Sunday, September 30, 2012

Institute of Medicine Issues Report on Waste in Medicine - Why Whistleblower Readers Should Care?

It was recently discovered that Fareed Zakaria committed plagiarism in an essay he wrote for Time Magazine on gun control.  He confessed and apologized.  I think he could have been fired for this as plagiarism, aka theft, is a cardinal offense for a journalist and a news magazine where trust is a central pillar.  This was not a matter of an indiscretion in his private life or an offense that doesn’t threaten his profession’s central mission. This was dishonesty in a job that should demand honesty in every syllable.  Zakaria is a Harvard graduate and a Yale trustee.  How would these institutions have ruled on a student who admitted committing plagiarism?  CNN and Time ‘suspended’ him.  Was Zakaria too big to fail?

I’ve devoted several posts in this blog to professional integrity and personal ethics.  Medical plagiarism is a serious ethical wound in the medical world and all of us must hold our academic colleagues, medical students and practicing physicians accountable.

In September 2012, the Institute of Medicine (IOM) issued a report that delivered a bold and unexpected message – our health care system is wasting money!  Who knew?  I have to assume that this 18-member panel has plagiarized the Whistleblower as so many posts here are devoted to this issue long before their report was published.  I’ll leave it to readers to decide if I should seek judicial redress on this unethical appropriation.  This is an opportunity for an ordinary reader to become a Whistleblower.


Whistleblower Readers are Watching!


This panel after a year and a half of study concluded that we’re incinerating a ton of money. Lest you accuse me of hyperbole, $750 billion are being vaporized annually, nearly a third of every dollar spent.  How would your personal or professional balance sheet appear if you wasted 30 cents of every dollar?  No business or home can remain solvent under that scenario, and neither can the health care system.
Why are there no checks on this system?  Here are a several reasons why unnecessary care is practiced.
  • Fee-for-service medicine where physicians like me are reimbursed in an a la carte manner.
  • Defensive medicine where physicians like me order unnecessary tests to reduce legal risk.
  • Pressure from patients who desire more testing and treatment believing that more medicine is better medicine.
  • Patients who pursue expensive care of questionable value that they don’t have to pay for.
  • Physicians who practice non-evidenced based medicine.
  • Rising administrative costs.
  • Fraud.
Feel free to add to the list.  Climbing out the hole will be like scaling a glass skyscraper.  Every reform measure angers and threatens a powerful player in the medical arena.  I support initiatives like comparative effectiveness research and the more recent Choose Wisely program, which represent the first steps of what will be a very long odyssey. 

If any blogger has their eye on this post with an aim of posting it as his own, caution.  Whistleblower readers will be watching.



Sunday, September 23, 2012

Are Organic Foods Healthier?

In American society, packaging trumps contents. Look at both the Democratic and the Republican presidential nominating conventions we all just endured. In the old days, these conventions had a purpose – to select nominees. Now, they are scripted, grandiose infomercials that insult our intelligence more than they inform us. They are coronations. I heard great oratory, decent rhetoric and pabulum. The spectacles wasted tons of money that could have been devoted to charity or some other worthy cause. As marketing and political folks understand well, packaging sells products. Think of this the next time you are choosing a bottle of shampoo off the shelf. Are you really buying the sleek bottle? Are you voting for the sleeker and more likable candidate?

Except for Mitt Romney, it seemed that every other speaker was raised in a log cabin. Lincoln would have no advantage if he were running today.

There’s plenty of packaging and fluff in the medical universe also. Complementary and alternative medicine, in my view, lures us with a seductive ‘package’ that often overpromises on what it can deliver. Don’t misunderstand me here. I am not dissing C & A medicine categorically or suggesting that it is not worthy of study. I maintain that any medical treatment that we contemplate for our patients should be based on science and not faith. Admittedly, in many clinical circumstances, we physicians must make a judgment before science has ruled on the issue. Yes, there is artistry in medicine.

I dine out often with close friends who believe that organic foods are more healthful. I’m skeptical of this and many other health claims made with regard to stuff that we eat. Is irradiated milk really dangerous even though this label sounds like we should be hearing scary music when we open the carton? Remember the phrase ‘farm fresh eggs’ which are no better than competing chicken eggs even though the label conjures up feelings of health and wellness? And probiotics? This requires its own blog post to sort out what we know from what we believe.

I’ll admit that the organic food label suggests a higher quality product, but this is not evidence. Just because we think, or other folks want us to think, that something is better for us, doesn’t make it so. Hebrew National hotdogs had a brilliant ad campaign years ago when they told viewers that their company ‘answered to a higher authority’ suggesting that their kosher product had a divine imprimatur. I’m not certain, however, that these porkless franks were truly food for the gods.

