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March 24, 2021 Policy Proposals

By Robert Popovian and Wayne Winegarden The time has come for us to think about incremental, evolutionary, and targeted changes to the healthcare system to reduce costs rather than focusing on grand bargains. It is time for practical solutions that will likely have broad consensus amongst patients, providers, employers, and policymakers. While the debate over the merits of private sector healthcare solutions versus government control of healthcare continues, a group of policy experts with support from the Arnold Ventures and Tobin Center...

March 22, 2021 Blog

As the Biden administration engages the COVID-19 pandemic, a public tug-of-war has emerged over who should be nominated to run the Food and Drug Administration, a pivotal participant in the effort. An analysis of the two perceived front-runners illustrates that neither would likely introduce the kinds of reform needed at the agency. One candidate is acting Commissioner Dr. Janet Woodcock, a long-serving top FDA official with widespread institutional respect, both inside and outside the agency. To her (far) left is Dr. Joshua Sharfstein, who served briefly as...

March 4, 2021 Coronavirus

By Henry Miller, M.S., M.D. and John Cohrssen Over the weekend, the FDA issued an emergency-use authorization for Johnson & Johnson's Covid-19 vaccine, clearing the path to market for the third coronavirus vaccine. The FDA had previously approved the Pfizer-BioNTech and Moderna Covid vaccines in record time—mere weeks after their makers submitted results of the clinical studies demonstrating safety and efficacy. When the FDA wants to, it can get desperately needed products expeditiously to those who need them. But for some other...

March 1, 2021 Industry Trends

BY ROBERT POPOVIAN & WAYNE WINEGARDEN President Joe Biden should take advantage of a bipartisan opportunity to meaningfully reduce patients’ out-of-pocket spending on biopharmaceuticals. Seizing this opportunity requires the president to recognize that the drug cost problem exists because the current system inappropriately shifts too much of its expenditures to patients. Consider that hospitals’ total expenditure in 2019 was $1.2 trillion, or three times the total of the spend on pharmaceuticals. However, patients’ out-of-pocket spending on drugs in 2019 was $54 billion, or 50 percent higher than...

February 1, 2021 Coronavirus-Alternate2

By Henry I. Miller and Shiv Sharma Even as the amazingly fast development of new high-tech COVID-19 vaccines enthralls the world, a simple piece of fabric has become the surprise emblem of the fight against one of the worst health crises in the nation’s history. The ordinary facemask has brought home a basic truth about public and personal health: simple and smart works. The lost jobs and monumental personal costs of widespread lockdowns have made simple, inexpensive means of deterring the virus’...

January 26, 2021 Coronavirus

By Sarah Downey, Northern California Record With California now predicting it could take months longer than anticipated to vaccinate people ages 65 and older, a health policy expert said a wider distribution network could improve efficacy and help the state advance further in its economic recovery. California has received nearly 5 million COVID-19 vaccine doses but only 2.2 million have been administered, according to the latest data from the CDC. . . . . . “They need to get with the program and get the vaccines out there...

January 19, 2021 Coronavirus - Alternate

By John J. Cohrssen and Henry I. Miller, M.S., M.D. The World Health Organization has called attention to a COVID-19 “infodemic” – “an overabundance of information … that includes deliberate attempts to disseminate wrong information to undermine the public health response and advance alternative agendas of groups or individuals.” Part of that inaccurate information is the patently false and misleading claim that COVID-19 is like the flu, only less lethal. In less than a full year, COVID-19 has killed more than 380,000...

January 7, 2021 Innovation

By Henry Miller, M.S., M.D. and Kathleen Hefferon, Ph.D When was the last time you read an online magazine or newspaper, only to find yourself bombarded with shopping ads specifically targeted to your preferences and needs, seemingly by magic? How about the detection of fraud or the filtering of spam from your email inbox? Well, that was most likely the handiwork of "machine learning," a subset of artificial intelligence that uses computer algorithms that over time and multiple experiences, or iterations,...

December 21, 2020 Industry Trends

By Wayne Winegarden and Robert Popovian The Department of Health and Human Services (HHS) finalized a regulation on November 20, 2020 that removed the safe harbor protections for rebates on prescription drugs paid to pharmacy benefit managers (PBMs) and Part D plans. This analysis evaluates the expected impact from this regulation on Medicare premiums and patient out-of-pocket (OOP) costs. Based on the data from the California Department of Managed Health Care (DMHC), the loss of manufacturer drug rebates would cause the average insurance...

December 21, 2020 Blog

By Henry Miller, M.S., M.D. and Andrew Fillat Profit motive and patent protection are the very keys to innovation. Without them, millions of doses of COVID-19 vaccines developed in record time would most certainly not be en route to hospitals and providers in all 50 states as we write. Still, some just will not accept this reality. If we were writing this article for a medical journal, we would begin by saying that we were identifying a previously undescribed and destructive outbreak...

