Effective Health Policy Strategies

Improve Adult Vaccination Rates

The Problem. The value of immunizations in preventing childhood diseases has been established over decades and pediatricians have fully incorporated vaccines into routine care. The same cannot be said for adults.

Our Engagement. We are often engaged to find ways to improve vaccine-preventable diseases in adults.

We assessed vaccine medical society guidelines and identified confusing―even contradictory―vaccine recommendations. We summarized them in a side-by-side formatand used that tool to facilitate a summit attended by experts from those societies. Summit attendees could readily see the confusion created by conflicting guidelines and resolved that by harmonizing the guidelines and widely promoting the revision within their societies and within the ACIP.

We assessed the gap between the rates of influenza vaccination and the size of the patients at high risk who should have been immunized. The analysis showed that current, risk-based recommendations did not result in vaccination. Pediatric experience indicates that age-based vaccination recommendations succeed. By the age of 50, virtually all Americans have at least one disease risk-factor for the flu vaccine.

We presented this evidence to a summit of medical specialty groups and were successful in securing their―and soon after the ACIP’s―an agreement that all people over age 50 should receive an annual influenza vaccine.

For the American Medical Association (AMA) we helped to plan, facilitate, and author a report of a National Congress on Immunization to address improving immunization in adolescents and adults.

We worked to secure the support of governments for the new generation of more expensive vaccines. We reverse-engineered the decision-making process of government officials and built the first set of evidence-based policy messages to provide comprehensive information to help in policy and budget discussions. We built the case for the economic and humanitarian value of vaccines that have been used in many countries. The China CDC incorporated these into a book that is currently used in medical schools and public health departments.

Improve Children’s Pharmaceutical Care

The Problem. Of medicines used to treat children, 85% had never been studied in children.

Our Engagement. We were engaged by the NIH Child Health and Human Development Institute to help improve the R&D of medicines used to treat children to help ensure they received quality pharmaceutical care.

We identified and analyzed the scientific, technical, economic, regulatory, legal, and ethical barriers to R&D in children. We also reviewed the state of product development, prescribing, adherence, and pediatric pharmaceutical care programs.

We inventoried the capabilities of NIH’s Pediatric Pharmacology Research Units (PPRU), identified their technical capabilities, compared them to contract research organizations, and made recommendations accelerate research efforts.

We recommended NIH and FDA support an “orphan drug”-style legislation to grant market exclusivity to companies that conducted studies of existing medicines to determine their safety and efficacy in children. The agencies agreed, the Clinton Administration proposed it to Congress and, in 1997, Congress passed the Food and Drug Administration Modernization Act. In it was a provision―Section 505A (21 U.S.C. 355a) ―providing six months of pediatric market exclusivity to companies conducting studies requested by the FDA.

Craft a Digital Health Oath

The Problem. The number of digital health companies is growing exponentially as better quality, lower cost, and improved patient experience become the triple aim of health care. My work on covenants in healthcare suggests that digital health is an extension of traditional healers’ work and, for that reason, should ascribe to a healer’s oath.

Our Engagement. Karen Snyder of TYM Studio, Producer of Healthcare Games Showdown agreed with that rationale when we discussed this at the 2019 Consumer Electronic Show. She asked that I develop an oath for those involved in digital health, vet it with a group of advisors, and teach her students about it. Students in the Showdown were given the opportunity to take this oath (or not) or to craft their own oath. At the finale of the Showdown, each of the students ascribed to the oath.

Eliminate Viral Hepatitis

The Problem. There are many types of viral hepatitis and, thanks to vaccines and medicines, it is more preventable and treatable than ever before. Gaps remain, however, and there are unmet prevention, vaccine, treatment, and research needs.

Our Engagement. We were engaged to help a coalition of public and private sector stakeholders collaborate to eliminate viral hepatitis in the U.S. We developed the fundraising strategy and assisted in raising more than $1.1 million in grant funds and $1.5 million in in-kind resources. We facilitated the organizational meetings to form the National Viral Hepatitis Roundtable, designed and led a national strategy summit to develop a plan, and, using the output from the summit, authored a plan that was presented to Congress.

Improve Veterans’ Health

The Problem. Veterans’ groups provide services to returning soldiers. Increasingly, veterans have unmet health needs. This prompted leaders in the veterans’ groups to join together to create an advocacy agenda.

Our Engagement. We were engaged to help plan and facilitate the first-ever meeting on health at which all veterans’ groups would participate. We worked with these groups to identify, prioritize, and select health issues experienced by veterans of the World War II, Korea, Vietnam, Iraq, and Afghanistan conflicts to prioritize and select issues for discussion. We prepared speakers, facilitated the meeting, and finalized the meeting report to attendees.

