Medicine's Not-So-Silent Killer: Studies Under Scrutiny

Each year, $84 billion is spent on drug development. The rush to create better pills and more effective medicine could be costing the people who take them more than their money -- it could cost them their health. Is medicine losing out to the almighty dollar? Are clinical trials rigged? The results skewed?

There's a lot on the line. The prescription drug market is a $162 billion dollar a year business. But some say the studies done to get these drugs to market can -- and are -- being manipulated.

"Negative studies? We don’t hear about them," Peter Lurie, M.D., Deputy Director of Public Citizen's Health Research Group, told Ivanhoe.

“Many medical journals are becoming marketing instruments for the drug companies," Sidney Wolfe, M.D., Director of Public Citizen's Health Research Group, said.

A new study finds 2 percent of scientists admit they have fabricated, falsified or altered data to improve the outcome at least once. About 35 percent admit to questionable research practices. A JAMA study reveals that 30 percent of the original research studied was either false or exaggerated. Problems include small study size, design flaws, publication bias and failure to publish negative results.

"A smart drug company -- maybe not an ethical one, but a smart one -- might decide to publish only those studies that put its drug or device in the best light," Dr. Lurie said.

Case in point: $25 billion worth of statins are sold each year to help lower cholesterol. Pharmaceutical companies are racing to create a new improved product.

“Every statin company is trying to make people believe their statin is better than another one," Dr. Wolfe said.
 
After astronaut and flight surgeon Duane Graveline’s cholesterol went up from 230 to 270, NASA doctors put him on Lipitor. An under-reported side effect changed his life

“I didn’t know my wife, and I didn’t know my home," Graveline told Ivanhoe.

Graveline was suffering from transient global amnesia. 

“The doctors said, no, no, no, statins don’t do that," Graveline said.

Graveline found studies -- not widely reported -- that show statins impact cholesterol in your brain that affects memory.

“In our attempt to control the blood cholesterol, the statin drugs were adversely affecting the brain," he added.

Graveline found about 1,000 cases of amnesia reported to the FDA.

“Not one of these has ever been reported back to the medical community," he said."

Erick Turner was a doctor who reviewed trials for the better part of his career. When he became a reviewer for the FDA, he got the surprise of his life. 

“I, first of all, was shocked at the number of negative trials, because I had never seen a negative trial before," Dr. Turner, Senior Scholar at the Center for Ethics and Health Care at Oregon Health and Science University in Portland, told Ivanhoe. "I had been clueless … These were studies that simply weren’t getting published, or perhaps they were being presented in a way that made them look positive." 

A JAMA study found industry-sponsored research was positive 87 percent of the time compared with 65 percent of non-industry-sponsored research. UCLA professor Jerome Hoffman says it’s not just the companies that profit from positive results. 

"The financial success of medical journals, particularly the major journals, is intimately tied to meeting the needs of the companies that sponsor these big studies," Dr. Hoffman told Ivanhoe.

The push is on for more disclosure. This year the New England Journal of Medicine now requires authors to disclose any patents or royalties related to their research and it publishes the information with the studies. JAMA and other journals have followed suit. Many believe this is the first step to fixing the problem.

“No study is perfect," Dr. Hoffman said. "The large majority come to conclusions that can be questioned."

Those inaccuracies and misrepresentations can end up costing lives.

Some researchers believe the only way to completely fix the problem is to take private funds out of research. The down side to that? Private companies have more money to spend on research than the federal government. Others are pushing for a drug trial registry that would allow the public to see if any trials ended with negative results.

Article Source http://www.ivanhoe.com/channels/p_channelstory.cfm?storyid=21773

Urgent and Emergent

Nation's Trauma & Emergency System Nears Breaking Point
Congress is currently considering two pieces of legislation that many leaders in trauma care and emergency medicine consider a lifeline for their respective specialties. Without intervention, these professionals fear a time will come when a call for emergency care cannot be answered.
 
