Author: James A. White

Congress is getting ready for another episode of its recurring doctor drama: Block the Medicare Payment Cuts If You Can!

Actually, in this installment of the long-running production, Congress has already missed the deadline for new legislation to block cuts of 21% in Medicare payments to doctors. The pay reduction officially took effect April 1, but the Centers for Medicare and Medicaid Services — the federal agency that oversees the giant health systems — put a hold on processing physician payments for 10 business days, effectively pushing off the bite on payments for physicians’ services until April 15.

So that’s the new deadline facing Congress if it wants to pass a new law delaying the cuts from really going into effect. The lawmakers have done the delay dance repeatedly over the years to avoid more unpleasant alternatives. If they allow the cuts to go into effect, there would be an outcry from Medicare docs and their patients, while if they remove the planned payment cuts from the books, it would add billions to the official deficit tally.

Things are looking up for congressional action after a vote yesterday in which four Republican senators — Brown of Massachusetts, Collins and Snowe of Maine and Voinovich of Ohio — joined with Democrats and independents to move ahead with the extension legislation. But some doctor groups like the American Academy of Family Physicians are warning that there still may not be enough time to adopt final legislation approving a delay before April 15.

If it passes, the current bill would only push back the Medicare payment cuts until April 30 by which time Congress is slated to take up a delay lasting until October. The Medicare provision is part of a much bigger package before Congress that includes extended jobless benefits, subsidized COBRA health benefits for those losing jobs and a flood-insurance program.

Photo of the Capitol dome by alykat via Flickr

You wouldn’t think that getting world-wide figures on the number of mothers who die in pregnancy, childbirth or afterward would be particularly tricky for the experts. But there’s more evidence that such is the case.

New data on the subject comes in a study published in the Lancet saying that the number of maternal deaths had fallen to 342,900 in 2008 from 526,300 in 1980, a 35% decline. The trend “for the first time in a generation, is one of persistent and welcome progress,” a Lancet editorial says.

But the editorial also notes that there are “wide uncertainty intervals around these numbers” in the study, which was led by researchers at the University of Washington and funded by the Bill and Melinda Gates Foundation. Indeed, the new numbers contradict data from the World Health Organization, which reported last May that mothers and newborns are no more likely to survive now than 20 years ago, notes Reuters.

The Lancet said the authors used new analytical methods on the latest data to come up with their findings for 181 countries.

The new data found that while there was progress on maternal deaths, much remained to be done. More than half of all maternal deaths occurred in only six countries in 2008 — India, Pakistan, Nigeria, Afghanistan, Ethiopia and the Democratic Republic of the Congo. HIV remains a huge problem; without the disease, the number of maternal deaths world-wide would have been 281,500 in 2008, the study said.

And the Lancet study also found the rate of maternal deaths in the U.S. rose to 17 per 100,000 live births in 2008 from 12 per 100,000 in 1980. Researchers said they found no complete reason for the increase nor why U.S. maternal deaths are double the rate in Britain, triple that in Australia and four times the rate in Italy.

Image: iStockphoto

It’s been almost a year since the headlines about the latest bout of H1N1 swine flu first began to appear — so now it’s time for the why-wasn’t-the-flu-as-bad-as-it-could-have-been and could-it-have-been-handled-better probes to begin.

WHO Director General Margaret Chan today opened the first meeting of 29 experts looking into the response to what became the first pandemic of the 21th century. “We want to know what can be done better and ideally how,” she said.

One speaker at today’s session said that international preparations for the swine flu were aided by the outbreaks of the more deadly bird flu in recent years, but then what turned out to be the relative mildness of the H1N1 pandemic worked against it. “It wasn’t that mild when you see the number of deaths in the young, but the customer expected it to be much more severe,” Australian infectious diseases specialist John Mackenzie said in an AFP report.

WHO flu chief Keiji Fukuda added that “H5N1 [bird flu] really sent up expectations not only among planners but also among populations. It really set the emotional tone.” He also said that the discovery that a single dose of swine flu vaccine was enough to provide protection for most people, instead of the two doses originally expected, had been “a big surprise,” according to AFP.

Governments now are trying to figure out what to do with their excess vaccine supplies. See here and here for more on that.

