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CHICAGO (CBS) -- U.S. Customs and Border Protection (CBP) officers at Chicago O'Hare's International Mail Branch intercepted and seized a shipment containing $1 million worth of counterfeit designer merchandise.

The illicit shipment from Thailand included fake designer watches, bracelets, handbags, and scarves. If these items had been genuine, the value would have exceeded $1 million.

What happened: On Aug. 10, officials from U.S. Customs and Border Protection (CBP) and the U.S. Chamber of Commerce (Chamber) signed a five-year renewal of a memorandum of understanding (MOU) creating a groundbreaking public-private partnership to fight counterfeit products entering U.S. markets.

Small packages: Following the MOU re-signing, industry representatives toured the John F. Kennedy International Airport (JFK) international mail facility. Small parcels entering the United States via U.S. mail are a vital distribution channel for global counterfeiters, meaning that fake, illicit, or sub-standard products are now being delivered directly to the consumer’s door.

I believe that we will increasingly understand good and evil, right and wrong, in scientific terms, because moral concerns translate into facts about how our thoughts and behaviors affect the well-being of conscious creatures like ourselves. If there are facts to be known about the well-being of such creatures—and there are—then there must be right and wrong answers to moral questions. Students of philosophy will notice that this commits me to some form of moral realism (viz. moral claims can really be true or false) and some form of consequentialism (viz. the rightness of an act depends on how it impacts the well-being of conscious creatures). While moral realism and consequentialism have both come under pressure in philosophical circles, they have the virtue of corresponding to many of our intuitions about how the world works. Here is my (consequentialist) starting point: all questions of value (right and wrong, good and evil, etc.) depend upon the possibility of experiencing such value. Without potential consequences at the level of experience—happiness, suffering, joy, despair, etc. —all talk of value is empty. Therefore, to say that an act is morally necessary, or evil, or blameless, is to make (tacit) claims about its consequences in the lives of conscious creatures (whether actual or potential).I am unaware of any interesting exception to this rule. Needless to say, if one is worried about pleasing God or His angels, this assumes that such invisible entities are conscious (in some sense) and cognizant of human behavior. It also generally assumes that it is possible to suffer their wrath or enjoy their approval, either in this world or the world to come. Even within religion, therefore, consequences and conscious states remain the foundation of all values. 

What turn-of-the-millennium science is telling us is that human moral judgment is not a pristine rational enterprise, that our moral judgments are driven by a hodgepodge of emotional dispositions, which themselves were shaped by a hodgepodge of evolutionary forces, both biological and cultural. Because of this, it is exceedingly unlikely that there is any rationally coherent normative moral theory that can accommodate our moral intuitions. Moreover, anyone who claims to have such a theory, or even part of one, almost certainly doesn't. Instead, what that person probably has is a moral rationalization.¶ It seems then, that we have somehow crossed the infamous "is"-"ought" divide. How did this happen? Didn't Hume (Hume, 1978) and Moore (Moore, 1966) warn us against trying to derive an "ought" from and "is?" How did we go from descriptive scientific theories concerning moral psychology to skepticism about a whole class of normative moral theories? The answer is that we did not, as Hume and Moore anticipated, attempt to derive an "ought" from and "is." That is, our method has been inductive rather than deductive. We have inferred on the basis of the available evidence that the phenomenon of rationalist deontological philosophy is best explained as a rationalization of evolved emotional intuition (Harman, 1977).¶ Missing the Deontological Point I suspect that rationalist deontologists will remain unmoved by the arguments presented here. Instead, I suspect, they will insist that I have simply misunderstood whatKant and like-minded deontologists are all about. Deontology, they will say, isn't about this intuition or that intuition. It's not defined by its normative differences with consequentialism. Rather, deontology is about taking humanity seriously. Above all else, it's about respect for persons. It's about treating others as fellow rational creatures rather than as mere objects, about acting for reasons rational beings can share. And so on (Korsgaard, 1996a; Korsgaard, 1996b).This is, no doubt, how many deontologists see deontology. But this insider's view, as I've suggested, may be misleading. The problem, more specifically, is that it defines deontology in terms of values that are not distinctively deontological, though they may appear to be from the inside. Consider the following analogy with religion. When one asks a religious person to explain the essence of his religion, one often gets an answer like this: "It's about love, really. It's about looking out for other people, looking beyond oneself. It's about community, being part of something larger than oneself." This sort of answer accurately captures the phenomenology of many people's religion, but it's nevertheless inadequate for distinguishing religion from other things. This is because many, if not most, non-religious people aspire to love deeply, look out for other people, avoid self-absorption, have a sense of a community, and be connected to things larger than themselves. In other words, secular humanists and atheists can assent to most of what many religious people think religion is all about. From a secular humanist's point of view, in contrast, what's distinctive about religion is its commitment to the existence of supernatural entities as well as formal religious institutions and doctrines. And they're right. These things really do distinguish religious from non-religious practices, though they may appear to be secondary to many people operating from within a religious point of view. In the same way, I believe that most of the standard deontological/Kantian self-characterizatons fail to distinguish deontology from other approaches to ethics. (See also Kagan (Kagan, 1997, pp. 70-78.) on the difficulty of defining deontology.) It seems to me that consequentialists, as much as anyone else, have respect for persons, are against treating people as mere objects, wish to act for reasons that rational creatures can share, etc. A consequentialist respects other persons, and refrains from treating them as mere objects, by counting every person's well-being in the decision-making process. Likewise, a consequentialist attempts to act according to reasons that rational creatures can share by acting according to principles that give equal weight to everyone's interests, i.e. that are impartial. This is not to say that consequentialists and deontologists don't differ. They do. It's just that the real differences may not be what deontologists often take them to be. What, then, distinguishes deontology from other kinds of moral thought? A good strategy for answering this question is to start with concrete disagreements between deontologists and others (such as consequentialists) and then work backward in search of deeper principles. This is what I've attempted to do with the trolley and footbridge cases, and other instances in which deontologists and consequentialists disagree. If you ask a deontologically-minded person why it's wrong to push someone in front of speeding trolley in order to save five others, you will getcharacteristically deontological answers. Some will be tautological: "Because it's murder!"Others will be more sophisticated: "The ends don't justify the means." "You have to respect people's rights." But, as we know, these answers don't really explain anything, because if you give the same people (on different occasions) the trolley case or the loop case (See above), they'll make the opposite judgment, even though their initial explanation concerning the footbridge case applies equally well to one or both of these cases. Talk about rights, respect for persons, and reasons we can share are natural attempts to explain, in "cognitive" terms, what we feel when we find ourselves having emotionally driven intuitions that are odds with the cold calculus of consequentialism. Although these explanations are inevitably incomplete, there seems to be "something deeply right" about them because they give voice to powerful moral emotions. But, as with many religious people's accounts of what's essential to religion, they don't really explain what's distinctive about the philosophy in question.

