Friday, June 29, 2007
Storing medical information under your skin:
By Phillip T. Alden – San Mateo Daily Journal
For publication – July 3, 2007
A recent article in Yahoo! News stated the American Medical Association's (AMA) support of a small, rice grain sized chip that can be implanted under the skin of a patient. When said patient arrives in an emergency room doctors can employ a hand-held device that reads the information.
The data is supposed to include the patient's medical history, and illnesses or diseases they may be suffering from, and a complete list of all the medications the patient is currently taking.
The technology behind these chips is known as Radio Frequency Identification Tags, (or RFID,) is already widely used in shipping and inventory processes for large companies like Wal-Mart. It's been said that RFID tags will replace the old "bar code" price tags, enabling the merchant to scan the item at the register, automatically order replacement inventory, and even act as security devices to thwart shoplifting.
Although the retail RFID chips are said to become inactive once they have been scanned, there is no guarantee of this actually happening. Privacy advocates are justifiably concerned that such tags could be used to track the spending habits of consumers, (which the companies have stated as a goal,) and possibly track the people themselves. Many privacy advocates feel there are already too many ways that American citizens can be tracked.
And they have good reason for concern. The Bush Administration has shown time and time again they are willing, (and in some cases eager,) to ignore the laws that insure the privacy rights of Americans. Their illegal wire-tapping program under the guise of "fighting terrorism" is a good example. Even though the 9-11 attacks were planned and carried out by people from Saudi Arabia, the Bush Administration decided to make all Americans terrorist suspects for the purpose of suspending our rights using abhorrent pieces of legislation like the ill-named Patriot Act, rammed through an American government so controlled by one party that it destroyed our system of checks and balances.
I understand the reason and logic behind the AMA's support for these medical chip implants. When a patient is brought into an emergency room they are often not in a condition to give the doctor accurate and complete information about their health status. Doctors are afraid of administering a drug that may interact with an pre-existing condition or drug in the patient's system.
In a country where we could count on our government to not abuse its power, the implementation of such a program might not generate so much controversy. But our government has shown time and again that it cannot be trusted to abuse its power, and at the moment the American people are stuck with a government they know they cannot trust. The anti-American secrecy of the Bush Administration, especially the Vice-President's office, and the long list of lies and illegal activities they have engaged in does not create an atmosphere of trust among the American people.
As a compromise, the AMA could issue "dog tags" like our soldiers have, or a wallet card with the RFID chip implanted in the card. That way, Americans concerned about their right to privacy and unwarranted government intrusion into their private lives, could make a choice to carry the chip or leave it at home or in the car. They could also shield the tag by placing it in a bag that deflects unwanted scans.
The doctors who support this idea and the AMA might not like this compromise, but with the current state of American politics, they may have to make such allowances for Americans like myself who still value our right to privacy.
By Phillip T. Alden – San Mateo Daily Journal
For publication – July 3, 2007
A recent article in Yahoo! News stated the American Medical Association's (AMA) support of a small, rice grain sized chip that can be implanted under the skin of a patient. When said patient arrives in an emergency room doctors can employ a hand-held device that reads the information.
The data is supposed to include the patient's medical history, and illnesses or diseases they may be suffering from, and a complete list of all the medications the patient is currently taking.
The technology behind these chips is known as Radio Frequency Identification Tags, (or RFID,) is already widely used in shipping and inventory processes for large companies like Wal-Mart. It's been said that RFID tags will replace the old "bar code" price tags, enabling the merchant to scan the item at the register, automatically order replacement inventory, and even act as security devices to thwart shoplifting.
Although the retail RFID chips are said to become inactive once they have been scanned, there is no guarantee of this actually happening. Privacy advocates are justifiably concerned that such tags could be used to track the spending habits of consumers, (which the companies have stated as a goal,) and possibly track the people themselves. Many privacy advocates feel there are already too many ways that American citizens can be tracked.
And they have good reason for concern. The Bush Administration has shown time and time again they are willing, (and in some cases eager,) to ignore the laws that insure the privacy rights of Americans. Their illegal wire-tapping program under the guise of "fighting terrorism" is a good example. Even though the 9-11 attacks were planned and carried out by people from Saudi Arabia, the Bush Administration decided to make all Americans terrorist suspects for the purpose of suspending our rights using abhorrent pieces of legislation like the ill-named Patriot Act, rammed through an American government so controlled by one party that it destroyed our system of checks and balances.
