?me-too? Drugs: Good or Bad?

organisms. The third generation drugs provide resistance against the beta lactamase enzyme, as well as acting against some of the most intractable infections, such as those caused by Pseudomonas and Klebsiella strains.

Even while the pharmaceutical industry turns out families of me-too drugs for relatively mild conditions in affluent people, it pays almost no attention to serious diseases, such as malaria, affecting impoverished people. It also gives short shrift to less profitable drugs, so there now are shortages of some vaccines and life-saving drugs9.

The big problem with me-too drugs is that they are chemically very similar to other drugs already available, yet they are marketed as if they were important new breakthroughs, with very high prices. Many new, expensive me-too drugs are not necessarily better than older and less expensive drugs. Most of the time they are compared with placebos and not older drug comparisons.

“Me-too” drugs are responsible for 80% of increased spending in recent years, and on average they are four times more expensive than the comparable, older alternatives10. By Patented Medicines Pricing Review Board’s (PMPRB) definitions, at the time of their introduction “me-too” drugs were judged to provide moderate, little or no improvement – in terms of effectiveness and safety – compared to older alternatives. However, on average, “me-too” drugs cost about 2.5 times as much per prescription as comparable older drugs. The question is whether the perceived or real differences justify the increased costs. New drugs do have a role in some situations and for some patients. However, it makes sense to use the older equally effective drugs whenever possible11.

Changing FDA rules to discourage me-too drug approvals would make R&D far more expensive, would discourage competition and therefore raise healthcare costs, and would forestall the wave of new research that has revolutionized our scientific understanding of the therapeutic categories where competition has been most intense.

Conclusion

New drugs are not required to improve on old ones, and there’s usually no way to know whether they do. Although the FDA must test drugs before they are marketed, they don’t need to be compared with similar drugs already on the market. The FDA only requires they be reasonably safe and better than nothing-a low standard indeed. This loophole in FDA regulations opens the door for an unlimited number of me-too drugs, which are easier to develop than innovative drugs.

Given everything, it should come as no surprise that these more expensive “me-too” drugs cost the medical industry money. The prevalence of the me-too’s really says an awful lot about the lack of innovation within the pharmaceutical industry. If you look at the new drugs marketed over the last six years, 78 percent weren’t even new chemical compounds. They were just new combinations or different formulations of old drugs. And 68 percent were classified by the F.D.A. as unlikely to be improvements over drugs already on pharmacy shelves.

At the same time, there are shortages of some important drugs that the pharmaceutical companies aren’t much interested in making because they are not as profitable as the me-too’s. But the companies don’t have to turn out needed drugs, if they are not lucrative. And they don’t.

References

1. http://www.medterms.com/script/main/art.asp?articlekey=33748

2. http://www.motherjones.com/news/qa/2004/09/09_401.html

3. http://polyscience.org/2005/09/me-too-drugs

4. http://www.shvoong.com/books/465475-me-too-drugs

5. http://www.pharmabiz.com/article/detnews.asp?SecArch=&articleid=14604&sectionid=46

6. http://direct.bl.uk/bld/PlaceOrder.do?UIN=162532605&ETOC=RN&from=searchengine

7. http://www.archivum.info/sci.med/2005-09/msg00257.html

8. http://www.aei.org/publications/filter.all,pubID.27443/pub_detail.asp

9. http://blogs.wsj.com/health/2007/05/17/in-praise-of-me-too-drugs

10. http://www.chepa.org/KnowledgeExchange/LabelleLectureship/tabid/84/Default.aspx

11. http://www.ti.ubc.ca/pages/letter59.html

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