Feeds:
Posts
Comments

Posts Tagged ‘heartwire’

This story on Heartwire.com will surprise none of my American readers:

Researchers found that ‘Statin’ drugs – the life-saving cholesterol drugs that are prescribed to ALL Americans after a heart attack, stroke, stent placement of bypass surgery cost FOUR times more for Americans than British residents..  (These drugs are also used for several other conditions such as high cholesterol, peripheral vascular disease, carotid stenosis..)

Feeling ripped off much?  This gouging of the American consumer needs to stop.  These business practices when combined with medication shortages are hurting our patients – and hurting our (doctors, nurse practitioners) ability to treat disease.

Currently – I prescribe $4 generics for most of my patients – but this still hinders my ability to treat patients at the highest level of the care – should I prescribe the recommended version (which much of the latest research is based on) BUT my patient can’t afford?  Or do I settle for a drug that may be (who knows?*) second best – so my patient can actually afford to take it…

What about other classes of drugs.. ARBS are a perfect example – as there are no ARBS on the national chain pharmacies $4 lists.. But sometimes patients need them.. Ultimately,  I think it actually hurts drug companies.. Since ACEs are recommended equally for the treatment of heart failure, and cardiac care after myocardial infarction (heart attack) or heart surgery but have several versions AND doses listed in the low price formularies** – I probably prescribe this class of drugs FIFTY times more often.  I’m now way, way more familiar with these drugs as a result (in comparison to ARBS – since I use them so frequently, and follow the research on them.)

It’s part of a conversation I have with all my patients before they leave the hospital – as we discuss the risks, benefits and alternatives to the Rx available.  I try to allow patients to weigh in on the discussion – but for many people there is no real option..  It’s either four of five RX that will cost $400. a month or those same type of medications for 12.00 to 16.00 a month.. For the majority of people, particularly those without prescription drug benefits – it’s not really a choice at all..

What’s the answer???  It’s not prescription drug coverage for all – that just means the pharmaceutical companies gouge the government (which still costs all of us money..)  The answer needs to be a change in the way the companies do business in this country.  With over 300 million people in the USA (and most people on at least one prescription medication) – volume sales alone ensure profits for all players.

** Research results vary as to whether certain more costly statins offer benefits over other versions for the majority of patients.  In fact, one of the older statins, pravastatin sodium is actually preferred in patients on amiodarone (black box warning) and in patients that tolerate other statins poorly.

* ACE drugs also have additional ‘side benefits’ for many of my patients that make them preferable for treating the majority of my patients.  But that is not always the case..

Original Heartwire.com Article re-posted below:

Statins cost four times more in US than UK

January 11, 2012

Shelley Wood

Boston, MA (updated) – The cost of statins in the US is radically higher than the costs paid for the same brands in the UK, and many more insured Americans are prescribed statins, raising the overall costs in that country [1]. According to Dr Hershel Jick (Boston University School of Medicine, MA) and colleagues, who used 2005 numbers for their analysis, statin costs were as much as 400% higher in the US than in the UK. They report their findings in the January 2012 issue of Pharmacotherapy.

Speaking with heartwire, Jick pointed to an earlier study he did looking at prescribing patterns in the US and the UK, showing that drugs were prescribed in far greater numbers in the US [2]. This new paper provides a missing piece that wasn’t available previously, Jick said, adding that the sheer difference in costs should shock others as much as it did him.

“I don’t like to talk too much about my science, and I have to remain impartial,” he said. “But this really blew me away.”

Jick et al looked at US citizens aged 55 to 65 who were covered by private insurance plans who’d been prescribed at least one drug in 2005. UK subjects, whose data are housed in the public UK General Practice Research Database and whose drug costs were covered under the public plan, were matched by age and sex with 280 000 insured American patients.

Of these, write Jick et al, 33% of Americans were prescribed a statin as compared with 24% of the matched British subjects. The analysis included only patients who received continuous statin therapy over the course of the year.

Researchers then explored the type of statins being prescribed in both countries and the cost of those drugs, yielding some surprises. While the lowest-priced statin in the US at the time, generic lovastatin, cost $313 per year, the lowest-priced statin in the UK, generic simvastatin, cost just $164. At the high end, nongeneric simvastatin in the US cost $1428 per patient per year, while the top-priced statin in Britain was nongeneric atorvastatin, which cost $509 per patient per year.

