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STEM CELLS: House Passes Bill; White House Makes Veto Threat
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The House on Thursday voted 253-174 to approve a bill (HR 3) -- called the Stem Cell Research Enhancement Act of 2007 -- that would expand federal funding for human embryonic stem cell research, the New York Times reports (Kirkpatrick, New York Times, 1/12). 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 Stem Cell Research Enhancement Act of 2007 is the same as the bill Bush vetoed. The Senate is expected to consider the legislation in a few weeks (American Health Line, 1/11). The House was 37 votes shy of the 290 votes needed to override a presidential veto. Thirty-seven Republicans and 216 Democrats voted for the legislation, and 158 Republicans and 16 Democrats voted against it (Epstein, San Francisco Chronicle, 1/12). A motion to send the bill back to committee and amend it to forbid research that involves human cloning failed 238-139. Eighteen more House members voted for Stem Cell Research Enhancement Act of 2007 than voted for the Stem Cell Research Enhancement Act of 2005. Most of the new votes for the legislation came from the 32 new House Democrats who were elected in November 2006, while some came from lawmakers who changed their position since last year's vote, CQ Today reports. According to CQ Today, it is not clear how soon the Senate will either consider the House bill or if it will consider its own measure (Wayne, CQ Today, 1/11).
Bush Opposition, Reaction
The White House in a statement released Thursday reiterated Bush's intent to veto the measure. "The bill would compel all American taxpayers to pay for research that relies on the intentional destruction of human embryos," the statement said (New York Times, 1/12). During three hours of debate in the House some legislators spoke of family members and friends who they said could be helped by embryonic stem cell research, while others said that the measure would involve the government in the destruction of human embryos, the Los Angeles Times reports (Gaouette, Los Angeles Times, 1/12). Rep. Diana DeGette (D-Colo.), co-sponsor of the bill, said Bush should begin negotiating with Congress to draft compromise language for the bill. The Senate lacks only one vote for a two-thirds majority needed for an override, and the Democrats' majority position will allow them to use procedural rules in their favor, the Washington Post reports. "While [the House vote is] not enough to override a veto, it's enough to show we have tremendous momentum," and it "shows that productive discussions might be a very, very good idea for all concerned," DeGette said (Weiss, Washington Post, 1/12).
Broadcast Coverage
Several broadcast programs reported on the passage of the embroynic stem cell research bill. Some of them are summarized below.- NPR's "All Things Considered": The segment includes comments from Rep. Steve Kagan (D-Wis.) and Jim Langevin (D-R.I.). (Seabrook, "All Things Considered," NPR, 1/11). Audio of the segment is available online. NPR on Wednesday included a web extra featuring a timeline of the stem cell research debate. The report is available online (Godoy/Palca, "All Things Considered," NPR, 1/10). The transcript of a Q&A with NPR reporter Joe Palca about stem cell research also is available online (Palca, "All Things Considered," 1/11).
- NPR's "Science Friday": The segment includes comments from Anthony Atala, director of the Institute of Regenerative Medicine at the Wake Forest University School of Medicine (Flatow, "Science Friday," NPR, 1/12).
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MEDICARE: Bush Says He Would Veto Rx Negotiations Bill
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President Bush on Thursday indicated he would veto 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, the New York Times reports (Pear, New York Times, 1/12). The White House in a written statement said that the bill, which the House is scheduled to consider on Friday, would create "[g]overnment interference [that] impedes competition, limits access to lifesaving drugs, reduces convenience for beneficiaries and ultimately increases costs to taxpayers, beneficiaries and all American citizens alike" (Espo, AP/Atlanta Journal-Constitution, 1/12). The White House statement said that competition among private insurers under the Medicare drug benefit "is reducing prices to seniors, providing a wide range of choices and leading to a more productive environment for the development of drugs" (Gibson/LaMendola, South Florida Sun-Sentinel, 1/12). White House spokesperson Tony Fratto said that the House proposal "looks good on a bumper sticker, but it's not practical. The evidence is in that the market is working to lower drug costs" (Lopes, Washington Times, 1/12). According to the New York Times, the White House veto threat is "an effort to hold down the number of [House] votes and to prevent the measure from gaining any more momentum" (New York Times, 1/12). House Energy and Commerce Committee Chair John Dingell (D-Mich.) said, "The president and his Republican allies have argued that this bill would do nothing. Then why, I must ask, would he bother to veto it?" House Ways and Means Committee Chair Charles Rangel (D-N.Y.) urged Bush to withhold the veto threat and work with Congress to improve the Medicare drug benefit (AP/Atlanta Journal-Constitution, 1/12).
