Are Generic Drugs as Effective as Name Brands?

• “No”

  

  “We Have Enough Variance in Drug Therapeutics—We Don’t Need More”

• No Objections Yet

We Have Enough Variance in Drug Therapeutics—We Don’t Need More

Peter Kowey, MD

Main Line Health

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Obtaining a satisfactory clinical response to drug therapy in clinical practice is painstaking, and requires scrupulous monitoring. For example, when initiating warfarin, frequent INR sampling is mandatory, and despite this, a large percentage of patients continue to have variance unexplained by changes in concomitant drug therapy or diet. Drugs like amiodarone are even more challenging because there is no easily measurable surrogate for clinical efficacy, and its unusual pharmacokinetic profile makes patient dose titration almost impossible. Most patients receive the same arbitrary dose of the drug until they have a clinical recurrence, yet the drug’s bioavailability is mightily influenced by a host of factors including food (see reference). Formulation changes (and there are multiple generic versions of amiodarone) just add to the complexity, and place patients at high risk for recurrence of serious, and in some cases, life-threatening arrhythmia.

Evidence

Text

Meng X, Mojaverian P, DoedeeM, et al

Bioavailability of amiodarone tablets. Am J Cardiol 2001; 87: 432-5

Next Argument

"No" Peter Kowey MD

• Therapeutic Margins Are Too Small
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• Low Drug Levels are As Bad As High Levels
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• We Have Enough Variance in Drug Therapeutics—We Don’t Need More
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"No" ConsumerLab

• Consumers are Reporting Problems When Switched to Generic Drugs
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• Generics Are Not Tested for Safety and Efficacy
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• Generics Drugs are Given Much Leeway in How They Perform
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• Binders, Fillers, and Other Chemicals May Be Different
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• Delivery Mechanism and Rate of Release May Be Different
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• Product Information for Generics May be Incorrect and Misleading
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• There May Be Manufacturing Problems with Some Generics
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"Yes" Generic Pharmaceuticals Association

• By Law, Generic Medicines Are the Same Medicines as Brands
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• Generic Medicines and Brand Medicines Deliver the Same Health Benefits
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• Generic Medicines Must Meet Same High Quality Standards as Brands
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• Post-Marketing Surveillance Requirements
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• Generics Provide Significant Savings to Consumers
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"Yes" Consumers Union

• Generics Must Have the Same Active Chemicals
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• The Basics
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• Switching Drugs
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"Yes" Amer Soc of Health System Pharmacists

• Generics are as Effective as Brand-Name Medications
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• Individuals May React Differently to Any Drug
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• Affordable Medications Bring Good Health to More People
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Most Objections

• Generics Must Have the Same Active Chemicals
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• Generics Drugs are Given Much Leeway in How They Perform
  0

Do Generic Drugs Work?

• Yes
• No

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