Indeed, different statins were generic in the two countries in 2005: in the US, lovastatin was the only generic statin on the market, whereas in the UK in 2005 both simvastatin and pravastatin were generic and lovastatin was not sold. For brand-name drugs available in both countries, however, American costs were double the British costs for both atorvastatin ($997 vs $509) and rosuvastatin ($903 vs $467), while the cost of fluvastatin was nearly three times higher in the US than in the UK ($763 vs $258).

“I’ve done a lot of research of this variety, and I knew the cost would be higher in the US,” Jick said. “But frankly, I was pretty stunned by the difference.”

Given the greater proportion of patients taking statins and the higher costs, researchers estimate the total cost of statin use in the US in 2005 at $64.9 million compared with just $15.7 million in the UK. Jick et al’s sample included just 1% of the US population in this age group who were taking a statin over the course of the year, so this represents just a fraction of the US spending on statins.

Finally, in an addendum to their paper, Jick et al note that generic simvastatin was approved in the US market in mid-2006, prompting them to do some recalculations. They noted that in the six months postapproval, more than 60% of US users switched from brand-name simvastatin to a generic formulation, leading to a 60% drop in US costs. Even still, the US price for generic simvastatin remained nearly four times higher than the cost of the generic formulation available in the UK.

Jick notes that private insurers cover roughly 200 million US citizens, but that the military, veterans, government employees, the elderly, and other groups have their drugs covered by the government, and there is no publicly available information as to just what the price is that the government pays companies for the same products. Estimates of drug costs in these groups “could provide a useful basis for further insight into the nature of the remarkable difference—at least for statins—in prescription drugs costs between the US and UK,” the authors write.

Additional References (full text unless noted)

Therapeutic Interchange & Economic Benefits of generic drugsBritish paper discussing different implications of drug substitution from both economic and patient derived health benefits.

American study on cost-savings with statin substitution

Pravastatin has superior results in triple therapy compared to atorvastatin in diabetic patients.  (in press)

Crestor associated with negative metabolic side effects compared to pravastatin (note dose discrepancy in this study.  Generally Crestor 5mg = Pravastatin 40mg)

Advertisements

Read Full Post »

As many readers know, I advise caution to patients prior to pursuing TAVI (or transcatheter aortic valve implantation, primarily because there is no long-term data on durability or long-term effects.

One of these days, I may have to eat my words – and when that day comes; I will be happy to do so (and will do it with a 14-point font).  But that day is not today.

As reported by Reed Miller over at Heartwire, there are the first results of a very small Canadian study with average follow-up 3.7 years after implantation..  Unfortunately, its way too small of a sample – and mean follow-up falls short of the five-year mark.

But given the rate of implantation in Europe (Germany, in particular) and the fact that these valves are used in younger patients over there – we should have some large (thousands of patients enrolled) studies with five-year data in just a year or two.. One of two well designed studies with a large study population would sure make a lot of us over here (in the USA) feel a lot more comfortable about the safety and efficacy of these devices in our patients.

Now, I bet most of you have gotten pretty good at picking through these Heartwire articles to get to the bit of truth inside – and the experts quoted here do a much better job at providing straight forward answers (unlike the cast of characters quoted for many of the articles regarding the stent scandals.)

(I’ll re-post below so you can see for yourself.)  I’ve also included links to our little collection of TAVI articles here – or the ‘TAVI library” for first-time readers to catch up.

1.  Aortic Stenosis – more patients need surgery  – for some background on the issue (more articles on Aortic stenosis under cardiology)

2.  TAVI  – ‘a new stent scenario’ – discussing concerns with the widespread adoption of this therapy

3.  TAVI recommendations and guidelines –  the most recent established US guidelines for therapy

4.  TAVI – an overview – getting back to the basics

5.  TAVI – mortality data – this had some pretty frightening results, another reason for caution.

6. TAVI and FDA approval: what does it mean? – talking about the implications of FDA approval, and the history of FDA approval of medical devices.

CoreValve TAVI maintains durability out to four years in small study

(Reed Miller)

[Bold type from original article]

Paris, France – The longest follow-up of patients implanted with the CoreValve (Medtronic) transcatheter aortic-valve implantation (TAVI) device presented so far suggests that it is reliable and durable in high-risk patients, according to the study investigators [1].

