Supreme Court's gun ruling may be prescription for injuries and death, legal expert says

Doctors may not make a habit of following the Supreme Court, but a decision handed down this week has the potential to affect the well-being of their patients, a UCLA law professor and physician warns in the New England Journal of Medicine.

The case in question is McDonald vs. Chicago. In a 5-4 decision, the justices said that states and cities may not abridge the 2nd Amendment right of people to keep handguns in their homes for self-defense.

The plaintiff in the case, Otis McDonald, wanted a gun to protect himself from the drug dealers and other assorted thugs that had taken over his neighborhood and broken into his home. But the gun he seeks “may just increase the risks of homicide, suicide, and accidental injury and death of those who live in or, like his grandchildren, visit his home,” writes Dr. Julie Cantor, whose scholarship focuses on the intersection of health, law and ethics.

Cantor points out that gun violence causes more than 30,000 deaths and 60,000 injuries each year, making it a leading public health problem. Studies have shown that the mere presence of a handgun substantially raises the risk of homicide and suicide, with abused women being particularly vulnerable.

“To the extent that McDonald means more handguns, physicians have reason to be concerned,” she writes. One of her suggestions: “Physicians should remain vigilant and address gun issues, such as access and storage, with patients, especially those who may be suicidal, have survived domestic violence or live with children.”

-- Karen Kaplan

Photo: A legal expert with a medical degree warns that handguns may be hazardous to your health. Credit: Kamil Krzaczynski / EPA

Jewelry seems too risky; maybe we should buy kids some string

There's much to be said for those craft-your-own friendship bracelets.

In the wake of recalls of cadmium-tainted kids'  jewelry from Wal-Mart and Claire's, Good Housekeeping has done its own tests. The magazine's research institute tested kids' jewelry from Wal-Mart and Claire's, and also Target, for heavy metal content. All topped the government's recommended lead limits. And (surprise!) cadmium was plentiful as well. Here's the Good Housekeeping report.

And here's some recent kids' jewelry advice from the chairman of the U.S. Consumer Product Safety Commission:

We have proof that lead in children’s jewelry is dangerous and was pervasive in the marketplace. To prevent young children from possibly being exposed to lead, cadmium or any other hazardous heavy metal, take the jewelry away.

On the up side, summer has just started. With the right supplies, your kids could be doling out lead- and cadmium-free bracelets by the dozens come fall. Here's how to make a friendship bracelet.

-- Tami Dennis

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Photo credit: Ken Hively / Los Angeles Times

Earlier school start time linked with more teen car crashes, study finds

Extra sleep could make students more alert for class, and also for driving. Car crash rates were lower in an area where high school classes started later, according to a new study.

The study, presented today at the annual meeting of the Associated Professional Sleep Societies in San Antonio, compared crash rates in two Virginia towns: Virginia Beach, where high school classes started at 7:20 a.m., and Chesapeake, where classes started at 8:40 a.m. Teen crash rates in 2008 were about 41% higher in Virginia Beach than in Chesapeake.

Car crash statistics were compiled from the Virginia Department of Motor Vehicles. For every 1,000 teen drivers in Virginia Beach, there were 65.4 car crashes, versus 46.2 crashes for every 1,000 teens in Chesapeake. The neighboring cities share similar demographics.

When researchers broke down the accidents by the time of day they occurred, they found that afternoon crash rates were higher than morning crash rates in both cities. The school day wrapped up in Virginia Beach around 2 p.m., and the afternoon crash rate there was highest from 2 p.m. to 6 p.m. School got out in Chesapeake about 3:40 p.m., and afternoon crash rates there were highest from 4 p.m. to 5 p.m. Overall afternoon crash rates for teens were higher in Virginia Beach than in Chesapeake.

"We believe that high schools should take a close look at having later start times to align with circadian rhythms in teens and to allow for longer sleep times," said Dr. Robert Vorona, the study's lead author. Vorona, associate professor of internal medicine at Eastern Virginia Medical School in Norfolk, Va., warned that the study shows a link between school times and crash rates but does not imply cause and effect. He added, "Too many teens in this country obtain insufficient sleep. A burgeoning literature suggests that this may lead to problematic consequences, including mood disorders, academic difficulties and behavioral issues."

— Jeannine Stein

Photo credit: Mark Boster / Los Angeles Times

Embargo break on cellphone-brain tumor study adds to controversy

The controversial Interphone study-- the largest, longest study on whether cellphones increase the risk of brain tumors -- was due to be released Monday at 4:30 p.m. PDT, in the International Journal of Epidemiology. The embargo was broken over the weekend, however, and many fingers are pointing to the British media as the culprits. But it's obvious that stakeholders on both sides of the issue would like to shape the message from this confusing and problematic study.