Photo: Associated Press

The recent history of a medicine used to treat gout provides another chapter in the book of unintended consequences. We’ll recount some highlights of the tale as spelled out in this morning’s WSJ:

A common gout drug, colchicine, has been around for so long that pre-dated the FDA and until last year, it had never been approved by the agency. As part of a push by the FDA to bring such drugs under its umbrella, a company called URL Pharma commissioned studies to show that colchicine was safe and effective, and last summer the FDA approved the company’s version and gave URL three years of marketing exclusivity for the drug.

Here come the unintended consequences. While the FDA says it hoped there wouldn’t be a significant run-up in the price of colchicine — sold as Colcrys by URL — the retail cost has soared to more than $5 a bill from the previous pennies a tablet. URL Pharma also sued five makers of manufacturers of colchicine, saying they have been illegally marketing their colchicine products since Colcrys’s approval. One of those makers has settled the matter and stopped production. The other four companies are fighting the lawsuit.

URL Pharma says it priced Colcrys in line with other approved, branded drugs used to treat gout pain. It’s also trying to help patients who need financial assistance, including providing a three-months’ supply to low-income patients for $15.

Further, URL Pharma says its trials helped make colchicine safer for everyone, noting there wasn’t even a standard dosage for the medicine until the company went through the FDA approval process.

“We took bad guidance, even guesswork, and made this evidence-based medicine,” URL Pharma CEO Richard Roberts said.

Photo: iStockphoto

This item by the WSJ’s Gerald F. Seib was first posted on the Capital Journal blog:

In Congress, tough votes have real consequences, as Rep. Bart Stupak has just reminded us. The question is: Which other lawmakers also have to worry about that harsh reality?

Stupak, a conservative Democrat from Michigan, announced Friday he’s retiring after nine terms. He was among the most influential figures in the just-completed health debate, first forcing the House to adopt tough anti-abortion language in is version of the health bill. Then he voted for a final version that didn’t have that same language, in exchange for a presidential executive order asserting that federal dollars wouldn’t pay for any abortions.

His reward: He went from hero to villain in the eyes of many in the anti-abortion movement, and became a target of tea party followers for voting in favor of the final legislation.

Stupak is insisting that his angry foes aren’t driving him out, but it’s likely that the idea of a tough and ugly re-election race didn’t make the idea of sticking around any more especially appealing to him.

But Stupak is hardly the only Democrat who cast a tough vote on health care that could color a re-election campaign this year. Among the others:

Colorado Rep. Betsey Markey has been targeted by health-overhaul foes for her vote in favor of the legislation, as the Journal has written. Beyond her, the Cook Political Report, which follows congressional races exhaustively, has noted the health-vote problems facing Democrats Steve Driehaus of Ohio, John Boccieri of Ohio and Earl Pomeroy of North Dakota. It also cites these Democrats who figure to have health-care issues:

–Rep. Ann Kirkpatrick, a freshman from Arizona. Her vote in favor of health overhaul “amounts to a big political risk in a substantially rural district with a libertarian streak,” the Cook report says.

–Rep. Suzanne Kosmas of Florida. “As if Kosmas’s switch from opposition to support of health care reform wasn’t enough of a leap of faith in a district that voted for GOP presidential nominee John McCain in 2008, her eleventh hour negotiations with the White House and Democratic leaders were a public relations mess.”

–Rep. Debbie Halvorson of Illinois. She “has done little to distance herself from the Democratic leadership on major votes.”

–Rep. Mike Arcuri of New York. His problem arises from fellow Democrats upset he ultimately voted against the health bill. The Cook report says “his vote against the Senate version of health care reform, which came just five months after his vote in favor of the House version, has drawn the ire of labor groups who now seem bent on giving Arcuri his comeuppance.”

–Rep. Kurt Schrader of Oregon. “Schrader, a former state senator, has voted with Democrats down the line on major votes, and this suburban district is the most marginal in the state.”

–Rep. Kathy Dahlkemper of Pennsylvania. Also an anti-abortion Democrat, Dahlkemper followed Stupak “from the ‘no’ to ‘yes’ camp, calling the bill a ‘whole-life’ piece of legislation.”

–Rep. Gerry Connolly of Virginia. The Cook Report says: “Knowledgeable observers say Connolly’s vote in favor of health care reform may soften some of his support in northern Virginia’s business community.”

