Hepatitis C miracles--courtesy of "me-too" drugs.

If there is a perfect example of 1) state of the art pharmaceutical research, and 2) the importance of the so-called "me-too" drugs, it is the massive effort over the past two decades to find treatments for (and possibly eradicate) hepatitis C--a blood borne viral infection of the liver that has infected about 200 million people worldwide--four times the number of people infected by HIV.

The causative pathogen, hepatitis C virus (HCV) takes hold in the liver, where it relentlessly replicates, causing irreversible damage, often leading to cirrhosis and less frequently, liver cancer over the course of two to three decades. It is the leading cause of liver transplants in the U.S.

Beginning in the 1990s, virtually all major pharmaceutical companies had major HCV research efforts, and to say that it worked out is quite an understatement. But there was a long way to go.

Until 2011, when two HCV protease inhibitors, Incivek (Vertex) and Victrelis (Schering-Merck), the first direct-acting antiviral agents for HCV were approved, the standard of care was interferon and ribavirin-- a combination that was less than 50% effective and fiendishly toxic, causing many patients to stop treatment, even though they may have been signing their own death certificate in the process.

The two protease inhibitors, which were coincidentally approved within two weeks of each other, boosted the cure rate to about 80%--a huge advance, but not without some problems--sometimes severe skin rashes and anemia. And each drug was meant to be added to the interferon-ribavirin combination rather than replacing it, making the side effects even worse.

As is so often the case in drug research, the breakthrough drug against a given disease, while extremely important, will often be surpassed by the next generation of similar drugs, often referred to (usually in a pejorative way) as me-too drugs. This is precisely what is happening in the world of HCV research right now.

Gilead, Abbott (now AbbieVie), and Bristol-Myers Squibb are leading the way with drugs and cocktails that not only eliminate the need for interferon, but show cure rates approaching 100 percent--something that was unimaginable even 10 years ago.

This has created an interesting dilemma. Three years ago, some doctors were suggesting that patients wait until Incivek and Victrelis were approved rather than undergo the older interferon-based therapy. And this is happening once again. There is an ongoing debate over whether it makes sense for previously-untreated patients to wait a few months until the second-generation drugs are approved.

In drug research, this is about as good as it gets. Using a strategy of drug design similar to one employed in HIV research, pharmaceutical companies succeeded in doing something that was thought to be impossible--potentially wiping out one of the most world's most important viral infections.

These results highlight the obvious-- it is counterproductive and illogical to forgo research in a particular area simply because there are already drugs approved for that indication. Right now there are least three more protease inhibitors in the pipeline and roughly ten different polymerase inhibitors (drugs that act by a different mechanism). Unnecessary? Hardly.

It is all but certain that of the multiple "me-too" drugs in development, some will rise to the top and some will fail as they are subjected to more pre-and post-approval scrutiny. This will mean a world of difference for patients as the best drugs and drug combinations become clear--something that would be impossible without multiple therapy options.

This should really go a long way towards shutting up fools like Marcia Angell of the Harvard Medical School, a perennial industry critic who believes that one drug is sufficient for any disease, and that "me-toos" are simply tools for maximizing drug company profits. It would be impossible for her to be more wrong.

This mindset was dead wrong with HIV. Without multiple choices, optimized cocktails, which are now doing incredible things, would have been impossible. It is just as wrong here. The lives of 200 million people will bear this out.

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