Archive for the ‘Uncategorized’ Category

Medical Progress and Creative Destruction

Tuesday, June 30th, 2015

“Creative destruction”, a sometimes throwaway phrase with deep implications, occurs when creativity in all its forms (novelty, invention, or imagination) lays waste to established forms of culture, belief,  politics, business (manufacturing and distribution,) even behavior. The results can be as profound as revolutionizing, annihilating or causing replacement of whatever existed before. Examples abound throughout history.  Consider: the railroad and the automobile vs. horse and carriage, radio vs. the telegraph, email vs. the post office, social networks and the Internet vs. the publishing industry, the smart phone vs. the recording business, photography, even TV. At times, the obverse, “destructive creation” can be inferred as a kind of feedback loop.  The crossover point is somewhere between progress and failure.

Examples of destructive creation come to mind, such as software upgrades killing off perfectly good software to force consumers and industry alike into upgrading.  Consider the cost we endure for the replacement rate resulting from new products.. By discarding our household goods, cars, old TV’s, computers, and mobile phones, we “destructively” increase toxic and other waste. “Progress” thus results inevitably in environmental degradation.

Destructive Creation and Medicine

Medical Progress in the form of immunization, antibiotics, cardiac surgery, revolutionary imaging, etc. has been a colossal success story over the past century, conferring on our age extravagant improvement in health and longevity. Yet from time to time, we suffer disillusion when we learn, often long after the fact, that some promising new drugs are so dangerous they’ve been taken off the market, that uncountable cardiac procedures, such as catheterization, stent placement, implantable pacemakers were not indicated, that tens of thousands of joint replacement need never have been performed.

Dr. Eric Topol, in his 2011 book, “The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care”, rhapsodizes over our smart phone detecting cancer cells, monitoring your brain waves, or warning you of an imminent heart attack. Could this be overshooting the runway? At the same time Topol was on the money when he predicted our vital signs could be monitored continuously, perhaps even our blood chemistries. After all, we now have the soaring stock price of the new IPO, Fitbit, “which tracks every part of your day—including activity, exercise, food, weight and sleep—to help you find your fit, stay motivated, and see how small steps make a big impact.

Does this mean we can now commodify the medical profession, as well as healthcare itself, by simply replacing them with digital technology and mobile devices?

 

Martin F. Sturman, MD, FACP

copyright 2015, Mathemedics, Inc.

 

Anti-Vaccination Madness

Friday, April 10th, 2015

Once any idea becomes accepted by the general public, it becomes frozen by habit and time; when it’s proven wrong the “falsehood index” hardly declines. New evidence is ignored in the zeitgeist of immutable belief. I am indebted to the comedian, Stephen Colbert, for introducing us to his term, truthiness-in the dictionary now-signifying imitation or ersatz truth, the appeal of raw feeling over proven reality.

Tragically, truthiness can get dangerous. Vaccine-preventable diseases, such as diphtheria, pertussis, tetanus, measles, mumps, and rubella are increasing.  The anti-vaccination hysteria which has resulted in measles (as well pertussis) coming back to haunt us after years of virtual disappearance.   By 2000 measles was virtually eliminated in this country.  But worldwide, there are still about 20 million cases a year; in 2013, 145,700 people died of measles. Last year several hundred new cases were reported in the U.S., the largest outbreak in almost 20 years.  Parents have elected not to vaccinate their children because they can; 19 states have philosophical exemptions to vaccination, and 47 have religious exemptions. Between October 1990 and June 1991, 1,400 people living in Philadelphia were infected with measles and nine children died.  The Centers for Disease Control (CDC) found that the deaths had nothing to do with a new strain, and “everything to do with the parents.” They have recently reported that one-third of all children between 1-3 years have not been immunized. The percentage of American who believe vaccines are safe or effective is only 53%.

One estimate (JAMA) suggests that from 1924 to 2012 childhood vaccinations prevented more than 100 million cases of serious disease. The fundamental question is: do parents’ right to raise their children justify their decisions to not to vaccinate, thus putting the entire community at risk for disease?

Stay tuned.

Martin F. Sturman, MD, FACP

copyright 2015, Mathemedics, Inc.

 

How and When Medicine Was Sold Out

Thursday, February 12th, 2015

 

That’s the kind of ad I like, facts, facts, facts.

Samuel Goldwyn

What is a Profession?

