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DEMOCRATS: Bills To Address Stem Cell Research, Rx Benefit
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House Democrats on Friday plan to introduce bills that would reduce restrictions on federal funding for embryonic stem cell research and allow HHS to negotiate directly with pharmaceutical companies on prices for medications under the Medicare prescription drug benefit, incoming House Majority Leader Steny Hoyer (D-Md.) said on Wednesday, CQ Today reports. House Democrats have promised to pass both bills within the first 100 hours of the 110th Congress, which begins on Thursday (Ferrechio, CQ Today, 1/3). House Democrats plan to address the embryonic stem cell research bill on Jan. 11 (Weisman, Washington Post, 1/4). Sen. Tom Harkin (D-Iowa) on Thursday plans to introduce the legislation in the Senate, although the Senate might wait to address the bill until late January or early February, Harkin aides said. President Bush vetoed similar legislation last year (Norman, Des Moines Register, 1/4). According to CQ Today, because Democrats "have nowhere near the two-thirds majority of both chambers needed to override a presidential veto, ... they will have to decide fairly quick whether they want to enact laws or make political points" (Kady, CQ Today, 1/2).
Medicare Rx Drug Benefit Bill
House Democrats plan to address the Medicare prescription drug benefit bill on Jan. 12 (Washington Post, 1/4). The legislation would provide the HHS secretary with broad flexibility in negotiations with pharmaceutical companies on prices for medications, according to a Democratic aide familiar with the legislation. According to CongressDaily, the HHS secretary would only have to negotiate with pharmaceutical companies on prices for medications with "outlandish" costs to meet the requirements of the bill. Under the legislation, the HHS secretary could not restrict access to certain medications for Medicare beneficiaries. The bill would require the HHS secretary to report his progress in negotiations with pharmaceutical companies on prices for medications to Congress on June 1 and six months later (Johnson, CongressDaily, 1/4). House Democrats plan to avoid the committee process and limit the ability of Republicans to amend the legislation. Incoming House Speaker Nancy Pelosi (D-Calif.) likely will "make it nearly impossible for drug makers, health insurance companies and lobbies to stop the bill from passing," according to The Hill. Prospects for passage of similar legislation in the Senate are less certain. Incoming Senate Finance Committee Chair Max Baucus (D-Mont.) last year voted against a similar bill, and he "has not endorsed the leadership's plan," The Hill reports. Bush and HHS Secretary Mike Leavitt also oppose the legislation (Young, The Hill, 1/4).
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MEDICARE: Rx Drug Benefit Enrollment Smoother in Second Year
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The commencement of the Medicare prescription drug benefit's second year has gone more smoothly than the first year as hundreds of thousands of beneficiaries are entering the program or changing plans, federal health officials and representatives of seniors and pharmacists said Wednesday, the AP/San Francisco Chronicle reports. In the first week of 2006, CMS received a "barrage" of complaints from beneficiaries who were not listed in insurers' databases and from pharmacists who sought to verify coverage, according to the AP/Chronicle. CMS spokesperson Jeff Nelligan said of this year, "It's very quiet, but we're always on the lookout. There's nothing that has risen to the level of crisis." Carol Cooke, spokesperson for the National Community Pharmacists Association, said, "It's not perfect, but it seems a lot better than last year." Deane Beebe of the Medicare Rights Center said, "It's nothing overwhelming like last year. But, yes, there is a smattering of problems we're hearing about. We've also spoken with pharmacists who say it's too soon to tell" (Freking, AP/San Francisco Chronicle, 1/3).