“In due time, I’m sure we will see a gradual decrease in the average patient age, treating patients with less comorbidity than was done in the beginning, strengthened by these types of results showing the durability of the implants,” study lead-investigator Dr Peter den Heijer (Amphia Hospital, Breda, the Netherlands) told heartwire.

Here at the European Society of Cardiology 2011 Congress, den Heijer presented long-term follow-up results from 52 patients implanted with the second-generation version of CoreValve in 2005 and 2006 in Europe and Canada. All of the patients in the study were at least 80 years old with a logistic EuroSCORE over 20 or over 65 years old with at least one high-risk comorbidity. All of the patients had severe aortic stenosis and an aortic-valve annulus diameter between 20 mm and 24 mm. Two-thirds of the patients had NYHA class 3 heart failure and almost 20% had class 4 heart failure.

Four-year follow-up data was collected on 20 patients, but 26 patients died, including 13 cardiac deaths. Overall survival was 58.5% at two years and 45.1% at four years. At four years, the surviving patients showed significant improvement in heart-failure symptoms, with 61% in class 1 heart failure and 22% in class 2. Nearly a third of patients showed grade 2 or 3 aortic regurgitation at baseline, but after four years 57% showed no regurgitation and 43% showed grade 1 regurgitation. The mean valve gradient decreased from 41 mm Hg at baseline to 12 mm Hg at 30 days and 10 mm Hg at four years.

There were no strokes reported in the study population between three months and four years and no frame fractures, valve migrations, valve endocarditis, or structural valve deteriorations leading to stenosis or regurgitation. “That’s important, because the goal of this treatment is to provide patients with severe aortic stenosis, a severely life-limiting disease, with a better prognosis, and it appears to be not at all hampered by the structure of the valve,” den Heijer told heartwire.

In a 70-patient study by Dr Ronen Gurvitch (University of British Columbia, Vancouver) colleagues, the Sapien (Edwards Lifesciences) transcatheter aortic valve showed no structural valvular deterioration, stent fracture, deformation, or valve migration over a mean follow-up of 3.7 years [2].

CoreValve is available in Europe and is being tested in a major US clinical trial that Medtronic says will be completed in 2012. The FDA is expected to approve Edward’s Sapien TAVI device soon, following a positive appraisal by its advisory committee.

Still much too early to assess long-term TAVI results

Surgeon Dr Craig Miller (Stanford University, CA), one of the investigators of the pivotal PARTNER trial of Sapien, told heartwire that while the four-year results with CoreValve are “decent,” the clinical community will “need much larger numbers of patients followed at two, three, and four years for the hemodynamics to mean much.”

PARTNER investigator Dr Michael Mack (Medical City Dallas Hospital, TX) told heartwire, “Although it’s reassuring that there are now results out to four years and there’s no sign of structural valve deterioration, it really adds minimal information to what we know already.

“There’s only 20 patients alive at four years, so how do you know what happened to the other 30 patients [in the trial]? Some died of cardiac death and some died of unknown causes. How do you know they didn’t die of structural valve deterioration?” he said. “A better way of doing this study for all aspects is that all the information should be on matched patients.”

Mack said that the real long-term durability of transcatheter valves will become more clear with more data from the SOURCE registry and the long-term follow-up of PARTNER trial, which will include annual core-lab-adjudicated echocardiography follow-up out to five years.

In an email to heartwire, Dr Grayson Wheatley (Arizona Heart Institute, Phoenix) pointed out that although the study had a high percentage of cardiac-related deaths, the arrhythmia-related deaths were a smaller proportion than in some other recent studies. But Mack and Wheatley also pointed out that because there was no echocardiographic core lab in this study, the functional assessments of the valve may not have been always accurate.

Wheatley also pointed out that this study used an older version of the CoreValve, so “this study doesn’t relate too well to real-world use of the CoreValve due to new design changes in the valve system, but it does show that, in general, TAVI procedures can be used in high-risk cardiac patients and that there will be long-term survivors.”

 

TAVI overseas –

As mentioned above, TAVI has rapidly been implemented in Europe.  Latin American medicine has begun to embrace this emerging technology as well.  In fact, US physicians are travelling outside the country to perform this procedure on their patients (since it’s not FDA approved.)

