The American Hospital Association has urged constituents to oppose a proposal by the Senate Finance Committee that would require hospitals to provide “a minimum annual level of charitable care” in order to obtain or keep their tax-exempt status as charitable organizations.

The proposal would prevent tax-exempt hospitals from refusing service to those unable to pay for it, and require them to follow specific procedures before initiating collection activities against patients.

Hospitals found to violate the rule could lose their tax-exempt status or be slapped with excise taxes by the government.

Currently non-profit hospitals pay no federal income tax, and can access government-issued tax-exempt bonds. They can also receive tax-deductible contributions. The Congressional Joint Committee on Taxation believes these tax breaks are worth more than $6 billion per year.

“Ask your senators to oppose the charity care proposal,” read the bold type in an AHA bulletin released last week.

“A formulaic, one-size-fits-all charity care standard will hamstring hospitals’ efforts to respond to the unique needs of their communities,” it continued.

“It would penalize children’s, teaching and research hospitals and those in rural areas because they provide community benefit in a variety of forms other than just charity care.”

The new standards were floated by Finance Committee chairman, Max Baucus, a Montana Democrat, and Iowa’s Charles Grassley, the senior-ranking Republican on the Committee.

Mr. Grassley reasoned that hospitals received “a tremendous advantage” from their tax-exempt status, but don’t always provide enough charity care to justify it.

Grassley, for the life of him, couldn’t see why the AHA was raising such a ruckus on the matter. “If, as a result of health care reform, everyone has health insurance, presumably hospitals should see a steep decline or the elimination of uncompensated care,” Grassley reasoned to the New York Times.

Six weeks after Sanofi-Aventis coughed up $500 million for a company with 18 employees, the deal already smells like roses.

When Sanofi reeled in San Francisco-based BiPar Sciences, the prize was an investigational drug known as BSI-201, the furthest along of a new breed of cancer fighters known as PARP inhibitors.

That drug—it was revealed at the recently concluded meetings of the American Society of Clinical Oncology—prolonged survival in women with a particularly nasty form of breast cancer by 61%, to 9.2 months, when added to standard chemotherapy.

That result was hailed as “a huge bombshell” by Powel Brown, director of Baylor’s Breast Center. He predicted the FDA would approve the drug within 2 years.

In commenting on Paris-based Sanofi’s shrewd acquisition, Chief Executive Officer Chris Viehbacher told Bloomberg, “the size of teams and the size of their budget do not correlate to research and development success.”

After chemotherapy or radiation damages the DNA of cancer cells, they typically mobilize PARP enzymes to repair the damage. PARP inhibitors block these enzymes, thereby enhancing the efficacy of the initial treatment.

The ASCO study focused on 116 patients with triple-negative breast cancer, an aggressive form of the disease that is usually unresponsive to treatment because it lacks all 3 genetic targets which have become the focus of modern treatments. About 15% of breast cancer cases are triple-negative.

Nearly 60% of the patients randomized to receive BSI-201 experienced tumor shrinkage or at least slowed progression. That was 3 times more than those receiving standard chemotherapy.
 
Sanofi ‘s next step is to begin a larger trial designed to confirm the findings. That could be completed within a year and then, assuming results hold, they’re off to see the wizards at FDA.

A panel of experts has recommended that the FDA should ban the prescription painkillers Vicodin and Percocet, and that the “safe maximal” dose of Tylenol be reduced significantly.

The panel voted 20 to 17 to ban on the 2 narcotic-acetaminophen combo drugs.

It also recommended that extra-strength Tylenol be made available by prescription only, and that dosing recommendations for children’s Tylenol be reexamined.

The problem with all of them, according to the panel, is acetaminophen, which has long-since been linked to liver damage.

The group recommended that the FDA “send a clear message that there’s a high likelihood of overdose from prescription narcotics and acetaminophen products,” Sandra Kweder of the FDA’s Office of New Drugs said at a press conference.

Acetaminophen overdoses prompted 56,000 emergency room visits, 26,000 hospitalizations and 458 deaths in the 1990s, the FDA reported.  It is also, according to the CDC, by far the most common cause of acute liver failure, which strikes about 1,600 people each year.

