YOUR MEDICINE CHEST

It's amazing how many things in life we take for granted. How many strangers' opinions we trust. How much faith we put in things we can't control -- like the safety of medicines we take and give our families.

Today the News Moms reported on stronger warnings placed on drugs for people with ADHD. Though rare, some of those drugs have been linked to dangerous side effects like serious heart problems and psychotic behavior. Today we reported that after FDA advisors disagreed on whether stronger warnings were necessary, the agency quietly asked drug manufacturers to beef up the labeling to warn doctors -- without alerting the public until this week.

Much of what's being added, doctors already knew and consider when prescribing these drugs. So for most of the four million Americans taking Ritalin, Adderol, Concerta, Dexedrine and other drugs, there's no cause for alarm.

But what struck me as interesting is how much we patients take for granted. We ASSUME the drugs we're taking are safe because they've been through years of clinical trials and screened by experts at the FDA. Yet recent recalls of Vioxx, Bextra and other drugs have certainly called that so-called assurance into question.

The FDA has been under fire for a few years now, accused of not doing its job -- protecting Americans from bad medicine. The harshest critics claim the agency bows to pressure from the drug industry because it receives millions in funding from drug companies to complete its work.

In a report out last spring, the Government Accountability Office (the federal government's internal watchdog) said the FDA hasn't been as vigorous as it should be in ensuring drug safety. And it criticized the agency for quashing the opinions of scientists and drug safety experts who question the status quo. It noted a recent survey that concluded one in five FDA scientists have been asked to change their findings in official reports, and 40 percent fear retaliation for questioning decisions.

The FDA has rigorously defends itself, stating that the agency is diligent and is in the midst of a systemwide review to improve operations. This summer the agency streamlined rules for scientists who advise the agency on key drug decisions, but also are paid consultants for drug companies. The new policy is an attempt to reduce conflicts of interest, or even the appearance of it. Dr. Andrew von Eschenback, the agency's acting commissioner who will likely soon be confirmed by the Senate, has promised a top-down review to further strengthen the agency and restore public confidence.

I can tell you from a journalists' point of view, the FDA is very selective about sharing information about how it does business -- especially when it involves controversial issues. Often requests for interviews and information go unanswered, are not answered in a timely manner, or are simply turned down without explanation. As a journalist who seeks to tell the whole story -- and as a mother -- that's concerning.

Which leads us back to the idea of putting faith in things we can't control. I wonder: do we really have a choice?

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