Henry Miller
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Articles by Henry Miller
Two Views: Let’s not make the AI cure worse than the disease
The drumbeat for regulating artificial intelligence is growing louder by the day, largely due to a coordinated campaign that magnifies the technology’s risks. It ignores the critical question: Can we regulate effectively without causing a disaster for our technology leadership and economy? That is not to say, however, that some form of control to prevent the worst consequences of AI — especially “superintelligent AI” — is not needed. More on that below.
POINT: Let's not make the AI cure worse than the disease
The drumbeat for regulating artificial intelligence is growing louder by the day, largely due to a coordinated campaign that magnifies the technology's risks. It ignores the critical question: Can we regulate effectively without causing a disaster for our technology leadership and economy? That is not to say, however, that some form of control to prevent the worst consequences of AI - especially "superintelligent AI" - is not needed. More on that below.
Henry I. Miller: AI provides progress in antibiotics (Opinion)
There is hardly an adult American who at some point hasn’t needed antibiotics — for bronchitis or a urinary tract infection, for example, or something more serious like pneumonia or blood poisoning. Seldom do we think about their long and storied history. Nearly a century ago, a stroke of luck changed the course of medicine. In 1928, Scottish microbiologist Alexander Fleming returned from vacation to find that one of his bacterial culture plates had been contaminated with mold.
Miller: Politicizing science has harmful consequences
Half of all pregnant women take acetaminophen — better known as Tylenol or paracetamol — to relieve pain or reduce fever. The drug has been around for decades, is available without a prescription, and is often one of the few options doctors consider safe during pregnancy. However, on Sept. 23, the Food and Drug Administration announced that it would require new warning labels, citing a “possible association” between prenatal use and autism in children.
Short Film: BLUE RIBBON | Backstage
EXPIRES: Seeking talent from Atlanta, GA Roles paying up to US$200.00 COMPANY DETAILS Helios F.C Siddharth Sivakumar, Executive Director Member since May 11, 2022 PROJECT DESCRIPTION This is a comedy on the President and the different personalities in the Oval Office.
Henry I. Miller: States will now have to lead public health (Opinion)
Restoring gold standard science. Implementing radical transparency. Making America healthy again. While these are all worthy goals for science and health care, they will likely be undermined by deep staff and resource cuts and structural changes imposed on our nation’s public health institutions. Unless the public health infrastructure is strengthened, continued cuts may lead to worse health outcomes and the erosion of trust in the government.
Miller: Longevity drug for dogs may be on horizon
Dog owners do many things to keep our canine companions happy and healthy. I flew from San Francisco to Albuquerque last summer to pick up a 4-month-old Bedlington terrier and have seldom been separated from her since. Asta gets human-grade food mostly (loves rotisserie chicken) to complement a small amount of kibble and, of course, lots of exercise, cuddles and necessary vet visits. It might not be long until I can add something significant: an anti-aging pill.
Does the FDA’s future under Trump 2.0 mean innovation or instability? | Opinion
With the new administration of President Donald Trump and the GOP’s control of Congress, the stage is set for seismic shifts in the nation’s regulatory agencies. That includes the Food and Drug Administration (FDA), which oversees products responsible for approximately 25 cents of every consumer dollar, encompassing drugs, biologics, medical devices and food.
Opinion: The FDA Needs a Dedicated ‘Center for Rare Diseases’
When I joined the FDA to be its “biotechnology czar” more than 40 years ago, genetic engineering was still a new concept. To fully grasp the nuances of the latest technological advances, we brought together experts in different scientific disciplines from across the organization. The first “biopharmaceutical” was human insulin synthesized in genetically engineered E. coli bacteria.
Texas Hunters Expo an event for entire families
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Opinion: AI already plays a vital role in medical imaging and is effectively regulated
Artificial intelligence (AI) is all the rage in many aspects of our lives, from composing students’ essays to designing new fashions. Its use in medicine has enabled physicians and other trained health professionals to make more timely, accurate diagnoses and guide effective treatment plans, from patient triage to detecting abnormalities during diagnostic procedures.
Opinion: ‘Holiday Heart Syndrome’ Can Make the Season One You Won’t Want to Remember – Inside Sources - NewsBreak
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The FDA needs more reforms, less status quo
When Dr. Robert Califf was selected by President Joe Biden for a second stint as Food and Drug Administration commissioner, we called it a safe but uninspired choice. Unfortunately, we have been proven right. Califf is a distinguished academic cardiologist and clinical trial specialist, but the day-to-day regulatory decision-making happens at organizational levels below the commissioner, and he seems unwilling to engage with them.
