How much will that cost me? On hospital pricing

Hospital pricing is notoriously difficult to understand. Until very recently, it was also impossible to find out how much a hospital was going to charge you for a test or procedure until you got the bill.

Starting January 1, 2021, each hospital operating in the United States was required to provide clear, accessible pricing information online about the items and services they provide both as a comprehensive machine-readable file with all items and services and in a display of shoppable services in a consumer-friendly format.

Initially this rule was largely disregarded, and those hospitals that did post prices did so in a way that only computer geeks could access. Gradually, more hospitals are complying.

Does this matter to you? If you have good health insurance, it may not matter that much, as your insurance company will have negotiated rates for most hospital services. If you are uninsured (still 10% of the U.S. population) or if you are among the many more with high-deductible plans, it matters a lot.

If you have a high-deductible plan, you may have to pay the entire charge for an MRI of your knee, and so if it is $800 or $2800 matters.

There are two things you need to know before “price shopping” for a test or procedure.

The first is that prices vary wildly, and with little correlation between price and quality. A recent study found that the hospital charge for uncomplicated vaginal childbirth varied from $1183 to $55,221 (that is not a typo!).

The second is that if you call the hospital billing department and ask the price, there will often be a major difference between what you are told and what is posted on the hospital website. In only 15% of hospitals that both posted prices on-line and gave them over the phone were the prices the same, and differences often exceeded 50%.

So…if you are uninsured or underinsured, take the time to price shop when you can – when it is not an emergency. Try the websites for several hospitals near you to get an idea of which are at the high end and which at the low end. Then, try calling the billing departments. If they quote you a lower price than the on-line price, get in in writing by email or post.

Two other cost-conscious suggestions:

When you are well, check which hospitals near you are in your insurance network – when you are ill this will probably not occur to you, and going to an out-of-network hospital can cost you dearly.

Just because your doctor says you need something does not guarantee that it will be covered. Always ask if prior authorization is needed before having the test or procedure.

The money you may save will be yours!


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But I read it on Facebook!

The Internet has led to democratization of information access. Information that was locked away in libraries or simply not readily available to most of us can now be found with a simple search.

Along with that, however, has come a flood of misinformation. When you do a Google search, the leading links may be pure gold or utter dross. How can you tell the difference?

If you were to open your favorite social media site and read that Frigidaire appliances were suddenly bursting into flames, would you immediately put your refrigerator out on the street? I doubt it – you would probably check this out on Consumer Reports or call your appliance store. You would also apply your common sense.

So, why is it that some of my patients would come to a visit and say they had stopped their cholesterol medication because they saw a post that the medicine caused dementia?

Anything can be posted on the Internet. Some flagrantly racist or other hate speech may (or these days may not) be taken down, but grossly misleading health information usually stays on-line.

When you search, the top hits are often sponsored links or sites that have carefully managed their description to get a high ranking, with minimal relation to the quality of the content.

How can you tell if a site is worth visiting? Focus on the messenger before looking at the message. The best place to look for scientifically valid and unbiased information are sites maintained by the National Institutes of Health. These will always have the domain nih.gov as part of their URL. Another great source of information is the National Library of Medicine, whose URL will contain medlineplus.gov.

If these do not give you what you want, go next to websites maintained by major medical centers such as the Mayo Clinic, Johns Hopkins or Mass General-Brigham. These will obviously lean towards attracting patients to their institution, but still have high quality content.

Avoid celebrity sites and those that are trying to sell products or services.

The quickest way to decide if a link is likely to be useful is to go first to those tagged .gov, then to those tagged .edu and third to those tagged .org.

When seeking health information, caveat emptor!


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Bird flu - time to panic?

Spoiler alert: No.

What is bird flu? It is an influenza virus, related to the seasonal flu viruses that plague us every winter but one which predominantly spreads among birds. The specifics are that is an H5N1 form of influenza. (Those letters and numbers describe certain proteins on the virus surface and vary quite a bit from year to year, epidemic to epidemic.)

This particular virus has reached pandemic status among birds – it has been found on every continent but Australia and has killed millions of birds. It seems to be spread by migrating wild birds but has been lethal to domestic fowl, leading to the culling of many flocks in Europe and America. The price of foie gras may go up.

The reason for the recent interest is that the virus can spread from birds to mammals. Foxes, cats, seals, dolphins and bears have been infected. Most recently, outbreaks of bird flu have occurred in dairy cattle in the U.S. Herds in at least five states have been infected.

