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Week Ending
Friday, January 12, 2007



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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).
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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).
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CALIFORNIA: Schwarzenegger Announces Health Insurance Proposal
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California Gov. Arnold Schwarzenegger (R) on Monday announced a proposal that would require all state residents to obtain health insurance and would share the cost among employers, individuals, health care providers, health insurers and the government, the San Francisco Chronicle reports (Chorneau, San Francisco Chronicle, 1/9). About 6.5 million California residents lack health insurance. According to the Census Bureau, in 2005 19.4% of California residents lacked health insurance, compared with 15.9% nationwide (Carlton, Wall Street Journal, 1/9). Under the proposal, employers with 10 or more employees would have to offer health insurance for workers or pay a fee of 4% of payroll to a state pool that would help workers purchase coverage, with the amount that they pay based on income. Employees could pay for health insurance with pretax income (Steinhauer, New York Times, 1/9). The proposal would provide additional subsidies to help state residents with annual incomes of as much as 250% of the federal poverty level purchase health insurance (Appleby, USA Today, 1/9). The proposal would require health insurers to sell policies to all state residents, regardless of whether they have medical conditions (Benson/Rojas, Sacramento Bee, 1/9). State residents who refuse to obtain health insurance could face reductions in their state income tax refunds or have their wages garnished (Geis/Lee, Washington Post, 1/9). The proposal also would extend coverage under Medi-Cal, the state Medicaid program, to all adults with annual incomes of as much as 100% of the federal poverty level and to children -- regardless of their immigration status -- in households with annual incomes of as much as 300% of the federal poverty level (New York Times, 1/9). In addition, the proposal would increase by $4 billion reimbursements to health care providers under Medi-Cal (USA Today, 1/9). Under the proposal, physicians would have to pay 2% and hospitals would have to pay 4% of their revenue to help cover the cost of the proposal (Ainsworth, San Diego Union-Tribune, 1/9). According to Schwarzenegger aides, the governor would finance the proposal in part with about $5 billion in federal matching funds that the state will receive as a result of restructured health care programs and with state funds currently used to finance charity care (New York Times, 1/9).



Comments
Analysts said that the proposal "is illustrative of the resurgence of interest among politicians at all levels in expanding health coverage to the uninsured and that it provides fresh evidence, with Congress stalled on enacting comprehensive health care reform, the states are beginning to take matters into their own hands," the Post reports (Washington Post, 1/9). Schwarzenegger said, "If you can't afford it, the state will help you buy it, but you must be insured" (Rau, Los Angeles Times, 1/8). According to Schwarzenegger, the cost of health care for state residents without health insurance has contributed to increased premiums for other residents. He said, "We are paying a hidden tax. We are paying higher deductibles. We are paying higher out-of-pocket co-pays, and the list goes on and on (San Diego Union-Tribune, 1/9). States Assembly Speaker Fabian Nunez (D) called the proposal "a good start," adding, "When it's all said and done, employers in California will pay a portion of their payroll deductions toward the cost of insuring their employees" (Los Angeles Times, 1/8). Karen Davis, president of the Commonwealth Fund, said, "This is a very significant proposal. It is not just children he is talking about. It is really dealing with the whole problem of the uninsured, with concrete positions to raise revenues to pay for that coverage and the philosophy of shared responsibility. I think this shows health care is going to be a major issue in the 2008 presidential election" (New York Times, 1/9). Diane Rowland, executive vice president of the Kaiser Family Foundation, said, "Health care for the uninsured is back on the agenda," adding, "The governors are trying to lead the way, but it's also going to take national action to try to address this problem" (Washington Post, 1/9). Bruce Bodaken, chair and president of Blue Shield of California, said, "Taking each part separately, there's something for everyone to hate, but, taken as a whole, there's a lot to like" (Carlton, Wall Street Journal, 1/9).



Criticism
Anmol Singh Mahal, president of the California Medical Association, said, "A tax on physicians is really a tax on those who are sick because it is the sick who go to see their doctors. Deborah Burger, president of the California Nurses Association, criticized the proposal as "a fresh coat of paint on a collapsing house" and a "huge gift to the insurance industry." Burger added, "There are no limits on skyrocketing health premiums, no requirements on what will be included in the required plans" (San Francisco Chronicle, 1/9). State Assembly member Mike Villines (R-Clovis) said that Republicans oppose health insurance proposals with a mandate on employers. He said, "If we put any form of mandate on a business, we are seeing a jobs tax. This isn't a philosophical discussion. This is a jobs discussion. This is the difference between employees having a job and a jobs tax that says no to that" (Los Angeles Times, 1/8). NPR's "All Things Considered" on Tuesday reported on the proposal. The segment includes comments from NPR health policy correspondent Julie Rovner ("All Things Considered," NPR, 1/9). Audio of the segment is available online.
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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).
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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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HEALTH CARE SPENDING: Growth Slows for Third Consecutive Year
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U.S. health care spending increased 6.9% in 2005, marking the third consecutive year that the growth rate declined, according to an annual government report published in the January/February issue of Health Affairs, the New York Times reports. The growth rate was the lowest reported since 1999 (Pear, New York Times, 1/9). The health spending growth rate in 2004 was 7.2% (Alonso-Zaldivar, Los Angeles Times, 1/9). The report, prepared by the CMS Office of the Actuary, states, "This might be an encouraging sign for the individuals, businesses and governments that finance health care; however, it is unclear whether this ... is temporary or indicative of a long-term trend" (Appleby, USA Today, 1/9). According to the report, the U.S. spent $1.988 trillion, or $6,697 per person, on health care in 2005. State and federal governments paid about 40% of health care costs, totaling $736.3 billion (Zhang, Wall Street Journal, 1/9). Though the rate of growth in health spending slowed, it continued to rise more quickly than the economy as a whole, wages, and general inflation (Los Angeles Times, 1/9). Health spending accounted for 16% of the gross domestic product in 2005, up from 15.9% the previous year. Public-sector spending on health care increased 7.8% in 2005, compared with a 7% growth rate for businesses and a 6.2% increase for households, according to the report (Zhang, Wall Street Journal, 1/9).



