Author: James A. White

  • Wait! Could There Actually Be Votes on Health Care Up Ahead?

    logoIt’s another Monday and another week of to-ing and fro-ing on the health-care bill in Washington. But this week is different because there could actually be votes on the legislation.

    The gameplan has been set for a while now: first the House passes the same health bill approved in the Senate on Christmas Eve and that completed legislation goes to President Obama for his signature. The ink on that may hardly have time to dry before the House then takes up a package of changes to the new health law.

    Those changes — sometimes called a “sidecar” in Washington talk, the WSJ tells us this morning — would add more subsidies for low-income people to buy coverage than are contained in the health bill just passed. There are also other related amendments as well as completely unrelated changes to federal student-loan programs that Democrats also decided to load in the sidecar. Both House votes could take place this week.

    Next the sidecar has to pass the Senate. Using the reconciliation process we’ve heard so much about, Democrats would be able to get those changes through with 51 votes. Assuming that happens, the sidecar goes to the White House for the presidential fountain pen (or more likely, pens).

    Of course, pitfalls await the plan. Congressional aides figure there are more than 200 House votes committed to voting yes, but still short of the 216 Democrats need. Suspicions remain in the House that the Senate will balk and decide not to pass the sidecar.

    Assuming everything falls into place, then it’s only a matter of implementing and paying for what’s contained in the 2,700 pages of the health bill. And Republicans warn that Democrats will have “poisoned the well” on other issues if they force through the health overhaul.


  • Tough Talk About the Health Overhaul, Coming From Democrats

    pollThere are some harsh words for Democrats trying to overhaul health care in the Washinton Post this morning.

    Comprehensive health care has been lost. If it fails, as appears possible, Democrats will face the brunt of the electorate’s reaction. If it passes, however, Democrats will face a far greater calamitous reaction at the polls. Wishing, praying or pretending will not change these outcomes.

    Such rhetoric is common coming from Republicans these days, but this is different. The broadside comes in an opinion piece from Patrick H. Caddell and Douglas E. Schoen, pollsters for the last two Democratic presidents, Jimmy Carter and Bill Clinton. The pollsters agree that health care needs to be retooled, but they say that horse has left the barn.

    Health care is no longer a debate about the merits of specific initiatives. Since the spectacle of Christmas dealmaking to ensure passage of the Senate bill, the issue, in voters’ minds, has become less about health care than about the government and a political majority that will neither hear nor heed the will of the people.

    Bottom line, write Schoen and Caddell: “Unless the Democrats fundamentally change their approach, they will produce not just a march of folly but also run the risk of unmitigated disaster in November.”

    Illustration: Getty Images


  • What Student Loans Have to Do With the Health-Care Bill

    logoSome wrinkles in the health-overhaul orchestrations are in the news this morning:

    Washington Democrats are working on an idea to pair the health-care bill bill with another Democratic priority of increasing federal aid for college students. The notion isn’t a firm plan, but as Senate Budget Committee head Kent Conrad told the Washington Post, “I’d say yes, we’re leaning toward it.”

    Mixing the health and education bills might seem a stretch, but Democratic backers figure it might give them a 2-for-1 legislative bang. Dems already plan to use the reconciliation process in the Senate to make fixes to the version of the health bill passed by the Senate on Christmas Eve.

    Adding the education package to the reconciliation vote, which requires a simple majority for passage, could mean both pieces of legislation would clear the Senate without a filibuster. The overhaul of the student loan programs in the education bill is another of the Obama administration’s domestic priorities.

    As for the health overhaul, Democrats remain vexed about how to handle abortion restrictions, but party leaders appear willing to write off the votes of a dozen or so antiabortion Dems in the House if need be, the New York Times reports. The House abortion foes want tougher language to ban using federal subsidies to pay for abortions than those contained in the current Senate legislation.

    One compromise would be for the House foes to accept the Senate language initially and then tighten the provisions later. But doubts persist. “I’m not going to trust that [tougher language] is going to pass the House and Senate” after the original bill passes, said Dem Rep. Daniel Lipinski told the WSJ.

    Just when health-care bills will be put to a congressional votes remains up in the air. Lawmakers haven’t seen the latest draft texts and the Congressional Budget Office hasn’t calculated estimated costs. A March 18 target, which President Obama had hoped for, isn’t workable at this point, everyone was saying yesterday.

