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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 3 of 3. This is the beginning of the thread.
Posted by ed_uk on December 10, 2004, at 12:37:00
Hi,
What do people think about the way that regulatory authorities such as the FDA and the MHRA restrict access to medicines?
Currently, drugs are approved/licensed based on their supposed safety, efficacy and quality. Obviously, no drug is going to be completely safe. Some are more dangerous than others. The problem with the regulatory authorities it that once a drug is approved many people assume that it will have a good safety record. Unfortunately, many approved drugs have serious side effects, many of which are recognised many years later. Some drugs are then withdrawn from the market. Although withdrawing drugs may improve safety, it also restricts the number of treatments available to seriously ill patients.
Although the FDA has a role in regulating quality control in the pharm industry, how useful do you think it is in assessing safety and efficacy? ........particularly when you consider that the info about new drugs comes straight from the pharm companies own research!
Do you agree with the way that the FDA restricts access to drugs which are on the market in other countries? Once accurate information is available, to what extent do you think it should be up to the individual doctors and patients to decide which medicines have an acceptable risk/benefit ratio? Should 'withdrawn' drugs be made more readily available to people who have failed to respond to other treatments?
Ed.
Posted by Sebastian on December 10, 2004, at 14:41:53
In reply to Access to medications, posted by ed_uk on December 10, 2004, at 12:37:00
I don't think you should even have to go through a doctor to get meds. You should be able to just buy it your self. Call doctor for advice. But not a necesity.
Posted by banga on December 10, 2004, at 20:23:25
In reply to Access to medications, posted by ed_uk on December 10, 2004, at 12:37:00
I think that, as we know ALL drugs can have side effects, which can largely differ from person to person, the whole quiestion of where to draw the line--what to approve and what not to-is rather hard to answer.
I believe that patient and doctor education is more important--the way drugs are handed out to the public--is where change ought to be. For instance, in handing out a drug, currently the typical doctor hands out the prescription, and at most murmurs what side effects could be. I think the mode should be altered to one that is more a serious discussion between the doc and patient of the risk/benefit profile of the drug for the patient--a serious weighing of both sides. An up-front acknowledgement that ALL drugs have side effects, and some are serious.
Of course in my book I would actually put more emphasis on the patient being an informed, responsible consumer. But in the US, many people do not do this, and to suddenly expect a shift there would be dangerous. But of course this should be the long-term goal...
So in terms of the FDA and other regulating bodies, I think the perception of their role should change--and what approval says about the drug. It should not be that the drug is assumed safe, but rather that it is not generally lethal, and the possible side effects and dangers are well studied, and the info is available for the doctor and patient to discuss.
This may not elaborate much on your thoughts--but I think the key is your asking "to what extent should it be left in the docs and patients hands to assess risk/benefits..." The problem is that noone is taking responsibility. Like the FDA saying to the doc--"but I thought YOU were going to look over risks benefits and evaluate safety" and the doc and consumer saying to the FDA "but I thought YOU were going to evaluate safety."
The FDA shouldnt have the otal overall role and responsibility. It should be shared--FDA, drug company, doctor, patient, and perhaps roles and the process of prescribing drugs should be defined more clearly at the outset
Im rambling now....
This is the end of the thread.
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