Baucus Considers Some Form of Negotiation
Following a Senate Finance Committee hearing on the issue, committee Chair Max Baucus (D-Mont.) said "the total prohibition on negotiation should be eliminated" (New York Times, 1/12). However, he "indicated that he would not endorse the House Democrats' bill," CQ Today reports (Armstrong, CQ Today, 1/11). At the hearing, three out of four academic witnesses "agreed that limited and targeted government intervention could be helpful in driving down the prices of some crucial drugs," but all four witnesses cautioned that "price controls or attempts to drive down prices by broad negotiations could be ineffective or counterproductive," according to CongressDaily (Lee/Hess, CongressDaily, 1/11). Baucus said the "'non-interference clause' in the original Medicare Modernization Act is prohibiting us from pursuing constructive efforts to make the benefit work better for seniors" (CQ Today, 1/11). Baucus and other Senate Democrats said HHS should negotiate prices in select areas where competition has not resulted in lower prices (New York Times, 1/12). Baucus also supports the creation of a program to provide beneficiaries with "consumer-oriented" information about the effectiveness of competing drugs, with the aim to increase use of the most cost-effective choices, the Los Angeles Times reports. Baucus said that "there are areas of the drug benefit in which market competition is not working," but added, "I see nothing that warrants heavy-handed intervention in this market" (Alonso-Zaldivar, Los Angeles Times, 1/12). Senate Finance Committee ranking member Chuck Grassley (R-Iowa), who is leading Senate opposition of mandatory price negotiations, "sounded more open to Baucus' proposal" of eliminating the existing ban on price negotiations than to the House bill, CQ Today reports. Grassley said, "If we can come up with something that doesn't harm the great success of the competitiveness of the 2003 bill, I'm willing to look at it" (CQ Today, 1/11).
Snowe/Wyden Bill
Sens. Olympia Snowe (R-Maine) and Ron Wyden (D-Ore.) on Wednesday introduced a potential compromise bill that would repeal the ban on price negotiations. The bill would require HHS to help negotiate contracts for drugs that were developed with substantial funding from the federal government, and it also would require negotiations when a brand-name drug is available from only one manufacturer and no "therapeutic equivalent" or substitute is on the market (New York Times, 1/12). Wyden said, "The key for Congress is to zero in so that negotiations are in critical areas where bargaining power can really be of benefit to seniors and to taxpayers." Snowe said that negotiations do not "have to be an all-or-nothing proposition." The Congressional Budget Office has indicated that the Snowe/Wyden bill could save the government money, while it did not come to the same conclusion on the House proposal (Los Angeles Times, 1/12).
Additional Comments
Grassley said that Democratic proposals on requiring price negotiations are "a stalking horse for price controls," adding, "We have enough votes to sustain a veto" (New York Times, 1/12). Grassley also said, "Federal price negotiations would unravel the whole structure of the Medicare drug benefit, which relies on competing private plans" (Washington Times, 1/12). Richard Frank, a professor of health care economics at Harvard University, said that cost controls on drugs might pose "particular risks to precisely the research and development that should be most encouraged." Meanwhile, the Congressional Research Service said that pharmaceutical companies might respond to lower Medicare prices by increasing prices for other drug buyers. "While drug prices paid by Medicare beneficiaries may fall, overall drug prices may increase for other consumers, specifically for the under-65 population," CRS said (New York Times, 1/12).
Lobbying Efforts
In related news, the Washington Post on Friday examined how the pharmaceutical lobby "continues to wield tremendous power in the Democratic-controlled Congress." According to the Post, Democratic House leaders last week "briefly considered" proposing a government-run prescription drug program, but then "stepped back largely out of concern that the pharmaceutical industry would stall a complex change." Aides said that Democratic leaders were concerned that this proposal would "deny them a quick victory on a top consumer-oriented priority," the Post reports. Drug firms, which have given more campaign contributions to Republicans in recent years, are now "transforming their Washington operations by hiring top Democratic lobbyists to gain access to new committee chairmen, bolstering Democratic political donations and spending millions on public relations campaigns to overcome an image, indicated in recent surveys, that the industry puts profits ahead of patients," the Post reports (Smith/Birnbaum, Washington Post, 1/12).
Broadcast Coverage
APM's "Marketplace Morning Report" on Friday included a discussion on drug price negotiations under Medicare with "Marketplace" reporter Helen Palmer (Jagow, "Marketplace Morning Report," APM, 1/12). Audio of the segment is available online.
