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Congressmen For Snake Oil: How The Supplement Industry Is Preventing The FDA From Protecting Consumers

The weakness and ineffectiveness of the law in the U.S. regulating dietary supplements has been a frequent topic here on Science-Based Medicine, including the continued failure of efforts to address the serious shortcomings of current law and the illogic at its very heart. Indeed, over the last decade or so that I’ve paid attention to relevant issues regarding supplements continually amazed at how much supplement manufacturers can get away with and for how long. For example, one of the most recent atrocities against science occurred when Boyd Haley, disgraced chemistry professor at the University of Kentucky and prominent member of the mercury militia wing of the anti-vaccine movement, tried to sell an industrial chelator as a dietary supplement to treat autistic children. True, that was too much even for the underfunded, undermanned FDA to ignore, but it was amazing how long he got away with it. Apparently it takes someone trying to market a chemical compound that can’t by any stretch of the imagination be characterized as a “nutrient” or “food” to be so obviously against even the travesty of a mockery of a sham of a law regulating supplements (the Dietary Supplement Health and Education Act of 1994, or the DSHEA) that the FDA could take action.

Of course, here at SBM, we’ve written numerous posts on the shortcomings of the DSHEA. Basically, this law created a new class of regulated entities known as dietary supplements and liberalized the sorts of information that supplement manufacturers could transmit to the public. The result has been this:

It [the DSHEA] also expanded the types of products that could be marketed as “supplements.” The most logical definition of “dietary supplement” would be something that supplies one or more essential nutrients missing from the diet. DSHEA went far beyond this to include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. Although many such products (particularly herbs) are marketed for their alleged preventive or therapeutic effects, the 1994 law has made it difficult or impossible for the FDA to regulate them as drugs. Since its passage, even hormones, such as DHEA and melatonin, are being hawked as supplements.

One might wonder how such a bad law could survive for so long (seventeen years now), but it has its defenders. One man, in particular, defends the DSHEA against all regulatory threats, Read more »

*This blog post was originally published at Science-Based Medicine*

A Brief History Of Vaccines, The Anti-Vaccination Movement, And Modern Quackery

A good case of smallpox may rid the system of more scrofulous, tubercular, syphilitic and other poisons than could otherwise be eliminated in a lifetime. Therefore, smallpox is certainly to be preferred to vaccination. The one means elimination of chronic disease, the other the making of it.

Naturopaths do not believe in artificial immunization . . .

—Harry Riley Spitler, Basic Naturopathy: a textbook (American Naturopathic Association, Inc., 1948). Quoted here.

Here’s what a good case of smallpox will do for you:

If you’re lucky enough to beat the reaper (20-60%; 80% or higher in infants) or blindness (up to 30%), those blisters will leave you scarred for life. Oh, and the next time a good smallpox epidemic comes around, your children born since the last one will catch it and contribute their fair share to the death rate. But not you because you’ll be immune, so you’ll have the “preferred” experience of watching your children die well before you do.

Variolation and Vaccination

Except that none of this will happen, because the disease has been eradicated from the world—thanks, of course, to vaccination, which Napoleon reasonably called “the greatest gift to mankind.”

Smallpox was “the most terrible of the ministers of death.” It began at least several thousand years ago and rapidly spread wherever its human carriers traveled, eventually to the entire populated world. In endemic regions, it wiped out 1/4 to 1/3 of children in epidemics that occurred every few years. In epidemics among people who had not previously seen it, such as the natives of the Western Hemisphere during the early years of European explorations, it wiped out as many as 90% of everyone. It brought down armies and empires. Monarchs dropped like flies; it spared no socioeconomic class. Gods were invented in its name. There was never an effective treatment for it once it had begun.

Prior to the advent of vaccination, there was a heroic method that proved useful in reducing the severity of the disease. This was inoculation (‘variolation’): crude matter from a pustule of someone with the disease was etched into the skin of an uninfected person. This resulted in somewhat more indolent clinical cases, with death rates of ‘only’ around 2%, but the disease remained terrible and those so infected could still transmit it to others by means other than inoculation.

