Cardiology Fellows as "Experts"

Either we're not paying our cardiology fellows enough, or they have too way much time on their hands:

Consulting Services:
As a member of the Intota consultant network, Expert is a specialist who provides technical consulting to corporate, legal and government clients. Expert provides professional consulting as a Cardiology Consultant. Expert may consult as an independent consultant or as a member of a consultancy, consulting company, or consulting firm. Consultants service will be covered by a consulting contract. Ask an expert initial screening questions and ask the experts services particulars, by simply submitting an expert request.

Expert Witness:
Intota experts can serve as expert witnesses or litigation consultants offering expert testimony, expert advice, litigation support, forensic services, and related expert witness services. Expert can serve as an expert witness or litigation consultant in intellectual property (patent, trademark, trade secret, copyright), product liability, and insurance matters. Expert may provide forensic expert witness testimony, litigation consulting services, forensic investigation, and forensic testing if appropriate in litigation areas as a Cardiology Expert Witness. Intota provides attorneys and legal professionals the opportunity to ask an expert initial screening questions and ask the experts services particulars by submitting an expert request.

I bet Expert wishes he never advertised for this.

-Wes

How I Saved My Patient $53 per Month

She came to me for a refill for metoprolol succinate (Toprol XL) at $60.61 for 50 tablets (slower release, taken once daily). Note that the linked webpage does not offer a generic equivalent suggestion, even though this one exists:

Metoprolol tartrate $7.18 for 100 tablets (25 mg are taken twice daily)

With all the fancy smancy multi-million dollar electronic medical record and e-prescribing systems out there, the ability of these systems to suggest cheaper drugs for our patients should be requirement for systems going forward. I'm willing to bet most patients wouldn't mind taking a pill twice a day if it saved them over $600 per year.

-Wes

Why Lawyers Will Get Every Heart Test Known to Man

... because if you don't predict the unpredictable, they sue:

A doctor failed to see that former Tompkins County District Attorney George Dentes had heart disease, and this professional negligence led to Dentes' fatal heart attack in October 2006, his widow is alleging in a medical malpractice suit starting in county court this week.

Dr. Jonathan Mauser of Cayuga Cardiology Associates P.C. improperly interpreted Dentes' April 2005 stress echocardiogram, failed to suspect that Dentes had coronary artery disease and failed to recommend or perform a cardiac catheterization to confirm it, Elsie Dentes claims in the suit. Mauser and Cayuga Cardiology Associates are named as defendants.

Remember, the doctor did not give this patient heart disease, God did.

While I do not know the circumstances surrounding the case in question, it is clear that our society increasingly accepts that all diseases are preventable, life is limitless, and all tests we perform perfect. Of course, none of these are true. Yet when something doesn't follow the Western psyche's playbook, someone has to pay. All too often, that someone is the doctor.

This, my friends, is why doctors will continue to order every test known to man... as this case exemplifies, there is simply no incentive to do otherwise.

-Wes

Why Did Dick Cheney Develop Heart Failure?

Years ago, when I was indoctrinated as a fellow in to American College of Cardiology, Dick Cheney - then a former secretary of state, was the keynote speaker at our commencement ceremony. His keynote speech reflected on what it was like to watch his father die following a massive heart attack, comforted only by morphine, oxygen, bed rest. By then, Mr. Cheney, already a recipient of two bypass operations, made a point to thank the cardiovascular community for helping him.

Many years later, Mr. Cheney's complicated yet remarkable cardiovascular history reads like a social studies timeline - one with heart attacks, arrhythmias, blood clots, and now, congestive heart failure. (Of course, political spin meisters want to make sure we call it "fluid retention" rather than congestive heart failure, since "failure" is not an option when speaking of all things political).

Congestive heart failure is nothing more than an insufficient pumping of blood to meet the body's needs. As a result, the kidneys detect the decreased perfusion pressure and trigger the release of a cascade of hormones to increase the blood pressure to maintain perfusion of the tissues. Some of the hormones help retain fluid in the vascular space. If this fluid becomes too excessive, the fluid can spill into the lung resulting in a sensation of shortness of breath, usually worse when lying flat. One of the main drugs used to fool the kidneys to release the accumulated fluid are diuretics - the most common being furosemide (Lasix).

There are a number of things that may have contributed to the development of Mr. Cheney's heart failure. Since HIPAA knows no bounds with disclosing Mr. Cheney's heart history, we can use this opportunity to tease apart a few possibilities.

