Brain Injury Patient Recovers with Radical New Drug

Story first appeared in The Detroit Free Press.

INDIANAPOLIS -- On the night of the Indiana State Fair stage rigging collapse, a mother had no idea whether her adult daughter would survive.

As Indiana University Health Methodist Hospital neurosurgeons operated on the injured young woman, hospital staff asked the family whether they wanted to enroll her in the experimental use of a drug to treat traumatic brain injury.  No proven medicine exists to treat traumatic brain injuries, but a sex hormone had produced promising results in earlier trials, the family learned.

At the time, the family did not know whether the patient, 30, would survive, much less say yes to anything ever again.  They chose to enroll her in the testing because it is what they felt she would want.

Eight months after the injury, the Pendleton, Ind., resident can walk and talk. She's in intensive rehabilitation in a Michigan facility, but she can already engage in those every-day activities that most people take for granted, like playing hide and seek and making cupcakes with her five year old daughter.

Neither the family nor her doctor knows whether she received the drug or the placebo, but they agree that her recovery has been remarkable.  The patient herself believes that she did receive the drug, because she has come so far with such a devastating injury.

In general young women recover from traumatic brain injuries better than young men, an insight that led scientists to study progesterone.  Studies with pregnant rats showed they recovered faster than nonpregnant rats, prompting the idea that progesterone, a hormone produced in high levels during pregnancy, played a role. Male rats who received progesterone also did better.  Now an international million study of 1,180 patients is exploring whether delivering progesterone to a victim soon after the injury makes a difference.  As of yet, there have been no drugs approved in the treatment of traumatic brain injury cases, this may be the first.

Doctors now provide supportive care to patients with traumatic brain injury, ensuring their blood pressure remains stable and their brains do not swell.  To be eligible to participate in the progesterone study, patients must have been injured within eight hours and be in a coma. Participants receive progesterone for the five days after the injury.  Doctors then follow the patients to see how they do on a variety of measures. An early preliminary trial of progesterone saw that the drug both lowered mortality and improved outcomes.

Neither patients nor health care providers will know for a few years whether they received progesterone or a placebo. So-called double-blinded trials -- such as the one the patient is in -- are standard in medicine to ensure that neither patient nor the doctor who is assessing them attributes faster, better recoveries to the drug being studied.

Finding patients within the window that treatment that would prove effective has posed a challenge.  Since some brain injury patients arrive at the hospital without identification, making it impossible for doctors to contact family members. In other cases, no one may know when the trauma occurred.

The patient was in the audience of the Sugarland concert on the evening of Aug. 13 when a gust of wind blew down the stage rigging at the State Fair's Hoosier Lottery Grandstand. Seven people died and dozens were injured.

She still doesn't know for sure what hit her that night, but she knows it was heavy. She has lost all memory of that night and the following three months.  At one point, doctors thought she might be paralyzed, but many of her abilities returned although she still can't use her left arm. This fall she will have another surgery on her skull.

BHR Pharma will do an interim analysis on results of the progesterone study at the end of this year and if the results are exceptionally good, they will make those results public.   If not, they likely will not have results until some time next year.

Still, patients like this one and another patient who is graduating from Purdue this spring have greatly impressed the medical community.  Most traumatic brain injury victims don't go on to graduate from college within a year of their brain injury.  That's a real spectacular outcome, and the medical officials don't even know if he got the drug or the placebo.

For more healthcare and medical related news, visit the Healthcare and Medical News blog.

St. Jude Under Fire for Faulty Device

Story first appeared in The New York Times.

As St. Jude Medical defends itself against reports of deaths and injuries linked to problems with an implanted heart device, it finds itself in familiar territory. Since 2005, two competitors, Medtronic and Guidant, have faced similar scrutiny about critical flaws in their products.  This could result possible medical malpractice claims coming to light in the near future.

But St. Jude is distinguishing itself with what doctors and others say is a rare response — a scorched-earth defense of its policies and products. The company’s chief executive has led that charge, accusing Medtronic of trying to undercut St. Jude to gain business. He and other company executives have also gone after a prominent researcher, contending he made crucial errors and showed bias in a study critical of a St. Jude heart device component at the center of the safety issue.

The mode of attack, however, may be backfiring. On Tuesday, the medical journal that published the report challenged by St. Jude said it had rejected the company’s request to retract it. And interviews suggest that some of the comments are upsetting some doctors essential to St. Jude’s success — specialists who implant heart devices.

On Wednesday, St. Jude shares climbed 70 cents to close at $39.23, but were still down more than 11 percent since March 30. The scope of the problem involving the component, a wire or lead that connects a defibrillator to a patient’s heart, is still unfolding. The lead, a model called the Riata, has been implanted in about 128,000 patients worldwide.