Vaccination, as many readers already know, was introduced near the end of the 18th century in England by the physician Edward Jenner. Jenner neither discovered it—it seems to have been discovered by milkmaids (and their close associates) who had noticed that after experiencing a cowpox blister, they never caught smallpox—nor was he the first to use it purposefully or even to write about it. He was the first, however, to conduct and report a series of convincing experiments demonstrating that people previously infected with cowpox could not subsequently be infected with smallpox (by variolation). He also showed that cowpox could be transferred from person to person by inoculation of matter from the cowpox blister, thus offering the first method for widespread use. Jenner is thus given credit not only for having introduced vaccination for smallpox, but for having introduced the concept of vaccination in general, although he would not live to see another example.

The Antivax Movement is Born

Opposition to smallpox vaccination (the name comes from the Latin for “cow”) began almost immediately after Jenner’s reports and remained substantial for more than 100 years. Some opposition was explicitly religious; some was based on disbelief in the method or, later, in the Germ Theory; some objectors claimed that vaccination caused terrible diseases, including smallpox itself; some voiced a political objection to state mandated vaccination programs. An early cartoon suggested that if Jenner had his way, people would start to look like cows:

Two antivax organizations in 19th century Britain were the National Anti-Vaccination League and the Society for the Abolition of Compulsory Vaccination. They sought to discredit Jenner’s reports and to argue, in keeping with the popular “hygiene” and “sanitation” movements of the day, that “cleanliness is more likely to prevent smallpox than [is] introducing filthy matter into the body.”

The Holy Trinity of American Quackery

These were, in the late 19th and early 20th centuries, homeopathy, chiropractic/osteopathy, and naturopathy. Hahnemann himself had approved of his contemporary Jenner’s assertion, believing that it confirmed “like cures like” (ably refuted by Oliver Wendell Holmes, Sr.). Constantine Hering, however, the “Father of American Homeopathy,” was the first homeopath to declare his opposition to vaccination. He called it “always a poisoning” and asserted, “we learn from year to year a more certain and better way of curing small-pox homeopathically.” He nevertheless admitted in 1883, near the time of his death, that this ‘better way’ had not achieved the certainty of prevention by vaccination.

In 1918, Benedict Lust, the “Father of American Naturopathy,” wrote this:

Like the alchemist of old who circulated the false belief that he could transmute the baser metals into gold, in like manner the vivisector claims that he can coin the agony of animals into cures for human disease. He insists on cursing animals that he may bless mankind with such curses.

To understand how revolting these products are, let us just refer to the vaccine matter which is supposed to be an efficient preventive of smallpox. Who would be fool enough to swallow the putrid pus and corruption scraped from the foulest sores of smallpox that has been implanted in the body of a calf? Even if any one would be fool enough to drink so atrocious a substance, its danger might be neutralized by the digestive juices of the intestinal tract. But it is a far greater danger to the organism when inoculated into the blood and tissues direct, where no digestive substances can possibly neutralize its poison.

The natural system for curing disease is based on a return to nature in regulating the diet, breathing, exercising, bathing, and the employment of various forces to eliminate the poisonous products in the system, and so raise the vitality of the patient to a proper standard of health.

Official medicine has in all ages simply attacked the symptoms of the disease without paying any attention to the causes thereof, but natural healing is concerned far more with removing the causes of disease…

In those words we find several of the recurring themes in quackery that were evident in the 19th century and remain so today. We know that naturopaths continued to espouse this view of vaccination at least until 1968, when the quotation at the top of this essay was among the materials they submitted to the Department of HEW in an unsuccessful attempt to be covered by Medicare. They’ve since learned to be somewhat more subtle about the issue, possibly because of the 1968 failure, but their distaste for vaccinations in general persists, as explained here.

An Aside: the “Cause of Disease,” Naturopathy-style

I’m sure you’ve been wondering, so here it is, right from the pen of Harry Riley Spitler, the author of the quotation that began this piece (courtesy of the 1968 HEW report):

The primary cause of disease is reaction to unnatural environment . . . When the body is weighted down by toxins in excess of the amount with which the vital force is able to cope, then enervation… supervenes and there is a lag in the body’s power to expel the “ashes” of metabolism… Enervation leads to the secondary cause of so-called disease — toxemia. Toxemia is the state of auto-intoxication resulting from the accumulation ot poisons in the body – poisons taken in from without in the form of incorrect food, impure water, vitiated air, etc., and which are not thrown off by the body because of its enervated state, and in addition thereto the poisons formed within the body itself by the processes of metabolism. . . The presence of these poisons within the blood stream and tissues causes the vital force to make efforts to eradicate toxemia, and these efforts are what is called “diseased crises.” . . . Disease, therefore, is not a hostile entity to be attacked, but is rather a manifestation of vital force in its efforts to continue to live and to remove anti-vital conditions caused by man’s deliberate, or ignorant, breaking of the laws of health and life … Disease, then, is the result of stagnation and accumulation of filth in the blood stream and in the tissues.

