Johnson & Johnson Charges

Johnson & Johnson faces possible criminal charges for pattern of violations.
ABC World News (5/27, story 6, 2:45, Stephanopoulos) reported, "Government officials said today they are considering criminal charges against Johnson & Johnson, stemming from last month's huge recall of Tylenol and other popular over the counter children's medicines."
NBC Nightly News (5/27, story 5, 2:25, Williams) reported, "Johnson & Johnson insists it has taken dramatic steps to clean up the plants where the recalled products are made. Meanwhile, the FDA says it has referred the matter to its criminal division for consideration."
On the front of its Business Day section, the New York Times (5/28, B1, Singer) reports, "The Johnson & Johnson unit that recalled millions of bottles of liquid children's Tylenol and other pediatric medicines last month may face criminal penalties, product seizures, or other sanctions, an official from the Food and Drug Administration said Thursday." Notably, the "agency is considering further actions against McNeil Consumer Healthcare...after a pattern of violations in manufacturing and quality control practices led to a number of recent recalls," Sharfstein "said at a Congressional hearing on Thursday."
The Washington Post (5/28, A03, Layton) notes, "When faced last year with Motrin IB caplets that were not dissolving properly, McNeil Consumer Healthcare, a division of Johnson and Johnson, hired contractors to buy the products under orders not to mention the term 'recall,' according to documents released by the House Committee on Oversight and Government Reform." Then, "after the Food and Drug Administration discovered the effort -- because one of the contractors accidentally dropped an instruction sheet on the floor of a store -- McNeil announced a recall of roughly 88,000 packages of the product." And, in the last year, there have been "four recalls of McNeil products...including the April 30 recall of 136 million bottles of infant and children's Tylenol, Motrin, Benadryl and Zyrtec, which have shaken consumers' confidence and threaten to stain Johnson and Johnson's brand name."

Orlistat Warning

FDA now requiring liver-injury warning label on "popular" diet drug.
ABC World News (5/26, story 8, 0:20, Sawyer) reported, "There is a new warning about...popular weight loss drugs," medicines that have been taken by nearly "40 million people." After receiving "reports of liver damage by some users," the FDA has decided to put "a new warning on" Xenical (orlistat), developed by Roche's Genentech, "and its over-the-counter version, Alli," which is manufactured by GlaxoSmithKline (GSK), NBC Nightly News (5/26, story 9, 0:20, Williams) reported.
To date, the agency has identified "13 cases of severe liver damage associated with the drugs, one in the United States and 12 abroad," according to the Los Angeles Times (5/26, Maugh) "Booster Shots" blog. "Two of the patients died from liver failure and three others required liver transplants."
Last August, "the FDA initiated a review of the drug after receiving 32 reports of serious liver injury with hepatocellular necrosis or acute hepatic failure, 30 of them outside the US," MedPage Today (5/26, Neale) reported. The "current announcement of a labeling change comes at the end of the agency's review process."
Now, the revised label for orlistat (Xenical) will "include new safety information about rare cases of severe liver injury," Medscape (5/26, Lowes) reported. "In addition, the Drug Facts label for an over-the-counter, 60-mg formulation of orlistat (Alli) will now feature a warning about severe liver injury." The agency stated, however, that "it has not yet established a causal relationship between orlistat use and severe liver injury" for a few reasons. For instance, some of the patients in question were taking other drugs while using the diet medications, Dow Jones Newswire (5/27, Dooren) reports. Others may have had conditions that exacerbated their liver issues.
Still, HealthDay (5/26, Gardner) reported, the agency is "'telling consumers and healthcare providers to be vigilant should [patients] develop symptoms suggestive of liver impairment,' said FDA spokeswoman Elaine Gansz Bobo." She added, "We are not advising routine monitoring of liver enzymes as that will not help predict who may develop hepatic impairment on the drug."

Unhealthy Restaurant Dishes

Group unveils list of most unhealthy restaurant dishes.
NBC Nightly News (5/25, story 8, 2:30, Williams) reported, "There are certain things we like to eat, we eat them knowing they are not great for us. And then about once a year a group comes along to warn us all and tell us exactly what's in what we're eating. Well, it's that time of year. This year with about 1/3 of the American population classified as obese, the so-called extreme eating awards take on a new urgency."
ABC World News (5/25, story 7, 1:40, Sawyer) reported that "in America, where two of three adults are already considered overweight or obese, a new wakeup call tonight" about a "list of restaurant dishes that simply top the charts." ABC (De Nies) added, "They're big sellers at top food chains across the country, loaded with hidden fat, salt and sugar."
The Los Angeles Times (5/26, Stein) reports that "the Center for Science in the Public Interest has come out with its Xtreme Eating awards, giving dubious honors to restaurant fare that maxes out on fat and calories." The Times adds, "Among the winners (or should that be losers?) is the pasta carbonara at Cheesecake Factory; when served with chicken this dish comes in at 2,500 calories and 85 grams of saturated fat. Also on the list is the New Zealand rack of lamb at Outback Steakhouse. The lamb alone (no sides) is 1,300 calories and 60 grams of saturated fat, plus 1,340 milligrams of sodium (recommended daily allowance of sodium is from 2,400 milligrams for a healthy adult, although some health experts think it should be far lower)."

