Should companies be allowed to patent genes? They are right now, and an HHS-advisory committee has warned that such practices threaten medical progress and could drive critical bio-medical research overseas in search of friendlier legal environments.

The HHS Advisory Committee on Genetics, Health, and Society also said in a report dated February 5 that the cost of genetic analysis has plummeted recently to a point where there is substantial potential to improve health using gene-based technologies.

But existing patent laws pose serious obstacles to “the promise of these developments,” according to the report. As evidence for this assertion, the report cites several labs that run multiplex gene testing but do not report the results regarding patent-protected genes to patients or clinicians, because they worry about being sued.

The Committee recommended that the US should create broad exemptions from liability for infringement of patent claims on genes used in diagnostic testing for patients, as well as in the use of patent-protected genes in research.

The Committee also recommended that guidelines be established to promote non-exclusive licensing for genomic and diagnostic genetic technologies, improved transparency in licensing, and creation of an advisory board focused on gene patenting and licensing practices and their impact on health.

The report was ordered by HHS Secretary Sebelius at a time when a bevy of lawsuits have put judges in the position of deciding whether gene patents are enforceable.

 “Patenting has moved upstream; instead of covering only commercial products, patents can now control foundational research discoveries, claiming the purified form of genes. Fragmented ownership of these patents on genes by multiple competing entities substantially threatens clinical and research use,” according to the report. “Fragmented ownership may create problems such as patent thickets, blocking patents, high transaction costs, royalty stacking, and holdouts.” (more…)

Preschool-age children adopted from foreign countries learn English in the same sequence as US-born babies do: they begin with single words and move to word combinations and complex grammar, according to Harvard scientists.

Psychologist Jesse Snedeker and colleagues reached this conclusion after videotaping language acquisition by 141 international adoptees and comparing these observations with those made involving younger US counterparts.

Thus after being in the US for a few months, a 3 ½ year-old adoptee might use word combinations like “Andy shoe,’’ just like an 18-month old US-born child. A year later, the now 4 ½ year-old adoptee might have progressed to “my red shoe,’’ just like a US toddler would have done.

“Because babies are immature in so many ways, it’s easy to assume their language is simple because their minds are simple,’’ Snedeker told the Boston Globe. Her research has shown that’s not the case.

Snedeker’s research has shown that the older adoptees are quicker at progressing through English language acquisition than US-born babies, but they progress through the same stages and make the same kinds of grammatical mistakes.

Thus it seems that humans “might need to learn words like ‘ball’ and ‘shelf’ before they can learn a word like ‘on’ ’’ and produce a sentence like “the ball is on the shelf,’’ Snedeker told the Globe.

The one exception, according to Snedeker, is that the older adoptees tend to be quicker in using words referring to time, the future and the past. So apparently there are at least some areas where cognitive maturity comes into play.

More than one is 5 US teenagers has an abnormally high cholesterol level, according to federal health officials who say the new data provides striking evidence that the nation’s epidemic of obesity is threatening an entire generation with increased risk of cardiovascular disease and stroke, among other things.

To reach these astonishing conclusions, Ashleigh May of the CDC and colleagues analyzed data collected between 1999 and 2006 from a nationally representative sample of 3,125 youths who were between 12 and 19 years old. The data came from the National Health and Nutrition Examination Survey.

The scientists found that 20.3% of the subjects had at least one abnormal blood lipid test—either low levels of high-density lipoprotein (HDL, or good cholesterol), high levels of low-density lipoprotein (LDL, or bad cholesterol), or high levels of triglycerides.

What is more, the kids’ risk of having an abnormal lipid test increased with increasing weight. Thus 14.2% of those whose weight was normal had an abnormal value, but the incidence rose to 22.3% and 42.9% among those who were overweight and obese, respectively.

“This is the future of America,” said Linda Van Horn, a Northwestern University professor told the Washington Post. “These data confirm the seriousness of our obesity epidemic. This is an urgent call for health-care providers and families to take this issue seriously.”

Although previous studies have raised these concerns, this is the first to confirm and quantify the potentially devastating effects of America’s teen obesity epidemic. Other studies had linked the epidemic to high blood pressure, diabetes and arthritis, which had been presumed rare in adolescents.

“This problem is poised to negate all of the advances we’ve made in cardiovascular health,” said Denise Simons-Morton of the NHLBI.

The write-up appears in the CDC’s Morbidity and Mortality Weekly Report.

Shortly after taking the oath of office, President Obama made food safety a domestic priority. He called recent national outbreaks of food-borne illnesses a “troubling trend” and a “risk to public health.”

But more than a year later, the Obama administration has yet to fill the chief food safety official post at the Department of Agriculture. He just nominated someone though, Elizabeth Hagen, 40, a person few in the field  had heard of before the announcement.

