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Sunday, February 01, 2015

Measles vaccine not an economic return on investment reported in Forbes

Finally, the truth about vaccines and money is getting attention! If vaccines made money, like Viagra and all the other designer drugs that do not correlate with saving lives, the return on investment to pharmaceutical companies would prompt more production. Unfortunately, an op-ed in Forbes says one problem is also over burdened regulations on the vaccines.....but (Hello?) consumers hear a litany of side effects for Viagra.....and it's still being pushed as being safe, in spite of a litany of risks. Vaccines have a high probabability of saving lives while Viagra may be deadly, especially with long term use. Where are consumers' values? Well, sadly, that's a rhetorical question. While sex sells, vaccines are simply not glamorous.

"Each year, approximately 42,000 deaths of children and 50,000 adult deaths in the United States are prevented by immunizations."

Obviously, our public health initiatives must be enhanced if we are to see a return on the investment for pharmaceutical companies who are turning to producing designer drugs rather than preventive medicines.

Henry L. Miller writes an opinion on this subject in Forbes:
Henry I. Miller, a physician and molecular biologist, is the Robert Wesson Fellow in Scientific Philosophy and Public Policy at Stanford University’s Hoover Institution; he was previously a Research Fellow at the NIH and the founding director of the FDA’s Office of Biotechnology.
Thanks to the availability of safe, effective, affordable vaccines, parents today know little of the fear–much less the reality–of deadly childhood diseases. Vaccines are the best value in our healthcare system, but a New York Times medical writer thinks they’re too expensive.

It wasn’t so long ago that epidemics of highly communicable diseases such as diphtheria, measles, polio and whooping cough regularly killed large numbers of American children or left them with permanent disabilities. But thanks to the miracle of vaccines–which are arguably the greatest public health triumph of the 20th century–these devastating epidemics became rare and well contained. Moreover, compared to many other pharmaceuticals, vaccines are cheap, which is why I was astonished to see New York Times reporter and physician Dr. Elisabeth Rosenthal (reporting) about the price of vaccines.

Center for Disease Control (CDC) reports on the benefits derived from the 20-year-old federal Vaccines for Children program, which pays for about half the vaccines administered in this country, are impressive: 

“Among 78.6 million children born during 1994–2013, routine childhood immunization was estimated to prevent 322 million illnesses (averaging 4.1 illnesses per child) and 21 million hospitalizations (0.27 per child) over the course of their lifetimes and avert 732,000 premature deaths from vaccine-preventable illnesses.”

Each year, approximately 42,000 deaths of children and 50,000 adult deaths in the United States are prevented by immunizations.

Not only are vaccines effective, they are also cost-effective. Every dollar spent on pediatric vaccines saves $10.20. In fact, the U.S. saves almost $70 billion in direct and indirect costs each year as a result of the pediatric vaccination program.

It’s unclear, therefore, why Rosenthal took aim at vaccine prices. It’s true that the cost of new vaccines is higher than those introduced in the 1950s, but she misidentified the reasons. What Rosenthal attributes to industry greed is primarily the result of developers tackling more complicated diseases and confronting more complex, demanding, highly risk-averse and costly government regulation.

A vaccine can take between 10 and 15 years to develop and faces escalating regulatory burdens. 

Increasingly defensive about accusations that drugs and vaccines are inadequately tested for safety, in recent years safety-obsessed regulators have required massive, hugely expensive and time-consuming clinical trials designed to detect even very rare side effects. For example, before its U.S. approval, a vaccine to prevent rotavirus infection (a common, sometimes fatal gastrointestinal infection in children) was tested in more than 72,000 children, and another 40,000-plus in post-marketing studies. On a similar scale, a vaccine to prevent human papilloma virus infection and cervical cancer was tested in almost 30,000 girls and young women. Such studies are very costly, and, by any reasonable standard, the number of subjects included in them was grossly excessive. By contrast, two Hepatitis B vaccines (Recombivax and Engerix-B) made with then relatively new gene-splicing technology were approved during the 1980’s on the basis of clinical trials with about 3,000 and10,500 vaccineees, respectively.

But the regulation-related costs don’t stop there. Vaccines need special, state-of-the-art facilities for manufacturing that can cost hundreds of millions of dollars. They are built according to strict requirements of governments around the world, and scientists working at these facilities continually run tests to demonstrate product quality. As Dr. Luis Jodar, a Pfizer vice-president, wrote in a published letter to the New York Times in response to Rosenthal’s article, “Prices reflect many factors beyond the complexity of developing and manufacturing vaccines and the cost of clinical trials. There are large post-licensing commitments, and continued safety monitoring and investments in equipment and facilities to assure the supply and quality of the vaccine.”

Today’s vaccines are challenging to develop, which of course translates into vast expenditures on projects that may never bear fruit. Thanks to this investment by vaccine manufacturers, more than a dozen new vaccines have been introduced since the 1980’s to prevent serious infections with organisms such as Haemophilus influenzae Type b (Hib), meningococcus, rotavirus, human papillomavirus and pneumococcus.

Another burden is that vaccines are the only medical products that once approved by the FDA must then be recommended by another governmental entity–the CDC’s Advisory Committee on Immunization Practices–before they can be widely used (and reimbursed) in the United States. And the fact that vaccines are administered as a single dose—or, at most, several doses—to each patient is another challenge to a robust return on investment (as compared, say, to financial blockbuster drugs for high cholesterol, diabetes or hypertension, which may be taken daily for decades).

In any discussion of the value and price of vaccines, we need to consider the consequences–monetary and otherwise–of not vaccinating to prevent infectious diseases. For example, a recently approved two-drug regimen, sofosbuvir and ribavirin to treat Hepatitis C (for which there is as yet no vaccine), is about $84,000 wholesale; and Truvada, the new drug combination of emtricitabine and tenovir for HIV prophylaxis, costs $15,000 per year. In addition, there are numerous little-used drugs whose cost for the average patient exceeds $200,000 per year.

Vaccines save lives and money and they are exceptionally safe. Before carping about one of the greatest public health successes in history, Rosenthal might have pondered how much better it is in every way to prevent a case of a life-threatening infectious disease than to treat it. Or to lose a child to it.

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