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MEDICINE SHOULD NOT BE PROVEN 100% SAFE BEFORE RELEASED TO THE MARKET
*I was assigned this topic. I truely don't believe in it* Medicine shouldn't be proven because it wastes money and time that could be used in making medical breakthroughs. It is pointless.
Medicine should not be proven 100% safe before released to the market
Yes, because... More likely to help.
Medical advancements, by nature are designed to save or improve lives. The possibility of suing mean that medical researchers are careful before releasing - too careful if anything. It is therefore much more likely that a new medicine will be helpful than harmful to human health (though this is not impossible). If these two propositions are accepted, it is likely that a new release will save more humans lives than it harms. Ergo, it should be released.
Selling defective medication does not help people. Whenever a pharmaceutical sells defective medication, unnecessary deaths result.
A recent case is of a two year old boy who died of liver failure because the strawberry flavoured children's Tylenol his parents gave him was not really safe.
"Daniel and Katy Moore of Ellensburg, Wash., claim 2-year-old River Moore was given Very Berry Strawberry flavored Children's Tylenol for a slight fever late on July 22, 2010 and began spitting up blood 30 minutes later.[1] He was rushed to a hospital and died the next day of liver failure. The family's lawyer, Joseph Messa of Philadelphia, said Thursday that the liquid medicine contained excessive acetaminophen that damaged the child's liver, causing his death"[2] "The newest development in the Yaz litigation is the settlement of a case in which 26 states sued Bayer AG for misleading advertising regarding potential risks of Yaz and improperly broadening promotion of Yaz to include symptoms of premenstrual syndrome (PMS) when Yaz was not approved to treat this condition. From 2004 to 2008, the FDA received 50 reports of death linked to Yaz... If you have suffered serious gallbladder injury, pulmonary embolism or stroke which associated with your use of Yaz, our defective drug attorneys will work hard to get you the best results possible. The lawsuits filed regarding the dangerous side effects of Yaz involve both dangerous blood clotting issues and gallbladder disease."-[3]- ^ http://www.lieffcabraser.com/personal-injury-mass-torts/case/430/acetaminophen-and-tylenol-liver-failure
- ^ http://www.huffingtonpost.com/2012/01/05/jj-child-childrens-tylenol-defective_n_1187736.html
- ^ http://www.montlick.com/montlick-blog/montlick-law-blog/419-bayer-settles-case-regarding-deceptive-advertising-of-yaz
Vote on this point: More likely to help.
See history of changes to this point
Medicine should not be proven 100% safe before released to the market
Yes, because... There is no 100%.
There is *no* 100% certainty. Even established ideas like Evolution or that the heart pumps blood around the body are not 100% known. Maybe 95%,maybe 99.9999999% percent certainty is achieved, but 100% never is and never will be. New techniques would be trapped in a never ending cycle of tests.
When 100% safety is aimed, 90% is achieved. The purpose of charging pharmaceuticals with the responsibility to produce quality products that are to their optimum standard is that they try to make medicines as safe as possible.
There may not be a 100% but the point is to make a 100% effort to keep/make medicines safe and not to be cavalier with people's lives.
Vote on this point: There is no 100%.
See history of changes to this point
Medicine should not be proven 100% safe before released to the market
Yes, because... Exhaustive clinical trials are costly and time consuming
The problem with trying to test a drug on as representative/large a sample as possible/plausible is that , many patients who could be helped with the use of the test-drug are deprived in the meantime. Lives that could have been saved are lost. The other issue is that the longer a study is stretched in the hope of maximizing the accuracy of results, the more funds are needed to fuel research. If a study takes too long, funds can be shut midway and the medicine even if it is very useful never makes it to the shelves of a pharmacy.
Medicine should not be proven 100% safe before released to the market
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.
Vote on this point: Possibility of harm to patient.