    But House leaders now want the vote to occur before a two-week spring break scheduled to start on March 26, the NYT said. More meetings by House Democrats are slated for today.


  • Starting on the Long Road to Accrediting a Med School

    stethoscope on booksConnecticut’s Quinnipiac University announced earlier this year that it wanted to open a medical school, beginning a push that will take until 2013 or 2014 to get the first med students in the door.

    The new school would be located in several buildings that the university, located near New Haven, purchased in nearby North Haven from WellPoint’s Anthem unit for $32 million several years ago. Read more on the plans here.

    Schools like Quinnipiac that want to grant MD degrees go through a lengthy process required by the Liaison Committee on Medical Education. The panel is made up of med-school officials, practicing docs, public members and med students. It currently has 132 fully accredited schools in the U.S. schools and 17 in Canada.

    Seven new schools — two each in Michigan and New Jersey and one each in California, Florida and South Carolina — have reached applicant status with the committee, meaning they has gotten through the preliminaries and paid a $25,000 fee. Another, Hofstra University in New York, is currently the only one at the next step in the process when the first site visit by the LCME takes place,

    Six schools now have preliminary accreditation, meaning they can recruit and accept students. This group now includes two more Florida schools and others from Michigan, Pennsylvania, Texas and Virginia.

    One last level (no schools currently here), a few more hurdles like a final vote and at last — it’s accreditation time. For lists of the schools at different levels on the accreditation journey, see here.

    Image: iStockphoto


  • In Massachusetts, the Pros and Cons of New Imaging Technology

    imageFast-growing spending on imaging tests in Massachusetts gives a closeup view to the many-sided question of whether improved technology is really worth the extra cost.

    The facts, as laid out by the Boston Globe this morning: Spending on MRIs, mammograms, and other imaging tests for privately insured Massachusetts residents jumped 20%, or $214 million, between 2006 and 2008, according to consultants hired by the state. Doctors ordering more tests was one reason for the added spending.

    Digital mammography was another prime driver as some insurers pay more for these breast-screening tests and hospitals have invested upward of $400,000 for such new machines, compared with $100,000 for earlier units. The digital technology is faster and can be used with electronic health records.

    But there hasn’t been any evidence that digital mammograms hold a significant edge in detecting cancer in most women compared with older tests, the Globe says. It also turns out that more imaging tests these days are being done in hospitals, which charge more for the services than independent clinics.

    “A scan done in a hospital is of no better quality and is not being read by a more qualified radiologist than one done in a freestanding clinic,’’ the paper quotes an official at insurer Harvard Pilgrim Health Care as saying. On the other side, the Globe writes that hospital officials believe

    the state’s consultants overstated the role higher provider fees are playing in pushing up costs. And, they said, the increase in the number of scans has slowed significantly since 2008, as more insurers began requiring preauthorization for certain scans.

    A company that manages radiology benefits for insurers also tells the Globe that makers of imaging equipment lobbied Congress for higher payments from Medicare to encourage service providers to buy the new technology and helping generate premium payments from private insurers for tests done with digital gear.

    Photo: Associated Press


  • Heart Roundup: Device-Maker Probes, Too Many Angiograms

    heartThe annual meeting of the American College of Cardiology gets underway this weekend and some heart-related items are in the news this morning:

    Documents from leading medical-device makers suggest some companies seem to have encouraged the use of surgical ablation to treat atrial fibrillation, a front-page article in the WSJ reports. The problem, of course, is that the devices that can carefully destroy heart tissue linked to A-fib troubles aren’t FDA-approved for that purpose. A-fib is the most common type of faulty heartbeat.

    The Justice Department is investigating and has won settlements with two lesser-known device makers. A former device saleswoman who brought those two cases has also sued Boston Scientific, Medtronic and St. Jude Medical. The DOJ hasn’t joined in those cases and the companies say none of their top execs were involved in any illegal marketing of the devices. More on the situation is here.

    Coronary angiograms, widely used tests to detect artery blockages in the heart, often turn up little or no evidence of disease, a study in the New England Journal of Medicine found. That suggests that the more than a million U.S. patients who undergo the diagnostic test each year at a cost of about $10,000 each, are frequently exposed to unneeded risks of a costly procedure, the WSJ says in another article.

