Monday, March 5, 2012

The Bottom Line: What is good for shareholders may not be good for patients

This post was written by Dr. Kelly Wright, a minimally invasive gynecologic surgery fellow in the Boston area.

It’s cool. So cool, that President Obama used one. So cool, it’s been on the cover of Newsweek. It’s been in multiple television commercials, radio advertisements, highway billboards, and was even coined one of the top 14 medical breakthroughs of 2011 by Boston Magazine, a city teeming with medical innovation. Yet surgeons and health economists are unable to explain the fascinating rise of robotic-assisted surgery.

Currently, a single company manufactures and distributes the robot, a line of surgical equipment used to conduct robotic-assisted surgery. The robotic system consists of a surgeon’s console with 3-dimensional high definition vision and a patient-side cart featuring robotic arms with proprietary wristed instruments. The system translates the surgeon’s natural hand movements on instrument controls into corresponding movements of instruments inside the patient, giving the surgeon control, range of motion, and depth of vision similar to open surgery.

The sole manufacturer hopes to establish the robot as the standard for surgical procedures by encouraging surgeons and hospitals to adapt the technique while marketing aggressively to patients about the benefits of robotic surgery. As of June 2011, the manufacturer had installed 1,933 robotic systems. They estimate that 278,000 robotic-assisted surgical procedures were performed in 2010, up 35% from 2009, and aim to achieve one million annual procedures in the United States over the next few years (Investor Report 2011). To achieve this goal, the manufacturer strategically markets to smaller hospitals and surgeons who may not be skilled at conventional laparoscopy to give them an edge for attracting patients.

The robotic systems are sold to hospitals for a cost of $1.0 - $2.3 million, depending on the version. Mandatory annual service agreements range from $100,000 to $170,000 per year. These prices are paying off for the manufacturer. In 2010, the company reported revenues of over $1.4 billion from the sale of systems, and most recently, a 38% increase in instrument sales and 25% growth on systems revenues for the third quarter of 2011 (S&P stock report 2011). Since 2006, the company reports gross profits at 66%-73% of revenue.

Who regulates these costs? Only the sole manufacturer does. The robotic surgical system is the only FDA-approved robotic system on the market. In addition, the manufacturer owns or has exclusive rights to over 2000 patents and patent applications, derived from the acquisition of other robotic devices and companies. Extensive regulations administered by the FDA act as a barrier to entry by other competitors, and since the manufacturer’s acquisition of its major competitor in 2003, there are no direct commercial competitors in the robotic-assisted surgery market. Without competition, a single company runs the robotic market without any regulation.

Shareholders are thrilled. The stock value continues to rise in a recession and has just passed the $500 per share mark. Patients want it. Hospitals are buying it. So why isn’t everyone excited about robotic-assisted surgery?

Unfortunately, the exuberant and rapid adoption of robotic-assisted surgery has occurred in the absence of randomized trial evidence validating its use. Instead, marketing by the manufacturer accounts for the exponential use of robotic surgery over the past five years rather than clinical evidence.

In fact, researchers from Johns Hopkins found that hospital websites, using manufacturer-provided content, misled patients with clinical claims that have not been substantiated (1). The researchers found approximately 4 in 10 hospital websites in the United States publicize the use of robotic surgery. What was most concerning was that 89% of these hospital websites made a statement of clinical superiority over conventional surgeries, the most common being less pain, shorter recovery, less scaring, and less blood loss. 32% made a statement of improved cancer outcome, and none mentioned any risks or costs.

The evidence is just beginning to emerge to the contrary. Literature has shown that while clinical outcomes are similar to or no better than conventional surgery, the robotic technique is more expensive than conventional laparoscopy for a number of surgeries including cholecystectomy (2) and hysterectomy for endometrial cancer (3). For some procedures, including benign hysterectomy, sacrocolpopexy (4), and myomectomy (5), the robotic technique is even more expensive than conventional laparoscopy and laparotomy. Despite the large number of robotic prostatectomies performed to date, evidence has yet to show improved clinical, cancer, or cost outcomes for robotic prostatectomy (6). In addition, studies show that robotic-assisted surgery is consistently $1600-$3000 more than conventional laparoscopy or open surgery (7,8). Our institutional data for hysterectomy showed that robotic-assisted surgery translated into a $6000-$10,000 increase in expenses to the patient over all other methods of hysterectomy. If the 600,000 hysterectomies performed in the United States each year were all converted to robotic-assisted hysterectomies, this would represent a $3.6 billion to $6 billion increase in patient costs. An increase in patient costs for no clinical benefit.

What does the literature show? High-volume subspecialty surgeons have better patient outcomes and use less hospital resources and health-care dollars than low-volume, less-skilled surgeons (9). In fact, a hospital’s investment into a moderately priced robotic system over 5 years would provide an average salary for a fellowship-trained minimally invasive surgical subspecialist (conventional laparoscopist) for 10 years. Instead of investing in a marketing technique, hospitals should invest in and develop talented high-volume surgeons because the clinical benefit is proven.

In a time where medical bills are the leading cause of personal bankruptcy in the United States and health care spending is nearly 18% of the GDP, why are patients paying more for a technique without any proven benefits over conventional therapies? Why are hospitals marketing robotic-assisted surgery to patients without reviewing the manufacturer’s claims? Why are we allowing a single company’s bottom line to increase while insurance premiums and out-of-pocket spending for patients increase every year? We have to stop pursuing things because they are marketed to us. In medicine, there are always procedures that are feasible, but they are not always the right clinical choice; similarly, they are not always the cost-effective choice. In the case of robotic-assisted surgery, it shows neither improved clinical outcomes nor lowered costs.

1 comment:

  1. Kelly: Great post. Thank you for speaking out about this. Our system needs more thoutful and courageous doctors like you.