Acetaminophen is also found in NyQuil, Pamprin, Allerest and dozens of other OTC remedies for colds and flu, headache, menstrual symptoms, allergies, insomnia, arthritis and other minor ailments.

The panel decided against recommending a ban on OTC drugs containing acetaminophen, since they cause less than 10% of all overdoses with this drug.

Abbott Laboratory’s Vicodin and its generic congeners are the most frequently prescribed drugs in the US, according to IMS Health. Nearly 124 million prescriptions were written for the juice last year alone.

The FDA is not required to follow the recommendations of its panels, though it usually does.

Research suggests that violent video games promote aggressive thoughts, and probably, violence itself. The thing is, not all video games are violent. In fact some actually reward socially constructive behavior like sharing things or saving the planet.

Could these so-called “pro-social” video games foster salutary behavior in players?

Two recent studies suggest the answer might be yes.

In the first, Iowa State’s Douglas Gentile, a noted video-game researcher, and his colleagues asked 161 students to play one of 6 games for 20 minutes. Some were assigned Ty2 or Crash Twinsanity, which feature wall-to-wall violence.

Others were told to play Chibi-Rob!, in which players help video characters with chores, or Super Mario Sunshine, in which participants erase graffiti and eliminate pollution. A control group got to play neutral maze games like Pure Pinball and Super Monkey Ball Deluxe.

After the session, the scientists asked participants to select from a smorgasbord of easy, medium and hard puzzles that a partner would complete, and told them the partner would receive a gift upon their successful completion.

Students assigned to the pro-social games were more likely to select easy puzzles for the partner, while those assigned violent games selected the more difficult puzzles.

In the second experiment, Tobias Greitemeyer and colleagues from the University of Sussex asked 46 students to play either Lemmings, a pro-social game, or Tetris, a neutral control.

After the session, the scientists asked students to complete story lines such as what happens after a driver nearly collides with a bicyclist. Lemmings players proposed endings characterized by fewer aggressive thoughts, responses and actions than Tetris players.

Alas, the medium is rarely the message. Both write-ups will be published in the Journal of Experimental Social Psychology.

The number of Americans that adhere to a healthy lifestyle has plummeted 46% in the last 20 years, according to scientists at the Medical University of South Carolina. 

Just 8% of adults between the ages of 40-74 practice all 5 of the following behaviors: exercising, eating fruits and vegetables, maintaining a healthy weight, drinking alcohol in moderation and not smoking.

That number was 15% in 1988, according to Dana King and colleagues, who published the distressing findings in the American Journal of Medicine.

“These findings should provide new motivation for an increasing commitment to promoting healthy lifestyles for the public good,” the researchers told MedPageToday.

To reach their conclusions, the scientists pulled data from the National Health and Nutrition Examination Survey (NHANES), which uses self-reported data on such behavior.

Over the 18 year study period, the percentage of adults classified as obese, which is to say having a BMI of 30 or above, rose from 28% to 36%.

The proportion adults that exercised at least 12 times per month dropped from 53% to 43% while those eating 5 daily servings of fruits and vegetables dropped from a hard-to-believe 42% to 26%.

Smoking rates remained at 26.5%.

Non-Hispanic whites exhibited the steepest declines in overall healthy behaviors, and those with cardiovascular disease, high blood pressure and diabetes were not more likely than others to adhere to recommendations for a healthy lifestyle.

The scientists suggested that increased reliance on cars as well as changes in attitudes about the importance of diet and exercise might be driving the numbers.

Health care costs will surely continue upward and hard-earned gains in longevity will be reversed ”if middle-aged adults do not increasingly adopt a healthy lifestyle as the primary approach to prevention and treatment of hypertension, diabetes, and hyperlipidemia,” they warned.

There once was a time when college students asked classmates or TAs for help when it came time to prepare for exams.

Now it seems, these tried and true resources have been replaced by Web sites which offer answers to textbook problems, copies of old exams, lecture notes, and on-line help from paid experts among other things.

“Many professors won’t tell you how you got (something) wrong — just that it’s wrong. This way you complete the feedback process, which is essential to learning,” Columbia sophomore Chris O’Connor explained to the New York Times.