I understand the reason and logic behind the AMA's support for these medical chip implants. When a patient is brought into an emergency room they are often not in a condition to give the doctor accurate and complete information about their health status. Doctors are afraid of administering a drug that may interact with an pre-existing condition or drug in the patient's system.
In a country where we could count on our government to not abuse its power, the implementation of such a program might not generate so much controversy. But our government has shown time and again that it cannot be trusted to abuse its power, and at the moment the American people are stuck with a government they know they cannot trust. The anti-American secrecy of the Bush Administration, especially the Vice-President's office, and the long list of lies and illegal activities they have engaged in does not create an atmosphere of trust among the American people.
As a compromise, the AMA could issue "dog tags" like our soldiers have, or a wallet card with the RFID chip implanted in the card. That way, Americans concerned about their right to privacy and unwarranted government intrusion into their private lives, could make a choice to carry the chip or leave it at home or in the car. They could also shield the tag by placing it in a bag that deflects unwanted scans.
The doctors who support this idea and the AMA might not like this compromise, but with the current state of American politics, they may have to make such allowances for Americans like myself who still value our right to privacy.
Thursday, June 21, 2007
More about counterfeit medications:
(Part III of a III part Series)
By Phillip T. Alden – San Mateo Daily Journal
For publication – June 19, 2007
A couple of weeks ago I wrote about a report from Dr. James Adams at the USC School of Pharmacology, detailing problems in our drug distribution chain, including the sale of counterfeit medications, which accounts for $39 billion in sales in the U.S. annually.
And while pharmaceutical drugs sold over the Internet were singled out for special consideration, the problems were not related solely to that avenue. The report stated that; "counterfeit drugs kill thousands of people world-wide every year," and that the U.S. Food and Drug Administration was keeping the problem quiet to avoid having American consumers lose confidence in the drug market.
And while there are press releases on the FDA web site, they only work if the press actually reports on them. There are not many people who check the FDA or the CDC web sites on a regular basis to find out if there are any major health risks in their area, (but it's not a bad idea.) Also, a press release by itself says very little about the scope and severity of a given event. It gives enough information to satisfy our sound-bite mass media, but fails to truly inform the average citizen.
Dr. Adams' report also states that a large part of the problem involves imported drugs or compounds used as a base in drug manufacturing. These various chemical compounds and/or finished medications "[may be contaminated, may contain the wrong amount of active agent, may be manufactured by another company in places like Russia, China, India and Pakistan; and may be packaged or labeled incorrectly."
These tainted products make their way into the U.S. pharmaceutical supply chain through large wholesalers who import nearly all of these chemicals, (think about the recent pet food poisoning tragedy that involved nearly every brand of food on the American market.) When counterfeit drugs and compounds find their way into one of the few giant wholesalers, they end up distributed throughout the system.
These wholesalers get big discounts when they buy these drugs from certain countries, so they choose profit over domestic manufacturers who would be bound by U.S. rules and regulations, and who would be much less likely to endanger the lives of American consumers. If a family member died from a drug distributed from New Jersey, but containing a contaminated chemical manufactured in China or India, the people responsible for the death are rarely identified or prosecuted.
But the victims of these phony medications are hardly limited to the United States. Examples include the following:
"Meningitis in Niger 1995 – 50,000 people were inoculated with counterfeit vaccine, resulting in 2,500 deaths."
"China in 2002 – 8% of all Over-The-Counter (OTC) drugs were counterfeit."
"Kenya 2005 – 30% of the drugs in the country were found to be counterfeit, including AIDS medications."
There are diluted or useless Malaria vaccines sent to places like Africa where 1 million children die from the disease annually.
The FDA has attempted to stop counterfeit drugs from reaching the American market using things like RFID tags, cross-border purchasing laws and regulations, a National Drug Code, (NDC,) changes to labels and packaging, and other measures.
But one huge gaping hole in this regulatory scheme is strict oversight and regulation of our domestic pharmaceutical industry. Considering the industry's tentacles have found their way into every corner and crevice of national politics, and their corruption of our political system through money and lobbying makes them nearly untouchable, I wouldn't expect any serious changes there in the near future.
(Part III of a III part Series)
By Phillip T. Alden – San Mateo Daily Journal
For publication – June 19, 2007
A couple of weeks ago I wrote about a report from Dr. James Adams at the USC School of Pharmacology, detailing problems in our drug distribution chain, including the sale of counterfeit medications, which accounts for $39 billion in sales in the U.S. annually.