From a statement by the University of Miami Medical School – International Medicine Institute: [verbatim]

“New Technology Treats Aortic Heart Valve Disease Without Surgery

 At 86, Dr. Isaac Hariton is back to walking three miles a day since getting a new aortic valve this past June. To avoid surgery, this retired surgeon traveled to Cali, Columbia, for his procedure.  Hariton’s doctor is Eduardo de Marchena from UHealth – University of Miami Health System, who traveled with him to implant a valve not FDA approved for use in this country.”

Read Full Post »

Below is a re-post from Heartwire.com on the use of multi-vessel PCI (stenting) for patients presenting with an acute myocardial infarction (heart attack).  As you can see for the headlines – two research studies suggest “Don’t do it.”  The studies suggest that only the culprit (or vessel causing chest pain/ heart attack) should be treated during the event.  Of course, these studies ignore the other, BIGGER question of whether we should be doing multi-vessel PCI (staged or not) AT ALL.  There is quite a bit of research (presented in other posts) to suggest that the strategy should be stenting the culprit vessel (to treat the immediate ischemia) followed by surgery, not more stents.  But since interventional cardiologists were conducting the study, not surgeons – this isn’t addressed at all.

Of course, I am speaking from my own position as someone who has worked in both cardiology and cardiothoracic surgery – which carries it’s own bias.  But, I do know the long-term data, which clearly favors surgery for multi-vessel disease.

Multivessel PCI during STEMI associated with higher short- and long-

term mortality

August 5, 2011            |            Michael O’Riordan

Groningen, the Netherlands and Tel Aviv, Israel – Two new studies published this week confirm clinical recommendations that a deferred angioplasty strategy of nonculprit lesions should remain the standard interventional approach in patients with ST-segment elevation MI (STEMI) undergoing primary PCI [1,2].

In the first study, an analysis of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS AMI) study, investigators, led by Dr Ron Kornowski (Tel Aviv University, Israel), observed significantly higher one-year mortality and stent-thrombosis rates among patients undergoing multivessel PCI compared with individuals undergoing staged PCI.

In the second study, a meta-analysis that included 18 studies and more than 40 000 patients, the investigators report that multivessel PCI was associated with the highest rates of death in short- and long-term follow-up when compared with culprit-lesion PCI and staged PCI.

Dr Pieter Vlaar (University Medical Center, Groningen, the Netherlands), the lead researcher of the meta-analysis, told heartwire that the results support current guidelines discouraging multivessel primary PCI for STEMI patients. That said, the guidelines are not based on large randomized controlled clinical trials, and this had led to some confusion and variability across different centers. Even at their institution, Vlaar said clinicians differ in their opinions about whether nonculprit lesions should be treated during the initial intervention. However, these new data suggest that when significant nonculprit lesions are suitable for PCI, “they should be treated only during staged interventions.”

Both studies, as well as an accompanying editorial [3], are published in the August 9, 2011 issue of the Journal of the American College of Cardiology.

HORIZONS-AMI and the meta-analysisIn the meta-analysis, Vlaar and colleagues included data from four prospective and 14 retrospective studies involving 40 280 patients with multivessel disease undergoing primary PCI for STEMI. Three treatment strategies were compared:

  • PCI of the culprit vessel only.
  • Multivessel PCI, defined as PCI of the culprit vessel as well as one or more nonculprit vessel lesions.
  • Staged PCI, defined as PCI confined to the culprit vessel only, with one or more nonculprit lesions treated in staged interventions.

Compared with the staged-PCI strategy, PCI of the culprit lesion only and multivessel PCI were associated with a significant three- and fivefold increased risk of in-hospital/30-day mortality, respectively. In addition, 30-day mortality was significantly lower in patients treated with culprit PCI compared with multivessel PCI (odds ratio 0.66; 95% CI 0.48-0.89). Regarding long-term mortality, multivessel PCI was associated with a 60% increased risk of long-term mortality compared with culprit PCI, as well as a significantly greater risk compared with staged PCI.

