How’s this for a cool high-school science project?

Brenda Tan and Matt Cost, a pair of students at Trinity High School in Manhattan, recently performed DNA analysis of food items and other objects collected in their homes and surrounding environs.

They found a hellacious mix of mislabeled and possibly tainted food items and raised a ton of questions in the process.

Among their notable discoveries:
-  A pricey chunk of so-called sheep’s milk cheese turned out to have been derived from cow’s milk,
-  Fish labeled smelt turned out to be Japanese anchovy,
-  “Venison” dog treats were actually made from beef
-  Sturgeon caviar samples contained DNA from that widely-known delicacy, the Mississippi paddlefish.

The students dubbed their project “DNAHouse.” They analyzed their collections using the Barcode of Life Database which is normally used in species identification. They secured help from DNA barcoding experts at Rockefeller University and the American Museum of Natural History for their project.

A write-up of their work appears here.

“We do not know where or why the mislabeling occurred, but most cases appeared to involve substitution of a less expensive or less desirable item, suggesting the possibility of deliberate mislabeling for economic gain,” the authors wrote. “We also think mislabeling is a serious problem because certain individuals have allergies or dietary restrictions regarding certain foods.”

Trinity has a track record for producing these kinds of stories. Last year, 2 other Trinity students created a stir by reporting that one-quarter of the fish at local markets and restaurants was mislabeled.

Of note, Tan and Cost also sampled hair from several classmates. “We were happy to report,” they wrote, “that our classmates came back as 100% human.”

More than half of American adults, 54%, drink coffee regularly. They consume nearly 400 million cups of it each day making its active ingredient, caffeine, by far the most widely consumed drug in the country.

So you’d think we’d have reached some general agreement on how the stuff affects our health by this time, no?

Alas, that’s not the case.

Recent studies of the matter  suggest that coffee has beneficial effects on health. Last month for example, scientists reported that people who consumed 3-4 cups of Joe per day developed Type 2 diabetes 25% less frequently than those who had less than 2 cups per day.

Another group recently reported that men who drank at least six cups per day developed advanced prostate cancer 60% less often than abstainers.

Earlier studies had, in addition, linked coffee consumption to a reduced risk of colon cancer, head and neck cancer, endometrial cancer, cavities, gallstones, Parkinson’s disease, cirrhosis of the liver and Alzheimer’s disease.

On the other hand, many studies show that coffee, and caffeine in particular, raises heart rate and blood pressure as well as homocysteine levels in the blood. The latter is an amino acid that has been associated with stroke and heart disease.  Other studies have linked caffeine to bone loss in elderly women and shown that pregnant women who consume 2 or more cups per day have higher rates of miscarriages and low birth-weight babies.

What explains the confusion? It’s certainly possible that coffee has protean effects on the human body, and a mixed bag of health outcomes. After all, many drugs fall into that category. Another possible reason is that most studies of coffee’s health effects (including the 2 recent ones mentioned above) feature an observational trial design, in which scientists troll large data sets for associations between behavior and health outcomes, without a particular hypothesis in mind at the onset. (more…)

Ever wonder how safe and reliable Granny’s new pacemaker is? In most cases it turns out nobody really knows, because the quality of the evidence used by the FDA to approve these devices is poor, according to a study published in JAMA last week.

Sanket Dhruva and colleagues from UCSF drew these conclusions after examining the premarket approval process (PMA) for 78 high-risk cardiovascular devices that received FDA approval between January 2000 and December 2007.

PMA is the most stringent FDA review process for medical devices. The scientists found that 65% of the PMA applications for devices were supported by exactly one study.

And overall, the quality of the studies was abysmal. Some failed to provide details like the number of enrolled participants. Only 27% of them were randomized and even less, 14%, were blinded (blinded, randomized, controlled trials represent state-of-the-art scientific research).

The scientists concluded that in general, the FDA’s premarket approval process for cardiovascular devices lacked statistical firepower required to control for bias and hence draw valid conclusions.

