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.

To 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.”

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.

Overall, 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.

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.

Last 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.

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.

BPA 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.

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.

But 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.

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.

The 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.”

More women than ever are better-educated than their husbands and in nearly 20% of marriages, they earn more than their husbands, according to a report released last week by the Pew Research Center. 

To reach these conclusions, Richard Fry and colleagues examined Census Bureau data for US-born married couples between the ages of 30 and 44, an age group that was the first ever to feature more women with college degrees than men.

The Pew study revealed that men nowadays tend to get an economic boost when they marry someone with as much or more education than they have. 

“Marriage now is a better deal for men,” Fry told the Washington Post. “Now when men marry, often their spouse works quite a bit. Often she is better-educated than the guy.”

According to the report, more than half of all married couples nowadays feature spouses with nearly equal levels of education. In 28% of all marriages, the wife had more education, whereas in 19% the man had more.

Even so, 78% of married men make more money than their wives, although the gap is narrowing.  In 1970 for example, 96% of married men earned more than their spouses.

This income gap is narrowing across all economic strata. For example, in 1970, 4% of male high-school grads had wives that earned more money than they did. That number is now 24%. The numbers are nearly identical for those with “some college” education. For male college graduates, 3% had wives that earned more than they did in 1970. That number is now up to 18%.

Currently, the median income for men is about $46,000, about 30% higher than the median income of women. Back in 1970, men’s incomes were twice that of women’s.

Last month, Google announced that its systems were subjected to coordinated cyberattacks beginning in December. The intrusions probably originated in China. They targeted Google source code and more than 30 other defense, tech and financial companies as well. The Gmail accounts of human rights activists on 3 continents were compromised.

Google threatened to retaliate against the Chinese government, but has yet to take action.

Now, according to Washington Post sources, Google has approached the National Security Agency for help defending itself and its users from similar attacks in the future.

Terms of any possible deal between Google and the NSA have not been finalized, but they would likely cover a review of possible vulnerabilities in Google’s hardware and software and the hacking techniques used during last month’s attack.

If the deal were consummated, Google says it will not disclose information regarding what was stolen and will not violate company policies or laws designed to protect the privacy of US citizens’ online communications. In any deal, the NSA will not become privy to users’ searches or e-mail accounts.

Cyberspace cannot be protected, Director of National Intelligence Dennis Blair told the Post, without a “collaborative effort that incorporates both the U.S. private sector and our international partners.”

The Google-NSA deal worries privacy advocates, who remember all too well the NSA’s warrantless wiretapping of Americans’ phone calls and e-mails in the aftermath of the Sept. 11, 2001 terrorist attacks.

A federal judge has told the FDA to quit blocking the importation of electronic cigarettes from China and ruled the devices should be regulated like tobacco products rather than as drugs or medical devices.

Judge Richard Leon of Federal District Court in Washington issued the order in a lawsuit brought by e-cigarette distributors.

e-Cigarettes are battery-powered tubes that heat liquid nicotine into a vapor which is subsequently inhaled. The devices also add ingredients that give the vapor a taste and smell just like cigarette smoke.

According to e-cigarette distributors, the inhaled mix does not contain cancer-causing chemicals. The FDA argues they have not been proven safe.

Judge Leon ruled that last year’s tobacco legislation gave the FDA power to regulate the contents and marketing claims of e-cigarettes just like traditional tobacco products, but not to ban them.

The FDA released a statement in response: “The public health issues surrounding electronic cigarettes are of serious concern to the FDA. The agency is reviewing Judge Leon’s opinion and will decide the appropriate action to take.”

Ray Story, a VP at Smoking Everywhere, the plaintiff in the suit, claimed the ruling was a victory for people who want a safer cigarette. “The public will have a less harmful alternative to tobacco products,” Story said. “Wherever they’re sold, we are going to be sold.”

Matthew Myers, president of the antismoking advocacy group Campaign for Tobacco-Free Kids, decried the ruling. “These products could serve as a pathway to nicotine addiction for children,” Meyers told the New York Times.

People have estimated e-cigarettes could grow to become a $100 million business nationwide. Traditional cigarette makers are not involved in the e-cigarette business.

Australian scientists have found a correlation between the time spent watching TV and all cause mortality. What is more, the relation holds even among people who exercise regularly. The problem, it seems, is prolonged inactivity.

To reach this surprising conclusion, David Dunstan of Melbourne’s Baker Heart and Diabetes Institute followed 8,800 people who were at least 50 years of age for 6 years. 284 of them died during the study, including 125 from cancer and 87 from cardiovascular disease.

Dunstan found that all cause mortality risk increased by 11% for each hour watching TV per day. The findings held up after adjustments were made for exercise duration, gender, age and waist circumference.

People who watched TV at least 4 hours per day were 46% more likely to die of any cause and 80% more likely to die of cardiovascular disease than those who watched 2 hours per day or less.

“It’s not the sweaty type of exercise we’re losing,” Dunstan told the Wall Street Journal. “It’s the incidental moving around…utilizing muscles that [doesn't happen] when we’re plunked on a couch in front of a television.”

