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Category: Late Breaking Data

Medical and surgical offices need to adopt Apple Pay ASAP

October 21, 2014- By Steven E. Greer

Another huge credit card data security hack was in the news today. Read more »

Second-gen Sapien TAVI valve does not reduce stroke problem

March 10, 2013 By Steven E. Greer, MD  The Healthcare Channel1-s2.0-S1875213612000459-gr7

The main reason that Medicare has limited coverage for the Edwards Lifesciences (EW) Sapien percutaneous aortic valve is the high perioperative complication rate of ischemic strokes, in excess of 9%, as well as femoral artery complications. The newer second generation Sapien XT, with a smaller diameter “French” profile, was hoped to reduce the complications and make the TAVR procedure safer. The newest data on the second-gen Sapien do not seem to support the claims from Marty Leon, financial backer of the valve, that the new valve is safer.

LeonThe PARTNER II study was presented at the ACC meeting in San Francisco. Read more »

100 HIV researchers killed as Russian missile takes down jetliner MH17

19jet4-superJumboJuly 19, 2014- By Steven E. Greer, MD

I emailed earlier today a leading HIV researcher, Monica Gandhi MD, MPH from Read more »

TAVI: Comparing CoreValve to Sapien

Interviewed by Steven E. Greer, MD

William O’Neill, MD of Henry Ford discusses the recent pivotal data for the Medtronic CoreValve device, soon to be approved, and how this new device will compete in the clinical arena with the Edwards Lifesciences Sapien valve.

Matthews Chacko, MD: Renal denervation to treat HTN

December 29, 2010

Many medical devices cause a far greater clinical impact than pharmaceutical therapies such as statins and chemotherapies. For example, ICDs have a dramatic life-saving capability, but for only a small portion of the patients receiving an ICD. Likewise, coronary stents improvement survival in patients with acute MI, but merely alleviate angina in most other patients.

A new device, unknown to most doctors, currently being investigated in Australia, Europe, and South America, could confer the most dramatic clinical benefit to the largest group of patients in the history of medical devices. That device is the Ardian renal artery/nerve ablation catheter to treat essential hypertension, recently acquired by Medtronic.

Medications to treat high blood pressure deliver tens of billions in revenue to the pharmaceutical companies, yet the magnitude of effect is just a few millimeters of mercury reduction in hypertension. In a small, but well designed, trial of the Ardian device, improvements in blood pressure of the magnitude of 30 mmHg were seen in almost all patients. If these data hold up, and safety concerns do not arise, this device would turn the hypertension market upside down, to the dismay of Big Pharma. Total medical costs could be reduced as well if damage to the kidneys, eyes, and hearts of millions of patients are avoided.

Matthews Chacko, MD, Director of Peripheral Vascular Intervention at Johns Hopkins, discusses this device, the data in The Lancet, and his thoughts on safety and efficacy.


CBS allows TV doctor to make egregious claims about statins

Can a “calculator” really tell doctors who should be on Lipitor?

Nortin Hadler, MD: lack of evidence for widespread statin use

The risk of diabetes associated with statin drugs

“You’re telling me this now?” Why the news is suddenly critical of statins and antidepressants

 Sanjay Kaul, MD: The Crestor JUPITER indication label expansion

The Yale led reanalysis of the BMP-2 InFuse trials

Interviewed by Steven E. Greer, MD

Medtronic granted rare access to a team led my Yale’s Harlan Krumholz and turned over the complete datasets on 17 InFuse (BMP-2) clinical trials. The goal was to determine whether adverse events being reported in real world usage were significant trends requiring new label warnings. Yale contracted Oregon Health and Sciences University to conduct one of the meta-analysis. We interviewed the lead author, Rongwei Fu, PhD.

Dr. Fu explains her findings. BMP-2 showed no efficacy advantage over other methods to fusing the spine, while also showing increased adverse event rates. In the cervical spine, their group concluded that BMP-2 was contraindicated.

