painThe finding that NSAIDs can cause heart attacks and strokes in certain patients  has disrupted the lives of millions of arthritis patients as well as throwing a scare into the pharmaceutical industry.

But it needs to be put in perspective. There is no better place to start than with the famous dictum of the Swiss Renaissance physician Paracelsus: “All things are poison, and nothing is without poison. It is the dose alone that makes a thing not a poison.” In the case of the painkillers, it is likely that lower doses and limits on the duration of therapy would avoid most problems. Quite possibly, some of the people who suffered heart damage belonged to high risk categories for whom most or all prescription painkillers would be dangerous. In fact, NSAIDs and other pain relief drugs have shown themselves to be very effective and safe for certain groups of patients in modest doses for limited periods of time, so it is unreasonable to withdraw them from the market. Of course, they should compete there on the basis of their merits compared to other drugs.

The controversy over pain relief drugs raises a more general issue. On the surface, the requirement that drugs be tested in healthy volunteers seems sensible. But in fact it contains two serious flaws.

First, healthy volunteers cannot possibly properly assess the risk they are undergoing in offering to take novel drugs. So this seemingly reasonable practice poses a real ethical problem. The drugs reportedly have harmed healthy volunteers, perhaps needlessly. In terms of pharmacology, to test a drug in a healthy subject is to ask for trouble, for drugs that don’t have disease targets in the body will start to target healthy groups of cells instead (Dillon, 1994). Ironically, in many cases a diseased person would be less likely to suffer damage from such a drug because his/her inflammation or infection or tumor will tend to absorb the drug to such an extent that there will not be enough left to do damage to healthy cells.

Second, as a result of this pattern, it is possible that testing drugs in healthy volunteers has led to quite a few instances in which potentially beneficial drugs were ruled out before they ever reached the people who really needed them and in whom a more accurate assessment of safety and effectiveness could be made.

Therefore, it would seem wise to use the momentum from the pain relief drug controversy to take a new look at our general testing methodology for all drugs. The clear alternative to current policy would be to conduct initial testing of drugs in volunteer patients, not in healthy volunteers. Given the importance of this issue, at a minimum careful studies should be conducted to establish whether initial testing in healthy volunteers or in volunteer patients makes more sense, as well as conforming to ethical standards.

Other Pain Remedies

Fortunately, standard drugs are not the only way to treat arthritis pain. Over the course of history, the inventive human species has come up with many arthritis pain remedies. Some are well known: cold, heat, exercise.

The benefits of one remedy–marijuana–are oversold, while its many drawbacks are often ignored. Marijuana (1) harms the lungs; (2) causes secondary smoking; (3) interacts with other drugs; (4) can be addictive; (5) impairs driving safety; (6) reduces sperm production; (7) causes psychological involution and apathy; (8) causes memory deficits; and (9) is supplied in part by drug syndicates.

But at least three remedies are greatly underused.

The first is the copper bracelet. A Mayo Clinic clinical study (Bratton et al., 2002) found that such bracelets were effective in reducing musculoskeletal pain in 75 percent of users. Copper bracelets are inexpensive and have few side effects (however, copper bracelets are counter-indicated for cancer patients because copper can promote metastases).  Their mechanisms of action are not yet clear; but a body of information, analysis, and hypotheses has accumulated that can lead to solid scientific explanation of their effects. It is possible that copper-zinc bracelets are more effective than pure copper ones, and sufferers from arthritis and other types of chronic pain should wear the bracelets for at least two months to see if they convey benefits.

In a recent case, an arthritis patient with swollen fingers twisted and frozen into place wore a copper-zinc bracelet for 18 days without any results. On the 19th day, her pain disappeared and she could wiggle her fingers. In general, such bracelets seem more frequently effective in pain localized in small areas rather than spread over a large area, as in backache. One mechanism of action may be the correction of micromineral deficiencies.

The second therapy is low-dose methotrexate. This simple folic acid antagonist enjoys an excellent track record against rheumatoid arthritis and has been found effective in other autoimmune and inflammatory disorders as well. While high-dose methotrexate has upon occasion caused serious side effects when used in cancer chemotherapy, when used in proper low doses in the treatment of rheumatoid arthritis, methotrexate is much safer. Important precautions are to dose just once per week, to curtail the intake of alcohol, especially on the day of intake, and to take folic acid supplements. Low-dose methotrexate is a generic drug that costs a fraction of the cost of prescription painkillers.

The third is Biophotonic Therapy (Photoluminescence), which involves treating a small amount of blood with light, then reinfusing the blood. Clinical trials have shown that BT is safe, and it is effective in 75-80 percent of cases of rheumatoid arthritis and osteoarthritis, roughly the level of effectiveness of other drugs (Dillon, 1998, 2003, 2008). BT is relatively low in cost and is dispensed in a clinical setting, which reduces concerns over patient compliance or overdosing.

Why aren’t these therapies much more widely publicized and used, especially now that the standard pain relief drugs have run into such trouble? One could adduce a number of reasons for this anomaly. An obvious reason is that no pharmaceutical company stands to make a lot of money from these generic physical therapies. At any rate, here is the situation:

  • many people are afraid to take standard pain relief drugs that, in proper doses and in the right patients, are probably very safe and effective;
  • other patients who are willing to accept the (likely exaggerated) risk of Vioxx cannot obtain it because the manufacturer has withdrawn it from the market;
  • healthy volunteers have been harmed in testing, while the principle upon which drugs are tested first in healthy volunteers appears dubious at best; and
  • the media lament the lack of safe pain relief drugs while ignoring copper bracelets, low-dose methotrexate, and Biophotonic Therapy.

The solutions for this deplorable situation are to distinguish between levels of dosing, rethink the practice of initial testing in healthy volunteers, and make use of the above three physical therapies.


Bratton, Robert L. et al. (2002). “Effect of ‘Ionized’ Bracelets on Musculoskeletal Pain: A Randomized, Double-Blind, Placebo-Controlled Trial”. Mayo Clinic Proceedings 77, 1164-1168

Dillon, Kenneth J. (1994). Apprentice to Paracelsus. McLean, Virginia: McLean Research Associates

Dillon, Kenneth J. (2003). Close-to-Nature Medicine. Washington, D.C.: Scientia Press

Dillon, Kenneth J. (1998). Healing Photons. Washington, D.C.: Scientia Press

Dillon, Kenneth J. (2008). Intriguing Anomalies: An Introduction to Scientific Detective Work. Washington, D.C.: Scientia Press

*****

Kenneth J. Dillon is an historian who writes on science, medicine, and history.  See the biosketch at About Us.

 

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