And the cure? Back to Lust:

The Program of Naturopathic Cure

1. ELIMINATION OF EVIL HABITS, or the weeds of life, such as over-eating, alcoholic drinks, drugs, the use of tea, coffee and cocoa that contain poisons, meat-eating, improper hours of living, waste of vital forces, lowered vitality, sexual and social aberrations, worry, etc.

2. CORRECTIVE HABITS. Correct breathing, correct exercise, right mental attitude. Moderation in the pursuit of health and wealth.

3. NEW PRINCIPLES OF LIVING. Proper fasting, selection of food, hydropathy, light and air baths, mud baths, osteopathy, chiropractic, and other forms of mechano-therapy, mineral salts obtained in organic form, electropathy, heliopathy, steam or Turkish baths, sitz baths, etc.

And, of course, enemas.

Natural healing is the most desirable factor in the regeneration of the race.

Wow. It’s all kind of fascistic, no? But I’m digressing.

More on the Holy Trinity

You probably noticed Lust’s approval of chiropractic, another field with a rich tradition of antivax fervor. Some chiropractors have learned to be a bit more subtle; others have not (and not all contemporary chiropractors are opposed to vaccinations). If you’ve perused the 1968 HEW report, you also know that the American naturopathic schools of the mid-20th century were mostly spawned by chiropractors, and that for some time there was little distinction between naturopaths and “mixer” chiropractors. Many “NDs” of that time also had “DC” after their names.

You may also know that contemporary naturopaths love homeopathy. Lust didn’t include it in his NEW PRINCIPLES OF LIVING, probably because of his emphasis on “drugless healing.” Nevertheless, he praised Hahnemann for having shown “the physicians of his day…that just as good results could be brought about by means so gentle that even a delicate child could be treated, without the slightest particle of danger.” It seems to have been left to the next generation of American naturopaths to fully embrace homeopathy, and this was done most conspicuously by a man who himself embodied the Holy Trinity of Quackery: John Bastyr, N.D., D.C. (1912-1995), the “Father of Modern Naturopathic Medicine.”

Bastyr was also described as a

…third-generation homeopath from Dr. Adolph von Lippe. His teacher was Dr. C. P. Bryant (who had been, in 1939, president of the International Hahnemannian Association). C. P. Bryant had been taught by Walter Bushrod James who had been one of Lippe’s closest students. He received doctorate degrees in naturopathy and chiropractic from Northwest Drugless Institute and Seattle Chiropractic College, respectively. He became licensed to practice naturopathic medicine in 1936. He is also credited with being the Father of Modern Naturopathic Medicine. Because of Bastyr’s influence naturopaths have been at the forefront of the rebirth of homeopathy in this country. He made sure that homeopathy shared equal emphasis with nutrition, hydrotherapy and botanical medicine in naturopathic education. Dr. Bastyr considered manipulation the most important therapy in his practice.

So there you have it: the mystical unity of three seemingly incompatible True Causes (Psora, Subluxations, Toxemia), and of three seemingly incompatible True Cures (similia similibus curentur, spinal manipulation, enemas). No wonder that John Bastyr the chiropractor is credited with having been the Saviour of naturopathy and homeopathy in the United States.

Another Aside: Early Vaccinations really were Dangerous

It’s ironic to consider that many of the early objections to smallpox vaccinations were somewhat justified, far more so than are contemporary objections to contemporary vaccinations. Material gathered from cowpox blisters, transferred from human to human, was invariably contaminated. Diseases plausibly attributed to such “arm to arm” vaccinations, in the era before the Germ Theory elucidated such risks in advance, included syphilis, hepatitis, and even smallpox itself, due to contamination from variolations occurring within the same hospitals or clinics. The advent of exclusively animal sources of cowpox didn’t occur until the mid-19th century, and “arm to arm” vaccinations weren’t outlawed in Britain until 1898. Preparations of pure virus—vaccinia—were introduced only in the mid-20th century.

