Venezuela's Chavez undergoes cancer surgery in Cuba

(Reuters) - Venezuela's Hugo Chavez underwent surgery in Cuba on Tuesday for a cancer recurrence that has thrown his presidency into jeopardy and upended politics in the South American OPEC nation.
"My dear friend and colleague, Comandante Hugo Chavez, is going through the toughest times of his life," said Ecuadorean President Rafael Correa, a fellow leftist. "He is being operated on right now. It's a very delicate operation."
The 58-year-old socialist leader's surgery in politically allied Cuba was his fourth since mid-2011. Cancer was found again in his pelvic area soon after his October re-election, leading him to name a successor in case he is incapacitated.
Chavez's ministers have been parading on state TV to pledge loyalty to their boss but have given no details of his condition, which is treated virtually as a state secret.
A government source confirmed Tuesday's operation. Supporters were holding prayer meetings around the country in solidarity.
Having declared himself cured twice in the past, Chavez now worries the latest recurrence could end his tumultuous 14-year rule. He retains hope of recovering in time for the January 10 start of a new six-year term.
Chavez named his vice president and foreign minister, Nicolas Maduro, as a potential heir to lead his self-styled revolution in a nation of 29 million people with the world's largest oil reserves.
Maduro, 50, a former bus driver and union activist, lacks his boss's charisma and political flair but would represent policy continuity should he take over. He has already taken control of day-to-day government business.
'NOT A MONARCHY'
The naming of Maduro has irked some in Venezuela's opposition, who say voters - not Chavez - will decide who follows him if an election is held within 30 days of his leaving office, as required under the constitution.
"Venezuela is not a monarchy with a prince as heir," said one opposition leader, Antonio Ledezma.
Should an election be held, opposition flag bearer Henrique Capriles, who lost to Chavez in the October presidential ballot but scored a record 6.5 million votes for the opposition, could have a second crack at power.
In a newspaper interview on Tuesday, Capriles declined to speculate on a possible new presidential bid and repeated his best wishes to Chavez for recovery. But he criticized the secrecy surrounding the president's treatment.
"Venezuelans have the right to know," he said.
Chavez was assumed to be a patient once more at Havana's Cimeq hospital, though no official information on the situation was coming out of the communist-run Caribbean island.
The stakes are high for Cuba and various other socialist-run nations around Latin America and the Caribbean who depend on the Chavez government for subsidized oil and other economic aid.
Messages of support have poured in.
"He changed the history of Venezuela and of a large part of Latin America," said Correa, a central member of the Chavez-led Alba bloc of leftist nations in the region.
"He's in good spirits. You know what Hugo's like, always ready for tough battles with optimism and faith ... I'm not going to lie, we're very worried. It's a serious matter."
U.S. actor Sean Penn, one of Chavez's most prominent international supporters, joined a vigil in Bolivia. "He's one of the most impressive forces on the planet and we need to show him our love," Penn was quoted as saying by local media.
INVESTORS WATCH
Chavez's health woes had sparked a rally in Venezuela bonds, given many investors' preference for a more business-friendly government in Caracas. Gains were trimmed slightly on Tuesday.
Western investors have increasingly shunned Venezuela under Chavez - especially given his nationalizations of large swathes of the economy - giving companies from China, Russia, Iran, Belarus and other allies a chance to grab footholds.
In London, veteran emerging market investor Mark Mobius said any change to a more market-friendly government in Venezuela would encourage him to invest there once more.
"Regime change has probably entered into a countdown phase," New York-based Jefferies' managing director Siobhan Morden said in a research note.
The health saga has once again eclipsed major national issues such as state elections on Sunday, a widely expected devaluation of the bolivar currency and a proposed amnesty for Chavez's jailed and exiled political foes.
"The nation is paralyzed," said Jorge Botti, head of the main private business group, Fedecamaras, urging the government to boost sales of dollars through its currency-control system.
The lack of greenbacks has left merchants struggling to import products and pushed the black market rate for the bolivar currency to four times its official rate of 4.3.
Venezuelans were expecting a currency devaluation around the New Year, though Chavez's illness has put this in doubt.
Maduro is a committed socialist who has espoused Chavez's views on the international stage for the last six years, including his vitriol against Washington.
He has indicated he would follow Chavez's main policies, including heavy state control of the economy.
"Currency controls have worked well, and yes, they can be improved. They are going to be improved," Maduro said.
(Additional reporting by Eyanir Chinea and Diego Ore in Caracas, Eduardo Garcia in Quito; Editing by Brian Ellsworth, Philip Barbara and Bill Trott)

CANCER - Could a strong immune system be the missing link?

CANCER - Could a strong immune system be the missing link?

Could a strong immune system be the missing link? With billions and billions of dollars going into cancer research, wouldn't you think there should be very promising cancer cures available by now? Well...a good case could be made that the billions of dollars that have been poured into cancer research have been focusing on all the wrong areas. The reason, I believe, that the research has focused on the wrong areas are not an accident. I believe the reason is simple: BIG MONEY! Consider how this research through the years has primarily focused on developing new drugs for treatment of cancer but not in prevention. There are obscene amounts of money at stake in the race to develop new drugs whereas there is very little money for profit while preventing cancer in the first place. A healthy patient is a customer lost. I realize what seems unlikely or maybe even unthinkable to most, is the idea that money could be more important than human life. But along with this sobering news, there is also some really good information about cancer treatment and prevention that hasn't exactly been "in the news". If you do just a little bit of research into cancer research BEFORE we get into the great news, I think you might agree that there is something very FISHY going on in cancer research. For a short eye-opening article, click here: HTTP://www.eurosolve.com/charity/bava/cancer.html While this article is very disheartening, there is good news. Some very conclusive research has proved that our OWN body's immune system is the real key to beating cancer! How? It seems that if our immune system is working at full strength, it AUTOMATICALLY provides all the necessary killer cells to fight off cancer. A NEW WAY TO BEAT CANCER In spite of what you may have been told, there are some new and very effective ways to beat cancer. Here is an example: In 1993 a four step treatment protocol using "microcurrents" was developed and then tested on cancer and AIDS patients over the next ywo years. This treatment plan proved to be nearly 100% effective against not only cancer and AIDS, but also many other diseases as well. This treatment protocol was effective at killing ANY type of disease caused by a virus, bacteria, or fungi. The researchers were absolutely astonished to find the treatment was so effective with a HUGE array of different diseases including; cancer, HIV, epstein-barre, hepatitis, chronic fatigue, meningitis, tuberculosis, just to name a few. The real strength of this treatment is that it completely restores the body's immune system, allowing it to finally work as it was designed. A good example of this is with cancer. Any oncologist will agree that a properly functioning immune system will eliminate cancer cells from the body. With the immune system at full strength, the body will produce INTERFERON and INTERLEUKIN which easily takes care of the malignant cells. Another really good example of how much difference a healthy immune system makes is with AIDS. As you may already know, people with AIDS don't die from the virus, they die from some other type of infection the the immune system couldn't fight off. They lose their lives simply because their immune system wasn't functioning properly. The researchers testing this microcurrent technology found it was extremely powerful because of two direct effects on the body. First the microcurrents completely disabled or destroyed all harmful pathogens in the body (including all viruses, bacteria, and fungi) at the same time, leaving beneficial enzymes, bacteria, etc. intact and healthy. Second : the long term benefits were a completely restored immune system. When all the viruses, bacteria, fungi, and other parasites were cleared from the patient's bodies, their immune systems magically started to function at full strength again. The best part of the story is that nine years ago, a treatment protocol was developed that was safe, inexpensive, and effective at treating cancer (and for that matter, most other diseases). This treatment IS a reality NOW! Not in the future but NOW! You can do the research yourself and prove this. Not only is this protocol safe and effective, it can also be used to easily treat yourself in the privacy of your own home! Are you finding this hard to believe? That is the real crux of the problem. For over one hundred years, generation after generation, has been led down the golden path of teaching that we CANNOT and SHOULD NOT take responsibility for our own health. The medical establishment has cleverly taught us that they are the ONLY ones who can diagnose and treat disease. We have been conditioned to believe that the medical establishment has ALL the answers for proper treatment. However, the reality is FAR different. The reality is that most people in the medical establishment simply don't know that easy, safe, non-invasive, inexpensive, and in-home methods even exist. The governing bodies (American Medical Association, Food and Drug Administration, National Cancer Institute, etc.) know these methods exist. If fact if you research this yourself, (which is easy to do) you can prove there is a long history of cover-ups and suppression dating back over one hundred years. So why cover up such a simple and effective method that saves millions of lives while at the same time improving the quality of those lives? The answer, of course, is MONEY! Cancer by itself is a multi-billion dollar per year industry. Did you know that the average cost of conventional cancer treatment is $250,000-$750,000? Can you imagine how much money is at stake if we threw most every other disease into the mix? The amount involved is astronomical! That my friends, is the very foundation of this problem. GREED! What a sad state of affairs. There is a simple solution to this dilemma, though. Do the research, learn the truth about this and take charge of your OWN health! Then let others know the truth.
About the author: Dan Clizer is a cancer researcher with 20 years of experience in Alternative Treatment and is the co-author of the new E-book, Cancer Secrets. For more information and research on new treatments, see: HTTP://www.cancercuresecrets.com

Author: Dan Clizer

AIDS fight enters new phase with prevention pill

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CHICAGO (AP) — Condoms and other safe-sex practices have accomplished only so much. Now the 30-year battle against AIDS is on the verge of a radical new phase, with the government expected to endorse a once-a-day pill to prevent infection with the virus.

Some doctors are already giving patients the drug, Truvada, to ward off infection. But Food and Drug Administration approval would expand that practice and could make the highly expensive medicine more affordable. Truvada costs around $11,000 to $14,000 a year.

Approval seems likely after an FDA advisory panel Thursday endorsed the use of Truvada for prevention.

In the generation-long fight against AIDS, "it's the first time we have talked about a medication for prevention of HIV," said Dr. Lisa Sterman of Francisco, who treats HIV-positive patients.

