Showing posts with label Pharma. Show all posts
Showing posts with label Pharma. Show all posts

Wednesday, July 22, 2026

"Take this, it's good for you!" Or maybe it isn't.

“Take this, it’s good for you!”

 You probably heard this growing up from your parents, or grandparents, or others, about lots of things. Medicines, foods, supplements, and even activities (“Do this, it’s good for you!”). You probably have continued to hear this from other people even if you are now grown: friends, family, people you have just met, and that most reliable of all sources, random posts (I was going to say “random people” until I realized that many or most of them could be bots) on the internet! So, should you take it? I mean, is it good for you?

I know my answer is going to be shocking: “It depends.”

On what? On a whole lot of things.

The whole idea that there is a general concept of things that are “good for you”, whoever you are and what you are hoping to achieve, is nonsense. What is good for one person – say an infant or a toddler – may well not be good for a middle-aged or older adult, and vice versa. And, of course, the most important question is “good for what?” What do you seek to have happen to you that this nostrum is “good for?” Do you even share the interest in achieving the end goal that the recommender presumably does? Lower cholesterol, lower weight, more muscle mass, stronger bones, having better balance or more stamina, improved sexual function, looking younger, better bowel movements, avoiding a deficiency disease like rickets, scurvy, or pellagra? Sometimes even cheap and easily available things from which big corporations or influencers do not make a lot of money, and that in fact do work well, are also unnecessary. Parents and grandparents may push things that their parents and grandparents told them were good for them, and they might have been, back once, but are not now. Back then, when our diets were often lacking in essential vitamins, scurvy, pellagra, and rickets were real issues in the US (and may still be in some parts of the world), but are not, generally, here now. In the not-too-distant past parents gave their kids castor oil, either as a treatment for a condition that the child might or might not have, like constipation or worms, but there are much better, safer, less unpleasant, and more effective treatments for both now. (That is not considering those who gave it as punishment!)

After you have answered the question of “good for what?” and decided that that “what“ is something you want to achieve or more toward, the next set of questions are “will it do that, does it actually work?”, “does it work for everyone the same or are there some groups of people (based on age, gender, health status, etc.) for whom it works better or not as well, and “what are the untoward effects that may, or even are likely to, happen, which may be far worse than the benefit?” Anabolic steroids, for example, do work to increase muscle mass, endurance, and power (see: sports stars) but also cause serious bad things (liver disease, testicular shrinkage, and a host of others). If it is legal and you are not competing in a sport where it is banned, it is up to you to decide whether the risk:benefit ratio is one you are willing to take (provided you are an adult, since in this area as many others, teens are poor judges of risk:benefit and do not have a good long view). Psyllium seed powders can be good for your bowels, lowering cholesterol, and helping to control your appetite, but some people have problems with the side effects. Testosterone, now being pushed by the Secretary of War who is competing with the Secretary of HHS and the President for being the administrations most macho ignoramus, can be good for some people who are deficient who should not be, but is far from a panacea that turns regular people into mindless Orcs (many medical professionals disagree, Doctors question evidence behind Pentagon testosterone plan). By the way, this is a good time to note the intrinsic contradictions in the “men’s health” movement. Its two big issues are prostate disease (especially cancer) and “low T”. Testosterone will not only make prostate cancer (or even benign prostatic hypertrophy) worse, blocking endogenous testosterone is the mainstay of treatment for prostate cancer. Oh, well, let’s see what it does for Pete Hegseth.

Some things generally are good for you. For example, age-appropriate vaccines are good for almost everyone (except those with known allergies to its components or previous severe reactions, by which I mean things like Guillain-Barre Syndrome, not a sore arm or short-term fever). Virtually all vaccines for children and adults (MMR, DTP, meningococcus, chicken pox, H. flu, influenza, Covid, shingles, polio, etc.) are really wonderful miracles that save thousands (sometimes millions, see: “Covid” and influenza) of lives, even more thousands or millions saved from serious morbidity, and with a very low rate of any significant negative effect. This is true. If you hear different information from your favorite TikTok star or Facebook friend, or Secretary of HHS, they are wrong.

