After a 10-to-1 vote in the Board of Supervisors, San Francisco stands poised to force cellphone makers to display the level of radiation their phones emit next the phone’s display in a store. It would become the first American city to do so.
The mayor, Gavin Newsom, supported the measure and will probably sign it into law. If he does, the rules will be phased in February next year, and violators who don’t provide the information will be charged up to $300. Predictably, the move is lauded as progressive and pro-consumer if you ask supporters and cast as a misleading ordinance if you ask the Cellular Telecommunications and Internet Association. But what does it actually mean?
The number in question is called the specific absorption rate, or SAR. It’s a measure of how much of the phone’s radio frequency energy gets absorbed into a person’s tissue. Although no clear picture has emerged of what effects cell phone radiation has on health (though there are plenty of interesting and contradictory studies), there are already legal upper limits for the SAR of phones. Here in the United States, the Federal Communications Commission is responsible for testing those levels and won’t allow anything higher than 1.6 watts per kilogram of body weight. In Europe the cap’s a little higher—2 watts per kg.
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The Food and Drug Administration has a message for the personal genomics revolution: slow down.
Personal DNA tests have been available for years now from companies like 23andMe and Pathway Genomics, and the direct-to-consumer tests have sold briskly even while the companies tried to sort out whether or how their systems would be regulated by the FDA. Then last month, Pathway took the next big step, offering to sell their tests over the counter in the nation’s largest drugstore chain, Walgreens.
For the FDA, that was one step too far, and it began to make noise about regulation. Now the agency’s leader in this field, Alberto Gutierrez, has sent official letters to all the major personal DNA-testing companies saying it intends to regulate the tests as medical devices, and that the companies must provide evidence of their scientific validity.
The letters, posted on the F.D.A. Web site on Friday, say the companies must apply for approval or discuss with the agency why certain test claims do not require such approval. But the letters stop short of saying the tests must be taken off the market until they are approved. Dr. Gutierrez said in an interview that it would be unfair to remove the tests from the market because the agency had not clearly told the companies that the devices needed approval [The New York Times].
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Last month, Costa Rica’s health ministry halted treatments at the country’s largest stem cell clinic, arguing that the treatments are unproven and possibly unsafe.
Though the Obama administration has expanded federal funding of stem cell research and there are ongoing clinical trials, there are currently no FDA-approved stem cell treatments. So some Americans, suffering from conditions ranging from cancer to spinal injuries, have looked elsewhere for experimental stem cell-based remedies, and clinics in countries such as Costa Rica, China, India, and Mexico have grown into stem cell tourist destinations.
Costa Rica’s largest clinic, the Institute of Cellular Medicine in San Jose, was operated by American entrepreneur Neil Riordan; it attracted about 400 patients for these treatments. The clinic used adult stem cells, which Costa Rica’s government had allowed the clinic to take from patients’ fat and bone marrow. The government had not authorized the clinic to use these cells for treatment.
“If (stem cell treatment’s) efficiency and safety has not been proven, we don’t believe it should be used,” said Dr. Ileana Herrera, chief of the ministry’s research council. “As a health ministry, we must always protect the human being.” [Reuters]
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When Walgreens, the nation’s biggest drugstore chain, announced last week that personal genomics tests would join diet soda and pregnancy tests in its aisles, we gave some reasons that might not be such a great thing. We weren’t the only ones concerned: The Food and Drug Administration said it would investigate the tests, and now Congress is involved. It opened an investigation into personal genomics tests yesterday.
House Committee on Energy and Commerce, chaired by Rep. Henry A. Waxman, just sent out official requests for information to the big three personal genomics companies—23andMe, Navigenics, and Pathway Genomics.
Waxman’s interest was piqued by the move—quickly rescinded last week after the FDA objected—by Pathway to sell its DNA-collection kits in Walgreen’s drugstores. The letters ask the companies for information on, among other things, how they analyze test results to determine someone’s risk for any disease or drug response, and how accurately the DNA tests identify genetic risks [Newsweek].
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The USA Patriot Act and the Bioterrorism Preparedness Act, both enacted not long after the 9/11 attacks, contained measures to make it harder for anybody to get their hands on the kind of pathogens one might need to launch a bioterror attack. There was just one problem: The rules also slowed down and constrained our own scientists’ abilities to learn about those pathogens, according to a study out this week in the Proceedings of the National Academy of Sciences.
To be specific, lead researcher Elizabeth Casman found while there was a touch of good news—the laws didn’t appear to deter new scientists from entering the field—the major effect of those acts has been to make research on ebola virus and anthrax much more expensive, and much slower.
The researchers did find an increase in the total number of papers published. But before the laws, 17 anthrax papers appeared per million dollars of funding. With the restrictions, only three papers appeared per million dollars of funding. For ebola, the numbers dropped from 14 to six papers per million dollars. Figures for the control stayed the same [Scientific American].
