EasyDiagnosis Second Opinions

Everything is so dangerous that nothing is really very frightening.

Gertrude Stein

Most trans fats consumed today* are created industrially through adding varying amounts of hydrogen to plant oils (”unsaturated”), tending to solidify them into fats, called “saturated.” This process was developed in the early 1900’s and was first commercialized as Crisco in 1911. These more saturated fats have a higher melting point, which makes them attractive for baking and extends their shelf life. The consumption of trans fats is supposed to increase one’s risk of coronary disease by raising levels of “bad” LDL cholesterol and lowering levels of “good” HDL cholesterol. Various self-appointed, as well as official health authorities, including the Government, the FDA, the American Heart Association, and others, recommend that consumption of trans fat be reduced to trace amounts.

Trans fats from partially hydrogenated oils are described as dangerous, even life-threatening. Coronary-provoking, life-threatening foods once included red meat, eggs, butter and other dairy products, (though once upon a time, Crisco® and margarine were the mainstay of deep frying.) but now dangers range from Big Mac’s and Whoppers, to egg rolls and French fries soaked in trans fats, and other deep fried delectables, tuna salad with the wrong mayonnaise, even girl scout cookies (sic!).

Trans fat alarmists would have you believe that transient changes in blood fats or lipids are a direct assault on survival by increasing your chances of a heart attack. But the available scientific data fails to to back up that assertion. A number of studies of human populations have attempted to associate consumptions of trans fats with increased heart attack risks, but the only conclusion that can be fairly drawn is that, if indeed there is a risk, it is statistically unprovable. As I have pointed out in my recent blog of June 26, there are are over 260 “risk factors”, i.e. stress, smoking, heredity, diabetes, high blood pressure or being just alive, all associated with the risk of developing coronary disease, heart attacks, or sudden death.

Yes, blood lipids, serum cholesterol, etc. are included prominently among these risks, but to jump from diet to serum blood lipids to heart attacks is more than a leap of faith, it is a magisterial mockery of scientific logic. This was amply illustrated a few years ago when the National Academy of Sciences’ Institute of Medicine (IOM) jumped on the trans fat bandwagon. “While touting studies showing that trans fats temporarily altered blood chemistry, the IOM glaringly did not cite any studies showing that trans fats posed any real risk to real people.” See Steve Milloy’s interesting site. As he also pointed out in one of his newsletters written for Easydiagnosis, “Thirty years ago, the diet police scared us away from animal fat-based butter and began singing the praises of what they said was a healthier alternative, trans fat-based margarine. Now, the diet police have done an about-face and want to scare us away from those same trans fats – all the while omitting mention that their butter scare was bogus from the (start).”

Now, according to last week’s New York Times, restaurants are preparing for the “Big Switch.” No longer is it unhealthy to eat trans fats, it is probably illegal to sell them: In New York City as of July 1, if restaurants and other commercial food purveyors add baked goods to fried foods among those (other foods) that must be free of trans fat they risk fines up to $2,000. Many foods your mother warned you about, including butter, palm oil, and lard are back in style and completely legal.

Since the New York ban on trans fat, a dozen other cities, including Boston, Philadelphia, and Seattle have called the Trans Fat Help center in NYC for advice in implementing their own bans. Watch the menus everywhere for warnings, and don’t forget to check your supermarket and food labels on everything from corn flakes to canned peas. -Uh-oh, I forgot, natural trans fats found in meat from animals and dairy products are acceptable and declared safer than the manufactured variety. They are still legal. the question is, for how long?

*If you want to learn some interesting things about the chemistry of cis or trans, stereochemistry, enantiomers, etc. I suggest this excellent Wikipedia site. The simplest way to describe the geometrical forms of some compounds is in the context chirality in which two mirror images of a molecule cannot be superimposed onto each other, much like the concept of the spacial difference between the left and right hand. The left glove can never be worn on the right hand. In chemistry these differences are referred to as enantiomers , and occur in two forms, cis and trans or “optical isomers,” because they rotate a beam of polarized light in counter-or clockwise directions. The property was first described in 1815!.

“Part of the secret of success in life is to eat what you like and let the food fight it out inside.”