Electrical wires within the Riata lead are breaking through the insulation and causing unintended shocks in some patients. An even greater concern is that the wires may fail when needed to deliver a lifesaving jolt to restore a failing heart to normal beating. Minneapolis Medical Malpractice Lawyers view this as negligence, based on the fact that the company is aware of the device shortcomings.

The company stopped selling the Riata in late 2010. But the intensity of St. Jude’s response appears to reflect a high-stakes effort to protect its newer lead, the Durata, from any suggestion that it might be prone to the same problem.

The Durata has an added insulation sheath that St. Jude says should prevent the problem; thus far, it has a good safety record, but data is only a few years old.

It is little wonder, given the importance of the Durata to St. Jude’s future, that company officials would aggressively defend it. Still, their argumentative manner appears to run the risk of alienating physicians.

For example, in comments to Wall Street analysts in January, he described as a “nonevent” a recent meeting of leading device experts in Minneapolis who had gathered to better understand the safety problems posed by the Riata and how to address the lead’s risks in patients. Doctors are grappling with the issue of whether it is more dangerous to remove the lead if it is failing, or leave it in.

In his comments, St. Jude's chief executive seemed to minimize the meeting’s value, describing it as lightly attended. He added that he also saw it as a sales opportunity for St. Jude, claiming that many doctors in attendance used competitors’ products.

One expert who attended the meeting, said that St. Jude executives might better serve the company’s interests by focusing on patients and their safety. He and other doctors have complained that St. Jude was slow to respond to the Riata problem and initially tried to play it down.


Another expert, said she doubted the suggestion that the meeting was filled with physicians who did not use the company’s devices. However, the expert, who serves on the St. Jude medical advisory board, said she thought the company had been open in dealing with the Riata issue.

In a telephone interview Tuesday, St. Jude's chief executive said his public comments were not intended to be strident but added that he felt it was critical for him to correct mistaken information about St. Jude’s products.

He also said that his remarks about the Minneapolis meeting reflected his view that the safety issues surrounding the Riata had already been addressed by a professional group representing heart device experts. But St. Jude officials may also have been mindful of another issue: in a poll taken of experts at the beginning of the Minneapolis gathering, two-thirds of those who responded said they would reduce the number of newer Durata leads they implanted or not use them for now.

This is not the first time he and the company have taken a combative position: in 2009, St. Jude quit the industry trade group AdvaMed because he argued that the group’s stance on health care reform was placing some device makers like St. Jude at a disadvantage to others.

Some Wall Street analysts said the St. Jude chief executive was acting appropriately in his recent comments, by addressing concerns about the Riata lead without overreacting and scaring investors in the process. While still others feel he is acting rashly.


He said the company had sent him an e-mail contesting his report, then forwarded it to competing analysts. On Wall Street people are still trying to digest this level of aggression.

St. Jude, however, show no signs of backing off. On Tuesday, rather than react in a news release to the decision by the medical journal to deny its request to retract an article, St. Jude apparently shifted to Plan B.

It announced that it had posted data on the Internet intended to show that the researcher with whom it has clashed had made critical mistakes. In response, the opposing doctor said he stood by his report and that the difference between his findings and St. Jude’s reflected methodological, rather than substantive, differences.

Some doctors said that they were tired of the sideshow, and that what they wanted from St. Jude was information about how to deal with patients who have disintegrating Riata leads.

For more healthcare related news, visit the Healthcare and Medical News blog.

Illegal Immigrant Receives Kidney Transplant

Story first appeared in The New York Times.

When restaurant customers learned that the waiter they liked was in the hospital with kidney failure, they stuffed bills into a collection jar to help support his family. His brother offered something more precious: a healthy kidney to restore his life.

But for two years, the obstacles to the transplant seemed insuperable. The patient, the father of two American-born children, is an illegal immigrant. And a maze of conflicting health care and immigration policies meant that while the government would pay for a lifetime of dialysis, costing $75,000 yearly, it would not pay for a $100,000 transplant that would make dialysis unnecessary.  A Raleigh Immigration Lawyer is following the case.

Yet Tuesday morning, he and his brother were undergoing the surgery in adjacent operating rooms at Mount Sinai Medical Center. And all the other barriers receded in importance as doctors swabbed bare skin with antiseptic and prepared to cut.

The brothers had hugged when they met at 4 a.m. at a subway station in Brooklyn for the trip to Mount Sinai, in Upper Manhattan. Now, under the cool green lights of one operating room, the healthy brother was covered with blue sterile drapes, and his flesh was pierced with the tools of laparoscopic surgery, computer monitors showing an inner human landscape of pulsing blood vessels and vital organs.

