PharmD|Pharmacy Schools : 2007 : 2007_11_14

4 patients get HIV from organ donor

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Tue, 13 Nov 2007 23:12:41 GMT
By LINDSEY TANNER, AP Medical Writer

CHICAGO - A troubling case in which a high-risk organ donor infected four patients with the AIDS virus and hepatitis has led medical ethicists to warn that patients need to know more about whose organs they're getting.
Public health officials said Tuesday the Chicago case is the first known instance of HIV transmission through organ transplants since 1986.

It's also the first ever known instance in which one organ donor has spread hepatitis C and HIV at the same time, said Dr. Matt Kuehnert of the federal Centers for Disease Control and Prevention.

The CDC and other public health officials are investigating the Chicago cases.

But they emphasized that the risk of getting any disease from transplanted organs is less than 0.01 percent. Noting that more than 400,000 transplants have occurred nationwide in the past two decades, they called the transplant system safe.

But it's not 100 percent safe: Standard testing failed to detect HIV in the Chicago case. People waiting for organs should be told as much pertinent information as possible about potential donors, said University of Pennsylvania medical ethicist Art Caplan.

Transplant surgeons generally decide what information is given to patients and their families. Sometimes it's not much because of the circumstances — patients are very sick, organs are scarce and usable for only a short time, Caplan said.

"You really have to put your faith in the transplant surgeon," agreed Ronald Taubman, who received a kidney-pancreas transplant six years ago.

The suburban Los Angeles man said he rejected one kidney because of concerns raised by his doctor, and was lucky that a better one became available.

But Caplan noted that not all patients have that choice.

"It's obviously very, very difficult because the availability of organs is such that if you pass, there's a possibility you won't get one," he said. Still, the Chicago case shows that to make an informed decision, patients "have a right to more information" than doctors often give, Caplan said.

Not every aspect of a potential donor's life is fair game, but patients have a right to know "if a donor dropped dead in a bathhouse with a needle in his arm," Caplan said.

It's not clear why the donor in the Chicago case was considered high-risk, or how much the four patients were told. But University of Minnesota ethicist Jeffrey Kahn said it underscores the importance of the consent process "and an individual's right to decide what's right for them."

Officials declined Tuesday to identify the Chicago patients, the donor or what organs were transplanted.

The four patients got their organs in January at Northwestern Memorial Hospital, Rush University Medical Center and the University of Chicago Medical Center. Two had their operation at the University of Chicago hospital.

That hospital issued a statement Tuesday saying the donor died after "traumatic injury" but wouldn't provide more detail.

The cases came to light within the past two weeks after one of the patients was evaluated for a possible "re-transplant" and had blood tests, the hospital said.

A screening questionnaire revealed that the donor had engaged in high-risk behaviors, said Alison Smith of Gift of Hope Organ & Tissue Donor Network, the Elmhurst, Ill., group that procured the organs. She declined to elaborate, citing privacy concerns.
High-risk behaviors include gay men having sex within the past five years, people having sex for money or drugs within the past five years, and intravenous use of recreational drugs within the past five years. The CDC says people in any of these categories should be excluded as organ donors unless the need outweighs the risks.
The Chicago hospitals were told that the donor was high-risk, but none would say what information was relayed to the patients or their families.
Initial tests on the donor for HIV, hepatitis and other conditions came back negative, most likely because the donor had acquired the infections in the last three weeks before death.
It takes 22 days from the time of exposure to HIV for antibodies to be picked up in the standard HIV test. During that time, a person can still be infectious.
Because of that lag, there's growing support for a newer costlier test that can detect the virus earlier but takes several hours longer to get results.
Not many centers use it, including the Gift of Hope. Because of the Chicago cases, momentum favoring it likely will grow, said Dr. Michael Millis, chief of transplantation at the University of Chicago Medical Center.
"We have to reassure the person that's coming in for a transplant tomorrow that the transplant system is safe," said Millis, who supports use of the newer test. "Can we do better? I think we can."
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CDC: http://www.cdc.gov

Iraq vets may suffer depression stress

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Tue, 13 Nov 2007 23:08:48 GMT
By CARLA K. JOHNSON, Associated Press Writer

CHICAGO - The euphoria of a soldier's homecoming from Iraq often gives way to depression, stress and trouble dealing with family members during the first months home, a new Pentagon study finds.
And the adjustment struggle was more profound for National Guard troops and reservists than it was for active-duty soldiers.

About 42 percent of the Guard and reserves, compared to 20 percent of active-duty troops, were identified as needing mental health treatment in two screenings. The first testing was immediately upon return from Iraq and the second six months later.