Mark Twain

There are over 260 “risk factors”, i.e. conditions, habits, stress, or being just alive, all associated with the risk of developing coronary disease, heart attacks, or sudden death. Unlike bacteria causing specific infections, however, these risk factors are not proven causes of coronary disease. Proving true causality in medicine, in fact, is often a game of endless pirouettes, stretches and rule changes.

For example, these risk factors may be strong and therefore impressive, or weak and debatable. Strong associations with coronary disease, besides age and gender, include heredity, smoking, high blood pressure, diabetes, obesity, probably in that order-and for true believers, the worst culprits are serum fats or lipid levels which include total triglycerides, total cholesterol and its sidekicks, LDL and HDL cholesterol, among other fatty compounds.

Dietary fat has been blamed over the decades for affecting, if not controlling, the blood level of serum lipids. The link, however, between diet, especially the consumption of cholesterol and different types of fats- solid or semi-solid fats (”saturated”) vs. oils or liquid fats, and the level of various lipids or fats in the blood continues in many quarters to be highly questionable.

Moreover, the secondary link between blood levels of fat, including cholesterol-related lipids and the development of coronary disease is a variable, and often confusing one. While individuals with certain metabolic diseases, especially diabetes, have abnormal levels of blood lipids and a high incidence of coronary disease, many normal people with high lipids never develop significant heart disease. Further, almost half of all coronary patients and patients admitted for heart attacks have normal blood lipids. For years, the dietary research community has been reluctant to admit that the scare over dietary fats has long been over-hyped. Diet fat hysteria received its final coffin nail last year when a major study concluded that low-fat diets provide no demonstrable health benefits over high-fat diets.

For decades the diet police told us animal fats like butter were dangerous, and more recently announced that fettucini Alfredo was “a coronary on a plate.” They urged us to substitute margarine for animal fats, and to stay away from red meat. Of course in those rosy times, no one talked or wrote about “trans fats,” abundantly produced when vegetable oils were turned into solid fats like Crisco and margarine. Now, the diet police have done an about-face all the while failing to admit that their butter scare was bogus from the outset, but margarine, containing high trans fats was bad. It turns out that now butter, palm oil, lard, containing natural trans fats, and (new) Crisco, if not tops on the list of desirable fats, are at least considered OK by the diet dogs.

Stay tuned for more on diet and trans fats.

Falls increase with age and are a stronger predictor of fractures than bone mineral density (BMD) measured by osteoporosis screening, according to the JAMA (Mar.26, 2008). Also, a person after age 45 with a history of fracture resulting from mechanical forces that would not ordinarily cause fracture in a healthy adult (fragility fracture) has a higher risk of bone fracture than an individual without such a history, all other factors, including age and T- score being equal.

More falls with increasing age, are a major cause of death in the elderly, and result from the normal loss of coordination, balance, quick reflexes, and strong muscles. Thus, the ability to avoid injury is a major determinant of fracture, more important than bone strength per se. BMD, bone mineral density which is measured in only two or three pre-defined locations varies greatly from one area of bone to another, and is only one measure of bone strength, the others being the size and thickness of the bone itself, bone microstructure, amount and type of bone protein cross links, porosity, accumulated damage (microcracks), etc.

Bis- or diphosphonates, such as Alendronate (Fosamax ©), Ibandronate (Boniva ©-Thanks, Sally Field), calcium, vitamin D, and estrogens have all been shown to increase bone mineral density and decrease fractures and mortality. “However, in two well-designed studies in which elderly individuals were enrolled on the basis of being at increased risk of hip fracture because of factors other than low BMD, treatment with bisphosponates did not decrease risk of hip fractures.”

Common sense suggests that training exercises for all patients, not just the elderly, to improve muscle strength, balance, techniques to avoid falls, even tai chi, -should be as good an investment as putting everyone on diphosphonates. The World Health Organization (WHO) and other organizations have recommended using an individual’s 10 year-fracture risk as a guide to treatment decisions, not just the BMD.

Far too many patients, especially younger women may be taking diphosphonates solely on the basis of abnormal bone mineral density tests. After all, it’s a $6 billion market, beginning to shrink until the latest and more risky long-acting compounds, such as Zolendronate started appearing. Read what Gillian Sanson has to say in her outstanding book, The Myth of Osteoporosis MCD Century Publications, 2003.

What is lust, after all, but the desire to recapture the heady sensations of adolescent sexuality?

