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..... | News & Views Newletter edited by Jack Nicholas, cornishpro@aol.co
PSORIATIC ARTHRITIS NEWS AND VIEWS Random thoughts from your newsletter editor: I find it an excellent practice to ask your Pharmacist, what the retail cost for a prescription is going to be, if it is not submitted through your insurance program. Our personal prescription coverage carries a $30.00 and $15.00 co-pay for brand and generic drugs. (We feel very fortunate to have prescription coverage.) This year we were required to use the Insurance Company mail order house for maintenance drugs with a minimum shipment of three-month quantities. I miss the personal care we always received from our local Pharmacist, let alone helping your own community economy. Recently, a prescription of mine written by my cardiologist for a new beta-blocker, needed to be filled. If submitted to the insurance company, the deductible would have been $15.00; however, the cost to me direct from the Pharmacist for a months supply was $10.32. The same holds true for my 5mg prednisone tablets that costs about 40% less than the standard co-pay when I pay cash for them. Because of psoriatic arthritis, psoriasis, coronary heart disease, fibromyalgia, etc, I am obliged to take a long, list of medications. When you can save a buck or two, as Martha Stewart would say, "It's a good thing". It doesn't seem like big savings, however, over a period of a year, it can certainly add up. Check it out! **************************************************** EARLY RESULTS SUGGEST ALEFACEPT PLUS LIGHT THERAPY MAY CLEAR PSORIASIS Cambridge, MA - November 22, 2002 Biogen, Inc. announced that 76 percent of 21 patients with psoriasis achieved "clear" or "almost clear" results based on preliminary data from an open-label study combining alefacept and narrow band ultraviolet B light (NB UVB). The results were presented today at the Psoriasis: From Gene to Clinic International Congress in London, England. The lead investigator in the study, Dr. Jean-Paul Ortonne, Chairman of the Department of Dermatology at the University Hospital of Nice-Sophia Antipolis, Nice, France, said, "In real-world settings, physicians may combine biologics with other therapies. We are pleased to see that in this preliminary study, alefacept plus narrow band UVB provided encouraging results." All 21 patients in the arms of the study receiving combination therapy achieved a 75 percent reduction in baseline PASI (Psoriasis Area and Severity Index), a standard measure of psoriasis severity. The open-label study randomized 30 men and women with chronic plaque psoriasis into three treatment groups: alefacept alone, alefacept plus 6 weeks of NB UVB and alefacept plus 12 weeks of NB UVB. Two weeks after the last dose of alefacept, patients' psoriasis was evaluated using PASI and PGA (Physician Global Assessment) measurement scales. The objectives of the study were to determine the safety and tolerability of combination therapy, the efficacy of combination therapy and the total amount of light therapy needed to achieve a 50 percent PASI improvement. The current FDA-recommended efficacy endpoint for psoriasis medications is PASI 75 reduction, which means that patients must achieve at least a 75 percent reduction in their disease area and severity. All of the patients treated with alefacept plus NB UVB achieved a 75 percent reduction in their PASI score over the course of the study. After three weeks of combination therapy consisting of alefacept plus NB UVB, 71 percent (15 of 21 patients) experienced 50 percent reduction in PASI and, after four weeks, 57 percent (12 of 21 patients) experienced 75 percent reduction in PASI score. The most common adverse events in the study were rash in the alefacept plus NB UVB groups (6 of 21 patients) and pruritis in the alefacept monotherapy group (4 of 9 patients). With the exception of accidental injury in two patients, no other adverse events were experienced by more than one patient. Similar decreases in CD4 counts were reported in all three study groups. In this study there were no infections reported among the 19 patients receiving alefacept alone or with six weeks of NB UVB. In 11 patients receiving alefacept plus 12 weeks of NB UVB, four infections were reported, with one case each of periodontal abscess, acne and bronchitis and one case of general infection (e.g., the common cold). There were no opportunistic infections reported in the 30 patients. In regards to NB UVB dosing, six weeks was as effective as 12 weeks of treatment, with the majority of patients in both groups achieving "clear" or "almost clear" results. In the study, alefacept was administered in 12 weekly 15 mg intramuscular injections and NB UVB light treatment was provided in an upright Waldman 7001 K irradiation