Category Archives: Uncategorized

Overweight people live longer

woman with scale

A new study from Canada, one of the largest of its kind, has confirmed yet again that overweight people live longer. The study, published in the journal Obesity, followed over 11,000 Canadian adults for 12 years. The study found:

Overweight (BMI 25 to <30) was associated with a significantly decreased risk of death (RR = 0.83, P < 0.05). The RR was close to one for obesity class I (BMI 30–35; RR = 0.95, P >0.05). Our results are similar to those from other recent studies … showing that when compared to the acceptable BMI category, overweight appears to be protective against mortality…

Morbid obesity increased the risk of death, but underweight increased it even more:

A significant increased risk of mortality over the 12 years of follow-up was observed for underweight (BMI <18.5; relative risk (RR) = 1.73, P < 0.001) and obesity class II+ (BMI >35; RR = 1.36, P <0.05). In other words, for a woman who is 5’5″ tall, and “ideal” weight is considered to be 114-149 lbs. But those women weighing 150-174 lbs actually lived longer than those weighing less than 150 lbs and women weighing 180-204 lbs lived as long as women of “ideal” weight. Those most at risk for shorter lifespan were women weighing less than 114 pounds. As the authors indicate, this study merely confirms what decades of scientific evidence have already demonstrated. Contrary to the conventional wisdom, overweight people live longer. It’s worth asking: if the scientific evidence shows that overweight is protective, why has it become conventional wisdom that being thin is healthiest? The answer, I believe, is prejudice. Simply put, being overweight is associated with being poor. As I have written in the past, many American predilections are grounded in economic status, and weight is no different. When poor people were thin because they didn’t have enough to eat, being overweight was a sign of status. Similarly, when poor people were tanned because of working outside, white skin was a sign of status. When poor women couldn’t afford anesthesia for childbirth, access to chloroform was a sign of status. Now, of course, status is associated with a midwinter tan (courtesy of a tropical vacation), a commitment to “natural” childbirth, and, especially, being thin. Wealthy people are thin, and celebrities are thin. Indeed, we are so obsessed with being thin as a sign of status that both women’s magazines and celebrity magazines are filled with diets and the tales of people who have successfully lost weight. By implication, the overweight are poor and less desirable. The idea that being thin is healthier also dovetails nicely with another American fantasy: that we can control our health by what we eat. Of course morbid obesity is a serious health problem with potentially deadly consequences. However, simply being overweight is not only safe, but actually appears to be protective compared to “ideal” weight. That’s what the data really show. Thin is in, because it is viewed as a sign of economic status, and an indication of personal rectitude, but it is not justified by the scientific data, nor by the fact that weight is now a proxy for wealth. Like any prejudice, it is not justified at all.

Can we please stop pretending that preventive medicine saves money?

healthcare savings

Conventional wisdom about healthcare reform rests on a big lie. Most major proposals for healthcare reform depend for financing in part on the purported savings from preventive care. The problem is that preventive care does not save money.

No less an authority than the Congressional Budget Office has pointed out that both the scientific and the financial literature indicate that preventive care is at best a break-even proposition, and may actually cost money. Members of Congress and proponents of healthcare reform have expressed shock at the CBO’s findings, but it’s not really surprising when you consider what preventive care is, what it can do, and what it costs.

A fundamental lay assumption about health is that all people could be healthy if we simply tried hard enough. That’s a corollary to the American fantasy that we have far more control over our health than we actually do. While personal habits and the environment do have an impact, health is largely beyond our control, depending as it does on genetic factors, natural pathogens like bacteria and viruses, and the inevitable wear and tear of aging. In fact, most people, if they live long enough, are sure to get sick. Thus preventive healthcare, even at its most effective, can only postpone disease or turn fatal diseases into chronic diseases.

The benefits of preventive care to the individual are beyond dispute. It is obviously better to be healthy or at least healthier than to be sick. The benefits to society, on the other hand, must be balanced against the costs of preventive care, and, it turns out, preventive care costs quite a bit.

