Author: James A. White

It seemed like only a question of time, but Bristol-Myers Squibb said this afternoon that Lamberto Andreotti, its president and chief operating officer since last March, would succeed James M. Cornelius as CEO.

Andreotti, a 12-year veteran of the company, is 59 years old and Cornelius is 66. Cornelius was tapped as Bristol-Myers CEO in 2006 (first on an interim basis) and then got the added job as chairman in 2008. Picking a successor was one of his key missions.

Andreotti takes command after Bristol-Myers decided to sit out the wave of multibillion-dollar takeovers that saw big competitors Pfizer, Merck and Lilly get even bigger. Bristol-Myers instead has pursued smaller biotech deals and alliances as well as developing its own pipeline through what it called a “string of pearls” strategy. The company also decided to shrink its non-core units with the split-off of its Mead Johnson baby-formula business.

Looking ahead, Bristol-Myers will have to cope with the loss of patent protection for money spinners like the company’s anticlotting pill Plavix, the world’s second best-selling drug after Pfizer’s Lipitor. The company has cut costs through layoffs, plant closures and wage freezes, Dow Jones Newswires notes.

Cornelius will remain as the drug maker’s chairman when the switch is made May 4. In 2008, his compensation topped $21 million.

Photo: Bristol-Myers Squibb via Bloomberg

In what could be a win-win decision for both Teva Pharmaceutical and Merck, a federal court said that Teva was entitled to six months of exclusivity to sell generic versions of two hypertension medicines made by Merck.

A district court ruled in July that Teva, the largest of the generic drug makers, had forfeited the 180 days of exclusivity that usually goes to the first applicant seeking FDA approval to make a generic versions of drugs — in this case, copycats of Merck’s Cozaar and Hyzaar.

But Teva said today an appeals court found the Israeli company should get the exclusive sales period once its gets the FDA go-ahead to market the drugs. Teva said it would be eligible to begin sales in April.

Merck benefits because it was expecting a gaggle of generics for the two drugs to hit the market right away, according to Reuters. The U.S. company said its lawyers were reviewing the decision, the report said.

World-wide sales of the hypertension drugs were $3.6 billion in 2009. The exclusive-sales period allows a generic maker to charge a little more for having the first copycat version on the market, Reuters notes.

Here’s more from Dow Jones Newswires.

Image: iStockphoto

This post by WSJ’s Peter Landers also is appearing on the Washington Wire blog.

The fate of the Democrats’ health bill is likely to come down to the House, and the vote there hinges on wavering Democrats. The Associated Press surveyed all 39 Democrats who voted against the version of the health overhaul approved by the House on Nov. 7 and found nine who said they would consider switching to yes.

If House Speaker Nancy Pelosi is to achieve a majority, she’ll probably need some of those nine, because some of those who voted yes last time –- including Rep. Bart Stupak of Michigan –- have said they’re planning to vote no this time. The vote in November was 220-215.

Three of the nine –- Reps. Brian Baird of Washington and Bart Gordon and John Tanner of Tennessee –- are retiring and don’t need to worry as much about defending their vote before constituents, notes the AP.

Another five –- Reps. Suzanne Kosmas of Florida, Frank Kratovil of Maryland, Scott Murphy of New York, Glenn Nye of Virgnia and Michael McMahon of New York –- are first-termers and perhaps more susceptible to arm-twisting by the Democratic House leadership. The ninth is Rep. Rick Boucher of Virginia.

Photo of the Capitol dome by alykat via Flickr

Hundreds of thousands of Americans usually stay home at some point during the winter battling fever, aches and pains — all the result of a normal flu season. But this flu season is clearly marching to a different drummer.

The H1N1 swine flu came and mostly went and seasonal flu has barely come at all in the U.S., the WSJ says in a survey of the flu front this morning. It’s a puzzle why there isn’t more swine flu around, given how many people haven’t been infected or vaccinated, according to the experts.

That said, another H1N1 wave may be in the wings and could come soon. “We’ve had peaks [of flu] as late as May, so we’re not out of the woods yet,” a CDC influenza official told the WSJ. But future outbreaks aren’t likely to be as large as the one last fall, say some flu trackers.

The lack of punch from seasonal flu is also a mystery. One theory, the WSJ says, is that that people infected with H1N1 swine flu may produce a chemical in their bodies that protects them against other flu viruses.

