Saturday, March 25, 2006

ethics and allopathy


ive often made references to allopathy's unsavoury ethics. let me explain (again) that first, it is the system i attack : at an individual level, people are often inspiringly wonderful - i personally know of a few very ethical and compassionate allopathic doctors who put patient welfare before allopathy every time. i deeply respect their effort and ability to heal people, as well as their ethical integrity and their courage in handling conflicts between loyalty to the system and to the people they heal.

i think such doctors are healers in the most basic sense of the word - they are so gifted, that even within allopathys rotten framework, they manage to work their miracles. which brings me to the second point on my agenda. why is the system still important then?

well, because the system isnt really structured with those of exceptional ability as its primary focus. the system aims to address the average elements (if not the below par) - the average doctor in this case, with an average sense of ethics, and average knowledge. the system is supposed to lay down guidelines when such people are in sticky, potentially complicated or dangerous situations. just like the protocols to be followed in an emergency treatment. if a system has gaping loopholes, or is inadequate, or even worse - is unethical, then the chances of these "averages" making mistakes or being unethical increases, and puts the people the system should be protecting, at much greater risk.

when i was working within an allopathic framework, it was maybe easier for me to examine issues with more detachment since i wasnt a doctor (and therefore not someone who would have to pledge blind loyalty). when i underwent training in medical ethics i had several questions. many of the questions were based on very specific trends and events - landmarks, in fact, in allopathic history and bioethics.

unfortunately there are so many instances i could think of to discuss here. for brevity’s sake, i’ve shortlisted two studies. one is the Tuskegee syphilis study, because I think it provides an excellent example of how corrupt the system can get, and how ostensibly “unrelated” social factors have a major influence. it offers a perspective on how serious the issue of medical ethics is. the second the study is the thalidomide disaster. the sort of loopholes that even i, an inexperienced layman can find are so many. also, this disaster underscores the importance of informed consent, something that i think is treated a little too glibly, and not given the consideration it deserves, especially in a country like ours.


the syphilis study.

the study subjects were 399 african american men with latent syphilis and 201 men without disease. they were enrolled based on a survey/study conducted in 1930 on venereal disease control. this study identified macon as having the highest prevalence of syphilis amongst the six southern states covered.

in 1933, the us public health service in macon county in Alabama started an investigation to study the disease progression when left to itself, without active treatment. tuskegee was a rural settlement, consisting of a high african american population. it was poor, with a high rate of illiteracy, and insufficient medical care. the incentive to enroll in the study was free food, medical care and burial insurance. the men were told they were being treated for “bad blood” and thereon exploited by the study investigators.

this study lasted for 40 years and featured only sporadic clinical re-examinations as and when a public health physician happened to come to tuskegee. when the study commenced, there was no known cure for syphilis. when during its course, penicillin was discovered as a cure, it was withheld from the participants.

it was not mere oversight either that denied these men treatment: in 1942 when the assistant surgeon general came to know that some of these men had been called for medical examination before enrollment in the army (for this was the time of bloody international conflicts as well), and been directed to undergo treatment for syphilis, he took action to “safeguard” the study. the macon county selective service board was supplied with a list of 256 names of men under 45 years of age to exclude from the list of draftees to receive treatment.

the rationale given for withholding treatment when the cure was discovered, was

"...Such individuals seemed to offer an unusual opportunity to study the untreated syphilitic patients from the beginning of the disease to the death of the infected person. An opportunity was also offered to compare the syphilitic process uninfluenced by modern treatment, with the results attained when treatment had been given.”

the study was exposed only in 1972. by then a 100 men had died due to syphilis related complications, and 28 because of syphilis. at 40 wives had been infected, and 19 children had the disease at birth.