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Yesterday, a government entity called the President’s Cancer Panel released an alarming report declaring that environmental toxins are causing “grievous harm” to Americans. The authors of the report (pdf) went on to say that while much more research needs to be done to determine the long-term effects of exposure, they believe that the “true burden of environmentally induced cancer has been grossly underestimated.”
But no sooner had they released the report than other cancer experts came forward to say that it wasn’t alarming, but rather alarmist.
First, the panel’s findings. In the 240-page report, the advisory panel noted that Americans are exposed to chemicals whose safety hasn’t yet been definitively established–like the chemical BPA that’s found in some everyday plastics, pesticides, and the substances found in industrial pollution. They write:
“With nearly 80,000 chemicals on the market in the United States, many of which are used by millions of Americans in their daily lives and are un- or understudied and largely unregulated, exposure to potential environmental carcinogens is widespread” [TIME].
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Last night, President Obama issued a memo that will change hospital visitation rights around the country. The administration will draft new rules declaring that any hospital participating in the government’s Medicare and Medicaid programs—which is most of them—will no longer be allowed to bar visitors that patients desire to have access to them.
This has been a particular hardship for gay Americans, who have been turned away from visiting sick loved ones because of policies that allow visiting rights solely to spouses or family members. They aren’t the only ones, either, Obama argues. He cited widows or widowers without children, members of religious orders as examples of people who have been unable to choose the people they want to be at their side [Reuters].
The changes won’t take effect right away. The Department of Health and Human Services must draft the new rules, then put them in place and police them. But in addition to expanding visitation rights, the order also requires that documents granting power of attorney and healthcare proxies be honored, regardless of sexual orientation. The language could apply to unmarried heterosexual couples too [Los Angeles Times]. You can read Obama’s memo here.
The President was particularly inspired by the case of a Florida couple, Janice Langbehn and Lisa Pond. When Pond suffered an aneurysm, Langbehn was denied visiting access at the hospital, despite the fact that she carried power-of-attorney and the couple had adopted four children. Pond died before Langbehn was allowed access. On Thursday night, Mr. Obama called her from Air Force One to say that he had been moved by her case. “I was so humbled that he would know Lisa’s name and know our story,” Ms. Langbehn said in a telephone interview. “He apologized for how we were treated. For the last three years, that’s what I’ve been asking the hospital to do” [The New York Times].
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In a far-reaching judgment that could have major implications for the biotech industry, a federal judge in Manhattan has struck down patents related to two human genes linked to hereditary breast and ovarian cancers, BRCA1 and BRCA2.
Myriad Genetics held the patents, and women who want to find out if they have a high genetic risk for these cancers have to get a test sold by Myriad, which costs more than $3,000. Plaintiffs in the case had said Myriad’s monopoly on the test, conferred by the gene patents, kept prices high and prevented women from getting a confirmatory test from another laboratory [The New York Times]. In his decision, United States District Court Judge Robert W. Sweet found that the company’s patents were invalid because the genes are “found in nature,” and products of nature can’t be patented. In essence, he agreed with the plaintiffs’ argument that the genetic code contained in each human being’s cells shouldn’t be private property.
Tuesday’s decision, if upheld, could have wide repercussions for the multi-billion dollar biotech industry, which is built on more than 40,000 gene patents. Already, about 20 percent of the human genes have been patented. The decision, however, is not binding on other federal courts and other judges may or may not abide by it. But it does the set the stage for years of litigation over other gene patents. Myriad Genetics plans to appeal the judgment.
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After months of party wrangling that culminated in a Sunday night political spectacle, President Obama has finally managed to push through far-reaching reform to the country’s health care system. The House voted 219-212 for final approval of the legislation, and on Tuesday the President will sign the bill into law.
The new law would require most Americans to have health insurance, would add 16 million people to the Medicaid rolls and would subsidize private coverage for low- and middle-income people, at a cost to the government of $938 billion over 10 years, the Congressional Budget Office said [The New York Times].
Here’s a primer on what some of the biggest changes will be in the current health care system. While some changes won’t come into effect till 2014, there are some things that will affect your insurance this year.
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Former President Bill Clinton is out of the hospital today after seeing a doctor in New York about chest pains this week. Clinton showed no evidence of a heart attack and his prognosis is excellent after a procedure Thursday to insert two stents in a coronary artery that had become blocked, said his cardiologist Dr. Alan Schwartz [Los Angeles Times].
Clinton’s rush to the hospital brought new attention to the common medical practice of using stents in heart patients. A stent is a small wire mesh tube that is inserted into an artery in order to prop it open, like a miniature scaffold. Surgeons use stents to improve blood flow to the heart muscle and relieve symptoms such as the chest pain that Clinton experienced [ABC News]. Most people who undergo coronary angioplasty procedures receive stents. Once the tube is in the artery, the artery grows over it and it becomes a permanent part.
