Atul Gawande’s surgical checklist fails in real world study

March 15, 2014- By Steven E. Greer, MD

In 2009, Atul Gawande, MD, MPH and his large international team published in the New England Journal of Medicine (NEJM) an observational study that showed a significant reduction of death and “complications” after non-cardiac surgery. The World Health Organization (WHO) created the checklist used in the NEJM paper. After this non-randomized, non-controlled, observational study was published, entire nations adopted the surgical checklist system.

Now, in 2014, a population study drawing from Ontario surgical patient data, published in the NEJM, showed no significant benefit from the widespread adoption of the same WHO surgical safety checklist that Dr. Gawande popularized. This study was also observational, but it was stronger than the 2009 Gawande study in that it included the entire population within a region.

What went wrong? Read more »

NEJM letter casts doubt on original Gawande checklist paper

June 11, 2014- By Steven E. Greer, MD

When the recent Canadian studied published in the NEJM failed to show any benefit from the WHO surgical checklist championed by Atul Gawande, The Healthcare Channel pointed out that the original Gawande paper was possibly the problem. It was designed poorly, and collected data from non-U.S. countries with little oversight.

Now, in the current online NEJM, letters to the editor are coming in. One writer echoes our concerns about the original Gawande paper. Read more »

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.

David Kallmes, MD: Is vertebroplasty futile?

 

Two important government-funded clinical trials on vertobroplasty were published today in The New England Journal of Medicine. Both trials showed that the practice of injecting cement into spinal compression fractures of the elderly do not help alleviate pain and disability better than control sham procedures. However, as with most spine trials, there is plenty of room to dice the data and find flaws in the conclusions.

The relevance to investors is that vertebroplasty is the direct competitor to Medtronic’s Kyphon balloon kyphoplasty device. On one hand, the two negative studies in the NEJM could cast doubt of the concept of repairing fractured osteoporotic spines, and be a negative for MDT as well. On the other hand, there is a good argument that kyphoplasty is significantly different from vertebroplasty and that the negative studies will drive more cases to be preformed using kyphoplasty.

We interviewed the principle investigator of the US trial, Dr. David Kallmes of the Mayo Clinic.

Is the healthcare industry a bubble slowly deflating?

December 3, 2011

Steven Greer, MD- The Healthcare Channel

Two weeks ago, we issued the story, below, about possible layoffs and cuts in the healthcare industry due to a “Healthcare Bubble”. At the medical center level, we said that it would be likely that doctors, normally a profession with great job security and in demand, would see layoffs. To add a real case example to that story, Cedars Sinai in Los Angeles, a medical center with a profit margin far greater than the national average and often the treatment choice for celebrities, is now completely closing its psychiatry department to save money. Their pediatric and OB/GYN services have also been scaled back.

Now, CMS Medicare is planning to make it much more difficult for medical centers to perform the most lucrative of procedures (i.e. spine fusion, joint replacement, and numerous cardiac procedures like stents and ICDs). Just a few years ago, many medical centers greatly expanded their cardiac cath labs to try to perform more coronary stenting. Clinical data and evidence of unnecessary implantation of stents has already decreased the volume of stenting. These new CMS measures might lead to another 20% reduction, according to a cardiologist we spoke with. Spine fusion cases are also very vulnerable to reductions in case volumes due to fears of Medicare audits finding the cases to have been unnecessary.

Already, the bad economy, high unemployment, and fewer insured, have caused reductions in procedure volume. CMS seems to be adding to the strangling pressures. We expect to see significant layoffs in the ranks of spine surgeons, orthopedic surgeons, and interventional cardiologists, if these case volumes are reduced.

Related to stocks, we continue to believe that Medtronic would do well to spin off the spine and ICD divisions. Questions about strategic divestitures were common from callers on the recent earnings call. Edwards Lifesciences (EW) will also face a much more challenging reimbursement climate making for a slower launch of their new TAVR Sapien valve, in our estimation.

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Is the healthcare industry a bubble slowly deflating?

November 15, 2011

By Steven Greer, MD

Throughout the economic depression that began in 2007, the healthcare industry has continued to add jobs. Healthcare providers are still in demand and command good wages and job security. However, can the good times last much longer as the global depression seems to be worsening rather than improving?

The “Super committee” in congress might trigger cuts next week to the HHS Medicare/Medicaid budget and the White House is also advocating cuts. The passage of the ACA health insurance reform law also requires $500 Billion in cuts. Governments have poor track records at making cuts to entitlements, but the private sector might be the most powerful force to enact cuts to the healthcare industry.