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MEDICARE: New Part B Payment Method Reduces Spending, MedPAC Says
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Medicare's new payment method for reimbursing physicians for prescription drugs under Part B has reduced spending, according to a report to Congress prepared by the Medicare Payment Advisory Commission, CQ HealthBeat reports. The new payment method, known as the Average Sales Price system, reimburses physicians for drugs covered under Part B, which include intravenous drugs that generally cannot be administered by patients themselves (Reichard, CQ HealthBeat, 1/3). Under the previous system, Medicare Part B reimbursed doctors for such drugs based on the average wholesale price reported by pharmaceutical companies. Critics said that under that system, doctors paid lower market prices to purchase the drugs and then kept the difference from the higher reimbursements. In an effort to address the issue, lawmakers included in the 2003 Medicare law two changes to the system. Under one change, reimbursement would be based on ASPs. The other change was the creation of an optional competitive acquisition program for physicians (American Health Line, 7/14/06). The MedPAC report stated that since the payment change, spending on Part B drugs fell from $10.9 billion in 2004 to $10.1 billion in 2005. According to the report, the decline stemmed from fewer prescriptions and lower drug prices. MedPAC also found that to offset the reimbursement reductions, physicians are cutting costs and pursuing other sources of revenue, such as imaging services. The report stated that there was "no indication that quality of care was affected" by any of the changes, adding that investigators' "ability to measure quality changes is limited" (CQ HealthBeat, 1/3).
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FDA: Approvals of New Medications To Increase by 2010
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FDA approvals of new medications, which have decreased in recent years, by 2010 likely will increase as pharmaceutical and biotechnology companies seek approval for about 2,000 compounds currently in early stage clinical trials, according to a study released on Wednesday by the Tufts Center for the Study of Drug Development, the Newark Star-Ledger reports. According to the Star-Ledger, FDA in 2006 approved only 17 new medications, "matching the lowest number of newly approved compounds since the peak of 53 approvals a decade ago." In addition, since the September 2004 market withdrawal of the COX-2 inhibitor Vioxx, FDA has approved 37 new medications, compared with an average of 28 annually in the years prior to the withdrawal. The lack of new medications, which in recent years has prompted pharmaceutical companies to spend $40 billion annually on research and development, has led to flat earnings and sales for many companies and strong generic competition for older treatments. Kenneth Kaitin, director of the Tufts center, said, "The industry is still suffering from very significant pipeline problems. The short-term future does not look tremendously promising for the pharma industry." According to the Pharmaceutical Research and Manufacturers of America, pharmaceutical companies have in development 646 compounds for cancer, 146 for heart disease and stroke, 77 for HIV/AIDS and 56 for diabetes. Alan Goldhammer, a deputy vice president for PhRMA, said, "There would be a much greater concern if there were a few number of compounds going into trials." However, Sidney Wolfe, director of the Health Research Group at Public Citizen, said, "The number of real innovations for diseases that never had a treatment before or drugs that are really better, there is just not much there. There just are not a lot of innovations lately" (Jordan, Newark Star-Ledger, 1/4).
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GSK: Legal Issues Could Complicate Paxil Settlement
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"Criticism and legal wrangling" over a class-action settlement regarding GlaxoSmithKline's antidepressant Paxil "are calling into question" an agreement between the drug maker and law firm Korein Tillery, the St. Louis Post-Dispatch reports (Jadhav, St. Louis Post-Dispatch, 1/3). GlaxoSmithKline has agreed to pay $63.8 million to settle a class-action suit filed over allegations that the company promoted the antidepressant Paxil for use in children and adolescents and withheld information about potential safety risks. Under the settlement, members of the class -- which includes all U.S. residents who purchased Paxil and Paxil CR, a controlled release version of the medication, for their children -- could receive full refunds, provided that they have records of their purchases. Members of the class who do not have records of their purchases could receive $15. Payments to members of the class will depend on the number of claims filed. Plaintiff attorneys could receive about $16.6 million of the settlement to cover their fees. Madison County Associate Judge Ralph Mendelsohn -- who approved the settlement on Oct. 6, 2006, and unsealed the agreement on Oct. 27, 2006 -- will hold a hearing on March 9 to determine whether the settlement is fair and whether plaintiff attorneys should receive the fees they have requested (American Health Line, 11/2/06). Mendelsohn also issued an injunction preventing other Paxil cases from proceeding. Allegations surrounding the settlement "range from closed-door deals to a $5 million demand to end a competing lawsuit over purchases" of Paxil for use by children and adolescents, the Post-Dispatch reports. The current legal conflict involves players including GSK, Korein Tillery and law firm Brown & Crouppen, which has filed a competing claim against GSK over Paxil (St. Louis Post-Dispatch, 1/3).
