So why are some of those very firms that have played their role in extending our life expectancy getting such bad PR these days?
A "New York Times" report from earlier this week highlights a pretty good reason why.
According to the Times
, one retiree the paper spoke with is unsure how he will be able to afford his medication for Wilson disease, after Valeant Pharmaceuticals International more than quadrupled the price of the drug Cuprimine. The report came after Turing Pharmaceuticals made international headlines after announcing it was hiking the cost of Daraprim
, a drug for toxoplasmosis, from $13.50 to $750 a pill. That move prompted presidential candidate Hillary Clinton
, among others, to question the soaring prices. (The company quickly backed down, saying it would reduce the price jump, although it did not say by how much).
But while dramatic price hikes are not necessarily breaking any laws, they do raise larger moral concerns.
Corporations claim they charge these extraordinary prices to pay for research and development into new drugs. But the truth is that many spend more money on marketing (think about all those TV ads for drugs) than on R&D
. Meanwhile, many patients who need these drugs will not actually be able to get them because of the costs. Yes, drug companies are entitled to profit, but as some economists have suggested
, that should be more to the tune of 10 times the cost of R&D, not several times that, as sometimes happens now.
However, it's not just drug companies' pricing practices that need to be addressed -- we are also about to face key decisions about drug company research.
Back in 1974, Congress passed the National Research Act, following revelations about the Tuskegee Syphilis Study
, in which government-funded researchers examined poor African-American men with syphilis in Alabama, without offering or discussing effective treatment when it became available.
This act led to the creation of research ethics committees, known as institutional review boards (or IRBs), to oversee the right of "human guinea pigs." Thousands of these committees now exist, monitoring tens of billions of dollars of research, funded by drug companies, federal agencies from the NIH to Homeland Security, and others. Yet over the past 40 years, medical research has changed, and these committees have not kept up.
Increasingly, when you are a patient, hospitals collect and store tissues from biopsies that researchers there and at drug companies often use -- sometimes reaping profits without a patient's knowledge or permission. For instance, the cancer cells taken from Henrietta Lacks, an African-American woman who died in 1951, advanced science and earned large sums for drug companies and others.
In addition, patients are also now routinely asked to sign consent forms to protect their rights. Unfortunately, these documents are now frequently dozens of pages long, filled with complex scientific information. As a result, many patients simply say, "just tell me where to sign" (just as most of us giving sensitive information on websites simply scroll down and click or sign under "I accept"). Yet countless patients then end up entering studies without understanding all the potential dangers or the low likelihood that new experimental drugs will actually work. In some cases, IRBs have approved research studies and processes that later prove harmful, in which patients are injured or die.
With such problems in mind, the Obama administration, through the U.S. Office for Human Research Protections, last month released a Notice of Proposed Rule Making
(NPRM) suggesting several much-needed reforms in how research by drug companies and others is overseen, changes that should help increase transparency.
One proposal is that researchers post consent forms for all clinical trials online for everyone to see (with any proprietary information removed), which should encourage scientists and IRBs to make these forms more comprehensible. The document also proposes that study subjects be told beforehand whether samples from their bodies may be used for commercial profit, and whether the subject will or will not share in these financial rewards.
These suggestions are important steps in the right direction, and seem like commonsense. Unfortunately, they will likely encounter much opposition -- drug companies have already been pushing hard to reduce the federal oversight of research and deregulate this area, so they are unlikely to be happy with more regulations.
In the meantime, public comments about the NPRM are being accepted until December 8, after which the Obama administration will weigh the feedback and issue final reforms that the FDA will closely follow as well.
Countless drug and other experiments will be affected by these rules, and the clock is now ticking. Patients and their family members, patient groups, doctors, drug companies, health care officials, and policymakers have only three months to provide any comments. It is therefore time for all those concerned about drug company practices to weigh in on a set of issues that need more attention and discussion than they have so far received.
The health of our nation, its medical care, and ultimately each of us, are all at stake.