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MEDICARE: CBO Says Rx Negotiations Bill Would Not Lower Prices
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A bill (HR 4) that would require the HHS secretary to negotiate directly with pharmaceutical companies on prices for medications under the Medicare prescription drug benefit would not lead to lower prices, according to acting Congressional Budget Office Director Donald Marron, the AP/Richmond Times-Dispatch reports (AP/Richmond Times-Dispatch, 1/11). News reports suggest that the House likely will approve the legislation on Friday (American Health Line [1], 1/10). In a letter sent on Wednesday to House Energy and Commerce Committee Chair John Dingell (D-Mich.), who sponsored the legislation, Marron wrote, "The secretary would be unable to negotiate prices across the broad range of covered Part D drugs that are more favorable than those obtained by (the plans) under current law" (AP/Richmond Times-Dispatch, 1/11). However, Dingell said, "Common sense tells you that negotiating with the purchasing power of 43 million Medicare beneficiaries behind you would result in lower drug prices." He added, "This isn't the first time the Congress and CBO differed on the amount of savings a particular bill would achieve" (CongressDaily, 1/11).
Senate Developments
Sens. Olympia Snowe (R-Maine) and Ron Wyden (D-Ore.) on Thursday introduced a similar bill in the Senate. Senate Majority Leader Harry Reid (D-Nev.) on Wednesday "signaled that a showdown looms" with Republicans over the legislation. Reid said, "My intention now is to have Medicare negotiate for lower prices." Senate Finance Committee ranking member Chuck Grassley (R-Iowa) earlier this week said that he would lead an effort by Republicans to defeat the bill with a filibuster. Sen. Jim DeMint (R-S.C.), who also plans to filibuster the legislation, said, "It'll be close," adding, "I intend to make it a clear ideological communications battle." Sen. Norm Coleman (R-Minn.) said that he would vote against the bill unless supporters can prove that the legislation would lead to lower prices. He said, "How are they going to do it without upsetting the (prescription Part D initiative)?" (Wodele, CongressDaily, 1/10).
Medicare/VA Price Comparison Study Questioned
In related news, the Washington Post on Thursday examined reaction to a study released on Tuesday that found prices in Medicare prescription drug plans on average are 58% higher for the most commonly prescribed medications than prices paid by the Department of Veterans Affairs, which negotiates directly with pharmaceutical companies on prices for treatments (Lee, Washington Post, 1/11). The study, conducted by Families USA, used data submitted in November 2006 by the five Medicare prescription drug plans with the highest enrollment numbers. The prices in Medicare prescription drug plans used in the study represented the amount that beneficiaries would have to pay for medications when they reached the so-called "doughnut hole" coverage gap. For the study, researchers considered prices for the 20 medications most commonly prescribed to seniors (American Health Line [2], 1/10). According to some experts, the study "ignores important differences between the two systems," the Post reports. For example, VA receives an automatic 24% discount on the average wholesale prices of medications, and the department has a limited formulary of approved medications. CMS "is prohibited by law from adopting such a list" for the Medicare prescription drug benefit, in part because beneficiaries "want to have a wide range of drug choices," according to the Post. In addition, VA has a much larger health care infrastructure than Medicare. Former CMS Administrator Mark McClellan said, "It's apples to oranges. The VA is a closed health care system relying on mail-order and a tighter formulary than Medicare beneficiaries have shown they prefer." Robert Laszewski, a health policy consultant, said, "The federal government can get lower prices, but only if it's willing to exclude a certain number of drugs from the formulary. And that's a huge political leap that I would be very surprised if this Congress took" (Lee, Washington Post, 1/11).
Opinion Pieces
A radio program and a newspaper featured commentaries on the bill that would require the HHS secretary to negotiate directly with pharmaceutical companies on prices for medications under the Medicare prescription drug benefit. Summaries appear below.- Robert Reich, "Marketplace": The bill allows Democrats to "tell seniors and the all-important AARP they're forcing Medicare to negotiate with drug companies -- but then turn around and tell Big Pharma not to worry: their drugs will still be approved, regardless of price," Reich, a professor of public policy at the University of California-Berkeley, says in a commentary on APM's "Marketplace." According to Reich, the legislation lacks "real teeth," and Democrats should introduce a bill to allow "Medicare to set up its own drug plan to compete with those of private insurers" (Reich, "Marketplace," APM, 1/10). The complete segment is available online in RealPlayer.
- Mike Leavitt, Washington Post: "Some observers point to the massive buying power of the federal government as the means to exert clout over drug companies, but the federal government has nowhere near the market power of the private sector," HHS Secretary Leavitt writes in a Post opinion piece. Leavitt adds that, under the bill, "one government official would set more than 4,400 prices for different drugs, making decisions that would be better made by millions of individual consumers" (Leavitt, Washington Post, 1/11).
Broadcast Coverage
WBUR's "Here & Now" on Wednesday featured a discussion on the bill that would require the HHS secretary to negotiate directly with pharmaceutical companies on prices for medications under the Medicare prescription drug benefit. Guests on the program included Robert Moffit, director of health policy studies at the Heritage Foundation, and Ron Pollack, executive director of Families USA ("Here & Now," WBUR, 1/10). The complete segment is available online in RealPlayer.
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KENNEDY: Proposes To Extend Medicare to All U.S. Residents
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The federal government should implement a program to provide health insurance to all U.S. residents by 2010, Senate Health, Education, Labor and Pensions Committee Chair Edward Kennedy (D-Mass.) said at a hearing held by the committee on Wednesday, the AP/Houston Chronicle reports (Freking, AP/Houston Chronicle, 1/10). Kennedy proposed a plan that would extend Medicare to all residents and allow them to select from health plans offered to federal lawmakers and the president. According to Kennedy, the plan would save an estimated $380 billion annually through reduced administrative costs, a national electronic health records system and reduced overhead costs. In addition, the plan would reduce costs because residents would receive preventive care for health conditions before they become more serious and expensive to treat, Kennedy said (Johnson, CongressDaily, 1/10). Kennedy said, "The stakes couldn't be higher. Too many trends in health care are going in the wrong direction. Insurance coverage is down. Costs are up, and America is heading to the bottom of the league of major nations in important measures of the quality of care."