First, dead meat don't beat.

It doesn't help that Mr. Cheney has had many heart attacks in the past. With the progressive loss of healthy muscle cells to to the heavy lifting of contraction, the ejection fraction falls. At first, the heart compensates by recruiting other, non-injured segments of heart muscle to take up the slack, but with each successive heart attack, the reserve heart muscle dwindles. Lose enough muscle and the heart must rely on increasing the rate at which if contracts to increase output, but for hearts already with limited blood flow this might lead to futher shortage of oxygen to the heart muscleto When this happens, the heart rate kicks up just a bit to increase cardiac output. If it kicks up too much, the heart can outstrip it's own oxygen supply, resulting in additional injury to the heart. This is part of the reason medication that slow the heart rate (beta blockers) can be helpful adjuncts to preserving heart muscle function and slowing the progression of worstened heart failure.

Second, Mr. Cheney's atrial fibrillation.

The loss of coordinated pumping of the top chambers (atria) just before the lower pumping chambers (ventricles) can lead to 10-20% drop in effective cardiac output in some patients. The irregularity of the heart's rhythm while in atrial fibrillation also causes a loss of coordinated closing of the normally one-way valves that direct the flow of blood through the heart, further compromising the heart's pumping ability. Rate control of atrial fibrillation or the restoration of normal sinus rhythm in the heart are often important adjuncts to the treatment of atrial fibrillation.

Third, is the presence of Mr. Cheney's defibrillator.

Although we do not know for sure, it would not be surprising if many of Mr. Cheney's heart beats are being supplied by his defibrillator's pacemaker feature. Excessive pacing the right ventricle can cause a dis coordinated beating of the lower pumping chambers, resulting in a subtle, but real, fall in cardiac function during paced heart beats compared to beats that are not paced and normally conducted from the top to bottom heart chambers. At some point in the future, Mr. Cheney might benefit, in appropriate circumstances, by adding extra pacing wire to his existing defibrillator system (so-called biventricular pacing) to re-coordinate the contraction process of his heart chambers above and beyond that which can be achieved with medications alone.

Finally, might he have new portions of heart muscle lacking sufficient oxygen?

Not all coronary arteries that might be partially blocked can be revascularized during surgeries or angioplasties. As a result, some segments of heart muscle might not have enough blood flow to maintain proper function, yet have just enough to survive intact. Many of our medications help lower blood pressure to decrease the work the heart has to perform on a beat-to-beat basis, dilate blood vessels to improve coronary blood flow, and work to decrease the negative affects that excessive adrenaline-like compounds can have on the heart's remaining muscle cells. The very fact that his doctors did not feel further invasive procedures were necessary suggests Mr. Cheney's revacularization options are limited at this point.

So given his current setback, what should we expect regarding his prognosis?

Hard to know. But given what I know about the successful management of heart failure these days, I wouldn't count him out quite yet.

-Wes

Can You Lower Your Health Care Bill?

From the Chicago Tribune:

Get multiple quotes in writing. Before your procedure, shop around to various doctors to find out how much they charge and how much they expect insurance to pay. Get those price quotes in writing, with a name, title and signature, so that you have a paper trail if you end up getting charged more later. Remember to cover all the costs associated with the procedure and every doctor in the room: lab costs, the anesthesiologist, the radiologist, etc.

You may want to consult the "Healthcare Blue Book" beforehand (healthcarebluebook.com). It's a medical pricing guide that states the average compensation that medical providers accept from insurers for services ranging from surgery to dental and eye-care procedures.

It's especially helpful for those with high deductibles or who are paying out of pocket.

"Healthcare Blue Book is a great tool," Hicks said. "We're actually partnering with them, and will have a service in place for our members this summer that will let them click a few buttons to access local medical costs so they can find fair prices and save money. We'll rely on Healthcare Blue Book to provide that information."

I would add a word of caution about Healthcarebluebook.com promoted in this article: some of the data are simply not accurate.

For instance, I looked up the costs for placing a permanent pacemaker and for a cardiac defibrillator, and the costs quoted by the site for the two different devices were identical: $4275. Further, there is no differentiation made regarding the type of pacemaker or defibrillator (such as single, dual, or biventricular devices).

Still, it's a start and the other points made by the article are worthwhile. Just don't be surprised if the medical billing office won't come close to matching some of the prices they quote online.