The CDC is still pushing swine-flu vaccines. About 155 million doses of H1N1 vaccine have been distributed this flu season, and about 86 million people have been vaccinated — a few million less so far than normally get vaccinated for seasonal flu, according to numbers cited by the WSJ. Children under 10 who have only had one dose should get a second for full protection, the CDC says.

Nancy Cox, the CDC’s influenza chief, says pandemic H1N1 virus is likely to eventually become a seasonal strain, though it isn’t one yet. An overview from the CDC is here.

Photo: Associated Press

It’s not a pretty process, but a deal seems to be shaping up to stave of the start of a 21% cut in Medicare fees paid to doctors.

The cuts were due to kick in today because Congress failed to pass a temporary extension as a result of objections by Sen. Jim Bunning to a bill that also contained job measures and other health-care provisions. But the Centers for Medicare & Medicaid Services, the federal agency that runs Medicare, has put a hold for 10 business days on physician Medicare claims, in effect giving Congress two more weeks to work things out before the payment cuts affect reimbursements to doctors.

To make legislation happen, Republicans now are pledging to get a temporary fix through. The House approved its version of the bill last week but Bunning, a Republican from Kentucky, balked at adding to the deficit. The Senate now may have to use a longer process to avoid Bunning’s objections. Here’s more from the Associated Press.

All this adds a bit more drama to what has been a routine stalling action by Congress since 2003. The Medicare cuts started off as deficit reduction measure, but after many delays, the bite on docs grew too large for Congress to actually allow them to go into effect. On the other hand, if Congress eliminates the planned reductions permanently, as urged by the AMA and other doctors’ groups, it would add billions in Medicare costs to the defcit.

The AMA warned the situation could become a “meltdown” in medical services for seniors.

To hear some Democrats tell it over the weekend, the health-care overhaul has already passed Congress, leaving just some procedural matters to wrap up before the changes begin.

“Health-care reform has already passed both the House and the Senate with not only a majority in the Senate but a supermajority. And we’re not talking about changing any rules here,” White House adviser Nancy-Ann DeParle says in the Washington Post this morning.

The House and Senate passed different bills, however, so the problem remains of how to get them to match up. President Obama made clear at last week’s health summit that he’s prepared to back a Senate procedure called reconciliation that requires only a simple 51-vote majority — not the 60-vote supermajority — to get revisions through the Senate. In the House, approval by a regular majority would be still needed.

Under Obama’s preferred plan at the moment, WaPo says, the dance would have the House pass the same bill that came out of the Senate in December. The Senate would then pass changes demanded by some House Dems. But the process of keeping enough Democrats in line for even a simple majority is tricky: House members in particular still like their bill better than the Senate version and the changes they seek from the Senate also aren’t a sure thing before the House votes.

Still, House Speaker Pelosi said everywhere over the weekend that the Democrats had enough House votes to approve the overhaul. Republicans again predicted they would take over the House in the fall elections if the health bill was pushed through.

Some obese children as young as 3 years old have elevated levels of a marker that is linked to heart disease in later life, a new study says.

Nearly 30% of obese 3-to-5-year-olds in the study had elevated blood levels of C-reactive protein–a widely studied marker for inflammation — compared with 17% of healthy-weight kids of the same age, according to the research being published today in the journal Pediatrics. CRP can help predict risk of heart disease, stroke and death under certain conditions, experts say.

The results suggest that obesity-related disease processes may start even younger than previously believed, the WSJ says in a report on the study. Previous studies have found that overweight and obese adults show elevated levels of CRP, but less has been known about CRP levels in children.

Almost one in three children is overweight or obese, and obesity-related illnesses cost the nation $147 billion a year, according to figures from the White House, which recently launched a drive spearheaded by First Lady Michelle Obama to curb the problem. More on that here.

Finding elevated CRP in such young children raises concerns that its effects could be cumulative. Future research is needed on that front, one of the study’s researcher’s said.

Image: iStockphoto

The clock is running out before a 21% cut in Medicare payments to doctors kicks in. Plans to block the reductions have gotten hung up in Congress.