Last week, the virus was confirmed to have infected a human: a farmworker in Texas. This is not new; scientists have known for some time that people who have direct contact with sick birds or mammals can be infected. To date, there have been no known cases of human-to-human spread.

The virus has been found in the milk from infected cows and eggs of infected chickens, but the virus is killed by pasteurization or cooking. It could potentially be spread by consuming raw milk or using uncooked eggs.

To become a serious threat to human health, the virus would have to undergo major mutations to allow human-to-human spread. Not impossible, but unlikely.

Also in our favor is that the few people proven to be infected with H5N1 have had very mild illness. The man in Texas had only conjunctivitis (“Pink eye”).

Finally, the antiviral drugs like oseltamivir (Tamiflu) work well to reduce symptoms, and are readily available.

So… stay away from raw milk for now, be sure to cook your eggs, and, most important, do not pick up or examine dead birds or animals, and warn your children not to do so. A veterinarian called to a north shore beach found that the dead birds were all infected. Let the pros handle it.


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Colon cancer - find it early!

Cancer of the colon and rectum is very common. Colorectal cancer will occur in over 150,000 Americans this year. It is the third-leading cause of death in men and the 4th in women. Because it is an “equal opportunity” scourge, it is the second-leading cause of death when combining men and women (just behind lung cancer).

Very troubling is the increasing incidence in younger people, a phenomenon that doctors cannot yet explain. We used to think that it was very rare in people under 50 unless you had an uncommon genetic risk, but colorectal cancer is being increasingly diagnosed in people in their 40’s or even 30’s.

When caught early, it is very curable. The secret is early detection.

The controversy is how best to detect it early and when to start looking.

Most cancers begin as polyps, some of which slowly develop into cancer. The hallmark of such pre-cancerous polyps is “atypia,” which can only be proven with microscopic examination. If all polyps are removed, the likelihood of ever developing cancer is minimal.

Clearly the ‘gold standard’ of early curable cancer detection is colonoscopy. After a good clean-out, allowing the gastroenterologist to see well, any polyps present can be removed and sent for examination. Ideally, everyone over 40 should have a colonoscopy (5 years ago I would have said over 50). If it is entirely normal, your next one can be in 8-10 years. If polyps are removed, that timetable will be shortened.

The problem is that no one LIKES having a colonoscopy. It is really not that bad. When you finish this post, Google “Dave Barry colonoscopy.”

No matter how much I or your primary care doctor urge it, not everyone will consent. There are other ways to detect colorectal cancer before symptoms develop, when it is often advanced.

The commonest test is to check for hidden bleeding in the bowel, which can herald polyps. Of the available tests for this, the current standard is the FIT (fecal immunochemical test), which has only about a 25% predictive value for cancer and advanced polyps when positive. A negative test does NOT guarantee you are in the clear, and to be useful the test must be done annually.

Another option is a stool DNA test, which is much more specific for advanced polyps and early cancers. On the horizon are blood tests that are fairly accurate.

Key to properly using any stool or blood test is to follow a positive test with a colonoscopy – sadly only half of people with such positive tests get one in a timely manner.

Buck up – listen to Dave Barry and just do it. The life you save will be your own.


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Kidney from a pig - is it really a big deal?

Your kidneys are critically important organs that clear toxic substances from the body and regulate your fluid balance. Kidney disease is very common, affecting millions of Americans. So-called “end-stage” kidney disease is kidney disease so advanced that without treatment, death is imminent. Presently, over 800,000 Americans are affected by this advanced stage of the disease.

It is very rare that kidney disease can be cured surgically or medically. Instead, you must either get a new kidney from a donor or go on dialysis. Dialysis is a technique in which the blood is filtered by a complex machine that tries to do what the kidneys are no long capable of doing. The technique was developed in the 1940’s but only became widely used in the 1970’s.

Dialysis, to be blunt, is no fun. You have to be connected to the machine 3 times a week and stay at the center for 3 to 4 hours each visit. About 1 in 7 dialysis patients, who have good home support, can do the procedure at home. While it is life-saving, patients on dialysis rarely feel really well.

A breakthrough in the treatment of kidney failure came in 1954 with the first transplantation of a kidney from a human donor to a patient with end-stage kidney disease. This was done by Dr. Joe Murray at the Brigham, and the donor was the recipient’s identical twin. The first transplant from an unrelated donor came 8 years later, in 1962.

