Until 2015, there was exactly one treatment for hepatitis C infection, and it was terrible: Interferon (IFN), an immune booster plus ribavirin (RBV), a non-specific antiviral. The IFN/RBV combinations not only didn't work well (failure rates as high as 80 percent, depending on the strain of the virus), but had god-awful side effects:
• Fatigue
• Headache
• Nausea and vomiting
• Anorexia
• Diarrhea
• Insomnia
• Irritability
• Depression (and this can be very serious, including suicidal ideation)
• Alopecia (hair loss)
• Skin Rash
• Anemia
• Thrombocytopenia (low platelet count)
• Shortness of Breath
• Chest pain
• Visual Changes
• Thyroid Dysfunction
All of this changed in 2013 when Gilead received FDA approval for Sovaldi—the first effective, specific anti-HCV drug. Not only did Sovaldi and its newer and even more effective cousin Harvoni—a combination of Sovaldi and ledipasvir, another Gilead drug), work beyond expectations (cure rates of about 100 percent), but there is quite a difference in safety:
"The most common side effects reported with this drug were fatigue and headache. When this drug was studied with ribavirin, the most common side effects of the combination were consistent with known ribavirin side effects; frequency and severity of the expected side effects were not increased. Therapy was permanently discontinued due to side effects in 0%, less than 1%, and 1% of patients using this drug for 8, 12, and 24 weeks, respectively, and less than 1%, 0%, and 2% for patients using [the Sovaldi-ribavirin combination] for 8, 12, and 24 weeks, respectively."
OK, so we now have treatments for hepatitis C that are nothing short of miraculous. But who should get them? This is where things get touchy. Because of money.
Sovaldi costs $1,000 per pill—$84,000 for the 12 week treatment, and Harvoni costs about $100,000. These numbers are not relevant in the real world, since this is not the price that is actually paid— it is almost always discounted. (Gilead just announced that it would discount Sovaldi by 46 percent.)
Ironically, the remarkable efficacy of these new medicines has created an ethical dilemma: Since they work so well, most people who are infected will want them. However, given the large number of Americans who are infected—3.2 million—and the price, hepatitis C treatment is putting a strain on budgets of a number of providers, such as Medicaid, the Veteran's Administration, and insurance companies.
So, who should get the drugs? Assuming the answer is "not everyone," which you can pretty much bet your life on, a decision has to be made. This is where rationing comes in. Can rationing be rational? Yes, it sure can. Here is why:
This may sound harsh and possibly even judgmental, but I believe that there are valid arguments why many HCV-infected patients should not have access to these drugs.
First, hepatitis C is a very unusual infection. Functional signs of liver damage typically do not show up until as long as two or three decades following infection. During this time, even though the virus is rapidly replicating, there will be no symptoms until the liver is sufficiently damaged (cirrhosis). In a perfect world, all people who are infected would get treatment right away. But this isn't going to happen, especially given the price tag, so is there a fair way to determine who gets treated and who doesn't'? I say yes, there is. Here's why:
- The downside of waiting for 10 years (or perhaps even 20)—at which time these drugs will be generic, and much less expensive—is minimal. People who have unknowingly been infected for 30 years are now being cured.
- A little more controversial: Should a 25-year old heroin addict, who became infected from sharing needles, receive a $100,000 treatment, given the likelihood that he or she will most likely still be addicted after they are cured, only to become reinfected from the same behavior that got them infected in the first place? To me, this is a pretty easy one: No.
This dilemma is not new, nor is it strictly a medical issue. It is about both medical ethics and medicine. Should alcoholics receive new livers if they continue to drink following the transplant? Most, but not all medical ethicists believe that a 6-month abstinence interval prior to transplant should be required, and there are strong arguments to support this. Every transplanted liver that is "wasted" on someone who is going to receive, and then destroy it, is a liver that will not go to someone else who needs it, and will not destroy it.
The parallel to HCV treatment dilemma is obvious, and so is the conclusion. Spending a very large amount of money on people who are going to effectively "waste" it makes no sense. And, whatever is spent/wasted, will be at the expense of others who will not waste it.
No—it makes no sense to commit significant financial resources to people who are likely to throw it all away. There are more than enough people with legitimate medical needs who are already being denied medical care because of lack of insurance, or disputes with benefit providers.
Even though this issue is chock full of medically ethical issues, in the real world, it is actually rather simple.
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