The scientists understood that it is more difficult to subject medical devices to blinded studies, since there is no way to produce a “sugar pill” (that is, placebo) for medical devices.

“But we were surprised that so many devices were approved on the basis of a single study,” Dhruva told the Los Angeles Times.

The FDA started approving medical devices in 1976. Recently, there has been a marked increase in the number of cardiovascular devices implanted in Americans.  In 2008, 1.2 million people received stents in the US alone. 350,000 people received pacemakers and 140,000 received implantable cardioverter-defibrillators.

Last month, 7 CIA operatives stationed at a forward operating base in the mountains of Afghanistan were blown up by a suicide bomber. Among other things, the tragedy highlighted the CIA’s transformation into a paramilitary organization that operates on the front-lines of America’s war on terror.

The dead operatives had been begun a campaign against a radical nut job known as Sirajuddin Haqqani and his woefully enslaved followers. This crew has claimed responsibility for killing dozens of US soldiers.

In the past year, the CIA has amassed dozens of forward operating bases like this in eastern and southern Afghanistan. In so doing, it has exposed its operatives to enormous risk.

In the 1983 Beirut car bombing, remember, it took a car bomb loaded with 2,000 pounds of explosives to kill eight CIA officers who were based at the heavily fortified American Embassy. All it took this time was one guy dressed in loose-fitting Afghan army fatigues.

These remote outposts are just one feature of the newly militarized CIA. The clandestine agency also uses unmanned drone attack aircraft to pin down and kill nut jobs in Pakistan, and has many operatives in Yemen, home of Umar Farouk AbdulMutallab, the notorious testicle bomber.

According to the New York Times, the CIA has long-since maintained a paramilitary branch known as the Special Activities Division. But the branch was small and rarely used.

Things changed after 9/11 however, when President George W. Bush expanded the agency’s purview to include the capture and/or killing of al Qaeda operatives. The new responsibilities were assigned to Special Activities, which deftly moves and out of countries where the US military can’t operate legally.

The CIA’s expanded mission has included at various times activities such as running a war in Pakistan, organizing secret jails where terrorist suspects could be interrogated, and running an assassination program that once outsourced sensitive operations to Blackwater, a privately-held security company.

President Obama shut down the prisons and called off the dogs, literally, when it came to interrogating terrorism suspects, but green lighted the CIA’s drone program.

Sanofi-Aventis has announced plans to acquire Chattem, maker of popular consumer products like Icy Hot pain reliever and Selsun Blue dandruff shampoo.

The $1.9 billion buy would be the second consumer-focused company purchased by the Paris-based drug giant in less than a year. The other one was France’s Laboratoire Oenobiol, which makes health and beauty supplements and nutritional products.

The moves should help Sanofi diversify beyond prescription drug revenue, which seems like a good idea since its 4 big drugs, Lovenox, Plavix, Ambien CR and Eloxatine will all face generic competition soon.

To accelerate its move into consumer health, Sanofi plans to release an OTC version of Allegra, its allergy drug, which has begun losing market share to Teva’s generic competitor. 
 
Even before the acquisition of Chattem and with little presence in the US consumer products market, Sanofi  managed to generate about $2 billion per year in world-wide OTC sales.
 
“The acquisition of Chattem (gives us) the ideal platform in the US consumer healthcare market,” Chris Viehbacher, CEO of Sanofi told BurrillReport. “Our ability to convert prescription medicines to OTC products will be enhanced by Chattem’s sales, marketing and distribution channels.”
 
Sanofi’s offered Chattem $93.50 per share, a 34% premium. The companies said the transaction should close in Q1, 2010. The deal would make Sanofi the fifth-largest consumer healthcare company in the world as measured by product revenues.
 
Sanofi was notably acquisitive in 2009. In addition to the purchase of Laboratoire Oenobiol, it bought BiPar Sciences and Fovea Pharmaceuticals, and a majority stake in a Russian insulin maker. Sanofi also acquired rights to an anti-MRSA vaccine produced by Syntiron and formed a research alliance with Cal Tech.