"With this recommendation, we're nearing a watershed moment in our fight against HIV," said James Loduca, a spokesman for the San Francisco AIDS Foundation. "We know this isn't a magic bullet, and it's not going to be the right prevention strategy for everyone, but it could save thousands of lives in the United States and potentially millions around the world."

Truvada has been FDA-approved since 2004 for treating people infected with the AIDS virus. Once a drug is on the market, doctors are free to prescribe it for off-label, or unapproved, uses, and that's what some have been doing in giving Truvada to patients who are healthy but in danger of getting the virus from their partners or through risky sex.

Official FDA backing of the practice would allow Truvada's maker, Gilead Sciences Inc. of Foster City, Calif., to market it for prevention. Approval would also probably lead many more insurance companies to pay for the drug. And by widening the market for Truvada, it could prompt Gilead to lower the price.

An FDA decision is expected by June 15.

The FDA is also considering approving the first over-the-counter HIV test for use at home. Experts said it could help slow the spread of HIV.

An estimated 1.2 million Americans and millions more around the world have HIV. Unless the virus is treated with antiviral drugs, it can turn into full-blown AIDS. Antivirals have made the disease more manageable and allowed patients to live much longer than when the epidemic began in the early 1980s.

Nevertheless, about 50,000 new infections are diagnosed in the U.S. each year, a number that has held steady for about 15 years.

Truvada represents "a pretty radical step, but I think it's a necessary step," said Sterman, who prescribes it to infected patients and those who are healthy but at risk. "We've come as far as we can with condom use and safe-sex strategies."

The drug would be recommended for people at high risk of getting the virus, such as gay men with multiple sex partners, prostitutes and people whose partners are infected.

In one U.S. government study of more than 1,200 men and women in Botswana, Truvada lowered the HIV infection risk by about 78 percent. Another larger study in Africa found a slightly lower rate of effectiveness, but researchers say that if used as directed, the pill can be 90 percent effective or higher.

It is available as an HIV treatment in Africa and other poor regions, but Gilead is seeking approval for prevention in the U.S. only, a company spokeswoman said. Some experts have expressed concern that the use of Truvada for prevention could cause shortages in poor countries that desperately need the drug to treat infected people.

Not everyone in the HIV community is gung-ho about the drug.

Michael Weinstein, president of the AIDS Healthcare Foundation, a Los Angeles-based group that calls itself the nation's largest provider of medical care for HIV, said his main concern is that patients won't take the drug as directed — once a day, while also using condoms. Misuse could create drug-resistant HIV strains and lead to more infections.

The FDA panelists acknowledged that concern and said people should be tested to make sure they don't have HIV before starting Truvada. Patients who already have the virus could develop resistance to the drug.

As for the drug's high cost, generic Truvada for HIV treatment is available in poor countries for as little as $9 per month, a Gilead spokeswoman said. But generic versions are not available in the United States and won't be until after Truvada's U.S. patent expires in 2021. Sterman said she hopes FDA approval leads Gilead to lower the price.

The lifetime cost of treating one person diagnosed with the AIDS virus has been estimated at more than $600,000.

"It's much more cost-effective to prevent a new infection than it is to treat someone for their lifetime," Loduca said. "Of course, the ultimate goal is a vaccine and a cure, but we're many years away from that."

Some of the more serious complications linked to Truvada include kidney and liver problems. But for some people, the risk of kidney problems "10 years down the line may be less than the risk for acquiring HIV, which is significantly more problematic and can be fatal," said Jim Pickett, director of prevention advocacy at the AIDS Foundation of Chicago.

Nick Literski, a government employee in Seattle, has been taking Truvada for HIV prevention for more than a year because his partner is infected. He said the drug has helped prevent the breakup of relationships like his.

"Many HIV-positive men end up ending their relationships with HIV-negative men out of fear of infecting their partner," Literski said.

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AP Health Writer Matthew Perrone contributed to this story from Washington.

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Online:

FDA: http://www.fda.gov

AIDS: http://www.aids.gov

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AP Medical Writer Lindsey Tanner can be reached at http://www.twitter.com/LindseyTanner

Exclusive: China amends patent law in fight for cheaper drugs

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HONG KONG (Reuters) - China has overhauled parts of its intellectual property laws to allow its drugmakers to make cheap copies of medicines still under patent protection in a move likely to unnerve foreign pharmaceutical companies.

The Chinese move comes within months of a similar move by India to effectively end the monopoly on an expensive cancer drug made by Bayer AG by issuing its first so-called "compulsory license".

Similar action by China will ring alarm bells in Big Pharma, since the country is a vital growth market at a time when sales in Western countries are flagging.

The amended Chinese patent law allows Beijing to issue compulsory licenses to eligible companies to produce generic versions of patented drugs during state emergencies, or unusual circumstances, or in the interests of the public.

For "reasons of public health", eligible drugmakers can also ask to export these medicines to other countries, including members of the World Trade Organisation.

Compulsory licenses are available to nations to issue under WTO rules in certain cases where life-saving treatments are unaffordable.

"The revised version of Measures for the Compulsory Licensing for Patent Implementation came into effect from May 1, 2012," China's State Intellectual Property Office said in a faxed statement to Reuters.

The changes can be found on the website of China's State Intellectual Property Office at http://www.sipo.gov.cn/.

China is known to be looking at Gilead Sciences Inc's tenofovir, which is recommended by the World Health Organisation as part of a first-line cocktail treatment for AIDS patients, two sources with direct knowledge of the matter said.

China's generic drugmakers were getting ready to produce tenofovir, they added.

At a drug access workshop hosted by the United Nations and health activists in Bangkok in early June, Chinese officials spoke of the changes to its patent law. Officials from Cambodia, India, Indonesia, Malaysia, Myanmar, the Philippines, Thailand and Vietnam also participated in the meeting.

"In May 2012, China created a change in their IPR (intellectual property rights) legislation to be able to issue compulsory licenses. China is considering further strengthening its legal framework, so as to make use of legal space to produce generic drugs," said Bob Verbruggen, senior adviser for the UNAIDS Asia Pacific office, who was present at the workshop.

"China's action plan at the workshop seemed to confirm that it intends to become a generic producer for the domestic and international market," he told Reuters by telephone.

CHINA PREPARED LONG AND HARD FOR THIS

China's move follows India's granting of a compulsory license in March to local generic drugs firm Natco Pharma to manufacture Bayer's cancer drug Nexavar, used for treating kidney and liver cancer.

However, China had signaled interest in the idea from at least 2008-2009, when its State Intellectual Property Office invited foreign experts to Beijing to show Chinese officials how to prepare the legal grounds for issuing compulsory licenses.

"They wanted to know the legal perspective ... They wanted to know about Thailand's IP Act that allowed us to make a CL (compulsory license) under the law for public interests, in an emergency," said Vithaya Kulsomboon, associate professor at Thailand's Chulalongkorn University, who was invited to Beijing at the time.

Kajal Bhardwaj, a legal expert from India who is working on health, HIV and human rights trade laws, said China's move was well within the limits of international trade agreements.

"CLs have previously been issued in the region by Malaysia, Indonesia, Thailand and India. CLs have also been issued on multiple occasions by developed countries including the U.S. and EU member countries," Bhardwaj said.

"It is very encouraging that China is seeking to ensure that this right ... is reflected in its legal regime on intellectual property," she added.

SABRE-RATTLING

China's stable of generic drugmakers has been producing the key ingredients - or active pharmaceutical ingredients (APIs) - in medicines for years, exporting them to foreign drugmakers, which then sell the patented finished products back to China at prices which the average Chinese citizen often cannot afford.

In particular, the government is struggling to provide newer HIV drugs, such as Gilead's tenofovir, known by its brand Viread and which had worldwide sales last year of $737.9 million.

China's government, initially slow to acknowledge the problem of HIV/AIDS in the 1990s, now admits to having a ballooning number of HIV/AIDS cases.

Although Gilead moved to share its intellectual property rights on its medicines in a patent pool with generic drugmakers from many countries last July in return for a small royalty, China was excluded, which meant it had to continue paying high prices for tenofovir.

Since the change in China's patent law, Gilead has offered certain concessions, including giving China a substantial donation of tenofovir if it continues to buy the same amount, said Paul Cawthorne, coordinator for Medecins Sans Frontieres' Access Campaign in Asia.

"This is all a negotiation game; this offer from Gilead came about once the news that the Chinese was considering issuing a CL came out. The end game is okay, you get a better deal or you use the CL, it's a strategy that many countries use," he said.

Gilead in Hong Kong declined to comment. No one was immediately available to comment at its head office in California.

All eyes are now trained on how China battles it out with big foreign drug exporters, especially from 2013 when the Geneva-based Global Fund to Fight AIDS, Tuberculosis and Malaria will no longer give grants to China to fight HIV.

(Reporting by Tan Ee Lyn in Hong Kong and Beijing newsroom; Additional reporting by Ben Hirschler in London; Editing by Anne Marie Roantree and David Cowell)

Centene sees second quarter loss, cuts 2012 view, shares plunge

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(Reuters) - Health insurer Centene Corp said it will post a loss in the second quarter and slashed its earnings forecast for 2012, citing higher costs and claims in Texas and Kentucky, and its Celtic individual health business.

The company's shares plunged 21 percent to $28.00 in premarket trade on Monday.

The health insurer also said it was evaluating the goodwill and intangible assets of its Celtic business and the review may result in a non-cash charge of about $28.0 million. The charge has not been accounted for in the current outlook, it added.

Centene now expects 2012 earnings of $1.45 to $1.65 per share, down sharply from its previous outlook of $2.64 to $2.84 a share.

The company said it expects to return to profitability in the third quarter, even as rising costs at its Texas, Kentucky and Celtic businesses impact results for the rest of the year.

The news comes less than a week after rival Molina Healthcare Inc withdrew its 2012 earnings forecast, claiming it was facing margin pressure in a Texas Medicaid plan.