    The study of nearly 400,000 angiograms performed between 2004 and 2008 in the U.S. found that 62% of the patients didn’t have evidence of significant obstructions, while 38% had important blockages. Of course, a clean angiogram can still provide useful informaton and the findings don’t apply in cases when there is established heart disease or the threat of an imminent heart attack. Patients included in the study weren’t previously diagnosed with heart disease and represent about 20% of those who get angoigrams.

    Still, the data indicate overuse of angiograms. “We’ve got to get much smarter about how we’re ordering and interpreting these tests,” a Mayo Clinic cardiologist told the WSJ.

    Photo by CarbonNYC via Flickr


  • FDA to Review Bone Drugs After Studies Report Hip Breaks

    boneThere have long been safety questions — and lawsuits — over whether bone-building drugs like Merck’s Fosamax can actually increase the chance of femur fractures. Today, the FDA said it was going to take another look at the safety issues.

    In a posting on its Web site, the FDA said a 2008 examination of data from makers of osteoporosis drugs containing bisphosphonates didn’t show that women taking the medications had an increased risk of fracturing their femurs — the bone just below the hip joint.

    But studies released today at the annual meeting of the American Academy of Orthopaedic Surgeons raised new questions about the risks for long-term use of bisphosphonates by post-menopausal women. USA Today has more.

    In its latest review, the FDA said it would work with outside experts on the matter. While that’s happening, people on the medications should continue taking them but should talk to their doctors if get any new hip or thigh pain, the agency said.

    Bisphosphonates have combined annual sales topping $3.5 billion. In addition to Fosamax, drugs in the group includes Actonel marketed by Sanofi-Aventis and Warner Chilcott, Boniva marketed by Roche and GlaxoSmithKline and Novartis’s Reclast. Reuters and Dow Jones Newswires have more details.

    Merck is defending itself against more than 900 product-liability lawsuits by patients mostly claiming Fosamax caused death of their jaw-bone tissue. The FDA more recently has held up approval of other drugs in the bone-treatment pipeline as the agency has sorted through a variety of safety concerns.

    Correction: An earlier version of this post said incorrectly that Actonel was marketed by Procter & Gamble,

    Photo: Associated Press


  • Not ‘War and Peace’ But Orphan-Drug Applications Are Few

    fdaThe Orphan Drug Act has been around since 1983 offering tax incentives and competition protection for drugs aimed at treating rare diseases. But there have been relatively few orphan drugs developed, so the FDA is beating the bushes for more participation.

    FDA staffers recently ran a two-day workshop in Claremont, Calif., to help drug developers fill out the application to get orphan-drug status, the WSJ says in an article this morning. Another workshop is planned for the University of Minnesota in August and there’s talk about doing one in Europe.

    There are roughly 350 orphan drugs currently approved, covering about 150 rare diseases. The core requirement for orphan status is that the medicine treats a disease affecting fewer than 200,000 Americans, a limited market that often makes such treatments very expensive. Last year, 250 requests for orphan designation were filed with the FDA, and 160 received it.

    Of course, getting more applications doesn’t mean more drugs will make it through the FDA approval process, orphan status or not, the WSJ notes. But the FDA officials with the orphan program hope that increasing the application pool will boost the chances of getting more rare-disease treatments to market.

    The first workshop drew 29 potential sponsors, three-quarters of which said they had never filed an orphan-drug application before. Not that the process is really that hard. “It’s not ‘War and Peace,’ ” an FDA official told the WSJ. “The applications are six or seven pages.”

    Case history bonus: See here for the story of a mother seeking orphan status for a drug to help her twin girls with a rare but deadly cholesterol metabolism disorder.


  • As Health-Care Finale Gets Closer, Both Sides Boost Spending

    adsIt’s crunch time in the fight over a health-care bill, so groups for and against the legislation are getting ready for a final push before congressional votes that could come later this month.

    These efforts take money, of course, and advocate groups have put together war chests, much of it slated to go to advertising. Here are some of the spending plans outlined in a WSJ report this morning:

    • A business coalition backed by the U.S. Chamber of Commerce and other groups will allocate between $4 million and $10 million on anti-bill ads. They will be targeted against several dozen Democratic lawmakers with the message that the changes would cause job losses.
    • Another anti-overhaul group, Americans for Prosperity, will use radio and TV ads in about 21 House districts, spending $350,000. It also plans rallies at lawmakers’ district offices.
    • Some labor unions and progressive groups called Health Care for America Now are running $70,000 in TV ads in Washington. The ads tell Congress to “listen to us, not the insurance companies. Pass health-care reform now.”
    • Seniors group AARP, a heavy spender on TV ads backing a revamp earlier, now is concentrating on contacting constituents in districts with wavering lawmakers to boost support for the bill.