In response, the AMA is telling its members what they can do about the lower payments, including closing their doors to new Medicare patients, CNN reports. “To our physicians, we are providing information on their Medicare participation options, including how to remove themselves from the Medicare program,” AMA President James Rohack told the cable channel.

There’s nothing new about these cuts — they have been scheduled to go into effect regularly since 2003. Congress has blinked with a temporary reprieve each time in the past, but hasn’t done so yet this time with the cuts slated to begin Monday. Here’s why:

The House yesterday adopted a one-month delay in the cuts as part of a $10 billion employment bill with various other health provisions. “The legislation, which the Senate may take up next week, would give lawmakers more time to debate the fee cuts,” Bloomberg reported today.

But there could be a big hangup in getting that bill through the Senate in a hurry because Republican Sen. Jim Bunning of Kentucky wants to delay any swift action. That runs counter to what Senate leaders on both sides of the aisle had in mind, but senators can do that. Here’s how Politico describes the messy situation.

The AMA wants a permanent fix to banish the planned cuts in Medicare fees that they think are too low to begin with. There was an effort to include a long-term fix as part of the health overhaul, but we all know that hasn’t happen, at least not yet. So a temporary patch became part of the employment bill, but that hasn’t happened yet, either.

Photo: Associated Press

New Novartis chief Joe Jimenez (right) is looking at beefing up some business segments with acquisitions, but has nothing in mind as big as its $39.3 billion plan to buy the rest of eye-care company Alcon.

“We may go for smaller, bolt-on acquisitions to help build scale in vaccines, generics and consumer health, but we will not go for one of the same size and scale as Alcon for the foreseeable future,” Jimenez said at the Novartis annual meeting, according to Reuters. Jimenez, who succeeded Dan Vasella as Novartis CEO this month, didn’t comment on the plan for buying the shares it doesn’t already own in Alcon.

At the meeting in Basel, 95% of the Swiss company’s shareholders also backed the introduction of a “say on pay” provision that will give holders a vote on executive and board-member remuneration issues at least every third year but not on individual salaries. Dow Jones Newswires reports on that angle.

Vasella, who is one of the highest-paid managers in Switzerland and received around $18.6 million last year in stock and options, has been repeatedly criticized for his remuneration packages, DJ adds. He remains chairman of Novartis.

As for Novartis overall, Reuters notes that its shares trade at a premium to GlaxoSmithKline, AstraZeneca and Sanofi-Aventis thanks to promising new drugs like multiple sclerosis pill Gilenia. “Novartis has better prospects than many of its European competitors, except Roche, to overcome the challenges posed by the patent cliff in the period between 2010 and 2012 …,” it quotes an analyst as saying.

Photo: Associated Press

Yesterday’s health summit produced seven hours of televised history but little evidence of movement toward a health-care overhaul. No surprise there, but the dividing lines between Democrats and Republicans are clearer now and there could be a silver lining in that.

The big gulfs come down to three basic philosophical disagreements, the WSJ’s Capital Journal column says this morning:

• Is the goal comprehensive or incremental change? Dems want a big ball of wax that expands coverage, curbs costs and revamps insurance regs. Republicans want to go “step by step.”

• Is access or cost the top priority? Control costs and you make it easier for people to buy and keep coverage, the GOP says. The Democrats say expanding access will drive down costs.

• Should government or markets set the standards? Easy to guess how they come out on this. Dems think there has to be a government insurance referee; Republicans want to leave that to market forces.

Capital Journal calls all of these “honest disagreements,” and then notes President Obama’s closing summit comments about trying to bridge the philosophic divide. “I don’t know frankly whether we can close that gap,” the president said.

Well, there was no breakthrough of understanding between Democrats and Republicans over health care at today’s summit, but there were areas of agreement on some issues. Of course even where there were shared goals, there was division over how to achieve them.

But the aim of the summit was to find shared ground, so here are some small patches of agreement during the session:

Medicare malpractice: Republicans have push hard for curbs on malpractice suits to cut costs, something the Democrats have been slow to endorse. President Obama said today he wanted to work with the GOP on changes, although he disputed the size of the prospective cost benefits. Possible limits on malpractice damages remain a major sore point.

Purchasing pools: Democrats back purchasing exchanges for individuals and small businesses to pool their purchasing power and get better coverage for the buck from plans meeting federal standards. Republican Sen. Mike Enzi told the summit that he goes along with purchasing exchanges, but they should include all the plans insurers want to offer.