Any time an organ is transplanted from anyone but an identical twin, the body recognizes the transplanted organ as foreign, and tries to eliminate it, the way it tries to eliminate bacteria. To prevent rejection of the new kidney, the body’s immune system must be suppressed, leaving the recipient at higher risk of infection.

When transplantation is successful, the recipient of the new kidney feels much better, physically and emotionally, as they can now lead a normal life rather than being tied to a dialysis center.

Why don’t all patients with end-stage kidney disease get a transplant? Simple: there are not enough organs available. Of the 800,000 with the condition, over 2/3 are on dialysis and fewer than 1 in 3 have had a transplant.

If the recent transplant, from a pig that was genetically engineered to have kidneys that were closer to human genes, is successful, the huge bottleneck that is availability of kidneys for transplant would be removed.

Can we declare success? Not yet. The two men who had pig hearts transplanted both died soon after the surgery. We hope the Boston man who got the recent transplant does well, but only time will tell. There are too many unknowns to predict the outcome. In addition to the problem of rejection of the new organ, pigs carry many viruses that humans do not, and one or more of these may cause problems.

If this volunteer is alive and with a functioning kidney in several years, a giant step will have been achieved.

The number one cause of chronic kidney failure is poorly controlled high blood pressure, so if you have hypertension, be sure to have it controlled with medication.


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Ultra-processed foods: what are they? Why should you care?

About half the calories consumed by people in high income countries such as the United States and Canada come from ultra-processed foods, and such a high consumption of these “Franken-foods” contributes to many health problems.

What are ultra-processed foods?

Most of our food is processed to some degree, if only with preservatives, and not all processing is bad. Pasteurized milk is “processed,” and is generally safer than unpasteurized milk. Iodine added to salt gives health benefits.

There are many ways to classify how foods are processed, but the most widely used system is NOVA, developed by academic food scientists in Brazil.

NOVA Group 1 includes unprocessed or minimally processed foods. The latter includes removal of inedible parts, drying, roasting, freezing, etc., with no additives.

Group 2 includes processed ingredients such as salt, sugar and oils that are used as additives.

Group 3 includes foods where the Group 2 ingredients are added to Group 1 food to increase their durability and enhance their flavor.

Group 4 foods are those that are ultra-processed, foods that are manufactured, often in several steps. Natural food products are fractionated into sugars, protein, oil and fats, starches and fiber. These component parts are then chemically treated, most often by hydrolysis or hydrogenation. The final food product is then assembled with various industrial techniques and colors, flavors and preservatives are added.

Common ultra-processed foods we may consume daily include carbonated soft drinks, packaged snacks, ice cream, flavored breakfast cereals, prepared pies, pasta dishes and pizzas, “nuggets,” hot dogs, sausages and powdered instant soups and desserts. Note that some of these may be labelled “all-natural” or organic.

Why should you care? High consumption of ultra-processed foods has been linked to such health problems as obesity, diabetes, high blood pressure, cancer and many gastrointestinal disorders.

Recent studies have shown that ultra-processed foods, usually high in both sugar and fat, trigger a similar brain response as do addictive substances like nicotine and alcohol.

What should you do? First, realize that U-P foods are not arsenic. Having a scoop of ice cream or some fries once in a while will not kill you. In moderation, they can be part of a healthy diet. The goal is to keep U-P foods to less than 25% of your daily calories.

Eat fresh or stewed fruit in place of store-bought pies and cakes. For breakfast, have oatmeal or minimally processed granola with fruit rather than sugary cereals. Cook more: bake chicken or fish rather than heating up prepared frozen dinners.

Look at labels. If a product contains 4 or more ingredients, some of which you cannot pronounce, put it back. If it is obvious where the food came from (eggs come from hens, apples from trees) it is generally OK. If the origin is unclear, try something different.

Don’t fall for hype – an “organic natural” packaged cookie might still be ultra-processed.


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Why do so many American women die from childbirth?

For most of human history, pregnancy and childbirth was the cause of many women’s deaths. In the modern era, this should be an extremely rare event, and in most of the developed world it is.

About 800 women in the U.S. die every year during pregnancy, delivery or the 6 weeks that follow delivery. Our maternal mortality statistics are our shame. Maternal mortality per 100,000 live births is 4.4 in Sweden, 8.0 in France, 9.2 in the United Kingdom and 7.3 in Canada, while in the U.S. it is 26.4.

