Archive for June, 2010

MS PATIENTS CREATE OWN INFORMAL EXPERIMENT, GOING IN DROVES FOR UNPROVEN THERAPY

Setting aside my own personal bias for news on Multiple Sclerosis, this article is very telling on the impact of social media as it relates to government regulations protocols.  People frustrated with the “system” are taking matters into their own hands and creating in affect their own clinical trial.

Publication Date: June 28, 2010

Source: Associated Press

TORONTO – Scores, even hundreds of people with multiple sclerosis have in the last half-year or so undergone a procedure many hope will cure or at least improve their disease symptoms. And with each passing week, more are travelling abroad to have the untested therapy, which most cannot get in North America.

But instead of results of their treatments showing up in the pages of scientific journals, they are appearing in YouTube videos and website testimonials. It’s as if there were a large, informal experiment underway. But it’s one that isn’t likely to persuade scientific skeptics that the therapy is useful in treating MS.

The liberation treatment, as it is called, is based on an unproven theory that blocked neck and spinal cord veins are to blame for MS and that opening up those blockages gives MS patients back some of the ability to function that the disease has stolen from them.

The condition has been given the name chronic cerebrospinal venous insufficiency – CCSVI. Clinics in Poland, Bulgaria and India are opening the blockages for patients who can afford to travel to them and are healthy enough to do so.

But just how much scientific followup is being conducted on treated patients is unclear. Patients themselves seem to be amassing the evidence of successes and failures – and there have been both – on the electronic bulletin boards of websites like This Is MS.

“If CCSVI turns out to be gospel truth and it actually helps people then it’s terrific for the patients that are getting the procedure and getting benefit from it. But it’s doing nothing to advance the science – which is really what needs to happen,” says Marc Stecker, who has MS and who writes about life with the disease on the blog Wheelchair Kamikaze.

Stecker thinks CCSVI may be part of what is going on with MS. And he would like to see the scientific community conduct treatment studies now to capture the type of evidence that isn’t being methodically gathered on patients who are getting treated outside of North America and outside of clinic trials.

But many in the scientific community insist it’s too soon for that. At this point, they say, it’s not even clear that the venous blockages – first identified by Italian doctor Paolo Zamboni – are abnormal, let alone whether they are involved in the MS disease process and can be treated in a way that will benefit patients over the long term.

Such basic questions need to be answered before clinical trials designed to see how best to treat the problem can start, they say.

“We don’t know the normal anatomy of the venous system…. What does a normal venous system normally look like?” notes Dr. Paul Hebert, a critical care physician and editor-in-chief of the Canadian Medical Association Journal.

“How much stenosis (blockage) is normal? Most of us probably have elements of this.”

Hebert is worried patients will die while the world looks for answers. Though treatment advocates believe it is relatively risk-free, Hebert says manipulating fragile veins can be dangerous.

“We normally only dilate arteries. Dilating veins is highly experimental and the structures are so weak that people will die,” he warns. “At some point it will happen because putting in vascular catheters is dangerous at the best of times.”

On Monday, Hebert’s journal joined the growing debate. In an editorial he co-wrote with another editor, Hebert argues that pressure from advocacy groups – fanned by positive media coverage – cannot be allowed to trump science, or in this case a lack of it.

“Good health policy decisions should not be based on hope and desperation,” the editorial insists.

Some patients believe there is already solid evidence – the positive stories they share with each other. Some talk of regaining lost function in their feet or their hands almost immediately after having a blocked vein opened, others about how the crushing weight of fatigue has lifted since the treatment.

Brian Light, a Toronto man with MS, argued during the Multiple Sclerosis Society of Canada’s recent board meeting that scientists should accept the stories told by returning patients as proof of the merit of the treatment.

But in the world of science, one person’s story is an anecdote, not evidence. And multiple anecdotes don’t constitute data.

“I call them the miracle videos,” Stecker, who lives in New York and who has had MS since 2003, says of some of the testimonials.