And while pharmaceutical drugs sold over the Internet were singled out for special consideration, the problems were not related solely to that avenue. The report stated that; "counterfeit drugs kill thousands of people world-wide every year," and that the U.S. Food and Drug Administration was keeping the problem quiet to avoid having American consumers lose confidence in the drug market.
And while there are press releases on the FDA web site, they only work if the press actually reports on them. There are not many people who check the FDA or the CDC web sites on a regular basis to find out if there are any major health risks in their area, (but it's not a bad idea.) Also, a press release by itself says very little about the scope and severity of a given event. It gives enough information to satisfy our sound-bite mass media, but fails to truly inform the average citizen.
Dr. Adams' report also states that a large part of the problem involves imported drugs or compounds used as a base in drug manufacturing. These various chemical compounds and/or finished medications "[may be contaminated, may contain the wrong amount of active agent, may be manufactured by another company in places like Russia, China, India and Pakistan; and may be packaged or labeled incorrectly."
These tainted products make their way into the U.S. pharmaceutical supply chain through large wholesalers who import nearly all of these chemicals, (think about the recent pet food poisoning tragedy that involved nearly every brand of food on the American market.) When counterfeit drugs and compounds find their way into one of the few giant wholesalers, they end up distributed throughout the system.
These wholesalers get big discounts when they buy these drugs from certain countries, so they choose profit over domestic manufacturers who would be bound by U.S. rules and regulations, and who would be much less likely to endanger the lives of American consumers. If a family member died from a drug distributed from New Jersey, but containing a contaminated chemical manufactured in China or India, the people responsible for the death are rarely identified or prosecuted.
But the victims of these phony medications are hardly limited to the United States. Examples include the following:
"Meningitis in Niger 1995 – 50,000 people were inoculated with counterfeit vaccine, resulting in 2,500 deaths."
"China in 2002 – 8% of all Over-The-Counter (OTC) drugs were counterfeit."
"Kenya 2005 – 30% of the drugs in the country were found to be counterfeit, including AIDS medications."
There are diluted or useless Malaria vaccines sent to places like Africa where 1 million children die from the disease annually.
The FDA has attempted to stop counterfeit drugs from reaching the American market using things like RFID tags, cross-border purchasing laws and regulations, a National Drug Code, (NDC,) changes to labels and packaging, and other measures.
But one huge gaping hole in this regulatory scheme is strict oversight and regulation of our domestic pharmaceutical industry. Considering the industry's tentacles have found their way into every corner and crevice of national politics, and their corruption of our political system through money and lobbying makes them nearly untouchable, I wouldn't expect any serious changes there in the near future.
ADAP Under Fire Once Again:
By Phillip T. Alden – San Mateo Daily Journal
For publication – June 26, 2007
As a result of the hard work of AIDS activists in the 1980s Congress established the AIDS Drug Assistance Program, (ADAP.) It's also known as The Ryan White CARE Act, named after the young Florida boy whose heroic fight against stigma and hatred of People With AIDS (PWAs) changed the face of AIDS in America.
Against the wishes of AIDS activists and PWAs in general, ADAP was folded into the Medicare Part D drug program. It was thought at the time that the Bush Administration would use this change to cut even more funding for people with HIV, and unfortunately this is exactly what has happened.
The Bush Administration has not been a friend to AIDS patients and AIDS prevention programs. One of their first acts was to funnel millions of dollars from proven AIDS prevention programs like the Stop AIDS Project in San Francisco, to religious groups, in clear violation of the separation of powers act. These groups discarded the effective and proven comprehensive AIDS education programs and replaced them with misinformation about the value of condoms in preventing the spread of STDs. The harm done by these acts cannot be measured, but it's been shown that, under these groups, prevention efforts failed and infection rates went up.
Now they're at it again. A couple of weeks ago it was announced that ADAP funding in San Mateo County will be cut by 30%. This leaves the county with some ugly choices, and regardless of those choices, prevention and treatment will suffer.
While the federal government has funneled billions of dollars into corporations like Bechtel and KBR, they have also done their best to cut what little funding there is to help the weakest members of our society. There's no reason for this. Compared to the $750 Billion we annually spend on military-industrial projects and research, the cost of these life-saving domestic programs that benefit not only people with illnesses like AIDS and Hepatitis C, but everyone through improved public health, is a drop in the bucket.
