Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Tuesday, June 30, 2026

If you hear a health claim sounds too good to be true..

We all have things we believe without evidence. We particularly have things we believe without good evidence. I am not even talking about religious beliefs, which are, by definition, acts of faith, but what we can call lay beliefs about the world. One area in which this is both important and widely variable is health and medicine. There is a tremendous amount of information out there, and much of it is correct, and much is not, and sometimes some correct stuff seems, on the surface, to contradict other correct stuff. If that is true, what is a person to do?

One option is to learn about things in detail, understand the scientific method, understand statistics, and understand how “truth” evolves and changes with new discoveries. Or, alternatively, to know that there are people who do know and understand these things, who have spent years and decades learning about them, being trained in the subtleties of science and research, and listen to what they say. For decades, say roughly from WWII, this is how our public health developed. We didn’t just trust scientists, we trusted science. We could see the progression of scientific knowledge, and how it positively impacted ourselves, our communities, and our nation and world.

You don’t have to be a statistician and understand all the intricacies to understand, for example, the basics of probability. When something is more likely than something else, that doesn’t mean it will always happen. When you throw a pair of dice, it is more likely to come up 7 than any other single number (6 of the 36 possibilities – 1 in 6 -- are 7). This does not mean it will always be 7, or usually be 7, or even be 7 a majority of the time, but (given enough throws) it will be 7 more often than any other number. If you understand this, you are on your way to interpreting scientific data. If you don’t, don’t shoot craps.

In medicine, a diagnostic test or treatment that works only 1/6 times is not likely to be used, so the probability that it will give an accurate diagnosis or a successful treatment is going to be much higher. But almost never 100%. 99% is very good; 1% is a small chance, and if you had a 1% chance of getting 7 and crapping out, or getting a wrong answer on a test, you’d go for it. But if something is done a million times, 1% is 10,000. You, or a loved one, could be one of the 10,000 in whom a test is inaccurate, a treatment fails, or even a side effect kills you. That is terrible for you, but doesn’t increase the likelihood of it happening to the next person. If you throw dice, the odds of a certain combination are the same every single time. Even if someone, say, rolls 11 six times in a row it doesn’t change the probability (1/36) of getting an 11 the next time. There is no such thing as “hot dice” or a “hot shooter”. If you don’t understand that, don’t play craps.

Enough of probability now. The main point is that because something bad sometimes happens with a test or treatment doesn’t make it bad. Some of the issues in health that are most controversial now, like vaccines, are phenomenally and overwhelmingly good. Most of the bad things attributed to it are completely made up (not that the bad thing happened to someone, but that it was the result of the vaccine), and the others are very rare, far more rare than the bad things happening to the unvaccinated.

While truth does evolve and change with new discoveries, those changes are usually logical and stepwise. We know about something, and new information increases our knowledge. It rarely completely contradicts everything we know; it theoretically could and there have been some discoveries that did, but if a claim seems to it is very unlikely. It is usually internet spam, promulgated by people who think you are a sucker and may pay them for something that magically solves a problem. If you have a health problem, this is almost never the way to go. Sure, pharmaceutical companies are scum-sucking parasites who would kill their mothers, not to mention you, to make a buck, but that doesn’t mean the medications that they make are bad, ineffective, or more dangerous than what you can buy over the internet because somebody says it works. The FDA (at least historically, before it became decimated) required rigorous testing of medications before they are released to the public, while the miracle cures you see on the internet have not. In addition, the doses are standardized and consistent. You can know what you are getting, and if you cut the dose in half or double it, that is what you are doing. With unregulated drugs, you don’t know.

Yes, there are many natural substances that can help, and indeed many prescription and regulated drugs have their origin in them. But even though aspirin may have originated from willow bark, how much willow bark is the right dose for you? From what age tree? Growing in what conditions? In what season? What about next time? Or your next door neighbor? Or your kids? A good rule of thumb is the old saying: If something seems too good to be true, it probably is. “Magical” cures on the internet never are. Another old saying, attributed to P.T. Barnum, is “a sucker is born every minute”. No one wants to be that sucker, but people are remarkably inconsistent about when they will be judicious and when they will swallow the Kool-Aid whole.

If someone you hate and think is stupid tells you something that sounds ridiculous and unbelievable, you probably won’t believe them. But what if it is a friend? If what they say is something that you already think might be true? Looking things up on the internet (sometimes called “doing your research”) is actually not a bad way to start. You usually find accurate information. This is really different from reading something sent to you or spammed out by bloggers (like me) or “influencers”; if someone is “reaching out” to you, it is basically marketing. Think of the difference between you calling your bank to find something out about your account and getting a call from someone that says that they are your bank!