On Course Hero for example, students can access 3 million student-submitted items from 400,000 courses at more than 3,500 schools, including study guides, lecture notes, lab results, presentations, essays, research papers, and homework assignments.

Those who submit the goods can navigate Course Hero for free. Everyone else forks over a monthly fee. The site has several hundred thousand users.

On Cramster, 500,000 visitors have sought answers to science and math textbook problems. Answers to odd-numbered problems are free, but for those particularly tricky even-numbered problems, students must pay $9.95 per month.

Advocates for the Web sites, which include some professors, argue that many documents housed on the sites have been accessible to fraternity and sorority members since Animal House.

David Sachs, an associate dean at Pace University who has joined Cramster’s advisory panel, argues that “if Cramster and all these companies disappeared tomorrow, you could still do a Google search and find what you’re looking for in 5 minutes.”

And William Kinney, a Physics professor at SUNY Buffalo believes the system is “self-policing.” “If the students just copy down answers to the homework, they will not do well on the exam,” he told the Times.

Studies from Germany, Sweden and Scotland, published last Friday in Diabetologia, suggest a “possible link” between the use of Lantus insulin and cancer.

The findings prompted the European Association for the Study of Diabetes to make an urgent call for additional research into the association.

The EASD added that patients who are presently taking the relatively new, synthetic insulin should continue to do so, although some might wish to consider alternative types of insulin.

Human insulin, the older form of the hormone, has been used for decades. Its safety is beyond doubt, according to the EASD. Lantus has been used widely, but only since 2000.

The German study looked at an insurance database containing information regarding 127,000 insulin-treated patients. Scientists found that patients who had used Lantus were more likely to be diagnosed with cancer, and the effect was dose-dependent.

Thus, in patients receiving a dose of 10u, patients taking Lantus had cancer rates that were 9% higher than those taking human insulin. For those receiving 50u, the increased risk associated with Lantus was 31%.
 
Diabetologia editor Edwin Gale and EASD president Ulf Smith had become aware of the German findings awhile ago, according to an EASD press release. They decided to seek confirmatory evidence prior to announcing them formally.

As a result, similar database-driven studies were carried out in Sweden, Scotland, and the UK.

The Swedish study showed that patients taking Lantus insulin alone had twice the risk of breast cancer. The Scottish study revealed a statistically insignificant increased risk for breast cancer. The UK study was entirely negative.

Gale and Smith, in their press release, emphasize that all the studies have important methodological limitations.

In particular, patients taking Lantus insulin tended to be older, more obese and to have higher blood pressure than those receiving other forms of insulin. These pre-treatment differences could by themselves explain any differences in cancer rates between the groups. Read the rest of this entry »

Things aren’t so good these days in Sergiyev Posad, the small town in northeastern Russia that is generally considered to be the birthplace of the matryoshka, the iconic nesting dolls that represent Russian folk culture and a simpler time, generally.

The wooden, black lacquered dolls that come in sets with each one fitting just so inside the next have become an endangered species, squeezed as they have been off vendors’ shelves by cheap plastic knock-offs from Asia and now threatened by the global economic slowdown.

The dolls are produced by hand in small factories or in  workshops by artisans that have spent years learning to use a lathe.

“The matryoshka is our face” to the world, Galina Subbota, the town’s deputy mayor told the Washington Post. “Even if it is not economically profitable, we can’t allow it to disappear from our lives.”

But in the setting of the Great Economic Crisis, souvenir shops have slashed orders and the tourists have all but vanished. Recently, nesting doll producers approached Moscow for financial aid which is necessary, they say, to save the industry from extinction.

In response, the Kremlin pledged to buy nearly $30 million worth of the dolls and began requiring  officials to distribute them as gifts.

But the artisans view the largesse with skepticism and have indicated they would prefer that Moscow cut export taxes and make it easier for them to obtain existing subsidies.

“For 12 years, I’ve heard the government talking about support for folk crafts,” Oleg Korotkov told the Post. The director of Semyonovskaya Painting, a nesting doll manufacturer that has seen sales drop more than 90% added, “unfortunately, there’s never any real help.”