USA Today reported this week that, thanks to the Bush Administration, our country has amassed 59 Trillion dollars in national debt, and this number continues to climb as we continue the occupation of Iraq. This is the economic legacy our children will inherit.
And now, with San Mateo County losing an additional 30% in badly needed funding for AIDS prevention and treatment, one has to question if good public health is a priority for our federal government. These types of destructive cuts to public health affects us all, rich and poor alike. Strong public health is essential for every country, essential for the health and well-being of all its citizenry.
We need to increase the amount of money we spend on programs like Medicaid and ADAP, and we need to move prevention and education funds back to the organizations that promote comprehensive education and prevention without a religious agenda. We need to strengthen the Centers for Disease Control, (CDC,) the Food and Drug Administration, (FDA,) and the Environmental Protection Agency, (EPA.)
A Pew Research Poll taken earlier this year showed that 76% of Americans view universal health care a priority for our country, and similar polls show strong support for robust and effective public health programs.
It's time to demand strong support and increased spending on domestic public health programs right now, for the welfare of all Americans.
By Phillip T. Alden – San Mateo Daily Journal
For publication – June 26, 2007
As a result of the hard work of AIDS activists in the 1980s Congress established the AIDS Drug Assistance Program, (ADAP.) It's also known as The Ryan White CARE Act, named after the young Florida boy whose heroic fight against stigma and hatred of People With AIDS (PWAs) changed the face of AIDS in America.
Against the wishes of AIDS activists and PWAs in general, ADAP was folded into the Medicare Part D drug program. It was thought at the time that the Bush Administration would use this change to cut even more funding for people with HIV, and unfortunately this is exactly what has happened.
The Bush Administration has not been a friend to AIDS patients and AIDS prevention programs. One of their first acts was to funnel millions of dollars from proven AIDS prevention programs like the Stop AIDS Project in San Francisco, to religious groups, in clear violation of the separation of powers act. These groups discarded the effective and proven comprehensive AIDS education programs and replaced them with misinformation about the value of condoms in preventing the spread of STDs. The harm done by these acts cannot be measured, but it's been shown that, under these groups, prevention efforts failed and infection rates went up.
Now they're at it again. A couple of weeks ago it was announced that ADAP funding in San Mateo County will be cut by 30%. This leaves the county with some ugly choices, and regardless of those choices, prevention and treatment will suffer.
While the federal government has funneled billions of dollars into corporations like Bechtel and KBR, they have also done their best to cut what little funding there is to help the weakest members of our society. There's no reason for this. Compared to the $750 Billion we annually spend on military-industrial projects and research, the cost of these life-saving domestic programs that benefit not only people with illnesses like AIDS and Hepatitis C, but everyone through improved public health, is a drop in the bucket.
USA Today reported this week that, thanks to the Bush Administration, our country has amassed 59 Trillion dollars in national debt, and this number continues to climb as we continue the occupation of Iraq. This is the economic legacy our children will inherit.
And now, with San Mateo County losing an additional 30% in badly needed funding for AIDS prevention and treatment, one has to question if good public health is a priority for our federal government. These types of destructive cuts to public health affects us all, rich and poor alike. Strong public health is essential for every country, essential for the health and well-being of all its citizenry.
We need to increase the amount of money we spend on programs like Medicaid and ADAP, and we need to move prevention and education funds back to the organizations that promote comprehensive education and prevention without a religious agenda. We need to strengthen the Centers for Disease Control, (CDC,) the Food and Drug Administration, (FDA,) and the Environmental Protection Agency, (EPA.)
A Pew Research Poll taken earlier this year showed that 76% of Americans view universal health care a priority for our country, and similar polls show strong support for robust and effective public health programs.
It's time to demand strong support and increased spending on domestic public health programs right now, for the welfare of all Americans.
Tuesday, June 12, 2007
Counterfeit Medications:
(Part II of a series)
By Phillip T. Alden – San Mateo Daily Journal
For publication – June 12, 2007
In my next article I will go further into Dr. Adams' study, but in this part I would like to discuss one of the causal factors behind the drug crisis in America today.
As an AIDS activist I have a unique perspective when it comes to drug companies and our drug delivery system. I have been to numerous medical conferences, spoken with research scientists and health care providers, and dealt with insurance companies and drug companies on many different levels.
Research scientists and doctors are very busy people. Most researchers have no idea what happens after their compound is turned over to a drug company. When, as AIDS activists, we took the time to educate these men, they were shocked at the behavior of the drug companies. Here's an example:
Abbott Labs makes a Protease Inhibitor (PI) called Norvir. The drug is too toxic to be taken by itself, but they discovered that a small amount of Norvir (100mg) boosts the levels of other PIs in the bloodstream. So Norvir is either taken with another PI or incorporated into the other PI. This advantage has been a boon to Abbott Labs, (to say the least.)
A few years ago Abbott decided to raise the price of Norvir by 400%, making all other PIs very expensive and making their lead PI at the time (Kaletra) the cheapest PI on the market. Numerous states ended up launching criminal investigations against Abbott Labs for violating the rules of free-trade we have established to protect the consumer.
But the research scientists and the doctors knew nothing about this until we told them. Doctors get a rather myopic view through publications sent to them like "Managed Care Magazine," which is produced by the health insurance industry and driven by drug ads. It's propaganda of the worst sort that tells doctors that, if we enact national health insurance, their workload will explode and their compensation will take a nose-dive.
So we not only told the doctors what was happening, we got them to sign a boycott of Abbott products. They agreed to write a prescription for a non-Abbott drug whenever possible, they signed on to a letter to the drug company, and they refused to see Abbott drug representatives when they came to their offices.
Abbott ignored everything until their reps came back saying the doctor refused to see them. Of all the steps we took, even the threat of criminal investigation mattered little to Abbott. But refusing to see reps shook the company and scared them. They feared we'd use this strategy more often, that we'd educate the doctors.
So they caved and lowered the price of Norvir.
But this is a major part of the problem. PHARMA lobbyists give a lot of money to both Democrats and Republicans at the state and national level, assuring favorable treatment regardless of how the political winds blow. They influence drug policy on many levels. They are a prime example of how corporate influence has polluted politics, and they are part of the reason that, even though 76% of all Americans favor some form of national health insurance, our political leaders refuse to address our health care crisis.
(Part II of a series)
By Phillip T. Alden – San Mateo Daily Journal
For publication – June 12, 2007
In my next article I will go further into Dr. Adams' study, but in this part I would like to discuss one of the causal factors behind the drug crisis in America today.
As an AIDS activist I have a unique perspective when it comes to drug companies and our drug delivery system. I have been to numerous medical conferences, spoken with research scientists and health care providers, and dealt with insurance companies and drug companies on many different levels.
Research scientists and doctors are very busy people. Most researchers have no idea what happens after their compound is turned over to a drug company. When, as AIDS activists, we took the time to educate these men, they were shocked at the behavior of the drug companies. Here's an example:
Abbott Labs makes a Protease Inhibitor (PI) called Norvir. The drug is too toxic to be taken by itself, but they discovered that a small amount of Norvir (100mg) boosts the levels of other PIs in the bloodstream. So Norvir is either taken with another PI or incorporated into the other PI. This advantage has been a boon to Abbott Labs, (to say the least.)
A few years ago Abbott decided to raise the price of Norvir by 400%, making all other PIs very expensive and making their lead PI at the time (Kaletra) the cheapest PI on the market. Numerous states ended up launching criminal investigations against Abbott Labs for violating the rules of free-trade we have established to protect the consumer.
But the research scientists and the doctors knew nothing about this until we told them. Doctors get a rather myopic view through publications sent to them like "Managed Care Magazine," which is produced by the health insurance industry and driven by drug ads. It's propaganda of the worst sort that tells doctors that, if we enact national health insurance, their workload will explode and their compensation will take a nose-dive.
So we not only told the doctors what was happening, we got them to sign a boycott of Abbott products. They agreed to write a prescription for a non-Abbott drug whenever possible, they signed on to a letter to the drug company, and they refused to see Abbott drug representatives when they came to their offices.
Abbott ignored everything until their reps came back saying the doctor refused to see them. Of all the steps we took, even the threat of criminal investigation mattered little to Abbott. But refusing to see reps shook the company and scared them. They feared we'd use this strategy more often, that we'd educate the doctors.
So they caved and lowered the price of Norvir.
But this is a major part of the problem. PHARMA lobbyists give a lot of money to both Democrats and Republicans at the state and national level, assuring favorable treatment regardless of how the political winds blow. They influence drug policy on many levels. They are a prime example of how corporate influence has polluted politics, and they are part of the reason that, even though 76% of all Americans favor some form of national health insurance, our political leaders refuse to address our health care crisis.
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.
