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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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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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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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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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.

Could Compound in Artificial Sweeteners Worsen Crohn's Disease?

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MONDAY, May 21 (HealthDay News) -- The food additive maltodextrin, commonly used in some artificial sweeteners, may worsen Crohn's disease by encouraging the growth of E. coli bacteria in the small intestine, a new study suggests.

However, researchers stressed that the findings are preliminary and the tests were conducted in the lab, not in people, so it's too soon to advise those with the inflammatory bowel disease to avoid maltodextrin.

Maltodextrin is a white powder used in many processed foods as a thickener or a filler, including the artificial sweeteners Splenda and Equal, along with cereal, canned fruits, packaged desserts, instant pudding, sauces and salad dressings. Maltodextrin, typically derived from corn or wheat starch, is also used in some medication coatings.

In the study, researchers placed Equal, Splenda and another sweetener, Stevia, in a dish along with E. coli bacteria taken from people with Crohn's disease. While E. coli is commonly found in the digestive tract of humans, it's usually found in the large intestine, explained senior study author Christine McDonald, assistant staff in the pathobiology department at the Cleveland Clinic's Lerner Research Institute. Prior research has found that people with Crohn's tend to have E. coli in their small intestine.

Though the precise role that E. coli plays in Crohn's is unknown, it's thought that the bacteria may contribute to the inflammation that marks the condition.

When grown in the dish with the Equal (which contains aspartame, dextrose and maltodextrin) and the Splenda (which contains sucralose, dextrose and maltodextrin), the E. coli grew stickier, forming a thick biofilm, according to the researchers. The same didn't happen with the Stevia, which is made from the leaves of a South American plant and does not contain maltodextrin.

Researchers then repeated the experiments, culturing E. coli with maltodextrin alone, and the same sticky biofilm formed.

"In the lab, the E. coli becomes stickier, and it sticks to intestinal cells," said McDonald, who conducted the research with graduate student Kourtney Nickerson. "But we haven't tested this in animals to see if there is a particular amount you need to eat to have this effect. It may be that in people who have other risk factors for inflammatory bowel disease, this may tip them over the edge."

The study, which was funded by the U.S. National Institutes of Health, was to be presented Monday at the Digestive Disease Week meeting in San Diego.

Crohn's disease is an inflammation of the digestive tract that can lead to swelling, pain and ulcers. Although the disease can affect any part of the digestive tract from the mouth to the anus, the most common spot is the small intestine.

It's unknown what causes the disease, although it's believed that microbes -- along with genetics and other environmental factors -- play a role, said Dr. Jerrold Turner, an associate chair in the department of pathology at the University of Chicago.

A healthy gut contains a multitude of bacteria that aid in the digestion of food and extraction of nutrients from foods. A healthy intestine has a layer of mucus that keeps the bacteria away from the lining of the intestine itself. Prior studies have found that, in people with Crohn's, the thickness of that mucus layer decreases, meaning there are more bacteria directly on the cells lining the intestine, possibly leading to inflammation, Turner explained.

The sticky biofilm may also mean there are more bacteria on the lining of the intestines, McDonald said.

No specific diet has been shown to prevent or treat Crohn's disease, according to the U.S. National Digestive Diseases Information Clearinghouse. However, the incidence of Crohn's has been rising in the United States in recent decades, leading researchers to suspect that something about the modern American diet is contributing.

In addition, many people with the disease notice that certain foods or types of foods seem to make their symptoms worse.

McDonald said people with Crohn's may want to try avoiding maltodextrin and see if their symptoms improve, but she and Turner both said more needs to be learned before they recommend that people with Crohn's or a susceptibility to Crohn's avoid the additive.

"It's a very interesting and provocative finding, and [it] may tell us something about the bacteria and what is happening in the intestines, but it's really too preliminary to make any recommendations," Turner said.

A group representing the artificial sweetener industry said the finding was too preliminary to prompt any changes in how artificial sweeteners are made or sold.

"This study was done on cells in petri dishes, therefore it is not possible to apply these findings to humans," the Calorie Control Council said in a statement released Monday. "Even the researcher has stated that it is too early to conclude that maltodextrin promotes disease. Further research is needed before any human nutrition recommendations can be made."

Because this study was presented at a medical meeting, the data and conclusions should be viewed as preliminary until published in a peer-reviewed journal.

More information

The U.S. National Digestive Diseases Information Clearinghouse has more on Crohn's.

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Fate of 'uninsurables' hinges on Supreme Court

AppId is over the quota
AppId is over the quota

WASHINGTON (AP) — Cancer patient Kathy Watson voted Republican in 2008 and believes the government has no right telling Americans to get health insurance. Nonetheless, she says she'd be dead if it weren't for President Barack Obama's health care law.