Molina's Medicaid plans servicing the El Paso and Hidalgo counties in Texas saw high medical costs that outstripped the company's premium revenue from the region.

The El Paso and Hildago service areas experienced significantly higher-than-expected utilization in a contract that became active in March, Jefferies & Co analyst David Windley said in a note on Molina last week.

Centene too said on Monday it saw a significant rise in certain non-inpatient claims in its Hidalgo service area.

Other health insurers, such as Amerigroup Corp and Cigna Corp, which have plans for the El Paso and Hidalgo counties, may also be affected.

Shares of Molina had crashed early last week after it withdrew its full-year outlook, dragging down Centene shares with them. However, both stocks recovered much of the lost value later in the week as Molina and Centene won back a Medicaid contract in Ohio.

Centene shares, which have lost 5 percent of their value since Molina announced its margin issues in Texas, closed at $35.47 on Friday on the New York Stock Exchange.

(Reporting by Esha Dey in Bangalore; Editing by Sreejiraj Eluvangal)

Dieting May Lower Hormone Levels Tied to Breast Cancer

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MONDAY, May 21 (HealthDay News) -- New research suggests that weight loss through exercise and dieting helps overweight women lower the levels of certain hormones in their blood, potentially raising the odds that they'll avoid developing breast cancer.

The findings don't prove that losing weight this way will prevent breast cancer. Still, women who take medications to prevent the disease "need long-term solutions for managing their risk," study co-author Dr. Anne McTiernan, director of the Prevention Center at the Fred Hutchinson Cancer Research Center, said in a news release from the center.

"Weight loss represents an additional option for long-term breast cancer risk reduction without significant or bothersome side effects," McTiernan added.

The study is published in the May 21 online issue of the Journal of Clinical Oncology.

Previous research at the center has suggested that "losing just 5 percent or more of one's weight could cut by a quarter to a half the risk for the most common, estrogen-sensitive breast cancers," McTiernan said.

In the new study, researchers wanted to understand how weight loss through exercise, diet or both would affect potentially dangerous levels of hormones in the body.

The investigators randomly assigned 439 overweight-to-obese women to one of four groups. One group exercised (mainly through walking), one group dieted, one group did both and the remaining group did neither. The women were aged 50 to 75 with an average age of 58.

Those who dieted or dieted and exercised lost an average of about 10 percent of their weight. In addition, they lowered the levels of several hormones.

"The amount of weight lost was key to changes in hormone levels," McTiernan said. "The biggest effect was through diet plus exercise; exercise by itself didn't produce much of a change in weight or estrogen."

Dr. Robert Hiatt, professor and chair of the department of epidemiology and biostatistics at the University of California, San Francisco, cautioned that weight loss has been connected to breast cancer risk after menopause only. "In this stage of a woman's life, most of the circulating estrogens are no longer coming from the ovaries, which cease to function, but from fat tissue that is capable of producing the same types of estrogens," said Hiatt, who's familiar with the study findings.

He cautioned that "the study does not say that losing weight lowers the risk of breast cancer. It would take a larger and longer study to prove that. It does, however, suggest than weight loss has the right kind of effect on circulating estrogens, and it would be reasonable to expect that breast cancer rates would subsequently fall in such women."

More information

For more on breast cancer, visit the U.S. National Library of Medicine.

Copyright c 2012?HealthDay. All rights reserved.

Docs win most malpractice suits, but road is long

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NEW YORK (Reuters Health) - Malpractice claims against U.S. doctors are often dismissed, and when they go to trial, the verdict is usually in the doctor's favor, according to a new study.

But even when a case is dismissed, the road is typically long for both doctors and the patients suing, researchers said.

"Most claims go in favor of the physician, and they take a long time to resolve," said lead researcher Dr. Anupam B. Jena, of Massachusetts General Hospital and Harvard Medical School in Boston.

Medical malpractice claims have become a hot-button issue in the U.S., coming up repeatedly in debates about healthcare reform. Some specialists must pay a couple hundred thousand dollars a year in premiums for insurance against malpractice claims -- though rates vary by state.

But not much has been known about how long malpractice claims take to resolve, or what proportion of them actually end in a payment to patients, according to Jena.

For their study, he and his colleagues looked at more than 10,000 malpractice claims against U.S. doctors closed between 2002 and 2005.

They found that of all claims, about 55 percent resulted in an actual lawsuit.

Of those litigated claims, more than half were dismissed by the court. And out of the rest, most were resolved before a verdict; less than five percent ended up being decided by a trial verdict.

When there was a verdict, it went in favor of the doctor 80 percent of the time, Jena's team reported in the Archives of Internal Medicine.

What stands out in the findings, Jena said, was the length of time cases took to resolve -- even when they were dismissed.

On average, lawsuits dismissed in court took more than 20 months, and those resolved before a verdict took over 28 months.

Cases that went all the way to a trial verdict typically lasted a few years: 39 months, on average, when it went in favor of the doctor, and close to 44 months when the patient won.

"It is hard on everyone," Jena told Reuters Health.

For doctors, the outcomes of claims varied by specialty -- which is not surprising, Jena noted.

For example, internists were among the most likely to have cases against them dismissed in court. Pathologists and pediatricians were least likely: about 36 percent of cases against pathologists, and a little over 40 percent against pediatricians, were dismissed.

That makes sense, according to Jena. Pathologists study lab test samples and are key in diagnosing diseases. If they seem to have missed something, there is going to be more scrutiny. The same may be true in cases against pediatricians because a child is involved.

DEALING WITH ERRORS

"Medical malpractice is necessary," Jena said, "because there are clearly cases where patients are harmed by negligent care."

But, he added, the lengthy legal process, even in cases that are dismissed before trial, is an issue.

For doctors, Jena said, "there's anxiety, and the potential for damage to their reputation."

And for patients, those that have suffered real harm often end up in a long battle. "We need better ways of identifying those patients and making sure they are compensated more quickly," Jena said.

He pointed to some measures that already exist. Some hospitals and healthcare systems have started "early disclosure" programs, where they try to spot medical errors and proactively tell patients about them and offer compensation.

And a majority of U.S. states now have so-called "apology" laws. Under those, doctors who have made an error can own up to it, without having that apology used as evidence against them if there is a lawsuit.

The goal of those laws has been to curb malpractice claims, because litigants often cite anger over a doctor's perceived lack of remorse as a reason for suing.

And a recent study hinted that apology laws may be working as intended. Researchers estimated that in states with apology laws, cases involving the most severe injuries settled about 20 percent faster, and payments in those cases were lower.

SOURCE: http://bit.ly/JxuSmP Archives of Internal Medicine, online May 14, 2012.

Chicago protests on eve of NATO summit raucous, peaceful

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CHICAGO (Reuters) - Hundreds of demonstrators staged raucous protests against Chicago Mayor Rahm Emanuel's budget cuts and other economic issues on the eve of the NATO summit, but police said there were few arrests and only minor clashes.

The crowds were in the hundreds on Saturday, down from an estimated 2,500 people on Friday at Daley Plaza, named for longtime Mayor Richard J. Daley, who headed the city during bloody clashes between police and anti-Vietnam War protesters at the 1968 Democratic convention.

The violence that was anticipated before the NATO summit never materialized, although the biggest rally was expected on Sunday. Chicago police Superintendent Garry McCarthy said late on Saturday there had been 18 arrests during the week.

One protester was taken to a hospital after a group of people swarmed on a police vehicle and slashed a tire, McCarthy said. Local media showed video of the man in front of the vehicle trying to stop it but it was unclear if he was run over.

Another protester spray-painted an "A" for anarchy on the door of a Verizon Wireless store.

Saturday's marches began early, with an estimated 500 people protesting outside Emanuel's home to criticize cuts in city mental health services.

McCarthy said protesters were "making noise and disrupting some people's lives," but that overall, events were going well.

While the city of Chicago had not granted a permit for Saturday's protests, police allowed several groups of protesters to wander around the city guided by officers mostly on bicycles. There was some pushing and shoving between police and protesters but no major clashes.

Saturday's protests followed the announcement that three men arrested earlier in the week had been charged with conspiracy to commit terrorism. Prosecutors said the three self-described anarchists were planning to attack President Barack Obama's Chicago campaign headquarters and Emanuel's home.

'SHAME ON YOU'

Again on Saturday, the protests stressed economic and social policy issues rather than international questions, such as the war in Afghanistan, expected to be discussed by world leaders at the NATO summit on Sunday and Monday.

Three protest leaders said they met with NATO Ambassador Kolinda Grabar of the military alliance's public diplomacy unit.

"My message to Ambassador Grabar was that we are very aware of the immense violence and oppression that the U.S. in its NATO guise does to the world, and that no amount of words from her or pronouncements from the summit itself will obscure that," said Andy Thayer, one of the protest leaders.

Many of the protesters were from the Occupy Wall Street movement that began in New York last autumn to protest policies that lead to income inequality. The group says 1 percent of the U.S. population holds too much of the nation's wealth.

The protest included some former patients of six city-run mental health clinics that shut at the end of April to save $2.3 million to help close the city's $650 million budget deficit.

"He (Emanuel) hasn't talked to us once, not once, since he's been in office," said Marti Luckett, 60, a patient at one of the shuttered clinics. "We want him to show up.

"I think President Obama should be calling Rahm Emanuel and say, 'Shame on you.'" Emanuel is Obama's former White House chief of staff.

The city says patients should be able to receive care at the six remaining clinics or some run by outside groups.

Small groups of protesters, some carrying signs that read: "Food not bombs" and "seize the peace," accompanied former patients of the clinics dressed in green hospital smocks going door to door to talk to residents in Emanuel's neighborhood. The former patients wore signs saying: "Welfare not warfare."

(Writing By Nick Carey; Additional reporting by James Kelleher; Editing by Peter Cooney and Doina Chiacu)

California voters split on $1 per pack tobacco tax

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LOS ANGELES (AP) — A California ballot initiative to raise the tax on cigarettes that pitted big-spending tobacco companies against cycling legend Lance Armstrong and the New York City Mayor was too close to call Tuesday night.

