Author: Wayne Winegarden

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July 20, 2020 Policy Proposals

The pharmaceutical industry has responded to the Covid-19 pandemic with, arguably, the greatest surge in drug innovation in history. Consider that Remdesivir (produced by Gilead) has already received an emergency use authorization by the FDA for Covid-19. Losmapimod (produced by Fulcrum) is another promising treatment for Covid-19 that is in Phase III trials. And, these are just two of the many treatments that are showing great potential for patients. There are also multiple vaccines that are advancing at light speed while still maintaining the necessary safety protocols....

May 21, 2020 Issues, Price and Costs

[vc_row css_animation="" row_type="row" use_row_as_full_screen_section="no" type="full_width" angled_section="no" text_align="left" background_image_as_pattern="without_pattern"][vc_column width="2/3"][vc_column_text css=".vc_custom_1590107672986{padding-right: 40px !important;}"]DOWNLOAD THE PDF In October 2019, the Center for Medical Economics and Innovation at the Pacific Research Institute, under the direction of Dr. Wayne Winegarden, released its second study documenting the savings potential enabled by biosimilars. Biosimilars are medicines manufactured in, or derived from, biological sources that are developed to be similar to FDA-approved reference products. Biosimilars are only approved to compete in nine biologic drug classes in the U.S....

May 15, 2020 Innovation, Issues

Medical innovations do not happen overnight. Whether it is gene therapies, new vaccines, or cutting-edge medical equipment, developing innovative medical products is a risky venture. It also takes time, lots of financial resources, and most importantly, human ingenuity. Developing new drugs, for instance, can take between 10 and 15 years. Now, more than ever, it is imperative that our regulatory framework encourages innovation and protects the intellectual property that makes innovation possible. Otherwise, the medical advancements we desperately need will cease....

May 11, 2020 Coronavirus, Issues, Price and Costs, Value

There they go again. In the midst of the race for an effective COVID-19 treatment the Institute for Clinical and Economic Review (ICER) has performed an incomplete analysis of remdesivir in order to produce a cost estimate that is, by definition, precisely wrong. Remdesivir, produced by Gilead Sciences Inc., is an experimental antiviral medication that did not work as hoped to treat Hepatitis C, but is showing promise as a treatment for viruses such as SARS and COVID-19. If ICER’s analysis were...

May 8, 2020 Blog, Issues, Policy Proposals

It was not long ago that the economy’s rising tide was supporting state budgets across the country. As the Pew Charitable Trusts noted, widespread economic prosperity was supporting tax revenue growth and creating budget surpluses. When times are good, saving money is not always a priority in state capitols. But, times are no longer good, and saving money is now a top policy priority. The carnage is not contained to state budgets either. Businesses large and small are losing money, families are struggling...

April 30, 2020 Blog, Coronavirus

Forcing a restructuring of the current pharmaceutical supply chain is a terrible idea. Yet, as a recent Wall Street Journal editorial exemplifies, there is growing support for this ill-considered policy. And, these proposals are not simply mere academic musings. The Trump Administration may implement an Executive Order that would turn this idea into actual policy. Congress, not to be outdone, is also considering several proposals that would force federal agencies to purchase drugs and medical supplies exclusively from U.S. suppliers. If implemented, these “Buy...

April 6, 2020 Blog, Coronavirus

The Centers for Disease Control and Prevention (CDC) has issued guidance for healthcare facilities in response to the COVID-19 virus including asking all U.S. healthcare facilities to “explore alternatives to face-to-face triage and visits.” The CDC has issued this recommendation to help contain the spread of the virus, protect healthcare workers from unnecessary exposure, and protect the health of patients who do not require face-to-face medical visits (particularly patients with underlying health issues including those with heart, kidney and weakened immune systems). In light...

March 31, 2020 Blog, Coronavirus

Private pharmaceutical companies and the National Institutes of Health have outdone themselves. Thanks to the funding provided by the NIH, a Phase 1 clinical trial for a COVID-19 vaccine  is underway. In separate efforts, Inovio, Sanofi, Vaxart, GlaxoSmithKline, and Johnson & Johnson are all developing potential vaccines. In total, “about 35 companies and academic institutions are racing to create a vaccine, at least four of which already have candidates they have been testing in animals. The first of these – produced by Boston-based...

March 17, 2020 Blog, Policy Proposals

The costs of economic fallacies are magnified during times of crises. Unfortunately, the Trump Administration’s trade fallacies are not only threatening our economic well-being, they are now putting people’s lives at risk. It is becoming politically incorrect to recognize that the expansion of international trade has helped Americans live better, more prosperous, lives. But, that does not change the reality that Americans benefit greatly from the global economy. As Dr. Arthur Laffer explained in a 2007 speech on the pillars of Reaganomics at the...

