If you are looking to have a rational discussion about the value of pharmaceuticals rather than just the cost, you should avoid Vermont.
Sen. Bernie Sanders (I-Vt.) plans to hold a hearing on the high cost of drugs, especially those for hepatitis C, which have revolutionized the treatment of the infection in previously-unimaginable ways.
Of course, Sanders, who pretty much wants everything to be free will almost certainly focus on just the cost of new drugs not their benefit.
ACSH s Dr. Josh Bloom, a former researcher (and subject matter expert) in the hepatitis C (HCV) area says, If Sanders is looking to make a point (if? please), he is picking the wrong area. Yes new hepatitis C drugs are expensive, but their value is essentially priceless. They will eventually eliminate a serious infection that affects 170 million people worldwide.
Putting aside the value of the drugs for a moment, virtually no one knows what it took to get to this point. For more than 20 years, dozens of clinical and preclinical hepatitis C candidates went down in flames.
But, what is really underappreciated in this case, says Dr. Bloom, is what happened to companies that succeeded in finally getting new HCV therapies approved. This is far from obvious, and is discussed in part in Dr. Bloom s Science 2.0 piece entitled Drug Discovery Even When You Win, You Still Can Lose.
But there is even more going on than meets the eye. Following are some of the important timelines in HCV research based on some of the key moments during the 20+ year time frame.
- 2003: Boehringer Ingelheim's ciluprevir, the first specific antiviral drug for HCV, as well as the first to demonstrate efficacy in humans is discontinued due to unexpected heart toxicity. The enormous program to discover ciluprevir is arguably the most impressive campaign in the history of medicinal chemistry. (The first of many papers alone contains 30 authors). Hundreds of researchers worked on the ciluprevir project.
- 2011: Boceprevir (Schering) becomes the first-ever approved specific HCV drug. It is an economic disaster. Its total sales amount to about 10-20 percent of its development costs because it is beaten by telaprevir (below). It is no longer marketed.
- 2011: Within weeks of the approval of boceprevir, telaprevir (Vertex) is approved, after eight years of research. It is superior to boceprevir, and takes away all of its sales. Telaprevir has sales of more than $400 million in its first quarter alone.
- 2012: Clinical trials of newer, better drugs show amazing results in late stage clinical trials. Doctors begin advising patients to wait for the new drugs. Sales of telaprevir (Incivek) drop like a rock. (See graph below)
- Vertex lays off 15 percent of its employees.2013: Sovaldi (Gilead) is approved. It is far superior to previous drugs and its sales reach $3.5 billion in its second quarter alone, making it the best selling drug in history.
- 2014: Other drugs from AbbVie and Johnson and Johnson outperform Sovaldi, and will cut into Gilead s sales perhaps substantially.
Dr. Bloom adds, This demonstrates how difficult it is to succeed in the pharma world. Despite pouring billions of dollars into development of HCV drugs, pioneering companies came up empty, or finally gained FDA approval and still bombed. When you add in the limited patent life of new drugs, plus the fact that these new drugs cure the infections ensuring that the need for them will drop over time the reality is far more complex than the blather.
But politicians eager to score points will either not know, or ignore all of this.