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Rx INDUSTRY: Trade Group Bans Expensive Gifts to Physicians
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The International Federation of Pharmaceutical Manufacturers and Associations, a trade group that represents pharmaceutical companies worldwide, on Wednesday announced that members no longer can provide expensive gifts to physicians under a revised code of ethics, Bloomberg/South Florida Sun-Sentinel reports. Under the code, which IFPMA revised on Jan. 1 for the first time in 10 years, members cannot provide physicians with money or expensive gifts -- such as trips to golf resorts or stays in luxury hotels -- that might affect their prescription drug selections. In addition, according to the 21-page code, medical and scientific meetings held by members should not occur at "renowned or extravagant venues," and hospitality at such events should not exceed the level for which physicians would pay personally. The code allows members to provide physicians with gifts that are related to prescription drugs or that are inexpensive, such as pens or stethoscopes. IFPMA has established a network of pharmaceutical industry sources to monitor compliance with the code, as well as a panel of experts to hear complaints and appeals. In addition, IFPMA will make violations of the code public. Harvey Bale, director general of IFPMA, said, "What we're trying to do is prevent as many of the activities as possible that have not helped the reputation of the industry," adding, "We need to make sure the product is the best product for the patient and it's not influenced by gifts and it's not influenced by hospitality or vacations." IFPMA members include Pfizer, GlaxoSmithKline, Sanofi-Aventis, Eli Lilly, AstraZeneca, Merck and Novartis (Gerlin, Bloomberg/South Florida Sun-Sentinel, 1/4).
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ZYPREXA: NYT Examines Possible Link to Heart Disease, Death
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The New York Times on Thursday profiled John Kauffman, who died from heart disease after gaining 80 pounds while undergoing therapy for bipolar disorder with Eli Lilly's antipsychotic Zyprexa. His mother, Millie Beik, believes that the drug contributed to his weight gain and death (Berenson, New York Times, 1/4). The Times reported last month that Lilly over the past ten years has attempted to conceal the potential side effects of Zyprexa. The report was based on documents provided to the Times by an attorney who represents mentally ill patients in a lawsuit against the company (American Health Line, 12/18/06). Kauffman, who maintained a normal weight throughout his 30s, gained about 80 pounds while taking Zyprexa for five years. Previously, while taking the older antipsychotic drug Stelazine for a period of eight years, Kauffman's illness remained under control and he did not gain weight, according to Beik. It cannot be determined whether Zyprexa was responsible for Kauffman's weight gain, heart disease and death because he also was a smoker and lived a "sedentary" lifestyle during the final years of his life, the Times reports. However, Beik -- who is not suing Lilly -- said she wants her son's story to serve as cautionary tale about Zyprexa's tendency to cause severe weight gain, according to the Times. She said, "I don't think that price should be paid." Lilly in a statement said that it had reported the death to federal regulators -- as it is legally required to do -- but would not comment on specifics regarding the causes of death. Lilly also noted that Kauffman had a "complicated medical history that may have led to this unfortunate outcome." Lilly added that Zyprexa "is a lifesaving drug and it has helped millions of people worldwide with schizophrenia and bipolar disorder regain control of their lives." Nassir Ghaemi, a specialist on bipolar disorder at Emory University, said, "Lilly always downplayed the side effects. They've tended to admit weight gain, but in various ways they've minimized its relevance" (New York Times, 1/4).