-Wes

Fellowship Graduation

Dr. Wes with Colleagues and Friends
Cardiology Fellowship Graduation,
National Naval Medical Center, Bethesda, MD
1993

I'm not sure there's ever a time in medical training where one is so happy to get on with their careers as the day you complete your fellowship training. For a few very intense years, a special bond forms between you and those who work beside you - you've seen tough cases, sad cases, spectacular cases, together.

Fellowship was a chance to focus on the science and art of a very narrow segment of medicine. In my case, it was cardiology and (later) cardiac electrophysiology. I was glad I was able to retrieve the picture above, taken just before I completed by cardiology fellowship training. I wonder where all those magnificent people are now, and marvel at the young faces, the tennis shoes, the film canisters above the image intensifiers that are now obsolete, replaced by fancier digital acquisition systems.

It was with some poignancy that I saw another graduating class in hail the efforts of the graduating cardiac electrophysiology fellows on Friday.

There they are, surrounded by friends, staff members, family members, and a whole host of support personnel (nurses, technicians, education administration, etc.) They are, for now, at the peak of their game - as ready as they can possibly be for working independently (we hope). They look back. Remember all the good times and bad. They get gifts to wish them well. They get signed momentos. Joy - pure, nervous joy.

And that's the paradox of such moments when we part ways, isn't it? We leave our friends and closest colleagues to head off on our own and make a mark. What lies ahead, we haven't a clue...

...because despite all the hours and effort, that's when the learning really starts.

-Wes

"Reasonable Consumers" Unite! Kill Drug Ads

It seems the FDA is looking for input on how drug companies explain the side effects of their drugs in direct-to-consumer advertising.

But the pharmaceutical industry is requesting that only "reasonable consumers" need to be addressed about those side effects. Anyone that doesn't act "reasonably," well, so sorry.

Seriously?

About the only reasonable thing that can be said about direct-to-consumer advertising are three things:

1. They are horribly expensive, with the US shunting over $2 billion dollars annually per pharmaceutical company to the advertising industry.


2. It should also be noted that the FDA has a huge conflict of interest with the pharmaceutical industry, since it receives large sums from them to review their new drug applications.


3. Note, too, that only two countries in the world permit these ads: the US and New Zealand.

I find it interesting that I can't get a $0.10 pen from the drug companies any longer, but our patients can get billions of dollars in advertising given to them "free" without any concern about what this is costing our health care system.

-Wes

When Hospitals Divorce Their Doctors

As doctors increasingly become physician-employees, there's no longer a need to share resources with University specialists:

Three University of Virginia cardiologists have been told by the Augusta Health board they will lose their hospital privileges next week, impacting the 2,500 patients the doctors serve.

Augusta Health officials told the doctors in a letter that they won’t be able to treat their patients in emergencies or otherwise at the hospital in Fishersville.

. . .

Crow’s statement said the board is limiting cardiology department participation to doctors “under contract to Augusta Health.”

Augusta Health has four cardiologists on staff, and will soon have a fifth, he said.

Limiting cardiology participation to the hospital’s own doctors will allow Augusta Health “to build a strong and financially viable community-based cardiology program,” Crow said.

Universities have a long history of exporting their clinical expertise in the hopes of capturing more complicated surgical cases from their imbedded specialists. With more and more health systems consolidating (note the three-for-one swap above), the days of collaboration and shared resources between health systems are ending and patients are finding access to doctors more challenging.

-Wes

Addendum 26 Jun 2010 @ 05:45am: It seems procedures, not patients, are what's at stake:

"“Twenty-five hundred [patients] is significant, but is not going to generate that many procedures on a yearly basis,” he said.

Sometimes Lab Staff Can Be So Helpful

... and even a bit creative when you've misplaced your reading glasses:

Click image to enlarge

-Wes

How to Balance Health Care Budgets: Close Hospitals

It appears Cook County has a plan to make their struggling health care system solvent - close hospitals:

Most controversial in the new strategic plan is a proposal to convert Provident Hospital and Oak Forest Hospital into large outpatient centers, a move that could endanger jobs at the two underused medical centers and that has drawn strong union opposition.

"Our concern is that people won't have access" to needed hospital care, said Christine Boardman, president of Service Employees International Union Local 73, which represents 1,500 workers in the health system.

The situation surrounding Provident Hospital — a pioneering African-American hospital with deep roots on the South Side — is especially complex. If negotiations under way over a possible relationship with the University of Chicago Medical Center are successful, the institution would remain largely intact.