The study showed no link to two types of brain tumors in adults but found a slightly increased risk of brain tumors among people who used wireless phones the most and the longest and who held their phones to the same side of their heads each time. The Mobile Manufacturers Forum, a wireless industry trade group, considers the study proof that cellphone technology is benign, saying in a news release that the study "provides significant further reassurance about the safety of mobile phones. The overall analysis is consistent with previous studies and the significant body of research, reporting no increased health risk from using mobile phones."

Janet Raloff, writing for Science News, notes that the manufacture's trade group provided some funding for the Interphone study -- one of the many criticisms of the Interphone study. Further, Raloff points out that the MMF's release doesn't exactly mirror the news coverage:

"This interpretation departs dramatically, however, from what several UK news organizations reported.
–  Says London’s Sunday Times online: 'People who use their mobile phones for at least 30 minutes a day for 10 years have a greater risk of developing brain cancer, a landmark study has found.' 
– The Telegraph noted in its story that 'The final results paper of the study, one quarter of which was funded by the mobile phone industry, has been delayed for four years while the authors argued over how to present the final conclusions . . .'
– A longer version of the above story by Mark Smith in the Scotsman leads off with: 'A major international study has found a link between mobile phone use and certain brain tumors.'

With such news accounts emerging, no wonder MMF wanted to put some calming interpretations out regarding the data."

The embargo break is unfortunate because it prevents news organizations, including The Times, from proceeding with a full accounting of the study from a variety of viewpoints. Critics of the study have also been clamoring for media attention. The Interphone study has many flaws, said Joel Moskowitz, director of the Center for Family and Community Health, School of Public Health, UC, Berkeley. In October, Moskowitz published a paper in the Journal of Clinical Oncology analyzing 23 studies on the link and finding that eight of the most scientifically rigorous of the studies showed a 10% to 30% increased risk of tumors among cellphone users compared with people who rarely or never used the phones.

The Interphone study, which was coordinated by the International Agency for Research on Cancer, reflects a much lower rate of cellphone usage than is common today, Moskowitz said in an interview Friday. Average cellphone users in the study used a wireless phone for an average of 2 to 2.5 hours a month -- compared with the average use presently of 21 minutes a day. Moreover, the study only examined adults, and data collected on two other types of tumors, on acoustic neuromas or salivary gland tumors, has not been released for unexplained reasons. The study also described people who used cordless phones but did not use cellphones as people who "never used" wireless technology. That could have also skewed the findings.

"We have known for some time that there were problems with methodology with this study," Moskowitz said. "Cellphone use has increased a great deal since this study has been done. The levels of use we're seeing today, the study doesn't bear on that. I think they really blew it."

A new study is set to begin, funded by the European Union, to investigate the risk of brain tumors among children and teens using cellphones. Cellphones may confer different risks on younger people, whose brains are still developing. However, many kids today text on cellphones more than talk.

Interphone leaves many questions unanswered. That makes it difficult for lawmakers in this country and elsewhere to weigh suggestions that cellphones carry health warning labels as a prudent step while further research on safety is conducted. An April report from the President's Cancer Panel, "Reducing Environmental Cancer Risk," lists as its No. 1 recommendation: "A precautionary, prevention-oriented approach should replace current reactionary approaches to environmental contaminates in which human harm must be proven before action is taken to reduce or eliminate exposures."

-- Shari Roan

Photo: Jagadeesh NV / EPA

Diabetes drug trial unethical and dangerous, researcher charges

The Canadian physician whose research escalated safety concerns about the Type 2 diabetes drug rosiglitazone (marketed as Avandia) is urging the U.S. Food and Drug Administrationto call a halt to a major international trial designed to compare the safety of Avandia against another diabetes drug in the same class.

Dr. David Juurlink, chief of clinical pharmacology and toxicology at Sunnybrook Health Sciences Center in Toronto, was the lead author of a 2009 study that found that compared to elderly diabetics taking a drug called pioglitazone (marketed as Actos), those taking Avandia were about 30% more likely to suffer heart failure or death. On Tuesday, Juurlink joined with Dr. Sidney Wolfe, director of health research for the consumer watchdog group Public Citizen, in calling a further clinical trial pitting the two diabetes drugs against each other "unethical" and "dangerous."