Perry wishes more people were familiar with the concept of “expected value.” That is a statistical way of understanding events of very large magnitude that have a low probability. The large magnitude event could be something good, like winning a lottery ticket. Or it could be something bad, like a nuclear bomb exploding. Because the odds of winning the lottery are so low, the rational thing is to save your money and not buy the ticket. As for a nuclear explosion, by Perry’s lights, the consequences are so grave that the rational thing would be for people in the United States and everywhere to be in a state of peak alarm about their vulnerability, and for political debate to be dominated by discussion of how to reduce the risk. And just how high is the risk? The answer of course is ultimately unknowable. Perry’s point, though, is that it’s a hell of a lot higher than you think. Perry invites his listeners to consider all the various scenarios that might lead to a nuclear event. “Mathematically speaking, you add those all together in one year it is still just a possibility, not a probability,” he reckons. “But then you go out ten, twenty years and each time this possibility repeats itself, and then it starts to become a probability. How much time we have to get those possibility numbers lower, I don’t know. But sooner or later the odds are going to get us, I am afraid.” *** Almost uniquely among living Americans, Bill Perry has actually faced down the prospect of nuclear war before—twice. In the fall of 1962, Bill Perry was 35, father of five young children, living in the Bay Area and serving as director of Sylvania’s Electronic Defense Laboratories—driving his station wagon to recitals in between studying missile trajectories and the radius of nuclear detonations. Where he resided was not then called Silicon Valley, but the exuberance and spirit of creative possibility we now associate with the region was already evident. The giants then were Bill Hewlett and David Packard, men Perry deeply admired and wished to emulate in his own business career. The innovation engine at that time, however, was not consumer technology; it was the government’s appetite for advantage in a mortal struggle against a powerful Soviet foe. Perry was known as a star in the highly complex field of weapons surveillance and interpretation. So it was not a surprise, one bright October day, for Perry to get a call from Albert “Bud” Wheelon, a friend at the Central Intelligence Agency. Wheelon said he wanted Perry in Washington for a consultation. Perry said he’d juggle his schedule and be there the next week. “No,” Wheelon responded. “I need to see you right away.” Perry caught the red-eye from San Francisco, and went straight to the CIA, where he was handed photographs whose meaning was instantly clear to him. They were of Soviet missiles stationed in Cuba. For the next couple weeks, Perry would stay up past midnight each evening poring over the latest reconnaissance photos and help write the analysis that senior officials would present the next morning to President Kennedy. Perry experienced the crisis partly as ordinary citizen, hearing Kennedy on television draw an unambiguous line against Soviet missiles in this hemisphere and promising that any attack would be met with “a full retaliatory response.” But he possessed context, about the capabilities of weapons and the daily state of play in the crisis, that gave him a vantage point superior to that of all but perhaps a few dozen people. “I was part of a small team—six or eight people,” he recounted of those days 54 years earlier. “Half of them technical experts, half of them intelligence analysts, or photo interpreters. It was a minor role but I was seeing all the information coming in. I thought every day when I went back to the hotel it was the last day of my life because I knew exactly what nuclear weapons could do. I knew it was not just a lot of people getting killed. It was the end of civilization and I thought it was about to happen.” It was years later that Perry, like other more senior participants in the crisis, learned how right that appraisal was. Nuclear bombs weren’t only heading toward Cuba on Soviet ships, as Kennedy believed and announced to Americans at the time. Some of them were already there, and local commanders had been given authority to use them if Americans launched a preemptive raid on Cuba, as Kennedy was being urged, goaded even, by Air Force Gen. Curtis LeMay and other military commanders. At the same time, Soviet submarines were armed and one commander had been on the verge of launching them until other officers on the vessel talked him out of it. Either event would have in turn sent U.S. missiles flying. The Cuban Missile Crisis recounting is one of the dramatic peaks in “My Journey on the Nuclear Brink,” the memoir Perry published last fall. It is a book laced with other close calls—like November 9, 1979, when Perry was awakened in the middle of the night by a watch officer at the North American Aerospace and Defense Command (NORAD) reporting that his computers showed 200 Soviet missiles in flight toward the United States. For a frozen moment, Perry thought: This is it—This is how it ends. The watch officer soon set him at ease. It was a computer error, and he was calling to see whether Perry, the technology expert, had any explanation. It took a couple days to discover the low-tech answer: Someone had carelessly left a crisis-simulation training tape in the computer. All was well. But what if this blunder had happened in the middle of a real crisis, with leaders in Washington and Moscow already on high alert? The inescapable conclusion was the same as it was in 1962: The world skirting nuclear Armageddon as much by good luck as by skilled crisis management. Perry is part of a distinct cohort in American history, one that didn’t come home with the large-living ethos of the World War II generation, but took responsibility for cleaning up the world that the war bequeathed. He was a 14-year-old in Butler, Pennsylvania when he heard the news of the Pearl Harbor attack in a friend’s living room, and had the disappointed realization that the war might be over by the time he was old enough to fight in it. That turned out to be true—he was just shy of 18 at war’s end—a fact that places Perry in what demographers have called the “Silent Generation,” too young for one war but already middle-aged by the time college campuses erupted over Vietnam. Like many in his generation, Perry was not so much silent as deeply dutiful, with an understated style that served as a genial, dry-witted exterior to a life in which success was defined by how faithfully one met his responsibilities. Perry said he became aware, first gradually and over time profoundly, of the surreal contradictions of his professional life. His work—first at Sylvania and then at ESL, a highly successful defense contracting firm he co-founded in 1963—was relentlessly logical, analyzing Soviet threats and intentions and coming up with rational responses to deter them. But each rational move was part of a supremely irrational dynamic—“mutually assured destruction”—that placed the threat of massive casualties at the heart of America’s basic strategic thinking. It was the kind of framework in which policymakers could accept that a mere 25 million people dead was good news. Also the kind that in one year alone led the