The CBO explains the different costs of preventive care:

The direct cost of the preventive service;

The cost of treating any adverse reactions to the preventive
service;

The cost of follow-up testing and treatment for patients with positive screening tests; and

The cost of treating unrelated diseases that occur because of an individual’s extended life span. (emphasis in the original)

These costs can vary widely depending on the specific type of preventive care. Consider Pap smears, the test for cervical cancer. Pap smears are relatively inexpensive and have no adverse reactions. However they have a high false positive rate (many more women have abnormal Pap smears than have cervical cancer and pre-cancer). Every woman with an abnormal Pap smear will need to have an intensive follow up exam with special instruments and biopsies of the cervix, but most won’t have the disease. Early cervical cancer is relatively easy to treat successfully, leading to many more years of productive life. Ultimately, of course, a woman cured of cervical cancer will go on to develop other medical problems that will cost money. On balance, though, the costs of prevention are small, and the benefits are large.

On the other hand, diseases like AIDS have a very different cost benefit ratio. HIV testing for the virus is relatively inexpensive, and the follow up testing is not expensive, either. However, the treatment is extraordinarily expensive and it does not cure the disease. It can cost upwards of $10,000 a month for anti-retroviral medication. And the medication merely turns a disease that is fatal in the short term, to a chronic disease that may last years and is often fatal in the long term. The benefits to the patient and his family are, of course, incalculable, but the financial costs are massive.

That does not mean that we should stop HIV testing or other extremely expensive forms of preventive care. We are ethically mandated to provide testing and treatment, even though it costs a considerable amount. It does mean, though, that we must shed out delusions that the “cost savings” of preventive medicine can finance healthcare reform.

Associated Press writer Carla K. Johnson reports:

Legislation pushed by Senate Democrats mentions “prevention” repeatedly. The Senate panel heading up health reform also calls for more research on prevention…

President Barack Obama as recently as April said investing in prevention “will save huge amounts of money in the long term.” And it has become almost an article of faith among Republicans, Democrats and business leaders that prevention reduces health care costs.

But the Congressional Budget Office last week issued a statement on health care overhaul that dismissed the notion that prevention saves money. Prevention “would have clearer positive effects on health than on the federal budget,” the CBO said…

[R]esearcher Peter Neumann of Tufts Medical Center said counting on disease prevention to save money “promises painless solutions to our health cost problems. I don’t think they’re going to be painless and they have to be done.”

Healthcare reform is going to involve extremely difficult financial choices, and the sooner we stop pretending that preventive medicine will minimize the need for such financial choices, the better off we will be.

I couldn’t figure out the correct dose, so I just gave her the whole bottle.

nurse drawing up medication

Medical errors are a very serious problem in the United States, causing harm to tens of thousands of patients each year. A substantial proportion of those problems are actually nursing errors, not really medical errors at all, and many of those are medication errors: wrong dose, wrong medicine, wrong method of administration. And some are truly spectacular failures of judgment.

When I was a chief resident, I admitted Mrs. B who had a history of a near fatal pulmonary embolus (blood clot in the lung) in her first pregnancy. She survived after treatment with anti-coagulants (blood thinners) and went on to have a healthy baby. Mrs. B was advised that if she ever got pregnant again she should call her doctor immediately. That’s because pregnancy is a hypercoagulable state making pregnant women much more likely to develop blood clots. She needed to be started on injectable blood thinners as early in her pregnancy as possible to prevent the development of another embolus.

Most medications have a set dose, or at least a dose based on the patient’s weight. Blood thinners, however, have no set dose. Each patient needs a different amount to achieve the right balance between reducing the risk of blood clots and still retaining enough clotting ability to prevent internal bleeding. The patient was admitted to the hospital to find the correct dose for her.

In the end, the correct dose for Mrs. B turned out to be 5600 units twice a day, a rather large dose. Since heparin came in glass vials containing 1000 units per cc (cubic centimeter), each injection contained more than 5 cc of heparin. It was very painful for the patient to have such a large amount injected each time. Mrs. B reminded me that when she took heparin to treat her pulmonary embolus she used a more concentrated version, 10,000 per cc. She needed only slightly more than ½ cc in each injection, and it was far less painful. I promised her that I would arrange for the more concentrated version of heparin.