cabinet. ***************************************************** RESEARCHERS SHOW COX-2 INHIBITORS INTERFERE WITH BONE GROWTH, HEALING November 21, 2002, Acurian Source: Stanford University Medical Center Researchers at Stanford University Medical Center have found that selective COX-2 inhibitors -- a class of medications widely prescribed for painful inflammatory conditions such as osteoarthritis and rheumatoid arthritis -- interfere with the healing process after a bone fracture or cementless joint implant surgery. Their findings, published in the November 2002 issue of the Journal of Orthopaedic Research, suggest that patients who regularly take COX-2 inhibitors should switch to a different medication, such as acetaminophen or codeine derivatives, following a bone fracture or cementless implant. The study, conducted in rabbits, also suggests that physicians should consider changing prescribing patterns since many doctors commonly prescribe anti-inflammatory drugs including COX-2 inhibitors under the very circumstances in which the drugs should be avoided. "It's very common. You break a bone and go to the ER. The doctor sets it in a splint and prescribes one of these anti-inflammatory drugs (including COX-2 inhibitors) for pain," said Stuart Goodman, MD, professor of orthopaedic surgery at the Stanford School of Medicine and lead author of the study. "We now know that could actually delay healing." The enzyme Cyclooxygenase-2, or COX-2, is produced by the body in response to injury or inflammation. COX-2 inhibitors, including anti-inflammatory medications such as rofecoxib (Vioxx), celecoxib (Celebrex) and others, block production of this enzyme. Goodman's research shows that COX-2 inhibitors also impede the new bone growth that normally helps heal a fracture or stabilize a joint implant. Belonging to a class of medications called non-steroidal anti-inflammatory drugs, COX-2 inhibitors were developed in the late 1990s as an alternative to another group of medications called nonspecific NSAIDS, which inhibit the production of COX-2 along with the enzyme Cyclooxygenase-1, or COX-1. Nonspecific NSAIDS, including aspirin, ibuprofen, naproxen and others, often cause stomach irritation and a tendency to bruise easily. COX-2 inhibitors largely avoid these side effects. Researchers confirmed years ago that nonspecific NSAIDS inhibited bone growth and healing, but the Stanford study is among the first to show that COX-2 inhibitors have the same effect. In the tibia bone of eight New Zealand white rabbits, Goodman and his team implanted a titanium device called a harvest chamber, which resembles a small screw. The device has a removable, hollow inner core that allows researchers to periodically extract the tissue growing inside. The growth of new bone into the chamber simulates healing of a fracture or joint implant. Researchers gave the rabbits the following oral treatments for four weeks each: plain water; water with naproxen; plain water again; and sugar-coated pellets of rofecoxib (a COX-2 inhibitor). After each treatment, researchers removed the harvest chamber's core and extracted the tissue growing inside. After preserving the tissue in liquid nitrogen, the researchers sectioned and processed it with special stains including monoclonal antibodies, allowing them to see how new bone had grown back. Because a harvest chamber allows new tissue to be extracted multiple times as it grows back, the rabbits served as their own control groups (after consuming plain water) as well as the two experimental groups (after consuming naproxen and rofecoxib). The researchers found that while the tissue in the control group contained 24.8 percent and 29.9 percent new bone growth, the tissue harvested after the rabbits consumed naproxen and rofecoxib contained significantly less -- 15.9 percent and 18.5 percent respectively. The difference in new bone growth associated with the two drugs was statistically insignificant; practically speaking, the COX-2 inhibitor impeded new bone growth as much as the nonspecific NSAID. While acknowledging the limitations of animal research, Goodman said this study "has great applicability to humans, because the healing process is virtually the same" for rabbit and human bones. Goodman is having his own patients avoid COX-2 inhibitors for six weeks after a fracture or joint implant, and he recommends other physicians do the same. "This research has very practical applications." Goodman said his recommended six-week "time-out" period is an educated guess, because his study didn't address how long the bone-growth-suppressing effects of COX-2 inhibitors last. To answer that question, Goodman and his colleagues recently began a follow-up study. Copyright (c) 2002 Acurian Inc. **************************************************
