Author: James A. White

Eli Lilly executives said there’s every reason to be optimistic about future sales of Effient, the blood thinner launched last summer with expectations of perhaps growing to become a billion-dollar seller one day. The only worry seems to be early sales of the drug are headed in the wrong direction.

Reporting its fourth-quarter results, Lilly said that sales of Effient, which the company co-markets with Japan’s Daiichi Sankyo, slid to a tiny $3.8 million world-wide in the fourth quarter. In the third quarter following the drug’s August launch, world-wide sales totaled $22.6 million.

On the conference call with analysts, Lilly execs said they were undeterred about Effient’s prospects, offering comments like “we feel just as good about Effient today as we did when we launched the product.” CEO John Lechleiter explained it was still early days in the roll-out and noted there was an initial jump in third-quarter sales because wholesalers were stocking up on the drug.

Lilly has long had high hopes for Effient to help replace the revenue from drugs that are losing patent protection in the next few years. But Effient also is in a tough market, competing against Plavix whose fourth-quarter sales rose 10% to $1.6 billion, Bristol-Myers reported today.

There was some better fourth-quarter numbers in Lilly’s results today and Lilly and Bristol-Myers also announced a settlement in a fight stemming from Lilly purchase of Imclone in 2008. Here’s the Dow Jones Newswires report with more details.

Photo credit: Lilly

Pfizer gave its first pipeline update since it took over Wyeth in October. Bottom line: The company now has has about 500 products somewhere along the path between early-stage human trials and registration, down from about an initial 600 in the combined company’s pipeline.

The company also announced it had dropped its bid to combine its Lyrica pain medication with other treatment for generalized anxiety disorder. Lyrica is already approved for fibromyalgia. Pfizer recently failed to win FDA approval to use Lyrica as a stand-alone treatment for generalized anxiety disorder.

The drug maker is targeting six research areas for the post-merger company: oncology; pain; inflammation; Alzheimer’s disease; psychoses; and diabetes. It said that 70% of Pfizer’s research projects and 75% of the late-stage portfolio now fall into these areas.

Among other stats, Pfizer said it has 30 oncology compounds in development, as well as 10 for Alzheimer’s, eight for pain and 11 for inflammation. On the vaccine front, its Prevnar 13 product to prevent pneumococcal disease in infants and young children has won approval in 34 countries but is still awaiting action in the U.S.

More details on the pipleine are available here.

Scottish pipeline photo by nz_willowherb via Flickr

The CBO budget report released today says the growth in Medicare and Medicaid spending during the next decade “will be somewhat slower than the average rate seen over the past 10 years.”

Sounds too good to be true — and it almost certainly is. As is standard operating procedure for the CBO, its cost estimates build in savings that are planned under current law. In the case of Medicare, CBO’s calculation of a slowdown in Medicare growth includes a substantial 21% cut in payments to doctors now slated to go into effect in March.

Those Medicare payments to docs were supposed to be cut on Jan. 1, but Congress passed a two-month patch to delay the cuts. In fact, they’ve been scheduled to go into effect every year since 2003, but Congress typically balks, pushing the effective date down the road.

The big health-care overhaul is very much up in the air, but both parties have said they want to block the planned pay cuts to doctors. So it’s likely there will be another last-minute patch to prevent the cuts from kicking in.

But, today’s CBO report notes, preventing those pay cuts will be expensive. “Maintaining the nominal 2009 payment rates through 2020 would increase Medicare outlays over that period by about $300 billion,” the report says.

Here are some other tidbits to digest in the CBO report:

• Medicare and Medicaid spending (excluding the 2009 stimulus legislation) is projected to rise an average of about 7% a year between 2011 and 2020.
• With the growing numbers of Baby Boomers reaching retirement age and future cost-of-living increases, Social Security spending will be growing 6% a year in 2020, up from 3% this year.
• Gross spending for Medicare will total $528 billion in 2010 and more than $1 trillion by 2020.

For more on the deficit projections, read the WSJ story.

