Calling the current supply of vaccines in the United States "precarious" and a "threat to the public's health," a National Academy of Sciences committee recommended on Monday the establishment of a new, national commission on vaccines, which would "oversee the wide range of factors that affect the nation's vaccine supply."
The commission's duties would include guaranteeing that an adequate supply of various vaccines exists and developing a new system to compensate people injured by a vaccine. This compensation system would "reduce liability uncertainties among manufacturers," said Dr. Jay Sanford, chairman of the NAS committee.
Fear of lawsuits from people injured by vaccines has led, in recent years, to a sharp decline in the number of drug companies willing to make vaccines for such wide-ranging diseases as influenza, measles, mumps, rubella, diphtheria, tetanus and pertussis (whooping cough).
Seven of the vaccines against important childhood diseases, such as measles, are distributed by just three firms, and "most of them are produced by just a single manufacturer," said Sanford, who is president and dean of the Uniformed Services University of the Health Sciences in Bethesda.
Drug manufacturers have claimed a reluctance to produce vaccines based on a rising number of lawsuits filed by people who experienced side-effects from immunizations. Included among the claims in recent years are people who have experienced side-effects from swine-flu vaccine, polio vaccine and more recently pertussis -- the vaccine for whooping cough. At least two of the claims resulted in million dollar plus awards.
One recent case involved a father who allegedly contracted polio from his child who had been given live polio virus vaccine. In 1984, a jury awarded a total of $10 million because the parent had not been informed of the risks involved with the vaccine or of the availability of another type of polio vaccine which does not carry that risk. An appeal is pending.
The proposed vaccine commission would help remedy both shortage and liability problems, concluded the $300,000 study, whose sponsors included the National Research Council, the Department of Defense and three drug companies involved in the production of vaccines -- Lederle Laboratories; Merck, Sharp and Dohme, and Merieux Institute Inc. of France.
"The availability of vaccines," Sanford said, "depends almost entirely on the willingness of commercial manufacturers to produce them."
As a result, last December, the United States faced a serious shortage of the DTP vaccines which provides protection against diphtheria, tetanus and pertussis. "That particular shortage was relieved when one of the firms decided to return to the market," Sanford said. "But it brought home just how precarious our vaccine supply is."
The federal government stockpiles essential vaccines in case of a disruption in supply. But this stockpile "cannot protect the public against a company's decision to stop manufacturing a vaccine all together," Sanford said.
Moreover, the 12-member committee found that no contingency plan exists "for dealing with the situation in which no American [drug] manufacturer is willing to produce a pediatric vaccine."
"We consider this a grave situation," Sanford said.
But it's a problem that could be alleviated by establishing a national vaccine commission, which would be chartered by Congress, and could also oversee research and development of new vaccines plus supervise vaccine supplies, the NAS committee concluded after a two-year study of vaccine supply and innovation in the United States.
The committee also emphasized the importance of helping people who have been adversely affected by a vaccine. "No vaccine is without some risk," Sanford noted. "Fortunately the risk is small. But it does exist."
People who become ill as a result of being immunized need to be compensated because they are reducing disease risk for society, the committee said. "Society has a responsibility to develop some means of compensating those with vaccine-related injuries," the report concluded.
Exactly how much money should be set aside to help these people was not studied, Sanford said. But it would cost an estimated $1 million to establish the national vaccine commission.
In a separate report released last week, the National Academy of Sciences recommended that nutrition courses move into the mainstream medical school curriculum right beside anatomy, pharmacology and physiology since six of the 10 leading causes of death in the United States are linked to nutritional problems.
Current instruction of diet and nutrition is "largely inadequate," the NAS committee reported after surveying medical schools, deans and students.
"We found that less that half of medical schools in the United States had a required course in nutrition," said Dr. Myron Winick, director of Columbia University's Institute of Human Nutrition and chairman of the NAS committee. And some 20 percent of medical schools offered only 10 hours of instruction in nutrition.
Yet the need for nutrition courses is overwhelming, the committee reported, noting that "diet is not only a factor in the etiology [development] of these diseases, but also is important in their treatment." A variety of major illnesses have important nutritional components, NAS notes, including heart disease, high blood pressure, diabetes, cancer and the degenerative bone disease, osteoporosis.
To teach future doctors about nutrition, the committee recommends:
*Teaching 25 to 30 classroom hours of nutrition during the first two years of medical school, and then reinforcing that information during the clinical years -- the last two years which students spend in the hospital seeing patients.
*Placing one faculty member in charge of nutrition education at a medical school. "Faculty responsibility for nutrition varies widely," the committee found, "thus undermining chances for success."
*Establishing strong research programs in nutrition at medical schools, a move, the committee said would "foster the discovery of new knowledge, secure the position of the faculty, enhance their credibility and provide the scientific rationale for inclusion of nutrition in medical practice."
*Expanding the scope of the examinations given by the National Board of Medical Examiners to medical students to "reflect more accurately the current knowledge in nutrition." National boards today, the committee found, emphasize certain aspects of nutrition, "whereas others were ignored."
The NAS report is being criticized by the Association of American Medical Colleges (AAMC), a group which represents the 127 medical schools in the United States. "I think that the [NAS] study and report has flaws," says Dr. John A.D. Cooper, AAMC head. "What is meant by nutrition is not defined by the committee," Cooper says. The report also overlooks the fact, he says, that a great deal of nutrition education is included in various medical school courses, such as biochemistry and physiology.
Many specialities ask for more time in medical school, Cooper notes. "But unless we want to extend medical school for eight years," they can't all be accommodated.
That's a view disputed by Winick. "We think that one of the main problems with including more nutrition education in medical school curriculum is not a question of resources or lack of hours," said Winick. "We think that the number of hours necessary could be found. We think that there is a philosophical reticence to recognize the importance of prevention and of nutrition within that context."