Issues

On April 13th, citing "an abundance of caution," after the appearance of a few rare blood clots in the brain (cerebral venous sinus thrombosis, or CVST) following administration of the Johnson & Johnson COVID-19 vaccine, the FDA announced a "pause" in its administration. Regulators reversed course just ten days later, after confirming that the incidence of that adverse reaction was, indeed, extremely low, and that the benefits of receiving the vaccine overwhelmingly outweighed the risks. The decision to pause was precipitated...

A very bad regulation is coming. Here's the short of it. In 2016 Congress passed the National Bioengineered Food Disclosure Law. That law directed the U.S. Department of Agriculture to promulgate regulations for the mandatory labeling of "bioengineered" (or "genetically engineered") foods for human consumption. Consequently, the USDA issued the National Bioengineered Food Disclosure Standards (NBFDS) in December 2018. Although those regulations became effective in February 2019, the USDA allowed food manufacturers (the regulated entities) until Jan. 1, 2022, to come into full...

The Food and Drug Administration recently approved two over-the-counter, at-home rapid coronavirus tests. Harvard epidemiologist Dr. Michael Mina called this development “a major advance.” He’s right. But the FDA should have reached this milestone months ago. Regulators dawdled, and thousands of people died. Public health experts have been calling for at-home COVID-19 tests since the early days of the pandemic. With more testing, more people would know they had the virus, stayed home, and slowed the virus’s spread. For much of the past...

This week, lawmakers in the House and Senate introduced bills that could preserve access to telehealth for Medicare and Medicaid beneficiaries beyond the pandemic. The House measure would allow Medicare beneficiaries to continue receiving “audio-only” remote care — that is, by phone. The Senate bill would direct the federal government to come up with a list of telehealth services that state Medicaid and the Children’s Health Insurance Program should cover. This sustained enthusiasm for telehealth is great for patients. State and federal officials relaxed...

Dr. Henry Miller, M.S., M.D. joined the nationally-syndicated Lars Larson Show to talk about funding at the National Science Foundation and National Institute of Health. Dr. Miller and Larson go over some of the questionable funding sources that NIH and NSC have committed to research and science. Lars Larson National Podcast · Lars Larson National Podcast 05-18-21...

There's dissension within House Democrats' ranks. Last week, no fewer than 10 House Democrats urged Speaker Nancy Pelosi to abandon H.R. 3, as the legislation is known, in favor of a more bipartisan approach that can "preserve our invaluable innovation ecosystem." Slapping new taxes and price controls on prescription drugs, as H.R. 3 would, has always been a bad idea — one that is guaranteed to undermine research into new drugs and vaccines. But it's borderline reckless to do so right as...

Proponents from states such as California, Oregon, and Connecticut all claim that “pay for delay” legislation is necessary to rein in the pharmaceutical industry’s anti-competitive practices. If implemented, the bills will impose a high cost on patients by raising the costs of medicines and delaying generic entry into the market. Pay for delay tactics refers to the practice of patented drug manufacturers paying off generic manufacturers for the sole purpose of delaying the launch of competitive products. When successful, such tactics...

How the New Price Transparency Rules are Affecting Stakeholders May 13, 2021 Deborah Abrams Kaplan Although the hospital price transparency final rule took effect in January, it will take time for it to get its sea legs, whether that means 100% hospital compliance, inspiring patients to use it for their own healthcare decisions or for hospitals to reevaluate their pricing based on their competition. Eventually, though, “I think it will open up the market and, hopefully, reduce the cost of healthcare,” says Sally...

Medicare for All just won’t die. More than 100 House Democrats have signed onto new legislation that, if passed, would outlaw all private insurance and put all Americans on a federally run insurance plan within two years. The bill’s chief sponsor, Rep. Pramila Jayapal, D-Wash., says Medicare for All is the “solution” to the covid-19 crisis and will improve access to quality care in the long run. Health care is a human right, she says. She could hardly be more wrong. A...

[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_1621192674245{padding-right: 40px !important;}"]DOWNLOAD THE PDF In October 2019, the Center for Medical Economics and Innovation at the Pacific Research Institute 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 approved to compete in nine biologic drug classes in the U.S., and are available in seven of these drug...

Last year was the first year in which physicians working in private practice accounted for fewer than half of all practicing doctors, according to a new new report from the American Medical Association. Many of these formerly independent doctors went to work for big healthcare systems. That finding may sound obscure. Why should patients care whether a doctor draws his or her paycheck from a hospital or a private practice he or she owns? But the corporatization of medicine could be bad news for...

President Biden recently backed a World Trade Organization proposal to waive intellectual property protections on COVID-19 vaccines and therapies — a move the Trump administration rejected just a few months ago. The White House’s decision is a catastrophe. The waiver will do nothing to increase access to vaccines. It will, however, undermine the system of intellectual property protections that made these breakthrough vaccines possible. Patients today and well into the future will suffer, as investors think twice about funding risky efforts to research and develop therapies...

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...

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...

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...

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...

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...

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...

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...