Wednesday, February 28, 2007

Patient Safety and Physician Regulation

At a symposium yesterday at the University of Denver Sturm College of Law, leaders of the medical and legal professions in Colorado and national and international experts in medical regulation discussed how improvements in medical regulation and medical injury dispute resolution can support patient safety enhancements, with particular attention to the role of state medical boards. Speakers included Dr. Randy Bovbjerg of The Urban Institute, Dr. James Thompson, President and CEO of the Federation of State Medical Boards, David Swankin, President of the Citizen Advocacy Center, and Dr. Marie Bismark, a medical injury compensation expert from New Zealand. The event was coordinated by Common Good Colorado. The overriding theme?
If we could improve the regulatory environment of health care, what would those improvements be, and what would it take for us to achieve them?
A webcast of the proceedings can be seen here (just click on the person's name in the left-hand column to view their presentation - Windows Media player required).


Hat tip: Sarah, web editor, Common Good.

Heart Failure Device: Diagnose or Adios?

Tomorrow, the FDA will review the Chronicle – an implantable hemodynamic monitor (measures heart pressures) made by Medtronic, Inc. that is used for long-term measurement of patients with congestive heart failure. The device looks just like a pacemaker (in fact it uses one of their old pacemaker generator cans) but does not pace. Instead, the device measures the time, surface EKG, temperature and right ventricular heart pressures on a continuous basis. Patients can then upload this information via the internet to a central database for their doctor to review in an attempt to facilitate their management.

So why is this such a big deal?

Because it will be the first time the FDA considers an implantable device that has no therapeutic value – only diagnostic. It heralds the beginning of a development cycle for numerous other devices soon to be developed for this and other ailments by Medtronic and their competitors including pressure and chemical sensors. Importantly, it will also provide the FDA with data regarding the utility of these devices to facilitate management of complicated patients with heart failure and avoid hospitalization.

Why might such a device be needed?

Clinicians are keenly aware of their inability to reliably assess fluid status in a number of select patient groups: the obese, those with underlying lung disease, etc. Patients with recurrent admissions for congestive heart failure exacerbations might be good candidates for such a device, provided the company can convince the FDA that the benefits of the diagnostic data can outweigh the risks of implanting the device.

How Does it Work?

The Chronicle system is composed of three parts: the sensor lead, Chronicle device, and an external pressure reference device that the patient wears. The lead is implanted into the patient’s right ventricle, preferably in an area of high blood flow (to assure non-fouling of the sensor), and connected to the Chronicle device planted beneath the skin of the chest just below the collar bone. The patient also wears a device that measures ambient barometric (atmospheric) pressure throughout the day. Every so often, the patient downloads the pressure and temperature information stored on the Chronicle by first placing their external pressure reference in a base station (similar to a wireless phone’s base station) that is plugged into a phone jack and contains a wand. The wand is then placed over the person’s implanted Chronicle device and the information stored in the Chronicle (time, pressure and temperature information) are downloaded. During the download process, the Chronicle’s internal clock is synchronized with the clock on the external pressure reference to permit adjustments to measured heart pressures based on the ambient atmospheric pressure at a given time. The time, pressure, and temperature data are then uploaded via the internet for the physician’s review.


While it is uncertain where a stand-alone pressure sensor such as the Chronicle will gain approval (but I think it will be at least approved for the sickest of patients), the technology is sure to be incorporated in future devices incorporating pacing and defibrillation in the future – and this might be the best news of all for those suffering with severe heart failure.


References: Wall Street Journal (subscription)

Medtronic COMPASS-HF Study Press release summarizing the Chronicle heart failure study data.

Tuesday, February 27, 2007


Amazing images of a rare case of pneumopericardium (air in the sac that surrounds the heart) from Dr. S. Venkatesan From Madras Medical College in India:


Nicotine Wars

It still puzzles me that we use an incredibly addictive drug, nicotine, to help smokers quit their habit. It's like we've given up and decided that Nicorette gum is to the smoking addiction as methadone is to a heroin addiction. To make matters worse, it now seems that the pharmaceutical industry, in its press to promote its products, wants to limit the verbage on the warning label on the smoking cessation drugs.
(WSJ) As evidence mounts that nicotine-laced stop-smoking aids are producing only limited gains, some critics are calling the products over-rated and over-promoted.

But some high-profile public-health experts say the problem may be over-regulation. They say that federal law requires nicotine gums, patches, lozenges and other products to carry so many warnings that smokers are reluctant to use them. Indeed, the warning literature on a package of nicotine gum is about 20 times lengthier than the warning on a package of cigarettes.

So tobacco researchers and policy makers are starting to argue that the federal Food and Drug Administration should tone down the warnings on pharmaceutical nicotine. At a day-long summit last week in Austin, Texas, entitled "The Case for More Flexible Regulatory Policy," public-health experts discussed a number of changes they may seek to current regulations. Among other possibilities, they say they may recommend relaxing the health cautions for pregnant women and eliminating the requirement that teenagers refrain from using over-the-counter nicotine products without the approval of a physician.

"A 17-year-old smoker of 25 cigarettes per day is doing the right thing to use nicotine gum," says Jonathan Foulds, a tobacco researcher at University of Medicine and Dentistry of New Jersey. "Why give him another hurdle to cross to get help?"
Over-regulation as the cause for lack of utilization? How about the methadone/heroin analogy? Maybe the reason people aren't using these meds is because they're expensive and people don't like taking drugs - especially one that is powerfully addictive. And there are even researchers who question the efficacy of these drugs to stop the smoking habit in the first place.
Recent studies of successful quitters have suggested that the significant benefits of nicotine products seen in randomized clinical trials may not apply in real-world conditions. Critics say the public-health experts who favor nicotine medicines are too financially tied to manufacturers to see the products' limitations. And use of nicotine by teens, pregnant women, heart-disease patients and smokers who haven't quit remains controversial.

"The use of nicotine, whose efficacy in treating nicotine addiction is controversial even in adults, must be strictly avoided in pregnancy, breastfeeding, childhood and adolescence," argues an editorial in the current Journal of Health Psychology, written by a group of eight researchers and antismoking advocates.
To think that people actually READ a warning label and that this is the sole cause of the lack of utilization of these smoking cessation drugs belittles any real analysis of human behaviour.

The reality? We have been incredibly successful in the US at educating our population about the effects of smoking and reducing the number of individuals who smoke. Smoking bans have also been remarkably effective. Why make us smoke this lame excuse for "limited gains" of achieving our goals of smoking cessation in the interest of making pharmaceutical companies more money? Maybe, just maybe, the real reason that smoking cessation aides are producing only limited gains (in sales) is because fewer people are smoking.

Monday, February 26, 2007

Personal Health Insurance Claims Adjusters

Online claims adjusters, like the web-based My Medical Control, will soon be commonplace on the American Health Care landscape where individuals will need to control more of their out-of-pocket expenses.
(NYT) Mr. Fontana, a 42-year-old salesman, has a high-deductible health plan coupled to a health savings account. Since he was nowhere near meeting his deductible, he was on the hook for the entire bill.

So he did something that insurance companies routinely do: he forwarded the bill to a claims adjuster, in this case My Medical Control, a Web-based company that reviews doctor and hospital bills for consumers.

After concluding that Mr. Fontana was not getting the best possible price, the company’s representatives called the imaging facility and demanded a lower one, promptly saving him $200 — minus a 35 percent collection fee.
I think this will get filed under "Why didn't I think of that?"

But even more interesting is the company, that estimates nation-wide prices negotiated for by insurers and compares them to list price. Here's the information for a pacemaker and a defibrillator implant. (Where they got 5 days as an average length of stay for these procedures is anybody's guess: our length of stay is under 1 day, but I digress). These guys, too, will negotiate a lower fee on behalf of patients, not to mention permit ratings of hospitals and doctors along the way.

Transparency of sorts is here, it seems. The real question is, will people switch facilities for a lower price? I suspect if they're paying a bigger piece of the pie, they will. But "quality" of care rendered by a cheaper facility is still difficult to gauge, even for those of us in the business. Where the dust will settle with this price/quality war is anyone's guess.

No matter how we slice it, it seems the terrain for health care delivery has forever changed.


When More Is Not Enough

I was feeling down that I just haven't been able to get enough done lately. Especially at work. There just hasn't been enough to multi-task, so I became dysphoric and upset. So in an effort to do more and be more, I sought evaluation and discovered that I, too, suffer from dysphoric social attention consumption deficit anxiety disorder (DSACDAD).

I thought this was a terminal condition, until I found the drug that saved me. I'm sure it can save you, too.

If you doubt it, be sure to check out the testimonials under the "resources" tab on their website. I mean, it helped them, didn't it?


Hat Tip: Claudius, a faithful reader

Obesity and Government Intervention

In England, it seems the government can take your child if he's gaining too much weight:
Dr Colin Waine, chairman of the National Obesity Forum, said that removing a child from their family could be justified.