It should have been sufficient for me to write the order for 5600 units twice a day using heparin 10,000 units per cc, but mindful of the potential for confusion, I wrote a far more detailed order and attached a note to the chart alerting all the nurses to the change. I emphasized that the patient would be getting the exact same dose of heparin. The only difference is that it was dissolved in a tenth the amount of sterile water.

Imagine my surprise when, sitting outside the nurses station med room, I overheard the following conversation at “report,” the hand over of patients from one nurse to the next.

“Dr. Tuteur changed the heparin order. Remember Mrs. B was getting 5600 units of heparin twice a day? Remember how we gave her heparin from 5 and 6/10th vials of medication? Now the heparin comes in 10,000 units in each vial,” the first nurse reported.

“How do you get 5600 units out of a vial of 10,000 units?” asked the second nurse.

The first nurse breezily replied, “Oh, you can’t. That’s just impossible.”

“So what did you do?” the second nurse inquired.

“I couldn’t figure out what to do, so I gave her the whole bottle!”

The nurse had given Mrs. B a massive overdose of heparin. Had she received another such dose, she probably might have had a stroke or other form of internal hemorrhage. As it was, her blood was so “thinned” that she was not allowed out of bed for 48 hours for fear that she might bump herself and develop a life threatening hemorrhage.

It was just a matter of luck that I overheard the nurses’ conversation. Otherwise, the grievous mistake would not have been discovered until after the patient was desperately ill or dead. It was not simply one error, but a long chain of mistakes: failure to calculate the correct dose (by simple division), failure to ask for clarification when the nurses didn’t understand the order, and the completely inexplicable decision to give the contents of the entire bottle when she couldn’t figure it out.

I wish I could tell you that this was a rare error, but it was not. Many times my patients received too much medication, or received an intravenous medication too quickly, or didn’t get a medication at all. We can put into place systems designed to reduce errors, but if nurses don’t understand how to calculate a dose, and don’t understand that they must always get clarification if they have any doubt, patients will continue to be injured by nursing errors.

Is God a narcissist?

God written in sand

Anyone who doubts that God has been created in the image of Man would do well to contemplate God’s supposedly bottomless need for praise. The God of the world’s three monotheistic religions is nothing more than an ancient tyrant writ large, reflecting the social hierarchy of ancient civilizations. God, like a Pharaoh, apparently requires an endless diet of praise, flattery and supplication. Without strenuous and continuous efforts at placation, God, moody and unpredictable, may lash out in ways that cause grievous harm.

The belief that God needs to be praised and flattered is a feature of all three monotheistic religions, but it is most obvious in Fundamentalist Christianity. I was forcibly struck by this fact in reading and writing about a family who recently lost a baby to a potentially preventable cause at a homebirth. During labor, the mother supposedly suffered a rare and often fatal complication, amniotic fluid embolus. Her baby died (though it is not clear whether the baby died before or after the embolus) and the mother ended up intubated in the hospital ICU.

The reaction of the family and its Fundamentalist supporters has been to carefully ignore the multiple disasters that have taken place, and praise God repeatedly and fulsomely for not having killed everyone involved. The mother was “led” by her religious convictions to make a foolish and dangerous choice to give birth at home; she was led by her religious convictions to ignore the signs that something was very wrong; she experienced a rare and devastating complication; the baby is dead; she is fighting for her life in a hospital ICU.

Other people might be angry at these tragic developments, but the family and its coreligionists simply ignore these disasters. No blame can be attributed to God, because God apparently cannot handle, and therefore must never be exposed to, criticism. God must be flattered by insisting that he is always right, no matter how cruel and tragic the outcome. Instead, focus is directed toward the fact that the tragedy has not been a completely unmitigated disaster. God must be praised for “healing” (i.e. not killing) the mother.

God, portrayed as an unreasoning tyrant, and must be placated like an unreasoning tyrant. God is just a bigger version of Pharaoh. Yes, God, you struck down a woman and her unborn child, leaving the woman desperately ill and the child dead, but we are ever so grateful that you, in your endless wisdom and as the result of your praiseworthy judgment, saw fit not to kill the mother, too.

