After nearly a decade of inaction, the US government is finally going to set safety standards for perchlorate in the nation’s water supply.

Perchlorate is a rocket fuel additive that causes thyroid abnormalities in newborns and children. Even tiny amounts of perchlorate can impair thyroid hormone production, especially in utero and in newborns. The resulting metabolic abnormalities can lead to irreversible loss of IQ and increased perceptual and behavioral problems.

Nearly all the perchlorate found in drinking water is the result of lax disposal methods at chemical plants, rocket test sites and military installations. Government estimates say that 16 million Americans are exposed to unsafe levels of the chemical. Independent scientists using state and federal data suggest the number is twice that.

White House and Pentagon officials, primarily in the Bush administration, had pressured the Environmental Protection Agency for years to refrain from establishing safe, allowable levels of the chemical in tap water, presumably because the cost of a national cleanup would cost several hundred million dollars.

But under new management (the Obama Administration), the EPA has announced it will establish standards for the toxic compound sometime during the next 2 years.

“As improved standards are developed and put in place, clean water technology innovators have an opportunity to create cutting edge solutions that will strengthen health protections and spark economic growth,” EPA administrator Lisa Jackson said in a press release.

As far back as 2002, an EPA risk assessment determined that safe levels of perchlorate in drinking water should be set at 1 part per billion. After 6 years of complete non-action on the matter, the Bush administration decided not to regulate the chemical. Instead, it established an “advisory guideline” that perchlorate concentrations should not exceed 15 parts per billion. (more…)

Most people don’t like them. Privacy advocates abhor them. But really, how many things can you name that save lives AND generate revenues for cash-strapped local and state governments?

Red light cameras are one such item.

A recent study by the Insurance Institute for Highway Safety has shown that red light cameras saved 159 lives over a 4-year period in the 14 large US cities where the study took place.

The scientists claimed that more than 800 traffic fatalities would have been prevented during the course of the study if the cameras had been deployed in all large US cities.

The scientists compared fatal car crash rates in US cities with populations of at least 200,000 for two 4-year periods: 1992-1996 and 2004-2008. They excluded cities that had already deployed red light cameras in the earlier period, and cities that instituted cameras during the later period.

In the 14 cities that used red light cameras during 2004-08, the rate of fatal red light running crashes was 35% lower than in 1992-96. The crash rate did drop in cities that never deployed camera programs, but only by 14%.

Based on these data, the scientists determined that the rate of fatal red light running crashes was 24% lower in cities with cameras in 2004-08 than it would have been had they not deployed the cameras.

In fact, the benefits of red light cameras were actually larger than this. The rate of all fatal crashes at intersections with signals (not just red light running crashes) dropped by 14% in cities that deployed red light cameras, whereas it increased by 2% in other cities. (more…)

Virtually all bottled beverages you can buy have handy-dandy nutrition labels from which you can access information about calories, carbs and so forth. All beverages except the ones containing alcohol, that is.

Why is that?

Maybe it’s because alcoholic beverages contain little to no protein, sodium, cholesterol, Vitamin A, Vitamin C, calcium and iron (remember, alcohol is metabolized as a fat, not a carbohydrate), so why bother?

Then again, alcohol does contain calories, a lot of them. Would people drink less if they knew how many calories they were consuming? Would they drink less if they knew how many “servings” of alcohol were contained in the bottle they just purchased?

Maybe it’s because of the cost of performing nutritional analyses on each vintage of wine, each and every year, would turn profitable vineyards into money losers? Then again, plenty of niche beverage producers who run reasonably narrow margin businesses have never complained about the requirement to provide nutritional information.

The Tax and Trade Bureau is the federal agency that decides what information must appear on the labels of alcoholic beverages. Currently, it does not require manufacturers of wine, beer and the hard stuff to list ingredients. It does require them to list chemicals that folks might have an adverse reaction to…things like sulfites, aspartame and dyes.

The Bureau also mandates that wines containing 14% or more alcohol by volume must state this fact on a label. Wines containing less than 14% can either specify the alcohol content or affix the words “light wine” or “table wine” to their labels. In addition, “light” beer bottlers must state calorie and carbohydrate content, and distilled liquor bottlers must specify the alcohol content by volume.

