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Questions About Rheumatoid Arthritis
Is Rheumatoid Arthritis deadly?I don't think it is, but i just need to be sure
no, not at all.
I don't think so.
no but it can be extrememly painful
No, but very painful.
no its not it just cripples you
Not that I know of.
eventually, but so is pure air. Listen to your doc.
Rheumatoid ArthritisCelebrex arthritis drug was prescribed to help treat symptoms of rheumatoid arthritis. Rheumatoid arthritis affects a high number of people; approximately one in 100 suffer from some severity of rheumatoid arthritis. With rheumatoid arthritis, the joints swell, stiffen, and become very sore and can affect the entire body. Often a life-long disease, rheumatoid arthritis can greatly disrupt a persons life.
I don't think it is. It just feels like it is.
Only if you choke on a biscuit whilst saying it
can be, it can affect the heart
No it is not. It is a degenerative disease/disorder that affects the bones causing pain.
No, I was diagnosed with it 6 years ago but I have had it since I was a teen. It is not fatal.
I hope not. I was diagnosed with RA 10 years ago. Pretty tough at first, but after we got the right medication everything is ok now. Been in remission for about 5 years. I never asked your question even though I'd heard from others who related RA as athe killing arthritis. SO to answer your question, I don't know. However, I really don't know I have it unless I over do it on the weekends.
No ... my younger sister had it for 35 years ... but it sure is painful! The "cure" for her was moving from MI to a warm climate (NM, then FL).
no, deffo not, it's like aids, aids breaks down ur immune system, its what you get afterwards that ACTUALLY kills you.with arthritis, you get asthma, and various other things, which ARE potentially life threatening, but it's not the arthritis itself that kills you.
Rheumatoid Arthritis-Part I-General Overview-Part AAn FDA panel of experts recommended that more safety information needs to be added to the labels of certain rheumatoid arthritis drugs because of rare cases of serious side effects. About two million Americans suffer from rheumatoid arthritis. The original standard chemical treatment for RA was a cancer drug called methotrexate. The next generation of treatment for RA after methotrexate became Arava, a chemical that blocks the overproduction of immune cells that inflame joints. Aventis SA's Arava became the next chemical drug of choice in fighting RABeginning in 1998 however the next generation of RA drugs were those drugs that sop up the different inflammation-causing protein tumor necrosis factor (TNF). The three best known drugs in this category are Johnson & Johnson's Remicade, Amgen's Enbrel, and the most recent addition to the group Abbott Labs' Humira. The FDA has always warned however of the serious risks associated with these drugs.Arva patients were found to suffer a higher rate of liver damage and the drug could cause birth defects. The TNF drugs carry the warnings that they could suppress the immune system enough to cause severe, even deadly, infections and could increase the risk of cancer. The FDA has reports of 170 cases of lymphoma among users of TNF drugs. At a safety meeting held by the FDA in August 2001 in connection with Remicade and Enbrel ( Humira was not on the market at that time), the FDA said that the benefits of the drugs outweighed their risks.According to a study reported on from the Mayo Clinic in Rochester, Minn.a high incidence of rheumatoid arthritis was found in patients who have damaged immune systems. Up until now it was thought that overactive immune systems were somehow involved in RA. According to Dr. Cornelia Weyand, a rheumatologist who led the study, "Until now we have thought that these patients had overactive immune systems which is why we have aggressively treated the symptoms of rheumatoid arthritis with medications that suppress the immune system". RA is classified as an autoimmune disease, because the immune system mistakenly attacks healthy tissue or the joints. The study found that the T-cells (immune cells programmed to recognize and attack invaders) were worn out in individuals who had RA. Dr. Weyand stated that further study is now needed to determine which came first the rheumatoid arthrititis or the exhausted immune system.Rheumatoid Arthritis (RA), the most common type of arthritis, is found in about 0.8% of the adult population. Epidemiological studies indicate that it reaches its peak incidence during the fourth and fifth decade of adult life. It is more prevalent in females than males. It is a chronic inflammatory disease, which primarily affects the joints, but it can also damage pulmonary, ocular and vascular structures. An interesting observation has been that during pregnancy, women who had RA experience a lessening of symptoms.The inflammation of the joints causes pain, swelling and stiffness. Morning stiffness is the problem cited that most effects the quality of life for the individual. Lambert et al showed that there is a correlation between the duration of morning stiffness and clinical measures of psychological well being and depression. The stiffness occurs mostly in hand joints, which leads to hand related disability i. e. trouble getting dressed, eating etc. The disease process can affect the joint and its function, causing severe impairment. An important factor that may explain the difference in disability in patients with similar disease activity and impairment is the patients way of behavioral coping with the disease. Coping is a defined "as cognitive and behavioral efforts to manage specific external and/or internal demands that are appraised as taxing or exceeding the resources of the person". Passive, avoidant, wish-fulfilling fantasy, depressive stance etc. are related to poorer psychological adjustments. On the other hand, active, information seeking, cognitive restructuring, rational thinking all seem to help patients to adapt psychologically to the physical and emotional stressors of the disease.Kotte showed that limiting the level of activity results in progressive loss of functional capacity. The patients behavioral reaction to pain may be an important predictor of the patients future physical well being. "Behavioral coping is not only related to current dexterity, but also has an effect on subsequent dexterity Passive coping strategies predicted lower physical functioning 6 months laterRemaining active, in spite of the pain, has beneficial