31 July 2010

Researchers Engineer Malaria-Proof Mosquitoes

LA Times


The parasite that causes the disease is unable to infect the genetically modified insects, a possible step toward eradicating the infection that kills nearly 1 million people a year.

Malaria kills nearly 1 million people a year, but it has a weakness — to infect humans, it needs mosquitoes. In a potential step toward eradicating the disease, researchers report that they have developed a genetically engineered breed of mosquito that cannot be infected by the malaria-causing parasite.

Genetically-modified mosquitoes are far from ready for use in the field, but the researchers achieved an unprecedented 100% blockage of the Plasmodium parasite, highlighting the promise of this approach, according to their study.

 The team, led by entomologist Michael Riehle at the University of Arizona, created the mosquitoes by changing a single gene, one involved in the production of insulin. To test the effect of that change, researchers injected 90 of the mosquitoes with the malaria parasite. Ten days later, at a point when normal mosquitoes would have bellies full of parasites, they didn't find a single one.

This is the first instance of a genetic modification that completely blocked development of a malaria parasite that can infect humans. The research was reported online this week in the journal PLoS Pathogens.

"We were just hoping to see any reduction," Riehle said. "We were pretty shocked that it was that great."

Total blockage is not only impressive, it's biologically crucial. Other groups have achieved 90% to 95% blockage by combining various genetic alterations, but such less-than-perfect protection could allow the parasite to evolve around the mosquito's blocking mechanism, in much the same way that drug-resistant bacteria can arise if antibiotic treatments aren't completed.

The researchers used a slightly modified version of a cellular signaling gene that already exists in mosquitoes. That signaling process influences the mosquito's life span, as well as its immune response. By targeting this gene, they were aiming to create insects that died young so that the malaria parasite didn't have the 16 days in the mosquito gut it needs to mature.

It worked — the mosquitoes on average lived about 20% shorter lives than normal mosquitoes. The complete blockage of the parasite development was an unexpected bonus. The researchers don't yet understand how the genetic change makes the mosquitoes malaria-proof.

Despite this genetic engineering success, there are two main hurdles before such mosquitoes could be used to reduce malaria infections. First, the modified gene would have to spread throughout the entire mosquito population. Normally, this would occur only if the gene provided a great evolutionary advantage, but these malaria resistance genes don't have that effect.

"It's like a train," said Mark Benedict, a medical entomologist and consultant for the Centers for Disease Control and Prevention. "You've got to have a car — that's the gene — but you've got to have an engine as well." The engine could be provided by connecting the gene to a piece of DNA that helps it spread by, for example, producing something that kills any mosquitoes that don't contain the desired gene. Other research groups are working to develop such clever genetic tricks, but they are still years away from implementation.

 It is also possible that releasing an engineered flying insect into the environment could prove damaging to other plants and animals. Before researchers could undertake any field trials, they would need to do extensive safety testing.

Riehle suspects that, in time, researchers will perfect their ability to effectively use genetically modified mosquitoes and that governments and public health organizations will work together to deploy them. However, experts agree that such an approach is at least 10 years away, if not 20 or more.

Even so, researchers are optimistic that genetic engineering of mosquitoes will be an important piece of the malaria-prevention puzzle.

"The investment is well worth it," Benedict said. "The power to affect human health in a positive way is tremendous."

Vaccines are also expected to be a crucial part of the malaria-fighting effort. A two-pronged approach that targets both disease-transmitting mosquitoes, perhaps via genetic engineering, and susceptible human populations, probably by vaccines, will probably be required for eventual eradication of the disease.

"We definitely don't imagine this to be the magic bullet," Riehle said of his mosquito, "but it's another tool in the toolbox."

30 July 2010

Vaccine Urged as Whooping Cough Epidemic Grows

Fresno Bee

State health officials today urged more Californians to get vaccinated for whooping cough, as the disease grew to epidemic proportions.

To date, about 1,500 people in California have become infected with pertussis -- a five-fold increase from the same time last year. Five infants, all under 3 months old, have died from the disease, and one additional case is under investigation by the California Department of Public Health.

"We are facing what could be the worst year for pertussis that this state has seen in more than 50 years," said Dr. Gilberto Chavez, the agency's chief of the state's Center for Infectious Diseases.

Health officials are recommending more people get vaccinated, including anyone 7 years and older. In particular, women of childbearing age -- before a planned pregnancy, during gestation or immediately after childbirth -- should get immunized.

Those over 64, especially grandparents caring for infants, should also get the vaccine -- as should other people who have contact with infants or pregnant women.

While adults usually recover quickly from whooping cough, infants, because of their delicate airways, have more difficulty surviving an infection.

Researchers use Ecstasy to Treat PTSD

US News & World Report

 
A small study suggests that the illicit "club drug" Ecstasy may have one positive use: making psychotherapy more effective for people with post-traumatic stress disorder (PTSD).

The drug, also known by its chemical acronym MDMA, appears to benefit patients for whom standard treatments have failed. But experts stressed that the study is preliminary and safety issues must be resolved before any recommendations can be made.

"PTSD treatment involves revisiting the trauma in a therapeutic setting, but many patients become overwhelmed by anxiety or numb themselves emotionally, and so they can't really successfully engage," said study lead researcher Dr. Michael Mithoefer, a psychiatrist in private practice in Charleston, S.C. "But what we found is that the MDMA seemed to temporarily decrease fear without blunting emotions, and so it helped patients better process their grief."

In PTSD, the sufferer typically "relives" the trauma via flashbacks or in other ways, such as becoming hyper-vigilant to everyday sounds. Other mental health issues include depression, anxiety disorder, adjustment disorder and alcohol and substance abuse.

Mithoefer and his colleagues studied 20 patients who'd had PTSD for an average of 19 years but had failed to get relief from psychotherapy and medications. The study participants underwent two eight-hour psychotherapy sessions scheduled about a month apart, with 12 patients taking MDMA, and eight taking a placebo. Subjects were also given psychotherapy on a weekly basis before and after each experimental session. An independent psychologist evaluated each patient's symptoms of PTSD prior to and after the sessions.

At the end of the trial, more than 80 percent of the patients who received a combination of MDMA and psychotherapy no longer met the diagnostic criteria for post-traumatic stress disorder, compared with only 25 percent of the placebo group. In addition, the three patients who reported being unable to work due to post-traumatic stress disorder were able to return to work following treatment with MDMA.

During the trial, none of the patients had any drug-related side effects or neurocognitive problems related to the drug, the researchers reported.

The study is the first completed randomized, double-blinded clinical trial to evaluate MDMA as an adjunct to psychotherapy in any patient population, the researchers said. It was sponsored by the Multidisciplinary Association for Psychedelic Studies, a Belmont, Mass.-based nonprofit group that focuses on the medicinal uses of psychedelic drugs.

The phase 2 study, the second of three phases of research required by the federal government before approving a drug for a specific use, was published online July 19 in the Journal of Psychopharmacology.

Before MDMA began to be used recreationally under the street name Ecstasy, many psychiatrists and other therapists in the United States and Europe used the compound as a catalyst to psychotherapy, the study authors noted. However, the drug has been illegal in the United Kingdom since 1977 and was criminalized in the United States in 1985.

People with post-traumatic stress disorder who may want to experiment with the drug should know it can be dangerous when not used properly, Mithoefer said. "It needs to be taken in a therapeutic setting with careful monitoring and a lot of follow-up to help patients integrate the experience successfully," he said. "I've had patients with PTSD outside the study tell me that they've used MDMA at a party and had bad experiences, because when feelings about the trauma came up, they weren't prepared to deal with them."

One important limitation of the study, Mithoefer said, was that most participants guessed accurately whether they were in the treatment or the placebo group, and trial investigators could detect raised blood pressure and other symptoms in the MDMA group. He added that an upcoming phase 2 trial -- looking at the effects of MDMA-assisted therapy on veterans with PTSD -- will hopefully avoid this problem, since all patients will receive the drug, but in different dosages.

Another PTSD researcher said the study results were intriguing but added that important safety concerns need to be resolved.

"Some animal studies have shown that MDMA is a neurotoxin, so there's a lot of work that needs to be done to make sure there are no long-term side effects," said Keith A. Young, co-director of the Neuropsychiatry Research Program at Texas A&M Health Science Center College of Medicine.

Young, who is also core leader of the VA Center of Excellence for Research on Returning War Veterans in Waco, predicted that the findings would spur more research. "A lot of clinical scientists will be interested in seeing this data," he said.

29 July 2010

Researchers Find Way to take the 'Shot' out of the Flu Shot

LA Times

The microneedles on this flu patch are shorter than the width of a nickel. (Georgia Tech, Sean P. Sullivan / July 19, 2010)
 
There are so many things wrong with flu shots. For starters, they usually involve needles. The alternative, spraying vaccine up into the nose, isn't exactly comfortable either.

There are logistical problems too. Flu vaccine has to be kept refrigerated or else it will go bad. The shots and sprays must be administered by a doctor or nurse, which typically necessitates a trip to a medical office. Then there is the problem of disposing of so many syringes and spray tubes.

If only there were a way for people give themselves the flu vaccine. It would have to be simple — as easy as applying a Band-Aid. It would have to be painless. It would have to work at room temperature and be available at the corner drugstore. And, as long as we're dreaming up this wish list, why not insist that it not produce any biohazardous waste?