In the second operating room, the patient, a small man in his 30s who had dwindled to 115 pounds during years of shuttling between work and dialysis, was soon draped too. Only his exposed abdomen and the beep of the heart monitor marked his living presence when the masked team prepared to slice and sew.

The patient's quest for a transplant was chronicled in a Dec. 21 article in The New York Times about a paradox in health care rules. In New York, Medicaid, the federal-state health insurance program for the poor, covers the cost of dialysis, considering it an emergency measure, regardless of whether the patient is a legal resident of the United States. But while a transplant is far cheaper in the long run, that procedure is covered by Medicare, which does not extend to illegal immigrants.  It would make sense to go ahead with the transplant regardless of the national status of the patient as long as it took care of the problem without extenuating circumstances, states an Immigration Lawyer in Raleigh.

The article drew more than 600 comments online, many expressing anger at illegal immigrants or frustration at the impasse in national immigration and health care policies. Others called for compassion and asked where they could send donations. About $14,000 from readers was collected with the help of a health lawyer at the New York Legal Assistance Group.

A wealthy Texas rancher pledged $75,000, which he felt should be enough to pay the whole cost of the operation. But it was not enough, and the confusion that reigns over health care costs, combined with philanthropic complications, almost derailed everything.

Mount Sinai, one of the world’s leading transplant centers, had originally set the price for the operation at $200,000 in advance, to cover any possible postoperative complications; it lowered that to $150,000, given the youth and health of the brothers, but barred further reductions as a slippery slope to unaffordable demands for uncompensated care.

A surgeon and the associate director of Mount Sinai’s Recanati/Miller Transplant Institute, had been trying to help the patient and refused to give up. In February, at her request, a former patient from Florida sent $75,000, to match the Texan’s pledge. But the Texan dropped out, irritated that what he called “legal aid” was collecting the donations, he said, and upset that the operation was going to cost more than it would at a Texas hospital where he is a trustee.

North Shore University Hospital volunteered to consider the brothers for a transplant and to absorb the cost. The patient, who like his brother did not want to be fully identified for fear of provoking immigration authorities, was grateful for North Shore’s offer, but decided not to start all over with tests there while doctors at Mount Sinai were still trying.

In the end, the associate director raised an additional $18,000 from an anonymous donor, and after much soul-searching, the hospital agreed to do the surgery for $100,000, the Medicare rate.

It was done by teams with years of experience, as diverse as the city itself. One doctor, a native of the Patagonia region of Argentina, maneuvered tiny tools that cut and cauterized at the same time, separating the healthy kidney from connective tissue in several hours of painstaking work.

He unfurled a special zip-lock bag inside the brother’s abdomen, first enveloping the kidney, and only then cutting it free from the blood supply and the bladder, and pulling the bagged organ through a small incision into the waiting hands of the director of the transplant institute.

The director of the institute, who grew up in Louisville, Ky., carried the kidney, cleaned and cooled, to the second operating theater, where a surgical technician born in Haiti was deftly reordering an array of scalpels, syringes and sutures.

In a safety ritual, a nurse from the Philippines called “time out,” invoking the patient’s name, birth date and blood type, and the organ he was about to receive.

The goal was to connect the kidney to the recipient’s blood flow in less than 45 minutes. It took 30.

For more health care related news, visit the Healthcare and Medical News blog.

Common Antibiotics Cause Emergency Eye Problems

Story first appeared in FoxNews.com.

A common class of antibiotics was linked to a higher risk of so-called retinal detachment -- when the light-sensitive tissue in the eye separates from gel that fills the eyeball, in a new Canadian study.

People treated by ophthalmologists for the emergency condition were five times more likely to be taking drugs known as fluoroquinolones, which include ciprofloxacin (marketed under names including Zoxan, Proquin and Cipro) and levofloxacin (Levaquin, Cravit), than those who didn't have retinal detachment.  Instances of retinal detachment in patients may result in personal injury claims, state Salt Lake Personal Injury Lawers.

Retinal detachment, which starts as the appearance of lines, dots or "floaters" across the eye, can cause permanent blindness in some cases if it's not surgically treated within a few days.

Data from doctors' treatment records for everyone in British Columbia who saw an ophthalmologist between 2000 and 2007 was used-- almost one million patients. That included about 4,400 people diagnosed with retinal detachment when they were an average of 61 years old.

Prescription records showed that one out of every 30 patients with retinal detachment was taking a fluoroquinolone at the time, most commonly ciprofloxacin. Most antibiotic users were taking the drugs for respiratory or urinary tract infections.

Among a similar group of patients who visited an ophthalmologist but didn't have retinal detachment, just one in 167 had been recently prescribed the antibiotics.

