FDA-Encourages Medical Device Hucksterism: Surgical Sinus Treatment_NY

The FDA is putting the U.S. government seal of approval on one after another expensive, invasive, worthless,  medical device requiring surgery– without a shred of scientific evidence that there is any benefit for patients who are essentially hoodwinked by doctors who have a financial stake in performing the surgery, and often in the device manufacturer.
 
The latest device purports to improve breathing–Acclarent, balloon sinusplasty–was approved by the FDA last year without even requiring the company to "demonstrate that its system was either safe or effective."

The New York Times reports that knowledgeable critics point out: "….the rush to embrace balloon sinuplasty is an example of how the loose regulation of medical devices can enable procedures to be adopted more on the basis of astute marketing than clinical science…"

Indeed, "Of the two studies conducted so far, one involved 6 cadavers and the other was based on only 10 patients – 8 of whom also had traditional
sinus surgery, making it difficult to determine whether the system, made by Acclarent, a privately held company, really helped. While those studies help
show that it is possible to open a sinus with a balloon, they do not address whether sinuplasty provides lasting relief for sinusitis, a condition in which the sinuses become inflamed or infected."

 All the company needed to show, "was that its device was essentially no different from other surgical tools already on the market."

An added caveat illustrates that the FDA provides cover for unscrupulous business practices about which patients are unaware.  Patients are being
corralled into unnecessary, surgery involving risks, expense, and no benefit by doctors who have a personal conflict of interest.

The Times reports that "the company places pressure on doctors who are eager to be trained in the technique. Sinus specialists who want training beyond a simple introduction to the technology must make an upfront commitment to buy $20,000 worth of Acclarent’s equipment, including the catheters and balloons involved. Each system, which is disposed after a single use, costs about $1,200."

The FDA similarly gave its seal of approval to two other radical surgical procedures for depression–VNS (Vagus Nerve Stimulation)  and DBS (Deep
Brain Stimulation)–without evidence of their safety or efficacy.

See: Senate Finance Committee report by Senator  Charles Grassley, Review of the FDA’s Approval Process for the VAGUS NERVE STIMULATION THERAPY System for Treatment -Resistant  Depression at: http://finance.senate.gov/press/Gpress/02_2006%20report.pdf
See: A Depression Switch? By DAVID DOBBS THE NEW YORK TIMES April 2, 2006 http://www.ahrp.org/cms/content/view/129/28/  
See: F.D.A. Considers Implant Device for Depression By BENEDICT CAREY THE NEW YORK TIMES May 21, 2005 http://www.ahrp.org/infomail/05/05/21.php  

There is less and less justification to support the $1 billion budget allocated to the FDA, an  agency that has so far deviated from its public mission. The FDA no longer protects taxpayers from snake oil merchants–it protects the financial interest of those merchants.  If the public knew that the FDA seal of approval is routinely bestowed on unsafe and worthless medical products–devices, drugs, vaccines; that unsafe products are approved contrary to the recommendations of FDA’s own safety officers; the public would be on guard against hucksterism and take steps to protect their health and their children’s health by resisting the latest offers of "cures."

Contact: Vera Hassner Sharav
veracare@ahrp.org <mailto:veracare@ahrp.org>  
 

http://www.nytimes.com/2006/05/04/business/04sinus.html
THE NEW YORK TIMES
May 4, 2006
Too Soon to Breathe Easy?
By REED ABELSON

Some doctors hail it as a major breakthrough that offers hope to many of the nation’s 37 million sinusitis sufferers. A new procedure opens the sinuses without invasive surgery, allowing patients to breathe easier and resume normal activity within a day.

The procedure, called balloon sinuplasty, can cost thousands of dollars and has been performed on about 500 patients since November 2004. It has
received glowing coverage in local and national news media. Doctors like to tell patients they are the first in their area to offer the procedure.

But there is a problem: There is virtually no scientific evidence that the procedure, which involves inflating a small balloon in the sinus cavity, actually works.

Of the two studies conducted so far, one involved 6 cadavers and the other was based on only 10 patients – 8 of whom also had traditional sinus
surgery, making it difficult to determine whether the system, made by Acclarent, a privately held company, really helped.

While those studies help show that it is possible to open a sinus with a balloon, they do not address whether sinuplasty provides lasting relief for
sinusitis, a condition in which the sinuses become inflamed or infected.

The hype may be getting ahead of the science, say some leading sinus specialists, who concede that sinuplasty may hold promise. They see the rush
to embrace balloon sinuplasty as an example of how the loose regulation of medical devices can enable procedures to be adopted more on the basis of astute marketing than clinical science.

Under the Food and Drug Administration rules governing medical devices, Acclarent was not required to demonstrate that its system was either safe or effective before the F.D.A. allowed it to go on the market last year. All Acclarent needed to show was that its device was essentially no different
from other surgical tools already on the market. "This is clearly not ready for prime time," said Dr. Donald C. Lanza, a sinus doctor in St. Petersburg,
Fla., and a past president of the American Rhinologic Society, the physician group for nose and sinus specialists. "It may help people, but it is investigational," said Dr. Lanza, who emphasized that he was not speaking on the society’s behalf.

Acclarent, which has received $42.5 million in venture capital financing and is based in Menlo Park, Calif., has trained about 150 doctors in balloon sinuplasty. The company has also been successful in finding several high-profile specialists to serve as company consultants. The authors of the
most recent study – the one involving 10 patients – were two doctors, one of whom, Dr. William E. Bolger, serves as a consultant and has options in the company. He did not return several phone calls seeking comment.

Acclarent says that more research is under way and that sinuplasty is intended to be simply another tool for doctors to use in sinus surgery and is not intended for all patients.