A blizzard of industry-financed radio and television advertisements over the last two months closed the gap on an effort to impose an additional $1-per-pack tax on cigarettes to fund cancer research.

In March, a statewide poll suggested the measure would pass with two-thirds approval. But support slipped just below percent of the vote with more than 3 million ballots cast.

With millions of votes still to be counted, it could be days or longer before a winner is declared.

The attempt to hike taxes on cigarettes and other tobacco products became a national fight with tobacco companies pouring in millions to quash the effort and celebrities urging voters to support it.

Tobacco taxes have been proven to reduce smoking. But opponents said the initiative would create an unaccountable bureaucracy and hurt the economy by sending tax money raised in California to other states.

An extra tax in the nation's most populous state also could mean major losses for tobacco companies.

Both camps said Tuesday night that they had anticipated a close race and remained confident.

"It's going to be a long night, and that's what we expected," said Beth Miller, spokeswoman for the no on 29 campaign. "It's been a question of the voters taking a look and deciding that they really didn't want to support this measure, but it's also coupled with the fact that people generally do support cancer research."

Supporters promised the tax revenue would stay in California and said tobacco companies were inventing arguments to obscure their true motive — safeguarding profits.

"We've been ahead all night and we expect to stay ahead," Jim Knox of the American Cancer Society said Tuesday. "I think the public health message has gotten through the smoke screen of the tobacco companies' nearly $50 million misinformation campaign."

Armstrong and a coalition of anti-smoking groups raised about $18 million to bolster the measure. New York City Mayor Michael Bloomberg gave $500,000 to the campaign to help offset the industry donations.

The tax would generate about $735 million a year, according to the independent legislative analyst's office.

Voters on both sides of the issue expressed strong convictions Tuesday.

"I think that we should aggressively discourage smoking — make it less convenient, make it more expensive," said Susan Hyman, a Democrat who cast her ballot at a Long Beach polling station.

In nearby Glendale, Craig Jerpseth, a 43 year-old nurse, was equally certain about voting the measure down, along with anything or anyone who might mean more taxes.

"I hope we don't get any more taxes. That's pretty much it," he said.

A slew of newspapers, including the Los Angeles Times, have opposed the measure while proclaiming their reluctance to side with tobacco companies. They argue that the revenue should go to the state, which Gov. Jerry Brown announced last month now faces a deficit of $16 billion.

With a smoking rate of 12.1 percent, California has not raised these taxes since 2000. If the measure passes, California would still have only the 16th highest tax rate in the nation.

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Associated Press writers Raquel Maria Dillon in Los Angeles and Amy Taxin in Long Beach and contributed to this report.

After abuse investigation, kids often remain at risk

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NEW YORK (Reuters Health) - Children who remain at home after an abuse investigation are often still facing risk factors for maltreatment a few years later, a new study finds.

In the U.S., states' Child Protective Services (CPS) investigate more than three million new cases of possible child abuse each year. In a small percentage of cases -- less than 10 percent -- the child will be placed into foster care.

A number of studies have looked into how children fare in the foster-care system. But a lot less has been known about that vast majority of kids who remain at home.

"CPS involvement in homes is actually really common in this country," said Dr. Kristine A. Campbell, a pediatrician at the University of Utah in Salt Lake City who led the new study.

It may be easy to make the assumption that those parents are "bad," she noted in an interview.

"But most of them are struggling with risk factors like poverty and poor social support, and may actually be trying to do well," Campbell said.

In her study, it did turn out that many families investigated by CPS were poor, or headed by a mother with depression or suffering abuse from her partner, for example. And at least some of those risk factors were still apparent three years after CPS came to the home for the first time.

The findings, which appear in the Journal of Pediatrics, are based on a national sample of 5,500 children who were followed after a first-time CPS investigation.

At the first CPS visit, 44 percent of families were below the poverty line. Just over 36 percent of moms or other caregivers said they lacked supportive people in their lives, and one-quarter of them had depression symptoms.

On top of that, 22 percent of women were suffering physical abuse from their partner.

All of those issues are also risk factors for child abuse. And Campbell's team found that for the most part, the prevalence of those risk factors did not change much over three years.

There were, however, some bright spots: Fewer women were being abused three years later -- down to just under 14 percent, from 22 percent.

And when CPS gave women a referral to domestic-abuse services, it seemed to make a huge difference, Campbell said. Among those women, the prevalence of partner abuse went from 54 percent to six percent.

"When they get some services, intimate-partner violence does go down dramatically," Campbell said.

And that's important not only for mothers themselves, she pointed out. Children often have to witness the abuse, or become victims themselves.

"We think the intimate-partner violence often precedes the abuse," Campbell said.

Research has also found that partner abuse often goes hand-in-hand with maternal depression, another risk factor for child abuse.

Of course, not all families investigated by CPS end up in any kind of program or service.

Of the families in this study, child abuse or neglect was substantiated in 28 percent of cases. And CPS gave service referrals to two-thirds of those families.

That meant one-third received no apparent help. "It's disappointing, but not surprising," Campbell said.

The reasons for the finding are not clear. But Campbell pointed out that CPS workers typically have "huge" caseloads and deal with situations where families may be less-than-welcoming.

"They have a very difficult job," she told Reuters Health.

That's where pediatricians can step in to help, according to Campbell. If they know a family has been investigated by CPS, they can follow up with the parents to see if they used referrals to any services.

"We can't make assumptions that everything's been taken care of," Campbell said.

The American Academy of Pediatrics now recommends that pediatricians screen mothers for postpartum depression.

Pediatricians do not routinely screen for domestic violence, but some will ask about it if they have reason to be concerned. There's no widespread routine screening because no one knows yet whether it's actually effective, Campbell explained.

What's "encouraging" in the current findings, she said, is that domestic-violence services did appear to help when they were offered.

Certain risk factors for child abuse, such as poverty, may be difficult to change, at least in the shorter term. "The system may not be able to fix everything that's wrong," Campbell noted.

But, she said, it's important to find out which risk factors can be changed, and then get those services to the families that need them.

SOURCE: http://bit.ly/KZmL1d Journal of Pediatrics, online April 4, 2012.

Autism brain samples damaged after freezer problem

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BELMONT, Mass. (AP) — Scientists say a freezer malfunction at a Boston-area hospital has damaged one-third of the world's largest collection of autism brain samples.

The Boston Globe (http://bo.st/NsoCwH) reports that an official at Harvard-affiliated McLean Hospital in Belmont discovered the freezer had failed in late May without triggering alarms. Inside, 150 thawed brains had turned dark from decay. About a third were part of a collection of autism brains.

Dr. Francine Benes, director of the Harvard Brain Tissue Resource Center, says it was "a priceless collection."

The collection is owned by the advocacy and research organization Autism Speaks. The group says the loss's impact on future research is unclear. A spokeswoman says the brains had been split in half and the halves that were stored elsewhere weren't damaged. Some of the damaged brain tissue had already been used in studies.

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Information from: The Boston Globe, http://www.boston.com/globe

Auction claims it's selling vial with Reagan blood

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LONDON (AP) — A Channel Islands auction house says it's selling a vial that allegedly contains blood residue from Ronald Reagan — a move denounced Tuesday by the late U.S. president's family and his foundation.

The vial being auctioned online was used by the laboratory that tested Reagan's blood when he was treated at George Washington University hospital after a 1981 assassination attempt in Washington, the PFCAuctions house said.

Reagan's son Michael condemned the auction but said he was confident it was not his father's blood.

"Whatever's in the vial — could be mouse blood — it's certainly not Reagan blood," Reagan said in a telephone call from Los Angeles. "And what an outrageous thing to do to (Reagan's widow) Nancy and the family. I hope the world calls on this organization to cease and desist because it's so bogus."

"Even if it were true, how dare they, how dare they do such a thing?"

John Heubusch, executive director of the Ronald Reagan Presidential Foundation in California, condemned the auction and vowed to try to halt it. Bidding for the vial had passed the 7,000-pound ($11,000) mark Tuesday, the house said, and the auction ends Thursday.

"If indeed this story is true, it's a craven act and we will use every legal means to stop its sale or purchase," Heubusch said in a statement. "We've spoken to GW (George Washington) Hospital and are assured an investigation as to how something like this could possibly happen is under way.

"Any individual, including a president of the United States, should feel confident that once they enter into the care of a medical system their privacy and rights are held inviolable," he said.

The auction house on the Channels Islands between England and France said on its website that the blood vial did not come from the Washington hospital that treated Reagan but from the Bio Science Laboratory in Columbia, Maryland.

No listing could be found for Bio Science Laboratory in Columbia. The lab company appeared to have changed hands a number of times since 1981.

A spokesman for George Washington University hospital , Steven Taubenkibel, declined to comment.

The item is a five-inch (12.5-centimeter) glass vial that is one half-inch in diameter and has a green rubber stopper. The auction house says it clearly contains traces of dried blood.

The vial is being sold by a man whose late mother took it from the laboratory with permission weeks after the tests were made, auction house spokeswoman Kylie Whitehead told The Associated Press.

"No one from the foundation or from the family has complained to us," she said Tuesday.

In a statement on the auction house's website, the seller said he tried to interest the Reagan library in purchasing the vial from him but did not succeed. He said the lab director told his mother she could take it.

The auction house website says the seller claimed he was a supporter of Reagan's conservative economic policies and believes the late president would have wanted him to sell the vial rather than donate it.

Reagan required emergency surgery after he was shot by John Hinckley Jr. outside the Washington Hilton Hotel shortly after speaking to labor union officials on March 30, 1981. Hinckley fired six shots at the president from close range. All six missed, but one bullet ricocheted and hit Reagan.

The president was wounded barely two months after taking office. He suffered a punctured lung and severe internal bleeding that required life-saving surgery.