United States to produce 8,000 nuclear bombs. By the end, the Cold War left the planet with about 70,000 bombs (a total that is now down to about 15,500). “I think probably everybody who was involved in nuclear weapons in those days would see the two sides of it,” Perry recalls, “the logic of deterrence and the madness of deterrence, and there was no mistake, I think, that the acronym was MAD.” *** Perry has been at the forefront of a movement that he considers the sane and only alternative, and he has joined forces with other leading Cold Warriors who in another era would likely have derided their vision as naïve. In January 2007, he was a co-author of a remarkable commentary that ran on the op-ed page of the Wall Street Journal. It was signed also by two former secretaries of state, George Schulz and Henry Kissinger and by Sam Nunn, a former chairman of the Senate Armed Services Committee—all leading military hawks and foreign policy realists who came together to argue for something radical: that the goal of U.S. policy should be not merely the reduction and control of atomic arms, it should be the ultimate elimination of all nuclear weapons. This sounded like gauzy utopianism, especially bizarre coming from supremely pragmatic men. But Perry and the others always made clear they were describing a long-term ideal, one that would only be achieved through a series of more incremental steps. The vision was stirring enough that it was endorsed by President Obama in his opening weeks in office, in a March 2009 address in Prague. In retrospect, Obama’s speech may have been the high point for the vision of abolition. “A huge amount of progress was made,” recalled Shultz, now 93. “Now it is going in the other direction.” “We have less danger of an all-out war with Russia,” in Nunn’s view. “But we have more danger of some type of accident, miscalculation, cyber interference, a terrorist group getting a nuclear weapon. It requires a lot more attention than world leaders are giving it.” Perry’s goal now is much more defensive than it was just a few years ago—halting what has become inexorable momentum toward reviving Cold War assumptions about the central role of nukes in national security. More recently he’s added yet another recruit to his cause: California Governor Jerry Brown. Brown, now 78, met Perry a year ago, after deciding that he wanted to devote his remaining time in public service mainly to what he sees as civilization’s two existential issues, climate change and nuclear weapons. Brown said he became fixated on spreading Perry’s message after reading his memoir: He recently gave a copy to President Obama and is trying to bend the ear of others with influence in Washington. If Bill Perry has a gift for understatement, Brown has a gift for the theatrical. In an interview at the governor’s mansion in Sacramento, he wonders why everyone is not paying attention to his new friend and his warnings for mankind. “He is at the brink! At the brink! Not WAS at the brink—IS at the brink,” Brown exclaimed. “But no one else is.” A California governor can have more influence, at least indirectly, than one might think, due to the state’s outsized role in policy debates and the fact that the University of California’s Board of Regents helps manage some of the nation’s top weapons laboratories, which study and design nuclear weapons. Brown, who was a vocal critic in the 1980s of what he called America's "nuclear addiction," reviewed Perry's recent memoir in the New York Review of Books, and said he is determined to help his new friend spread his message. “Everybody is, 'we are not at the brink,' and we have this guy Perry who says we are. It is the thesis that is being ignored." Even if more influential people wake up to Perry’s message—a nuclear event is more likely and will be more terrible than you realize—a hard questions remains: Now what? This is where Perry’s pragmatism comes back into play. The smartest move, he thinks, is to eliminate the riskiest part of the system. If we can’t eliminate all nukes, Perry argues, we could at least eliminate one leg of the so-called nuclear triad, intercontinental ballistic missiles. These are especially prone to an accidental nuclear war, if they are launched by accident or due to miscalculation by a leader operating with only minutes to spare. Nuclear weapons carried by submarines beneath the sea or aboard bomber planes, he argues, are logically more than enough to deter Russia. The problem, he knows, is that logic is not necessarily the prevailing force in political debates. Psychology is, and this seems to be dictating not merely that we deter a Russian military force that is modernizing its weapons but that we have a force that is self-evidently superior to them. It is an argument that strikes Perry as drearily familiar to the old days. Which leads him the conclusion that the only long-term way out is to persuade a younger generation to make a different choice. His granddaughter, Lisa Perry, is precisely in the cohort he needs to reach. At first she had some uncomfortable news for her grandfather: Not many in her generation thought much about the issue. “The more I learned from him about nuclear weapons the more concerned I was that my generation had this massive and dangerous blind spot in our understanding of the world,” she said in an interview. “Nuclear weapons are the biggest public health issue I can think of.” But she has not lost hope that their efforts can make a difference, and today she has put her graduate studies in public health on hold to work full time for the Perry Project as its social media and web manager. “It can be easy to get discouraged about being able to do anything to change our course,” she said. “But the good news is that nuclear weapons are actually something that we as humans can control...but first we need to start the conversation.” It was with her help that Perry went on Reddit to field questions ranging from how his PhD in mathematics prepared him to what young people need to understand. “As a 90s baby I never lived in the Cold War era,” wrote one participant, with the Reddit username BobinForApples. “What is one thing today's generations will never understand about life during the Cold War?” Perry’s answered, as SecDef19: “Because you were born in the 1990s, you did not experience the daily terror of ‘duck and cover’ drills as my children did. Therefore the appropriate fear of nuclear weapons is not part of your heritage, but the danger is just as real now as it was then. It will be up to your generation to develop the policies to deal with the deadly nuclear legacy that is still very much with us.” For the former defense secretary, the task now is to finally—belatedly—prove Einstein wrong. The physicist said in 1946: “The unleashed power of the atom has changed everything save our modes of thinking and we thus drift toward unparalleled catastrophe.” In Perry’s view the only way to avoid it is by directly contemplating catastrophe—and doing so face to face with the world’s largest nuclear power, Russia, as he recently did in a forum in Luxembourg with several like-minded Russians he says are brave enough to speak out about nuclear dangers in the era of Putin. “We could solve it,” he said. “When you’re a prophet of doom, what keeps you going is not just prophesizing doom but saying there are things we do to avoid that doom. That’s where the optimism is.”