Witness Testimony
At the hearing, employer, labor and think tank representatives asked lawmakers to take action to reduce health care costs and the number of uninsured residents. Witnesses also asked lawmakers to fully fund the SCHIP program this year. In addition, some witnesses proposed to eliminate the relationship between employers and health insurance, provide employers with more flexibility to for purchasing pools to reduce health insurance costs, provide consumers with more information on health care quality and compare the effectiveness of the U.S. health care system with the systems of other nations. Service Employees International Union President Andrew Stern, said, "We don't have a problem, we have a crisis. And it's getting worse. The solution is no longer a matter of policy -- but politics." Karen Davis, president of the Commonwealth Fund, said, "Other countries are achieving universal coverage, much lower spending per capita and better health outcomes" (Agnes Carey, CQ HealthBeat, 1/10). Sen. Mike Enzi (R-Wyo.), ranking member of the committee, said, "My primary interest is to provide health insurance reform for small businesses and working families, and I believe that 1 million more people will be insured if we enacted the (small business health plans)" (AP/Houston Chronicle, 1/10).
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STEM CELLS: House Expected To Pass Bill; White House Releases Report
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The House on Thursday is expected to pass by a "substantial margin" a bill (HR 3, S 5) -- called the Stem Cell Research Enhancement Act of 2007 -- that would expand federal funding for human embryonic stem cell research, the Washington Post reports (Weiss, Washington Post, 1/11). Federal funding for embryonic stem cell research is allowed only for research using embryonic stem cell lines created on or before Aug. 9, 2001, under a policy announced by President Bush on that date. Bush in July 2006 vetoed the Stem Cell Research Enhancement Act of 2005 (HR 810), which would have expanded stem cell lines that are eligible for federal funding and allowed funding for research using stem cells derived from embryos originally created for fertility treatments and willingly donated by patients. The House and Senate versions of the Stem Cell Research Enhancement Act of 2007 are the same as the bill Bush vetoed. The Senate is expected to consider the legislation in a few weeks. Bush is all but certain to veto the measure again if it is passed by Congress (American Health Line, 1/9).
White House Report, Reaction
The White House on Wednesday as expected released a report that urged Congress to consider nonembryonic stem cell research funding, the New York Times reports. The report, titled "Advancing Stem Cell Science Without Destroying Human Life," highlighted the benefits of adult stem cell research and mentioned a study published in the Jan. 7 online edition of the journal Nature Biotechnology that found stem cells derived from human amniotic fluid appear to offer many of the same benefits of embryonic stem cells (Swarns, New York Times, 1/11). "The stem cell debate is only the first in what will be an onrushing train of biotechnology challenges in our future," the report said, adding, "We must establish a constructive precedent here for taking the moral dimensions of these issues seriously." It also stated that "[w]ithout an understanding that life begins at conception and that an embryo is a nascent human being, there will always be arguments that other uses, takeovers and makeovers of embryos are justified by potential scientific and medical benefits" (Fox, Reuters, 1/10). White House spokesperson Tony Fratto said Bush administration officials were "reaching out" to House members to advocate the president's position. "A thoughtful review of the issue would lead most reasonable people to believe this is a line that we don't need to cross," Fratto said, adding, "This is a vote of conscience for a lot of members. We hope they take the time to review all aspects of it before casting their vote." Rep. Diana DeGette (D-Colo.), co-sponsor of the Stem Cell Research Enhancement Act, said the White House "keep[s] trying to muddle the issue," adding that none of the types of stem cell research highlighted in its report is "a substitute for embryonic stem cell research" (New York Times, 1/11). According to Rep. Michael Castle (R-Del.), co-sponsor of the bill, the Senate might add amendments to the measure, including adding funding for programs that donate discarded frozen embryos, requiring additional ethical management for stem cell research or increasing support for parallel studies of nonembryonic stem cells. DeGette said Tuesday at a news conference that compromise language "is welcome" but added that Bush has rejected appeals for a compromise on the issue (Washington Post, 1/11).
Broadcast Coverage
APM's "MarketPlace" on Thursday interviewed Joanne Kurtzberg of Duke University Medical Center about federal human embryonic stem cell research funding (Babin, "MarketPlace," APM, 1/11). The complete segment is available online in RealPlayer.
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REIMPORTATION: Bipartisan Group of Lawmakers To Introduce Bill
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A bipartisan group of lawmakers on Wednesday introduced a prescription drug reimportation bill with "high hopes for success, given the new congressional leadership and political climate on Capitol Hill," CongressDaily reports. The legislation -- sponsored by Sens. Byron Dorgan (D-N.D.) and Olympia Snowe (R-Maine) and Reps. Rahm Emanuel (D-Ill.) and Jo Ann Emerson (R-Mo.) -- would establish a regulatory framework for pharmacies and wholesalers to reimport FDA-approved prescription drugs from FDA-approved manufacturing facilities in certain industrialized nations. In addition, the bill would require FDA to regulate shipments of prescription drugs reimported into the U.S. for commercial or personal use. Bill sponsors expect broad support for the legislation in the Senate and House. According to CongressDaily, the "biggest question mark hangs on a possible presidential veto and, if so, whether the Congress can override it." Emanuel said that the House is "within striking distance" of the number of votes required to override a veto of the bill, and Dorgan said that he hopes the Senate will approve the bill by an "overwhelming" margin. Bill sponsors maintain that prescription drug reimportation would open the prescription drug market to international competition and reduce prices. However, according to the pharmaceutical industry, led by the Pharmaceutical Research and Manufacturers of America, prescription drug reimportation poses a safety risk (Lee, CongressDaily, 1/10).
