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MEDICARE: GOP Senators Discuss Rx Benefit With McClellan, Leavitt
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About 30 Senate Republicans on Tuesday met privately with HHS Secretary Mike Leavitt and CMS Administrator Mark McClellan to discuss concerns about the Medicare prescription drug benefit, The Hill reports. According to an unidentified senator who attended the session, lawmakers questioned Leavitt and McClellan about concerns that the drug benefit offers too many plans and could confuse beneficiaries. In addition, the senator said, lawmakers discussed the so-called "doughnut hole," or the gap in drug benefit coverage, under which Medicare beneficiaries are responsible for annual drug costs between $2,250 and $5,100. Leavitt and McClellan told senators that 24 million of 42 million eligible beneficiaries have enrolled in the drug benefit; 250,000 beneficiaries sign up weekly; and average monthly individual premiums have decreased from $37 to $25. To address concerns about the doughnut hole, the government is sending letters to beneficiaries to alert them when their medication costs are approaching the coverage gap, Leavitt and McClellan said. The alert could allow beneficiaries time to switch plans to avoid the doughnut hole, they said.
Senators' Comments
Sen. Pete Domenici (R-N.M.) said legislative changes to the drug benefit are unnecessary, adding that "every management tool should be used to smooth this over as best as possible." He said, "When it works it's going to help a lot of people," but that "it's too bad management-wise we haven't got better assistance and put out [a] better word." Sen. Larry Craig (R-Idaho) said he disagreed with colleagues who said the drug benefit offered too many plans or could confuse beneficiaries. He said, "My retort was: 'You want one federal program, take it or leave it?'" Sen. John Ensign (R-Nev.), who voted against the drug benefit, said Congress should "restructure the program and make it means-tested."
Democrats
Tuesday's meeting comes as Republican lawmakers "prepare for an expected Democratic assault" on the drug benefit, The Hill reports. Last week, Democratic strategists Stan Greenberg, James Carville and Matt Hogan released a memorandum urging Democrats to criticize the Republican's handling of the drug benefit. The memo says, "Democrats now have the opportunity to raise opposition to the drug benefits to new heights and use the plan as a powerful symbol of Republican corruption and irresponsibility." It continues, "Coupled with attacks over budget cuts to Medicare, an assault on the prescription drug program could cause serious damage to the GOP, especially among seniors." According to the memo, opposition to the drug benefit among voters ages 50 to 64 has increased from 38% in the fall to 51%, and voters ages 65 and older are opposed to the drug benefit by a 28-point margin. Sen. Jay Rockefeller (D-W.Va.), ranking member of the Senate Finance Committee Health Subcommittee, said he had drafted legislation that would eliminate coverage gaps for low-income and disabled beneficiaries. Rockefeller said other Democrats have drafted legislation to alter the drug benefit, but they are waiting to reveal their proposals as a comprehensive party plan for Medicare. Rockefeller said, "The question is whether we come out with plans right now or let [Republicans] vent" (Bolton, The Hill, 2/15).
Avalere Health Poll
Monthly premiums and formularies vary greatly among Medicare drug plans, according to an analysis of the Medicare prescription drug benefit by Avalere Health, CQ HealthBeat reports. The report analyzes data on 3,000 Medicare drug plans. According to the report, Medicare drug plans are more likely than other health plans to implement prescription drug cost controls such as step therapy, prior authorization and quantity limits. In addition, cost sharing tends to be higher in Medicare drug plans than other health plans, the report says. According to the report, average monthly premiums for Medicare Advantage plans are nearly $18 lower than for prescription drug plans. Overall, 496 drug plans offer plans with no premium, the report finds. In addition, the report finds:
- On average, formularies for PDPs include 1,526 medications, compared with 1,456 medications for MA plans;
- Formularies for Medicare drug plans tend to include fewer medications than formularies for commercial drug plans;
- 66% of PDPs and 75% of managed care plans offer zero- or reduced-deductible plans;
- 51% of stand-alone PDPs and 63% of MA plans have at least four coverage tiers, compared with an average of three tiers for commercial plans; and
- Few plans offer coverage during the doughnut hole (Carey, CQ HealthBeat, 2/14).