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COMMUNICATION: Few Areas Have Adequate Emergency Systems
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Most U.S. metropolitan areas have not developed adequate communications systems for emergency workers in the event of a terrorist attack or other disaster, according to a Department of Homeland Security report obtained Tuesday by the Associated Press, the AP/South Florida Sun-Sentinel reports. The report includes the results of a DHS survey of 75 metropolitan areas, including large cities, small cites, suburbs and U.S. territories. The report found that all areas surveyed have developed policies on emergency communications but that regular testing and exercises are needed "to effectively link disparate systems." Six areas -- Columbus, Ohio; Laramie County, Wyo.; Minneapolis-St. Paul, Minn.; San Diego; Sioux Falls, S.D.; and Washington, D.C. -- received the highest possible scores. Areas receiving the lowest scores were American Samoa, Baton Rouge, La.; Chicago; Cleveland; and Mandan, N.D. According to the report, cooperation among emergency workers is high, although "formalized governance (leadership and planning) across regions has lagged" (Barrett, AP/South Florida Sun-Sentinel, 1/3).
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ACRYLAMIDE: Group Asks FDA To Publish Data on Levels in Foods
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The Center for Science in the Public Interest recently sent a letter to FDA to request that the agency publish additional data on the levels of the chemical acrylamide in foods, the AP/Wall Street Journal reports (AP/Wall Street Journal, 1/3). Acrylamide forms when asparagine, an amino acid, is heated to high temperatures with certain sugars such as glucose. Fried foods produce high levels of acrylamide, and foods such as cereal, toast, coffee or cookies when cooked or heated for longer periods also can produce the chemical. In February 2003, FDA announced that some nutritious foods, such as cereal and toast, contain low levels of acrylamide. According to FDA, such foods, when consumed often, could have a large impact on exposure to potential carcinogens. FDA in March 2004 published data on acrylamide levels in 750 foods (American Health Line, 3/30/04). Studies have linked acrylamide to cancer in mice and rats but not in humans (AP/Wall Street Journal, 1/3). In the letter, CSPI Executive Director Michael Jacobson said, "It's simply impossible for consumers to try to keep track of how much acrylamide is in different foods and different brands" (Quaid, AP/Albany Times Union, 1/2). Jacobson said that FDA no longer publishes data on acrylamide levels in foods and that food companies will not release such data on their products (Bloomberg/Kansas City Star, 1/3). FDA spokesperson Julie Zawisza said, "We have already done extensive sampling to make this determination on exposure. We don't believe additional sampling will inform our exposure assessment significantly" (AP/Wall Street Journal, 1/3).
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PARKINSON'S: Two Rx Can Increase Risk for Heart Valve Damage
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Two medications used to treat Parkinson's disease can increase risk for serious heart valve damage, according to two studies published on Thursday in the New England Journal of Medicine, the New York Times reports. FDA and foreign regulators have approved one of the medications -- pergolide, marketed as Permax -- as a treatment for Parkinson's. Foreign regulators have approved the second medication -- cabergoline, marketed as Dostinex -- as a treatment for Parkinson's, but FDA has approved the medication only as a treatment for a hormone condition. FDA requires a black box warning on the label of pergolide over increased risk for heart valve damage and a lesser warning on the label of cabergoline. According to the two new studies, which were larger than previous studies conducted on the medications, the "valve problem is more common than initially thought, and that people who took the highest doses for the longest time had the greatest risk," the Times reports (Grady, New York Times, 1/4). For one of the studies, Rene Schade and colleagues in Berlin and Montreal examined the records of more than 11,400 Parkinson's patients in Britain between 1988 and 2005 (Marchione, AP/USA Today, 1/4). The study found that 19% of participants who took pergolide or cabergoline experienced heart valve damage, five times the rate of those who did not take the medications, and that the risk increased at higher doses of the treatments (Hechinger, Wall Street Journal, 1/4). For the second study, Renzo Zanettini of the Instituti Clinici di Perfezionamento in Milan, Italy, and colleagues examined echocardiogram images of 155 Parkinson's patients who took different medications and compared them with those of a group of 90 healthy individuals. The study found that 23% of participants who took pergolide and 29% of those who took cabergoline experienced moderate to severe heart valve damage. About 6% of healthy participants experienced moderate to severe heart valve damage, according to the study (AP/USA Today, 1/4).