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MEDPAC: Recommends 1.7% Payment Increase for MDs in 2008
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The Medicare Payment Advisory Commission on Wednesday voted unanimously to approve a recommendation to Congress to increase reimbursements to doctors by an estimated 1.7% in 2008, CQ HealthBeat reports. Without action from Congress, physician reimbursements in 2008 would decrease by 10% under the current payment formula. MedPAC calculated the new figure using expected 2008 "input prices" -- the expenses that go into providing physician services -- and expected increases in physician productivity. Commissioners also agreed that a $1.35 billion "Physician Assistance and Quality Initiative Fund" created by Congress late last year should be used to fund the 2008 payment update. American Medical Association Chair Cecil Wilson said that his group "concurs with MedPAC's recommendation that Congress stop the 2008 payment cut and update payments in line with medical practice cost increases." MedPAC also approved a recommendation to Congress that reimbursements for long-term care hospitals not be increased in 2008 and that payments for inpatient rehabilitation services be increased by 1% (Reichard [1], CQ HealthBeat, 1/10).
Hospital Inpatient Care
In related news, MedPAC Executive Director Mark Miller said that bonus payments for high quality inpatient hospital care, which were recommended by the commission earlier this week, could be considerably higher than 1% or 2% (CQ HealthBeat, 1/10). MedPAC voted unanimously to give hospitals a full "market basket" increase in FY 2008 payments for inpatient and outpatient care. The payment increase -- currently projected at 3.1% -- would be tied to the adoption of a "quality incentive payment program" (American Health Line, 1/10). Miller said the HHS secretary would determine the size of the bonus payments (CQ HealthBeat, 1/10).
Nursing Homes
The nursing home industry has expressed opposition to MedPAC's recommendation that Congress freeze their reimbursement levels in 2008. MedPAC released data showing that profit margins on Medicare beneficiaries in skilled nursing facilities will average 11% in 2007. However, nursing home advocates say that is "not an excuse for freezing Medicare payments because Medicaid payments fall far short of the cost of care they provide for Medicaid patients," CQ HealthBeat reports. Alan Rosenbloom, president of the Alliance for Quality Nursing Home Care, said the recommendation "would undermine the great strides skilled nursing homes have taken to improve the quality of care and provide a fair wage to hundreds of thousands of caregivers." American Health Care Association CEO Bruce Yarwood said that "long term care funding stability in conjunction with reasonable inflation adjustments are the critical policy prescriptions necessary for our profession to sustain ... the rigorous and comprehensive quality improvement initiatives under way in our nation" (Reichard [2], CQ HealthBeat, 1/10).
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FOOD SAFETY: FDA Response To Probe Indicates Need for Oversight
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A response from FDA officials to an investigation into food safety by the House Energy and Commerce Committee indicates a need for more congressional oversight of the agency, committee ranking member Joe Barton (R-Texas) said on Tuesday, CQ HealthBeat reports. According to Barton, the response from FDA officials to a letter sent by him and Rep. Edward Whitfield (R-Ky.) "shows the need for an ongoing look at how and how well" the agency addresses food safety issues. The letter questioned FDA officials about their response to an E. coli outbreak last year caused by bagged spinach. "Regardless of whether sickness is caused by E. coli or al Qaeda, is a 16-day wait for toxicology analysis acceptable?" Barton asked, adding, "Americans seem less likely to fall victim to a bioterrorist than to bad spinach or a tainted taco, but where and how does FDA determine its protection priorities?" Barton also asked that Democrats join Republicans "in a continuing and vigorous oversight effort to protect Americans from illness" (CQ HealthBeat, 1/9).
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FDA: Requests Rx Companies To Re-Evaluate Testing Done by MDS
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Citing safety concerns found during routine inspections of two Canadian facilities operated by MDS Pharma Services, FDA on Wednesday said it will notify all pharmaceutical companies that submitted drug approval applications since 2000 containing testing data from MDS that they must reevaluate their results, the Wall Street Journal reports (Corbett Dooren, Wall Street Journal, 1/11). Drugmakers often hire other companies to test new medications. MDS was hired by a number of drugmakers to measure the level of a new drug in patients' blood. Such testing "can be integral to the FDA's determination that a drug works safely," according to the Baltimore Sun. Several routine inspections conducted at MDS facilities in Montreal and Blainville from July 2003 through March 2006 found that previous contamination problems had not been corrected, unexpected results were not investigated and data might have been reported inaccurately, according to FDA officials and agency documents (Rockoff, Baltimore Sun, 1/11). FDA said it will send more than 1,000 letters to companies that used MDS services to request that they review their results. The agency noted that no evidence of problems with the quality and purity or efficacy of affected drugs has been reported. Joseph Famulare, deputy director of the office of compliance in the agency's drug evaluation and research division, said, "The FDA is taking this precautionary measure to make sure the data submitted to the agency is of the highest quality." Companies have six months to comply with the request.
Hundreds of Medications Affected
FDA officials identified all of the 217 generic drugs that either already have received approval or are seeking federal approval that included MDS testing data. Officials are uncertain which brand-name companies used MDS services, so FDA will notify all brand-name drug makers that submitted the more than 900 applications received since 2000 to research their own files. MDS in a statement said it has taken numerous corrective actions to meet FDA standards but has not been able to fully satisfy all of the agency's requirements. It will redirect efforts to support its clients using independent audit activities, the company said. Stephen DeFalco, president and CEO of MDS, said, "While we are disappointed in the time and effort that it has taken to get to this course of action, we believe that it will benefit everyone involved to have a crisp path forward to resolve this issue." DeFalco added, "We will fully support our clients with data and information from their studies to help bring this issue to a rapid and complete resolution" (Bridges, AP/Long Island Newsday, 1/10).