Harris Interactive Poll
According to a separate poll by Harris Interactive, most beneficiaries enrolled in a Medicare drug plan have found it difficult to choose a plan and understand the plan's benefits, but most enrolled beneficiaries do not consider their plan difficult to use, Wall Street Journal Online reports. The poll, which was conducted online from Feb. 7 to Feb. 9, surveyed 2,477 U.S. adults of all ages. Of respondents ages 65 and older who are enrolled in Medicare drug plans, 60% agreed with the statement, "It is/has been difficult for me to choose a plan," and 63% agreed with the statement, "It is/had been difficult for me to understand the benefits." However, only 26% agreed with the statement, "It is/has been difficult for me to use the plan." In addition, 60% of enrolled beneficiaries said they have not had trouble reaching a person "who could answer questions about their benefit plan" (Wall Street Journal Online, 2/15).
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ASBESTOS FUND: Bill Close to Failure Over Budget Point of Order
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Asbestos legislation (S 852) sponsored by Senate Judiciary Committee Chair Arlen Specter (R-Pa.) was "all but kill[ed]" when an effort to secure 60 votes to waive a budget objection fell short, the New York Times reports (Labaton, New York Times, 2/15). The bill would create a $140 billion trust fund to reimburse people who claim to have been injured by asbestos exposure and would be paid primarily by companies with asbestos liabilities and their insurers (Mullins, Wall Street Journal, 2/15). Sen. John Ensign (R-Nev.) raised the budgetary point of order last week, stating that the bill violated a congressional limit on spending (New York Times, 2/15). The effort to clear the procedural objection failed 58-41 after Senate Majority Leader Bill Frist (R-Tenn.) reversed his vote from a "yes" to a "no" in order to have the right under parliamentary procedure to raise the bill for another vote. Specter said the vote would have reached 60, but Sen. Daniel Inouye (D-Hawaii) -- who indicated that he supported waiving the budget objection -- was unable to vote because he was with his wife, who had fallen ill. Specter said, "We will have [Inouye] on the motion to reconsider, and we may change another vote or two, so we may win this one yet" (Hurt, Washington Times, 2/15). Eleven Republicans and 30 Democrats voted against waiving the objection (Stern, CQ Today, 2/14). Frist earlier on Tuesday said, "If we are unsuccessful this week in addressing asbestos, that is it for this year" (New York Times, 2/15).
Reaction
Sen. John Cornyn (R-Texas) said, "My suspicion is the leader may pull it down because we have run out of time" (CQ Today, 2/14). Sen. Richard Durbin (D-Ill.), who opposes the bill, said it "was a clash of the special-interest titans on both sides," adding, "We have to find a reasonable way to help those victims" (Murray, Washington Post, 2/15). Sen. Jim DeMint (R-S.C.), who also opposes the bill, said, "We have a serious problem with asbestos litigation that has already forced 70 American companies into bankruptcy and cost over 60,000 Americans their jobs. But creating a multibillion-dollar government entitlement program that punishes taxpayers and rewards trial lawyers is not the answer" (Washington Times, 2/15). Sen. Dianne Feinstein (D-Calif.), one of 20 bill co-sponsors, said that while the bill is not perfect, it is necessary to address compensation to people with asbestos-related injuries and high court costs. Feinstein also disagreed that taxpayers would have to pay for the trust fund if it ran out of its initial resources (New York Times, 2/15).
Broadcast Coverage
NPR's "Morning Edition" on Wednesday reported on the Senate's vote on the objection to the asbestos bill (Inskeep, "Morning Edition," NPR, 2/15). The complete segment is available online in RealPlayer.
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HEALTH CARE COSTS: Hubbard Attributes Problem to 'Perception'
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Allan Hubbard, director of the National Economic Council, on Tuesday said that the largest factor behind increased health care costs is the public "perception that health care is free," CQ HealthBeat reports. At a breakfast with reporters, Hubbard said that U.S. residents overuse health care services because health insurance covers most of the cost. He added that a proposal by President Bush to expand health savings accounts, which seek to make individuals more responsible for their health care spending, would help reduce costs. Hubbard did not estimate the amount of the savings that would result from the proposal, which would cost $29 billion over five years, but said, "We'll know its working when growth starts to slow." According to CQ HealthBeat, the "idea is that once patients are forced to pay more costs out-of-pocket, they will begin to comparison shop and request quality data, eventually driving down the costs of health care." Hubbard also addressed concerns that only higher-income individuals will enroll in HSAs. According to Hubbard, the high-deductible health plans associated with HSAs are less expensive than traditional health insurance. About three million U.S. residents have enrolled in HSAs, and the Bush proposal would increase enrollment to 21 million by 2010, Hubbard said (Schuler, CQ HealthBeat, 2/14). Hubbard on Tuesday answered questions about HSAs in an "Ask the White House" online chat. The complete transcript is available online.
