Science-based Policy Making in Health

Richard Mahoney

The 1960s and 1970s saw the introduction and rapid growth in use of several new contraceptives including intrauterine devices and pills. The Ford Foundation had large programs run out of the regional offices and a headquarters program, the Population office, under the visionary leadership of Bud Harkavy. The regional offices were leaders in working with developing country governments to design and launch family planning programs that delivered these technologies. The Foundation's Population office undertook a wide ranging set of activities including a major program – at one time, the world's largest – to support research in reproductive biology and contraceptive development. While this natural science program focused on basic biological research, the office also supported work by the Population Council and others to undertake product development and to work on various social science and policy issues. This latter work included dealing with anti-family planning advocates and their sometimes inflammatory claims about the safety and efficacy of new, and old, contraceptives. The issues that were addressed in those days concerning contraceptives are echoed today in the field of vaccines and immunization. Family planning and immunization are two fields that have attracted zealous opposition and the way in which this opposition has been addressed illustrates the value of science-based policy making.

Science has come a long way in the last 200 years. Medical investigators have learned to do studies that assess whether vaccines really do what we hope they do. The carefulness with which these studies are carried out is illustrated by the fact that the cost of developing a new vaccine is now roughly $1 billion, of which the cost of conducting clinical trials to demonstrate safety and efficacy is a very large part. In the last few years, new vaccines have been developed against cervical cancer and against pneumonia and diarrhea in infants. The global use of these vaccines will save annually the lives of many hundreds of thousands of women and of over 1 million children who might die from pneumonia or diarrhea.

Studies are constantly underway to assess the safety of vaccines. Because vaccines are given to otherwise healthy individuals (as with contraceptive), the safety standards they must meet are naturally higher than for drugs for treating serious illnesses. Sick individuals are willing to suffer side effects to obtain the benefits of the medicines. But parents do not and should not accept vaccines that do not achieve the highest level of safety possible. Thus, the US Centers for Disease Control and Prevention, the National Institutes of Health, and pharmaceutical companies spend billions of dollars each year supporting studies to evaluate the safety of vaccines. Vaccines are considered by experts in public health to be perhaps the most cost-effective intervention available to combat disease.

There are problems with vaccines but not the problems we might expect. Ironically, one of the problems for vaccines is that they prevent people from getting sick. Why is this a problem? It is a problem because, if a person doesn't get sick, you don't see that the person didn't get sick - it's a non-event. This has become a major problem in United States and elsewhere. Many diseases that were very common in human history have virtually disappeared. These include polio, measles, mumps, diphtheria, tetanus, pertussis (whooping cough), and meningitis. One of the difficulties of modern medicine is that young doctors in training do not see patients who suffer from these diseases, and these young doctors are not able to sufficiently address the needs of such patients in the rare cases they are encountered. Perhaps the greatest public health achievement in history was the eradication of smallpox through vaccination. We don't see headlines in newspapers hailing the number of children who did not die this year as a result of smallpox. That is simply not news.

Another reason why the success of vaccines is a problem is that parents get used to the idea that their children do not and probably will not ever get these diseases. They take the absence of these diseases as a fact of life. Headlines in newspapers that report on claims of vaccine adverse events may have greater impact on parents than the fact that their children are not getting sick from the diseases. Such claims with respect to vaccines against pertussis and measles led to a dramatic drop in vaccination against these diseases in Europe some years ago. The claims were eventually not confirmed, but in the meantime many children died or suffered severe avoidable illnesses. The claim that hepatitis B vaccine causes autism in children has also had a substantial negative effect on the uptake of this very important vaccine and numerous studies including one published just in 2008 have failed to confirm any association between hepatitis B vaccine and autism.

Another claim about vaccines is that a mercury-containing preservative – thimerosal - used in multi-dose vials might adversely affect the health of children. No scientific evidence has been reported demonstrating an association between vaccinations and illness caused by mercury. However, when anti-vaccination advocates raised concerns, the companies concluded that the cost of protecting themselves from potential liability suits was greater than the cost they would incur by removing mercury from vaccines. Also, public health officials at CDC were exposed to intense pressure that led to decision making that was probably not wise. One step for the manufacturers was very simple. They stopped putting vaccines in multi-dose vials. A preservative had to be put in multi-dose vials because health personnel would often vaccinate a number of individuals using the vaccine from a single vial over several days, thus the need for a preservative. However, there is a high cost now being borne by the American public for this removal of mercury from vaccines based on unsubstantiated claims. Vaccines in single dose vials are much more expensive than vaccines in multi-dose vials. Fortunately, the World Health Organization and governments of developing countries have largely continued to use multi-dose vials with thimerosal.

Other anti-vaccine proponents point out that vaccines are not 100% effective or 100% safe and thus try to discourage their use. No medicine or vaccine is 100% effective or 100% safe. To advise individuals not to be vaccinated because a vaccine is not perfectly effective or safe is to assume to one's self a power that boggles the mind – the power of life and death. Getting the flu, especially if you are over 60, can be a very serious, life threatening event.

Skepticism about science and medicine is healthy. There should not be an unquestioning acceptance of recommendations to use vaccines and other drugs. However, there is an obligation upon anti-vaccine and family planning groups to understand the harm they may do, as well as the good they think they may achieve. Opposition to contraception, sometimes put forward with unsubstantiated claims of adverse effects, did much to impede women's access to methods that could give them greater control of their fertility. In recent years, opposition to the use of condoms in HIV prevention programs has done much harm. It is well documented that restrictions on access to contraceptives are effective in increasing the incidence of abortion. Impediments to vaccine access leads directly to otherwise avoidable mortality and morbidity. Policy making based on the best available science is the best policy making. The Foundation deserves great credit for the work it did in family planning to ensure a sound scientific basis for policy making.