March 9, 2020 Briefs, Price and Costs

Expanding the use of biosimilars to treat serious illnesses like cancer or auto-immune diseases could reduce a patient’s out-of-pocket costs by 17 percent, finds a new issue brief released today by the Center for Medical Economics and Innovation at the Pacific Research Institute. Click here to download the study “Biologics effectively treat very serious illnesses but can often be very expensive and lead to patients incurring significant out-of-pocket costs,” said Dr. Wayne Winegarden, director of PRI’s Center for Medical Economics and Innovation...

February 24, 2020 Blog, Issues, Policy Proposals

California wants to get into the drug making business. Gov. Gavin Newsom just announced his intention to have the state contract with generic drug manufacturers to make drugs to sell to state residents, presumably at lower cost than they’re available on the market today. But the plan won’t deliver much in the way of savings. In fact, it could cost taxpayers a significant amount of money. There are far more effective ways to make prescription drugs more affordable — say, by injecting...

January 23, 2020 Policy Proposals, Price and Costs

Twenty-five years ago, the leading cause of death for adults between the ages of 25 and 44 was complications from HIV. At the time, 50,000 Americans were dying from AIDS-related causes a year, with the African American community particularly hard hit – 49 percent of the people dying from AIDS-related deaths were African Americans. Today, thanks to highly active antiretroviral therapies (HAART), along with other medical advances, people with HIV like basketball great Magic Johnson are living longer and healthier lives. And,...

January 8, 2020 Blog, Price and Costs

As each new year begins, the increases in the list prices of drugs are announced. And, following these announcements, the political class complains that something must be done. This year, following the price announcements, Speaker Nancy Pelosi tweeted “Enough is enough” while Senator Grassley emphasized that a “call to action” on drug prices is needed. Undoubtedly, there are real problems. Unfortunately, the politicians seem more interested in espousing simple talking points rather than effective actions that would simultaneously promote innovation and...

January 8, 2020 Briefs, Price and Costs, Resources, Studies

As Washington pushes for price caps and government controls to address prescription drug prices, a new issue brief released today by the Center for Medical Economics and Innovation at the Pacific Research Institute argues that reforming the complex drug supply chain and ending the current drug pricing system that overcharges patients – along with system-wide reforms – are what’s needed to lower America’s health care costs. “Politicians are promoting drug price caps and increased regulation in a futile attempt to increase...

December 13, 2019 Issues, Policy Proposals

Yesterday the House passed the ill-considered “Pelosi bill” that would impose draconian price controls on drugs. Ignoring the bill’s many adverse impacts, price control advocates like Speaker Pelosi appear to believe that these command and control schemes can solve the systemic health care affordability problem. But, as the latest government data illustrates, such efforts are a fool’s errand. Consider that back in 1960 national health expenditures equaled 5.0% of GDP. Health expenditures have been growing faster than the economy ever since reaching 17.7%...

November 7, 2019 Blog, Innovation, Policy Proposals

Once wide coercive powers are given to government agencies…such powers cannot be effectively controlled. F.A. Hayek As part of the chorus calling for drug price controls, the New York Times editorial page has claimed that “Americans will need to accept a trade-off that other advanced nations long since come around to: Slightly fewer new drugs will come to market, in exchange for better prices on the medications that already exist”. There is not one part of this statement that is true. Worse, if the Times’...

October 29, 2019 Innovation, Price and Costs

“Three hundred forty-five billion dollars in savings versus the cost of eight to 15 fewer drugs over 10 years, I frankly think it’s worth it.” Rep. Darren Soto (D-FL), hearing before the House Energy and Commerce Committee In the above quote, Representative Soto is defending H.R. 3, the drug price control bill Speaker Nancy Pelosi is advocating. While the Congressman believes that the costs of price controls are “worth it”, patients living with diseases that lack an effective treatment may disagree. While there has...

October 22, 2019 Blog, Policy Proposals

In September 2018, the Centers for Medicare & Medicaid Services (CMS) sent an email announcing that it would no longer cover Auryxia®. Auryxia® is an FDA approved medicine that treats iron deficiency anemia (anemia) for patients with chronic kidney disease (CKD) but who are not on dialysis. People with CKD have damaged kidneys that no longer filter their blood properly. Currently, 30 million people in the U.S. are living with CKD, and for these patients, anemia is common. If left untreated,...

October 21, 2019 Blog, Price and Costs

Despite their abysmal track record, government solutions are back in vogue. Ostensibly, government’s scale, leverage, and freedom from profit will unlock potential health care savings that are beyond the reach of the private sector. At their most extreme, reforms such as “Medicare for all” call for a complete government takeover of the health care system. Proponents of single payer reforms claim that only a complete government takeover of the health care sector can eliminate the health care sector’s inefficiencies and ensure 100 percent...