Related Broadcast Coverage
NPR's "Morning Edition" on Wednesday reported on the Bush health care agenda. The segment includes comments from Drew Altman, president and CEO of the Kaiser Family Foundation; HHS Secretary Mike Leavitt; and Theodore Marmor, a public policy professor at Yale University (Rovner, "Morning Edition," NPR, 2/15). The complete segment is available online in RealPlayer.
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RODHAM CLINTON: Pushes Rx Benefit Changes, Promotes Health IT
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Sen. Hillary Rodham Clinton (D-N.Y.) at a meeting on Tuesday urged AARP to join her in attempts to fix the new Medicare prescription drug benefit and to persuade the House to pass a Senate-approved bill promoting health care information technology, CQ HealthBeat reports. She said her larger goal is to make the health care system more efficient with information technology, preventive care and research identifying the most effective forms of treatment, with any resulting savings funding coverage of the uninsured (Reichard, CQ HealthBeat, 2/14). Rodham Clinton said the system could be less costly if government dollars were linked to results, adding that the government is not getting its money's worth for its health care spending. Rodham Clinton also said she is working with Senate Finance Committee ranking member Max Baucus (D-Mont.) on a proposal to make improvements to the Medicare drug benefit. She said they are developing a bill that would create a regulatory structure to find and remove less-effective private drug plans. In addition, she is working with Finance Committee Chair Chuck Grassley (R-Iowa) on ways to expand and improve long-term care options (Fagan, Washington Times, 2/15). Rodham Clinton said that the government should have the authority to negotiate for lower drug prices in Medicare and that pharmacists should be reimbursed for filling prescriptions for Medicare beneficiaries who were unable to prove eligibility because of computer glitches. The Feb. 15 deadline for reimbursing states offering Medicaid coverage to address coverage gaps should be extended, she said (CQ HealthBeat, 2/15). "We are approaching a real turning point. Everyone is agreeing we need to address" health care, Rodham Clinton said, adding that solutions will require lawmakers to "check their ideological baggage at the door" to "hammer out what kind of a health care system we want, we need and can afford" (Washington Times, 2/15).
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FDA: Asks Cytosol Laboratories To Recall Eye Solution
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FDA has asked Massachusetts-based Cytosol Laboratories to recall its entire inventory of a saline solution used in cataract surgery after receiving more than 300 reports of injuries related to the product, the Wall Street Journal reports. The solution -- which is marketed under the brand names Cytosol Ophthalmics, AMO Endosol and Akorn -- can become contaminated with high levels of endotoxin, which is a bacterial poison that causes fevers, shock, changes in blood pressure and other circulatory problems, according to FDA. The agency said 300 patients were diagnosed with Toxic Anterior Segment Syndrome, an inflammation in the eye that can cause permanent damage. According to the agency, one million units of the solution were sold in 2005. Douglas Koch, a professor of ophthalmology at Baylor College of Medicine in Houston, said TASS "is not something to be taken lightly," adding that the condition can lead to retinal injury if it is not treated (Sataline/Westphal, Wall Street Journal, 2/14).