Photo: Associated Press

Many college health-insurance plans fail to provide students with minimum coverage and often pay out far less in benefits than they collect in premiums, New York State Attorney General Andrew M. Cuomo says.

Plans with low coverage limits, numerous exclusions and high premiums “leave students at risk while providing massive profits for insurance companies,” the high-profile AG and likely NYS gubernatorial candidate said in a statement yesterday. He said his office has subpoenaed 10 insurers that are big players in the college health market as well as five insurance brokers, agents and others in the field.

Aetna, one of those receiving a subpoena requesting information, defended its plans. “The plans are very affordable based on the population; they average about $1,100 a year” and cover students “at home, at school and even internationally,” a spokesman told the New York Times.

A big issue here is the loss ratio — how much of their premiums collected are paid out in benefits. Plans in NYS usually have to have a ratio of at least 65% but Cuomo’s investigation found college plans that didn’t. Under the new federal health overhaul, most large plans, including college-sponsored offerings, the NYT says, will be required to have loss ratios of 85%.

But the federal overhaul will affect the college plans in another way because parents will be able to keep coverage for children until their offspring reach age 26, likely cutting into the college market. Cuomo said the college market — made up of generally healthy students — produces more than $1 billion in revenue for the insurers, which charge premiums anywhere from $100 to $2,500 a year for each policy.

Cuomo has written to more than 300 colleges advising them to check their plans for shortcomings and for conflicts with the new fed rules. No legal action has resulted from any of this, but memories are still fresh about Cuomo’s probe into student-loan practices that shook up a lot of colleges and lenders starting in 2007.

You can see Cuomo’s statement and those getting requests for information here.

Photo: Getty Images

And speaking of private equity (see our previous post), there is more chatter today that the owners of HCA are getting ready for a sale of stock in the hospital chain that could be the biggest U.S. IPO in two years.

HCA, the nation’s largest hospital operator by revenue, has been doing very well despite the economy and uncertainties connected with the health overhaul. With the operating environment looking to get stronger still, HCA’s owners are preparing to raise between $2.5 billion and $3 billion and maybe as much as $4 billion, Bloomberg News reported today.

HCA was acquired in a leveraged buyout four years ago that was led by private-equity groups KKR and Bain Capital, both of which declined to comment on a possible IPO, as did HCA, Bloomberg said. Others involved in the buyout included the Frist family, who co-founded Hospital Corp. of America. Bloomberg said money raised in the IPO would reduce HCA’s debt, which stood at $25.7 billion at year end.

Of course, there has been repeated talk of an IPO at HCA, which the WSJ ranks among “the most successful deals struck during the buyout boom from 2005-2007.” Helping fuel the talk these days is that the company is coming off strong financial results in 2009 and the outlook is cleared with the lifting of the overhaul-related worries.

Photo: Bloomberg News

.

We can fill in the another line on that always-popular list — Where Are the Ex-Pharma CEOs Now?

This time, the career move involves Bob Essner, who was CEO of Wyeth between 2001 and the end of 2007 and retired a few months later as chairman of Wyeth (now part of Pfizer) at age 60. Today, private-equity group Carlyle Group said that Essner (pictured in 2004) will become a senior adviser on the firm’s health-care investments.

Carlyle Group is a behemoth in private-equity circles and has plunked down money for a bevvy of health-care investments over the years (here’s a rundown from its Web site). Essner will help manage businesses like U.S. nursing-home operator HCR Manor Care and Qualicaps Group, a Japanese capsule manufacturer, the WSJ says.

Essner told the Health Blog earlier this year that the pharma industry today “is radically different than what I grew up in [it], in the ’80s and early ’90s.” He added: “It’s a much tougher environment. It’s in some ways a more punishing one, more cost-conscious and productivity-oriented.”

As Wyeth’s CEO, he led the company as it coped with the litigation fallout over a diet-drug cocktail known as fen-phen that ended up costing tens of billions of dollars. See more on his ups and downs at Wyeth, see here and here. Of late, Essner has been teaching at the Columbia Business School and is lead director on the board of Massachusetts Mutual Life Insurance.