Hagen, a physician, has never published a word on the subject of food safety. She spent much of her career as a clinician and educator in the field of infectious diseases. She left practice 4 years ago for the USDA, where rose quickly through the department’s Food Safety and Inspection Service.

“Consumer advocates who work closely with [the Department of Agriculture] on policy issues have had limited direct experience with Dr. Hagen,” said the Consumer Federation of America in a release cited by the Washington Post.

Hagen was tapped for the post after the Administration approached at least two other people. Last February for example, it vetted and offered the job to Mike Doyle, a nationally recognized microbiologist. That nomination collapsed after Doyle refused to divest his financial interest in an effort to commercialize a microbial wash for meat.

Whoever fills the position will oversee the safety of meat, poultry and eggs, which comprise 20% of the nation’s food supply.

Last year, there were 13 recalls of beef products contaminated with E. coli. Already this year, there have been six recalls of tainted meats, including an ongoing situation with salami that has sickened hundreds in 40 states.

Since Michael Sokolove’s “Warrior Girls” brought the matter public attention, many people know that young women athletes are in the midst of an epidemic of knee injuries, including the most dreaded of them all: a tear of the  anterior cruciate ligaments (ACL). In fact girls are three to eight times more likely than boys to sustain that injury.

This stunningly high ratio says the issue goes beyond the fact that girls participate in competitive sports as much as boys do. Given only that, the ratio should be even. The real problem, it turns out, has to do with anatomical and physiological differences between girls and boys.

Girls have thinner ACLs for example. And their pelvises are wider, which has the effect of putting more stress on the knee ligaments during both normal and recreational activities. The anatomy of their femurs (the large, upper leg bone) favors fraying of the ACL. And as well, some female reproductive hormones make their ACLs more lax. 

The epidemic has spawned a host of workouts and training programs designed to help prevent knee injuries in young female athletes. These programs focus on strengthening muscles like the quadriceps that help support the knee, and the core muscles which help stabilize the body during stops and starts, which are so often the times when ACL injuries occur.

The programs have different time requirements, but a 45 minute session, twice a week is  typical.  Also included in most sessions are tips about landing softly and using multiple joints (ankle, knee, hip) for bracing against falls and the like.

“You can’t make an ACL bigger,” Trent Nessler, executive director of Baptist Sports Medicine in Nashville told the Washington Post. “So what we tend to look at is what factors can you affect through training.”

Nessler asserts that girls who participate in these programs can reduce their risk of knee injuries by up to 88%…and even if he’s half right, that seems like something worth doing.

China, not the US, holds the dubious distinction of having the highest number of private computers that have been commandeered by hackers with malicious intent, according to a report by McAfee, an Internet security firm.

MaCafee monitors Internet-based threats targeting computers in 120 countries. It found that in the fourth quarter of last year, about 1,095,000 computers in China and 1,057,000 in the US had been infected.

Those numbers don’t count the roughly 10 million computers in each country that had previously been infected.

Infected, or “zombie” computers are typically linked together as botnets and then used to send spam e-mail or launch Denial of Service attacks on Web sites.

McAfee suggested that Chinese computers are particularly vulnerable to hackers since software piracy is common there, and computer users frequently do not download patches for their machines.

In a recent speech about Internet freedom, Secretary of State Hillary Rodham Clinton suggested that the Internet is a “global networked commons” for which “norms of behavior” ought to be developed by nations.

“An attack on one nation’s networks can be an attack on all,” she said. “Countries or individuals that engage in cyberattacks should face consequences and international condemnation.”

The US will have trouble heeding Clinton’s call for accountability and norms because it has so many infected computers. “The government could crack down on botnets, but doing so would raise the cost of software or Internet access and would be controversial,” Harvard Law professor Jack Goldsmith  wrote in the Washington Post.

“So it has not acted, and the number of dangerous botnet attacks from America grows.”

Older moms have a greater risk of giving birth to a child with autism, according to a study by scientists at UC Davis. 

To reach this conclusion, Janie Shelton and colleagues reviewed all births in California during the 1990s.

They found that the risk of having a child with autism jumped 18% for each 5-year increment in maternal age. A 40-year-old woman had a 50% higher risk of having an autistic child than a 25 year-old woman.
 
Previous research had identified increased paternal age as a risk factor, but this one, by far the largest of its kind, showed that father’s advanced age matters only if the mom is under 30. For older moms, the risk is predicted solely by maternal age.
 
“This study challenges a current theory in autism epidemiology that identifies the father’s age as a key factor in increasing the risk of having a child with autism,” Janie Shelton, the study’s lead author told BurrillReport. “While maternal age consistently increases the risk of autism, father’s age only contributes an increased risk when the mother is under 30 years old.”
 