Prescription Drug Costs
A slowdown in prescription drug spending growth was the largest reason for the lower overall growth rate during 2005, according to the report (Krasner, Boston Globe, 1/9). Spending on prescription drugs increased 5.8% in 2005, marking the first time since 1993 that drug spending grew more slowly than overall health care costs. The drug spending growth rate has declined each year since 1999, when it peaked at 18.2%. Drug spending totaled $200.7 billion in 2005, representing 10 cents of every dollar spent on health care (New York Times, 1/9). Health insurers have slowed the growth of drug spending with tiered plans that have patients pay larger copayments for brand-name drugs than generic drugs, the Globe reports. Separate insurance efforts have encouraged the use of less expensive drugs, with more expensive drugs being used only when cheaper products are ineffective (Boston Globe, 1/9). Medicaid spending on prescription drugs increased 2.8% in 2005, coming after an average annual increase of 15.4% from 1994 through 2004, according to HHS economist Aaron Catlin, the principal author of the report. Catlin said that 42 states had slower Medicaid drug spending increases in 2005 than in 2004 by taking such actions as pooling their buying power, negotiating discounts with manufacturers and increasing the use of generic drugs (New York Times, 1/9). Other contributing factors to the drug spending slowdown were pharmaceutical companies' decelerated introduction of new drugs, as well as the immediate aftermath of the withdrawal of Vioxx from the market because of safety concerns, the report found. The report does not include data on the Medicare prescription drug benefit, which was implemented in 2006 (Wall Street Journal, 1/9).



Additional Results
The report also contains the following findings:
- Home health care was the fastest-growing spending category in 2005, increasing 11% in 2005 -- the third consecutive year of double-digit growth. Spending on home health care totaled $47.5 billion.
- Spending on hospital care increased 7.9% in 2005, while spending on physicians increased 7% (New York Times, 1/9).
- Health insurance premium rates increased 6.6% in 2005, "continuing a moderating trend seen in the past couple of years," USA Today reports.
- Out-of-pocket expenses for workers increased 5.8% in 2005, up from 5% in 2004 (USA Today, 1/9).
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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).
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Rx DRUGS: Cost Less Through VA Than Medicare Part D, Study Finds
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Prices in Medicare Part D prescription drug plans are on average of 58% more for the most commonly prescribed medications than prices paid by the U.S. Department of Veteran Affairs, according to a study released Tuesday by Families USA, the Arizona Daily Star reports (Arizona Daily Star, 1/10). The study used data submitted in November 2006 by the five health plans with the highest Part D enrollment figures. The prices represent charges that would be paid in full by Medicare beneficiaries in the so-called "doughnut hole" coverage gap. Researchers considered Part D and VA prices for the top 20 drugs prescribed to seniors (Lade, South Florida Sun-Sentinel, 1/10). The study found that the VA was able to use its purchasing power to negotiate for lower drug prices. Under the 2003 Medicare law, Medicare does not have the right to negotiate with drug companies. All 20 drugs cost more under Medicare Part D than under VA programs (Arizona Daily Star, 1/10). The differences in price ranged from 34% higher for the bloodthinner Plavix to as much as 10 times higher for the statin Zocor. Families USA Executive Director Ron Pollack in a statement said, "These high prices devastate seniors who need to take multiple medicines," adding, "They are also a rip-off of American taxpayers" (South Florida Sun-Sentinel, 1/10). The report also "challenged assertions" that pharmaceutical companies need Medicare's revenue to fund research and development, according to the Detroit Free Press. The report suggested that drug companies could shift money from marketing, advertising and administration -- which consumes 32% of the top seven companies' budgets -- to research and development, which takes up 13.9% of revenue, according to 2005 filings with the Securities and Exchange Commission. "The industry could absorb a reduction in revenues resulting from negotiations with Medicare without paring back R&D spending," the report stated (Anstett, Detroit Free Press, 1/10). The study is available online. Note: You will need Adobe Acrobat Reader to view the study.
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