William Boyd, The New Confessions

(Sex) is something the children never discuss in the presence of their elders.

Arthur S. Roche

Is that a gun in your pocket or you just glad to see me?

Mae West (to a Chicago police officer the only time she was ever arrested)

If sex, as Russell Baker remarked, is the last important human activity not subject to taxation, times they are a-changing. Every sincere supporter of the Abstinence-Only programs funded by the Federal Government, knows that sex is bad, especially for children: it can lead to pregnancy, sexually transmitted diseases (STD), and of course, in the unmarried, to moral decay. By 2005 there were more than 800 programs that had been funded with over $1.5 billion to promote and fund programs that advocated sexual abstinence as a way to deal with adolescent sexuality. President Bush’s 2009 budget which cuts funding for HIV/AIDS and STD, designated $204 million for abstinence only programs. Federal Fund recipients for Abstinence Education programs cannot even be used to provide more information on contraception or safer sex practices to prevent STDs, even if nonfederal funds are used for that purpose.

Three Government reports were released in 2007 with final evaluations. The May 7, 2008 JAMA quoted Bruce Trigg, MD, of the New Mexico Department of Health, who said the programs “had absolutely no measurable impact on initiation rates, ages of first intercourse, or number of partners, no impact on pregnancies, births, or STDs, and the same rates of condom and birth control use.” “In some cases,” he added, “kids sat through 3 years of mandatory abstinence-only classes.” Talk about academic torture!

Because of increasing pressure to revamp sex education programs and to expand funding for other types of sexual education initiatives, many states have refused federal funding for these abstinence-only programs.

The very concept that propaganda for abstinence might replace common sense talk with mom and dad about the birds and the bees, is a breathtaking example of ideological prudery, misspent Federal funds-or is it the sex-speak of superannuated virgins?

Deceptive marketing and advertising sometimes gets punished, though not often enough, especially when it comes to food claims. Pinkberry, a frozen yogurt chain hit it big after opening its first store in West Hollywood when it started selling “chilly bliss” and “swirly goodness,” products it claimed to be healthy, nonfat, all-natural, but did not state what it contained. The unproven health benefits attributed to yogurt that were previously posted on the walls of Pinkberry (e.g., cures colon cancer, fights yeast infections) have since been removed. See this site.

The California Department of Food and Agriculture determined that Pinkberry, sold as yogurt, did not contain the requisite amount of bacterial cultures per ounce to fit the definition. According to the Los Angeles Times, Pinkberry’s product had only 69,000 bacterial cultures per gram, compared to 200,000 for Baskin-Robbins. The National Yogurt Association (NYA) established its own criteria for live and active culture yogurt. In order for manufacturers to carry their Live and Active Culture seal, refrigerated yogurt products must contain at least 100 million cultures per gram at the time of manufacture, and frozen yogurt products must contain 10 million cultures per gram at the time of manufacture. Pinkberry (and Red Mango, too) now enjoy the NYA seal of approval.

But the specific health benefits of live cultures, now called probiotics have not yet been determined. Even Dannon got in trouble over claims that the benefits of its probiotics were “clinically and scientifically” proven.

After a class action lawsuit was filed last year accusing the company of deceptive marketing, Pinkberry posted 23 ingredients on its website, including sugars, additives, preservatives, emulsifiers, artificial coloring and flavoring. The case was settled just two weeks ago, early April, 2008. According to the New York Times, Pinkberry agreed to donate $750,000 to hunger and children’s charities, but Ray Gallo, a lawyer for the plaintiff, remarked, “Personally, I would have preferred that the money go toward consumer advocacy against misleading food marketers.”

From inability to let well alone; from too much zeal for the new and contempt for what is old; from putting knowledge before wisdom, science before art and cleverness before common sense; from treating patients as cases; and from making the cure of the disease more grievous than the endurance of the same, Good Lord, deliver us.

And

It is unnecessary - perhaps dangerous - in medicine to be too clever.

Sir Robert Hutchison

To throw open the mind’s door and allow diseases to enter into consideration each time that we are called to a bed side is foolish in the attempt, and impossible in the performance. Each case should lead us to arrange before the mind’s eye a selected group of reasonably probable causes for the symptoms complained of and for the signs discovered. What we select should depend upon the clues furnished us by the patient himself or by the results of our own examination.