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VIOXX: Plaintiff Rests in Retrial of First Federal Lawsuit
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The editors of the New England Journal of Medicine decided to publish an editorial online on Dec. 8, 2005, that criticized a Merck study of the COX-2 inhibitor Vioxx because they had believed the jury in the original trial of the first federal lawsuit related to the medication would view a videotaped deposition of NEJM Executive Editor Gregory Curfman on that date, Curfman testified on Monday in a retrial of the case, the AP/Long Island Newsday reports (McConnaughey, AP/Long Island Newsday, 2/13). Merck, which withdrew Vioxx from the market in September 2004 over safety concerns, faces more than 9,000 lawsuits related to the medication in state and federal courts. In the current case, plaintiff Evelyn Irvin Plunkett alleges that Vioxx caused the death of her husband, Richard Irvin, who experienced a fatal heart attack in 2001 after he took the medication for one month (American Health Line, 2/10). The original trial resulted in a mistrial (AP/Long Island Newsday, 2/13). Curfman was deposed on Nov. 21, 2005, and deposed a second time in January after the publication of the editorial (American Health Line, 2/10). Jurors in the retrial on Friday and Monday viewed the videotaped depositions. According to testimony in the second deposition, NEJM editors believed that they should publish the editorial before jurors in the original trial viewed the first videotaped deposition over concerns that the public would misinterpret information in the testimony. "As far as I was concerned, the issue was not the trial," Curfman said, adding, "The issue was my personal testimony and how it would be played and how it might be interpreted or misinterpreted by members of the media." On Monday, attorneys for the plaintiff rested their case (AP/Long Island Newsday, 2/13).
Retrial Examined
In related news, the AP/Baton Rouge Advocate on Sunday examined how "the evidence and witness lists have changed" since the original trial, an indication that a retrial "doesn't mean replay" (McConnaughey, AP/Baton Rouge Advocate, 2/12).
New Jersey Cases
Meanwhile, Merck attorneys on Friday filed a motion to oppose a plan by New Jersey Superior Court Judge Carol Higbee to consolidate two state Vioxx lawsuits in a single trial, the AP/Newark Star-Ledger reports (AP/Newark Star-Ledger, 2/14). Higbee has overseen the more than 3,250 Vioxx lawsuits filed in New Jersey, where Merck is headquartered (American Health Line, 11/29/05). The lawsuits each involve men who experienced nonfatal heart attacks after they took Vioxx for at least two years. In the motion, Merck attorney Hope Freiwald writes that jurors in the trial "would inevitably be unable to divide their brains in half and restrict their consideration of evidence to the case for which it is admissible while ignoring that same evidence in the other case where it is not." Freiwald also writes that consolidation of the lawsuits would confuse the jury and that the jury would "most likely resolve that confusion in favor of the sympathetic plaintiffs and against the big pharmaceutical company." However, attorney Perry Weitz, who represents one of the plaintiffs, said, "Merck doesn't want to consolidate cases because they want to stall the litigation and trickle cases out of the system and starve out the plaintiffs so they take less money" (AP/Newark Star-Ledger, 2/14).
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J&J: Announces Plans To Reduce Sales Force for Procrit
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Johnson & Johnson has announced plans to reduce the number of sales representatives for the anemia medication Procrit because of a recent loss of market share, the Wall Street Journal reports. Ortho Biotech Products, the J&J division that markets Procrit, expects the move to result in 105 layoffs, in large part among sales representatives for the medication. Ortho Biotech also will reassign an unspecified number of employees involved with Procrit to other areas of the company or other divisions of J&J. Procrit sales have decreased recently because of competition from Aranesp, a rival medication marketed by Amgen as a treatment for anemia in cancer patients in chemotherapy. Officials from J&J in January said that fourth-quarter 2005 Procrit sales decreased by 7% from a year earlier and that the market share held by the medication decreased to 47% from 55% a year earlier. Aranesp sales increased by 32% to almost $3.27 billion in 2005 (Loftus, Wall Street Journal, 2/14).
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ASTRAZENECA: To Withdraw Exanta Over Liver Injury Concerns
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Officials for AstraZeneca on Tuesday said that the company will withdraw the blood thinner Exanta from the market and end development of the medication because of concerns about increased risk for liver injury, AP/Wall Street Journal reports. AstraZeneca said that recent clinical trials indicated "a potential risk of severe liver injury, with an observation of rapid onset of signs and symptoms in the weeks following the end of the 35 days treatment." However, the trials found no evidence of increased risk for liver injury among participants who took Exanta for approved uses for 11 days or less, AstraZeneca said. AstraZeneca will end the trials and withdraw all regulatory applications for Exanta in the U.S. and Europe, and the 400 patients who currently take the medication will switch to different treatments, according to the company. AstraZeneca marketed Exanta in a number of European and South American nations. Exanta in 2004 failed to receive FDA approval because of concerns about increased risk for liver injury (AP/Wall Street Journal, 2/15).