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SCHIP: Reauthorization a Top Priority This Year, Lawmakers Say
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Reauthorization of the SCHIP program is a top priority this year for the House Energy and Commerce Subcommittee on Health, according to subcommittee chair Frank Pallone (D-N.J.), CongressDaily reports. According to House Ways and Means Subcommittee on Health Chair Pete Stark (D-Calif.), the subcommittee will seek to find at least $15 billion over five years to pay for the reauthorization. The House Energy and Commerce Committee has jurisdiction over SCHIP, but the House Ways and Means Committee will have to find the additional funds. Congress last year passed a stopgap bill to provide funds for the SCHIP program through May, and House and Senate leaders have said that they hope to complete the reauthorization before the legislation expires. Pallone said, "I think that as Democrats, we'd rather look at things and reauthorize programs long term than do stopgaps. That would be the goal. That's why we need to start the process early" (CongressDaily, 1/12).
Children's Hospitals, Advocacy Groups Seek Expansion
In related news, children's hospitals and child advocacy groups nationwide on Thursday began an effort to expand health insurance for children, the AP/Cincinnati Enquirer reports. In a satellite address to audiences in 36 cities, a group of four senators -- Jay Rockefeller (D-W.Va.), Max Baucus (D-Mont.), Orrin Hatch (R-Utah) and Gordon Smith (R-Ore.) -- said that reauthorization of the SCHIP program is a top priority this year. Baucus said, "I think the passion (for children's health care) is still there." Smith said that reauthorization of the SCHIP program has bipartisan support, adding that he asked President Bush to support additional funds for the program to account for increased costs from inflation. Rockefeller said that Congress might not have the ability to increase funds for the SCHIP program because of tax cuts and the cost of the war on terrorism (Sheeran, AP/Cincinnati Enquirer, 11/12).
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FDA: Proposes 29% Increase in User Fees Paid by Rx Companies
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FDA on Thursday proposed a 29% increase in the annual user fees paid to the agency by pharmaceutical companies to improve oversight of prescription drug safety, reduce approval times for new medications and monitor direct-to-consumer television advertisements for treatments, the Newark Star-Ledger reports (Cohen, Newark Star-Ledger, 1/12). Under the 1992 Prescription Drug User Fee Act, pharmaceutical companies agreed to pay user fees in exchange for reviews of new medications in 12 months or less. Pharmaceutical companies pay user fees when they file applications for new medications based on the number of manufacturing facilities that they operate and the number of products that they market in the U.S. The law will expire this year without reauthorization by Congress (American Health Line, 10/2/06).
Proposal Details
Under the proposal from FDA, pharmaceutical companies in fiscal year 2008 would pay the agency about $393 million in user fees, compared with $305 million in FY 2007. FDA would use about $30 million of the additional funds to improve oversight of prescription drug safety (Wilde Mathews, Wall Street Journal, 1/12). FDA would hire 82 additional experts to examine prescription drug data from health insurers, physicians and pharmaceutical companies to find patterns of safety problems. In addition, FDA would use almost $12 million of the additional funds to cover rent and other costs related to the move to a new facility in Silver Spring, Md. (Ginsberg, Philadelphia Inquirer, 1/12). FDA would use $4 million of the additional funds to purchase technology that would allow pharmaceutical companies to submit applications for new medications electronically (Reuters/Los Angeles Times, 1/12). FDA would use $6.3 million of the additional funds to hire 27 staff members to review DTC TV ads for medications before they air. FDA said that the practice would provide pharmaceutical companies with "input on whether or not the advertisements are accurate, balanced and adequately supported, enabling them to address any problems before the advertisements are shown to the public." FDA also would use $4.6 million of the additional funds to hire 20 staff members to advise pharmaceutical companies on improved clinical trial designs and use some of the funds for work with outside researchers to develop "biomarkers" that would help the agency to determine whether medications are safe and effective. FDA will submit the proposal to the House Energy and Commerce Committee and the Senate Health, Education, Labor and Pension Committee for consideration after a public comment period and a public meeting scheduled for Feb. 16 (Reichard, CQ HealthBeat, 1/11).
Comments
Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs, said that the proposal is "going to mean that the FDA will have more resources for doing some of the things it needs to do to improve the drug safety program" (Bloomberg/Chicago Tribune, 1/12). HHS Secretary Mike Leavitt said, "The proposal recommendations would support significant improvements in FDA's ability to monitor and respond to emerging drug safety issues, as well as continuing FDA's commitment to scientific improvements and streamlining the drug approval process" (Pugh, Miami Herald, 1/11). Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers of America, said that the proposal calls for "comprehensive improvements in all areas that are essential to timely, safe and effective use of new medicines by millions of American patients" (Newark Star-Ledger, 1/12). However, Sen. Chuck Grassley (R-Iowa) said that the proposed increase in user fees would provide only a "modest contribution" toward improved oversight of prescription drug safety. He said, "I don't want to denigrate any step in that direction when a step is made with good intention, but, to make sure the FDA is doing everything it should to keep American consumers safe, comprehensive reform of the agency's structure and culture is needed" (Miami Herald, 1/11). Bill Vaughan, senior policy analyst for Consumers Union, said, "At a time when countless drugs have safety problems, it isn't enough to just rely on money paid by the pharmaceutical industry to fund needed drug safety reforms" (CQ HealthBeat, 1/11).