How does this relate to social justice? Are there not believers and non-believers in data and science in both majority and minority groups, among the young and old, among the rich and the poor, among liberals and conservatives? Sure, but the impact is different among these different groups. Many people are not only acting on their own fringe and unscientific views, but pushing and promulgating them to others. And, as always and as in almost everything, it is the poorest, least empowered, least educated, most marginalized, those with the thinnest safety net, who suffer the most. We may occasionally read of someone who has been hoist on their own petard, refused vaccination and died of the disease, followed a wacko diet or taken unregulated medication who gets ill or dies from it, but when the society or government rejects science in favor of public health policies based on fringe beliefs, it is the least well off who are most often harmed.

Remember, there may be magic in the movies, but there is not real magic in the world. If something sounds to good to be true…


Monday, April 14, 2025

RFK, Jr.: The Secretary of Health and Human Services is Dangerous to Your Health!

It can sometimes seem like the public health and medical communities are “ganging up” on Robert F. Kennedy, Jr., with ongoing criticism and attacks on his beliefs and, more important, his policies. The rebuttal is that this man, whose thinking is wildly unscientific and fringe, is the incredibly powerful Secretary of Health and Human Services, in charge of the second biggest department in the US government (after Defense) in budget and staff, and responsible for the diverse, varied, and highly important components of that department. These include Medicare, the health insurance system for the aged and disabled and Medicaid, the federal/state partnership that provides insurance for many low-income Americans (mostly children and their mothers in number, mostly long-term care in dollars). It also includes the Centers for Disease Control and Prevention (CDC), which studies and intervenes in both infectious and chronic disease, the Food and Drug Administration (FDA) that oversees the safety and effectiveness of our – food and drugs, the National Institutes of Health (NIH) that funds and supports most medical research, and other major agencies, including the Indian Health Service (IHS) that provides health care on Native American reservations, the Health Resources and Services Administration (HRSA) that funds community health centers and many other major service delivery and educational program, and the Substance Abuse and Mental Health Services Administration (SAMHSA) that supports addiction and mental health services. It’s a big, responsible, job.

And, so, there are a lot of things that can be screwed up. And a lot things are being screwed up. By him. In part, this may be because of his general incompetence and lack of actual knowledge about health care (knowing little about their portfolio is a common thread among those Trump has selected to lead federal departments). Kennedy is not a health professional, although he is a health “profess-er” – he professes a lot of opinions.  A lot of the screw up is the result of the DOGE-created cuts of 10,000 people from the HHS workforce in all of these agencies. Some of it is the administration’s political antipathy to programs (like Medicaid) that help people in need instead of the wealthiest in society who don’t need help at all. And no small part of it is because the beliefs that he has about health that come from fringe proponents of every bizarre remedy from ivermectin (good for worms, not for COVID) to hydrogen peroxide to Vitamin A to prevent measles, and opponents of many of the health interventions that we know really work to save lives. Let’s look at some of these.

Measles is a bad disease. It causes a great deal of morbidity. I come from a generation of children who almost all had measles – and varicella (Chicken Pox) and rubella (German measles), and mumps. Most of us survived, without even being hospitalized. But some did not. About 20% (1 in 5) people/children with measles are hospitalized, which means they are very sick. From 1-3 per 1000 die. That is a lot. Not as many as currently die from, say, being shot at school, but a lot. The thing is, though, that measles is preventable by vaccine. Per the CDC:

A vaccine became available in 1963. In the decade before, nearly all children got measles by the time they were 15 years old. It is estimated 3 to 4 million people in the United States were infected each year. Among reported measles cases each year, an estimated:

·       400 to 500 people died

·       48,000 were hospitalized

·       1,000 suffered encephalitis (swelling of the brain)

 

After the vaccine, measles went from being an endemic disease to one that was essentially eliminated. Until many people stopped vaccinating their children, based on unfounded fears of side effects, especially autism, being promoted by unscientific “experts” – like Kennedy. He has commissioned a new study on the link, to be done by discredited physician Andrew Wakefield, and thus is ignoring hundreds of studies with over 3 million children that show no link! Kennedy has also promoted using Vitamin A to prevent or mitigate measles. While in countries where there is widespread Vitamin A deficiency, this is a good strategy, there is no significant prevalence of Vitamin A in the US. And taking more to “be safe” is a bad idea since Vitamin A, a fat-soluble vitamin, accumulates and causes toxicity. So now, in addition to over 700 cases and at least 3 deaths (which suggests the number of cases is an underestimate) from measles, we have children being hospitalized for Vitamin A toxicity! And measles is only one serious condition; I have written about infections in children with Hemophilus influenza B and even worse polio (Raw milk, vaccines, and RFK, Jr: Some dates worth remembering, November 15, 2024) and was reminded of its effects on a recent episode of “Call the Midwife” which featured a man in an iron lung. Let’s not bring polio back!