    Meanwhile, the health insurance industry is starting to show ads on cable TV networks aimed at blunting White House criticism of insurance rate increases, USA Today reports. The industry group America’s Health Insurance Plans says it’s spending at least $1 million on the ads, but won’t elaborate.

    More than $200 million was spent on ads during the overhaul debate last year, making the health-care fight the largest single advocacy campaign ever, according to Campaign Media Analysis Group, which tracks issue advertising. Spending on both sides was about equally split last year, the group tells the WSJ.

    Photo of Washington protest Tuesday by Agence France-Presse/Getty Images


  • InterMune’s Lung Drug Gets Backing From FDA Panel

    pillAnother day, another stock-price jump.

    First, the preliminaries: An advisory panel this afternoon recommended the FDA approve a lung drug developed by InterMune, with majorities of the outside experts saying the proposed treatment appeared effective and safe.

    The FDA is expected to decide by early May whether to go along with the panel’s recommendation on pirfenidone, which is intended to treat patients with idiopathic pulmonary fibrosis. The FDA usually follows the lead of its advisory committees.

    This all comes as good news for investors in InterMune, whose shares streaked nearly 60% higher Friday because the questions posed by the FDA staff for today’s advisory committee meeting weren’t uniformly negative.

    The stock price then barely budged yesterday and trading in the shares was halted today in anticipation of the meeting news. But in after-hours trading today, the news sent the shares soaring up 65% to $38.43. That compares with the stock’s price under $15 at the close last Thursday.

    The experts voted 7-5 on the question of data for pirfenidone showing “substantial evidence” of effectiveness. The medicine passed the safety vote 9-3. InterMune had told the panel that “pirfenidone provides a clinically meaningful benefit to patients by reducing decline in lung function.”

    Panel member Leslie Hendeles of the University of Florida told Dow Jones Newswires that he didn’t think the data met FDA’s substantial-effectiveness test, but he voted in favor of the medicine because he would want a chance to take the drug if he were diagnosed with pulmonary fibrosis.

    The FDA is giving the InterMune drug candidate a priority review process that’s reserved for advances over existing treatments. There aren’t any FDA-approved drugs now for IPF. Here’s more on the disease.


  • Obama Takes Case Against Health Insurers on the Road

    logoPresident Obama was back on the campaign trail Monday, using his election-style oratory to stump for a health-care overhaul that still awaits an uncertain fate in Congress.

    As is the case routinely these days, the president took aim at health insurers. He lambasted them 22 times in a speech to a college audience near Philadelphia, according to the Washington Post. “How much higher do premiums have to rise until we do something about it,” Obama said in the speech punchline.

    HHS Secretary Kathleen Sebelius yesterday also sent off a letter to officials of big health insurers calling for them to publicly justify their proposed hikes in insurance premiums. This follows the in-person grilling the execs got in Washington last week. Here’s more from the WSJ.

    Meanwhile, part of the latest Obama overhaul proposal that is supposed to help hold down those premiums got some negative reviews this morning. As proposed by the president, the Health Insurance Rate Authority overseen by HHS would have the power to survey health-insurance premium increases and step in to thwart those considered excessive.

    But there could be a problem with that setup, the New York Times reports. It notes that while federal officials are focusing on holding down premiums, state officials will have to make sure of the solvency of the insurers they regulate.

    Of course, curbing premiums doesn’t necessarily do anything to hold down the cost of providing care — the things that doctors and hospitals charge for. “You can’t separate the underlying solvency of companies from the rates they charge,” the Wisconsin insurance commissioner tells the NYT.


  • Merck, Sanofi Herd Animal-Health Businesses Into One Corral

    sanofiChances have been good that Sanofi-Aventis and Merck would re-establish their animal-health joint venture, as company officials have been more than hinting for months. Today, the reunion plans became official.