Some things are generally bad for almost everyone, like taking dangerous drugs for unapproved indications (e.g., ivermectin for Covid), not to mention drinking or injecting bleach! The internet is full of recommendations for magic bullets that will cure whatever ails you or doesn’t even ail you but tells you it will or might if you don’t buy their solution. These claims are no more reliable than the clothes, makeup, hardware, and amazing items that will solve all your household worries. That is, some may be of value, for some people, in some circumstances, but often are not and even are dangerous, but all make money for those selling them (or in the modern world, selling their ability to influence others to the companies that make the products).

A big issue, it seems, is whether to take drugs, especially prescription drugs, manufactured by big, evil, pharmaceutical companies and heavily advertised by them, or to take “natural” over-the-counter drugs made by any-old-person or company and pushed by – any-old-person (or bot). Pharmaceutical companies are evil, as are most huge for-profit corporations (and they are usually the most for-profitable!) because their profits, not your health, is their main function. This does not mean that their products (or at least all of them) are not effective or safe when “used as directed”. They have two important characteristics non-prescription, even “natural” remedies, do not. First, they are tested, and approved after an extensive process, by the FDA (or were, before the FDA was decimated by the administration), which other remedies are not. Second, the doses are standardized, so you know what you’re getting. Even when plants (natural) are the basis for the drugs – say willow bark for aspirin – dosing is an issue. How much willow bark? From how old a tree? Growing in what setting? An aspirin tablet is standardized. Taking unregulated medication is akin to taking street opiates – you cannot be sure what, and how much you are getting. Plus, remember “natural” is not intrinsically good, safe, or protective. There are at least as many natural poisons as beneficial substances. If something you ingest, “natural” or manufactured, has a biologic effect that you desire, it also can (and likely does) have biologic effects that you do not desire (“side effects”, a term meaning biologic effects you don’t want). Testing and standardization are keys. Not that this in any way excuses the rapacious profit-taking of Pharma, but neither does it of those selling unregulated nostrums.

Finally, and I have said this before and will say it again, when thinking about whether something is “good for you” and whether you should take it, anything that sounds too good to be true probably is.

Wednesday, March 1, 2023

Making people healthy or making money: What should be the goal of our health system?

In the February 16, 2023 issue of The Nation, epidemiologist Gregg Gonsalves writes about The Fight for the Soul of American Medicine. It is a particularly good and thorough review of the corruption of American medicine by the quest for profit, and the growing resistance of many physicians to its adverse effects on themselves and, more important, the health of their patients.

He cites several other recent articles that emphasize different aspects of this situation. Eric Reinhardt, writing in the New York Times about physician burnout, calls for increased unionization of physicians to counter the power of the corporate controllers of US medical care. Gonsalves also cites a JAMA Viewpoint by former CMS administrator Don Berwick calling out the many ways that greed perverts and destroys American healthcare, using the old Pompeiian phrase Salve lucrum, “Hail Profit”, and naming it an existential threat. Finally, he cites an article in the Journal of General Internal Medicine by Gondi, Kishore, and McWilliams called “Professional Backgrounds of Board Members at Top-Ranked US Hospitals” which identifies the fact that US hospitals are run by people with finance, not healthcare, backgrounds:

At top-ranked US hospitals, the most common professional background for board members is finance, far exceeding representation from physicians, nurses, and other health care workers. Over half (~56%) of board members are from finance or business, while a small minority (~15%) have clinical training or are from the health services sector.

Gonsalves notes how the perversion of healthcare, particularly medical care, by an explicit profit motive leads to the US having both the greatest cost and the worst health outcomes of the wealthy countries of the world, but then goes beyond that to further criticize our reliance on medical care as the avenue to people’s health. He cites the National Academy of Sciences estimate that medical care accounts for only 10-20% of health, with social determinants (and, one could convincingly argue, social determination) accounting for the other 80-90%. Social determination is found in the structure of our society, conceived perversely on democracy and plutocracy, rooted in the extermination of one set of peoples and the enslavement of another, and the racist roots that continue to poison our social structures today. Social determinants – including poverty, housing, food, education, childcare, and others -- are well documented, and are profoundly poorly addressed by us in the US.

