New meds aren't always 'safe and effective'
 New meds aren't always 'safe and effective'
Foff Member (3166posts)
9/3/2008 8:29:00 AM
The Globe and Mail
Link to full article -> http://www.theglobeandmai...ldoses29/BNStory/National

If you want to avoid potential adverse reactions from prescription drugs you should shy away from new medications that have been on the market for less than two years, a health-systems expert warns.

"It is assumed by the general public that new drugs ... have been put through exhaustive trials and found to be safe and effective," said Donald Light, a sociology professor at the University of Medicine and Dentistry of New Jersey. But, he added, new products are not necessarily better or safer than drugs already available.

In fact, reviews of the medical literature reveal that only one in seven new drugs is superior to existing medications. What's more, two out of every seven new drugs result in side effects serious enough to eventually warrant special warnings or even withdrawal from the market.

And a big problem is that many of these adverse reactions don't become apparent until a drug has been used by millions of patients for several years.

That's why Dr. Light suggests that patients who are doing fine on their existing prescriptions should not quickly switch to a newly introduced medication.

"Don't take any new drug, unless you absolutely have to, for two years."

In addition to a number of Doctors comments which agreed with the title, I found this comment particularly interesting.

I run clinical trials and I've been giving the advice in this article to every family member I have for the past five years. The pharma industry operates in subtle beautifully hideous ways. Everyone involved in clinical trials is carefully selected for their willingness to "play ball". It is unspoken of course. Before a drug is approved it has to go through a final phase III trial. These trials are pivotal and are usually run in private clinics. Physician selection is critical for the drugs "success". A skeptical MD above would probably be selected for one trial. If he asks too many questions he would be dropped from the trial due to some made up diplomatic excuse. Physicians and their study coordinators get to go to five star hotels for "trial start up" meetings with all the pertinent perks. Pharma reps bring high quality food to each clinic every week (not officially study related but...). In return for their work the doctor gets on average 58k per trial. A crooked MD i know in newmarket runs up to twelve trials. You do the math. They are the ones who are in charge of analyzing adverse events and they are the ones who deem them drug related or not. Physicians aren't pushed to find no adverse events. It's just that they know where the bulk of their money comes from (for a family physician running clinical trials the trial money far exceeds the salary). They give new drugs the extreme benefit of the doubt during the trial so that when the drug is approved its likely to have a littany of unknown adverse events. Then during marketing, big pharma asks you to ask someone you trust about x condition. You then go to your physician and its likely he'll be in the pocket of big pharma. The same people who were in charge of getting dangerous drugs approved are the ones advising you to take them when they are approved. Quite the system...In the end the marketing department dictates: drug Y will make us 5 billion before its pulled. Settlements will cost us 3 billion. Profit 2 b

wolfchick Moderator (45828posts)
9/3/2008 9:41:00 AM

I'm still baffled by how many parents are willing to have their teenage daughters injected with Gardisil as protection against potential future cervical cancer. You're messing with something to do with the reproductive system before we know the outcome of a generation. Your daugther may be fine now, but did it harm her future child? Did it harm her ability to reproduce later?
The ads for these are very insulting... they insinuate that smart women will get vaccinated, and those who don't aren't "smart".

Don't get me wrong... I'm not cutting down Gardisil... it may be the best drug of our generation... but I'm questioning the strong push for it when we don't know yet the long term outcome.

Why risk your daughter as a guinea pig?

Foff Member (3166posts)
9/4/2008 9:22:00 PM
I know very little about Gardasil, however, I wouldn't want to be first in line for any vaccination new to the market.

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