"The long-term impacts of this child's gross obesity are frightening.

"He has great risk of diabetes and coronary illness.

"His life expectancy is severely prejudiced. So action is required if his health is to be safeguarded."

A spokeswoman for North Tyneside Council and North Tyneside Primary Care Trust, a spokeswoman said on Sunday: "We share the concerns over the child's health and well-being.

"We have been working with the family over a prolonged period of time and will continue to do so.

"The child's interests are paramount."
It seems his mother feels otherwise:
She said she had seen doctors, but no-one had actually stepped in to offer her help.

She said that taking Connor into care would be "disastrous".
Can anyone say "civil liberties?"


Sunday, February 25, 2007

Protecting Kids from Sudden Cardiac Death

More sadeness reigned down on the Denver Broncos as they lost another young athlete, Darien Nash, to sudden death. It is interesting to note that his younger brother had a heart ailment that required a transplant the year before. Whether it as an idiopathic dilated cardiomyopathy (enlarged weakened heart muscle) or hypertrophic cardiomyopathy (thickened, stiff heart muscle), these ailments can be transmitted in an autosomal dominant fashion (50% of offspring). The mother is absolutely right in insisting that her daughter be tested for the potential of carrying a gene that may have caused Darien Nash's death.
After one son’s death and a heart ailment that caused another son to require a transplant last year, Kim Nash is taking her daughter to a cardiologist next week.

“My son,” she told The Associated Press amid sobs, “is giving me the strength right now to talk.”

Damien Nash collapsed in his suburban St. Louis home after returning by limousine with his wife, Judy Nash, and their daughter from a game at his high school to benefit The Darris Nash Find a Heart Foundation. The organization raises money for heart transplant research.
How very ironic and very sad.

As if pre-ordained, this segment aired on MSNBC Nightly News the very same day that Darien Nash died - a story about another mother, Rachel Moyer, simarly affected after the death of her son, age 15, collapsed after a basketball game.

But this story has an important message. Ms. Moyer has helped organize a non-profit foundation, Parent Heart Watch, which brings together the collective efforts of families who have lost children to sudden death to raise funds to provide automatic external defibrillators for high schools. More important, they lobby Congress to assure defibrillators are available in our kids' schools across America. Amazingly, only 8 of 50 states (Texas, Illinois, Colorado, Florida, Pennsylvania, Maryland, New York and Ohio) have enacted these laws, even though 20% of sudden deaths occur to people under 21 years of age. Parent Heart Watch is pushing for an AED in every elementary, middle school and high school in America.

So support this legislation in your state or around the globe. If one life is saved, especially if it's a child, then it makes that single $2000 investment for an automatic external defibrillator seem totally worthwhile.


Paget-von Schrötter Syndrome

Interesting piece on thoracic outlet syndrome as a cause for pulmonary embolus was presented today in the New York Times. As such, this was not thoracic outlet syndrome, but rather thoracic "inlet" syndrome (veins bring blood flow into the thorax, after all), also known as Paget-von Schrötter syndrome:
Three potential compression sites responsible for thoracic outlet syndrome include:

1. Interscalene triangle - borders include anterior and medial scalene muscles and the first rib.
2. Costoclavicular space - between clavicle and first rib.
3. Pectoralis minor tunnel - space between pectoralis minor tendon anteriorly and coracoid process of scapula.

The majority of patients have one of the following congenital or acquired conditions in one or more of the potential compression sites:

Congenital lesion include cervical ribs, scalenus minimus muscle, wide insertion or hypertrophy of anterior scalene muscle, anomalous first rib, slender body habitus with a long thin neck. Acquired lesions include extreme muscular build, fractures to clavicle or first thoracic rib with nonanatomic alignment or exuberant callus formation, supraclavicular tumors or lymphadenopathy.

Effort thrombosis is a form of post-traumatic thrombosis of the axillary vein, usually observed in younger individuals following exercise or occupational activity. The etiology is compression of the axillary vein by either subclavian muscle or costocoracoid ligament during forced abduction. This is known as Paget-von Schrötter syndrome.
Physical exam: the lost art of medicine.


Photo credit.

On the Value of CPR

A truly inspiring story about the value of cardiopulmonary resuscitation (CPR):
"I noticed everybody was standing around him and he was just laying there dead on the floor and nobody was doing anything," DeYoung said. That's when instinct took over for DeYoung, who gets annual CPR training for his Statesville job.

"I don't even remember walking over to him," he said. "I just remember being next to him and starting to do chest compressions."

Meanwhile, a bystander had pulled Edwina away from the blackjack table and pointed to her husband. She rushed over and time seemed to slow down as she saw DeYoung begin CPR.

"It was very surreal, like my own out-of-body experience," Edwina said.

As the scene unfolded, Edwina remembers with crystal clarity that a woman, another partygoer, took a deep breath and said, "Oh my God, it's me" before joining DeYoung at Hal Cowell's side.

The woman was Nancy Flitcraft, who had her own slow motion moment in the instant after Cowell collapsed.

She immediately thought back to the day in 2000 when she and her husband tried to revive a 7-year-old boy who had suffocated in an accident. Flitcraft, a nurse who had performed CPR before on several occasions, had given her husband hurried instructions as they worked over the boy's body, but it was too late. He was gone.

Flitcraft hadn't done CPR since the boy died. Her family had spent years trying to work through their sadness about witnessing the accident and not being able to help. But in the few moments after Cowell collapsed, instinct took over for her, as well.
It's amazing how many people were at this fundraiser, but how few knew (or were willing to acknowledge their knowledge of) CPR.

Although I've seen lots of stories about cardiovascular "saves," this one struck home - perhaps because of Ms. Flitcraft's prior experience with a 7 year old boy. Read the article to see how this story ended.


Addendum: Time is of the essence: time to CPR, time to defibrillation, and the time needed to administer advanced cardiac life support (ACLS).

Saturday, February 24, 2007

Video Slideshow of Heart Bypass Surgery

A fairly well-done (but perhaps graphic for some) video slideshow of coronary bypass surgery was reported by the New York Times and demonstrates some aspects of "beating heart" bypass including the harvesting of the left internal mammary artery and use of Guidant's (now Boston Scientific's) Acrobat Mechanical Off-Pump System that is used to lift and stabilize the heart for sewing of the grafts.


Big Belly People

The Portugese Cardiology Foundation knows how to get the point across:


A New LVAD Device Begins Early Testing

Testing of a new left ventricular assist device (LVAD) developed by an Australian company, Sunshine Heart, is in its very early stages of testing that has the advantage of not contacting the blood pool. In its early design shown here, an inflatable bladder encases the ascending aorta and uses the patient's own EKG to time the inflation and deflation of the bladder surrounding the aorta - it deflates when the heart contracts (systole) and inflates when the heart is relaxed (diastole). It function is analogous to intraaortic balloon pumps used in catheterization laboratories that use counterpulsation to decrease the work of the heart and improve coronary blood flow, but its mechanism resides outside the aorta, rather than within it, limiting the need for blood thinners with the device. An animation of the device is also demonstrated at the company's website.

At first glance, I was surprised that the device was placed on the ascending aorta (probably to facilitate access by the implanting surgeon), but the potential for migration of the device toward the coronary arteries and aorta (causing compromized coronary blood or changes to closure of the aortic valve) and its potential to disturb existing plaque in the ascending aorta and shower it to the brain suggests its use, in its present design, will be limited to younger patients or those without aortic disease. Whether such problems with this new device will manifest remains to be seen.

Friday, February 23, 2007

Treat or Triage?

Pronunciation: trE-'äzh, 'trE-"
Function: noun
1: the sorting of and allocation of treatment to patients and especially battle and disaster victims according to a system of priorities designed to maximize the number of survivors.

– from the French word “trier” – “to pick, cull” with some convergence from the Latin “tria,” or “three.” In World War I, it was adopted for the sorting of wounded soldiers into three groups according to the severity of their injuries. It is a term commonly used in emergency rooms, on battlefields and at disaster sites when limited medical sources must be allocated.
If we think of our national health care funding resources as limited, then should we invoke a philosophy of triage of those resources - that is, distribute these resources to do the most good for the most people?

* * *

Ms. S. was a frail 92 year old woman with a long history of Alzheimer’s dementia who had been confined to a nursing home for the past five years. She presented to the Emergency Room after caregivers at the Nursing Home noticed her collapse suddenly to the floor, striking her forehead on the night table creating a large laceration above her eye. She was unconscious briefly, yet awoke several seconds later, unaware of what had just transpired. She had been fine and talkative just before the event.

Her examination, aside from her baseline confusion, disorientation, and laceration disclosed no clues as to the origin of the event. A quick review of her medications disclosed no blood pressure lowering medications, and her blood work was otherwise normal. Her compulsory CT of the head and neck fortunately disclosed no significant neck or head pathology.