Well, dear reader, you'll be happy to hear that the good folks at Georgia Tech and Emory University are a few steps ahead of you.

These researchers have invented a microneedle patch that can deliver flu vaccine painlessly to the skin. Here's how they describe it in a paper published online Sunday in the journal Nature Medicine:

"Microneedles are micron-scale structures that painlessly pierce into the skin to administer vaccines in a minimally invasive and targeted manner."

Each microneedle is 650 microns long, about as tall as 10 human hairs stacked on top of each other. (In the picture accompanying this post, you can see that the needles are significantly shorter than a nickel laid on its side.) They are arrayed in a grid-like pattern on a patch that's easy to stick on your arm. The researchers experimented with one by pressing it onto the skin of a pig cadaver and found that nearly 90% of the microneedles dissolved within five minutes.

It turns out the skin is a great place to inject vaccine. As it forms a natural barrier between your internal organs and the outside world, it is fairly brimming with cells that are on the lookout for foreign invaders and stand ready to initiate an immune response when any are detected. Some studies have found that flu vaccine can be given in lower doses if injected into the skin instead of the muscle (which is where needles deliver their payload).

The researchers put their flu patch to the test by giving it to mice and comparng them to other mice who got their vaccine in an old-fashioned needle. Both groups of mice made flu antibodies and were able to withstand a flu challenge 30 days after vaccination. None of the unvaccinated mice survived beyond six days.

Two months later, the researchers infected both groups of immunized mice again. The ones who got the flu patch were 1,000 times more efficient at clearing the virus from their lungs than the ones who got the flu shot.

"Overall, these results show that dissolving microneedle patches offer an attractive approach to administer influenza vaccine with improved safety, immunogenicity and logistical operations that may enable an increased population coverage for influenza vaccination," the researchers concluded. Moreover, their patch "also provides a new platform technology for simple administration of other vaccines and medicines to skin without the need for hypodermic needles."

28 July 2010

The Do-It-Yourself House Call

The Wall Street Journal

Technology that aims to keep congestive heart failure patients out of the hospital is gaining traction.

 
 
 
The idea is for heart patients to take readings like their weight, blood pressure and other key metrics using wireless and other technologies; the data are then transmitted to a case manager or medical care giver. That way health care givers can catch, and address, warning signs before the patient lands in the ER with shortness of breath or a heart attack. In the past, patients have found such technology difficult to use. But a number of managed-care companies are experimenting with electronic devices meant to make the process easier.

A big benefit is that it allows patients to stay in their homes, but the systems can't catch everything, and patients shouldn't be lulled into a false sense of security by the technology.

WellPoint Inc.'s Anthem unit in California is piloting a wireless scale and blood-pressure cuff that communicates in real time with nurses on alert for fluctuations that can signal heart failure, or when the heart can no longer pump enough blood to the body's organs. Humana Inc. in January will launch a program to track heart patients' vital signs wirelessly and link them up via video to chat with nurses if appropriate.

And Aetna Inc. is running a clinical trial with Intel Corp. to assess how remote monitoring of vital signs can cut down on unnecessary hospitalization for heart patients.

It is more important than ever for health plans and patients to combat medical costs, growing at a clip of between 6% and 9% a year, according to various estimates. Heart failure—which can be triggered by simple mistakes such as consuming too much salt—is a leading cause of hospital readmissions, with about 25% of patients returning to the hospital within 30 days. It's also one of the biggest single claims expenses at insurance companies. Aetna estimates that 40% of readmissions are avoidable.

For patients, the extra surveillance could cut down on trips to the hospital and provide peace of mind. That's what Carolyn Brown, a 63-year-old retired teacher's aide from Bronx, N.Y., found when she started using a new monitoring system covered by her insurer, MetroPlus Health Plan Inc., after she suffered two heart attacks.

"I was constantly going to the doctor. Now they can tell right away if I am in trouble," she said.

The program puts a scale, blood-pressure cuff and glucose monitor into patients' homes and then collects the data daily via wireless or landline. Nurse case managers follow up with the patients if any of the vital signs seem worrisome.

The plan, which specializes in Medicaid and Medicare and is owned by the New York City Health and Hospitals Corp., says it pays about $6,300 for a Medicaid heart patient's typical hospital stay. The plan foots the bill for the remote monitoring system, which is rented and worth approximately $626.

Such remote monitoring programs have limitations. Doctors can get over-alerted when patients put the cuffs on wrong, or step onto the scale with their shoes on. The technology requires ill patients to remember to use it, and can be troublesome if it acts up. For instance, Ms. Brown's data at first weren't uploading through the modem correctly, a problem that was solved within 24 hours when the machinery was converted to a wireless hookup.

Both Humana and WellPoint are incorporating video-chat into their approaches to connect members more closely with nurses. UnitedHealth's wireless scale asks a series of questions in the morning and evening that are followed up by nurses and doctors if appropriate. "The relationship between the consumer and doctor is primary," said Sam Meckey, chief operating officer for disease solutions at UnitedHealth's OptumHealth unit.

Ray Freeland, a 54-year-old heart patient who is part of Anthem's pilot program, said the system he uses to monitor his weight and blood pressure has "eliminated those trips to the doctor to find out everything is still the same." But in March, the system picked up through Mr. Freeland's pulse measurements that he might be experiencing abnormal heart rhythm. Mr. Freeland, who lives in Glendale, Calif., was sent to his doctor to shock his heart back into a normal rhythm. His medical center, Cedars-Sinai, estimates that about $30,000 was saved on Mr. Freeland's care between March and July.

New approaches aim to find problems earlier. A study of 1,450 patients out Tuesday in Circulation, a journal of the American Heart Association, showed that implantable defibrillators that wirelessly transmit data on the patient's heart function reduced in-hospital evaluations by 45%. Suspected cardiac events were evaluated in less than two days compared with 36 days.

Another approach being tested by devicemaker CardioMEMS Inc. uses an implantable sensor device to measure pulmonary artery pressure and wirelessly transmit readings to a secure Web site for doctors and nurses. The idea is to detect changes and intervene before the patient has to be hospitalized. The wireless transmitter resulted in a 30% reduction in hospitalization for heart-failure patients, the study of 550 patients released last month showed.

Health Law Augurs Transfer of Funds from Old to Young

The Wall Street Journal

 
Mark Baumann, a 44-year-old uninsured diabetic, sees in the Obama administration's health-care law a future with stable coverage to pay for his insulin shots and blood tests. Currently unable to meet costs such as Anthem health insurance quotes, he will rely on reform measures to meet his medical needs.

That's likely to come indirectly at the expense of his mother's generous health-care plan.

Humana Inc., Mary Baumann's insurer, intends to pare her "Medicare Advantage" plan to make up for the smaller government payments it will soon receive as a result of the new law, leaving her with higher costs or fewer services. On the table are beefed-up co-payments and premiums, as well as the loss of perks such as her free membership at a health club.

Across the country, dozens of private insurers that run similar Medicare plans are preparing to pare dental, vision and certain prescription-drug coverage starting next year, according to consultants who have helped them assemble annual bids.

Although some planned cuts might not materialize given Congress's history of tabling unpopular measures, the law represents the tip of a broader change. Most Americans know the overhaul is designed to cover the uninsured, a decades-long goal of Democrats. But it also represents a change in how the government spreads its social safety net underneath Americans. Already, it's creating tensions that are a harbinger of debates to come.

Since the creation of Social Security and Medicare, younger workers have funded programs for the elderly. It's a compact in which workers paid for retirees with the understanding that they'd be looked after by the generation behind them.

The health overhaul diverges by tapping a program for the elderly to help provide insurance to 32 million Americans of younger generations. Nearly half the funding for the law is supposed to come from paying lower fees to hospitals, insurers and other health-care providers that participate in Medicare, the federal insurance program for Americans age 65 and older, as well as younger disabled people.

The 44 million Americans on Medicare won't see changes to their guaranteed benefits under the law. But of those, 11.3 million on Medicare Advantage plans, a public-private hybrid of the type used by Ms. Baumann, who is 79, are likely to begin seeing extra benefits go away as soon as next year. Medicare Advantage cuts are slated to pay for 15% of the health-care law's tab.

The trims mark the leading edge of a spending shift that could broaden as lawmakers grapple with a deficit expected to hit $1.47 trillion this year. Left unchanged, Medicare and Social Security will consume half of all federal spending by 2035, up from about one third today, according to the Congressional Budget Office.

A White House-sponsored commission that is examining ways to reduce the budget deficit is considering how to tackle Social Security, too. Even AARP, the seniors group, recently embraced the prospect, noting that to keep Social Security viable, Congress "needs to make some small adjustments." AARP supported the health-care overhaul.

Prominent lawmakers in both parties have suggested restrictions on future Social Security benefits, such as a higher retirement age for younger workers and financial means testing to determine who gets benefits.

"We badly need to, over time and very gradually, reallocate resources from the elderly to younger families and their children," said Isabel Sawhill, senior fellow at the liberal-leaning Brookings Institution.

