The initial approval is for patients who undergo angioplasty (and typically get a stent) to unclog one or more arteries around the heart. Effient will carry a boxed warning alerting doctors and patients to the risk of serious bleeding associated with the drug.

The FDA’s approval isn’t just a big win for Eli Lilly. It’s also a boost for Daiichi Sankyo, which discovered the drug and will co-market it in the U.S. with Lilly.

Japanese companies have been responsible for several big cardiovascular drugs. Sankyo, one of the two companies that merged to form Daiichi Sankyo in 2005, discovered the cholesterol-lowering drug pravastatin, which was sold in the U.S. as Pravachol by Bristol-Myers Squibb. (Bristol, by the way, co-markets Plavix with Sanofi-Aventis.) More recently, AstraZeneca has turned Crestor, a cholesterol drug invented by Shionogi, into a multibillion-dollar-a-year seller.

This 2003 WSJ story described the prowess of Japanese drug discovery. But, like their American counterparts, Japanese companies have had a tougher time lately. Effient (also known by the generic name prasugrel) is the first Japanese-originated drug in a while that has a shot at being a big seller.

A successful showing by Effient would be particularly welcome for Daiichi Sankyo; earlier this year, the company took a write-down of nearly $4 billion on its recently acquired majority stake in Ranbaxy, the Indian drug maker.

Image of red blood cells by Janice Haney Carr via CDC

The kids were supposed to be wearing pedometers to measure the number of steps they were taking each day. But some of those in the study got the bright idea to clip the pedometers to the collars of their pet dogs, upping the distance the youngsters appeared to be moving each day, according to the BBC.

So it goes in conducting research studies in the real world. Studies that use so-called self-report measures, in which individuals have to recall and record their own actions or attitudes, have to be looked at with some skepticism because they depend on participants’ ability or willingness to report accurately.

In research on obesity and weight loss, it’s long been known that individuals often underreport what foods or how many calories they have eaten during the day, or how much exercise they’ve engaged in.

So researchers have tried to come up with better measures to ensure accurate findings, such as by asking participants to weigh out their food on a scale. For physical activity, pedometers are supposed to be another way to improve accuracy.

The British researchers told the BBC that it isn’t the first time that people have tried to fiddle with the pedometers. Unfortunately, once the pedometers were adjusted to take into account the help from pets, the boys walked or ran only 12,620 steps a day, compared with the recommended level of 15,000 steps. The girls took 10,150 steps daily, versus the recommended 12,000 steps.

Image: iStockphoto

Charles Rangel, the House Ways and Means Committee chairman, is considering a plan to drop the drug-advertising deduction to raise as much as $37 billion over 10 years toward overhauling the health-care system. Rangel has said his committee needs to come up with $600 billion from new taxes over the decade to help finance planned changes.

Yesterday, the four big television networks — Walt Disney’s ABC, CBS, News Corp.’s Fox and General Electric’s NBC — and the Chamber of Commerce wrote Rangel urging him to drop the idea of ending the tax deduction on drug ads because U.S. advertising supports more than 21 million jobs, including 1.3 million in New York. News Corp. also owns Dow Jones & Co., publisher of Dow Jones Newswires and the Health Blog.

In addition, the Advertising Coalition, which also includes other media companies, sent a separate letter to President Obama asking him to oppose the proposal. (Read the letters to Rangel here and here, and to Obama here.)

“Elimination of pharmaceutical advertising as a business expense would make
it more expensive and inevitably would reduce the amount of this advertising,” wrote the networks in the letter to Rangel. Because the tax deduction currently applies to all businesses, ending it for pharma “would send a discordant note to other businesses in America if we begin using the Tax Code to favor or disfavor one form of advertising over another.”

It’s not the first time that advertisers and media have gotten involved in supporting Big Pharma. In 2007, their lobbying efforts helped water down provisions to restrict drug-ad marketing in an FDA bill.

Needless to say, pharmaceutical marketing is big business in the U.S. The industry was the 10th biggest advertiser in 2006 with $5.3 billion in spending, or 3.5% of the U.S. ad market.

The excising of the editorial was first noticed by bioethicist Udo Shuklenk, who says on his blog that the purging of the document is both unusual and in apparent violation of normal protocol in medical research publication. Ordinarily, he writes, such a move would be accompanied by a retraction or some notice to readers as to why the document is being removed.