8 months after the study was abandoned, a case was filed against the institutions and people involved for $1.8 billion dollars. a civil rights lawyer, fred gray, took up the case and demanded $ 3 million as damages to be paid to each living participant and the successors of the deceased participants. the case was never tried, and the us government made an out of court settlement whereby each survivor got $ 37,500 and the heirs got $ 15,000.

im sure you do not need me to point out issues about patient confidentiality, physician’s ethics, racism, the deliberate and utterly irresponsible use of the trust vested in the public health authorities, basic human rights etc.

if this sort of thing seems a one–off, freak disaster, I would only request a closer look at recent incidents like this one where columbia university medical center doctors assisted glaxo smithkline in a study to administer trial medicines for AIDS on 3 year old children, in an orphanage in no less prominent a place than new york.

lets move on.

thalidomide.

recap

in the 1950s thalidomide was sold as an over-the-counter drug in Australia, japan, Canada, brazil and Europe. it was supposed to help with several ailments, including morning sickness during pregnancy. it was so popular, it was around the third largest selling drug in Europe. the drug was manufactured by a german company which declared that it was perfectly nontoxic, lacked a hangover effect, was nonaddictive etc.

the german company, however, did not have any human safety data for it. knowing that the fda would require this information, in 1959 (19 months before submitting the drug to the fda for approval) the American distributor of thalidomide approached private physicians and recruited them to distribute the drug and report their observations to the company if they felt it was necessary.

by 1961, European, Australian and a few American doctors reported that children of mothers who had been treated with thalidomide were born with severe birth defects. before thalidomide was pinned down as the cause, over 8000 infants were born of whom several were without arms or legs.

post thalidomide, there was a bit of a flap about need for human data and informed consent for administration of a study drug.

loopholes

when the fda received the application for thalidomide, it was given to dr.kelsey, a newcomer, as an “easy” case. if dr kelsey’s team had not communicated with the company within 60 days, the company could assume that the drug had been approved.

the medical officer handling the case could either call a pharmacologist, or handle it themselves. fortunately, dr kelsay chose the latter option. the pharmacologist found that there was not enough data on absorption, and also that toxicity studies had not run for an adequate time period.

the application records consisted to a large degree, of german reprints with English translations. (this translation and back translation process still has several loopholes which make it extremely easy to misrepresent data).

the chemist happened to have been educated in german, and so was able to fluently read the application material. she found errors in translation. she also found problems with the manufacturing controls.

several of the sweeping claims made about the drug, its toxicity, potency, absorption and so on were watered down and eventually altered in the data submitted to the fda.

the fda team did not know that the drug had already been marketed in germany as a paediatric medicine. it had also been sold in Britain but had been eventually withdrawn because of toxicity in humans.

there was a shipping strike, and so the team didn’t receive several foreign publications in time because mail was delayed. they did fortunately manage to get one publication on time, which described related cases of severe peripheral neuritis. the fda then took that up with the manufacturer.

manufacturers' and study investigators' claims about drugs proposed for studies often sound like sales pitch. when reading the transcript of the NIH FDA conference on thalidomide, this caught my eye.

The very severe adverse effects are very clearly a detriment to some of the investigation that has occurred. It's particularly important, then, that one look at the potential benefits, and that these benefits meet a higher standard, I think, a standard that will remove the onus of the very severe adverse effects that occur.

there is also a reference to the informed consent template used by the investigators, which opens up new avenues of worry and fear.

there's an informed consent document that's being used for research purposes. So most of the investigators who are doing research with thalidomide probably are using this, or some form. (emphasis added)


after all that, thalidomide continues to be explored as a means of curing prostrate and other cancers, leprosy, physical deterioration in AIDS, obesity etc. hmmmm.

so yes, this sort of background is my frame of reference when i speak negatively of allopathy.



brownskinspeak, feminist issues

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17 Comments:

Blogger Falstaff said...

Two things:

a) It's a little ironic that you start your post by talking about how you're interested in the system, not the outliers - because that's what most of the cases you talk about are. The SYSTEM is designed to safe-guard human rights - no researcher studying human subjects today could get funding / approval for his study without having the design reviewed by an Ethical Review Board, whose key purpose is to ensure that no harm is being done to human subjects and no opportunities are being unfairly denied. Not conforming to that standard will end your career. Obviously, these are relatively new safeguards - ones that certainly did not exist back in the 1930s (isn't it interesting that your two key examples both date from decades ago). But they exist today. And sure, the system can be corrupted or can make mistakes, certainly large drug companies can get questionable drugs passed (I'm surprised you didn't bring up vioxx), but that's always going to be true of any system. The bulk of medical trials, at least in the developed world, are ethically sound.