The political objection to mandatory vaccinations also had more clout in the early days, when the concept of “herd immunity” had yet to be introduced.

“All this has happened before, and all this will happen again.”

This is from a meeting of the Connecticut Homeopathic Medical Examining Board, March 12, 2003:

TREATMENT OF SMALLPOX

The Board reviewed the following procedures for the prevention and treatment of smallpox as submitted by Dr. Mullen:

PREVENTION

Malandrinum

It is recommended to administer it at a potency of 30 CH twice a day for up to 5 days as a preventive. This remedy is also very useful to combat the ill effects of Allopathic small pox vaccination, as well as to control the disease that happens when a person gets unwillingly infested by the vaccine received from another.

Sarracenia

It is recommended to administer this remedy at potencies of up to 9 CH. I believe a good dosage schedule would be once a week for 2 or 3 weeks. It is recommended to administer this remedy at a potency of 6 CH every 8 days. Also useful in recent and distant ill effects of Allopathic vaccination.

Vaccininum

An indication for the use of vaccininum would be a patient’s fear of contracting smallpox.

Variolinum

Both Drs. Allen and Vosin enthusiastically endorse this remedy for the prevention of small pox. I would advice to administer it at potencies of 30 CH or 200 CH weekly for 3 or 4 weeks.

TREATMENT

Malandrinum

It is recommended to administer it at a potency of 30 CH. This remedy is particularly useful in patients whose symptoms are more evident in the lower half of the body. I would recommend daily administration for 5 consecutive days and then re-evaluate the patient.

Mercurius 200 CH every other day alternating with Thuja 200 CH.

I would recommend to use this combination up to 10 consecutive days and then re-evaluate the patient.

Sarracenia

It is recommended to administer this remedy at a potency of 9 CH. I would recommend to use it for 5 consecutive days and then re-evaluate the patient. This remedy can stop the disease in its earliest stages, including the development of pustules. The patient may be very sensitive to light, weak in the shoulder area and have shooting pains in zigzag from the lumbar region to the middle of the scapula.

Variolinum

It is recommended to administer it at any potency. I would recommend using it for up to 5 consecutive days, depending on the potency, and then re-evaluate. Variolinum is useful in patients with mild and uncomplicated small pox. Also when pustules are surrounded by a red halo and are often very itchy. Every other day for up to 10 consecutive days and then reevaluate the patient.

Thuja 200 CH

Every other day for up to 10 consecutive days and then re-evaluate the patient.

Wow. What exquisite, quaint, balderdash. Here’s a fun exercise that readers might enjoy: see what contradictions you can find between what you’ve just read and other efforts of the Connecticut Department of Public Health. Hint: start here. Then look at some of the practice acts, such as those for homeopathy, naturopathy, and chiropractic. Does one hand know what the other is doing?

*This blog post was originally published at Science-Based Medicine*

Health And The Value Of Open-Mindedness

Three recent sto­ries lead me to my open­ing topic for the year: The value of open-mindedness. This char­ac­ter­is­tic — a state of recep­tive­ness to new ideas — affects how we per­ceive and process infor­ma­tion. It’s a qual­ity I look for in my doc­tors, and which I admire espe­cially in older people.

Piece #1 — On the brain’s matu­rity, flex­i­bil­ity and “cog­ni­tive fitness”

For the first piece, I’ll note a Dec 31 op-ed piece that appeared in the New York Times: This Year, Change Your Mind, by Dr. Oliver Sacks, the neu­rol­o­gist and author. In this thought­ful essay, he con­sid­ers the adult brain’s “mys­te­ri­ous and extra­or­di­nary” power to adapt and grow: “I have seen hun­dreds of patients with var­i­ous deficits — strokes, Parkinson’s and even demen­tia — learn to do things in new ways, whether con­sciously or uncon­sciously, to work around those deficits.”

