Justifying Drug Risks:  The German pharmaceutical giant Boehringer Ingelheim announced last week that over 2,000 lawsuits have been filed in the United States related
to episodes of severe and fatal bleeding caused by its stroke prevention drug Pradaxa (dabigatran). Pradaxa sales totaled over $836 million in the United States in 2013.

The company is confident that it will prevail in the suits because the risk of side effects, including fatal hemorrhage, was known and had to be weighed against the drug's life-saving potential. It is an argument commonly used to justify adverse effects of medications.

In our drug oriented society pharmaceutical companies are in a win-win situation. If someone refuses to take a medication and has a poor outcome the response is, "If they had only
taken the drug everything would have been okay.” If they agree to take the drug and die as a direct result of having done so the response is, "It’s unfortunate, but we did
our best. The odds are they would have died of the disease we were trying to prevent had they not taken it.”

The challenge is that medications are always compared to each other or to doing nothing. They are never compared to non-pharmaceutical interventions. In the case of Pradaxa it can be argued that the drug has been shown to cause fewer fatal hemorrhages than Coumadin(warfarin), its primary competitor. Neither drug has ever been compared in effectiveness and safety to
omega-3 fatty acids, which decrease the risk of blood clots by enabling the body to manufacture platelets in a manner in which they do not stick together when they shouldn’t. Neither drug has been compared in safety and effectiveness to nattokinase, an enzyme that lowers the risk of clot formation without raising the risk of severe or fatal
bleeding. Neither drug has been compared
to a combination of omega-3 fatty acids and nattokinase in stroke prevention.

The challenge is that drugs like Coumadin and Pradaxa do not eliminate the risk of a stroke or abnormal blood clot; they only decrease the risk. Omega-3 fatty acids and
nattokinase do not eliminate the risk of a stroke or abnormal blood clot, but they too decrease the risk. The drugs may lower the risk to a greater degree, but that has not been proven. That they cause more serious and fatal hemorrhages is certain. If a study comparing the outcome of individuals given one of the drugs to that of persons taking the
nutritional supplements were to be done it is certainly possible that the odds of healthy survival would favor supplementation. Unfortunately, we may never know.

If someone taking Pradaxa has a stroke we are told that it is unfortunate,but every effort had been made to prevent it. If someone taking omega-3 oils and nattokinase has a stroke we are told that it wouldn’t have occurred had they been taking one of the drugs. The possibility that the odds of healthy survival may be better if taking supports that decrease the risk of stroke without the risk of hemorrhage is never considered.

There are instances in which drugs such as Coumadin or Pradaxa are clearly indicated, but this is often not the case. I discuss this in detail in my article Coumadin:  Is it Right for You?  If a drug has been prescribed to prevent blood clotting it’s important to clearly understand the risks and benefits involved. If the risk of a fatal clot outweighs the risk of a fatal hemorrhage continue it. If the benefits of taking the drug
are questionable challenge the prescriber to provide clear evidence that the
risks involved in taking the drug are justified.