Problems showed up more often on the second screening. From the time they returned, there was a fourfold increase in interpersonal problems, for example, likely driven by family conflicts as the returning soldiers adjusted to home life.

Almost a third of the more than 88,000 returning soldiers in the study had signs of depression, post-traumatic stress disorder, conflicts in relationships or other problems after six months.

That compared to about 17 percent when the soldiers first got home, according to the report that appears in Wednesday's Journal of the American Medical Association.

"We're trying to study these mental health impacts as the war unfolds and we're trying to apply what we're learning to set up new systems of care," said Dr. Charles Milliken of the Walter Reed Army Institute of Research, who led the study.

Questions about alcohol, which were only on the second questionnaire, found that 12 percent of active-duty soldiers and 15 percent of National Guard and Reserve soldiers said they were having drinking problems six months after returning home.

But alcohol treatment was rare. Of more than 6,600 active-duty soldiers with drinking problems, only 134 were referred for treatment and only 29 were seen within 90 days, the study found.

"We still have some work to do. The referral rate was low," Milliken said.

Alcohol treatment in the military is not confidential; in fact, it triggers the automatic involvement of a soldier's commander. That may explain the small percentage getting help, Milliken said.

Iraq veterans are being screened for mental health problems earlier and more often than previous vets. Shortly after starting the ground war in Iraq in 2003, the Pentagon began requiring returning troops to complete a three-page survey that is used to decide who needs help.

Among other things, the veterans are asked if they have nightmares, are constantly on guard or easily startled, and whether they feel numb or detached from others.

In the new study, the higher rates of problems reported by the Guard and reserves may reflect a need to document problems so treatment can be paid for by the military or Veterans Affairs, Milliken said.

For those citizen soldiers, the military's Tricare health insurance benefits expire after six months; VA benefits expire two years after a soldier's return to civilian status.

A report released in June said more money and people are needed to care for troops suffering mental health problems because of their war experiences. It also said the Pentagon needs to build a culture of support in the military to help remove the stigma of seeking psychological help.

Brig. Gen. Stephen L. Jones, an assistant surgeon general, said the military is making headway on that front.

The Army has created a training program called Battlemind that helps troops and families prepare for the stress of war and what signs of trouble to watch for.
"We're teaching our soldiers that seeking care is a sign of strength not of weakness," Jones said.
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On the Net:
JAMA: http://jama.ama-assn.org
Army: http://www.behavioralhealth.army.mil/

Medical privacy rule may hurt research

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Tue, 13 Nov 2007 23:09:01 GMT
By CARLA K. JOHNSON, Associated Press Writer

CHICAGO - A federal patient privacy rule has had a chilling effect on medical research, making it tougher to recruit patients and use their health records, the first national survey on the topic suggests.
Two-thirds of the more than 1,500 epidemiologists surveyed said the Health Insurance Portability and Accountability Act, also called HIPAA, has made their research more difficult.

Important research has been stymied by the privacy rule, said Dr. Roberta Ness of the University of Pittsburgh, who led the survey. One in nine researchers said they had abandoned a research idea because they thought it wouldn't be approved because of the HIPAA privacy rule.

A Pittsburgh colleague of Ness' said enrollment in a study on preeclampsia, a complication of pregnancy, dropped from eight women a week to one per week because of HIPAA. Researcher Nina Markovic said they weren't allowed to look at patient information and recruit women only for the preeclampsia study. Instead, clinic staff had to ask patients to join a registry that gave all researchers access to their medical charts.

Eventually, the researchers reached a compromise with the hospital and got the recruitment rate up to four women per week.

"We never did reach our final estimated recruitment numbers," Markovic said.

The rule also put on hold a 25-year study of stroke and heart disease that used the medical records of more than 40,000 Minnesotans, said Dr. Russell Luepker of the University of Minnesota.

"We've been waiting to see if HIPAA becomes more clear and defined and reassures the hospitals that they're not going to jail if they work with us," Luepker said.

The survey results appear in Wednesday's Journal of the American Medical Association. The Web-based survey had weaknesses, Ness acknowledged. Respondents were recruited by e-mail sent to more than 10,000 members of 13 epidemiology societies, so individuals could have answered the survey more than once. Scientists with strong feelings may have been more likely to participate, which would have skewed the results.

A privacy advocate said the protections offered by HIPAA are needed and desired by patients.

"The public DOES overwhelmingly support research but not without consent," said Dr. Deborah Peel of the Patient Privacy Rights Foundation, a watchdog group, in an e-mail.