Pre-existing coverage denials: There’s general agreement that insurers shouldn’t be allowed to deny coverage for pre-existing health conditions. But Republicans favor setting up pools for high-risk coverage while Democrats want to mandate that most people buy insurance, which would spread the risk.

Dems and Republicans all pledged to try to build on the areas of agreement, such as they are. But it wasn’t clear if the efforts would get any further than the bipartisan bickering before the summit. There’s more on the consensus areas broached at the summit here.

Photo: AFP/Getty Images

This post by WSJ’s John D. McKinnon also appears on the Washington Wire blog.

Is the budget-reconciliation loophole being stretched too far by the current Democratic health-care legislation?

Maybe. But it’s only the latest chapter in a long-running narrative that both parties have taken part in.

After losing their filibuster-proof 60-vote Senate majority in January, Democrats began planning to move much of their health-care revamp using budget procedures that require only 51 votes –- a simple majority –- in the Senate.

At today’s health summit, Republican Sen. Lamar Alexander of Tennessee complained that that’s going too far. Yes, Republicans have used the budget-reconciliation process, too. But “it’s never been used for anything like this,” he said.

In broad terms, that’s probably true. Of the 19 previous successful uses of reconciliation since 1980, nothing quite matches the current health-care overhaul in terms of sheer magnitude and impact.

But both sides have used the procedural maneuver for some pretty far-reaching measures. Some of the first bills passed under reconciliation in the early 1980s were among the most far-reaching, making cuts to welfare programs and significantly raising taxes, for example. A 1985 bill established the Cobra health-insurance program.

Changes in 1986 narrowed the scope of reconciliation somewhat. But many of the biggest bills continued to pass under reconciliation -– the big deficit-reduction bills of 1990 and 1993, for instance. Welfare changes and the Children’s Health Insurance Program both passed under reconciliation in the 1990s.

President George W. Bush’s big tax cuts of 2001 and 2003 also passed under reconciliation, as Democrats often point out, even though they actually reduced government revenues rather than shored up the budget.

But critics say there has been a worrisome trend lately that the health-care bill might expand – the use of reconciliation to push through major rewrites of federal programs that make only minor impacts on the budget. That began in earnest in 2007 with a student-aid overhaul that Democrats pushed through under reconciliation. The health-care revamp would take that trend another step, the argument goes.

Supporters of the Democrats’ health-care rewrite argue that the short-term budget savings might be minor, but the longer-term savings –- those beyond the first decade –- could be much larger.

Here’s a Q&A with more on how reconciliation works.

Photo of the Capitol dome by alykat via Flickr

We recounted earlier this week that Roche’s cancer drug Avastin had missed achieving its main target in a stomach-cancer study. Today the news is flipped as a new study reported Avastin showed positive results in the treatment of advanced ovarian cancer.

The latest showed that women who continued using Avastin alone after receiving Avastin in combination with chemotherapy lived longer without the disease worsening, compared with those who received chemotherapy alone. The 1,873 women in the study had already undergone surgery to remove as much of their tumors as possible. Here’s the Roche announcement.

A Sanford C. Bernstein analyst told Dow Jones Newswires that “2010 is going to see a slew more Avastin data,” including two continuing studies that test Avastin in prostate cancer and in early-stage colorectal cancer. Avastin is already approved to treat advanced colorectal, breast, lung and kidney cancer.

Avastin’s sales totaled $5.75 billion last year and the drug could eventually reach peak sales of more than $8 billion if it also is approved for treating other cancers, according to DJ Newswires.

Photo: Bloomberg News

As expectations hover at low levels for the outcome of today’s bipartisan health summit, the Obama White House is preparing a modest overhaul proposal in case more-sweeping plans remain stalled in Congress.

The fallback plan would extend health insurance to around 15 million people by expanding current federal-state programs, the WSJ reports this morning. Insurers also would be required to allow family members to stay on their parents’ health-care plans up to age 26, it says.

No final decisions have been made on proceeding with the trimmed-down plan, which would mark a sharp retreat in scope from earlier Democratic measures. Differing overhaul bills approved by both the House and the Senate would expand coverage to some 31 million Americans and the president’s own omnibus proposal unveiled Monday maintained the same target to take a bigger bite out of the 46 million uninsured population.

