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Harvard Health Blog
The trouble with new drugs
Robert H. Shmerling, MD,
Senior Faculty Editor, Harvard Health Publishing
As a service to our readers, Harvard Health Publishing provides access to our library of archived content. Please note the date of last review or update on all articles. No content on this site, regardless of date, should ever be used as a substitute for direct medical advice from your doctor or other qualified clinician.
I sympathize with the difficulties that new drugs are presented with and the inherent unknowns they create and then must somehow be managed. Nevertheless the problem does not go away and will get predictably worse as more and more drugs are introduced and adopted by MD’s. The number of reported issues and categories can be assumed to be understated as no adequate reporting is required by the patient and a reluctance to take drugs off the market unless there is solid evidence or a safer drug. I would assume that a person taking the drug has not sat down and read all the known side-affects and possible ones that that can occur due to poly pharmacy which now makes the possible side-affects multiplied again. But who is to be responsible for this as I think the family doctor is over worked and under pressure already and the extra paper work and surveillance to keep track and monitor historical data of each patient would be a monumental task. Yet perhaps some responsibility should be transferred to the patient to record and report on-line themselves for each drug and any red flags then sent to alert the family doctor. I can not see any body else doing it given the scope and size of the problem. But in doing this there may be some privacy issues and trust issues so I think it must be a volunteer system. I am sure clever programmers could create such a system or else you’d better come up with a non drug solution that has passed all the clinical trials as required by the FDA. Good luck there. But this article was a fair analysis of the problem but by no means a solution nor meant to be.
In other words, everyone who takes a new drug is a guinea pig. Particularily w/regards to long term effects as drug trials last a relatively short time.
Reporting side effects is a great idea, an even better idea is for health care providers to ASK if the person’s experiencing side effects from a new medication, if so, what are they (i.e, listen to the patient’s answer for as long as is necessary to elicit a full answer) and finally, actually take note of & report what the patient has said. Not many health care providers I’ve been to do so. In reality, when I once reported what to me was a significant side effect (sudden onset of a severe headache in a young /late 20’s person who rarely experienced headaches, then they were usually sinus headaches, which this was not) I was told, oh, just keep taking X medication, it’ll probably go away.
My response was, no, what’s going to happen is that I’ll be given a prescription for a different medication. I was well enough to see the MD (not the provider who told me to “just keep taking the medication”), I was prescribed a different med & I had no more headaches.
In addition, some cancer medications are known to have unpleasant side effects, and most MDs will tell their patients to keep taking the medication anyway, for as long as the person can tolerate the sx, if the med appears to be doing what it’s supposed to do. Seems to be particularly true both of chemo, and “living with cancer” meds like Ibrance & similar meds. Or that seems to be the experience of the people I’ve known who unfortunately have to take those meds (and their insurance pays for the bloated medication cost).
My opinion is the high rate of warnings, etc. on new meds means that the FDA is too easily swayed by the corporations it’s supposed to regulate. It approves too many medications w/questionable trial structures and questionable results.
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