But those talks have been rocky. If they fail, the proposed strategic plan would significantly scale back services at Provident, which would keep its ER open and retain a few dozen hospital beds for patients who need to stay overnight.

The county began the process of closing Oak Forest's long-term care unit several years ago. The fewer than two dozen patients who remain would be placed in nursing homes and rehabilitation facilities under the plan; the facility's ER and hospital beds would close.

"That concerns us because this is an area where medical needs are growing," said William McNary, co-director of Citizen Action/Illinois.

Foley acknowledged that to take care of county patients, "we would really need to build relationships with other hospital providers" on the Far South Side.

Granted, hospitals lose money, and while closing hospitals will save money, it is interesting to note where the patients at those hospitals are planning to be sent:

The county began the process of closing Oak Forest's long-term care unit several years ago. The fewer than two dozen patients who remain would be placed in nursing homes and rehabilitation facilities (emphasis mine) under the plan; the facility's ER and hospital beds would close.

Further, there might be a little flaw in the logic about cost savings with moving to the more lucrative outpatient service model:

"There will be considerably greater convenience for most patients," said David Dranove, professor of health industry management at Northwestern's Kellogg School of Management. But costs don't necessarily plummet when a hospital is converted to outpatient care, he said.

What we're seeing is a planned shift of moneys from the state government dole to the nation's government dole as plans are underway to offload state's health care obligations to the US government as a whole.

The only problem is, when too many patients leave the local government's hospitals for greener pastures, those cornerstones of public health will struggle to survive as patient volumes (and US government payments for services via Medicare and Medicaid) dwindle:

Hundreds of thousands of poor, uninsured adults — the county health system's core clients — will gain insurance cards and the ability to choose medical providers for the first time in 2014. If large numbers of people elect to leave the county health system, that could prove devastating. "We've got to improve our services and improve our infrastructure or we'll lose a large part of our patient base," Foley said.

Which all goes to show: quality, quality, or low cost of healh care - pick any two.

-Wes

When Lightning Strikes

... it can make some pretty dramatic video. Here's what happened in Chicago last evening: simultaneous strikes of (left to right) The John Hancock Building, Trump Tower, and the Willis Tower (formerly the "Sears" Tower):

From Craig Shimala on Vimeo.

-Wes

Cool SVT Animations

For medical students and others who want to see some nice animations of various forms of supraventricular tachycardias (SVT) in living color, be sure to checkout the free SVT animations at Blaufuss.org (requires Adobe Shockwave player available from the site).

-Wes

h/t Vijay Sadasivam, MD via Facebook and Ves Dimov, MD via Twitter

It's Official: Guidelines for Care Are Now Mandates for Care

Want a pacemaker or defibrillator on your dying UnitedHealthcare patient with complete heart block? Sorry, in many states you must first ask permission from the insurer beginning 1 July 2010:

UnitedHealthcare claims this protocol is not a pre-certification, pre-authorization program or medical necessity determination. A notification number must be obtained in accordance with the Cardiology Notification process prior to perform EP implant procedures. Failure to complete the notification process will result in an administrative denial. All procedures require notification regardless if they are elective or emergent. (Emphasis mine)

Prior notification may be obtained online, by telephone or fax:

■Online: UnitedHealthcareOnline.com (User ID and password are required)
■Telephone: +1 (866) 889-8054
■Fax: 1 (866) 889-8061

Cardiology Notification process? WTF? Where, exactly, do we place this "notification number" in patient patient's chart? In their operative report?

I can see it now as P waves are dancing across the screen:

"Hold on there, Ms. Smith! Just trying to place this temporary pacing wire... Um, give me a minute, okay.... Uh, which insurance do you have?.... er, please ma'am, don't talk right now - I might hit your lung.... It wouldn't be Unitedhealthcare, would it? Wait, don't talk.... okay, which one? Yes? Does anyone have UnitedHealthcare's Cardiology Pay-to-Play number???..."

"Okay, Ms. Smith... Ms. Smith????... Ms. Smith???...."

(gurgling noises hard in background)

And will the service will be 24/7/365?

Of course not!