The White House says the health law doesn't take from seniors to help younger generations, but instead eliminates overpayments to private companies, particularly insurers that run Medicare plans like Ms. Baumann's. By lowering payments to health providers, the new law extends the life of Medicare's trust fund by 12 years, according to an actuarial report from Medicare's umbrella agency.

"I'm sure that some of those additional benefits have been nice," Nancy-Ann DeParle, who runs the White House's Office of Health Reform, says of Medicare Advantage plans. "But I think what we have to look at here is what's fair and what's important for the strength of the Medicare program long term."

Stuart Butler, a vice president at the conservative Heritage Foundation, says the White House is misrepresenting the benefits that accrue from Medicare payment cuts. "It uses it to create a new entitlement for a separate group of people rather than strengthening" the program, he says. Moreover, such cuts alone don't pay for the law.

The law will spend $938 billion over a decade, mostly to expand coverage to lower-income Americans. To finance that, there will be $455 billion coming from cuts in government payments to health-care providers that serve patients on Medicare and two other federal programs. The hardest hit—to the tune of $136 billion—will be private insurance companies that run Medicare Advantage plans.

Most of the rest will be funded by new levies, including taxes on health-care companies, a higher Medicare payroll tax for wealthy Americans and a tax on high-value insurance plans. Critics of the law say its total cost is likely higher than advertised.

Some older Americans are irate, including some of Ms. Baumann's gym-mates. One has joined the tea-party movement, in part to protest the cuts. Democrats are worried about the political pressure from seniors, who vote in large numbers, especially in midterm elections, and represent a political force that is disproportionate to their numbers.

The party has played up the perks for seniors included in the law. Among other things, it closes a gap in Medicare prescription-drug coverage and makes preventive services free for enrollees.

Ms. Baumann has few medical needs except two daily blood-pressure medications and dental work, but she is torn about the changes. She credits the gym membership with helping her overcome her husband's death in 1994. She couldn't afford it on her fixed annual income of $17,000 and has voiced that concern at meetings of Humana's local consumer advisory board, of which she is a member.

"I think there's other cuts we could make besides our age group," she says. But she wants her son to get insured.

The Congressional Budget Office says on average, Medicare Advantage enrollees will get $68 less a month in benefits by 2019 because of the law. The payment cuts to Medicare Advantage begin in 2012.

John Gorman, a consultant who helped insurers prepare bids, says his clients are planning to raise non-essential emergency room co-pays to $500 from $200. They're pushing enrollees toward generic drugs and charging more for optometrist visits.

Ms. Baumann and her late husband, Donald, raised six children around New Orleans. Donald Baumann worked as a switchman for the phone company and earned $40,000 a year when he retired in 1982. Ms. Baumann stayed home to raise their children and later sold cosmetics at an Estee Lauder counter.

Donald Baumann's health plan from BlueCross BlueShield of Louisiana kept their costs low. When their youngest child, Mark, was diagnosed with Type 1 diabetes at 16, the insurance covered his two-week hospital stay.

After college, Mark Baumann bounced between jobs in Chicago selling hotel rooms to corporate groups. The hotels offered patchy insurance. In 2008, shortly after Mr. Baumann moved back to Louisiana to be closer to his family, he lost his $44,000-a-year sales job at a New Orleans Best Western.

"I thought I'd be employed within a month," Mr. Baumann said one afternoon as he sat on his mother's couch petting his Chihuahua, Peanut. He didn't worry about housing since he lived in his mother's one-story home, perched eight feet above ground to protect against flooding from nearby Lake Pontchartrain. He limited discretionary spending to splurges such as $150 in plants for their garden.

Mr. Baumann began stretching the time between daily blood sugar tests to make his supply of testing strips, which cost $1.20 each, last longer. He skipped three annual blood tests. Last summer, he went to a low-cost clinic and accepted three vials of free insulin that had been partially consumed. In the fall, an intense side pain landed him in the emergency room, resulting in an $8,000 bill. The facility waived it after he wrote a letter saying he couldn't pay.

Cobra, the federal insurance program for people between jobs, was too costly. Louisiana turned him down for Medicaid, saying he didn't qualify because his unemployment benefits—$3,096 over three months—put him over the income limit.

Under the health law, that will change by 2014. If Mr. Baumann is earning under $43,320 a year then, he'd qualify for a health insurance tax credit. If unemployed, he has a better chance than now of qualifying for Medicaid, the federal-state insurance program for the poor.

Mr. Baumann's unemployment benefits recently lapsed, and he's now leaning on $200 a month of food stamps. He got a break last month, when his local health clinic told him he qualified for the state's low-income care program, which paid for a CT scan and other tests to diagnose bouts of fainting. The program will defray his medical costs until he finds a job, but still leaves him without insurance.

Ms. Baumann has one of the best government insurance deals the country offers. Since 2003, she has been enrolled in a Humana Gold Plus HMO. The plan is part of an experiment Congress started decades ago to make Michigan Medicare plans more efficient by paying private insurers to administer coverage. In rural areas, private insurers didn't rush into the market, prompting Congress in 2003 to raise the rate it paid.

The government now pays private insurers an average of 9% more to operate the plans than it costs to run traditional Medicare, according to the Medicare Payment Advisory Commission. Insurers must spend most of that overpayment on enrollees.

As a result, Ms. Baumann's plan covers her "Silver Sneakers" gym membership, worth $54 a month, at Franco's health club and spa. The plan includes $10 a month worth of sunscreen, vitamins, laxatives and other products. She pays no premium beyond what seniors pay for traditional Medicare.

Humana, which administers Medicare Advantage plans to 1.75 million seniors, is trying to pare 15% of its overall costs, in part to offset lower expected government payments.

"There's no question that either premiums go up or either benefits go down over the long term," said Michael B. McCallister, Humana's president and CEO. "Everything is on the table."

Word of cuts has Ms. Baumann's gym mates in a huff.

"With the president being younger, my biggest concern is that we don't mean anything," said Sandy Reed, a 61-year-old who has a Medicare Advantage plan because she qualifies as disabled. "We're disposable."

One recent morning, Ms. Baumann and her son drove her 1999 Lexus SUV 35 miles to the Louisiana State University Bogalusa Medical Center. It sells insulin for at least 50% less than a traditional pharmacy. Ms. Baumann lent her son $100 to buy it.

He ducked his head into the pharmacy window, underneath a burned-out light bulb, and a woman handed him a paper bag with 100 syringes and three vials of insulin for $83.

Back in the car, he lamented his finances. "Maybe I shouldn't have bought all those plants," he said.

The next morning, Ms. Baumann walked past the waterfall in the lobby of her health club. She brought Mr. Baumann as a guest so he could lift weights. The facility has two pools, waterslides, a Starbucks counter and a grill which sells quesadillas and avocado mint smoothies.

After Ms. Baumann's "Dancin' to the Oldies" class, some of the women fretted that the free memberships they get through Humana could go away.

"Most of these older people don't like change," Ms. Baumann said. "But they have to get used to it. There will be change."

26 July 2010

Treatment for HIV Increased 30% in 2009, UN Says

Bloomberg

The number of people receiving treatment for HIV rose 30 percent in 2009, the biggest leap in a single year, according to the World Health Organization.

About 5.2 million people were receiving treatment for the AIDS-causing virus in 2009, up from 4 million in 2008, the United Nations health agency, also known as WHO, said today in an e-mailed statement.

WHO is pushing for earlier treatment of HIV at this week’s International AIDS Conference in Vienna, stating that early use of medicines also acts as a preventative measure by reducing levels of the virus in the body, so carriers are less likely to pass on the disease. HIV-related deaths could be reduced by 20 percent in the next five years if guidelines for early treatment are implemented, according to WHO.

“Starting treatment earlier gives us an opportunity to enable people living with HIV to stay healthier and live longer,” said Gottfried Hirnschall, WHO director of HIV and AIDS, in the statement.

Results last week from a study of 816 HIV patients by the New England Journal of Medicine showed that early treatment of HIV cut the risk of death by 75 percent.

25 July 2010

Obese Patient Falls off Table in O.R., Dies

Fort Wayne Journal-Gazette

MINNEAPOLIS – Max DeVries was sedated and awaiting a routine surgery when he rolled off the operating table and hit his head on the floor, in the spot where doctors had earlier removed part of his skull because of brain swelling following a stroke.

The 61-year-old St. Paul, Minn., man later died, and his family contends St. Joseph’s Hospital of St. Paul didn’t use proper procedures and equipment to safeguard DeVries, who was 5-feet-5 and weighed about 330 pounds.

With growing obesity and about 30 percent of Americans obese, having adequate equipment for very heavy people has become an issue for hospitals and skilled nursing facilities for bariatric surgery in Detroit and elsewhere .

According to a lawsuit filed Thursday in Ramsey County District Court, “The fall from the operating table was a direct cause of, or contributed to, the death of Max DeVries.”

Robert Hajek, the family’s attorney, said the table’s three Velcro straps couldn’t hold DeVries.

The lawsuit contends that the hospital lacked “appropriate facilities and equipment, including wide enough tables and adequate restraints to perform an operation on Max DeVries.” The suit argues that DeVries’ weight “is not an unusual or abnormal weight for patients that experience stroke.”

In some cases, hospitals have bolted surgical tables to the floor to prevent heavy patients from tipping them over. How to care for overweight surgical patients has generated new operating-room products as well as medical journal articles and books in recent years.