b) Where the real issue lies, I think, is in clinical trials in the developing world. Because laws / standards for clinical trials in countries of Africa / South Asia are nowhere near as rigorous as those in the West, there is some evidence to suggest that drug companies may be abusing this laxness by conducting trials in third world countries that would never be allowed in their own home nations. See, for instance, this article in the NY Review of Books by Marcia Angell (it starts off being a review for Constant Gardener, but quickly moves on):

http://www.nybooks.com/articles/18301

if you really want to critique the ethics of drug companies, that's where you need to look. Though of course, when you get there, many of the ethical issues get a lot murkier.

7:41 am  
Blogger Wrong number said...

This comment has been removed by a blog administrator.

8:04 am  
Blogger oof ya! said...

m. thanks for explaining the links bit!

9:25 am  
Blogger m. said...

falstaff:

ethical review boards, are certainly a step in the right direction, but they still look better on paper. the members of the ethical review boards often also partner the research organisations in other projects - hence they are not completely unbiased and free of vested interests.

for simple example, you only have to look at the seemingly proper SAE (bleh!) literature.

you scratch my back i scratch yours is closer to what reality is like.

i cannot speak for all fields, but especially in hiv - a still small, but highly lucrative one - there is no such real threat to your career. the system is so poorly conceived that a staggering amount of garbage can go on before being detected, let alone responsibility being pinned on any person.

if i wanted to pin responsibility on single entities, then i would take each pharma to task. however my focus is on the system that allows them to play their dubious games in the first place.

the cases are far from buried. i merely chose them since they are well documented and landmark studies. (if youd followed links, youd have seen the GSK trials. thats pretty recent wouldnt you say) furthermore, they are studies that happened in the context of supposedly safer first world countries. ho hum. it raises certain stark questions as to the state of ethical research here, legal redressal, unreported or suppressed violations etc.

when you speak of pharmas not being allowed to test drugs in other countries and then trying them in third world countries, do also look up which countries those very companies are from. we are glorified guinea pigs. it is the height of naive misplaced faith to expect the first world to guard the third worlds interests.

looking only to blame the drug companies is a way of avoiding the more disturbing questions of what the hell the study investigators and physicians were up to, in actively conducting such trials. they, as the more "trusted" authorities, have betrayed us more seriously.

thanks for the link. will look it up this weekend.

saale: im torn between being utterly horrified and laughing. atom bombs tested the way drugs are? gleeps! And the argument that this sort of testing is the only one available, is not acceptable. i hear you! :)

oof ya: hey, glad to be of help. happy blogging :)

2:34 am  
Anonymous Anonymous said...

http://one.aidindia.org/manipur

6:25 pm  
Blogger Falstaff said...

m: I'm a little confused. I still don't see how the system is to blame (as you claim) if the problem is that the system is being corrupted by drug companies playing the reciprocity game. I mean, it's not as though the system is designed to be corrupted. The fact that drug companies manage to get around the system doesn't mean that the system is unethical, only that it's ineffective. That's not what I thought you were arguing. There's a big difference between - we need to change the system vs. we just need to enforce it more strictly.

Oh, and the points I was making in the first point were meant only for First World countries. Obviously, the system in the Third World sucks (that's pretty much the point of the NYRB article). I'm not expecting the First World to protect Third World interests at all - I'm saying precisely that the First World is doing a good job of making sure that it's people are protected and it can afford to do that because systems for ethical review in the Third World are so flimsy. Just so we're clear - I completely agree with everything you said in your post as it applies to Third World countries. That's precisely why I remain unconvinced that the outrages you're talking about in the First World are anything but anomalies.