If notification is required on an emergent basis or notification cannot be obtained because it is outside of UnitedHealthcare’s normal business hours, the service may be performed, and notification can be requested retrospectively. Retrospective Notification requests must be made within 14 calendar days of the service. Rendering physicians should follow the same notification process outlined for a standard request. Documentation must include an explanation as to why the procedure was required on an emergent basis or why notification could not be obtained during UnitedHealthcare’s normal business hours. If a claim is submitted prior to the Retrospective Notification Process being completed, it will receive an automated denial for lack of notification; however, the claim will be reprocessed if Retrospective Notification is received within 14 calendar days of the date of service, and it meets criteria as an emergent procedure.

Just think how many hours upon hours of doctors' time will now be spent holding online waiting for a college dropout to tell us our notification number!

Damn, what a waste of resources.

This is our "guidelines" for care are now mandates for patient care and will be used against us in our new era of health care reform.

Deviate from them and your patient will pay...

... and pay dearly.

-Wes

Addendum: Dr. John Mandrola, another EP, shares a similar story, even before these new mandates go into effect.

Wide and Thin or Narrow and Thick

Get your mind out of the gutter. We're talking about defibrillators here.

There's a great picture comparing the size of implantable defibrillators for the management of ventricular arrhythmias and heart failure (and a nice article on the not-so-new wireless telemetry features) over at the New York Times today.

Here's the question:

If you needed a new defibrillator and assuming all implantable devices had identicle capabilities, which would you rather have: (1) a wide and thin device (a la the "Cognis 100-D" device of Boston Scientific's), or (2) a thicker and slightly narrower device (sported by Medtronic's Consulta CRT-D and St. Jude's EPIC-HF devices)?

Go ahead and place your vote in the comments section.

For fairness, here's a side view of the three devices arranged left-to-right as in the prior picture:

(Click to enlarge)
Left: St. Jude; Middle: Boston Scientific; Right: Medtronic

(Industry reps needn't vote. Thanks.)

-Wes

The Microbiology of Trophies

Remember "cooties" in grade school? You know, the germs or disease that girls gave boys or boys gave girls in grade school if they touched? Well, it seems they're becoming an an epidemic (video).

So thank goodness someone checked for "cooties" on the Stanley Cup:

The NHL champion Blackhawks' beloved trophy stopped by the Chicago Tribune newsroom Thursday, and so we took the opportunity to do something the Cup's keeper said had never been done: We swabbed it for germs.

We sent the samples to the Chicago lab EMSL Analytical, which found very little general bacteria and no signs of staph, salmonella or E. coli.

"It's surprisingly clean," lab manager Nancy McDonald said.

Just 400 counts of general bacteria were found, she said. By comparison, a desk in an office typically has more than 10,000.

No staph species detected?

Hmmm.

Me thinks there was a sampling error...

-Wes

Pensions and the Challenge to Health Care

I am not a finance guy, but was struck by what I read in the New York Times this morning:

Despite its pension reform, Illinois is still in deep trouble. That vaunted $300 million in immediate savings? The state produced it by giving itself credit now for the much smaller checks it will send retirees many years in the future — people who must first be hired and then, for full benefits, work until age 67.

By recognizing those far-off savings right away, Illinois is letting itself put less money into its pension fund now, starting with $300 million this year.

That saves the state money, but it also weakens the pension fund, actually a family of funds, raising the risk of a collapse long before the real savings start to materialize.

“We’re within a few years of having some of the pension funds run out of money,” said R. Eden Martin, president of the Commercial Club of Chicago, a business group that has been warning of a “financial implosion” for several years. “Funding for the schools is going to be cut radically. Funding for Medicaid. (emphasis mine) As these things all mount up, there’s going to be a lot of outrage.”

Joshua D. Rauh, an associate professor of finance at Northwestern University who studies public pension funds, predicts that at the current rate, Illinois’s pension system could run out of money by 2018. He believes the funds of other troubled states — including New Jersey, Indiana and Connecticut — are also on track to run out of money in less than a decade, unless they make meaningful changes.

If a state pension fund ran out of money, the state would be legally bound to make good on retirees’ benefits. But paying public pensions straight out of general revenue would be ruinous. In Illinois’s case, it would consume about half the state’s cash every year, bringing other vital state services to a standstill.

Of course, Illinois hospital systems know this. They are, after all, some of the largest and most lucrative employers in our state and are very savvy when it comes to the money of medicine.

As a result, large hospital systems purchase credit default swaps to hedge against the collapse of the Illinois bond market. Just this week, the price for those "swaps" (derivatives) just exceeded those for the state of California and are approaching the swap price for Greece.