A review of her chart disclosed she had been seen in the Emergency Room on multiple occasions over the past 5 years with atrial fibrillation with rapid ventricular response and an underlying right bundle branch block. Today’s EKG was different, demonstrating normal sinus heart rhythm at 44 beats per minute with the same right bundle branch block.

An extensive workup was underway: echocardiogram to “rule out“ critical aortic stenosis, bilateral carotid ultrasounds to make sure no significant blockages existed to the blood flow to her brain, and telemetry monitoring.

Seeing her, I knew we’d be asked for the inevitable: a pacemaker. While the etiology of her sudden loss of consciousness and fall will likely never reach a conclusive end with her admission, the prior EKG’s of atrial fibrillation that now has restored to normal rhythm after all of these years suggests one possibility for her collapse: an abnormal sinus node (or pacemaker cells in her heart). Atrial fibrillation that suddenly stops after years of activity is rare, but is often followed by a long period of asystole (no heart beat) before the normal sinus beat resumes. This asystole deprives the brain of oxygen-rich blood for the brief instant and precipitates the loss of consciousness, resulting in her fall. It is quite possible that when her heart beat finally did recover, she awakened back to her remarkably confused and disoriented world. Admittedly this sequence was all conjecture, but after seeing this scenario in several other similar circumstances, I suspected this was what happened.

So how to proceed?

It was clear that discussing this with Ms. S. was an exercise in futility. Her next-of-kin would have to be contacted. They, now, get to make the tough decision: does their elderly mother get a pacemaker? Certainly to have one will prevent further falls. To not have one now would spare her the minor surgery to implant the device. If the procedure were done, it would have to be performed with anesthesia assistance to assure she hold still long enough to implant the device safely. Risks, although small, are real. Costs, unfortunately, spiral. The patient will forever be unaware, except to awaken with a sore chest wall. Ms. S. will return to her nursing home. And after "curing" her cause of the fall, we’ll all feel good – another life saved.

Now as physicians, we are taught primum non nocere – first do no harm. But the decision process that follows quickly becomes a comedy of errors: families feel obligated to say "yes" to approve a procedure often for ridiculous reasons - some of guilt, perhaps fear of death, compulsion or misguided responsibilities to their loved one. So, too, are doctors pushed to say "yes" to the procedure for reasons of liability concerns and political correctness. Certainly, it is far easier (an more financially rewarding for the physician) to deliver care than to withhold it. Everyone says "yes" with at least the comfort that they're doing no harm.

Yet there is harm being done in terms of ever escalating costs of health care delivery. Health insurance already out of reach for many, and the problem is likely to grow in severity over the years to come, irrespective of policies developed by various health care policy wonks. So, too, is there the potential for harm and discomfort from the procedure itself - especially in an individual incapable of comprehending what will occur. Often, the recipients of our beneficence are left confused, befuddled, and unhappy. Does the patient consider themselves "better" in such circumstances?

So how do we wrestle with these issues of costs and end-of-life care for the elderly? Do we triage resources, reserving these invasive and expensive procedures for the more intellectually or physically viable patients? Or should the sanctity of life be held above any other consideration like the quality of life? Who should decide what "quality" entails?

Few physicians I know would subject themselves to the potential liability concerns generated by withholding care in such a circumstance unless carefully considered with the family and documented in the patient's record. Older readers may faintly remember saner, less technical times when these decisions were not an issue. It was simpler and more direct then. Families and doctors trusted each other enough to conclude it was their loved one's "time" without fears of retribution or judgement. But with the advance of technology, the ever-present drum beat of marketing a prolonged life, it becomes increasingly difficult for individuals to consider less aggressive options for end-of-life care. With such forces, most true thoughtful discussion of allocating our precious health care resources is forestalled.

So get ready. Think about creating your own living will. After all, with the advances in healthcare today, Ms. S. could be you in a few years ... provided our health care system still has enough funding to have this debate when you get to be that old.


Photo credit.

Thursday, February 22, 2007

RFID Tags in Pills?

With the ever-smaller RFID tags, I wonder if pharmaceutical manufacturers will consider placing one of these in their pills or capsules to limit pharmaceutical counterfeiting.

- Wes

PS: Royalites for this idea can be sent to PO Box 6....

Hospitals: The Insurers of the Uninsured

Hospital groups, calling themselves the "insurers of the uninsured," join the fray over universal health care coverage, but offer no ideas on how to fund their $119 billion proposal.


Wednesday, February 21, 2007

Heart Disease Prevention Suggestions: Some Good, Some Bad

It's been a while since my last post. I've been looking for something different, creative or idiotic to talk about as it pertains to the heart, but things have been a bit lean of late. Fortunately, heart disease prevention literature seemed to rise to the top this week - some good, and some bad.

In the "good" category, was the American Heart Associations's "Evidence-based Guidelines For Cardiovascular Disease Prevention in Women: 2007 Update," published in Circulation online before print this week. One amazing factoid that I did NOT hear emphasized in the media from that paper:
"In many countries, including the United States, more women than men die every year of cardiovascular disease, a fact largely unknown by physicians."
Some tidbits from that paper:
  • Don't smoke
  • Get active (Walk 30 min/d)
  • Limit saturated and trans fat intake, sodium intake (less than 2.3 grams/day) and eat more fish (at least two times/week)
  • Keep your waist less than 35 inches or body mass index between 18 and 25.
  • Consider Omega-3 fatty acids for women with coronary disease
  • Keep blood pressure under control (<140/90 for sure)
  • Keep LDL low and HDL high
  • And keep diabetes controlled with hemoglobin A1C measurements less than 7%.
  • Take a slightly higher (325 mg) aspirin rather than 160 mg, if you're at high risk of another cardiovascular event
  • Use beta blockers and ACE inhibitors (or angiotensin receptor blockers) after a heart attack
In summary, not much new here, really. But what WAS interesting are the things NOT found helpful to prevent coronary disease in women:
  • Hormone replacement therapy
  • Antioxidant vitamin supplements (Vitamin E, C, and beta carotene)
  • Folic Acid with or without B6 or B12 supplementation
  • Routine use of aspirin for women under the age of 65

Now in under the category of "bad" prevention recommendations, comes this trial from the American Journal of Clinical Nutrition that was just released today on Reuters newswire touting the benefits of caffeine at preventing heart disease deaths in the elderly. A closer look at this study demonstrates it used survey data from 1982-1984 with follow-up surveys analyzing deaths from follow-up surveys in 1986, 1987, and 1992 and used ICD9 codes to determine the cause of death from death certificates. The "study" data do not take into account improvements in cardiovascular care over that period. Thank goodness the authors admitted:
The current study was an epidemiologic study and does not prove a cause-and-effect relation. This study does not provide a valid basis for recommending increased consumption of caffeinated beverage.
Too bad the press couldn't have read this as well before publishing their piece suggesting that grandma or grandpa get stoked with coffee each morning to prevent a cardiac death.


Monday, February 19, 2007

The Denial-of-Payment Game

“Hello, Ms. Nicestpersonintheentireworld.”


“How are you feeling after your ablation?”

“Tired. You know I was in the hospital for pneumonia?"

“No, I’m sorry, I wasn’t aware that you were admitted.”

“Yeah, they thought my CT looked bad, so they put me on antibiotics for a while, so I’m recovering from that. And you know what else?”

Gulping and concerned what would come next, “No, what?”

“The insurer won’t pay for my ablation.”

“What??? You mean they won’t pay for a person with documented supraventricular tachycardia (SVT) at 180 b/min that occurred in the hospital while you were receiving treatment for your breast cancer that was very symptomatic? The same SVT that was refractory to medical therapy and required several doses of adenosine to correct?”

“That’s right. They’re denying payment saying I didn’t need the ablation – they said you should have called the insurer first and that I should have been treated with drugs first.”

“But you were in the hospital... So even though you’ve got lung disease and use inhalers, they want me to use drugs first and even though this flies in the face of established guidelines?.”

“I guess so.”

It’s all a big game, this denial of payment thing. Here’s the score as I see it:

* * * S C O R E B O A R D * * *
Patient: 0, Insurance Company: 1

Now we have 14 more rounds to go to get this settled, if we're lucky. And meanwhile, Ms. Nicestpersonintheentireworld not only gets to deal with all the aspects of her cancer care, she gets to worry about whether she gets to pay for the ablation, too.


Your Blinkin' Heart

For the craftspeople and engineering wannabe's out there, now's your chance to make your own LED heart t-shirt. You'll need:
A T-shirt that you are willing to sacrifice in the name of love
98 3mm red LEDs (1.8-2.1V @ appx 10 mA)
two DM7474 IC's (flip flops)
one DM7492 IC (2 input nand gate)
one ne555 timer
4.7 uf capacitor (over 9 volts)
.01 uf capacitor
.1 uf capacitor
one variable resistor (100k ohm max)
one 470 ohm resistor
three 1k ohm resistors
one 560 ohm resistor
1 nine volt battery + clip
Hard Drive cable (or wire)
Another T-shirt or some fabric
Needle + Thread (or a sewing machine)
wire cutters
Soldering Iron
I just don't know how comfortable it would be, but it sure would turn some heads.