Image: iStockphoto

The USNS Comfort, a converted supertanker that is now a Navy hospital ship, opened its 12 operating rooms and 1,000 beds to Haiti earthquake victims even before it dropped anchor off Port-au-Prince.

Patients started landing Tuesday night via helicopter, including some that had been temporarily cared for on the aircraft carrier USS Carl Vinson. Among the first dozen patients, one was 82 years old; another was 72 hours old, the Miami Herald reported today.

Sailing from its home port of Baltimore, the Comfort arrived short-handed, with about 350 crew members still expected to arrive in the next few days to bring the ship up to capacity, the Baltimore Sun said. The ship, which was launched as a supertanker in 1976 and converted to a hospital ship in 1987, normally has a crew of 61 civilians, 259 Navy support personnel and 956 Navy medical staff, according to this Navy fact sheet.

Among the Navy docs aboard is Mill Etienne, a Haitian-American neurosurgeon, who was named chief of its Comfort’s ethics committee for the mission to deal with issues such as performing surgery on children, according to the Sun. “We’ve stressed to the staff that though we’re on a humanitarian mission, we don’t want to be paternalistic,” the paper quoted Etienne as saying.

The Comfort is no stranger in Haiti, having visited there most recently in April as part of a four-month tour with various Latin American and Caribbean stops. Its missions also include several earlier trips to Haiti and it has seen service in the Persian Gulf, in New York after 9/11 and along the Gulf Coast after Hurricanes Katrina and Rita.

Picture of Comfort anchored off the coast of Haiti: AP Photo/Navy Visual News Service

You’re a TV correspondent on the scene in Haiti, reporting on the devastation following the Jan. 12 earthquake. But you’re also a doctor in the place where there’s an intense need for people to treat the injured. How do you keep the normally distinct roles of doctor and journalist separate?

The biggest broadcast networks and CNN all have doctor-journalists on the ground in Haiti who have ended up providing emergency care in addition to performing reporting duties, the Los Angeles Times and the Washington Post report. Their medical rounds have included splinting bones, helping deliver babies and performing operations.

Reporters usually try to avoid becoming part of the story they’re covering and most journo-docs told the papers they didn’t plan to be aid givers. “I don’t think our intention is to ever make the story about myself,” CNN’s Sanjay Gupta, who performed surgery aboard the aircraft carrier USS Carl Vinson to aid a girl with a skull fracture, told the Times. (That operation is shown in the picture at right; Gupta is third from the left.)

Other medical correspondents echo the sentiment. “Five days after the quake, a nun at a charity said to me, ‘We need you,’” CBS’s Jennifer Ashton told the WaPo. “I came to the decision that I am first and foremost a physician.”

Bob Steele, journalism values scholar at the Poynter Institute and journalism professor at DePauw University, told the Times that “news organizations at some point appear to be capitalizing for promotional reasons on the intervention by journalists.” See here for more such concerns.

Richard Besser, a former doc affiliated with the CDC who joined ABC four months ago, says the Hippocratic oath requires docs to help when there is need is there but he wants to avoid participating as much as possible. “My primary role is to report on the public-health consequences of this earthquake,” he told the Post.

Photo: Getty Images

It looks like Scott Reuben, the Massachusetts anesthesiologist said to have used phony research data in 21 published papers, has reached a plea deal with the feds.

Federal prosecutors accused Reuben of health-care fraud for allegedly faking data that suggested after-surgery benefits from painkillers including Merck’s Vioxx and Pfizer’s Bextra and Celebrex, the Justice Department said yesterday. The Justice announcement said he faces as much as a 10-year sentence and a $250,000 fine.

But the Associated Press said Reuben, the former chief of acute pain at Baystate Medical Center in Springfield, has agreed to plead guilty in exchange for prosecutors recommending a more lenient sentence. The sentence would also reportedly include forfeiting assets of at least $50,000 that Reuben received for the allegedly phony research. The Republican, a Springfield newspaper, said Reuben has signed a plea agreement under which he must pay $420,000 in restitution to pharmaceutical companies.

