Confessions of a Quackbuster

This blog deals with healthcare consumer protection, and is therefore about quackery, healthfraud, chiropractic, and other forms of so-Called "Alternative" Medicine (sCAM).

Tuesday, December 21, 2004

Risks and Medications-Before you switch to willow bark

Risks and Medications-Before you switch to willow bark

by Robert S. Baratz, MD, PhD, DDS

There are thousands of medications, both prescription and over-the-counter. Some medications are taken as combinations (containing more than one ingredient), others may be taken as single entities. Those who take medications often take more than one, and one must consider these combinations as well. Interactions among medications are common.

Then there are pseudo-medications, 'food supplements'. Some of these are pure chemicals, well studied, with known effects. Most others are crude extracts of herbs and other biologicals. Some others are 'standardized extracts' (enhanced quantities of some, and/or other unknown ingredients). Still others are 'herbal' copies of known medications (Metabolife 356 was apparently one of these), and a host of other iterations.

Recent press regarding Cox-2, and now Cox-1 inhibitors suggest a link between chronic use of these medications and increased risk for heart disease, and/or strokes. The data are just coming in, and are likely to spawn more studies.

Every medication I've ever heard of has "side effects" in some people. Whether these are idiosyncratic to the medication or the patient is often elusive. Whether these are "real", and linked exclusively to the material in question, or the result of concomitant exposure to other materials is often unknown. For example, many foods, e.g. tomatoes, contain pharmacologically active substances such as salicylates.

So before you stop using ketchup on your hamburger and fries sit back and take a deep breath. I just heard a report of a patient with severe osteoarthritis discuss how worried they will be about the pain they will now have if they abandon naproxen, which they had been taking for years, without problems. Ibuprofen doesn't work for them.

The lessons from the recent hubbub on Cox-1 and Cox-2's, and experience with "supplements" are clear:

a.. Pharmaceuticals can be life giving and life saving.

b.. Calling a pharmaceutical a "supplement", or regulating it as a "food" doesn't change its chemistry or pharmacology.

c.. No medication is free from risk, especially those that are effectively unregulated.

d.. One size does not fit all. Ethnic, genetic, sex, age, and other factors may influence who may benefit and who may have a problem with any given medication. Our knowledge of individualized aspects of medication tolerance and effectiveness is in its infancy. Identifying sub-sets of patients who may have problems with particular medications is an important and growing area of medical research and medical science.

e.. Taking medications must always be a carefully considered a balancing act between potential gain and potential liability.

f.. "Natural" does not equal "safe" and/or effective.

g.. The protective role of the US FDA in ensuring safe and effective medications works. It may not always work at a speed and in ways that meet everyone's desires and expectations,but the process is effective. Dangerous substances usually wash-out before approval. The approval process often reveals information that was not previously known. The labeling that goes on a product is backed by science and data. Labeling can be changed as new information comes forward.

h.. Approvals are always subject to "post-market surveillance", and problems that are found with marketed products can be exposed and, if necessary, proper safeguards instituted, even if that means withdrawal from sale.

i.. Not every risk, or potential problem with a medication can be known or anticipated as it goes through the approval process. Sometimes only large population data will reveal a problem with a small subset of patients.

j.. It is better to have a regulatory agency that can protect the public than one that can't.

k.. Some people may not like the approval process as it currently exists, and feel that drugs are approved "too easily". If that turns out to be the case, the process can be changed. The process will never be perfect.

l.. It is better to have an approval process than none at all, e.g DSHEA.

m.. Counseling patients about the risks, benefits, and liabilities of medications is best done by their licensed health-care providers, not by the press, celebrities, advertising, promoters, or charlatans.

Enjoy your ketchup, but don't expect it, or tincture of willow bark, to treat the pain of your arthritis.

Robert S. Baratz, MD, PhD, DDS

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