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MEDIMMUNE: Can Pursue Lawsuit in Patent Dispute With Genentech
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The Supreme Court on Tuesday ruled 8-1 that Maryland-based MedImmune can pursue a lawsuit filed against California-based Genentech over a patent dispute related to Synagis, a respiratory medication for children, although MedImmune had agreed to pay royalties to the company, the Washington Post reports (Washington Post, 1/10). Synagis, an injectable medication that contains antibodies to protect young children from respiratory syncytial virus, had sales of $1.24 billion in 2005 and accounted for 80% of revenue reported by the company (Bravin/Chase, Wall Street Journal, 1/10). Under protest, MedImmune agreed through 2018 to pay millions of dollars in royalties to Genentech for the use of a patent for the production of monoclonal antibodies, the main component of Synagis. MedImmune in 2003 filed a lawsuit in U.S. District Court over allegations that Genentech obtained the patent through improper collusion with a British company and that the patent amounts to an illegal 12-year extension of a previous patent (Bishop, Baltimore Sun, 1/10). Genentech argued that the court should dismiss the lawsuit because MedImmune had agreed to pay royalties (Washington Post, 1/10). The court dismissed the lawsuit, and a federal appeals court upheld the decision. The Supreme Court decision returns the lawsuit to the district court for "proceedings consistent with this opinion" (Baltimore Sun, 1/10).
Decision Details, Implications
In the Supreme Court decision, Justice Antonin Scalia wrote on behalf of the majority that MedImmune "assuredly did contend that it had no obligation under the license to pay royalties on an invalid patent" (Yost, AP/Wilmington News Journal, 1/9). He added, "Promising to pay royalties on patents that have not been held invalid does not amount to a promise not to seek a holding of their invalidity." Justice Clarence Thomas dissented in the case. MedImmune officials in a statement said they plan to pursue the lawsuit "vigorously and are confident that our position will prevail." Genentech in a statement said, "The Supreme Court's decision has no impact on the validity of the ... patent." Legal analysts said that the decision "opens the door for more patent lawsuits across a variety of sectors," the Sun reports. In addition, those who "license access to patented technology may now decide it's more in their interests to try to have a suspect patent legally overturned," and "patent holders may likely scrutinize potential partners more closely or charge higher fees to cover the risk of a lawsuit," according to the Sun. George Best, senior counsel with Foley & Lardner, said, "It essentially gives your licensee a free shot at knocking out the patent and their obligation to pay royalties, and from a licensor's -- from Genentech's -- point of view, that's not a good thing" (Baltimore Sun, 1/10).
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WAL-MART: Says It Provides Health Care Coverage To More Employees
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Wal-Mart provides health coverage for 47.4% of its employees, an 8% increase from last year, while 43% of its employees have health coverage through another source and 10% are uninsured, according to a recent company-sponsored survey, Reuters reports (Reuters, 1/11). The survey of more than 200,000 Wal-Mart employees found that 22% of workers receive health benefits under a spouse's plan; nearly 5% are covered under Medicare; and 4% are insured through their parents, school or college. About 2% of employees are covered by Medicaid and 1% are enrolled in other state health insurance programs (Mui/Joyce, Washington Post, 1/11). The survey also found that 76.3% of its workforce was eligible for health benefits during the most recent open-enrollment period (Reuters, 1/11). Fifteen percent of workers said the cost of Wal-Mart's plans was their reason for declining coverage and 4% said they did not need the company's plans, the survey found (McWilliams, Wall Street Journal, 1/11). According to the Washington Post, the survey is the retailer's "first effort to capture such data as it faces criticism from labor unions that accuse it of paying low wages and skimping on health benefits." The company has also tried to counter criticism by offering $4 generic prescription drugs at its pharmacies and making changes to its coverage, the Post reports (Washington Post, 1/11). Last year, Wal-Mart lowered plan premiums to as little as $11 per month for individual coverage, cut the waiting period from two years to one year for part-time employees to become eligible for benefits and extended coverage to children of employees (Wall Street Journal, 1/11). The $11 per month benefit includes three generic prescriptions and three physician visits before the deductible takes effect, typically $1,000 for an individual employee and $3,000 for an employee's family (Barbaro/Abelson, New York Times, 1/11).
Comments
Linda Dillman, Wal-Mart's executive vice president of benefits, said, "Whatever numbers you use, the fact is there is a consistent upward trend" in the percentage of employees with Wal-Mart health coverage. She added, "Over the past three years, we've seen steady increases in associates who take our plans" (Kabel, AP/Atlanta Journal-Constitution, 1/11). Len Nichols, a health economist at the New America Foundation, said that though the company has tried to reach out to the uninsured, Wal-Mart might not be able to convince workers to obtain coverage if they believe they are healthy and can rely on hospital emergency departments for care. He added, "Eleven dollars a month is about as good as its going to get for low-wage workers" (New York Times, 1/11). JoAnn Volk, a health care lobbyist for AFL-CIO, maintains that the number of employees who still are not covered by Wal-Mart "is proof that low-wage workers are not finding a high-deductible plan to be a good deal. The premium is no benefit if you're not getting adequate coverage for the care you need" (Wall Street Journal, 1/11). Chris Kofinis, a spokesperson of WakeUpWalMart, a union-backed anti-Wal-Mart group, said, "The brutal truth is that Wal-Mart's health care crisis has worsened. The percentage of Wal-Mart workers without company health care has actually increased, but rather than be embarrassed at their health care failures, Wal-Mart is trying to brag that leaving well over half of your employees and their families without company health care is improvement" (AP/Atlanta Journal-Constitution, 1/11).