The findings likely apply to other sedentary activities like sitting in front of a computer, driving or reading.

“The implication of these findings is that the extraordinary amount of sitting can undo the good effects that we know are a benefit when we get regular exercise,” Dunstan told the Journal.

A recent study by Neilson Co. found that Americans watch 5 hours of TV per day, on average.

Simple strategies to combat the problem include incorporating household chores like folding laundry into TV-time or (god forbid) getting up to change a TV channel rather than using a clicker.

The article appears in Circulation.

Many people know that regular physical activity can reduce perceived stress, blood pressure, LDL (bad) cholesterol levels and the risk of Type 2 diabetes.

It turns out there are many more benefits than that.

For example, regular exercise can increase the body’s capacity to prevent viral and bacterial infections, and boost the body’s response to the influenza vaccine, making it more effective.

 It probably reduces cancer risk as well.

David Nieman, of Appalachian State University has published several randomized trials showing for example that people who walk briskly for 45 minutes, 5 days per week have fewer and less severe upper respiratory tract infections, and 25-50% fewer sick days than sedentary controls.

“No pill or nutritional supplement has the power of near-daily moderate activity in lowering the number of sick days people take,” Nieman told the Wall Street Journal.

Other studies suggest that regular exercise reduces breast cancer risk by 20-30%, and that for patients with hormone-responsive breast cancer, walking for 3-5 hours per week cuts mortality in half.

Still other research shows that exercise retards aging processes like telomere shortening. Telomeres are DNA strands at the tips of chromosomes. When they become too short, cells can’t divide and trigger biochemical processes associated with aging, cancer formation and death.

Two years ago, the Department of Health and Services issued national exercise guidelines for the first time. The guidelines recommend 2 ½ hours per week of moderate aerobic exercise, or 1 ¼ hour per week of vigorous exercise. The guidelines say that additional health benefits accrue to those who double these amounts. They also call for muscle-strengthening activities at least twice per week.

According to the CDC, 36% of US adults undertook no leisure-time physical activity in 2008.

Scientists have made some progress in their effort to develop a vaccine for cocaine addiction. The vaccine is actually a series of injections that trigger an immune response to cocaine. The newly-created antibodies prevent the drug from entering the brain and thus blunt its euphoric effects.

To assess the safety and efficacy of their coke vaccine, Thomas Kosten and colleagues at Baylor randomized 115 cocaine addicts to receive either 5 shots of the vaccine over a 12 week period or a series of similarly timed placebo injections.

They monitored cocaine intake using urinalyses.

Most subjects smoked crack cocaine. Many also used marijuana (18%), alcohol (10%), and narcotics (44%).
 
Among subjects who received all 5 shots, 38% achieved sufficient antibody levels to blunt the effects of the drug. Antibodies remained in the bloodstream for 8-10 weeks after the final stick.

In this subset, 53% of the subjects stopped using cocaine—significantly more than the 23% of subjects who did not produce enough antibodies.

The vaccine was well tolerated, with no treatment-related serious adverse events or deaths.

But the partial success was associated with some risk. Some subjects began snorting massive amounts of the drug in an effort to overcome the vaccine’s effects. Some amassed 10 times the amount in their systems than had been encountered before the trial began.

“After the vaccine, doing cocaine was a very disappointing experience for them,” Kosten told the Washington Post.  “Previous research has shown that a reduction in use is associated with a significant improvement in cocaine abusers’ social functioning and thus is therapeutically meaningful.”

Kosten plans to begin a larger vaccine trial this spring.

About 2.1 million Americans have used cocaine in the last month, studies show. 

The write-up appears in the Archives of General Psychiatry.

The Gräfenberg Spot, or G-Spot is, according to popular culture and a few questionable scientific studies, an elusive erogenous zone located in the anterior vagina. When stimulated, the G-spot can lead to intense sexual arousal and hellacious orgasms that rival or surpass those provoked by clitoral stimulation.

Alas, the latest study on the matter suggests it doesn’t exist.

To reach these conclusions, Tim Spector and colleagues at King’s College London asked 1,800 women whether they had a G-spot, and if so, where it was located. All the women were pairs of identical and non-identical twins.

If a G-spot did exist, both identical twins (who have the same genes) would be expected to report having one in the same place. In fact, the scientists found that identical twins were no more likely to share a G-spot than non-identical twins (who share half their genes).

“This is by far the biggest study ever carried out and shows fairly conclusively that the idea of a G-spot is subjective,” Spector told the BBC.

Colleague Andrea Burri voiced concern that women who couldn’t find a G-spot might feel inadequate. “It is rather irresponsible to claim the existence of an entity that has never been proven and pressurize women and men too,” she said.

Commenting on the study, Petra Boynton, a psychologist at University College London, said “it’s fine to go looking for the G-spot but do not worry if you don’t find it. It should not be the only focus. Everyone is different.”

