Archive for September, 2010

Drug Laws Vex Employers

September 13th, 2010 | No Comments | Source: Wall Street Journal

Current Federal drug rules list marijuana as a Schedule I drug, along with LSD and heroin. Meanwhile, 14 states have laws that permit people with medical conditions like cancer and chronic pain to possess and use marijuana without fear of prosecution.

blindfold 300x199 Drug Laws Vex EmployersThis confusing situation turns chaotic when it comes to the field of employment law. For example, the Supreme Courts in Oregon, California and Montana—states with permissive laws about possession and use of cannabis—have allowed employers to fire medical-marijuana patients for using the drug. In other states like Maine and Rhode Island, medical-marijuana laws proscribe such behavior.

A pending lawsuit in Michigan might clarify matters. In that case, Joseph Casias, a Michigan resident who uses the drug to control pain associated with a brain tumor, has sued Wal-Mart, his employer, after the retailer fired him for failing a drug test on the job.

Casias claims he uses marijuana legally according to Michigan law. He takes the drug at night and has never come to work high. The drug test was administered per company policy after he strained his knee one day at work.

A Wal-Mart spokesman told the Wall Street Journal that Casias’ case was “unfortunate,” adding that “as more states allow this treatment, employers are left without any guidelines except the federal standard. Until further guidance is available, we will default to what we believe is the safest environment for our associates and customers.”

No one suggests that workers should be permitted to use marijuana on the job. But advocacy groups suggest that if employees show no clear signs of impairment, employers should assume those with valid medical-marijuana registration cards are taking the drug responsibly.

That doesn’t sit well with some employers, who cite statistics showing that cannabis is implicated more frequently than any other drug in workplace accidents causing injury or property damage. Time to fix this, fellas.

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FDA Green-Lights Stem Cell Trial

September 10th, 2010 | No Comments | Source: Associated Press, Wall Street Journal

Last week, federal regulators gave the go-ahead for the nation’s first trial of embryonic stem cells in human beings. Geron Corporation will run the trial. It is designed to assess the safety of so-called GNROPC1 oligodendrocyte stem cells in treating spinal cord injuries.

Geron plans to begin testing by year-end. It will enroll about 10 patients over 2 years and follow them for 15 years after treatment. For safety reasons, Geron will space-out each enrollee by at least 30 days.

greenbaypackerstemcells 300x228 FDA Green Lights Stem Cell TrialThe primary purpose of the trial will be to determine whether GRNOPC1 is safe. Geron will assess efficacy as a secondary outcome.

The treatment involves injecting the stem cells into the spinal cord of injury victims 1-2 weeks after the injury occurs.

The FDA originally accepted Geron’s study application in January, 2009. It subsequently held things up after Geron reported that mice treated with GRNOPC1 had developed tiny cysts on their spines. According to Geron, many patients with spinal cord injuries develop larger cysts as the injury heals. Geron also reported that the cysts were not observed in a second animal study.

Oligodendrocyte stem cells mature into myelin-producing oligodendrocytes. Myelin forms a sheath around nerve cells that protects them and facilitates conduction of impulses via the nerves from the brain to the muscles, skin and internal organs. The hope is that the GRNOPC1 stem cells will facilitate healing of damaged spinal cord tissue and restore normal nerve conduction.

Embryonic stem cell research is controversial because in some cases, the cells are obtained from aborted human embryos. In 1996, Congress prohibited federal funds from being used to support stem cell research. Six years later, President Bush relaxed the ban by allowing federal funds to be used for research on stem-cell lines already in existence. In March, 2009, President Obama lifted the ban altogether.

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FCC, FDA Team-up on mHealth

September 9th, 2010 | No Comments | Source: BurrillReport

Recent, widespread dissemination of smartphones and improvements in wireless network coverage have created an opportunity for people to take a more active role in maintaining their health. It also permits physicians to remotely monitor patients and detect evolving health issues quickly and cheaply.

nofear 300x300 FCC, FDA Team up on mHealthOne potential impediment to such progress would be an overbearing regulatory environment which could slow innovation and discourage investment at a critical juncture in the evolution of the technologies.

To their credit, the Food and Drug Administration and the Federal Communications Commission have recognized this risk. Recently, the 2 agencies held a joint summit in which they tried to address the matter. During the summit, they agreed to cooperate on matters that cross their traditional domains, while focusing on ways to assure the safety and reliability of wireless medical devices and increase their availability to providers and consumers of health care.

“The American public–including industry, providers, patients, and other interested stakeholders–should have clear regulatory pathways, processes, and standards to bring broadband and wireless-enabled medical devices to market,” the agencies said in a joint statement. “This includes clarity regarding each agency’s scope of authority with respect to these devices, predictability regarding regulatory pathways, and streamlining the application process, as appropriate, to facilitate innovation while protecting patients.”