The researchers couldn't be sure why the drugs were tied to an increased risk of retina problems, but said the most likely explanation is that they damage fibers and connective tissue attaching the retina to the eye's vitreous gel.

There have been "lingering concerns" about the possible effects of fluoroquinolones on the eye for a while, said a doctor from the Bascom Palmer Eye Institute at the University of Miami Miller School of Medicine.
He told Reuters Health the new study suggests an association between fluoroquinolones and retinal detachment, but doesn't prove that everyone on the drugs will be at extra risk.

For example, it may be that people who are already prone to tendon problems -- such as older patients -- will be the ones who could be affected by certain drugs.

The extra risk due to the antibiotics was small. Etminan and his colleagues calculated that 2,500 people would need to be taking fluoroquinolones for any reason for one to have retinal detachment.
Another class of antibiotics that includes penicillin wasn't tied to more retina problems, the researchers reported Tuesday in the Journal of the American Medical Association.

Non-drug risks for retinal detachment include a past cataract surgery, being nearsighted or having an eye infection.

Bypass Surgery Better than Angioplasty?

Story first appeared in US News.

Study found those with multi-vessel heart disease showed reduced risk of dying four years later.
Patients over the age of 65 who have severe coronary artery disease fare better with bypass surgery than with minimally invasive angioplasty, a large, new study indicates.

Although there was no significant difference in mortality after one year, patients who had undergone bypass surgery had a 21 percent reduced risk of dying after four years compared to those who had received angioplasty, the researchers found.

The trend in cardiology more recently has been to favor angioplasty over surgery.

During angioplasty, cardiologists insert a small "balloon" into the blocked vessel via a catheter. Once in place, the balloon is inflated to widen the vessel. The procedure can be done with or without placing a stent, a wire mesh scaffold that keeps the vessel propped open.

Coronary artery bypass surgery involves grafting part of a healthy vessel onto the blocked vessel to reroute blood flow, bypassing the blocked part of the vessel.

The chair of cardiology at Christiana Care Health System in Newark, Del., said he did not envision an immediate sea change in clinical practice as the result of these findings.

A doctor and his colleagues combined information from two large databases which, all told, included about 200,000 patients, all elderly and all with more than one blood vessel blocked.

About 86,000 underwent surgery and 104,000 had angioplasty. Of those who had angioplasty, 78 percent received drug-eluting stents, 16 percent received bare-metal stents and 6 percent had no stents.

Drug-eluting stents, considered state-of-the-art, ooze a drug out into the artery that prevents scar tissue from building up.

Patients undergoing surgery tended to have more complications such as diabetes, lung disease and heart failure, although the authors did adjust for these factors.

Although the study was not a randomized, controlled trial -- considered the gold standard of medicine because those studies randomly assign people to different treatments and compares them with those who are untreated -- it had several advantages, including the fact that it was looking at a real-world population in real time.

This older population is very broad and represents probably the largest proportion of individuals who need this type of treatment, although the results probably can be extrapolated to other groups.

For more health care related news, visit the Healthcare and Medical News Blog.

Live Liver Donor Dies - Substandard Care a Factor?

Story first appeared on CNN.

2,500 live donors have shared liver in past 25 years; 4 have died since 1999

(CNN) - Before dawn on her 57th birthday, the donor's wife and her husband, the donor, piled into their brother-in-law's Lexus in Pelham, New Hampshire, with the donor's wife and her sister in the back seat and the men up front.  They never would have expected to end up needing the services of a Wrongful Death Lawyer in Westwood, Mass.

As the donor's wife sat in the waiting room with her sister that May morning two years ago, she prayed her husband's liver lobe would cure her brother-in-law. She prayed for her husband, too, but she was less worried about him, since she says the surgeons had reassured them while liver donation wasn't without risks, it was safe for him, a 56-year-old man in good health.

Neither of her prayers came true. Her brother-in-law died less than a year later, after receiving the transplanted part of the liver. He was 58. Her husband died that very day on the operating room table.

The donor, an electrician for the Florida Department of Transportation, was one of more than 4,500 people in the United States in the past 25 years who have donated a section of their liver while still alive. Death is rare -- besides this instance, only three other donors have died since 1999. 

The relatives of the other donors -- they died in 1999, 2002 and 2010 -- have gone public, but this is the first time the wife has discussed her husband's death.

Living organ transplants are a miracle of modern medicine. In all, more than 100,000 people in the U.S. have donated a kidney, a liver lobe or another body part while still alive to save someone else's life. Most of the time, the surgeries go well. Not only are donor deaths rare, but major complications of any kind are the exception rather than the rule.

This makes it all the more difficult to understand why he was one of the few who didn't make it.

