Several weeks ago, I was talking to the University of Virginia’s Chair of Pharmacology, Doug Bayliss, about the cost of discovering new drugs and their ultimate cost to patients. During the conversation the term “ethical drugs” came up and Doug chuckled saying the makers of ethical drugs today do not seem to be too ethical. This led me to cogitate about the etymology of “ethical drug”, which I will return to a little later in this blog. Of course, there has been considerable press about Gilead’s highly effective hepatitis C treatment, Sovaldi (sofosbuvir), which costs $84,000 ($1,000 per pill) and threatens to tax greatly our public health care system with the large number of potential patients in need of treatment. Sanofi’s $11,000 per month colon cancer drug Zaltrap (ziv- aflibercept) also has provoked outcry from patients and doctors.
Both Hillary Clinton and Bernie Sanders have used the egregious overnight 5,000 percent increase in the price of a 60-year old anti-infective drug Daraprim (Pyrimethamine) by Turing Pharmaceuticals CEO Martin Shkreli, as prime example of the extreme profiteering that they believe has become the industry standard. The blogosphere is replete with supportive conversations. One of the best in my opinion is the six-part series on PLOS BLOGS entitled Talking about Drug Prices & Access to Medicines. Check out: (http://blogs.plos.org/yoursay/2015/10/13/talking-about-drug-prices-access-to-medicines/). Drs. Peter Bach, Leonard Saltz and Robert Wittes write in a New York Times Op Ed (http://www.nytimes.com/2012/10/15/opinion/a-hospital-says-no-to-an-11000-a-month-cancer-drug.html?_r=0) that we can no longer ignore drug pricing when we are considering cancer treatments as patients are suffering from something akin to financial toxicity.
So are why are prescription drugs also called “ethical drug”, as opposed to non-prescription or “over-the counter” drugs one can buy at any supermarket, pharmacy or health store without a doctor’s permission? By the way there are such things as “behind-the-counter drugs”, which are dispensed by a pharmacist without needing a doctor’s prescription, not to mentioned “illegal drugs”, which could be the source of another blog in the future (think medical marijuana for a start). Prescription drugs can only be obtained with permission of licensed medical professional, usually a physician. There are the prototype prescription drugs, which are protected by patents preventing others from selling them, and generic drugs, which must also be approved by the FDA but are generally copies of a once patented drug. Think aspirin or acetaminophen (Tylenol).
According to the Collins Dictionary the term “ethical drug” was first published in the 1935. Its usage peeked in 1977 but it seems to be coming back in fashion. It is not clear to me why the adjective “ethical” was adopted but I suspect it was used to differentiation the highly regulated prescription drugs from the nostrums and quack medicines that were common at the time.
Almost everyone agrees finding ethical drugs is an expensive and risky enterprise. The independent Tufts Center for the Study of Drug Development reports that the average cost to bring a single FDA-drug to market is a whooping $2,600,000,000. This number is often used by the industry to justify the high price of new drugs along with the defined patent protection period. I find the argument somewhat compelling for new drugs as generic drugs, which now comprise 80% of all prescription, according to the FDA cost on average 80-85% less that the patented version. In 2010 alone, the use of FDA-approved generics saved $158 billion, an average of $3 billion every week. It is not a cogent argument for high prices for recycled drugs like pyrimethamine.
The public often view the high cost of drugs as the core of escalating health care costs. According to the Centers for Medicare and Medicaid Services, however, pharmaceuticals account for ~10% of the US annual health-care costs. Nonetheless, if you are patient presented with a $10,000 a month bill for your cancer drugs, you will be little concerned about average costs. One derivative of the so-called precision and targeted cancer therapy movement has been the recognition that we may be entering an era when there will be a need for perhaps thousands of drugs to address the potentially thousands of mutations, amplifications, deletions and alterations that we find in human tumors. How will the industry ever be able to finance new drug discovery and development with drugs that may only be effective for a few thousand patients unless they demand seemingly obscenely high prices?
So what is the solution? I am not sure. Senator and Doctor Tom Coburn and Mr. Paul Howard, a senior fellow and director of health policy at the Manhattan Institute suggested in a recent Wall Street Journal article (October 22, 2015) entitled “The answer to high drug prices is more drugs, faster” that focusing on short-term drug costs, as Mrs. Clinton and Senator Sanders do, dooms us to the technology of today. They argue accelerating the number of safe and effective products and services reaching patients is “the best way to both manage prices and promote better health”. I hope we can convince the public that the best hope for our cancer patients is to accelerate new drug discovery and development. After all in less than a generation the drugs of today will be generic.