effects on future physical functioning."Evidence suggests that Tumor Necrosis Factor (TNF) concentrations are increased in synovial fluids of persons with active RA, and increased plasma levels of TNF are associated with joint pain. This recognition has lead to the use of substances to specifically block the pathway of the disease. Given the compelling evidence that pro-inflammatory cytokines are involved in the pathogenesis of RA, interference with the cytokine cascade earlier in the course of the disease may be a therapeutic benefit. The goals of Rheumatoid Arthritis treatment are to decrease pain and inflammation, preserve joint function and prevent deformity. Non drug treatment includes such general measures as rest together with a controlled program of physical therapy and exercise. Current drug therapy includes salicylates and other non-steroidal anti-inflammatory drugs; disease-modifying anti-rheumatic drugs (DMARDs), which include antimalarials, gold, penicillamine, methotrexate and azathioprime; corticosteroids; and analgesics. The two newest DMARDs, leflunomide and etanercept have recently been added to the therapeutic armentarium.Nonsteroids are the traditional first-line drug treatment for rheumatoid arthritis. They relieve pain and suffering and reduce joint inflammation, but do not alter the disease progression and can cause gastric mucosal injury, thus calling for co-administration of other drugs. The two new DMARDs not only ameliorate the signs and symptoms of rheumatoid arthritis and retard joint damage but also have well-tolerated side effect profiles. Research suggests the initiation of DMARDs should not be delayed for more than three months in any patient whose disease remains active despite adequate treatment of NSAIDs. Leflunomide is an oral agent and entanercept is administered parenterally.Leflunomide (Arava), an immunosuppressive medication, inhibits mitochondrial enzyme involved in pyrimide synthesis. It also has anti-proliferation and anti-inflammatory effect. Most common adverse effects were diarrhea, respiratory infections, hair loss, rash, nausea, and increase risk of hepatotoxicity. This drug costs about $250 per month for chronic therapy, after the three day loading which costs $125.Etanercept, a tumor necrosis factor (TNF) inhibitor, blocks its interaction with cell surface TNF receptors, and thus inhibits the inflammatory process of rheumatoid arthritis and the resulting joint pathology. Response to medication usually occurs in one to two weeks after initiation of therapy and nearly always occurs within three months. It improves joint pain and swelling and morning stiffness. It is injected subcutaneously two times per week. Adverse events include respiratory infections, headache, and rhinitis. Its cost is approximately $110 per month.The newest drug that the FDA is considering is Infliximar (Remicade) used for Chrohns disease. It is a monoclonal antibody that neutralizes the activity of TNF alpha, reducing the infiltration of inflammatory cells and reducing production of TNF alpha production. Adverse events noted include headache, nausea, abdominal pain, fatigue, fever and vomiting.We are still a long way from preventing the expression of rheumatoid arthritis, especially in the elderly. Science is beginning to understand the mechanism and has become aware of the fact that there is more than one kind of rheumatoid arthritis. Many medications today are able to alleviate symptoms. We still have to await tomorrows discoveries to conquer this disabling disease.BibliographyLambert VA, Lambert CE, Kipple GL, Mewshaw EA. Relationship among hardiness, social supports severity of illness and psychological well being in women with Rheumatoid Arthritis. Health are Women Int. 1990; 11:159-173.Kitte FJ. The effects of limitation of activity upon the human body. JAMA 1966; 196:117-122.Supplement to article on Rheumatoid ArthritisIn order to present the broadest range of information to our readers, we are adding this supplement to the article on Rheumatoid Arthritis. Much of the information available is anecdotal, but we feel is worth mentioning in light of the debilitating nature of this disorder.The following is a list of measures that is found in a review of the literature to reduce arthritic pain for those who do not ascribe to use of pain killers. While no researcher has shown robust results in professional peer review journals, these measures are worth noting as a complement to more traditional pain relieving medications. Scattered citations continue to pop-up from time to time advocating one of these methods as valuable in pain management.Individual planned exercise Deep breathing application of heat or cold Meditation Massage Guided imagery Movement and posture reeducation and improvement Therapeutic touch Chiropractic treatment Acupuncture Herbs: yucca, devils claw, hawthorn berries Shark cartilage Magnet therapy Analgesic medication The following supplements have been suggested as influencing joint flexibility:Niacinamide, Vitamin A, B1 , B6 and Vitamin EThe supplements mentioned below have been reported to have anti-inflammatory action:Zinc, copper, selenium, manganese, panthothenic acid, flavonoids, tryptophan, sulfur, bee pollen, royal jelly and evening primrose.We would suggest that individuals interested in getting more information about Rheumatoid Arthritis contact one of the organizations listed below.Arthritis Associations Rheumatoid Disease Foundation 5106 Old Harding Rd.Franklin, TN 37064 www.mail-net.com/arth/ American Rheumatism Association 17 Executive Drive NE, Suite 480Atlanta, GA 30329 404-633-3777 Arthritis Foundation 1314 Spring St. NWAtlanta, GA 30309 800-283-7800 www.arthritis.org Association for People with Arthritis 6 Commercial St.PO Box 954Hicksville, NY 11802 800-323-2243 National Osteoporosis Foundation 1150 17th St. NW, Suite 500Washington, DC 20036 202-223-2326 www.nof.org/ Rheumatoid Arthritis- TNF- Part II(12/25/05)- The FDA has granted approval to Bristol-Myers Squibb to sell its anti-TNF rheumatoid arthritis drug Orencia. Please see our item below dated 9/10/05 for the advisory panel's decision on this matter. Bristol said it hoped to begin to market the drug in February using a special sales force that has extensive experience in rheumatoid arthritis.Orencia is administered as a 30-minute intravenous infusion on a monthly basis. The company has not indicated yet what the cost for the drug will be. Orencia will compete with Enbrel by Amgen, Remicade by J&J, and Humira from Abbott, which are the other approved anti-TNF drug treatments for rheumatoid arthritis.Clinical tests showed that Orencia worked in a significant number of patients who did not respond to other anti-TNF agents or another commonly used drug, methotrexate, There are about 2 million rheumatoid arthritis patient sufferers in this country, of which about 250,000 are on anti-TNF therapy.