This is the second part of a blog I am posting about the lessons learned regarding the history of biomedical research from reading Polio, An American Story by David M. Ochinsky which I purchased from Chirp (see Part I) (1). Part 1 contained the information this book revealed to me about:
- Increasing scale of clinical research
- Changing ethics of research
In this second part of my blog about the Polio book, I discuss:
- Developing sources of research funding
- Evolving status of intellectual property for vaccines
- Organizing for respect for people with disabilities
Developing sources of research funding
Fund raising approaches
Founded by the President Franklin D. Roosevelt in 1938 to develop a cure for polio, as well as to provide care of people with polio, the National Foundation for Infantile Paralysis (NIFP; now known as the March of Dimes Foundation), used a number of novel approaches to raise a large amount of funding that not only provided the best care for polio victims, but also eventually resulted in a polio vaccine and eradicated polio as a significant infection in the U.S. Three of these novel fund raising techniques were:
- Use of FDR’s illness
- March of Dimes
- Use of FDR’s birthday
Use of FDR’s illness. Fund raising was certainly strong because it focused on polio, an illness scaring many parents because it threatened their children’s health with a potential death or a life-long debility which no parent would want for their child. However, because the President had the debility, most Americans were aware of polio and its potential life-long effects.
Use of FDR’s birthday. Established prior to the formation of the NFIP in 1938, the President’s Birthday Ball was to fund the Georgia Warm Springs Foundation which supported the rehabilitation of polio victims at the resort that the President purchased in Warm Springs, Georgia. Run around the country on the President’s birthday, these celebratory balls were very successful events which demonstrated the power of local organizations to raise small gifts for to produce significant funds. As a president of the Georgia Warm Springs Foundation, Basil O’Connor, Roosevelt’s law partner, was the natural person to become the chair and president of of the NFIP when it was founded, and thus a transition was made for political reasons to the NFIP with a broader context to develop a vaccine and treat polio victims. Thus, the NFIP replaced the Warm Springs Foundation as the supporter of Warm Springs, Georgia, and the organizer of the Birthday Balls. (1)
The March of Dimes. The President could attract leading celebrities including Eddie Cantor who was notable for being the leading black face entertainer – something that has brought him much infamy today. Cantor thought of taking advantage of a familiar newsreel called The March of Time, to create a NFIP campaign in which people were asked to send their dimes directly to the President at the White House. Cantor used his show on radio to announce “The March of Dimes”. Then they got the Lone Ranger, Jack Benny, Bing Crosby, Rudy Vallee, Edgar Bergen and many others to promote the campaign. They raised $268,000 in dimes and thousands of additional dollars fro checks and small bills sent to the White House. For now on, the fund raising arm of the NFIP would be called the March of Dimes. Actually the Roosevelt dime was released in 1946 to commemorate the late President’s birthday.
Increased awareness of need for public research investment resulting in growth of NIH funding
The NFIP demonstrated a strong need for and public interest in providing funds for research support. It wasn’t until the 1950’s, around the time of the effort to fund a vaccine for polio, when the government started to substantially increase funding for the National Institutes of Health when it went to $52.7 million a 50 fold increase since 1943. This investment doubled by 1957, and doubled again in only two years to $210 million in 1959. By 1963 the investment in biomedical research had increased another 4 fold to $810 million. In 2020 that research investment has reached $46 billion, a clear indication that government funding of research is critical. (2) These increases were mostly driven by influential citizen advocates of funding for particular diseases such as polio, tuberculosis, malaria, muscular dystrophy, alcohol and drug addiction, heart disease, diabetes, kidney disease, etc. More recently continued concern about AIDS, ALS, depression and other behavioral disorders, and emerging infectious diseases have encouraged further increases in funding, while the constituencies funded, the major academic medical centers and other research institutions, have fought to maintain and further strengthen funding.
This funding of NIH was not primarily for vaccine research, in fact most of this money would go towards basic biomedical research – the money that discovered foundations of biomedical knowledge that any researcher, public or private, could use in the development of vaccines or treatments like drugs, devices or other forms of improved care. Investments in vaccines, like the Salk and Sabine vaccines, were heavily purchased by government agencies focused on public health, whereas in the U.S., the trend is to have preventative treatments like vaccines administered by health practitioners and paid for by private health insurance companies and Medicare/Medicaid. Furthermore, after the 9/11 terrorist attacks increased funding has been provided to support development of key vaccines that could be needed for biodefense purposes. For instance, small pox vaccine has been purchased from industry and stockpiled in millions of doses for this purpose.