In the HORIZONS-AMI study, the investigators compared primary PCI of the culprit and nonculprit lesions with patients who underwent PCI of the culprit lesions only and those who underwent staged PCI of the nonculprit lesion at a later date. Of the 3602 patients enrolled in the trial, 668 underwent PCI of the culprit and nonculprit lesions for multivessel disease, of whom 275 underwent a single PCI strategy and 393 underwent staged PCI.

At one year, patients who underwent single PCI had a mortality rate of 9.2% compared with 2.3% in patients who underwent staged PCI. In addition, single PCI was associated with significantly higher rates of cardiac mortality compared with staged PCI (6.2% vs 2.0%, respectively) and higher rates of definite/probable stent thrombosis (5.7% vs 2.3%, respectively).

In their paper, Kornowski and colleagues, including senior investigator Dr Gregg Stone (Columbia University, New York), state that a “deferred angioplasty strategy of nonculprit lesions should remain the standard approach in patients with STEMI undergoing primary PCI, as multivessel PCI may be associated with a greater hazard of mortality and stent thrombosis.”

Some unanswered questionsCommenting on the findings for heartwire, Dr David Kandzari (Piedmont Heart Institute, Atlanta, GA) said, “Both papers provide welcome information to clinicians,” especially since there are few randomized trials to provide sufficient information to guide treatment decisions. Most of the clinical recommendations are based on some clinical evidence, including cohort and retrospective studies, but they are largely the opinion of interventional experts.

In the US, the American College of Cardiology/American Heart Association guidelines state definitively that PCI “should not be performed in a noninfarct artery at the time of primary PCI in patients without hemodynamic compromise.” The class-III (harm)/level-of-evidence B recommendation differs slightly from the European Society of Cardiology/European Association for Cardiothoracic Surgery guidelines, which are slightly more lenient. The European guidelines state that with the exception of cardiogenic shock, PCI for STEMI should be limited to the culprit lesion (class IIa, level of evidence B).

To heartwire, Kandzari explained that treating other lesions in patients with cardiogenic shock remains a “bit of a gray area” in the US. Although the guidelines explicitly state not to perform PCI of the nonculprit lesions, some clinicians will treat other stenoses in cardiogenic-shock patients in an attempt to provide as much flow as possible. That said, there is a discrepancy between the number of clinicians performing multivessel PCI and rates of cardiogenic shock. Dr John Bittl (Ocala Heart Institute, FL), who wrote an editorial accompanying the published studies, observed a similar discrepancy. For example, in HORIZONS-AMI, 18.5% of patients underwent multivessel PCI, but only 1.5% had cardiogenic shock. In the New York State registry, 12.5% of patients were treated with multivessel PCI, but only 4.4% met the definition of hemodynamic compromise.

Kandzari said he would like to know the reasons that the clinicians performed multivessel PCI in these STEMI patients, noting that in some instances it is difficult to determine what the culprit lesion is in acute MI. Some centers might not perform left and right coronary angiography before revascularizing the patient, and without assessment of the entire coronary anatomy, it is possible, although rare, to treat the wrong lesion. Some patients might not show any improvement following culprit PCI and as a result will undergo treatment of other lesions, he said.

In his editorial, Bittl made similar statements, noting that “no single approach is applicable to the myriad presentations of STEMI.” He also noted that multivessel PCI might be necessary in the cases where patients do not show improvement following primary PCI of the culprit lesion. He added that patients with severe multivessel disease might require follow-up angiography and that fractional flow reserve (FFR) can be considered during the acute phase, but the “results should be used whenever possible to support a decision for staged PCI.”

To heartwire, Vlaar said the benefit of staging patients is that angiograms can be discussed with a joint heart team and additional noninvasive ischemia tests and FFR can be performed before deciding to perform additional revascularizations.

Kandzari told heartwire that there still remain some questions regarding staged PCI in STEMI patients. For example, Kandzari said the optimal time for the second PCI is unknown. In the US, revascularization is driven by reimbursement issues, with physicians not compensated for staged PCI performed within 30 days of PCI for acute MI, so most clinicians are reluctant to treat other vessels even when the patient is in the hospital.

“Financial issues aside, we still don’t know if it’s better to treat the nonculprit lesions when the patient is still in the hospital, two weeks after the primary PCI, or four weeks after primary PCI,” said Kandzari.