The husband wrote on his wife’s blog:

Praises to Our Lord and the healing Master! [My wife] is truly a miracle of God’s healing power and a testimony of His strength. [She] was quickly treated for AFE (amniotic fluid embolism) when we arrived at the ER on Friday…

I know what the outcomes usually are and that my wife has dodge a bullet but I believe in the power of prayer and have been humbled by so many people praying for my wife. God is so good and is the rock in which our family stands!

God’s healing power? He’s the one who struck her down and killed their son. The fact that he didn’t kill her too is hardly a testimony to his healing power.

This is the same view of religion that is on display at major sporting events, as when a receiver scores a touchdown and then points toward heaven to give credit to God. Now we know why God has no time to address thorny problems like the starving multitudes in Darfur. He is too busy checking out who is praising him and awarding them touchdowns.

This God is a petty God, a narcissist who exists on praise and flattery. There’s no better sign that this God is nothing more than the creation of Man, the figurative equivalent of the carved idols of old. He is in every respect the image of a human tyrant, with all the worst foibles of any human being.

Homebirth midwives are quacks

quacks
There’s very little that makes me angrier than the unnecessary deaths of babies. That’s why homebirth often makes me very angry indeed.

In the US, most doctors and certified nurse midwives refuse to attend homebirths because of the danger. Therefore, most US homebirths are attended by “direct entry” midwives (DEM), aka certified professional midwives (CPM). These are just fancy names for midwives with no medical training. The statistics on neonatal death at homebirth are so appalling, that Midwives Alliance of North America (MANA), the trade union for homebirth midwives, refuses to release the death statistics to the public; they are available “friends” of midwifery.

American homebirth midwives are grossly undereducated, grossly undertrained, and downright dangerous. The national and state statistics bear this out, but nothing illustrates it better than a real life example. This tragedy was brought to my attention by a commenter who had been following the story on the mother’s website.

Carri, a mother of 8, had been planning an unassisted homebirth. I recently wrote about this appalling stunt and its high death rate (Stuntbirth). Carri had had 4 successful unassisted deliveries and was planning a 5th. As the due date approached, even Carri, as deluded as she was about the safety of unassisted childbirth, could not deny that her uterus was much larger than expected, and she sought the “advice” of Brandi, a CPM, at Central Indiana Home Birth Midwives.

Brandi diagnosed twins (without the aid of ultrasound), and noted elevated blood pressure. She advised the typical homebirth midwives quack “treatment,” a high protein diet, which, not surprisingly, accomplished nothing. As the pregnancy advanced, first one week beyond the due date, then two weeks, then almost three, Brandi counseled waiting for nature to take its course.

And nature did take its course. Carri’s baby is dead, and she is now fighting for her life in an ICU. The presumed cause is an amniotic fluid embolus.

There was only one baby, not two. That’s at the top of the long and horrifying list of mistakes. It is unheard of for a responsible practitioner to diagnose twins when only one baby is present on ultrasound, but Brandi assured Carri that one baby was “hiding” behind the other.

Even more appalling, if possible, is Brandi’s reaction when she heard only one heartbeat. According to Carri (posting on MotheringdotCommune):

One time the midwife gets two heart beats and the last time she just could not find the other and felt okay to let it be because there was active movement …

It would be laughable, were it not deadly. The homebirth midwife “diagnosed” twins, then clung to that delusion even though there was only one baby on ultrasound, and only one heartbeat.

Not surprisingly, someone deluded enough to believe that there were twins when only one baby could be seen was also deluded enough to believe that a clearly pathological pregnancy was normal. Carri measured much larger than expected even though there was only one baby. Almost certainly, there was a massive excess of amniotic fluid (polyhydramnios), both a sign of problems, and a risk factor for future complications (including amniotic fluid embolus). Carri’s abnormally elevated blood pressure was untreated by the quack remedy that was “prescribed.” Pregnancies over 2 weeks past the due date have a dramatically increased risk of stillbirth, as well as life threatening birth complications. The midwife pretended that this was not so.

So now Carri’s baby is dead, and Carri is fighting for her life.