(9/10/05)- An FDA advisory panel voted in favor of recommending to the FDA that Bristol-Myers rheumatoid arthritis drug Orencia was effective, but at the same cautioned that it might lead to a slightly higher risk of infections. The drug was found to be effective in easing the symptoms of rheumatoid arthritis, slowed joint damage from the disease and improved patients' physical functions.In three studies, at least half of the patients taking Orencia showed signs of improvement after six months, and in one of the trials, 68% showed improvement. On the other hand anywhere from 20% to 40% of the patients taking placebos showed improvement.Bristol is seeking FDA approval to market the drug to patients with moderate to severe rheumatoid arthritis who have not responded to other treatments, including Abbott Lab's Humira and Johnson & Johnson's Remicade. The drug is designed to inhibit certain aspects of T-cell functioning, which are involved with inflammation and disease progression. T-cells are involved in the body's immune system, and suppressing them increases the risk of infection and some types of cancer.Data presented by the FDA during the panel meeting suggested that those on Orencia had a higher rate of infections such as pneumonia and bronchitis, compared with those taking the placebos. The infection rate was higher among patients on other rheumatoid arthritis drugs known as TNF-inhibitors when combined with Orencia.Bristol said that if the FDA does approve the drug, the label would include a warning to not prescribe it on top of the TNF drugs such as Humira and Remicade, as well as Enbrel, which is marketed by Amgen Inc. and Wyeth. The company further stated that it would conduct additional studies as to the infection and cancer rates, as well as create a patient registry.(3/31/03)-It seems as if the sales of Abbott Laboratories' rheumatoid arthritis drug Humira is rapidly growing its share of the market. Miles D. White told analysts at a meeting in New York that he expected sales of the drug to be more than $250 million, up from a previous estimate of $200 million in 2003. Mr. White estimated that sales from the drug would grow to over $500 million in 2004, making the drug one of the most important products in Abbott's drug line in the next five years.The rheumatoid arthritis drug Humira, was originally called D2E7. A European advisory panel has recommended approval for Humira to be sold in the European countries, but final approval to sell the drug there is still pending. Abbott developed the medication along with Cambridge Antibody Technology Group of Britain. Abbott acquired rights to the drug when it bought the Knoll Pharmaceutical unit of German's BASF AG. Humira is administered through injection every other week. The drug works the same way as the other two drugs do by blocking an inflammartory protein called TNF-alpha. Humira requires only one injection every two weeks as opposed to Enbrel which must be injected twice a week, and Remicade which is given by intravenous infusion every two months, or sometimes more frequently. Please keep in mind that since Remicade is given intravenously in the doctor's office, it is reimbursable by Medicare.Abstracts for the European Congress of Rheumatology's (EULAR) annual meeting held in Stockholm from June 12-15 have been posted on the organization's website. There are seven late-stage abstracts that pertain to Abbott's Humira (D2E7) (Adalimumab).The studies suggest that D2E7 is very safe and also indicate that it is the first fully human anti-TNF monoclonal antibody that is effective in reducing the symptoms of the disease. The therapeutic benefits also appear to be very durable, with patients continuing to benefit from the drug for at least 2 1/2 years after therapy.With Remicade from Johnson & Johnson and Enbrel from American Home Products having achieved annual sales of about $1.5 billion there is a huge market out there for this type of product. The company submitted data on D2E7 based on 23 clinical trials involving 2,300 patients to the FDA seeking marketing approval for the drug. D2E7 like Remicade and Enbrel is a so called anti-TNF-alpha drug because it blocks the effects of a pro-inflammatory protein, called Tumor Necrosis Factor, that is secreted by the cells of the immune system. People with high levels of the protein suffer from rheumatoid arthritis. D2E7 was initially developed by Cambridge Antibody Technology Group PLC and licensed to Knoll Pharmaceuticals before Abbott acquired the company.Roughly two million Americans suffer from rheumatoid arthritis, and the approval of Humira brings another participant into the battle with Amgen's Enbrel and Johnson & Johnson's Remicade. Abbott has set the wholesale price of Humira at $13,500 for a year's treatment, the same as Enbrel. Remicade costs upwards of $13, 940 a year to administer. In a particularly aggressive stance to gain market share of this market Abbott is offering its new drug Humira free to seniors who lack prescription drug benefits. "The program is directed at people who couldn't afford the drug and don't have insurance, " said Abbott's chairman and chief executive, Miles D. White, in an interview.Genentech Inc. of South San Francisco, Ca. And Xoma Ltd of Berkeley, Ca. jointly announced that they were halting further tests on people with rheumatoid arthritis with their biologically engineered drug Raptiva. The companies had determined that the drug failed to effectively help the patients in the trial study group.Amgen announced that the FDA has requested a review of the safety of TNFa inhibitors. The review will be held at a meeting on March 4-5 and will focus specifically of the incidence of lymphomas in patients taking TNFa inhibitors. The review could result in stronger warnings being added to TNFa inhibitor products specifically warning about lymphoma. Embrel, Remicade and Humira already contain warnings against lymphoma/malignancies on their labels.Remicade has to be administered intravenously and therefore, even if administered in a doctor's office rather than in an outpatient clinic, is reimbursable through Medicare. Embrel and Humira are both administered