“You see before and the person is struggling to get by on like two canes and a crane. And then the day after they show them sauntering around Poland or wherever they’ve gone to have the procedure done.”

Stecker is among a group of patients not featured in the YouTube videos nor most of the news reports on the liberation procedure. He had the treatment done, but his doctor was not able to open all the blockages he found. Stecker has not experienced the benefits he’s seen others enjoy.

Stecker knows of other patients who also didn’t benefit. Some, like him, couldn’t have their blocked veins reopened, because of where blockages were located. Others had blockages opened but felt no benefit.

“A couple of us haven’t seen great results – it’s like the liberation losers’ league,” Stecker quips.

“I know personally through the blog and from people that I’ve met just in MS circles who have had it done (that) it seems to be that it’s not a small percentage that are not finding any benefit.”

Other patients report benefits that are fleeting, lasting merely months. Some people have travelled back to Europe to have the treatment redone a second time after their initial gains disappeared.

This is all useful information for people considering whether to undergo the procedure. But in the world of scientific evidence, it doesn’t make it over the bar. So health-care policy-makers under pressure to approve funding for the procedure here or in the U.S. still have nothing solid on which to base their decisions.

“That is one of the sad byproducts of this,” acknowledges Dr. Aaron Miller, head of the MS clinic at New York’s Mount Sinai Hospital and chief scientific adviser to the U.S. National MS Society.

Could these unmonitored treatment trips lead to conclusive evidence? Miller suspects not.

“One would be dependent on the people doing the procedures to provide useful information. And the validity of the information provided by the people doing these procedures is not necessarily the kind of information that we would like from a scientific perspective.”

Miller explains the procedures are mainly being done by interventional radiologists. They know about imaging vessels, but they may not know a lot about multiple sclerosis.

“So if they alone are going to provide the data, the data is of questionable validity. It would be comparable to my trying to produce credible information on some other subspecialty area that I don’t have any expertise in.”

(c) 2010 The Canadian Press
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GEORGIA TRIAL JUDGE TOSSES MED MAL CAPS

In February 2009, Fulton County State Court Judge Diane E. Bessen tossed out the provisions limiting to $350,000 against doctors, or $700,000 in cases against multiple medical facilities.

http://www.dailyreportonline.com/Editorial/PDF/PDF%20Archive/Order-Declaring-Unconstitutional.pdf

Another trial judge has struck down as unconstitutional limits on how much in pain and suffering damages a jury can award plaintiffs in medical malpractice cases.

Late Monday, Fulton County State Court Judge Diane E. Bessen tossed out the provisions limiting to $350,000 against doctors, or $700,000 in cases against multiple medical facilities.

In her decision, Bessen said the caps, part of the 2005 legislative package known as Senate Bill 3, violated the Georgia Constitution’s guarantee of a right to jury trial since they strip juries of their ability to determine appropriate damages.

The caps also violate the state Constitution’s Separation of Powers doctrine because, she wrote, the statute does not allow the court to offer any chance for judicial review of its mandated reduction of any award exceeding the limits.

“In effect,” she wrote, “the statute completely disregards the jury’s deliberations and findings in determining the amount of damages which, in its sole discretion, fairly compensates the plaintiff. Instead, in all cases to which it applies, the cap substitutes a predetermined amount of noneconomic damages which the legislature has deemed appropriate. Moreover, it does so arbitrarily, without any consideration of the specific facts and circumstances of the case. Equally important, it does so without the option of a new trial for the injured plaintiff. As such it unduly encroaches upon the judiciary’s constitutional right and prerogative to determine whether a jury’s assessment of damages is either too excessive or inadequate within the meaning of the law.”

Bessen also found that the law violates constitutional equal protection guarantees, which require a showing that a legislative action must have a “rational relationship to a legitimate governmental purpose.”