The IRS defines a trade or business as “…generally including any activity carried on for the production of income from selling goods or performing services… ” But if traders are performing services, what separates this from a profession where services are also performed? Let me explain.  Professionals, such as lawyers, and especially physicians, enjoy an unusual magnitude of trust by serving society and represent  a safe haven of respect, unlimited privacy, and intimacy. Equally important, doctors were not expected to sell anything.

Historical Background

To distinguish themselves from the archipelago of fraudulent health care providers, 19thCentury physicians not only instituted higher educational standards and licensure but also demanded that their members refrain from advertising to the public. Not unexpectedly, members of the medical profession framed their rejection of advertising as an ethical objection.According to the first AMA code of Ethics (1847), it was “derogatory to the dignity of the profession to resort of public advertisements.”

When Medicine Became a Business

For over a century following the AMA Code of Ethics, up to the early 1970’s physicians and lawyers exercised rights to establish their own professional boundaries, especially prohibitions of advertisements or promotions in any venue. These prohibitions included promising cures, publishing testimonials, pushing pills, and selling medical services or devices by any means. To violate these rules resulted in censure and ostracism. An unforgettable example was related to me a few years before I opened my own practice. It involved a physician whose announcement of arrival and a brief biography in a local newspaper resulted in his ultimate excommunication from the local medical society!

The rules about professionals advertising suddenly changed when the legal profession first got the axe in 1975. The Federal Appeals Court had held that publication of a fee schedule by the Fairfax County Bar Association was immune from liability for price fixing because the practice of law was a learned profession, not trade or commerce under the Sherman Antitrust Act. “Not so,” said the (Burger) Supreme Court, (8 to 0), stating that the Virginia State Bar enforcement mechanism …through the prospect of professional discipline, “constituted price-fixing” and indeed was a violation of the Sherman Act. See  Goldfarb v Virginia State Bar. Two years after the successful suit the Federal Trade Commission (FTC)  confirmed the commission’s perception of health care as a “commercial marketplace in which goods and services are bought and sold,” and accused the profession of “restraint of trade.” At that point the AMA in a final “phase transition” removed all prohibitions to advertising, retaining only a weak restriction against false or misleading advertising. (Opinion 5.02, issued in 1975 amending the 1847 Code of Ethics almost completely.)

Some Unanticipated Results of Medical Advertising

Advertising is the foundation of commerce in capitalistic economies; it is widely acknowledged as a crucial investment in maintaining trade, employment, and profitability. It is crucial to the survival of business and trade by enabling consumers to make informed, or at least, reasonable judgments, about purchasing most of the goods and services they require.

Then what could possibly be wrong with conflating commerce and its undeniable need for advertising, with medicine and health care? The profound implications of this marriage becomes obvious since physicians, like any people in business, are in constant search of new customers, they are free to market their services as goods in order to sell health and longevity.

The public, obviously, has no choice in the matter but is compelled to seek medical care when ill or for preserving life, by preventing and alleviating sickness. What is true for health (read “disease”) does not hold for bananas, smart phones, and deodorants, the purchase of which is optional. It is the very genius of promotion and marketing of health care that ignores these questions by turning them on their head. In this manner, advertising health in America becomes a powerful cultural influence, by creating a public preoccupation with health and longevity. Privatization of healthcare has always been part of the American Experience, but commercialization is only forty years old. Promotional exuberance encouraged by competing health care entities soon edged into a financial arms race to the bottom line. We now enjoy lives crammed full of advertising doctors, hospitals, ER’s, nursing homes, insurers, other health businesses  such as “alternative” medicine, exercise centers, health food stores, etc. all competing for business, making such goods and services into some of our most impressive growth industries. Increasingly, the entire health care universe begins to mirror Big Pharma, as it floods TV with drug ads.  Solicitation in effect becomes compensation.

Increasing demand for health care services fueled by advertising is responsible in large part for making U.S. health care, according to the 2014 Commonwealth Fund report, the most expensive in the world. yet (it) “…consistently underperforms other countries in most dimensions of performance.” Currently, according to the report, the U.S. ranks last among 11 major industrialized nations in efficiency, equity, and health outcomes attributable to medical care.

To paraphrase Napoleon, it’s worse than a tragedy, it’s a mistake.

Martin F. Sturman, MD, FACP

Copyright 2015, Mathemedics, Inc.

 

Are You a Gluten for Punishment?