Inhibiting an enzyme known as Sirt1 in a particular region of the brain helps reduce food intake, according to scientists at Brown University. The discovery could open the door to new pharmacologic options for the management of obesity.

Sirt1 is found in many tissues including the liver and pancreas.

Earlier studies had shown that Sirt 1 had a fundamental role in cell differentiation, aging and death.

In these studies, both fasting and the antioxidant compound resveratrol-which is found in red wine–activated Sirt1 in peripheral tissues. This phenomenon was associated with improved exercise capacity, improved glucose control and prolonged survival in rats.

The Brown study, conducted by Eduardo Nillni and colleagues, is the first to study Sirt1 activity in the hypothalamus, a region of the brain known to be associated with appetite. 

Nillni’s team used 2 methods to inhibit hypothalamic Sirt1 activity: pharmacological inhibition and RNA transcription blockade. Both approaches resulted in reduced food intake and weight loss.

The scientists also found that fasting increases hypothalamic expression of the Sirt1 gene, which makes it even more likely that Sirt1 plays a central role in moderating appetite and hunger in mammals.

Nillni now plans to study how obesity affects Sirt1 activity in the brain.

The write-up is in PloS One.

Medicare has stopped paying claims to Miami-based Fernando Mendez-Villamil, MD, until it can figure out whether his prolific prescription writing is legit. The psychiatrist has written 96,685 prescriptions to Medicaid patients over the last 21 months.

That works out to an astonishing clip of 150 prescriptions per day, 7-days per week. It is nearly twice as many as the runner-up prescriber, Huberto Merayo, whose office is just a few blocks from the Prescription King.

In fact, the top 7 prescribers of mental-health drugs in the state all reside in the Miami-Dade area.

According to the Miami Herald, Miami-Dade is at or near the top, depending on the measure, of the most expensive places to get health care in the nation.

“While the state is investigating, we haven’t paid his claims,” Medicare spokesman Peter Ashkenaz told the Herald. Apparently, Medicare cut off the spigot last May.

The story hit the press after Charles Grassley, a Republican Senator from Iowa released a letter he had written to Medicare and Medicaid officials in which he inquired about their procedures for detecting over-utilization of medical services. The letter didn’t mention Mendez-Villamil by name, but did cite the number of prescriptions he had written.

The Herald used the astronomical number to trace the allegation back to Mendez-Villamil.

The psychiatrist told The Herald that he prescribes only drugs that are medically necessary, that he works long hours, averages 10 minutes per patient visit, and many of his patients are taking 4 or 5 drugs.

Grassley’s letter, it should be noted, concerned only Medicaid prescriptions. No one seems to know how many scripts the prolific psychiatrist penned for patients covered by Medicare.

It’s been a week since Google announced its Gmail systems had been breached by cyber criminals based in China, but the scope of the attack is just now being appreciated.

It looks as though the attack was part of a large corporate and political phishing ploy that leveraged security flaws in e-mail attachments to break into the networks of at least 34 companies including  Yahoo, Symantec, Rackspace, Adobe and Northrop Grumman.

According to Google, the hackers accessed the Gmail accounts of Chinese human rights advocates around the world, as well as other human rights groups that shape the national debate on human rights in China.
 
Google has threatened to retaliate by pulling out of China altogether.

The attacks were more sophisticated than their predecessors, according to security experts, in that they simultaneously exploited flaws in many software programs.

“Usually it’s a group using one type of malicious code per target,” Eli Jellenc told the Washington Post. Jellenc, the head of international cyber-intelligence for VeriSign’s iDefense Labs, added that “in this case, they’re using multiple types against multiple targets. That’s a marked leap in coordination.”

The standoff between Google and China creates a headache for federal officials, since it cuts to the heart of many current issues in U.S.-China relations: from human rights and censorship to intellectual property protection and access to military technology.

Since it entered the Chinese market in 2005, Google has clashed with the Chinese government about which search topics should be censored. The company’s service has been blocked when it defied government wishes.

