Reports of adverse drug events increase, but the risk can be reduced

The Washington Post, Tuesday, February 16, 2010; HE02
Full item: http://www.washingtonpost.com/wp-dyn...021204117.html

More than half of all prescription drugs cause adverse effects -- some of them serious or fatal -- that aren't detected until after the Food and Drug Administration has approved 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.

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.
Holes in trials process

Clinical trials involving drugs that have not yet been approved by the FDA have several limitations, some of them unavoidable. They can't adequately assess safety because they're:

-- Too small. They typically involve only about 500 to 3,000 volunteers, enough to spot only the more common adverse effects. Rarer ones may emerge only after millions of people take the drug.

-- Too short. 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. Adverse events are not the focus of the studies and therefore may not be detected.

In addition, the FDA may approve some new drugs more quickly than others. The time devoted to preapproval review, particularly for drugs deemed "priority," has dropped substantially since 1992. Congress passed a law designed to speed up the FDA approval process for some drugs to get them to the market faster. But doing so may have come at a significant cost. A 2003 survey of FDA reviewers indicated that they generally felt rushed and, in some cases, pressured by their supervisors to approve medications.

[Pharmacogenetics MUST become more available , more affordable and more utilized by physicians. the prevalence of individuals with mutations in the detoxifying systems that determine how well a drug is utilized and or cleared from the body have been reported for several of these systems. those with mutations in the CYP450 system as well as any of the transporter protein systems are at untenable risks for adverse drug effects. These mutations are not rare, yet with all this scientific information available, it is not applied to clinical practice. I understand this branch of science is in its infancy; it does not preclude the application of what is known now. I wonder if perverse incentives to delay application of this science occurs within the pharma and insurance industry.