Given these disparate theoretical bases, structures, and goals, I am uncomfortable with Halabi’s ostensible equation of the different intellectual property disciplines. In short, Halabi seems to treat all categories of IPR as equals in his estimation of their detrimental effects on basic needs. Halabi makes his primary arguments about IPR’s impact on public health and welfare using examples from patent law, focusing on the pharmaceutical and agrochemical sectors. Patents on pharmaceuticals put medicine prices out of step with what patients in developing countries can afford, and agricultural dominance by large firms undercuts both independent farmers and indigenous populations. Halabi then acknowledges similarities, as to foundational principles and effects, between patent law and copyright law, claiming thus equivalent impact in the educational materials sector. Copyright protections put academic textbooks and journals out of reach of most students in developing countries. Halabi’s inclinations on both patent and copyright law are more or less sound. In both patents and copyrights, society tolerates monopoly-style rents on items in the name of spurring both innovation and the disclosure of the fruits of that innovation to the world. At some point, the cost of those rents exceeds the benefits to society of paying them, and Halabi does an admirable job of articulating that patents and copyrights on goods essential to human growth and development are pretty close to that line. But trademarks are different, and I question the societal benefit of restricting them through use of international intellectual property shelters. One key difference between patent and copyright law on the one hand, and trademark law on the other, is the direct link between strong trademarks and direct societal benefits. In short, trademarks are designed to aid the public. They guide consumers in purchases, minimize transaction costs, and incentivize trademark holders to police the marketplace against confusing copycats. These functions are clearly consonant with the goals that the crafters of the international intellectual property shelters—and the domestic governments that use those shelters—hope to achieve. I have touched on this difference in a previous review of Halabi’s work on the subject, and I develop the points further in a forthcoming article. In the upcoming piece, I detail the ways in which trademark restrictions in the name of public health in some instances actually undermine public health. In short, too many commentaries on plain packaging laws or similar trademark-inhibiting laws ignore the enforcement implications of restricting trademarks. These implications are serious, especially in the sectors at issue in Halabi’s analysis, where counterfeits can be dangerous or even deadly. Legitimate producers of consumer goods in key public welfare sectors—including consumables—must comply with regulatory practices governing their ingredients, disclosures, and advertising. Trademark restrictions risk opening the market to counterfeiters, who are not subject to the same regulatory structures as legitimate producers. Ultimately, when counterfeits invade markets directly relating to basic needs, consumers suffer. What is more destructive to infant health than mothers choosing infant formula over breastfeeding? Mothers unwittingly choosing counterfeit infant formula. What is more destructive (gasp) than even Marlboro® cigarettes? Unregulated, fake Marlboro® cigarettes.