“After review,” wrote Bessen, “this Court finds that there is no rational relationship between statute and the expressed government interest. Most obviously, it is a complete contradiction to state that the overall quality of healthcare would be improved by shielding negligent health care providers from liability.”

The order also takes aim at claims that the caps keep down the cost of healthcare, pointing to studies showing that, in states where such caps exist, insurance rates have increased, while in Minnesota, which eliminated its caps, costs went down.

Finally, she wrote, “[t]he cap’s greatest impact falls on those who are most severely injured … and discriminates against those low-income individuals who are unable to prove large economic damages but nevertheless may sustain large noneconomic damages.”

If appealed, Bessen’s decision sets up a showdown at the state Supreme Court, which was set to rule on the caps’ constitutionality. The high court last year was considering a similar ruling by Fulton County Superior Court Judge Marvin S. Arrington, but the parties settled and the case was dismissed.

The winning lawyer, Adam Malone, said Monday night, “I’m very pleased with Judge Bessen’s order.” He represented a woman whose face was left with permanent bruises and discoloration following a facelift and other elective procedures. “There’s no rational reason to give negligent health care providers the protection of a cap.”

Jonathan C. Peters, who represented the doctor, could not be reached immediately.

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Italian doctor touts unproven MS treatment; society wants more studies

OTTAWA – An Italian doctor pioneering an unproven treatment for multiple sclerosis says it’s “not responsible” to deny Canadian patients access to the procedure.

Dr. Paolo Zamboni told MPs the controversial procedure has so far shown promising results.

Zamboni’s research suggests MS patients have blocked neck veins that may be linked to the disease.

He contends a build up of iron in the brain because blood isn’t draining properly triggers MS – and that patients’ symptoms can be alleviated by opening up the veins to restore blood flow.

The MS Society of Canada wants more evidence before backing Zamboni’s procedure and the group and its American counterpart granted $2.4 million in research funds last week.

But Zamboni and other doctors who appeared before a House of Commons committee say Canada needs to begin clinical trials as soon as possible.

(c) 2010 The Canadian Press

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MEDICAL PROFESSIONALS WILL TRY TO SPOT ELDERLY FRAUD VICTIMS

WASHINGTON – State regulators, social service workers and several medical organizations are teaming up to help health care providers identify and protect older patients who are vulnerable to financial abuse and scams.

“Our goal is to improve the communication among medical professionals, older Americans, (their) adult children and state securities regulators in order to head off financial swindles before the damage is done,” said Don Blandin, president of the Investor Protection Trust, one of the groups behind the new campaign.

The effort to curb the financial exploitation of seniors was announced Tuesday on World Elder Abuse Awareness Day. It comes as a new survey by the trust shows that one in five Americans over age 65 – more than 7.3 million people – reported being victimized in a financial swindle at some point in their life.

In fact, the survey of more than 2,000 adults found that half of older Americans were ripe for potential financial victimization. For example, of 590 respondents age 65 and older, 37 percent reported being solicited by phone for money, while 16 percent said they weren’t confident making big financial decisions by themselves.

Elder financial abuse can assume many forms, including telemarketing or mail fraud, contracting and repair scams, or bad advice from financial services professionals such as insurance salesmen and accountants. It can also include identity theft, abuse of guardianship or even Medicare fraud.

The “Elder Investment Fraud and Financial Exploitation” project will train medical professionals across the country to identify patients with mild cognitive impairments who are most susceptible to financial scams. The goal is to have caregivers inform state regulators about patients who pose the greatest risk for abuse.

Elder financial scams are believed to be the third most common form of elder abuse, behind neglect and emotional abuse, according to the National Council on Aging.

A 2009 study by the MetLife Mature Market Institute found that financial abuse costs America’s seniors more than $2.6 billion a year. The study found that up to 1 million older victims may be targeted each year, but 80 percent of cases go unreported. Family members and caregivers were the perpetrators in 55 percent of reported cases.

