Notice that there are two different forms or isomers of the same substance. They are mirror images of each other. One is beneficial in minimizing morning sickness during pregnancy. The other causes substantial birth defects if taken within the first 50 days of pregnancy.
Sometimes research into medicine and the commercial product sold create human tragedy. An example of this is the use of thalidomide by pregnant women in the 1950’s and 1960’s . Over 10,000 birth defects due to thalidomide were documented in Europe but only 17 cases in the
“Thalidomide (also known under the brand names Contergan® in
Please follow the following links to learn more about thalidomide.
General information http://en.wikipedia.org/wiki/Thalidimide
Tony overcame his disability http://www.tonymelendez.com/
Current use(s) of this drug
http://www.bbc.co.uk/insideout/southwest/series7/thalidomide.shtml
Your assignment is to review the information on the links above and respond to the following questions.
(1) What responsibility does the government have to protect people when new drugs are administered to its citizens?
(2) What responsibility does the research / drug company have?
(3) What responsibility does the pregnant women’s personal doctor have?
(4) What responsibility does the women (and/or her husband / family) have when taking newly marketed medicine(s)?
Refer to the blog posting rubric. This assignment is due on or before Monday 09.22.
Questions? Ask in class / email doug@dougabshire.com. Mr. A
19 comments:
1) I think that the government has the responsibility of checking the FDA's work and making sure that the medicine they are creating isn't harmful to the ones who take it. Thalidomide was thought to be harmless until babies were being born with shortened limbs.
2) It is the responsibility of the pharmaceutical companies to know all of the side effects of all medicines they make. They should test it in many different situations and see what happens in each one.
3) Personal physicians should also check their patients past and see if the medication they are prescribing them could be harmful to them in any way.
4) The patient who is taking the medication should ask their doctors and/or do research on the medication they are taking to see what has happened in past uses.
>Morales<
its the governments job to ensure the safety of the public, if there not sure of the effects, then the medicine shouldnt be released to the public. this should also apply to the pharmacies. also the job of the parent to discover the effects of the drug and judge on weither or not it would be harmfull. so when you look at it, it is everybodies responsibility.
1.)physicians should also check their patients to see if they have any allergic reaction to medications. The patient who is taking the medication should ask for research to see what harmful side effects could potentually occur.
2.) the resonseability the drug companies have is to test the drug to see if it is made of takin with another drug wat risks or effects it could have.
3.)the responseability of the pregnant women's doctor is to make sure that she has no drug allergies and do research on the drug him/herself.
4.)the responseability of the family is to be aware of any effects of the drug. also to let their doctor know of and symptom that they are experiancing.
The government plays a huge part in protecting people when new drugs are administered because its their duty to make sure that the FDA is doing their job with the development of the drugs and they need to make sure that they are doing thorough research multiple times before they put it on the market. Its the drug companies responsibility to know absolutely EVERYTHING that they can about this new drug including the risks and side effects. The pregnant womans doctor is respnsible for letting her know that there is a slight chance of chronic severe teratogenic effects. And its the couples responsibility to possibly do research before they think about being administered this drug and they should be FULLY aware of the possible end result.
~SeReNa~
I think that the FDA should take tremendous responsibiltiy for thier actions. First off, I understand that, at the time, little was known about the drug Thalidomide, and its side-effects.
But that doesnt help the fact that people are borned with shortened limbs. Perhaps the FDA shouldve had more thorough reseach conducted into the drug before ti was passed.
The pahrmeceutical companies should know all the side effects and risks of a drug, beofre they are massed produced and given to numerous people. Like i stated earlier, more thorough research should have been conducted.
Physicians certainly should understand the drug thoroughly before they even consider givign it to the patients. They should know the effeects of the drug, both good and bad. They should also know if it right for the person by conduting multiple tests.
The person is somewhat at fault, but a person trusts the doctor or physician. It is somebody who is to make us feel better, not worse.
-Ricky G.-
1. i think the government should take responsibiltiy for there actions of not testin the drug properly and not knowing the side effects.
2.pharmaceutical companies should know the side effects and what the drug does before they sell it.
3.Personal physicians should not even sell it knowing what the side effects are.
4.The patient who is taking the drug should have done more research on the drug before even taking it.
all these people are at fault in this situation.
*grace*
When new drugs are administered to its citizens, it is the governments responsibility to make sure that the FDA or who ever is the drug administrator of that country is fully checking to make sure that the drug is not malignant or does not have any type of horrid side effects. The government needs to be 100 percent sure that the new drug that will be administered will work for that particular disease that it was created to fight off. It is also, the duty of the government to announce any type of side effect that the new drug might have to its citizens, that way the people that might decide to take it know what risks are involved.
The responsibility that the research and drug company have are to be 100 percent assertive about what the medication will do to the patient, whether it is positive or negative. The drug company cannot be just able to say that it will help with calming leprosy or helping reduce morning sickness; they should be able to tell the public what are the other effects of taking the medication. The research and drug company should test the drug many times until they are positive about the effects it will have on its patients before they decide to prescribe it to the public.