Over the past few years, there has been increasing interest (Peifer, 2017) in how the National Institutes of Health (NIH) funding support is distributed, with concern voiced by some that there may be excess concentration of support given to men and to the most well-funded late-career investigators. In a report (National Institutes of Health, 2019) issued by an NIH Working Group to the Advisory Committee to the Director (ACD), it was noted that "In biomedical science, power stems from who has access to awards. The Working Group heard repeatedly that the concentration of funding in a relatively small number of investigators (who are overwhelmingly white, cisgender, straight men) incentivizes universities to protect researchers bringing in high levels of grant funding".

Recently published literature has raised concerns regarding how NIH distributes funding support. One report (Katz and Matter, 2020) which focused on all ‘R’ grants found increasing inequality of funding support over 30 years (1985–2015). A research letter (Oliveira et al., 2019) found lower levels of support for grants in which women were identified as Principal Investigators. Other reports have documented disproportionate aging of the research workforce (Blau and Weinberg, 2017) and stresses particular to mid-career investigators (Charette et al., 2016); these reports are concerning given evidence that there is no correlation between research stage and scientific impact (Sinatra et al., 2016).

This study is to explore why modern medicine fails to find cures for chronic diseases. By conducting a review of NIH funding policies, I found that NIH is primarily responsible for creating the narrow modern medicine that is unable to cure chronic diseases. By influencing research programs for decades, NIH has promoted peer review system, the general acceptance standard, the use of randomized controlled trials, objective evidence standard, precision medicine, evidence-based medicine, exclusion of personalized medicine, rejection of broader mind-body model, rejection of personal observational evidence, etc. By influencing research programs, NIH is primarily responsible for excluding, rejecting, and suppressing personalized medicine including fork remedies, family-owned remedies, and personal discoveries from the world, and forming the wrong notion of incurable diseases. While most of the NIH research programs may yield potentially useful medical knowledge, most funded programs intended to treat diseases by directly intervening human biological networks failed for decades. I must find that such research programs are expected to fail forever. The bases of my prediction are that (1) medical research methods are grossly inaccurate with most mathematical models being wrong, (2) some fundamental concepts in biochemistry are inaccurate, always incomplete, or even completely wrong, and (3) most health properties beneath the life phenomenon are beyond human ability to characterize. Scientists are unable to characterize the full details of human biological networks and biological pathway interactions. Those limitations are insurmountable in light of the fact that chronic diseases are caused by small departures in process attributes in the human biological pathway networks. I must also predict that most NIH-funded research programs attempted to intervene the human biological networks are deemed to fail or will not benefit people in our time. I urge NIH to deeply examine its past funding policies and consistent failure in chronic diseases, and expand its funding scope to cover evolution-compatible remedies, fork remedies, and personal discoveries, many of which have been proved by irrefutable evidence to be predictable cures for chronic diseases.

Pharmaceutical companies also benefit from research and development tax credits. The federal R&D tax credit was first introduced in 1981 to encourage private sector investment in pioneering research.21 This tax credit is available to businesses that attempt to develop new, improved, or technologically advanced products or trade processes.22 In 2015, former President Barack Obama signed into law the Protecting Americans from Tax Hikes Act23, which made these tax credits permanent and extended them to small businesses and startup companies.

Pharmaceutical industries also receive a tax deduction for their marketing and advertising expenses. According to a report in the Journal of the American Medical Association, “From 1997 through 2016, medical marketing expanded substantially, and spending increased from $17.7 to $29.9 billion,24 with direct-to-consumer advertising for prescription drugs and health services accounting for the most rapid growth, and pharmaceutical marketing to health professionals accounting for most promotional spending.” The report also found that from 1997 through 2016, “the number of advertisements … increased from 79,000 (including 72,000 television commercials) in 1997 to 4.6 million (663,000 television25 commercials) in 2016.”

Today, U.S Senator Joe Manchin (D-WV) applauded the Centers for Medicare and Medicaid Services ’ (CMS) selection of the first ten prescription drugs for Medicare price negotiations, as directed by the Inflation Reduction Act. This new authority will reduce drugs prices for West Virginians and Americans through the first-ever direct negotiations between Medicare and pharmaceutical manufacturers over a set of medicines. “Thanks to the Inflation Reduction Act, drug costs for millions of families across the country are on their way down. In addition to allowing Medicare price negotiations for drugs like Eliquis and Xarelto, representing over $30 billion in annual Medicare Part D spending, the IRA capped Medicare recipients ’ insulin cost at $35 a month which is a significant savings for more than 400,000 West Virginians and millions of Americans. No family should have to choose between life-saving medication and putting food on their table or a roof over their heads. I will continue working to ensure the IRA is implemented correctly to reduce costs for folks across the country,” said Senator Manchin. Prescription drugs selected for Medicare price negotiations: Eliquis Jardiance Xarelto Januvia Farxiga Entresto Enbrel Imbruvica Stelara Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill

Today, the U.S. Department of Health and Human Services (HHS) announced actions to lower health care costs and implement President Biden’s lower cost prescription drug law – the Inflation Reduction Act (IRA) – which is already saving covered seniors and people with disabilities hundreds of dollars annually. HHS released revised drug price negotiation guidance from the Centers for Medicare & Medicaid Services (CMS). The guidance is a critical step in implementing the IRA, which finally took on Big Pharma and will allow Medicare to negotiate lower drug prices on behalf of people with Medicare. “The Biden-Harris Administration isn’t letting anything get in our way of delivering lower drug costs for Americans,” said Secretary of Health and Human Services Xavier Becerra. “Pharmaceutical companies have made record profits for decades. Now they’re lining up to block this Administration’s work to negotiate for better drug prices for our families. We won’t be deterred. President Biden made it possible for Medicare to negotiate prescription drug prices. Today’s action is a critical step in reaching that goal.” Starting this year, Medicare will begin to negotiate directly with drug manufacturers to bring down the price of covered high-cost prescription drugs. CMS will announce the first 10 drugs selected for negotiation by September 1, 2023. The first round of negotiations will occur during 2023 and 2024. The prices that are negotiated will be effective starting in 2026. In March, CMS released initial guidance on the process for drug price negotiation, which outlined how the agency will select drugs for negotiation this year and how those negotiations will be conducted. Today, CMS released revised program guidance, informed by public input, that outlines how CMS will negotiate to reach agreement on a maximum fair price for a selected drug with participating manufacturers, ensuring that Medicare beneficiaries have access to innovative, life-saving treatments at costs that will be lower for both them and Medicare. HHS today also announced that President Biden’s cap on insulin costs at $35 per month will go into effect for people who get their insulin through Medicare Part B and Medicare Advantage with use of a traditional pump starting tomorrow, July 1, 2023. Millions of people with Medicare Part D are already benefiting from the Inflation Reduction Act’s $35 monthly cap on insulin costs, and if these rules for Part B and Part D had been in effect in 2020, 1.5 million beneficiaries would have saved an average of $500 per year.

Grievances against the pharmaceutical industry are common in new media spaces. Influencers on Instagram tell us to shun drugs and embrace the “natural.” Diatribes are shared on Facebook against the profit-seeking motives of Big Pharma. Podcasts, websites, and videos try to convince us that the prescription drug business simply cannot be trusted. Joe Mercola, an osteopath who has set himself up as the one-stop shop alternative to medicine, recently declared on his site that “the drug industry has become the #1 cause of death and disability worldwide, hands down.”

This bag of grievances carries a heavy and myriad load of claims, some more believable than others. And it is precisely those more believable claims that help the conspiratorial pill go down.

There is a lot of discussion about how “divided” we are as a nation. And on many issues, that is absolutely true. But there is one issue that most Americans agree on, and that is that they are sick and tired of being ripped off by the pharmaceutical industry. Almost all Americans agree. We must lower the outrageously high cost of prescription drugs.

And that is why, as Chairman of the Senate Committee on Health, Education, Labor, and Pensions (HELP), I recently held a committee hearing to hold Big Pharma accountable and to help Americans understand why we pay, by far, the highest prices in the world for prescription drugs. You can watch the full hearing HERE.

Antibiotics are among the most important medicines known to humankind, but we are of this crucial resource. Decisive action is needed if we are to retain access to them. This includes rethinking our reliance on private companies and of crucial parts of the antibiotic pipeline. Since the 1930s, antibiotics have transformed the way we treat diseases, ranging from syphilis to . They have enabled increasingly complex forms of surgery and organ transplantation. They have protected people with weakened immune systems, such as those undergoing chemotherapy for cancer treatment, from life-threatening infections. And they have facilitated the industrialisation of . So important have antibiotics become that some researchers compare essential infrastructure, such as hospitals and ambulance services. But this infrastructure is at risk. After decades of increasing use, our antibiotic workhorses are worn out. The reason for this is : every use of an antibiotic can select for bacteria that are resistant to antibiotics’ effects. Because their competitors are killed by antibiotics, these resistant bacteria can proliferate rapidly and pass on their resistance genes to their offspring and often to other, unrelated bacteria. Over the last 80 years, human antibiotic use has that are increasingly effective at resisting our drugs.Penicillium mould producing spores. , Antibiotic development has not kept pace with this rapid microbial evolution. After a golden age of innovation between the 1930s and 1970s, the 1980s saw global investment in antibiotic research and development (R&D) – just when old scourges, such as and were becoming harder to treat. The reason for this was . Don’t let yourself be misled. Understand issues with help from experts Get the newsletter Despite , private companies were unwilling to invest in drugs that would only be taken for a short time and be subject to usage restrictions because of their selection for antimicrobial resistance. Instead, contemporary experience showed that investment in cancer drugs and , which would be taken for long periods, or in treatments for so-called lifestyle diseases, such as , would be far more lucrative than sponsoring further antibiotic research. The pipeline for new antibiotics has become drier ever since. In fact, it has been since a new class of antibiotics with a distinct new mode of antibacterial action has entered the market. All the while, bacteria have honed their defences. By 2016, a major commissioned by the British government predicted 10m deaths annually resulting from antibiotic resistance by 2050 if no action was taken, and exhorted both the global community as well as private companies to reinvest in new antibiotics research. These warnings of an international emergency have since been echoed by organisations ranging from the to . But development , despite many attempts to make commercial antibiotic development more attractive. Recent years have seen substantial public of private development, with widespread subsidised research and clinical trials, along with incentives, such as , quicker licensing, supplemented prices for new antibiotics , and NHS England’s new “” for antibiotic access. Despite this, no new antibiotic class has emerged. Even worse, the injection of since 2016 has not prevented the industry from further contracting. Between 2016 and 2019, major producers, such as Sanofi, Novartis and AstraZeneca shuttered their . This resulted in the closure of well-financed industrial research departments and a critical global loss of human capital and expertise in antibiotic R&D. According to a , there is “now a shortage of experts qualified to lead research programs employing promising new antibiotic discovery methods”. Although international non-profit organisations are to subsidise for-profit development, it is questionable whether this public-private model will bear fruit. After over three decades of market failure and in the face of a critical contraction of remaining industry activity, alternatives beyond the market should urgently be explored. The public is already sponsoring the high-risk phases of drug discovery and trialing by university researchers and private companies but own none of the intellectual property once antibiotics go to market. There has also been little public pay-off either in terms of new antibiotic classes or increased access to effective drugs in low-income countries. The market is broken. It is time to apply recent of “public money for public goods” to areas beyond farming and seriously consider public ownership of antibiotic research, development and production.