Ex-CEO Fred Hassan of Schering-Plough (now part of Merck) has been working with private-equity firm Warburg Pincus and last month was named chairman of Bausch & Lomb, a Warburg holding. Soon to join the ex-CEO list is Bristol-Myer Squibb’s Jim Cornelius, who will remain the company’s chairman.

Buyout bonus: Clayton Dubilier & Rice announced ex-CEO A.G. Lafley of Procter & Gamble is joining that private-equity firm as a special partner. Here’s the WSJ article.

Photo: Bloomberg News

The FDA today disclosed several warning letters it had sent to drug makers and weight-loss spas for “false” and-or “misleading” claims for their products. Here’s a rundown:

• Biogen Idec was cited for a promotional Webcast involving the multiple sclerosis drug Tysabri because it minimized the risk of a serious brain infection, the FDA said. The letter also cited the company for failing to submit the Webcast for FDA review 30 days in advance. Tysabri is sold jointly by Biogen and Elan.
• Gilead Sciences was cited for a print ad for involving its HIV drug Truvada, which the FDA said overstated the effectiveness of the products and minimized the risks associated with the
  drug.
• Half a dozen spas offering “lipodissolve” injections to get rid of small fat deposits received letters because the FDA said the therapy hasn’t been cleared by regulators. “The claims made for your lipodissolve products are false and misleading in that they are not supported by substantial evidence or substantial clinical experience,” one letter said.

Update: A Biogen spokeswoman told Dow Jones Newswires that the company believed “the content and means for communicating this safety information was appropriate, timely, factual and non-promotional, and we plan to have further conversation with the agency.” Gilead said in a statement that takes the FDA’s concerns regarding the advertisements seriously “and we will be working to respond to the FDA promptly,” according to DJ Newswires.

The board of St. Vincent’s Hospital in lower Manhattan threw in the financial towel last night, voting to close in-patient services that had been a medical mainstay in Greenwich Village for 160 years.

The decision wasn’t a surprise, having dragged on for six months as the 727-bed hospital tried to come up with a rescue plan to handle $700 million in debt. Still, the closure will deal a blow to medical services in the area as well as marking the end of an institution filled with history.

St. Vincent’s was founded by four Sisters of Charity in 1849 to treat victims of a cholera epidemic and is the last Catholic general hospital in New York City. It treated victims from the sinking of the Titanic to the Sept. 11, 2001, terrorist attacks, and was one of the early institutions to respond to the AIDS epidemic.

New York state recently loaned St. Vincent’s $9 million and there was talk by politicians of trying to save a scaled-down version of some of the Greenwich Village facility. In the meantime, elective surgeries will end by April 14 while outpatient services and other facilities and services are slated to stay open in hopes of lining up partners or other operating plans.

Here’s more from the WSJ, New York Times and the Associated Press. St. Vincent’s has put out info starting here.

Photo: Associated Press

A two-year climb in the rate for teenagers having babies ended in 2008, according to the latest government data that also confirmed the overall U.S. birth rate declined for the year.

A report issued today by the CDC found the teen birth rate dropped 2% in 2008 and the rate for Hispanic teens hit a two-decade low. There had been declines in the birth rate for U.S. girls ages 15 to 19 between 1991 and 2005. Then increases in the birth rate among teens for the next two years had caused worry among public-health officials that the climb might be becoming permanent.

“This is good news,” said Stephanie J. Ventura of the National Center for Health Statistics, told the Washington Post regarding the latest teen data. “It might come as a surprise because people were concerned the teen birth rate was on a different course.”

Birth rates in 2008 also fell for women in their 20s and 30s, and the overall birth rate declined 2%. Officials said that could be linked to the economic downturn and a slowdown in immigration to the U.S. resulting from the weak job market.

Bucking the downward trend, however, were women over 40. Those in their early 40s posted a surprising 4% rise in their birth rate last year, reaching their highest mark since 1967. The data show that the older women got, the less willing they were to postpone a birth, the report’s lead author, Brady Hamilton of the CDC’s National Center for Health Statistics, told the Associated Press.

Image: iStockphoto

Anyone who follows health IT knows that the Department of Veterans Affairs often gets high marks for being an early adopter of electronic medical systems in the U.S. Now a study in Health Affairs tries to put a price-tag on what the VA systems collectively called Vista, for Veterans Health Information Systems and Technology Architecture.