The FDA Needs More Reforms, Less Status Quo – DC Journal - InsideSources
When Robert Califf was selected by President Biden for a second stint as FDA commissioner, we called it a safe but uninspired choice. Unfortunately, we have been proven right. Califf is a distinguished academic cardiologist and clinical trial specialist, but the day-to-day regulatory decision-making happens at organizational levels below the commissioner, and he seems unwilling to engage with them.
Henry I. Miller: When and how to be an air travel vigilante (Opinion)
A Utah man was charged recently with carrying a weapon on an airplane and assault with a deadly weapon after he held a razor near the throat of the passenger sitting next to him on a Jet Blue flight from New York to Salt Lake City. He eventually surrendered the weapon, and nobody was injured. Still, in September, a passenger punched an American Airlines flight attendant in the back of the head during a flight from Mexico to Los Angeles.
The FDA and Death by Dietary Supplement – InsideSources
The wife of California Republican congressman Tom McClintock, Lori McClintock, died of dehydration due to gastroenteritis caused by “adverse effects of white mulberry leaf ingestion,” according to a just-released coroner’s report. That herb is just one of many dubious and potentially life-threatening herbal remedies and other dietary supplements on the market today. Dietary supplements are big business. Three out of four Americans take one or more regularly.
We Need Both High- and Low-Tech Approaches to the Shortage of Organs for Transplantation
Modern medicine has produced many kinds of high-tech miracles, among them gene therapy to correct malfunctioning genes, electrical stimulation devices to restore significant function after traumatic spinal cord injury, and robotically-executed surgery. Another sector of medicine that desperately needs breakthroughs is transplantation of solid organs.
The FDA needs reform. Biden’s nominee is not the person to do it
When President Joe Biden nominated Obama-era Food and Drug Administration Commissioner Dr. Robert Califf to return to his old post, he made what is widely seen as a safe, if uninspired, choice. Califf is a distinguished cardiologist and clinical trial specialist, but the day-to-day regulatory decision-making happens at the organizational levels below the commissioner.
The FDA Needs to Join the Twenty-First Century
After nearly a year, President Joe Biden has nominated a new commissioner of the Food and Drug Administration (FDA). The agency—where we spent a combined forty-two years—is arguably America’s most ubiquitous regulator, overseeing almost $3 trillion in drugs, biologicals such as vaccines and antibodies, medical devices, tobacco, and about seventy-eight percent of the U.S. food supply. It also spends American tax dollars looking for opportunities to expand its oversight and influence.
Can 'fixing food' fix food regulation?
The Food and Drug Administration is “a slow-moving target that bleeds profusely when hit,” quipped a former agency head. Now, retired FDA food economist Richard A. Williams takes shots at the agency in his new book, Fixing Food: An FDA Insider Unravels the Myths and the Solutions. Reacting to exposés describing filthy food manufactured with inedible and unsafe ingredients, Congress first prohibited adulterated and misbranded food in interstate commerce in 1905.
Ready, set, go for the worst regulation ever
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.
FDA Overregulation Slows Biotech Progress
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.
High-tech medical and dental innovation garner the headlines but the most impactful practices are mostly lower tech and prevention-focused
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 rare childhood genetic disease, spinal muscular atrophy, that costs just over $2 million for the single dose of the treatment.
The Record-Time FDA Approval that Almost Didn’t Happen.
For the more than 7 million Americans who inject insulin, Friday will mark an important anniversary: 38 years since the Food and Drug Administration (FDA) approved the use of human insulin synthesized in genetically engineered bacteria. This momentous event launched a revolutionary new era in pharmaceutical development, and, as the FDA medical reviewer of the product and the head of the evaluation team at the time, I had a front-row seat.
COVID-19's silent dental epidemic
As the nation slowly emerges from lockdown, we’re beginning to appreciate the full impact of the pandemic and that the sickness and death directly caused by the virus are only part of the picture. The three-month-plus suspension of routine, non-emergency medical care has created secondary, silent epidemics of untreated medical issues that require the urgent focus of both our public health officials and the public themselves.
EPA’s Superfund Program Should Be a Casualty of the Pandemic.
The COVID-19 pandemic has revealed regulatory obstacles that could inhibit the private sector’s often-heroic responses. Regulations such as trade barriers and “Buy American” provisions boost prices, limit choices, and can keep critical products out of the country. As far as coronavirus relief efforts are concerned, it’s all hands on deck for American regulators. There have been some timely adjustments.