    The combined business would be the largest seller of animal drugs and vaccines in the world, the companies said, although the deal still will have to pass muster with antitrust watchdogs. Here’s more from Dow Jones Newswires and Reuters.

    Of course it was because of antitrust reasons that the companies had to break up their joint animal business called Merial last year. Merck was taking over Schering-Plough, which also had significant animal-health operations, so Merck sold its 50% Merial stake to Sanofi for $4 billion. The companies figured they might together again on animal care down the road.

    Now, the planned combination of Merial with the Merck-owned Intervet/Schering-Plough business would surpass No. 2 Pfizer in animal-health sales, even after any divestitures, officials said. One area in which the venture may have to dispose of operations is poultry vaccines, where their combined market share would be about 75%, DJ Newswires notes.

    Why all this interest in taking care of animals? Sanofi CEO Chris Viehbacher said it was because of growth expected in emerging markets and because of an aging population, which is seen as favorable to pet ownership, according to Reuters.

    The animal-health market is estimated at $19 billion, and should grow 5% annually through about 2014, the companies said. They hope the deal will close within 12 months.

    Photo: Bloomberg News


  • Soft-Drink Score: Lower Sales in Schools; More Talk About Taxes

    sodaThe sales volume of soda and other drinks shipped for sale at U.S. secondary schools has dropped 72% since late 2004, resulting in an 88% drop in beverage calories sold in schools, drink makers said today.

    Local and state regulations aimed at curbing sweetened beverages in schools explain part of the decline, but a report by the American Beverage Association also says its efforts played a big role, according to the WSJ. Soft-drink consumption nationwide is also down, but the report by the industry group didn’t look at consumption habits by kids out of school.

    The results come as efforts to fight childhood obesity have gotten a recent boost from First Lady Michelle Obama Let’s Move drive and other pushes. Beverage makers pledged in 2006 to push to eliminate sales full-calorie sodas in schools, joining in a drive with the American Heart Association and the William J. Clinton Foundation. American Heart Association President Clyde Yancy told the WSJ he was “really floored” by the decline in soda with calories sold and the change in product mix.

    The drop in school consumption might become a talking point for the industry to argue against taxes on sweetened drinks that are getting more attention from politicians facing budget gaps. NYC Mayor Michael Bloomberg said yesterday said that such a state tax proposed in New York ”just makes sense” to fight obesity and help with deficits.

    New York state has been down the road before, but a 2009 effort stalled in the face of fierce opposition. The latest proposed tax would raise an estimated $1 billion in annual revenue and would be dedicated mostly to health-care spending, the New York Times reports.

    In Philadelphia, city officials have proposed a tax on sweetened beverages they say would raise $77 million a year.

    Photo: iStockphoto


  • InterMune Stock Gets Boost as FDA Staff Questions Lung Drug

    pillThe FDA staff said it has a bunch of questions about InterMune’s new drug to slow deteriorating lung functioning. But investors figure the concerns weren’t as bad as they could have been, sending the biotech’s shares soaring.

    The stock jumped as much as 74% after FDA reviewers said only one of InterMune’s two late-stage trails for the experimental drug pirfenidone had met its main goal and added that “the clinical significance of the treatment effect size is uncertain.” The FDA documents, which were released ahead of an advisory panel meeting to discuss the drug Tuesday, also had a mix of other things to say.

    All things considered, an Oppenheimer analyst noted the “tone was less negative than expected,” all things considered and there was room for the drug to still get FDA approval. The shares settled down in later trading, but still finished up nearly 60% for the day.

    InterMune often appears on lists of likely biotech takeover candidates. FDA approval of pirfenidone would give it two drugs on the U.S. market.

    The new drug would treat idiopathic pulmonary fibrosis, which affects about 200,000 Americans, the majority of whom eventually die of respiratory failure. The FDA noted that there aren’t any approved drugs to treat IPF, although drugs like corticosteroids and drugs that suppress the immune system are used, according to Dow Jones Newswires.

    The company also put out material noting that “the slowing of progression in loss of lung volume constitutes a clear benefit to patients,” Reuters said. Here’s more from the company.
    .


  • Abortion Remains High Hurdle in Health-Care Push

    logoThe overhaul swirl of late has been focused largely on medical costs, insurance regulation, coverage mandates and the like. One pivotal issue has gotten less attention: abortion.