Sunday, February 18, 2007

Another Chapter

"You have completed all requirements to receive retired pay at age 60 under the provisions of references (a) and (b)."

That's how the letter started that I received yesterday. Hard to believe that it's been that long since I started medical school under the Health Profession Scholarship Program with the United States Navy.

They were some of the best years of my medical career. There is a certain camaraderie that one gains when you're in the same "canoe club." To all of my doctor, nurse, and corpsman colleagues before and to those who still serve, thank you.


(a) 10 U.S.C. 1223
(b) BUPERSINST 1001.39E

Saturday, February 17, 2007

Food Nazis Strike

As reported in the Chicago Tribune this AM, the foie gras ban law in Chicago was actually enforced:
Chicago's first foie gras bust went down Friday morning at a hot dog joint on the North Side, just as Doug Sohn was about to open for the day.

It could hardly have come as a shock.

Sohn, the owner of Hot Doug's, had been itching for a fight since the City Council overrode the angry veto of Mayor Richard "It's the silliest law ever" Daley. The ordinance took effect Aug. 22.

Sohn was issued a warning several months ago, but he stood his ground. He continued to serve his foie gras-laced hot dogs at his restaurant in the 3300 block of North California Avenue, advertising their ingredients on his Web site and on a board hung boldly near his front door. "I was poking the grizzly bear, and it snapped my head off," Sohn said Friday.

He was slapped with a citation, and his foie gras was sealed as evidence by a Health Department inspector. Sohn faces a fine of $250 to $500 at his March 29 date with a hearing officer, who could set the amount at the higher end if he or she senses a disregard for the law.

On Friday afternoon, Sohn seemed to be considering whether to fight on. He took the duck-liver dogs off the menu and got ready to go on vacation. If anyone wants to reach him, he'll be considering his options over a plate of foie gras in France, where they are surely shaking their heads.
We'll be looking for similar busts in New York (and other locales nation-wide) over the recent trans fat ban.


Big Brother

Secret surveillance in hospitals: is this what infectious disease and preventative medicine/risk management programs have come to?
The program aired secretly shot video of a Vancouver doctor touching a table in a contagious person's room and not washing his hands after, and a nurse who changed the bandages on an open wound and did not wash her hands.
Good grief! The real question is, did they play "gotcha?"


Body Worlds

Today Medpundit offers troubling insights to the Body Worlds exhibition that is now here in Chicago at the Museum of Science and Industry.


Friday, February 16, 2007

Atrial Fibrillation Ablation Nirvana

Sometimes you have moments when you are reaffirmed that you have one of the coolest jobs in the world.

Atrial fibrillation is a remarkably common heart rhythm disorder that effects many, many individuals. For many a cardiologist, it can be remarkably frustrating to treat, since our drugs are often ineffective or toxic. Patients feel a wide range of symptoms: some feel nothing while others are debilitated by the irregularity or rapid heart rates that can accompany this arrhythmia.

I have posted on this before and interested readers can review the methods (and risks) of how I perform this procedure using a "wide area" catheter ablation technique here. On occassion, however, even after performing a catheter ablation procedure (also called a "pulmonary vein isolation procedure") for atrial fibrillation, patients have to undergo a re-do procedure in an attempt to assure that no residual connections between the pulmonary veins and the left atrium have become re-established and re-initiated the person's atrial fibrillation.

The above figure is an example of recordings taken on a re-do ablation procedure in a patient with recurrent symptoms despite a prior atrial fibrillation ablation procedure. The signals were recorded come from a series of catheters (wires) in the heart as shown:
The "basket catheter" is actually an 8-splined catheter with 8 electrodes per spline and is shown here:
Now, with all of those wires in the heart, we can record signals from all of them simultaneously and display them on a computer. An example of the recordings taken from all of these wires is shown here (click to enlarge):

Now, most of my cardiology colleagues get glassy-eyed when they see these tracings. But for the electrophysiologist, they can be heaven! Here's what this series of tracings shows:
  • The top three lines represent different signals from the surface electrocardiogram (EKG). These surface signals are a portion of what your doctor sees when an "EKG" is performed so he (or she) can understand what's going on electrically in your heart. But beneath the first three lines is MUCH more...

  • The next two lines have signals recorded from the right atrium, where the normal heart beat starts for two consecutive heart beats.

  • The next two lines represent the signals from those two heart beats recorded at the AV node - the electrical connection between the right and left atrium that electrically connects the upper atria to the lower ventricles.

  • The next five lines are signals obtained within the coronary sinus (a vein that lies along the left atrium) at varying intervals proceeding from right to left.

  • The next 16 lines are signals obtained from the basket catheter positioned into the left upper pulmonary vein. Note that there is a series of six closely coupled signals that occur very rapidly and have no association with the activation in the left atrium (those in the coronary sinus) nor the surface electrocardiogram (EKG). This clearly demonstrates that the left upper pulmonary vein is "disconnected" (or "isolated") electrically from the rest of the left atrium. Hence, although this person's pulmonary vein is occassionally having rapid electrical firings within the structure, it can no longer perturb the remainder of the atria and this patient will be clinically "cured" from atrial fibrillation.

While we were happy to find this during our repeat ablation procedure, we mapped the other pulmonary veins and discovered the right upper pulmonary vein had re-established an electrical connection. Isolating that pulmonary vein rendered this patient arrhythmia-free.

Man, you gotta love this job!


Addendum: 17 Feb 2007 @ 0830 CST: This morning I saw this video demonstration over at Kidney Notes and I could see the future of atrial fibrillation ablation...

Buying the FDA

Public speaking is a difficult and damning business. When a spokesperson for a company during a time of crisis says something like “Widgetco would never cheat it’s customers,” what one word does one remember from that sentence?

Simple: “Cheat.”

I learned this from one of the masters of public speaking education years ago when I lived in Washington, DC: Merrie Spaeth. She even nominates people who say dumb things in public like this to her “Bimbo Awards.”

So to hear (and read) the FDA commissioner, Andrew von Eschenbach state that “No one is buying the FDA,” I can only hear one word: “buying.”

And with good reason. Doctors are very aware of the effects of lunches bought for our offices by drug companies, of the costs of “free” pens and brochures littering our waiting rooms, and of the effect free samples of drugs distributed to our offices has regarding drug choice. These methods coerce, manipulate, and entice both the physician and patient. To think otherwise is foolhardy.

So it is interesting to hear a similar mantra from the good Commissioner as he relishes the windfall his agency is about to inherit:
"The FDA knows that our actions and our decisions require adequate resources," he added. "We are not focused on where the resources come from, but only the purpose for which those resources are in fact necessary - to protect and promote the health of the public we serve."
They are not focused on where the resources come from?

Well I believe they should be acutely focused.

Particularly since public confidence demands that FDA officials and their “expert panelists” remain impartial and unbiased regarding not only their review of drug approval trials, but for post-market safety monitoring of drugs. The fact that the FDA has “negotiated” a proposal with drug companies for the fees already suggests the companies got something in return. You see, the mere suggestion that the drug companies must “pay to play” is worrisome and erodes public confidence.

Congress must step up to the plate here. The FDA has the unenviable position of raining on the drug companies’ parties frequently in the name of public safety. But once the FDA is bankrolled by the pharmaceutical and device industries, these industries will own its very existence.

Is this what we want?


Grand Theft Defibrillator!

These thieves knew how to strike paydirt! Only problem is, how does one sell these stolen devices? I mean, pacemakers and defibrillators might seem fun and lucrative to steal, but how will they cash out? On E-bay? In veterinary clinics? On the black market?

Oh, and don't forget, all of the devices have serial numbers...


Thursday, February 15, 2007

Videos Disclose Bridge over Troubled Water

From Nature Cell Biology magazine:
Walther Mothes of Yale University in New Haven, Connecticut, and his colleagues fluorescently labelled three retroviruses, including HIV, and tracked their movement between cells. Compressing a video of the process into a single picture reveals the tracks of viral particles (which appear green in the image) crossing cytoplasmic bridges. Interactions between a viral envelope protein and proteins on the uninfected cell surface seem to stabilize the bridges.

The experiments were performed in cell culture, but if the findings hold in vivo they could suggest new therapies to limit retroviral spread.

Wednesday, February 14, 2007

Playing Beat the Clock

Too bad medicine in the primary care arena has come to this - an average primary care physician covers six topics in 15.7 minutes, one of which covers 5 minutes and the others about 1.1 minutes. This leaves 5.2 minutes for the physical exam, formulation of a plan, prescription writing or lab ordering, documentation, and billing.