After her husband was wheeled into surgery, the wife, her father-in-law and sister walked around the block a bit and got a bite to eat in the hospital cafeteria. Then shortly after 1 p.m., about four and a half hours after the surgery began, she says the coordinator of the transplant team came out to talk to them.

Sitting next to her, their knees nearly touching and speaking in a near whisper, she says the coordinator told her they were having trouble getting her husband's blood to coagulate and that an expert had been called in. Then about an hour later, the coordinator came out again to say her husband was having irregular heart rhythms.

The coordinator's cell phone rang, and she answered it. She hung up and rubbed the wife's arm, which she found strange, and told her she'd be back in five minutes.

When she returned, she asked the family to come into a small, private waiting room. The donor's wife remembers her father-in-law screaming, but the coordinator wouldn't say anything. The family sat there for about 40 minutes. Then the coordinator asked the family to go into a conference room farther away from the waiting area.

Suddenly the conference room filled with doctors, counselors and pastoral staff.

She stayed with her husband's body until the coroner came to take him away. She says the next day people from the hospital called her six times, offering condolences and to pay for her husband's funeral. She didn't want to talk to them.

Then in July, about two months after her husband's death, she stopped by her post office after grocery shopping to pick up her mail. In her box was a thick envelope from the Massachusetts Department of Public Health. Inside was a nine-page report with the details of what happened during the surgery.

Finally, she thought, her questions would be answered. Finally, she would find out why her husband died.

The Department of Public Health report gives a rare and gruesome picture of a surgical procedure gone horribly wrong.  A Medical Malpractice Lawyer in Detroit has been following the case.

The department's account is based on medical records, operating room communications and two days of interviews with the attending transplant surgeon and other doctors, nurses and administrators.

After she and her sister kissed their husbands good-bye, the men were wheeled into separate operating rooms. Everything went fine until about four hours into the operation, when a vein that carries blood away from the liver partially tore off and started bleeding.

The donor's surgeons immediately called for assistance. More doctors and nurses arrived in his operating room. It was to be the beginning of a two-and-a-half-hour fight to save him.

The partially torn vein came all the way off, and doctors sewed up that tear, but then they noticed bleeding coming from somewhere else. As they searched for the source, a clamp on a vein got knocked off, injuring the vein. Repairing that injury, they noticed more tears. They fixed those tears, all the while giving him blood products and drugs to raise his blood pressure.

It seemed like he might be getting better, but then he started to bleed from several areas all at once. His heart started to beat very fast. Doctors performed CPR and when that failed, they cut his chest open, massaged his heart directly, and shot drugs into his heart to get it going again. But none of it worked.

The donor was pronounced dead at 3:01 p.m. on May 24, 2010.

A spokeswoman for the Lahey Clinic, one of the largest liver transplant centers in the country, declined to comment about the details in the state's report. Lahey voluntarily stopped operating on living liver donors for about four months.

The Massachusetts Department of Public Health did not cite the hospital for any deficiencies. The Lahey Clinic conducted its own internal investigation into the donor's death and hired outsiders to conduct an external investigation. Lahey declined CNN's request for copies of both these reports.

The donor's widow read the Department of Public Health report sitting in her car in the parking lot of the Tampa post office. As she read the details of her husband's failed surgery, she wondered whether all the tears and bleeding were anyone's fault or were they just unavoidable consequences of surgery, inevitable events that statistically speaking happen sometimes, and he was just unlucky?

Three other items in the Department of Public Health report raised even more questions.

First, she found out he had been given a pre-operative EKG, and it was abnormal. It showed he might possibly have had a past heart attack, but then follow-up testing showed no evidence of poor blood flow to his heart.

The report doesn't say whether the donor knew about his abnormal EKG, or if a cardiologist was called in to evaluate whether his heart was strong enough to tolerate surgery. The Lahey Clinic spokeswoman, declined to answer questions about the EKG or about any aspect of the surgery or pre-operative care.

Secondly, the report pointed out that a special, high-speed blood pump wasn't used to give the donor blood.

The $20,000 device pumps blood at least three times faster than other pumps. Called a Belmont Pump, it's saved soldiers' lives as they lay massively bleeding on battlefields in Afghanistan and Iraq.

Lahey owns a Belmont Pump. At the time of the surgery, it was nearby in the receiving patient's operating room. But as the donor lay bleeding to death for two and a half hours, no one brought it in to his operating room.

Thirdly, the report describes how the surgeons never activated a set of procedures used when a patient is massively bleeding.  Called the "Massive Blood Transfusion Protocol," it directs surgeons to call the hospital's transfusion services and activate a set of procedures so a patient who's bleeding profusely can most efficiently get the blood products he needs.