Connie Potter, RN, MBA, MHA, president of the Trauma Center Association of America (formerly the National Foundation for Trauma Care), said emergency and trauma medicine couldn't continue on the current trajectory, and the recent economic downturn only makes matters more precarious for facilities that are teetering on the brink of closure.
 
She noted there were 20 closures among trauma centers and 13 downgrades in a five-to-six year period at the beginning of this decade. A 1994 survey found trauma centers were losing 8 percent of costs. "For every $1 spent on trauma care, they received 92 cents," she said. "We repeated that study in 2004 with a government grant … and lo and behold, we had slipped to 14 percent so for every $1, they received 86 cents. If you're a Burger King, and you are selling a burger for 86 cents that costs a $1 to make, how long are you going to be able to stay open?"
 
Emergency departments aren't in any better shape. James Eadie, MD, a spokesperson for the American College of Emergency Physicians (ACEP), noted there were 119.2 million visits to emergency departments in 2006, which represented a 32 percent increase in traffic compared to 1996. "We've had a 30 percent increase in utilization. While at the same time over that decade," he continued, "we saw a decrease in the number of emergency departments by 186 … or 5 percent."
 
Eadie added, "We want to intervene before the emergency department needs life support. It's overburdened, under funded and highly fragmented."
 
National Trauma Center Stabilization Act of 2009 (S 733/HR 936)
This bill would provide federal funding ($200 million in Senate version and $125 million in the House legislation) to assist trauma centers with uncompensated care, core mission services and emergency needs.
 
"Eisenhower understood way back in the 50s that to move military vehicles we needed better than our two lane roads," Potter said, drawing an analogy to our current trauma system. "We have yet to see a trauma patient that will stop at a border … including our U.S. border. We cannot just put it (care) in little silos and tell each state to take care of their own."
 
She continued, "Our overarching goal is that anywhere you're injured in this country, you'll have access to a trauma center, and … should you need it … be transferred rapidly in a pre-planned manner to the highest level trauma center necessary."
 
The first $100 million in provisions are nearly identical in the Senate and House versions. This portion of the legislation is divided into three sections: $20 million would be set aside for the core mission of each trauma center such as administrative costs; $70 million is earmarked for unfunded care compensation; and $10 million is set aside to provide temporary assistance to distressed trauma centers that are on the brink of closing … or, if they do close, to help other hospitals in the region develop a trauma program. In each of these sections, 75 percent of the funding is designated for Level I and Level II trauma centers with 25 percent earmarked for Level III and Level IV centers.
 
The additional $100 million in the Senate version is a grant program to develop new trauma centers or consortiums of hospitals and trauma centers. States would receive $20 million to administer the grants with the balance being available to upgrade capacity and technology, hire trauma specialists, and to make capital acquisitions and other necessary infrastructure investments. The additional $25 million in the House version is for the development and maintenance of innovative information technology systems with an eye toward communication in times of natural disaster, pandemic or acts of terrorism.
 
"This is the second reintroduction of this bill," Potter noted. "It's been authorized and never appropriated." She added that whereas this legislation was primarily an urban bill in the past, its current iteration is much broader and an integral part of healthcare reform, which she hopes will help the legislation pass and be funded.
 
To do nothing is no longer an option. "These hospitals are the linchpin of our national disaster infrastructure whether we know it or not," she pointed out. "It (trauma care) needs to be there ever vigilant, ever present, ever ready."
 
Access to Emergency Medical Services Act of 2009 (S 468/HR 1188)
"The emergency rooms and emergency departments are really at the foundation and core of our healthcare delivery system," said ACEP spokesperson James Eadie, MD, who is a board certified emergency medicine physician.
 
Unfortunately, he continued, we cannot take for granted that care will always be there in every community. Eadie pointed to a landmark 2006 Institute of Medicine study that found our nation's emergency medical system to be highly fragmented and at the breaking point. In December 2008, ACEP released a National Report Card on the State of Emergency Medicine which assigned a D- nationwide in terms of access to emergency care.
 