ELECTION GIVES DRUG INDUSTRY NEW INFLUENCE IN CONGRESS WASHINGTON, Nov. 20 -- Having spent more than $30 million to help elect their allies to Congress, the major drug companies are devising ways to capitalize on their electoral success by securing favorable new legislation and countering the pressure that lawmakers in both parties feel to lower the cost of prescription drugs, industry officials say. The industry's hand appears stronger now than at any other time in recent years, a result of its large donations to political parties and candidates and millions of dollars spent on television advertising by industry-financed groups. The money was spent overwhelmingly on behalf of Republicans, who now control both houses of Congress. Executives of the major drug manufacturers met last week at the Westfield International Conference Center, near Dulles International Airport in Northern Virginia, to plan ways to turn that influence into legislative victories. The executives included Robert Essner, president of Wyeth; Peter R. Dolan, chairman of Bristol-Myers Squibb; Sidney Taurel, chairman of Eli Lilly; and Raymond V. Gilmartin, chairman of Merck. They discussed specific ways to leverage their investment in this year's elections to advance their agenda on Capitol Hill, participants said. The meeting was described by an industry lobbyist as a "strategic planning retreat" and "deep philosophical conversations about our message for 2003." A pervasive theme was how to block proposals that could erode profits by limiting drug prices or making it easier for people to buy low-cost generic versions of brand-name medicines. Drug industry executives who attended the conference, put on by the industry's main lobbying arm, the Pharmaceutical Research and Manufacturers of America, said they were delighted with the election results, yet cautious and apprehensive, given the pressure that Republicans as well as Democrats face from voters demanding lower drug prices. "Sure, we will have more access," one executive said. "Our hand is stronger because of the election results, but who knows how much stronger it really is." Already, industry executives have been encouraged by a recent move to insert a provision in the domestic security bill limiting the legal liability of vaccine manufacturers like Eli Lilly. On Tuesday, several senators from both parties said Republican leaders had promised to alter the provision next year, so it would apply only to vaccines made in the future. But today, aides to Representative Tom DeLay, the incoming House majority leader, said Mr. DeLay had agreed only to consider such proposals. Aides to several Republican senators troubled by the provision said they were confident that the deal would stand. Senator Byron L. Dorgan, Democrat of North Dakota, a frequent drug company critic, said: "With the election, they certainly have more friends in Congress. They should be feeling their oats these days." The pharmaceutical industry topped the Fortune 500 list of the most profitable industries, providing investors with an 18.5 percent return on revenues last year. But many drug companies report sagging profits in 2002. The industry's No. 1 goal is to shape legislation that both parties advocate to provide prescription benefits to the 40 million elderly and disabled people in the Medicare program. What the industry fears most is price controls or any federal effort to establish a list of preferred drugs that leaves out other medications. Democrats want to give the government a large role in managing Medicare drug benefits, while Republicans would rely more on competing private health plans, insurance companies and pharmaceutical benefits managers. The industry is also fighting legislation that would speed the approval and marketing of generic drugs. The Senate passed such a bill in July, with support from 49 Democrats and 28 Republicans, but it died in the House. So far, most Republicans have backed the brand-name drug industry in its battle with generic drug makers. But brand-name drug makers worry that the pressure to limit drug spending, and the cost of Medicare drug benefits, will lead more Republicans to promote the use of generic drugs. "We know that Democrats don't look favorably on our industry," a drug company lobbyist said. "But there is growing concern that some Republicans vote the same way, and their rhetoric is becoming just as harsh." The industry's agenda also includes these items: * Drug companies adamantly oppose legislation making it easier for consumers, pharmacists and wholesalers to import drugs from Canada, where prices are usually lower. Such imports could endanger public health, they say. * Drug makers oppose Congressional efforts to limit or discourage drug advertising on television and in newspapers and magazines. Drug makers say such advertisements convey useful information, but critics say they contribute to explosive