PharmD|Pharmacy Schools : 2007 : 2007_10_16

Study Dentist shortage plagues Britain

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Tue, 16 Oct 2007 20:37:32 GMT
By THOMAS WAGNER, Associated Press Writer

LONDON - A shortage of National Health Service dentists in England has led some people to pull out their own teeth — or use super glue to stick crowns back on, a study says.
Many dentists abandoned Britain's publicly funded health care system after reforms backfired, leaving a growing number of Britons without access to affordable care.

"I was not surprised to hear those horror stories," said Celestine Bridgeman, 41, of London. "Trying to find good NHS dentists is like trying to hit the lottery because the service is underfunded."

The National Health Service provides care to the vast majority of Britain's people, often for free. Unlike doctors who work for the health service, dentists work on a contract basis and can leave whenever they wish.

Though private treatment by dentists is available, the tradition of publicly funded care means most people rely on it. But now there are fewer dentists to see patients.

In April 2006, the government reformed National Health Service dentistry in an effort to increase patients' access to treatment and to simplify payments. Dentists objected, complaining it reduced income. Some dentists cut the number of health service patients — or stopped taking them altogether.

Forty-five percent of dentists surveyed said they no longer accept National Health Service patients.

"This survey underlines the significant problems caused by both dentists and patients by the new dental contract," said Susie Sanderson, executive board chairwoman of the British Dental Association, a trade union of thousands of dentists.

"The picture it paints, of patients unable to access care ... and anxieties about the new charging system, is an all too familiar one," she said.

The study released Monday by the commission contained no figures detailing the National Health Service dental shortage. But earlier this year, then-Health Minister Rosie Winterton told Parliament more than 2 million people were unable to find an NHS dentist.

The survey of 5,212 patients and 750 dentists in England found 6 percent of patients resorted to self-treatment, including one person who extracted 14 of his teeth with pliers. Other patients reported using super glue on crowns after they popped off, the study said.

"These findings indicate that the NHS dental system is letting many patients down very badly," said Sharon Grant, chairman of the Commission for Patient and Public Involvement in Health, the independent body that commissioned the study.

The survey found nearly 20 percent of patients have gone without dental treatment because of the cost. Thirty-five percent of those not now using dental services said they cannot find an NHS dentist near where they live.

"It felt like being put on the streets when my NHS dentist changed to private," the survey ed one unidentified patient as saying.

Seventy-eight percent of private dental patients left the National Health Service because their dentist stopped treating NHS patients or they could not find an NHS dentist, the study said. Only 15 percent claimed they switched to get better treatment.

Edward Leigh, 37, an IT consultant from London, said the government should reconsider its reform.

"The few wild stories are probably untypical, but there is a clear problem with the way the contracts of the dentists have been handled," he said.


Drug companies ties to schools common

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Tue, 16 Oct 2007 20:47:24 GMT
By LINDSEY TANNER, AP Medical Writer

CHICAGO - Nearly two-thirds of academic leaders surveyed at U.S. medical schools and teaching hospitals have financial ties to industry, illustrating how pervasive these relationships have become, researchers say.
Serving as paid consultants or accepting industry money for free meals and drinks were among the most common practices reported by the heads of academic departments.

Drug companies and makers of medical devices often use these connections to influence doctors to use products that aren't necessarily in the patient's best interest, said Eric Campbell, the study's lead author. He is a researcher at Massachusetts General Hospital and Harvard Medical School.

Since academic department heads set the tone for appropriate conduct at their institutions, their actions signal to medical students and others that this is appropriate behavior, Campbell said.

The survey went to all 125 accredited medical schools and the nation's 15 largest teaching hospitals. About two-thirds of the department heads responded. The study gave no specific examples, nor did it name any institutions.

Many studies have examined doctor ties to drug companies. Campbell co-authored research last year that found company ties were common among hospital review boards that oversee experiments on patients.

The new study shows that drug companies "are involved in every aspect of medical care," Campbell said.

Overall, 60 percent of department heads reported some type of personal financial relationship with industry. More than one-quarter — 27 percent — said they had recently served as a paid consultant. The same percentage reported serving on a company scientific advisory board; and 21 percent who headed departments of medical specialties closely related to patient care said they had served on speakers' bureaus for industry.

The results appear in Wednesday's Journal of the American Medical Association.

Alan Goldhammer of the industry group, Pharmaceutical Research and Manufacturers of America, said the study results don't mean these relationships are a problem. He said it makes sense to reach out to academic heads because they have the most expertise.

But Dr. Jerome Kassirer, a former New England Journal of Medicine editor and frequent critic of industry influence over doctors, called the study eye-opening.

"I was appalled by the results," Kassirer said. "No one knew that so many chairs of medicine and psychiatry were paid speakers. We've never had that data before."

He noted that financial ties can benefit patients when they are related to research or other scientific purposes that increase doctors' education or lead to the development of better drugs or medical products.

But they are dangerous when doctors are so beholden to the company that they withhold safety concerns or push the newest or most expensive products when they aren't necessarily best for the patient, Kassirer said.

The researchers sent surveys last year to 688 department heads at all 125 accredited U.S. medical schools and the 15 largest teaching hospitals. A total of 459 people responded, or 67 percent. Included were departments closely related to patient care, such as surgery or anesthesiology, and "nonclinical" departments more closely related to basic science.

Among those in charge of departments related to patient care, 65 percent said their departments had recently accepted industry money for continuing medical education; half reported recently getting industry money for food or drinks; 30 percent reported getting money for travel and meetings.

Overall, 67 percent said their departments had received some type industry money.

