc) infantile quotation.
Posted by: Back-door Recent Grad. Gal/Guy (XX/XY) | October 06, 2006 at 09:57 AM
There's "first, do no harm", and then there's "prescribe drugs as fast and as often as you can".
If we interpret "first, do no harm" to mean "take intervening action only when the benefits are carefully documented to exceed the risks", which sounds quite reasonable to me, then doctors who follow this tenet should, statistically speaking, not score as the third leading cause of death. Since allopathic medical care does, in fact, score that high in the USA, it is obvious to me that modern allopathic doctors are far closer to the "prescribe drugs and surgery fast" end of the spectrum than the "apply interventions only when more likely to do good than harm" end.
So even if it is not technically possible to "first do no harm" without simply sitting back and doing nothing whatsoever, it is quite obvious to me that the medical system as it currently stands is broken. I would suggest at least *aiming* for the trusty Hippocratic Oath, even if it is not possible to quite reach it.
DT, there is no need to worry about going too far in the Hippocratic direction. Indubitably, patients will tell their doctors if they think they've gone too far in choosing to withhold intervention. Contrariwise, it is much more difficult for patients to resist prescribed interventions, even should it occur to them to attempt to do so.
Posted by: Steve | October 06, 2006 at 10:10 AM
"I predicted my comments about "First do no harm" would be quoted out of context,"
If it really were so Dr. DDT (I presume), you should be proud. You're the first HIV/AIDS apologist ever to come up with a true prediction.
Posted by: MacDonald | October 06, 2006 at 07:09 PM
DT,
The post isn't about you. It's about Lazarou and 106K deaths/year by drugs intended to help, not kill.
Have you read Lazarou?
If yes, hopefully it was before today. Please address it.
HankB
Posted by: hankbarnes | October 06, 2006 at 07:46 PM
Hank, your OP may have been about Lazarou, but it was also about me. Your post said:
"The learned commentator in one of our threads, who asserted: "It is not possible to follow the tenet 'First, do no harm", needs to read Stephen Davis' Wrongful Death. He just might see the writing on the wall."
Posted by: DT | October 09, 2006 at 12:59 PM
Dr. Learned Commentator,
Are you going to address Lazarou (106,000) deaths/year by "medicine" or not?
Hank
Posted by: hankbarnes | October 09, 2006 at 07:30 PM
Hank, maybe he feels that like war, these are acceptable casualties. I can think of no other industry in this country which would allows this to happen. Does the mining, nuclear, or airline to name a few allow this? They all have accident investigation boards to look into mishaps. Who monitors the drug industry, themselves?
Posted by: noreen martin | October 09, 2006 at 07:41 PM
Noreen,
Like in war, Dr. DDT doesn't feel he should pick fights he can't win. That's why he prefers discussing Tea Tree oil and PH with the girls.
Posted by: Lise | October 09, 2006 at 09:37 PM
I agree the Lazarou study is important, since it attempts to puts some sort of quantitative scale on the adverse events related to drug therapy in hospitalised patients. However, it has been widely criticised for overinflating mortality data in particular. There has been plenty of debate on the validity of the study, as a trawl through the not inconsiderable JAMA (and other major journal) correspondence and subsequent published papers has shown. Hank surely cannot be unaware of this, but he conveniently declines to mention it.
Nevertheless the point is well made - drugs have side effects which can kill, something I have never denied. Noreen put the problem into perspective with her comment: "Of course there are risks involved with any drug. Life is all about taking risks. We are looking at the larger picture here. When drugs are having more and more dangerous effects which seem to be more than the original problem, does this make sense to you?"
We are indeed looking at the larger picture. If drugs have more dangerous effects than the original problem, that certainly does not make sense to me.
Leukemia drugs cause far worse toxicity than HIV meds, but chemotherapy leads to remission rates of up to 80% for what would otherwise be a fatal disease. No-one should doubt that the risks of chemo are worth taking, even though many chemo-related ADRs might help plump up Lazarou-type data.
Aspirin is another example of a drug which seems to account for a lot of in-hospital morbidity and mortality. Deaths from aspirin could certainly be cut if people (doctors included) were more careful about when it is used and by cutting the dose to the minimum dose required for efficacy. Yet there is no denominator when one considers aspirin ADRs - we don't know how many million doses are taken usually by the population.
