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Medical Statistics - The Art of Deception

“There are three kinds of lies: lies, damned lies and statistics.”   There is much truth in this quotation of uncertain provenance.  We see this phenomenon regularly in the medical profession.  We see it in medical journals when statistics are presented in a manner that exaggerates the benefit of a treatment or a diagnostic test.  Massaging numbers is raised to an art form by the pharmaceutical companies who will engage in numerical gymnastics to shine a favorable light on their product.   It’s massaging, not outright mendacity.   The promotional material that pharmaceutical representatives present to doctors is riddled with soft deception. A favorite from their bag of tricks is to rely upon relative value rather than absolute value.  Here’s how this works in this hypothetical example. A drug named Profitsoar is tested to determine if it can reduce the risk of a heart attack.  Two thousand patients are participating in the study.  Each patients receives either Profitsoar or a

Should the FDA Approve Experimental Treatment for Severe Diseases?

I’ve never had the pain and agony of having a kid who is truly sick.  Broken bones and minor surgeries don’t count.  Even one of my kid’s bout with malaria doesn’t rate, as this illness was easily cured. Parents of kids with chronic illnesses would sacrifice anything to help their kids get better or to suffer less.  In the news recently is a conflict between families of kids with Duchenne muscular dystrophy and the Food and Drug Administration (FDA).  A very small study of an experimental drug called eteplirsen suggested some benefit.   Understandably, the families want the FDA to grant approval so that their kids and others could have access to this drug that will fight a dreadful disease that is fatal.  Families argue that these kids have nothing to lose and can’t wait another 5 years waiting for more definite evidence of efficacy to emerge.  The FDA is legally required to approve drugs that are safe and effective.  Obviously, the definitions of safe and effective are subjec

Risks of Probiotics - Who Cares?

Earlier this year I read about a medical study that concluded that a diet high in saturated fat won’t kill you after all.  Moreover, piling on polyunsaturated fat won’t save you. Hee hee.  I love this stuff.  Established medical dogma back flips every 10 years.  Butter in, butter out.  Hormone replacement treatment for perimenopausal women is mandatory, until it isn’t. Who knows what to believe when even doctors are confused or just don’t know. We have a medical industrial complex that is a beast that needs to be fed.  It fuels itself on our fidelity to medical practices that are labeled as truths.  ‘Wellness’ rules.  How many decades did the public and the medical community preach that the P.S.A. blood test saved men’s lives?  While I believe that urologists were sincere in their mistaken beliefs and practices, there was a whole industry behind the scenes that was fueling the fire.  It was good business for hospital operating rooms, medical device companies and radiation

Do Nexium and Heartburn Medicines Cause Dementia?

Proton pump inhibitors, or PPIs, are among the most common drugs prescribed in the United States.  They are extremely safe and highly effective for gastroesophageal reflux disease (GERD).  Are there potential side-effects?  Of course.  Look up the side effects of any of your medicines and you will soon need an anxiety medicine to relieve you of side-effect stress.  The side-effect lists of even our safest medicines are daunting.  PPIs are associated with a growing list of potential serious side-effects, at least according to the lay press.  A few clicks on your computer, and you will find that these medicines can cause pneumonia, C difficile colitis, malabsorption of nutrients, bone fractures and anemia.   The latest report to emerge links these drugs with dementia.  In the past two weeks, I’ve been questioned about this repeatedly by my patients.  One stopped her medication from fear that her heartburn medicine might be incinerating her neurons. Enemy of Heartburn Medicines

Hear Ye, Hear Ye, Probiotics Cure All!

A probiotic rep came to our office bearing lunch and billions of bacteria.  Who on their staff, I queried, counts the bacteria verifying that each packet has 3 billion disease-busting germs?  I suspect that these quantities are only estimates and that consumers may be unwittingly subjected to either an inadequate dosage or a toxic amount.   Caveat emptor! I surmise that plaintiff law firms are hiring germ counting experts hoping to establish with clear and convincing evidence that the product's label is false and misleading.  Soon, we can expect to see TV commercials when we will hear an authoritative announcer asks, "If you or someone you love took probiotics and developed fatigue, joint pains, weight loss, weight gain, nightmares, daydreaming, lack of energy, excess energy, loss of a sense of humor, extreme frivolity, lackluster performance reviews at work, basement flooding or any other adverse life outcome, then you may be entitled to compensation.  Call 1=800 GETCASH

The Daraprim Debacle - The Smell Test Sniffs Out Price Gouging.

