Obama taps Unknown to be Food Safety Czar

March 12th, 2010 | Sources: Washington Post

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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.”

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

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Preventing ACL Injuries in Girls

March 11th, 2010 | Sources: Washington Post

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.

soccerThis 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.

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China’s Hacked Computers

March 10th, 2010 | Sources: Washington Post

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.

urwishisourcommandMaCafee 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.”

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Autism and Older Moms

March 9th, 2010 | Sources: BurrillReport

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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.

crapshootThey 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.

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Lancet Retraction Ends Vaccine-Autism Debate

March 8th, 2010 | Sources: Wall Street Journal

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.

Rejected stampTen 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.

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US Unprepared for Bioterrorist Attack

March 5th, 2010 | Sources: Washington Post

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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.

spoiledrottenThe 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.”

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Text Message Program Gives Pregnancy Tips

March 4th, 2010 | Sources: Washington Post

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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.

lovedthatoneThe “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.

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Memory Lapses and Alzheimer’s: Where do you Draw the Line?

March 3rd, 2010 | Sources: Washington Post

“Senior moments” like forgetting someone’s name or where you parked your care are common in elderly and even middle-aged folks, so how does one know whether they represent something more serious such as dementia?

Where'dIputmyglasses“It’s the degree of the problem,” James Lah, an Emory University neurologist recently explained to the Washington Post. “If you forget where you place your keys, that’s common. But if you put them in the refrigerator repeatedly, that’s a problem.”

Other Examples
NORMAL: Forgetting where you parked.
PROBLEMATIC: Forgetting where you parked once a week.

NORMAL: Forgetting a person’s name.
PROBLEMATIC: Forgetting a person’s name and then repeatedly asking him or her, “What’s your name again?”

NORMAL: Inability to program the cable box.
PROBLEMATIC: Forgetting how to turn on the television.

Fast Facts
People begin having memory lapses in their 20s, though few worry about it until they’re into their 50s. Peak performance for human memory occurs at about age 22. By age 50, most people are aware their memory ain’t what it used to be. But they can take heart in this: people’s general knowledge-base increases until at least age 60.

Just 10 minutes of brisk walking per day reduces memory losss and the risk of developing Alzheimer’s disease. Amazing but true.

There is growing evidence that Gingko biloba does not work, and there is some positive, but very early buzz surrounding omega-3 fatty acids and pomegranate juice, of all things.

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Those Lost Bush-Era Interrogation emails

March 2nd, 2010 | Sources: Washington Post

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Democratic lawmakers and watchdog groups resumed demands last week that the Department of Justice should explain how emails from Bush administration lawyers that supported harsh interrogation tactics were lost. The same groups raised concerns that their absence might taint the findings of a recent ethics report which cleared the lawyers of charges that they engaged in professional misconduct.

they'llneverfindoutThe emails in question cover a critical period in 2002 when attorneys from Justice prepared a memo that cleared the way for CIA operatives to use waterboarding, sleep deprivation and other techniques against al-Qaeda suspects, according to the Washington Post.

“Why were these critical records deleted? Why were they kept from investigators?” Senate Judiciary Committee Chairman Patrick J. Leahy asked at last week’s hearing.

Acting Deputy Attorney General Gary Grindler responded that the ethics report “does not suggest there is anything nefarious” about the lost emails, but that he had asked a department administrator “to determine what was going on with respect to the archiving of these emails.” “If they are retrievable, I will retrieve them,” Grindler said.

Also last week, the National Archives asked why Justice had not notified it about the missing emails before the ethics report was released. And Citizens for Responsibility and Ethics in Washington has asked Justice to launch a criminal inquiry into the lost emails.

Months ago in an internal review, Justice’s Office of Professional Responsibility concluded that former department lawyers John Yoo and Jay Bybee had committed misconduct in preparing those emails and memos. That decision was later overruled by Associate Deputy Attorney General David Margolis who found instead that the lawyers had exercised poor judgment.

At the last week’s Senate hearing Grindler said that Margolis’ ruling was made “without interference” by senior Justice Department officials.