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BIOTECH Rx: Generic Versions Closer to European Approval
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The Boston Globe on Monday examined how the European Medicines Agency's decision last month to recommend approval of a generic version of a biotechnology drug "marks the first real threat to the nearly permanent franchise enjoyed by any company that manages to bring a successful biotechnology drug to market." EMA on Jan. 26 recommended approval of Sandoz's growth hormone Omnitrope, which is a generic version of an existing growth hormone prescribed for small children. The drug could reach the market later this year if the European Commission gives it final approval, and Sandoz said it has several other generic drugs in its pipeline. European regulators have "smoothed" the arrival of "biogenerics" by drafting regulatory guidelines on how companies can prove their drugs are equivalent to brand-name biotech drugs, according to the Globe. However, the "movement has been slower" in the U.S., where "companies are still protected by tough approval rules from competition by generic manufacturers," the Globe reports. Generic drug makers, including Barr Laboratories, are lobbying FDA to loosen its rules on generic biological drugs. However, the biotech industry argues that quick approval of complex biotech drugs could be dangerous. They are pushing for regulators to require full human clinical trials of generic versions of existing treatments. Meanwhile, for patients, the "potential savings [from biogenerics] are large," and with biotech drugs taking up an increasingly larger "chunk of the national health care bill," biotech companies are under growing competitive pressure, the Globe reports. Michael Ringel, a biopharmaceutical specialist with Boston Consulting Group, said, "It's stuck in a political limbo in terms of what happens in the U.S., but there are enough political forces bringing to bear that a solution should emerge" (Heuser, Boston Globe, 2/13).
Anonymous Petitions Slow Generic Approvals
In related news, the Seattle Times on Monday examined how FDA approval of generic drugs can be slowed by "months on end" because of anonymous citizens' petitions filed with the agency. Generic-drug applications were the subject of at least 43 citizens' petitions in 2005, according to FDA's Web site. The agency is not required to resolve a petition before acting on a specific drug application, but doing so is common practice. The Generic Pharmaceutical Association said its members have seen an increased number of citizen petitions since legislation was approved recently limiting other methods of slowing generic drug approvals (Romano, Seattle Times, 2/13).
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MEDICARE: AHL Rounds Up State-Related Developments
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Two states recently took action related to the new Medicare prescription drug benefit. Summaries appear below.- Arkansas: The state will continue paying the cost of providing drugs to dual eligibles under the new Medicare drug benefit through March 17, despite "lacking assurances from the federal government" that the costs will be reimbursed, state officials announced on Tuesday, the Arkansas Democrat-Gazette reports (Bleed, Arkansas Democrat-Gazette, 2/15). The federal government has said it will provide reimbursements to states for emergency coverage for dual eligibles through Feb. 15 (American Health Line, 2/10). HHS Secretary Mike Leavitt has said he will "entertain" requests for extensions of the Feb. 15 deadline, according to Roy Jeffus, director of Arkansas' Medicaid program. Noting that California already has received an extension, the Arkansas Department of Health and Human Services has asked for federal approval of a waiver to continue receiving federal reimbursements for its program. State HHS spokesperson Julie Munsell said she expects the federal government to approve Arkansas' request but added that the state will have to "absorb the costs" if permission is not granted. The state so far has spent more than $4.8 million to provide drugs to 21,000 dual eligibles, but the number of requests from pharmacies for reimbursement is declining (Arkansas Democrat-Gazette, 2/15).
- Minnesota: Gov. Tim Pawlenty (R) on Tuesday said he expects HHS to grant the state a waiver to allow Minnesota to continue to reimburse pharmacists for costs related to dual eligibles under the Medicare prescription drug program "with the expectation of reimbursement from federal coffers," the St. Paul Pioneer Press reports (Stassen-Berger, St. Paul Pioneer Press, 2/15). On Jan. 14, Pawlenty issued a five-day emergency order that said the state would cover the cost of medications for beneficiaries eligible for both Medicare and Medicaid who experience problems with access under the prescription drug benefit. His executive council later extended the emergency order by 30 days. An additional extension requires action by the state Legislature (American Health Line, 2/14). However, the Legislature is in recess until March 1, and the emergency program expires at midnight on Friday. The state has asked the federal government to reimburse it for costs incurred after Feb. 15, and Pawlenty said he feels assured the waiver will be granted this week (St. Paul Pioneer Press, 2/15).