For HIV dissidents, it always comes back to the old HIV problem. For someone who believes HIV is nonexistent, or harmless, or a cofactor, or electron microscopic vesicle debris, or whatever the denialist explanation of the week is, HAART is always going to be worse than the disease. Rational arguments about a balance of benefit vs harm, which any right minded person can understand when it comes to any other drug, fall by the wayside when HIV is discussed.
Posted by: DT | October 11, 2006 at 01:33 PM
DT,
Better, but you still make uncited claims and stray far afield. Here's 2 examples:
You write:
"However, it has been widely criticised for overinflating mortality data in particular."
Widely criticized? Oh really? By, ahem, the same people who make a living pushing the drugs and ignoring the problem?
Starfield cited it -- without criticism -- and raised the ante to 220,000 iatrogenic deaths per year. You need to deal with this, not dismiss it.
Finally, please name a published criticism of Lazarou, instead of hand-waiving various unspecified "critiques" from JAMA, and why you, personally, found this critique persuasive. I suspect -- like a security blanket -- you just glad that critiques may have been made.
This is the heart of your problem when you write:
"If drugs have more dangerous effects than the original problem, that certainly does not make sense to me."
Have you heard of Vioxx? Thalidomide? Prescribing arsenic for syphillis? Bleeding patients for yellow fever? From time immemorial, the medical "experts" of the day have gotten it wrong, and killed a lotta people in the process.
The problem is, they're still doing it today.
Hank
Posted by: hankbarnes | October 11, 2006 at 01:59 PM
DT, you bring up that chemotherapy is worse than the HAART but is an necessary evil. However, the problem that must of us have with the HAART is that a toxic drug is being given to person's without any symptoms. Do you agree with this?
Posted by: noreen martin | October 11, 2006 at 02:54 PM
Noreen, HIV therapy is started either when the patient develops symptoms or when immunological parameters indicate that significant immunodeficiency (and therefore risk of severe opportunistic infection) is imminent. UK guidelines state that therapy should be started before CD4 count drops below 200/ml.
So yes, many will not have experienced symptoms, but several studies on progression/the natural history of untreated HIV indicate that this is the right time to do it. Clearly commencing HAART when CD4 counts are higher (500) poses a risk of unacceptable toxicity, since it may be several years before patients might drop nearer the danger zone.
An analogy could be drawn with a condition such as cervical cancer. Obviously women with symptoms get immediate treatment. However, screening can yield smears can show advanced grades of CIN that require the same treatment, even when there are "no symptoms". (Very minor cervical abnormalities can be monitored with repeat smears, rather than immediate treatment.)
Treatment for cervical carcinoma can be harmful. I assume from your comments here that you would advocate waiting until the woman showed symptoms before attempting treatment.
Posted by: DT | October 11, 2006 at 08:26 PM
There again DT, it would depend upon what grade the abnormalities are for the pap smear. For instance, if she is mildly abnormal or class I, why would a hysterectomy be given at such an early stage to prevent cancer thus causing a host of other problems to the patient. The prudent medical treatment would be to perform a staining, coposcopy, biopsy if needed and the patient followed-up more frequently, therefore devising a better medical plan for the patient.
In regards to if one is diagnosed with HIV, so what. Many are walking around on the planet 15 or more years without any symptoms. You think that they should be on medicine because of CD4's?
Olympic athletes have been known to have low CD4's. I am not an athlete by any stretch of the imagination, however, my CD4's have been higher with a higher viral load than they were with a lower viral load. Even my physicians admit that the test is not that accurate. It can be off at least 30%. They vary from the time of day that the test was taken to the lab which is reading the test. They are a piece of the pie, but not the whole pie. Last test, mine were at 191.
According to you, I should be hitting the "panic" button by now. Hank has my permission to post my results(updates made)if he wishes. If as one website called us, "statistical flukes", then I'm the healthest one around.
Posted by: noreen martin | October 12, 2006 at 03:08 AM
Hank, the Lazarou publication prompted a lot of debate and plenty of soul searching. But there was also plenty of criticism over its innacuracies and poor methodology, none of which negates its importance in bringing the problem into focus, however.
Here is one paper specifically addressing the failings of the Lazarou study. It reanalysed all their data and one of their comments was:
"Simple pooling of fatal event frequencies from only those studies specifically reporting the number of fatal ADRs, as was done in the meta-analysis of Lazarou and colleagues, is likely to dramatically overestimate the death rate.