Commentary: FDA’s New Commissioner Needs to Shed Bloat, Put Patients First
March 5, 2020 By Henry Miller, M.D., Jeff Stier Now that the Trump Administration’s new U.S. Food and Drug Administration (FDA) commissioner, Dr. Stephen Hahn, has been confirmed, he’ll find he has one of the most difficult and important jobs in government. The FDA’s purview is wide, regulating pharmaceutical and other medical, food, and vaping products that account for more than 25 cents of every consumer dollar—over a trillion dollars annually.
The Optimism about a Coronavirus Vaccine Is Misplaced | National Review
President Donald Trump with Anthony Fauci, director of the NIH National Institute of Allergy and Infectious Diseases, during a roundtable briefing at the National Institutes of Health Vaccine Research Center in Bethesda, Md., March 3, 2020. (Leah Millis/Reuters) Vaccines take time to develop and deploy. It won’t be any different for coronavirus.
Viewpoint: How politics pollutes the FDA's genetically modified animal regulations and stifles innovation
Dogs bark, cows moo, and regulators regulate,” former U.S. Food and Drug Administration commissioner Frank Young once quipped to explain regulatory agencies’ expansionist tendencies. There may be no better example than the FDA’s oversight of genetically engineered animals. This oversight misguidedly extends a regulatory regime designed specifically for the approval of new animal drugs to the regulation of the animals themselves.
Yes, The FDA Is In Trouble, But The New York Times Would Make It Worse
A recent New York Times editorial about the Food and Drug Administration reflects a systematic weakness at the once-venerable Gray Lady: The members of the editorial board often rely on sloganeering and popular wisdom instead of substantive evidence. The editorial was headlined, “The FDA Is in Trouble. Here’s How to Fix It.” The agency is in trouble. But it’s due to the very kinds of “fixes” the Times recommends.
Miller/Cohrssen: How drug companies over-rely on China
By Henry I. Miller and John J. Cohrssen Los Angeles Times Friday Dec 13, 2019 at 1:17 PM China has become the world’s largest producer and exporter of “active pharmaceutical ingredients,” the base components drug companies use to manufacture most of the medications we rely on. China’s dominance puts both the health of Americans and our national security at risk.
Commentary: Drug companies over-rely on base components from China
By Henry I. Miller and John J. Cohrssen/Los Angeles Times Thursday Dec 12, 2019 at 6:40 PM China has become the world's largest producer and exporter of "active pharmaceutical ingredients," the base components drug companies use to manufacture most of the medications we rely on. China's dominance puts both the health of Americans and our national security at risk.
Commentary: Drug companies over-rely on base components from China
By Henry I. Miller and John J. Cohrssen/Los Angeles Times Thursday Dec 12, 2019 at 6:40 PM China has become the world's largest producer and exporter of "active pharmaceutical ingredients," the base components drug companies use to manufacture most of the medications we rely on. China's dominance puts both the health of Americans and our national security at risk.
Commentary: How drug companies over-rely on China
China has become the world’s largest producer and exporter of “active pharmaceutical ingredients,” the base components drug companies use to manufacture most of the medications we rely on. China’s dominance puts both the health of Americans and our national security at risk.
Commentary: How drug companies over-rely on China
China has become the world's largest producer and exporter of "active pharmaceutical ingredients," the base components drug companies use to manufacture most of the medications we rely on. China's dominance puts both the health of Americans and our national security at risk.
Much of the Buzz About Genetically Engineered Mosquitoes Is Wrong
Genetic engineering has delivered monumental scientific, technological, and humanitarian achievements – from producing human insulin in bacteria and gene therapy to treat genetic diseases to increasing food security and reducing malnutrition in developing countries. But it continues to face brickbats, sometimes from unexpected directions. The most recent were directed at an extraordinarily important product that helps reduce populations of the invasive mosquito species Aedes aegypti.
High-Tech Medicine Gets the Headlines, But Low-Tech Also Saves Lives
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 health care costs into the stratosphere. In both medicine and dentistry, however, there is an important role as well for ingenious, low-tech, less expensive approaches to improved health and increased longevity.
Politicians are scapegoating e-cigs for harm they haven’t done
By Jeff Stier and Henry I. Miller September 16, 2019 | 9:05pm When there’s an outbreak of deaths or illnesses from injected street drugs, do public health authorities demand diabetics and doctors stop using syringes? Of course not. Yet a host of public officials — from President Trump to Gov. Andrew Cuomo to members of the Squad — are taking just that sort of approach in responding to the spate of vaping-related illnesses and deaths around the country.