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AVASTIN: New York Times Examines Concerns Over High Cost
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The New York Times on Wednesday examined how doctors are warning that the potential $100,000 annual price for use of Genentech's colon cancer medication Avastin as a treatment for breast or lung cancer could discourage patients from seeking the treatment. According to the Times, studies show that Avastin -- which is FDA-approved for the treatment of colon cancer -- prolongs late-stage breast or lung cancer patients' lives by several months if combined at a higher dose with existing drugs. Some doctors currently prescribe Avastin for off-label use to treat breast or lung cancer, and Genentech later this year plans to seek FDA approval for such uses, the Times reports. The company has announced that it plans to charge approximately $100,000 annually for Avastin as a treatment for breast or lung cancer, nearly double the drug's current cost as a colon cancer treatment. According to the Times, pharmaceutical companies commonly attribute high drug prices to research and development costs. However, executives at Genentech and Roche, the company's majority shareholder, attribute Avastin's price to its value as a lifesaving therapy, the Times reports. The higher price for Avastin as a treatment for breast or lung cancer can be partly attributed to using a higher dose of the drug to treat those conditions, the Times reports.
Health Insurance Issues
Some doctors say the proposed price is discouraging patients from taking Avastin as a breast or lung cancer treatment, and health insurers often do not cover treatments for uses that do not have FDA approval, the Times reports. "Insurers may say, 'It's not approved for that indication, so we're not paying for it,'" Paul Bunn, director of the University of Colorado Cancer Center, said. Patients who want to take Avastin for breast or lung cancer treatment have to sign a waiver promising to reimburse the hospital for the cost if their health insurers decline coverage, according to the Times. "A couple of patients have refused to sign or take treatment," Bunn said. Some doctors also say Genentech's $8,800 per month pricing plan for Avastin could encourage other pharmaceutical companies to raise prices for their cancer treatments, the Times reports. Susan Desmond-Hellmann, president of product development at Genentech, said, "I don't think any patient should go without a Genentech drug for an inability to pay" (Berenson, New York Times, 2/15).
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MORTALITY: 12-Question Test Can Help Predict Risk, Study Finds
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A 12-question test can help individuals ages 50 and older predict their risk for death within the next four years, according to a study published on Wednesday in the Journal of the American Medical Association, the Long Island Newsday reports (Taylor, Long Island Newsday, 2/15). The study -- led by Sei Lee, a geriatrics researcher at the San Francisco Veterans Affairs Medical Center, and funded with a grant from the National Institute on Aging -- involved 11,701 U.S. residents ages 50 and older who participated in a national health survey in 1998. Researchers analyzed the health outcomes of participants over a four-year follow-up period and developed the test based on the factors that appeared to predict their risk for death (AP/USA Today, 2/15). The test includes questions related to gender, weight, age, smoking habits, current illnesses and other problems with health and memory (Long Island Newsday, 2/15). Each response to questions on the test has a point value, and a lower total score indicates a lower risk for death. A score of zero to five on the test indicates a less than 4% risk for death within four years, and a score of 14 points indicates a 64% risk. The test is about 81% accurate and "can give older people a reasonable idea of their survival chances," USA Today reports. However, the test does not account for family history; is less accurate for younger individuals; and does not include specific questions about diabetes, blood pressure or cholesterol levels.
Comments
The test seeks "to try to help doctors and families get a firmer sense for what the future may hold," Lee said. He added, "We know that patients and families want more prognostic information from doctors. It's a very natural human question of, 'What's going to happen to me?' We also know that doctors are very cautious about giving prognostic information because they don't want to be wrong" (USA Today, 2/15). Aloysius Cuyjet, a cardiologist at Nassau University Medical Center, said that the test could help physicians convince patients to "engage in behaviors to reduce their risk" but added that individuals should only take the test with advice from their physicians (Long Island Newsday, 2/15). Kenneth Covinsky, a co-author of the study and a Department of Veterans Affairs researcher, said, "Even if somebody looks at their numbers and find they have a 60% risk of death, there could be other mitigating factors" (USA Today, 2/15). An abstract of the study is available online.