Read Full Post »

Here’s another re-post from Heartwire :

Midei and unnecessary stents—or lack thereof—make news again

April 25, 2011            |            Shelley Wood

Baltimore, MD and Greensburg, PA – “Unnecessary stents” and the people who place them have been back in the news this past week with a confusing twist of the tale in Pennsylvania, previously reported by heartwire, where two cardiologists stepped down on charges of unnecessary stenting [1], and a published Commentary, by Dr Mark Midei, in the Baltimore Sun [2].

The latest development in the Greenburg, PA case, reported Saturday in the Pittsburgh Tribune-Review, involves an admission by the hospital’s chief medical officer that at least six of 141 Westmoreland Hospital patients sent letters telling them they may have received “unnecessary stents” in fact never got stents in the first place. Instead, the hospital now says, these six patients underwent angioplasty procedures that appeared, on review, to not have been medically warranted, although no stents were placed.

The two cardiologists who treated the 141 patients—Drs Ehab Morcos and George Bousamra—voluntarily resigned after hospital administrators first questioned the medical necessity of the procedures. Those questions stemmed from the conclusions of eight independent cardiologists, as part of a review by the American Medical Foundation in Philadelphia. The hospital alerted patients to the situation via a letter, and 19 patients have since launched lawsuits against the two cardiologists and the parent health organization for the hospital, Excela Health.

The hospital has now sent new letters “of clarification,” the Tribune-Review reports, a move that has been slammed by lawyers handling the lawsuits and by outside observers.

“It is confusing,” Dr Gregory J Dehmer (Texas A&M University College of Medicine, Temple) is quoted in the article. “The bottom line is that it was an unnecessary procedure, whether they got a stent or not.”

Midei’s day in the Sun

Meanwhile, Dr Mark Midei, whose predicament in Baltimore is viewed by many as the catalyst for the stepped-up scrutiny of interventionalists around the US, once again lays out his side of the story—this time in the Baltimore Sun, the newspaper that has meticulously covered this saga. In the article, published Friday, Midei notes that he will soon be appearing before the Maryland Board of Physicians to “make the case for retaining my license to practice medicine” but in the meantime wants his voice heard.

Midei repeats an allegation he made when he first spoke out on the case, in an interview with heartwire, saying that St Joseph used him as a “decoy” when the hospital was embroiled in a federal investigation.  He has also, he says, been falsely portrayed as “manipulating” the peer-review process at the hospital, when in fact “any doctor, nurse, technologist, or physician assistant could suggest additional cases for review.” As well, he notes, he was not paid by the hospital based on the number of cases he performed, as press reports have suggested.

As for his relationship with stent manufacturers, he says he never accepted gifts or offers from companies, and any personal honoraria were donated to outside charities or foundations. He does not specifically address the now famous “appreciation pig roast” paid for by Abbott held for St Joseph’s cardiac staff in Midei’s backyard.

But he does, with some humility, acknowledge that may not “have been perfect in my practice of medicine; no doctor can make that claim.”

And he concludes: “I can say unequivocally that my decisions as a doctor have been motivated by one thing only: The well-being of my patients.”

As reported by heartwire, two cardiology organizations recently asked the state of Maryland to legislate cath lab oversight in an effort to avoid the tangles unraveling in Baltimore and Pittsburgh; that plan has since been nixed.

Update: 22 July 2011 – Dr. Midei’s medical license has been revoked. (article re-post – Heartwire.com in another report by Shelley Wood).

Dr Mark Midei’s medical license revoked

July 13, 2011            |            Shelley Wood

Baltimore, MD (updated) – The Maryland Medical Board has concluded its review of Dr Mark Midei, deciding to revoke his license, calling his violations of the Medical Practice Act “repeated and serious.”

The disciplinary actions alert published on the board’s website today notes that the board will not accept any application for reinstatement by Midei for at least two years. At that time, it is up to the board whether it will consider reinstatement of his license.

As previously reported by heartwire, Midei is alleged to have implanted hundreds of unneeded stents when he worked at St Joseph Medical Center in Towson, MD. The imbroglio was ultimately taken up by the US Senate Finance Committee, which issued a damning report back in December 2010.

