Medicine should not be proven 100% safe before released to the market

Selected Version - Version 3 (Current Version) : 22 Jan 2012 | 11:38 | NADIA999

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On the point: Possibility of harm to patient.

All drugs have side effects. Some drugs that are very effective on certain patients, can be fatal for others. FDA(Food and Drug Administration) warnings are based on clinical tests on a set number of people (or animals in most cases).

Thing is, that these people can already be ill, e.g anti-carcinogenic drugs are only administered to cancer patients and as such tend to have 'death/fatality' listed as a major side-effect. When it comes to psychological drug tests such as ones done for antidepressants, the volunteers or patients being tested are known to be psychologically ill. That is it is unlikely that antidepressants are tested on Individuals labelled psychologically normal. Since antidepressants are tested on clinically depressed people it is likely that clinical tests on these people revealed that some of the test patients remained/became suicidal despite taking the drug.

The job of the FDA is simply to report the results of clinical trials, even though these clinical trials are very unrepresentative of the population as a whole and the results may not be causal but correlated. A drug is normally tested on at most twenty people. These people are kept in as controlled an environment as plausible but many factors related to genetics, history, medical history, diet and so on are readily missed. In many cases because 20 people is such an unrepresentative sample, drug tests do not reveal many important side effects. Many contraindications are also simply observed results for a small sample of patients e.g "those who ate chocolate with this drug had stomachaches" this may as well be a coincidence but the FDA will report it.    
it.  
Just as mangoes may effect the potency of drug"A" but it is possible that none of patients in a the clinical trial for drug "A" ate mangoes.    
Either way since human testing is such an issue and most patients are not willing to participate in drug tests, even exhaustive clinical testing will not give incontestable results.

Just as any scientific hypothesis must be scrutinized, examined and peer reviewed before being accepted as a theory, medicine must be *proven* to work before it is used.
A short look at the history of medical practitioners shows that from shamans to priests, blood drainers to modern day homeopaths, "doctors" have long bent the truth to make a profit. Saying that is unlikely to happen today is to ignore the reality of organizations like GlaxoSmithKleine.
For one example, their anti-depressant Paroxetine, released to the public in 2002. In March 2004, the FDA was forced to place a warning on the box that the drug could lead to suicidal thinking (!) and it is recognised as having worse withdrawal symptoms than many class-A drugs!
In this and other examples, exhaustive clinical testing could have saved many lives.

Yes, because...

 

No, because... Possibility of harm to patient.

All drugs have side effects. Some drugs that are very effective on certain patients, can be fatal for others. FDA(Food and Drug Administration) warnings are based on clinical tests on a set number of people (or animals in most cases).

Thing is, that these people can already be ill, e.g anti-carcinogenic drugs are only administered to cancer patients and as such tend to have 'death/fatality' listed as a major side-effect. When it comes to psychological drug tests such as ones done for antidepressants, the volunteers or patients being tested are known to be psychologically ill. That is it is unlikely that antidepressants are tested on Individuals labelled psychologically normal. Since antidepressants are tested on clinically depressed people it is likely that clinical tests on these people revealed that some of the test patients remained/became suicidal despite taking the drug.

The job of the FDA is simply to report the results of clinical trials, even though these clinical trials are very unrepresentative of the population as a whole and the results may not be causal but correlated. A drug is normally tested on at most twenty people. These people are kept in as controlled an environment as plausible but many factors related to genetics, history, medical history, diet and so on are readily missed. In many cases because 20 people is such an unrepresentative sample, drug tests do not reveal many important side effects. Many contraindications are also simply observed results for a small sample of patients e.g "those who ate chocolate with this drug had stomachaches" this may as well be a coincidence but the FDA will report it. Just as mangoes may effect the potency of drug"A" but it is possible that none of patients in a the clinical trial for drug "A" ate mangoes.

Either way since human testing is such an issue and most patients are not willing to participate in drug tests, even exhaustive clinical testing will not give incontestable results.

 

Just as any scientific hypothesis must be scrutinized, examined and peer reviewed before being accepted as a theory, medicine must be *proven* to work before it is used. A short look at the history of medical practitioners shows that from shamans to priests, blood drainers to modern day homeopaths, "doctors" have long bent the truth to make a profit. Saying that is unlikely to happen today is to ignore the reality of organizations like GlaxoSmithKleine. For one example, their anti-depressant Paroxetine, released to the public in 2002. In March 2004, the FDA was forced to place a warning on the box that the drug could lead to suicidal thinking (!) and it is recognised as having worse withdrawal symptoms than many class-A drugs! In this and other examples, exhaustive clinical testing could have saved many lives.

 
22 February 2011