People need to understand American homebirth midwives are a second class of midwives with less education and training than other American and European midwives. The standards for direct entry midwives, in terms of educational requirements and clinical training, are far below those of any other midwives in the industrialized world. American homebirth midwives are, by and large, quacks, and babies are dying as a result.

Addendum: One of the things I find most interesting is how everyone involved understands that the refusal to seek real medical care led to this tragedy. Carri’s family has removed the posts detailing her actions in the weeks leading up to the catastrophe, and MotheringdotCommune has removed the posts by Carri and those responding to her. The baby died possibly because of unassisted birth/homebirth, and now supporters and the family want to remove the evidence.

What Jon and Kate should say, but won’t

Jon and Kate wedding

Jon and Kate Gosselin have announced that they will issue a “life-changing decision” on June 22 during their hit reality TV show, Jon and Kate Plus Eight. The Boston Herald described the commercial airing in advance of the one hour special episode:

“Recently, we’ve made some life-changing decisions – decisions that will affect every member of our family, ones that we hope will bring each of us some peace,” Kate says in the spot.

The promo features giant graphics with phrases like “A family in turmoil” and “A relationship at a crossroads” flashing across the screen.

Here’s what they ought to say, although I know that’s never going to happen. They ought to say:

After deep and soul-searching reflection, and with the aid of our pastor and strong religious faith, we have come to the conclusion that we can no longer continue appearing on television. We have been married for 10 years and recently renewed our vows. We take those vows seriously.

Marriage is a promise to stay together through good and bad. No one needs to promise to stay together when things are good, so in essence, marriage is a promise to stay together and stand by each other when things are not good. As the public is aware, each of us has gone through a period of sadness and confusion. It seems like it might be easier to separate, but marriage is not about taking the easy course.

To honor the unbreakable commitment that we made to each other before our family, friends, and before God, we have regretfully come to the conclusion that we need time and privacy to repair our relationship. We need to concentrate on each other and our family, and a TV show and publicity tours are simply not compatible with what our family needs now.

We love our children more than life itself, and we know that more than anything, more than money or fame, our children need to grow up sheltered under the umbrella of the strong relationship of their father and mother. We want to show our children the true meaning of marriage and commitment. We are willing to forgo the temporary rewards of money and fame for the more lasting rewards that come from putting marriage and family before anything else.

We thank the public for being guests in our home and lives, but there comes a time when the guests must leave. We appreciate the love and concern that so many have show to us, and we hope that everyone will respect our need for privacy at this time. There will be no more TV show, no more books, and no more publicity tours for the foreseeable future.

In truth, this is a financial and emotional sacrifice for us, but marriage and children often require sacrifices of both partners. Although it is a sacrifice, we expect profound rewards: the deepening of our commitment to each other as spouses, friends and parents of eight precious children.

That’s not what they are going to say, of course. They are going to announce a separation, or even a divorce. And they are going to continue to capitalize on the boost in popularity that a troubled marriage has brought them. That’s why they put out press releases, why they are staging a “special episode” and why they are running commercial spots to promote it. They are no longer a family, but merely a business, and business is booming even as their family falls apart.

The man who wouldn’t stop bleeding

blood

Surgeons can do amazing things. They can remove an appendix that is about to burst, bypass blocked arteries in the heart, or even carefully excise a tumor from the brain. But surgeons never work alone. They always depend on the human body’s intrinsic abilities, the ability to clot blood, the ability to combat bacteria, and the ability to heal.

A surgeon knows that if he removes a gangrenous appendix the patient will get better, but it isn’t the removal that makes him better. The surgeon assumes that the stitches will stop the bleeding at the site where the appendix was removed, the immune system will clear away the residual infection, and the skin and deeper tissues will heal themselves together again.

I always assumed that, too, until I met the man who wouldn’t stop bleeding.

Met is probably the wrong word, since my first encounter with him occurred while he was under general anesthesia on the operating table. It was early in my internship year and I was called to the operating room to provide assistance during a disaster of major proportions. A young man undergoing a surgical repair of a damaged artery would not stop bleeding. I was called merely to hold the retractors that kept the surgical wound open so that the surgeons could see the area in question. Another intern had been holding them for many hours and I was sent to relieve him.