With appro­pri­ate and very-real respect, I ques­tion Sacks’ objec­tiv­ity on this sub­ject — he’s referred some of the most out­stand­ing (i.e. excep­tional) neu­ro­log­i­cal cases in the world. And so it may be that his care­ful reports are per­fectly valid but not rep­re­sen­ta­tive; for most of us, the adult brain’s capac­ity to estab­lish new cir­cuitry for lan­guage learn­ing or music appre­ci­a­tion may be lim­ited. What his sto­ries do show is that unimag­in­ably strange things hap­pen in our brains, at least occa­sion­ally. And maybe we should just accept that and take notes (as he does so care­fully), and keep an open mind. Read more »

*This blog post was originally published at Medical Lessons*

Echinacea For Colds: Does It Really Work?

Does echinacea, the popular natural cold remedy, really work?

It depends on what you mean by “work.” Results [recently] reported in the Annals of Internal Medicine found that echinacea may reduce the length of a week-long cold by 7 to 10 hours and make symptoms a little less onerous. That can’t be characterized as a major effect, so many people may figure that the trouble and expense of echinacea just isn’t worth it (fortunately, side effects from echinacea don’t seem to be much of an issue.)

But others may decide that some benefit is better than none, and these results do fit with others that have left the door slightly ajar for echinacea having some effect as a cold remedy — a modest effect, but an effect, nonetheless.

A summary for patients published by the Annals summed up the situation nicely:

People who take echinacea to treat colds may experience a decrease in the length and severity of their cold symptoms but to such a small degree that they may not care about the difference. Although many studies of echinacea have been performed, researchers still disagree about its benefits in treating the common cold. This study is unlikely to change minds about whether to take this remedy.

Have you tried echinacea as a cold remedy? Has it worked? How do research findings, pro and con, affect your opinion of so-called alternative medicines?

Many of the echinacea studies, especially early on, were sponsored by companies making or selling the product. This study was supported by a grant from the National Center for Complementary and Alternative Medicine, which is part of the National Institutes of Health.

- Peter Wehrwein, Editor, Harvard Health Letter

*This blog post was originally published at Harvard Health Blog*

Immunizations: NCCAM Fails To Provide Responsible Information

If you go to the website of the National Center for Complementary and Alternative Medicine (NCCAM), you’ll find that one of its self-identified roles is to “provide information about CAM.” NCCAM Director Josephine Briggs is proud to assert that the website fulfills this expectation. As many readers will recall, three of your bloggers visited the NCCAM last April, after having received an invitation from Dr. Briggs. We differed from her in our opinion of the website: One of our suggestions was that the NCCAM could do a better job providing American citizens with useful and accurate information about “CAM.”

We cited, among several examples, the website offering little response to the dangerous problem of widespread misinformation about childhood immunizations. As Dr. Novella subsequently reported, it seemed that we’d scored a point on that one:

…Dr. Briggs did agree that anti-vaccine sentiments are common in the world of CAM and that the NCCAM can do more to combat this. Information countering anti-vaccine propaganda would be a welcome addition to the NCCAM site.

In anticipation of SBM’s Vaccine Awareness Week, I decided to find out whether such a welcome addition has come to fruition. The short answer: Nope. Read more »

*This blog post was originally published at Science-Based Medicine*

Latest Interviews

How To Make Inpatient Medical Practice Fun Again: Try Locum Tenens Work

It s no secret that most physicians are unhappy with the way things are going in healthcare. Surveys report high levels of job dissatisfaction burn out and even suicide. In fact some believe that up to a third of the US physician work force is planning to leave the profession…

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Caring For Winter Olympians In Sochi: An Interview With Team USA’s Chief Medical Officer Dr. Gloria Beim

I am a huge fan of the winter Olympics partly because I grew up in Canada where most kids can ski and skate before they can run and partly because I used to participate in Downhill ski racing. Now that I m a rehab physician with a reconstructed knee I…

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Latest Cartoon

Richmond, VA – In an effort to simplify inpatient medical billing, one area hospitalist group has determined that “altered mental status” (ICD-9 780.97) is the most efficient code for use in any patient work up.

“When you enter a hospital, you’re bound to have some kind of mental status change,” said Dr. Fishbinder, co-partner of Area Hospitalists, PLLC. “Whether it’s confusion about where your room is located in relationship to the visitor’s parking structure, frustration with being woken up every hour or two to check your vital signs, or just plain old fatigue from being sick, you are not thinking as clearly as before you were admitted. And that’s all the justification we need to order anything from drug and toxin screens, to blood cultures, brain MRIs, tagged red blood cell nuclear scans, or cardiac Holter monitoring. There really is no limit to what we can pursue with our tests.”