Reuben is accused with taking pharma money for doing research, then fabricating results and getting studies published in anesthesiology journals.The tale began to unravel last year as Baystate said it found Reuben had faked data and the Boston U.S. attorney began looking into the case. (For refreshers, see our posts here and here.)

Reuben’s attorney has said in the past his client cooperated with the hospital review and expressed regret. The lawyer didn’t immediately return a call for comment after Thursday’s federal complaint, the AP said.

Photo: Associated Press

Patent deals between generic and branded drug makers have been getting lot of attention lately on both sides of the Atlantic. Today, Pfizer took a turn in the spotlight.

The world’s largest pharma company said it was among those asked Tuesday by European regulators to disclose their patent agreements with generic makers. Pfizer said that its record is clean and that it’s cooperating with European Union officials, Dow Jones Newswires reported.

The EU’s regulatory arm has been upset that cheaper generic drugs aren’t getting to consumers faster as they come off patent and it wants to know if branded makers are making payments to generic rivals to delay the competition. As we noted yesterday, the EU also sent requests for information to AstraZeneca, GlaxoSmithKline, Roche, Novartis and Sanofi-Aventis.

U.S. regulators are stoking the pay-for-delay issue as well. The FTC said this week that payments in patent settlements typically delay generic competition by 17 extra months, compared with deals when there are no payments. Here is more on what the FTC found.

Image: iStockphoto

Walgreens is threatening to stop filling Medicaid prescriptions at 64 of its 121 pharmacies in Washington state because of state cuts in payments.

Walgreens, the biggest drug-store chain in the country, has been down this road before. It threatened to pull out of Medicaid programs last year before settlements were reached in Delaware and in an earlier dust-up in Washington state.

This time, the chain says it is losing money on 95% of the brand-name drugs it dispenses to Medicaid patients in Washington, so it will end Medicaid participation at the 64 stores on Feb. 15. Here’s the company’s announcement from last night and a report from Dow Jones Newswires.

All the bluster could go away with another settlement, of course. But the dispute also serves as a reminder of the continuing friction surrounding Medicaid reimbursement rates while most of the health-care focus is on the big overhaul taking place in that other place named Washington.

Congress plans to use Medicaid, which was set up in 1965 to provide health benefits for the poor, to expand coverage as part of the overhaul. That’s because many poor Americans actually don’t get benefits via Medicaid. The bills passed by the Senate and House would both increase the number of people with Medicaid, but the plans differ in the details about who would qualify and how the expanded program would work.

Because Medicaid’s payment rates to doctors are lower than those paid by Medicare and private insurers, lots of docs refuse to take Medicaid patients. That issue inevitably will become a bigger sore point if the Medicaid umbrella expands.

Walgreens Neon Sign by puroticorico via Flickr

More than a third of U.S. adults are obese. But at least the climb in the country’s obesity rate seems to be slowing.

Figures from the National Center for Health Statistics showed 34% of Americans age 20 and older were obese in 2007-08, according to a study of CDC data published in JAMA today. Add in people who are overweight and the total goes to 68%. Seventeen percent of children ages 2 through 19 were obese and 32% were overweight, another JAMA study said.

Sounds grim. But CDC statisticians said the rapid obesity growth rates of the ‘80s and ‘90s were slowing for women and, more recently, for men as well. The obesity rate for men rose to 32% in 2007-08 from 27% in 1999-2000, but most of the increase was in the early years of that period.

“I see this as relatively good news,” the director of the CDC’s division of nutrition, physical activity and obesity told Dow Jones Newswires. “It suggests we’ve halted the progression of the epidemic.”

The obesity rates were based on survey data of the height and weight of 5,555 adults and nearly 4,000 children who are considered representative of the U.S. population. For adults, overweight was defined as a body mass index of 25 to 29.9. Obesity was defined as a BMI of 30 or higher. (Calculate your BMI here.)

