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Dr. Florence Ricciuti

2/26/15

Alternative medicine was the topic of the day, presented by, Dr. Florence Ricciuti.

She began by explaining that prescription medications were FDA approved and had undergone extensive testing for both safety and efficacy before being placed on the market.  These drugs bore the results of these tests on their labeling, which is the long small printed material that accompanies these drugs.  Such drugs also have claims to help with the diagnosing, mitigating, curing, or preventing disease.

Alternative medications or treatments are products derived from natural sources such as dietary supplements and probiotics, or manipulative treatments such as yoga, meditation and mind-body practices.  These are used in place of conventional medicine or as complements to conventional medicine.  They are moving toward integration with conventional medicine toward health promotion. 

Such alternatives have a very small body, if any, of objective scientific evidence supporting their safety and/or efficacy.  They have not undergone the large trials that would produce such evidence, but depend instead on personal referrals and anecdotal evidence.  The claims for alternative medications are prohibited from the specificity of prescription medication due to the lack of such evidence and any FDA approval.  Instead they bear more vague claims such as “promotes better health”.  Such alternative medications must also bear a label disclosure that they have not been evaluated by the FDA.

 Additionally, a label reading of alternative medicine does not provide any assurance of quality. The label accuracy depends entirely on the manufacturer’s practices and studies, which are not required to be reviewed by any outside independent body.  Any assurance of accuracy must be gained through the imprimatur of independent agencies such as USP that have examined the product’s contents and determined that the contents are accurately reflected on the label.  But such agencies make no studies dealing with safety or efficacy.  The FDA and FTC do monitor alternative drug labels for inaccurate or misleading statements, but any such products may prove to be beneficial, harmful, or of no effect whatsoever.

The safety of alternative medicines poses concerning issues.  Because there is no oversight or standard protocols in their manufacturing or labeling, alternative medicines may be mislabeled, cause interactions with other drugs, have harmful additives, or even be toxic in certain dosages. Dr. Ricciuti pointed out a recent New York Times article that reported on an investigation revealing that many alternative medicines in major stores such as Target, Walmart and GNC didn’t contain the active ingredient represented on their labels.  These stores recalled the drugs, but the investigation revealed some serious problems in the alternative medicine world.

Some Federal proposals have been made to correct the alternative medicine problems found in dietary supplements.   One such proposal would have examined such factors as history of use, formulation and recommended duration of use.  It quietly died under pressure from the dietary supplemental drug industry.  Another is the currently pending Dietary Supplemental Labeling Act, which is probably doomed to go nowhere in the current political climate.

Dr. Ricciuti did acknowledge that alternative medicines often work.  She ascribes much of this success to the placebo effect.  This results when someone expects something to work or has been told that it will.  The expectation itself produces a bodily reaction that can eliminate the underlying problem that brought about the drug’s use, or at least modify it.  But there still can be side effects that are negative.  Another factor that can effect a person’s reaction to a drug, or alternative medicine is the effect of a physician.  A physician’s demeanor, communication skills and perceived honesty can lead to positive expectations, which then manifest themselves. 

Recommended Websites that can be used for alternative drug research include the following:

    • Concepts to take home are:

      • Natural doesn’t mean safe
      • Always read drug labels
      • Always inform your physician of any drug usage including alternative drugs
      • Take advantage of Website reference material

      Q&A

      Q.  How do you feel about the drug ads on TV with all their warnings and what about drugs that are legal in other countries, but not here?

      A.  The warnings given in drug ads are required by law and the ads themselves have proven to be good marketing for the drug companies.  Foreign countries have their own drug standards although many are similar to what we have here, but some countries take cost into consideration and may also require trials that are run in their countries with their residents.

      Q.  How do vitamin labels arrive at the percentages they give for their dosage being related to the recommended amounts?

      A.  They probably are referring to the historical amounts taken.

      Q.  What are your thoughts on the decline of fish oil popularity and probiotics?

      A.  Fish oil is still very popular.  Probiotics are bacteria and we are finding out just how important bacteria in our system are to our health.

      Q.  Are you familiar with Consumer Laboratory?

      A.  This is one of the organizations that guarantee the accuracy of the label with regard to ingredients.

      Q.  What are the causes of the different prices between countries for the same drug?

      A.  These are probably due to the differing medical systems and their cost controls.

      Q.  Do you know why the FDA moves so slowly to correct problems?

      A.  No, but it is probably due to poor communications.

      Q.  Can I hire you to review my drugs?

      A.  No.  Consult your physician and pharmacist.

      Q.  The Ebola drugs being sent to Africa haven’t undergone the extensive testing you referenced.  Are we using Africa as a test lab?

    • A.  Using developing nations as a test doesn’t work well especially for life threatening diseases like Ebola.  You can’t give a placebo, which you would normally due for some test subjects as a control.  In these nations there is also the problem of informed consent, which is required, but almost impossible to obtain given the cultural and physical conditions.