The Health Blog contacted JAMA for comment but hasn’t received a response.

The March editorial came after Tennessee researcher Jonathan Leo told the Wall Street Journal that he and the dean of his medical school were threatened by JAMA editors after he publicly flagged a conflict of interest problem in a study published last year in JAMA.

The same editors who allegedly threatened Leo penned the March editorial. In that editorial, editor in chief Catherine DeAngelis and deputy editor Phil Fontanarosa lambasted Leo for making his concerns public before JAMA finished its own investigation of the matter. The editors have denied issuing any threats.

Leo says he only went public after waiting five months for JAMA to investigate a charge – later substantiated – that the study on the use of antidepressants in stroke patients written by a University of Iowa psychiatrist failed to disclose the researcher had a financial relationship with the maker of the drug studied.

Also in the March editorial, the JAMA editors said that anyone filing a complaint about unreported conflicts of interest in the future would “be specifically informed that he/she should not reveal this information to third parties or the media while the investigation is underway.”

In a new editorial appearing in this week’s JAMA, the editors printed a modified version of the March editorial that deletes any mention of Leo and backs off the gag order regarding conflict of interest complaints. See more here.

The new editorial came after a committee that oversees the editorial operations of JAMA presented its findings from an investigation of the Leo matter to the board of the American Medical Association in June. The AMA, which publishes JAMA, has said it acted on recommendations made by the committee, but wouldn’t provide any more details.

Photo: Associated Press

First, the familiar practice: A big pharma company cuts a licensing deal with a biotech shop promising hundreds of millions of dollars in “milestone payments” if an experimental drug is successful — you know, $100 million if your drug gets regulatory approval, $50 million for bringing it to market, etc. This is so common that the promised milestone payments (which often go unpaid because the drug fails to reach the milestones) have their own name: biodollars.

Today’s twist: The biotech shop turns around and puts hundreds of millions of dollars of milestone-payment rights up for sale — effectively allowing third parties to bet that the drug will hit its milestones, and buy the promised milestone payments at a discount.

The drug, in this case, is Vertex’s telaprevir, which is in late-stage trials for treating hepatitis C. In 2006, a J&J subsidiary cut a deal in which it promised to pay Vertex $250 million for the development and launch of telaprevir in Europe.

In a statement today announcing the move, Vertex said that if things go well, the milestone payments could come due by April 2012. “If the intended sale of the future milestone payments announced today is successful, Vertex would receive a one-time cash payment that reflects a substantial percentage of these future milestones,” the company said.

The drug-deal wonks over at the In Vivo Blog note that Vertex has raised plenty of cash lately, but add that “drug development is damn expensive, and even for a company like Vertex, cash is king.”

Now Grassley, the top Republican on the Senate Finance Committee, and Chairman Max Baucus are trying to force change. They are considering provisions as part of the health-care overhaul that would target nonprofits’ tax breaks, which were designed to help those hospitals provide charity care, according to the WSJ.

Options include setting a minimum threshold of charity care that nonprofit hospitals must provide, limiting the amount they charge the uninsured and curbing instances of aggressive collection practices. Hospitals not meeting goals would be penalized with an excise tax, according to the ideas under consideration.

The scrutiny of nonprofits and their tax benefits has heightened amid the drive to overhaul health care. In theory at least, there should be less need for charity care if the number of uninsured Americans drops, as would be the goal if a revamped health system that requires universal coverage or something close to it.

The hospital industry agreed earlier this week to cuts worth a projected $155 billion over 10 years. But other proposals, such as withholding Medicare and Medicaid payments from hospitals in the cases of patients readmitted for the same problem within a certain period of time, are still under consideration, says the WSJ.

Some nonprofits are worried about any across-the-board changes that might be applied to the industry. “That’s awfully simplistic,” Bruce McPherson, president and chief executive of the Alliance for Advancing Nonprofit Health Care, told the WSJ. “Then it just becomes a numbers game.” A “softer” measure, where hospitals would be assessed individually, would be preferable, he said.

The backstory: Last year, as California was heading into its current financial crunch, the state legislature passed a law that would have cut by 10% reimbursements for treating patients covered by Medi-Cal. That’s the state’s version of Medicaid, the health insurance program for the poor, which is jointly funded by the state and federal governments.