This is more than coincidental. Gonsalves refers to a book by Bradley and Taylor, The American Health Paradox: Why spending more is getting us less (which I discussed, along with a NY Times op-ed they wrote, in a blog post To improve health the US must spend more on social services Dec 18, 2011). The essential point of that book is that, while the US spends far more than other wealthy countries on medical care (twice as much as a few and three times or more as much as most others), it spends far less on other social services and social supports. Furthermore, as Bradley and Taylor document, the US is unique in that of all its spending on social service and medical care, the vast majority is on medical, dwarfing expenditures on food, housing, childcare, job training, and social supports that are far more important in maintaining health and preventing disease, while medical care is focused on treating disease once it is there (for those who can access it, at enormous cost).

These are all true things. Our society spends most of its “social services” money on medical care, and it is directed at the most expensive types of care, those that generate the most profit for the big corporate and venture capital players in the hospital, nursing home, and ambulatory care fields as well as the better-documented profiteers in the pharmaceutical and insurance industries. The burnout of physicians from overwork is real and is simply what industrial workers used to call “speed-up”, the demand for more production in the same hours (and for the same pay). In industrial workers, speed-up was and is well known to increase the rate of accidents, both minor and major, and to destroy the psychological health of those workers, so that it is unsurprising that it does the same to doctors and other health workers. What is more surprising is that it has taken so long for them to realize it; over a few decades corporations have taken over almost all of health care delivery, with independent physicians and physician groups that own themselves almost disappearing.

Most hospitals, or “health systems”, are controlled by large corporations – or so they are called if they are for profit. The non-profit health systems, however, including academic health centers, behave scarcely less like corporations, chasing increased revenue (if not “profit” per se), and are, as Gondi et al., demonstrate, just as likely to be led by people with financial backgrounds, rarely medical ones. The good aspect of for profit relative to non-profit hospitals is that they, at least, pay taxes rather than be the recipients of government largesse through being tax-free in return for ostensible, and increasingly unrealized, community benefit. The bad side is that they provide even less community benefit, and generally have worse quality care, than non-profits. In addition, the positive side of the non-profit ledger is enhanced by inclusion of those hospitals in rural areas and inner cities that actually do care for the needy. These, however, are the very ones that are at greatest risk of going bankrupt, and closing because their patients are uninsured or are underinsured, including by Medicaid and even Medicare. A NY Times article recently addressed the increasing closure of rural hospitals, and an even more recent one documents how many rural hospitals are closing their maternity units, because it is a high-cost, low-revenue “service line”, causing rural women to have to travel dangerous distances for pregnancy care and delivery.

In terms of other healthcare operations, such as physician practice groups and nursing homes, “private equity”, venture capital groups, are playing a larger and larger role. Nursing homes have long been primarily private, and of generally poor quality, but they are increasing being acquired by such private equity or health corporations. Those physician practice groups that are not already owned by hospital systems (including academic ones) are often being acquired by the same groups. The results can be disastrous for their patients, particularly when encouraged by the government, as in the ACO/REACH program which I recently discussed (Privatizing Medicare through "Medicare Advantage" and REACH: The Wrong Way to Go!, Jan 20, 2023). Of course, one reason these (misad-)ventures are successful is that their downsides tend to only be apparent once you need care, when you are sick, when the less obvious odious characteristics of such arrangements can stymie you effective access to care. And, of course (and thankfully!) most of us are not sick at any given time.

I have often written that profit, in any form, does not belong in health care. This is absolutely true. The most egregious forms are the corporations that make and sell pharmaceuticals and the insurance companies that existence as parasitic middlemen between health care and patients, not only sucking off money but also limiting care in ways that actually and frequently harm people. But that is only the tip of the corrupt iceberg. Being “non-profit” does not prevent a health system from acting in the same fashion, to maximize revenue, and reward “successful” (i.e., money-making) management accordingly in seven figures.

It is time to have no incentives of any kind that allow any person or organization in health care to make money beyond that which is required to run a high-quality operation and pay workers a reasonable salary or wage. Indeed, the impact on the health care of patients should be the sole criterion for anything that is done or reimbursed.