The bottom line: “We conservatively estimate that the VA’s investments in the four health IT systems studied yielded $3.09 billion in cumulative benefits net of investment costs by 2007,” say the authors, a team from Center for IT Leadership at Partners Healthcare in Charlestown, Mass. The results looks at measures such as reduced workloads, freed workspace and savings from items such as unneeded medical tests and avoided hospital admissions.

The biggest VA outlay — and its biggest savings generator — was the Vista’s Computerized Patient Record System, the home-grown system for electronic health records that was found by the study to cost $3.6 billion. Other IT networks for administering medications with bar codes, picture archiving and communication systems and the Laboratory Electronic Data Interoperability application together cost $470 million.

The study also did comparisons between the VA and the private sector. It found the government agency had spent proportionally more on IT than the private sector but could claim better performance in such areas as cancer screening and better glucose measures for diabetics.

The authors cites lots of limits on their data. They also note the VA has a unique, integrated structure that is more likely to produce results from IT projects and is hard to match in the private sector. In short, they say your results may vary.

Here’s an abstract of the study. For those who can’t get enough of this stuff, the latest issue of Health Affairs has numerous other articles on the track record and outlook for health IT in the U.S.

Photo of VA medical record system by Joshua Roberts/Bloomberg News

These look to be good times for the generic drug makers. Copycat drugs accounted for 75% of the U.S. prescription drug volume last year, up from 57% just five years ago, data tracker IMS Health reported just last week.

All well and good, but even with billions in potential sales coming available as branded blockbusters lose their patent protection, makers of generics are likely to face a tougher road ahead on several fronts, the WSJ’s Heard on the Street column argues this morning. The key dangers cited in the column:

• New upstarts are boosting generic competition. One analyst cites the case of Camber Pharmaceuticals’ recently introduced generic version of the blood-pressure drug Norvasc. It took nine percentage points of market share over just a few months, largely at the expense of Mylan, itself a big generic manufacturer.
• Branded giants like Pfizer have gained experience with generics. Pfizer’s market share of its epilepsy drug Neurontin slipped to 10% when the compound went off patent in 2004, but has said that after it introduced a generic Neurontin, its share returned to 50% of U.S. prescriptions.
• Stepped-up product recalls make safety a greater concern. The big Indian generic maker Dr. Reddy’s has recently recalled batches of four different drugs and slowed overall production.

One positive for generic makers is that the new health legislation in the U.S. doesn’t seem to pose problems for them, the column says. A proposal to do away with so-called pay-for-delay deals — under which generic and branded makers reach deals that often slow the introduction of the copycat versions — didn’t make the final version of the overhaul bill.

Image: iStockphoto

The costs that corporations say they will have to pay because of the new health legislation continue to climb as Verizon Communications said it will post a one-time charge of $970 million in the first quarter.

The overhaul blocks companies from deducting tax-free subsidies they get from Washington for providing retirees with prescription-drug benefits. That change doesn’t kick in until 2013, but companies are taking the charges now in anticipation.

That’s a bone of contention as the Obama administration officials have said companies are exaggerating the overhaul’s impact because they don’t like the new law. The charges are only a bookkeeping move and don’t require cash payouts by the companies, but corporate tax bills will eventually go up.

First-quarter charges related to the retiree drug benefits for companies in the Standard & Poor’s 500-stock index could reach $4.5 billion and affect as many as 1,400 corporations, some analysts say.

Companies with large groups of retirees will be affected most by the change. AT&T last week announced a $1 billion charge; Verizon’s charge of $970 million is the second largest so far, according to Dow Jones Newswires. Others high on the list include, Deere & Co. ($150 million), Boeing ($150 million), Caterpillar ($100 million) and Prudential Financial ($100 million).

Since the Medicare Part D program was enacted in 2003, the federal government has been providing the tax-free payments to the companies as an incentive to maintain their drug-benefit programs. More on the charges is here and here.

Image: iStockphoto

First the problem was getting enough vaccine to treat the first flu pandemic in decades. Now the problem is getting rid of millions of doses of the H1N1 vaccine before they go bad.

