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May 12, 2021 Industry Trends

By Henry Miller, M.S., M.D., and Kathleen Hefferon, Ph.D The controversy over genetically engineered organisms (sometimes called “genetically modified organisms,” or “GMOs”) is genuine, not faux — but only because of uninformed, exaggerated concerns about the most recent techniques’ “newness.” What is faux and disingenuous are the arguments put forth by genetic engineering’s opponents. Humans have been modifying the DNA of our food for thousands of years (even though we didn’t know that DNA was mediating the changes until the 20th century). We call...

May 11, 2021 Coronavirus-Alternate2

Dr. Henry Miller talks about the unintended and negative consequences of the Biden administration invalidating patents for COVID=19 vaccines. Dr. Miller explains that while removing patent rights will enable other companies and institutions to produce these vaccines, Biden and the U.S. should have focused on increased production to ship elsewhere. Miller says that vaccines are considered biologicals and are often difficult to manufacture and that these copies of the COVID-19 vaccines are "biosimiliars," which follow different rules and guidelines including...

May 10, 2021 Coronavirus

Don't throw those masks away just yet. Last week, the Centers for Disease Control and Prevention (CDC) relaxed mask-wearing guidance for those who have been fully vaccinated. But only outside. And only in settings that aren't crowded. However, the CDC could've issued much of this new guidance months ago. Epidemiologists have known since last summer that it's nearly impossible to contract the virus outdoors, even for an unvaccinated person. Waiting to ease mask restrictions is part and parcel of a doomsday mentality...

May 6, 2021 Innovation

By Henry Miller, M.S., M.D. and Andrew I. Fillat Sometimes the sheer stupidity, posturing, and lack of insight by policymakers are breathtaking. As a form of virtue signaling, the Biden administration has just announced U.S. support at the World Health Organization (under TRIPS, the Agreement on Trade-Related Aspects of Intellectual Property Rights) for waivers of patents on COVID-19 vaccines. Patents are widely misunderstood. They do not so much permit the holder to do something; rather, they prohibit others from copying the patented “invention,” and, thereby, can...

April 28, 2021 Industry Trends

By Robert Popovian, Pharm.D., MS, and Wayne Winegarden, Ph.D. Biologics are not natural monopolies, as certain individuals continually assert. This assertion threatens future innovations, greater healthcare affordability, and patient access. It is well understood that biologics have improved our ability to treat diseases such as cancer and autoimmune ailments. Biologics are also expensive; they now represent 43% of invoice spending, and spending has been growing 14.6% annually over the past five years. Until recently, originator biologics lacked any meaningful competition from less costly off-patent generic copies...

April 26, 2021 Coronavirus

Several European countries just instituted another round of lockdowns amid a new wave of Covid-19 cases. This turn of events is sobering but puzzling. Europe seemed to have Covid-19 under control a few months ago, at least compared to the United States. What happened? The countries' vaccination rates offer an explanation. Europe has inoculated far fewer people than the United States. So while Americans may enjoy some semblance of normalcy by summer, Europeans may face dark days ahead. Unfortunately, European countries can only blame themselves for their...

April 26, 2021 Blog, Policy Proposals

The U.S. House of Representatives is once again considering “The Lower Drug Costs Now Act”. It was a bad idea in the last Congress, and it is still bad policy today. If it becomes law, this Act (H.R. 3) empowers the federal government to negotiate prices on select drugs for the entire country. By statute, the government will base the negotiations on the prices charged in other nations. Since these nations impose stringent price controls on drugs, H.R. 3 is a...

April 21, 2021 Coronavirus-Alternate2

It seems obvious that a rapid, widespread vaccination campaign offers our nation the best chance of bringing the COVID-19 pandemic to a swift end. That observation is apparently lost on federal public health officials. Last week, the Centers for Disease and Control and Prevention and the Food and Drug Administration told healthcare providers to stop administering Johnson & Johnson's one-dose COVID-19 vaccine over concerns that the shot could cause blood clots in rare cases. Dr. Anthony Fauci, the head of National Institute of...

April 19, 2021 Multimedia, Policy Proposals, Resources, Value

Watch PRI's Dr. Wayne Winegarden discuss the importance of improving competitions for biosimilars to increase access to these high value medications for more patients on two "Bending the Cost Curve" panel discussions hosted by State of Reform. https://youtu.be/oJTD34j-E-Y https://youtu.be/hu8sWIn3u_A...