The report notes that surgeons thought none of these things -- the abnormal EKG, the lack of the high-speed pump, the inactivated protocol -- contributed to his death.

Based on the lack of proper care, the clinic could be held liable for wrongful death, states a Salt Lake Medical Malpractice Lawyer.

Nonetheless, the report shows the hospital did think they could have done some things differently.

After the donor's death, staff questioned whether there needed to be a "higher standard" when evaluating patients with abnormal EKGs. They said it would have been "nice" to have had a Belmont Pump in the room. They educated staff about activating the blood transfusion protocol.

In the end, the Department of Public Health report didn't answer the widow's questions as she'd hoped. She still didn't know what had killed her husband. Nearly two years after her husband's death, she still has no peace and no closure.

The donor's widow located the widow of a donor who died in 2002.  She was introduced to a friend who may have been able to shed some light on the situation.

That friend was a nurse in Ohio who donated a kidney to her sister in 1994. Now an associate at the Center for Biomedical Ethics at Metrohealth Medical Center and Case Western Reserve University in Cleveland, the nurse has developed an interest in the ethics of living organ donation.  Working with the nurse, the donor's widow found out there was something else she didn't know about her husband’s surgery.

Most liver donors in the United States have "open" surgeries with a long incision across the abdomen. According to medical records obtained by CNN, her husband had laparoscopically assisted surgery, a minimally invasive technique with three very small cuts.

The advantage of "lap-assisted" surgery is a much easier recovery for the patient. The down side, surgeons say, is if a patient starts bleeding it can be harder to find the source since they can only look through small incisions rather than a very large one.

The nurse told her that she thought the Lahey surgeons might not have had much experience with "lap-assisted" surgeries on liver donors. The technique had only been used for a few years in the United States when her husband had his surgery, and some surgeons were trying it out for the first time.

A patient safety expert at Johns Hopkins University School of Medicine in Baltimore agrees.

A spokeswoman for Lahey declined to say how many laparoscopic liver donor surgeries had been done at Lahey before the donor's operation.

Three months after her husband died, another live donor died after donating a liver lobe to his brother in Colorado. His death received a great deal of media attention, and the American Society of Transplant Surgeons released a statement.

Now, nearly two years after her husband's death, after poring over the Department of Public Health report and her husband's medical records, she still wonders whether she could have done anything to keep from losing her husband on her 57th birthday.

She says there's one thing she knows she would have done differently. She had only enough time off work to fly from Florida to Boston for the surgery itself, so she wasn't there for his pre-operative testing. He did that on his own.

Now she wonders if Lahey gave her husband all the information he needed to make a smart decision about whether to go under the knife.

An inspection seven months after her husband's death by the federal Centers for Medicare & Medicaid Services (CMS) revealed that Lahey violated several federal rules for informing and protecting donors.

Under these regulations, each donor is supposed to be told about how other organ donors fared after their surgeries, both nationwide and at Lahey specifically. Studying the records for seven liver donors, CMS found Lahey failed to provide all of them with the most current surgical outcomes.

The chairman of surgery at Lahey when the donor died, agrees that the data wasn't as up-to-date as it should have been.

The CMS report noted that Lahey was out of compliance in another area.

Transplant centers are supposed to assign a staff person, such as a doctor or social worker, to be an independent advocate for the donor. The donor advocate is supposed to take into account only the donor's concerns -- for example, in this case, the abnormal EKG findings -- and not the concerns of the recipient, since sometimes there can be a conflict of interest between the two.

To make sure the advocate is focused solely on the donor, there's supposed to be a "wall" between the donor advocate and the recipient's team, but federal inspectors observed Lahey's donor advocate going on medical rounds and participating in meetings run by the recipient's team.

According to CMS, the hospital corrected the problems and was back in compliance with federal regulations about three months later.

The widow knows she may never get all her questions answered about why her husband died that May afternoon.

She looks back on the day her husband made the decision to donate part of his liver with a mixture of sadness and pride. It was Thanksgiving Day, 2009, and they were at a Cracker Barrel in Tampa with their two grown sons.

During dinner, her cell phone rang. When she answered the call and heard her sister crying, she excused herself to take the call outside.

When she returned to the table, she told her husband and their sons the bad news.  Her brother-in-law was very ill and would die if he did not receive a liver donation soon.  Getting a liver from a cadaver was out of the question since he was so sick he'd never live long enough to get off the waiting list.  Her husband and son immediately volunteered to get tested as possible liver donors for their family member.

Before the son could protest, the donor told his son he'd fly to Boston first to get tested first, and if he wasn't a match, then his son could try. That turned out not to be necessary, as the tests showed him was a perfect match.  Before the donor flew to Boston for the transplant, the couple's other son, saw his father off at the Tampa airport.