Globally, maternal mortality has been steadily falling while in the U.S. it has been rising.

There is a clear racial disparity, with deaths from pregnancy much higher among Black and Native American women than among white, Asian and Hispanic women. For Black women, poorer care compounds their tendency to more of the hypertensive disorders of pregnancy. However, even white women die at a higher rate in the U.S. than in any of our peer developed countries.

Why is this? Doctors here are often too slow to recognize the importance of even mild high blood pressure in a pregnant woman and fail to treat it, leading to the dangerous condition called eclampsia. Because severe complications of pregnancy at any given hospital are rare, most hospitals do not have an organized plan to deal with severe hemorrhage after delivery or embolism of the amniotic fluid (large bubbles of amniotic fluid entering the mother’s circulation).

Experts who study maternal deaths estimate that about 70% of the deaths due to hemorrhage, infection or cardiovascular conditions are preventable. California adopted a comprehensive plan to lower maternal deaths, with “best practice” guidelines widely distributed to every hospital and obstetrician, and was able to cut its death rate in half between 2006 and 2013.

Additionally, many women die from treatable mental health problems, notably depression and suicide, that are missed, often because the new mother is not seen after delivery. While most women bring their infants in for a well-baby visit, many skip their own post-partum check, often because they do not want to take time off from work.

Most western countries provide ample paid time off for new mothers, no matter their occupation, while in the U.S. this tends to be a “luxury” afforded only to highly paid professionals. We should be advocating for 3 months paid maternity leave for ALL women.

Ask your local hospital if it has systems in place to deal with the infrequent but lethal emergencies that occur during pregnancy and delivery. Make sure any friends and relatives who deliver have adequate support. Offer to take them for post-partum checks.

We should be emulating Sweden and Canada, not Afghanistan and Swaziland.


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Who will care for me when I am old and gray?

Every day, 12,000 Americans turn 65. In 2022, 58 million were over 65 – 17% of the population – and estimates are that by 2040, seniors will make up 22% of the population.

While most people over 65 are healthy, as we age illnesses and frailty become increasingly common, and growing numbers need at least some care in their daily lives. How do they get that care?

Unlike many other western countries, the US has no organized program to help seniors who are unable to live and function independently. In many cases, particularly for those over 80, the choices come down to placement in a nursing home or a lot of help at home to allow them to avoid that dreaded option.

Many elders and their families are surprised to learn that Medicare does not pay for anything but short-term rehabilitation, either for nursing home stays or home health care. If you have a hip replaced, Medicare will cover a week or so at a rehab facility and a few weeks of home PT and visiting nurses, but if you are simply too frail and sick to live independently, you are on your own.

Long-term care insurance is available, but it is very expensive and frequently does not cover the full cost of nursing homes or extensive home care.

To get the care needed at home, home health aides are available but this “system” is full of problems. Such care is generally provided through agencies that hire and vet the aides. They charge the patient a lot and pay the aides very little. Most home health aides get minimum wage for very demanding work, resulting in a huge turn-over. Why lift and clean an elder when you can earn the same hourly wage at McDonalds?

In the end, it often falls to family members to provide needed care, difficult at best when families are scattered around the country and often trying to hold down a job while assisting their parent(s).

Medicaid will pay for nursing home care, but to be eligible, the recipient must spend down most of their assets and become impoverished. They cannot give away assets to their family – this is carefully scrutinized. Moreover, Medicaid rates are generally so low that you will not find many “upscale” homes willing to take you.

What can you do? Don’t get old. Seriously, one important factor is to stay as fit as you can to avoid the need for help. While exercise increases longevity, its more important benefit is to keep you independent longer.

If you can afford it, investigate long-term care insurance. Be very careful in reading the policy and assessing the likelihood that the policy will cover your needs.

While you are healthy, begin to make your home more “aging-friendly.” Get grab bars in the shower, railings on all stairs, better handles on doors and cabinets and put shelves lower.

Write to your state and federal legislators and ask them to start working on a plan, either at the state or national level, to improve the care we offer our frail elders. Part of any such plan must include better pay for home health aides to encourage people to make this a career.


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The heart risk factor no one knows about

Most readers of these columns, I assume, are aware of the relation between elevated cholesterol and coronary heart disease, and of the benefit of reducing high cholesterol with diet and medication. The statins have saved many lives, and newer agents have come to market for those who cannot take statins.