Max DeVries’ son, Shawn DeVries, said his father’s fall could have been prevented if the hospital had used bigger bariatric patient restraint straps or maybe rails.

“Realistically, 330 pounds isn’t that much,” he said. “I’m 220 pounds. There are a lot of people who are this size.”

The operating room fall caused “substantial additional injuries,” the lawsuit contends. Additional surgeries were performed to save DeVries’ life, the suit states.

Max DeVries later suffered a massive stroke, Hajek said. He died on April 13.

22 July 2010

The Debate Over Electronic Medical Records

Forbes
How the rules about electronic medical records will change our perceptions about all information technology.

 
After more than a year of review, the federal government has finally released its "meaningful use" guidelines for electronic medical records. For the health care field this is particularly meaningful because it's the first step taken toward adding the kinds of consistency and efficiency through IT that most corporations take for granted.

Electronic records can eliminate duplication in testing, bring together complete medical histories, disclose adverse drug interactions, reduce errors in patient care, add transparency into a system that has been largely closed to review, and set forth best practices for treating illnesses. The meaningful use regulations allow hospitals and physicians to recoup their IT investments toward this end, at once both modernizing an antiquated health care system and helping to reduce the overhead associated with medical care.

All of this makes sense on paper. The whole purpose of IT is to improve efficiency and make information more readily available to those who are qualified to receive it. But it's also about to set off a debate that will likely last years, if not decades, about the trade-offs between efficiency and patient care, patients' rights and what constitutes adequate care. This is the kind of debate that hasn't taken place outside of groups like the American Hospital Association and the American Medical Association; it's now wide open for public review.

The players in this debate will include lawyers, health care providers, insurance companies, chief information officers, chief medical information officers, chief security officers, technology companies, drug companies, lobbyists and government and private oversight agencies and committees. They will define the types of records that need to be kept, how that information is used and by whom, how it should be stored and new ways to utilize that information for improving treatment and identifying trends.

What's not readily apparent, though, is the effect this will have on the rest of the technology world. Throughout the history of IT there has never been a national debate on how technology gets applied to problems. Decisions typically have been made based upon the needs of a particular company and the capabilities of technology producers to meet those needs. One size doesn't fit all, and best practices often are closely guarded secrets.

To be sure, these best practices can be a competitive advantage or disadvantage, depending upon both short-term and long-term outcomes and how effectively technology is applied. Some companies have scored big with technology. Others have not. Witness the widespread use of commodity Intel ( IN TC - news - people )-based servers in the 1990s, which created massive integration headaches and caused energy use to spike unnecessarily. Those problems are only now being addressed through virtualization and outsourcing into clouds.

While the meaningful use rules are vague about the exact technology, over time they're going to become very clear about the processes involved in standardizing records so that when a patient visits one hospital the records can be transferred from another hospital or doctor's office. This will foster debate about technology practices that have never been out in the open, including the costs of this technology, acceptable times for implementation, upgrade schedules, as well as what works best with what and for what purpose.

In the end, meaningful use will foster meaningful debate, and that debate will reach well beyond the medical field to expose some other closely guarded secrets.

19 July 2010

Insurers Push Plans That Limit Choice of Doctor

NY Times

At Haro Bicycle in Vista, Calif., Joe Hawk, president, and Peter Skoda, controller. Facing a possible 35 percent hike in rates, the company offers its employees a limited-choice health plan.
 
 
As the Obama administration begins to enact the new national health care law, the country’s biggest insurers are promoting affordable plans with reduced premiums that require participants to use a narrower selection of doctors or hospitals.

The plans, being tested in places like San Diego, New York and Chicago, are likely to appeal especially to small businesses that already provide insurance to their employees, but are concerned about the ever-spiraling cost of coverage.

But large employers, as well, are starting to show some interest, and insurers and consultants expect that, over time, businesses of all sizes will gravitate toward these plans in an effort to cut costs.

The tradeoff, they say, is that more Americans will be asked to pay higher prices for the privilege of choosing or keeping their own doctors if they are outside the new networks. That could come as a surprise to many who remember the repeated assurances from President Obama and other officials that consumers would retain a variety of health-care choices.

But companies may be able to reduce their premiums by as much as 15 percent, the insurers say, by offering the more limited plans.

“What we’re seeing is a definite uptick in interest because, quite frankly, affordability is the most pressing agenda item,” said Dr. Sam Ho, the chief medical officer for UnitedHealth’s health-care plans.

Many insurers also expect the plans to be popular with individuals and small businesses who will purchase coverage in the insurance exchanges, or marketplaces that are mandated under the new health care law and scheduled to take effect in 2014.

Tens of millions of everyday Americans will buy their coverage through those exchanges, a vast pool of new customers, including many of the previously uninsured, whom insurers expect will be willing to accept restrictions to get a better deal.

“What this does is eliminate the Gucci doctors,” said Peter Skoda, the controller of the Haro Bicycle Corporation, a Vista, Calif., business that employs 30 people. Facing a possible 35 percent increase in its rates, Haro switched to an Aetna plan that prevents employees from seeing doctors at two medical groups affiliated with the Scripps Health system in San Diego. If employees go to one of the excluded doctors, they are responsible for paying the whole bill.

“There wasn’t any pushback,” Mr. Skoda said. Haro’s employees are generally young and healthy, he said, and they rarely go to the doctor. Instead, they want to make sure they have adequate coverage if they go to the emergency room.

The company’s premiums average $433 a month, Mr. Skoda said, with employees paying one-fourth of the expense. A few employees opted for more traditional coverage, enabling them to go where they please. But they are paying significantly higher deductibles and out-of-pocket costs that could add thousands of dollars to their medical bills.

The last time health insurers and employers sought to sharply limit patients’ choice was back in the early 1990s, when insurers tried to reinvent themselves by embracing managed care. Instead of just paying doctor and hospital bills, insurers also assumed a greater role in their customers’ medical care by restricting what specialists they could see or which hospitals they could go to.

“Back in the H.M.O. days, it was tight networks, and it did save money,” said Ken Goulet, an executive vice president at WellPoint, one of the nation’s largest private health insurers, which is experimenting with re-introducing the idea in California.

The concept was largely abandoned after the consumer backlash persuaded both employers and health plans that Americans were simply not willing to sacrifice choice. Prominent officials like Mr. Obama and Hillary Rodham Clinton learned to utter the word “choice” at every turn as advocates of overhauling the system.

But choice — or at least choice that will not cost you — is likely to be increasingly scarce as health insurers and employers scramble to find ways of keep premiums from becoming unaffordable. Aetna, Cigna, the UnitedHealth Group and WellPoint are all trying out plans with limited networks.

The size of these networks is typically much smaller than traditional plans. In New York, for example, Aetna offers a narrow-network plan that has about half the doctors and two-thirds of the hospitals the insurer typically offers. People enrolled in this plan are covered only if they go to a doctor or hospital within the network, but insurers are also experimenting with plans that allow a patient to see someone outside the network but pay much more than they would in a traditional plan offering out-of-network benefits.

The insurers are betting these plans will have widespread appeal in the insurance exchanges as individuals gravitate toward the least expensive options. “We think it’s going to grow to be quite a hit over the next few years,” said Mr. Goulet of WellPoint.

The new health care law offers some protection against plans offering overly restrictive networks, said Nancy-Ann DeParle, head of the office of health reform for the White House. Any plan sold in the exchanges will have to meet standards developed to make sure patients have enough choice of doctors and hospitals, she said.

Ms. DeParle said the goal of health reform was to make sure people retained a choice of doctors and hospitals, but also to create an environment where insurers would offer coverage that was both high quality and affordable. “What the Congress and the president tried to accomplish through reform is to transform the marketplace by building on the existing system,” she said.

But most of these efforts have been limited to a small number of markets. How widespread these plans will become is anybody’s guess, and some benefits consultants wonder if these plans represent any real solution to high medical costs. The narrow network, if it is based on the insurers’ ability to demand low prices, may be “just another short-term fix,” warned Barry Schilmeister, a consultant at Mercer.

What’s more, no one is predicting a wholesale return of the classic H.M.O. as an employee’s only option of health plan. “We went through the choice battle with the managed care wars,” said Andrew Webber, the chief executive of the National Business Coalition on Health, which represents employer groups that purchase health care.

A lot has also changed in the last 15 years. The average premium for family coverage is now more than $13,000 a year, and many businesses have already asked their employees to pay a much greater share of their premiums and more of their overall medical bills.

UnitedHealth is experimenting with a more limited plan in California and Chicago and plans to expand to four or five other markets next year. Patients are allowed to see a doctor who is not in the network the insurer established, but they pay much higher out-of-pocket costs than they would in a traditional plan offering out-of-network benefits.

UnitedHealth is also starting a new plan in San Diego, which was developed for a collection of school districts, representing some 80,000 people. The plan creates tiers of doctors, and employees who use physicians deemed to offer high-quality care at low price will pay the least for their medical care.

Even large employers, worried that the new law will result in higher prices for care as government programs pay less, are reconsidering their earlier stance.

When Cigna informally asked some of its clients about their interest in these plans before the legislation passed, very few were receptive. But that has changed, said David Guilmette, a senior executive for the insurer.