In 2007, the FDA issued two separate safety warningson Avandia and required the drug's maker, GlaxoSmithKline, to post "black box" warnings on the medicine's patient instruction sheet indicating the drug might put patients taking it at higher risk of ischemic heart attack or heart failure. The agency also ordered GSK to conduct a post-marketing safety trial of Avandia. That planned trial is expected to draw from sites in 14 countries, including a number of newly-added developing countries such as Pakistan, India, Latvia, Chile, and Mexico, and to enroll 16,000 subjects. Called the TIDE trial, or Thiazolidinedione Intervention in Vitamin D Evaluation, was the subject of Tuesday's appeal from Juurlink and Public Citizen.

In act, both drugs have been tagged with safety issues: In addition to raising rates of cardiovascular events, the class of Type 2 diabetes drugs known as thiazolidinediones (or TZDs) have been linked in studies to higher rates of edema, macular edema, bony fractures, anemia and acute liver injury. Older diabetes medicine such as metformin and sulfonylurea are widely believed to be safer alternatives. 

At the same time, the drugs are widely used and have many defenders in the care of Type 2 diabetes -- an obesity-related condition that has exploded in the U.S. population in recent decades. But extensive financial ties between the drug companies that make the medicines and many of the clinicians and researchers who have defended them have prompted some -- including leaders of the Senate Finance Committee -- to ask whether the safety debate has been tainted by industry influence. 

There is scant evidence that the proposed clinical trial will yield more reliable evidence of Avandia's relative safety profile than existing research has done, Juurlink and Wolfe wrote in a Tuesday letter to FDA Commissioner Margaret Hamburg. Nevertheless, it will expose "thousands of high-risk patients with diabetes to a drug with an unfavorable safety profile and clinical advantage over its comparator," they wrote. The "price of definitive proof" of the drug's safety hazards, they added, "will almost certainly be measured in the lives of study subjects who have been incompletely informed about the risks and benefits of participation" in the trial, they added.

--Melissa Healy

Supplements guru sues over his own product

The world of dietary supplements is unpredictable and sometimes, well, zany. But here's a story that should give pause to anyone lured by the extravagant claims of many supplements makers.

Gary Null, a nutrition and fitness guru, critic of conventional medicine and hawker of dietary supplements on his website, filed a suit Monday with the Supreme Court of New York County against one of his own herbal supplements -- or more specifically, a company that provided some of its nutrient ingredients. The suit alleges that after taking two daily doses of the product, Ultimate Power Meal, for a month, Null fell ill with "excruciating fatigue along with bodily pain" and bleeding "from within his feet."

A visit to his physician revealed extremely elevated levels of Vitamin D in Null's body, which led Null to investigate the contents of the Ultimate Power Meal. Null's complaint charges that the defendant in the civil case, Triarco Industries Inc., had erred in preparing the Vitamin D source for the product, making it 1,000 times more potent than the product's content label claimed. The suit seeks damages of $10 million.

As The New York Post, which broke the story, observes, "not exactly a ringing endorsement" of his own product.

Null consumed his power meals after his symptoms appeared, believing the product "would help him and relieve his condition."

"Fortunately, only one lot of Power Meal was defective and none of the product reached the retail market," says Null on his website's "store." But the New York Post, citing papers filed in the suit, reports that "six consumers were hospitalized with severe kidney damage" and that Null, while ill, "had dozens of his customers calling him, as well as threatening and condemning him."

It's not at all uncommon for the content of dietary supplements to contain doses wildly different than those indicated on their labels--and that's when nutritional contents are listed on labels, which is not always. (At least one commercial lab regularly issues reports documenting the mislabeled and unlabeled contents of dietary supplements.) 

New federal rules make the manufacturers of dietary supplements subject to inspections to ensure "good manufacturing procedures." Those rules aim to improve quality problems that have long plagued the supplements industry. But for the smallest manufacturers, those regulations are just now coming into force. Otherwise, the Food and Drug Administration's role in regulating dietary supplements is very limited: Dietary supplements are allowed onto the market without prior approval from the FDA. So, unless the agency has reports that indicate a product may be harmful, it can stay in broad circulation indefinitely.

So, buyer beware -- and apparently that goes for Gary Null, whose "Ultimate Power Meal," fortunately for him, didn't quite live up to its name.

As for Vitamin D toxicity -- this is controversial. Most of us do not get enough of this vitamin, which our bodies produce in response to sunlight as well as take in from dietary sources, and evidence is mounting that adequate Vitamin D levels are important for staying healthy. But the National Institutes of Health have said that 50 micrograms, or 2,000 international units, is the safe daily limit for anyone over a year old. The Vitamin D Council, headed by Dr. John J. Cannell, counters that adults can tolerate more than 10,000 IU daily safely.

--Melissa Healy

Don't just flush those leftover meds

Unused medications create a dilemma -- what to do with the things? They obviously shouldn't be left lying around accessible to bored teenagers or curious kids. Nor should they be flushed; medication traces are already showing up in the water supply. But just dumped in the trash...? Maybe they should be taken back to a pharmacy.