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Anesthesiologist Data Fraud Case

March 1st, 2010 | Sources: MedPageToday

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The Massachusetts anesthesiologist accused of cooking up data for use in trials of pain medications has agreed to plead guilty to criminal charges in a deal with federal prosecutors.

gotchaScott Reuben, who had been among the nation’s most respected investigators on the subject, had been charged with one count of healthcare fraud.

Reuben’s trouble began last year, when an internal audit conducted by Baystate Medical Center in Springfield, Mass., revealed he fabricated data for 21 studies he had conducted during the last 15 years.

The criminal charge had focused on one of these, a trial of Celebrex as part of a “multimodal” pain regimen for knee surgery. The study showed the drug was effective and was published in 2007 in Anesthesia & Analgesia.

“In fact,” the prosecution wrote in a court filing, “Reuben had not enrolled any patients into that study, and the results reported…to Anesthesia & Analgesia were wholly made up by Reuben .”

Had he not copped a plea, Reuben could have spent 10 years behind bars and been fined $250,000. The plea convinced prosecutors to recommend lighter penalties.

After Baystate spilled the beans, journals that had published his tainted articles retracted them.

Baystate terminated its contract with Reuben last spring. At the same time, he reportedly agreed to suspend his practice and was stripped of a professorship at Tufts.

Several widely accepted medical beliefs need to be re-examined in light of the scandal. Topping the list are the effect of COX-2 inhibitors on bone healing and the role of multimodal analgesic regimens in managing chronic pain.

With respect to the former, Reuben’s studies suggested the drugs had no effect on bone fusion, a finding that was contrary to the results of several animal studies.

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Internet Drugs for Erectile Dysfunction

February 26th, 2010 | Sources: BurrillReport

Men who buy erectile dysfunction drugs on the Internet risk ingesting hazardous contents and may miss out on treatment for associated conditions like cardiac disease and high blood pressure, according to a study in the International Journal of Clinical Practice.

OxycontinTo reach these conclusions, Graham Jackson and colleagues reviewed more than 50 studies of Internet drug purchasing behavior that had been published between 1995 and 2009.

ED drugs were the most commonly counterfeited product purchased over the Internet, presumably because of their high cost and the stigma associated with the underlying condition.  As many as 2.5 million men are using counterfeit Viagra in the European Union alone, according Jackson’s group.

As many as 2.3 million ED drugs are orderred online each month worldwide, and most of them are secured without a prescription. Approximately 44% of the Viagra purchased on line is counterfeit.

Counterfeit forms of other drugs are a problem as well, Jackson’s group found. In Argentina for example, 2 pregnant women died after receiving injections of a bogus iron preparation, and 51 children died of kidney failure in Bangladesh after swallowing a Tylenol-like syrup laced with antifreeze.

Jackson’s study also revealed examples of counterfeit contraceptives, antimalarials and antibiotics.

Global sales of counterfeit drugs will reach $75 billion this year, according to the Center for Medicine in the Public Interest. That’s up 92% in just 5 years. Nearly 90% of the bogus elixirs are sold on the Internet.

“In some cases producing counterfeit medicine can be 10 times as profitable per kilogram as heroin, yet in the UK someone can face greater legal sanctions if they produce a counterfeit T-shirt,” Jackson, a London cardiologist told BurrillReport.

 “What is clear is that we need much greater public awareness of the risks of buying counterfeit drugs, as lives are at risk.”

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VC Spending Still Weak

February 25th, 2010 | Sources: Wall Street Journal

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The year-long tailspin in venture-based activity ended on an up note, according to Dow Jones VentureSource. In Q4, 2009, venture investors invested $6.3 billion in 743 deals, up slightly from the $6.1 billion invested in 619 deals during the previous fourth quarter.

pulluppullupOverall, there were 2,489 deals completed and $21.4 billion in venture capital invested in 2009 in US companies. That represented a 31% drop from 2008, when $31 billion was invested in 2,817 deals.

