By Drs. Sylvain Ehrenfeld and Reba Goodman
Public health measures such as clean water, sanitation and the beginning of drug development have increased the average lifespan by nearly 40 percent, from 50 years at the start of the 20th century to 77 years in the 21st century. Pharmaceutical companies have pioneered key drugs to combat illnesses such as antibiotics, vaccines, insulin and penicillin. In recent years, there have been increasing ethical concerns about some of the activities of the multibillion-dollar pharmaceutical industry. One concern is high drug pricing, which makes drugs unaffordable in much of the poorer parts of the world. Another concern is the globalization of research and the outsourcing of clinical drug trials. These trials have been carried out with reduced and often questionable ethical oversight.
Because pharmaceutical companies are businesses, there is often a lack of research into diseases that affect the world’s poor populations. The companies rarely make a profit when developing drugs for those diseases.
Another concern is the politics of patents. Many developing countries are facing high drug prices because patents are blocking the development of lower-cost generic versions of medicines. Some of these patents and their extension are unwarranted. Doctors Without Borders has launched a campaign to combat unwarranted patent requests.
Let’s look at some of these issues.
Medical research and outsourcing of medical trials
Medical research and human experiments require special attention to ethical concerns. After World War II, the barbaric medical experiments by the Nazis on concentration camp inmates resulted in ethical guidelines, The Nuremberg Code, to govern medical experiments. The most pertinent of the 10 principles is the first one: human subjects in experiments should understand what they are getting into and agree to participate. In other words, informed consent.
During the 1950s and the 1960s, medical researchers continued to conduct experiments on powerless subjects, clearly violating the Nuremberg code. For example, in 1952 Jonas Salk conducted early trials of his experimental polio vaccine on mentally retarded children at the Polk State School in Pennsylvania. In many cases, only the state officials, who were legal guardians of the children, gave permission. Hardly in the spirit of the Nuremberg code.
The Salk trials are reminiscent of the shocking, infamous Tuskegee Syphilis Study, in which the U.S. Public Health Service in Alabama deprived hundreds of African-Americans proper medical treatment from 1932 to 1972. The untreated Tuskegee subjects had unwittingly infected twenty-two women and seventeen children. The study revealed nothing about syphilis, but much about racism.
Increasingly, pharmaceutical companies have been using clinical trials for new drugs in developing countries. The main advantages for them are easier access to patients, less stringent ethical review, lower risk of litigation and lower cost. In short, a less demanding environment. In some cases, the trials are subcontracted, making them difficult to monitor. The upsurge of outsourced clinical trials has led to problems. Some examples:
In 2005 and 2012, the deaths of 2,644 Indian subjects were linked to unethical clinical trials. A number of school girls were alleged to have died after taking part in trials of the human Papillomavirus (HPV) vaccine.
In Uganda, between 1997 and 2003, women took the anti-transmission drug Nevirapine and experienced serious adverse effects (unreported). Fourteen women died.
In Hydererabad, India, in 2003, eight test subjects died during the testing of the anti-clotting drug Streptokinase.
In Kano, Nigeria, Pfizer tested a new drug called Trovafloxacin on children infected with meningitis without informing their parents; five died in treatment. Clearly, these and other examples call out strongly for much more monitoring.
Politics of patents and the cost of drugs
A patent for a new drug lasts 20 years. During this period, the patent holders can charge as much as they decide. After this period, companies that manufacture generic versions of the drug can market them usually at a much-reduced cost.
Pharmaceutical companies have several strategies for prolonging the life of a patent.
One technique is called “product hopping,” making small structural and insignificant changes in a drug whose patent is about to expire, so that the drug is technically new.
Another technique that drug companies use is to aggressively advertise prescription brands long after their 20-year patent has expired, so patients ask their doctors for them. America is one of the few advanced countries that allows direct advertising for prescription drugs. Still another tactic is for drug companies to pay the makers of generic drugs to delay their cheaper version. These “pay-for-delay” agreements are profitable for both. The consumer pays.
This brings us to a basic question: To what extent should the research, development and availability of vital drugs depend on the profit motive?
Dr. Sylvain Ehrenfeld, an IHEU representative to the UN, and Dr. Reba Goodman are members of the Ethical Culture Society of Bergen County.