Health-care providers sued to block the cuts last year, and a federal judge in Los Angeles ruled in their favor. A three-judge appeals panel yesterday upheld the ruling. The panel found that the cuts drove so many doctors and others to stop seeing Medi-Cal patients that patients’ ability to get care was jeopardized, violating a federal law that covers Medicaid funding to the states.

California spends $38 billion a year on Medi-Cal, its second largest expenditure after education, according to the LAT.

The U.S. is planning a vaccination campaign that could start in October, with school-age children among the first to be offered a shot, Dow Jones Newswires reports. The new vaccine still has to be developed and tested. But if it works, the government will purchase much of the vaccine. Unlike seasonal flu, which disproportionately affects the elderly, the swine flu has hit particularly hard among school children.

Officials have documented three cases of Tamiflu-resistant swine flu, but they appear to be isolated cases and not evidence of widespread resistance, the WHO said. In one case, testing revealed that a teenage girl who flew from San Francisco to Hong Kong was infected with a Tamiflu-reistant strain, despite the fact that she hadn’t been treated with Tamiflu — suggesting a resistant strain that has the ability to spread from person to person, the New York Times reports. There is no evidence that the resistant strain is widespread, and Tamiflu-resistant flu is susceptible to Relenza, another drug.

The French government is planning to spend nearly $1 billion to buy 100 million doses of vaccine from Sanofi-Aventis, GlaxoSmithKline, Novartis and Baxter, reports the French newspaper Le Parisien. (The U.S. has already appropriated $1 billion for vaccine ingredients and up to $7.5 billion more for rolling out the vaccine if initial testing goes well, the NYT notes.)

Image of a flu-virus particle via CDC

Critics see it as limiting individuals’ freedom, and in 2005, the New York Lawyers for the Public Interest also alleged that the law was disproportionately affecting blacks more than whites. Today, the New York State Office of Mental Health released a independent report evaluating the court-ordered program, known as assisted outpatient treatment, or AOT.

Researchers from Duke University Medical Center found that those who were mandated to get outpatient treatment were substantially less likely to be subsequently hospitalized. Those studied were also more likely to receive intensive outpatient case management and more likely to be getting medication appropriate to their diagnosis, according to Jeffrey Swanson, a professor of psychiatry and behavioral sciences at Duke and one of the authors of the report.

The report examined data from hospital admission records, case manager reports and evaluations for 6,919 individuals covered by AOT orders since 1999. Researchers compared individuals before and after they were mandated to receive treatment. Some people voluntarily receiving services known as assertive community treatment also were compared with those receiving these services under court order.

The researchers also found that there was an overpresentation of blacks in the AOT system, but the difference wasn’t due to more frequent court petitions or a greater likelihood that they would be mandated to get treatment. Instead, blacks were more likely to be in receiving services from public mental-health services and they had higher rates of psychiatric hospitalization — factors “upstream” from the court mandates, Swanson told the Health Blog.

“We didn’t find huge differences in people under AOT feeling very coerced and that they had been treated unfairly,” Swanson said. But “the fact is that, yes, there is a court order and the person is mandated to follow that, and that can be perceived legitimately as a limitation on their right to refuse treatment.”

Overall, “the main effect [the AOT program] has is on providing these services” to individuals who otherwise may not receive them, said Swanson.

Image: iStockphoto

Stay with us, though, for the unusual history and strikingly wide array of uses already found for rapamycin (which also goes by the name sirolimus).

The name comes from Rapa Nui, the Polynesian name for Easter Island. Scientists first isolated the compound from bacteria from the island’s soil; the bacteria apparently secrete it to fend off bacterial and fungal rivals, notes ScienceNOW.

Today, it’s used to reduce the risk of rejection for organ transplant recipients (Wyeth sells it under the brand-name Rappamune). It’s also used in some drug-coated stents (including J&J’s coated Cypher stent).

What’s more, Wyeth’s kidney cancer drug Torisel (generic name: tensirolimus) is closely related to rapamycin, and Novartis has been working on a similar drug.

If you really want to geek out on rapamycin, read this explainer from Novartis on mTOR (mammalian target of rapamycin), the pathway that’s at the heart of how these drugs work.

Easter Island photo by Phillie Casablanca via Flickr