Common causes of mental status changes in the elderly include medicine-induced cognitive side effects, disorientation due to disruption in daily routines, age-related memory impairment, and urinary tract infections.

“The urinalysis is not a very exciting medical test,” stated Dr. Fishbinder. “It doesn’t matter that it’s cheap, fast, and most likely to provide an explanation for strange behavior in hospitalized patients. It’s really not as elegant as the testing involved in a chronic anemia or metabolic encephalopathy work up. I keep it in my back pocket in case all other tests are negative, including brain MRIs and PET scans.”

Nursing staff at Richmond Medical Hospital report that efforts to inform hospitalists about foul smelling urine have generally fallen on deaf ears. “I have tried to tell the hospitalists about cloudy or bloody urine that I see in patients who are undergoing extensive work ups for mental status changes,” reports nurse Sandy Anderson. “But they insist that ‘all urine smells bad’ and it’s really more of a red herring.”

Another nurse reports that delay in diagnosing urinary tract infections (while patients are scheduled for brain MRIs, nuclear scans, and biopsies) can lead to worsening symptoms which accelerate and expand testing. “Some of my patients are transferred to the ICU during the altered mental status work up,” states nurse Anita Misra. “The doctors seem to be very excited about the additional technology available to them in the intensive care setting. Between the central line placement, arterial blood gasses, and vast array of IV fluid and medication options, urosepsis is really an excellent entré into a whole new level of care.”

“As far as medicine-induced mental status changes are concerned,” added Dr. Fishbinder, “We’ve never seen a single case in the past 10 years. Today’s patients are incredibly resilient and can tolerate mixes of opioids, anti-depressants, anti-histamines, and benzodiazepines without any difficulty. We know this because most patients have been prescribed these cocktails and have been taking them for years.”

Patient family members have expressed gratitude for Dr. Fishbinder’s diagnostic process, and report that they are very pleased that he is doing everything in his power to “get to the bottom” of why their loved one isn’t as sharp as they used to be.

“I thought my mom was acting strange ever since she started taking stronger pain medicine for her arthritis,” says Nelly Hurtong, the daughter of one of Dr. Fishbinder’s inpatients. “But now I see that there are deeper reasons for her ‘altered mental status’ thanks to the brain MRI that showed some mild generalized atrophy.”

Hospital administrators praise Dr. Fishbinder as one of their top physicians. “He will do whatever it takes to figure out the true cause of patients’ cognitive impairments.” Says CEO, Daniel Griffiths. “And not only is that good medicine, it is great for our Press Ganey scores and our bottom line.”

As for the nursing staff, Griffiths offered a less glowing review. “It’s unfortunate that our nurses seem preoccupied with urine testing and medication reconciliation. I think it might be time for us to mandate further training to help them appreciate more of the medical nuances inherent in quality patient care.”

Dr. Fishbinder is in the process of creating a half-day seminar on ‘altered mental status in the inpatient setting,’ offering CME credits to physicians who enroll. Richmond Medical Hospital intends to sponsor Dr. Fishbinder’s course, and franchise it to other hospitals in the state, and ultimately nationally.

***

Click here for a musical take on over-testing.

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Latest Book Reviews

The Spirit Of The Place: Samuel Shem’s New Book May Depress You

When I was in medical school I read Samuel Shem s House Of God as a right of passage. At the time I found it to be a cynical yet eerily accurate portrayal of the underbelly of academic medicine. I gained comfort from its gallows humor and it made me…

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Eat To Save Your Life: Another Half-True Diet Book

I am hesitant to review diet books because they are so often a tangled mess of fact and fiction. Teasing out their truth from falsehood is about as exhausting as delousing a long-haired elementary school student. However after being approached by the authors’ PR agency with the promise of a…

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Unaccountable: A Book About The Underbelly Of Hospital Care

I met Dr. Marty Makary over lunch at Founding Farmers restaurant in DC about three years ago. We had an animated conversation about hospital safety the potential contribution of checklists to reducing medical errors and his upcoming book about the need for more transparency in the healthcare system. Marty was…

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