Chinese officials have announced that beginning on July 1, all computers sold there must include government-designed software that blocks pornography.

OK fine, but a few Internet savants smelled a rat and set out to test the so-called Green Dam-Youth Escort software.

Their conclusion: Green Dam also censors religious and anti-government Web sites, disables programs after people input certain words, monitors personal communications, and tracks the Internet explorations of Chinese citizens, according to the Wall Street Journal’s Gordon Krovitz.

China is in effect asking computer makers to help block access to information and punish citizens if they visit unsavory sites or express themselves freely online.

Green Dam, dubbed derisively by its own citizens as the “Great Firewall of China,” has also been found to close computer applications without warning and create serious security problems.

So far Dell, HP, Apple and Lenovo—whose biggest shareholder is China’s government—have tread lightly around the subject, allowing their trade associations to gently press the matter with Beijing.

But now, US Trade Representative Ron Kirk and Commerce Secretary Gary Locke have begun quietly pressuring China to shelve the program altogether. They claim the program may violate commitments that China made to the World Trade Organization.

In letters to 2 Chinese ministries yesterday, the US officials said, “China is putting companies at an untenable position by requiring them, with virtually no public notice, to pre-install software that appears to have broad-based censorship implications and network security issues.”

The letters encouraged China to seek ways to promote parental control without restricting freedom to roam the Internet, freedom of expression and the free flow of information, according to the Washington Post.

Since forever, the Big O has argued that comprehensive health reform was a prerequisite to revivifying the nation’s flagging economy.

Last week, his argument got support from a report by the Council of Economic Advisors, which claimed that cutting annual growth in health-care spending from 6% to 4.5% could create 500,000 jobs per year and increase annual family income by $2,600 over the next decade.

Alas, the report lacked details regarding how such goals would be met, and failed to mention the extra dollar or two in government spending that would be needed to jump-start the process.

The report also acknowledged that the 25% reduction in the rate of growth in spending was “near the upper bound of what is feasible.”

Republicans and independent analysts were deeply critical of the report, decrying in particular the assumption that a broad expansion of health insurance could translate into long-term savings for the government and the economy as a whole.

“This report is nothing more than smoke and mirrors,” seethed House Minority Leader John Boehner to the Washington Post. “The administration hasn’t offered a credible plan to (cut costs) without raising taxes or rationing care.”

Nevertheless, the Unflappable One pushed onward, releasing the contents of a letter from a consortium of industry stakeholders that promised to help save money over the next decade. 

In it, American Hospital Association pledged to fight nosocomial infections and readmissions. The AMA said it would coax physicians to follow evidence-based guidelines for back pain, heart disease and prenatal care. Big Pharma said that starting drugs earlier in the course of certain illnesses could reduce the need for more costly interventions later on.

One can only wonder why these obviously good ideas weren’t implemented long ago.

This post first appeared on the Practice Fusion Blog.

During Tuesday’s press frolic, the Big O put some mustard on his pitch for a public option, dismissing as “not logical” suggestions that a government plan would sink Big Insurance faster than the Titanic.

He followed quickly with a favorite refrain, which is that good, old-fashioned competition from a public plan would be an “important tool to discipline insurance companies.”

Then, in a denouement worthy of at least runner up at a Harvard Law Debate Club, he triple-dog-dared anyone to come up with a better plan that met his 2 etched-in-stone requirements. “Reform has to control costs and it has to provide relief to people who don’t have health insurance or are underinsured,” he said.

Big Insurance, destined in this match to play Smokin’ Joe to the Big O’s Ali, released a wild haymaker of its own 2 hours before the Big O even showed up.

“We do not believe it is possible to create a government plan that could operate on a level playing field,” quoth Karen Ignagni, president of America’s Health Insurance Plans, and Scott Serota, president of the Blue Cross and Blue Shield Association in an open letter to the Senate.

“Regardless of how it is initially structured, a government plan would use its built-in advantages to take over the health insurance market,” the letter continued.

No doubt the Big O smirked when he read that.

Meanwhile, Kent Conrad, the intrepid Senator from North Dakota has created a stir with his suggestion that nonprofit consumer-owned cooperatives could be an alternative to the government plan.

