Monday, June 11, 2007
Counterfeit Medications:
(Part I of a series)
By Phillip T. Alden – San Mateo Daily Journal
For publication – June 5, 2007
This article would not have been possible without the help of Peter Adams, and Dr, James Adams, Associate Professor of Pharmacology, USC School of Pharmacology. I am grateful for their work in calling attention to this alarming problem.
Drugs, even prescription drugs, can be dangerous. Millions of Americans take one or more pharmaceutical drugs every day and the pharmaceutical industry rakes in billions of dollars every year. Most of these drugs are as safe as they can be, and your pharmacist is a valuable gate-keeper that deals with the drug manufacturers, the insurance industry and your health care provider.
But even Over-The-Counter (OTC) drugs can be dangerous. Nobody knows just how their body will react to a new drug until they take that first dose. Sometimes the drug may cause a rash. Sometimes the drug kills the patient. When this happens it's known as an Adverse Drug Reaction, or ADR. Thankfully, most people take a drug and their symptoms or illnesses are successfully treated.
For any medication to reach the public it must first run the labyrinth of safety trials. Phase I trials usually involve lab animals, and if the drug is found to be safe for the animals in question, it goes on to human clinical trials, (also known as Phase II and Phase III trials.) The Federal Drug Administration (FDA) examines the results of the trials and makes a decision to either approve or reject the drug in question.
Recent advances in computer modeling have lessened the use of animal subjects in Phase I trials and increased the efficacy and safety of a given compound before it goes to human trials.
But there are problems with the drug distribution chain, and a recent FDA report, along with the work of people like Dr. James Adams, has found an alarming rise in the number of counterfeit drugs reaching patients in America and around the world.
According to Dr. Adams, "counterfeit medications kill thousands of people worldwide every year and account for $39 billion of the $216 billion drug market in the U.S. yearly." These phony drugs are often found in the Internet pharmaceutical business but can occur in retail pharmacies as well.
In addition, the FDA has been keeping this problem quiet to avoid having American consumers lose confidence in the drug market. They have released various media statements through their website, but this response is anemic in relation to the problem.
Most alarming is the counterfeiting of AIDS drugs, which can lead to drug resistance, increased viral load, and disease progression. The viability of AIDS drugs in particular is of utmost importance due to the nature of the disease and how it's treated. One bad drug in a combination can cause resistance to the rest of the regimen, limiting the number of drugs a patient can use and increasing their chances of disease progression.
As an aside, there is also a counterfeit market of veterinary drugs; specifically NSAIDs, heartworm medications, and flea and tick preparations.
"Any medication that is contaminated, contains the wrong active agent, contains the wrong amount of active agent, is packaged or labeled incorrectly, poorly stored or expired," can have adverse effects, according to Dr. Adams' report. Counterfeits may be sold under both the generic and the brand name. These drugs are often imported into the United States from other countries, and "up to 40,000 counterfeit parcels pass through [U.S. mail facilities] every day."
This dangerous and complex problem will be further addressed in future articles. Stay tuned.
(Part I of a series)
By Phillip T. Alden – San Mateo Daily Journal
For publication – June 5, 2007
This article would not have been possible without the help of Peter Adams, and Dr, James Adams, Associate Professor of Pharmacology, USC School of Pharmacology. I am grateful for their work in calling attention to this alarming problem.
Drugs, even prescription drugs, can be dangerous. Millions of Americans take one or more pharmaceutical drugs every day and the pharmaceutical industry rakes in billions of dollars every year. Most of these drugs are as safe as they can be, and your pharmacist is a valuable gate-keeper that deals with the drug manufacturers, the insurance industry and your health care provider.
But even Over-The-Counter (OTC) drugs can be dangerous. Nobody knows just how their body will react to a new drug until they take that first dose. Sometimes the drug may cause a rash. Sometimes the drug kills the patient. When this happens it's known as an Adverse Drug Reaction, or ADR. Thankfully, most people take a drug and their symptoms or illnesses are successfully treated.
For any medication to reach the public it must first run the labyrinth of safety trials. Phase I trials usually involve lab animals, and if the drug is found to be safe for the animals in question, it goes on to human clinical trials, (also known as Phase II and Phase III trials.) The Federal Drug Administration (FDA) examines the results of the trials and makes a decision to either approve or reject the drug in question.
Recent advances in computer modeling have lessened the use of animal subjects in Phase I trials and increased the efficacy and safety of a given compound before it goes to human trials.
But there are problems with the drug distribution chain, and a recent FDA report, along with the work of people like Dr. James Adams, has found an alarming rise in the number of counterfeit drugs reaching patients in America and around the world.
According to Dr. Adams, "counterfeit medications kill thousands of people worldwide every year and account for $39 billion of the $216 billion drug market in the U.S. yearly." These phony drugs are often found in the Internet pharmaceutical business but can occur in retail pharmacies as well.
In addition, the FDA has been keeping this problem quiet to avoid having American consumers lose confidence in the drug market. They have released various media statements through their website, but this response is anemic in relation to the problem.
Most alarming is the counterfeiting of AIDS drugs, which can lead to drug resistance, increased viral load, and disease progression. The viability of AIDS drugs in particular is of utmost importance due to the nature of the disease and how it's treated. One bad drug in a combination can cause resistance to the rest of the regimen, limiting the number of drugs a patient can use and increasing their chances of disease progression.
As an aside, there is also a counterfeit market of veterinary drugs; specifically NSAIDs, heartworm medications, and flea and tick preparations.
"Any medication that is contaminated, contains the wrong active agent, contains the wrong amount of active agent, is packaged or labeled incorrectly, poorly stored or expired," can have adverse effects, according to Dr. Adams' report. Counterfeits may be sold under both the generic and the brand name. These drugs are often imported into the United States from other countries, and "up to 40,000 counterfeit parcels pass through [U.S. mail facilities] every day."
This dangerous and complex problem will be further addressed in future articles. Stay tuned.
# posted by Phillip T. Alden @ 9:01 PM 