Most Americans want to know how their personal medical records are used in research and want to be asked for their consent before those records are used, Peel said.

Medical research was never the target of HIPAA. It was intended to make it easier for people to keep their health insurance coverage when they change jobs. HIPAA, which went into effect in 2003, set standards for protecting patient privacy during the electronic transfer of information.

The rule makes exceptions for certain research. Public health agencies can monitor disease outbreaks, for example. And scientists can seek waivers to analyze health records without authorization from each patient. Researchers also can use data that has been stripped of information that would identify patients.

The rule has resulted in longer consent forms that patients are less likely to read before taking part in research, said Dr. Norman Fost of the University of Wisconsin School of Medicine. Fost, who was not involved in the survey, wrote an accompanying editorial in JAMA.

"Patients are worse off. They are drowning in more material and don't know where to start," Fost said in an interview.

Institutional review boards, which oversee research, spend valuable time complying with HIPAA requirements that could be better spent on protecting the rights of research subjects, Fost said.

"It's like requiring pilots to make sure tray tables are in their full upright and locked position when they should be flying the plane," he said.
The survey was commissioned by the Institute of Medicine, which has a committee studying the issue.
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On the Net:
JAMA: http://jama.ama-assn.org
HIPAA: http://www.hhs.gov/ocr/hipaa

Plastic surgery complications rare

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Tue, 13 Nov 2007 23:11:59 GMT

LOS ANGELES - Plastic surgery is generally safe, but like any operation, it does carry risk of complications. Grammy winner Kanye West's mother died Saturday after having plastic surgery, and an initial coroner's investigation said Donda West's death may have been due to surgical complications.
A 2004 study in the journal Plastic and Reconstructive Surgery found that serious complications from tummy tucks, breast enlargement or reduction, liposuction and other cosmetic fixes were rare.

Out of 411,670 procedures analyzed at certified office-based surgery centers over a 2-year period, researchers found serious complications occurred in 1 in 299 cases. Complications included bruises, infections, respiratory problems and heart problems. Death occurred in 1 in 58,810 procedures. The risks from surgery done in offices is comparable to procedures done in hospitals, according to the researchers.

"Surgery is still surgery. There is always some risk," said Dr. Richard D'Amico, president of the American Society of Plastic Surgeons.

Almost 11 million cosmetic surgery procedures were done in the United States last year, up 7 percent from 2005, according to the society.

To minimize the risks, experts recommend finding a well-trained surgeon and getting an extensive medical checkup beforehand to determine if existing health problems may interfere with the surgery or recovery.

___

On the Net:

American Society of Plastic Surgery: http://www.plasticsurgery.org


Occasional binge drinking may not harm fetus study

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Wed, 14 Nov 2007 00:09:48 GMT
By Michael Kahn

LONDON - Pregnant women who occasionally overindulge in a night of drinking may not be harming their fetuses but more evidence is needed to determine whether this is really the case, British researchers said on Wednesday.
A review of 14 studies also suggested children whose mothers binge drank throughout pregnancy may suffer learning problems later in life, prompting a call for further research to see if any links exist.

&;Just because we haven't been able to find much evidence doesn't mean there is no effect,&; said Ron Gray, a clinical epidemiologist at the University of Oxford, who led the study. &;Our view is there needs to be more research.&;

A number of studies have linked heavy drinking on a regular basis during pregnancy to stunted growth, birth defects and brain development problems.

Less clear is the effect of occasional binge drinking, which amounted to about 5 drinks in one session in the studies Gray and his team reviewed.

The researchers initially identified more than 3,500 scientific papers between 1970 and 2005 looking at pregnancy and alcohol, which they winnowed down to 14 focusing on binge drinking.

LITTLE EVIDENCE

They found little substantive evidence binge drinking once in a while caused problems such as miscarriage, stillbirth, abnormal birth weight, or birth defects such as fetal alcohol syndrome.

But one study suggested binge drinking could damage brain development resulting in reduced verbal IQ, learning problems and poorer academic performance.

&;However, this study only counted women as bingers if they binged throughout pregnancy, not just on a single occasion,&; the researchers wrote.

Animal studies have shown harmful effects from binge drinking, which means pregnant women should still take care no matter how much they consume, Gray said.

At the same time until researchers have more evidence, women who binge drink on occasion should not fret unnecessarily about potential harm they are causing to their fetuses, he added.

&;When pregnant women report isolated episodes of binge-drinking in the absence of a consistently high daily alcohol intake, as is often the case, it is important to avoid inducing unnecessary anxiety as, at present, the evidence of risk seems minimal,&; the researchers wrote.




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