Since 2003 however, consumer and public health advocates have lobbied the Tax and Trade bureau to require that labels on alcoholic beverages include more information than this. They want things like calories, carbohydrates and alcohol per serving, as well as the number of servings contained in the bottle to be included as well. (more…)

Two years ago, Congress passed a law which tasked the FDA to regulate tobacco products. The legislation required the agency to ban cigarettes flavored with candy, fruit or spices because they might prompt younger people to start smoking. But the law punted a decision on the thornier issue of whether to ban menthol flavored cigarettes–which account for 30% of domestic cigarette sales–to the FDA.

To help the FDA decide this matter, Congress established Tobacco Products Scientific Advisory Committee. The committee’s final report on menthol cigarettes is due by the end of March. It could recommend an outright ban on the sale of menthol cigarettes, or that certain restrictions be placed on advertising these brands. Or it could recommend that the FDA take no action whatsoever.

Sometime after that, FDA will make a final call on the matter. Its decision will have a huge impact on Lorillard, the nation’s third largest cigarette manufacturer, since nearly 90% of its revenues are derived from the sale of Newport, a menthol-flavored cigarette.

Menthol is a naturally-occurring chemical that comes from mint plants. Manufacturers have added it to cigarettes for nearly a century, presumably because its local anesthetic effects and cooling sensations mask the harsh taste of cigarette smoke. The effect seems to attract young smokers in particular. A 2009 government study has shown for example, that nearly half of all smokers between the ages of 12 and 17 use menthol-flavored cigarettes.

Menthol cigarettes are also the overwhelming choice of African-American smokers. Government studies have shown that as many as 80% of African-American smokers prefer these brands, particularly Salem, Kool and Newport. Cigarette manufacturers have directed marketing campaigns for menthol cigarettes toward African-Americans for decades (see above picture). (more…)

Last year was another lackluster one for the drug and biotech industries, as the FDA seemed to ratchet-up its scrutiny of trial data and set the bar higher on requirements for drug efficacy. Overall, the regulatory agency approved 24 new drugs in 2010, which was slightly down from the 26 it approved in 2009 and dead-even with the 24 it approved in 2008. Only 17 were approved by the FDA in 2007

Two of the newly approved drugs appear to have a shot at becoming blockbusters: these are Gilenya, which is Novartis’ pill for multiple sclerosis, and Provenge, Dendreon’s injectable treatment for advanced prostate cancer. A pair of much-anticipated obesity drugs, Arena Pharmaceuticals’ lorcaserin and Vivus’ Qnexa were rejected by the FDA, as were many others. Perhaps the biggest news however, focused on the FDA’s handling of safety issues surrounding drugs it had approved in previous years. Here’s a summary of some winners and losers:

Newly Approved Drugs
Multiple Sclerosis-Patients with multiple sclerosis did have a good deal to cheer about last year. In addition to Gilenya, the FDA approved Ampyra (Acorda Therapeutics) to improve gait disturbances in MS patients.

Advanced Prostate Cancer-Dendreon finally won FDA approval for its cancer-fighting vaccine, Provenge. The regulatory agency had previously rejected the drug and required that additional trials be performed, despite early clinical trials which were generally positive.

Stroke Prevention-Drug makers have been vying for years to replace warfarin, the widely used anticoagulant that has been available for more than half a century. After receiving approval for its drug, Pradaxa to prevent stroke in patients with cardiac arrhythmias, Boehringer Ingelheim now has a head start in this highly lucrative field.

Emergency Contraception-HRA Pharma’s drug ella, was approved by the FDA last summer. It blocks pregnancy up to five days after sexual intercourse, a full-day longer than other drugs on the market. The drug is now marketed in the US by Watson Pharmaceuticals.

In Limbo
Stroke Prevention-The FDA asked AstraZeneca for more information from a generally positive study of the anticoagulant, Brilinta assuring a longer glide path to market for Boehringer’s entry into this space (see above). (more…)

Later this year, federal regulators will begin reviewing requests by private health insurers who wish to raise premiums by 10% or more, year-over-year. The move represents an expansion of federal regulatory power since until now, the review of such proposals has been carried out exclusively by the states.

The new federal guidelines will take effect on July 1, and were called for by provisions in the Affordable Care Act. The guidelines specify methods by which the feds will determine whether the proposal is reasonable. These will include the percentage of premiums spent on direct medical care and whether the rates include higher premiums for some, but not all enrollees with similar health risks.

The new regulations should help Democrats respond to the lambasting they received last fall by the GOP and consumer advocates after several private insurance companies jacked their premiums by 20% or more. At the time, the companies claimed the increases were driven by soaring medical costs as well as certain provisions in the Affordable Care Act, the health reform law that was enacted last March.