“We still need to figure out what it is about older parents that puts their children at greater risk for autism and other adverse outcomes, so that we can begin to design interventions,” said Irva Hertz-Picciotto the senior author on the study.

In this regard, UC Davis scientists reported in 2008 that they found antibodies to fetal brain protein in some mothers of children with autism, but not in the mothers of normal children. Others speculate that certain environmental toxins accumulate in the body with age and may play a role as well.

The write-up appears in Autism Research.

Two weeks ago, the prestigious medical journal Lancet retracted a 1998 article that purported to show a link between childhood vaccines and autism. The article stimulated a decade-long debate about vaccine safety, and the Lancet’s retraction effectively ended reasonable scientific discourse on the subject: the vaccines are safe.

Ten of 13 authors of the paper had issued a partial retraction 6 years ago, but the first author, Andrew Wakefield, did not. 

Wakefield’s study had focused on 12 children that had gastrointestinal problems. Eight had symptoms that their parents or a doctor thought were caused by the MMR vaccine, and 9 exhibited autistic behaviors.

That study triggered widespread concern that measles-mumps-rubella vaccine caused autism. Parents decided against immunizing their children as a result. Roughly 2.1% of US children weren’t immunized with the MMR vaccine in 2000, nearly triple the rate of 0.77% in 1995, according to a study in Pediatrics.

This occurred despite the publication of several subsequent studies which showed that vaccines were safe. The most notable among these were a 2004 review of the literature by the Institute of Medicine and a 2008 study by the CDC which looked specifically at children with GI problems.

“This retraction by the Lancet came far too late,” Paul Offit, chief of infectious diseases at Children’s Hospital of Philadelphia told the Wall Street Journal. “It’s very easy to scare people; it’s very hard to unscare them.”

The Lancet pulled the plug after a UK-based health care regulator concluded the Wakefield study was bogus. The General Medical Council’s report included allegations of ethical violations by some investigators, including “cherry-picking” children for the study, rather than taking kids as they presented randomly to the hospital, as had been implied in the paper.

Fully 8 years after the anthrax attacks of 2001 showed that bioterrorism can happen in the US, the nation remains woefully unprepared for a large-scale attack, according to a Congressional Commission.

The WMD Commission evaluated the government’s performance in 17 key areas. It nailed the White House and Congress with an “F” for not creating a rapid-response capability to handle disease outbreaks from bioterrorism, or providing adequate oversight of security and intelligence agencies.

As evidence, the Commission cited the government’s stuttering response to the swine flu epidemic. It pointed fingers at several administrations and branches of government.

In other news, the panel handed out “As” to government programs that secured dangerous viruses and bacteria, and to the Obama administration’s reorganization of the National Security Council so that it could handle other threats from weapons of mass destruction.

The Commission’s report cited in particular the White House’s efforts to strengthen international controls on nuclear technology and components.

“Each of the last three administrations has been slow to recognize and respond to the biothreat,” former senator Bob Graham (D-Fla.) told the Washington Post. Graham co-chaired the panel with former senator James M. Talent (R-Mo.). “We no longer have the luxury of a slow learning curve when we know al-Qaeda is interested in bioweapons.”

In his State of the Union address last month, President Obama revealed plans to fill many of the gaps that were identified by the Commission. In particular, he wants to improve the performance, scalability and flexibility of drug distribution systems.

According to White House spokesman Nick Shapiro, “the goal is a national capability for the rapid, reliable and affordable production of an array of medical countermeasures against public health threats.”

Voxiva, a Washington DC-based mobile technology firm, has launched a government-sponsored program that uses standard text messaging to educate and encourage healthy habits in pregnant women.

The “Text4baby” program sends tips to expectant mothers who sign up using their cell phones. To participate, women text the word, “baby” (or “bebe” for Spanish speakers) to the number 511411. 

Enrollees receive 3 text messages per week, timed to correspond with the woman’s delivery date. The messages cover nutrition, health maintenance and pregnancy management.

The service is entirely free to end-users thanks to government subsidies and the largesse of the wireless carriers. Launched last month, the service had 6,500 sign-ups in the first day. Before this program, Voxiva offered similar text-based services in the US, but they were not free.

Voxiva has launched more than 150 mobile health campaigns in Africa, India and Latin America, areas characterized by developing economies and/or a scarce supply of physicians. These projects are usually underwritten by governments or pharmaceutical firms. They provide news and treatment tips for people with AIDS, obesity, diabetes and smoking.

One of main goals of Text4baby is to discourage alcohol and tobacco use, habits that increase the risk of premature birth. In the US, one out of 8 babies, or about 500,000 births per year, is born prematurely each year. 

Despite the buzz about health-related apps for the iPhone and other smart phones, text messages are ideal for reaching Text4baby’s most important target group, which includes women that can’t afford smart phones. About 90% of US adults carry a cell phone, and nearly all of them support text messaging.