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CAREMARK Rx: Lawsuits Filed To Block Acquisition by CVS
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Pharmacy benefit manager Express Scripts has asked the Delaware Court of Chancery to void a $675 million breakup fee that PBM Caremark Rx must pay in the event that the company does not complete a planned acquisition by CVS, the AP/Philadelphia Inquirer reports. According to Express Scripts, the breakup fee is unreasonable, improper and coercive, and the fee illegally ties Caremark to the CVS offer (AP/Philadelphia Inquirer, 1/11). CVS in November 2006 made an offer to acquire Caremark for about $21.3 billion. Under the offer, which has received approval from the Federal Trade Commission, Caremark shareholders would receive 1.67 shares of CVS stock for each Caremark share. CVS shareholders would own 54.5% of the combined company -- CVS/Caremark -- and Caremark shareholders would own 45.5%. Express Scripts in December 2006 made a rival offer to acquire Caremark for about $26 billion. Under the offer, Caremark shareholders would receive $29.25 in cash and 0.426 shares of Express Scripts stock for each Caremark share. Caremark shareholders would own about 57% of the combined company, and Express Scripts shareholders would own about 43%. Caremark on Sunday rejected the Express Scripts offer and announced plans to continue with the rival offer from CVS. In response, Express Scripts announced plans to nominate four candidates to the Caremark board at the next shareholder meeting (American Health Line, 1/9). A Caremark spokesperson called the request by Express Scripts to void the breakup fee a "frivolous" effort to block the acquisition by CVS.
Second Lawsuit
In related news, the Louisiana Municipal Police Employees' Retirement System on Wednesday filed a lawsuit over allegations that the CVS offer "improperly benefits Caremark executives at the expense of shareholders," the New York Times reports. According to the lawsuit, the CVS offer is significantly lower than the Express Scripts offer, and Caremark officials improperly accepted provisions that prevent other offers. The lawsuit also alleges that the CVS offer would financially benefit Caremark CEO Edwin Crawford and other company officials. A Caremark spokesperson said that the lawsuit lacked merit and that the company would fight the allegations (Morgenson, New York Times, 1/11).
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ASTRAZENECA: To Partner With BMS To Develop Diabetes Drugs
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"In an unusual arrangement between fiercely competitive pharmaceutical giants," AstraZeneca and Bristol-Myers Squibb on Thursday announced they will collaborate to develop and market two drugs to treat type 2 diabetes, the Wall Street Journal reports. According to the Journal, while large drug companies often partner with smaller firms to develop experimental drugs, "such deals between big drug companies are less common" (Whalen, Wall Street Journal, 1/12). Under the deal, AstraZeneca will make a $100 million upfront payment to BMS for saxagliptin, known as a dipeptidyl peptidase-4 DPP-4 inhibitor, and dapagliflozin, a sodium-glucose cotransporter-2 SGLT2 inhibitor. Both were developed BMS. AstraZeneca also could pay BMS an additional $950 million in development milestone payments and share proceeds if the drugs are approved by FDA (Ginsberg, Philadelphia Inquirer, 1/12). BMS will manufacture and market both drugs (AP/Baltimore Sun, 1/12). Both drugs are in late stage clinical testing. Under the agreement, AstraZeneca will pay 75% of development costs through 2009 and the companies will split equally any additional costs after that (Wall Street Journal, 1/12). The Sun reports that by "joining forces, the companies lower the financial risks of drug development at a time numerous high-profile products haven't proved effective in late-stage clinical trials." The companies plan to seek FDA approval for saxagliptin in early 2008. Dapagliflozin is in a slightly earlier stage of development, so the companies will seek approval for it at a later time (AP/Baltimore Sun, 1/12).
Possible Sale of BMS?
In September, BMS officials "all but announced it was for sale" although "no potential suitor has emerged," the New York Times reports. According to the Times, the sale of BMS has some "major deterrents," including its "price; two pending Justice Department investigations; and a looming patent trial involving the company's blockbuster drug Plavix" (Saul, New York Times, 1/12). Some analysts say BMS' deal with AstraZeneca, in which they would be splitting revenue, might make it less attractive to an acquirer (May, Newark Star-Ledger, 1/12). BMS on Thursday declined to comment on speculation involving a possible acquisition (New York Times, 1/12).