The respected journal the Annals of Internal Medicine recently published a study concluding that organic foods were not more healthful than ‘inorganic’ alternatives. There were some differences found with regard to antibiotic-resistant germs and pesticide exposure, but this does not mean that these products are safer for consumers.

Organic food is big business and it’s getting bigger. Tens of billions of dollars are spent on them each year by Americans who believe that these foods are higher quality. There is one indisputable difference that distinguished organic stuff from the rest of the stale and moldy stuff that I eat regularly. It sure costs more. Maybe the higher cost is part of the packaging to convince us that it’s really better. Remember the hair color product that used the phrase ‘it costs a little more, but it’s worth it’ to convince us that a higher price implied higher quality?

So, whom should I vote for this November? I’ll likely be voting against the president, although neither candidate inspires me. However, when it comes to packaging, the president is far ahead. Barack Obama is presented as the organic candidate. Romney is white bread.



Sunday, September 16, 2012

Medical Complications and Medical Negligence: What's the Difference?

The day before this writing, a patient who was minutes away from his colonoscopy, asked me how many colonoscopies I had performed. Before I could answer, he quickly followed-up asking if any of my patients developed perforation of the colon after the procedure.

I satisfied his initial inquiry when I informed him that I have intruded into at least 20,000 colons in the past 2 decades. With regard to his second and more ‘penetrating’ question, I told him, yes, there have been a few perforations. I continued the dialogue in order to place the issue in context for him and his wife so he wouldn’t be spooked before his procedure. We didn’t want a panicked patient leaping off the gurney and high-tailing through our waiting room in a flapping opened-back gown to the parking lot. Fortunately, our discussion accomplished its purpose and his procedure proceeded calmly and uneventfully.

Sure, complications matter, but numbers can deceive. Our most highly experienced physicians have likely had more complications than other medical colleagues, although their complication rate may be very low. For example, a known complication of heart surgery is the dreaded complication of a stroke. A heart surgeon, who has operated on thousands of patients, may have had 25 stroke complications. A younger surgeon, however, may have only have had 3 or 4 stroke complications in his briefer career. Which surgeon would you choose?

In addition, a doctor’s higher complication rate may reflect that he accepts more risky and challenging patients that other physicians have rejected.

Perforation of the colon after a colonoscopy is a terrible event, mostly for the patient and the family, but also for the physician. While it is rare, it is inevitable. If your gastroenterologist has never had one, he likely has very limited experience. If this is the case, don’t jump off the gurney. Recognize, however, that a perfect record doesn’t mean medical perfection.

Keep in mind that complications are blameless events. They are not negligent. If you prescribe penicillin to a patient who denies allergies, and a severe rash develops, then a complication has occurred. The physician is not culpable. However, if the patient had a known penicillin allergy, and the physician neglected to inquire about medication allergies, then the same rash is not a complication, but is the result of medical negligence. The distinction between complications and negligence is not appreciated by most lay individuals and many plaintiff attorneys.

Physicians will be increasingly tracked on various ‘quality’ measurements that will be accessible to the public. While knowledge is power, incomplete and deceptive knowledge can mislead and confuse. When you are reviewing the quality statistics on your doctor, be skeptical that this data is a true measurement of medical quality.  In medicine, what really counts can't be easily counted.  Conversely, what's easy to measure rarely measures up. 

While poking a hole in the colon is thankfully a rare event, pay-for-performance and other medical quality initiatives have more holes than Swiss cheese. These are not complications.  It's negligence.

Sunday, September 9, 2012

How to Take a Medical History: A D-Day Approach

One of the joys of being a physician is learning the patients' histories. A joy, you say? Isn't taking the history simply part of the doctoring routine? You've all been there.







When did the pain start?
What made it worse?
Did it move around or stay in one place?

I agree that inquiries like these are not intrinsically joyful, but this is not my meaning here. I refer to history here in the conventional sense. I am interested in who the patients are as people, what they did and what they saw.

It is amazing how many seemingly ordinary folks have extraordinary tales and vignettes that they are quite willing to share, if they are asked.  I have a sense that they are a reservoir of wisdom that we must actively draw from, as they may not volunteer their advice.

