African-American Men More Likely to Stay Alive In Prison than Out. A study of North Carolina inmates found that African-American males are half as likely to die in prison as out of prison. The study, in the Annals of Epidemiology, found that African-American inmates were protected against drug and alcohol-related deaths, fatal accidents and some chronic diseases.

Injuries of Veterans, Football Players Linked to Dementia Later in Life. Two studies provide new evidence that head injuries such as concussions are linked to dementia later in life and may make the brain more vulnerable to the development of symptoms characteristic of Alzheimer’s disease.

A Wife May Shorten Time to MI Care. Married men arrive at a hospital quicker than age-matched single men after developing chest pains suggestive of a heart attack, researchers found.

FDA Issues Draft Document on Mobile App Regulations. The 30-page draft provides guidance outlining how mobile medical apps should be regulated as medical devices, targeting an issue that has long plagued physicians looking to adopt apps and vendors wondering how far they can go without incurring the regulations.

Reddit Cofounder Charged With Hacking MIT Computer. Federal prosecutors have accused Aaron Swartz of stealing 4 million documents over a 3-month period in 2010. He faces charges of wire fraud, computer fraud, unlawfully acquiring information and recklessly damaging a protected computer. If found guilty, Swartz could spend 35 years in jail and be fined $1 million.

Next Virus Victim: Your Doctor’s Or Nurse’s iPad? Networked devices used by medical personnel are vulnerable to viruses and security threats, requiring careful teamwork between IT and clinical engineering, experts say.

New York City’s Ban on Smoking Called ‘an Absolute Joke’. In the first month of the Big Apple’s new smoking ban in 1,700 parks and along 14 miles of beaches, the city issued exactly one ticket.

Diabetes Drug May Help Others Lose Weight. The diabetes drug liraglutide (Victoza), touted for its weight-loss effects in that patient population, may also help non-diabetic patients keep pounds off, researchers said.

Nearly 10% of the World’s Adults Have Diabetes. In addition, the prevalence of the disease is rising rapidly, researchers found. Increased obesity and inactivity are the primary reasons in wealthy nations and developing nations as well.

RunKeeper Adds New Integration to its Health Graph. The company has been building a tool to identify correlations between a user’s eating habits, workout schedule, social interactions and more, according to TechCrunch.

Best Buy Leads $5.5M Investment with Valencell. The Series B investment in the mobile health company was joined by TDF and True Ventures. Valencell’s Healthset sensor tracks heart rate, calories burned, steps taken, distance traveled, speed and more through earbuds.

Once Rare, Infection by Tick Bites Spreads. Babesiosis, a potentially devastating malaria-like infection spread through tick bites, has gained a foothold in the Hudson Valley and the coastal Northeast, researchers have found.

FDA Okays New Abuse-Resistant Opioid. The regulatory agency approved a narcotic painkiller with abuse-deterrent properties, Pfizer has announced. The new drug, Oxecta, uses a “unique composition of commonly used pharmaceutical ingredients” to stop potential abusers from crushing, chewing, snorting, or injecting the opioid.

FDA Issues Draft Guidance for Artificial Pancreas. Addressed in the FDA’s document is a Low Glucose Suspend System, which can reduce the severity of hypoglycemic episodes by temporarily reducing insulin delivery. The early-stage system requires patients to manage glucose levels with a meter and give themselves insulin as needed.

Crow’s Feet Faceoff Yields Clear Winner. Crow’s feet responded significantly better to treatment with abobotulinumtoxinA (Dysport) than with onabotulinumtoxinA (Botox), according to results of the first-ever randomized comparison of the two botulinum toxin compounds.

Federal Panel Votes To Delay Stage 2 Meaningful Use by One Year. The Health IT Policy Committee, an advisory panel to the federal government, divided over the appropriate start date for implementing Stage 2 EHR meaningful use requirements, voted to delay Stage 2 from 2013 to 2014.

Startup Health Launched to Spur Innovation in Healthcare. Former Time Warner CEO Jerry Levin will be chairman of the new program that proposes to help health startups raise capital, offer long term mentorship, and bring other resources to bear.

Pfizer Clinical Drug Trial Implemented through Phone, Computer. Results of the trial of the overactive bladder drug Detrol will be compared with those from a previous, traditional trial of the same drug. A close correlation might eventually help reduce the cost of commercializing other drugs.