You don’t need to be an ear, nose & throat doctor to be conversant with the ‘smell test’.   We use this technique in everyday life.  This diagnostic test is used to determine if a situation is an egregious deviation from established norms.  The beauty of the smell test is that one need not be encumbered by facts and data.  It relies upon emotion and instinct, which greatly simplifies its use.  Let me illstrate. Situation When Smell Test Does Not Apply Grading the SAT Examination.  Sniffing and smelling just won’t work here. Situation When Smell Test Applies A city mayor hires his brother in a no-bid contract as a consultant.  Are you catching on here? The Mother of All Smell Testers I surmise that my erudite and insightful readers would sniff deeply through flared nostrils if they confronted the following situations. “A double dip ice cream cone, which yesterday cost $4.25 is now $57.85.  A severe shortage of sugar cones developed last night.”

Does Nexium and other Heartburn Medicines Cause Osteoporosis?

Every week, I am asked by patients if their heartburn medicine causes osteoporosis.  The most effective heartburn medicines are called proton pump inhibitors, or PPIs.  If you watch more than an hour of TV per week, then you have seen ads for some of them.   Nexium, Prilosec and Protonix are 3 examples of these medicines. Many of them are now available over-the-counter at reduced dosages.  Patients today are incredibly informed, and sometimes misinformed, about their medical conditions and their treatments.  Most of their information is from the internet, and it’s easy for patients to become unwittingly trapped in the world wide web. The information dangling in cyberspace is entirely unregulated.  Information can be made to appear authoritative and objective when it actually is a paid advertisement.  Many blogs may appear to function to inform the public, when their true purpose is to serve the corporation that sponsors it.  If you are learning about probiotics, for exampl

Is Hepatitis C Treatment Cost-effective?

One catch phrase in health care reform is cost-effectiveness.  To paraphrase, this label means that a medical treatment is worth the price.  For example, influenza vaccine, or ‘flu shot’, is effective in reducing the risk of influenza infection.  If the price of each vaccine were $1,000, it would still be medically effective, but it would no longer be cost-effective considering that over 100 million Americans need the vaccine.  Society could not bear this cost as it would drain too many resources from other worthy health endeavors.  Economists argue as to which price point determines cost-effectiveness for specific medical treatments.  As you might expect, insurance companies and pharmaceutical companies might reach different conclusions when the each perform a cost-benefit analysis.  Remember, it’s not just cost we’re focusing on here, but also effectiveness.  If a medicine is dirt cheap, but it doesn’t work, it’s not cost-effective.  Get it? Pharmaceutical companies who are

Why I Won't Refill Your Prescription

Giving prescription refills is not quite as fun as it used to be.  Years ago, we doctors would whip out our prescription pads – often sooner than we should have – and we’d scribble some coded language that pharmacists were trained to decipher.  I’m surprised there were not more errors owing to doctors’ horrendous penmanship.  On occasion, the Food and Drug Administration (FDA) would require a pharmaceutical company to change the name of a drug so it wouldn’t be confused with another medicine with a similar name.   The name of the heartburn drug Losec was too similar to congestive heart failure drug Lasix, so the former drug name was changed to the familiar Prilosec.  Pharmacists Used the Rosetta Stone to Decode Prescriptions Photo Credit Nowadays, we physicians refill medicines with point and click techniques within our electronic medical record (EMR) system.  When this works, it’s a breeze.  Three clicks and the refill has been transmitted to the patient’s pharmacy. Alert

Is My Medicine on the Prescription Drug Formulary?

One of the frustrating aspects of medical practice is trying to divine if the medication I am prescribing is covered by the patient’s insurance company.  Even with the advent of electronic medical records, which should be able to determine this, we are often left to hope and pray. Here’s how it works.  Individual insurance companies have formularies – lists of approved drugs – that they encourage patients and their physicians to use.  Of course, this is all about the money.  There’s nothing evil about an insurance company making a deal with a particular drug company that gives them a price break.  The drug company will be delighted to offer the insurance company a discount in return for an anticipated high volume of prescriptions.   You can easily picture an insurance company negotiating with several different GERD medication representatives watching them each lowering their bid trying to get the contract.   Nexium Guy:   We’ll only charge you $.67 a pill Prevacid Gal:  We’l

Do Doctors Practice Evidence Based Medicine?