Obama’s proposal indicated the president isn’t ready to throw in the towel on a comprehensive plan, despite urging by a key aide, White House Chief of Staff Rahm Emanuel. to think about a “skinny bill.”

The WSJ said Emanuel didn’t devise the more modest package, which would provided added coverage through expansion of Medicaid and the Children’s Health Insurance Program, according to one person familiar with the ideas.

With few positive results expected from today’s confab, congressional Democrats also are looking beyond the session, but hoping Obama will bring more forceful leadership to the health-care fight, according to the Washington Post this morning. “Only if the president is willing to take command of the debate, Democrats in both chambers said, will a health-care reform bill have any chance of reaching his desk,” the WaPo reported.

Pfizer has won FDA approval of a product developed by Wyeth, which Pfizer bought last year for $68 billion. And it’s a biggie — a updated version of the world’s best-selling vaccine Prevnar. See the Pfizer announcement.

The new version of the childhood vaccine called Prevnar 13 is intended to fight six more varieties of ear infections, meningitis and pneumonia than the current version of the vaccine. Pfizer says the new vaccine will cover 90% to 95% of the causes of pneumococcal disease in the U.S. Here’s more fromthe Associated Press.

Prevnar posted sales of $2.7 billion in 2008 and Credit Suisse analyst Catherine Arnold estimates that Prevnar 13 will have $5.9 billion in sales in 2015, more than any other single Pfizer product, according to the WSJ. “We think it is the most important value driver for the future of Pfizer,” she said.

Pfizer has been counting on the addition of Wyeth’s pipeline to help offset patent expirations, including global top-seller Lipitor that loses protection starting late next year. Wyeth has had approval for Prevnar 13 on the horizon for a long time and that was a key reason Pfizer was willing to shell out so many billions for its rival.

In another piece of good news for Pfizer today, a panel of experts from the CDC recommended the vaccine’s routine use for children between two months and 59 months.

In case your invitation got lost in the mail, here’s what you need to know for tomorrow’s bipartisan health summit:

When and where: The festivities kick off at 10 a.m. Washington time, and are slated to run six hours. The venue is Blair House (right), the government guest house located across the street from the White House.

Who’s coming: President Obama, Vice President Biden and three dozen lawmakers, plus other health biggies like HHS Secretary Sebelius. Some key Republicans say they will show up, but they remain skeptical to say the least. “We’re happy to be there, but I’m not quite sure what the purpose is,” Senate Minority Leader McConnell said yesterday.

What’s on the agenda: After opening comments by the president and others from both sides of the political divide, there will be four themes, according to the WSJ: controlling health-care costs, overhauling the insurance market, reducing the deficit and expanding insurance coverage. For lunch there will be a buffet.

What won’t be there: a podium. Republicans insisted that attendees be seated around a big table so that everyone will be at the same height, according to Politico. “We don’t want any more of that Professor Obama lecturing to us stuff,” one GOP staffer told Politico.

Those not invited can still follow the summit action as it will all be televised. And for those really wanting an invite to the session, here’s the letter that the administration sent to Congress to set up the affair.

File photo: Associated Press

The method of making flu vaccines from chicken eggs is slow and expensive, but it has proved reliable for 60 years. So that’s what drug makers used last year in ramping up a new vaccine to offer protection from the sudden spread of the H1N1 virus.

But “the response to H1N1 was a disaster,” said Brett Giroir, vice chancellor for research at Texas A&M University System, says in a WSJ report this morning on an unusual plan to use tobacco plants to make flu vaccines. That’s a technician soaking a tobacco plant in bacterial solution to make a plant-based vaccine in the picture.

Texas A&M is part of a consortium getting $40 million from the U.S. Defense Department to test plant-based vaccines and to produce an initial 10 million doses to combat H1N1, otherwise known as swine flu. The consortium will invest another $21 million in the project known as GreenVax, which is being announced today, the Journal says.

There have been numerous approaches to try to improve vaccine production in recent years, including a new Novartis plant in North Carolina that is growing flu viruses in vats of cells derived from dog kidneys. But animal parts can contain pathogens harmful to humans.

