Today, consumers can purchase dozens of medical tests without a prescription–tests that tell them whether they are pregnant, have a urinary infection, their cholesterol is too high, and so on.

Should direct-to-consumer (DTC) genetic tests be as readily available? These are the mail-in saliva tests that tell consumers about their genetic susceptibility to Alzheimer’s disease, type 2 diabetes, heart disease and other conditions.

DTC genetic tests are different from the genetic tests that have been used for decades in prenatal and newborn screening, and more recently in predictive testing (like the BRCA test for breast cancer risk).

The difference is not the substrate being tested. In both cases, it’s DNA. Rather, it’s who owns the testing process.

For the legacy DNA tests, health professionals own the process. As per protocol, they obtain permission (informed consent) from patients before ordering the test. Then, they consult with and support the patient once the results are known.

In contrast, DTC genetic tests transfer ownership of the genetic testing process to consumers. A person can decide for herself whether to get a DTC genetic test. She doesn’t need permission from a provider, and has no obligation to share the information with her provider.

This bothers many physicians, bioethicists and consumer advocates. They point out that DTC genetic test reports can be difficult to interpret (for physicians as well, I might add, despite claims that they are universally qualified to do so). They decry the lack of regulatory oversight of testing facilities which might help assure the accuracy and reliability of the information. Furthermore, reports of “egregious…deceptive marketing” by some DTC genetic testing vendors suggest that consumers maybe harmed, they say.

These people call for regulatory oversight of DTC genetic testing. The FDA has in certain limited instances, already begun to do just that.

Physician organizations tend to support the regulation of DTC genetic testing. In particular, they favor rules that transfer ownership of DTC genetic testing to (guess who?) physicians who can then serve as custodians of the information, just as they do for the traditional genetic tests mentioned above.

Set the Data Free
I disagree. People who want access to their genetic-risk information should be free to pay their own money to obtain it, period. The only place where regulation has a role in DTC genetic testing is to assure the quality of the results being generated. That’s it.

(more…)

Nicotine replacement therapy makes it easier to quit smoking by providing a therapeutically safe fix of the chemical that makes cigarettes addictive in the first place. In the 25+ years since nicotine-laced patches, gum and lozenges became available, they have amassed a remarkable safety record. In fact thousands of people—and perhaps many more than that–have used NRT products for decades with few or no untoward effects (other than a notably thinned-out wallet). 

As a result, the FDA may soon relax the warning label verbiage affixed to NRT products. Currently, the FDA recommends that such products should be used for no longer than 12-weeks. The recommendation under consideration is that NRTs can be used for prolonged periods—perhaps indefinitely.

“There really doesn’t appear to be any great harm” with the use of NRT over long periods of time, said K. Michael Cummings, chair of the department of health behavior at the Roswell Park Cancer Institute in an interview. “You’re better off chewing gum or wearing a patch than smoking.”

Public health advocates like Cummings have petitioned the FDA for years to relax its recommendations. They received a boost from a 2009 law which empowered the FDA for the first time to regulate tobacco products. A provision in the law tasks the agency to consider relaxing the warning labels on NRT products.

Labels on NRT products advise users to taper-off on their consumption of the products over a 12-week period. These recommendations have stood since the FDA first approved nicotine gum in 1984. They were established to be consistent with the duration of NRT product utilization during clinical trials that were designed to test their efficacy, rather than scientific data regarding health risks associated with long-term NRT use.

There is no evidence that nicotine is carcinogenic in its own right, at least in humans. It may however increase cardiovascular risk because it causes mild tachycardia and mild elevations in blood pressure. (more…)

Most people know that sugary cola drinks have no nutritional benefits, promote weight gain, obesity and diabetes, and contain caffeine, a mildly addictive stimulant. Some people know these drinks contain phosphoric acid, which promotes tooth decay and bone loss, especially in females. But until last week, almost nobody knew that the artificial brown “caramel” coloring that gives cola drinks their familiar appearance contains carcinogens.

How can something as apparently benign as caramel coloring contain cancer-causing agents? Isn’t caramel coloring derived from caramel, that simple homemade treat created by melting sugar in a saucepan?

It turns out that there are several ways to create caramel coloring. The one used to create the caramel coloring found in Coca-Cola, Pepsi, and other foods involves chemical processes that include ammonia. This particular process produces so-called Caramel IV and a pair of byproducts, 2-methylimidazole and 4 methylimidazole, which have been shown to cause cancer of the liver, lung and thyroid, as well as leukemia in laboratory animals.

The disquieting news came in the form of a regulatory petition filed by the Center for Science in the Public Interest, which also called for the FDA to ban these substances from food and drinks that are consumed by US consumers. 

The petition cited studies from the National Toxicology Program which provided “clear evidence” that both substances are animal carcinogens. It also cited studies by scientists at UC Davis, which found the chemicals in several popular cola brands.

“Carcinogenic colorings have no place in the food supply, especially considering that their only function is a cosmetic one,” CSPI executive director Michael Jacobson said in a press release. “The FDA should act quickly to revoke its approval of caramel colorings made with ammonia.” (more…)

More than 70% of all medical devices that have been recalled by the FDA for safety concerns were not subjected to rigorous clinical testing before the agency approved them, according to a new study.

The study authors were Diana Zuckerman and Paul Brown from the National Research Center for Women and Families, a consumer group, and Steven Nissen, a cardiologist at Cleveland Clinic.

The authors reported that overall, the FDA recalled 113 medical devices between 2005 and 2009. Of these, 21 had been approved on the basis of rigorous clinical trial data. Eighty others had been approved under a less stringent, expedited approval process known as 510K, in which a device maker needs only to show that its new product is substantially similar to one already on the market. An additional 8 devices were exempt from FDA regulations, and 4 more were either counterfeit or classified as “other.”

Devices approved using the 510K approval process included mechanical ventilators, insulin infusion pumps, artificial hips and knees, and external cardiac defibrillators. The more rigorous process is typically reserved for life-supporting devices like implanted cardiac defibrillators. In the latter process, device makers must sponsor trials designed to prove their products are safe and effective.

Last summer, the FDA announced it was implementing some steps to “strengthen” the 510K process, but it deferred on a complete overhau pending the release of a report on the matter by the Institute of Medicine. The report is due later this year. (more…)

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…)