AND, then, we need to start taking much of the money saved by having less or none going to insurers, pharma, and hospitals and health systems and spending it on ensuring everyone has good financial health care coverage and the social systems needed to support the social determinants of health are in place.

Sunday, September 25, 2022

FDA should protect the American people, and Pharma should pay!

The Food and Drug Administration (FDA) regulates drugs, and, I guess, food, although I don’t know much about  what they do in that area. It also does not approve certain drugs because they are not classified as drugs, but rather “nutritional supplements” or in new jargon “nutriceuticals”. This is odd, because such a classification does not make them either safe or effective. If they ARE effective, do the good that is claimed for them, then of course they could have other effects, which could be bad. If they are biologically active, they could be harmful. The only way they can be presumed safe is if they have no effect. Oh, well.

The FDA has been prominent for several things in recent years, most commonly regarding the approval (or not) of drugs to treat COVID, and often for demonstrating that proposed treatments, even those endorsed by high-level elected government officials, were not effective. It also made news (and this blog, FDA approves Alzheimer's drug against the recommendation of its scientific panel. Be very concerned, June 21, 2021) by its approval of the Alzheimer’s drug, Aduhelm, against the recommendation of its committee of scientific experts (eventually Medicare, the largest payer, refused to routinely pay for it, although it will in some situations).

A recent article in the New York Times, F.D.A.’s Drug Industry Fees Fuel Concerns Over Influence, discusses the controversy over “user fees” that the agency charges drug and medical device makers to help fund its work. Well, “help” may be incorrect, because such fees account for 75% of its budget.  This requires annual negotiation between the agency and the trade organizations for the industry, and those negotiations often lead to concessions to the manufacturers. At the least, it creates a situation in which it appears that the manufacturers, rather than the public, are the agency’s clients. The Times notes that ‘The user fee program traces its roots to 1992, when AIDS activists pressed the F.D.A. to hasten drug approvals. About a decade later, drugs moved through the pipeline more quickly, averaging about 10 months from roughly 19 months,’ seen at the time as a big victory for AIDS patients. Of course, it is important to note that speedier approval is only a good thing if the drugs being approved work for their intended purpose; speedier (or any) approval is not a good thing if the drugs do not work, no matter how much people with AIDS or any other disease, or their advocates, or physicians or scientists or drug manufacturers, wish they did.

With the pharmaceutical and medical device industry paying for the costs of running the FDA, which should be high enough to ensure that adequate staff and time are available for thorough review of drugs. The agency would otherwise be funded by general tax revenue, and it seems entirely just that the industry that makes money from those approvals (an INCREDIBLE amount of money; the drug industry is regularly by far the most profitable in the US) should pay for them rather than the rest of us. What is wrong is for those payers to have any influence on how the agency operates, what it does, or certainly what drugs are or are not approved. It is an insane idea to think that they should have influence because “they are paying for it” as if it were a business deal, and yet this seems to be the perspective of some influential politicians, such as Sen. Richard Burr (R-NC).  ‘Mr. Burr, a business-focused conservative, complained that the program burdens companies with negotiating with the agency over the fees, which he predicted would rise even higher.’ They should rise as high as they need to in order to fund the agency and the industry should have zero input into their policy decisions (as, indeed, the tobacco industry apparently does not over the 1200 FDA employees in its tobacco division, although the division is entirely funded by user fees).

This issue with the FDA is one (important) example of how, when industries are unsuccessful in “persuading” the government (though large cash donations) to entirely privatize a public function, they seek control of it anyway. In some cases this is a win-win for the industry and the government: the industry not only gets effective control of policy but very large influxes of money from the government to their business, and also gets to deny complete responsibility since it is a "government program”. (See, for example,  Medicare Advantage and the DCE/REACH program, "Private Equity": Profiteers in nursing homes, Medicare Advantage, DCEs, and all of healthcare, September 16, 2022.) Of course, there is a lose-lose part of the equation that involves the other two parties: the sick people who need treatments that are both effective and affordable, and the rest of us who are funding these donations to corporate coffers. Guess which group, winners or losers, has more people? Guess which gives more money to politicians?