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WEIGHT LOSS: Sanofi-Aventis Drug Effective in Clinical Trial
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Individuals who took the weight-loss drug Acomplia, made by Sanofi-Aventis, lost more weight and kept it off compared with individuals who took a placebo, according to a study published in Wednesday's Journal of the American Medical Association, Long Island Newsday reports. Acomplia, also known as rimonabant, is the "first of a new line of medicines" that seek to block the body's cannabinoid receptors, which appear to govern mood and feeling, according to Newsday. For the study, researchers recruited more than 3,000 overweight and obese adults and assigned them to take either a 20-milligram daily dose of Acomplia or a placebo. They found that participants who took Acomplia daily lost about 17 pounds in one year compared with those taking a placebo, according to lead researcher F. Xavier Pi-Sunyer, chief of endocrinology at St. Luke's Roosevelt Hospital Center and a professor of medicine at Columbia University College of Physicians and Surgeons. After the first year of the trial, enrollees on Acomplia either continued taking the drug or were reassigned to a placebo, and only those who continued on the drug maintained their weight loss. The researchers found that participants taking Acomplia experienced a 1.2% increase in anxiety, irritability and depression. However, Louis Aronne, a professor of medicine at Weill Cornell Medical College and a principal investigator in the study, said the mood changes could be attributable to weight loss itself, because participants in a separate clinical trial testing Acomplia for its anti-smoking effects experienced no shift in mood. He added that participants in the weight-loss trial also saw a reduction in levels of triglycerides, bad forms of cholesterol and glucose, likely because the cannabinoid system regulates such actions as fat deposition and glucose uptake. Aronne said the study represented a "big advance," adding, "This is a promising drug." The study results, as well as the results of clinical trials on another 3,000 individuals, have been submitted to FDA (Talan, Long Island Newsday, 2/15). The study is available online.
Outlook
The Minneapolis Star Tribune on Tuesday examined Acomplia's chances of success. According to the Star Tribune, Acomplia could be the first weight-loss drug to reach the market since the late 1990s, and "so far there appear to be few negatives associated with [it]." However, given that the "history of the obesity epidemic is littered with drugs that started out as cures and ended as spectacular failures," doctors are smart to be "cautious about the hype surrounding Acomplia," the Star Tribune reports (Marcotty, Minneapolis Star Tribune, 2/14).
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EOSINOPHILIC ESOPHAGITIS: Scientists Find Genetic Link
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Scientists have discovered a gene that is linked to a rare esophageal disease called eosinophilic esophagitis, proving the condition is not acid reflux disease as is often suspected, according to a study published in the Journal of Clinical Investigation this month, the AP/Washington Times reports. The disease occurs when the immune system produces too many eosinophils in the gastrointestinal tract, causing inflammation and tissue damage. Doctors first diagnosed EE in 1977 and initially considered it to be a severe case of acid reflux, but acid reflux treatments do not relieve EE. For the study, researchers compared healthy patients, acid reflux patients and EE patients. They found that EE patients harbored a unique genetic signature, with more than 500 genes that operated differently. One of the genes, called eotaxin-3, was as much as 100 times more active in EE patients and appeared to attract eosinophils circulating in the body, the AP/Times reports. The condition generally affects people prone to allergic diseases, in which eosinophils play a role, and can require children to use liquid diets or feeding tubes and cause adults to choke on food. According to the AP/Times, the discovery of the gene that "seems to be the disease's main trigger" has "open[ed] a new direction in the therapy hunt, ... promising easier diagnosis for patients who can spend years dealing with vomiting, heartburn and stomach pain before doctors figure out what's wrong." Marc Rothenberg, the study's lead researcher and director of the nation's leading center for EE, said patients are "suffering a lot," adding that the genetic discovery "should give all these people hope" (AP/Washington Times, 2/14). The study is available online.