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Scientists have argued before that controlling the earth’s burgeoning population would be one of the most effective ways to slow global warming, since keeping millions of little consumers from being born would reduce the amount of fossil fuel that would have to be burned to keep them warm and fed and happy. Now, an advocacy group that focuses on overpopulation is taking the argument the next step, suggesting that people or companies looking to offset their carbon dioxide emissions should buy contraception that would be distributed in poor countries.
Optimum Population Trust (Opt) stresses that birth control will be provided only to those who have no access to it, and only unwanted births would be avoided. Opt estimates that 80 million pregnancies each year are unwanted. The cost-benefit analysis commissioned by the trust claims that family planning is the cheapest way to reduce carbon emissions [The Guardian].
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Don’t let anyone treat you badly because of your genes. As of this weekend, it will be against the law.
The Genetic Information Nondiscrimination Act (GINA) prevents both employers and insurance companies from requiring genetic tests or from using your family’s medical history against you. The biggest change resulting from the law is that it will–except in a few circumstances—prohibit employers and health insurers from asking employees to give their family medical histories. The law also bans group health plans from the common practice of rewarding workers, often with lower premiums or one-time payments, if they give their family medical histories when completing health risk questionnaires [The New York Times]. The law also bars employers from requiring genetic testing or using such information to make decisions on hiring, firing or promoting employees.
To alleviate the privacy concerns of people that have had genetic testing, Congress stepped in and passed GINA last year. The act takes effect Nov. 21 for all employers with 15 or more employees. It applies to group health insurers whose plan years begin on or after Dec. 7, and it took effect for individual health insurance plans last May. The act does not apply to life insurers. The act would ban a company from not promoting a 49-year-old to chief executive because it knew his father and grandfather died of heart attacks at age 50 [The New York Times]. It is still legal for employers to glean information about an employee’s medical history from family obituaries, or to inquire why an employee missed work to care for a sick relative under the Family Medical Leave Act. However, it will now be illegal to use this information to somehow penalize the employee.
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Image: flickr / IRRI Images
Aficionados of 3AM Vodka, Max Fury, and Slingshot Party Gel, take heed! The Food and Drug Administration is casting a wary eye on your classy energy drinks. The federal agency has requested proof from the drink manufacturers that these combinations of caffeine and alcohol are, in fact, safe to drink. The FDA never has approved the addition of caffeine to an alcoholic beverage, and a task force of state attorneys general and other officials has urged the agency to scrutinize the combination. The task force argues that the caffeine can mask the intoxicating effects of alcohol, possibly leading to an increase in drunk driving, sexual assault and other destructive behavior [Los Angeles Times]. Since the FDA never approved the drinks in the first place, the burden of proof falls on the manufacturers, and now the FDA is forcing their hands.
And the FDA isn’t joking around. Companies including Diageo North America Inc., Constellation Brands Inc. and United Brands Co. were told that unless they could provide evidence of safety, the agency will “take appropriate action to ensure that these products are removed from the marketplace,” according to letters sent to the companies and released by the agency [Bloomberg]. The drink companies now have 30 days to respond to the request.
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In an Italian court, a murderer has just had his sentence reduced because the judge agreed that the man’s genes predisposed him to violent behavior.
Abdelmalek Bayout, an Algerian immigrant to Italy, admitted to stabbing and killing Walter Felipe Novoa Perez, a Colombian, when the two men got in a fight over the kohl eye make-up that Bayout was wearing. At trial, the defense team argued that Bayout was mentally ill at the time of the murder; the judge agreed that his psychiatric condition was a mitigating factor, and gave him a reduced sentence of 9 years. But at an appeal hearing, Bayout’s lawyers argued that his sentence should be shortened further based not just on psychiatric evaluations, but also brain scans and genetic testing.
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The United States will end its long-standing ban that prevents foreigners with HIV from entering the country. President Obama announced the change on Friday, saying that the exclusionary rule had been “rooted in fear rather than fact.” The policy has been in place for 22 years, and was enacted at a time when people still wondered whether HIV could be transmitted through physical or respiratory contact. It will officially be repealed at the start of 2010.
The ban applied both to tourists wishing to visit the United States and to foreigners who hoped to live and work here. Only about a dozen other countries still bar people with HIV or AIDS from entering. “If we want to be a global leader in combating H.I.V./AIDS, we need to act like it,” Mr. Obama said. “Now, we talk about reducing the stigma of this disease, yet we’ve treated a visitor living with it as a threat” [The New York Times].
Gay advocates said the ban also discouraged travelers and some foreigners already living in the United States from seeking testing and medical care for H.I.V. infection. “The connection between immigration and H.I.V. has frightened people away from testing and treatment” [The New York Times], said Rachel Tiven of the advocacy group Immigration Equality.
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Image: flickr / Doug Letterman