as injections, so they do not qualify for Medicare reimbursement.Amgen announced that it is finally making inroads towards decreasing the amount of patients waiting to use Enbrel for the treatment of rheumatoid arthritis. Production problems had limited the availability of the drug. Amgen has completed its purchase of Immunex for $10 billion and thus will have both Kinert and Enbrel in the battle against rheumatoid arthritis.The company also announced that a clinical study showed that giving Enbrel once a week with two injections of 25 mg was just as effective as the current regimen of a 25 mg injection given twice a week. The company also stated that it is developing a single injection given once weekly. Amgen initiated this trial to counter one of the primary perceived advantages of Abbott's fully human anti-TNF monoclonal antibody called D2E7 or Humira.Amgen has received final approval to market Kinert, its treatment for rheumatoid arthritis. Kinert is being priced somewhat comparable to Immunex's Enbrel, with a wholesale acquisition cost (WAC) of $924 for a four week supply or about $12,000 per year. Amgen expects to launch the product early next year. The Food and Drug Administration has recommended widening the use of Enbrel to include patients just beginning to suffer from rheumatoid arthritis as well as those who have especially severe cases of the disease. The drug has been so successful in fighting arthritis that there is a 40,000 patient waiting list for it. At present about 350,000 patients are using the drug. The drug had slightly over $760 million in sales last year making it the fastest biotech launched drug in history. This injectable drug costs about $12,000 per year to use. The company is seeking to allow the label to contain the claim that it can inhibit the destruction of a patient's joints. Weighed against this cost is the fact that methotrexate, the standard therapy now in use costs about $1,500 per year and comes in pill form. Enbrel had previously been approved for patients in advanced stages of the disease that have failed to respond to other medications.On the negative side however is the fact that Immunex announced that Enbrel had failed in clinical trials to treat chronic heart failure and asthma. Immunex had thought that the drug could be used to treat these diseases as well as rheumatoid arthritis. Immunex announced at the same time that Enbrel had been effective in treating psoriatic arthritis, a joint condition that afflicts some people suffering from the skin disease psoriasis. The company will apply to the FDA in the middle of this year for approval to sell the drug for that condition which is said to afflict about 250,000 patients in the U.S.The production problem for Enbrel is one that the biotech industry faces compared to the non-biotech industry. It takes between 4 to 5 years to build and certify a plant to make a biotech drug whereas it only takes from 1 to 2 years to build and certify a non-biotech drug plant. The growing and harvesting of the cells needed for a biotech drug is much more complicated and expensive for this type of drug compared to a non-biotech drug. In order to be able to meet the present demand for Enbrel, Immunex would have had to have started construction of the plant in 1996, which was 2 years before the company won approval of the drug from the FDA.Remicade, made by Centocor Ind., a subsidiary of Johnson & Johnson is another new drug that is showing great promise in the battle against arthritis. It must be taken in combination with another drug methotrexate, which may potentially cause lung and liver damage. Knoll Pharmaceutical Co., a unit of BASF AG of Germany is finishing a large clinical trial for a drug called D2E7 that doctors say may be as effective as Enbrel. Knoll is in the process of being acquired by Abbott Labs which expects to start selling the drug in 2003.According to Dr. Arthur Kavanaugh, professor at the University of California at San Diego and an investigator in the study, Abbott Laboratories' experimental drug for rheumatoid arthritis proved as effective as Amgen's Enbrel and Johnson & Johnson's Remicade in treating the disease. Remicade is administered in the doctor's office and Medicare covers it. Injectible drugs are normally not covered by Medicare. Centocor, the subsidiary of Johnson & Johnson that sells Remicade came under some negative publicity recently because of the fact that its web site extolled the financial benefits to doctors for administering Remicade versus the other rheumatoid arthritis drugs.Another promising new drug in the battle against rheumatoid arthritis is Celltech's CDP 870 which for a fee is being co-developed by Pharmacia. It is also a monoclonal antibody therapy that is an anti-tumor necrosis factor and is a PEGylated compound (which makes it longer lasting). This drug is currently in Phase IIb dosing trials, which means that it is at least 2 years away from being launched. Amgen's Kineret is expected to be approved by year end when it may be another major drug in the battle against rheumatoid arthritis.This article presents the highlights of an international roundtable on anti-tumor necrosis factor (TNF) therapies for rheumatoid arthritis held in Lausanne, Switzerland, on February 19 and 20, 1999. Experts in rheumatology discussed the emerging role of anti-TNF therapies as well as the dominant drug in RA therapy, methotrexate, and the future role of combination therapy.It is known that the cytokine TNF-a plays a critical role in the inflammation of the lining (synovium) of the joint that leads to joint destruction and chronic pain. The anti-TNF agents bind to TNF having the effect of neutralizing it and thus substantially improving the symptoms of the disease. More is known about the mechanism of action of anti-TNF agents than is known about the action of traditional agents such as methotrexate (MTX), yet the latter has been used for twenty years and is the most studied drug in clinical trials for rheumatoid arthritis.According to Michael E. Weinblatt, MD, Professor of Medicine, Harvard Medical School and Brigham & Womens Hospital, Boston, MA, methotrexate consistently outperforms all other drugs for RA in comparative trials. It has been shown to be superior to oral gold, cyclosporine A, and azathriopine. Etanercept, the p75 TNF receptor, is being compared with MTX in a large US trial of patients with early-onset RA. "Methrotrexate has the highest long-term retention rate of any disease-modifying antirheumatic drug (DMARD)," Dr. Weinblatt