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WELLPOINT: Announces Proposal To Reduce Number of Uninsured
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WellPoint, the largest U.S. health insurer, on Monday announced a proposal to reduce the number of uninsured residents, the Louisville Courier-Journal reports (Howington, Louisville Courier-Journal, 1/9). Under the proposal, WellPoint will lobby states to expand their health insurance programs to children in families with annual incomes of as much as 300% of the federal poverty level (Davis, Denver Rocky Mountain News, 1/9). WellPoint also will lobby states to expand their health insurance programs to parents in families with annual incomes of as much as 200% of the federal poverty level and childless adults with annual incomes of as much as $10,000. WellPoint said that states could use funds from increased cigarette taxes to help cover the cost of expanded health insurance programs. In addition, WellPoint will establish new health plans that target large populations of uninsured residents, such as young adults, early retirees and Hispanics and will promote public-private partnerships to provide health insurance for those who do not qualify for public programs. WellPoint will spend $30 million over three years to support local programs nationwide that seek to improve health care access (Louisville Courier-Journal, 1/9).
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BIOTECHNOLOGY: JPMorgan Conference Discusses Future of Industry
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The JPMorgan Healthcare Conference, the nation's longest-running biotechnology conference, began on Monday in San Francisco to discuss recent successes and setbacks and the future of the biotech industry, the San Francisco Chronicle reports (Tansey, San Francisco Chronicle, 1/9). Discussions highlighted the growing importance of biotech partnerships with larger drug companies for developing "groundbreaking science that delves into the fundamental causes of disease," according to the Chronicle. Slowing growth rates and less-robust pipelines are causing traditional drug companies to seek new business by partnering with smaller biotech companies that are developing promising products. In addition, conference attendees discussed the rise in patent lawsuits within the biotech industry (Tansey, San Francisco Chronicle, 1/10).
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GENERIC INSULIN: Governors, Lawmakers Pressure FDA To Ease Entry
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Some federal lawmakers and governors have been lobbying FDA to ease the way for the production and sale of generic insulin, which analysts say would reduce the cost of the treatment by 25%, the New York Times reports. Generic insulin could mean spending reductions for Medicaid programs -- which spent $500 million on the treatment in 2005 -- as well as for people with diabetes. In addition, some observers say that the availability of generic insulin could ease development of other drugs in the class of biologics, which are medicines made from living organisms. However, many scientists say duplication of such drugs could be difficult, as they are variable and could cause allergic reactions in patients. The drug companies Novo Nordisk, Eli Lilly and Sanofi-Aventis "dominat[e]" the insulin market, the Times reports. Of the five insulin products sold in the U.S. in 2005, only Lilly's Humulin and Novo Nordisk's Novolin have lost their 20-year patent protection, while patents on other products "exten[d] into the next decade." Generic manufacturers say the first step to creating a competitor drug would be for FDA to adopt guidelines explaining the testing and documentation required to approve a generic version of insulin. In 2001, the agency announced it would develop guidelines for generic insulin and the human growth hormone, but those guidelines were never released, in part because of pressure from the Biotechnology Industry Organization, the Times reports. The group has said that some exemptions granted to conventional generic drugs that speed their market entry are not applicable for biologics. FDA has said that it might be more appropriate to develop guidelines applying to all biologics rather than individual treatments. According to the Times, the agency has said it will release a scientific background paper on the issue this spring. Sen. Orrin Hatch (R-Utah) and Rep. Henry Waxman (D-Calif.) last year said in a letter to FDA, "There is simply no excuse -- scientific, legal or otherwise -- for the FDA to delay the release of these guidelines." Mississippi Gov. Haley Barbour (R), one of 11 governors who have asked FDA to speed approval of generic insulin, said, "To have a lower-cost solution for our very large diabetic population is in the interest of the state and the interest of these people" (Saul, New York Times, 1/11).
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MODELS: MD Group Guidelines Include Age, Weight Recommendations
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The Academy for Eating Disorders, an international physician group, on Tuesday released guidelines for runway models that included age and weight recommendations, the New York Times reports. The guidelines recommend against use of runway models younger than age 16. In addition, the guidelines recommend that female runway models younger than age 18 have a body mass index higher than 17.4 and that those ages 18 and older have a BMI higher than 18.5. According to the Times, the guidelines "contrast sharply" with guidelines released last week by the Council of Fashion Designers of America that recommended educational reform and improved working conditions for runway models but did not include age and weight recommendations. Eric van Furth, president of the academy, said that the council did not seek medical opinions outside of a committee established by the editors of Vogue Magazine in the development of the guidelines. He said, "We believe the fashion industry should take responsibility for the health of its models. The way they are presenting their guidelines really shows they are not acknowledging the seriousness of the problem of eating disorders at all." Steven Kolb, executive director of the council, said that the committee included Joy Bauer, a nutritionist; David Kirsch, a fitness trainer; and Susan Ice, psychiatrist at the Renfrew Center, a clinic in Philadelphia that treats eating disorders. He said, "It is not as if what we are discussing is being developed without the advice of people who are experts in that area" (Wilson, New York Times, 1/9).
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WALGREEN: Company To Expand Number of In-Store Clinics
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Walgreen announced at the company's annual meeting on Wednesday that it plans to expand the number of walk-in clinics available at its 5,584 stores nationwide, the Chicago Tribune reports. Walgreen hopes the in-store clinics -- which offer treatment for minor ailments and are operated by nurse practitioners -- will boost prescription drug sales and encourage customer loyalty. Walgreen has opened 50 in-store clinics in five markets since last year and plans to operate 250 nationwide by August. Walgreen is moving forward carefully with the expansion in an effort to avoid alienating doctors, according to company officials. The American Medical Association has pushed for increasing scrutiny of in-store health clinics. "The clinics over time will help lower health care costs," CEO Jeffrey Rein said at a press conference following the meeting. CVS, Wal-Mart and Target in the past three years also have opened in-store clinics (Jones, Chicago Tribune, 1/11). Walgreen executives declined to rule out the possibility of acquiring a pharmacy benefits management company, the Sun-Times reports. Rein said, "We don't want to take it off the table. We consider everything" (Guy, Chicago Sun-Times, 1/11).