The responsibility that a pregnant women's personal doctor has is to let the women know what type of harmful effects the drug will have on her and her baby and not just tell her that it will help to calm or reduce her morning sickness. It is the doctor's responsibility to investigate all of the possible effects the drug will have on a patient, especially a pregnant women, before prescribing it.
The responsibility that women and her family members have when taking a newly marketed medicine is to ask their doctor about whether the medicine is safe and what are the side effects of the drug. The patient, if knowing she is or might become pregnant, should ask if it will harm her baby. She is the one that will decide whether to take the medication or not, it will be her responsibility if something goes wrong simply because she knew what the effects were going to be. But, if she didn't know what the side effects were then it is also her fault for not asking or investigating about the medication and its effects.
All in all, I believe that it is the responsibility of the government, the drug company, the doctor, and the patient taking a newly discovered drug to investigate and to know about all of the side effects that might in the future be harmful and do something that later will be regretted.
1. I do think the goverment should take the responsibility to look wat drugs are being used for in the U.S. cause one drug may not be harmful to one person but it be harmful to others
2. drug companies should also look over what they handout to the public because each drug is used for specific treatments.
3. they should not give anything
if they dont know the siteffects.
mike
I believe that thalidomine is perfectly safe given the possible side effects with your government, if the government has released these statements that it can mutate the fetus, it is then completely the users fault if it is used while pregnant. The government should not be blamed for the users actions.
2)Although it is the governments responsibility to tell you what the effects are, within reason of your pharmaceutical companies to tell you also.
3)Your doctor also has the responsibility to tell you the effects with giving you the drug
4)The persons who is taking the drug at this point has the full responsibility of taking it responsibly, knowing all of the side affests. MAAAAAAAAAAATtttttttt
My opinion is that the government should know whether a type of medicine can harm someone or not. It should be tested many times before it even goes out. Thalidomide afected babies, and was still being taken by the pregnant mothers. It shouldnt of been sold to pregnant mom's if problems have occured from it before. The patients who were taking this, should of also got more information about thalidomide. It is also their responsiblity to know what they are taking. Medicine should be tested to see whether the patient can be suscribed to it or not.
[yesenia_29]
Thalidomide is a drug that was massively underevaluated before being put into production and sold to the public. 10,000 defective births were reported in Europe and in 17 births in the United States. The blame has been pointed in many directions and placed on many people and organizations. Each is to blame.
1) By allowing thalidomide to be distributed to the general public, the government has neglected its responsibility to protect the people of the nation. The government is responsible for monitoring the safety and regulating the sale of potentially dangerous drugs such as thalidomide. Where's the FDA when you need 'em?
2) The pharmaceutical companies come in next, but certainly not in the rank of blame. The pharmaceutical companies neglected the safety of their clientel by using potentially deadly isomers of thalidomide that were clinically shown to have serious side effects. Without labeling the product with a warning sign to alert users of their risk in using it. By not doing so, the company has willingly and knowingly put the buyers in danger.
3) Personal physicians are among the most responsible. It is their duty and ethical responsibilty to thoroughly check the dangers of the products subscribed to their pateints. By giving thalidomide to their patients, they are breaking their own sacred oath of duty and should be sued for malpractice.
4) The victims themselves are not in the clear either. No person should ever take any kind of medicine, prescribed or otherwise, without full knowledge of the effects it may have on them. The person should take initiative to find out what dangers and risks are associated with thalidomide before blindly following the words of others, even if it is their physician.
The government is supposed to be responsible for the well being of its citizens. Of course this would mean that they must ensure that the substances people are taking are safe and won’t harm anyone specially a new life that will be scarred forever if the drug is not administered correctly or to treat the right symptoms. However the government can only do so much. I don’t understand why they didn’t test the substance correctly before prescribing it to patients? I believe that it is an immense responsibility for the doctors to inform the patient of the effects of the drug. Although thalidomide was used to cure morning sickness in pregnant women as well as helping them with their sleep, I think that it is much better to tolerate the morning sickness than to risk the future of a child. There were far more cases of birth defects because of the use of thalidomide in Europe and Africa than in the US. Approximately 10,000 children were harmed in Europe and Africa while only about 17 cases of thalidomide were presented in the United States. The company that is producing this drug should have definitely taken it off the market from the moment they heard about the defective children being born because of the drug. The mother should be informed about the drug before she takes it, which is something the government, doctors, and fabricants lacked; the ability to inform people correctly and thoroughly. If the mother still decided to take thalidomide then she was making the choice to have a child that would be born with severe abnormalities.
The Government has responsibility in making sure they correct the mistakes they make. Drugs should be tested over and over before they hit the market. In this case Thalidomide was released to soon causing birth defects to many.