Kennedy has also angered many Native American tribes, simultaneously calling for greater attention to their health status (good) and cutting the programs that benefit them, as covered by the Arizona Star (RFK Jr. says chronic disease in tribes a focus as program to do that gutted). He has also made the possibly not serious but nonetheless insulting proposal to move laid-off health workers from CDC and other HHS agencies to reservations (NY Times Kennedy’s Plan to Send Health Officials to ‘Indian Country’ Angers Native Leaders).

While on many of these issues, such as opposition to vaccines, Kennedy is simply wrong (and dangerous, see the recent NY Times article The many ways Kennedy is already undermining vaccines), on others it is less clearcut, which is why his opinions get traction. For example, he advocates strongly for the importance of diet and exercise to health. Those are generally are good. Most people should get more exercise and eat more healthful foods (and fewer unhealthful ones). But that is not a panacea. A healthful diet will not prevent measles – or COVID or smallpox or Hemophilus influenza B infections or cancer – although having good general underlying health will likely make one relatively able to weather such conditions better. Kennedy employs many logical fallacies in his pronouncements, including setting up “straw men” to knock down, using misdirection to keep you from looking at what he is saying, data-dumping to overload you, appeal to (false) authority (like Wakefield), and others. Some of these are discussed in the NY Times piece, From ‘Data Dumping’ to ‘Webbing’: How Robert F. Kennedy Jr. Sells Misleading Ideas and by Dr. Jessica Knurick.Your Local Epidemiologist”, Katelyn Jetelina, discusses the Progress on Make America Healthy Again (MAHA), his signature plan. It has made a lot of progress, although it has been in reverse, making America less healthy. For more on his strategy, check out Paul Offit, MD, of the American Council and Science and Health, who describes the RFK Jr. Playbook. And, of course, he has traded on his family name and the reputations of his father and uncle John, who would (like most of his surviving family) be outraged by his positions.

Kennedy’s ideas and actions are both unscientific and damaging to the public’s health, leading the American Public Health Association (APHA) to call on him to resign or be fired in a statement enumerating many of his most damaging actions and dangerous pronouncements. All the “charges” it lists are accurate, and serious, and he should be gone. He is a real danger to our health. But the things he has championed, his hypocrisy and sleight of hand, and the false relativism he promotes that is dangerous, would unfortunately not be likely to be better with any HHS Secretary nominated by the current President. Most of Trump’s Cabinet and other senior-level picks have been unqualified, uninterested, and incompetent at best, and evil at worst. It has been said that their only “qualification” needs to be obsequious loyalty to Donald Trump, but a serious commitment to ruining the lives of as many American people as possible also seems to be important.

And, of course, that is the intention.

Friday, December 20, 2024

Dark Times for Public Health and Healthcare: Will the insurance industry fix itself?

It’s an exciting time for both health care and public health! Anything goes, and almost anything is, or will in the near future! On the public health front, we have the nomination by President-elect Trump of Robert Kennedy, Jr. to the post of Secretary of Health and Human Services. Kennedy has long been what is generously called a “vaccine skeptic” and his lawyer, Aaron Siri, has sued the Food and Drug Administration to revoke the approval of the polio vaccine. Although the NY Times article says ‘Like Mr. Kennedy, Mr. Siri insists he does not want to take vaccines away from anyone who wants them. “You want to get the vaccine — it’s America, a free country." This is disingenuous. If the FDA approval is revoked, nobody will be able to get it.

I have written recently about the importance of vaccines, especially polio and measles, in preventing disease and death (Raw milk, vaccines, and RFK, Jr: Some dates worth remembering, Nov 15, 2024). A series of letters to the Times in response to the Siri article make clear the risk. Read them; they address the science, the controlled trials of polio vaccine, the experience of those who were doctors and children during previous polio epidemics, and touchingly, the experience of dancer Tanaquil LeClerq, wife of choreographer George Balanchine (short answer: no vaccine, polio, and paralysis). In regard to other vaccines, we can read in the Times ‘Tiny Coffins: Measles Is Killing Thousands of Children in Congo’ and imagine it happening in the US as a result of Kennedy’s anti-vaccine actions. Kennedy calls his movement “health freedom” and says that he will give infectious diseases a “break” (whatever that means), but in fact, as described by Gregg Gonsalves in The Nation, RFK Jr. Is Giving Infectious Diseases a Promotional Tour.