For years, however, watchers have been waiting to hear what the Maryland Board of Physicians concluded, having charged Midei with violating the Medical Practice Act back in July 2010, focusing specifically on five patients it was alleged may have received stents unnecessarily. A subsequent seven-day hearing before an administrative law judge (ALJ) led to her issuing a 77-page “proposed decision” that Midei have his license revoked for having violated five provisions of the act, specifically those prohibiting:

  • Unprofessional conduct in the practice of medicine.
  • Willfully making a false report or record in the practice of medicine.
  • Gross overutilization of health care services.
  • Violations of the standard of quality care.
  • Failure to keep adequate records.

In its “findings of fact,” the board concluded that Midei implanted six cardiac stents unnecessarily in four out of the five cases reviewed and noted in his charts that the extent of the stenosis was 80%, when in fact it was lower “and in most cases much lower.” In three cases he falsely reported that patients had unstable angina, when in fact they didn’t, and in all five patients he failed to obtain the active coagulation time and instead administered heparin while inserting the catheter. In one of the patients, Midei “also failed to look at or disregarded the hospital’s note that the patient had already been given an anticoagulant and should not be given another.”

In June, Midei filed exceptions with the board in an oral hearing, which was considered in advance of today’s announcement. Those included a request by Midei that the board reverse the judge’s opinion on which expert reviewer to believe. The ALJ had used Dr Matthews Chacko (Johns Hopkins Hospital, Baltimore, MD) as expert reviewer, whereas Midei’s primary expert witness was Dr William O’Neill (University of Miami, FL). The board’s “consideration of exceptions” notes that all of the experts were “qualified” but that the ALJ “made her determination based on the consistency of Dr Chacko’s testimony and his clear presentation and demeanor” as well as her consideration of professional publications. By contrast, the ALJ “noted some inconsistencies or equivocations in the testimony” of O’Neill. Also at issue was the fact that Chacko was paid $1400 for his report and expert testimony—something Midei raised as problematic. The board report notes that O’Neill, Midei’s expert, was “paid more than 20 times that much.”

Asked to comment, O’Neill emailed heartwire to say: “I think it’s a tragedy that a fine doctor’s reputation and livelihood are ruined when there was never a single shred of proof that he harmed any patient. I stand by my [previous] comment that after reviewing all the records and films personally, I would have no problem letting Dr Midei treat me or a family member. I pity any interventional cardiologist practicing in Maryland today; if Dr Midei can lose his license, any of them could.”

The board agreed with the ALJ’s conclusions and, “using its own expertise,” agreed that Chacko’s testimony “represents an accurate statement of the standard of quality care.” The board clearly took exception to Midei’s suggestion that he sometimes wrote “80%” as a form of shorthand for blockages that in fact were less than 50%, calling that “a justification for a blatant falsehood that resulted in patients receiving unneeded stents as well as the creation of false records.”

The board also questioned the believability of Midei’s testimony that his decision to stent certain patients was on the basis of “remembered” symptoms not recorded in patients’ medical records. “The ALJ found it not credible that Dr Midei could remember these unrecorded symptoms in the cases of patients who were among thousands that he saw only once, for very brief period of time (from 20 to 37 minutes) three years previously.”

As reported by heartwire, Midei, who is being sued by hundreds of former patients believing they received unnecessary devices, is himself suing his former hospital, St Joseph, alleging in part that he was a scapegoat in “an epic campaign of corporate deception, trickery, and fraud” relating to past business deals and a federal investigation. In his medical-board hearing, Midei was permitted to present evidence to support this claim; the board, ultimately, agreed with the ALJ that “nothing St Joseph Medical Center did or failed to do is relevant to the issues of this case.”

The final decision and order, signed by board chair Dr Paul T Elder, contains a number of scalding conclusions about Midei’s conduct, stating that he failed to deal honestly with patients and colleagues and that his reports intentionally and nonaccidentally “exaggerated” patient symptoms and degree of stenosis.

“Dr Midei’s violations were repeated and serious. They unnecessarily exposed his patients to the risk of harm,” the decisions states. “They increased the cost of the patients’ medical care. Dr Midei’s willful creation of false percentage numbers for the degree of occlusion of coronary arteries is indefensible and amounts to a deliberate and willful fabrication of medical records.”

Requests for a reaction from Midei’s lawyers have not been returned. Midei has 30 days to ask for a judicial review of the decision.

Read Full Post »