CMS Extends Deadlines for Medicare ACO Demonstration Program. The Centers for Medicare and Medicaid Services has extended its deadline for letters of intent and applications to participate in Medicare’s Pioneer Accountable Care Organization Model demonstration program for at least 5 years

Healthy Vision with Dr. Val Jones, Now Available on iTunes. The engaging, free program covers the importance of regular eye exams, contact lens care and UV protection for eyes. Jones is CEO of the popular health blog aggregator Better Health.

Data mining, EHRs Help Target Dangerous Drug Combo. Data mining and electronic health records helped researchers at some of the country’s most prestigious universities discover a dangerous side effect of a common drug combination.

FDA Signals Intent To Regulate Medical Apps. The agency’s Center for Devices and Radiological Health plans to issue guidance on mobile medical applications later this year.

HIV/AIDS Pandemic Hits 30-Year Mark. Thirty years ago this week, scientists were finalizing a landmark article for the Morbidity and Mortality Weekly Report. The report was the first dispatch from the front lines in a new war against a previously unknown virus.

CMS Aligns eRX Incentive with Meaningful Use. The Centers for Medicare and Medicaid Services has issued a proposed rule that would alter the Electronic Prescribing Incentive Program so as to be consistent with the HITECH incentive program.

GE, Thomson Reuters Develop Clinical Analytics Tool Using EHR, Claims Data. The joint initiative will let providers and researchers review and analyze de-identified data from electronic health records along with claims data to help determine the impact of various medical treatments.

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.

It’s almost never a good idea for governments to impede an individual’s right to access information, no matter its source. That’s especially true when the information concerns that individual only, as is the case with DTC genetic testing. It is information that absolutely cannot be used to harm other people or ‘the national interest,’ which are 2 legitimate reasons why a government might limit the free flow of information.

In fact, the information contained in a DTC genetic test is the most intensely personal information imaginable. Beyond this, the information isn’t ‘telling’ the consumer to ‘do’ anything (as Sarah Palin did, arguably, when she said we should ’target’ politicians with views that differed from hers).

What about the argument that the information contained in these reports is so complex that only a physician can understand it? Well, health consumers deal with vague medical information all the time. The risks and benefits of screening for and treating prostate cancer is a great example, as is the ever-conflicted literature on the risks and benefits of alcohol consumption.

And you know what? Consumers have waded through muddy waters rather successfully over the years. And with so many excellent sources of health information on the Internet, it’s easier now than ever before.

There is a more fundamental issue as well. State and federal policymakers have assured that millions of people in this country have zero access to preventive services. Given this, it is absurd, perhaps even cruel, to also prevent people from accessing information about their own bodies–free and of their own will–unless they do it under the supervision of a physician.

A federal panel advised the FDA last week that menthol cigarettes are more harmful to the public health than regular cigarettes. However, it did not recommend or endorse any actions the FDA should take to act on the advice.

www.youtube.com/watch?v=86lYG1V2-n4

According to the panel, menthol cigarettes drive-up cigarette smoking rates among youth and African-Americans because its minty taste attracts people to try cigarettes and makes it harder for them to quit. In addition, its mild anesthetic properties mask the harsh taste of cigarettes. That sensation might otherwise deter some from the habit before they get hooked. The report also cites evidence that consumers believe (incorrectly) that menthol provides some health protection or medicinal benefit.

“Removal of menthol cigarettes from the marketplace would benefit public health in the United States,” the panel’s report concludes.

The panel’s official name is the Tobacco Products Scientific Advisory Committee. Its report will likely trigger a lengthy test of the FDA’s ability to promulgate and enforce restrictions on cigarettes, nicotine and menthol. The FDA will review the report and other information before deciding what to do. It has no obligation to do anything.

Reaction to the report was mixed. Some saw it as a necessary first step toward an outright ban on menthol. Others were disappointed that the advisory group shied away from recommending steps the FDA might take to deal with the problem it identified.

As Pizaazz readers know, Lorillard Tobacco had a keen interest in the panel’s report. Fully 90% of the Greensboro, NC, company’s revenue is derived from its Newport brand, which is the market-leading menthol cigarette (35% the market). Lorillard’s stock jumped 10% the day the panel released its report, and it has remained high. 

“This is a huge victory for Lorillard,” Michael Siegel said. The tobacco expert and BU professor added that the panel’s decision not to recommend any specific action, “swept the issue under the rug by giving the FDA an out.”

Menthol cigarette sales account for about 27% of the highly profitable $80 billion US cigarette market. More than 19 million people smoke menthols in the US. A disproportionate number of these people are black, low income and young. Specifically, 80% of African-American smokers and nearly half of all smokers between the ages of 12-17 light-up menthols. By contrast, 22% of whites select menthols.