Funding as an art form – Indirect vs direct cost funding issue
As funding increased to academic and other research institutes, administrators quickly recognized that direct costs used for personnel, equipment, and supplies for completing a research project, were not adequately covering the indirect costs of research, particularly the cost for space and utilities to make that space usable, nor did it pay for the administrative infrastructure to keep the organization operating well-run research programs. Harry Weaver, the director of research for the NFIP from 1946 to 1953, recognized the problem and he saw this issue as a roadblock to the development of a polio vaccine. He created a complicated formula to pay a portion of indirect costs, changing eventually to a fixed percentage of direct costs:
- 46% on the first $10,000 of direct funding, plus
- 38% on the amount between $10,001 and $30,000, plus
- 6% on any remaining amount.
The NIH and the other federal agencies developed similar formulas. Eventually the most federal agencies provided much better indirect funding for research than any private funding agency could provide, driving researchers and their institutions to focus their fund raising efforts on those federal agencies.
Funding for public health initiatives by government
In reading Polio: An American Experience, I had a chance to see from past history, a possible future vision of what it might be like when it comes to distribution of a vaccine for SARS-CoV2, the viral agent of COVID-19. When the Salk Vaccine had been tested and was ready for distribution, President Eisenhower, a Republican, thought that individuals should pay for the vaccine through their normal service payments to their doctors. Note that in the mid-20th century, when this happened, there was no public insurance plan like Medicare for people over 65 nor was there an insurance for the poor, like Medicaid. So unless you had the funds, or you had a private insurance plan, you would not be getting the vaccine by Eisenhower’s plan, and that would mean that polio infection would continue as an problem for the uninsured and poor. The possibility of the distribution of the Salk Vaccine by the government raised fears in Republican and healthcare of “socialized medicine”. The drug companies agreed – lobbying for their usual way of business with the vaccine – selling directly through physicians who administered the drug.
Right after the announcement of the success of the Salk Trial, the Mayor of New York, Robert Wagner wired President Eisenhower on April 13, 1955:
Urgently request establishment of Federal supervisory allocations of Salk Vaccine similar to those set up in the early days of penicillin.
Oshinsky, Polio: An American Story, pp. 218.
The public made sure that they though the Federal government needed to step in to ensure extensive vaccination of children. The press and a large number of letters and telegrams to the White House demanded the resignation of the Secretary of Health and Human Services, Oveta Culp Hobby after she made a remark that they could not have foreseen the public demand.
As a different approach, the Canadian government, viewing polio as a national crisis, purchased and distributed Salk vaccine to all children. This approach very rapidly reduced the threat of polio in Canada. The drug companies feared this approach because it would fix the lowest cost for the vaccine. Eli Lilly priced the drug at $0.80 per cc, more than double what the NFIP paid at $0.35 per cc. Mrs. Hobby was thanked by the pharmaceutical industry for keeping to the privatization policy. However, even the New York Herald Tribune, with a Republican voice, wrote that this was a medical emergency and it needed to be handled as such by the Federal government, not the beginning of socialized medicine. As a result, later in 1955, President Eisenhower began leading a government with a major effort in the production, distribution and administration of the Salk vaccine.
If we continue to have a Republican controlled Senate and a Republic President, I’m guessing this same debate will evolve once there is an effective vaccine for COVID-19.
Evolving status of intellectual property for vaccines
Salk vaccine was not protected by a patent
Interestingly, Salk pushed to ensure that the Salk vaccine had no intellectual property protection. The NFIP and University of Pittsburgh lawyers sought to find something they could patent, and Salk refused to sit down with them to discuss the possibility. When pressed, Salk indicated that nothing of the process required to develop the vaccine was unique and patentable because it was all based on prior work. He may have never gotten the Nobel Prize because he made this argument, but he did substantially reduce the costs of the vaccine, as companies producing it did not have to pay any royalties for a license. Also, this made it possible to broadly distribute the Salk vaccine around the world, with minimal hindrances to the countries producing their own vaccines or purchasing vaccines from the companies producing it for the U.S.A. Sabin followed through also not patenting the Sabin vaccine. Thus, both Sabin and Salk essentially donated their vaccine to humanity. Have we seen this at any other time in recent history?
Organizing for respect for people with disabilities
People who were disabled as the result of polio virus infection, became major advocates for laws that protected the disabled from discrimination. In fact, they were some of the strongest voices to obtain support for the Americans with Disabilities Act of 1990 that legislated similar protections for the disabled as was provided to race, religion, sex, national origin, and others in the Civil Rights Act of 1964.
References
- Oshinsky, David M. Polio: An American Story. U.S.A.: Oxford University Press, 2005. https://www.recordedbooks.com/title-details/9781428129856.
- National Institutes of Health (NIH). “Appropriations (Section 2),” March 25, 2015. https://www.nih.gov/about-nih/what-we-do/nih-almanac/appropriations-section-2.
- “Supplement 1: The Evolution and Impact of Federal Government Support for R&D in Broad Outline – Allocating Federal Funds for Science and Technology – NCBI Bookshelf.” Accessed June 16, 2020. https://www.ncbi.nlm.nih.gov/books/NBK45556/.
T.P.Caruso 