The Skewed Values of Drug Prices

The eye-popping pricing strategies for two pharmaceuticals have been big news lately. First, the cost of a weekly progesterone injection, designed to prevent premature births in at-risk pregnant women, jumped from about $20 per shot to $1,500 per shot.

What happened? The active ingredient of the shot had been compounded by pharmacies as needed by physician request to prevent premature births in the past, while the FDA quietly looked the other way. But in February, the FDA officially approved KV Pharmaceutical's version of the shot, Makena, and KV Pharmaceutical decided to raise the price - a lot.

It was a stunning move for a product whose development was partially funded by taxpayers through the National Institutes of Health, and whose approval had been fast-tracked and supported by the FDA's Orphan Drug Act, according to a recent FDA statement. In response to public outcry, KV Pharmaceutical later dropped the price to $690 per dose. 

Then, on March 30, Medicare announced (in a preliminary decision still in the comment phase) that it would cover the $93,000 price tag of Dendron Corporation's prostate cancer vaccine Provenge, which extends life for a few months in cancer patients.

Dendron's website currently runs an ad for Provenge called "Jonathan's story." In the ad, the patient says "fighting my cancer could mean meeting my new granddaughter, who is due in a few months."  But ironically, current health care policy pits infant health against health care for the elderly.

Is it wise to pay for medication that could extend a long life a few months longer, while allowing companies to create financial barriers to accessing medicine that could help an infant get a healthy start on life? It isn't if you look at health care as a tool to extend healthy years of life, a view that is currently shifting kidney allocation rules, as I've blogged before. In an opinion piece in the Washington Post this weekend, a prostate cancer survivor points out a similar resource allocation problem with Provenge:

One thing I can assure you is that I would never ask Medicare to pay $93,000 for a treatment to extend my life four months. However, I would ask Medicare officials this: if Provenge is prescribed to me as a possible treatment and I turn it down, could I put the savings into a college fund trust account for my grandchildren? I feel the country would benefit much more from educating three of its citizens than from keeping me around another four months. I have a hunch Medicare's answer would be no. 

We need to ask what society owes to two vulnerable populations - pregnant young women at risk of preterm delivery, and terminally ill older men. Rather than pittting ACOG against the AARP, we should step back and ask what is a reasonable amount of funds to invest in protecting each of these populations. And what is a fair and ethical price to charge for the medications they need?

Infertility, Public Health, and Private Choices

Infertility is an increasingly common problem for many couples in the U.S, but infertility treatments are creating new problems, according to a report released last week by the CDC. In 2005, the most recent year with statistics available, assisted reproductive technologies (ARTs) such as in vitro fertilization had a 35% success rate (i.e., 35% of treatments resulted in a live birth). Forty-nine percent of these births were multiples (twins, triplets, or higher).

These ART-conceived multiple births may be a personal triumph but they are a public health disaster. Why? The chances of infant and maternal health problems increase with multiples, particularly those conceived with ARTs. Triplets and higher multiples conceived with ARTs, for example, have a 95% chance of having a low birthweight, according to the CDC. In 2005, although 13% of all infants were preterm, 42% of ART-conceived infants were preterm.

The public health cost of ART preterm births was approximately $1 billion in 2005, or an average of $51,600 per infant, the report stated. One percent of all U.S. infants born in 2005 were conceived with ARTs.

In the report “Assisted Reproductive Technology Surveillance – United States, 2005,” the CDC analyzed data from 89% of the 475 medical centers that treat fertility problems with assisted reproductive technologies.

The report stated that many ART medical centers are working to avoid multiple births in favor of singleton births by implanting fewer embryos at a time, but others are bowing to patient and marketing pressures to increase their success rate by implanting numerous embryos at once.

Successful fertility treatments themselves increase the number of children who are as genetically vulnerable as their parents were to infertility problems as adults. Successful treatments therefore create a new generation of customers for infertility clinics, and, barring medical advances in ARTs, fresh public health costs in the future.

There are alternatives. For a couple unable to conceive, adoption can help them build a family – a choice that helps both individuals and society. Considering the public health cost of ARTs and the dismal failures of the U.S. foster care system, it is in the government’s best interest to take two steps: regulate the use of multiple embryos in ART, and promote and streamline the domestic adoption process.

Addendum - July 17, 2008

Preterm birth can also have long-term consequences on an infant. Today, the New England Journal of Medicine published an article about the "Long-Term Medical and Social Consequences of Preterm Birth" among preterm infants followed to adulthood in Norway. Among this group, there was a significantly increased risk for cerebral palsy, mental retardation, and dependence upon disability payments as adults if they were born at 23 to 27 weeks. The abstract concluded that "the risks of medical and social disabilities in adulthood increased with decreasing gestational age at birth."