One way insurers say they hope to prevent another consumer backlash is by emphasizing that they are not choosing doctors on price alone. The insurers say they look to see how quickly a doctor’s patients recover from surgery, for example. But how much the insurers emphasize quality remains to be seen.

But many insurers say they are still figuring out how to persuade people to choose these plans rather than force them to enroll. “What’s not changed are the old techniques of black-belt managed care,” said Mark T. Bertolini, Aetna’s president. “We have to create the same kind of model without the ‘Mother, may I.’ What we want is the ‘Mother, should I.’ ”

17 July 2010

94 Charged in Medicare Scams Totalling $251M

Associated Press

Elderly Russian immigrants lined up to take kickbacks from the backroom of a Brooklyn clinic. Claims flooded in from Miami for HIV treatments that never occurred. One professional patient was named in nearly 4,000 false Medicare claims.

Authorities said busts carried out this week in Miami, New York City, Detroit, Houston and Baton Rouge, La., were the largest Medicare fraud takedown in history - part of a massive overhaul in the way federal officials are preventing and prosecuting the crimes.

In all, 94 people - including several doctors and nurses - were charged Friday in scams totaling $251 million. Federal authorities, while touting the operation, cautioned the cases represent only a fraction of the estimated $60 billion to $90 billion in Medicare fraud absorbed by taxpayers each year.

For the first time federal officials have the power to overhaul the system under Obama's Affordable Care Act, which gives them authority to stop paying a provider they suspect is fraudulent. Critics have complained the current process did nothing more than rubber-stamp payments to fraudulent providers.

"That world is coming to an end," Health and Human Services Secretary Kathleen Sebelius told The Associated Press after speaking at a health care fraud prevention summit in Miami. "We've got new ways to go after folks that we've never had before."

Officials said they chose Miami because it is ground zero for Medicare fraud, generating roughly $3 billion a year. Authorities indicted 33 suspects in the Miami area, accused of charging Medicare for about $140 million in various scams.

Suspects across the country were accused of billing Medicare for unnecessary equipment, physical therapy and other treatments that patients never received. In one $72 million scam at Bay Medical in Brooklyn, clinic owners submitted bogus physical therapy claims for elderly Russian immigrants.

Patients, including undercover agents, were paid $50 to $100 a visit in exchange for using their Medicare numbers and got bonuses for recruiting new patients. Wiretaps captured hundreds of kickback payments doled out in a backroom by a man who did nothing but pay patients all day, authorities said.

The so-called "kickback" room had a Soviet-era propaganda poster on the wall, showing a woman with a finger to her lips and two warnings in Russian: "Don't Gossip" and "Be on the lookout: In these days, the walls talk."

With the surveillance, the walls "had ears and they had eyes," U.S. Attorney Loretta Lynch said at a news conference in Brooklyn.

In a separate Brooklyn case, authorities charged six patients who shopped their Medicare numbers to various clinics. More than 3,744 claims were submitted on behalf of one woman alone, 82-year-old Valentina Mushinskaya, over the past six years.

At a brief appearance in federal court Friday, Mushinskaya was released on $30,000 bond and ordered not to return to the Solstice Wellness Center, scene of an alleged $2.8 million scam.

Authorities called Mushinskaya one of the clinic's "serial beneficiaries," with phony bills totaling $141,161 paid by Medicare.

Her nephew, Vladimir Olshansky, told reporters his Ukrainian-born aunt suffers from diabetes. "She doesn't know what this is about," he said. "She's in the dark."

In Miami, Daniel R. Levinson, inspector general of HHS, which oversees Medicare, said the arrests "illustrate how health care fraud schemes can replicate virally and migrate rapidly across communities."

Cleaning up Medicare fraud will be key to paying for President Barack Obama's proposed health care overhaul. Federal officials have allocated more money and manpower to fight fraud, setting up strike forces in seven cities with a plan to expand to a dozen more. So far, the operations are responsible for more than 720 indictments that collectively billed the Medicare program more than $1.6 billion.

Around the country, the schemes have morphed from the typical medical equipment scam in which clinic owners billed Medicare dozens of times for the same wheelchair. Now, officials say, Medicare fraud involves a sophisticated network of doctors, clinic owners, patients and patient recruiters.

Violent criminals and mobsters are also tapping into the scams, seeing Medicare fraud as more lucrative than dealing drugs and having less severe criminal penalties, officials said.

For decades, Michigan Medicare plans operated under a system that paid providers first and investigated later. That pay and chase method was a boon for crooks, giving them 90 days lag time to milk the system and flee with millions before authorities were aware a crime had been committed.

Sebelius toured vacant storefronts in Miami on Friday where Medicare fraudsters set up shop, including bogus clinics operated by Cuban immigrants Carlos, Luis and Jose Benitez. The brothers are the agency's most-wanted fugitives, charged with bilking $119 million for costly HIV drugs that patients never received - and buying hotels, helicopters, boats and even a water park with their spoils. They allegedly fled to Cuba, where authorities believe they remain.

A new joint effort by HHS and the Department of Justice enables law enforcement to view Medicare claims in real time and flag suspicious patterns. More stringent screening methods, including more comprehensive background checks, have also been put in place. The agency gets roughly 18,000 applications daily to become a Medicare provider. Now they can put a moratorium on new applications in certain areas, like physical therapy, if they notice a spike in fraudulent activities.

The changes are paying off.

Investigators visited 1,600 providers in Miami in the past few months, making sure legitimate businesses were operating at the addresses. In 2008, authorities required all medical equipment providers in Miami to apply for new certification, hoping the paper hurdle would deter scammers. The number of claims dropped by $1.6 billion.
                                                 

16 July 2010

Heart Tests add to U.S. Radiation Dose Concerns

Reuters

Heart imaging procedures can deliver a significant amount of radiation to patients, U.S. researchers said on Wednesday, urging patients and doctors to weigh the risks against the benefits.

They said nearly one in 10 adults under the age of 64 had a heart procedure involving radiation over a three-year period in five major healthcare markets.

"For many patients in the United States, there is a substantial cumulative radiation exposure from cardiac procedures," said Dr. Jersey Chen of Yale University School of Medicine, whose study appears in the Journal of the American College of Cardiology.

An advanced type of heart stress test called myocardial perfusion imaging, in which doctors inject a radioactive tracer in patients to test blood flow, accounted for 74 percent of radiation exposure from heart scans.

Heart catheterization and stenting -- procedures in which thin tubes are fished through blood vessels to open blocked arteries -- were the second biggest contributor to radiation exposure, Chen said.

More than half of the heart procedures using radiation were done in the doctor's own office, the team found.

"Policymakers have been concerned that there is a rise in physician office imaging and a rise in total use of imaging," Chen said in a telephone interview.

"I think there is legitimate concern that easy availability -- convenience -- makes the threshold for testing lower. Whether it is inappropriate or not, our study can't say."

While doctors disagree over how much, most agree that radiation can cause cancer, and researchers are growing concerned that an explosion in the use of medical imaging is making it more likely that patients may develop cancer.

A report last year by the National Council on Radiation Protection and Measurement found that Americans receive seven times more radiation from diagnostic scans than in 1980.

Chen's team, looking specifically at radiation exposure from heart imaging procedures in Indiana, studied medical claims records from nearly 1 million patients aged 18 to 64 insured by United Healthcare.

They calculated the annual radiation dose based on three exposure ranges: less than 3 millisieverts a year, the average exposure level for people from the sun and environment; between 3 and 20 millisieverts a year and more than 20 millisieverts a year, the upper safety limit for workers exposed to radiation.

Of those who got Indianapolis heart procedures using radiation, most fell into the middle range but more than 3,000 patients got more than 20 millisieverts a year over the three-year period and 75 people got more than 50 millisieverts a year.

"The average patient who gets a nuclear stress test is going to get 16 millisieverts each time. It's going to increase their risk on a statistical basis," Chen said.

Dr. Pamela Douglas of Duke University in North Carolina and a former president of the American College of Cardiology said doctors need to pay attention to radiation but she said the benefits of these heart tests and procedures should be weighed against the risk that a cancer might develop down the road.

"Let's not get hysterical," she said in a telephone interview.

"Overall, patients with heart disease are doing way better. The procedures are helping people. If we can change them or tweak them to help reduce radiation exposure even more, that would be wonderful."

Were we Born to Run Barefoot?

The Globe and Mail

 
Having seen how nimble shoeless marathoners are, I've decided to kick off my sneakers and jog as our hunter-gatherer ancestors did

This summer, I'm finally learning how to run.

For years, I have been a recreational jogger – the combination of inexpensive simplicity and immediate endorphin release has drawn me since university days – but now I'm at long last learning how to round the block the old-fashioned way: barefoot.

Last year, I ran the London Marathon.

It was an exhilarating race (although I use that adjective loosely, given the pace that I was going) and I'm still ludicrously proud of myself for finishing.

But I have to admit that, by mile 20, my feet really hurt. I don't just mean in an ouch-these-damn-heels sort of way.

I mean each step felt like my feet were slamming on a bed of nails or hot coals or an excruciating combination of both.

Suffice to say, it was fantastically painful. It was in that dark moment, staring tearfully at the ground, that I began to notice some of the other runners around me didn't have shoes on.