With the high unemployment rates has come a lower percentage of the population with full health insurance. This has already had a powerful impact on the healthcare industry. Fewer visits to the doctor and fewer elective (or even not so elective) procedures, combined with a higher mix of low-reimbursing Medicaid, is driving cost consciousness amongst the consumer patients and the hospitals.

We previously reported how newly-approved expensive branded drugs are selling poorly. Once deemed a positive event for a company, an FDA drug approval is now associated with significant reductions in share prices for the companies as investors become disappointed and change their expectations. $100,000 cancer drug prices might represent a pharmaceutical bubble.

JP Morgan’s medical device analyst issued a report detailing many of these repressive influences on the medical device sector. For the large companies such as Johnson and Johnson, Abbott, or Medtronic, the earnings growth rates have decreased from 10% down to 3%, and that is after considerable cost cutting measures were implemented in the form of mergers and layoffs.

Cutting operating expenses is a temporary measure and no substitute for revenue growth. When the companies have trimmed back to the bone, will growth turn negative?

If the ACA law continues to be implemented and is not overturned by the Supreme Court or the new congress next year, it will add millions of patients to the Medicaid system, further stressing state and medical center budgets, will we see salary cuts to doctors and layoffs in the healthcare sector?

If Greece, Italy, Spain, Ireland, etc. send Europe into a double dip depression, what will be the impact to the healthcare industry?

We will be interviewing healthcare economists, policymakers, and hospital executives over the next few months to try to answer some of these questions.

 

Current guidelines and methods for treating knee and head injuries in NCAA athletes

September 14, 2010

Lee Kaplan, MD, Chief of Sports Medicine at The University of Miami Health System and team doctor for the Miami Hurricanes football team discusses the state-of-the-art methods for surgically repairing torn knee meniscus injuries and for repairing torn ACL’s.

Clifton Page, MD, internists for the Miami Hurricanes football team, discusses the new guidelines for handling the return to play for athletes who have suffered a concussion, testing for sickle cell, and for monitoring heat exhaustion. (See Op-Ed How to Eliminate Head Injury in Football)

David Kallmes, MD: Kyphoplasty versus vertebroplasty

Dr. David Kallmes, professor of radiology at the Mayo Clinic, discusses the differences between balloon kyphoplasty and vertebroplasty.

Use medical device technology to seal the Gulf oil leak

Op-Ed The Healthcare Channel  May 16, 2010

It is now painfully obvious that the team of “expert engineers” working on ad hoc solutions to seal the oil-spewing pipe at the bottom of the Gulf of Mexico is incompetent. Saturday Night Live lampooned them on May 15^th. British Petroleum (BP) needs to look outside the box and learn from surgeons and the medical device industry how to seal a tube leaking fluid; whether it be high pressure arterial blood or oil at the bottom of the sea.

Every trauma surgeon and vascular interventional doctor knows that the first thing to do to stop a gusher is to apply pressure to the leaking pipe. Doctors do not try to suck up the blood, store it in a vessel, then rapidly reinfuse it back into the patient (although this can be done in surgery, but not as the first step). The latest solution by BP is to insert a pipe into the leaking broken pipe, bring the oil to the surface, then store it in a tanker. This is an idiotic idea. BP should be focusing on ways to seal the pipe.

The medical device industry has invented catheter balloons that can apply massive amounts of pounds-per-square-inch pressure to surrounding walls: enough pressure to expand bone during kyphoplasty spine procedures. Within 24 hours, if a team of engineers from Medtronic were dispatched to the Gulf to advise the BP team, a crude rubber balloon bladder surrounding a “catheter” could be devised, inserted into the leaking oil pipes, inflated, and seal the oil leaks. BP, the White House, and the medical device industry need to make this happen ASAP.

William Maisel, MD: discusses the Medical Device Safety Institute

The medical device industry has been replete with safety recalls and scandals at the CDRH device section of the FDA. Cardiologists have had to deal with most of the highest profile problems ranging from ICDs to drug eluting stents. As a result, cardiologist William Maisel of the Beth Israel Deaconess Medical Center founded the Medical Device Safety Institute.

Sundeep Khosla, MD: Denosumab

Sundeep Khosla of the Mayo Clinic who authored the NEJM editorial on Amgen’s denosumab discusses the drug and safety issues.