The surgery, which had been scheduled to last 2-3 hours, had been going on for more than 12 hours with no end in sight. On the wall of the operating room hung the empty plastic bags that had contained the 40 units of blood that had been given to the patient thus far. As I stepped to the table, having gowned and gloved, I could see that the wound was filling with blood as fast as the surgeons could suction it away. One of the surgeons noticed my presence and explained what was going on.

The young man, in his late twenties, had been diagnosed an aneurysm of the main artery feeding one of his legs. An aneurysm is a weakening and ballooning out of a blood vessel wall that will ultimately rupture (and kill the patient) unless surgically repaired. It usually occurs in people over age 60, generally smokers. While the surgeon who had planned the operation had recognized that an aneurysm in a young person is quite unusual, he hadn’t fully considered why this unusual event had occurred. Unfortunately, he quickly found out when he attempted to repair the artery.

The artery in question, indeed all the patient’s arteries, were unusually weak. We later learned that the patient suffered from a rare genetic disease that made his artery walls abnormally thin and weak. At the time, all we could see was that the artery would not hold stitches.

The aneurysm had been excised during the first hour of the surgery. In the subsequent 11 hours, the surgeon, ultimately aided by two colleagues, struggled to close the residual hole in the artery. Yet every time they successfully stitched it closed, one or more of the sutures tore through and a torrent of blood poured from the artery. The situation was truly desperate, and desperate situations call for desperate measures.

It was impossible to close the blood vessel perfectly, as would have been required in any other patient. The decision was made to close the artery as completely as possible and to control the residual bleeding with pressure. Just like you or I might stop the bleeding from a cut by applying pressure, we would try to do the same, except that the pressure would need to be applied inside the body, not outside.

The wound was packed with as much sponge and gauze material as could fit inside, and the incision was left often. The patient was transferred to the intensive care unit with the recognition that either the bleeding would gradually stop or the patient would die. The patient left the operating room 16 hours after he had entered it and the vigil began.

Amazingly, and against all odds, the bleeding slowed and eventually stopped. Although the artery itself was defective, the patient retained the ability to clot blood, and the combination of blood clot and pressure ended the bleeding. No one dared to risk further bleeding by removing the packing, so it was decided that the wound would be left often to heal itself from the bottom up.

And that is precisely what happened. Within several days, the artery healed itself, and we began gently changing the packing each day. It took 3 months for the wound to heal completely, with progress measure by the gradually decreasing amount of gauze sponges that could be fit inside the wound. Initially I would arrive at his bedside each day with a seemingly inexhaustible supply of gauze to replace the old packing. After 3 months, I needed to bring only a large surgical bandage to cover the wound.

Ultimately the patient walked out of the hospital alive, a tribute to the body’s ability to withstand tremendous trauma and to heal itself, even under less than ideal conditions. Unfortunately, the story does not have a happy ending. There was no way to treat underlying genetic defect in his arteries and several years later another aneurysm developed in a different artery. This time the surgeons could not get the bleeding under control no matter what they tried, and the young man eventually bled to death.

The Zicam scam and the gullibility of the American public

Zicam

You’ve got to hand it to the folks at Matrixx Initiatives. They managed to convince millions of Americans to paint the inside of their noses and throats with a toxic heavy metal that is ineffective in its stated benefit and destroys the nerves responsible for the sense of smell.

Matrixx marketed Zicam as a cold remedy. There is no evidence that Zicam has any effect on colds, but there is decades of data showing that zinc, the purported active ingredient, can damage the sense of smell. Indeed, since 2006, Matrixx Initiatives has been forced to pay $12 million dollars to 340 people who claimed that Zicam destroyed their sense of smell. Hundreds more lawsuits are still pending.

So how did Matrixx manage to convince Americans to apply a toxic heavy metal to sensitive internal tissues? They called it a homeopathic remedy and that allowed them to avoid having to prove that Zicam was effective or even safe. And, they relied on the gullibility of the American public and its current love affair with all things “natural.”

The Obama Administration is working to close the legal loophole that allows companies to market “natural” remedies without proving that they are effective or even safe. In the meantime consumers can become less gullible. The first step is to understand how we know whether a substance works. Answering the question goes far beyond giving the substance to individuals and asking them about their perceptions.