One exception to the promising trends was heavyweight boys, whose obesity rates continued to rise. “The heaviest boys may be getting even heavier,” researchers said.

The latest peace pact in the generics wars has been signed by AstraZeneca and Teva, shielding AstraZeneca’s mega-selling heartburn drug Nexium from Teva competition until 2014. Now the question is whether a similar deal with another generic maker — Dr. Reddy’s Laboratories — is far behind.

AstraZeneca said the deal will allow Teva to sell generic copies of Nexium in the U.S. starting on May 27, 2014, when the first of AstraZeneca’s patents on the drug expire. Back in 2008, AstraZeneca made a separate Nexium deal with India’s Ranbaxy Laboratories.

Morgan Stanley analysts quoted by Reuters said that India’s Dr. Reddy’s posed the only credible risk to Nexium sales before 2014; they predicted AstraZeneca would cut a deal with Dr. Reddy’s before the end of 2010.

All this fuss stems from the fact that Nexium is AstraZeneca’s biggest seller, ranking as the world’s third-largest drug, with sales of $7.8 billion, according to IMS Health.

Other drug makers have been cutting similar deals on mega-blockbusters losing patent protection in the coming years. Pfizer and Ranbaxy settled their legal fight over Lipitor when they agreed that Ranbaxy could start selling generic copies of the drug (the biggest seller of all time) in November of 2011.

Photo: PR Newswire

When the government announces its latest monthly unemployment report on Friday, it’s a safe bet that the data will include another uptick in the number of health-care jobs.

(Update: The latest BLS employment data Friday made it official, showing the health-care sector adding 21,500 jobs in December. Doctors’ offices added 8,900 jobs and home health-care services grew by 8,000 slots. Here’s the overview story from WSJ.)

That’s pretty much a no-brainer considering the health-care sector added 381,000 jobs in 2007 and another 372,000 in 2008, according to the Bureau of Labor Statistics. With the gains in the first 11 months of 2009, health care has expanded by more than 600,000 since the recession’s start in December 2007.

We won’t venture a guess at what December’s official numbers will show. You can look at what our colleagues at Real Time Economics said today if you want a peak at the overall jobs situation.

On the health-care front, online help-wanted data out today from the Conference Board showed demand increased the most in December for health-care practitioner and technical jobs. The business research group said that “advertised vacancies for healthcare practitioners or technical occupations outnumbered the unemployed looking for work in this field by almost 3 to 1,” citing November data.

The industry’s hiring wave is far from over. A report on NPR this morning notes BLS statistics that more than three million health-care jobs of all types will be added by 2018, including 581,500 registered nurses and almost 461,000 home health aides.

Image: iStockphoto

A bunch of European countries ordered too much swine flu vaccine, so after months of waiting around for the flu shots to show up, they now find themselves canceling orders.

The French government had planned on using 94 million individual shots to give two doses of the swine-flu vaccine to most of the country’s 65 million people. But it said Monday that it was canceling 50 million orders as one shot has been found to be effective and swine-flu cases in France have been dropping sharply, according to Reuters and other news reports.

France’s move follows similar steps this week by the Netherlands and last month by Germany, Spain and Switzerland, all of which could curb revenues for vaccine makers Sanofi-Aventis, GlaxoSmithKline and Novartis. The pharma companies face “significantly lower flu vaccine sales than forecast” as government buyers seek to renegotiate their purchase contracts, the Financial Times said this morning.

Even with seasonal flu, the vaccine business always carries hit-and-miss risks as there is often high demand for shots early on and too much supply later. As we noted last month, Moody’s said vaccines and treatments for H1N1 flu should provide “a nice boost to earnings in 2009 and also possibly in early 2010” for makers, but the credit-rating company also warned the swine-flu business is unpredictable and any upside might only be temporary.

Booster shot: WHO chief Margaret Chan finally got her H1N1 shot. It turns out she was vaccinated Dec. 30, a day after she acknowledged at a news conference that travel and other demands had meant she hadn’t squeezed in time for a shot.