In retrospect, the other son wishes he had advised his father to get a second opinion from another doctor about whether he was healthy enough to give away 60% of his liver -- from a doctor who didn't stand to financially gain from the transplant.

But his family says before the transplant, the donor wasn't looking for advice. He was looking to do good. Being a living donor was just an extension of the goodwill he did in his regular life, they say, like helping elderly people in his church with their home repairs for free.

For more health care related news, visit the Healthcare and Medical News blog.
For more law related news, visit the Nation of Law blog.

Michigan Abortion Providers Violate Safety Protocols

Story first appeared in the Detroit Free Press.

LANSING -- Abortion providers operate with minimal or no state oversight in Michigan, resulting in widespread violation of requirements for ensuring patient safety, the disposal of medical waste and patient privacy, according to a report by Right to Life of Michigan presented Thursday to a state Senate subcommittee.

Only four of 32 surgical abortion facilities in the state are currently licensed, the Right to Life's legislative director told the subcommittee. That lack of oversight results in widespread unsanitary conditions and serial violations of reporting requirements and result in rampant malpractice claims according to Detroit Medical Malpractice Lawyers.

In at least two instances in the last 10 years, the death of Michigan patients from abortion complications were not reported to the state, according to Right to Life, the state's leading anti-abortion lobby.

The director of the Bureau of Health Systems, which is responsible for the licensing and inspection of abortion clinics and a variety of other medical and psychiatric facilities, conceded the state provides relatively lax oversight. But many of the shortcomings pointed out in the report stem from the fact that so few clinics are licensed.  The agency doesn't have the authority to inspect an unlicensed facility.  But inspections even at the licensed facilities are infrequent, because of limited manpower. The licensing fees paid by the clinics are inadequate to support even a single full-time inspector.

For more health related news, visit the Healthcare and Medical Blog.
For more law related news, visit the Nation of Law Blog.

Doctors Decide to End Certain Cancer Treatments

Story first appeared in the Chicago Tribune.

NEW YORK (Reuters) - In a move that threatens to further inflame concerns about the rationing of medical care, the nation's leading association of cancer physicians issued a list on Wednesday of five common tests and treatments that doctors should stop offering to cancer patients.  Medical Malpractice Lawyers in Virginia Beach are concerned about the repercussions of such a decision.

The list emerged from a two-year effort, similar to a project other medical specialties are undertaking, to identify procedures that do not help patients live longer or better or that may even be harmful, yet are routinely prescribed.

As much as 30 percent of health-care spending goes to procedures, tests, and hospital stays that do not improve a patient's health, according to a 2008 analysis by the nonpartisan Congressional Budget office.

A task force assembled by the American Society of Clinical Oncology (ASCO), a group of more than 200 oncologists, released the list from a report in its Journal of Clinical Oncology.

Although the task force emphasized that its recommendations -- winnowed from about 10 suggestions by oncologists -- were driven by medical considerations, the report makes clear that expense was a major factor. A number of cancer drugs cost nearly $100,000 but extend life a few months or not at all. Widely-used imaging tests cost up to $5,000 yet do not benefit patients.

The list has been closely guarded, with public announcements scheduled for Wednesday. Patients, advocacy groups, and policy experts contacted by Reuters were mixed in their reaction to the recommendations.


PATIENTS VS. FINANCIAL INTERESTS

Advocates for cancer patients applauded the recommendations.  However, this could be seen as administration of substandard care by patients and charged as medical malpractice as a Salt Lake Medical Malpractice Lawyer has indicated.

Following the science, however, can lead to conclusions that do not sit well with all patients. A patient, who was diagnosed with metastatic breast cancer eight years ago and has been in remission since 2007, has already felt the brunt of one of the recommendations: that patients who have been successfully treated for breast cancer and have no symptoms of cancer not undergo CT, PET, other imaging, or bone scans to check for a recurrence or spread of the disease, known as metastasis.

Her insurer, guided by the same kind of studies that served as the basis for the ASCO list, would not cover the scan, citing that it provides no benefit.

ASCO recommends against routine use of four other procedures: chemotherapy for patients with advanced cancers who are unlikely to benefit; advanced imaging technologies such as CT and PET or bone scans to determine the precise stage of both early breast and prostate cancers at low risk for metastasis; and drugs to stimulate white blood cell production in patients receiving chemotherapy if they have a risk of febrile neutropenia, an often-fatal condition marked by fever and abnormally low numbers of certain white blood cells.

The supporting evidence for each recommendation is expected to surprise patients and even some physicians, since these very widely-used tests and treatments have little or no scientific basis, said Schnipper.