Until recently, the company’s Web site said that clinical studies had shown the treatment to be "safe and effective." But after being questioned about the site’s language, Acclarent modified it to say studies "indicate" that the treatment is safe and effective.

Acclarent says it bases its claims on the two completed studies, its other work on cadavers and the clinical experience of the doctors using the technology. Noting that the same technology has been used safely for years to open coronary arteries, the company says no serious complications have been reported by doctors using balloon sinuplasty.

"It is easy for the patient to be misled based on what is on Web sites and on what has been in the press or on the news," said Dr. David W. Kennedy, a specialist at the University of Pennsylvania Health System. Dr. Kennedy is chairman of a task force at a leading specialists’ group, the American
Academy of Otolaryngology – Head and Neck, to evaluate the role of balloon sinuplasty.

Dr. Kennedy pioneered the endoscopic sinus surgery in this country that is now the proven standard surgical treatment of sinusitis. Using a very thin
tube, an endoscope, to view the sinuses, surgeons can operate through the nostril.

One sinus specialist, Dr. James A. Stankiewicz, says that many sinus patients do not need surgery at all and that the majority of sinus sufferers are unlikely to benefit. Dr. Stankiewicz is the chairman of otolaryngology, head and neck surgery at Loyola University Health System in Chicago, which took the unusual step of cautioning patients about the new procedure. While Dr. Stankiewicz is skeptical, he described sinuplasty as an "elegant"
solution for some patients.

The hospital noted that Acclarent’s system still involves surgery and, unlike the traditional approach, requires the use of radiation  to enable doctors to see where to place the balloon.

Any sinus surgery – conventional or Acclarent’s – is likely to costthousands of dollars, although the procedures tend to be covered by insurance. For patients, the primary appeal of the Acclarent procedure, which is also administered through the nostril, seems to be the relative lack of trauma compared with standard surgery, which typically involves more pain and bleeding.

"It was wonderful," said Thomas O’Connell, who had undergone traditional surgery three times in the past before having balloon sinuplasty in late March. Although he received general anesthesia  for the procedure, which was covered by his insurance, he said that by the next morning he could barely tell he had undergone surgery at all. And he says he continues to breathe much better than before the treatment.

As much as patients may prefer the less invasive approach, many sinus specialists say the true test for sinuplasty is whether it will prove to be
effective over the long term at keeping the sinuses open. But doctors who are performing the procedure say it is an important innovation that the
company has been responsible in promoting.

"I felt pretty comfortable starting to do it," said Dr. Jack Coleman, a sinus specialist in Smyrna, Tenn., who said he had operated on 30 or 40
patients since December. Rather than relying on published studies, he talked to Acclarent and other doctors.

Acclarent considers sinuplasty simply "a tool, just like a shaver," something a surgeon would use in operating on a patient, said Kevin Knight,
a company spokesman.

A study following 115 patients for six months is near completion, Mr. Knight said. He added that many of the concerns stemmed from the fact that doctors in this field tended to be conservative and that a new technology like Acclarent’s threatened to disrupt how they practice. "It’s going to foment a lot of discussion," he said.

Doctors who use the Acclarent procedure say it may be best suited for patients with milder problems and those reluctant to undergo more extensive
surgery. About 330,000 people get traditional sinus surgery a year, but an additional 600,000 are referred to a surgeon and never have an operation,
the company said.

Sinuplasty, because it is so much less invasive, "is very appealing for patients," said Dr. Winston C. Vaughan, the director of the California Sinus
Institute in Palo Alto and a paid consultant to Acclarent. He is involved in the study of 115 patients to be presented in September, he said, and the
preliminary results "look extremely good."

Dr. Michael Friedman, who treated Mr. O’Connell, said that while the Acclarent treatment might not replace traditional surgery, "I don’t think we
should discount it."

Dr. Friedman, a professor at Rush University Medical Center and chairman of otolaryngology at Advocate Illinois Masonic Medical Center, is conducting a study of 90 patients, who will be followed for a year, to compare how they fare if they are treated with drugs only, with traditional surgery or with
sinuplasty. He says that he has no financial ties to Acclarent, and that the company is not financing the research. Like other medical device companies, Acclarent also makes use of paid medical consultants. Dr. Vaughan, who disclosed his ties to the company at the start of an interview, said he was simply being paid for his time. Acclarent said that it paid its consultants $300 an hour, with none of them performing more than a few days of work for the company every few months.

Critics of Acclarent are perhaps more concerned about the pressure the company places on doctors who are eager to be trained in the technique.
Sinus specialists who want training beyond a simple introduction to the technology must make an upfront commitment to buy $20,000 worth of
Acclarent’s equipment, including the catheters and balloons involved. Each system, which is disposed after a single use, costs about $1,200.

Dr. Jane E. Dillon, a physician in private practice outside Chicago, said an Acclarent sales representative tried to get her commitment to start using
the system on her patients and to persuade her hospital to buy 10 of the devices before the company would train her. The representative said
Acclarent "can’t afford to train physicians who won’t end up using their equipment," recalled Dr. Dillon, who said she told the representative she
could not agree to those conditions.

In a written response to a reporter’s question about that policy, the company said, "We can currently only work with physicians who want to move
forward with the technology and have the ability to get this technology into the hospital or surgery center for them to use." Acclarent says doctors need to train on 10 patients to become proficient.

But even some doctors who have been trained say they have not yet found a patient for whom balloon sinuplasty makes the most sense. "We’re all trying to figure out where this fits in the weaponry," said Dr. Brent A. Senior, a specialist at the University of North Carolina Medical School.

He says he is among the doctors who would like to see more research, given the times he has seen a new technology pushed by a manufacturer, receive enthusiastic media attention – only to fail to live up to the early hope.  

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