Oh, and as for the 'couldn't we find some other way of testing this stuff' argument - that's just logically flawed. Would you trust a drug that hadn't been tested on human subjects? Would you be okay with drugs that had been tested only on simulations (say) being approved for general use? I wouldn't. People are not hardware. If anything the reason we don't have tighter controls on testing is because there is no logical way to develop new drugs without human subjects to test them on. Someone is going to have to take the risk (and pay the cost) for new drug development The best we can do is make sure that these tests are conducted humanely and with the minimum possible level of distress. And that the we respect the suffering of those who these drugs are tried on by maintaining the sanctity of the tests. The real crime is not that Thalidomide got tested - the real crime is that after the tests came out negative (at unaccountable cost to those involved) we didn't act on them instantly.

5:22 am  
Blogger Wrong number said...

This comment has been removed by a blog administrator.

3:31 pm  
Anonymous Anonymous said...

“ive often made references to allopathy's unsavoury ethics" : I have not read any of those posts, but I was trained as an allopath and never came across anything that even vaguely gave me the feeling. In fact, if there are any cases of lack of ethics, it is the individual doctors or pharma companies who are responsible for it and not the system itself. In fact, I do not even understand your point about a medical system being unethical. As to your examples, I had never come across the syphilis study. The fact that the study was unethical does not imply that allopathy supports this study. Hence I do not see that your point about the unsavory ethics of allopathy has been made through this example. Thalidomide is a banned drug everywhere and has been for several decades. It is true that it was introduced hastily, but since then a lot of care is taken to make sure that the drugs in development are not toxic to humans. In fact, they are first tested for the presence of any possible harmful ingredients, then they are tested on lab animals and finally, there are clinical trials to test if the drug is toxic to humans or not. Even then, some drugs are toxic only after they are taken for very long periods and/or in very high doses (e.g. acetaminophen, a non-steriodal ani-inflammatory drug). Hence, there is usually no way to be sure, a priori, that the drug in question has no harmful side effects. In addition, the clinical trials naturally involve using the standard tests used in medical science to see if there are toxic effects on humans. And not all side effects can ever be picked up by any combination of the million medical tests available. So, there will never be an absolutely ethical system for testing drugs. But the system tries to make sure that the trials are as ethical as possible, given the present state of medical knowledge.
However, it is the job of the pharmaceutical company/ medical body in the country to make sure that the studies should follow the principles of ethical practice laid down by the syetem. Also, allopathy being scince, deals with trying to improve the healthcare system and does not by itself create the laws of ethical practice. It suggests what is ethical under the present state of knowledge.
And all the known side effects of a drug are available to the doctors who prescribe them and it is the responsibility of the doctor to let people know that such things can occur.
Falstaff has made excellent points above: the system is designed to safeguard human rights. Read any book on forensic or preventive and social medicine and you will see that this is true. And these are all allopathic books.
The mere fact that thalidomide is a banned drug and its use on humans, if proved, will be a criminal offence according to medical texts (not only will your registration be revoked, but you are very likely to go to jail for it) means that these contingencies have been thought of by the allopathic establishment and provision has been made for punishment of malpractice. So I totally fail to see your point about the system being flawed.
While it may be true that the pharma companies in the first world are using people from the third world for clinical studies, this is once again not a case of the failure of allopathy as a system but that of the governments in the respective countries and the pharma people to observe these guidelines. So, none of the points you raise provide strong support for the hypothesis that allopathy as a system is flawed. I would say more: I work as a medical researcher now and once again, there are extremely clear guidelines on all animal protocols about how to ethically treat the animals that are used in any biological experiment. And failure to follow those will mean the end of a person’s research career. Though I do not work in drug related research, there are clear guidelines for the ethical design of studies, ethical treatment of humans and animals involved in the studies even for things like fMRI that are harmful only under very special circumstances. So, an ethical code exists within the framework of allopathy to design studies involving efficacy and side effects of the drugs under investigation and these are being continuously modified to take into account every little bit of data added to the medical database.
I have worked in the HIV setting for a little bit, but more as a doctor than anything else, but would be glad to know what unethical guidelines have been authorized. It is true that there is some degree of murkiness when you have on one hand the certainty of death due to the disease itself and on the other, the possibility of the drug being effective but harmful in some other way and once again, medical system would say that such drugs should be used only when all other treatments have failed. Another case in point: cancer chemotherapy. All anticancer drugs are meant to kill tumour cells, so they would end up killing normal body cells as well. But then, you can still make poeple survive for long periods if proper care is taken. So, the therapy is justified since it helps preserve human life, though at some cost to other bodily function. Ditto with organ transplants. People have to be given very strong antiimmune drugs and the side-effects are very dangerous. But they can be managed, given enough infrastructure. That is one of the reasons why there are so few organ transplants in India: there is noit enough infrastructure to take care of the patient and most people cannot afford it even if it is available. But organ transplant is routine in first world countries. At each point, there are clear guidelines. I can go on, but you can get this from many excellent medical texts. But this long comment serves as a pointer to them. So you judge hastily indeed.