I posted on Facebook that I have heard people say “kids get too many shots”, and asked “then which preventable disease do you want your child to die of?” One comment I got from a colleague was that the problem was not that kids get too many shots, but that too many kids get shot! The most recent killings, in a Christian school in Madison, WI (15-Year-Old Girl Identified as the Shooter in a Wisconsin School) were at least the 323rd this year in the US! THIS is an epidemic, the extent of which people in most other countries cannot imagine, and, like many of us, wonder what will be done about it. Sadly, the answer is going to be very little, if anything; we may be closing out the statistics for deaths from school shootings in 2024, but nothing suggests that 2025 will be any better.

On the healthcare front, things are not getting better. The anger at the health insurance industry exposed by the shooting of UnitedHealthcare CEO Brian Thompson was deep, broad and well-justified, as I wrote in Murder of a Health Insurance CEO: People HATE the companies and the people who run them (Dec 8, 2024). Study after study continues to appear providing evidence that more and more people have inadequate, unaffordable, or no health insurance. The Commonwealth Fund recently published a report that shows Hispanic/Latino Adults Lack Adequate, Affordable Health Insurance Coverage,

and that this led to their having real trouble accessing health care. The breadth of this lack goes far beyond Latinos.

Maybe we can come up with a solution! I think I have already indicated several – mainly instituting a single-payer universal national health insurance program. Or, until we do, capping the amount of out-of-pocket costs a person can have to a reasonable number ($1000?). And limiting the profits of health insurers, or the ways in which health care providers (e.g., hospitals mainly, but also nursing homes, doctors, etc.) act to make money, whether technically profit or “non-profit”, at the expense of people’s health.

Others have entered this discussion. In a remarkable Op-Ed essay in the NY Times on Dec 13, UnitedHealth Group’s CEO Andrew Witty (Brian Thompson’s boss, who makes more than $20M a year) wrote The Health Care System Is Flawed. Let’s Fix It. Unfortunately, what is remarkable about this article is that the Times chose to run it at all, since it makes no significant suggestion on how to “fix” it, certainly none that would threaten UnitedHealth’s profits. It mostly displays the Times’ complicity in an effort to focus away from the righteous fury of the American people with the health insurance industry.

USA Today reports on Seven reasons why Americans pay more for health care than any other nation, and it gets most of them right. (Reason 1: Lack of price limits, Reason 2: Hospitals and doctors get paid for services, not outcomes, Reason 3: Specialists get paid much more ‒ and want to keep it that way, Reason 4: Administrative costs inflate health spending, Reason 5: Health care pricing is a mystery, Reason 6: Americans pay far more for prescription drugs than people in other wealthy nations, Reason 7: Private Equity.) There are a few others, but it is a good list. Despite that, however, it doesn’t come up with a meaningful, comprehensive solution to them, or any of them. Indeed, it ends up quoting the Witty piece referenced above, "We know the health system does not work as well as it should, and we understand people’s frustrations with it,” rather than having any kind of answer. Like, say, universal non-profit health insurance, limits on hospital system (and physician) incomes, and banning private equity and other for-profit players from the health system!

Maybe it is asking a lot for insurance companies, largely the perpetrators of this massive scam that is bleeding the entire US economy, to come up with a “solution”. But USA Today, Commonwealth Fund, and others that do such a good job of identifying the problem should be able to take the simple next step to recommending the fix. In what is to me an amazingly open (if entirely disgusting and reprehensible) acknowledgment of their agenda, CNBC reported back in April 2018 that Goldman Sachs, the huge investment bank (Jamie Dimon, CEO) raised the question (discussing biotech research) ‘Is curing patients a sustainable business model?’.

!!??

Actually, it’s a good question. Maybe the answer is “no”. Most ethical physicians I know (and it is the vast majority who are ethical) have always said something like “I look forward to the day when we can put ourselves out of business”. Investment banks and other forms of private equity, and the insurance companies like UnitedHealth and the providers that they control, do not see this as a positive. Maybe it is refreshing to see such a stark portrayal of the problem? Or not.

But I, and I believe most Americans, would rather see diseases and the people who have them cured, and would be happy to see the profits of any of these profiteers, privateers, just plain ganevem, and the salaries of their C-suite execs and Boards, disappear.

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.

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