The summit was attended by leaders from healthcare, technology, academia, and the venture capital sector. 

“The relationship between FDA approval and FCC certification of wireless-enabled medical devices must be further delineated and expedited to overcome hurdles to innovation identified by both agencies,” Joseph Smith, the chief science officer for the West Wireless Health Institute said at the conference.

Venture capitalists welcomed the initiative.  “As an area of investment, this arena is challenging, due to the regulatory uncertainty,” said Jim Glasheen, a general partner at Technology Partners. “I am enthusiastically supportive that the FCC is working together with the FDA in taking a first-step towards a pro-investment/pro-innovation policy.”

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Are US Cigarettes Deadlier than those Made Elsewhere?

September 8th, 2010 | No Comments | Source: Cancer Epi. Bio. & Prev., MedPageToday

Levels of cancer-causing nitrosamines are higher in US-made cigarettes than those from other countries, according to scientists at the Center for Disease Control.  That means they can potentially cause more cases of lung cancer.

squashed 200x300 Are US Cigarettes Deadlier than those Made Elsewhere?To reach these conclusions, David Ashley and colleagues group measured mouth levels of a highly carcinogenic substance known as NNK, and urinary levels of its major metabolite, NNAL in 126 smokers from New York, Minnesota, Australia, Canada and England. The US smokers used several popular brands including Camel Light, Marlboro, Newport and Newport Light. The scientists counted butts to assure smokers from each location consumed the same numbers of cigarettes.

It turned out that 24 hour mouth levels of NNK (in nanograms) were 1,490 in New York, 1,150 in Minnesota, 1,010 in England, 449 in Canada and 350 in Australia. There was a direct correlation between mouth levels of NNK and urinary levels of NNAL.

Of note, 2 recent studies have shown a direct relation between urinary NNAL levels and lung cancer risk.

Together, these findings suggest that “higher levels of tobacco-related nitrosamines in the smoke of US cigarette varieties lead to higher mouth-level exposure to NNK and increased NNAL, which may be associated with excess lung cancer burden,” wrote the scientists.

The scientists also hypothesized that high levels of NNK in US tobacco products result from domestic curing processes and the blends of tobacco used during production.

Unfortunately, lowering nitrosamine levels in US cigarettes might not make them safer because that may increase the amounts of other carcinogenic substances.

As well, the scientists “did not look at the two dozen other cancer-causing toxins,” according to John Spangler of Wake Forest University. “And it did not examine chemicals that might affect heart disease, stroke, emphysema, and other diseases caused by tobacco use,” he added.

The findings appear in Cancer Epidemiology, Biomarkers & Prevention.

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The Wild West of Genetic Testing

September 7th, 2010 | No Comments | Source: Washington Post

Last month, a mix-up at the genetic testing company 23andMe caused 87 people to receive incorrect results. In one case, a woman was told her son carried genes for a life-threatening disorder when in fact, he didn’t. Another woman who thought she was white, was told her genes resembled those of an African American. In a third case, an actual woman was told she was a man.

thyroidgenesahead1mile 300x225 The Wild West of Genetic Testing23andMe said it regreted the mishap, spotted the error, notified people quickly, and took steps to assure the problem wouldn’t happen again.

The gaffe has focused attention on the question of whether the government should begin to regulate the burgeoning genetic testing industry more aggressively.

Supporters of this view argue that some companies in the space have made claims that are not supported by fact, and that the results of genetic testing are too complicated for people to interpret by themselves. People who are told they don’t have genes that put them at very high risk for developing breast cancer might stop getting mammograms, for example.

The flip-side to the argument is that a heavy dose of regulation might stifle innovation and render the tests too expensive and unnecessarily difficult to access. In addition, it’s far from clear that the FDA has the resources to verify the complex scientific claims being made by genetic testing companies.

Amid the debate, the FDA has begun to intervene. This spring, it blocked an effort by Pathway Genomics to market genetic tests in drug stores. Soon thereafter, it notified 5 companies that were marketing testing kits over the Internet that their tests were medical devices which needed to pass through normal regulatory processes.

Despite these early interventions, genetic testing remains in the Wild West phase of commercial development. Caveat emptor.

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No One Knows What Chemicals are in Your Food

September 3rd, 2010 | No Comments | Source: Washington Post

Earlier this summer, dozens of people reported that their boxes of Foot Loops and Apple Jacks contained strange odors and tastes. Some complained of nausea and diarrhea after consuming the cereal. The complaints prompted Kellogg to recall 28 million boxes of the iconic breakfast treats.

Bestforyoueachmorning 300x173 No One Knows What Chemicals are in Your FoodKellogg subsequently blamed the problem on elevated levels of 2-methylnaphtalene, while adding that its experts found “no harmful material” in the cereals.