Sexologist Beverley Whipple, who helped popularize the G-spot concept, argued the study was flawed because the scientists failed to account for the impact of different sexual partners and different love-making techniques.

The write-up is in the Journal of Sexual Medicine.

When a US embassy employee in East Asia clicked on an e-mail attachment in May, 2006, she inadvertently unleashed the largest cyberattack ever launched against the State Department. The breach permitted China-based attackers to insert malicious computer code into the department’s networks throughout the region.

A cyber-threat response team leapt into action and toiled 24/7 for 2 weeks to isolate the code and develop a patch that officials claim prevented a gargantuan breach.

Unfortunately, State is better equipped to handle cyberattacks than other parts of the federal government. And 2 months later, the Bureau of Industry and Security, a part of the Commerce Department that oversees exports of technology that has both commercial and military uses, was attacked in similar fashion.

The attack was not recognized for days and Commerce was never able to determine when the initial intrusion took place (Commerce claims there is no evidence data was compromised as a result).

Commerce and other parts of government are trying to improve their performance in this regard, but their efforts are often stymied by a marked shortage of skilled computer-security workers, from front-line technicians to so called Security Generals. 

Meanwhile, according to the Government Accountability Office, the number of probes, scans and attacks reported to the Homeland Security Department’s Computer Emergency Readiness Team more than tripled between 2006 and 2008, from 5,500 to 16,840.

The manpower shortage is impacting Pentagon efforts to staff-up a new Cyber Command and Homeland Security’s plans to increase it’s cyber-staff by 1,000 people over in the next 3 years.

The intense demand has sparked bidding wars among agencies and contractors for a small pool of special talent: skilled technicians with security clearances. Some young people with 3 years’ experience and a clearance are commanding salaries over $100,000. 

Philip Reitinger, deputy undersecretary of Homeland Security’s National Protection and Programs Directorate, conceded he couldn’t match private sector pay scales. “But in government,” he told the Washington Post, “one can have a bigger ability to effect change at an earlier place in your career than anywhere else.” he said.

Besides, Reitinger added, “your country needs you.”

MannKind Corporation recently accounced that it has encountered a disappointing setback in its efforts to bring Afrezza to market. The FDA, it turns out, wasn’t able to sign-off on the company’s new drug application for the ultra rapid-acting form of inhaled insulin by January 16, the date the FDA had previously set for itself as a deadline for making this decision.

Apparently, the FDA has not completed inspecting the insulin manufacturing facilities of N.V. Organon, a third-party supplier to MannKind.

The FDA “must complete this inspection before it can finalize its review of our NDA,” said Alfred Mann, Chairman and CEO of MannKind. “To our knowledge, all other FDA inspections are complete. There are no pending answers to any FDA questions or other deliverables due on MannKind’s part.”

The FDA did not set a new date for completing the NDA.

Just one week before the FDA’s surprising announcement, Mannkind had suggested that FDA approval was in the bag.

According to Pharmalot, Mann has bet nearly half of his $2 billion fortune on Afrezza. Many competitors have given up on inhaled insulin products since Pfizer’s fiasco with a similar product, Exubera.

Some analysts were skeptical about the prospects for Afrezza in light of the recent surprise. For example, Hapoalim Securities’ Jon LeCroy said, “the fact that there is now no definite time-line for approval (is) a major negative, as drugs that have a missed PDUFA often take months to years to receive a final decision.”

However, Simos Simeonidis at Rodman & Renshaw believes there is a 75% chance the FDA will approve the drug this year.

Afrezza achieves peak insulin levels within 12-14 minutes of administration, which mimics the release of meal-time insulin in healthy individuals.

Running in commercially-available athletic footware puts more stress on the hip, knee and ankle joints than running barefoot, according to a new study. In fact, a good jog in those designer statements puts more stress on your joints than a walk in high-heeled shoes.
 
To determine the effect of modern-day running shoes on lower extremity joint torques during running, D. Casey Kerrigan and colleagues from JKM Technologies and the University of Virginia recruited 68 healthy young adult runners (37 women) that used commercially-available running shoes.
Subjects had no history of musculoskeletal injury and ran at least 15 miles per week.

Running shoes with typical design characteristics were provided to all subjects. The subjects ran barefoot and with the shoes. Running speed was controlled by the scientists.

Kerrigan’s team analyzed their subjects’ strides using three-dimensional motion capture and ground reaction force with a tricked-out treadmill.
 
The team found that running shoes increased joint torques at the hip, knee and ankle compared with bare feet. In fact, the shoes were associated with a 54% increase in hip internal rotation torque, a 36% increase in knee flexion torque, and a 38% increase in knee varus torque.

The team also found that running shoes caused pronounced stress at anatomical sites of the knee that are prone to the development of osteoarthritis.

They speculated that their findings were caused by the elevated heel and the padding under the medial arch which are typical of modern running shoes. They also acknowledge that running shoes provide good support and protection for the foot itself.

Reducing joint torques with footwear to that of barefoot running, while providing meaningful footwear functions should be the goal of new footwear designs,” the authors wrote.

The write-up appears in PM&R.