If true, the average patient would be well-advised to prepare for their visit ahead of time: bring your medication list with dosages, allergies and prioritize your concerns. That way, your short time is well spent.


Telepathic Light Switch?

Under the heading, "Nerds -R- Us," Medtronic engineers are working on systems to perform actions in response to neural signals:
The Medtronic engineer demonstrated a "brain clapper" that monitored alpha waves to tell when a subject's eyes were open or closed. By opening and closing his eye in a demo video, Denison was able to turn a light on and off in his lab.
Next up: a new way to select a tune on your iPod...


Is Ranolazine Safe?

Yesterday a colleague of mine returned from a drug company sponsored symposium for Ranexa (generic name, ranolazine) made by CV Therapeutics (CVTX) of Palo Alto, CA.

He was mad.

Real mad.

He thought he’d been sold a bill of goods.

You see he’s a cardiologist who reads and pays attention to all things new in an attempt to offer leading-edge innovations to his patients. He attended this meeting to inquire about little known safety data about the drug ranolazine (Ranexa).

In January 2006, the FDA approved ranolazine, a piperazine derivative, as a new drug for patients with angina (chest pain) refractory to conventional medical therapy. It was hailed as the first new drug to help patients with angina in the past 10 years. One of its mechanisms of actions is to inactivate slowly inactivating component of the late inward sodium channel which may reduce the deleterious effects of calcium overload and intracellular sodium that accompany cells of the heart when they lack oxygen. But the drug also prolongs QT interval, an important determinant of potential lethal arrhythmias in patients with diseased hearts from coronary blockages.

To serve as a bit of background, QT prolongation came to light as a cause of mortality in a much earlier drug trial called the Coronary Artery Arrhythmia Suppression (CAST) trial. This trial tested the safety of drugs that suppressed premature ventricular beats well but also prolonged the QT interval – and was shown to have an increased mortality of patients in the drug treatment arm as compared to placebo. Many, many other drugs have never made it to market (or have been pulled from the market, witness the withdrawl of terfanidine (Seldane)) because of QT prolongation effects and pro-arrhythmia.

The company had a "hired gun" expert speaker to present their data from the trials presented to the FDA called the MARISA, CARISA, and ERICA trials. The data from the clinical trials looked great. Ranexa was clearly the one and only QT-prolonging drug out there that was safe for patients with chronic refractory chest pain. At least so it seemed. But there were troubling issues about these trials.

First, there was the usual conflict-of-interest issues. Most of the "investigators" of the MARISA and CARISA trials were either paid grant recipients, consultant/speakers, or on CV Therapeutics' payroll and owned stock in the company. Worse still, the longest follow-up period of any of these trials was 12 weeks.

Concerns about QT prolongation were not lost on the US Food and Drug Administration, even in 2004. In the report from the 100th Cardiovascular and Renal Drugs Advisory Committee Meeting, ranolazine was reviewed and “the principle safety issue with the drug was related to QT prolongation.” The committee tabled approval but wanted long-term efficacy data in females, elderly patients, and African Americans.

So the presenting "doctor expert" was asked a question. He was asked how any drug could have been approved with only 12 weeks of clinical data upon which to base safety concerns – especially in a drug known to prolong the QT interval of such sick patients. My colleague was told by the respected physician speaker that night that "no data" exists to suggest the drug is anything but safe in this patient population.

But some data do exist on the FDA's website. In their slides, CV Therapeutics claimed that the efficacy and safety of ranolizine demonstrated “No evidence for an adverse effect of ranolazine on survival.” (See slide 27 of the FDA’s Powerpoint presentation by Dr. Thomas Wolff). But then we look at Slide 26 – the slide just before this that includes 4-month follow-up data of deaths found by “pharmacovigelence” after the study completion -- here’s what the slide says:

Incidence per Patient Yr of Death and Sudden Death
Cause of DeathTherapyEventsFollow-up,Pt yrIncidence(%) (95% CI)
Sudden Death, death due to ventricular fibrillation/tachycardia or cardiac arrestPlacebo2169.31.17
(0.14, 4.18)
(0.36, 5.05)
(1.76. 3.21)
All causePlacebo3169.31.76
(0.36, 5.05)
(2.13, 3.68)

There it is: 4-month safety data that demonstrates an increased cardiovascular and all-cause mortality incidence in folks on ranolazine. Yet the drug was approved by the FDA in January 2006.

Can this be true? Was this slide not presented to the FDA reviewers? Did they not see this?

Well it seems they did. I called Michael Sweeney, MD, Vice President of Medical Affairs at CV Therapeutics, and he was kind enough to return my call. He acknowledged the event findings in the slide above, but because the numbers fell well within the 95% confidence intervals, they were not considered significant. Over a 10:1 1.5:1 safety difference was not significant? Ah, the power of statistic-speak.

Now the company has embarked on a large 6500-patient, randomized, double-blind, placebo-controlled multinational clinical trial to evaluate the drug as treatment for adjunctive treatment in acute coronary syndromes (Heart attack and unstable angina) called the MERLIN-TIMI 36 trial (MERLIN is a pneumonic for Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST-elevation acute coronary syndromes) in an attempt to extend its clinical indications. This study results are to be released at 8:50 am Central Standard Time on March 27,2007 as a late-breaking trial at the American College of Cardiology Meeting in New Orleans, LA. The trial will evaluate safety and efficacy of ranolazine after 730 cardiovascular events and 310 deaths have occurred during the study period. It is important to realize that the study’s Data Safety Monitoring Board met when one half of the patients had their pre-determined adverse event and elected to continue the study (good news for CV Therapeutics). But given the company’s own follow-up data, it begs a question:

Given the former FDA data, has the MERLIN genie already been let out of the bottle regarding the safety of this drug in patients with chronic ischemic coronary disease?

There are long stock-holders who are painting a rosy picture of this drug’s chances, particularly since this individual notes that other large institutional investors are increasing their positions in CV Therapeutics.

So go ahead and take your chances. Make a guess how ranolazine will fair. But I'm waiting until the MERLIN TIMI-36 data are presented in March before any of my patients with chronic ischemic coronary disease are placed on this drug.


18:16PM Link fixed to FDA slides

Clarification: Several commentors to this post (see attached) have correctly pointed out the calculation for safety risk represents a 1.5:1 rather than 10:1 difference as I posted earlier. I regret the error.


In America, we love our ratings.

Like the Nielsen Ratings...

For the Best Nightly News Anchor...

Or the Grammys...

Or the ratings of the 100 Best Hospitals by a Magazine or the 100 Best Hospitals by a Company...

Or even the Best Doctors...

So tonight, who will win the most ratings?

Viagra or Cialis or Levitra?


Monday, February 12, 2007

Napping Study for the Heart is a Snooze


Just napping.

(If only I could believe this study where researchers claim to have found the best preventative measure for curing heart disease: naps! But before climbing in your hammocks at work, realize there were some significant problems with this population-based study in which folks self-reported their diet, exercise and siesta routines. Maybe this is why the paper appeared in the Archives of Internal Medicine (it needed to be archived quickly).

To summarize the Greek and Harvard-based authors' own feelings regarding the limitations of the study:
Among the weaknesses of our study are the relatively small number of outcomes (coronary deaths) and the comparatively short follow-up period. (6 years)
Note, these were not cardiovascular deaths, but coronary deaths and only men showed a difference in deaths (there were too few numbers of deaths in women). Hello, researchers! Too few data points are a big problem, no?

The study interjects many of the most common forms of bias in such clinical studies (recall bias, interviewer bias, follow-up bias and misclassification bias) due to its design - you think they could do better. But heck, all the news agencies (via the Associated Press) seem to think this is worth reporting, so wake me up when the hype is over.


Sunday, February 11, 2007

Valentine's Day a Bit Early

Cool 3-D "Have a Heart" art can be viewed over at


Bubble Logic

MIT researchers Manu Prakash and Neil Gershenfeld have succeed in creating a unique form of binary logic using tiny bubbles to simulate a computer's computational ability, allowing the potential for these bubbles to carry a tiny chemical payload that may have implications for drug-delivery systems built from tiny microfluidic circuits. You can see an example of their work here or read their paper in the journal Science.

Very cool.


Saturday, February 10, 2007

Anna Nicole Smith's Death - Cardiac?

With the sudden unexpected death of Anna Nicole Smith on February 8th at age 39, the media is furiously attempting to determine what might have been her cause of death. While foul play would make the most sensationalist headlines, often sudden death in the young is attributible to cardiovascular causes.

At this time, we have been told that “prescription drugs” were found in her room, but no pills were found in her stomach at autopsy. It is a useful exercise at times like this to consider the differential diagnosis of sudden death in young women. Although certain drugs, like tricyclic antidepressants, could cause abnormal heart rhythms, many, many other drugs can cause fatal heart rhythms as well. But what if Anna Nicole’s toxicology screen comes up negative? What other causes of sudden death can occur in the young?