growth in drug spending. * Many pharmaceutical companies want to limit damages in lawsuits filed by people who say they have been injured by the use of certain drugs. Many drug makers have been named as defendants in class action suits. Representative Rob Portman of Ohio, part of the House Republican leadership team, said, "There is a consensus now in Washington, not just in the House but in the Senate and at the White House, that we need to provide seniors with a prescription drug benefit under Medicare." On Oct. 21, President Bush proposed a regulation to get generic drugs to the market faster. Mr. Portman said, "It's possible we could see legislation there as well," to codify the president's proposal, or something like it. Over all, the pharmaceutical and health products industry gave about $20 million this year to House and Senate campaigns and national political parties, with three-fourths of the money going to Republican candidates and party committees, according to the nonpartisan Center for Responsive Politics. Top donors included Eli Lilly, Bristol-Myers Squibb, Pfizer and Glaxo Smith Kline. While those contributions put the industry among the largest donors, the totals actually understate its influence in Washington. In the last six years, according to Public Citizen, the group founded by Ralph Nader, the industry has spent close to $500 million on lobbying, including a force of 600 lobbyists that includes about two dozen former members of Congress. The industry also helped underwrite what Democratic strategists say was at least $15 million of television advertising supporting Republican House candidates, through groups that receive industry money, like the United Seniors Association. The industry has directed much of its largess to lawmakers who control the fate of legislation affecting prescription drugs. The chairman of the Senate Finance Committee, Max Baucus, Democrat of Montana, received $114,000 in contributions from executives of drug companies and manufacturers of health care products and from industry political action committees through Oct. 21, according to the Center for Responsive Politics. The panel's senior Republican, Senator Charles E. Grassley of Iowa, who is soon to be chairman, took in about $100,000. In the House, the chairman of the Energy and Commerce Committee, Representative Billy Tauzin, Republican of Louisiana, received about $100,000. Representative John D. Dingell of Michigan, the panel's senior Democrat, received a similar amount. Through Oct. 21, the largest recipient of direct contributions from the pharmaceuticals and health products industry -- close to $200,000 -- was Representative Nancy L. Johnson, the Connecticut Republican who is chairwoman of the Ways and Means Subcommittee on Health. Mrs. Johnson, who won re-election by defeating Representative Jim Maloney, a Democrat, also benefited from almost $700,000 that United Seniors spent on television advertisements in Hartford in the last two months of the campaign, according to the Wisconsin Advertising Project of the University of Wisconsin in Madison. Though Democrats say spending by United Seniors and other groups financed by the industry had an impact on the election results, there is some dissent among executives over such tactics. "We would be much better off taking those resources and committing them to explain what we really do," Henry A. McKinnell Jr., the chairman of Pfizer, said last month. ******************************************************
EXPERTS LAY DOWN THE LAW ON ACID REFLUX The acid reflux of heartburn comes with a common heartache -- doctors don't agree. They don't agree about treatment. They don't agree about testing. They don't agree about cancer risk. But now there's help. A panel of experts convened by the American Gastroenterological Association has laid down the law on acid reflux in a 25-page document. It's sure to be controversial, as it contradicts beliefs held by many doctors. Walter L. Peterson, professor of internal medicine at the University of Texas Southwestern Medical Center, chaired the panel. He says he and his colleagues ignored hearsay and looked only at rigorous scientific evidence. "This group of experts ... produced a document that may be controversial but is definitely factual," Peterson says in a news release. Heartburn is caused by acid reflux, or GERD -- gastroesophageal reflux disease. Acid reflux happens when the muscle between the stomach and the esophagus gets weak or relaxes at the wrong time. This lets the contents of the stomach, including acid, splash up into the esophagus. The esophagus doesn't have the same kind of protective coating as the stomach, so stomach acids burn it. Doctors treat acid reflux with over-the-counter drugs, prescription drugs, and surgery. What works? The panel of experts covered seven major questions.