10:17 pm  
Blogger littlecow said...

I might be repeating what some gentlemen have already said:

Despite your arguments, it is essential to recognize that allopathy has managed to cure many ailments. So, lets not be excessively harsh. As in any systems, there are pros and cons. By mixing medical cures with unbridled capitalism, we have let the pharma companies grow into monsters that deploy dubious means to test some of their drugs. Thats a problem, alright. But its a fallacious logical leap to extend that fact to blame the system as a whole? If you had one bad teacher, would you blame the entire education system?

Other methods of treatments like Homeopathy cannot cure all ailments (from my limited experience). So is it better to blame allopathy and let these people die or is it better to accept that both systems coexist and to take the best out of both?

Many things in this world are unjust, pathetic and annoying. Now, one can shun it all and live in a cave or fight until the day when you realize you cannot do anything anymore. Your approach seems to be one of closing the shutters and walking away. Is that good?

10:23 am  
Blogger Falstaff said...

saale: Sigh. I begin to understand why most software is so unreliable.

a) Drug testing is not a random process - human trials are only permitted after positive results from multiple stages of other tests have been tried and found to work. The initial human trials are carefully controlled, done on limited samples and only with the full consent of the patient. I don't know of and can't imagine a trial that involved testing on "someone off the street"

b) Most drug testing is done on people who actually suffer from the condition the drug is trying to cure. It would be kind of hard to test the efficacy of a drug on a subject who didn't have the condition, don't you think?

c) At this point you're probably going to say something about how the important thing is that the people who were being treated in your beloved pennicilin study were dying anyway, so it was okay to test on them. Leaving aside the questionable ethics of this (surely consent is what matters, not whether the person has the chance to survive or not), how do you then propose we test drugs that cure non-fatal conditions? Should we not test such drugs at all, since no one's going to die of the condition anyway, so it doesn't matter? Or should we wait till they're dying of something else and then try out the drugs on them, so that (assuming our study isn't hopelessly contaminated by survivor bias) we would actually be able to prove that drug X helps cure the common cold in people in the final stages of terminal cancer. Isn't that a useful finding?

As a matter of fact, testing only on the most serious patients raises a fairly serious ethical problem. Assume that you decide to test drug X on people who have no hope of survival (I'm skipping over the contentious issue of how we decide this - though that's a hornets nest all by itself). Assume that drug X doesn't work on such people, but would work on people in somewhat less advanced stages of the disease (remember, you don't know this - that's what you're trying to establish with the trial). Let's say you only offer the drug to people in the last stage who die anyway, whereas while you're busy doing these tests people in earlier stages, who would have been willing to take the drug and could have been saved by it shifted into the final stages. This means that by excluding these less critical people from your study you took away their chance for survival. Congratulations. Hopefully the jury in the law suit will buy the "I was only applying principles from software engineering" defense.

5:54 pm  
Blogger Wrong number said...

This comment has been removed by a blog administrator.

8:34 am  
Blogger Wrong number said...

This comment has been removed by a blog administrator.

1:30 pm  
Blogger Falstaff said...

saale: Ooh! I've been officially warned! How thrilling! Now I'm really scared!

Whatever. When you come up with a) an intelligent way of doing drug testing that addresses the concerns I've raised in my earlier comments or b) any facts to back up all your claims about the thousand of people who are being exploited, let me know. As long as the best you can come up with is there "HAS to be a more effective way" (ooh! capital letters! now I'm convinced!) you're not, in my opinion, worth seriously arguing with. Just fun to rile.