2-Methylnaphthalene may not be harmful, but it’s hard to know for sure. The FDA has no information about its impact on human health. Neither does the EPA, even though it has been asking the chemical industry to provide health information about 2-methylnaphtalene since 1994.

The EPA made the request 16 years ago because the chemical was being produced in massive quantities and finding its way into dozens, if not hundreds of consumer products.

The cereal recall has refocused attention on huge gaps in Federal regulators’ knowledge about chemicals in consumer products including food, children’s toys and clothing. According to the Washington Post, regulators don’t know squat about “the health risks posed by most of the 80,000 chemicals on the market today.”

The knowledge gap can be traced to the 1976 passage of the Toxic Substances Control Act which exempted 62,000 chemicals, including 2-methylnaphthalene, from regulatory oversight and stipulated that chemicals developed since then need not be tested for safety. Instead, manufacturers were encouraged to volunteer information concerning the health effects of their compounds and required to hand-over any data showing that a chemical harms health.

That created an enormous disincentive for manufacturers to test their chemicals.

Congress is working on legislation that would require companies to undertake health and safety assessments of existing chemicals and prove that new ones are safe before using them. The chemical industry thinks such laws could hamper innovation and competitiveness.

Pizaazz thinks it’ll take a US version of China’s melamine scandal before this legislation makes it to the President’s desk.

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Pay-for-Delay Drug Settlements Draw Fire

September 2nd, 2010 | No Comments | Source: BurrillReport

So-called pay-for-delay settlements involving generic and branded drug makers are becoming more common and costing consumers $3.5 billion each year, according to FTC Chairman John Liebowitz, who testified before Congress that he wanted to eliminate such agreements altogether.

chumpchange 300x199 Pay for Delay Drug Settlements Draw FireThese deals allow branded drug makers to sell their expensive products without generic competition for a period longer than the duration of the patents they hold on their drugs.

In the first 9 months of fiscal 2010, drug makers entered into 21 patent litigation settlements.  That’s more than the entire previous year.

“That’s almost an epidemic,” Leibowitz told BurrillReport. “Every single FTC Commissioner, going back through the Bush and Clinton administrations, has supported stopping these unconscionable agreements.”

The FTC supports legislation designed to halt pay-for-delay settlements. At the moment, this legislation is tucked into a Senate spending bill.

Both branded and generic drug companies would prefer to leave things just as they are. “The FTC’s testimony fails to present the whole story regarding patent settlements,” according to a statement released by the Generic Pharmaceutical Association. “Over the past 10 years, patent settlements have enabled dozens of first-time generics to come to market many months before patents on the counterpart brand drugs expired.”

The Pharmaceutical Research and Manufacturers of America, which represents branded drug makers, agreed. “A blanket ban could decrease the value of patents, remove an important option for a patent-holder’s defense of intellectual property, and reduce the incentives for future innovation of new medicines,” it said.

A Senate panel has already recommended banning pay-for-delay deals, but narrowly. Pennsylvania Democrat Arlen Specter introduced an amendment to remove the ban from the spending bill, but that amendment did not pass. The ban must pass the full Senate and House before becoming law.

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A Simulated Mission to Mars

September 1st, 2010 | No Comments | Source: Washington Post

Recently, 5 scientists clambered into a steel capsule and shut the door behind them, unceremoniously beginning a scientific experiment designed to simulate a 520-day flight to Mars. Their mission is to help space crews of the future understand the stresses of interplanetary travel.

mars A Simulated Mission to MarsThe all-male crew includes 3 Russians, a Chinese man, a Frenchman and an Italian-Colombian. They will execute a rigorous series of experiments and exercises, while being video-monitored the whole time by researchers from the European Space Agency, Russia’s Institute of Medical and Biological Problems and China’s space training center.

Conditions inside the capsule will mimic space travel in every respect, with the important exception of weightlessness.

The participants will communicate with “Earth” using an Internet connection that will be intentionally delayed and disrupted from time-to-time, to simulate likely communication outages during space travel. Their diet will consist of canned food similar to that consumed by astronauts on the International Space Station. They will shower once, and have 2 days off, per week except during simulated emergencies.

Of course, they can’t go far on their days off.

“For me, it will be mainly my family, the sun and fresh air,” French participant Romain Charles answered in response to a reporters question regarding what he will miss most during the project.

“Certainly, the crew is on its own here, with limited communications with the outside world,” the European Space Agency’s Martin Zell told the Washington Post. “They have to cope with a lot of conditions and organize themselves.”

Human beings are decades away from an actual Mars mission because of cost and technological barriers, including the creation of a lightweight shield to protect crews from space radiation.

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