Ben Goldacre's book, Bad Pharma: how drug companies mislead doctors and harm patients, is the latest of several books and articles in recent years to level criticisms at the way the pharma industry and regulatory authorities operate; criticisms that need to be taken seriously, revealing faults that need to be corrected. It makes uncomfortable reading. Goldacre chooses his targets well and shoots at them with well-documented examples, some of them truly shocking, many of them uncovered only after persistent and tenacious probing of reluctant sources. These are tales of secrecy, dishonesty, bribery and corruption that make for a compelling read, couched in prose reminiscent of scandalous revelations in the tabloid press. To the question of style, we will – as Goldacre himself so often says, to keep his readers hooked – come back later. The main target in the Goldacre cross-hairs is nondisclosure of data, particularly data from clinical trials. It is well recognized that negative or unfavorable clinical trials results are much less likely to be published than positive findings. The blame lies not only with the pharmaceutical companies, but also with journal editors, who judge that reports showing no significant benefit of a treatment compared with placebo do not deserve journal space. It proves difficult even for regulatory authorities and official advisory bodies, such as the National Institute for Health and Clinical Excellence, to unearth unfavourable data from company-sponsored trials. Goldacre cites the example of the antidepressant reboxetine, on which only one trial was published, out of seven in which it was tested against placebo. The published trial showed it to be effective; the other six, on many more patients, remained unpublished. Other unpublished trials, in which it was compared to selective serotonin reuptake inhibitors, suggested, contrary to the conclusions of the few published trials, that it was less effective, and had worse adverse effects, than these drugs. This is the best chapter in the book and is forceful, well argued and backed by detailed examples. Powerful voices, such as BMJ's editor Fiona Godlee, are supporting the need for all trials data, not only collated and processed summaries, on currently used drugs to be available publicly, and it will surely not be long before this happens. GlaxoSmithKline has already signed up to it, so that is an important victory in sight. However, it must be remembered that the full patient data for even a modest trial run to thousands of printed pages. It will, of course, be in electronic format, but even so the task of editing out confidential patient data, collating and analysing it for only one drug will be substantial, and for the backlog of a thousand or so in the British National Formulary, which need to be reviewed, massive and very costly. As with any medical resource, the benefit will need to be balanced against the cost. Neither seems to have been determined. The second main theme is criticism of the marketing culture of the pharmaceutical companies, its intrusion into medical education, its powerful influence on prescribing patterns, and the complicity of scientists, doctors and even regulators, in supporting it. It is a well-known, but still startling, fact that companies spend about twice as much on marketing as they do on research and development of new drugs. And much of what is done in the name of research is in fact undertaken for marketing purposes, though disguised as science. Although this will not surprise anyone familiar with the culture of the pharmaceutical industry, Goldacre does a skilled hatchet job, peppered with examples. Companies will, of course, defend their practices. Their priority, in a capitalist environment, is to sustain their businesses and provide shareholder value, which means making profits, which in turn depend on effective marketing. Profits also sustain drug discovery, and restricting the freedom of these behemoth companies risks, they can argue, throwing out the baby with the bathwater. But we do need a better assessment of how much real harm to patients is occurring, to balance against the likely future harm, through retarding drug discovery, contingent on wading in with further restrictions. Goldacre emphasizes repeatedly the harm to patients resulting from the biased and incomplete reporting of trials data, and other failures of drug regulation and marketing, but only quantifies it rarely. Concerning the CAST antiarrythmic drug trial [1], which showed, contrary to expectations, that Class Ic drugs, such as encainide and flecainide, increased deaths following a heart attack, he says that ‘well over 100 000 people died unnecessarily’ after these drugs were used to prevent ventricular arrhythmias, which is a startling and dramatic assertion. Where does it come from? The only source for this estimate that I could discover is a 1995 book [2] by T. J. Moore entitled Deadly Medicine, where the estimate was between 6000 and 25 000 excess deaths per year. In a careful analysis, Anderson et al. [3] checked whether this claimed rise in coronary disease deaths associated with flecainide and encainide genuinely happened in the USA. It did not. The already declining cardiac death rate showed no deviation whatever from the prevailing trend during the period when these drugs were being prescribed in large amounts, though the excess claimed by Moore, even at the lower limit, would have been clearly significant; nor was there a dip in mortality when prescriptions fell by 75% after the CAST trial result was published. A third theme, the shortcomings in the design and conduct of clinical trials, is also convincing and well researched, and his criticisms of pharmaceutical companies, regulatory authorities, ethical committees and journal editors, as well as participating clinicians and academics, will strike home. But the conventional double-blind randomized controlled trial, despite the shortcomings that Goldacre complains of in the design and analysis of many that are performed, has delivered a great deal of valuable information that benefits patients, and is rightly regarded as the best methodology when it is practicable. In devoting a whole chapter to a complementary approach – ‘Larger, simpler trials’ – Goldacre goes over the top. The idea is to use the electronic patient data records produced by general practitioners in their everyday practice to provide information on which of two or more treatments (on which there are currently no reliable data to guide clinicians on the best choice) works best. Large numbers of patients can quickly be recruited, and general practitioners only have to agree to randomize their treatment choice and log the patients’ progress in the usual way. The potential value of this ‘real world’ pharmacoepidemiological approach is well recognized, but it faces serious ethical and operational obstacles, as well as limitations in the kinds of outcome measures that can be used. The problems are outlined in detail in a recent BMJ article [4] co-authored by Goldacre. Of these manifold problems, the book mentions only one rather obvious shortcoming, namely the unavoidable lack of ‘blindness’. Devoting a whole chapter to enthusiastic endorsement of what is currently a plan in its infancy, and in no way a substitute for conventional trials, shows a lack of balance. Overall, the book delivers an important and convincing message, which is well pulled together in the final chapter, amounting essentially a call to arms for many parts of the biomedical community. What lets it down badly is its style. Its excessive length and repetitiveness simply dilute the message. The numerous conversational asides to the reader are at best superfluous and condescending, and at worst coercive. For condescension, how about: ‘I am very sorry if you have the flu, because it's hard being ill’, or (referring to a diagram) ‘So what's that on the right?’, or – it is hard to know where to stop because the examples are so abundant – ‘Don't worry if you don't understand everything, but here is one easy bit of background and one hard bit’. Does anyone find this cutesy drivel appealing? Why so often preface a statement with ‘In case you are interested …’ or ‘If you were wondering …’? Telling us that a statistical argument ‘makes my head hurt’, then setting it out in detail, is simply conceit disguised as modesty. These examples may be dismissed as a stylistic quibbles, but frequent assertions along the lines of ‘You will find the story I am about to tell truly shocking’ are coercive, and intended to pre-empt the reader's independent judgement based on the evidence presented. An author confident of his case should expect his readers to arrive at the same conclusions without such prompting. In short, this is a book badly in need of a good editor. Of more than stylistic concern is Goldacre's frequent recourse to the kind of journalistic hyperbole familiar from the red-top press. The first sentence in the book is exactly such a mindless attention grabber: ‘Medicine is broken’. How can a practising doctor possibly make such an assertion? Little concern, evidently, for the harm to patients – his mantra throughout the book – that this foolish remark could cause if anyone believed it. The fact is that medicine is one of the most successful and valued enterprises in the civilised world and, as Goldacre himself acknowledges, it owes a great deal to medicines developed in the last few decades, despite the flaws in the process. A little further on, he speaks of ‘a murderous disaster’ resulting from these flaws. Does he really believe that murder, i.e. deliberate killing, has happened? Of course not, but in this forum, impact matters more than meaning. This is a book with an important message that deserves to be taken seriously, despite the fact that its journalistic tricks and painfully beguiling style may cause many readers to throw it down in disgust.