said. This means that individuals stay on the drug for long periods of time without any untoward effects. He believes the most effective dose is about 18 mg per week. However, one of the participants reported that in his clinic about 20% of patients cant take more than 7.5 mg of methotrexate a week because of the adverse effects i.e. oral ulcers, unacceptable hair loss even with folic acid. James R. ODell, MD, Professor and Chair of Rheumatology and Program Director, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska reported on combination therapies in the battle against RA. He said, "until we get a lot of additional data, combination therapy is going to continue to be an art." He indicated that 99% of the US Rheumatologists surveyed use combination therapy to treat patients who arent responding as well as the physician would like. The American College of Rheumatology defines success of treatment as a 50% reduction in the number of tender and swollen joint counts.The problem with many of the past studies is that they do not distinguish between those with early RA (average disease duration, 4 months) and those who have suffered the disease for a long time or have had trials of medications prior to entering the study. Individual pharmacological response variation to medication is related to underlying genetic variations.There are several other new drugs in the pipeline in connection with the fight against rheumatoid arthritis. Johnson & Johnson's Remicade won approval in 1999 as a secondary treatment after other drugs have failed to work. Aventis's Arave has been approved in connection with the slowing of the erosion of the bone and cartilage associated with the disease.Candidates for anti-TNF include:Those who do not respond adequately to MTX alone. Those with a poor response to combination therapy with traditional disease-modifying anti-rheumatic drugs. Those patients on corticosteroids at a dose that is clearly going to be detrimental to them over several years of treatment. Elderly who are too frail to try MTX because of poor renal or cardiac function. Those who use alcohol excessively. In general, participants at this conference felt that anti-TNF therapies are new additions for the treatment of RA, but there are questions regarding dosages, toxicities, long-term effects, and appropriate target populations. While anti-TNF agents can alter symptoms, there is little known about whether they can alter the course of the disease as measured by the impact on bone erosion.Dr. Peter Lipsky, a leading expert in the field of arthritis research, was asked the question: "Is there any evidence that aggressive treatment of early rheumatoid arthritis produces a better long-term outcome than treating patients with established disease?" His response was: "That is our anticipation, but again, it needs to be tested, especially with these new powerful agents." Researchers still need to determine the characteristics of an individual that indicate response to a medication.In announcing it's quarterly earning report on July 12th, 1999 Amgen Inc. also announced some interesting news in the battle against rheumatoid arthritis. The company stated that it expects to file a request with the FDA for approval by year's end for its RA drug IL-1RA. The FDA had reviewed the results of two large studies that had been conducted using the drug and found that there would be no need for the final testing phase of a drug called the "Phase III" testing. This is an extremely rare occurrence and seems to indicate that the testing of the efficacy of the drug has gone exceedingly well. The drug has been previously tested for a different medical condition. Another drug in the fight against RA is Naproxen.Although these articles deal with Rheumatoid Arthritis we feel that it is important to report to you the results of a study done on a popular operation on the knee for osteoarthritis. This operation is done on at least 225,000 middle-age and older Americans at a cost of more than a billion dollars to Medicare, the Department of Veterans Affairs and private insurers.The operation is called arthroscopic surgery for the pain and stiffness caused by osteoarthritis. Investigators at the Houston Veterans Affairs Medical Center and Baylor College of Medicine reported that while the patients often said they felt better after the surgery, their improvement was just wishful thinking. Tests of knee functions revealed that the operation had not helped, and those who got a placebo surgery instead of the arthroscopic surgery felt just as good as those who got the surgery.There were 180 participants in the study who were randomly assigned to have the operation or to have placebo surgery. After they recovered from the operation, most patients said their knee pains had improved, and they continued to say that they were better for the two years that the researchers followed their progress. FOR AN INFORMATIVE AND PERSONAL ARTICLE ON PRACTICAL SUGGESTIONS WHEN SELECTING A NURSING HOME SEE OUR ARTICLE "Selecting a Nursing Home"See: Rheumatoid Arthritis Part I-General Overview-Part ASee: Rheumatoid Arthritis-Part III-Vioxx, Celebrex and the Elderly who Have Ulcers.See: Rheumatoid Arthritis-Part IV-General Overview-Part BHarold Rubin, MS, ABD, CRC, Guest LecturerAllan RubinUpdated May 31, 2003http://www.therubins.comTo e-mail: email@example.com or firstname.lastname@example.orgCox-2 Inhibitors and Rheumatoid Arthritis-Part III(4/22/06)- The Texas state court jury found for the plaintiff 71-year old Leonel Garza, and awarded $7 million in compensatory damages and $25 million in punitive damages to his family. For more particulars on this case please see the item below dated 1/11/06. The verdict came as no surprise since Starr County in Texas is considered to be a "plaintiff " county. The scoreboard now stands 3 cases in favor of Merck and 3 cases against the company in the Vioxx trials.Mr. Garza died from a heart attack in 2001, and had been using Vioxx for only about one month. Texas law caps punitive damages, so the amount of that phase of the verdict will be reduced to $7.75 million. Mr. Garza had a long history of heart disease, including a previous heart attack.Jurors had deliberated for about 8 hours, over 2 days before reaching their 10-2 verdict. The case was held in Rio Grande City, a South Texas town of 13,000, near the Mexican border. The case began in January, but jurors heard testimony for only four days a month because Judge Alex W. Gabert who presided over the court is responsible for cases in several counties.