Experts say elderly fraud victims are at a higher risk for an early death.

“In financial exploitation cases, when our victims have lost everything to someone that they trusted with their life, they tend to die shortly thereafter,” said Page Ulrey, an elder-abuse prosecutor in Seattle.

The typical victim of elder financial abuse is a frail, white female age 70 and older who is cognitively impaired, according to the National Adult Protective Services Association. Victims are often trusting, lonely or isolated.

The national effort is a collaboration between the Investor Protection Trust, the North American Securities Administrators Association and the National Adult Protective Services Association, along with the American Academy of Family Physicians, the National Area Health Education Center Organization and the National Association of Geriatric Education Centers.

The effort is modeled after a 2008 Texas program that tried to curb financial scams against older people whose diminished capacities made it impossible for them to make sound financial decisions. Hoping to reach these vulnerable seniors before they were victimized, the Baylor College of Medicine and the Texas Securities Commission provided training to alert medical personnel to the problem. They also distributed guidebooks with behavioral warning signs for caregivers to watch for.

Those who encountered problem patients would either contact the patient’s family, refer them for additional testing or alert the securities commission about their condition. Texas Securities Commissioner Denise Voigt Crawford said the notifications were completely confidential and didn’t violate patient privacy laws. Once notified, her staff would then check independently or with family members to make sure the patients weren’t being exploited.

Fifty-five percent of medical professionals who participated in the program found patients who could have been exploited, said Dr. Robert E. Roush of the Baylor College of Medicine. He said cognitive impairment makes older people more prone to take risks, which makes them more vulnerable to unscrupulous people who want to steal their money.”

“We’re extremely happy with the results here in Texas and now we want to take it nationwide,” said Crawford, who’s also president of the North American Securities Administrators Association.

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(c) 2010, McClatchy-Tribune Information Services.

Visit the McClatchy Washington Bureau on the World Wide Web at http://www.mcclatchydc.com.

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Small firms team up to win $29M in nursing home death in California Superior Court

Two small firm lawyers joined forces to win a $29 million jury verdict against a nursing home for delaying treatment of a 79-year-old woman who suffered a fractured hip and bed sore that led to her death.

Edward Dudensing, who runs a two-lawyer firm in Sacramento, Calif., and Jay Renneisen, founder of the two-lawyer Nursing Home & Elder Abuse Center in Walnut Creek, Calif., grew up in the same neighborhood, went to the same law school and both specialize in elder abuse cases.

Trying their first case together, they convinced the jury that the nursing home chain’s chronic understaffing and a corporate scheme that siphoned profits to an alter-ego entity merited punitive damages.

“The corporate manipulation of money earned by the facility supported our position that this was an organization that puts profits over patient care,” said Dudensing.

A decision to leave three health care workers on the jury – including a nurse who raised her hand during jury selection to say she thought jury awards are too high and that punitive damages are generally not a good idea – resulted in a surprise ending to the seven-week trial.

“We went back and forth about it, but we felt good about having health care providers on the jury for liability, and we were willing to take our chances that punitive damages would be lower,” said Dudensing.

In the end, however, the jury was so outraged that it ignored the plaintiffs’ request for $10 million in punitive damages and instead nearly tripled that amount to $28 million.

Defense attorney Michael Levangie of Prout LeVangie in Sacramento, Calif. did not return a call seeking comment.

Understaffing

The case alleged that Horizon West, owner of 33 nursing homes across California and Utah, delayed the diagnosis and treatment of Frances Tanner, a 79-year-old Alzheimer’s and dementia patient, for eight days after she fell and fractured her hip. During the delay, she developed a bed sore that was also listed as a cause of death on her death certificate.

At trial, the plaintiffs’ lawyers argued that the facility under-budgeted for staff and kept staffing at the bare minimum.

They introduced documents showing that the same day Tanner fell, the nursing home signed off on a “deficiency citation” from the department of health for staffing below the required 3.2 nursing hours per patient per day.