I do hope you are not among the third of Americans who do not know their cholesterol.

What I would like to discuss here is another heart risk factor, which has been prominently discussed recently in the cardiology community but has not received much attention more widely. This is lipoprotein(a), commonly referred to as Lp(a) and verbalized as “L p little a.”

Lp(a) is an LDL (low density lipoprotein) molecule with an apo(a) protein attached. It can be trapped in the arterial wall, causing atherosclerosis (“hardening of the arteries”) and it increases clotting.

We know a lot about Lp(a). It is genetically-determined; there is very little effect of diet on levels. This means that you don’t need to measure it on a regular basis – if it is high, it will stay high, and if it is low, it will stay low.

It is a major factor in causing coronary disease, independent of standard cholesterol values.

As of now, there are no medications available to lower it, but new medicines are on the horizon.

If we cannot treat it, you may ask, why measure it?

First, if it is elevated, your doctor can put you on cholesterol-lowering medication even if your standard cholesterol levels are normal and would not be treated. No one risk factor works alone, and even if we cannot yet lower a high Lp(a), we can still reduce your risk of heart attack by treating other risk factors.

Second, there is recent evidence that low-dose daily aspirin, which is now considered not appropriate for the general population, will cut in half the heart attack and stroke risk in people with Lp(a) over 50.

So, at your next visit, ask your doctor if they have ever measured your Lp(a), and request they do so if it has never been done.

Knowledge is power.


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Private Equity in Health Care

Those of you in the metro Boston news market have been regaled with the saga of the failing Stewart Health Care System, owner of nine hospitals in eastern Massachusetts. One eye-catching story described the $40 million yacht purchased by Stewart’s CEO, Dr. Ralph de la Torre, while Stewart hospitals were having equipment repossessed because of failure to pay their bills.

While a 190-foot yacht catches attention, it is only a symptom of a deeper problem.

Private equity (PE) firms’ business model is to buy companies as cheaply as possible, pull as much cash as they can from the company and then either resell it or declare bankruptcy. To be able to sell the business, they have to jack up profits by cutting costs and/or raising prices.

Private equity investment in healthcare is a recent phenomenon but one which is rapidly growing. These firms focus on specialties where lucrative procedures can be done and/or where patients have little choice. Many emergency medicine groups, pathologists and anesthesiologists now work for entities controlled by private equity. These groups were responsible for most of the “surprise” out-of-network bills that made headlines in the last few years. Knowing that patients rarely if ever have the option to select a physician in these fields, they would pull out of insurance contracts and then bill whatever they wanted.

Quality is secondary to the acquiring PE firm; profits come first. They can increase revenue by raising fees and/or encouraging their employed physicians to do as many well-paid procedures (such as catheterizations and endoscopies) as can be justified, even if not all are truly needed. They can cut costs by skimping on equipment and supplies that are not “revenue-producing,” even if they improve quality care. They can also substitute less-qualified, lower-paid personnel, such as aides in place of nurses.

Steward offers a textbook example. Cerberus Capital bought the troubled Massachusetts-based Caritas Christi hospital system, promising to turn it around. Soon after, they sold the land and buildings of its own hospitals to a real estate trust, pulling out $1.2 billion and saddling the hospitals with hundreds of millions in annual rent. That transaction allowed Cerberus to quadruple its investment and to pay its investors a $100 million dividend. They bought hospitals around the country, including Texas, Florida and Ohio. Many of these have since been closed, doubtless after the PE investors had pulled as much money out as possible.

So, Stewart’s CEO has a very expensive yacht and communities around the country are dreading the closure of what is often their only nearby hospital.

Tell your state legislators that private equity has no place in health care, certainly not without very strict guidelines and oversight.





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Do you want to live to be 100?

In 1521 Ponce de Leon arrived in Florida in search of the mythical fountain of youth; those who drank from it or bathed in it were said to be returned to their youth. Some 500 years later, the New York Times ran a lengthy article on a longevity guru whose disciples wear T-shirts emblazoned Don’t Die and who buy supposedly rejuvenating vitamins and supplements from him by the bushel.

What is real in our search for longevity? I assume that most of you, like me, are interested in healthy longevity – I would rather be well and active into my 90’s than live into my 100’s in a frail dependent state.

The maximum lifespan of any species, including our own, seems to be fixed. The longest documented human lifespan was 122 years, and the next oldest were 119. About 120 would seem to be as much as we can hope for.