News about Google’s public rebuke was censored in China, other than an op-ed piece in People’s Daily which called the search giant a “spoiled child” and predicted it would eventually back-off its threats.

The health reform “debate” (such as it is) has highlighted our nation’s PCP shortage, but there’s another area where the demand for MD-level services outstrips supply: pediatricians trained in sub-specialties like gastroenterology, rheumatology, and developmental -behavioral medicine.

NACHRI, the National Association of Children’s Hospitals and Related Institutions recently briefed Congress on the matter, in an attempt to favorably influence the “debate.” 

A recent survey of its members, NACHRI officials said, revealed widespread shortages in multiple pediatric specialties which have forced 90% of member’s facilities to delay appointments.

What is more, members reported that vacancies for specialty pediatricians often remained unfilled for more than a year. The most severe shortages are in cardiology, oncology, hematology and developmental-behavioral medicine.

The latter shortage is of particular concern in light of the recent spike in autism-related disorders. Half the members in the survey reported delays of more than 3 months before getting to see a developmental specialist as a result.

Part of the explanation for the shortage is the woefully inadequate compensation these specialists receive. It amounts to just more than half the haul raked in by their counterparts in adult care.

In this regard, a provision in the House bill which requires Medicaid to pay Medicare rates for office visits would really help, NACRI officials say. NACHRI is also lobbying for increased funding for specialty training and a loan-forgiveness program.

In Pediatrics, specialization requires 2 to 3 years of training after the general pediatrics residency is completed. 

“While most of us are driven into this profession because we love kids, the vast majority leave training with huge debt and the prospect of not making very much money at the end,” John McBride told the Wall Street Journal. McBride is a pediatric pulmonologist at Akron’s Children’s Hospital Medical Center.

Pfizer, the world’s largest drugmaker, has announced plans to pursue aggressive sales growth and market-share targets in China. In doing so, it hopes to take advantage of the nation’s unmet needs for health care which have been prompted by an economic boom and an associated increase in diabetes and hypertension.

In a recent interview with the Wall Street Journal, Pfizer’s Regional President of North Asia Allan Gabor said the company wants to increase sales in China by 25% per year.

“When you look at where we are in China today, even though our growth rate is high, the market share is relatively low. And that’s a function of … the nature of the competition here, and the fact that patent law wasn’t really established until 1993,” Gabor told the Journal.

Pfizer is well positioned in the cardiovascular disease market with the blockbusters Lipitor (for cholesterol) and Norvasc (for high blood pressure). Last month, Pfizer rounded out this portfolio by announcing a deal to help Takeda Pharmaceuticals market Actos, a drug for type 2 diabetes, in China.

Pfizer is already the largest foreign pharmaceutical company on the mainland, yet it controls only 2% of the market. The Chinese pharmaceutical market is remarkably fragmented, with thousands of local players in the mix.

The market for pharmaceuticals in China rose 27% last year, and most forecasters believe it will grow by at least 20% per year in the foreseeable future.

Pfizer’s recent acquisition of Wyeth will help. The latter’s pneumococcal vaccine, Prevnar, was “one of the most successful product launches in China history,” Gabor said. Wyeth also adds the popular vitamin supplement Centrum, and baby formula which became popular after last year’s melamine scare.

Pfizer’s move comes about 2 months after Swiss pharmaceutical giant Novartis announced it will invest $1 billion into an R&D facility in Shanghai.

People who look younger than their actual age have a longer life expectancy than those who look their age, according to Danish scientists.

To reach this conclusion, Kaare Christensen of the University of Southern Denmark and colleagues asked nurses, teachers-in-training and peers to guess the age of 1,826 pairs of twins from their photos.

The twins were at least 70 years old when they were photographed.
 
For all 3 assessor groups, perceived age of the twins was associated with their survival, even after adjustment for chronological age, gender, pre-existing medical conditions, cognitive abilities and socioeconomic status.