Miller/Cohrssen: There's a smarter way to curb drug prices
By Henry I. Miller And John J. CohrssenLos Angeles Times Monday Aug 12, 2019 at 5:49 PM The Trump administration last week announced steps that could lead to the importation of prescription drugs from Canada, where prices are lower. It is a goal supported by President Trump, but long opposed by many Republicans.
Miller: Curbing skyrocketing drug prices in US
By HENRY I. MILLER Sunday Aug 11, 2019 at 2:00 AM The Trump administration recently announced steps that could lead to the importation of prescription drugs from Canada, where prices are lower. It is a goal supported by President Donald Trump but long opposed by many Republicans. This latest initiative would allow states, pharmacies and drugmakers to seek federal approval for demonstration projects to import drugs that are similar or identical to drugs already approved by the FDA.
Miller: Curbing skyrocketing drug prices in US
By HENRY I. MILLER Sunday Aug 11, 2019 at 2:00 AM The Trump administration recently announced steps that could lead to the importation of prescription drugs from Canada, where prices are lower. It is a goal supported by President Donald Trump but long opposed by many Republicans. This latest initiative would allow states, pharmacies and drugmakers to seek federal approval for demonstration projects to import drugs that are similar or identical to drugs already approved by the FDA.
A smarter way to curb drug prices | Opinion
The Trump administration last week announced steps that could lead to the importation of prescription drugs from Canada, where prices are lower. It is a goal supported by President Donald Trump, but long opposed by many Republicans. This latest initiative would allow states, pharmacies, and drug makers to seek federal approval for demonstration projects to import drugs that are similar or identical to drugs already approved by the U.S. Food and Drug Administration.
OPINION EXCHANGE | Reciprocity of regulatory approvals: A smarter way to curb prescription drug costs
The Trump administration last week announced steps that could lead to the importation of prescription drugs from Canada, where prices are lower. It is a goal supported by President Donald Trump, but long opposed by many Republicans. This latest initiative would allow states, pharmacies and drugmakers to seek federal approval for demonstration projects to import drugs that are similar or identical to drugs already approved by the U.S. Food and Drug Administration.
A better way to reduce U.S. drug prices
By HENRY I. MILLER and JOHN J. COHRSSEN The Trump administration last week announced steps that could lead to the importation of prescription drugs from Canada, where prices are lower. It is a goal supported by President Donald Trump, but long opposed by many Republicans.
Commentary: A smarter way to curb drug prices
The Trump administration last week announced steps that could lead to the importation of prescription drugs from Canada, where prices are lower. It is a goal supported by President Trump, but long opposed by many Republicans. This latest initiative would allow states, pharmacies and drugmakers to seek federal approval for demonstration projects to import drugs that are similar or identical to drugs already approved by the U.S. Food and Drug Administration.
Commentary: A smarter way to curb drug prices
The Trump administration last week announced steps that could lead to the importation of prescription drugs from Canada, where prices are lower. It is a goal supported by President Trump, but long opposed by many Republicans. This latest initiative would allow states, pharmacies and drugmakers to seek federal approval for demonstration projects to import drugs that are similar or identical to drugs already approved by the U.S. Food and Drug Administration.
Consumers Will Suffer From EPA’s Ruling On 15 Percent Ethanol.
The Environmental Protection Agency released a final rule on May 30 that opens the door for gasoline to be blended year-round with up to 15 percent ethanol, a mixture called E15. This rule boosts by 50 percent the proportion of ethanol (denatured ethyl alcohol derived, most often, from corn) allowed in a gallon of motor fuel in the summer months.
Desperately Seeking a Reformer to Head the FDA
Federal regulation affects our lives every day in more ways than we realize. The Food and Drug Administration alone regulates products that account for more than a trillion dollars annually—25 cents of every consumer dollar; and the average cost (including out-of-pocket expenses and opportunity costs) to bring a new drug to market is now about $2.6 billion. FDA Commissioner Scott Gottlieb announced his resignation on March 5, and the search has already begun for a successor.
The FDA has problems -- Here are the qualities the next commissioner must have to fix them
The Food and Drug Administration (FDA) is the nation's most ubiquitous regulatory agency. It oversees a vast array of medical and food products that account for 25 cents of every consumer dollar, with a value of over a trillion dollars annually. And the agency has problems.
Opioid crisis -- Since when does the government write prescriptions?
Opioid-related deaths nationwide jumped four-fold in the last two decades, and the epidemic has made major inroads in the Eastern states, according to a new study by a U.S.- Canadian research team.
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