His popular press secretary, James Brady, was left paralyzed after being shot. Two people protecting Reagan were also wounded.

Hinckley was found not guilty by reason of insanity. He remains in a psychiatric facility in the Washington area but has been allowed to spend some time with his family.

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Jablon reported from Los Angeles. Associated Press writer Jessica Gresko in Washington contributed to this report.

California voters reject tobacco tax

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SAN FRANCISCO (Reuters) - A California ballot measure that would have added a $1 tax to a pack of cigarettes was narrowly defeated in the state's primary election Tuesday, an outcome observers attributed to a $47 million ad blitz by the tobacco industry.

The measure was defeated 50.8 percent to 49.2 percent on a day of light voter turnout across the state. The result reflected a long-standing political divide in California, with San Francisco, Silicon Valley and Bay Area counties showing heavy support for the measure, while conservative suburban counties in Southern California were overwhelmingly opposed.

Revenue from the proposed tax, estimated at $735 million in its first year, would have supported medical research on tobacco-related diseases and programs to prevent and control tobacco use.

The measure, championed, among others, by the American Cancer Society, cycling great and cancer survivor Lance Armstrong, had enjoyed a commanding lead in polls earlier in the year.

But opponents, led by tobacco giants Altria's Philip Morris and Reynolds American Inc, vastly outspent its rivals, blanketing the airwaves in much of the state in recent weeks with a message that cast doubt on how the new tax revenues would be spent.

The result mimicked a 2006 effort at increasing tobacco taxes, which was also rejected by voters after a fierce industry-sponsored ad campaign.

The last time California voters approved a measure to increase the state's tobacco tax was in 1998. It narrowly passed.

(Reporting by Jim Christie and Jonathan Weber in San Francisco; Editing by Lisa Shumaker and Paul Simao)

Danger at Home Lurks in Pills, Plants, Chemicals and More

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FRIDAY, June 8 (HealthDay News) -- If you have children or pets, you've probably looked around your house to see what potential hazards you need to lock up or move, like the cleaning products under the sink. But it's easy to overlook something a child might find appealing.

That windshield washer fluid in the garage might look like a big jug of blue fruit drink to a child. Medication that's red and round can look a lot like a candy to a youngster.

No home can be 100 percent safe, but you can take steps to protect your family from the most serious threats in your home.

"You have to anticipate what kids might do," said Rose Ann Soloway, a clinical toxicologist with the National Capital Poison Center in Washington, D.C. "They're smart and fast, and they like to imitate us."

"I compare children getting into medicines and poisons to a young child rolling over for the first time and falling off a bed or couch," Soloway said. "How often do you hear parents say, 'I didn't know he could do that' when a child rolls over for the first time? While it's not possible to be with a child 24 hours a day, it's important that the things that can really hurt them have as many barriers as possible. Keep anything dangerous locked up and out of reach. Children rely on us to provide a safe environment."

So what are the biggest problems that could be lurking in your home?

"The most dangerous are probably medications," said Dr. Jennifer Lowry, a medical toxicologist at Children's Mercy Hospitals and Clinics in Kansas City. "Parents don't always put them away. Grandparents don't always remember that they could be an issue. Their medications may be in pill boxes that are easy to open. And, older adults are on more medications that can be toxic to children."

Soloway said that the medications of greatest concern when taken by those who don't need them are blood pressure and heart medications, as well as narcotic medications to relieve pain. It's also not always children who are an issue with medications. Poison control centers get lots of calls from older adults who've mixed up their medications.

But even pills people might think are safe can be an issue if the dose is large enough.

"Everything can be a poison depending on the dose," said Lowry. People might not be concerned about leaving vitamins accessible, but iron can be extremely toxic, she noted.

Soloway said that personal care products also prompt a lot of calls to poison control centers. "The ones we worry about are those with alcohol in them," she said. "Children can get alcohol poisoning from mouthwash. Children see adults putting it in their mouths, so why wouldn't they? But, they don't get the swish-and-spit part."

Then there are pesticides, which can be dangerous if they're swallowed, breathed in or gotten on the skin. "It's so important to understand that these products are intended to kill an organism," Soloway noted.

Products called hydrocarbons, such as gasoline, kerosene, lighter fluid and lamp oil, are also a concern. Though they generally pass through the digestive system without causing too much damage, they can get into the lungs, causing a serious condition called aspiration pneumonia, if a child swallows one of the products and then vomits it up.

Immediate harm can come from products that can cause chemical burns on contact, including drain openers, toilet bowl cleaners and dishwasher detergent.

But preventing poisonings at home really boils down to common sense, Lowry said. Store cleaning products and other chemicals in their original containers and store them on a high shelf. The same goes for medications -- or, even better, keep them in a locked box. Replace childproof caps tightly after you use a medication.

If you have to use a pesticide or a cleaning product, use them in well-ventilated areas and follow the label instructions. "If a warning is there, pay attention to it," advised Soloway. She also recommended using just the amount of product that you need.

People who have plants in their homes need to know exactly what they are, as some can be irritating and others safe, Lowry said. And without knowing the kind of plant, it's difficult for poison control to help.

She also suggested getting down on your hands and knees and crawling around your house to get the same view your child might have. "That's when you'll see grandma's heart medicine that fell under the couch," Lowry said.

If the worst happens and you or a child has come into contact with a poisonous substance or ingested it, the first thing to do is to call 1-800-222-1222. That's a nationwide number that will link you to a poison control center, which has experts who can judge whether the situation can be handled at home or whether an ER visit is needed.

More information

The U.S. Centers for Disease Control and Prevention has more tips on preventing poisoning.

For more on the risks of poisonings at home, read a companion article on one woman's story.

Copyright c 2012?HealthDay. All rights reserved.

Exercise, vitamin D may prevent falls: guidelines

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NEW YORK (Reuters Health) - Older adults who are at high risk of falls should have physical therapy and take vitamin D supplements to reduce their chance of injury, according to new recommendations from a government-backed panel.

Falling is "a common problem and it's often overlooked because doctors may not be aware of their patients' fall risk," said Dr. Albert Siu, a professor at Mount Sinai School of Medicine in New York and vice co-chair of the U.S. Preventive Services Task Force (USPSTF), which came out with the recommendations on Monday.

"By asking about falls and by observing the patient in terms of walking, we might be able to asses who might be at risk and who can benefit from preventive measures," Siu told Reuters Health.

Falls are a leading cause of injury among older adults, he added.

According to the new guidelines, published in the Annals of Internal Medicine, 30 to 40 percent of people age 65 or older fall at least once each year, and five to 10 percent of them will have a serious injury such as a hip fracture.

The USPSTF makes recommendations on a range of prevention and treatment issues, and its guidelines on reducing the risk of falls in the elderly had not been updated since 1996.

There has been considerable research done since then on what seniors can do to prevent falls -- and what doesn't seem to work. For instance, correcting vision, wearing a shield called a hip protector, stopping some medications or taking protein supplements do not reduce the risk that someone will have a fall, according to the guidelines.

Vitamin D, exercise and physical therapy, however, are moderately beneficial, reducing the risk of falling by 13 to 17 percent (see Reuters Health report of December 21, 2010).

A 13 percent reduction in falls would mean that instead of 30 out of 100 older adults having a fall each year, that number would drop to 26.

In the USPSTF's review of the evidence on vitamin D, the panel found that to prevent one elderly person from falling, 10 would have to take vitamin D supplements.

Siu said the usual dose is 800 international units (IUs) per day, and studies suggest people should take vitamin D for one year to see any benefit.

For exercise or physical therapy, one person would be spared a fall among every 16 people who participate in a program for 12 weeks.

Siu said there's not one particular exercise regimen that works best for preventing falls, and that people should talk to their doctors about finding an exercise or physical therapy program they'll stick to over the long run.

"I know from experience, if you recommend something someone had very little interest in, it's not going to get done," he said.

Siu said doctors can pick out patients who are at a higher risk of falling by informal assessments, such as watching how steady they are on their feet and asking them whether they've had a fall recently.

Physicians can also use a more formal test that includes timing how quickly people can get up from a chair, walk a few paces and return to the same spot.

The USPSTF recommends against more detailed assessments of these higher risk patients, such as evaluating their balance and if their homes have tripping hazards.

There seems to be only a minor benefit from doing an in-depth examination of risks and how to manage them, according to Siu -- and such an undertaking should be reserved for just those patients that a doctor feels would truly benefit, rather than widely applied to all patients at risk of falling.

SOURCE: http://bit.ly/L9cPi0 Annals of Internal Medicine, May 28, 2012.

6.6 Million Young Adults Joined Parents' Health Plans in 2011: Report

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FRIDAY, June 8 (HealthDay News) -- About 6.6 million young American adults who would likely not have been able to be covered by their parents' health plans before the Affordable Care Act took effect joined such plans in 2011, a new report finds.

The new study from the Commonwealth Fund found that, in total, 13.7 million young American adults, aged 19 to 25, either stayed on or joined their parents' health plans last year.

But not all young adults can join their parents' health plans and many still have gaps in coverage and are burdened with medical bill problems and medical debt, the report found.

Nearly two in five young adults (39 percent) aged 19 to 29 went without health insurance at some time in 2011 and more than one-third (36 percent) had medical bill problems or were paying off medical debt. Of those who were dealing with medical bills or debt, many faced serious financial consequences such as using all of their savings (43 percent), being unable to make student loan or tuition payments (32 percent), delaying education or career plans (31 percent), or being unable to pay for necessities such as food, heat or rent (28 percent), the researchers said.

One-quarter of young adults with medical debt owed $4,000 or more, and 15 percent owed $8,000 or more, the report noted.

"While the Affordable Care Act has already provided a new source of coverage for millions of young adults at risk of being uninsured, more help is needed for those left behind," lead author and Commonwealth Fund Vice President Sara Collins said in a Commonwealth Fund news release.