The facility cut back on staff on weekends and holidays, including the Labor Day weekend when Tanner fell, because it would cost more to pay overtime, the plaintiffs’ attorneys argued.

“They budgeted to the bone on staffing,” said Renneisen, who presented evidence at trial that the facility had only one licensed nurse on duty for over 40 Alzheimer’s and dementia patients.

Renneisen also questioned a certified nursing assistant and former employee at the nursing home who broke down in tears when she testified that the reason she quit was because she felt the patients were not getting the kind of care they needed.

The plaintiffs’ lawyers, who tape all of their depositions, used the video at trial to expose contradictions in witness testimony.

For example, in her live testimony a nurse said that she remembered repositioning the plaintiff for her bedsore, even though there was no notation of turning or repositioning in the medical records.

But when they dimmed the lights and showed her videotaped deposition testimony, the nurse not only said she couldn’t remember whether she had repositioned the plaintiff but appeared annoyed that she would be expected to remember events that occurred five years earlier.

“One juror said that was the last thing left in his mind when they went into deliberations,” said Dudensing, who spoke to jurors after the trial.

‘Alter ego’

An initial hurdle in the case was proving to the judge in a mini- trial that the nursing home’s parent company was an “alter ego” of the local facility, a separate entity from its owners that in turn is owned by other entities.

“With all these layers of corporate protection, the unfortunate reality is at the facility level they don’t have any assets and no effective insurance. … It’s very difficult to sue and collect,” said Renneisen.

But they were able to show that through various self-dealing arrangements, the different entities all worked as one.

In one contract, the local facility paid the parent $500,000 for various overpriced “services.” In another, an insurance policy for $1 million with a $1 million deductible, essentially providing zero coverage, was purchased by the local facility for $100,000 paid to an insurance company owned by the parent.

“On the books [the local facility] showed a $750,000 loss, but in fact when you took out all the related party dealings [which were priced] above market value, it should have showed a $850,000 profit,” said Dudensing.

“We were able to show how all the profits and assets floated up to the top and all the liabilities were saddled on [the local entity], effectively leaving them with no assets,” said Renneisen.

Perhaps most damaging to the defendants was the testimony of the majority owner, Martine Harmon, one of 10 children of a wealthy real estate developer.

Testifying at both the alter ego trial and the jury trial, Harmon testified that she was not sure why she was on the board of directors of the local entity because she knew nothing about nursing homes but her lawyers thought it was a good idea for a family member to be on the board, according to Dudensing.

“These guys were real estate developers. They owned all this property and turned to skilled nursing to make profits. If you do that, you damn well better have people who know what they’re doing,” said Dudensing.

Instead, he charged, they had 24 accountants for the books and only three nurses for the patients.

Dudensing, who has settled all of his previous cases against the same defendant, offered to settle the case for $600,000, but the highest offer from the defendant was between $30,000 and $40,000.

In the punitives phase, Dudensing brought the defendant’s $200 million net worth into perspective for the jury.

He asked them to imagine that they were in charge of chaperoning a group of 13 boys at a county fair and gave each of them $20.

“If you have to punish them, are you going to reach into their pocket and take away 20 cents?” he asked the jury.

He argued that $10 million is the equivalent of taking one dollar out of $20.

The jury, a stricter chaperone than Dudensing, took away $28 million instead.

Plaintiff’s attorneys: Edward Dudensing of The Law Office of Edward P. Dudensing in Sacramento, Calif., and Jay Renneisen of the Nursing Home and Elder Abuse Center in Walnut Creek, Calif.

Defense attorneys: Michael LeVangie, Eric Emanuels and Kim Wells of Prout LeVangie in Sacramento, Calif.

The case: Tanner v. Horizon West; May 13, 2010; California Superior Court, Sacramento County; Judge Roland L. Candee.

(c) 2010 ProQuest Information and Learning Company; All Rights Reserved.

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