I believe that we must maintain the profit incentives that inspire companies and investors to take the financial risks of drug development, testing, and marketing. However, with "ownership" of effective drug products comes unique responsibilities.
In a discussion about the need for expanded/compassionate access to the most promising investigational agents, my friend wrote: “The product is their product and they have the legal right to throw every kg of it in the garbage tomorrow.”
I agree that this is a prevailing way for many in the industry to look at the issue. However, the products of science are dependent also on the labors of others who came before us, piece by piece … for centuries. And there could be no drug product if patients did not risk their lives (without financial compensation) to participate in the trials.
Further, no drug product could come to market without tax-payer-funded independent review to ensure that the drug is, on balance, effective as a treatment for a disease.
The drug products "owned" by companies do not emerge solely from their innovation or the inventiveness of any individual scientist. And in many cases the company with current title to ownership has merely purchased it from a group that invented the product or developed it based on targets discovered by government-funded basic research (Schilsky, MD, Chief Medical Officer at ASCO).
Access to investigational drugs
When standard therapies are not effective (only toxic), so-called compassionate access to a study drug can be the only chance the patient has to live better or longer. In such cases, Good Samaritan laws seem a legal precedent for requiring a company to establish an expanded access program for a drug that has advanced to late-phase testing. This to potentially meet the urgent needs of patients who are not eligible for the clinical trials. As my friend noted, we are not there yet, the company can legally deny the requests of the physician who seeks expanded access for his or her patient.
The cost of specialty drugs when granted monopoly status
Innovations that are not affordable - that bankrupt or prevent access to the product - are not true innovations. Some of the prices set for some specialty drugs have been alarming and unfair - excessively enriching shareholders by harming the primary stakeholder: the patients facing death from a disease.
The root purpose of patent law is to help patients by giving financial incentives to foster drug discovery and testing for the diseases that afflict the public. It grants a period (free from market competition) where it can charge any price it desires to offset the risks and costs of drug development.
In my view, oversight is needed to protect the public when the price of a specialty drug may be deemed excessive ... when the financial toxicity undermines the benefits of the drug, putting the drug out of reach of many, bankrupting others who sell homes and lose their life savings to pay for it, and putting the health care system at risk by contributing to the relentless rise of health insurance for everyone.
Finally, as described eloquently by Dr. Saltz 1 "Markets become dysfunctional when perverse incentives encourage sellers to sell, and buyers to buy, items whose values do not justify their prices. Consider that patients (or their insurance providers) pay for the full cost of specialty drugs even when the drug is marginally effective on average, or in individual cases causes only toxicity without any benefit.
In the upcoming policy deliberations, I urge all parties to be mindful that drug products are truly unique; and could not exist without patients who put themselves at risk to test them. Incentives are needed to develop them in order to address the unmet needs of patients, but oversight is also needed to protect patients and the health care system from companies who might set excessively high prices - taking advantage of the patients with life-threatening disease.
This is what I think. What is your point of view on this topic?
Karl Schwarz
President, PAL
Related topics:
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JCO, 2015, Dr. Saltz: The Value of Considering Cost, and the Cost of Not Considering Value http://bit.ly/1OqLOWz
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Financial Toxicity and Cancer Treatment (PDQ®)—Health Professional Version -
National Cancer Institute http://bit.ly/2bxFhmW
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Rising Costs and Access to Quality Cancer Care
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Final Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs http://1.usa.gov/1b7ekiJ
