The mantra of the anti-patent community is nearly in unison on the issue of patented drugs. Of course, everyone wants drugs to be developed, but no one wants to pay the exorbitant prices charged for blockbuster, patented drugs. You can add me to that list of individuals who doesn’t like the prices, but at least there is a benefit. Without appropriate financial incentives in place drugs would not be patented, but then again they wouldn’t be developed either. But what is the justification for scarcity and exorbitant prices of old drugs that are off patent?
In a recent survey of U.S. oncologists conducted by MDLinx reports that over 90% of oncologists are experiencing shortage of important cancer drugs in the United States. The survey conducted of 200 U.S. oncologists in April 2012 finds that 90.5 percent reported experiencing shortages of key cancer drugs in their practices.
“We have all read about the manufacturing challenges behind the shortages, but I was shocked to find that nearly all our physicians have experienced shortage issues. That represents a lot of cancer patients,” said Stephen Smith, Chief Marketing Officer for MDLinx. “The results become more alarming given the challenges already facing cancer patients and their doctors in the current financial environment. In an MDLinx survey in the third quarter of 2010, sixty-seven percent of responding doctors reported patients rationing medications or forgoing treatment due to financial and insurance coverage concerns,” said Smith.
The drug shortages reported by those in the survey related to the treatment of some of the most common cancers, including cancers of the breast, prostate, lung, and head & neck, as well as various leukemias and lymphomas. The most frequently mentioned drug shortage was for doxorubicin, with 70.5 percent of responding oncologists reporting experiencing a shortage of the drug in their practice. Cytarbine and methotrexate were the next two most commonly named drugs in short supply, at 40 and 30.5 percent, respectively.
According to the National Institute of Health’s online Library of Medicine, doxorubicin is in a class of medications called anthracyclines, which work by slowing or stopping the growth of cancer cells in the body. Doxorubicin is used in combination with other medications to treat bladder, breast, lung, stomach, bone, kidney and ovarian cancer, as well as Hodgkin’s lymphoma (Hodgkin’s disease) and non-Hodgkin’s lymphoma (cancer that begins in the cells of the immune system), and certain types of leukemia. Doxorubicin is also used alone or in combination with other medications to treat certain types of thyroid cancer and certain types of soft tissue or bone cancer.
Many will want to jump to the conclusion that the patent system is to blame for the drug shortage of doxorubicin, but that would be erroneous. While a cursory search of online patent databases revealed nearly 50,000 patents that in some way relate to or mention doxorubicin, at least since the early 1980 doxorubicin has been a widely used agent in anti-tumor therapy. See Background of U.S. Patent No. 6,210,930 titled process for preparing doxorubicin. In fact, one well known generic pharmaceutical company – Teva Pharmaceuticals – has all doxorubicin injections on back order, which was verified by the Food and Drug Administration on May 18, 2012. See Drug Shortages.
In fact, Doxil (doxorubicin hydrochloride liposome injection) has been in short supply due to manufacturing issues at an Ohio manufacturing facility. This facility voluntarily closed on November 19, 2011. Since that time the FDA has Janssen Research & Development LLC. (the distributor) and Ben Venue Laboratories, Inc. (Janssen’s contract manufacturer) to address the short supply.
In response to the critical shortage, on February 21, 2012, the U.S. Food and Drug Administration exercised its enforcement discretion for the temporary importation and distribution of Sun Pharma Global’s Lipodox (doxorubicin hydrochloride liposome injection) in the United States. The FDA acknowledged that the exercising of this extraordinary regulatory discretion was not expected to eliminate the shortage immediately, but the hope was that it would begin the process of addressing U.S. patient needs.
Temporary importation of foreign drugs is considered in rare cases when a shortage of an approved critical US drug exists and the shortage cannot be resolved by manufacturers of the approved drug in the immediate future. The survey, however, revealed that 42 percent of responding oncologists were concerned with the safety of imported cancer drugs approved on an emergency basis by the Food and Drug Administration (FDA), with 31.5 percent saying they were unsure and only 26 percent expressing full confidence in the overseas drugs. “Some drugs have to refrigerated,” pointed out one oncologist participating in the survey. “I worry about the efficacy of the drug when it has been shipped such long distances.”
Smith also pointed out that the combination of shortages, insurance limitations and financial pressures has some patients looking outside the system. “One in ten of our responding oncologists reported that they had experienced desperate patients going into the so-called “grey market” to find cancer meds. In addition to being expensive – the NY Times reported prices up to 650 percent of normal – these drugs may be less effective or even counterfeit,” said Smith.
Reuters today published a story titled U.S. hospitals fight drug scarcity, fear patients harmed. In this article Dr. Steven Allen, a specialist in blood cancers at North Shore University Hospital in New York, explained of a recent situation where the treatment of a young woman was compromised by the inability to obtain a certain cancer drug to treat a life-threatening cancer known as acute lymphoblastic leukemia. The drug combination that Dr. Allen wanted to try included thiotepa, an older drug his patient had not tried and could tolerate.
“When I ordered it, I was informed that there was none available, and it couldn’t be obtained,” said Allen. “We tried to make up a dose that was equivalent to thiotepa [with another drug] and hoped for the best… but I think it may have compromised her care.”
On May 14, the FDA announced it would allow temporary imports of thiotepa made by Italian company Adienne Pharma & Biotech, to relieve manufacturing delays at Bedford Laboratories, the only approved manufacturer of the drug for the United States.
The only approved manufacturer in the United States? Frankly, this is unacceptable. What is the FDA doing? People rail against patents and the patent system that result in exorbitant prices for the latest blockbuster drugs, but what is the excuse for older drugs that are off patent?
With respect to patented blockbuster drugs we justify the exorbitant prices because we want to encourage pharmaceutical companies to continue to research, develop and manufacture important, life-saving drugs or drugs that increase quality of life. We know that 10% or fewer of drugs researched ever become blockbuster drugs, yet the 90% (or more) of drugs that never prove successful still cost real money to develop, test and pursue through trials and market. We tolerate super-competitive prices for blockbuster pharmaceuticals knowing that in half a generation, or less, these drugs will be off patent and the price dramatically reduced with the entrance of generic drugs into the marketplace.
What is the rationale for accepting the shortage of drugs off patent? Exactly what logic or school of thought finds it acceptable to have a government bureaucracy stand in the way of people getting the drugs they need? What benefit is there to having only a single approved manufacturer of any drug for the U.S. market?
This is the problem with a regulatory regime that is so overburdensome that it strangles business to the point of crying uncle. What America needs is less regulation, period! I am not pollyannaish on the issue of regulation though. Yes, we absolutely need less regulation across the board, but we do need regulation that achieves the desired purpose, which is to protect the public and ensure a rule and observance of said rules to ensure a fair business climate for both small and large businesses alike. When was the last time the federal government had a legitimate top to bottom review to purge regulations that are nonsense and tailor the existing regulations to the least burden while achieving the desired goals of the regulatory apparatus? Oh, right. Never.
What we don’t need is an FDA that strangles patients, rationing critical drugs for no societal benefit!