It is tempting, when the nation’s people want something done right (like protecting them from unsafe and ineffective drugs) but do not want to pay more taxes to make it work, to enact things like “user fees”. This is certainly fairer; it is why, for example, semi-trailers pay higher highway taxes than cars --  because they travel so many more miles and are so much heavier they cause far more damage to the roads. (You used to see bumper stickers on them that announced how much, until, presumably, they realized, that the other folks driving on the highway had little sympathy and probably cheered and felt it wasn’t enough!) Thus charging the pharmaceutical companies who make so much money on drugs to pay for the FDA makes sense and is the way it should be, as long as they have no influence on the process. But that lack of influence is what irks Mr. Burr, and the drug makers who fund him.

Obviously, Burr is wrong, and so is the current process. Of the two sets of interests – the health of the American people and the profits of Big Pharma, the first should be the sole responsibility of the FDA, and the money to fund it should come from the second. Pharma will still make an exorbitant amount, no matter how much they and Sen. Burr cry that they do not have enough clout in the process to make even more, and they will continue to spend far more on marketing than on research and development.

And this should be the process for all government agencies. Fund them to protect the people from the profits of the companies that benefit.

Friday, October 15, 2021

Public Health, Abortion and Childcare: US far behind other countries

On October 3, I wrote about the viciously restrictive Texas (anti-) abortion law, The Texas Abortion Law is contrary to women, to science, and to human values. Texas is not the only state with such restrictive laws; in my own state, Arizona, a very restrictive abortion law has been passed by the legislature and signed by Republican governor Doug Ducey that makes it a crime for a doctor to perform an abortion on a woman “just” because it has a genetic defect (including those incompatible with life, or worse, yet, compatible with a short life full of suffering). While a US district court judge has enjoined the law, Arizona’s attorney general, Mark Brnovich, has asked the judge to allow him to continue to enforce that law while his appeal is pending. That could mean, of course, felony convictions for physicians. This follows the Supreme Court, in a “shadow docket” ruling, declining to invalidate that law despite a prior US Court of Appeals ruling that did so.

These actions by Republican-controlled states are all predicated on the assumption that the Supreme Court will soon invalidate Roe v. Wade and take away any Constitutional protection for women seeking, or doctors or others providing, abortions. This may well happen with a case on the agenda for this year challenging Mississippi’s draconian law virtually outlawing abortion. That this is a distinct possibility is because of the success of the Republican party and Sen. Mitch McConnell in ensuring that The Former Guy, Donald Trump, was able to appoint 3 justices to the Court, first by preventing President Obama’s nomination of Merrick Garland (the current US Attorney General) on the specious grounds that it was the last year of his term (while there were over 9 months left), and then going ahead and then entirely hypocritically approving the nomination of Amy Coney Barrett just a week before the election, which Trump lost. Thus we have a Supreme Court with 6 Republican justices of which Chief Justice John Roberts, Jr., is the least reactionary – but no longer a swing vote. Many, including Coney Barrett (referred to by NY Times columnist Maureen Dowd in her recent piece “The Supreme Court v. Reality” (Oct 9, 2021) as “Lady Handmaid’s Tale” for her advocacy for some of the repugnant and misogynistic practices described in Margaret Atwood’s book and the later TV series, strongly opposed to abortion. It is, of course, worth remembering that large majorities of the American people favor retaining the rights in Roe v. Wade, and that in some circumstances (such as rape and incest and a threat to the life of the mother) that support is overwhelming. Not, however, on GOP legislatures or on the Supreme Court.

Much of the support that exists in the US for overturning Roe v. Wade, and in general opposition to abortion, justifies itself by claiming abortion is murder, that they are only advocates for helpless fetuses, whom they call “babies”. There are undoubtedly many in their ranks who are consistent in their opposition to killing, opposing the death penalty and war (the late Joseph Cardinal Bernardin of Chicago comes to mind, and perhaps the current Pope Francis), but the vast majority of them, including all these legislators and SCOTUS justices, are not. And, indeed, their concern for babies and children only extends back from birth to conception, not forward from birth. We got you to there, they effectively say, but then you’re on your own. Or your parents are. This country is the meanest, using the word in both its senses, unkind and stingy, of all wealthy countries in providing support for infants, children and their parents. No box of baby necessities as in Finland (available for sale in the US, but provided by the government in Finland) . No requirement for parental leave. No guarantee of health insurance coverage, not to mention adequate coverage. No support for childcare. This one is the subject of a dramatic graphic included in the NY Times demonstrating how much countries in the Organization for Economic Cooperation and Development spend per child on early childhood care. The mean is $14,436. The second-lowest, Israel, is $3,327. Hungary spends twice that, Lithuania is over $8,000 and Slovenia over $11,000. The “poor” US comes in, as in virtually all measures of caring for its people, last, at $500. Well, you know, it costs a lot to provide care for its least needy; for the billionaires who need tax cuts.