He foresees the Feds forking over $3-4 billion to jumpstart the co-ops, after which time they would sink or swim on premiums and investment income, just like Big Insurance.

The Big O knows he can live with this or any approach that covers most everybody without breaking the bank, but on this day he was playing offense.

“If private insurers say that the marketplace provides the best quality health care, if they tell us that they’re offering a good deal, then why is it that the government — which they say can’t run anything — suddenly is going to drive them out of business?” Obama asked.

Mr. Spock himself couldn’t have asked a more logical question.

In 2006, Massachusetts enacted a law requiring that all residents obtain health insurance.

Ever since, developments there have been watched closely since what happens in the state might play out nationally should the Great American Health Care Do-Over include an individual mandate.

Unfortunately, the Bay State’s program has been plagued by unsustainable cost escalations since Day 1, and the situation has been exacerbated recently by recession-related budget shortfalls and rising unemployment.

It was a matter of time before cuts had to be made, and that happened yesterday when state policymakers announced they’re cutting $115 million, or 12% from the budget of Commonwealth Care, a centerpiece of the state’s initiative which subsidizes premiums for poor residents.

The cuts amount to a forced slowdown in Commonwealth Care enrollment. According to the Boston Globe, about 18,000 residents who qualify for subsidies but who have not designated a health plan will no longer be automatically enrolled in program.

Tentative cuts in dental coverage for 92,000 Commonwealth Care enrollees and health insurance for 28,000 legal immigrants have also been proposed, although these proposals  must be approved by governor Deval Patrick.

He has until Monday to decide.

Commonwealth Care currently has 177,000 members. It’s projected to have 212,000 by year end, 2010.

“No decision has been made’’ on the immigrant coverage issue, Leslie Kirwan, Patrick’s secretary of administration and finance told the Globe. “It’s certainly going to be at the top of the list’’ of items Patrick might restore to the budget, she added.

Leaders of Health Care for All, a Bay State consumer group, said the proposal would be tough on non-English-speaking residents who find it hard to navigate the complex enrollment process for Commonwealth Care.

“My concern is people will not get the care they need,’’ lamented the group’s representative, Lindsey Tucker to the Globe.

After being diagnosed with breast cancer 3 years ago, Genae Girard knew she faced medical travails and steep costs, but she didn’t necessarily expect to encounter a patent problem.

Still, that’s what happened after the 39 year-old Austin, Texas native underwent BRCA gene testing to determine whether she was at increased risk for ovarian cancer, perhaps necessitating that her ovaries be removed as well.

The test was positive.

She requested confirmation using another test, but was stoned by a decade-old Patent Office ruling that granted Myriad Genetics a patent on BRCA genes and the related testing procedures that determine ovarian cancer risk.

Now Girard is suing Myriad and the Patent Office. She has been joined by other cancer patients, professional organizations representing 100,000 pathologists, and a raft of genetic researchers. The ACLU organized the case and filed it in a federal court in New York. 

The coalition does not plan to accuse Myriad of being a poor steward of the information concerning the BRCA genes, but rather that BRCA testing could improve and costs could be reduced in the absence the monopoly held by Myriad as a result of the Patent Office’s decision.

“With a sole provider, there’s mediocrity,” Wendy Chung told the New York Times. Chung is a plaintiff in the case and directs clinical genetics at Columbia.

Companies like Myriad have contended in similar cases that the patent system fosters innovation by rewarding risky investments in research and development.

The Patent Office has already granted patents to single companies for genetic testing on long QT syndrome, a condition associated with cardiac arrhythmias and sudden death, and testing for the gene that causes hemochromatosis, a rare condition characterized by excessive iron accumulation.

What recession?

Clovis Pharmaceuticals, a Boulder-based start-up bred to acquire, develop and commercialize oncology products, has just raised $145 million, the largest such financing this year.

Clovis’ management team is the same one that grew Pharmion into a colossus that was snapped up by Celgene in 2008 for $2.9 billion.

Its financing comes from essentially the same VCs that backed Pharmion.
 
The timing of Clovis’ big raise is no accident. The Great Economic Crisis has left hundreds of Biotech companies in possession of promising molecules and not enough cash to develop them. Clovis, arguably, has its pick of the litter. 
 
