EasyDiagnosis Second Opinions

Don’t speak through the screen door, you’ll strain your voice.

                                                                                      Anon.

The idea of screening for disease sound great: discover the disease before symptoms appear, thus allowing an undiscovered condition-cancer, for example-to be treated early, thus saving lives.  This philosophy has both a light and a dark side.  Does the act of screening create more disease or reveal unexpected but benign conditions that lead to unnecessary and expensive, if not dangerous testing? See this previous blog.  Then again do we always achieve what we hope, earlier diagnosis? Another unanswered question: Even if earlier diagnosis is made, when and how often, in the present state of knowledge, does it change the patient outlook for survival? This would seem to be especially pertinent in the diagnosis, for example in case of lung, esophageal, and pancreatic cancers. Yet no one argues the value of screening for cervical or skin cancer and a host of other conditions. 

It turns out that “lead time bias” is one of the most pervasive problems in proving that screening does what it promises. This simply means we cannot routinely assume that the patient would have died earlier if screening had not been done. Looking at raw statistics and without long term followup of control patients who had not been screened we often draw the wrong conclusions: We have no consistently reliable way of knowing whether patients discovered at screening live longer than unscreened patients who would have died at the same time. In this case no additional life would have been gained through a screening test which did nothing except advance diagnosis. Indeed, there may be added cost in the form of anxiety as the patient must live with knowledge of the disease for longer.

An interesting example of this problem comes out of disputed research on screening for lung cancer, recently reported in the New York Times. Researchers at Weill Cornell Medical  did spiral CT screening of 35,000 people with a history of smoking or occupational exposure. 484 were found to have lung cancer, and most of the tumors were removed.  The researchers estimated that 92% with early stage tumors would be alive 10 years later, an amazing survival rate compared to the the 10% who survive that long after diagnosis discovered without screening. This sounds like a medical “slam-dunk case for screening,” but unfortunately there was no control group of patients who did not receive CT scanning; there was no proof that people who are screened die less frequently or live longer than people who are not screened.

To underscore this point, another study published in 2007 analyzing the results of CT screening in over 3,000 patients showed an increased number of small tumors found and the number of surgeries to remove them, but it did not reduce the total number of lung cancer deaths.  A possible explanation is that many tumors would not have killed even if left alone, while the truly lethal tumors were not actually caught earlier.  As of now, no major organization recommends widespread use of spiral CT screening for lung cancer, although individual patients may choose to have it.

The best hope of showing the effectiveness of lung cancer screening lies in a large federal trial of 50,000 current and former smokers comparing spiral CT screening with standard chest X-rays to see which”saves more lives.” This will take years to complete. The real issue remains, however, whether it will ever be easy to demonstrate that early diagnosis in a large number of conditions, prostate cancer, for example, really prolongs survival unless or until effective new treatments are developed.

Can you believe it? Cholesterol-lowering drugs for 8-year olds? Thanks go to the American Academy of Pediatrics (A.A.P.) who included in this pronouncement July 7, on lipid screening for infants and children “…For children who are more than eight years old and who have high LDL concentrations, cholesterol-reducing medications should be considered.” The idea is to give statin drugs early in life to children with elevated lipids-screening begins as early as “age 2, but no later than age 10,”-presumably to prevent heart attacks 30-60 years later. This assumes there is evidence these drugs when taken for decades actually helps prevent coronary disease.

Yet we have no idea even today what happens when people take statins for more than the 15-20 years, (since the onset of the statin “revolution.”) We do know some patients on these drugs-numbers continue to be hotly disputed-can suffer one or more of the following serious side effects, including, but not limited to: liver function abnormalities, memory loss and cognitive impairment, serious, even fatal muscle disease, an increase in cancer incidence, and a host of other problems, many of which are related to length of therapy.

A few doctors have applauded this stunning idea of the A.A.P., many others are shocked. “To be frank, I’m embarrassed for the A.A.P. today” said one academic authority, Dr. Lawrence Rosen. “Treatment with medications in the absence of any clear data? I hope they’re ready for the public backlash.” Dr. Darshak Sanghavi, a pediatric cardiologist and Professor at the University of Massachusetts Medical School, quoted in the New York Times, remarked, “How many heart attacks do we hope to prevent this way?”

Physicians who sat on the Academy’s committee on nutrition which issued the guidelines, admit there are no long-term data on statin use, but claim without citing evidence, there are adequate safety data to justify their recommendations. Safety data for 10, 30, or 50 years? Incidentally, the report’s lead author, Dr. Stephen Daniels, told The Associated Press that he had worked as a consultant to Abbott Laboratories, and Merck, but not on their cholesterol drugs. He was not available for comment when the study was released.

In the meantime, the Food and Drug Administration has already approved the use of the statin, Prevachol, for use in children as young as 8. One of the most serious problems may be opening the door for pharmaceutical advertising. I can see it now on Sesame Street, Nickelodeon, and the Disney channel, if not Desperate Housewives: “Tell your mom to have your cholesterol checked.”

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 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 merely 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 serve baked goods, fried foods-to virtually anything on the menu not 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 of chirality (chiral, derived from the Greek, meaning hand) 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.