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GENENTECH: Fourth-Quarter Profit Increases by 75%
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Genentech on Wednesday reported a 75% increase in net income in the fourth quarter and predicted an increase in 2007 earnings of 25% to 30%, the Wall Street Journal reports. U.S. sales surpassed $2 billion, marking a first for Genentech (Stepankowsky, Wall Street Journal, 1/11). The increase in income is attributed to surging sales of Genentech's drug for age-related blindness, Lucentis, and the expanded use of its cancer drug Avastin. Avastin is being tested for treatment of 25 types of tumors and is approved for use in colon and lung cancer patients (Bloomberg/Arizona Republic, 1/11). All three of Genentech's leading drugs -- Avastin, Rituxan and Herceptin -- had a double-digit percentage point gain in Q4 sales (Johnson, San Jose Mercury News, 1/11). Lucentis' sales grew to $217 million from $153 million in the third quarter (Reuters/Los Angeles Times, 1/11). The company said during a conference call Wednesday that it plans to spend 18% of the company's revenue -- which totaled $9.28 billion in 2006 -- on research and development in order to continue to grow at a double digit rate, although some analysts question if that amount would be high enough to ensure expansion, the AP/Florida Times-Union reports (Elias, AP/Florida Times-Union, 1/11). The solid growth of Genentech's three top-selling drugs "fully demonstrates the strength of this company's business model," Geoffrey Porges, an analyst for Sanford Bernstein, said, adding, "Everything seems to be working, and they put up a huge revenue number" (Reuters/Los Angeles Times, 1/11).
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PFIZER: Considers OTC Version of Viagra
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Pfizer officials on Wednesday said that the company has considered an over-the-counter version of the erectile dysfunction medication Viagra, as the treatment "faces tough competition" from Cialis, a rival medication manufactured by Eli Lilly, Reuters/Los Angeles Times reports. Pfizer officials said, "As with many of our products, Pfizer has routinely evaluated a number of options (for Viagra), including different formulations, new indications, over-the-counter, etc., and continues to do so." According to a Pfizer spokesperson, the company previously had not publicly expressed interest in the development of an OTC version of Viagra. She declined to comment on the merits of an OTC version of Viagra. Viagra had third-quarter worldwide sales of $423 million (Reuters/Los Angles Times, 1/11).
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KODAK: Sells Health Care Group to Investment Company Onex
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Eastman Kodak on Wednesday announced the sale of the Health Care Group, which includes X-ray film and medical imaging equipment operations, to investment company Onex, the New York Times reports (Austen, New York Times, 1/11). Under the agreement, expected to close in the first half of 2007, Kodak will receive an initial 2.35 billion cash payment and as much as $200 million in additional payments, provided that Onex shareholders receive an internal rate of return of more than 25% of their investment. (AP/Seattle Post-Intelligencer, 1/10). Kevin Hobert, president of the health group, will head the Onex operation, which will market products under the Kodak name (New York Times, 1/11). In a statement, Kodak officials said that the company will use some of the proceeds from the sale to pay down $1.15 billion in long-term debt and for other undisclosed purposes (AP/Seattle Post-Intelligencer, 1/10). Kodak spokesperson Christopher Veronda said that the company decided to sell the health group in large part because the transition to digital technology "was going to require a lot of investment" (New York Times, 1/11). According to the AP/Seattle Post Intelligencer, the sale "comes as the iconic photographic products company has been scrambling to generate larger profits from digital photography as its storied film business erodes" (AP/Seattle Post-Intelligencer, 1/10). Kodak posted a third-quarter net loss of $37 million, and the health group reported that earnings decreased by 29% from a year earlier to $68 million because of increased silver prices and costs associated with the study of new business strategies (Vuocolo, Wall Street Journal, 1/10).
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VIRGINIA MASON: 'Novel Solution' To Improve Efficiency Examined
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The Wall Street Journal on Friday examined how efforts at Seattle-based Virginia Mason Medical Center to more efficiently treat patients with certain conditions resulted in lower profits until the hospital developed a "novel solution" with a health insurer. According to the Journal, the case "offers a lesson in dealing with one of the most confounding elements in America's health care crisis: a perverse system of payments that rewards doctors and hospitals not for how well they treat patients but for how much they treat them." In 2004, Aetna said specialty practices at Virginia Mason cost twice as much as those of other hospitals in the area and planned to exclude the hospital from a new network of top health care providers. Virginia Mason began efforts to improve efficiency and reduce costs, but those efforts led to lower profits. Virginia Mason CEO Robert Mecklenburg said, "Everyone gained but Virginia Mason." In response, Virginia Mason and major Aetna customers, such as Starbucks and Costco, developed a system to pay the "medical center more for some cheaper treatments," the Journal reports. However, the system remains a "gamble" because Aetna accounts for only 10% of business for Virginia Mason, and other health insurers have not agreed to similar systems, according to the Journal (Fuhrmans, Wall Street Journal, 1/12).
