FDA (Food And Drug Administration)

Interesting question. Perhaps I should start by clarifying what the FDA (Food and Drug Administration) is responsible for... and that is pretty much just foods and drugs :). However, I also believe that it is responsible to treat nutritional supplements and herbal medicines "like drugs" in that we should consider things like effectiveness, dosing, safety, side effects, and drug interactions when we "prescribe" herbs and nutritional supplements. In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA) which has enabled the patients in this country to continue to have access to nutritional supplements and herbal medications of our choosing without a prescription. However, it also gave the FDA a different scope of regulatory oversight than we see with prescription drugs. The FDA is responsible for taking action against any UNSAFE dietary supplement after it reaches the market (which means that supplement manufacturers are responsible for bringing safe products to market). Prescription drugs must be proven to be safe and effective to get FDA approval. Nutritional supplements are not required by anyone to be safe and effective. I could go on at length about how to take supplements safely but that's not what you asked. As far as the way I practice medicine goes, I incorporate recommendations for any evidence-based therapy which is appropriate to my patient's needs whether that be conventional or complementary. Thanks for your question.

You're right, the data collection process has certainly been far from complete in terms of % of patients followed.

Personally I prefer to use the patient's own tissue for the breast reconstruction whenever possible. In my opinion it provides the most "natural" reconstruction and avoids the long-term issues that have been associated with implants.

However, no single procedure is best for everyone and patients must choose what they feel most comfortable with. Our job as plastic surgeons is to ensure our patients have all the information they need to allow them to make that decision.

Dr C
http://www.PRMA-enhance.com

Yes, FDA regulations for vitamins and supplements are similar to FDA regulations for food products. Note that health supplements do not have to meet FDA standards for drugs, which are more rigorous and require extensive testing for safety.

For more about vitamins and supplements, see our feature article: http://www.cfah.org/hbns/preparedpatient/Vol4/Prepared-Patient-Vol4-Issue4.cfm

The FDA recommendation re:Avastin is not about whether it will continue to be available for treatment of metastatic breast cancer. Since the drug is prescribed for treatment of other cancers, physicians will be able to prescribe it "off label" for breast cancer as well. The issue is largely one of health care coverage. Avastin runs as much as $8000/treatment, and without insurance coverage that is likely to be prohibitive. While, I have heard that Genetech is looking at capping fees at $55,000/a year, that is still WELL beyond the reach of most of us.

A related issue, as Dr. Attai discusses elsewhere, is the need to focus energy and funds on better understanding which drugs will work in which patients with which cancers, so that we can get Avastin to the right patients, and protect the ones who could be harmed.