All because the current union members want their pensions, some as early as age 55.

This presents very real problems for Medicaid patients:

Of the 32 million uninsured Americans expected to gain health coverage under the new law, as many as 20 million will be insured by Medicaid, experts estimate. Asset tests will be largely eliminated, so workers who lose their jobs can get health coverage even if they own their homes or have money saved for retirement. (Illegal immigrants will not be eligible.)

Absorbing that many people into the system will not be easy. The program is administered and partly financed by the states, which are now racing to figure out how to carry out the necessary changes and simplify enrollment even as they struggle to cope with severe budget cuts and staff shortages.

Many residents don’t realize they will be eligible, and it will be up to the states to let them know. And the program has long been haunted by questions about quality of care.

But why worry? Who cares if the states can't pay their Medicaid tab. The federal government will pay for the pension shortfall, right?

And it won't cost a thing... really...

-Wes

The Day After

It's rainy outside.

The dog's hungry and needs to be let out.

I still need to shave and shower.

And yes, I'm going to work today.

They tell me the doctor Medicare cuts went through. You mean the AMA, with all their sound and fury signifying nothing, failed to influence our Congressional leadership?

Gee, who knew?

Folks, this was the plan. The cuts were supposed to go through. So look at it on the bright side. Our government just saved $250 billion!

And quietly, practices will downsize their nicest employees or close all together. Many others will speed up their flight to be bought by big hospital systems - but these hospital systems will be more selective when deciding who they admit to their ranks. Inner city hospitals, struggling for survival, will look to the government for more subsidies to meet their demands for survival. Government will comply to protect themselves. Big hospitals and health systems with lots of doctor-employees will point to the decreased revenue by their doctors, tighten their belts a bit more by maintaining their months-long hiring freezes indefinitely, and fail to give those productivity bonuses to their workers as their construction contracts for their additions continue to get paid as they get ready for the "Big Wave."

In business, nothing changes quickly. Especially big, money-hungry, bureaucratic machines. But the paranoia will grow amongst the administrative and medical supplier ranks as senior leadership looks to cut back. You see, doctors are just the first.

And then there's the patients. If you're in a big town, you won't notice the difference. That's because in the operating rooms, there will still be one nurse where there had been two. In the ICU's, your nurse will visit you a bit less, but thanks to electronics, she'll still be watching or listening for you. You might notice it's harder to understand the foreign accent of your doctor, but he or she will be pleasant. At least until the next doctor arrives on the night shift.

But for the rural patients. Best of luck. Hope you've got frequent flier miles or low mileage on your car. You're going to need it. I have no doubt that you'll be able to get a telemedicine doctor to see you, provided you have more than a dial-up connection and a new computer with a videocam. What, you can't afford one? Better ask the government for a computer, then, okay? And while you're on the phone, ask them how possible acute appendicitis will be handled, will you?

Fortunately, if you're below 65, you'll see the effects a bit later. But if you're over 65, better tap into your savings a bit, so you can pay to have a doctor.

That's just the way it's going to be.

-Wes

Addendum: Some earlier takes here and here.

The Politics of Black Boxes

It's been several months since the black box warning on clopidogrel (Plavix) appeared and most cardiologists I know have not changed their practice as a result. I asked them to write about this on this blog, but because of the potential future legal ramifications of admitting as much, they politely declined.

For those unfamiliar, this black box warning, added to the drug's package insert by the FDA in March of this year, tells doctors who use this drug:

• Effectiveness of Plavix depends on activation to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19.


• Poor metabolizers treated with Plavix at recommended doses exhibit higher cardiovascular event rates following acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) than patients with normal CYP2C19 function.


• Tests are available to identify a patient's CYP2C19 genotype and can be used as an aid in determining therapeutic strategy (and to)


• Consider alternative treatment or treatment strategies in patients identified as CYP2C19 poor metabolizers.

When you ask interventionalists what they think about this genetic testing to assess who might be a "poor metabolizer" you get a blank stare and many reasons why no one does it, like:

• That black box was warning based on a single non-published crossover trial on 40 subjects:

  A crossover study in 40 healthy subjects, 10 each in the four CYP2C19 metabolizer groups, evaluated pharmacokinetic and antiplatelet responses using 300 mg followed by 75 mg per day and 600 mg followed by 150 mg per day, each for a total of 5 days. Decreased active metabolite exposure and diminished inhibition of platelet aggregation were observed in the poor metabolizers as compared to the other groups. When poor metabolizers received the 600 mg/150 mg regimen, active metabolite exposure and antiplatelet response were greater than with the 300 mg/75 mg regimen. An appropriate dose regimen for this patient population has not been established in clinical outcome trials.

