Surgeons conducting clinical trials to test Medtronic Inc bone-growth failed to report serious complications

Surgeons in Medtronic trials omitted results: report
Jun 28, 2011

(Reuters) - Surgeons conducting clinical trials to test a Medtronic Inc bone-growth protein used in spine surgery, some of whom got at least $62 million from the company, failed to report serious complications in their research papers, the Wall Street Journal reported.

Fifteen of the surgeons got at least $62 million from the company over the past decade, the paper said, citing an analysis of Medtronic documents and disclosures on the company's website.

A new study in the Spine Journal said serious complications including cancer, sterility, infections, bone dissolution and worsened back and leg pain, occurred in 10 to 50 percent of patients who were administered Infuse or a sister product in 13 clinical trials funded by Medtronic and conducted by the surgeons between 2000 and 2010, the Wall Street Journal said.

These complications weren't reported in research papers the surgeons wrote on those trials, even though the papers were peer-reviewed, the study said.

A U.S. Senate committee is investigating whether surgeons who were paid consulting and other fees by Medtronic failed to note the complications of Infuse.

The company last week said the three main side effect concerns raised by the committee are listed as warnings on the product labels, as approved by the U.S. Food and Drug Administration.

In a statement, Omar Ishrak, Medtronic's chief executive, on Tuesday said the Spine Journal study does not raise questions about the data Medtronic submitted to the FDA in the approval process.

"Based on that data, we strongly believe that the safety profile reported to the FDA and summarized in the product label support the safe use of rhBMP-2 for the identified indications," he said. The company will continue to investigate questions surrounding researchers' potential conflicts of interest and refine policies as needed, he said.

A company spokesman declined additional comment.

Kaiser is actively lobbying against AB 52, which will require health insurance companies to get state approval for rate increases.

Courage Campaign

This message is from Eennie Andrews, a 72-year-old Kaiser policyholder and Courage Campaign member who lives in the Central Valley. Eennie works as a caretaker for developmentally disabled people.



I don't have employer-provided health care coverage, so I buy my insurance myself from Kaiser Permanente. If my insurance rates were to increase greatly, I wouldn't be able to afford it.

That's why I'm concerned about Kaiser's decision to raiserates on 300,000 of its policyholders in California this year. And it's why I'm angry that Kaiser is actively lobbying against AB 52, which will require health insurance companies to get state approval for rate increases.

Tell Kaiser to put working Californians first and support AB 52.

Even though it's a "not-for-profit" company, Kaiser has made $5 billion in profits since 2009 and pays George Halvorson, its CEO, nearly $8 million a year.

On top of that, Kaiser executives are ignoring their own employees who are asking for adequate staffing levels at Kaiser facilities, and they're trying to cut benefits for caregivers.1

I signed this letter to Mr. Halvorson, asking him to support AB 52. This bill would give state regulators the authority to reject excessive and discriminatory rate increases.

Sign our petition to Kaiser execs to support real health care reform.

Kaiser has an opportunity to lead the industry by helping to reform health insurance in California, instead of raising rates on hundreds of thousands of us and lobbying to make sure they can do it again whenever they like.

Please join me in asking Mr. Halvorson and his team to stand for, not against, California.

Thank you for your help,

Eennie Andrews

Physicians in training work "dangerously long hours"

Residents doctors' shifts too long, report finds
CBC News
Jun 24, 2011

Physicians in training work "dangerously long hours" that should be reduced, a U.S. report says.http://www.blogger.com/img/blank.gif

New rules for residency training set to take effect in the U.S. on July 1 fall "considerably short" of what is needed to ensure patient safety, say the authors of a report in Friday's issue of the journal Nature & Science of Sleep. Residents' shifts should to be limited to a maximum of 16 hours to ensure patient safety, the authors of a report say.Residents' shifts should to be limited to a maximum of 16 hours to ensure patient safety, the authors of a report say.

"Few people enter a hospital expecting that their care and safety are in the hands of someone who has been working a double-shift or more with no sleep," said Dr. Lucian Leape, a professor of health policy at the Harvard School of Public Health and a co-author of the report.

"If they knew, and had a choice, the overwhelming majority would demand another doctor or leave," he added in a statement.

The report looked at residents' work hours, supervision, and safety. It is the product of a conference held last June at Harvard Medical School.

Under the new rules, first-year residents will work shifts no longer than 16 straight hours. But more experienced residents could clock up to 28 hours at a stretch.

The report's authors calls for all residents' shifts to be limited to a maximum of 16 hours.

Some of the other recommendations:

Require attending physicians to supervise all hospital admissions.
Identify in real time when a resident physician's workload is excessive and add more staff.
Assign other hospital personnel to fill out paperwork, start intravenous lines and draw blood to allow residents to instead maximize their time on tasks of more educational value.
Provide transportation to all residents who report feeling too tired to drive home safely.
Make fatigue management a national patient safety goal that applies not only to residents but also to nurses, attending physicians and other health care workers...

Drunk Director of Cardiology Tries to Operate on His Dog: Chicago Cops

Drunk Man Tries to Operate on His Dog: Chicago Cops
By Cynthia Hsu
Legally Weird blog
June 21, 2011

A drunk man's "dog operation" has led to an arrest and a charge of felonhttp://www.blogger.com/img/blank.gify animal cruelty. Stewart Gibbs, 44, was arrested last weekend by Chicago police.

Gibbs is the director of cardiovascular services at DuPage Medical Group.

Police initially responded after a call from Gibbs' landlord. The landlord had received some complaints about a leaking ceiling. The landlord let himself in after a knock had no response, and reportedly Gibbs ran towards him, naked, and covered in blood, reports the Daily Mail.