Their conclusion was that: "The methodology used was seriously flawed, and no conclusions regarding ADR incidence rates in the hospitalized population in the United States should be made on the basis of the original meta-analysis." Certainly you can quote Lazarou if you wish as a study highlighting morbidity from ADRs, but it is only fair to point out that the study overestimates mortality.
One concern regarding ADRs is that we should be draw a distinction between "avoidable" side effects - those which need never to have occurred because errors were made in prescribing the wrong drug, or giving the wrong dose, or not accounting for drug interactions etc, rather than "unavoidable" ADRs where there is always a quantifyable risk of a reaction but the drug has been given appropriately. many studies do not draw distinctions between these. Many ADRs leading to hospital admission appear to fall into the "avoidable" category, so there is clearly a lot of room for improvement.
Another issue is that the 2 types of drugs that are responsible for the majority of admissions to hospital and mortality -aspirin and non-steroidal anti-inflammatories (NSAIDS) are often taken by patients following over the counter purchase and not issued on prescription. That doesn't make the drugs less dangerous, I agree, but doctors have often not been responsible for the original prescription of the drug. Perhaps the pharmaceutical companies promoting OTC use of these drugs are more at fault than doctors.
You said: "Have you heard of Vioxx? Thalidomide? Prescribing arsenic for syphillis? Bleeding patients for yellow fever?" Interesting that you try to create a list of dangerous drugs, and can only come up with one (Vioxx) that is of any relevance in the last 40 years. No doubt with some more time you could find other examples. It's quite revealing how the old canard of Thalidomide keeps getting trotted out again and again. It seems there are very few drugs out of the thousands currently available in the pharmacopeia that the public can name as being dangerous. You need to realise that because the "medical experts" as you call them occasionally get it wrong it is incorrect to assume they always do. But I realise logical fallacies are not your strong point.
Also interesting that you place Vioxx in this category. In fact the reasons behind its (voluntary)withdrawl were not so much due to overwhelming evidence of serious harm but down to risk management and political shenanigans. Merck was guilty of glossing over safety data about cardiovascular events and trying to make the risks seem less than they were. In fact the entire class of Cox2 inhibitors and other NSAIDs have similar cardiovascular risks. It is clear they should only be taken when needed and potential for benefit outweighs possible harm.
Actually Vioxx and other Cox2 inhibitors have probably saved far more lives than they have been accused of losing. One of the main reasons for favouring a Cox2 is that they have a lower incidence of GI bleeding than do plain bog standard NSAIDs. Remember those? These are the same drugs that are the leading cause of admission to hospital and of death from GI bleeding as shown in the Lazarou and other studies. I wonder if Vioxx were not used, how many more GI bleeding fatalities there would have been?
Posted by: DT | October 12, 2006 at 05:53 AM
"Can only come up with one(Vioxx)that is of any relevance in the last 40 years"
Then there was DES, the live polio vaccine contaminated with SV-40, nearly 100 million exposed. The last case of polio in the U.S. was caused by the vaccine itself. According to Michele Carbone, Assistant Professor of Pathology at Loyola University, fragments of SV-40 have appeared in up to 40% of bone cancers and 60% OF MESOTHELIOMAS, a nasty lung cancer.
Medicine isn't perfect but the makers of these drugs and vaccinations should be held to a higher standard of accountability to the public.
Posted by: noreen martin | October 12, 2006 at 07:29 AM
DT,
Whether Dr. or no, after consultations with Hank and the other members of the YBYL staff, I am authorized to offer you a contributor's column much as our other distinguished contributors provide the ever growing (by leaps and bounds) readership here.
You would be free to discourse at appropriate lengths on any of the patrician (some might say patronizing) attitudes opinions and other assorted mental baggage you parade as 'insider knowledge'.
I am being a bit satiric, but not insincere in the offer.
We are confident such a column would be a big hit, and also keep you out of mischief maybe.
If you choose to provide your real name and a photograph, you can be listed with the other Contributors. Otherwise, you can be from one of the edges (the farthest one).
How 'bout it DT? Send Hank an email for "instructions to authors" and you too can be a star.
Posted by: Otis | October 12, 2006 at 12:04 PM
Leukemia drugs cause far worse toxicity than HIV meds, but chemotherapy leads to remission rates of up to 80% for what would otherwise be a fatal disease.