The National Community Pharmacists Assn., which represents independent community pharmacists, and Sharps Compliance, a medical waste management company, is offering a disposal method that may provide more peace of mind than the traditional "toss 'em in the rubbish bin and hope for the best" approach.

Go to www.disposemymeds.org for a list of pharmacies that will dispose of those meds for you. There are 800 participating pharmacies in 40 states, but it's a big country. Even in the L.A. area, you might have to search beyond a 5-mile radius to find one.

For people who can't find a pharmacy or would have to travel too far, the site offers a link to the Office of National Drug Control Policy's guidelines on medication disposal.

That, in a way, seems to bring consumers back to where many started -- at a bit of a loss. Among the tips are to take unused drugs to a collection program, of which there seem to be precious few. (Kudos, guys, for this one.)

But the guidelines do include useful advice as well -- such as, if you must trash the pills, mix them with kitty litter first. 

-- Tami Dennis

Photo credit: Los Angeles Times

Of medical malpractice and safety -- and what the connection portends

Surely, improved hospital safety would lead to fewer malpractice claims, yes? Perhaps, perhaps not. We've had little evidence either way. Enter the Rand Corp.

Researchers there have offered up their analysis of the connection, based on California's experiences. They say that a county with a decrease of 10 adverse events would see 3.7 fewer malpractice claims. Similary, an increase of 10 events would suggest 3.7 more malpractice claims.

From the Rand report's conclusion:

Arguments about the merits of statutory tort intervention will surely continue in the future,
but to the extent that improved safety performance can be shown to have a demonstrable
impact on malpractice claims, that offers another focal point for policymakers in seeking to
address the malpractice crisis. Based on the results of the current study, we would suggest that that focal point may be more immediately relevant than has previously been recognized.

Here's the full report: Is Better Patient Safety Associated with Less Malpractice Activity? Evidence from California. For a shorter version, go to the summary.

-- Tami Dennis

Most people can't talk on a cellphone and drive safely, study finds

Only a talented few can simultaneously talk on a cellphone and drive safely, according to a study from researchers at the University of Utah. The danger of a study like this is, of course, that everyone will think they are in the 2.5% of all people whom the study found to be "supertaskers." The pertinent fact is that 97.5% of us can't drive safely while talking on the phone -- even a hands-free phone.

The researchers assessed the performance of 200 people using simulated freeway driving while conducting a conversation on a hands-free phone that involved memorizing words and solving some math problems. Performance was measured in braking, reaction time, following distance, memory and math execution.

For the vast majority of people, performance suffered in both driving and comprehension. Braking time increased by 20% while following distances increased by 30%. Memory performance declined 11% and math performance 3%. The deterioration in performance was comparable to the impairment seen in drunk drivers, the authors said.

A few individuals, however, were supertaskers -- they could successfully perform the two tasks at once with no deterioration in performance.

"There is clearly something special about supertaskers," said the authors, David Strayer and Jason Watson, in a news release. More studies are needed to examine the abilities of such people, since multi-tasking is now expected of adults in many circumstances, such as the workplace, they said. However, multi-tasking is not expected while operating a vehicle, nor should it be. "While we'd probably all like to think we are the exception to the rule, the odds are overwhelmingly against it," the authors note.

The study is published this week in the journal Psychonomic Bulletin and Review. You can read more about the topic on David Strayer's blog at CarTalk's Driver Distraction Center.

-- Shari Roan

Photo credit: Mel Melcon / Los Angeles Times

Add 'behind the wheel' to places that BMI matters, especially for men

Extra padding in an automobile accident is not a good thing, not when that padding comes from fat.

Scientists at the Medical College of Wisconsin's Injury Research Center and elsewhere analyzed real-world data on almost 11,000 drivers involved in front-end crashes; they also crafted computer models and crash simulations. Their conclusion: In automobile accidents, obese men are much more likely to sustain serious upper body injuries than are normal-weight men.

Body shape and center of gravity are factors, but the researchers acknowledge that additional study is needed to put a fine point on the body mass index (BMI)-risk connection.

They conclude: "Our findings may have important implications for high-risk cohort identification (e.g., obese male drivers), traffic safety intervention, policymaking, and for motor vehicle design to protect more vulnerable body regions."

Here's the full driver-injury study, published in the March issue of PLoS Medicine.

And don't forget to click on "supporting information" for the crash-test dummy simulations.

On Southern California roads, we need as much safety-related information as we can get.

-- Tami Dennis

Photo: On the plus side, a high rate of speed is often unlikely.

Credit: Christine Cotter / Los Angeles Times