Although neurologic causes may occur, like a ruptured cerebral aneurism (blood bessel in the brain), by far and away, cardiovascular causes are the most prevalent cause of sudden death in the young. It was interesting to me that the cardiac examination was not mentioned in the press releases so far. Some cardiac causes of sudden death in the young are outlined below:

As a whole, these are disorders of the heart muscle itself.

Peripartum Cardiomyopathy
Weakening of the heart muscle that occurs in the last month of pregnancy or up to five months after pregnancy. It usually is more common in women with more than one child, and its cause is unknown.

Idiopathic Dilated Cardiomyopathy
A dilated, weakened heart not caused by occlusions of the blood vessels of the heart. Most often the cause is unknown, but viral causes are often blamed. Heart failure manifested by swollen legs, shortness of breath with exertion, cough when reclining is a common symptom, but weakened hearts can also lead to abnormal heart rhythms that can lead to sudden cardiac arrest. Myocarditis, or inflammation of the heart, is a common cause of dilated cardiomyopathy, and is often preceded by flu-like symptoms.

Hypertrophic Cardiomyopathy
An inherited disorder of heart muscle organization that causes the heart muscle to become thickened and stiff, leading to either a failure of the heart to relax so it can fill with blood, or causing obstruction to blood flow as blood leaves the heart.

Arrhythmogenic Right Ventricular Dysplasia
An inherited disorder that causes fatty deposits to occur within the heart muscle itself and leads to abnormal heart rhythms that can be fatal.

Coronary Artery Disease

Myocardial Infarction (Heart Attack)
Although uncommon in the young, certain types of lipid disorders could contribute to the development of premature coronary disease.

Long QT Syndrome
A genetic disorder of the major electrolyte (sodium and potassium) channels of the heart which can precipitate sudden unexpected life-threatening arrhythmias.

Congenital Abnormalities of Cardiac Anatomy

Congenital Anomalous Coronary Artery
Abnormal blood vessels that supply the heart can compromise blood flow to the heart, resulting in abnormal heart rhythms or a heart attack.

Unrecognized Valvular and Congenital Heart Defects
These are usually identified in children, but can be unrecognized

Connective Tissue Disease effecting the Major Blood Vessels

Marfan’s Syndrome/Ehler-Danlos Syndrome
These genetic abnormalities of the connective tissue that makes up the great vessels (and to some extent the heart) can lead to sudden rupture of these vessels and rapid death.

Pulmonary Embolus
Blood clots to the lungs can obstruct blood flow to the heart and result in death. Women who smoke and are on birth control pills can be particularly susceptible to this problem.

Conduction System Disorders

Wolff-Parkinson White Syndrome
Abnormalities of the heart’s conduction system can result in the development of very rapid heart rhythms that, in rare instances, can be fatal. Wolff-Parkinson-White Syndrome is caused by an abnormal muscle fiber that short-circuits the normally insulated valve rings that separate the upper from lower chambers of the heart called an accessory pathway. This pathway permits electricity to pass in a circular fashion from the upper chambers to the lower chambers and back again extremely rapidly. Rhythms that are very rapid may limit the time for the heart to fill with blood, leading to loss of consciousness in rare cases.

While this list may not be complete, it serves as a useful reminder of the complexities of the heart that must be functioning properly to maintain life.


El Corazon

Maybe if we really appreciated this, we'd treat it differently:

From A Hearty Life via Kidney Notes.


Friday, February 09, 2007

Smoking Cessation: Drugs or Cold Turkey?

Recently, I was involved in the management of a patient who smoked regularly 2-3 packs a day of cigarettes and presented to our Emergency Room with shortness of breath from atrial fibrillation and a very fast heart rate. Since this had been going on so long, he had also had the misfortune to develop heart failure (fluid on the lungs). We treated him with diuretics and heart rate-control medications and then admitted him to the hospital. Since I now have learned how to record his history in our electronic medical record, I dutifully entered his smoking history.

Little did I know what would happen next.

As I wrote the orders for admission, I was surprised to see a little "reminder" box pop up that I should offer this patient a nicotine patch. What?? A computer pushing drugs?

Well it seems that nicotine patches are now part of the federal guidelines regarding smoking cessation issued by the Public Health Service, a division of the Department of Health and Human Services. But an interesting twist to these guidelines was revealed yesterday (WSJ, subscription):
(Doctor) Michael Fiore is in charge of revising federal guidelines on how to get smokers to quit. He also runs an academic research center funded in part by drug companies that make quit-smoking aids, and he personally has received tens of thousands of dollars in speaking and consulting fees from those companies.


Dr. Fiore, a University of Wisconsin professor of medicine, headed the 18-member panel that created those guidelines. He and at least eight others on it had ties to the makers of stop-smoking products.

Those opposed to urging medication on most quitters note that cold turkey is the method used by the vast majority of former smokers. They fear the federal government's campaign could discourage potential quitters who don't want to spend money on quitting aids or don't like the idea of treating their nicotine addiction with more nicotine.

"To imply that medications are the only way is inappropriate," says Lois Biener, a senior research fellow at the University of Massachusetts at Boston who has surveyed former smokers in her state. "Most people don't want them. Most of the people who do quit successfully do so without them."
What is interesting is the way the government makes these recommendations: based on clinical trials. And who is better equipped to perform clinical trials than drug companies? (Bias 1). Further, all of the individuals in clinical trials must sign consent, and therefore have to be willing to take a drug (Bias 2). So these "clinical trials" are, by their very nature, skewed toward those willing to take a drug.

But in the interest of revealing effectiveness of these smoking cessation drugs in the real world, another type of study, an observational population trial that looks at all comers to the smoking cessation party, found this:
Studies of quitters outside clinical trials have shown no consistent advantage for medicine over cold turkey, the pharmaceutical industry's primary competitor. An unpublished National Cancer Institute survey of 8,200 people who tried quitting found that at three months, users of the nicotine patch and users of bupropion (Wellbutrin) remained abstinent at higher rates than did users of no medication. But at nine months, the no-medication group held an advantage over every category of stop-smoking medicine. The study was presented at a world tobacco conference last summer.
But the potential conflicts with the pharmaceutical industry don't end there:
The American Cancer Society has allowed its logo to be placed on stop-smoking products in exchange for money. A Cancer Society spokesman defends that decision, crediting the pharmaceutical industry for bringing invaluable marketing muscle to the society's Great American Smokeout every November.
Gee, I wonder why. Lots and lots of Wellbutrin and Nicorette is sold each November, I'm sure. Gotta "raise that public awareness" now don't we? It seems personal responsibility has gone out the window.

So smokers, go ahead, pay the drug companies to maintain your oral gratification. But just know what you're getting into. Oh, sure, there's the powerfully addicting nature of nicotine... but isn't that a drug, too?

Maybe before smokers buy the drugs, they should just quit. Do it any way you can - substitute a toothpick for a cigarette - I had one patient who liked dried apricots and sucked on those instead - whatever - just do it.

And see what happens.

Now, if I could figure out a way to bypass that computer prompt...


Defibrillators and Driving

New policy recommendations were released this week by the Heart Rhythm Society and American Heart Association regarding driving restrictions in patients with implantable cardiac defibrillators (ICDs). These newer guidelines were basically a supplement to earlier guidelines published in 1996 when most ICDs were placed after individuals already had a documented arrhythmia or episode of aborted sudden death ("secondary prevention"). These newer guidelines extend the former guidelines to also include patients who have never had an index arrhythmia, but instead have been implanted with an ICD to avoid their first arrhythmia ("primary prevention").