Friday, March 21st, 2014

Over 840 million people in the world are hungry. Yet for millions of Americans obsessed with food phobias, gluten – if you’ll pardon the expression – takes the cake. Time magazine, in its survey of Americans’ food eating habits, labeled the gluten-free movement number 2 out of its top 10 list of food trends in 2012. A recent market research report by the NPD Group states that of 1000 respondents one third are cutting back on dietary gluten big time.

Gluten (from Latin gluten or glue) is a composite protein in wheat, barley, and rye and thus found in foods processed from these grains, such as bread, cakes and other baked goods, as well as breakfast cereal and pasta. Rice, including “sticky rice” and corn are gluten-free.

What’s so Frightful about Gluten?

Celiac disease is an uncommon autoimmune disorder of the small intestine which occurs in genetically predisposed people.  Symptoms, most classically appear in children, include abdominal pain, chronic constipation, diarrhea, vomiting, weight loss, growth failure, and anemia due to malabsorption. In adults some of these complaints may be absent, and symptoms in other organ systems have been described. Increasingly, diagnoses are being made in asymptomatic persons as a result of various, if controversial screening tests for certain antibodies.True celiac disease, according to The University of Chicago’s Celiac Disease Center affects about 0.75% of Americans, about 1 in 133, but some figures quoted in Wikipedia suggest a much lower prevalence. Yet, despite these statistics, gluten fright has captured the public mind, becoming a “dietarily” correct food phobia on a level with the usual suspects: sugar, salt, saturated and trans fats, carbs, and cholesterol.

Why celiac disease symptoms, especially in adults, are so varied and why gluten may not be the culprit in non-celiac gluten sensitivity are discussed in this important article in the journal Gastorenterology. The authors reported results of various gluten challenge diets and compared them with reversion to a normal diet in 37 patients. Only 6 patients responded to pure gluten challenge. Although the study was limited, it raises vital questions about the oft-reported improvement on gluten free diets by the public. The researchers concluded that the large majority of people with self-reported gluten sensitivity didn’t experience symptoms after a gluten challenge when they had eliminated foods high in certain carbohydrates from their diets. *

Shopping for Gluten-Free and Your Grocery Bill

Another excellent article by Martha C. White, declaresl: “Why We’re Wasting Billions on Gluten-Free Food”. Ms. White points out that, as food fads go, we’re paying an enormous premium to avoid gluten without any legitimate medical reason. In effect, we are hypnotized by urban myths, advertising, and the profusion of gluten-free grocery shelves. The “99%” imagine they’ll feel better, attain good health, and who knows, longevity-by shelling out huge bucks for gluten free-food they probably don’t need.

Foody nonsense and fad diets along with their accompanying phobias masquerading as dietary theology, go back to the 70s, when sugar became the bête noir of foods. Then, as mentioned above, it was fat, salt, carbs, cholesterol-and finally the latest pariah ingredient, gluten. People who have bad reactions to common gluten-containing foods – pasta, breads, baked goods and breakfast cereal – may actually be sensitive to something else. It’s also probable that some people develop gastrointestinal or other symptoms simply because they believe they’re food-sensitive.

Researchers from Dalhousie Medical School at Dalhousie University in Canada compared the prices of 56 ordinary grocery items that contain gluten with their gluten-free counterparts. All of the gluten-free ones were more expensive, and some were much more expensive. The average unit cost of the gluten-free product was $1.71 while the average unit cost of the regular gluten-containing product was $ 0.61. This translates to gluten free products costing 242% more than the “real thing.”

The challenge has been met by an increasing number of food manufacturers who have happily entered this highly profitable growth industry. The market research company Packaged Facts said in a report last fall the gluten-free market in the United States was $4.2 billion last year. It predicts that the category will grow to $6.6 billion by 2017.

See my recent newsletter for a more complete discussion

Martin F. Sturman, MD, FACP

Copyright 2014, Mathemedics, Inc.

Government Shutdown Cripples CDC

Friday, October 4th, 2013

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Truth, Belief, and Human Survival

Tuesday, September 24th, 2013

Not a day passes when we don’t hear about the perils of HRT, antidepressants, “carbs”, cholesterol, sodium excess, gluten, and the importance of proper diet to protect us against obesity and diabetes, cancer, heart attacks, and death itself. Modern life as mirrored in the media, via our “devices”, hand-held and otherwise, offers 24/7 stimulation. This arrives in the form of entertainment, news, and advertising. Sadly, we are all drowning in “information,” whether it is advertising or government edict disguised as medical truth, or opinion parading as received wisdom. Public confusion reigns. The City of New York and other cities, decides to mandate the amount of trans fat allowed to be served in restaurants, the medical sovereigns or the Government tells us we will die of high blood pressure if we don’t restrict salt intake-the list goes on. In my opinion and that of others,  most of these decisions have been verified by a plethora of Junk Science. Many such beliefs edge into a form of snobbery when skeptics are ridiculed. We all want to be “right” and politically correct, even if, for example, Federal dietary guidelines change every few years or spectacular new medical treatments, such as anticoagulants and robotic surgery are proven to be dangerous.