In the famous Blue Zones, 5 scattered sites in Italy, Japan, Greece, Costa Rica and California, many people live healthy and active well into their 90’s, and much of what we know about healthy longevity came first from studying these populations, backed up by many other studies.

While heredity clearly plays a role – the best single predictor of a long life is having long-lived parents - only some 30% of your chance for a long healthy life comes from choosing the right parents. Much is under our control.

Diet is a critical factor. If longevity is very important to you, prepare to be hungry. There is incontrovertible evidence in mice and considerable data in humans that calorie restriction lengthens lifespan.

What you eat is important. Contributing to a long and healthy life is eating a plant-based diet, heavy in fruits and vegetables with little or no red meat. Get your protein from fish and nuts, and use olive oil in place of butter. This type of diet leads to less heart disease and less cancer.

Move. Regular exercise both leads to less premature death and better quality of life. While any amount of exercise is much better than none, more is better. Even walking 30 minutes a day will pay dividends, but exercising more and longer is even better. Do not forget strength. Aerobic exercise will do the most to extend life, but strength training prevents falls and injuries and strengthens the bones.

Don’t smoke. If you do, quitting now will do more to improve your health than anything else you can do.

Minimize your alcohol intake. There is soft evidence that moderate drinking may reduce heart disease, but it increases a variety of other disorders. One drink a day is probably a wash, but more is clearly bad.

Get enough sleep. Sleep is when we rejuvenate, and try for at least 8 hours a night.

Socialize. Spending time with friends and family and participating in group activities is very common in the Blue Zones and has been shown to be associated with less depression and better physical health.

See your doctor once in a while. Many chronic diseases that shorten life, including hypertension, high cholesterol and diabetes, have simple treatments that prevent premature death and worse diseases. A few preventive measures such as colonoscopy and immunizations have good data supporting their use.

Pills? Not many. As I wrote a while back, there is now data supporting the use of a daily multivitamin to stave off dementia. Softer evidence favors the amino acid taurine and the diabetes pill metformin; both are in early stages of testing and I do not take either. Most other supplements enrich their sellers but do not help you.

There are no quick fixes to let you live longer and better, but there are many things you can do.



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COVID - forgotten but not gone

Understandably, most of us have developed “Covid fatigue.” After what seems like years of warnings and behavior changes, we want to put it all behind us. Unfortunately, while we are tired of the virus, the virus is not tired of us.

The latest variant to appear, JN.1, is much more transmissible that its predecessor even though it has only a minor genetic change. It has rapidly become the dominant strain hitting the U.S. and much of the world. Fortunately, the last vaccine, aimed at an earlier variant, seems to be very protective against severe illness and death, even if not that good at preventing infection.

While not nearly as dramatic as the situation of 2-3 years ago, both case counts and deaths have been trending up. For the last period for which we have complete data, some 1500 Americans are dying of Covid every week – most, but not all, older and/or with severe underlying illnesses, and most not up to date on their vaccines.

Only 19% of adults 18 and older and 8% of children have received the current vaccine. Of those 65 and older, at highest risk of severe disease, only 38% have been fully vaccinated.

What should we do?

First and most important, get your booster! Vaccines only work when you get them.

Second, wear a well-fitted mask when you are indoors with lots of people. Think concerts, bridge games, indoor sporting events. While not a panacea, masks do cut down transmission of both Covid and other respiratory viruses such as colds and flu.

Finally, if you are sick, stay home. You do not want to be the one who recovers but finds out that you gave the virus to your elderly aunt who died. There will always be another event.

For those who do get sick, treatments are available that help. Paxlovid is under-used. In the older population, it cuts hospitalization and death by more than half. If you are very high risk, IV antibody treatments are even more effective.

We do not want or need to go back to the days of school closures and shuttered restaurants, but we can and should do these simple things that protect us all.



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Is the FDA protecting us adequately?

The high point of the FDA (Food and Drug Administration) showing its worth came in 1960, when Dr. Frances Kelsey refused to let thalidomide be marketed in the U.S. She prevented the U.S. from experiencing the epidemic of babies born with deformed limbs to mothers who were prescribed the drug for morning sickness in Europe.

Do we still have similar guardians? Recent years have seen a raft of drugs and devices of dubious value approved by the FDA.