April 15, 2021 Policy Proposals

Lawmakers in Colorado are trying to open their state's borders to prescription drugs from abroad. In 2019, they green-lit imports from Canada. They're still working on a plan to implement that policy that can garner federal approval. Then last week, legislators approved a bill that would allow Coloradans to import prescription drugs from other countries in addition to Canada, assuming the feds give the okay. More than a dozen states are making similar moves to permit drug importation. The professed goal of these efforts is to...

April 14, 2021 Coronavirus-Alternate2, Issues

Citing “an abundance of caution,” the FDA on Tuesday recommended a “pause” in the administration of Johnson & Johnson’s COVID-19 vaccine.  The essence of that decision is that, as usual, federal regulators have put covering their derrieres above public health.  Let me explain. The decision was precipitated by six cases in the U.S. of a “rare and severe type of blood clot” in women between the ages of 18 and 48 who had received the vaccine.  Almost seven million shots of the...

April 14, 2021 Issues, Policy Proposals

Policymakers across the globe are attempting to vilify the same private companies that have been invaluable partners in the fight against the COVID-19 pandemic. If these efforts are successful, it will be patients who are harmed the most. Globally, the World Trade Organization (WTO) wants to waive the patent rights for the companies that developed effective COVID-19 vaccines in record breaking time. Here in the U.S., states as diverse as Arkansas, California, and Texas are considering policies that use the pandemic as an...

April 12, 2021 Policy Proposals

For more than a century, National Geographic has produced a high-quality magazine that is well-grounded in science, history and culture. Lately, however, the editors have allowed agenda-driven articles based on flawed research to slip in between the covers. Take, for example, the latest piece by science writer Elizabeth Royte, which focused on the work of Jonathan Lundgren, who is portrayed as a hard-working scientist-farmer. He claims that widely used, state-of-the-art neonicotinoid insecticides “may be a threat to mammals,” as well as to...

April 9, 2021 Industry Trends

As Congress once again takes up legislation to reduce drug prices, one of the most important yet overlooked areas for reform is rebate walls. Rebate walls, also known as rebate traps, block competition in parts of the U.S. prescription drug market, especially immunology, which is home to some of the costliest drugs. They can favor older, more expensive and even less effective drugs over newer, more effective, and often cheaper alternatives. Thanks to rebate walls, patients are routinely forced to “fail first”...

April 8, 2021 CoronaVirusSlide3

I've been a science nerd almost all my life. In graduate school, I was the co-discoverer of a bacterial enzyme essential to DNA replication and of a key enzyme in the influenza virus. I have written more than a thousand articles concerned with science and science policy. I'm convinced that America's prosperity is based on post-WWII preeminence in science and technology, much of it financed by federal funding. You might think, then, that I'd be thrilled to learn that the science committee of the U.S. House of...

April 7, 2021 Coronavirus - Alternate

Henry Miller, M.S., M.D. and Lars Larson talk about vaccine "passports" and the concern that documentation for vaccines could be expanded for other uses. Larson compares the vaccine passports to the widespread use of social security cards and the pending policy questions from requiring medical documentation. Lars Larson National Podcast · Lars Larson National Podcast 04-06-21...

April 7, 2021 Coronavirus

Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention, recently expressed a sense of "impending doom" regarding the pandemic. Her fear is that, unless Americans keep abiding by strict Covid-19 protocols like mask-wearing, social distancing, and forgoing travel, a new surge in cases and deaths could be on the horizon. "I so badly want to be done," Walensky said. "So I'm asking you to just hold on a little longer." Dr. Scott Gottlieb, the former commissioner of the Food and...

April 1, 2021 Coronavirus-Alternate2

Dr. Henry Miller, M.S., M.D. joins the Lars Larson Show to discuss the impact of pesticides, GMOs, and agricultural chemicals and the role these products play in crop production. Miller talks about the umbrella term of pesticides, herbicides (removal of invasive plants), and insecticides (removal of harmful insects), and the impact of the environmental movement on how these products and practices are viewed. Lars Larson National Podcast · Lars Larson National Podcast 03-30-21...

March 31, 2021 Blog, Policy Proposals, Value

Despite the constant stream of dour news about drug prices, actions by employer-sponsored plans are providing reasons for hope. Instead of accepting the high-cost of originator biologics, companies as diverse as Disney, Costco, and CalPERS are “asserting their own desire to see biosimilars implemented among their employees.” Capturing these savings during the pandemic only increases their importance. Biologic medicines are high valued drugs that have meaningfully improved patient health, particularly for people living with cancer and auto-immune diseases. These medicines are also...