Cardiology in 2013: Like A Wrecking Ball

The New Guidelines

Probably I’m being overdramatic but I consider  the best metaphor for the year in cardiology is Miley Cyrus on the wrecking ball ball.

The Tips Wrecking Ball:Like Hannah Montana tips are supposed to be uninteresting and reputable.  But in 2013 the guidelines had been far more like Miley Cyrus. Like a wrecking ball, the NIH abandoned its lengthy-entrenched and hugely influential position in creating cholesterol and hypertension suggestions. Then the new ACC/AHA guidelines came along, abandoning tradition and targets and adopting a whole new approach. But the controversy did not go away. One particular simple prediction for 2014: we’ll see far more debate about guidelines.

The Outdated Guidelines

And then the wrecking ball metaphor might be all as well apt. Negative suggestions may possibly be deadly. Even though the subject of managing cardiovascular risk ahead of and in the course of non-cardiac surgical treatment appears boring and uncontroversial, it’s entirely possible that the European guideline on this subject, because it is primarily based on tainted analysis, could have induced far more than 10,000 deaths a 12 months in the United Kingdom alone.

The Scientific Misconduct Wrecking Ball: Is there anything far more destructive than significant scientific and health care misconduct? Sadly, 2013 was a banner year for negative conduct:

Japan: Following first allegations of misconduct in 2012, in 2013 it appeared like the total Japanese analysis system with the Novartis Novartis blockbuster hypertension drug Diovan was discredited. The European Heart Journal retracted the main outcomes of the Kyoto Heart Review, the Lancet retracted the Jikei Heart Study, Novartis acknowledged that its workers participated in ostensibly “independent” clinical trials without having disclosing their role in the company, and the Japanese government undertook a broader investigation.

Italy: A lot more than a year ago 9 Italian Cardiologists were arrested as part of a broad investigation into analysis fraud and misconduct. Due to the inefficiencies of the Italian legal method the complete extent of the investigation is even now unknown, but astute readers of this weblog recognized a wide selection of mistakes and discrepancies in published investigation by the group in Modena, like papers published in Heart, the American Journal of Cardiology, and Circulation:Cardiovascular Interventions.

Stem Cells Under Assault: To date stem cell investigation has produced far much more hype than concrete results. Last summer, a single sharp critic, Uk maverick cardiologist/professor Darrell Francis, pointed out severe flaws in analysis from two prominent stem cell investigation groups:

As I wrote at the time about the Strauer case, “the revelation of such widespread misconduct may possibly lead to broader disturbing queries about the dependability of scientific publications and the ability of the clinical study program to police itself.” However, it does not appear that the cardiology research establishment has any curiosity in vigorously following up on any of the above situations of misconduct.

And then there was plenty of plain outdated fraud and greed.  A New York area cardiologist acquired a 6 and one/2 yr sentence after admitting to $ 19 million in fraud. A 79-12 months-old Florida cardiologist was  sentenced to 7 years in prison for his participation in Fen-Phen fraud. And a Louisiana interventional cardiologist is now serving a 10-year sentence for Medicare fraud.

Viewing the Watchman: The Watchman device, Boston Scientific’s left atrial appendage closure gadget for the prevention of stroke in atrial fibrillation patients, was the source of considerably drama in 2013. Earlier this year a scandal broke out when the American School of Cardiology cancelled a prestigious late-breaking clinical trial presentation of the PREVAIL trial after the firm broke an embargo by offering trial outcomes to investors. Then, in December, the FDA’s Circulatory Program Products Panel advised the gadget get US approval, however the committee expressed many reservations and considerations, suggesting that the expected approval of the gadget in 2014 may come with a restrictive label.

It was a great 12 months for the Mediterranean Diet plan. The PREDIMED study provided the very best supporting proof however, even though it appears unlikely if any person will ever be in a position to type out the specific function of the individual components of the Mediterranean diet, which contain wine, olive oil, nuts, fish, and, of program, significantly less tangible issues like sunshine and life-style. The nuts component received a separate improve from the publication of an influential paper in the New England Journal of Medication.

Avandia Redux: In a outstanding if anticlimactic conclusion to a long-running drama, in November the FDA lifted major restrictions on rosiglitazone (Avandia, GlaxoSmithKline). The drug had been the subject of  intense criticism and controversy because the 2007 publication of the well-known Nissen meta-analsysis. Earlier in the yr, in June, right after a two day meeting, FDA advisors recommended that the extreme restrictions (REMS) positioned on Avandia be modified. The vote constitutes a modest revival in fortune for the embattled drug and its maker soon after a lot of years of controversy and undesirable news. But it appears unlikely that the action will outcome in a important revival in income of the former blockbuster.

There’s absolutely nothing genuinely new underneath the sun. A review this yr located that mummies were as likely as men and women today to get atherosclerosis. And, somehow reminiscent of the return of the mummy, the major final results of the PRAISE trial have been published in 2013 only 13 many years soon after their initial presentation.

A Excellent TASTE of the Long term: One of the few bright factors of the 12 months was the TASTE trial, presented at the ESC and published in NEJM.  The Scandananavian research will likely influence the remedy of heart attacks, largely ending the routine use of thrombus aspiration. But as I wrote at the time, the sweetest component of TASTE is that it utilized an fully new model for executing a clinical trial. TASTE was a registry-based mostly randomized clinical trial, which the paper’s editorialists said represents “a new paradigm… that can probably release us from the circular (and costly) trap of the randomized-versus-registry debate.” They continued: ”The TASTE investigators designed a big-scale trial to solution an crucial clinical query and carried it out at remarkably lower cost by building on the platform of an currently-current large-good quality observational registry. With this clever design, which leveraged clinical data that was previously currently being gathered for the registry and for other preexisting databases, the investigators were ready to rapidly determine potential participants, to enroll thousands of patients in little time…, to stay away from filling out prolonged situation-report forms, to obtain accurate comply with-up with minimal work, and to report their findings, all for significantly less than the volume of a normal modular R01 grant…”

Burton Sobel, 1 of the foremost cardiologists of his generation, died in May at the age of 75. Sobel played a important early part in the advancement of fibrinolysis and the first major biotechnology item, TPA. From his perch as the chief of cardiology at Washington University in Saint Louis and as the editor of Circulation, Sobel assisted set the agenda for cardiology.

TheHeart.Org lost its separate identity and grew to become absorbed into the Borg (a.k.a Medscape/WebMD). There’s nevertheless plenty of very good articles and information coverage, but now you have to wade through ever-growing amounts of promotional materials and, perhaps even worse, ostensibly non-commercial CME articles. (A recent review in JAMA pointed out that Medscape/WebMD is the greatest single recipient of sector funding amid health care communication businesses.)

Stents, Stents, Stents: When once again, stents provoked all sort of discussions. George W. Bush received a stent, and I wondered, along with a lot of other folks, whether or not this was a great determination, but the reality is that in the absence of much more information it was extremely hard to know. Some feel the ensuing debate was unseemly. I feel it served a great purpose, at the really least raising the concern and giving a basis for even more discussion.

Cardiology in 2013: Like A Wrecking Ball