    Republicans remain opposed to the health-care revamp, whether or not the legislation bans the use of federal money for abortion. But as many as a dozen Democrats in the House – a big number in this showdown – could vote against the overhaul if it doesn’t contain stiffened abortion restrictions like what House passed in November, Rep. Bart Stupak has said.

    There’s no solution to the impasse yet, but Democratic leaders are urging their fold to avoid making abortion a deal breaker. “This is not about abortion,” said Speaker Nancy Pelosi said yesterday, the Associated Press reported. “This is a bill about providing quality affordable health care for all Americans.”

    But the divide remains. Actually, neither camp on the abortion issue like mild abortion restrictions that passed the Senate in December, which is supposed to serve as the basis for the final legislation.

    “Abortion rights advocates have grown increasingly convinced that the language would restrict the reach of abortion coverage nearly as much as the Stupak language in the House bill passed in December,” the Washington Post said this morning. (The Stupak measure would require abortion coverage to be purchased separately to avoid using federal subsidies for health insurance.)

    Politico reported that Roman Catholic bishops have signaled that they could reach agreement with House leaders on anti-abortion language, the church would work to get the votes needed to protect those provisions in getting through the Senate. Approval in the Senate of abortion provisions still would need 60 votes to avoid GOP attempts to block it.


  • Another Plus Month for Health-Care Jobs

    jobsThe government said this morning that the unemployment rate held at 9.7% in February for the second month in a row. The health-care sector added 12,000 jobs.

    That continues the series of monthly job gains that has made health care an economic bright spot since the start of the recession. Read the latest Bureau of Labor Statististics summary.

    For February, the subsector for ambulatory health-care services posted the largest runup, adding 6,700 jobs. Nursing and residential-care facilities hired another 4,000, according to the BLS breakdown.

    Bonus: The economy and still-high unemployment rate may help explain why seasonal flu has seemed so mild this winter, according to research cited by our colleagues at the Real Time Economics blog. You can read why here.

    Image: iStockphoto


  • Storm Brews Over Snow-Related Firings at DC Hospital

    cancelHere’s a winter storm warning: show up for work during a blizzard or lose your job.

    Washington Hospital Center has fired eight more employees who didn’t show up for work during last month’s snowstorms that blanketed DC, the Washington Post reports today. That’s on top of 16 workers who had been previously fired. Three of those people have now been rehired, putting the termination count at 21 — 15 nurses and six support people, according to the WaPo.

    The storms were doozies but the hospital prided itself on keeping operations as normal as possible (see video below). In a staff memo released by the hospital, CEO Harrison J. Rider III said that “most of us served selflessly, but some chose not to come to work and walked away from the commitment they made to the patients and their fellow associates.” See more in this report.

    Union officials said they were “bewildered” by the firings and an official of the American Nurses Association told the Post she didn’t know of any other hospital taking similar action. Union reps said about 250 of the hospital’s 1,600 nurses didn’t report for shifts at some point during Washington’s storms between Feb. 5 and Feb 11, according to the paper.

    Washington Hospital Center is the district’s largest private hospital with 926 beds. Among its services, it has a big kidney transplant unit (see here for a neat chart on a 13-way kidney exchange done in with Georgetown University Hospital).

    Here’s a look at storm conditions at the hospital from a YouTube video:

    Cancel-button photo by greefus groinks via Flickr


  • FDA Finds Problems With Insulin Pumps ‘Across Manufacturers’

    fdaAll is not well in the land of insulin pumps — the devices that deliver insulin to mostly Type 1 diabetics — and the FDA wants to put a spotlight on the problem.

    Noting that there had been 18 recalls of pumps over five years because of hardware and software problems, the FDA said that “device problems critical to insulin pumps exist across manufacturers.” The agency has called a meeting of outside experts for Friday to see what can be done about the risks.

    The FDA didn’t cite particular manufacturers, but insulin-pump makers include Johnson & Johnson, Medtronic and Roche Holding. See comments from those companies and other details from Reuters and Dow Jones Newswires.

    People with Type 1 diabetes produce little or no insulin and increasing numbers are using insulin pumps to administer doses of the hormone. Defective pumps can allow blood sugar to rise too low or too high, which can be fatal.

    Some 375,000 adults with Type 1 diabetes used pumps in 2007 and there were nearly 17,000 reports of health problems over the three years ended in 2009, according to the regulators. Makers are required to report problems potentially connected with devices to the FDA.