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CALIFORNIA: Health Insurance Proposal Based on Massachusetts Law
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A proposal announced on Monday by California Gov. Arnold Schwarzenegger (R) that would require all state residents to obtain health insurance "draws heavily on Massachusetts' health care law in both philosophy and details," according to lawmakers and policy advocates, the Boston Globe reports. According to the Globe, several people who developed the Massachusetts law recently discussed the legislation with lawmakers and business groups in California, and their comments are "reflected in Schwarzenegger's proposal," with similarities that "extend beyond general policy to some of the plans' details." Michael Widmer, president of the Massachusetts Taxpayers Foundation, said, "Until Massachusetts passed its law, the common wisdom was that no state could do this alone. Now, everywhere our traveling troupe goes, the mantra is that if Massachusetts can do it, so can we." California Assembly member Hector De La Torre (D) said, "We looked seriously at the Massachusetts effort and wanted to see what was applicable to California."
Some Differences
However, "there are some striking differences between California and Massachusetts" that will make the implementation of the California proposal more difficult, the Globe reports. One in five Californians is uninsured compared to 7.2% in Massachusetts, according to the Globe. As a result, the California proposal would cost substantially more than Massachusetts law. Massachusetts also "had a funding advantage" because the state had established an annual pool of more than $500 million to compensate hospitals for no-cost care provided to uninsured residents prior to the implementation of the law, funds that went a "long way toward paying for free and subsidized care to newly insured residents," the Globe reports. Jonathan Gruber of the Massachusetts Institute of Technology, who provided analytic support to the California and Massachusetts efforts, said, "They have the same health coverage goodies we do but more costs and more opponents. It will be quite a struggle" (Krasner, Boston Globe, 1/11).
Broadcast Coverage
Several broadcast programs reported on the California proposal:- APM's "Marketplace": The segment includes an interview with "Marketplace" economics correspondent Chris Farrell (Jagow, "Marketplace," APM, 1/11). Audio of the segment is available online.
- NPR's "All Things Considered": The program includes comments from Kate Bisego of Health Care for All and John Kingsdale, executive director of the Massachusetts Commonwealth Connector (Knox, "All Things Considered," NPR, 1/11). Audio of the segment is available online.
- NPR's "Morning Edition": The program includes comments from Michael Miller, director of Community Catalyst (Inskeep, "Morning Edition," NPR, 1/11). Audio of the segment is available online.
- NPR's "Talk of the Nation": The program includes a discussion with Mark Smith, president and CEO of the California HealthCare Foundation; Stuart Altman, director of the Schneider Institutes for Health Policy at Brandeis University; and NPR science desk correspondent Joanne Silberner (Conan, "Talk of the Nation," NPR, 1/11). Audio of the segment is available online.
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CLINICAL TRIALS: Rx Companies Better at Reporting Information
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Eight percent of the 2,983 clinical trials sponsored by pharmaceutical companies in 2006 and entered into NIH's voluntary registration Web site clinicaltrials.gov did not include information on the outcomes being measured, compared with 26% of trials prior to 2006, according to an editorial published Thursday in the New England Journal of Medicine, the AP/Washington Post reports. In 2006, none of the filings omitted the name of the drug being tested, compared with a small number that excluded drug names from the registry before 2006, the editorial states. The editorial, by NEJM Editor in Chief Jeffrey Drazen and Deborah Zarin of the National Library of Medicine, attribute the decline to a declaration by the 11-members of the International Committee of Medical Journal Editors that they would only publish studies that are registered on the site before they are completed, "in part to keep drug companies from suppressing the results of experiments that did not turn out the way they wanted," the AP/Post reports (Johnson, AP/Washington Post, 1/10). Of the 20% of articles received by NEJM that meet the committee's public disclosure requirements, about 10% are rejected because they have not been registered, according to NEJM spokesperson Karen Pedersen. "Although more can be done, this improvement in registration quality is to be praised," the editorial states. Some Democrats, including Sen. Edward Kennedy (D-Mass.) and Rep. Edward Markey (D-Mass.), are expected to pursue a federal mandate requiring all clinical trials and results to be registered. "A voluntary registry is like allowing a student to pick which grades he wants to include on his report card and which ones he wants to leave out," Markey said (Rowland, Boston Globe, 1/11). The editorial is available online.
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TEA: Milk Could Eliminate Health Benefits, Study Finds
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The addition of milk or cream to tea could eliminate the health benefits, which include reduced risk for heart disease, stroke, osteoporosis and some cancers, according to a study published on Tuesday in the European Heart Journal, the Washington Times reports. For the study, Mario Lorenz and colleagues at the University of Berlin Charite Hospital used ultrasounds to measure the artery function of 16 healthy older women who drank black Darjeeling tea with and without milk. The study found that participants who drank tea experienced improved blood flow and that those who drank tea with milk did not experience improved blood flow (Harper, Washington Times, 1/10). According to the study, the pigments in tea that can improve artery function likely are affected by proteins in milk called caseins. Verena Stangel, a professor of cardiology at the hospital, said, "The well-established benefits of tea have been described in many studies." She added, "Our results thus provide a possible explanation for the lack of beneficial effects of tea on the risk of heart disease" in Britain, where residents often add milk to tea. Lorenz said, "We certainly don't want to dismiss the consumption of black tea. The results of our study merely attempt to encourage people to consider that, while the addition of milk may improve its taste, it may also lower its health-protective properties" (Bloomberg/Arizona Daily Star, 1/10).