This, of course, does not bother the majority of the Supreme Court. They are not looking for consistency. They are looking for two things: 1) to enact their political agendas, and those of the Presidents who appointed them, and 2) to have people ignore #1 and lash out at people who point it out, painting themselves as victims.

Meanwhile, thing as better on the health front in the small Central American nation of Costa Rica, as described by surgeon and health care pundit Atual Gawande in the New Yorker (‘Costa Ricans Live Longer Than We Do. What’s the Secret?’, August 23, 2021). In a country with a “per-capita income is a sixth that of the United States—and its per-capita health-care costs are a fraction of ours—life expectancy there is approaching eighty-one years. In the United States, life expectancy peaked at just under seventy-nine years, in 2014, and has declined since.” This latter fact has been described in great detail in recent years, particularly in the work of Anne Case and Angus Deaton (in the Proceedings of the National Academy of Sciences,Rising morbidity and mortality in midlife among white non-Hispanic Americans in the 21st century”, and discussed by me in Rising white midlife mortality: what are the real causes and solutions?, Nov. 14, 2015). Costa Rica, in 1970, had an infant mortality rate of 7%. By 1980, it was only 2%. “In the course of the decade, maternal deaths fell by eighty per cent. Part of the change is due to improvements in access to medical care, a characteristic of middle-income countries such as Costa Rica as well as most (obviously excepting the US) upper-income countries.” This points to the second big reason, and the focus of Gawande’s article, the emphasis on public health, on the health of communities, on interventions (and spending money) on things that improve the health of all people, in great contradistinction to the US focus on providing medical care for individuals.

Public health in the US is grossly underfunded, as has been apparent since the beginning of the COVID-19 pandemic. Well, it has long been apparent to those who thought about those things. The emphasis in the US is on individual medical care, and this is what is discussed by those who have power and those who fund them, and of course the mass of journalists and pundits.This is a failure of those who should be providing accurate information, but it is also the fault of our people’s willingness to deny a problem until it is right in their face. Many Americans do not even take the preventive measures that are easily available to them (the COVID vaccine, for some reason, comes to mind) and many others are unable to avail themselves of screening and early treatment because of a lack of money or decent health insurance and so end up in extremis and grateful for whatever invasive, expensive, and often unlikely-to-be-successful medical care is available. But, as I have said before, it is less common for people to wake each morning and be thankful that they don’t have cholera because they have clean water.

It is not that the American people are stupid or have the wrong values. If a large majority support Roe v. Wade, and much larger majority believes everyone has the right to health care and that we should have a universal health insurance system. And a huge majority (about 88% including 77% of Republicans) believe that drug costs are too high, that the reason is that drug companies make too much money, and that Medicare should be able to use its clout as the nation’s biggest insurer to negotiate drug prices. Also, while we’re on it, that all children should have an excellent education, and that childcare and parental leave are truly important priorities.

But we don’t have that. We don’t have the “Finnish baby boxes”, and we don’t have universal health insurance, and we don’t have requirements that all health insurance cover everything needed, and we don’t have childcare or parental leave or excellent education for all our children or a decently supported and effective public health system or even the ability of Medicare to negotiate drug prices. Of course the poster child for opposing this latter while her constituents favor it is my senator from Arizona, Kyrsten Sinema, who has gotten a lot of money from the pharmaceutical industry. Do we think that is part of it??

The only solution is to vote them out. Make supporting public health and universal health care and affordable drugs more important to re-election than opposing abortion rights.

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