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ARTHRITIS: Related Costs Increased to $128B in 2003, CDC Says
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The cost of arthritis and related conditions in the U.S. increased to $128 billion in 2003, the most recent year for which data were available, and the amount will continue to increase as the population becomes older and heavier, CDC said on Thursday, the AP/Long Island Newsday reports. According to CDC, the $128 billion in costs included $80.8 billion in direct costs, such as medical expenses, and $47 billion in indirect costs, such as lost wages. The $128 billion in costs represented a 48% increase from $86.2 billion in 1997, in large part because federal surveys identified nine million more cases of arthritis and related conditions, CDC said. CDC estimated that 46.1 million residents received treatment for arthritis and related conditions in 2003 and that 29.5 million of them lost wages. CDC said eight million additional residents likely will develop arthritis and related conditions from 2005 through 2015 and recommended broader use of self-management programs, which teach patients to manage their pain and continue to work with the condition, to help reduce costs (Yee, AP/Long Island Newsday, 1/12).
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JAPAN: Law Calls for Expanded Cancer Care; Cost Raises Concerns
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The Wall Street Journal on Thursday examined how legislation in Japan that calls for expanded cancer care in the country "raises the question of where nations should draw the line when modern medicine offers almost unlimited ways to spend money." The law, passed by the Japanese parliament in June 2006, does not call for immediate spending but would establish committees to encourage the health ministry to do more for cancer care. According to the Journal, the bill "was a signal victory for a spreading movement in Japan among patients who want American-style care and drugs for cancer." That push has become more prominent since the advent of the Internet, which has allowed cancer patients to learn more about treatments available abroad. Some policymakers are concerned about the cost to the Japanese government if advanced treatments and drugs were to be offered. Japan, which guarantees universal health care and pays for most of it, currently spends half as much on health care as the U.S., adjusting for the size of each country's economy. Japan is able to conserve by requiring less training of doctors and by paying them lower salaries than in the U.S. Patients rarely receive second opinions and are expected to follow treatments advised by their doctors, which is often limited to cost and availability. Nevertheless, Japanese women have the highest life expectancy in the world, while Japanese men have the fourth-highest. Masaharu Nakajima -- former director general of the Health Bureau at the Ministry of Health, Labor and Welfare -- said Japan already offers excellent cancer care and cannot afford to offer more. "If we keep going like this, Japan is going to be crushed under medical expenses," Nakajima said, adding, "America did too much of this and that's why their medical costs have grown." However, lawmaker Takashi Yamamoto said, "Even when there are treatments, people are being told they will never get better. These abandoned cancer refugees are roaming the Japanese archipelago" (Landers, Wall Street Journal, 1/11).
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PREVENTIVE CARE: Not Received by Millions of U.S. Residents
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Millions of U.S. residents do not receive necessary preventive care, according to two reports released on Thursday by the Agency for Healthcare Research and Quality, the AP/Arizona Daily Star reports. According to the fourth annual national health care quality and disparities reports, although the quality of the health care system continues to improve overall, lower-income and minority residents continue to receive a lower quality of care than other residents. In addition, the reports found that uninsured residents received the lowest quality of care and had the most problems with access. The reports also found that many residents overall -- with the majority low income, minority or uninsured -- do not receive necessary examinations, tests and advice from physicians that can prevent or limit the progression of asthma, cancer, diabetes and obesity. Physicians are less likely to advise obese black and Mexican-American residents than white residents that they are overweight, the reports found. In addition, the reports found that black residents with asthma are less likely than other residents to receive medications for their conditions and that black and Asian residents receive colon cancer tests at a lower rate than white residents. AHRQ Director Carolyn Clancy said, "It's encouraging to learn that overall quality continues to improve," adding, "At the same time, the message is clear: Much more can be done to prevent illness from occurring or progressing." Andrea Kabcenell, an executive director for the Institute for Healthcare Improvement, said, "If we can show health care organizations how to do the things that reduce disparities, they will jump on them. Nobody wants these disparities" (AP/Arizona Daily Star, 1/12).