WITHHOLDING CHEMOTHERAPY

One recommendation likely to stir controversy, and even revive charges of "death panels," is to not use chemotherapy and other treatments in patients with advanced solid-tumor cancers such as colorectal or lung who are in poor health and did not benefit from previous chemo.

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Unnecessary Medical Treatments Published As Harmful

Story first appeared in The Boston Globe and boston.com.

Nine medical specialty groups have released a list of 45 tests and procedures that patients often do not need - even though doctors routinely perform them. They include annual electrocardiograms, CT scans for low back pain, and chest X-rays before surgery.

Ordering these tests when they are not merited wastes money and can harm patients by exposing them to radiation and more unneeded medical procedures, the physician groups said. A Baltimore Medical Malpractice Lawyer has been following the story as an example of unneccesary treatments which could result in patient harm.

Recent estimates suggest that nearly 30 percent of the money Americans spend on health care is wasted, said the president of the American Board of Internal Medicine Foundation, a nonprofit organization based in Pennsylvania that is overseeing the project.

Doctors sometimes push these tests because they are not up to date with research questioning their effectiveness or because the tests generate revenue. But the physicians involved in the project said patients also play a role by demanding procedures they don’t need.

As a result, the foundation and the nine medical groups have partnered with Consumer Reports and 11 other consumer organizations to disseminate the list to millions of consumers.

The groups say the list will help combat defensive medicine, the practice of performing tests and procedures out of fear of malpractice lawsuits if a problem is missed.  However, if a complication from unneeded treatment does occur, a medical malpractice suit is a sure thing, a Medical Malpractice Lawyer in Baltimore points out.

The nine organizations that are part of the “Choosing Wisely’’ campaign - American Academy of Allergy, Asthma & Immunology, American Academy of Family Physicians, American College of Cardiology, American College of Physicians, American College of Radiology, American Gastroenterological Association, American Society of Clinical Oncology, American Society of Nephrology, and American Society of Nuclear Cardiology - each reviewed medical evidence over months and settled on a list of five tests and procedures that are often overused.

The complete list includes additional detail about when a test or treatment may be appropriate based on clinical evidence and guidelines. None of the groups estimated the number of unneeded tests performed or their cost.

The list includes widely used treatments, such as giving antibiotics for colds that last a week or less or ordering brain scans for uncomplicated headaches in generally healthy, low-risk patients.

But the specialty societies also include unnecessary tests and treatments given to sick patients, such as bone scans for early-stage prostate and breast cancer with little chance of spreading.

An oncologist at Beth Israel Deaconess Medical Center and chair of a national task force on the cost of cancer care, said that even when professional organizations issue clinical guidelines for oncologists to follow, many don’t adhere to them.

It can be even harder for doctors to say no to patients with advanced disease, even if the test or treatment will do them no good, said a nephrologist at Tufts Medical Center who helped draw up the list of potentially unneeded procedures for the nephrology society.

For example, that group recommends against routine cancer screenings such as mammography, colonoscopy, prostate-specific antigen, and Pap smears for patients on dialysis with limited life expectancy.

In other cases, such as cardiac stress tests given in a doctor’s office, physicians may have financial incentives for performing the test, the societies’ leaders said. Or, as with routine chest X-rays before surgery, the procedure has become habit when there is no reason for it.

About a year and a half ago, the chief executive of the American College of Physicians tore cartilage in his knee and needed surgery. When he scheduled the procedure, the receptionist said he needed a chest X-ray and various other tests even though he is healthy and never smoked or had lung disease.

Swine-flu Prescription Harmful to Children

Story first appeared on TheRealNews.com

Scientists urge the government to rethink its strategy of giving swine flu anti-virals to some children because the harmful side effects outweigh the preventative benefits.  A Baltimore Medical Malpractice Lawyer is following the story, as this could result in instances of incorrect prescriptions given or complications as a result of prescription.

Researchers have found that Tamiflu and Relenza may only reduce symptoms by one day in children up to 12-years old - and balanced against potential side effects they say it's not worth the risk.

The authors of the study have called on the Department of Health to urgently rethink its strategy and believe a more conservative approach should be taken to treating swine flu in this age group.

And the drug had little or no effect on asthma flare-ups, ear infections or the likelihood of a youngster needing antibiotics.  Their study found that Tamiflu caused vomiting in some children, which can lead to dehydration and complications.  The drug tended to only reduce the illness by a single day, and caused cases of vomiting in children.  Unfortunately, the side effects of vomiting in children is also in addition to the vomiting induced by the illness which could result in severe dehydration in children.

The Deputy Director of the Centre for Evidence-Based Medicine at the University of Oxford, told Channel 4 News at Noon that in any treatment you take the benefits of the treatment and relate them to the harms.