Once we begin to acknowledge that life is all about uncertainty, we are still left with that slippery word, “truth”, and its fashionable costumes of faith and belief. Ultimately, we are left to deal with faith, reason, and the actual basis of knowledge. According to Gallup, 40% or 125 million of Americans take a literalist view of creation, believing that God created the universe, (either in millions of years or in 6 days), but place the big bang “2,500 years after the Babylonians and Sumerians learned to brew beer.” Only 17% of us doubt that a personal God has authored the Bible, let alone created the earth and its 900,000 species of insects. As Sam Harris in The End of Faith also observes, “A survey of Hindus, Muslims, and Jews around the world would surely yield similar results revealing that we, as a species, have grown almost perfectly intoxicated by our myths.” Can the human race, its very existence now imperiled by the clash of beliefs and civilizations, afford to drift entirely free of reason and evidence?

More on Direct to Consumer Drug Advertising

Saturday, November 26th, 2011

Tremendous growth has occurred in direct-to-consumer pharmaceutical advertising  since 1998.  According to Pharma Marketing News (Pharmacy and Therapeutics, October 2011) spending in dollars rose from $1.2 billion in 1998 to $2.5 billion in 2000 and 4.5 billion in 2009, a 450% increase.

As I pointed out three years ago, prescription drug marketing directly to the consumer is routinely permitted under U.S. law. Notable, is the profoundly different regulatory environment in the European Union (EU), Australia, and Canada where pharmaceutical manufacturers are forbidden to advertise prescription drugs to the public.  Incredibly,  the U.S. and New Zealand are the only two countries in the world where it is legal for drug companies to advertise to the public.

Such “direct to consumer” or DTC advertising is meant, obviously, to create increased patient demand for specific drugs from their doctors. In this scenario, patients really become consumers, replacing the doctor as prescriber, if the physician is foolish enough to surrender his authority. Consumer Reports, in a 2006 survey found that 78 percent of doctors said that patients asked them at one time or another to prescribe drugs they had seen advertised on television.

While Congress recently gave the FDA more authority to regulate ads, it rejected a measure that would have allowed to agency to place a moratorium on ads for new drugs that raise safety concerns. The sad fact remains that Congress seems in no mood to address the main problem, the legality of advertising drugs to the public.

Don’t expect the ad barrage, TV or otherwise, to subside any time soon.  Evening and much of daytime TV is contaminated with advertising for various pharmaceutical products, including new antidepressants, new treatments for arthritis,  heart disease, diabetes, sexual malperformance-who can define “erectile dysfunction”?-a host of new anticoagulants-I could go on indefinitely. What I like best are the disclaimers:  Here’s an example from Chantix:

Some people have had changes in behavior, hostility, agitation, depressed mood, suicidal thoughts or actions while using CHANTIX to help them quit smoking. Some people had these symptoms when they began taking CHANTIX, and others developed them after several weeks of treatment or after stopping CHANTIX. If you, your family, or caregiver notice agitation, hostility, depression, or changes in behavior, thinking, or mood that are not typical for you, or you develop suicidal thoughts or actions, anxiety, panic, aggression, anger, mania, abnormal sensations, hallucinations, paranoia, or confusion, stop taking CHANTIX and call your doctor right away. Also tell your doctor about any history of depression or other mental health problems before taking CHANTIX, as these symptoms may worsen while taking CHANTIX.

Some people can have serious skin reactions while taking CHANTIX, some of which can become life-threatening. These can include rash, swelling, redness, and peeling of the skin. Some people can have allergic reactions to CHANTIX, some of which can be life-threatening and include: swelling of the face, mouth, and throat that can cause trouble breathing. If you have these symptoms or have a rash with peeling skin or blisters in your mouth, stop taking CHANTIX and get medical attention right away.

The real question is, why would anyone in his right mind take Chantix to stop smoking?  Or for that matter, a few hundred other drugs festooned with all those scary disclaimers.