I advocate evidence based medicine.  We should restrict our medical recommendations to those that have a reasonable underlying scientific basis.   On the opposite end of this spectrum is quackery, when snake oil and other potions are hawked that either have no scientific support or have been shown scientifically to be ineffective. I do not offer snake oil here as a historical reference.  We have more snake oil and its congeners today than ever before.  People who are sick want to believe the man who promises them healing, particularly when conventional medicine has not succeeded.  This belief goes to the core of human nature, at least as I have observed over the past 3 decades.  Of course, in the medical world, we don’t have enough science yet for all of the medical issues that we physicians confront.   That means that we guess a lot.  How often does this occur?  Every single day.   Patients would be quite surprised to learn that there is usually scant or conflicting medic

Should Drug Reps be Mute on Off Label Drug Use?

Am I an apologist for the pharmaceutical companies?  I don’t think so, but others may disagree based on some sympathetic Whistleblower posts that have appeared in this blog.  It is without question that the drug companies have been demonized and portrayed as rapacious gangs of greed who seek profit over all.  Haven’t you come across the pejorative term, Big Pharma?  Linguistical note:  The adjective ‘Big’ means evil. Consider: Big Oil Big Government Big Tobacco Get the point?   Big Elephant! I’m not suggesting that the pharm guys and gals are all Eagle Scouts.  These companies operate to make money, just like car companies, the cosmetic industry, the airlines, banks and financial institutions, hospitals, manufacturers, the hospitality industry and retailers throughout the land.  Here’s a bold Whistleblower pronouncement. There is nothing evil about making money. Of course, I want our drugs to be safe and effective.  We need the Food and Drug Admin

USPSTF Pushes Back on Hepatitis C Virus Mass Screening.

I spend a lot of my time reading, thinking and writing about politics and medicine.  I love the debate.  Three of the five Kirsch progeny engaged in serious school debate programs, and I believe that they received years of training at our dinner table.  I certainly learned a lot from them – and still do – and I hope they picked up a few worthy lessons along the way. Some time ago, an associate admonished me to avoid dialogue concerning religion or politics, two of my staple conversation themes.  This advice seemed misplaced as I’ve never had an argument in my life discussing a controversial issue.  Indeed, I seek out these opportunities. I don't want the other individual to change the subject; I want this person to change my mind. Controversy erupted recently when Hepatitis C enthusiasts pushed back against the U.S Preventive Services Task Force (USPSTF) draft recommendation regarding testing folks for hepatitis C virus (HCV). More turbulence is sure to follow. The Center f

Medical Device Approval Process Under Fire

All parents have heard their kids complain that but for 1 or 2 percentage points, they would have achieved a higher grade. “This is so unfair! My average is 89.9999 and he is still giving me a B+!” Every kid should receive an A, of course, since psychologists are now professing that every kid is a prodigy in some new measure of intelligence. Academic intelligence, the conventional and obsolescent notion, has been sidelined to make room for other types of smarts, such as musical intelligence, existential intelligence, interpersonal intelligence, spatial intelligence and many others. I agree that there’s a lot more to being smart than conquering number theory and linear algebra, but I wonder whether this effort to broaden the definition of intelligence is simply so more parents can have smart kids. Personally, I think that the conventional definition of intelligence is too rigid and we should be open to where rigorous research leads. Fortunately for me, I did not discover that th

Pharmaceutical Gifts Corrupt Doctors: A Physician Confesses

I write now in a moment of introspection wondering if I am a corrupt doctor. Why would I even consider that my integrity is in question? I am not on the payroll of any pharmaceutical company. I am not paid to speak to physicians or the public about the latest medical breakthrough for flatulence. I submit squeaky clean billings to Medicare and insurance companies. I do not order medical procedures on patients for personal gain. My failing, if it truly exists, is an example of the power of the pen. In our office, many of the pens floating around are labeled with the name of a new drug. I assume that these evil instruments are left by pharmaceutical representatives, but I never actually see them make the drop. They are the ‘Adam and Eve’ of medical practices; they are fruitful and they multiply. These pens over time have mutated, like bacteria and viruses, and can now exist in a variety of harsh environments. For example, when I am in a restaurant about to sign my credit card bill, the