After months of standing in line trying for adequate shipments of the H1N1 vaccine, pharmacies, supermarkets and other retailers with in-store clinics now are trying to make the most of an influx of supply now becoming more widely available.

“Right now there’s probably more supply than demand,” Troyen A. Brennan, chief medical officer at drugstore chain CVS Caremark, told the WSJ this morning. CVS is offering the swine-flu vaccinations in 23 states, while Rite-Aid has them in 30 states and Wal-Mart in 48 states. Walgreens, the No. 1 pharmacy chain by number of stores, will have them available in 49 states by year end, the WSJ says.

Of course, this ramp-up is happening while flu activity continues to decline in the U.S., according to the CDC. But the government push for people to still get H1N1 shots, especially now that there are enough supplies to give the vaccine to lower-risk groups.

For the retailers, vaccines may not be a huge profit center (most providers are charging $10 to $18 for a H1N1 shot), but they can build traffic. “We clearly see potential opportunity” in the vaccinations, spokesman Brian Dowling of supermarket operator Safeway told the WSJ. “The vast majority of our pharmacy customers shop the rest of the store.”

Booster Shot: WHO head Margaret Chan told a Geneva newspaper that “it is too soon to say that we have passed the peak of the [H1N1] flu pandemic on a worldwide scale….Winter is still long.” See more here.

Image of H1N1 by C. Goldsmith via CDC

The media coverage spawned by the health-care overhaul has taken many forms, but one of the most popular vehicles — according to our less-than-scientific observation — has been that venerable journalism standby, the Q&A.

Editors love the question-and-answer format for offering up lots of factoids about complex data in bite-size chunks. Deliver it in a conversational, reader-friendly tone and you’ve got a winner, the thinking goes.

So in case you share a hankering for Q&A’s, here a sampling from the many we’ve seen lately on newspaper and other journalism sites. We’ve included the first question in each Q&A to provide a flavor of the topics covered:

LA Times: Why require everyone to buy insurance? Also: Would insurance companies still be able to offer abortion coverage?

Kaiser Health News: What are the biggest disputes [between the House and Senate over their approved bills]?

USA Today: What aspects of the health care legislation would be implemented right away?

Reuters: What does the Senate healthcare bill do?

WSJ: Would the law force me to buy health insurance?

BBC: How is the US healthcare system currently structured?

Image: iStockphoto

Congress and the White House have set their sights on plugging the “doughnut hole,” the gap in Medicare drug coverage that can leave seniors liable for thousands of dollars a year in prescription costs. Bridging the gap might be easier if there were more data on how big the hole was and its closing costs down the road.

The Congressional Budget Office, the usual scorekeeper for tracking federal spending, hasn’t predicted how much it would cost to close the doughnut hole, a Washington Post article notes this morning. The paper says the only estimate of the cost of filling the gap comes from the Medicare program’s chief actuary, who put the figure at $31 billion over the next decade. There aren’t any budget forecasts going far enough into the future to predict what expanded drug benefit would cost the government once the gap is fully closed, the Post adds.

The House overhaul bill passed in November would gradually eliminate the doughnut hole over 10 years starting with adding $500 to cover drug costs covered by Medicare in 2010. The health overhaul passed by the Senate on Christmas Eve is missing that language, but Senate Leader Harry Reid said this month he wanted to adopt the House goal of closing the coverage gap in the final version of the legislation that Congress sends to President Obama for signing.

Drug makers said earlier this year they would offer a 50% discount on brand name drugs purchased by seniors in the doughnut hole. That’s part of the drug industry’s deal with Democrats to contribute $80 million over 10 years to the cost of the health overhaul. Here’s more on that.

Meanwhile, CBO did do a study in August on how plugging the doughnut hole would reduce what seniors’ total spending on prescription drugs but their Medicare premiums would increase. That study is detailed here.

Photo by Salim Virji via Flickr