(4/12/06)- The Atlantic City, NJ jury sitting in the state court has awarded the plaintiff, John McDarby, $9 million in punitive damages in connection with his suit against Merck and its painkiller drug Vioxx. The jury could have awarded him as much as $22 million, since he and his wife had won a verdict of a total of $4.5 million in their personal injury claim against Merck in the earlier phase of the trial. Under N.J. law a plaintiff can be awarded as much as 5 times the amount of the personal injury award in the punitive damage part of the award.The Atlantic City, NJ jury sitting in the Merck Vioxx cases awarded $3 million to plaintiff McDarby for personal injuries (pain and suffering), and $1.5 million to his wife (for her loss of "society and services of her husband"). The same jury rejected the claim of the plaintiff Cona for his personal injuries. The amount of any punitive damages to be awarded will be determined by the jury, which will hold hearings starting Thursday. In order to win a claim for punitive damages under New Jersey law the plaintiff will have to prove that Merck intentionally misled the FDA.The jury also ruled that Merck committed consumer fraud in the marketing of the drug by failing to provide adequate warning of the increased risk for cardiovascular events for patients who use the drug for more than 18 months.Both plaintiffs will be reimbursed for their attorneys' fees and their out-of-pocket costs for Vioxx-a sum that is tripled under New Jersey consumer fraud law. Mr. Cona will receive $135 for his proven Vioxx bill, and Mr. McDarby will receive $11,904 for his proven Vioxx bill. Only a portion of Mr. McDarby's legal fees will be reimbursed under the New Jersey consumer fraud law.Although the jury found that Merck concealed the risks for cardiovascular events from Cona's doctor, his heart attack was not a substantial factor in causing Cona's heart attack.Bonnie Zakotnik, the lawyer for Ellis Maximo Diaz, announced that she was dropping his federal lawsuit against Merck the maker of the drug Vioxx, because there was no way she could go through all of the available documents from Merck by June 12, when the federal trial was due to start. She had asked Judge Eldon E. Fallon of the Federal District Court in New Orleans to delay the trial, but he had refused to do so.Mr. Diaz, a retired medical photographer, had taken Vioxx for19 months before his heart attack in May 2004.(4/3/06)- Merck & Co. rested its case on Thursday after having called only five witnesses: two company scientists, two cardiologists and plaintiff Cona's psychiatrist. The company's defense was based on the fact that the plaintiffs' physical condition caused their cardiovascular problems not Vioxx. The company also claimed that it acted reasonably in connection with the safety issue for the drug.Lawyers for Cona and McDarby called 14 witnesses, using data from clinical studies of the drug to show that Merck knew of the high risk factor involved in using the drug for more than 18 months. McDarby's lawyers, Robert Gordon and Jerry Kristal acknowledged the physical ailments of their client, but they emphasized the fact that he would not have taken the drug had he been aware of the increased risk involved for someone in his physical condition.McDarby's physician testified that he would not have prescribed the drug had he been adequately warned of the risks involved for patients in the physical condition that his patient was in.Lawyers for all parties to the case will sum-up their cases to the six-woman, two-man jury on Monday. Judge Higbee will then issue her instructions to the jury either on Monday or Tuesday, and the jury will then begin its deliberations.(3/25/06)- U.S. District Court Judge Eldon E. Fallon of New Orleans, the federal judge who is overseeing the federal Vioxx cases, ruled that the plaintiff lawyers can depose David Graham, an FDA official who has criticized the agency for its handling of the safety issue of the drug. The FDA has traditionally tried to avoid being entangled in civil litigation, and it had denied lawyers requests for Dr. Graham to testify.When Dr. Graham testified before Congress in connection with the FDA's handling of the Cox-2 drug safety issue, Dr. Graham called Vioxx "a terrible tragedy and a profound regulatory failure." Dr. Graham has been a vocal critic of the FDA's handling of the safety issue for these drugs.Judge Fallon ruled that the deposition "must proceed because the FDA has acted arbitrarily and capriciously in failing to provide Dr. Graham for a deposition."(3/14/06)- Dr. John Braun, an internist from Oradell, N.J. testified on behalf of his patient John McDarby that he saw the plaintiff over a dozen times between 1998 and 2003, and prescribed Vioxx for his arthritis, which he said was effective in treating the pain. The doctor further testified that had he known that Vioxx increased Mr. McDarby risk of having a heart attack he would not have prescribed the medication for a man in his condition.Dr. Braun was not allowed to testify to the fact that he had taken Vioxx himself for nearly two years to treat his own neck pain. He also was not allowed to testify that he himself had suffered a heart attack and was presently suing Merck in connection with the Vioxx matter.The plaintiff, Thomas Cona, testified that a lot of the Vioxx that he had used, had been given to him by his physician, who had received a lot of the pills as samples from the Merck salesman. He also testified that he had not been entirely truthful in his pretrial depositions.