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If you took a prescription drug recently, more than likely it was generic. Nowadays, generic drugs constitute almost 70% of all the prescriptions dispensed nationwide, racking up $58 billion in sales in 2007. Anxious to cut costs, health insurance companies are stampeding to switch patients to drugs that are cheaper to make, test, and ultimately buy. This way, the manufacturers of these generic drugs can piggyback on the research and marketing already done by brand name drug companies.
Pharmacists in most states are also free to give patients whichever version of a drug is cheapest for them to supply, without telling the prescribing doctor. In some states, pharmacies are even "required" to make this switch. Further, few of us complain when it happens... people who wouldn’t dream of substituting Diet Pepsi for Diet Coke, simply because of the taste, eagerly swap vital medications, because the change can cut their co-pays in half.
Many lawmakers and health-policy experts say that this trend has next to no downside. Generic drugs have the same active ingredient that brand name drugs do and they are made in FDA-approved plants, just like the brand name drugs. For example, in a recent analysis, data was reviewed from 47 clinical studies and no evidence was found that patients on brand-name cardiovascular drugs had clinical outcomes superior to those on generic drugs. Given these results, and the lengths that some brand name drug companies have taken to protect their patents and profits, it is easy to believe that any supposed problems with generic drugs are not legitimate.
Over the course of a year, an investigation was done which included more than 50 nterviews and the records "leaked" from one of the world’s largest generic drug companies, raising questions as to whether some new generic drugs are as safe or effective as brand name drugs. However, many of these studies were completed before the recent flood of generic drugs hit the market and many factories manufacturing them moved overseas.
In FDA applications for new generic drugs, nearly 90% of the factories providing active ingredients are located overseas and the agency's inspection rate dropped 57 % between 2001 and 2008. The average citizen would want to know that someone is checking to make sure that manufacturers are making the actual drugs they have received approval to make and that’s not happening. The risk to consumers is potentially huge.
Generic drugs came into widespread use after Congress streamlined testing requirements in 1984 but, they are supposed to be tightly regulated. In the late 1980s, after companies were caught paying off inspectors in order to get generic drugs approved, the FDA overhauled its rules. The agency vowed to inspect each factory before giving the green light. It required any generic drug maker seeking approval to make one test lot of the proposed drug and then, produce three larger lots to show its manufacturing capabilities. They came a long way in how the inspections are done but, many of the FDA’s reforms have largely fallen by the ayside.
Pharmacists in most states are also free to give patients whichever version of a drug is cheapest for them to supply, without telling the prescribing doctor. In some states, pharmacies are even "required" to make this switch. Further, few of us complain when it happens... people who wouldn’t dream of substituting Diet Pepsi for Diet Coke, simply because of the taste, eagerly swap vital medications, because the change can cut their co-pays in half.
Many lawmakers and health-policy experts say that this trend has next to no downside. Generic drugs have the same active ingredient that brand name drugs do and they are made in FDA-approved plants, just like the brand name drugs. For example, in a recent analysis, data was reviewed from 47 clinical studies and no evidence was found that patients on brand-name cardiovascular drugs had clinical outcomes superior to those on generic drugs. Given these results, and the lengths that some brand name drug companies have taken to protect their patents and profits, it is easy to believe that any supposed problems with generic drugs are not legitimate.
Over the course of a year, an investigation was done which included more than 50 nterviews and the records "leaked" from one of the world’s largest generic drug companies, raising questions as to whether some new generic drugs are as safe or effective as brand name drugs. However, many of these studies were completed before the recent flood of generic drugs hit the market and many factories manufacturing them moved overseas.
In FDA applications for new generic drugs, nearly 90% of the factories providing active ingredients are located overseas and the agency's inspection rate dropped 57 % between 2001 and 2008. The average citizen would want to know that someone is checking to make sure that manufacturers are making the actual drugs they have received approval to make and that’s not happening. The risk to consumers is potentially huge.
Generic drugs came into widespread use after Congress streamlined testing requirements in 1984 but, they are supposed to be tightly regulated. In the late 1980s, after companies were caught paying off inspectors in order to get generic drugs approved, the FDA overhauled its rules. The agency vowed to inspect each factory before giving the green light. It required any generic drug maker seeking approval to make one test lot of the proposed drug and then, produce three larger lots to show its manufacturing capabilities. They came a long way in how the inspections are done but, many of the FDA’s reforms have largely fallen by the ayside.
According to sources knowledgeable about the process, there are less FDA inspections and instead of the three required lots, companies are making one or, in some cases, none. In addition, manufacturing problems have come to light with six generic companies recalling 20 products in 2008. One pharmaceutical company which manufactures heart and pain medicine, recalled every drug it released.
Between 2000 and 2008, the number of new generic drugs put forth for FDA approval went up 40% and approvals doubled. As a result, approximately 600 generic drugs were cleared to be sold last year. Generic companies are popular on Capitol Hill because the industry is powerful and voters are anxious for cheaper drugs. The pressure is always on for government to reduce any barriers to entry.
Because brand name medications have already been clinically tested, generic companies applying for FDA approval don’t have to repeat that process on their versions. Instead, they must test their medicine on a minimum of 20 people. The subjects used in these tests take a single dose so, the drug is not tested over time. If tests show that the generic contains the same active ingredient as the (brand name does and delivers about the same dose, the FDA considers it “bioequivalent” and clears it to be sold.