Herbal Supplement Contaminants

GAO study reveals contaminants in herbal supplements.
The New York Times (5/26, A15, Harris) reports, "Nearly all of the herbal dietary supplements tested in a Congressional investigation contained trace amounts of lead and other contaminants, and some supplement sellers made illegal claims that their products can cure cancer and other diseases, investigators found." Although the "levels of heavy metals -- including mercury, cadmium and arsenic -- did not exceed thresholds considered dangerous," almost half of them "contained pesticide residues that appeared to exceed legal limits." Notably, "Dr. Joshua M. Sharfstein, principal deputy commissioner of the Food and Drug Administration, said in an interview that he was not concerned about the safety of the supplements tested by the GAO investigators." Still, Sharfstein added that "the FDA had increased enforcement actions against supplements spiked with prescription drugs."

Sleep Apnea and Throat Exercises

Throat exercises may help patients with sleep apnea reduce their condition's severity.
According to the New York Times (5/24, O'Connor) Really? column, some sleep apnea sufferers "complain that the mask and headgear" used during CPAP "cause uncomfortable side effects, like congestion." There is new data, however, that may support a "free and fairly simple alternative" for such patients. "In a study published last year in the American Journal of Respiratory and Critical Care Medicine, scientists recruited a group of people with obstructive sleep apnea and split them into two groups." Three months into the trial, investigators found that "subjects who did the throat exercises snored less, slept better, and reduced the severity of their condition by 39 percent. They also showed reductions in neck circumference."

Blood Pressure and Soda

Drinking fewer sugary drinks may lower blood pressure.
The Los Angeles Times (5/24, Stein) "Booster Shots" blog reported that "there may be a link between drinking fewer sugar-sweetened beverages and lowering blood pressure," according to a study published in the journal Circulation: Journal of the American Heart Association. Researchers followed "810 men and women age 25 to 70 who were part of a lifestyle intervention study and had prehypertension or stage I hypertension." The researchers found that "drinking one less serving, or 12 ounces, of sugar-sweetened beverages per day was associated with 1.8 drop in systolic blood pressure, and a 1.1 drop in diastolic blood pressure over 18 months."
Reuters (5/25, Steenhuysen) quotes one of the study authors as saying, "If you reduce your consumption by two servings, you would probably lower your blood pressure even more."
The NPR (5/24, Knox) "Shots" blog pointed out that "Americans drink two 12-ounce servings of these sugary drinks a day, on average."

Delayed Vaccine Update

Delaying childhood vaccinations may offer no benefit.
The Los Angeles Times (5/24, Maugh) "Booster Shots" blog reported, "Now that the thimerosal-autism link has been thoroughly discredited, some autism advocates argue that neurodevelopmental problems are caused by overloading children's immune systems with too many vaccines too early in life." Consequently, a "growing number of parents are asking pediatricians to use alternative vaccination schedules that spread out the shots, even though there is no evidence to suggest that the practice may be helpful." That evidence, however, may be hard to come by, as scientists "cannot ethically conduct a clinical trial of delayed vaccinations because of the potential risks to the children involved."
To get around that issue, researchers at the University of Louisville School of Medicine decided to turn to data compiled through a project spearheaded by the CDC, the Wall Street Journal (5/25, Dooren) reports. Launched in 1990 with the help of eight managed care organizations, the Vaccine Safety Datalink project aimed to monitor safety and outcomes. The current study authors zeroed in on 1,047 children who received shots between 1993 and 1997. Between 2003 and 2004, all of the children were subjected to 42 tests which, among other things, assessed their IQs, verbal abilities, and coordination, Reuters (5/24, Joelving) reported. The cohort was then grouped according to whether they received all of their inoculations within the first year of life or somehow failed to follow the schedule.
Specifically, "children were classified as up-to-date if they had received at least two hepatitis B, three diphtheria-tetanus-pertussis (DTP), three Haemophilus influenzae type B (Hib) and two polio vaccines on time during the first seven months of life," HealthDay (5/24, Behen) reported. "A vaccine was considered on time if it was given within 30 days of the recommended age." After conducting "two separate analyses," the researchers "found no evidence to suggest that multiple vaccines in the first year of life negatively impact a child's cognitive abilities later. In fact, the first analysis revealed that children who received all their vaccines on time performed slightly better on two of the 42 tests," whereas those "who missed or were late on one or more doses of vaccine didn't do better on any test."
Notably, "children getting vaccines later than doctors' schedules were more likely to be from families with lower household incomes and had a lower percentage of mothers with college degrees," WebMD (5/24, Hendrick) reported. In comparison, "those with on-time vaccinations were slightly younger at the time of neuropsychological assessment (mean 9.2 versus 9.4 years)," MedPage Today (5/24, Gever) reported. Nevertheless, "'there was no evidence of neurodevelopmental delays or deficits associated with on-time vaccination," Michael J. Smith, MD, MSCE, and Charles R. Woods, MD, MS, wrote in a study published online May 24 in Pediatrics.