WHAT OVER THE COUNTER TREATMENT IS BEST? H2 receptor antagonists reduce production of stomach acids. These include drugs such as Axid AR, Pepcid AC, Tagamet HB, and Zantac 75. One drug -- Pepcid Complete -- combines an antacid with an H2 receptor antagonist. The panel finds that all these drugs work to various degrees. It found that Pepcid Complete worked better than either an antacid or H2 receptor antagonist alone. "For many patients with no 'red flags' -- experiencing heartburn for periods not exceeding four weeks -- over-the-counter agents provide rapid, effective, and safe relief," says panel member Hashem El-Serag, MD, MPH, in a news release.
WHAT PRESCRIPTION TREATMENT IS BEST? The panel found few differences between these drugs. However, they note that Nexium may heal sores in the esophagus faster. The panel recommends that patients and doctors choose the proton-pump inhibitor that costs the least.
DOES ACID REFLUX LEAD TO CANCER?
WHAT ABOUT NEW ENDOSCOPIC TREATMENTS? There are also two other techniques now in clinical trials: Enteryx and PMMA microspheres. The panel concludes that all of these procedures are still experimental. It does not recommend their use, and it advises doctors to warn patients about the "risks associated with unproven therapies."
CAN SURGERY CUT THE NEED FOR DRUGS OR PREVENT CANCER?
SHOULD HEARTBURN PATIENTS UNDERGO ENDOSCOPY?
DOES ACID REFLUX CAUSE ASTHMA OF OTHER LUNG SYMPTOMS? SOURCES: News release, American Gastroenterological Association o "Consensus Opinion in Gastroenterology," American Gastroenterological Association. ******************************************************
FDA APPROVES NEW CHOLESTEROL DRUG Merck and Co. and Schering-Plough Corp. said regulators have approved their new type of cholesterol-lowering drug called Zetia, a medicine expected to eventually reach blockbuster status because it significantly boosts the effectiveness of existing treatments. The news of Zetia's approval by the Food and Drug Administration on Friday sent shares of both companies higher on Monday. Zetia is viewed as life preserver for Schering-Plough, which is expected to lose crucial revenues when its top-selling allergy drug Claritin faces generic and over-the-counter competition later this year. There are about 13 million patients taking statins, the most common class of drug used to treat cholesterol. Approximately, 60 percent of those patients don't reach their desired cholesterol level. When Zetia is added to patients' regimen, studies showed 72 percent of patients reached their goal. On average, Zetia added to an ongoing statin treatment provided a 25 percent additional reduction in cholesterol, compared with a 4 percent reduction for placebo. Zetia can be taken alone, but only reduces cholesterol by about 18 percent, while statins alone lower it by about 40 percent. "We are at the dawn of new treatment paradigm" for lowering cholesterol, said Dr. Enrico Veltri, vice president of clinical research at the Schering-Plough Research Institute. Zetia should hit the market in a few weeks, the companies said. Yet, analysts say Zetia won't be profitable for at least two years and will require an exceptionally aggressive marketing push to overcome concerns about its cost and change the prescribing patterns of doctors, who don't want to load patients up with too many pills. The fundamental question is whether adding Zetia is clinically and economically better than just increasing the dose of the statin, which doesn't increase the cost but can increase side effects. The wholesale cost for a 30-day supply of Zetia is $57.90. That will be on top of the statin's cost. Merck's statin, Zocor, has a wholesale price of $105.81 for a 30-day supply regardless of the dose. Executives from the MerckSchering-Plough Pharmaceuticals LLC joint venture said doubling the dose of a statin will only reduce cholesterol by 6 percent. But Bernstein Research analyst Richard Evans said that 6 percent reduction will be enough to get 75 percent of patients who haven't met their goal to achieve it. Robert A. McMahon, vice president and general manager of the joint venture, said Zetia's price represents a good value and the drug is a tremendous opportunity for patients who aren't achieving complete success on statins alone. The companies are testing a pill that combines Zetia and