An estimated 71.5 million of the 229 million doses of swine-flu vaccine bought by the U.S. have been put in vials and syringes and will have to be discarded if they aren’t used before their expiration date, the Washington Post reported this morning. That’s after 25 million doses bought by the U.S. are sent to poor countries, the paper said.

Flu followers know that the latest pandemic hasn’t delivered the worst-case punch feared in the U.S. or in Europe, where governments also are trying to figure out how to unload unused vaccine supplies. Delivering the vaccine supplies was delayed by production problems, but after seeing two waves of swine flu that mostly affected children and young adults, many older people decided the pandemic wasn’t severe enough to worry about getting vaccinated.

The reasons for the relatively mild H1N1 outbreak — it still has killed some 12,000 Americans — haven’t been fully explained, but experts continue to warn that this could be the calm before a third wave of the flu. U.S. Surgeon General Regina Benjamin warned this week that the “flu season is not over.”

Between 72 million and 81 million Americans are estimated to have been immunized, a figure government officials told the Post they were largely satisfied with. That’s even though millions of vaccine doses purchased under the $1.6 billion program will likely go to waste.

“We were dealing with a very unusual situation. We had a pandemic. We had young people being killed,” the CDC’s Anne Schuchat told the paper. “We wanted to make sure we had enough. We didn’t want to be short. It was important to us to be able to protect the American people.”

Photo: Associated Press

The horse-trading that helped win doctors’ support for the health-care overhaul included replacing a proposed 5% tax on Botox treatments and elective cosmetic procedures with a 10% tax on indoor tanning services.

The tanning tax made it into the final law and is supposed to raise $2.7 billion over 10 years. The tanning industry’s trade group has been saying anyone who thinks the revenue target is realistic has been standing out in the sun too long. “It’s almost laughable,” the head of the Indoor Tanning Association told the WSJ in December.

An article in the Hill today walks through the math in more detail, using the association’s estimate that there are about 25,000 tanning-bed salons, including some gyms and nail salons, that would be subject to the tax. On that basis, each tanning business would have to collect $108,000 in taxes over the decade to get to the $2.7 billion revenue estimate, the group says.

Some 30 million Americans currently visit tanning salons at least once a year, according to the group. Based on an estimated cost of $7 per session, those customers would have to make about 3.9 billion visits over the decade to hit the tax target.

The Joint Committee on Taxation, which came up with the $2.7 billion figure, told the Hill it couldn’t divulge the economic models it used for the revenue estimate.

Dermatologists and other backers of the tanning tax, which doesn’t apply to sessions done for medical reasons, say it’s a good idea because it will discourage people from being exposed to added cancer risk.

Correction: This post originally said each tanning business would have to collect $108 million in taxes over the decade to get to the $2.7 billion revenue estimate.

Photo: iStockphoto

The U.S. Chamber of Commerce plans to spend $50 million in the months leading up to the fall elections in a continuing push against the health-overhaul legislation, the WSJ reports.

“The Chamber is going to carry a message across the country that says the health care debate is not over,” Thomas J. Donohue, the business lobbying group’s president and CEO, said in a letter sent to the chamber’s board members late Monday. The law “is a major step in the wrong direction and will prove to be a serious drag on our economy and the nation’s fiscal solvency,” Donohue wrote.

President Obama signed the reconciliation bill today, wrapping up the final changes to the health overhaul expected to cost $938 billion over the next decade. “This day affirms our ability to overcome the challenges of our politics and meet the challenges of our time,” Obama said during a signing ceremony.

But the chamber made clear in its letter that the health debate continues. It said the group will be paying close attention to the new regulations coming out of the health bill, devoting a staff team to monitor the rules being formulated. If regulators “exceed legislative mandates or try for end-runs around the lawful rulemaking process,” he wrote, the chamber “will take legal action.”

Medicare Bonus: Medicare payments to doctors won’t be cut April 1 when a 21% reduction was scheduled to go into effect, the agency that oversees Medicare has ordered. Read more about the latest temporary fix here.

AP Photo/Pablo Martinez Monsivais

A few items of interest involving the FDA:

Congress last year added the tobacco industry to the FDA’s regulatory mix and today a panel of health experts making up the agency’s new Tobacco Products Scientific Advisory Committee is kicking off a two-day meeting. First on the agenda: how menthol flavoring in cigarettes affects smokers’ habits.