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TRANS FATS: Los Angeles County To Study Possible Restrictions
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The Los Angeles County Board of Supervisors on Tuesday voted to study possible restrictions on the use of trans fats in restaurants, the AP/Newport News Daily Press reports. County supervisors will ask public health officials to study whether the county can restrict the trans fats in all areas or only in unincorporated areas and to review the issue with the restaurant industry and community health groups. County Supervisor Yvonne Brathwaite Burke said, "I'm very concerned about the whole trans fat issue," adding, "Every time I buy something, I look to see if it has trans fat." Jot Condie, president of the California Restaurant Association, said that restrictions on the use of trans fats in restaurants "has more cons than pros." He said, "What's next? Butter, cheese or anything that has saturated fat, which accounts for 15% of the average American diet and also is not healthy, but that also needs to be taken in moderation?" (AP/Newport News Daily Press, 1/10).
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NEJM: Studies Examine Anticholesterol Rx, Former Inmate Deaths
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American Health Line highlights two studies published on Thursday in the New England Journal of Medicine. Summaries appear below.- Anticholesterol medication: AEGR-733, an experimental medication developed by Bristol-Myers Squibb, can significantly reduce LDL cholesterol levels in patients with familial hypercholesterolemia, a rare genetic disease that causes a fatal accumulation of cholesterol in the blood, according to a study led by Daniel Rader of the University of Pennsylvania, USA Today reports. Patients with familial hypercholesterolemia have LDL cholesterol levels of 400 to 600 milligrams per deciliter of blood, more than quadruple the recommended level of 130. For the study, six familial hypercholesterolemia patients took four different doses of AEGR-733, each for one month. The study found that AEGR-733 decreased participant LDL cholesterol levels by 51%, triglyceride levels by 65% and total cholesterol levels by 58%. However, two participants developed evidence of accumulation of fat in the liver -- which can lead to lead to inflammation, scarring and cirrhosis -- and two others experienced a 30% increase in liver fat content, the study found (Sternberg, USA Today, 1/11). The study is available online.
- Former prison inmates: Former prison inmates are three-and-a-half times more likely than the general population and almost four times more likely than current inmates to die over a two-year period, according to a study led by Ingrid Binswanger, a public health researcher and assistant professor at the University of Colorado-Denver, the AP/Long Island Newsday reports. For the study, researchers compared the deaths of 26,270 men and 3,967 women released from Washington state prisons from mid-1999 through 2003 with those of other state residents of similar age, race and gender. During that period, 443 of the former inmates died, the study found. The study also found that 38 of the former inmates died within the first two weeks of their release, compared with an average of three deaths among the same number of state residents in the general population. The study found that drug overdoses were the leading cause of death among the former inmates, followed by heart disease, homicide and suicide (Johnson, AP/Long Island Newsday, 1/10). The study is available online.
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AUTISM: Universities To Start Databank
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The Simons Foundation has awarded scientists from the University of Michigan and 10 other universities a $10 million grant to create a databank of DNA samples from 3,000 patients with autism, the AP/Boston Globe reports. The researchers will aim to identify different kinds of autism and subsequent treatments. Catherine Lord, director of the University of Michigan's Autism and Communication Disorder Center, will lead the project, which is expected to last three years. Lord said that people with autism are known to have a lack of normal brain development in areas linked to social interaction and communication, but scientists do not know how many subtypes of the disorder exist. She said that the collected genetic data could help identify autism sub-groups, information that one day could be used to treat newborns. DNA samples for the databank will be collected from patients with autism by scientists at Boston University, Columbia University, Emory University, Harvard University, McGill University, Washington University, Yale University, the University of California-Los Angeles, the University of Illinois-Chicago and the University of Washington. The Simons Foundation's long-term goal is to spend $100 million to find a cure for autism. Lord said, "The Simons Foundation is hopeful the genetics will be just the beginning of a huge initiative" (AP/Boston Globe, 1/11).
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MEDICARE: Editorials, Op-Eds Address Rx Price Negotiation Bill
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Newspapers recently published editorials and opinion pieces commenting on a bill (HR 4) scheduled for vote Friday 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:
Editorials
- Aberdeen American News: "It just makes sense that the federal government should be able to use bargaining power to benefit the American public through Medicare" because the negotiation system already in place at the Department of Veterans Affairs has yielded results that have been "both positive and effective," an Aberdeen American News editorial states. "After all, no one is asking the government to pick up the entire tab, just that the government uses the collective power of the Medicare patient base to help negotiate better, more affordable prices on prescription drugs. It's not too much to ask," the editorial concludes (Aberdeen American News, 1/11).