The study of drug efficacy and safety is pharmacology. Pharmacology can be roughly divided into two areas: pharmacodynamics, how the substance acts on the body and pharmacokinetics, how the body acts on the substance.

Here are some basic questions that must be answered to find out how the drug works on the body:

How does the drug work? What is the active ingredient? What effect does the active ingredient have on the body?

What is the dose-response? In other words, as the dose of drug increases, does the response increase?

What is the ED50, the dose that produces a response in 50% of subjects, also known as the median effective dose?

What is the maximum effect that can be produced by the drug, also known as efficacy?

What is the therapeutic window? For every drug, there exists some concentration which is just barely effective and some dose which is just barely toxic. Between them is the therapeutic window where safe and effective treatment will occur.

In addition, we need to know how the body interacts with the substance.

How does it enter the body?

How is it removed from the body?

Does it have effects on other parts of the body besides its stated therapeutic effect?

What did the makers of Zicam know about their product before they put it on the market? The only thing that they knew is that the active ingredient is zinc. They did no testing that would tell them the mechanism of action, the dose response or even the effect of the zinc on other tissues of the body. Therefore, at no time did they have evidence that the drug was either safe or effective, yet they sold it anyway.

Determining drug efficacy and safety is complex. It is absolutely imperative to study the pharmacodynamics and pharmacokinetics of a substance before anyone can claim that it is effective or safe. As the case of Zicam illustrates, when it comes to “natural” remedies, these questions have not even been asked, let alone answered.

Genzyme, corporate pig

pig
In an industry noted for greed, sharp tactics and lack of social conscience, the drug company Genzyme has managed to set a new standard for depravity.

Yes, depravity. Genzyme’s latest strategy for amassing outsize profits, proudly described by company executives in today’s Boston Globe, is, in my judgment, nothing short of morally depraved.

Genzyme, as its name implies, has pioneered the use of genetic engineering techniques to create and manufacture drug treatments. The greatest potential of genetically engineered drugs lies in treatment for so called “orphan” diseases, those they afflict very few people, not nearly enough to form support groups, charities and public advocacy groups that pay for treatment. Although many companies have had success in creating novel, highly effective treatments for orphan diseases, they find it hard to profit from such treatments, because demand is very low.

Orphan diseases, by their very nature, are often difficult to diagnose and require sophisticated medical equipment and training to even identify. The chances of an orphan disease being diagnosed in the third world, let alone being treated, are extremely remote. Genzyme’s new corporate strategy is to search the third world for children suffering rare diseases, provide the technology and equipment to make the diagnosis and then attempt to force the government of the third world country into paying for the extraordinarily expensive treatment by diverting money that would otherwise be used to provide basic medical care for large numbers of people.

The idea is pure genius. By identifying a specific child who will die without treatment, by informing the child’s family that a lifesaving treatment exists, but will be withheld without full payment the drug company is able to exert far more pressure on the specific government than they could by a simple announcement that 1 or 2 children in any given third world country might benefit from the treatment.

The Globe details how this technique works in practice. Consider Tania, the Costa Rican girl, who is dying of the rare genetic disease Gaucher’s. Tania’s family did not know what was killing her, and they would never have known, if it were not for Genzyme’s efforts to find and identify Tania, and inform her family of the treatment that could save her life, the drug Cerezyme, at the cost of $160,000 per year:

Genzyme created divisions within the company to find overseas patients …

Costa Rica was part of this plan, a nearby country whose government, though poor, dedicates much of its budget to healthcare. Company executives began flying to the region and meeting with the person most likely to diagnose a Gaucher patient: Dr. Manuel Saborio Rocafort, who runs the only medical genetics department in Costa Rica. So when Saborio heard about Tania, not only did he know that he should test her for Gaucher disease, but he had the testing kit ready: Genzyme had provided it.

But Genzyme did not go to the trouble and expense of finding and diagnosing Tania in order to save her life. Their avowed corporate strategy involves letting her die, unless Costa Rica will pay the full $160,000 per year for Cerazyme. Absolutely no discount is allowed.