“Venture capitalists are still treading lightly when making investments,” said Jessica Canning, global research director for Dow Jones VentureSource. “In the fourth quarter, venture deal activity returned to levels seen before the collapse of the financial markets, but capital invested continued to lag as investors gave companies just what they need to reach the next milestone.”

2009 was also notable in that for the first time ever, the healthcare industry raised more VC capital than the Information Technology (IT) sector. Healthcare deals garnered $7.7 billion across 701 deals last year, a 14% drop from the previous year. That compared favorably to IT, in which VCs risked $6.1 billion in 817 deals last year, a 35% drop from 2008 and the industry’s weakest year since 1996.

The majority of VC money in health care went to biopharmaceutical companies, which raised $4.2 billion over 302 deals. Medical devices came in second at $2.9 billion for 291 deals.

The Energy & Utilities sector experienced a profound decline in VC investment last year. Companies in this sector raised just $1.2 billion in 87 deals in 2009, less than a third of the amount raised in 2008.

The median round size of venture deals in 2009 was $4.7 million, down from $6 million in 2008, according to VentureSource. Later-stage deals accounted for the largest slice of deal activity, attracting $11.4 billion in investment, whereas seed- and first-round deals garnered $3.7 billion.

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PhRMA Chief gets the Gold Watch

February 24th, 2010 | Sources: Wall Street Journal

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Billy Tauzin, Big Pharma’s top lobbyist,  is calling it quits amid growing uncertainty regarding the national effort to reform health care, an effort he supported.

Tauzin reigned for 5 years as president of the Pharmaceutical Research and Manufacturers of America.

RocherollsthediceLast June, he bet health reform would happen and decided to cozy-up to the Democrats.

In particular, he cut a deal in which drug makers agreed to contribute $80 billion in savings over 10 years by reducing the prices of certain drugs and closing the “donut-hole” coverage gap for Medicare beneficiaries.

Soon after that, the Big O stopped advocating for the importation of cheap drugs from Canada and stopped saying the feds should negotiate Medicare drug prices directly with drug makers. He had held these positions during the presidential campaign.

The Democrats’ health reform bill also guaranteed 12 years of sales exclusivity for BioTech drugs, which is longer than many Democrats and the generic industry preferred.

Of course, all this is in limbo right now.

Tauzin’s deals with the Obama administration drew fire from business representatives and Republicans. Notably, House minority leader John Boehner called his White House deal a “short-sighted” bargain with “Big Government.”

According to Thomas Donohue, president of the Chamber of Commerce, Tauzin improved his industry’s image during his reign. When he took over, Big Pharma was reeling from drug recalls and problems with popular drugs linked to death, diseases and suicide. “Billy stabilized the drug industry,” Donohue told the Wall Street Journal.

Tauzin, a former congressman from Louisiana, collected a $2 million salary from PhRMA. His last day is June 30.

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FDA Changes Course on BPA

February 23rd, 2010 | Sources: Washington Post

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In response to mounting evidence that bisphenol-A (BPA) is associated with multiple health problems, the FDA will undertake studies of the chemical and implement some regulatory tweaks that help it act quickly if the research uncovers problems.

PickyourpoisonBPA is a ubiquitous chemical that renders plastic bottles shatterproof. It is also used to coat cans and other containers for food, and is a component of a thousand other consumer goods as well.

The substance leaches from containers into food and can be detected in the urine of 90% of Americans, regardless of age.

Recent studies have linked BPA to cancer, sexual dysfunction, diabetes, heart disease and  abnormal development in fetuses, infants and children.

“We have some concern, which leads us to recommend reasonable steps the public can take to reduce exposure to BPA,” said Joshua Sharfstein, FDA’s deputy commissioner, in a call with reporters.

But the FDA stopped short of an outright ban, saying the data doesn’t justify one. 

Instead, the agency will study BPA and change its classification from a “food additive” to a “food contact material.” The former means manufacturers don’t have to tell the Feds which products contain BPA or in what amounts. The latter requires more disclosure and facilitates a rapid response from the FDA if the stuff is found to pose a risk.