U.S. Health Care Spending vs. Major Countries

Friday, August 12th, 2011

иконографияКартини

  • Health  care spending towers over other major industrial countries.  In 2008, hospital spending per discharge in the U.S. dwarfed all major industrial countries at $16,708.  This is nearly triple  the median of $5,949  according to the  Organization for Economic Cooperation and Development (OECD).  This analysis concentrated on 2010 OECD health data for Australia, Canada, Denmark, France, Germany, Netherlands, New Zealand, Norway, Sweden, Switzerland, the United Kingdom, and the United States. including the supply, utilization, and price of diagnostic imaging.  The country with the second-highest spending, Canada, spent only 75 percent as much per discharge ($12,669), and in both Germany and France, hospital stays were nearly one-quarter as expensive ($4,566 and $4,762, respectively.

This enormous difference in spending occurs despite the fact that the U.S. has fewer hospital beds and physicians, and sees fewer hospital and physician visits than in most other countries. Prescription drug utilization, prices, and spending all appear to be highest in the U.S.  OECD  tracks and reports on more than 1,200 health system measures across 34 industrialized countries. U.S. performance on other measures is variable. We ranking highly on five-year cancer survival, fair on in-hospital case-specific mortality, and poorly on hospital admissions for chronic conditions and amputations due to diabetes.

Shocking, isn’t it?  Stay tuned.
__________________________________

Knee and Hip Ops Almost Doubling in 10 Years

Monday, April 4th, 2011

Between 1996–1997 and 2006–2007, inpatient procedure rates among persons 45–64 years of age doubled for total knee replacements (from 12 to 26 per 10,000 population) and almost doubled from 7 to 12 per 10,000 population, for total hip replacements.

During this period, inpatient procedure rates for excision of intervertebral disc and spinal fusion, which are typically not performed on an outpatient basis, were unchanged among this age group.

Among persons 65 years of age and over, excision of intervertebral disc and spinal fusion procedure rates increased 67%, from 17 to 28 per 10,000 population, and total knee replacement procedures increased 60%, from 51 to 82 per 10,000 population, during this period. Stay tuned.

Are there that many more patients who require hip and knee replacements as well as spinal operations, or have the indications for performing these procedures changed that much in 10 years? What is the new complication rate? Stay tuned.

Source: National Center for Health Statistics. Health, United States, 2010. http://www.cdc.gov/nchs/data/hus/hus10.pdf

Criminal and Civil Penalties Against Big Pharm

Wednesday, December 29th, 2010

The Public Citizens Health Group recently reported U.S. spending on prescription drugs has increased from $40 billion in 1990 to $234 billion in 2008.  During this period, escalating drug costs have contributed to such inflated spending that  illegal pharmaceutical company activities are finally beginning to attract media attention.

Reported in major publications, recent billion-dollar settlements  with two of the largest pharmaceutical companies in the world, Eli Lilly and Pfizer, demonstrate the enormous scale of this wrongdoing.  However, according to The Public Citizen’s Health Group, the extent,  size,  and potential impact of these illegal and dangerous activities have not been previously analyzed.

Their study examined trends from 1991 to the present in federal and state criminal and civil actions against pharmaceutical companies by compiling a comprehensive database  to identify all settlements of at least $1 million during the past 20 years.

Of the 165 settlements comprising $19.8 billion in penalties during this 20-year interval, 73 percent of the settlements (121) and 75 percent of the penalties ($14.8 billion) have occurred in just the past five years (2006-2010).  Four companies, among the largest in the world, (GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough) accounted for more than half (53 percent or $10.5 billion) of all financial penalties imposed over the past two decades.

“While the defense industry used to be the biggest defrauder of the federal government under the False Claims Act (FCA), … the pharmaceutical industry has greatly overtaken the defense industry in recent years. The pharmaceutical industry now tops not only the defense industry, but all other industries in the total amount of fraud payments for actions against the federal government under the False Claims Act.”

The practice of illegal off-label promotion of pharmaceuticals has been responsible for the largest amount of financial penalties levied by the federal government over the past 20 years. This practice can be prosecuted as a criminal offense because of the potential for serious adverse health effects. Medicaid fraud, has been the most common violation against state governments and is responsible for the largest amount of financial penalties levied by these governments.

The rapidly rising number of criminal and civil penalties against Big Pharm in recent years have been described as a “veritable crime spree.”