Young adults in low-income households were most likely to be uninsured, the report said. Seventy percent of young adults with incomes below 133 percent of poverty ($14,484 for a single person) had a gap in coverage in 2011. That's more than three times the rate of those with incomes over 400 percent of poverty ($43,560 for a single person).

The study also found that only 17 percent of young adults aged 19 to 25 in low-income families stayed on or joined their parents' health plans, compared with 69 percent of those in the highest income households. Young adults older than 25 are not eligible.

Young adults who did not have insurance or had a gap in coverage were more likely than those with continuous coverage to skip or delay getting needed health care because of cost -- 60 percent, 56 percent and 29 percent, respectively.

However, Collins noted that "the law's major insurance provisions slated for 2014, including expanded Medicaid and subsidized private plans through state insurance exchanges, will provide nearly all young adults across the income spectrum with affordable and comprehensive health plans."

The findings are based on an online survey of 1,863 respondents, aged 19 to 29, that was conducted in November 2011.

More information

The U.S. Centers for Medicare and Medicaid Services has more about young adults and the Affordable Care Act.

Copyright c 2012?HealthDay. All rights reserved.

Amgen drug Sensipar fails to meet trial goal

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(Reuters) - Amgen Inc said on Friday a late-stage trial of its drug Sensipar failed to reduce the risk of death and cardiovascular problems in patients with a complication of kidney disease.

The goal of the study was to show a reduction in the risk of death, heart attack, unstable angina or heart failure in patients with chronic kidney disease who were receiving dialysis.

Although patients taking Sensipar experienced fewer events, the results were not statistically significant and the trial did not meet its goal, Amgen said in a statement.

Sensipar is approved to treat secondary hyperparathyroidism, a condition in which the body produces too much parathyroid hormone, a natural substance needed to control the amount of calcium in the blood. It can be a consequence of kidney failure.

Sensipar has been shown to lower calcium levels in the blood of patients who are on long-term dialysis for kidney disease. Amgen hoped to show it reduced death and heart risks.

Amgen's shares fell 22 cents, or 0.3 percent, to $68.88 in early trading on Nasdaq.

(Reporting By Toni Clarke; editing by M.D. Golan)

2 molecular biologists get $500K medical prize

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ALBANY, N.Y. (AP) — Two molecular biologists have been awarded the annual Albany Medical Center Prize in Medicine and Biomedical Research.

James Darnell Jr. and Robert Roeder received the prize during a ceremony Friday and will share $500,000, the largest award in medicine and science in the United States. The two men performed pioneering research on how cells express their genetic information.

Roeder heads the biochemistry and molecular biology lab at The Rockefeller University in New York City, where Darnell is emeritus faculty.

The two winners were announced in March.

Alzheimer's research fraud case set for trial

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BOSTON (Reuters) - Two Harvard teaching hospitals and a prominent Alzheimer's disease researcher accused of using falsified data to obtain a government research grant are set to stand trial after a federal appeals court said this week that a lower court erred when it dismissed the case.

The lawsuit accuses Marilyn Albert, a former professor of psychiatry at Harvard Medical School, and Massachusetts General Hospital (MGH), where she was conducting research, of submitting a grant application based on manipulated data.

The data showed results from a trial were scientifically significant when in fact they were not, according to the lawsuit.

Brigham and Women's Hospital, which collaborated on the research, is also a defendant in the case. The lawsuit was brought in 2006 under the False Claims Act, a 150-year-old federal law designed to recover government funds appropriated through fraud.

This is the first time a lawsuit dealing with alleged scientific fraud has been allowed to progress to trial under the False Claims Act, according to Michael Kohn, a lawyer with Kohn, Kohn & Colapinto in Washington, D.C.

Kohn represents the whistle-blower in the case, Kenneth Jones, a former statistician at Massachusetts General Hospital, who filed suit in 2006 claiming the defendants violated the act by including false statements in a $15 million grant application to the National Institutes of Health (NIH).

The case was dismissed in the lower court three days before it was due to go to trial. Barring settlement, a new trial could begin later this year in U.S. District Court in Boston, Kohn said.

If the defendants are found guilty, they could pay as much as $45 million to the U.S. government. By law, whistle-blowers in such cases receive 15 percent to 30 percent of funds recovered.

Albert, who is now director of the Division of Cognitive Neuroscience at Johns Hopkins University School of Medicine, declined to comment except to say in an email: "I am confident that there was no misconduct involved."

Both hospitals said they are confident the researchers acted appropriately and according to the highest standards of scientific integrity.

"While it is disappointing that additional time and resources will have to be devoted to defending the institution and its investigators, the MGH remains confident that the resolution of the case will show that the allegations are without merit," Massachusetts General said in a statement.

Brigham and Women's responded with an identical statement.

INFLUENTIAL RESEARCH

Albert's research was part of an ongoing investigation into the structure of the brain as it progresses toward Alzheimer's disease. She specifically hoped to show that it might be possible to predict, years in advance, who might be destined to develop the disease, based on measurements taken over time of certain regions of the brain.

The results of the trial were published in the scientific journal Annals of Neurology in April 2000 and, according to Jones, proved extremely influential.

"The data appeared to confirm what had been suspected by some very prominent scientists, which is that Alzheimer's disease is associated with decreased blood flow to the brain," Jones said in an interview on Thursday. "The MRIs showed the volume of certain parts of the brain was decreasing in the people who were sick."

There are multiple theories about the cause of Alzheimer's disease.

In March 2001, Jones discovered what he believed to be anomalies in the research, specifically in data produced by one of the researchers, Ronald Killiany. The lawsuit alleges that Killiany revised his initial MRI measurements to prove the hypothesis of the trial.

Killiany, now an associate professor at Boston University School of Medicine, did not return a phone call or email seeking comment. Kohn said he was not named as a defendant. In retrospect, Kohn said, "He probably should have been."

Jones took his concerns to Albert, who authorized an investigation into the matter by Killiany's boss, Mark Moss. She declined to appoint an independent investigator, as requested by Jones, according to the lawsuit.

Moss concluded that Killiany's second set of measurements was more accurate than the initial set. Albert accepted Moss's conclusion and proceeded to apply for an NIH grant in November 2001, according to the lawsuit.

The defense argued before the appeals court that it would not have been unusual or inappropriate for Killiany to re-measure patient brain scans as long as he remained blind to the clinical status of the participants, and that this was a matter for scientific debate.

This argument was accepted when the case was initially heard by the lower court in the United States District Court for the District of Massachusetts. On that basis, it dismissed the case in October 2010. Kohn said the court ruled that scientific fraud could not be brought under the False Claims Act, since the case related to a scientific dispute, not fraud.

The appeals court, however, rejected the argument, saying, "We disagree that the creation of the data in question was necessarily a matter of scientific judgment."

The court noted that the lower court's determination "misses the point that the various results produced in this case were obtained by one scientist purportedly using the same protocol."

The government's Office of Research Integrity declined to say whether it is investigating the case.

Jones said he hopes the trial will shed light on the issue of scientific misconduct.

"My interest is in correcting the science and bringing this academic cheating to light," he said, "and maybe sending a message saying, 'You're being watched, and you shouldn't do it.'"

The case is: U.S. ex rel. Jones v. Brigham and Women's Hospital, et al, 1st U.S. Circuit Court of Appeals, No: 10-2301.

(Editing by Michele Gershberg and Douglas Royalty)

Advocates: HIV prevention pill could save lives

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CHICAGO (AP) — A pill to prevent HIV infection is already being given to some healthy people, but without government approval, it remains out of reach and too costly for many who need it.

Doctors, patients and advocates say that would change if the Food and Drug Administration takes a landmark step and allows the pill, Truvada, to be marketed for prevention. The drug has been used for some time as a treatment for those already infected with the AIDS virus.

"This is a pretty radical step, but I think it's a necessary step," said Dr. Lisa Sterman of San Francisco, who prescribes the drug for already infected patients and those who are healthy but at risk of getting the virus from their partners or through risky sex.

"We've come as far as we can with condom use and safe sex strategies," Sterman said.

A panel of advisers to the Food and Drug Administration late Thursday endorsed using Truvada as a preventive.

In the 30-year battle against AIDS, "it's the first time we have talked about a medication for prevention of HIV," Sterman said.

Doctors are allowed to prescribe Truvada "off-label" for prevention, but FDA approval would formally allow the pill's maker Gilead Sciences to market it for that use. It would probably lead many more insurance companies to pay for the costly drug. The FDA usually follows advisers' recommendations and a decision is expected by June 15.

The panel's action "is a huge step forward," said Nick Literski, a federal worker in Seattle who has been taking Truvada for HIV prevention for more than a year. His partner has the AIDS virus. Literski's insurance covers his preventive treatment. The pill's annual cost ranges from just under $11,000 up to $14,000.

Using the drug for prevention "is really allowing people to make educated choices about their health," Literski said.

An estimated 1.2 million Americans have HIV and many more worldwide. AIDS can develop unless the virus is treated with antiviral drugs. The success of such medicines has helped make the disease more manageable and allows patients to live much longer than when the epidemic began 30 years ago.

About 50,000 new HIV infections are diagnosed in the U.S. each year — a number that has held steady for about 15 years.

"We're going to have to take some radical steps in order to stop this epidemic," Sterman said.

Truvada is marketed by Gilead Sciences Inc. of Foster City, Calif. Studies have shown daily use is highly effective at preventing HIV infections.

Some Truvada prevention studies took place in Africa, and the drug is available as an HIV treatment there and in poor nations elsewhere, but Gilead is seeking approval for using it for prevention in the United States only, a company spokeswoman said.

A September editorial in the medical journal Lancet raised concerns about using HIV treatments for prevention when many HIV infected people globally lack access to effective treatments.

James Loduca, a spokesman for the San Francisco AIDS Foundation, praised the advisory panel's action.

"With this recommendation, we're nearing a watershed moment in our fight against HIV," Loduca said. "We know this isn't a magic bullet, and it's not going to be the right prevention strategy for everyone, but it could save thousands of lives in the United States and potentially millions around the world."