Or rather they did, but not ones that I would recognize as athletic shoes.

One out of every couple of dozen runners seemed to be wearing what can only be described as foot gloves – rubbery socks with toes on them and no visible arch support or cushion.

And here's the thing: They were passing me. While my supported feet slapped down on the pavement heel-first, sending shock waves of pain through my body, their bare ones seemed to skip along the surface of the earth, carrying them more lightly and quickly than I could even dream of.

These foot gloves, which made the wearers look a little like fast-moving gorilla people, are called, I would later learn, Vibram FiveFingers – and they are at the cutting edge of a fitness trend that is both revolutionizing the athletic-shoe industry and bringing the original mode of human exercise back to basics.

Barefoot running has been around since humans evolved feet. Not only has it always been the mode of training for many elite African athletes (think world-record breakers such as Abebe Bikila, Tegla Loroupe and Zola Budd); it was the way our hunter-gatherer ancestors travelled, back in the days before the automobiles and Nike.

Chris McDougall, author of Born To Run, a bestselling book about the Tarahumara, a Mexican barefoot running tribe, is one of the people credited with popularizing barefoot running in North America and Europe.

His book, which chronicles his own superhuman efforts to organize “the greatest race the world has ever seen,” an uber-marathon pitting the elite athletes of the developed world against the Tarahumara, also offers an articulate, well-reasoned and exhaustively researched argument in favour of barefoot running over shod.

After suffering running injuries his entire adult life, McDougall began training barefoot and in nine months completed his 50-plus mile race through the canyons of the Sierra Madre.

He believes that running – ideally barefoot – is not just a recreational activity but a biological imperative. “Endurance is what humans are best at,” he told me recently via e-mail.

“Compared to other animals, it's the only thing we're really good at. We're not strong, we're not limber and we're certainly not fast – Usain Bolt is the fastest man on the planet, and he can get his butt kicked by a squirrel. That's why distance running has always been our number-one participation activity: For much of human history, it was necessary for survival and, recently, we've felt that tug of instinct drawing us back to our one natural talent.”

McDougall's argument for covering distances unshod is that it forces the body to conform to a safer, more natural mode of running. Barefoot, a runner naturally lands on the squishy ball of the foot, enabling the body to automatically absorb impact shock, whereas running shoes, with their high-tech built-up heel and arch support, force the foot to hit the ground with a heel strike – arguably the reason why, in spite of all the shoe technology the athletic-apparel industry can buy, it's estimated that 70 per cent of all avid runners get injured.

McDougall, who has been running pain-free since kicking off his shoes several years ago, is so fascinated by the naked stride that he has given up marathons and races altogether.

“I've really been fascinated by the challenge of learning how to run well and lightly,” he told me. “The kind of feedback and precision you can get from a barefoot stride is so compelling that I don't have any interest in other goals.”

As for me, I want to run barefoot, but not in a way that risks ruining my pedicure or stamping on a used needle in an urban gutter. With that in mind, I recently bought my first pair of barefoot running shoes.

Not the Vibram FiveFingers, which are a little too weird-looking for my taste, but a pair of Vivo Barefoot shoes by British company Terra Plana. They are small, unstructured, light as air and a hundred times better-looking than any athletic footwear or custom foot orthotics I've owned before.

The first couple of times I wore them, my calves tightened up – a common barefoot newbie symptom, McDougall told me, caused by the tendency to fire the calf muscle through the entire stride, rather than just the point of impact. So I stretched and practised relaxing and before long I was feeling stronger than ever.

These days, I'm running five miles in my Vivos three or four times a week without the slightest flinch of pain.

My legs are strong, my mind is clear and my feet are naked (well, almost). Marathon number two? I'm doing it barefoot.

15 July 2010

Sexual Contact now the Chief Cause of Ukraine's AIDS Epidemic

AFP

 
KIEV — "I am not a drug addict!" insisted Andri, 32, staring desperately at the walls of a clinic for people with HIV in Kiev.

The young father contracted HIV through a casual sexual relationship, like alarming numbers of others in a country where heterosexual transmission has overtaken drug abuse as the main cause of AIDS.

The trend has alarmed researchers, showing that the HIV epidemic in Ukraine has now moved out of the niche of intravenous drug users and into the heterosexual mainstream.

With an HIV prevalence rate of 1.11 percent among Ukraine's adult population as of 2009, the former Soviet republic is one of the states in Europe worst hit by the epidemic.

For years, the virus has been spread mainly in Ukraine by intravenous drug users but the trend has changed with startling speed.

Since 2008, more Ukrainians have been contracting HIV through heterosexual sex than through drug abuse. In 2009, 43 percent of Ukrainians infected with HIV caught the virus through heterosexual sex and 35 percent by drug injection.

Experts have warned that this means the epidemic risks no longer affecting mainly high-risk groups like drug users, prostitutes and homosexuals but the general population as a whole.

"There are already signs of a generalisation" with the HIV infection rate of pregnant women now standing at more than one percent in some regions, said Svitlana Antonyak, an official from the national HIV clinic.

"Two thirds of cases of sexual transmission are linked to intravenous drug use," said Tetyana Deshko of the Ukrainian branch of the NGO International HIV/AIDS alliance.

She described the typical path of transmission in today's Ukraine: "A drug user who probably does not know he is HIV positive has a relationship with a woman who probably does not know that her partner is a drug user."

Andri was infected with HIV during an adulterous relationship with a former lover who he suspects now is a drug addict.

"I saw the traces of injections on her arms but she said it was because she had just been to hospital," said Andri, who learned of his diagnosis at the start of the year.

He insists that he used a condom, but it broke. "I put another one on, and thought that it would do. It was stupid. Stupid!"

Almost half of Ukrainians between 25-49 who say they had more than one sexual partner in a year do not use condoms, said a national report compiled by the Ukrainian ministry of health for UNAIDS.

"A condom is often seen (in Ukraine) as a sign of not trusting your partner," said Tetyana Deshko. Moreover many in Ukraine still see AIDS as a problem affecting only disadvantaged groups."

"There's lack of information campaigns of good quality, capable of changing young people's behaviour," Antonyak said.

"My 20-year old son told me he always uses a condom because he was here, at the hospital, helped me and saw people suffering here. Probably that's what we need to do", she added.

Alarmingly "only one HIV victim in four" in Ukraine is actually aware that they have been infected, said the national report.

As of January, 101,000 Ukrainians were infected with HIV according to official figures but the real number is estimated at 360,000. The number of deaths from AIDS was 19,000 between 1987 and April.

However in a ray of hope, the use of antiretroviral therapy resulted in the first cut in the mortality rate from AIDS, of 2.6 percent, last year. Antiretrovirals were introduced to Ukraine only six years ago.

But funds are limited and at least 7,500 patients who need the drugs are not receiving them.

"We really need help from donors," said Svitlana Cherenko, head of the state committee for the fight against AIDS.

Ukraine already received 230 million dollars from the Global Fund to Fight AIDS, Tuberculosis and Malaria for the years 2004-2012 and will this month put in a new request with the organisation for estimated 300 million dollars for 2012-2017.

14 July 2010

Cancer Survival Figures Double since 1970s

BBC News

 
People with breast, bowel and ovarian cancers, and non-Hodgkin's lymphoma, are now twice as likely to survive for at least 10 years than in the 1970s.

Cancer Research UK's figures show leukaemia survival is now four times as high, although the charity warned there was still much work to do.

The Department of Health said it was "delighted" by the findings.

Launching a television campaign, the charity said investment in research was key to further boosting survival.

The figures go back to the early 1970s and include estimated survival rates for the latest diagnoses made in 2007.

In breast cancer, 10-year survival has jumped from less than 40% to a predicted 77% currently.

And half of people diagnosed with bowel cancer are now expected to survive at least 10 years compared with 23% in the 1970s.

For ovarian cancer and non-Hodgkin's lymphoma, survival has increased from 18 to 35% and from 22 to 51% respectively.

In cancers such as oesophageal cancer and myeloma, although survival rates are still very poor at below 20%, rates have improved almost threefold over the past few decades, Cancer Research UK said.

However, some other cancers have shown little improvement, most notably lung and pancreatic cancer, the figures show.
 
'Real progress'

Professor Peter Johnson, Cancer Research UK's chief clinician, said: "There are many reasons for our continuing success in the fight against cancer, including faster diagnosis, better surgery, more effective radiotherapy and many new drugs, all developed using the knowledge that our laboratory research has given us."

He said with further investment in research, he expected the trend to continue.

Professor Michel Coleman, an expert in statistics at the London School of Hygiene and Tropical Medicine, who calculated the figures, said the survival data reflected "real progress" in cancer diagnosis and treatment.

"Ten-year survival figures for patients diagnosed in 2007 are of course predictions, but they are derived from the latest national data on cancer patient survival - and for most cancers, the true 10-year survival for these patients will turn out to be higher than we report."

The figures prompted Professor Mike Richards, the Department of Health's national cancer director, to say: "We are delighted to note these improvements in cancer survival.

"Improving health outcomes is a key priority for the coalition government and will be a major focus of the forthcoming review of the Cancer Reform Strategy."

Harpal Kumar, Cancer Research UK's chief executive, said the improvements being seen in cancer care were "encouraging, but we have to do better".