Comments
In an editorial that accompanied the studies, Bryan Roth, director of the drug screening program at the National Institute of Mental Health, said the risk for heart valve damage is "so prevalent in people taking these medications, you kind of wonder why it was missed." Roth recommended that physicians no longer prescribe pergolide and cabergoline and instruct patients who took the medications to undergo echocardiograms to determine whether they experienced heart valve damage (Wall Street Journal, 12/4). Michael Okun, medical director for the National Parkinson's Foundation, said, "Patients should be given the choice of what to do. There are lots of people worldwide who have used these drugs successfully. Some patients, after being educated, may decide they want to accept the potential risk. Others may want to switch" (New York Times, 1/4). An abstract of the first study is available online. An abstract of the second study also is available online.
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LUNG CANCER: Five-Gene Test Might Determine Need for Chemotherapy
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An experimental five-gene test might be able to better determine low- and high-risk lung cancer patients and might show which patients should receive chemotherapy, according to a study published Thursday in the New England Journal of Medicine, the AP/South Florida Sun-Sentinel reports. The study, by Hsuan-Yu Chen and colleagues at Taiwan University, analyzed tumor samples from 125 patients with various stages of lung cancer. The researchers originally found 16 genes that seemed to indicate the rate of cancer recurrence or death, but eventually narrowed the number of genes to five. The five genes were tested on half of the tumor samples. Researchers found that, in the lowest-risk group, median survival time was 40 months and median relapse time was 29 months. The highest-risk group had a median survival time of 20 months and a relapse time of 13 months. Chen and colleagues validated the results in another study of 60 patients. Roy Herbst of the M.D. Anderson Cancer Center in an accompanying editorial called for more research on the test. "In breast cancer now, patients are being selected for chemotherapy based on studies like this. We have to move to the next step" with lung cancer, Herbst wrote (Marchione, AP/South Florida Sun-Sentinel, 1/3). The study is available online. The editorial also is available online.
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TRANS FATS: Starbucks Stores To End Use of Trans Fats in Foods
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Starbucks on Wednesday will begin to eliminate trans fats from foods served in company stores in 10 U.S. cities -- Seattle; Boston; Chicago; Los Angeles; New York; Philadelphia; Portland, Ore.; San Diego; San Francisco; and Washington, D.C. -- the AP/South Florida Sun-Sentinel reports (Woodward, AP/South Florida Sun-Sentinel, 1/2). Research indicates that trans fats -- which increase levels of LDL, or "bad," cholesterol and decrease levels of HDL, or "good," cholesterol -- can increase risk for cardiovascular disease (Harris, Seattle Post-Intelligencer, 1/3). In addition, Starbucks by the end of the year likely will eliminate trans fats from foods served in all 5,700 company stores in the U.S. and Canada (Allison, Seattle Times, 1/3). The elimination of trans fats from foods served in Starbucks stores will not result in increased prices, and the move will not affect licensed company stores, such as kiosks in supermarkets and bookstores. Brandon Borrman, a Starbucks spokesperson, said, "We started this process two years ago. We want to make sure our customers have high-quality, nutritious options" (Seattle Post-Intelligencer, 1/3).
Universal Theme Parks Eliminate Trans Fats From Many Foods
Universal Studios Florida, Islands of Adventure in Florida and Universal Hollywood on Dec. 24, 2006, eliminated trans fats from more than 90% of the foods served at the theme parks, the AP/Arizona Daily Star reports. The theme parks by the end of the year likely will eliminate trans fats from additional foods, Ric Florell, a senior vice president with Universal Orlando Resort, said (Change, AP/Arizona Daily Star, 12/28/06).