(3/9/06)- The first trial for Pfizer's Cox-2 inhibitor drug Celebrex has been set for June 6 in an Alabama state court. Celebrex is the only Cox-2 inhibitor rheumatoid arthritis drug that is still on sale in this country. Pfizer put a "black-box" warning, on the label for the drug upon the recommendation of the FDA in August 2005.The label warns that the drug may increase the risk of cardiovascular events, including heart attack and stoke. Total sales of Celebrex dropped in 2005 by 48% to $1.73 billion according to the sales figures from Pfizer.The plaintiff in the Alabama case is Rosie Ware, of Barbour County, Alabama who was 53 years of age at the time of her stroke. She is being represented in the case by the law firm of Beasley, Allen, Crow, Methvin, Portis & Miles PC of Montgomery, Alabama, which was the law firm that represented the plaintiff in the losing first federal trial of Merck's Vioxx.Ms. Ware's attorney in the case is Jere Beasley who said his client was a healthy, non-smoker who took Celebrex for a back pain that she was suffering from, who was left disable after suffering the stroke.There are more than 200 federal cases pending over Pfizer's two pain -iller drugs Celebrex and Bextra that have been consolidated before Judge Charles R. Breyer of the U.S. District Court for the Northern District of California. Bextra was pulled from the market by Pfizer in April of 2005The next of the Merck Vioxx trials started on Monday, February 27th in state court in Atlantic City, N.J. before New Jersey Superior Court Judge Carol E. Higbee. The trial will combine the cases of two plaintiffs at the same time, both of whom had taken Vioxx for more than an 18 month period of time.In this trial the plaintiffs' attorneys will try to convince the jury of Merck's liability because the company failed to properly warn users of Vioxx of the increased risk of heart attack and/or stroke. Mark Lanier will represent one of the plaintiffs in this trial. He is the same attorney who represented the plaintiff in the only case that Merck has lost at a trial in the Vioxx matter in a Texas state court proceeding. His client in this particular case is Thomas Cona, who survived a heart attack in 2003 after allegedly taking Vioxx for 20 months for back pain. Mr. Cona was 57 years old at the time of the heart attack, overweight and had high blood pressure and high cholesterol readings. Although conceding those points, Mr. Lanier will point out the fact that the Vioxx label had no warnings about the risk of the drug, even though Merck knew that it increased the risk of heart events for users of the drug.The other plaintiff is John McDarby, 77, who is represented by Robert J. Gordon. Mr. McDarby is a diabetic, who his attorney will argue, never would have taken Vioxx for his rheumatoid arthritis had the label properly warned him of the risks he was subjecting himself to in taking the drug.Christy D. Jones is Merck's lead lawyer in the case.The New England Journal of Medicine published a letter written by 11 scientists who were co-authors involved in the article on Vioxx that was published in the journal in November 2000. The letter reiterated their previous stance and its conclusions about the drug. Merck did not employ these scientists, but Merck did finance the study. Two Merck scientists who were also co-authors of the original study wrote a separate letter that was also published by the journal reiterating their original conclusions.Dr. Claire Bombardier, a Toronto rheumatologist was the lead outside author on the original study. The journal's editors also pointed out the fact that the study used an earlier closing date for evaluating the cardiovascular risk of the drug than they did for the gastrointestinal risk. Because of that fact they were able to exclude 3 deaths that took place among the Vioxx users, while using a one month later date for comparative purposes for the gastrointestinal comparison with naproxen, which is better known by its trade name of Aleve.The journal's editors however also reaffirmed their earlier complaint, saying that the article, "did not accurately reflect the potential for serious cardiovascular toxicity with Vioxx."According to an article in The Nutrition Business Journal, Americans spent $734 million on glucosamine and chondroitin in 2004, making them two of the most widely used dietary supplements in this country. A large federal study has determined that the supplements are being used to alleviate arthritic pain, the money in effect is being wasted.The study enrolled 1,583 patients with osteoarthritis of the knee who were randomly assigned to one of five groups for a 24-week period of time. Some of the patients took glucosamine, some took chondroitin and some took both. The rest of the patients in the study were either given a placebo, or celecoxib, which is also known as Celebrex.No statistical improvement was found in those patients who took the glucosamine, chondroitin, or combination of the two. The patients who took the celecoxib were found to have had a statistically significant improvement in their symptoms. Dr. Daniel E. Clegg, a researcher at the University of Utah School of Medicine was the lead author of the study. Dr. Clegg cautioned that addition studies would have to be conducted before the effectiveness of glucosamine and chondroitin could be finalized.The study was financed by the National Center for Complementary and Alternative Medicine and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Glucosamine and chondroitin are substances found naturally in our joints. Glucosamine is a modifiend sugar that is thought to play a role in the formation and repair of cartilage. Chondrotin is part of a large protein, proteoglycan, that provides elasticity to cartilage.Dr. Stephen E. Strauss, director of the Alternative Medicine and the National Institute of Arthritis and Musculoskeletal and Skin Diseases, a sponsor of the study, said a national survey in 2002 found that about 5.2 million Americans had used one or both supplements in the preceding year. Veterinarians prescribe glucosamine and chondroitin for treatment of pets with arthritis.(2/20/06)- The federal jury sitting in New Orleans in the retrial of the Irvin-Vioxx case decided that the drug, which is manufactured by Merck was not responsible for his death. See our note below dated 2/5/06 for more information in connection with the earlier trial. Richard Irvin was a 53-year-old Florida resident who had suffered a fatal heart attack about one month after he began taking Vioxx.The earlier federal trial, which was the first Vioxx case that was tried in the federal court system resulted in a hung jury. Mr. Irvin's widow, Evelyn Irvin Plunkett, and two of his children testified that Mr. Irvin's health had been excellent up to his heart attack. Andy Birchfield, a lawyer for Ms. Plunkett, said that the ruling by U.S.District Court Judge Eldon Fallon, that two of the plaintiffs' experts- a cardiologist and a pathologist- could not testify that Vioxx was the cause of the death, because they were not experts about Vioxx was the key reason for the plaintiff's losing the case.The jury deliberated for 3 hours and 40 minutes, the shortest period of any jury in the Vioxx cases.Dr. Richard Schirmer, who was Mr. Irvin's son-in-law, was an emergency room physician in another city who had prescribed the medication for him. Dr. Schirmer testified that he would not have prescribed the medication for his father-in-law had there been a warning on the drug label of the risk of heart attack.