Richard C. Cabot, MD
Differential Diagnosis, Philadelphia, WB Saunders, 1915

Each trade and profession “ridden by the routine of… craft.” “The priest becomes a form; the attorney a statute-book; the mechanic a machine; the sailor a rope of the ship.” (And the doctor an MRI scan?)

Emerson in The American Scholar, comment by Cynthia Ozick

Go to the patient, because that’s where the diagnosis is (à la Willie Sutton on why he robbed banks: “because that’s where the money is”).

William S. Dock, MD

New medicines and new methods of cure always work miracles for a while.

William Heberden

Medicine is like a woman who changes with the fashions.

Auguste Bier

Diagnosis is a system of more or less accurate guessing in which the end-point achieved is a name. These names applied to disease come to assume the importance of specific entities, whereas they are for the most part no more than insecure and therefore temporary conceptions.

Sir Thomas Lewis, Reflections of Medical Education. The Lancet, 1944

He is the best physician who is the most ingenious inspirer of hope.

Samuel Taylor Coleridge

Some words on being discharged: Remember to retrieve your medications before discharge (your personal supply will most likely have been taken from you on admission).

Obviously, you cannot be discharged from a hospital because your caregivers find you difficult. Moreover, you cannot be discharged absent reasonable medical judgment that you are well enough to leave. This latter rule is fortified by the malpractice statutes. Furthermore, you may request further hospitalization if you do not feel well enough to be discharged or transferred. If you are a Medicare and Medicaid patients, The Federal Government has ruled that before discharge, you have a legal right to demand further inpatient care, if you sincerely feel you are not well enough to leave. Fortunately, this issue rarely comes up. (In general, the less time you spend in the hospital, the better, considering the perils of hospital-acquired infections.)

At times, although your experience can be likened to incarceration, your confinement was voluntary and not court-ordered: the hospital is Not a prison. You cannot be kept there against your wishes for a single hour, nor can you be prevented, as some patients believe, from leaving on the basis of an unpaid bill or lack of insurance. You can fire your doctor or walk out the door any time you are fed up with your treatment or for any compelling personal reason. In this case the hospital quite reasonably, for reasons of liability, requires you to sign a release stating that you are leaving “AMA” (against medical advice).

On balance, however, nothing beats good rapport with the staff, your doctors, nurses, interns, residents, and technicians. Hospitalization should be remembered as, if not necessarily a happy, at least a health-restoring experience. You can be assertive, yet remain as polite and cooperative as you expect your caregivers to be. Never forget, you may be the patient, but you are also a paying customer, and have the right to demand the best medical care available.

Many patient “rights” are simply pious clichés,for example, the right to a “Choice of Provider,” your right to “Access to Emergency Services,” your right to “Participate in Treatment Decisions” the right not to be discriminated against, the right to privacy (see the HIPAA Privacy Act), the right to complain and appeal, etc. There are over 8 million sites on Google where you can find endless lists of patient rights issued by Government, uncountable medical organizations, HMO’s, private hospitals (see this nice one from Abington Memorial Hospital in suburban Philadelphia), etc.

I had something different in mind when I drew up the following list. If you are a hospitalized patient you indeed have, among other rights, the following:

1. The right to exchange immediately the disgusting open-at-the-back hospital gown for your own nightgown, pajamas, and robe. You also have the right to a bedside commode, with assistance, if you cannot make it to the bathroom.

2. The right to refuse any inedible meals offered you, along with the parallel right of ordering your own meals brought in from outside - or in extreme cases reported - walking out of the hospital and going to the pizza parlor or Chinese takeout across the street. Item: The hospital earns a negotiated daily (per diem) rate from Medicare and most insurers, between $1,000-$2,000 a day for your care and feeding. Compare that with $200-$300 per day at The Hilton.