It's a mystery to me why nobody jumped on this one. Well no, it's not. There seems to be such an overwhelming scientific consensus over the cancer item. You're all fighting over HIV does or does not cause AIDS but once people start talking cancer everybody agrees that toxic drugs may do harm, but it's the best we have. Hey, where did I hear that before? Oh yes, I remember. Aids apologist baby talk.
Chemo is the best we have against cancer. Everybody agrees? Everybody agrees. So let me be the first to pop that very convenient little bubble of consensus.
Leukemia drugs cause far worse toxicity than HIV meds
What a bullshit. AZT was first developed as a drug against leukemia, remember? Considered too toxic against leukemia in the sixties but, 20 years later, all of a sudden a wonderful remedy in the battle against AIDS. I understand now: applied against HIV, the meds cause less toxicity. What a joke: today we read things like AZT causes leukemia. That also reminds me of something...
but chemotherapy leads to remission rates of up to 80%
Yeah, sure. But for how long? One month? Two? Sweet Jesus, those leukemia chemo children, they sure look great don't they! Thanks to the wonders of chemo. What? Why do you get aggressive and want to hit me all of a sudden? Chemo kids don't look great at all, I'm a monster to write things like that? Yeah of course, I know. I was being sarcastic. Chemo kids look terrible. But even, we must not forget, they are in remission.
for what would otherwise be a fatal disease.
You blockhead! Leukemia and chemo is like AIDS and AZT. Treatment worsens everything + the child feels miserable because he knows, as everybody tells him, that he has this terrible disease. Exactly as the HIV+ patient feeling terrible about his condition. Aids and leukemia: It's quite the same story. Wake up!
Ever did a study on leukemia kids who were not treated at all? No? Give it a serious try, you'd be surprised. I guarantee: Within some years the world will be filled with long term symptom free leukemia survivors.
Drugs don't have side effects. They only have effects. First you try to fully understand disease, then you try to find remedies. Do no harm and quit being the wizard pupils. Remedies which give the impression that people feel worse after treatment than before are to be seriously questioned and should not be excused with nonsense phrases like "It's impossible to do no harm".
It's not "Treatment + Do no harm = impossible". Treatment + Do no harm + Earn big money: There's your incompatibility.
Posted by: henrysillian | October 12, 2006 at 03:58 PM
DT or whatever your initials are,
Since you read so much and know so much about cancer and its treatment, why don't you leave us some nuggets of your wisdom concerning this article by George Miklos, which undoubetedly you read when it first appeared in NBT, and surely when it reappeared at your favorite weblog?
http://barnesworld.blogs.com/
barnes_world/2006/09/george_gabor_mi.html
Posted by: George | October 12, 2006 at 04:34 PM
Henry, you are right. We are so "conditioned" to radiation and chemotherapy for the treatment of cancer that this is normal. Not the best but normal or the accepted treatments.
Many of us know of other, non-traditional treatments for cancer but just like the HAART for HIV or AIDS, they would go over like a lead balloon with the medical establishment.
Posted by: noreen martin | October 12, 2006 at 05:19 PM
Yes Henry, you are so right! How could I have been so stupid?
Your great powers of persuasion and irrefutable logic have revealed the truth to me. I now realise the world is full of untreated long-term leukemia "non-progressors" (elite controllers?), malignancies are in fact benign or able to be cured with homeopathy, mercury has given us all autism, Glaxo Smith Kline funded Osama binLaden, and Hitler never killed any jews.
Some people are in AIDS denial, others are just in denial.
Posted by: DT | October 13, 2006 at 08:14 AM
DT,
Even though you are a neutered, AIDS, Inc. robot machine, you are still invited (for the second time)to become a regular (irregular) columnist and "spew your garbagge" from the head of the class instead of the peanut gallery.
P.S. There were 2,167 independent visitors to YBYL yesterday, from about 15 countries.
What about it Mr. Know "Whatever"?
Posted by: Otis | October 13, 2006 at 09:13 AM
DT, what planet are you on? Your logic bounces all around like a ping pong ball! No one says that homeopathy cures cancer or that the drug companies fund Binladen or that Hitler didn't kill Jews.
We are not in denial but I am beginning to wonder about you.
Posted by: noreen martin | October 13, 2006 at 09:17 AM