Can you expand on how Big Pharma’s practices affect access to medicine in the Global South?

The pharmaceutical industry is not interested in making medicines for diseases suffered primarily by poor people in poor countries, like malaria and tuberculosis. In terms of diseases that affect both rich and poor countries, if cutting-edge medicines are stretching very rich countries with national health systems, it’s simply impossible to afford them in most other countries.

A total of 20 participants were interviewed. Participants had bought various types of POMs or medicines with the potential to be misused or that required a higher level of medical oversight (eg, antibiotics and controlled medicines). Participants demonstrated awareness of the presence and the risks of fake medicines available on the internet. The factors that influence participants’ decision to buy medicines on the web were grouped into themes, including the advantages (avoiding long waiting times, bypassing gatekeepers, availability of medicines, lower costs, convenient process, and privacy), disadvantages (medicine safety concerns, medicine quality concerns, higher costs, web-based payment risks, lack of accountability, and engaging in an illegal behavior) of purchasing medicines on the web, social influencing factors (interactions with health care providers, other consumers’ reviews and experiences, word of mouth by friends, and influencers’ endorsement), barriers (general barriers and website-specific barriers) and facilitators (facilitators offered by the illegal sellers of medicines, facilitators offered by internet platforms, COVID-19 outbreak as a facilitating condition, and participants’ personality) of the purchase, and factors that lead people to trust the web-based sellers of medicines (website features, product appearance, and past experience).

The drug industry is “burying its head in the sand” when dealing with health in developing countries and denying poorer people access to life saving drugs, a report claims this week.

A critical report by the international agency Oxfam says that the drug industry is refusing to change the way it does business in poor countries, despite promising that it would, and is undermining its own future.

Her story is becoming ever more common. Top execs have always traded the comforts of big pharmaceutical companies to lead biotech startups. But it’s now happening at a much faster pace, say biotech recruiters and analysts. Two reasons: The upstarts have plenty of cash, and increasingly they generate the lion’s share of innovative drugs. The shift is further fueled by rapid consolidation among the giants, shake-ups inside R&D departments, and succession planning inside big companies, says Graham Galloway of Spencer Stuart.

Among the many to make recent jumps from the mammoth to the minuscule are former Biogen (BIIB) R&D chief Doug Williams, who became CEO of cancer startup Codiak BioSciences, and Don Nicholson, who left Merck to lead Nimbus Therapeutics. Jeremy Levin, ex-CEO of generic giant Teva Pharmaceuticals (TEVA), became head of Ovid Therapeutics, targeting rare neurological diseases. Says biotech recruiter Jackie Bandish: “For many of these guys, a small company can be a breath of fresh air.”

Who is Big Pharma? What does it do, and why is it so powerful?

The term refers to the biggest pharmaceutical companies — the likes of Pfizer, Johnson & Johnson, Moderna, AstraZeneca, GSK — but it also implies a common way of operating, based on the monopolies these corporations enjoy, and the way they produce and market drugs.