Archive for February, 2010

Internet Drugs for Erectile Dysfunction

February 26th, 2010 | No Comments | Source: 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 | No Comments | Source: Wall Street Journal

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.



PhRMA Chief gets the Gold Watch

February 24th, 2010 | No Comments | Source: Wall Street Journal

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.



FDA Changes Course on BPA

February 23rd, 2010 | No Comments | Source: Washington Post

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.



Is Marijuana a Drug or a Medicine?

February 22nd, 2010 | No Comments | Source: Wall Street Journal

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.



China: Regenerative Medicine Power

February 19th, 2010 | No Comments | Source: BurrillReport, Regenerative Medicine

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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The Rise of Wives

February 18th, 2010 | No Comments | Source: Pew Research Center, Washington Post

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

I'mbuyingdolcegabannaTo 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.



Google-NSA Deal on Cybersecurity?

February 17th, 2010 | No Comments | Source: Washington Post

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.

offwiththeirheadsGoogle 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.


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Judge Rebukes FDA on e-Cigarettes

February 16th, 2010 | No Comments | Source: NY Times

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.

StickitJudge 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.


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TV Watching: It’s worse than you think

February 12th, 2010 | 1 Comment | Source: Circulation, Wall Street Journal

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.

notanotherlenorerunTo 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.



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