In particular, private insurers pointed to provisions in the law which require them to provide more comprehensive benefits to certain populations. They also claimed that rate increases were justified in response to the increasing trend by young and healthy people to forego health insurance, a trend that obligates insurers to raise rates for everyone else.

Spokespeople for private insurers also accuse the Obama administration of demonizing the health insurance industry for political gain. “Without a doubt, this is a political process, not a technical process,” Karen Ignagni, president of America’s Health Insurance Plans has said. (more…)

Last week, a federal appeals court ruled that electronic cigarettes should be regulated by the FDA as a tobacco product rather than drug-delivery devices, as the FDA had hoped. The latter are subject to far more rigorous regulatory control.

In reaching its decision, the 3-judge panel of the US Court of Appeals in Washington upheld a lower court ruling by Washington Federal District Judge Richard Leon. He had ruled against the FDA in a lawsuit brought by e-cigarette distributors. The successive judicial blows against the FDA means that for now, it cannot–as it would like–ban e-cigarettes until expensive, company-sponsored trials prove the products are safe and actually work as quit-smoking aids.

The FDA believes that e-cigarettes should be regulated in the same way as nicotine replacement products like chewing gum and patches. It also wants to curtail marketing campaigns for these products that are directed at children.

e-Cigarettes are battery-powered tubes that heat liquid nicotine into a vapor that is subsequently inhaled. They usually contain a small light on the tip which glows like a cigarette when the user inhales. The devices add ingredients that give the vapor a taste and smell that is reminiscent of cigarette smoke. They do not contain tobacco, and according to e-cigarette distributors, the inhaled vapors do not contain cancer-causing chemicals. More than 300 firms are believed to be involved in the production and distribution of e-cigarettes.

“We can now market our product the way we always should have been able to,” Matt Salmon, CEO of Sottera Inc., told the Associated Press. “This is plain and simple an alternative to smoking for committed, longtime smokers.” Sottera markets electronic cigarettes known as NJOY.

Sottera and other e-cigarette distributors claim their products are ideal quit-smoking agents because they address the behavioral aspects of smoking, like holding the cigarette, inhaling from it, observing smoke come out from it, and so forth. 

But Matthew Myers, the president of the Campaign for Tobacco-Free Kids released a statement saying that the court’s decision will permit “any manufacturer to put any level of nicotine in any product and sell it to anybody, including children, with no government regulation or oversight at the present time.”

“This ruling invites the creation of a wild west of products containing highly addictive nicotine,” Myers added.

The FDA is reviewing the court’s ruling.

Most e-cigarettes are imported from overseas. They hit worldwide markets in 2002 and became available in the US 4 years later. Industry spokespeople claim that 20,000 to 30,000 people try the products each week.

The FDA has been tough on diet drugs of late. Three years ago, it scuttled an attempt to get the European diet drug rimonabant approved for use in the US. More recently it rejected, at least temporarily, applications for Qnexa and Lorcaserin.

But that trend may have been reversed last week, when an advisory committee set the stage for possible FDA approval of Orexigen’s investigational diet drug, Contrave. By a 13-7 vote, the committee said in essence that the somewhat modest beneficial effects of the drug outweighed its tendency to increase blood pressure.

The FDA will make final decision on the matter by the end of January. It is not required to follow the advice of its advisory committees, but as was the case for the 3 diet drugs mentioned above,  it usually does.

Orexigen has petitioned the FDA to approve Contrave for the treatment of obesity and weight management in people who have a body mass index of at least 30, or at least 27 if they have at least one cardiovascular disease risk factor like diabetes, high cholesterol or high blood pressure.

Contrave is a combination of 2 drugs that were approved long-ago by the FDA and are widely used today. Naltrexone, the first of these, is used to treat opioid addiction and alcohol dependence. The second, bupropion, is used to treat depression and as a quit-smoking aide.

Before reaching its verdict, the FDA’s Endocrine and Metabolic Drugs Advisory Committee reviewed the results of 4 randomized trials that were sponsored by Orexigen. Together, the studies enrolled more than 4,500 overweight and obese subjects. The Committee noted that in pooled results from the 4 trials, the weight-loss difference between those receiving Contrave and those receiving a placebo was about 4.2%, which it deemed to be “of nominal statistical significance.” However, more than a third of subjects in the Contrave group did lose least 5% of their body weight during a 1-year follow-up period.

