<p>I'm reminded by the craze for formula feeding in the 1960's as being " better" than breastfeeding.
How long did that last?</p>
<p>With the amount of money to develop new medications and the cost of trials,pharma companies have much to gain from developing new formulations to take the place of those which now could be prescribed generically.</p>
<p>But are they being approved too quickly?</p>
More than half of all prescription drugs cause adverse effectssome serious or fatalthat aren't detected until after the FDA approves them, sometimes many years later.
Such delayed detection contributes to the high number of drug-related injuries in the United States. In 2008 alone, the FDA received more than 100,000 reports of serious injuries related to adverse drug events, an increase of about 25 percent over the previous year, according to the Institute for Safe Medication Practices.</p>
<p>Some of the delay is inevitable: It's simply not practical to detect every risk before doctors start prescribing a drug. Doing so would require clinical trials that would be prohibitively large, long and costly. The 2007 FDA Amendments Act promised many changes in the drug-safety system, but whether they will be sufficient remains to be seen. Here's a closer look at why you face these unexpected dangers, and what you can do to protect yourself.</p>
<p>Holes in the preapproval process
Clinical trials submitted to the Food and Drug Administration before approval have several limitations, some of them unavoidable. They can't adequately assess safety because they're:
Too small.<em>They typically involve only about 500 to 3000 volunteers, enough to spot only the more-common adverse effects. Rarer ones may emerge only after millions of people have taken the drug.
Too short.</em>The trials may last for just a few months, but some adverse effects develop only after patients take a drug for many years.
Too unrealistic.*Most trials are conducted under scrupulously controlled conditions, with carefully selected patients in order to demonstrate that the drug actually works. Indeed, randomly-controlled trials are the gold-standard for doing this. Yet adverse events are not the focus of the studies and therefore may not be detected.
In the real world, patients may receive lax care that exposes them to greater risks; moreover, doctors are allowed to prescribe approved drugs for unapproved purposes, sometimes for patients at considerably higher risk than the trial volunteers.