There is probably no more contentious issue that I struggle with as a cardiac electrophysiology physician than the question "When can I drive?" after implanting an ICD. People need their cars for a whole host of reasons. Our society is wedded to cars. So to tell someone who has been independent all of their life that they can no longer drive, becomes a personal affront to their independence - some would even claim to the extent that we are intruding on their personal rights. The guidelines admit to this dilemma:
In American society, there is a constant conflict between the rights of the individual and the good of society. The individual is given the right to act in whatever manner he or she chooses as long as that act does not impinge on the rights of others. The latter requirement demands that limits be placed on the rights of the individual just as limits are placed on the rights of society to restrict individual action. Ethics tries to address the delicate balance between these two conflicting principles. In American society, individual mobility and access to education, employment, health maintenance, and personal enrichment opportunities are highly dependent on the automobile. Being unable to drive puts limitations on the individual, which results in both emotional stress and loss of economic status. At the same time, the citizens of a society have the right to protect themselves against the harm caused by individuals who are unable to operate a motor vehicle in a safe and prudent manner. In a just and open society, all individuals are treated equally. Therefore, restrictions on the driving ability of patients with arrhythmias must be clearly elaborated and applied uniformly to all.
Okay, okay, but I have a bit of a problem with the last sentence of this paragraph. Is there no line to be drawn for the evaluating physician? But even harder to swallow was this paragraph:
The physician and other healthcare professionals are bound to uphold the confidentiality of information regarding a patient’s medical condition, and such information is shared with others only when consent is given by the patient. If a patient requests that medical information be withheld from his or her employer, the ethical physician will not comply with the patient’s request if doing so would pose a risk to others. In such instances, the patient should be asked to release this information. If, however, the patient does not agree, the physician is bound to breach confidentiality. Although breaking the principle of confidentiality may result in legal action by the patient against the physician, the ethical responsibilities of beneficence (“do good and avoid evil”) and nonmaleficence (“do no harm”) take precedence over the principle of confidentiality in this setting. In such situations, the ethical course is for the physician to release the required information to the proper authorities, such as the state or national departments of transportation, while providing full disclosure to the patient.
In effect, we get to be tattle tales in the interest of public safety. So much for your confidentiality. And this will be in spite of this tidbit of data:
Patients randomized in the AVID Trial reported resuming driving early regardless of medical advice to the contrary (80% were driving within 6 months), reported driving frequently (57% reported driving every day), and reported driving significant distances (25% were driving 100 miles/wk). However, these patients, who had survived a near-fatal episode of ventricular arrhythmia, had a very low rate of automobile accidents. Indeed, the frequency of automobile accidents (3.4% of patients per year) was less than that of the general driving population of the United States (7.1% patients per year). Nevertheless, the relatively high event rate soon after the index episode of ventricular tachyarrhythmias led to a suggestion that driving be restricted for all patients for 1 month and for most patients up to 8 months after such an event.
I agree with the task force's opinion that driving in primary prevention patients be restricted from driving for a week after a new implant, but asking patients to avoid driving for 6 months after they've had a significant arrhythmia in all cases seems excessive, specially if a precipitating cause (ischemia, heart failure, drug effect or device programming error) is identified.

Patients with these devices and their managing physicians need to beware of the implications of these recommendations. While these guidelines help standardize US practices regarding ICDs and driving, much of these are developed with very minimal data but have now been carved in stone - at least until new guidelines are published.


(1) Addendum to “Personal and Public Safety Issues Related to Arrhythmias That May Affect Consciousness: Implications for Regulation and Physician Recommendations: A Medical/Scientific Statement From the American Heart Association and the North American Society of Pacing and Electrophysiology” Public Safety Issues in Patients With Implantable Defibrillators A Scientific Statement From the American Heart Association and the Heart Rhythm Society*
Andrew E. Epstein, MD, FAHA, FHRS; Christina A. Baessler, RN, MSN; Anne B. Curtis, MD, FAHA, FHRS; N.A. Mark Estes III, MD, FAHA, FHRS; Bernard J. Gersh, MB, ChB, DPhil, FAHA; Blair Grubb, MD, FAHA; L. Brent Mitchell, MD, FHRS
Circulation published online Feb 7, 2007; DOI: 10.1161/CIRCULATIONAHA.106.180203

(2) Epstein AE, Miles WM, Benditt DG, Camm AJ, Darling EJ, Friedman PL, Garson A Jr, Harvey JC, Kidwell GA, Klein GJ, Levine PA, Marchlinski FE, Prystowsky EN, Wilkoff BL. Personal and public safety issues related to arrhythmias that may affect consciousness: implications for regulation and physician recommendations: a medical/scientific statement from the
American Heart Association and the North American Society of Pacing and Electrophysiology. Circulation. 1996;94:1147–1166.

Photo credit

Thursday, February 08, 2007

The Cardiologist Geek

If I used this electronic stethoscope made by ThinkLabs and recorded your heart sounds on a iPod for later playback, would I be cool or a geek?

I suspect the latter.


From iLounge via CrunchGear.

Wednesday, February 07, 2007

Anal Leakage Returns?

Wow, today the FDA approved a low-dose version of orlistat called Alli to be sold by GlaxoSmithKline PLC. The manufacturer claims the drug prevents absorption of 25% of fats consumed, or 150-200 calories. Whoopie! Go ahead, eat more! But beware (MSNBC):
When taken with meals, orlistat blocks the absorption of about one-quarter of any fat consumed. That fat — about 150 to 200 calories worth — is passed out of the body in stools, which can be loose as a result. About half of patients in trials experienced gastrointestinal side effects.
Anyone remember the alternate fat Olestra that stayed in your gut and caused, well, er, "anal leakage?" Look for Alli to be your ally in not only losing weight, but also treating constipation with interesting side effects (Medline Plus Drug Information):
The most common side effect of orlistat is changes in bowel movement (BM) habits. This generally occurs during the first weeks of treatment; however, it may continue throughout your use of orlistat. Tell your doctor if any of these symptoms are severe or do not go away:

  • oily, spotting BMs

  • gas with discharge

  • urgent need to have a BM

  • oily or fatty stools

  • an oily discharge

  • increased number of BMs

  • inability to control BMs

  • orange or brown color of a BM

  • stomach pain

  • irregular menstrual periods
How bad can this be? Just look at this hilarious post from Craig's List "Best of" Series regarding Pringles Fat-Free Potato Chips (warning, contains profanity). You might want to rethink how many pills you'll take!


How to Avoid a Sex Offender

... fake a heart attack.

Now that's creative!


Tuesday, February 06, 2007

Graphic Cigarette Warning Labels

Pictures speak louder than words. Cigarette labels like these from Thailand with a man on a ventillator (left) and another with rotten teeth (right) speak volumes. No one reads cigarette warning labels as they are in the USA. A recent study demonstrated that the warning labels in the US are not as effective as graphic labels used on cigarette packages from overseas.

Of course, adding a few dollars taxation to a pack of cigarettes helps deter the urge to smoke, too.


Picture credit.

Grand Rounds 3.20 is Up

Dr. Couz brings us the human side of medicine over at Tales From the Emergency Room and Beyond for Grand Rounds 3.20, a weekly summary of the best of the medical blog-o-sphere:
More than most other professions, medicine has the ability to devour all it touches. Those who enter the world of medicine as patients soon find it difficult to identify themselves beyond the confines of their label-- at least within the walls of the hospital. Those who enter into it as a career soon discover just how far-reaching a life in medicine is. Interests and relationships that once defined us as people too often take a backseat to the demands of medicine. Too easily we find that we lose sight of ourselves. We advise patients to rest, exercise, eat right, deal with stress, develop good coping mechanisms... and then we go home, order out, catch up on paperwork and try to fit in a few moments with our loved ones before catching a few hours of sleep.


CMS Could Retrict Payment for Drug-Eluting Stents

The Center of Medicare and Medicaid Services (CMS) is considering limiting reimbursement strategy for drug-eluting stents that are placed "off-label," like diabetics and those who having heart attacks. According to the Wall Street Journal this AM:
..."the Centers for Medicare & Medicaid Services, or CMS, says it is considering reopening its decision about how broadly to cover the stents. An agency spokesman said such a process, known as a National Coverage Determination, could result in restricting coverage of the stents to FDA-approved uses, keeping coverage the same, or something in between.
This could spell more bad news for Johnson and Johnson and Boston Scientific if further cuts in reimbursement for drug-eluting stents are implemented.

Almost on cue, data from a single-center observational study were published earlier this week in the American Journal of Cardiology that suggested that drug-eluting stents might be superior to bare metal stents in such "off-label" patients:
Abstract: In clinical trials of highly selected patients, drug-eluting stents (DESs) decreased restenosis but not the rate of acute myocardial infarction (AMI) or death. Whether DES use has an affect on the rate of AMI or death in unselected patients is uncertain. Bare metal stents (BMSs) were placed in 1,164 consecutive patients in the year before the introduction of DESs. DESs were subsequently placed in 1,285 consecutive comparable patients at Wake Forest Baptist Medical Center. Early and late clinical outcomes were compared. Propensity score analysis was used to adjust outcomes for baseline differences. Patient and procedural characteristics of the 2 groups were similar, with an overall incidence of 72% for acute coronary syndromes (p = NS). At 9 months, target vessel revascularization (2.8% vs 8.6%, p <0.001), AMI (3.7% vs 4.7%, p = 0.257), and death (4.9% vs 7.1%, p = 0.030) were lower in the DES group than in the BMS group. Propensity score-adjusted Cox proportional hazard ratios for DES versus BMS at 9 months were 0.71 (95% confidence interval 0.42 to 1.19) for AMI, 0.56 (95% confidence interval 0.36 to 0.87) for death, and 0.60 (95% confidence interval 0.42 to 0.86) for the combined end point of AMI or death. In conclusion, in this single-center observational study, use of DESs in consecutive unselected patients, most of whom would not have been eligible for inclusion in the randomized trials of DES versus BMS, was associated with lower AMI and death rates than in a comparable group of patients treated with BMSs in mid-term (9-month) follow-up.
This study was sponsored by Johnson and Johnson. What the effect on long-term clopidogrel therapy, recently recommended to prevent the late in-stent thrombosis of drug-eluting stents has on these "off-label" patients, especially after nine months (when in-stent thrombosis is seen), remains untested. Look for significant positioning by these companies to continue the status quo.


