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Posts Tagged ‘FDA’

The FDA has announced a new program to help doctors check the approved indications and other information in drug “labels.”  These “labels” are the FDA-approved educational information sheets that drug companies package with medication. See information below:

Online Service Enables Physicians To Check FDA-Approved Medication Labeling Via EHRs.

Healthcare IT News (1/27, Merrill) reported that to “boost drug safety, a new online service has been launched that allows doctors to check the FDA -approved labeling for the most commonly prescribed drugs.” The service is part “of a new campaign” called “Know the Label,” which is being “launched in concert with the FDA’s efforts to provide up-to-date and complete prescribing information to physicians.” It is being delivered to all US physicians and providers “electronically via the websites of PDR Network, The Doctors Company and other liability carriers, via EHR systems. … ‘We congratulate The Doctors Company and PDR Network for finding a practical and novel way for physicians to access the full updated labeling through electronic means and have it available at the point of prescribing,'” said Janet Woodcock, MD, Director of FDA’s Center for Drug Evaluation and Research.

I doubt this new program to disseminate the label information is going to help patients much.  At least in my field, use of medication is based on  patients’ individual conditions and results of studies that go far beyond what’s in the FDA-approved “label.”  Medications are used for conditions other than FDA-approved uses.  Different doses are used.  Combinations that the FDA-approved label says are bad may often be exactly what a patient needs. I guess it won’t hurt to give doctors the information on FDA-approved medication labeling, unless it discourages doctors from giving patients needed treatments for unapproved conditions.

For best results, a doctor’s  good judgment is the best guide to treatment.

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Clinical trials bring us the new wonder drugs that would have been considered either magical or miraculous in earlier times. Are you interested in how drugs are tested to assure efficacy and safety?

On two episodes of Getting Better Health Care, clinical researcher Bea Abrams, PhD, with over 30 years experience in pharmaceutical development, explains the process of clinical trials done to bring a new drug to market.  She shares with us critical information that lets us know how much we can trust new drugs and what to look out for.

In a subsequent episode, I’ll be talking with Dr. Lawrence Friedhoff — author of the book, New Drugs: An Insider’s Guide to the FDA’s New Drug Approval Process for Scientists, Investors and Patients — about myths that surround new drug development.

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The Washington Post reports that the FDA may try to recall a device that was approved for repairing damaged knee joints.  The report says that the device was originally approved with little testing under rules that allow fast-track approval for products that are similar to other products already on the market.

Apparently FDA scientists thought more testing needed to be done, but the product was approved because of political pressure.

The FDA has a tough job.  It has to assure the efficacy and safety of new drugs and medical devices.  But there’s no way to show that anything is completely safe.  There has to be a balance between assuring safety and making products available to help patients in need.

I don’t know how much need there was for this knee joint replacement product.  It may be that getting it to market quickly helped far more people than it hurt.  Ideally, though, it would be good if objective decisions about benefits and risks could be made without political interference.  But it’s also important that the folks at the FDA not be allowed to spend too much time and resources assuring safety if in doing so they block patients’ access to helpful new treatments.

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The news reported that cocaine may be adulterated with other dangerous drugs (http://www.bloomberg.com/apps/news?pid=20601124&sid=aN454DsoGaj4). Cocaine itself is a dangerous, potentially lethal, product. The take home message of this story is that unscrupulous manufacturers can adulterate any unregulated substance.

The FDA has documented many examples of so-called herbal and natural remedies that have been adulterated with real drugs (http://www.fda.gov/NewsEvents/Testimony/ucm184497.htm). Watch out. I have a lot of faith in the purity of regulated, prescription products. I have a lot of faith in over-the-counter products produced by large companies that have reputations to protect. I’d be circumspect about too-good-to-be-true claims of “natural” products that are supposed to work like miracles without drug side effects, especially when fly-by-night companies market those products.

Back in the 1990s, one of the most effective products ever seen for patients with skin disease was introduced and marketed as “natural”: a spray-on zinc product. Some thought it was a miracle cure for psoriasis. But then, lo and behold, researchers analyzed the product and found that it contained one of the most powerful steroids known to man.

We hear all about the side effects of real drugs. No drug is completely safe. Large clinical trials and careful follow up studies of drugs in widespread use are able to identify rare but serious side effects and increased risks of drug products. We know a lot about the benefits and risks of regulated drug products. It is folly to think that natural products are going to be able to magically produce the benefits of real drugs without any of the risks.

I’m not saying there isn’t a place for non-medicinal products. I am saying: Be Careful! Make sure you let your physician know all the products you are using, even if they aren’t prescription products. And take special care with products that come from companies you’ve never heard of. Such companies may have something to gain and little to lose by adulterating their products.

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