Eadie said there are three key parts to the bipartisan legislation, which attack the issues facing emergency care from different vantage points. The first, he said, is to bring stakeholders to the table by establishing a national commission on access to emergency medical services to examine factors affecting the delivery of care in emergency departments.

Author CINDY SANDERS

Full article here http://www.medicalnewsinc.com/news.php?viewStory=237

Devoted dad key to reducing risky teen sex, Moms help, but an involved father has twice the influence, new study finds

When it comes to preventing risky teen sex, there may be no better deterrent than a doting dad.

Teenagers whose fathers are more involved in their lives are less likely to engage in risky sexual activities such as unprotected intercourse, according to a new study. 

The more attentive the dad — and the more he knows about his teenage child's friends — the bigger the impact on the teen's sexual behavior, the researchers found. While an involved mother can also help stave off a teen’s sexual activity, dads have twice the influence.

“Maybe there’s something different about the way fathers and adolescents interact,” said the study’s lead author Rebekah Levine Coley, an associate professor at Boston College. “It could be because it’s less expected for fathers to be so involved, so it packs more punch when they are.”

Understanding a father's influence in teen sexual behavior is important, experts say. One in four American adolescents under the age of 15 has had sexual intercourse and, by age 18, two-thirds have had sex, according to research. The concern is, many sexually active young people aren’t using protection, a contributing factor in rising teen birth rates. Approximately 750,000 teenagers become pregnant each year and about 3 in 10 teenage girls become pregnant at least once before age 20, according to government statistics. 

For the new study, which was published in the journal Child Development, Coley and her colleagues surveyed 3,206 teens, ages 13 to 18, once a year for four years. The teens, who all came from two-parent homes, were asked about their sexual behaviors and about their relationships with their parents. 

Researchers posed a series of questions about both mothers and fathers, such as “how much does s/he know about whom you are with when you are not at home?” The teens were also asked how often they interacted with their parents in activities such as eating dinner, playing games or attending religious activities.

Dad's positive effect
Parental knowledge of a teen’s friends and activities was rated on a five point scale. When it came to the dads, each point higher in parental knowledge translated into a 7 percent lower rate of sexual activity in the teen. For the moms, one point higher in knowledge translated to a 3 percent lower rate of teen sexual activity.

The impact of family time overall was even more striking. One additional family activity per week predicted a 9 percent drop in sexual activity. 

Child development experts said the study was carefully done and important. “It’s praiseworthy by any measure,” said Alan E. Kazdin, a professor of psychology and child psychiatry at Yale University. “The strength of this study is that it helps us identify the children who might be engaging in risky sexual behavior.”

Why would dads have a more powerful influence? 

“Dads vary markedly in their roles as caretakers from not there at all to really helping moms,” Kazdin said. “The greater impact of dads might be that moms are more of a constant and when dads are there their impact is magnified.”

Also, Kazdin said “when dads are involved with families, the stress on the mom is usually reduced because of the diffusion of child-rearing or the support for the mom." 

In other words, dad's positive effect on mom makes life better for the child, Kazdin explains.

The study underscores the importance of parental engagement overall, said Patrick Tolan, a professor of psychiatry and director of the Institute for Juvenile Research at the University of Illinois in Chicago. 

A recent study from the Centers for Disease Control suggests teen sex is decreasing while condom use is increasing. NBC’s chief medical editor Dr. Nancy Snyderman on the results.

“For one thing, the more time you spend with them, the less time they’re going to be on their own in places where they can get into risky behavior,” Tolan explained. “Also, if you’re spending time talking to them, they’re going to get your values and they’re more likely to think things through rather than acting impulsively.”

But simply requiring more family dinners won't necessarily reduce the risk that a teen will engage in unprotected sex. The families that are spending more time together may be different in some way from those that are spending less: they may simply be warmer and have closer ties, Kazdin said. If the kids are avoiding their parents because the atmosphere in the home is tense, adding more together time isn’t going to help, Kazdin said.

