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.

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