“As far as efficacy goes, I think they made it by the hair of their chinny chin chin,” Melanie Coffin, a patient representative on the Committee told ABC News.

The Committee did raise concerns about several side effects of Contrave, including seizures and suicidal ideation, although it was clearly most concerned about the drug’s tendency to increase blood pressure, a phenomenon that seemed to be most apparent in the first few weeks after the drug was started. Ultimately though, the Committee decided there wasn’t enough data to draw clear conclusions about the cardiovascular risks of Contrave. It did recommend that Orexigen should submit post-market data on the matter, if and when it receives full FDA approval.

Currently, the only anti-obesity drug on the market is Orlistat (also known as Xenical and Alli). Recently, Abbott pulled another one, sibutramine (Meridia) after mounting evidence suggested it was associated with strokes and heart attacks.

The Federal Trade Comission has charged POM Wonderful, makers of several drinks containing pomegranate juice and a host of supposedly healthful dietary supplements, with making “false and unsubstantiated claims that their products will prevent or treat heart disease, prostate cancer, and erectile dysfunction.”

The FTC’s deceptive advertising complaint came a few months after the Food and Drug Administration warned POM Wonderful about the same thing.
 
Both regulatory agencies cited claims like “30 Percent Decrease In Arterial Plaque,” “Super Health Powers” and, “Promotes Healthy Blood Vessels” in their complaints.

The ads in question appeared in Parade, Fitness, the New York Times, and Prevention magazines, on bus stops and billboards, on tags attached to the product, and on Internet sites like pomtruth.com, pomwonderful.com, and pompills.com.

“The available scientific information does not prove that POM Juice or POMx effectively treats or prevents these illnesses,” David Vladeck, the director of the FTC’s Bureau of Consumer Protection told NPR.

For example, Vladeck explained, POM says its products are 40% as effective as Viagra. The FTC complaint indicates that the study referred to in making this claim actually showed the juice was no more effective than a placebo.

In its response to the FDA, POM Wonderful said its claims were valid and backed by scientific research. The FTC is “wasting taxpayer resources to persecute the pomegranate,” the company said. It added that the product research it conducted was “unprecedented among food and beverage companies” and that the FTC was “acting beyond its jurisdiction, exceeding its authority, and creating a new regulatory scheme that attempts to treat our juice as a drug, which it is not.”

A hearing on the FTC complaint will take place 8 months from now.

Amid the burgeoning worldwide epidemic of obesity, scientists and pharmaceutical companies have spent hundreds of millions of dollars to develop drugs to help people lose weight. The effort has failed spectacularly so far, and 2 recent setbacks have fueled increasing pessimism that things will change for the better anytime soon. 

The first setback occurred last month when the FDA put the kibosh on Arena Pharmaceuticals’ New Drug Application for lorcaserin, an investigational weight loss drug. In rejecting the application, the FDA  cited several concerns including low efficacy and the results of animal studies which suggested that it increased the risk of breast cancer.

In its letter to the San Diego-based drug company, the FDA said “the weight loss efficacy of lorcaserin in overweight and obese individuals without type 2 diabetes is marginal.” The letter also said the regulatory agency needed more information from a study that is now underway before considering the matter further, and that if Arena could not provide data to “alleviate concern regarding clinical relevance of the tumor findings in rats, additional clinical studies may be required to obtain a more robust assessment of lorcaserin’s benefit-risk profile.”

The FDA’s snub of lorcaserin was followed in short order by an announcement by Abbott Laboratories that it was withdrawing the diet drug Meridia from the market. Abbott’s decision was prompted by FDA findings that showed the drug’s limited efficacy was outweighed by significant risks associated with the drug.

Meridia had long-since been known to increase blood pressure, but the death knell came in the form of a European study which showed it was associated with a 16% increased risk of cardiovascular problems including heart attacks, strokes and death.

Nearly 100,000 Americans take Meridia at the moment. The FDA advised all of them to stop taking the drug, and instructed physicians to stop prescribing it. European regulators had taken Meridia off the market in January.

“It’s been very frustrating,” Jennifer Lovejoy, the incoming president of the Obesity Society told the Washington Post. “We desperately need safe new drugs so we can begin to have something effective against this public health epidemic.”

Meanwhile, experts continue to emphasize that the best way to stay healthy is to avoid gaining weight in the first place by eating well and exercising regularly…