• Presence of a gene does not mean it is expressed clinically.


• There are no data to demonstrate that outcomes have been effected by the use of genetic testing in a large cohort of patients, only a retrospective analysis of outcomes reported in the New England Journal of Medicine.

Forty prospective patients. Non-peer-reviewed data. Retrospective studies. And a black box warning, the FDA's most severe.

We know that there is a political push by President Obama and his NIH director, Francis Collins, MD, PhD (a geneticist) to use "personalized medicine" (read: genetic tests) as a way to come up with recommendations for medical care:

"As we learn more about individual's risk – from family history to DNA testing to understanding of environmental exposures – we ought to be able to come up with recommendations that are more personalized. I think people are ready for that. I think they're hungry for that. I think they are more likely to be responsive to that, but we have a long ways to go in terms of preparing people for that kind of individualized approach to medicine."

Ironically, Dr. Collins admitted:

Today, "you can get fancy DNA tests for hundreds of dollars," Collins told The Endocrine Society meeting - but your better bet for now may be a simple family tree of health, checking what ailments Mom, Dad and Grandpa had to predict your own future. "That's a free genetic test of great power."

So we should ask ourselves why a 40-patient crossover trial and retrospective analysis of outcomes qualifies as top-notch research on which to base a black box drug warning that also supplies no dosing recommendations to doctors if such a test is positive.

It wouldn't be the money generated by genetic testing for companies (see here and here) and hospitals who stand to make a pretty penny on them, would it?

-Wes

Addendum 18 Jun 2010: They just won't quit, and admit:

"The challenge is to deliver the benefits of this work to patients. As the leaders of the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), we have a shared vision of personalized medicine and the scientific and regulatory structure needed to support its growth. Together, we have been focusing on the best ways to develop new therapies and optimize prescribing by steering patients to the right drug at the right dose at the right time."

Look for more black boxes applied to more drugs with no understanding of the legal ramifications of their use. Is this the caliber of scientific rigor we are to expect from our government's reform agendas?

Addendum 29 Jun 2010 @ 14:38PM: TheHeart.org reports on the ACC and AHA's recommendations regarding the black box warning.

Tails You Win, Heads You Lose

Looks like they picked heads - 40-60 of 'em:

Gruesome and equally bizarre cargo is causing some serious controversy after a Southwest Airlines employee opens a package and finds a shipment of human heads.

A shipment of human heads bound for Fort Worth, Texas, remained in Little Rock, Ark., Thursday after a Southwest Airlines employee opened the package and called police.

The Fort Worth medical-research company where the heads were expected, Medtronic, said the 40 to 60 heads are for educational purposes.

It's not unusual for an airline to ship bodies, or body parts, for medical research.

The problem was the heads were not properly packaged or labeled.

Southwest Airlines said a courier showed up with the package and claimed to not know the contents.

The Southwest employee looked inside the package and found the heads.

The airline called police, and the department turned the package over to the county coroner, who has plenty of questions.

"In our discussion with the health department, we've come to the conclusion that there is a black market for body parts out there. We just want to make sure these specimens aren't part of that underground trade," Pulaski County Coroner Garland Camper said.

Looks like heads are going to roll!...

-Wes

Normal Echocardiogram Reading Error Rate 0.2% - By Technicians

In a "study" that is unlikely to ever be repeated again, we find that echocardiogram technicians are pretty good at screening normal echos, and have, according to credentialed cardiologists, a 0.2% reading error rate:

Harlem Hospital Center has completed an investigation of 7,000 heart tests going back five years, most of which had never been reviewed by doctors, a spokeswoman for the hospital said on Wednesday.

The investigation found that 14 patients might have been misdiagnosed because their tests had not been handled properly, said the spokeswoman, Ana Marengo. Twelve of the patients had been contacted, and none of them were found to have suffered adverse effects from the failure to properly read their tests, Ms. Marengo said."

Recall that the echocardiogram technicians were only sending abnormal tests for cardiologists to review, and only presumed normal tests were never read (or signed) by a certified cardiologist.

I wonder what the "normal" echocardiogram reading error rate is for board-certified cardiologists?

-Wes