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SARS: Report Says Ontario Epidemic Caused By Poor Preparedness
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The 2003 SARS epidemic in the Toronto area that killed 44 people largely was caused by an inadequate public health system and poor safety practices at health care facilities, according to an investigative commission report released on Tuesday, the Chicago Tribune reports (Chicago Tribune, 1/10). Of 375 reported cases of SARS in the Ontario province, about 45% were health care workers (Mason, New York Times, 1/10). Nearly 75% of people in Ontario who contracted SARS were infected in hospitals, which should have been able to prevent the disease's spread, according to the report. The report said, "This was a system failure. The lack of preparation against infectious disease, the decline of public health, the failure of systems that should protect nurses and paramedics and others from infection at work" all failed. The report continued, "The only thing that saved us from a worse disaster was the courage and sacrifice and personal initiative of those who stepped up -- the nurses, doctors, paramedics and all the others -- sometimes at great personal risk, to get us through a crisis that never should have happened." Tony Clement, the federal health minister for Canada and former health minister of Ontario, said the situation has improved since the outbreak, adding, "In terms of infectious disease controls in hospitals, we are much better prepared. I would argue we have the best infectious disease control in the world now" (Struck, Washington Post, 1/10).
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BLOOD DONATION: New Risks Might Reduce Number of Eligible Donors
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Two new risks associated with blood donations might reduce the number of eligible donors, the Wall Street Journal reports. The recent discovery that certain antibodies in the blood of women who are or previously were pregnant can cause transfusion-related acute lung injury, a potentially fatal condition, and might affect the use of some blood components from 10% to 20% of female donors. According to researchers, TRALI can occur when certain antibodies produced by pregnant women to prevent rejection of male blood cells in their fetuses react with the cells of recipients of their blood and allow fluid to enter their lungs. The risk for TRALI is small, with more risk for recipients of blood plasma or platelets than for those who receive whole blood, but the condition "has emerged as the leading cause of transfusion-related deaths," with 50 to 100 deaths associated with the condition annually, the Journal reports. As a result, many blood banks have begun to use only blood plasma and platelets from male donors. In addition to TRALI, increased concerns about Chagas disease, a potentially fatal blood-borne disease prevalent in Latin America, might affect the eligible blood donors as immigration from that area increases. FDA last month approved a test for Chagas that likely will increase the cost of blood collection by between $5 and $7 to $54, according to Brian Custer, an investigator for the Blood Systems Research Institute. The U.S. currently has an adequate supply of blood, with about 15 million units donated annually, but, according to HHS, the difference between the supply and demand for blood has reached a record low. In response, "there is growing debate about lifting bans" on blood donation from gay men, the Journal reports (Landro, Wall Street Journal, 1/10).
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OBESITY: AHL Highlights Recent Developments
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Several newspapers recently published articles related to obesity. Summaries appear below.
- Acomplia: The Washington Times on Tuesday examined how "determined dieters" in the U.S. "are turning to the Internet to get prescriptions filled overseas" for Acomplia, a weight-loss medication not approved by FDA. Acomplia received approval from the European Union last year after studies showed it to be effective in weight loss and improved blood pressure and cholesterol levels. Internet sites, which "seem to operate with impunity," fill Acomplia prescriptions for between $230 and $285 for one month's supply once customers fill out an in-house doctor's health questionnaire, according to the Times. Some experts caution about the risks associated with purchasing prescription drugs over the Internet (Kargman, Washington Times, 1/9).
- China: USA Today on Tuesday examined how children in China are becoming more overweight, a trend that is "prompting fears of an American-style obesity crisis." Six-year-old urban Chinese boys are 2.5 inches taller and 6.6 pounds heavier on average than they were 30 years ago, according to Health Ministry data, and the Education Ministry reports that 8% of children ages 10 to 12 in China's cities are considered obese, while 15% are overweight. The Chinese government is addressing the issue, in part, by building more play areas for children and requiring students to exercise or play sports for one hour per day at school (MacLeod, USA Today, 1/9).
- Eating habits: Adults who have children living in the home eat higher fat diets than those who do not live with children, according to a study published in the online issue of the Journal of the American Board of Family Medicine, the AP/Richmond Times-Dispatch reports. For the report, lead researcher Helena Laroche of the University and Iowa and colleagues at the University of Michigan examined data from the federal government's National Health and Nutrition Examination Survey, which includes detailed food questionnaires of 6,600 adults living with and without children under age 17. The study found that adults living with children in the home consumed more than 91 grams of fat daily, compared with 86.5 grams for adults not living with children. While the reasons are unknown, Laroche said adults living with children might be influenced by their eating habits (Lorentzen, AP/Richmond Times-Dispatch, 1/9). An abstract of the study is available online.
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UNIVERSAL HEALTH COVERAGE: Editorials, Op-Eds Address Issue
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Newspapers recently published editorials and opinion pieces addressing California Gov. Arnold Schwarzenegger's (R) recent proposal to provide universal health care coverage in the state and other issues related to providing universal health care nationwide. Summaries appear below.
Editorials
- Albany Times Union: Schwarzenegger's proposal "should serve as a wake-up call to the new Democratic leaders in Congress that ... health coverage is a national crisis that requires a national solution," a Times Union editorial states. "Health care shouldn't depend on what state a person lives in," the editorial states, adding, "And the Democrats who now lead the Congress should say as much" (Albany Times Union, 1/10).
- Arizona Daily Star: Universal "health care coverage appears to be gaining momentum on the national agenda" as "major corporations like Wal-Mart, General Motors, Ford and Chrysler" struggle with "skyrocketing" premiums, an Arizona Daily Star editorial states. The editorial calls for a universal health care system because it "is clear that both corporations and consumers are finding health care costs increasingly difficult to tolerate" (Arizona Daily Star, 1/9).
- Christian Science Monitor: "California may show the nation that it is possible to provide health insurance to all citizens," a Christian Science Monitor editorial states. "But that doesn't address the equally urgent need to control health care costs," according to the editorial. The editorial concludes, "Until runaway costs can be contained, no one can claim to have fixed the broken health care system" (Christian Science Monitor, 1/10).