Example: Zurzuvae was approved in August 2023 to treat postpartum depression. This is a major depressive disorder that begins during pregnancy or within 4 weeks after delivery. Standard recommended care is psychotherapy or the well-studied group of antidepressants called SSRIs (selective serotonin reuptake inhibitors). Zurzuvae works on the same brain receptors as benzodiazepines (think Valium, Xanax) and barbiturates, and so not surprisingly causes sedation, sleepiness and dizziness, and most people who take it for over a week suffer withdrawal symptoms when they stop.

Two studies of Z were done in women with severe postpartum depression, and in both it was compared to placebo, not SSRIs. It was superior, but the placebo group saw about 75% of the improvement seen in active drug users. The real test would have been comparison with a safer SSRI, not a placebo.

Moreover, even though only patients with severe depression were studied, the drug was approved for all patients with the disorder. I’d avoid it.

Example: In Dec 2019, the FDA approved the oral drug Olaparib for treatment of pancreatic cancer. This drug is priced at $12,000 PER MONTH. The study leading to approval showed a very modest improvement in survival: 18.9 months vs. 18.4, with no quality-of-life benefit. Statistically significant perhaps, but clinically? I’d also question using placebo rather than existing approved drugs as the comparison.

In addition to drugs, I could describe many devices of dubious value, but will only mention one in the interest of brevity.

In 2023 the FDA approved two devices that destroy nerves to the kidney to treat high blood pressure without medication. Two studies have been done. One showed no benefit and one showed statistical lowering, but by an average of 3 mm – less than the usual variation I would see between two measurements in the same visit. Is that worth the estimated $6000 that using the device will cost? Do we have data showing long-term benefit? (No!)

We should require that the pharmaceutical and medical device industries fund studies that clearly define which patients will benefit from new drugs and devices. We should then also require our regulators to protect the public by forcing new innovations to pass a proper bar before being allowed on the market. “Might help some people,” at high cost and with potential side effects is not a high-enough bar, not when lives are at stake.

Let the FDA know they need more Dr. Kelseys and fewer rubber stamps.



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Who makes the decisions about your health care?

If you have commercial health insurance or are one of the over half of Medicare enrollees who have a “Medicare Advantage” plan, decisions about your health care are not decided solely by you and your doctor(s). There is a third party in the room: your insurer, whose interests are financial rather than health.

As medicine became more complex and much more expensive, one response of health insurance companies was to try to decrease the use of expensive tests and treatments. They developed lists of tests, medications and procedures that could in some cases be substituted by older cheaper tests and treatments. When a doctor wished to order an expensive new approach, they had to justify why this was necessary.

If done properly, this was fair and reasonable. Every expensive new drug is not always better than a cheap old one. Every patient with back pain does not need a CT scan or MRI. The problem is that insurers went overboard.

The process works like this: your doctor sends a prescription to your pharmacy or asks their staff to schedule you for an imaging test. They then hear from the pharmacy or the radiology department that your insurance company requires “prior authorization.” The cost will not be paid until the insurance company agrees it is needed. The doctor’s office calls the insurer and are questioned by a clerk with no medical background using a checklist. Sometimes miracles happen, every box is checked and you get approval.

More often, your doctor is told that the request does not meet their criteria for necessity and will not be paid. There are now three choices: do it anyway and have you, the patient, pay the bill; forget about it and try a different approach; request an appeal of the decision.

For all but the very wealthy, paying out of pocket is very difficult. If there indeed is a good cheaper alternative the system has worked as intended. Most of the time the request is necessary for the best outcome and the doctor must appeal.

A survey found that the average doctor’s office devoted 14 person-hours a week to prior authorizations – time that costs the doctor money and takes away resources that could be better spent on care. Clearly the insurers hope that if they deny needed care, the doctor may sometimes decide it is not worth the time and effort to appeal.

Recent investigations by ProPublica and others have found that many insurance companies rely on biased algorithms to deny needed care. They have also documented that insurance company medical directors review 10,000 cases/year or more, and often make decisions without even looking at the patients’ charts. Moreover, many companies employ as medical directors doctors who have been driven out of practice by disciplinary action or numerous malpractice suits.

If your doctor’s suggestion is denied by your insurance company, what can you do? If you and your doctor agree that the denied service is truly best for you, insist on appealing. While the doctor’s office has to take the lead, you can add your voice to the process. Get the HR office at work to intercede on your behalf. Threaten to – and do if necessary – contact the state office of consumer affairs.

It is their money – but it is your life and health.



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