Coley hopes that the study will encourage both moms and dads to keep trying to connect with their teenage children, even as their kids are pushing them away. 

“While it’s normal for teens to want to pull away from the family, that doesn’t mean they don’t want to engage at all,” Coley said. “It’s extremely important to continue to do things together. And it’s up to parents to set the expectations and standards when it comes to spending time together. It doesn’t have to be anything fancy or expensive."

Linda Carroll is a health and science writer living in New Jersey. Her work has appeared in The New York Times, Newsday, Health magazine and SmartMoney.

Source of article http://www.msnbc.msn.com/id/31086977/ns/health-kids_and_parenting/

Fingerprints do more than bust us

British researchers have found fingerprints actually make it more difficult for us to hold flat, smooth things. So, what is the biological purpose of those tiny, raised crinkles — other than placing us at the scene of a crime?

Bill Briggs in his post "We are our fingerprint" answers  this question. 

From the loops on our thumbs to the whorls on our pinky toes, no human shares the same delicate swoops on the skin of our palms and feet. But those inimitable wrinkles on our digits didn’t develop just to let us access keyless doors, or bust us for being at the scene of a crime. What is the biological purpose of those tiny, raised crinkles?

It’s long been thought that the distinct skin patterns reduce surface friction when we’re grasping or holding objects — that the the friction improves our grip. However, British researchers have found that fingerprints actually make it more difficult for people and primates to grip and hold flat, smooth things.

To get a better grasp of the science, Ennos’ team built a contraption that looks a little like a guillotine. A sheet of Perspex (a plastic also known as Plexiglas) was hung from a cross beam. The beam was then lowered and raised while student Peter Warman held the strip between the fingers and thumb on his right hand. While measuring the force of his clasp on the Perspex, the machine pulled the strip down via a weighted plastic cup. The team tried three different widths of Perspex as well as three different grip angles to mathematically separate Warman’s own pressing force from the contact area, and to weed out any variables. 
Their research, published in the June Journal of Experimental Biology, found the student’s fingerprints added slip, not grip.

“Because the skin is ridged, a lot of the fingertip isn’t touching the surface,” explains lead researcher Dr. Roland Ennos, a biomechanics expert at the University of Manchester in England’s faculty of life sciences. “Think of the tires on a Formula 1 race car, or on an Indianapolis car. They want to have the best grip as possible, so they use flat tires. In just the same way, our fingertips – because they are ridged – don’t have the same grip they would if they were perfectly flat.”

Humans aren’t the only creatures with skin prints, either. Why do koalas have them? Why do monkeys in South America have similar prints on their tails? Ennos has a theory.

The padded sections of our hands and feet that do the toughest physical work – grabbing, twisting, pushing, pulling and thrusting – are laced with prints. The grooves and ridges give those swaths of our skin more elasticity. They allow the skin to stretch and distort as the labor takes place. The opposite is true of the smooth areas of our hands and feet. After withstanding excessive friction, they rip or collect fluid between the skin's various layers.

“When you do ‘DIY’ work or when you’re walking with ill-fitting boots, it’s the areas which haven’t got the ridges that tend to get blisters,” Ennos said. “My idea is that by having fingerprints, the skin is actually about twice as flexible. It struck me that having a fingerprint is part of a design package that strengthens the skin, allowing it to deform an awful long way without being damaged.”

Ennos believes that fingerprints also allow us to more easily grab rougher surfaces and wet objects while they also add sensitivity to our feel. But touch cannot be their main function, he theorized, because the heel is covered with skin ridges yet “isn’t used to discriminate anything” if, say, we’re trying navigate a dark room. 

The British researcher has applied for additional funding to conduct extra tests on the friction-prevention qualities of our fingerprints. But here’s a warning to all interested student subjects: Blisters are part of the job.

Source of post "We are our fingerprint": http://bodyodd.msnbc.msn.com/archive/2009/06/23/1975088.aspx