I recall a science teacher whose prior occupation was serving as a commander of a nuclear submarine. Even years later, his secrets remained tightly held, despite my gentle entreaties. He was, to borrow a phrase, a tomb of confidentiality. Perhaps, the sedation I would be administering prior to a future colonic violation might loosen his tongue. Oh, the secrets I've extracted in the endoscopy suite!  Relax, patients. What's uttered in the endoscopy suite, stays in the endoscopy suite, our own version of the Vegas Rules.

Another patient, now elderly participated in a historical event that changed the world. He took a leisurely boat ride across the English Channel on June 6, 1944 reaching the shores of Normandy. I've been to beaches many times in my life, but his experience was quite different. I was mesmerized as he recalled the fear that he and his men suffered as their craft approached the French shoreline. He told me of a chilling order that he never had to carry out. If any soldier refused to leave the craft, he was to shoot him. When I was an 18-year-old, I was a comfortable pre-med student. When he was the same age, he walked through the valley of the shadow of death and, unlike the psalmist, he did fear evil.

Another patient, now a nonagenarian, was a scrawny 17-year-old kid who awoke up one morning to hear bombs bursting in air. This quiet and modest man, several decades ago, was stationed in Pearl Harbor on the date that lived in infamy. I was tingling.

Just a few weeks back, an old man came to see me wearing one of the veteran baseball- style caps that many aging vets wear. For me, these caps are a reliable sign that there will be more to talk about than just heartburn and hemorrhoids. "Where we're you stationed," I asked. "Iwo Jima," he answered. You know what's coming now, readers. This man witnessed the marines raising the flag on Mount Suribachi in, perhaps, the most iconic image ever captured in American military history.

Over the years, I have related these treasured vignettes to the kids, who rightly wondered if I actually performed any medical work in the office. For the years that we home schooled the 2 boys, my patients' experiences became part of their curriculum whenever possible. On more than one occasion, these gracious individuals met with us so that we could hear history directly from the folks who made it happen.

Seasoned physicians may not know the answers.  But, they know what questions to ask.  When your doctor is taking your history, is he asking the right questions?  Am I?

Sunday, September 2, 2012

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 there is a category of navigational intelligence, which would have cost me at least 40 revised IQ points.

In my day, a grade of 94% was a solid A, and we strived to reach this threshold. Were our teachers too lenient? Should a grade of A required that at least 99% of our answers were correct? Where do we draw the lines to separate excellence from acceptable? Who makes the decision?

Last year, a public fight erupted over an Institute of Medicine (IOM) report that had not even been issued that argued for tougher rules for medical device companies. The report had been commissioned by the FDA and was in response to several recalls of medical devices that had malfunctioned and harmed patients. Advocates of medical device companies cried foul claiming that the 12-member panel was biased. Look for a lot more of this strategy when comparative effectiveness research (CER) goes forward. If a CER panel’s conclusion is against your interest, then attack the panel. Lawyers have mastered this technique generations ago. If the facts are on your side, attack the law. If the law is on your side…


IOM Report Targets Medical Device Industry

Is the IOM on target or is the aggressive pushback from the industry legitimate?  I do know that is an easy task to make medical device companies and pharmaceutical companies appear callous, avaricious and indifferent to human suffering, when this may be entirely false. Can you say ‘demonization’?

Of course, we want medical devices and pharmaceuticals to be safe and effective. We expect that artificial hips, pacemakers, defibrillators and stents will perform superbly. Safety and testing policies should be made by experts independent from industry, but I believe that industry is an important voice at the table. Indeed, several constituencies should be represented, including the public. If we strive to eliminate every real and potential conflict of interest, then we will lose many voices of medical experience from the real world.

I'm not suggesting that reform in the device approval process is unnecessary. But, there are truths that must be acknowledged.

  • No medical device or drug is 100% safe or effective.
  • A percentage of medical devices will fail which may result in injury, reoperation or death.
  • A failed medical device is not tantamount to corporate misconduct
What percentage of medical devices should perform as intended? 90%? 95% 98%?

How much testing and clinical trials should medical devices be required to undergo before they can enter the market? If the device is similar to an existing device, or is an existing device that is applying for a new use, should the testing process be the same as for a new product?

A grade of 98% sounds like an A+ to most of us, but this may not be sufficient in the medical device universe. Would we be content on an airplane knowing that we have a 98% chance of landing safely?

If we all agree that the medical device industry needs tougher standards so that their safety and effectiveness levels approach 100%, then we will need to accept higher medical costs and a reduction in innovation. Will this trade off serve the greater good?

I’m sure if the federal highway speed limit were lowered to 50 miles per hour that lives would be saved. No one is hollering for this reform. What should the medical device speed limit be?

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