Furthermore, the bigger the difference in perceived age within the pair, the more likely it became that the older looking twin died first.

The authors even provided a possible physiological explanation for their finding: key pieces of cellular DNA known as telomeres, which predict the ability of cells to replicate, were also linked to perceived age, the group found.

Shorter telomeres are associated with more rapid ageing, and the scientists found that people who looked younger had longer telomeres.

Christensen suggested to the BBC that people who have had a tougher life are more likely to die early – and that their life is reflected in their face.

“It’s probably a combination of genes plus environment over a lifetime that are important,” said UK professor Tim Spector, who has been doing similar research on twins. “We are also finding this in our study.”

The write-up is in the British Medical Journal.

The radiation produced by CT scans performed in 2007 will cause 29,000 cancers and kill 14,500 Americans, according to a study published in the Archives of Internal Medicine. 

To reach this conclusion, Amy Berrington de Gonzalez and colleagues from the National Cancer Institute used a computer simulation to estimate the impact of the 70 million or so CT scans that were performed in the US that year (only 3 million were performed in 1980).

The scientists estimated that about a third of the future cancers will occur in people who were between the ages of 35 and 54 when they received their CT, and 15% of them will develop in people who were children or teens when the scan was performed.

About two-thirds of the new cancers will develop in women, since they are more vulnerable to radiation.

“There is a significant amount of radiation with these CT scans, more than what we thought, and there is a significant number of cancers,” Rita Redberg, the editor of the Archives of Internal Medicine, told the LA Times.

“While certainly some of the scans are incredibly important and life saving, it is also certain that some of them were not necessary,” Redberg added.

CT scans provide pristine images by combining data from multiple x-ray images. They can also expose patients to up to 400 times more DNA-damaging radiation than conventional chest x-rays. 

In another study, Rebecca Smith-Bindman and colleagues from UCSF found that radiation exposure varies almost 13-fold for different kinds of CT studies, from about 2 millisieverts for a routine head CT scan to 31 millisieverts for a scan of the abdomen and pelvis.

The average American receives about 3 millisieverts of radiation per year, a level not considered to be a health risk.

Drug induced increases in levels of the brain neurotransmitter norepinephrine can overcome memory problems and improve cognitive development in mice with genetically-engineered Down syndrome, according to scientists at Stanford.

Ahmad Salehi and colleagues postulate that similar interventions, if applied early enough in children with Down syndrome, might improve their cognitive development as well.
 
Their write-up appears in Science Translational Medicine.

In the article, Salehi’s group showed that drugs which enhanced norepinephrine signaling in the brains of the genetically engineered mice rapidly restored cognitive function, enabling them to handle simple challenges like building a nest.

The treated mice could make nests as well as normal mice. Untreated mice were unable to do so. The beneficial effects became apparent just hours after treatment was initiated. They waned quickly following discontinuation of the drugs.
 
Salehi’s genetically-engineered mice exhibited early degeneration of the locus ceruleus, a part of the brain that supplies norepinephrine to the hippocampus, which is involved with memory formation. The same findings have been demonstrated in humans with Down syndrome.

Several drugs that have been approved by the FDA for treatment of depression and ADHD have the same effects on brain norepinephrine levels as those used in the Stanford study. Because these drugs have proven to be safe in humans (though not infants), Salehi told BurrillReport he hoped his results would quickly lead to human trials.
 
Previous efforts to modify the course of Down syndrome with drugs have focused on acetylcholine, a separate neurotransmitter that also acts on the hippocampus.

Employees of Xe Services, formerly known as Blackwater Worldwide occasionally operated alongside CIA and Special Forces operatives during missions to kill or capture members of al-Qaeda and other undesirables in Iraq and Afghanistan, former government officials have told the Washington Post.

Such behavior would exceed the protective role assigned to Blackwater in a contract with the CIA, the sources said.

The missions were approved and planned by CIA officials. But when it came time came to carry out those raids, local CIA operatives delegated responsibilities to available personnel regardless of whether they were contractors or federal employees.