See history of changes to this point
Medicine should not be proven 100% safe before released to the market
No, because... A balance needs to be struck between the ready need for a medicine and amount of research put into it
How exhaustive(in terms of time and money) a testing process should be is, contingent upon: (A) What the test-drug is for? (i)is it a fatal disease? (ii) Is it for a chronic(long term) or acute(fast-acting)? (B) How many people can potentially be helped? (C) Is the drug a cure? (i)Is it a complete cure? (ii) Does it activate other drugs/chemicals/enzymes which act as a cure? (D) What are the side effects? (i) Are sideeffects worth risking? (E) Are there any withdrawal symptoms? (F) Is the drug administered in small regulated doses over a long period of time? (G) Will the effectiveness of the drug be depleted if patients do not complete the prescription? (H) Is it affordable? (I) Are similar alternatives already available in the market?
A cough medicine need not be very potent, it also should not adversely affect major organs or create blod clots. A cough medicine should be mild and must in no case, directly cause death. A medicine to be taken by those in last few stages of cancer can however include fatality as a side-effect.
Point 1. More likely to help.
Medical advancements, by nature are designed to save or improve lives. The possibility of suing mean that medical researchers are careful before releasing - too careful if anything. It is therefore much more likely that a new medicine will be helpful than harmful to human health (though this is not impossible). If these two propositions are accepted, it is likely that a new release will save more humans lives than it harms. Ergo, it should be released.
Selling defective medication does not help people. Whenever a pharmaceutical sells defective medication, unnecessary deaths result.
A recent case is of a two year old boy who died of liver failure because the strawberry flavoured children's Tylenol his parents gave him was not really safe. "Daniel and Katy Moore of Ellensburg, Wash., claim 2-year-old River Moore was given Very Berry Strawberry flavored Children's Tylenol for a slight fever late on July 22, 2010 and began spitting up blood 30 minutes later. He was rushed to a hospital and died the next day of liver failure. The family's lawyer, Joseph Messa of Philadelphia, said Thursday that the liquid medicine contained excessive acetaminophen that damaged the child's liver, causing his death"[1]
Point 2. There is no 100%.
There is *no* 100% certainty. Even established ideas like Evolution or that the heart pumps blood around the body are not 100% known. Maybe 95%,maybe 99.9999999% percent certainty is achieved, but 100% never is and never will be. New techniques would be trapped in a never ending cycle of tests.
When 100% safety is aimed, 90% is achieved. The purpose of charging pharmaceuticals with the responsibility to produce quality products that are to their optimum standard is that they try to make medicines as safe as possible.
There may not be a 100% but the point is to make a 100% effort to keep/make medicines safe and not to be cavalier with people's lives.
Point 3. Exhaustive clinical trials are costly and time consuming
The problem with trying to test a drug on as representative/large a sample as possible/plausible is that , many patients who could be helped with the use of the test-drug are deprived in the meantime. Lives that could have been saved are lost. The other issue is that the longer a study is stretched in the hope of maximizing the accuracy of results, the more funds are needed to fuel research. If a study takes too long, funds can be shut midway and the medicine even if it is very useful never makes it to the shelves of a pharmacy.
Point 1. Possibility of harm to patient.
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.
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.
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.
Point 2. A balance needs to be struck between the ready need for a medicine and amount of research put into it
How exhaustive(in terms of time and money) a testing process should be is, contingent upon: (A) What the test-drug is for? (i)is it a fatal disease? (ii) Is it for a chronic(long term) or acute(fast-acting)? (B) How many people can potentially be helped? (C) Is the drug a cure? (i)Is it a complete cure? (ii) Does it activate other drugs/chemicals/enzymes which act as a cure? (D) What are the side effects? (i) Are sideeffects worth risking? (E) Are there any withdrawal symptoms? (F) Is the drug administered in small regulated doses over a long period of time? (G) Will the effectiveness of the drug be depleted if patients do not complete the prescription? (H) Is it affordable? (I) Are similar alternatives already available in the market?
A cough medicine need not be very potent, it also should not adversely affect major organs or create blod clots. A cough medicine should be mild and must in no case, directly cause death. A medicine to be taken by those in last few stages of cancer can however include fatality as a side-effect.