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A Shopper’s Guide To Use Of Generic Drugs
The Advocate
By Herb Denenberg, The Bulletin
For 40 years or more, there’s been a continuing controversy over generic drugs and whether they are as safe as their more expensive brand-name equivalents. In the last 40 years, there has been a growing acceptance and use of generic drugs, but some nagging questions remain unanswered. In the early 1970s, the issue was called to my attention by a classic book by Dr. Richard Burack titled The Handbook of Prescription Drugs. A later edition (1970) was retitled The New Handbook of Prescription Drugs. In that 1970 edition, Dr. Burack wrote, “The average physician either does not know of the availability of generic drugs, or if he does, he has been led to believe that they may be inferior.” We’ve come a long way, but not all of the way.
Doctors get used to writing for the brand name during the 17-year patent period, and even when the generic drugs come on the market, they may continue the habit. Dr. Burack explained that in part by the way drugs are named: “The brand name is nearly always easier to say, spell, and remember. Unlike the generic name it usually has a ‘merchandizing’ quality, too, often suggesting what the pharmacological action of the drug is claimed to be.” He illustrates with the example of the sedative chlordizepoxide hydrocholoride, so-named generically, but with a brand name of Librium. You can understand why doctors get in the habit of writing for the brand name and why patients often know drugs only by the brand name.
At that time, as Pennsylvania Insurance Commissioner, I was trying to reduce the cost of health insurance, so I pressured Blue Cross plans to require greater use of generics rather than their more expensive brand-name equivalents. That provision went into the Blue Cross hospital contracts and was one of the reasons those contracts saved the public many millions of dollars. I’ve followed the generic/brand-name controversy since 1971 and it still rages on. As this column frequently notes, one of the best sources of reliable information on drugs is The Medical Letter. So, I was glad to find that this issue was again reconsidered in its Oct. 1, 2009 letter. In an article titled “Generic Drugs Revisited,” The Letter writes, “The equivalence of generic drugs to their brand-name precursors continues to be controversial. The last Medical Letter review of this subject (2002) concluded that well-documented therapeutic inequivalence between brand name and FDA-approved generic drugs had not been reported. Is that still true? New data have become available for some drugs.” Here are some of the latest findings suggested by that new data.
The conclusion reached shows that the controversy is still not totally resolved: “The continuing claims of pharmaceutical manufacturers and others that generic drugs are inferior to brand-name originals still lack convincing documentation. Nevertheless, with levothyroxine [to treat thyroid conditions] and antiepileptic drugs, Medical Letter consultants recommend using one formulation (brand name or generic) consistently or, if consistency is not possible with generics, prescribing the brand name routinely.”
You can understand the difficulty of reaching conclusions on this matter with certainty, by examining the studies of brand name and generic antiepileptic drugs. The Medical Letter cites the following study: “Another retrospective cohort study found that generic substitution of topiramate (Topamax, and others) was associated with significantly more hospitalizations and injuries, longer hospital stays and increased healthcare costs; this study was sponsored and conducted in part by the manufacturer of brand name Topamax.” Other such studies are cited and then, in part, dismissed: “Retrospective studies can be misleading; patients who are switched from one product to another may be different from those who are not. No prospective, randomized controlled study has shown therapeutic inequivalence of antiepileptic drugs.” This dismissal of these studies gives you the feeling that perhaps there is some uncertainty surrounding the conclusion and that more studies are needed.
The same kind of uncertainty is suggested in The Medical Letter’s discussion of levothyroxine products, which includes Synthroid, the market leader. The Medical Letter explains that the FDA has determined that some generic formulations of levothyroxine are “therapeutically equivalent” to specific brand-name products: “That determination was based not on evidence of equivalent clinical outcomes [those involving treatment of patients and determination of drug’s effects], but on bioequivalence [whether the same amount of drug gets into the patient’s system in the same time]. It then observes, “Well-documented therapeutic inequivalence between brand-name and FDA-approved generic formulations of levothyroxine has not been reported.”
The last two paragraphs of this column provide the basis for applying special caution when dealing with the antiepileptics and levothyroxine. In addition, you should be aware that some experts have offered many questions about the wisdom of using generic drugs in lieu of certain brand names. Perhaps the most prominent dissenter is Joe Graedon of peoplespharmacy.com and author of an important series of books including The People’s Pharmacy. You should also check to see if any drug you may be taking is among those few that carry recommendations not to switch from pills made by one manufacturer to another. For example, the drug sotalol, used to treat heart arrhythmias, carries this caution in drug information provided patients by one major drug chain: “Some sotalol products are used to treat certain types of fast/irregular heartbeats (atrial fibrillation/flutter). These products come with additional written information from the manufacturer for patients with atrial fibrillation/flutter. If you have these conditions, read the provided information carefully. Do not switch brands of sotalol without checking with your doctor.” This all suggests that when a drug is initially prescribed, you should ask about the availability of generic formulations and whether there is any reason to avoid switching between different manufacturers.
The decades’-long battle between brand name and generic drugs continues, but with fewer and fewer exceptions, the controversy continues and there can still be questions about their equivalence.
Herb Denenberg served as Pennsylvania Insurance Commissioner, Public Utility Commissioner, and the Loman Professor of Insurance at the Wharton School. He was elected to the Institute of Medicine of the National Academy of Sciences and has frequently testified before Congress on health care, insurance, and consumer affairs. He can be reached at advocate@thebulletin.us.