Small wonder that menthol is getting early attention, says the New York Times, which notes menthol butts account for almost a third of the $70 billion U.S. cigarette market. After more meetings, the advisory panel will send recommendations to the FDA, which could eventually decide to ban menthol products or take steps to curtail their marketing, Dow Jones Newswires says.

At a meeting of a separate FDA advisory panel today, experts will hear testimony about the amount of radiation exposure Americans receive from CT imaging scans and whether the benefits of the technology are worth the cancer risk from overuse.

The issue is well-traveled territory (see here, here and here), but the NYT reported earlier this week that FDA bosses had ignored warnings from its scientists about routine use of CT scans for colon cancer. A former FDA scientist told the panel today that he was fired after raising concerns about the risks of radiation exposure from high-grade medical scanning, according to the Associated Press.

The FDA said late last year it wanted more time before deciding whether Cephalon’s sleep-disorder drug Nuvigil could also be used as a treatment for jet lag. Yesterday the drug maker said it received a complete response letter from the FDA, meaning no approval for jet-lag use — at least for now.

Cephalon gave the FDA data on 427 people who flew from the eastern U.S. to France. Those who took Nuvigil for three days showed a statistically significant improvement of jet-lag symptoms over those who took a placebo, the company said. But the FDA questioned the quality of some of the data, according to Cephalon, which said it would work with the FDA on how to proceed.

Cephalon has been eager to expand uses for Nuvigil, which has patent protection through 2023. Cephalon’s predecessor drug for sleep disorders, Provigil, could face generic competition as soon as 2012.

The problems facing Boston Scientific over implantable heart defibrillators have grown deeper as federal authorities are delving into events causing the company’s recent recall of the devices.

The Justice Department has sent Boston Scientific a subpoena seeking documents, and the Securities and Exchange Commission has begun an informal inquiry, according to an internal company memorandum detailed in a WSJ article this morning. The company declined to discuss the memo that Boston Scientific General Counsel Timothy Pratt sent to certain employees Friday, the Journal said.

The disclosure adds to the woes of Boston Scientific as it tries to get its seven brands of defibrillators back on the market after a recall earlier this month. The recall was sparked by the company’s disclosure that it had failed to obtain FDA approval before implementing some manufacturing changes. Boston Scientific said it had no reports of patients being injured.

The federal investigators want company documents on how it discovered the problem as well as communications with regulators, doctors and stock analysts, the WSJ said. SEC and Justice officials declined to comment.

Boston Scientific is also under a separate Justice investigation looking into whether it and other companies marketed so-called surgical-ablation devices, which destroy small segments of heart tissue, for unapproved uses. Boston Scientific notes it’s no longer in that business.

Last year, Boston Scientific agreed to pay $296 million and plead guilty to two misdemeanor charges to settle a Justice probe into problems with defibrillators made by its Guidant unit. More on that here.

Photo by CarbonNYC via Flickr

A simple test blood could help doctors determine which multiple-sclerosis patients will respond to the top-selling MS drug, sparing patients not likely to benefit the cost and flu-like symptoms connected with the treatment.

A study led by Stanford researchers said that sorting between those likely and unlikely to respond to the drug beta-interferon was possible with the test that is slated to be submitted to the FDA for approval in a year or two, the WSJ says today. Stanford has already applied for a patent on the blood test.

Multiple sclerosis is a nervous-system disease that damages the myelin sheath surrounding nerve cells, interferring with vision and causing muscle weakness. It affects 400,000 in the U.S., most of whom suffer from periodic bouts of the disease.

Interferon can help delay relapses of the disease for some MS patients. But the drug also causes side effects such as aches and fever, sometimes discouraging its use by patients who may not know for long periods if it is helping them or not. Injections of the drug also can cost $25,000 or more a year.

Interferon is a $4 billion a year drug made in various forms by companies including Biogen Idec, Bayer, Elan and Novartis. An official from Biogen quoted in the WSJ article described the work as “interesting but preliminary” and said it “could be a very useful advance for MS patients.”

The research was done first in mice, and then using blood samples from 26 MS patients. Here’s a summary of the article published online yesterday in Nature Medicine and a writeup on the study by the National Multiple Sclerosis Society.

Image of human interferon molecule by iStockphoto