Resumo de "me Too" Drugs

Title: ?Me-too Drugs?: What are they and are they necessary?Introduction: What Are "Me-Too" Drugs? The process of new Drug development is complicated, time-consuming, and expensive. Drugs are discovered and developed through the process of screening thousands of molecules for a variety of disease conditions, using in vitro and animal models. After a drug is found to be reasonably safe and effective in these models, human testing is done. Once a drug is demonstrated to be reasonably safe and effective, in patients, the drug is permitted by the regulatory authorities to be marketed. If a drug is successfully marketed and enjoys a reasonable prescription base, other, similar drugs also enter the market, at a gap ranging from a few months to a few years. Several examples can illustrate this phenomenon: propranolol was followed by atenolol, metoprolol, acebutolol, esmolol, carvedilol, timolol, labetalol, etc.; cimetidine was followed by ranitidine, famotidine, nizatidine, and others; sumatriptan was followed by narratriptan, almotriptan, rizatriptan, zolmitriptan, etc. Many other examples can be given:?E inhibitors, AT blockers, proton pump inhibitors, calcium channel blockers, etc. One study showed that two-thirds of the prescription drugs approved by the Food and Drug Administration (FDA) between 1989 and 2000 were modified versions of existing medicines or identical to drugs already on the market, i.e., were me-too drugs, also known as incrementally modified drugs (IMDs); only about one-third were drugs based on new molecules that often treat diseases in novel ways (new molecular entities or NMEs). And only 15% of drugs approved during were deemed by the FDA to provide significant improvement over existing medicines.<1> The study also showed that new drugs of all types were priced much higher than the older drugs they replaced. In 2000, the average retail price per prescription for drugs approved before 1995 was $37.20. In contrast, priority-rated new molecular entities cost an average $91.20 per prescription. New standard-rated incrementally modified drugs cost an average $65.07 per prescription. And priority-rated incrementally modified drugs cost an average $142 per prescription (primarily because of the inclusion in this category of some very expensive HIV/AIDS drugs). Brief History of ?Me-too? drugsUS President Franklin Roosevelt?s only son, Franklin Delano Jr., had a bad case of tonsillitis and with fever soaring, the White House physician George Tobey Jr feared the worst. The infection had seeped into the blood, which in those days was a potentially fatal condition. More out of desperation than any sense that it might help the young man, Tobey gave the president?s son a new German drug called Prontosil. To Tobey?s surprise, young Roosevelt?s fever quickly subsided. A few days later the press heralded both the medicine and the miraculous recovery in the first family. "New control for infections," the New York Times headlined its front-page story. The era of wonder drugs was underway.Prontosil not only heralded in the modern era of drug therapy, it ushered in the modern era of drug marketing. Prontosil was discovered by Gerhard Domagk, a young physician on the staff of Bayer Laboratories in Elberfeld, Germany. Domagk published the first report about his miraculous cures in February 1935 in an obscure academic journal. Researchers around the world immediately began trying to replicate his results.
Development of "Me-Too" DrugsThe success rate in the discovery of new chemical entities with fundamentally new chemical and biological profiles of activity is very low. In fact, even chemical entities within the same structural class of an approved drug are becoming rare now, compared to the period of sixties to eighties. In 2001, $ 26 billion was spent on developing new drugs and only 9 new chemical entities were approved by the U.S. FDA. At the same time, two thirds of the drugsapproved from 1989 to 2000 were modified versions of existing drugs or even identical to those, in newer forms and formulations. Why do we need "Me-Too" drugs?Notwithstanding such perceptions, historically, many "me-too" drugs have proved to be considerably better than their original counterparts. Examples are a series of generations of beta-blockers, which came up after the original drug propranolol was discovered by ICI, with most of them having merits in terms of better efficacy, cardio-selectivity and safety. It is perhaps questionable whether each of the over two dozen beta-blockers in the market has unique properties to warrant their preferred usage over the earlier ones. Marketing or Real Advantage?Whether such success in the market is entirely due to the merits of the individual drugs or due to marketing strategies and inputs has been debated. With "me-too" drugs, yet another differentiator, assuming that they are more or less equal in other parameters, is their pricing. However, since the later generation drugs enjoy longer patent protection, compared to the original one, they are generally more expensive. The fact is that marketing is meant to sell drugs, and the less important the drug, the more marketing it takes to sell it. Important new drugs do not need much promotion. Me-too drugs do.<5> ConclusionsDespite their criticisms, me-too drugs are likely to stay and prosper too. This is so because small changes can actually make for important improvements. What could be more me-too than a once-a-day pill replacing a twice-a-day pill? Yet, to dismiss this change is to overlook the people factor. A once-a-day regime that people stick to is much better than a twice-a-day regime that people fail to follow. More competition also ensures some price controls-another advantage of me- too drugs.

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