"We need to develop even more effective treatments that can prolong life further and we need to ensure that each individual patient has optimal treatment."

12 July 2010

In Ventura County, Half of Doctors Nearing Retirement Age

Ventura County Star

 
Out of a group of more than 750 doctors in Ventura County, half will turn 55 or older before the end of the year, according to a local medical association. One of three will turn 60 or older.

The doctors aren’t growing crow’s feet alone. About half of the registered nurses in Ventura, Los Angeles and Orange counties were 50 and older in 2008, according to the California Board of Registered Nursing. About 18 percent of the nurses were in their 60s, more than those who were 34 and younger.

The graying numbers don’t surprise Dr. Gary Proffett, the 62-year-old medical director of an Oxnard-based physicians network who has decided he can’t retire because of the economy. But he is alarmed at the number of healthcare professionals who could pack away their stethoscopes before hospitals and clinics are flooded by aging baby boomers with longer life expectancies and the uninsured people who will be covered by federal healthcare reform in 2014.

“Who’s going to see them?” he said. “Who’s going to see millions of people? I don’t know.”

There are 1,095 doctors in Ventura County. The Ventura County Medical Association has birth dates for its membership of nearly 300 doctors and, through the Medical Board of California, 471 other physicians. The median age of the doctors is 55. About 50 percent were born in 1955 or earlier; 33 percent were born in 1950 or earlier.

Some doctors suggested the data could be skewed by the demographics of the medical association membership or by medical school and residency requirements that mean almost no doctors are practicing on their own before their 30th birthday. The statistics also could be affected by doctors who are still licensed but no longer practicing.

A 2008 study from the California HealthCare Foundation suggests a more modest trend with about 36 percent of the doctors in Ventura County 56 and older. But a forthcoming report from the foundation suggests 29 percent of California’s doctors are 60 or older, higher than any other state. Data from the Association of American Medical Colleges suggests 39 percent of the nation’s doctors — 43 percent in California — are 55 and older.

The numbers vary. The bottom line is the same, said Edward Salsberg, director of the Center for Workforce Studies at the Association of American Medical Colleges.

“You need to be worrying about the next decade,” he said, predicting a deepening shortage of healthcare professionals. “When the recession ends and the economy improves, I think millions of Americans, not just doctors, will say I’m ready for retirement.”

Theories to explain the aging trend sprout like, well, gray in a salt-and-pepper beard: Enrollment bottlenecks at medical schools and residency programs, cost of living expenses that push new doctors away from expensive California coastal areas and economic pressures that delay retirement.

“What we get paid for surgery now, for tonsillectomy, is what we got in 1980,” said Dr. John Edison, focusing on Medicare reimbursement. The Ventura ear, nose and throat doctor is 71, has been practicing in Ventura since Jimmy Carter brought peanuts to the White House and is old-school enough to wear a head mirror.

He’s not retiring but is making the transition this month from full time to part time, providing more opportunities for backpacking and skiing in Mammoth.

Edison doesn’t think the math is all that complicated. Retiring doctors combined with an infusion of new patients through healthcare reform adds up to more patient care being delivered by physician assistants and nurse practitioners.

“I think it will be harder to see certain specialists and family doctors, too, probably,” he said.

Nursing numbers add to the same connect-the-dots sketch. The California Board of Registered Nursing reported the average age of RNs in the state jumped from 43 in 1990 to 47 in 2008. About half of the state’s nurses are 50 and older, the same as in the region comprising Ventura, Los Angeles and Orange counties.

Forget about Carter. Greg Thayer started his career at the Ventura County Medical Center in 1974 when Gerald Ford was trying to stabilize the country.. Thayer was a 20-year-old orderly surrounded by other people his age and a handful of older nurses who served as mentors.

Things are different now. The newbies are in their 30s and 40s and they’re dwarfed by the veterans.

“Two thirds of the work force are the old war horses,” said Thayer, who at 56 counts himself in that category. “I’m a swayback. I don’t know if anyone would ride me to war.”

Thayer echoes doctors who predict the aging trend will bring more reliance on healthcare workers imported from other countries.

A waiting list for a nursing program at Ventura College stretches 12 months or longer and at CSU Channel Islands, 314 people applied for 33 spots in its nursing program.

But Joanne Spetz, a researcher at the Center for Health Professions at UC San Francisco, said state-supported efforts to expand nursing programs are generating more young nurses. Provisions in healthcare reform are designed to boost doctors and other health professionals dedicated to primary care.

She thinks the efforts along with the infusion of immigrant health workers could limit the damage of shortages.

“It could have a negative impact on healthcare, but I don’t think it’s a done deal,” she said, suggesting a wild card will be the availability of state and government funding to create more slots in medical schools or provide other fiscal support.

Others predict a work force tilted heavily toward retirement age will mean people waiting longer for appointments and depending more on professionals who don’t have an M.D. after their names.

A system that relies heavily on physicians in their 60s may struggle because studies show older physicians spend less time on patient care and more on administration, said Craig Paxton, a health economist and primary researcher for the upcoming California HealthCare Foundation report on doctor demographics.

Other solutions have trapdoors, too. Outsiders want to dramatically expand training programs but don’t understand that schools struggle to find nursing faculties, said Joan Beem, director of the nursing program at Ventura College.

She is one of many who thinks D-Day will come when healthcare workers feel confident that the recession is over despite growing California health insurance quotes. They’ll retire and the system designed to provide their replacements will still be crimped.

“I think we’re going to have significant problems,” she said.

10 July 2010

New Study shows Link between Depression and Dementia

Daily News Tribune

A new study using data from the Framingham Heart Study shows that having depression may double a person’s risk of developing dementia later in life.

The study was published in today’s issue of Neurology, the medical journal of the American Academy of Neurology, and was authored by Jane Saczynski, PhD, of the University of Massachusetts Medical School in Worcester.

The study, which looked at 949 people in the Framingham Heart Study over a 17-year-period, found that 22 percent of participants with symptoms of depression at the start developed dementia, compared with 17 percent of those without depression.

"While it’s unclear if depression causes dementia, there are a number of ways depression might impact the risk of dementia," said Saczynski. "Inflammation of brain tissue that occurs when a person is depressed might contribute to dementia. Certain proteins found in the brain that increase with depression may also increase the risk of developing dementia."

Saczynski added lifestyle factors related to depression such as diet and exercise could affect the onset of dementia as well.

Saczynski said she hopes the study will highlight the connection between depression and dementia in Detroit - a link that past studies have not definitively shown.

The study was funded by the National Institute on Aging, the National Institute of Neurological Disorders and Stroke, and the National Heart Lung and Blood Institute.

How Doctors Deliver the News: It's Cancer

LA Times

Anyone who has undergone a biopsy or other test to detect cancer knows the agony of waiting for the test results. Doctors face the dilemma of how to divulge the bad news to their patients. Call the minute you receive the results and let the patient know? Schedule a face-to-face office visit and explain the findings there?

A new study suggests that doctors should usually disclose a cancer diagnosis in a personal setting, taking plenty of time to discuss what the diagnosis means and explain treatment options. The study involved a questionnaire given to 437 patients who received a cancer diagnosis. The researchers, From the National Cancer Institute and Columbia University, found that 54% of patients were told their diagnosis in person in the doctor's office while 18% got the news by phone and 28% while in the hospital.

Perhaps more surprising, 45% of the patients reported discussions of 10 minutes or less. Options for Indianapolis cancer treatment were not discussed in 31% of the conversations. In 39% of the cases, the patient had no other person -- such as spouse, sibling or child -- present when they received the news.

When asked how satisfied they were with the way the cancer diagnosis was delivered, the average score on a scale from 0 to 100 (the most satisfied) was 73.5. Having another person present when the diagnosis was given did not seem to matter to most patients. However, where and how the news was delivered did matter. Patients who heard their diagnosis in person had much higher satisfaction scores than those who received the diagnosis over the phone. Conversations that took place in the doctor's office were rated higher by patients than talks that took place in an impersonal setting, such as a recovery room or Dearborn radiology suite. Only a small percentage of patients reported very poor communication and lack of trust in their doctor. There were a few horror stories. "...my doctor at the time called me on Valentine's day to say I had a lesion in my chest.... He left this message on my home answering machine."

Some situations may warrant using the telephone to divulge a cancer diagnosis, the authors wrote, such as when the patient already knows that cancer is suspected and has been waiting for several days to learn the test results. But, in general, a cancer diagnosis should be made in-person in a hospital room or doctor's office with sufficient time available to discuss prognosis and treatment. "...having more than 20% of patients told their diagnosis in an impersonal manner suggests too many physicians are either unaware of or not practicing good communication skills in such bad news circumstances," the authors wrote. The study was released Tuesday in the Journal of Clinical Oncology.

09 July 2010

Pfizer Spies Uncover Spanish Villa, Rolex and Bentley in Fake Viagra Bust‏

Bloomberg

 
With the millions he made peddling fake Viagra, Martin Hickman bought a beachside villa on Spain’s Costa del Sol, a diamond-studded Rolex and a flat in London. Pfizer Inc. aims to make sure he never gets to enjoy them.