The false epidemic of autism

autism_01Update March 20 , 2013

The annual CDC autism report is out again, misleading the public about a non-epidemic.

Update March 29, 2012

The high prevalence of “autism” was in the news again with a CDC report claiming that the rates were even higher than reports last year.

May 9, 2011 Steven Greer, MD

The national TV news and papers jumped on a press-release-promoted paper in The American Journal of Psychiatry that summarized a trial led by Yale researchers evaluating the prevalence of autism on South Korea. The press misinterpreted the goals and conclusions of the paper and led with sensational headlines indicating that American children might have a 100% higher prevalence of autism than previously estimated. Previous estimates suggested a 1/100 or lower prevalence, and the new paper suggested a 1/38 (2.64%) prevalence.

The authors of the paper, Kim et al, never intended the study to answer any hypothesis about autism in North America. Studies were heretofore lacking in Asia. They wrote, “Research suggests that ASD onset, core symptoms, and prevalence are similar across European and North American populations. Nevertheless, with the exception of Japan and Australia, the data are insufficient to characterize ASD prevalence in other cultures. This is the first population-based autism prevalence study in Korea.”

The authors of the paper made no conclusions about autism in North America. They wrote, ” Conclusions: Two-thirds of ASD cases in the overall sample were in the mainstream (Korean) school population, undiagnosed and untreated. These findings suggest that rigorous screening and comprehensive population coverage are necessary to produce more accurate ASD prevalence estimates and underscore the need for better detection,  assessment, and services.”

It is becoming increasingly known that non-North American data, such as these from the Yale Korean study, are not adequately relevant to the North American population to allow for clinical changes or approval of new drugs. These Korean data were from a homogenous population that represent a small portion of the North American population.

One also needs to be aware of political factors that have caused the increase in “autism” being diagnosed. In the year 2000, President Clinton signed into law the Children’s Health Act of 2000. The law specifically addressed autism and created new research branches within the CDC, NIH, and several medical centers. Congress has allocated close to a billion dollars to these programs in total, with a significant portion going toward the autism efforts.

It is a rule of political science that all bureaucracies have a tendency to grow and claim more of the federal budget. Lowering the bar and expanding the diagnostic criteria for “autism” is consistent with increased funding. The authors of the paper acknowledge this and wrote, “The increased prevalence appears to be attributable to greater public awareness, broadening ASD diagnostic criteria, lower age at diagnosis, and diagnostic substitution. Additionally, study design and execution have affected prevalence estimates, limiting the comparability of more recent estimates.”

The national media coverage of the paper in question also failed to explain that the researchers counted all forms of mild “autism” in the study. These were not the profoundly autistic patients that one thinks of when they hear the word “autism”. Many people with mild forms of autism are highly functional professionals that seem just a bit “odd”. These broad inclusion criteria can be found here. The new DSM-V expands the criteria ever further.

Proponents of diagnosing more children with “autism” claim that early treatment improves lifelong outcomes. Critics are worried that labeling a child for life carries with it tremendous stigma and harm to self esteem. They assert that it also places the child at risk of receiving harmful unnecessary medications as seen in the inappropriate prescribing of powerful antipsychotics to toddlers with “bipolar disorder”.

Moreover, as the incidence and prevalence of “autism” rise, human nature will erroneously attribute other medical therapies as the cause. Currently, the world medical societies are actively trying to undue the myth that vaccinations cause autism.

Every news outlet with a large viewership must begin to make an attempt to hire qualified producers who can properly screen press release medical news and filter out the junk science. Unlike other news, bad reporting on healthcare affects lives.

ASCO 2012 preview: new therapies for melanoma

Dr. Sara Hurvitz and Dr. Antoni Ribas of the UCLA Jonsson Cancer Center preview the new melanoma therapies to be presented at the 2012 ASCO meeting.

Gordon Guyatt, MD: Does coffee reduce mortality?

In full screen 1080i HD for better viewing of the data graphics

and NBC’s egregious coverage

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