Related News
- Bergen Record: The Record on Tuesday examined how federal, state and local officials last year "served up a plateful of regulations" on the use of trans fats (Groves, Bergen Record, 1/2).
- Jackson Clarion-Ledger: The Clarion-Ledger on Tuesday examined how, despite recent restrictions on trans fats and efforts by restaurant chains to eliminate trans fats from their menu items, some "health and restaurant industry experts say reversing a lifetime of bad eating habits is not just a corporate responsibility"(Goodman, Jackson Clarion-Ledger, 1/2).
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'GROWTH ATTENUATION': Ethical Debate Over Treatment Examined
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The Los Angeles Times on Wednesday examined the ethical debate over a decision by a Seattle couple to limit the growth of their nine-year-old daughter, Ashley, who has static encephalopathy -- a severe brain condition that leaves her unable to talk, walk, eat and perform other functions -- over concerns that she "would become too big one day -- too big to lift, too big to move, too big to take along on a family outing." Over the past few years, Ashley has received "growth attenuation" treatment, which will maintain her height at 53 inches and her weight at about 75 pounds for the rest of her life. As part of the treatment, Ashley has received a hysterectomy, surgery to prevent breast growth and high doses of estrogen. Physicians, who expect Ashley to have a normal life span, have estimated that without the treatment she would have had a height of 66 inches and a weight of 125 pounds. In a statement posted on their Web site, the couple wrote that the "biggest challenges" Ashley faces from her brain condition are "her comfort and boredom." They added, "(The treatment) goes right to the heart of these challenges, and we strongly believe that it will mitigate them in a significant way and for the rest of her life." Daniel Gunther -- who oversaw the treatment, which Ashley received at Seattle Children's Hospital and Regional Medical Center -- said, "What I have found is that if you really examine it, if you actually lay out the benefits of this to the child, then people start to see the possible wisdom in this."
Criticism
Some physicians and caregivers maintain that the treatment is a "violation of a person's dignity" and the medical oath, the Times reports. In an editorial published in the October 2006 issue of the Archives of Pediatric & Adolescent Medicine, Jeffrey Brosco of the University of Miami and Chris Fedtner called the treatment "ill advised." They wrote, "If we as a society want to fundamentally revise the nature of the harrowing predicament that these parents face, then, in the end, more funds for home-based services not more medication is what is called for" (Howe Verhovek, Los Angeles Times, 1/3).
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PERSONALIZED MEDICINE: 'Promise,' Problems Examined
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The Contra Costa Times on Wednesday examined the "promise and pitfalls" of personalized medicine, the practice of "tailoring treatments to individual genetic traits." The Times profiled the Oncotype DX test, a test developed by California-based Genomic Health that helps determine the risk of breast cancer recurrence (Johnson, Contra Costa Times, 1/3). The Oncotype DX test checks the surgically removed tumors for 21 different genes whose interactions can predict the likelihood of breast cancer recurrence to determine whether patients will benefit from chemotherapy (American Health Line, 6/14/06). Since 2004, Genomic Health has sold 17,000 Oncotype DX tests, but most health insurers do not cover the tests, which cost $3,460 each. According to the Times, despite "widespread hopes that mapping the human genome this decade would usher in a flood of drugs for genetically similar patients, few such products have hit the market, largely because of fears that insurers will not cover their cost." David Lawrence, former CEO of Kaiser Foundation Health Plan and Hospitals, said, "This is really a sea change in medicine. The whole question of what gets paid for and who pays it is going to take awhile to get sorted out." Randy Scott, CEO of Genomic Health, said, "We do see over the coming year a significant policy shift toward coverage. Personalized medicine can be successful" (Contra Costa Times, 1/3).
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Seeking Approval
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