Fewer than 10 percent of chairs with personal financial relationships said those ties had any negative effects.
Dr. David Korn, a senior vice president at the Association of American Medical Colleges, which helped conduct the study, said the results aren't surprising or necessarily cause for concern.
Medical schools generally have policies governing relationships with industry to "make sure that they remained principled," Korn said.
"There is a real need to have good exchanges of information" between medical schools and industry, Korn said. "After all, when a new product is approved," the maker "knows about it better than anyone else."
Still, "gifting and favoring" are problematic, he said, and an association task force is examining the issue.
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On the Net:
JAMA: http://jama.ama-assn.org

Device woes said reported before recall

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Tue, 16 Oct 2007 21:34:31 GMT
By LAURAN NEERGAARD, AP Medical Writer

WASHINGTON - Hundreds of injuries linked to a brand of heart defibrillator wires were reported to the government by last winter, a consumer advocate said Tuesday in asking why the wires weren't recalled until this week.
Medtronic Inc. pulled its Sprint Fidelis defibrillation wires off the market Monday, after identifying five patient deaths in which broken wires may have played a role.

These wires, officially called leads, connect patients' hearts to a device that sends an electrical shock if it senses a life-threatening abnormal heart rhythm. A fractured lead can leave the defibrillator unable to send a lifesaving shock, or prompt it to deliver painful unnecessary shocks.

The Food and Drug Administration had received 599 reports of malfunctions and injuries associated with the Fidelis leads as of Jan. 10, including 204 where patients had been inappropriately shocked, according to a count by the consumer group Public Citizen.

The FDA had received 27 failure reports in the first two months of 2006 — but 152 in the first two months of 2007, the group found.

"Why did the FDA, aware of the rapidly mounting number of injury reports, not force the company to recall defibrillators not yet implanted in the early part of this year?" Public Citizen's Dr. Sidney Wolfe wrote FDA's commissioner on Tuesday.

Wolfe said since Jan. 10, FDA had received another 1,030 reports of malfunctions.

The FDA would not respond to Wolfe's letter Tuesday — but noted that any defibrillator lead can break, and insisted there was no early evidence that the Fidelis was riskier than others.

"Once the needle in the haystack has been pointed out to people, it seems like it's obvious to see," said FDA's Megan Moynahan, who led monitoring of the device.

Still, "we will go back and look at our actions and say, 'Should we have done something a little bit different?'" she added.

Medtronic spokesman Robert Clark said the company acted as soon as it "had the appropriate information to make a decision ... and we did so with patient safety and well-being as our primary concern."

The FDA began monitoring the Fidelis in February, when a prominent cardiologist — Dr. Robert Hauser of the Minneapolis Heart Institute — brought concerns to the agency.

Leads are fragile, and the new trend in defibrillator technology is to make them increasingly thin for easier insertion. The Fidelis was a popular thin version.

Hauser's hospital quit using it earlier this year. In a published review of leads implanted there and of reports to FDA's injury database through February, Hauser wrote that the thinner model was "significantly less reliable" than Medtronic's own thicker predecessor.

In March, Medtronic wrote physicians to urge care in how they implanted the leads. FDA still didn't agree there was reason to do more, Moynahan said, until Medtronic ended sales, based on recent death reports.

The agency is now reexamining similarly-sized defibrillator leads, she said.

Medtronic and FDA say the risk of breakage is low: More than a quarter-million Fidelis leads have been implanted worldwide, and fewer than 1 percent have failed.

FDA cautions worried patients not to have the wires surgically removed, a risky operation itself. Instead, doctors may monitor them carefully, or consider capping the wire so it no longer works and implanting a different version.

Heart patients sue Medtronic over device

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Tue, 16 Oct 2007 20:52:52 GMT
By JOSHUA FREED, AP Business Writer

MINNEAPOLIS - A man who claims he received 47 unneeded jolts from his implanted defibrillator is suing Medtronic over the broken wires the company is recalling.
Plaintiffs Leonard Stavish and Kelly Luisi seek class-action status in U.S. District Court in Minneapolis as representatives of people they say were hurt.

The lawsuit's allegations include emotional distress and negligence, and it seeks restitution, disgorgement of profits, and punitive damages.

Medtronic Inc., maker of pacemakers and other heart devices, has acknowledged that wires connecting its implantable defibrillators to patient hearts break more often than it expected. It said five deaths may be linked to the broken wires. Medtronic said some 235,000 people have the Sprint Fidelis lead wires.

Medtronic spokesman Rob Clark did not immediately return a phone message seeking comment.

Attorneys for Stavish claim his defibrillator had to be removed because he got 47 jolts he didn't need. They said the device was replaced with another defibrillator and a new set of Sprint Fidelis wires.

The lawsuit also said Luisi went to the emergency room after experiencing "frightening episodes of unnecessary shocks." At the hospital, Luisi's defibrillator "began delivering unnecessary shocks over and over again," after someone from Minneapolis-based Medtronic used an instrument to check her device, according to the lawsuit. The lead was removed a month later.

Removing the leads can be dangerous because it may tear at scar tissue that builds up around the wires. The lawsuit said Luisi was forced to have her lead removed, "scarring her already fragile heart, and forcing her to undergo additional and unnecessary complicated surgery."

Carol Levenson, an analyst at Gimme Credit, wrote in a note on Tuesday that a 2005 Medtronic recall over defibrillator battery failures, which Levenson said was less severe than the new one, brought more than 1,000 personal injury cases.

"We would expect the litigation floodgates to open over the current recall as well," she wrote.


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