A former CIA official with experience in Middle East covert operations confirmed that such decisions would be “practical…there was no bench strength with either the CIA or Special Forces, so sometimes they would turn to contractors, who often had the same skills,” he told the Post.

Former CIA officer Robert Baer said that such arrangements would short-circuit normal chains of command that CIA and military personnel must abide by. “Once you cede your authorities, people are no longer restrained by regulations and federal law,” Baer said. 

Earlier this year, CIA Director Leon Panetta terminated several contracts with Blackwater, but the agency still relies on the firm to provide security for agency employees and assets.

Former Washington-based CIA counterterrorism officials said CIA headquarters was not aware of such actions. They confirmed that Blackwater employees engaged in firefights while protecting CIA officers undertaking lethal raids, but characterized these actions as defensive, not offensive.

Currently, 5 Blackwater guards are standing trial in federal court on manslaughter and other charges stemming from the killing of 14 Iraqi civilians in Baghdad in September, 2007. In a separate civil case, 70 Iraqi civilians are alleging that Blackwater engaged in “lawless behavior” and covered up killings.

Executives from Google, the Washington Post and New York Times have announced a new partnership to create living story pages, tools which they believe might revolutionize the way people find news on line.

The concept is to group developing stories about a particular subject on one Web page which automatically updates when new content is added.

“So much of what you see online today is a reflection of the way it’s told in newspapers,” Josh Cohen, senior business product manager for Google News told Post media critic Howard Kurtz. “They haven’t taken advantage of what the Web offers to tell news in a different way.”

The Post and Times could conceivably boost their rankings on Google by grouping stories in this manner. This could increase the likelihood that people will click on their stories, and that might translate into increased revenue for the beleaguered print giants.

The Times has established 5 living story pages covering Afghanistan, executive compensation, global warming, health care and swine flu. Meanwhile, The Post has launched 3, devoted to DC schools, health-care reform, and the moribund Washington Redskins.

The experimental story pages currently reside at Google Labs as the parties work out the kinks. The goal is to transfer the pages to the Web sites of the newspapers themselves.

“Over the coming months, we’ll refine Living Stories based on your feedback,” Google says in a blog posting. If the format gains traction, Google plans to offer it to any interested newspaper, magazine or Web site, at no charge.

Kurtz reports that the living story page concept grew from discussions last spring involving Google CEO Eric Schmidt and Donald Graham, CEO of The Washington Post Co. Later, Google began separate conversations with executives at the Times.

As scientists race to create an AIDS/HIV vaccine, few have asked whether people can be persuaded to take the jab in the event it someday becomes available.

To assess HIV vaccine acceptability among high-risk adults, Peter Newman and colleagues from the University of Toronto interviewed 1,164 adults that have visited sexually transmitted disease clinics, needle/syringe exchange programs, and community health/HIV prevention programs in Los Angeles.

During the interviews, participants were asked to rate the acceptability of eight hypothetical vaccines, which varied in their effectiveness, cost and side effect profile, and to discuss how each one would impact their use of condoms after receiving the vaccine.

The scientists found that many high-risk individuals would not accept the vaccine, no matter what its characteristics were. Vaccine effectiveness turned out to be the attribute most likely to drive vaccine acceptance, followed by side effects and out-of-pocket cost.

The scientists also found that nearly 10% of the at-risk adults in the study might be more prone to engage in unprotected sex after they were vaccinated. This is critical since initial HIV vaccines are probably going to be only partially effective in preventing HIV infection.
 
“Merely having a vaccine available doesn’t mean it gets to the people who need it—a fact that is evidenced by the issues we’re seeing now around H1N1 vaccines,” Newman told BurrillReport. “If we want HIV vaccines to be acceptable and accessible to people, we need to consider all of these factors before we have a safe and relatively effective vaccine on the market.”

Newman added that educational programs built to support any future HIV/AIDs vaccine would have to explain in lay terms how it worked and what scientists mean when talking about the efficacy of a vaccine.