Doctors get used to writing for the brand name during the 17-year patent period, and even when the generic drugs come on the market, they may continue the habit. Dr. Burack explained that in part by the way drugs are named: “The brand name is nearly always easier to say, spell, and remember. Unlike the generic name it usually has a ‘merchandizing’ quality, too, often suggesting what the pharmacological action of the drug is claimed to be.” He illustrates with the example of the sedative chlordizepoxide hydrocholoride, so-named generically, but with a brand name of Librium. You can understand why doctors get in the habit of writing for the brand name and why patients often know drugs only by the brand name.
At that time, as Pennsylvania Insurance Commissioner, I was trying to reduce the cost of health insurance, so I pressured Blue Cross plans to require greater use of generics rather than their more expensive brand-name equivalents. That provision went into the Blue Cross hospital contracts and was one of the reasons those contracts saved the public many millions of dollars. I’ve followed the generic/brand-name controversy since 1971 and it still rages on. As this column frequently notes, one of the best sources of reliable information on drugs is The Medical Letter. So, I was glad to find that this issue was again reconsidered in its Oct. 1, 2009 letter. In an article titled “Generic Drugs Revisited,” The Letter writes, “The equivalence of generic drugs to their brand-name precursors continues to be controversial. The last Medical Letter review of this subject (2002) concluded that well-documented therapeutic inequivalence between brand name and FDA-approved generic drugs had not been reported. Is that still true? New data have become available for some drugs.” Here are some of the latest findings suggested by that new data.
The conclusion reached shows that the controversy is still not totally resolved: “The continuing claims of pharmaceutical manufacturers and others that generic drugs are inferior to brand-name originals still lack convincing documentation. Nevertheless, with levothyroxine [to treat thyroid conditions] and antiepileptic drugs, Medical Letter consultants recommend using one formulation (brand name or generic) consistently or, if consistency is not possible with generics, prescribing the brand name routinely.”
You can understand the difficulty of reaching conclusions on this matter with certainty, by examining the studies of brand name and generic antiepileptic drugs. The Medical Letter cites the following study: “Another retrospective cohort study found that generic substitution of topiramate (Topamax, and others) was associated with significantly more hospitalizations and injuries, longer hospital stays and increased healthcare costs; this study was sponsored and conducted in part by the manufacturer of brand name Topamax.” Other such studies are cited and then, in part, dismissed: “Retrospective studies can be misleading; patients who are switched from one product to another may be different from those who are not. No prospective, randomized controlled study has shown therapeutic inequivalence of antiepileptic drugs.” This dismissal of these studies gives you the feeling that perhaps there is some uncertainty surrounding the conclusion and that more studies are needed.
The same kind of uncertainty is suggested in The Medical Letter’s discussion of levothyroxine products, which includes Synthroid, the market leader. The Medical Letter explains that the FDA has determined that some generic formulations of levothyroxine are “therapeutically equivalent” to specific brand-name products: “That determination was based not on evidence of equivalent clinical outcomes [those involving treatment of patients and determination of drug’s effects], but on bioequivalence [whether the same amount of drug gets into the patient’s system in the same time]. It then observes, “Well-documented therapeutic inequivalence between brand-name and FDA-approved generic formulations of levothyroxine has not been reported.”
The last two paragraphs of this column provide the basis for applying special caution when dealing with the antiepileptics and levothyroxine. In addition, you should be aware that some experts have offered many questions about the wisdom of using generic drugs in lieu of certain brand names. Perhaps the most prominent dissenter is Joe Graedon of peoplespharmacy.com and author of an important series of books including The People’s Pharmacy. You should also check to see if any drug you may be taking is among those few that carry recommendations not to switch from pills made by one manufacturer to another. For example, the drug sotalol, used to treat heart arrhythmias, carries this caution in drug information provided patients by one major drug chain: “Some sotalol products are used to treat certain types of fast/irregular heartbeats (atrial fibrillation/flutter). These products come with additional written information from the manufacturer for patients with atrial fibrillation/flutter. If you have these conditions, read the provided information carefully. Do not switch brands of sotalol without checking with your doctor.” This all suggests that when a drug is initially prescribed, you should ask about the availability of generic formulations and whether there is any reason to avoid switching between different manufacturers.
The decades’-long battle between brand name and generic drugs continues, but with fewer and fewer exceptions, the controversy continues and there can still be questions about their equivalence.
Herb Denenberg served as Pennsylvania Insurance Commissioner, Public Utility Commissioner, and the Loman Professor of Insurance at the Wharton School. He was elected to the Institute of Medicine of the National Academy of Sciences and has frequently testified before Congress on health care, insurance, and consumer affairs. He can be reached at advocate@thebulletin.us.
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Reader Comments
The following are comments from the readers. In no way do they represent the view of thebulletin.us.
fussymeds wrote on Nov 16, 2009 3:59 PM:
" Came accross Herb Denenberg's article from 11-9-06 in my files. I really would like to know if the generic form of a drug has the same anount of the name brand drug. Common sense to me would be no, and in the long run you would need more of a dose to match the name brand. Experienceds myself has been on several occassions that the filler made a difference and in two caes I had an allergic reaction to something I had had for years. I would be thrilled to here that I am wrong in my assumptions. Am I? I know pharmacies buy on the cheap side, and change makers for that reason. Only stands to reason there would be differences. I once heard that only 70% if the generic would be the original drug once off patent. Is this still true?????? "
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macneillock wrote on Nov 1, 2009 5:01 AM: