Interviewed by Steven Greer, MD
Harlan Krumholz, MD, cardiologist from Yale, discusses his open letter in the journal Circulation recommending that LDL be scrapped as a treatment target for statins.
Cardiology, Cardiology/medicine, Policy, Yale | apples49 | 
March 14, 2015 2:30 pm | 
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February 7, 2014- By Steven E. Greer, MD
The Patient Centered Outcome Research Institute (PCORI) was created by the PPACA “ObamaCare” law in 2010. Well-funded with approximately $3 Billion over ten years, the mission was, among other things, supposed to be to conduct comparative effectiveness research (CER) that would determine whether costly therapies are any better than cheaper alternatives.
The rise of CER has been one of the most feared developments by the drug and device industries. To avoid powerful lobbying efforts that could have resulted in de-funding and the death of PCORI before it got started, the institute steered away from even hinting at conducting CER. Now, almost four years later, PCORI is finally funding CER research. However, critics, such as former White House Director of Office of Management and Budget, Peter Orzag, say that the money spent by PCORI on CER is still not enough.
Meanwhile, a leading doctor in charge of PCORI research strategies, Harlan Krumholz, MD, Read more »
AHRQ, Biostatistics, CMS Medicare Medicaid, FDA, HHS, Op-Ed, Policy, Yale | apples49 | January 14, 2015 8:47 am | Comments (1)
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.
FDA, Internal medicine, Late Breaking Data, Medical Devices, Neurosurgery, Oncology, Oregon H&S Univ, Spine surgery, Yale | apples49 | August 6, 2013 7:27 am | Comments (0)
Update 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.
Late Breaking Data, Neurology, Op-Ed, Policy, Psychiatry, Yale | apples49 | March 21, 2013 7:51 am | Comments (0)
(Viewable in full screen 108oi HD)
Pharmacist Cynthia Jackevicius of Western University of Health Sciences discusses her New England Journal of Medicine article, co-authored by Harlan Krumholz of Yale et al, on the cost savings to the American healthcare system from cheaper generic Lipitor and the strategies Pfizer is using to delay the market share shift to generics.
This is a case study on a larger issue. The generic drug industry has morphed into a hybrid of branded and generic business models and using ever more sophisticated strategies to exploit loopholes in the patent law and FDA regulations. As a result, once cheap generic drugs are often becoming much more expensive. Fewer generic manufacturers exist due to mergers and consolidation, and it is not uncommon to find a single manufacturer of a generic drug charging branded drug prices exerting monopolistic pricing power.
Cardiology/medicine, NEJM, Policy, Western Univ Health Sciences, Yale | apples49 | January 30, 2012 7:45 pm | Comments (0)