Not everyone in the HIV community is so gung-ho about using Truvada for prevention.

Michael Weinstein, president of the AIDS Healthcare Foundation, is among the most vocal opponents. His Los Angeles-based group bills itself as the nation's largest provider of medical care for HIV and AIDS, and Weinstein's main concern is that patients won't take the drug as directed — a pill a day plus the use of condoms. Misuse could create drug-resistant HIV strains, and lead to more infections.

The FDA panelists acknowledged that concern, and said people should be tested to make sure they don't have HIV before starting Truvada. Patients who already have the virus and begin taking Truvada could develop a resistance to the drug, making their disease even more difficult to treat.

Justin Terry-Smith, a Washington-area writer with HIV, has different concerns. He took Truvada for four years to suppress his infection. He said he has friends with the AIDS virus in other cities who can't find the drug, and he worries that making it widely available for prevention could result in shortages and pose problems for patients who need it for treatment.

"There has to much more production of this drug for this to actually go forward," he said.

His doctor recently put him on another drug regimen — switching medicines is a common tactic in HIV treatment. But unlike his other HIV medicines, Truvada had no side effects, and he said it needs to remain available for already infected patients.

Sterman said approval of Truvada for prevention would be unlikely to lead to shortages because the drug would be recommended only for people at high risk for getting the virus.

"I don't think demand for it is going to be that high," she said.

Truvada's costs are another concern. But supporters of the drug note that the lifetime cost of treating one person diagnosed with the AIDS virus has been estimated at more than $600,000.

"It's much more cost-effective to prevent a new infection than it is to treat someone for their lifetime," Loduca said. "Of course the ultimate goal is a vaccine and a cure but we're many years away from that."

Jim Pickett, director of prevention advocacy and gay men's health at the AIDS Foundation of Chicago, has had the AIDS virus since 1995. He says his medical costs, mostly covered by health insurance, have continually increased since then; his HIV medicines alone cost $30,000 a year.

He took Truvada for a while for HIV treatment and had no complications. Side effects from long-term use are unclear, but some of the more serious complications linked with Truvada include kidney and liver problems.

The potential for those problems shouldn't be dismissed, but it's not a reason to reject using the drug for prevention, said Pickett, whose group is not affiliated with the San Francisco foundation.

For some people, the risk of kidney problems "10 years down the line may be less than the risk for acquiring HIV, which is significantly more problematic and can be fatal," Pickett said.

"We need options for people. This is one option. It wouldn't be an option for everybody. It's not meant for everybody," Pickett said.

___

AP Health Writer Matthew Perrone contributed to this story from Washington.

___

Online:

FDA: http://www.fda.gov

AIDS: http://www.aids.gov

___

AP Medical Writer Lindsey Tanner can be reached at http://www.twitter.com/LindseyTanner

Correction: Diabetes Drugs story

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AppId is over the quota

TRENTON, N.J. (AP) — In a June 10 story about diabetes treatment research, The Associated Press reported erroneously that LY2605541 is a short-acting insulin. It is a long-acting insulin.

Also, Johnson & Johnson applied for U.S. approval to sell its experimental diabetes pill canagliflozin on May 31, not May 29.

After stinging report, Pope softens tone for U.S. nuns

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VATICAN CITY (Reuters) - Pope Benedict on Friday held out an olive branch to American Roman Catholic nuns, who are reeling from a stinging Vatican report that criticized them as being feminist and politicized.

"I wish to reaffirm my deep gratitude for the example of fidelity and self-sacrifice given by many consecrated women (nuns) in your country," he said in an address to visiting U.S. bishops.

In a reference to the malaise felt by many American nuns after the report issued last month, he said he hoped that "this moment of discernment will bear abundant spiritual fruit for the revitalization and strengthening of their communities in fidelity to Christ and the Church ..."

A month ago, the Vatican's doctrinal department, which the pope headed for many years before his election in 2005, issued a blistering report on the activity of the majority of American nuns.

It was issued after a Vatican investigation determined that the Leadership Conference of Women Religious, whose 1,500 members represent some 80 percent of American nuns, had "serious doctrinal problems" and promoted "radical feminist themes incompatible with the Catholic faith".

The report, which also criticized the LCWR for sometimes challenging bishops, shocked most American nuns and led to an outpouring of popular and editorial support for them and their work among the poor, and in schools and hospitals.

A Twitter drive in the support of the nuns attracted thousands.

The report said the LCWR had been "silent on the right to life" and had failed to make the "Biblical view of family life and human sexuality" a central plank in its agenda.

In his address to visiting U.S. bishops, the pope did not mention the scolding report and used much softer language in describing his view of religious life.

"The urgent need in our own time for credible and attractive witnesses to the redemptive and transformative power of the Gospel makes it essential to recapture a sense of the sublime dignity and beauty of the consecrated life ..." Benedict said.

Last month's report prompted much criticism of the Vatican attempt to rein in the nuns, who were seen by many as helping the image of the Catholic Church in the United States at a time when it was engulfed the scandal over sexual abuse of minors by priests and accusations and bishops covered it up.

A New York Times editorial called the Vatican's report "a misreading of the very fine work in schools, charities, prison and impoverished neighborhoods being done by about 60,000 nuns across the nation".

The editorial, one of many to defend the nuns, said: "It would be a tragedy, far beyond the Church, if their fine work and their courageous voices were constrained."

American nuns and U.S. bishops have been at odds over several issues social issues. They supported President Barack Obama's health care reform which the bishops opposed it.

The Vatican named Seattle Archbishop Peter Sartain and two other U.S. bishops to undertake the reforms of the conference's statutes, programs and its application of liturgical texts, a process it said could take up to five years.

(Reporting By Philip Pullella Editing by Maria Golovnina)

Diabetes Can Take a Toll on Your Emotions

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THURSDAY, May 17 (HealthDay News) -- Many people know diabetes -- both type 1 and type 2 -- can take a serious toll on physical health. But these blood-sugar disorders also can affect your emotions and, in turn, your emotions can wreak havoc on your diabetes control.

Extremes in blood-sugar levels can cause significant mood changes, and new research suggests that frequent changes in blood-sugar levels (called glycemic variability) also can affect mood and quality of life for those with diabetes.

Depression has long been linked to diabetes, especially type 2. It's still not clear, however, whether depression somehow triggers diabetes or if having diabetes leads to being depressed.

More recent research in people with type 1 diabetes has found that long periods of high blood-sugar levels can trigger the production of a hormone linked to the development of depression.

People with type 1 diabetes no longer can make their own insulin; people with type 2 diabetes need insulin treatment because their bodies can no longer produce it in sufficient quantities.

"Diabetes gives you so much to worry about that it's exhausting. It can make you feel powerless," said Joe Solowiejczyk, a certified diabetes educator and a manager of diabetes counseling and training at the Johnson & Johnson Diabetes Institute in Milpitas, Calif. "I think it's important to acknowledge that, from time to time, you're going to have a meltdown. You're going to have days when you feel exasperated, frustrated, sad, in denial and physically exhausted."

Solowiejczyk, who has type 1 diabetes himself, said these feelings become a problem "when you're not able to get on with your life, and you're persistently not taking care of your diabetes."

Not only does diabetes increase the risk of serious health complications, but uncontrolled diabetes also may worsen depression, causing a vicious cycle.

In addition to an increased risk of depression, diabetes can affect mood even from minute to minute. For example, someone who experiences low blood sugar may suddenly become irritable, even combative, and may act as if they are drunk, slurring their words.

Low blood-sugar levels (also known as hypoglycemia) occur when someone has taken too much insulin or hasn't eaten enough food. Exercise, alcohol and many other factors can lower blood-sugar levels unpredictably.

The problem, Solowiejczyk said, is "that the brain operates totally on glucose. When you don't have enough glucose, things start breaking down and your cognitive function doesn't work that well. This is a physiological, not an emotional, response."

Dr. Vivian Fonseca, president of medicine and science for the American Diabetes Association, said, "Hypoglycemia reactions are very understandable. There are also some fluctuations that are not quite in the hypoglycemia range that may affect anxiety levels."

High blood-sugar levels (hyperglycemia) also can lead to mood changes. "Hyperglycemia can affect your ability to concentrate and can make you feel grouchy," Solowiejczyk said. "Any change in the blood sugar outside of the normal ranges makes you feel weird and uncomfortable."

A small study in the April issue of the journal Diabetes Technology & Therapeutics found that frequent fluctuations in blood-sugar levels in women with type 2 diabetes were associated with a lower quality of life and negative moods.

Fonseca said, however, it's important for these findings to be replicated in a larger population.

Although diabetes and blood-sugar levels can affect emotions, emotions also can affect patients' blood-sugar levels and diabetes control.

In another study in the same journal issue, researchers tested blood-sugar levels in non-diabetic bungee jumpers, and found that the stress of the jump caused their blood-sugar levels to rise significantly. Not surprisingly, their stress hormones also were higher due to the body's normal fight-or-flight response. When this happens, the liver releases glucose to make energy available to the body's cells, according to the American Diabetes Association.

People with diabetes don't have sufficient insulin to let that glucose into the body's cells, however, so instead of providing energy, the sugar just builds up in the blood.

Another emotional minefield often associated with type 2 diabetes is the concept of blame. Most people with type 2 diabetes are overweight, and many are sedentary. Being overweight alone, however, doesn't cause type 2 diabetes. There are other factors, such as a genetic predisposition, at play. But because exercise and losing weight can help prevent -- or, in some cases, reverse -- type 2 diabetes, society often blames people with the disease. (Type 1 diabetes is an autoimmune disease that is not caused by diet or lack of exercise.)

"I think there is a prejudice against overweight people and people with type 2 diabetes, and that's something they have to deal with," Solowiejczyk noted.

What's important, he said, is that if you're persistently having trouble dealing with any of the emotions that come with diabetes, you talk with your doctor, diabetes educator or therapist.