References: Robert J. Applegate, Matthew T. Sacrinty, Michael A. Kutcher, Talal T. Baki, Sanjay K. Gandhi, Renato M. Santos and William C. Little, Comparison of Drug-Eluting Versus Bare Metal Stents on Later Frequency of Acute Myocardial Infarction and Death, The American Journal of Cardiology, Volume 99, Issue 3, 1 February 2007, Pages 333-338.

Keith Winstein, "Agency Reviews Stent Coverage," Wall Street Journal (Subscription), 6 February 2007, Page D4.

Monday, February 05, 2007

The Over-the-Hill VooDoo Doll

Heh, just stick pins in what ails you. It brought a smile to the 'ol man.


The Jet Stream

When I was a young boy, I would lay in our pasture and stare up at the clouds, fascinated that they took different shapes as they moved across the sky and could grow to become a serious storm, or wither to just obscure the sun. I later learned that the growth of clouds was caused in part by ambient heating of the earth, moisture flows from the North or South, or surface wind currents. Still later I learned that above it all was the jet stream – the high-altitude fast moving winds created by warming of the earth from the sun coupled with the Earth’s rotation – that really created the change in weather patterns. Predicting the weather involves knowing these jet stream patterns and interpreting them – getting these predictions wrong could put lives at stake.

The practice of medicine is like studying ever-transforming clouds – you never really know what shape a patient’s illness will bring, nor their response to their illness. But by using deductive reasoning or listening to trusted colleagues or opinion experts, we usually can hazard a guess at where a case will go and react accordingly.

But sometimes we have to look beyond the clouds, beyond what the experts and textbooks tell us. Sometimes we have to collect our own observations, gather data, and delve deeper to get the real gist of a case to save a life.

Beginning in February 2005, a series of defibrillator recalls rocked our cardiac electrophysiology community. First, was an extensive defibrillator battery recall from Medtronic. Soon after in May 2005, Guidant Corporation issued a recall of its Ventak Prism II defibrillator line. What was concerning about this recall was that it occurred, we learned, only after two physicians notified Guidant that the New York Times was to publish an article about a young 21-year-old patient that died when their defibrillator failed to perform properly nearly three years after the company knew of the root problem. The episode highlighted an important issue:
New York Times, 5/24/05: “Doctors and patients are not always told when a medical device maker has data indicating that its product has a flaw that, while rare, poses potential dangers. Also, companies are not required to report immediately all safety modifications to the Food and Drug Administration.”
The cases regarding this recall and others are still winding through the courts, and will be for some time to come. St. Jude, too, had their own recall that year as well. In all, over 100,000 patients were affected by a recall or advisory condition about their device that year. Companies realized that there could be significant risks with keeping the public uninformed about known flaws in the design of their devices. They hurried to inform physicians and patients about their concerns, leaving doctors to notify their patients and try to determine the best course of action with very little real information. These concerns lead the Heart Rhythm Society, in conjunction with physician, patient, government and industry input, to issue new device performance policies and guidelines regarding notification of physicians and patients. A new defibrillator registry was also implemented to track currently implanted devices to determine the incidence data of defects with defibrillators.

But most important with the former fiasco, implanting physicians like me were sensitized, ever-cautious to take what industry and the FDA tells us with a grain of salt.

So on January 29, 2007, when I learned that Medtronic was being investigated by the FDA for concerns raised by a former engineer, Christopher Fuller, regarding how their new wireless Concerto defibrillator was tested, I listened. Carefully. According to the Wall Street Journal, he resigned over concerns the the device "exhibited instabilities in testing" and that Medtronic "has chosen to ignore the problem." Press releases like this one and this one were released on 30 January with FDA spokesperson Heidi Rebello reassuring us that “We are investigating.” Funny, because Medtronic didn’t seem to know anything about an investigation: 30 Jan 07 3:22PM: The Minneapolis-based device maker put 11,000 Concerto devices on the U.S. market after the FDA approved it in May of 2006, said Medtronic spokesman Robert Clark. But Clark said the FDA has not discussed the investigation with Medtronic.
"Medtronic has not been contacted by the FDA in regards to an investigation in this matter," said Clark.
I called David Steinhaus, MD, Director of Cardiac Rhythm Management at Medtronic in an attempt to better understand the situation and see if they felt there issues I should know about with their device. He returned my call the next day and reassured me that there were no issues with any of the 11,000 devices implanted to date. He referred me to this news release from Ms. Rebello, issued later the same day as the earlier press releases, that “all is well.” Everything’s been checked. We’ve looked into it, really. Medtronic tells us that over 11,000 devices have been implanted and no patient safety issues have occurred. Really. It’s fine. Nothing to worry about. They’ve checked the manufacturing plant – its fine. They’ve reviewed their FDA submission and their data – it all looks good:
"The agency has completed a thorough investigation of the charges. To date, FDA has found nothing that would have influenced its decision to approve this device." Rebello added the investigation included a scientific review of the employee's allegations, an inspection of the company's manufacturing facility and a review of various available data. "All of this information was analyzed with respect to whether or not the allegations identified a safety concern for patients that substantively altered the risk/benefit profile for this device," she added.
We can only hope for such governmental efficiency in all of our agencies: the ability to achieve complete clarity in a matter of hours. What, exactly, can you clarify in a few hours – the data or the spin? If everything was wrapped up, why didn’t they tell us this with the first press releases? And what does the term “substantively altered the risk/benefit profile for this device” mean, really? Did they find something that looked “risky?” If so, what was it?
Reuters Jan 30,2007 @ 6:49PM: Medtronic said it has had no reports of patient safety issues related to the wireless features of the device.
Then I checked the FDA database for Concerto-related injuries myself and found this. Since I cannot determine the nature of this device’s defect, I am left to wonder: could this have been caused by one of the ex-Medtronic engineer’s concerns? And regarding Medtronic’s knowledge of an FDA inspection: did they know about the FDA inspection of their manufacturing facility or didn’t they? Why not level with me, one of their biggest advocates?

Everything now is in question. The bloom is off the rose.

To be fair, I still believe that all of the device manufacturers in this business are reputable companies. Medtronic, Guidant (now Boston Scientific), and St. Jude have been in the business for years and have remarkably reliable devices that have saved many, many lives that otherwise would have been lost. They constantly strive to improve their products, tirelessly check devices for me in the field, and help develop policies to promote the well-being of patients. Many individuals from these companies have devoted their lives to improving the well being of their fellow man. The FDA, too, has a very arduous approval process in the interest of public safety. Every side effect of every device tested is scrutinized by Data Safety Monitoring Boards made up of many physician-reviewers.

But in regards to the handling of this piece from the Wall Street Journal – I feel it would have been far better to have stated the data when responding to physicians or the press. An example might have been something like this (this is my example only):
Review of our worldwide experience to date has identified only one (actual number) of 11,012 implanted devices (give the actual number here) that has demonstrated device malfunction with compromised therapy. This failure rate falls well below the anticipated incident rate of annual failures of 20.7 per 1000 devices implanted annually for such devices outlined by the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines. We are investigating/have investigated the root cause of this malfunction. (Explain what was/was not found here). We do/do not feel this device malfunction is related to the concerns raised by our former employee.
But this is not what was said. Instead we were obfuscated with PR-speak. “We are investigating” became “we found nothing” in less than 24-hours. Well if I could find one injury on the FDA’s own database, how hard did the FDA look?

Which returns to my real question: how can a physician verify if the press releases from industry and the media are valid?

Has the FDA’s responded to the engineer’s concerns? Wouldn’t it be nice to see their response to him on the MAUDE database? Instead, to investigate the current situation, I called the Office of the Inspector General (OIG) over at the Department of Health and Human Services (to whom the FDA Director reports) and was politely told by HHS OIG spokesperson Donald White that they can’t and won’t release if or when there was an investigation. “I’m sorry, we cannot help you. We do not release information regarding investigations. This information is not covered under the Freedom of Information Act.” I was told.

The lines are blurred. By not giving physicians and the public the truth, the whole truth, and nothing but the truth in press releases or through company spokespersons, public trust is eroded. Worse still, could I be liable to my patient for not telling knowing the facts that exist on the publicly searchable FDA database because I listened to others rather than checked myself? My patients trust that I know the data.

But there is nothing verifiable in this PR world, it seems. It’s as though my clouds of concern are being manipulated by a bigger jet stream high above our work-a-day world. Doctors are often blown about by economic and political forces about which they know little. But what was clear about the handling of the current allegations, especially in light of our prior experience in 2005 with the earlier defibrillator device recalls, is that device manufacturers and the FDA have learned little about earning public trust.

When it comes to public safety, there is no room for PR spin.

So where, my friends, is the weather satellite above the jet stream?