Using plants is an alternative, with tobacco proving especially attractive because it’s cheap to grow and can yield large amounts of vaccine in a matter of weeks instead of several months under the egg method, the WSJ says. It also cites other plant-based work going on at Arizona State and by Germany’s Bayer.

The military is backing the GreenVax project because it was unnerved by delays in producing the H1N1 vaccine and it wants a more sure-fire way to protect soldiers from infectious diseases, not to mention bioterrorist threats. The Pentagon is also trying to tell when soldiers are getting a cold before they go into combat.

Pandemic update: World Health Organization experts decided today it is too soon to say swine flu has peaked so it’s still officially a pandemic. Read the official reasoning here.

Photo: Bloomberg News

Roche’s Avastin chalked up another miss in a study, this time failing to meet its main target of prolonging the lives of patients with late-stage stomach cancer in combination with chemotherapy.

Last April, Roche said Avastin didn’t meet its main goal in another study of preventing colon cancer from returning in patients in the early stages of the disease after surgical removal of the cancer. That was just after Roche agreed to pay $46.8 billion for the shares that it already didn’t own of Genentech, the biotech that developed Avastin.

In the stomach-cancer trial, Roche said the drug didn’t extend overall survival in patients treated with the drug in combination with chemotherapy when compared with the same chemotherapy treatment plus a placebo. But the drug maker added that no new safety issues were raised in the trial and that work on Avastin would continue.

Avastin is already approved to treat advanced colorectal, breast, lung and kidney cancer. Here’s more from Dow Jones Newswires and Reuters.

Photo: Bloomberg News

As the dust settles on the White House announcement yesterday of its health-care overhaul, here are some further details worthy of note in the proposal:

Pay for delay would go away. The Federal Trade Commission would get power to block deals where a generic maker delays bringing a cheaper copycat drug to market in return for something of value from the branded maker. CEOs of branded pharma companies also would be required to certify to the accuracy of any of any agreements filed with the FTC.

Pay for delay has been a sore point with the FTC, which estimates such deals would cost consumers $35 billion over 10 years if unchecked. European regulators also are probing deals that delay cheaper generics from arriving on the market, asking big branded makers including Pfizer, AstraZeneca, GlaxoSmithKline, Roche, Novartis and Sanofi-Aventis for info on the topic.

A path to a pathway. The Obama proposal “creates a new pathway to create generic versions of biological products,” as the White House proposal puts it without giving details. Makers of biologic drugs hope that means that Obama is sticking to provisions passed by both the House and the Senate giving them 12 years of patent protection before facing copycat competition, and not a shorter period as the president has advocated in the past.

No score from the CBO. The head of the Congressional Budget Office said in a blog entry Monday that more detail than the White House has provided would be needed to tot up the cost the Obama plan, according to the New York Times. The White House put the price-tag at $950 billion over a decade, but the CBO figure will be the one that Congress wants to see.

President Obama has juggled the health-overhaul plans approved by the House and the Senate and added some twists of his own to come up with a White House proposal he hopes can win enough support for passage in both chambers.

The Obama plan is crafted mainly from the Senate-passed bill, but not entirely.
Here are some of the big points in the proposal, as posted on the White House Web site:

• The plan’s cost is pegged at $950 billion over a decade — more than the Senate bill but less than the House measure — and is supposed to reduce the deficit by $100 billion over 10 years.
• A proposed tax on high-end, or “Cadillac,” health plans would be delayed until 2018 for all workers, and the value of such plans triggering the proposed tax would be raised to $27,500.
• The so-called doughnut hole in Medicare drug coverage would be closed entirely, with fees on brand-name drug companies being increased by about $10 billion above the fees on the drug industry already provided in the Senate bill.
• A new Health Insurance Rate Authority would determine what it considers reasonable rate increases for health coverage, and those hikes considered unjustified could be blocked.
• Medicare taxes would apply to unearned income for upper-income households and more cuts would be made to the Medicare Advantage program, private plans that serve some seniors.
• More money would be raised through penalties on businesses that don’t offer coverage and individuals who don’t carry it. Companies with more than 50 employees that don’t offer coverage would pay $2,000 per person.

In line with the earlier bills, the new plan would cover some 31 million people and bar insurers from dropping coverage for preexisting conditions. It also increase subsidies to make coverage more affordable. Here’s more from the WSJ and USA Today.

Photo: Getty Images