"You should be feeling bad or resentful or angry sometimes," he said. "Diabetes is hard, and all of those feelings come along with the disease. But if you're [irritable] and angry or if you're sad all the time, you're not going to take care of yourself."

The same advice is true for partners of people with diabetes and parents of children with diabetes, he said.

More information

Learn more about the emotional side of diabetes, and the signs of depression, from the American Diabetes Association.

Copyright c 2012?HealthDay. All rights reserved.

Common Painkillers May Help Prevent Skin Cancer: Study

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AppId is over the quota

TUESDAY, May 29 (HealthDay News) -- Taking nonsteroidal anti-inflammatory drugs (NSAIDs) -- which include medicine cabinet staples such as aspirin, Motrin and Aleve -- appears to significantly lower the risk for developing several major forms of skin cancer, a new Danish study reveals.

What's more, the apparent protective impact of both prescription and nonprescription NSAIDs on skin cancer risk seems to be stronger the longer someone takes them.

Over-the-counter NSAIDs are used to control pain, fever and swelling. NSAIDs also include prescription medicines called COX-2 enzyme inhibitors, such as Celebrex (celecoxib).

"Our study showed that users of common painkillers, known as NSAIDs, have a lower risk of the three major types of skin cancer, [including] malignant melanoma, basal cell carcinoma and squamous cell carcinoma," said study lead author, Sigrun Alba Johannesdottir, at the department of clinical epidemiology at Aarhus University Hospital in Aarhus, Denmark.

"The greatest effect," she noted, "was found for squamous cell carcinomas and malignant melanoma, especially when [these painkillers were] taken frequently and over a long time period."

The study appears in the May 29 online issue of the journal Cancer.

The authors noted that prior work supported the notion that NSAIDs may offer some measure of protection against cancer (most notably colorectal cancer), by specifically impeding the cancer-causing activities of COX-2 (cyclooxygenase) enzymes.

However, the team suggested that past investigations into how NSAIDs may affect skin cancer risk, in particular, had key design problems that undercut efforts to nail down any NSAID-skin cancer connection.

For the new study, the researchers analyzed prescription databases and health information registries including the Danish Cancer Registry and the Danish Civil Registration System.

The team focused on diagnostic and death records concerning nearly 2,000 cases of squamous cell carcinoma, about 13,300 cases of basal cell carcinoma and nearly 3,250 cases of malignant melanoma diagnosed between 1991 and 2009 when the patients were at least 20 years old.

In turn, prescription histories were gathered for both the cancer patient group and almost 179,000 healthy Danes. Records covered the use of both low- and high-dose aspirin (ranging from 75 milligrams to 500 milligrams), so-called "nonselective" NSAIDs (such as ibuprofen [Advil] and naproxen [Aleve]), and both older and newer types of COX-2 inhibitors. Researchers noted the number of prescriptions issued per patient and their length of use, with short-term use defined as fewer than seven years.

The result: The relative risk for squamous cell carcinoma was found to have dropped by 15 percent among those Danes who had filled more than two NSAID prescriptions, compared to those who had filled two or less.

Similarly, malignant melanoma risk fell by nearly as much (13 percent) among those filling more than two NSAID prescriptions.

However, the same dynamic was generally not seen with regards to basal cell carcinoma. But taking NSAIDs for long periods of time, and at relatively high doses, was associated with a reduced risk (between 15 and 21 percent), specifically for basal cell cases that manifested in skin regions that typically experience relatively little sun exposure (areas other than the neck or head).

On that front, long-term users and those who took NSAIDs at relatively higher doses appeared to benefit from the strongest protective effect, suggesting that when it comes to skin cancer risk reduction, more NSAID use is better.

The researchers pointed out that the NSAID-cancer connection could be affected by a range of lifestyle factors they did not account for, such as an individual's specific skin type or sun exposure patterns.

But Johannesdottir added that "we hope that our finding will inspire more research on skin cancer prevention. Also, the potential cancer-protective effect should be taken into account when discussing benefits and harms of NSAID use," she noted.

However, "other studies need to detail the association further and to examine benefits versus risks," she cautioned. "Meanwhile, the most important prevention against skin cancer remains sun protection."

Meanwhile, Dr. William Ting, a private practice dermatologist in San Ramon, Calif., praised the study despite agreeing that many factors are at play when it comes to skin cancer formation.

"Now we have a better understanding that inflammation also plays a significant role in cancer formation and even skin cancers," he said.

And, "this exciting article gives physicians and consumers a relatively simple way of diminishing one's risk of skin cancer by doing what most of us are doing already for heart health," Ting added. Ting also advised that people consult with their doctor before starting on any blood thinner.

While the study found an association between skin cancer risk and NSAIDs, it did not prove a cause-and-effect relationship.

More information

For more on NSAIDs and cancer, visit the U.S. National Cancer Institute.

Copyright c 2012?HealthDay. All rights reserved.

Canada abortion foe may be treated as criminal: court

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AppId is over the quota

OTTAWA (Reuters) - The province of Ontario was within its rights to press criminal charges against a grandmother who has spent 10 of the last 18 years in jail for defying court orders not to demonstrate outside abortion clinics, the Supreme Court of Canada ruled on Friday.

Linda Gibbons, 63, appealed to the Supreme Court last year on a technicality, arguing that disobeying a court order should not be punished under the Criminal Code.

Gibbons, who had an abortion in 1970 before becoming convinced that abortion was wrong, argued that she should not get a criminal record for penalties imposed by Ontario courts. The Supreme Court disagreed in an 8-1 decision.

"It's a huge victory for women," said Maria Corsillo, manager of the Scott abortion clinic in Toronto where Gibbons was arrested in 2008. The clinic performs about 2,000 abortions a year.

"They (women) have the right to access health care without having to run a gauntlet through people who want to impose their views on them."

Due to the Supreme Court's decision, the case against Gibbons in connection with her activities at the Scott clinic will now go to trial.

Under what was supposed to be a temporary injunction in 1994, Gibbons is not allowed to come within 60 feet of a number of Toronto clinics.

She is currently in a Toronto prison in connection with another bubble-zone violation and was not available for comment.

Santoro said Gibbons would continue her fight in the courts, arguing that it is "an abuse of process" for police to continue to make use of an 18-year-old temporary court order.

"She's a peaceful protester, and she's never caused any trouble," said her lawyer, Daniel Santoro. Corsillo said Gibbons would sometimes approach women arriving at the Scott clinic and tell them, "Your baby loves you; don't do it."

Canada has no law on abortion and Conservative Prime Minister Stephen Harper has promised not to reopen the issue.

The name of the case is Linda Dale Gibbons v. Her Majesty the Queen (33813).

(Reporting by Randall Palmer; Editing by Peter Galloway)

Doctors sometimes over-treat blood pressure: study

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AppId is over the quota

NEW YORK (Reuters Health) - A new study suggests veterans hospitals are following guidelines when it comes to treating patients with diabetes and high blood pressure -- but some diabetics with healthy readings may also be getting intensive blood pressure treatment that won't do them much good.

"Good control of blood pressure is important for decreasing bad outcomes for patients (with diabetes), such as heart attacks and kidney disease," said Dr. Eve Kerr, the study's lead author from the Department of Veterans Affairs Ann Arbor Healthcare System and the University of Michigan.

Doctors have gotten very good at making sure everyone at risk gets treated with blood pressure medications, she added. But some patients who needed blood pressure medications to begin with might end up not needing them later on.

"Sometimes when blood pressure gets too low, it's okay to back off," Kerr told Reuters Health.

Her team examined the medical records of close to one million diabetes patients treated at VA medical centers and outpatient clinics.

The vast majority of patients age 18 to 75 -- 94 percent -- either had normal blood pressure or were getting high blood pressure treated according to guidelines.

That means most diabetic veterans are getting the help they need when it comes to high blood pressure monitoring and treatment. But although under-treating blood pressure may not have been a big problem in the VA group, over-treatment seemed to be at least as common, if not more so, the researchers found.

More than one-third of patients treated at the VA with a blood pressure below 130/65 mm Hg were on at least three blood pressure lowering drugs, or were having their drug regimen increased. That was equal to eight percent of all diabetic veterans.

High blood pressure is considered to be 140/90 mm Hg or higher, according to the National Institutes of Health.

Depending on the hospital, between three and 20 percent of diabetic veterans were possibly being over-treated with blood pressure medications, Kerr and her colleagues reported Monday in the Archives of Internal Medicine.

Not only might those drugs be unnecessary, but they could cause problems for patients as well, researchers said.

"You don't want to put patients on medications unnecessarily, because there's risks with any medication -- whether it's a nuisance risk of a dry mouth or it could be potentially more serious, like making your blood pressure too low and having you more at risk for falls," said Eileen Handberg, a cardiology researcher from the University of Florida in Gainesville.

"You don't want to treat someone's blood pressure to the point that they're weak and dizzy because their blood pressure is too low," Handberg, who wrote a commentary published with the study, told Reuters Health.

She said guidelines don't currently set a lower limit for recommended blood pressure in diabetic patients -- and because of that, it's hard to say doctors in this study were doing anything wrong when they prescribed more blood pressure lowering drugs to people who might not have needed them.

Still, Handberg added, "There is a lot of conversation about, maybe lower isn't always better."

One limitation of the new study is that it can't show whether patients were actually harmed by their blood pressure getting too low, said Dr. Franz Messerli, director of the high blood pressure program at St. Luke's-Roosevelt Hospital in New York.

"We don't know whether over-treatment or under-treatment increased heart attack, stroke or death, and that's obviously the important issue," Messerli, who wasn't involved in the research, told Reuters Health.

Kerr said the new study can help inform future guideline-makers about how diabetic patients are currently being treated -- and how often too much blood pressure treatment might be a concern.

Researchers agreed that patients who find their blood pressure numbers dropping very low or who have side effects such as dizziness should talk with their doctors about their blood pressure and the possibility they can ease off aggressive treatment.

SOURCE: http://bit.ly/LPkvZ8 Archives of Internal Medicine, online May 28, 2012.