The spoils of Hickman’s crimes helped settle a trademark infringement lawsuit brought by the world’s largest drugmaker three years ago. It’s the biggest example of a new approach Pfizer is taking to fight counterfeiting of prescription drugs, an industry that’s almost doubled to $75 billion in five years, according to the New York-based Center for Medicine in the Public Interest.

Pfizer, whose erectile dysfunction pill Viagra is one of the most copied medicines, once relied on local authorities and criminal courts to hunt down offenders. Now it’s hired former U.S. customs officials, FBI agents, Turkish narcotics experts and Hong Kong police to find counterfeiters. In China, they’re tracking fakes to the source, raiding derelict warehouses for evidence of illegal drug-making. In the U.K., they’re using civil courts to hit fake pill peddlers where it hurts most.

“The point is to make them realize that there’s no sense from a business perspective in counterfeiting our products, because if we find you, we’re taking your money away,” says John P. Clark, a 55-year-old U.S. law enforcement veteran who now serves as New York-based Pfizer’s chief security officer.

Pfizer estimates it has prevented about 58 million counterfeit pills from reaching patients since 2004, worth more than $860 million, according to Bloomberg calculations.

Tougher Stance

Clark spent 28 years in law enforcement, starting with border patrols where he “learned Spanish and rode a horse,” and ending as the top civil servant for U.S. Immigration and Customs Enforcement, the agency responsible for stemming the flow of narcotics into the U.S. and the flow of drug money out.

He joined Pfizer in 2008 to help the fight against fake medicines by deploying the same tactic he used with cocaine traffickers, gun runners and money launderers: pursuing civil lawsuits and asset seizures. The company still works with police and the criminal system to catch counterfeiters.

Hickman was one of the first test cases of Pfizer’s tougher stance. Between 2003 and 2007 he sold more than 6 million pounds ($8.9 million) of bogus Viagra and another impotence drug on about 150 websites, according to Britain’s Medicines and Healthcare products Regulatory Agency, or MHRA.

‘Tidy Nest-Egg’

Hickman used the money to buy a four-bedroom farmhouse near Manchester, a 2.5 million-pound flat in Chelsea, a villa near Marbella, Spain, a Bentley Arnage and two Range Rovers. He also had an insurance valuation for jewelry totaling 267,000 pounds, including a diamond-studded gold Rolex watch and a Piaget watch worth about 100,000 pounds each, and a Louis Vuitton bracelet valued at 25,000 pounds, according to Pfizer.

In 2007 Hickman was sentenced to three months in jail for contempt of court, less than a year after he was ordered to stop advertising Viagra and another impotence pill on the Internet, according to the MHRA. His websites kept operating, Pfizer said.

“A three-month penalty is not going to discourage you from going back and doing it again,” Clark said in an interview in Singapore. “You put your money offshore, it’s there in a little tidy nest-egg, you come back out, you help fund your start-up operation again, and you’re back in business.”

Money Laundering

Pfizer won permission from the High Court in London to raid Hickman’s home and office and freeze his assets. The day he was released, the company sued him for infringing its trademarks. Within weeks, Hickman agreed to a 1 million-pound out-of-court settlement, giving Pfizer a $769,600 net gain on the money it spent investigating and suing him.

“Hopefully we made an impression on Mr. Hickman as to the consequences of counterfeiting our product,” Clark said. “It was a new way of doing business for Pfizer.”

Previously, the company would refer counterfeiting cases to regulators and police for criminal prosecution. It still does, though the addition of civil suits gives Pfizer an extra weapon, and allows it to conduct investigations and raids itself with a judge’s authorization, according to Clark.

In a second criminal prosecution in June last year, Hickman pleaded guilty to six counts of selling and supplying fake and unlicensed medicines and money laundering, and was sentenced to two years’ jail, according to the MHRA. The regulator is now taking legal action to seize his assets, William Mach, a spokesman for the MHRA, said in an e-mail.

Making Pills

John Gollaglee, a lawyer for Hickman at Pannone LLP in Manchester who represents Hickman in the criminal cases, declined to comment. Alex Megaw, Hickman’s lawyer in the civil suit brought by Pfizer, said he no longer acts for Hickman and had no way of contacting him. He referred enquiries to Pannone.

Pfizer isn’t alone in taking civil action. Eli Lilly & Co., the maker of the impotence drug Cialis, investigates phony pill makers with Pfizer because their products are often copied together, said Bruce Longbottom, legal counsel for Indianapolis- based Lilly.

“The civil action gives the financial deterrent where they’re actually hit in the pocket book,” Longbottom said in a telephone interview. “We do think that sends a message that’s a little bit different from what a criminal action might give us.”

International criminal syndicates are increasingly turning to prescription drugs because they offer higher returns and lower risks than narcotics, according to Aline Plancon, an Interpol officer who works with police worldwide to investigate counterfeiters.

“These people mastered the technology of making pills, because they are doing narcotics,” she said. “They know that the risks of being punished are low compared to the benefit.”

Growing Business


Plancon estimates that $1,000 spent making heroin can earn a return of $20,000. The same investment in copied medicines can earn as much as $450,000.

The global trade in counterfeit drugs will rise to $90 billion by 2015, according to the Center for Medicine in the Public Interest. The Organization for Economic Cooperation and Development says it’s hard to put a value on the problem because of “a paucity of reliable data.” Trade in all counterfeit and pirated goods rose to about $250 billion in 2007 from about $200 billion in 2005, the OECD estimated in November.

There were 2,003 discoveries of counterfeit, illegally diverted or stolen medicines worldwide last year, compared with 195 reported in 2002, according to the Pharmaceutical Security Institute, a Vienna, Virginia-based nonprofit organization that monitors fake medicines.

Human Toll


“I’m not so sure that law enforcement officers around the world know very much about the dangers of counterfeit medicines,” said Tom Kubic, the institute’s president, in a telephone interview. “In some countries where they do, they’re grossly understaffed and frankly unable to effectively address it.”

Counterfeits take a toll on human life. Fake medicines against malaria and tuberculosis alone are responsible for about 700,000 deaths a year, the London-based International Policy Network estimated in a report last year.

“A mother who buys fake medicine to treat malaria does not know that she is paying for her own death or that of her sick child,” Jacques Chirac, a former president of France, said in a speech to the World Customs Organization’s council on June 24. Chirac’s charitable foundation is working to combat fake drugs.

Fake Pills


Viagra copies were found to have entered Australia’s pharmaceutical supply chain for the first time last month. At least 776 packs of phony erection medicine were found in the states of New South Wales and Victoria after customers complained the blue diamond-shaped pills they had bought didn’t work, according to Maida Talhami, a Sydney-based spokeswoman for Pfizer. Tests showed they contained the wrong amount of sildenafil, Viagra’s active ingredient.

Counterfeits with the same batch number seized in other countries have been traced to China, Talhami said. China and India are the source for most fake drugs, according to the Pharmaceutical Security Institute’s Kubic. Tracking them to the source has proved difficult.

“You’re dealing with finding a fairly small operation,” Kubic says. “We’ve seen recent inquiries in China where there are cancer medications being counterfeited with no active ingredient that are being made in a small one-bedroom apartment in major cities, with literally hundreds of well-copied packages and capping equipment which sits on the top of a table.”

Dusty Vats, Derelict Warehouse

Pfizer says it’s making progress in China. In December 2008 a Chinese court sentenced Zhou Ju, the head of a manufacturing and distribution network for fake pills, to 17 years in prison, the nation’s longest term for the crime, and fined him 5 million yuan ($732,000), Pfizer said.

Zhou was arrested in June 2007 in a raid on his factory in Jining, Shandong province, after an investigation led by Pfizer and the Shandong Public Security Bureau. Police seized 892,000 fake pills worth 13 million yuan, including illegal copies of Viagra, Lilly’s Cialis, and Sanofi-Aventis SA’s diabetes pill Amaryl, as well as 280 kilograms of bulk pharmaceutical ingredients, according to Pfizer.

Yang Jie, a defense lawyer for Zhou, said his client was convicted of making fake Viagra and given a sentence in keeping with local laws. The case also implicated retailers who were ordered to pay fines, Yang said in a telephone interview.

Pictures of Zhou’s factory show dirty, dust-covered mixing vats, sacks of ingredients piled in a bare concrete warehouse, tubs of blue dye used to color Viagra pills, and rolls of foil used to seal blister packs, printed with the logos of Zithromax, a Pfizer antibiotic, and Lipitor, its best-selling cholesterol drug. That’s evidence of an ancillary industry supplying fake packaging, said Paul Newton, a University of Oxford researcher who studies counterfeits from an office in Vientiane, Laos.

“There are people making packets and holograms especially for the counterfeiters,” Newton said. “It’s not just a one-man show, it’s all inter-linked with different nefarious business activities.”

For Pfizer, the strategy shift is yielding results. Since 2007, the company has spent $3.3 million on investigations and legal fees and recovered about $5.1 million. The company expects to collect an additional $5.3 million from ongoing cases.

In the U.K., Pfizer says its civil suits have reduced the availability of fake drugs over the Internet. The drugmaker says it has sued at least seven other counterfeiters, and last month settled its first civil suit in the U.S.

“As long as there are people in the world who think they can make money by putting other people’s lives at risk, this is a clear and present danger,” Jeff Kindler, Pfizer’s chief executive officer, said at a briefing in Singapore today.