- New York Times: The bill scheduled for a vote on Friday "is sufficiently flexible to allow older Americans to benefit from the best efforts of both the government and the private drug plans" and "should pose no threat to the free market," a New York Times editorial states. The bill would not require the secretary to negotiate the prices of all drugs used by beneficiaries, and a "smart secretary could simply determine which prices paid by the plans seemed most out of line with the prices paid by other purchasers and then negotiate only on those drugs," the New York Times writes (New York Times, 1/12).
- Rochester Democrat & Chronicle: Establishing "Medicare as the prime force in prescription drug purchases won't by itself save a health entitlement that needs broad-based reform," but "[c]hanging the buying structure would help" make medication affordable for all seniors, a Rochester Democrat & Chronicle editorial states. The Democrat & Chronicle notes that the VA "has negotiated these purchases for years and has been able to offer a complete formulary at lower prices" (Rochester Democrat & Chronicle, 1/12).
- Washington Times: "Despite flabby language in the legislation that claims the bill would not require Medicare to restrict access to medicines in order to bargain down prices, those voting for the bill will be voting against the freedom of seniors to choose the drugs they want from private plans that compete for business based on cost, quality and service," according to a Washington Times editorial (Washington Times, 1/12).
Opinion Pieces
- Jay Hancock, Baltimore Sun: "Getting discounts by negotiating with drug companies will get [Democrats] only partway" to their goal of "filling the 'doughnut hole' coverage gap in Bush's irresponsible Medicare drug plan," Sun columnist Jay Hancock writes in a letter to House Speaker Nancy Pelosi (D-Calif.). Hancock says the only way to fill the doughnut hole would be to increase copayments, which "would be unpopular with voters" (Hancock, Baltimore Sun, 1/10).
- Peter Pitts, Long Island Newsday: The problem with the proposal for the federal government to use its "large market share -- some 42 million beneficiaries -- as a big chip to negotiate dramatically lower prices" on prescription drugs is that the "bargaining chip isn't nearly as big as they think," Pitts, director of the Center for Medicine in the Public Interest, writes in a Long Island Newsday opinion piece. According to Pitts, pharmaceutical companies, which often have sole rights to a particular drug, "will have the upper hand [in negotiations] because there are no competitors the government can approach for an alternative." He writes that, consequently, "the government's negotiator will have a relatively weak position" (Pitts, Long Island Newsday, 1/12).
- Rep. Jim McCrery (R-La.), Washington Times: The Democrats' proposal to negotiate drug prices "will either be largely ineffective, or it will cause undesirable results: it will restrict seniors' choices, devastate local pharmacies, raise prescription drug costs for veterans and stifle innovation," McCrery, ranking member of the House Ways and Means Committee, writes in a Washington Times opinion piece.
- Robert Goldberg, Washington Times: What "Democrats really mean by direct negotiations with drug companies" is to "peddl[e] influence to create earmarks," Goldberg, a vice president for strategic initiatives for the Center for Medicine in the Public Interest, writes in a Washington Times opinion piece. He adds, "It doesn't take a village to figure out that government prices will become a floor upon which companies will walk -- away from negotiating or selling to government altogether" (Goldberg, Washington Times, 1/12).
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CALIFORNIA: Health Insurance Proposal 'Encouraging,' Has 'Flaws'
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A proposal announced this week by California Gov. Arnold Schwarzenegger (R) that would require all state residents to obtain health insurance is "very encouraging" and supports the "principle that all Americans are entitled to essential health care," but the plan has "serious flaws," columnist Paul Krugman writes in a New York Times opinion piece. The proposal "forces everyone to buy health insurance, whether they think they need it or not; it provides financial aid to low-income families, to help them bear the cost; and it imposes 'community rating' on insurance companies, basically requiring them to sell insurance to everyone at the same price," Krugman writes. "As a result, the plan requires a much more intrusive government role than a single-payer system," he writes, adding, "Instead of reducing paperwork, the plan adds three new bureaucracies: one to police individuals to make sure they buy insurance, one to determine if they're poor enough to receive aid and one to police insurers to make sure they don't discriminate against the unwell." Krugman concludes, "I suspect that the real question is what to do after the plan founders from its own complexity. And the answer is, damn the insurers -- full speed ahead" (Krugman, New York Times, 1/12).
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Josh Kotzman, Cheryl Skrzat, Editors
Amanda Wolfe, Editor in Chief
Allison Czapp, Amy Dietterich, Daniel Esquibel, Jennifer Haliski, Kimberley Lufkin, Contributing Editors
Bryn Lansdowne, Tessa Moran, Justyn Ware, Sherkiya Wedgeworth, Cameron Williams, Staff Writers
Sarah Mann, Chris Sowerwine, Copy Editors
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