In 2008, Babies R Us and other retailers announced they would no longer stock baby bottles made with BPA. Canada and several US cities and states have already banned BPA from baby bottles.

Until Sharfstein’s announcement, the FDA had maintained that BPA was safe. Its policy was based largely on 2 studies that were funded by the chemical industry. An internal advisory panel criticized this position while calling attention to more than 100 studies that raised doubts about BPA.

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Is Marijuana a Drug or a Medicine?

February 22nd, 2010 | Sources: Wall Street Journal

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Fourteen states have legalized marijuana for medical uses and the Department of Justice has announced it will not prosecute people who use marijuana while under a doctor’s care and in accordance with state rules.

It'sadrug,manBut even as the regulatory landscape clears, the medical issues associated with smoked marijuana remain muddled. Scientists simply don’t know how effective it is as a therapeutic agent. Remarkably, the literature contains fewer than 20 randomized trials of smoked marijuana for all therapeutic indications combined.

Among these, research findings that support using marijuana for neuropathic pain are probably the strongest. For example, in a trial of AIDS patients published in Neurology, scientists found that 52% of those who smoked marijuana reported at least a 30% reduction in pain, as compared with 24% of those who smoked placebo cigarettes.

Smoked marijuana has also been shown to have a modest anti-nausea effect in cancer patients receiving chemotherapy, and to improve appetite and trigger weight gain in HIV-positive patients.

That said, marijuana has not been shown to help patients with a variety of other conditions ranging from epilepsy to immune system disease.

The muddled situation is further complicated by the fact that the FDA doesn’t regulate marijuana. That means, among other things, that the potency of products available in medical-marijuana dispensaries is likely to vary.

“It’s difficult to understand how we can call it medicine if we don’t know what’s in it,” Stephen DeAngelo told the Wall Street Journal. DeAngelo runs a medical-marijuana dispensary in Oakland.

Marijuana, it must be noted, has been associated with palpitations, memory loss, anxiety, psychotic experiences and, yes, an inability to concentrate.

It also carries a risk of physical dependence, though it is not as addictive as nicotine or alcohol. Smoked marijuana may also irritate bronchial tissue, but a study in Cancer Epidemiology, Biomarkers & Prevention found no link between smoking marijuana and lung cancer.

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China: Regenerative Medicine Power

February 19th, 2010 | Sources: BurrillReport, Regenerative Medicine

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China’s enormous investment in the field of regenerative medicine has catapulted the nation to the world’s fifth most productive contributor to the scientific literature, despite continued international condemnation of it research methods, according to a study in Regenerative Medicine.

CuringMSThe report was authored by Dominique McMahon and colleagues at the McLaughlin-Rotman Centre for Global Health.

It describes China’s aggressive efforts to recruit top international scientists, as well as the broadly impugned practice of administering unproven stem cell treatments to thousands of domestic and foreign patients.

Chinese researchers contributed more than 1,100 articles on the subject to peer-reviewed journals in 2008. That’s up from 37 in 2000 and more than any country in the world except the US, Germany, Japan, and the UK.

McMahon and colleagues indicate that China has recently instituted new rules governing stem cell treatments, but they need to be enforced more strictly if the nation is to repair its seedy reputation in the field.

Right now in China, more than 200 hospitals use stem cell therapy to treat patients with autism, cataracts, diabetes, Lou Gehrig’s disease, multiple sclerosis, Parkinson’s disease, stroke traumatic brain and spinal cord injury and many other conditions.
 
Yet until May 2009, China did not require such therapies to have been subjected to clinical trials designed to assess the safety and effectiveness of such therapies. 

China made the change after international experts and many Chinese researchers complained about gross violations of standard scientific research principles.

“China is an important player in regenerative medicine,” McMahon told BurrillReport. “Despite the media’s focus on stem cell tourism, the international community needs to recognize that Chinese researchers are making important contributions to the science of this field, and China should be included in international discourses on standards and regulations.”

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