“There’s a significant need for this type of company in almost any financial circumstance because the discovery abilities of our industry have really exceeded the development capacity of our industry,” Patrick Mahaffy, president and CEO of Clovis told BurrillReport.

“We (are) well capitalized…and many other companies are struggling…companies that may have wanted to be or had been an acquirer, or buyer, or partner of rights, have backed away,” he summarized.
 
Versant Ventures participated in the financing. For its managing director, Brian Atwood, the real appeal in the deal was Clovis’ management team, with which he worked as a Pharmion investor. “The guiding principle…for our firm is to find great management teams,” he confirmed.
 
Accompanying Versant in the round are Domain Associates, New Enterprise Associates, Aberdare Ventures, ProQuest Investments, Abingworth and Frazier Healthcare Ventures. All but the latter had invested in Pharmion.

Accompanying Mahaffy at Clovis will be CMO Andrew Allen, EVP of Regulatory Affairs and Technical Operations Gillian Ivers-Read, and CFO Erle Mast. All are reprising their roles at Pharmion, which Mahaffy founded 9 years ago. 

As part of its crackdown on free speech following last week’s rigged elections, Iran’s government is exerting unprecedented control over the country’s Internet communications. And to do that, it’s using products supplied by European companies.

Based on interviews with technology experts inside and outside Iran, the Wall Street Journal reported yesterday that those pesky mullahs are carrying out deep packet inspection on a massive scale.

In addition to blocking or slowing Internet communication, deep packet inspection gathers information about users and can be used to alter the content of the communication itself—changing a “yes” to a “no,” for example—which may be more disruptive than shutting off Internet communication altogether.

The nefarious capabilities are there for the mullahs to use, courtesy of a JV between the German multinational, Siemens, and Nokia, a Finnish mobile phone provider.

According to spokesperson Ben Roome, the company installed a “monitoring center” within the Iran’s government-run telecom monopoly as part of a larger gig that included the installation of mobile-phone networks.

“If you sell networks, you also, intrinsically, sell the capability to intercept any communication that runs over them,” Roome told the Journal.

The Iranian government had briefly experimented with the Big Brother-like equipment in the run-up to last week’s travesty, but few people fully understood the system’s capabilities until its powers were unleashed in the face of escalating street protests.

Deep packet inspection involves the deconstruction and subsequent reconstitution of Internet data including email, Internet phone calls, and images and messages sent via social-networking sites like Twitter and Facebook.

It could explain why the mullahs allowed Iran’s Internet to function rather than shutting it down altogether, and why it has been running at glacial speed since things started getting out of hand.

Iran is “now drilling into what the population is trying to say,” Marshal8e6 director of technical strategy Bradley Anstis told the Journal. “This looks like a step beyond what any other country is doing, including China.”

When the Big O lifted the curtain on federal funding for embryonic stem cell research in March, scientists applauded the move as a long-overdue boost for the promising field.

Now, these same scientists worry his plan may have the unintended effect of dampening progress by forcing researchers to comply with ethical standards that were enacted after their research began.

“We’re very concerned,” Amy Rick, chief executive of the Coalition for the Advancement of Medical Research told the Washington Post. “If they don’t change this, very little current research would be eligible. It’s a huge issue.”

Ongoing stem cell research has already passed ethical scrutiny, but when Obama lifted the ban, he charged the NIH to develop new guidelines governing the field. Those guidelines would be difficult to meet in retrospect.

This is essentially moving the goal post,” the Harvard Stem Cell Institute’s George Daley told the Post.

For example, the new NIH guidelines require that couples sign documents stating that they agree to donate their embryos for research and that they have been informed about other options like donating the embryos to other couples instead.

Many clinics did just this, but their consent forms did not necessarily specify as such.

No one knows how many stem cell lines would be affected by retrospective enforcement of the NIH guidelines, but experts believe most would not pass muster.

The NIH has a chance to clean up the mess when it releases the final version of its guidelines on or before July 7. 

“We know issues like this have been raised, and we will take them into consideration,” Raynard Kington, the NIH’s acting director told the Post. “The intent of the president was to expand opportunities and research in this area.”