Protect Pharmaceutical Donations

The Problem. Draft World Health Organization (WHO) Guidelines threatened to hinder―and possibly prevent―pharmaceutical companies from donating medicines to NGOs who serve the needs of the poor in developing nations.

Our Engagement. Working with companies and NGOs, we developed an alternative to WHO’s approach, secured the agreement of all U.S.-based stakeholders, and successfully secured WHO’s an agreement to modify the Draft Guidelines. We then facilitated discussions among key U.S.-based leaders to form the Pharmaceutical Quality Medical Donations (www.pqmd.org), which is now more than a decade old. Its members subscribe to the high standards of donations, have donated more than $1 billion in medicines globally, and have been instrumental in re-supplying U.S. Community Health Centers following hurricane disasters.

We remain advisors to many of the stakeholders and participate in their discussions. One such discussion was held in 2002 at the conference on Ethical Issues in Access to Care held at Notre Dame.

Improve Stroke Care

The Problem. Stroke is the third leading cause of death in the United States and the leading cause of adult disability. While experts agree that stroke is a medical emergency and, despite proven preventative therapies, stroke care in the United States has limited acute treatment options, low public awareness, and inconsistent response by local health-care delivery systems.

Our Engagement. Stroke experts identified the need for a real-time national stroke registry to improve the care of stroke patients, intending that it would improve rapid response, create timely and accurate patient assessments, validate and track key epidemiological risk factors, and help secure access to new acute stroke-care products.

With the Congress ready to depart for re-election campaigns, in just two weeks, we developed and executed a strategy to secure funding in last-minute budget negotiations. The result was $4.5 million was budgeted in 2001 for The National Paul Coverdell Acute Stroke Registry. Funding has continued since and studies have demonstrated improved care for patients.

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Develop Biowarfare Countermeasures

The Problem. The Department of Defense asked the Institute of Medicine, National Academy of Sciences to review its research programs to protect members of the armed services from biological warfare agents.

Our Engagement. With 16 other experts, I was appointed to the Committee on Accelerating the Research, Development, and Acquisition of Medical Countermeasure Again Biological Warfare Agents. I served on the Committee during its hearings, review, and report writing and, with the Committee Chair and Institute of Medicine leadership, participated in briefing White House officials.

Prepare State Legislators for a New Child Health Program

The Problem. The State Children’s Health Insurance Program (SCHIP) was an important step in improving access to care for children. States received Block Grant funding and were encouraged to find creative ways to provide and monitor child health care and measure child health outcomes. State Legislators, responsible for program oversight, had not previously been responsible for programs of this type.

Our Engagement. We were engaged to help State Legislators prepare. The key to both challenges was helping them to better understand children’s health care and child-centric health outcome measures. With New Directions for Policy, we reviewed the literature on health care, pediatric care, and quality outcome measures and developed an easily readable guide for State Legislators. It included an overview of the essentials of child health, a primer on quality measurement in general, on quality measurement for children’s health care, specifically, and suggested next steps to guide legislator’s actions.

Grow Biomedical Research in NJ

The Problem. The State of New Jersey is home to global biopharmaceutical companies, major research, and teaching institutions, and is poised to be a Life Sciences Supercluster and national leader in bioscience research; but only if the government, academia, and industry collaborate.

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Make Sense of Comparative Effectiveness

The Problem. Comparative Effectiveness studies burst onto the health policy scene, providing new hope they’d help make health care more affordable and help clinicians deliver care of higher quality.

Our Engagement. We were engaged by patient groups to understand the issues to help them engage in policy meetings underway in both the public and private sectors. Our analysis is available in text and animated PPT slide versions are open-sourced here and available for use under a Collective Common Attribution License.

Protect Patient Privacy

The Problem: Patient advocates voiced concerns about the inappropriate disclosure of patients’ personal information.

Our Engagement: We were engaged by several pharmaceutical care organizations to analyze the concerns of advocates and propose solutions. We tracked the views of companies, advocacy organizations, academia, and government. Specific consultations with clients are confidential, but the general findings and a specific approach to protecting privacy are the basis of two published articles.

Protect Medicine Supplies as Y2K Approached

The Problem. Yes, it was the last millennium. At the time, many in government feared supplies of medicines would be interrupted. Many in the private sector feared that the government would seize control of pharmaceutical distribution and their operations would be usurped by government agencies.

Our Engagement. We were engaged by the National Wholesale Distributor Association (now called the Healthcare Distribution Management Association) to lead a collaborative effort of biopharmaceutical companies, distributors, and pharmacists to develop a private-sector solution. We planned and facilitated a multi-stakeholder group that successfully designed and implemented a private sector response to Y2K. The result assured the Clinton White House that the nation’s supply of drugs was secure and that no government intervention was necessary. And, it gets better: the industry received an award for its efforts.