TCS Daily

Are All Generic Drugs Equal?

By Roger Bate - October 28, 2003 12:00 AM

It is likely that within the next week or so Congress will approve appropriations for President Bush's AIDS plan. The amount, set to be $2 billion in new money every year for the next five, will be used to improve education about AIDS and treat those with the killer plague. One of the thorny questions is what drugs the US administration and US Agency for International Development will buy with their share of the money?


The major drug companies, like Merck and Pfizer, that developed the AIDS drugs in the first place want to supply the drugs. But there is stiff political, activist and foreign corporate opposition to this, with claims that the brand drug prices are too high and that cheaper generic drugs, from companies in India Brazil and soon Canada should be used instead. Some of President Bush's advisors are advocates for generic drug use, including Anthony Fauci of the National Institute s of Health.


There is a danger to innovation of reducing reliance on brand-name drugs, in favor of generics. But regardless of this, recent activities at the health activist group Doctors Without Borders (Medecins San Frontieres, MSF) have raised another question -- are all generic drugs equal?


Almost without exception all brand name drugs are of high quality. There are instances of low quality and counterfeits being passed off as branded drugs, but on the whole the quality is not in question. But generics are a different matter. A genuine generic is a drug that is bioequivalent to the branded drug. In other words it is indistinguishable from it. This is obviously important because a doctor prescribing a generic medicine has to expect that it will perform as well as the branded original.


All branded drugs have passed US Food and Drug Administration style regulations of production quality processes. Many will be approved by the World Health Organization's qualification system. But some groups such as MSF prescribe drugs that MSF approves, without recourse to a separate authority. Now, these drugs could be as good as those passing FDA regulations; but the certainty is lower.


Safety has been a significant concern promoted by the branded drugs industry, and no doubt they have played it up for all its worth. MSF is adept at manipulating the WHO into following certain approaches and practices. So when MSF says that we need "simplified treatment guidelines," it's really saying, we don't need to monitor the safety of drugs as much as before. The WHO, which also wants to promote simplified treatment guidelines, since so few people are receiving treatment, may be convinced of MSF's own statements: "As MSF was one of the first NGOs providing ARV [antiretroviral] therapy, the WHO requested that MSF document its procurement experiences in 10 countries where it has ARV treatment programmes, so that others could benefit from what has been learnt."


The problems with treating patients with less certain drugs are threefold: it may enhance drug resistance if formulations are not as good (leading to lower efficacy of better generic copies of the branded original); second line treatments (with newer and more expensive drugs) will have to be brought on line sooner, which will increase overall costs; and if resistance builds up doctors won't know whether the drug is less effective, or if its formulations are just incorrect, so useful drugs may be discarded too early.


The evidence from MSF's work is instructive here. So far MSF has treated 3,556 patients in 10 countries, ranging from Thailand to Mozambique in the past three years. MSF is already discussing second line treatments in most locations at a high cost of $2,388 per person per year. Treatment started in most of these locations in the past two years, which indicates that resistance has built up relatively quickly. That's indicative -- but not conclusive evidence -- of inferior drugs.


The main drug MSF bought for at least 7 countries, is a fixed-dose ARV (d4T/3TC/NVP), and is produced by Indian manufacturer Cipla. It is not pre-qualified by WHO, and has not been passed by other reputable agencies. Cipla's standards are considered relatively high by industry insiders but MSF is using its own judgment in this matter. And Cipla may be producing some form of drug "copy," which is not the same as a generic. It's possible that to increase standards from a copy to a proper generic, following Good Manufacturing Practice in production runs, costs could rise by 20%.


And the likelihood that the WHO will follow MSF's approach and approve copies, not generics, is increasing. The new head of the AIDS division at WHO is Paulo Teixeira. Dr. Teixeira used to run Brazil's highly regarded but patent-threatening HIV program. Drug resistance is higher (about 6% and rising) in Brazil than in most other locations and it's possible that this is due to lower quality drugs. In the Washington Post this week he said: "If we have this regimen in fixed-dose combinations, it will be the best...I hope very soon we will have more and more fixed-dose combinations."


Cutting corners when millions of people have a disease is understandable, and the copies may be as good as the generics and branded drugs, but doubt remains. If the Bush administration decides to buy generic drugs it should ensure that those drugs are bioequivalent to branded drugs, and not something different.


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