However, it seems that patients are finding many differences among drugs the FDA has deemed to be equivalent. There have been complaints about dozens of generic drugs used for depression, hypertension, high cholesterol, and many other conditions. Consumers described these drugs as having no effect, caused bizarre side effects, or made their conditions worse. The outpouring of complaints has been astounding. It is becoming more apparent that nobody is monitoring the equivalence of these drugs. The goal of low-cost medicine should not and cannot come at the expense of public safety.
Between 2000 and 2008, the number of new generic drugs put forth for FDA approval went up 40% and approvals doubled. As a result, approximately 600 generic drugs were cleared to be sold last year. Generic companies are popular on Capitol Hill because the industry is powerful and voters are anxious for cheaper drugs. The pressure is always on for government to reduce any barriers to entry.
Because brand name medications have already been clinically tested, generic companies applying for FDA approval don’t have to repeat that process on their versions. Instead, they must test their medicine on a minimum of 20 people. The subjects used in these tests take a single dose so, the drug is not tested over time. If tests show that the generic contains the same active ingredient as the (brand name does and delivers about the same dose, the FDA considers it “bioequivalent” and clears it to be sold.
However, it seems that patients are finding many differences among drugs the FDA has deemed to be equivalent. There have been complaints about dozens of generic drugs used for depression, hypertension, high cholesterol, and many other conditions. Consumers described these drugs as having no effect, caused bizarre side effects, or made their conditions worse. The outpouring of complaints has been astounding. It is becoming more apparent that nobody is monitoring the equivalence of these drugs. The goal of low-cost medicine should not and cannot come at the expense of public safety.
In this bleak economy, generic drugs have become even more important, as the cost of drugs could lead patients to stop taking needed medicine altogether. So, how can authorities ensure that generic drugs are safe for patients? The FDA can’t even keep pace with the inbox, let alone invest in better science. This need will become even more acute in the coming months, as generic drug companies push Congress for permission to make delicate, injectable biologic medicines, such as those often taken by cancer patients, because they are more complex to manufacture than traditional pills.
Doctors are eager to subject highly sensitive drugs that require time-release formulas or precise dosing to more extensive clinical testing. Some would like to see random, off-the-shelf testing of a generic drug’s ingredients and effectiveness after it hits the market. More dynamic oversight would also require equal inspections of brand name and generic plants, regardless of where they are in the world and this is beginning to happen. In recent months, the FDA has opened bureaus in China, India, Central America, and Europe and plans to expand its presence to Mexico, South America, and the Middle East. The FDA Globalization Act of 2009 will provide funds for further reforms. Still, there is no magic point in this process by which everything can be tested.
Some doctors remain troubled that most state laws allow pharmacists to change from brand names to generics "at will" (as well as changing between generics). The law should require them to notify treating physicians of any change. As it stands, doctors who want to ensure their brand-name prescriptions are obeyed must write “Do Not Substitute” on their prescriptions but, this does not guarantee that insurance companies will cover the extra cost. Other doctors argue that, if pharmacists had the added burden of informing doctors, they would be less likely to dispense generics drugs and it would help brand name companies preserve their monopolies, which translates into higher prices for consumers.
In the meantime, patients should and can help themselves by knowing who made the medications they are taking, noting when their prescriptions change, and if they suffer new side effects or a relapse in their condition as a result. One could argue that doctors see too many people, they see them too fast, and they don’t ask their patients many important questions that should be asked. The bottom line is... when your health and well-being are at stake, you need to proactive, know your own body, and don't be afraid to be your own advocate.
Doctors are eager to subject highly sensitive drugs that require time-release formulas or precise dosing to more extensive clinical testing. Some would like to see random, off-the-shelf testing of a generic drug’s ingredients and effectiveness after it hits the market. More dynamic oversight would also require equal inspections of brand name and generic plants, regardless of where they are in the world and this is beginning to happen. In recent months, the FDA has opened bureaus in China, India, Central America, and Europe and plans to expand its presence to Mexico, South America, and the Middle East. The FDA Globalization Act of 2009 will provide funds for further reforms. Still, there is no magic point in this process by which everything can be tested.
Some doctors remain troubled that most state laws allow pharmacists to change from brand names to generics "at will" (as well as changing between generics). The law should require them to notify treating physicians of any change. As it stands, doctors who want to ensure their brand-name prescriptions are obeyed must write “Do Not Substitute” on their prescriptions but, this does not guarantee that insurance companies will cover the extra cost. Other doctors argue that, if pharmacists had the added burden of informing doctors, they would be less likely to dispense generics drugs and it would help brand name companies preserve their monopolies, which translates into higher prices for consumers.
In the meantime, patients should and can help themselves by knowing who made the medications they are taking, noting when their prescriptions change, and if they suffer new side effects or a relapse in their condition as a result. One could argue that doctors see too many people, they see them too fast, and they don’t ask their patients many important questions that should be asked. The bottom line is... when your health and well-being are at stake, you need to proactive, know your own body, and don't be afraid to be your own advocate.
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