- The Washington Times - Sunday, June 12, 2005

Reports of new vaccines have those of us in public health excited, but these vaccines may never get into the marketplace. Why? A combination of political, economic, and regulatory factors make vaccine development, production and marketing increasingly difficult for drug manufacturers.

Here are a few of the amazing vaccines in various stages of production:

• A vaccine against the varicella-zoster virus (which causes chickenpox in youngsters) has been shown to prevent half of all older adults’ cases of shingles and reduces by about two-thirds a devastating, painful complication, postherpetic neuralgia.

• The human papillomavirus (HPV) — at least, certain subtypes — causes cervical cancer. A vaccine has been shown to be highly effective in preventing this infection when given to young women and girls before exposure, generally from sexual contact. When approved by the Food and Drug Administration and widely administered, this vaccine may drastically reduce incidents of cervical cancer.

• Recent studies show a booster shot against pertussis, or whooping cough, prevents a high proportion of cases in adults. The public is largely unaware this disease remains a serious problem, not just in children but also in adults, accounting for thousands of cases of persistent, disabling cough.

• Researchers announced they are closing in on a vaccine effective in primates against the deadly tropical viral diseases, Ebola and Marburg virus.

• Early advances have been reported in the long-term quest for a vaccine against malaria, over the millennia one of the greatest killers in poorer, tropical areas.

• Researchers worldwide are working feverishly to produce a vaccine against avian influenza (“bird flu”), a potential cause of a devastating pandemic, if epidemiologists working in Southeast Asia are correct. Some experts say it’s likely this virus will transform from an avian form to one that can infect humans and to which we have minimal immunity.

None of these vaccines, which have the potential to prevent millions of infections and deaths, are available for public use yet. It is possible they never will be, even if approved as safe and effective. Pharmaceutical companies have fled the vaccine market in droves over the last 40 years. The research and development for vaccines is too expensive and the market too small for drug makers, contrary to the popular image of profit-raking pharmaceutical giants, and this is only worsening.

In 1967, 12 years after the polio vaccine become Page One news around the world, 26 companies were making vaccines. Today there are five. Among the 12 vaccines recommended for infants and children, seven are made by one company. Vaccines given to children over a short timeframe earn much less than “blockbuster” drugs meant to be taken repeatedly over many years, such as statins and heart drugs. Therefore, drug companies can stop making vaccines without any major effect on their bottom lines. In fact, since 1998, shortages have occurred in 9 in 12 vaccines for children.

Another factor, at least in the adult vaccine market where vaccination is optional, is market unreliability: Despite the “crisis” surrounding the 2004 flu vaccine “shortage,” millions of unused doses were dumped, at significant manufacturer cost.

But the two major reasons for this frightening situation are the dominance of the drug market by one buyer — the government — and the burden created on companies by safety liability:

(1) Government insurance reimbursement for providers to purchase and administer vaccines is barely enough to cover their costs. When support (infrastructure) costs are considered, doctors may actually lose money for each patient given a shot. The federal government, in the guise of the Centers for Disease Control, is the major player in the vaccine market, giving it de facto market control via pricing leverage.

(2) In contrast to the situation in the 1950s when polio was being conquered, over the past decade anti-vaccine activists, with agendas based on conspiracy theories and superstition, have convinced some politicians and members of the public that vaccines cause various childhood diseases. Autism-spectrum disorders have been targeted most prominently — though there is overwhelming evidence against such an association. Nevertheless, vaccine manufacturers are under attack in the press and in the courtroom from activists and litigators. Naturally, the effect on profits, especially when the profitability of vaccines is already tenuous, makes it tempting to abandon the vaccine market. After all, vaccine makers are not charitable enterprises, nor adjuncts of public-health agencies: They are businesses.

How can this dire scenario be remedied? The answers are obvious, but not easy to implement in the current litigious climate: The vaccine makers should receive more effective protection from frivolous, junk-science-based litigation. And if government is to remain the dominant purchaser, it should increase its payments to make vaccine marketing more profitable. At the same time, the pharmaceutical companies should expand their recently initiated outreach to help the uninsured gain access to newer, more expensive (and more effective) drugs.

Perhaps, if these recommendations are put into effect, instead of watching the few drug companies still in the vaccine business leave the field, the public will eventually reap the benefits of the vaccines now under development.

The federal government controls vaccine prices, and therefore availability. The consequences — shortages of lifesaving vaccines and market distortions as companies abandon the field — should be a wake-up call to those who advocate government intervention via price controls on the rest of the pharmaceutical industry.

Gilbert Ross, M.D., is the medical director of the American Council on Science and Health in New York City.

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