Companies should be on top of things before they put a lable on their medicine. It is their responsibilty to test and prove the facts they state. One side effect can lead to another, but naming only one wont do the trick.
A Dr. should be aware of what they give there patient. They should think ahead of time before they say the drug they are about to recieve is safe.
Family approval is important. Everything should be discussed together just to see what is going on and what can happen. In this case, Thalidomide within a family use. Each member should know the causes and defects it has against one. Whether it helped others or caused worse. Finding information from other users would can or could have been helpful.
The government has the responsibility of telling the public the possible dangers of the medicine that is being administered.They should make sure that the FDA is doing the best they can to provide safe and harmless drugs. The government cannot negglect their responsibilty to their Nation just because they think the FDA is doing a good job.
2)The drug companies should know what drugs they are administrating to the public.They also have the responsibility to discontinue the drug if they have reason to belive that the drug can be harmful. The drug companies also need to look through their research over and over again to make sure there is no mistakes in their data.
3)Personal Doctors need to advise their patients about the certin risks. They should also do test on the patient while they are taking the drug to make sure that the everything is in order and if they see something wrong they should stop the treatment.
4)The family has the responsibility of helping researching the drug and scheduling visits with doctors.They also need to know that their options and deside which drug to take that wont cause harm.
Maryann:)
1)It's the government's responsibility to make sure a new drug is tested properly before selling it to the public. Thalidomide was tested for its safety but those tests were not very extensive.
2)The drug companies respsibility is to be sure of the side effects and dangers of that new drug.
3)A person's or family doctor should tell their patient the possible side effects of a drug. They should also get a back ground check on there patient and patient's family.
4)A person taking a newly developed drug should pay close attention to their body for any weird feelings. If they do feel something they should go to a doctor. Also they should do research on that drug before taking it.
(1) When new drugs are administration the governments responsibility is to check the FDA's work by making sure the drug does not cause defects or causes any damage to the body. Also that the drug does what it supposed to and nothing else.
(2) It is the responsibility of the pharmaceutical companies to know ALL the side effects before the drug is ever released to the public. if even one side effect isn't discovered before the release of the drug and is after it could cause deaths of abnormalities in the human body.
(3)It is the responsibility of the patients doctor to give all the information about the new medicine and if the doctor does not know everything about the drug such as the side effects the doctor should not prescribe or suggest the medicine.
(4)It is the responsibility of the patient to know all the information about the new drug before taking it. knowing all of the side effects and if they are unsure about the medicine they should not take it.
I'm going to chime in here a bit. For years, the burden of proof was not on the chemical companies to prove that they are safe, but for the victims to prove the chemical caused them harm. The recent issue with Bisphenol-A is another example of a chemical that the FDA approved for use based on two studies that were done by the industry that made and used BP-A in their products. (Think of it as the tobacco industry providing studies showing that tobacco use was safe.) Yet, recent independent studies are indicating that BP-A affects not only fetal development, but also brain function and mood.
That being said, what ethical implications are there for each of the concerned parties when it comes to chemical usage in our society: the manufacturer, the distributor, the retailer, and even the consumer?
The drug thalidomide had terrible effects on thousands of people around the world before it was banned. Who's to blame for this tragedy?
The government clearly felt some blame for this because they had it banned. The government regulation of medication given to the public should have definitely went through some adjustments. The government should definitely be taking an active role in the administrating of prescription drugs. No government should allow a drug to disable thousands of people before it realizes something is wrong with it. The government should have more strict laws to ensure this.
The drug company that researched this chemical and had it cleared for general use should definitely take some responsibility as well. They clearly did not have enough research on the drug before it was prescribed. This led to a tragedy that effected thousands. That should set off a red flag that there need to be more adequate research techniques before administering a drug.
Doctors and patients on an individual level have no where near the amount of responsibility that the drug company and government have. When it comes to a drug that is supposed to help morning sickness, nobody should feel weary about side effects that extreme. It is not up to the doctors and patients to research every prescribed drug. Although this may be helpful this is work that should already be done for the individuals.
Thanks for your comments. No matter who(m) is to blame, how can we prevent this tragedy from happening again?
Some final thoughts:
"While the human misery that resulted from the introduction of this seemingly harmless drug is incalculable, an important new development was introduced. To make it less likely that other, yet unknown, bizarre effects from the introduction of new drugs can ever occur on the same scale, most countries have introduced a monitoring system. In the UK, practitioners record any effect a patient reports, or signs which become obvious upon examination, together with the drugs prescribed. This data is entered immediately onto a national database. Of course, most of the reported effects will be nothing at all to do with drug treatment, but as the data will come from an entire country, or group of countries, correlations of effects with drug usage will be quickly spotted and sound the alarm before thousands of people are affected. The thalidomide story also illustrates another problem in regard to the introduction of new drugs: the public demand the unattainable — that all drugs should be perfectly safe under all conditions — but ultimate answers can be provided only by the consequences of general release."
— Alan W. Cuthbert
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