Other suggested, specific rights of refusal

a. You may refuse multiple blood lettings for tests during a single day because an intern or attending has a new inspiration following the writing of morning orders.

b. You may refuse to remain attached to an IV line or an oxygen tube or other apparatus long after the need for them exists. (For courtesy, and if you’re in bad straights, I suggest consulting your doctor first on this one.)

c. You can refuse to be awakened at night for sleeping pills. (Or you can at least chew out the nurse.)

d. You may refuse to be taken anywhere else in the hospital without being told first where you’re going, what you’re going for, and who ordered the trip. You cannot be forced or coerced into taking any medication, including injectables with which you are unfamiliar or about which you are concerned.

e. Make sure you are properly identified before you receive medications or are transported anywhere. Believe it or not, misidentification of patients as well as medical orders for treatment or tests are still among the most prevalent and egregious hospital errors.

f. General right of refusal includes your right to challenge any treatment, diagnostic test, specific therapy, or other procedure of which you have no knowledge or have any unanswered questions. Remember these magic words which Must be obeyed when uttered: “I Refuse this (service)”, otherwise you may be manipulated or bamboozled into passivity and acceptance.

While this list of “rights” has a strong scent, it merely expresses a common sense approach to be applied whenever you have concerns, misgivings, or queries. If followed mindlessly and without tact, some of these “rights” may be counterproductive, irritating physician and staff. Still, in a reasonable universe, hospital staffs should be compelled to treat patients with exceeding respect and calm consideration.

Nothing can justify inconsiderate treatment of patients. When people find themselves sick in a strange environment, they are absolutely dependent on the kindness, let alone competence, of strangers.

Many years ago, even before rapid-acting diuretics like Lasix and telephone numbers like 911 had been introduced, I was called to see a familiar patient, a 62 year old gentleman with diabetes, chronic heart and kidney failure, and COPD. When I got to the house about midnight he was struggling for air, having gone into pulmonary edema (sudden fluid backup in the lungs). I immediately started the then current standard treatment: oxygen, injectable morphine, and applied rotating tourniquets-used to reduce temporarily the load of blood returning to the heart. The patient responded rapidly, so that by the time the emergency vehicle arrived, it appeared he was out of immediate danger.

As the patient was being carried into the ambulance, the wife, an impassive somewhat abrasive lady who had witnessed many such medical close calls of her husband, asked, “Well, doc, how much do I owe you?” “Fifteen dollars,” I answered, the going rate for a house call in those days.

“For What?” she retorted. Being a bit exhausted and surprised at her seeming ingratitude, I answered sarcastically, “Just for saving his life.”

“Yeah, but for how long, doc?”

Recent disclosures have again uncovered direct financial ties between orthopedic surgeons and device manufacturers. A well-known spinal surgeon and some of the nation’s most prominent orthopedic surgeons, reporting their results in peer-reviewed journals, hailed Prodisc, an artificial spinal disk as superior to conventional spinal fusion. Dr. Jack Zigler, one of the lead researchers in a study of almost 240 patients made the claim, as did doctors at almost half of the 17 major and academic research centers involved in the study. Unfortunately, 11 of these researchers had more than a scientific interest in the study results; they stood to profit financially if the Prodisc succeeded, according to The New York Times (Jan. 30, 2008) and information from a patient lawsuit settled last year.

The field of spinal surgery continues to foster controversy, particularly in the treatment of back pain, where significant debate continues over how many patients actually benefit from spinal fusion and other operations. As artificial disks become a growth industry, more skepticism is unleashed. Thousands of patients worldwide have received the Prodisc, which costs about $10,00 in the U.S. Yet Medicare and several commercial insurers generally refuse to pay for the surgeries which can cost additional thousands of dollars. The legal and clinical aftermath of Prodisc continue in the courts, and includes patients who had the device implanted only months after the FDA approved it. The FDA is now checking to see whether there was adequate financial disclosure information about the Prodisc researchers during the clinical trial and when the the application for official approval was submitted.

New spinal devices are only the tip of the iceberg. Five companies that account for nearly 95 percent of the lucrative market in hip and knee surgical implants have avoided criminal prosecution over financial inducements paid to surgeons to use their products by agreeing to new corporate compliance procedures and federal monitoring under 18-month agreements with the U.S. Department of Justice.

According to the above Government web site, four companies, have executed Deferred Prosecution Agreements (DPAs), which will expire in 18 months if they meet all of their respective reform requirements. Criminal Complaints were also filed against those four companies, charging them with conspiring to violate the federal anti-kickback statute. Those Complaints will be dismissed at the conclusion of the DPAs if the companies comply with their terms. The fifth company, Stryker Orthopedics, Inc., voluntarily cooperated with the U.S. Attorney’s Office before any other company