For his part, panel chairman Jonathan Samet, insisted his group actually did make a recommendation, citing the following statement from the report:  “Removal of menthol cigarettes from the marketplace would benefit public health in the United States.”

“To me that speaks quite clearly to what our recommendation is,” Samet said in an interview. “The statement about removal is what the public health recommendation is, and I think how one achieves that outcome depends on the strategies available to the FDA under the law. I’ll be watching with interest what the FDA does next.”

How this will shake out
Sadly, the FDA is unlikely to seek an all-out ban on menthol. The move would prompt years of expensive, distracting litigation for the agency. Oh, and according to UBS industry analyst Nik Modi, state and federal governments rake-in nearly $43 billion per year in cigarette excise taxes…a good chunk of this revenue could be lost if menthol smokers began purchasing their favorite smokes on the black market. Look for the FDA to initiate several years-worth of additional studies, and for fun, check out which members of congress get campaign contributions from Lorillard and other cigarette companies.

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.

If the FDA does relax its warnings, it will have followed a precedent set by the British Royal College of Physicians, which concluded 4 years ago that “medicinal nicotine is a very safe drug,” and “there are no grounds to suspect appreciable long-term adverse effects on health.” Regulatory authorities in the UK, Japan, Germany and Canada have already approved NRT product use periods between 6 and 12 months.

Glaxo markets the industry-leading product, the Nicorette brand of gum, patches and lozenges. It collects a lion’s share of an $800 million US market for NRT products. Pfizer and Novartis also play in the space.

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.”

“Most people would interpret ‘caramel coloring’ to mean ‘colored with caramel,’ but this particular ingredient has little in common with ordinary caramel or caramel candy,” Jacobson continued. “It’s a concentrated dark brown mixture of chemicals that does not occur in nature. Regular caramel isn’t healthful, but at least it is not tainted with carcinogens.”

Several experts on animal carcinogenesis joined CSPI in asking the FDA to ban Caramel IV from foods and beverages. “The American public should not be exposed to any cancer risk whatsoever as a result of consuming such chemicals, especially when they serve a non-essential, cosmetic purpose,” these experts wrote in a letter to FDA Commissioner Margaret Hamburg.

In a related development, California health officials recently added 4 methylimidazole to its list of “chemicals known to the state to cause cancer.” The state’s Proposition 65 requires that foods or beverages containing more than certain amounts of cancer-causing chemicals must carry warning labels. In the case of 4 methylimidazole, the state has established 16 micrograms per person per day from a particular product as the level that would trigger the need for a label.

Most cola brands contain about 200 micrograms of 4 methylimidazole per 20-ounce bottle. Many people consume far more than that each day. It’s quite possible therefore, that cola products sold in that state will soon have to have a cancer warning label…unless, of course cola producers opt for a kind of “caramel coloring” produced using a non-ammonia-dependent process. 

NOTE: CSPI added in its release that the 10 teaspoons of calorie-leaden sugars in each can of non-diet cola constitutes a larger health risk than 4 methylimidazole. Still, CSPI estimated that the carcinogen was probably responsible for “causing thousands of cancers in the U.S. population.” For people who needed another reason to kick the cola habit, here it is.

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.
 In an interview, Zuckerman said her group’s findings suggest that the FDA’s actions to date on 510K aren’t adequate. Device manufacturers have managed to expand the concept of “similar” well beyond the FDA’s original intent when the 510K law went live in 1976, Zuckerman explained. “The law has gotten looser and looser over time.”

The FDA blew-off Zuckerman’s findings as old news. According to a statement by the agency, the data had been presented by Zuckerman last year at a public meeting sponsored by the IOM.

For its part, the Advanced Medical Technology Association, a device industry trade group, said the study was misleading. It wasn’t surprising that 510K-approved devices accounted for most of the recalls, the group said, because most FDA-approved devices have gone through the 510K process.

Stephen Ubl, the Association’s CEO added that the study was “fundamentally flawed” since it focused “on the total number of recalls and ignored the fact that there are over 50,000 devices on the market.”

Ubl added that the percentage of products recalled for serious health problems or deaths was substantially below 1%. He added that an overly strict regulatory process would hinder innovation and prompt device manufacturers to move product development to other countries where regulatory scrutiny isn’t as intense.

Zuckerman’s write-up appears in the Archives of Internal Medicine.