Zocor that they plan to file with the FDA next year. If approved, the drug will breathe new life into Zocor, which is expected to lose patent protection in 2006. Sales of such a drug combination could reach $3.4 billion by 2006, said Prudential Financial analyst Tim Anderson, who said sales of Zetia alone could reach $1.1 billion by then. But those sales won't come easy. Anderson said it will take a "paradigm shift" to convince doctors to prescribe two pills instead of one to treat cholesterol. "It is going to take a heck of a lot of marketing spending to get this drug prescribed," Anderson said. "They are going to be pushing up hill." Lehman Brothers analyst Tony Butler said Zetia provides an alternative for doctors who don't want to increase patients' statin dose for safety reasons. Higher levels of statins have been linked to rhabdomyolysis, a life threatening condition which destroys muscle cells and releases them into the blood stream. Last year, Bayer AG withdrew its statin, Baycol, because it was linked more than 30 deaths. Clinical trials show that Zetia didn't' increase the risk of rhabdomyolysis. Zetia works by inhibiting cholesterol absorption in the intestine. Statins prevent cholesterol production in the liver. Statins are the most widely prescribed drugs in the United States, with total sales increasing 18 percent to $12.3 billion for the 12 months ended Aug 2, according to the research firm IMS Health. The number of prescriptions rose 8 percent to 115 million in the same period. In previous years, both numbers had been growing more than 20 percent. The slowdown comes even after federal guidelines widened the number of people who should be taking statins grew to 36 million. Evans attributes the muted growth to rising drug co-payments, which are causing some patients to rethink their medical choices. Cost-conscious consumers may be less willing to spring for another prescription, Evans said. Zetia was discovered by Schering-Plough and developed with Merck. Copyright 2002 The Associated Press. *****************************************
TWO ARTHRITIS DRUGS BETTER THAN ONE Nov. 6, 2002 -- Some rheumatoid arthritis sufferers don't get enough relief from methotrexate alone, which is the standard drug prescribed. A new study finds that they can safely take a second drug to get that pain relief. The combination treatment -- methotrexate plus Arava -- has shown positive results in a preliminary study, reports lead researcher Joel M. Kremer, MD, at the Center for Rheumatology in Albany, N.Y. His study, supported by Arava's manufacturer, Aventis Pharmaceuticals, appears in the Nov. 5 issue of Annals of Internal Medicine. In the large study, researchers looked at the effects of these two drugs over a six-month period. The study involved 263 patients in 20 arthritis treatment clinics across the U.S. and Canada. Each participant was taking methotrexate and was then given either Arava or a placebo. Compared to patients taking placebo, more than twice as many patients taking Arava had a significant improvement in symptoms -- fewer joint problems, less intense pain, and better ability to function. However, about 90% of patients in both groups reported some side effects, including diarrhea, upper-respiratory tract infections, nausea, headache, rash, dizziness, and hair loss -- although diarrhea was the most common problem, affecting one-quarter of the patients. One concern about giving patients both methotrexate and Arava is the potential for liver damage. In fact, people taking methotrexate alone have regular liver enzyme tests just to monitor this problem -- so very few have toxicity problems, notes Kremer. His study shows that the combination can be used "effectively and safely with careful monitoring," says Kremer. It represents a logical alternative for people who don't get enough relief from methotrexate alone, he adds. © 2002 WebMD Inc. **************************************** Please be reminded that our newsletter is for educational purposes only, and not intended as medical advice. Articles relating to general health issues can be equally important too. Occasionally there may be topics of sufficient value that warrant a good discussion with your medical caregivers. As always, I am open to your suggestions for future issues. Good Health to All
Jack Nicholas | |||||||||||||