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AVIAN FLU: Poses No Immediate Threat to Health, USDA Official Says
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Avian flu poses no immediate threat to human health in the nation, U.S. Department of Agriculture official Ron DeHaven said Monday at an agriculture conference, the Richmond Times-Dispatch reports. DeHaven, administrator for the USDA's Animal and Plant Health Inspections Service, said the U.S. has enough safeguards in place to prevent the H5N1 strain from entering the country. DeHaven said that the U.S. does not import birds from affected areas, and any birds that are imported are quarantined for 30 days to make certain they are disease-free. Virus checking among birds is very thorough in the U.S., so technicians are likely to find a strain of avian flu if there is one, according to DeHaven. However, he said that if avian flu ever develops into an easily communicable disease among people, it could cause a global pandemic. DeHaven added that U.S officials must assist nations affected by the H5N1 strain. He said, "The most significant thing we can do to protect the public health is to attack this virus at the source" (Trice, Richmond Times-Dispatch, 2/14).
Quarantine
In related news, Assistant Secretary for Homeland Defense Paul McHale said using the military to enforce a quarantine likely would not be necessary in any areas with a flu pandemic outbreak, CQ HealthBeat reports. President Bush in April 2005 signed an executive order to add pandemic influenza to the government's list of communicable diseases for which a quarantine is authorized. However, some experts believe that "it is highly unlikely that a quarantine would even be an effective strategy for confronting bird flu," according to CQ HealthBeat. McHale said that Pentagon officials have developed 15 different possible missions in response to a disaster with a medical element, including providing strategic airlift to move patients, ensuring security during the distribution of pharmaceuticals to those infected or strengthening civilian communications systems. McHale and Michael Hopmeier, an official at the scientific consulting firm Unconventional Concepts, said a quarantine could be effective in limited situations -- for example, if a group of people were exposed to a release of smallpox in an isolated place. Hopmeier said quarantines probably would not be effective in a flu pandemic because people infected with the disease would likely already have come into contact with so many individuals by the time they got sick that it would be impossible to track them all down and isolate them. He said an additional problem is that no one has discussed what types of areas would be quarantined and if it would be practical. Hopmeier said a better solution to preparing for a flu pandemic, or another type of attack, would be to get medical care prepared for everyone who might need it (Harrington, CQ HealthBeat, 2/13).
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LOW-FAT DIETS: Potential Effects of WHI Study Examined
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Two newspapers on Tuesday examined the potential effects of a Women's Health Initiative study published last week in the Journal of the American Medical Association. The study, which tracked almost 49,000 women for about eight years, found that a low-fat diet does not reduce risk for heart attack, stroke, breast cancer or colorectal cancer among women (American Health Line, 2/8).- New York Times: The Times examined how the study "raises important questions about how much even the most highly motivated people can change their eating habits and whether the relatively small changes that they can make really have a substantial effect on health." According to the Times, some scientists have criticized the authors of the study because they instructed participants to eat a low-fat diet, rather than revise their consumption of different forms of fat. However, other scientists have praised the study and have said that "it is about time that some cherished dietary notions are put to a rigorous test," the Times reports. In addition, the Times highlights dietary recommendations from the early 1800s through the 1900s (Kolata, New York Times, 2/14).
- Washington Post: The Post examined how the study indicates that "eating more fruit and vegetables, as well as less saturated and trans fats, cuts the risk of heart disease and cancer" -- information "often lost in news reports" about the study. In addition, the Post examined a separate WHI study published in January in JAMA that found "a direct link between fat intake and body weight" (Squires, Washington Post, 2/14).
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ALCOHOL: Rise in Use Among Young Women Worrying MDs, Experts
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The Wall Street Journal on Wednesday examined how "British women ... are leading a rise in drinking among young women across the industrial world --- a trend that is troubling public health leaders and spurring sales for the alcoholic beverage industry." According to a Datamonitor report released in April 2005, British and American women between the legal drinking age and age 24 consumed 33% more alcoholic drinks by volume in 2004 than five years earlier. According to the Journal, the increase in women's alcohol consumption is attributable to "[y]oung women ... starting families later and hav[ing] more disposable income than ever before," in addition to "cocktail-toting pop-culture icons" and an increase in marketing and advertising from the beverage industry. Meanwhile, doctors have noticed an increase in health problems with the "rise in drinking among young women." The American Medical Association said health risks from increased drinking include sexually transmitted diseases, brain damage, cancer and heart problems. Doctors also are seeing an increase in alcohol-related diseases, such as chronic liver disease. The liquor industry said it is responding to concerns about such risks by working to limit promotions that could encourage excessive drinking (Ball/O'Connell, Wall Street Journal, 2/15).
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