Lest anyone doubt that this is a deliberate corporate strategy, consider:

In Genzyme’s new glass Kendall Square headquarters, the president of the firm’s international group, Sanford Smith, keeps a brass gong outside his office. Every time a foreign government agrees to pay for one of the company’s drugs, he takes out a mallet and rings it.

Presumably, they rang the gong for Tania when Costa Rica agreed to pay the full price, the only price at which Cerezyme can be obtained. Yet the Costa Rican government is not without misgivings:

The Costa Rican healthcare system has survived paying for Tania’s medicine. What worries its leaders is the precedent. Energized by Genzyme’s success, more companies have developed high-tech drugs for other rare diseases. Genzyme’s pricing approach has become the standard for similar drugs…

It is difficult to imagine a corporate practice that is more ethically and morally depraved: deliberately identifying third world children whose lives can be saved by extraordinarily expensive drugs, refusing to provide those drugs at a discount or for free, and then ringing a brass gong to announce that another third world country has been blackmailed into diverting a large share of its healthcare budget to one child, and away from simpler medications and strategies that could save thousands of lives.

The executives responsible for this strategy should be ashamed.

The AMA, still crazy after all these years

AMA

There’s nothing worse than doctors who refuse to learn from their own mistakes.

The latest pronouncement from the American Medical Association opposing publicly funded healthcare (single payer) is foolish on its face, but it unforgivable when turns out that it is merely a recapitulation of a thoroughly discredited policy of the past. The fact that it is not in line with the views of the vast majority of American physicians makes it worse, and goes a long way toward explaining the increasing irrelevance of the organization.

The support for reform of the healthcare system has never been greater. The AMA, in a move supremely out of step with the majority of Americans, not to mention the majority of American physicians, has declared their opposition. According to The New York Times:

…[I]n comments submitted to the Senate Finance Committee, the American Medical Association said: “The A.M.A. does not believe that creating a public health insurance option for non-disabled individuals under age 65 is the best way to expand health insurance coverage and lower costs. The introduction of a new public plan threatens to restrict patient choice by driving out private insurers, which currently provide coverage for nearly 70 percent of Americans.”

The wording is rather ironic. Forty years ago, the AMA declared its opposition to creating a public health insurance option people over age 65, complete with dire predictions of the destruction of American medicine. That public health insurance option is known as Medicare, and far from destroying American medicine, it ushered in a golden age for American physicians.

The current opposition to healthcare reform, like the opposition to Medicare, is consistent with the AMA’s sad and sordid history of vociferous opposition to any attempt at healthcare reform. Truman first proposed universal compulsory health insurance in 1948. As Robert Ball explains:

The AMA’s opposition approached hysteria. Members were assessed dues for the first time to create a $3.5 million war chest-very big money for the times-with which the association conducted an unparalleled campaign of vituperation against the advocates of national health insurance. The AMA also exerted strict discipline over the few of its members who took an “unethical” position favoring the government program.

But AMA is no longer the force in American medicine that it was in the past. In the 1960’s, at the height of opposition to Medicare, the AMA claimed at least 70 percent of American doctors as members. Today, the AMA represents only a third of American doctors, most of them elderly. Almost 90 percent of doctors over age of 70 are members, but fewer than 35 percent of those aged 30 to 49 belong to the AMA

Its decline in membership and influence can be traced to its political positions and financial arrangements. Indeed, the majority of American physicians favor a national healthcare plan:

Of more than 2,000 doctors surveyed, 59 percent said they support legislation to establish a national health insurance program, while 32 percent said they opposed it …

“Many claim to speak for physicians and represent their views. We asked doctors directly and found that, contrary to conventional wisdom, most doctors support national health insurance,” said Dr. Aaron Carroll of the Indiana University School of Medicine, who led the study…

The Indiana survey found that 83 percent of psychiatrists, 69 percent of emergency medicine specialists, 65 percent of pediatricians, 64 percent of internists, 60 percent of family physicians and 55 percent of general surgeons favor a national health insurance plan.

The AMA is opposed to healthcare reform? Who cares? They don’t represent American physicians and they don’t represent the American people. The represent the worst of American medicine, a dying breed that deserves to fade into ignominy.