4:00 pm  
Blogger m. said...

first, my apologies to everyone for taking this long to respond. life was a little turbulent offline and needed some attention :)

falstaff: i understand what youre driving at, and ok, to an extent i agree: the first world does look after itself and get the third world to do its dirty work. what id like to bring up here is that in that kind of domination politics, the weaker segment is coerced. when its a matter of first vs third world, the first world sticks together. within the first world, however, the weakest segment is also liable to be coerced by the more powerful ruthless ones. power structures in society are after all very dynamic. so if you can bash 'em down, you do. since im interested in upholding human rights, its not ok by me that hey... today its the turn of a poor black man in the states, instead of mine. its still wrong.

yes, the whole issue of human testing is fraught with ethical complications. that's why its all the more important to tread gently and carefully. im even ready to put aside my zillion objections in this whole scenario to the issues of its always being necessary to test a drug on humans, that animal testing is ok.. fine. ill take all that up later. look at the disasters we've had with the tested-on-humans-declared-safe drugs. it took a long time for prozac to be pulled off the markets. and its still prescribed in some countries. ouch. (and prozac isnt a unique case either)the system is obviously far from adequate or perfect.

as for the difference between its being inefficient, and needing to be reinforced more strictly, point well made... and ill still say its inefficient! :)

these cases really arent exceptions. the system is supposed to protect us when personal or organisational ethics are zilch. that such a lack of ethics can be practised and applied is worrisome enough, but the system isnt supposed to have loopholes that can be manipulated with impunity in the first place. that is the issue im trying to raise here. (btw, did you notice that line in your link? "This system makes a mockery of the notion of informed consent")
as long as we keep saying that everythings perfect and there are adequate safety measures when there emphatically arent, these violations will continue because its unrealistic to expect (of all the groups!) pharmas and co to be ethical.

thank you for the link. it made good reading. thats evidently another movie that i must see!

anon: thanks for taking time to write that. because of integrity at an individual level, a certain degree of ethical adherence does exist. the point i was making was about incorporating these in the system so that its no longer an individual choice alone - in short, to ensure that even if an individual is unethical, (s)he cannot find so many ways by which to manipulate the system and hurt people.

littlecow: you seem to be saying that several things are an acceptable cost for the benefits gained. that is one of the most dangerous arguments ive heard. please ask these questions: how big a cost, paid by whom, who actually benefits, and does the person paying the price for this benefit have a genuine choice?

7:24 pm  
Blogger Falstaff said...

m: Right. I agree with all of that. Just to be clear: I'm not saying that the system is perfect or that it doesn't need improvement (though I do think that the third world problems are more serious than those in the first world). I'm perfectly willing to accept that the system may be ineffective in that it can be worked around by self-interested parties - suggesting that there may be a case for even stricter enforcement. I don't personally think it's quite so bad, but that's just a function of what examples you happen to see.

But being ineffective doesn't make something unethical - which is what you were arguing the system was in your post. Unethical is where the law is actively encouraging something that one is morally opposed to - so for instance I think legislation banning abortions is unethical. It's the difference between the evil villain and the doddering old watchman.

Oh, and the movie is definitely worth watching, though I think Rachel Weisz's performance in it was highly overrated. Ralph Fiennes is brilliant though. Actually, I reviewed the movie at some point, see:

http://considerablespeck.blogspot.com/2005/09/quiet-englishman.html

P.S. Sorry about the fairly trenchant conversation on your blog. On the off chance that it makes you uncomfortable (though I have to say nothing on your blog suggests you're squeamish) feel free to delete them.

11:58 pm  
Anonymous Anonymous said...

"mourning untimely consumes the sad. few are their days in the land of the living, beautiful daughter of toscar."

9:47 pm  
Blogger Apoplexy said...

Somehow I see JNU written all over it and of course assumtions which stem from knowing doctors and not being one oneself.
But then the strength of medical science aka allopathy lies in the fact that it exposes its underbelly to criticism and not just to the initiated, if the rationale is right and not just oft repeated sketchy incidents.Thats why amny medical ethicists make a living,...a downstream industry of sorts.

1:38 pm  

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