Now the Florida small businesswoman is worried the Supreme Court will strike down her lifeline. Under the law, Watson and nearly 62,000 other "uninsurable" patients are getting coverage through a little-known program for people who have been turned away by insurance companies because of pre-existing medical conditions.

"Without it, I would have been dead on March 2," Watson said of the Pre-Existing Condition Insurance Plan, known as PCIP. That's when she was hospitalized for a life-threatening respiratory infection.

It's not clear how the Supreme Court will rule on Obama's law, but Watson's case illustrates the potential impact of tying everything in the far-reaching legislation to the fate of one provision, the unprecedented requirement that most Americans carry health insurance.

The law's opponents say if that insurance mandate is found to be unconstitutional, the rest of the law should also go, since courts should not be picking and choosing policy. The administration defends the insurance requirement but says if the court decides to overturn it, most of the rest of the law should stay.

State officials who administer the federal pre-existing condition plan in 27 states are trying to make fallback arrangements in case the law is invalidated and coverage suddenly terminates.

"Some of these individuals are critically ill and are being treated for very serious illnesses, whether it be cancer or HIV-AIDS, and we feel a responsibility to them to do what we can to see they don't lose access," said Amie Goldman, who oversees PCIP in Wisconsin.

Federal officials who administer the plan in the remaining 23 states and Washington, D.C., remain mum on what might happen there if the law is overturned.

The White House line is that Obama is confident the Supreme Court will uphold the Affordable Care Act, and his administration therefore is making no contingency plans for a reversal. None of that sounds reassuring to Watson, who owns a medical transport service in rural north-central Florida.

"It's scary," she said. "They need to look at this carefully because it is going to affect a lot of people with a lot of bad conditions who are not going to have any health care coverage."

Before PCIP, Watson had been uninsured since 2003, originally turned down because of elevated white blood cells. About three years ago, she was diagnosed with a chronic form of non-Hodgkin's lymphoma, a cancer of the immune system. Unable to afford medications, she relied on the emergency room to treat flare-ups.

She tried applying to a major insurance company for a small business plan for her and her employees, and was quickly rejected. Then she heard about PCIP.

The temporary program is meant to serve as a patch until 2014, when the federal health care law will require insurers to accept all applicants, including cancer patients like Watson, regardless of medical history. The law's controversial mandate for individuals to carry health insurance is related to that guaranteed acceptance provision. By forcing healthy people to buy insurance, it would help keep premiums in check.

Initially, Watson could not afford the $800 monthly premium the government was asking for PCIP. High premiums are part of the reason the program has not attracted more people.

But officials retooled to make coverage more affordable. Watson applied again and was accepted. She met the basic requirements: uninsured at least six months, turned away because of pre-existing conditions, having U.S. citizenship or legal residence. Her premium is $363.

In March, Watson went to the emergency room with what she thought was pneumonia. She was admitted, and quarantined the next morning when tests showed she had an antibiotic-resistant bacterial infection, highly dangerous. She spent five days in intensive care.

Without her PCIP coverage, Watson is convinced she would have been sent home from the emergency room after initial treatment to ease her shortness of breath.

"I'm not a candidate for any for type of indigent program, and without insurance they would not have put me in ICU," she said.

"I would have gone into cardiac arrest and probably died," she added. Emergency rooms must treat the uninsured, "but they are only required to get you stable. And then they release you and tell you to go to the health department."

A government report this year found that people in the pre-existing condition plan tended to be middle-aged patients with no access to employer coverage and with medical conditions that require continuous care. The top five diagnoses: cancer, heart disease, degenerative bone diseases, organ failure requiring a transplant and hemophilia.

If the federal law is struck down, some state officials are considering taking the patients into their own, separate, state high-risk insurance pools. Wisconsin, for example, has decided that PCIP enrollees would be automatically accepted into its pool. But not all states have them. In the 35 that do, premiums would generally be higher, and there might be waiting periods.

Republicans, including presidential candidate Mitt Romney, have long favored insurance pools for high-risk patients. And Congress could take emergency action to keep PCIP going. But no assurances have been offered. Michael Steel, a spokesman for House Speaker John Boehner, says Republicans are ready to work on "step-by-step, commonsense" approaches.

Watson says she still disagrees with Obama's requirement that individuals have health insurance, either through an employer, a government program or by purchasing their own plan. "I approve of some of it," she said of the law, "I don't approve of the mandatory ... insurance."

But she doesn't want to go back to depending on the emergency room.

"I have no problem paying my insurance and paying my copays," she said. "I just think I should have the right to purchase insurance."

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Online:

Pre-Existing Condition Insurance Plan: https://www.pcip.gov/