Pharmacogenomics and pharmacogenetics will prove to be useful tools to limit the number of drug-related deaths and drug reactions. Prescription drugs are now the number four killer in the United States and drug overdose is now the leading cause of injury-related death. Get this. Properly prescribed drugs cause 1.9 million hospitalizations a year and 328,000 deaths a year. Anything that can reduce those numbers certainly would be most welcomed.
You might think that newer drugs would be safer. But, as a whole they are not. Newer drugs are not necessarily more effective than older drugs either and tend to have more serious reactions. In fact, the chance of getting a serious reaction from a new drug is one in five. Only 11% to 15% of new drugs have clinical advantages over older drugs.
We strongly encourage you to read this review on the safety and effectiveness of new drugs from the Center of Ethics at Harvard University. The section in the review called The Trial-Journal Pipeline discusses what we have stated in other articles that the pharmaceutical industry is a major funder of the FDA – it funds the federal agency that is supposed to regulate it. It also discusses the games pharmaceutical companies play to get their drugs approved and prescribed.
Since you and I do not control the safety of the drugs being manufactured what can we do to protect ourselves from the potential harm caused by prescription drugs that we may take? That’s where pharmacogenomics and pharmacogenetics come in.
Pharmacogenomics Versus Pharmacogenetics
Pharmacogenomics and pharmacogenetics are closely related and the two terms are sometimes used interchangeably but there are subtle differences between the two. Pharmacogenomics is the study of how the genes that make up the human genome determine drug behavior. Pharmacogenetics, on the other hand, studies the inherited individual differences in drug metabolism and response. Pharmacogenomics is the more general study of the interplay between genes and drugs while pharmacogenetics is specific to the individual.
Not all of us respond the same way to medication. Some people tolerate medications well and others seem to be sensitive to nearly every drug they take having any number of side effects. Some people metabolize medicine quickly and need more medication to obtain a desired result and others need just a small amount of a medication because they metabolize it slowly.
Also, in clinical trials to obtain FDA approval a single drug is studied for safety and efficacy with drug interactions being noted. But, drugs are frequently prescribed in clusters and it is really unknown how the combination of four or five drugs affects efficacy and safety.
All of this – how we metabolize drugs, how we respond to them, and whether or not we experience side effects is dictated by our individual genes.
Pharmacogenetics is a method to better predict which class of medications is more likely to be effective with fewer side effects. For instance, there are several classes of blood pressure medications including diuretics (water pills), beta-blockers, calcium channel blockers, ACE inhibitors, and ARB inhibitors. Would it not be nice to know which of those classes and which specific drug in a class a patient will do best with?
Through pharmacogenetics a doctor can better select an effective drug as well as the appropriate starting dose making prescribed drugs more safe. It is estimated that 17,000 strokes could be prevented if dosing guidelines for the blood thinner warfarin were based on genetic tests rather than blood tests.
How is Pharmacogenetic Testing Performed?
A swab of the lining of your mouth is performed collecting cells that then undergo genetic testing and analysis. Some labs will test anywhere from 11 to 23 or more genes associated with metabolism, response, and interactions on the more commonly prescribed medications. Once pharmacogenetic testing is done you can provide all the doctors you come in contact with the results of your testing to better manage your treatment.
Does Insurance Cover Pharmacogenetics Testing?
Insurance may or mat not cover the cost of testing which can exceed a $1,000. Some will cover the costs for limiting testing. Medicare will cover testing if it is the patient’s primary insurance and deemed medically necessary. But, with its ability to reduce costs we expect that pharmacogenetics testing will someday be routinely performed and covered.
Pharmacogenetic Testing Labs
Pharmacogenetic testing is a growing field and more labs are offering it. The following companies perform pharmacogenetic testing that we are aware of:
Drug Companies and the FDA
Like the Harvard University article we linked to above we too have discussed the cozy relationships among the FDA, pharmaceutical industry, and politicians in our recent article, Why Bad Medical Research Might Get Published.
From 2002 to 2011 the FDA approved 994 new drugs. Only 2 are considered breakthrough drugs, 13 real advancements, and 61 somewhat beneficial. The remainder offer no advantage over older drugs, but will have more side effects and cost more. These numbers comes from the chart at the end in the Harvard University article.
Perhaps pharmaceutical companies should only be granted patents on drugs that are safer and more effective than older existing drugs. This will motivate them to develop “blockbuster” drugs than simply tweak existing drugs to obtain patent protection.
The same forces that corrupt individuals and corporations are the same forces that corrupt politicians and government agencies which is why big government is ineffective yet costly. Who is to regulate the regulators and government? It is easier to deal with corruption or unethical behavior at its obvious “point of sale” rather than that hidden under the guise of government protection and regulation.