Is Treatment for Hepatitis C Hype or Hope? Big Win for Big Pharm

I see many patients with hepatitis C (HCV).  None of them are under treatment and they all feel quite well. Why don't I treat them?  After all, potential consequences of HCV include: Cirrhosis Hepatocellular carcinoma. or liver cancer End stage liver disease with all the trimmings Liver transplantation Death One would think that a portentous list like this would justify any treatment, even hazardous therapies.  But, I've never seen it this way, and my hepatitis C patients are all doing well under periodic observation. Yes, I know that the disease can be serious.  I recall one patient with advanced disease whom I referred for consideration of a liver transplant many years ago.  There may have been a few others along the way who received treatment for the disease also. The vast majority of hepatitis C patients I see in my community practice feel entirely well and the diagnosis is discovered by accident.  In other words, these patients did not exhibit symptoms or abno

Drug Marketing and Data Mining: Free Speech or Free Ride?

Pharm Tractor Mining Physician Data Drug reps come to our office fairly regularly, but not as often as they used to. Some of them look like regular folks, but many still look a lot like Barbie and Ken. These guys have a tough job. It’s hard to cultivate relationships when you can’t pay off physicians with free trips or offers of remuneration for serving as a ‘consultant’. Remember ‘dine and dash’? Despite these prior excesses, I do not disparage pharm reps, many of whom are ethical professionals who have developed vertical knowledge on a narrow niche of medicine. I have learned from them, but I remember that they are salesmen. Caveat emptor. Drug reps face other challenges beyond the ban on ballgame and theater tickets. We physicians are often constrained by insurance company formularies that dictate what we can prescribe. The insurance companies would balk at that statement and would offer a lawyerly response that, of course, we physicians can prescribe any drug that we believe

Pharmacy Benefit Managers vs Physicians: Let the Games Begin!

As a gastroenterologist, I treat hundreds of patients with heartburn. You already know the names of the medicines I prescribe, since they are advertised day and night on television and appear regularly in print newspapers. Pharmaceutical representatives for each one of these drugs come to our office each claiming some unique clinical advantage of their products over the competitors. They have a tough job since the medicines are all excellent, are priced similarly and are safe. On some days we will have 2 or 3 reps visiting us, each one proffering a medical study or two that supports their product. They show us graphs where their drug is superior to the others regarding an event of questionable clinical import. Their goal is to show that the graph line of their drug is going up, while those of their competitors are going down. Physicians, like me, who do give these folks some time, have mastered the art of the slow head nod as the drug’s virtues are being related. In the past, the rel

Are Plavix and PPI Medicines Safe Together? The Surrogate Marker Strikes Again!

When the medical press seizes a story, it can become an obsession. Any physician who is reading any journal is aware of the reported interaction between clopidrogel (Plavix) and proton pump inhibitor (PPI) drugs, including Prilosec and her cousins. PPI medicines are not exotic elixirs known only to medical professionals. They are known to any person with a working TV set or who still reads a newspaper, since ads for these drugs are omnipresent. Just google ‘purple pill’ and begin your entrance into the PPI Chamber of Advertising. PPI medicines are highly effective for peptic ulcers and gastroesophageal reflux, although I suspect that most patients on these medications do not have any true indication for them. (Disclosure: I’ve pulled the PPI trigger too quickly on many patients who do clearly require acid blocking medicines.) PPI medicines are prescribed to hospitalized patients almost by reflex, and are often administered by the intravenous route, even when patients can swallow pills

Free Drug Samples and Hospital Hotels: Which is the Greater Evil?

Many folks criticize pharmaceutical companies for providing physicians’ offices with free drug samples. They claim that this giveaway harms consumers because drug companies must raise their prices to cover the costs of these freebies. Of course, this is undeniable. Any business expense, such as payroll or advertising, has to be covered and is expectedly borne by the consumer. If a company chooses not to advertise, outsources manufacturing to a country with cheaper labor, offers limited benefits to its employees, then they can sell their product at a low price. In this hypothetical example, anemic sales may doom the company quickly. Naturally, free samples are not really free. The rest of us pay for them. While this is true, I don’t think it is evil. Unlike the U.S. government, at least drug companies are covering their costs and not simply borrowing money every year to meet budget. Interesting concept. Two of the community hospitals I work at have undergone transformations. One is