The landlord then left and called the police. When the police arrived, they found blood on Gibbs and an open wound on Gibbs' dog, a Doberman. The dog had a large open wound on his ear, according to the Daily Mail.

When questioned about what had happened, Gibbs simply told them that he was trying to remove a cyst on the dog's ear when the police arrived. He had been using a butcher knife, and had turned on the tap water in the bathtub to clean up the dog, reports the Chicago Tribune.

Police said that he was "highly intoxicated" and that he told officers had had been drinking at Trump Tower earlier before coming back to his apartment, drinking another half a bottle of wine, and then starting to perform the "surgery" on his dog, reports the Chicago Tribune.

Luckily, the dog is now fine. He was conscious and even very pleasant toward officers, and was treated at the Chicago Veterinary Emergency & Specialty Care center, and has been turned over to Chicago Animal Care and Control, reports the Chicago Sun-times...

Riverside: Kaiser Permanente doctor failed to properly diagnose stroke patient

Riverside: Doctor failed to properly diagnose stroke patient
June 10, 2011
By LORA HINES
The Press-Enterprise
http://www.blogger.com/img/blank.gif
A Riverside woman has been awarded more than $1.2 million after an arbitrator found that her Kaiser Permanente doctor did not properly diagnose and treat symptoms that might have prevented her 2009 stroke.

Linda De La Rosa, who was 42, had a stroke on Jan. 2, 2009, less than two weeks after she went to Dr. Francis Chu complaining of decreased vision, seeing flashes of light and feeling pressure near one of her eyes, according to court records.

Chu examined De La Rosa on Dec. 22, 2008, and ordered a brain scan, which didn't reveal signs of brain bleeding or masses.

However, Chu didn't order an MRI, which experts testified probably would have revealed signs that De La Rosa might have had a mini stroke and could suffer a more debilitating and life-threatening stroke.

De La Rosa's January 2009 stroke left her with permanent weakness on her left side and diminished feeling on her right side, court documents state.

Tests performed after De La Rosa's stroke showed a large blood clot on one of her arteries, according to court records.

Arbitrator John W. Kennedy Jr. ruled that proper diagnostic testing and treatment would have revealed De La Rosa's problem and prevented a stroke.

Dr. Francis Chu has a valid medical license and no history of problems with the Medical Board of California.

He still works at Kaiser's Riverside medical center, according to health care provider's website.

Kaiser spokesman Jim Anderson said officials disagree with the arbitrator's decision, but will abide by it.

Chu had been De La Rosa's doctor for eight years before her stroke, court records state. De La Rosa's attorney Robert Vaage said Chu knew that De La Rosa was at risk for getting blood clots and suspected that one of the possible causes for her vision problems and eye pressure could have been a mini stroke.

Vaage said that Chu should have ruled out a mini stroke to prevent the possibility of De La Rosa having a more devastating stroke.

De La Rosa's arbitration award includes compensation for pain and suffering, loss of income and future medical care, Vaage said.

Cancer costs put treatments out of reach for many

Cancer costs put treatments out of reach for many
By Debra Sherman
Jun 6, 2011
Reuters

The skyrocketing cost of new cancer treatments is phttp://www.blogger.com/img/blank.gifutting advances in fighting the deadly disease out of reach for a growing number of Americans.

Cancer patients are abandoning medical care because the costs are simply too high and medical bills -- even among the insured -- are unmanageable and risk bankruptcy, studies show.

"There's a growing awareness that the cost of cancer treatment is unsustainable," said Dr. Lee Schwartzberg, an oncologist who did a study examining the factors that contributed to patients quitting their oral cancer drugs.

Cancer is one of the most costly diseases to treat, largely because many patients are treated over a long term, often with expensive new drugs that are complicated to produce and not available in generic form. And as insurance companies cut all benefits, reimbursements on cancer treatments have also declined.

"When it's an expensive drug, we have to have the hard discussion about a very substantial out-of-pocket payment. I ask: 'Do you want to spend this money for an average improvement of just a few months of life?' I'm very uncomfortable having those discussions because I want to focus on the patient getting better," Schwartzberg, medical director of the West Clinic in Memphis, Tenn., said in an interview.

Schwartzberg's and other cost studies presented at the American Society of Clinical Oncology (ASCO) annual meeting come as U.S. lawmakers battle over ways to reduce the national debt, including cuts in healthcare funding. For full ASCO coverage see [nN05141382]

ASCO president Dr. Michael Link, a pediatric oncologist, said access to healthcare should be a national priority.

INSURMOUNTABLE BARRIERS

"We're thrilled with what we consider to be breakthroughs and wonderful new therapies ... yet the barriers for some patients to get them is insurmountable. It is an indictment of how we take care of patients in the United States," Link said.

Cancer is the second-leading cause of death in the United States, after heart disease. The incidence is expected to increase with an aging population.

The costs for cancer care topped $124 billion in 2010 in the United States, led by breast cancer, according to the National Cancer Institute (NCI). That number is expected to rise as more advanced treatments -- targeted therapies that attack specific cancer cells and often have fewer side effects -- are adopted as the standards of care. The NCI projects those costs to reach at least $158 billion by 2020.

Until recently, almost all cancer drugs were administered intravenously. Today, about a quarter of them can be given orally, which means fewer visits to the doctor. But pills are often more expensive, have higher co-payments, and are reimbursed by insurers at lower rates than IV drugs, he noted.

Using a database of pharmacy claims paid by private insurers and Medicare, he found, not surprisingly, that those with higher co-payments quit their drugs more often.

Patients with co-payments of more than $500 were four times more likely to abandon treatment than those with co-payments of $100 or less, Schwartzberg said. Claims with the highest co-payments had a 25 percent abandonment rate, compared with 6 percent for co-payments of less than $100...