For years, my cholesterol level remained high, regardless of what I ate. I gave up all butter, cheese, red meat, and fried food. But every time I visited my doctor, he still shook his head sadly, as he looked at my lab results. Then, anti-cholesterol medications became available, and I started one. I still watch my diet, but my blood levels became normal.
I am deeply grateful for the drug.
Over the past half-century, pharmaceutical companies have brought us many vital drugs. But increasingly, they are now conducting trials and engaging in practices that raise serious ethical concerns. Most recently, Gilead decided to charge $94,500 for a 12 week trial of Harvoni. Another company announced a 5,000% price increase for one drug – from $13.50 to $750 a pill. (The company backed down, under pressure, announcing it would lower the price hike, but not saying by how much).
Alas, countless patients will not be able to afford these drugs. Those that can obtain them often do so through insurance, including the Affordable Care Act, yet these higher prices then get passed onto taxpayers, and other insured patients.
Drug companies argue that they charge these high prices to cover costs of research and development (R & D), but they in fact spend more on marketing (paying for countless TV ads for drugs) than on R & D. Drug companies are certainly entitled to profit, yet some economists have argued that that should be perhaps 10 times the cost of R & D, not 80 to 100 times, as sometimes occurs now.
But while drug company prices have attracted headlines, we are about to confront critical decisions regarding these corporations’ research as well. In 1974, Congress passed the National Research Act, following revelations about the Tuskegee Syphilis Study, in which government-funded investigators followed poor African-American men with the disease in rural Alabama. When penicillin became available as a definitive treatment, the researchers, some of whom were affiliated with our nation’s major academic medical centers, decided not to tell the men about the cure, or to offer it to them, because doing so would destroy the experiment. The 1974 Act led to the development of research ethics committees, known as Institutional Review boards (or IRBs) to protect human subjects. In the US, over 4,000 of these committees now exist, overseeing tens of billions of dollars of studies, funded by pharmaceutical companies, NIH, and others.
Over the past four decades, however, science has changed and the regulations and these committees have not kept up.
In the past, countless studies were conducted at a single institution. Now, multi-site studies are common. To recruit enough patients, researchers need to work with 50 or 60 different hospitals, and dozens of different IRBs may then be involved. Yet these committees may disagree with each other, each seeking different sets of changes in a study. The data from these various hospitals may thus be hard to merge or compare. Informed consent forms are now often 40 or 50 pages long, filled with scientific details and legalese that most patients don’t understand.
The rapidly falling costs of whole genome sequencing, from more than $1 billion to now less than $1,000 per patient, have prompted drug companies and academic medical centers to build enormous biobanks filled with the DNA of patients. Yet major questions then arise of how much control, if any, patients should have over what happens to their genetic information. These may seem like minor issues, but the best-seller, The Immortal Lives of Henrietta Lacks highlights some of the problems. Physicians removed cancer cells from Henrietta, an African-American woman who died in 1951, and subsequent research on these cells earned companies massive profits, while her family continues to live in poverty.
As a result of these various problems, on 8 September 2015, the Obama administration released a Notice of Proposed Rule Making (NPRM) which suggested several key reforms in how IRBs work and oversee research by pharmaceutical companies and others. Many of these reforms constitute important steps in the right direction – requiring that researchers use central IRBs for multi-site studies, post consent forms online, and tell participants whether biological samples may be used for commercial profit, and if so, whether these subjects will share in these rewards.
The administration is allowing public comments through until 8 December.
Yet these proposals will no doubt confront stiff opposition. Pharmaceutical companies are already fighting to lower federal oversight of research. The 21st Century Cures Act, for instance, which the US House of Representatives recently passed, and which the Senate will now consider, would significantly lower the standards that drug companies have to meet to get FDA approval for new products. Companies could then market countless drugs that may harm more than help the public.
Admittedly, not all of these suggestions are perfect – some need to be refined. For instance, the administration proposes that consent forms to be posted only after participants have all been recruited. But these forms should be available online before and during recruitment, not just afterwards. Still, these proposals can offer important benefits, and require far more public attention and discussion.
Alas, these topics are complex, because as a society, we seek to balance two ethical goals that can compete – advancing science to help society, while protecting the rights of individual study participants. That balance is not always easy to achieve – especially since science continues to evolve and grow, the NIH budget has decreased in real dollars, and drug companies are pushing to increase their profits.
Drug companies will no doubt push hard, seeking to maximize their bottom line. But all of us – as patients, family members and friends of patients, patient advocacy organizations, health care policy-makers, and citizens should attend to these questions. Ultimately, these issues affect us all.
Feature image credit: Medicine research experiment by Jelly. Public Domain via Pixabay.