December 16, 2020 Coronavirus, Coronavirus - Alternate, Innovation

By Henry I. Miller, M.S., M.D. and John J. Cohrssen Few could have imagined a year ago that by now our world would be so profoundly changed by a pandemic that has killed more than 300,000 Americans; been confirmed in over 16 million; gone undiagnosed in scores of millions more; and caused debilitating, persisting symptoms in many who have “recovered.” Certainly, no credible drug manufacturer would have claimed that a new vaccine for this emerging infectious disease could go through all...

December 10, 2020 Blog, Innovation

By Henry Miller, Shiv Sharma Much of the progress in medicine during the past half-century has involved expensive, high-tech diagnostic tests and therapies.  The trend in this direction worries health economists and politicians because it has the potential to send already-high healthcare costs into the stratosphere. However, in both medicine and dentistry, there is an important role as well for ingenious, low-tech, less expensive approaches to improved health and increased longevity. The FDA last year approved a high-tech gene therapy drug, Zolgensma, for a...

December 7, 2020 Coronavirus-Alternate2

By John J. Cohrssen and Henry I. Miller, M.S., M.D. Relief from the scourge of COVID-19 in the United States may be in sight. Government and private sector initiatives should be able within months to provide enough safe, effective vaccines to begin to make a dent in COVID-19 cases, hospitalizations, and deaths. But for society to approach normalcy, people will need to be able to document that they are immune to COVID-19. Although vaccination is intended primarily to protect individuals against COVID-19...

November 25, 2020 Coronavirus - Alternate, Coronavirus-Alternate2, Issues, Multimedia

Dr. Henry Miller, PRI senior fellow in health care studies and former founding director of the FDA’s Office of Biotechnology, joins PRI's "Next Round" podcast with an update on efforts to develop vaccines and therapeutics to fight Covid-19.  He discusses how a transition between two presidential administrations will affect the work of the federal government in fighting Covid-19, whether a national mask mandate is a good idea, whether Governors like Gavin Newsom should initiate state-level reviews of potential vaccines, and...

November 25, 2020 Blog, Coronavirus-Alternate2, Innovation

By Henry I. Miller, M.S., M.D. and John J. Cohrssen The United States is one of the most seriously COVID-19-impacted countries, faring the worst among the ten most-affected countries worldwide, as measured by new cases. The pandemic threatens both American lives and the economy. Even more worrisome, as shown below in this figure, the situation is deteriorating. Two things about those trends are especially problematic: first, deaths are a lagging indicator, following chronologically behind cases and hospitalizations, so the death curve will continue upwards; and...

November 23, 2020 Coronavirus - Alternate

Shots Heard 'Round the World: Will Pfizer, Moderna Vaccines Start End of Pandemic? By Adam Smith, The Street The U.S. found itself this month both in the most dangerous stage of the Covid-19 pandemic to date, and in the most hopeful stage. Just as the daily case counts of new coronavirus infections surged toward 200,000, the developers of two different vaccines said their shots were around 95% effective at preventing development of full-blown Covid-19 in patients. . . . . . On the other hand,...

October 13, 2020 Briefs, Innovation, Price and Costs

A new brief released today by the Center for Medical Economics and Innovation at the nonpartisan Pacific Research Institute shows that counterfeit drugs put patients in harm’s way, hinder drug innovation, and lead to job losses. Proposals like drug importation or price controls, if implemented, would exacerbate the problem and result in more health and economic consequences. Click here to download the brief “Counterfeit drugs expose patients to potentially lethal contaminants, and may also increase public health risks by failing to effectively...

September 29, 2020 Coronavirus - Alternate

Ex-FDA Doc: Agency Suffering ‘Unprecedented’ Loss of Trust By Adam Smith Early this year, when the novel coronavirus that was devastating China began to spread to other countries, hope came in the promise of a quick vaccine, one that doctors and scientists bet could be created in just a year and a half if all went well. But some were cautious, such as Dr. Henry I. Miller, who for many years worked at the Food and Drug Administration and who was a founding director of the agency's...

September 29, 2020 Blog, Policy Proposals

Title: Big Pharma Backs Joe Biden, But People Don't Think He'll Fix Drug Pricing By Darragh Roche Former Vice President Joe Biden is winning the race for donations from Big Pharma but experts and industry stakeholders doubt his plans will successfully lower drug prices or address underlying issues in the industry. The pharmaceuticals and health products industry has donated more than $5.9 million to Biden's presidential campaign, according to OpenSecrets.org, a site run by the Center for Responsive Politics, which tracks political donations....