    Such reports don’t mean there is necessarily something wrong with a device or that it caused harm, but FDA reviewers found many reports “have not been thoroughly investigated and evaluated by manufacturers in determining causality and device failure,” according to the FDA. Of 310 deaths examined, for example, it said “the device problem was unknown and limited details of the event were provided” in 225 of the death reports.


  • A Jumpstart for Food-Safety Bill?

    A version of this post by WSJ’s Jean Spencer also appears on the Washington Wire blog.

    salmonellaA coalition of consumer, public-health and food-safety advocates is trying to jumpstart the food-safety legislation that is stalled in the Senate.

    To make its point, the Make Our Food Safe coalition is trumpeting a report by Ohio State University economist and former FDA official Robert Scharff that concludes that health costs associated with foodborne illnesses totals $152 billion annually in the U.S.

    The report was commissioned by Georgetown University’s Produce Safety Project, a coalition member that has been advocating for tougher food-safety rules. It also includes a state-by-state cost analysis that illustrates how much each state spends on foodborne illness, as well as a cost-per-illness breakdown.

    Scharff looked at 28 pathogens, including “unknown agents,” and the costs associated with illnesses, including physician visits, hospital charges as well as “quality of life losses” such as pain, suffering and death. He figured that each case of salmonella, which was linked to a large peanut-product recall begun in 2008, costs about $9,146, while E. coli 0157:H7, which was linked to spinach and cookie dough, costs about $14,838 per illness.

    The food-safety bill that passed the House in July would give the FDA authority to recall products, require more frequent FDA inspections of food-processing plants and better recordkeeping by food companies so contaminated products could be more easily traced. Similar legislation in the Senate has taken a backseat to health-care overhaul legislation and other priorities.

    It’s not as if food safety has completely fallen off the legislative platter. Democrat Sen. Tom Harkin said food safety legislation could reach the Senate floor around Easter and be “on the president’s desk by May.”

    Other coalition members include the American Public Health Association; the Center for Foodborne Illness Research & Prevention; Center for Science in the Public Interest; Consumer Federation of America; Consumers Union; and the Pew Charitable Trusts.

    For a CDC report published last year the most common types of foodborne illness in the U.S. and our post on it, see here and here.

    Image of salmonella at 8,000X magnification by CDC/Bette Jensen


  • Health Roundup: Obama to Add GOP Ideas, Medicare Cuts Avoided

    logoLots of health headlines this morning, most surrounding the Democratic overhaul efforts. Meanwhile, the Senate figured out a way to avoid crimping Medicare payments to doctors.

    President Obama kicked things off yesterday by saying he was open to a few cost-saving ideas that Republicans highlighted at last week’s bipartisan health summit. In a letter to congressional leaders, Obama proposed adding four GOP-backed items to the health-care mix that House and Senate Dems now are expected to put to votes later this month.

    Republicans weren’t mollified by the presidential gesture, saying adopting a few of their ideas wasn’t enough to rectify the nearly $1 trillion overhaul package. Obama is slated to speak more about the latest health-care push in remarks at the White House today. For more, see here, here and here.

    The measures listed by the president would included beefing up fraud prevention and expanding Health Savings Accounts. Two other ideas he wants to pursue should warm the hearts of many doctors: finding alternatives for settling malpractice suits and boosting Medicaid reimbursements for doctors, especially since the overhaul will be adding Medicaid benefits for more recipients that will need doctors.

    Docs participating in the Medicare program also got good news yesterday when the Senate overcame Sen. Jim Bunning’s objections to a $10 billion bill that included a 30-day delay in a 21% Medicare payment cuts to physicians. Extending health-insurance subsidies under the Corbra program also were part of the package, along with highway funding, jobless benefits and a hodgepodge of other provisions.

    For more on the Bunning saga, read here, here and here as well as our posts here and here. Senate Majority Leader Harry Reid has proposed a one-year extension of higher Medicare payments for doctors that would also give states help with their Medicaid budgets.

    White House Update: As expected, President Obama asked lawmakers to vote on health-care overhaul legislation “in the next few weeks,” signaling he will push approval even without Republican support. Obama will go on the road with his health-care message next week, speaking in Philadelphia and St. Louis on Monday and Wednesday, respectively. See more here.