- Los Angeles Times: "The governor certainly knows that the final version of the plan will deviate from the proposal he unveiled on Monday," according to a Los Angeles Times editorial. The editorial states that the governor's "determination to fix the state's broken health care system is a welcome sign of his commitment" and that he "should also make candor a part of the agenda" (Los Angeles Times, 1/9).
- Los Angeles Daily News: It "seems unlikely that all competing interests" in the health care system "can come together around a single plan that ... actually fixes what's broken," a Daily News editorial states. The editorial continues that by "focusing the debate on finding answers to the problem," the governor has "set the stage" for all parties to agree on a pragmatic and achievable plan" (Los Angeles Daily News, 1/9).
- Orange County Register: Schwarzenegger's proposal "piles on more of what created the health care mess in the first place: government mandates, government-imposed costs and government regulations," a Register editorial states, adding that "the governor's good intentions take us farther down the road of concession, not merely compromise" (Orange County Register, 1/9).
- Sacramento Bee: Schwarzenegger "deserves special credit" for his health care proposal because, "compared with the rest of his party, he has not seized on illegal immigration and made it an excuse for doing nothing on health care," a Sacramento Bee editorial states (Sacramento Bee, 1/10).
- San Diego Union-Tribune: The governor's proposal "evades the central problem -- the rising costs and poor quality of health care," according to a Union-Tribune editorial. "The governor has crafted a government-heavy plan, perhaps to win support from the Democrats," the editorial states, concluding, "He can salvage universal coverage by putting consumers in charge" (San Diego Union-Tribune, 1/9).
- San Francisco Chronicle: Schwarzenegger's proposal involves "a complicated system of tradeoffs, higher fees and tougher rules," a Chronicle editorial states. "There are plenty of barriers to achieving universal health care, and money is the object in each," the editorial states, adding, "Any attempt to mandate coverage must be accompanied by meaningful steps to contain costs" (San Francisco Chronicle, 1/9).
- San Jose Mercury News: Schwarzenegger "unveiled a bold, comprehensive health care reform plan that shows he's ready to tackle the issue by emphasizing a welcome concept: shared responsibility," according to a Mercury News editorial. Schwarzenegger "exceeded expectations by focusing on the basic principle that every Californian must be insured" (San Jose Mercury News, 1/9).
Opinion Pieces
- California Sen. Sheila Kuehl (D), Los Angeles Times: Proposals by Schwarzenegger and other California lawmakers "are short-term solutions that have the potential to expand coverage but at the end of the day can't be relied on to achieve ... a government guarantee of access to affordable health care coverage in the state," Kuehl, chair of the state Senate Health Committee, writes in a Times opinion piece (Kuehl, Los Angeles Times, 1/9).
- Ana Malinow, Houston Chronicle: Child advocates and elected officials who are meeting this week in more than 35 cities nationwide to discuss children's health insurance expansions "should stop looking for piecemeal solutions" like SCHIP programs and Medicaid "that are guaranteed to fail" and "instead support a system where everyone pays into it equitably and every one takes out according to medical need," Ana Malinow, a pediatrician at Ben Taub General Hospital in Texas, writes in a Houston Chronicle opinion piece (Malinow, Houston Chronicle, 1/9).
- Dan Walters, Sacramento Bee: "The overarching uncertainty" about Schwarzenegger's proposal "is whether such an ambitious scheme could survive the legislative grinder," columnist Walters writes in a Sacramento Bee opinion piece. He writes, "There are four possibilities: effectively reforming health care; enacting a minor, face-saving expansion of care; another gridlock failure; or creating another unworkable monstrosity" (Walters, Sacramento Bee, 1/9).
- Debra Saunders, San Francisco Chronicle: "Schwarzenegger deserves praise for attempting to tackle the thorny and thankless task" of reforming the health care system in California, but he "was wrong" in calling for health insurance coverage for undocumented immigrants, columnist Saunders writes in a Chronicle opinion piece. According to Saunders, "the unintended consequences" of such a plan "could cost billions, and the state already is running in the red" (Saunders, San Francisco Chronicle, 1/9).
- Diane Ernst, San Francisco Examiner: "Californians should not be fooled by schemes to cure health care woes with bigger government," Ernst, a public policy fellow in health care studies at the Pacific Research Institute, writes in an Examiner opinion piece. Ernst calls for reducing government regulations on insurers and hospitals and encouraging adoption of health savings accounts and use of retail clinics. She writes that Schwarzenegger and the state Legislature "should lift burdensome government regulations and allow market incentives to work in the Golden State" (Ernst, San Francisco Examiner, 1/9).
- Joanna Garritano, Seattle Post-Intelligencer: "Market-driven medicine tears at our moral fabric as people are seen as commodities -- mere bodies to insure rather than complex individuals with diverse human needs," Garritano, an emergency department physician at Virginia Mason Medical Center in Seattle, writes in a Post-Intelligencer opinion piece. Garritano concludes, "Single-payer publicly funded health insurance with privately delivered health care may just be the solution we are looking for" (Garritano, Seattle Post-Intelligencer, 1/10).
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OBESITY: Efforts To Measure BMI of Students Questioned
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The percentage of overweight U.S. children has tripled to 16% over the past 30 years, "so it would seem that anything that can help kids get to a healthy weight is worth considering," but "schools aren't helping if children think they're being labeled as fat," a New York Times editorial states. According to the editorial, programs recently launched in Arkansas, Pennsylvania and West Virginia that measure the body mass index of students and send the results to parents might have that effect. BMI measurements and the "percentile rankings can confuse already overburdened parents and demoralize students, who now have one more grade to consider," and the "index also isn't a particularly precise measurement tool," the editorial states. "If schools are going to hand out BMI reports, they need to do a better job explaining their significance to parents and children," the editorial states, adding, "In an environment in which even a pimple can upset the fragile social pecking order, why add the stress of having to make weight?" (New York Times, 1/11).
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