(2/05/06)- The federal retrial of the Evelyn Irvin Plunkett, the widow of Richard Irvin vs Merck over Vioxx will begin in New Orleans on Monday February 6 before U.S.District Court Judge Eldon Fallon. The retrial is necessary because the first trial, which was held in Houston because of the flooding in New Orleans as a result of hurricane Katrina, ended in a hung jury, with 7 of the jurors favoring Merck and 1 favoring the plaintiff. A jury of 5 males and 3 males was empanelled to hear the case.The second and third federal Vioxx trials which were scheduled to start in March and April, before Judge Fallon have been postponed for about two months. The second case involves Ellis Diaz, who was considered a medium-term user of Vioxx. His case was originally set to start on March 13, but it has been delayed until sometime in May, because according to his attorney Bonnie Zakotnik, the medical records of his doctor were damaged by the flooding that resulted from Katrina.The third case that is scheduled to be heard in the federal court is that of Charles Borowicz, who according to his attorney used Vioxx for more than 18 months. This case was originally filed in state court in Atlantic County, NJ, but was refiled as a federal case in New Orleans.Judge Fallon instructed both the Plaintiffs Steering Committee and Merck to each submit a list of five Louisiana cases for subsequent trials. Each side will be able to strike two cases from the other's list, leaving 6 cases "in queue". This in turn means that each side can formally ask the other side about evidence and witnesses that they may be using in connection with the impending trials.In a conference call after announcing its fourth quarter earnings, Merck revealed that it is now facing about 9,650 product liability lawsuits, including approximately 19,100 plaintiff groups, which is an increase of 450 cases since its last update on December 15. It also announced that it was increasing its reserves by $295 million for future Vioxx legal costs (the reserve was $685 million as of December 31), which the company believes will be spent through 2007. The company spent $285 million in aggregate on worldwide Vioxx legal expenses in 2005.(2/1/06)- We at therubins would like to apologize to our viewers for reporting in our item date 1/31/06 that the judge in the Garza Texas lawsuit had dismissed the plaintiff's action against Merck and the two physicians who had been treating him at the time of his death. We were mistaken in that report because that lawsuit is still continuing in the Starr County, Texas courthouse.On the other hand Judge Carol E. Higbee of Superior Court in Atlantic City N.J. granted Merck's motion for summary judgment, say that Edgar Lee Boyd, was unable to show he was hurt by Vioxx or by the company's alleged failure to warn of side effects.So far the scoreboard reads: one victory for the plaintiff (in a Texas state court); one for Merck (in a New Jersey state court) and a mistrial (in a federal trial in which the jury had voted 8-1 in Merck's favor) in the Vioxx trials.(1/11/06)-The Garza trial has been set to commence in state court in Texas, and as such it will become the fourth of the Vioxx cases to go to trial. This case was briefly part of a set of federal cases consolidated in the court of U.S. District Court Judge Eldon E. Fallon of the Eastern District of Louisiana, but it was sent back to Texas state court in November.The Garza case was originally set to start in February 2005, but had been stalled for months. The trial will take place in Starr County, Texas, a rural border county. Lionel Garza was a 71-year old male with a history of heart problems. He died of a heart attack only one month after starting Vioxx. Mr. Garza had a heart attack and had undergone an angioplasty to open clogged arteries months before his fatal heart attack in April 2001.According to Mr. Garza's co-lead attorney Jose Escobedo Jr, the plaintiff had a scan that showed normal blood flow to the area where the fatal clots occurred, and his doctors wrote in medical records that he was "stable."The next cases that are set to go to trial in the Vioxx matter after the Garza case, will take place in state court in New Jersey. The two plaintiffs in this lawsuit were taking Vioxx for more than 18 months before the events occurred that forms the basis of the suit. Please see our item dated 1/4/06 below.(1/4/06)- The next Vioxx case court trial is set for February 27, 2006 in state court in New Jersey. It will be a consolidated action with two plaintiffs. The McDarby and Cona consolidated trial will be heard in front of New Jersey Superior Court Judge Carol E. Higbee.John McDarby suffered a heart attack after using 25-mg of Vioxx for approximately 49months. He is 75-years of age and suffered from Type 2 diabetes. He did not have high blood pressure or high cholesterol. He did not smoke nor was he obese. He used to be quite active physically but he is now confined to a wheel chair after fracturing his hip after falling due to a myocardial infarction.According to the figures in Merck's latest 10Q filing, there are now 18,250 plaintiff groups suing on the Vioxx matter up from the 11,700 plaintiffs groups in its previous 10Q filing. That same new 10Q document shows that there are now 9,200 lawsuits filed versus the 6,400 lawsuits filed in the previous 10Q filing.Pfizer Inc. has agreed to finance a study that will be undertaken at the Cleveland Clinic, led by Dr. Steven E. Nissen, a cardiologist at the clinic as to the safety of Celebrex in high-risk patients. Dr. Nissen has been one of the loudest critics as to the safety of cox-2 painkillers. The study will enroll as many as 20,000 patients and will begin next year. It could cost as much as $100 million to run before it is completed. Celebrex had $1.26 billion in sales for the first nine months of this year according to Pfizer.Patients in the study will have some form of arthritis along with histories including a previous heart attack, stroke, angina, coronary bypass surgery or stent procedures. Others will have diabetes, a known risk factor for cardiovascular disease. Those enrolled in the study will be followed for a two-year period of time.One-third of the patients will be given Celebrex; one-third Motrin, or ibuprofen; and one-third will receive Aleve or Naprosyn, both brand names for naproxen. The study will end when about 700 of the patients have died or had a heart attack or stroke, thenumber expected in such a high-risk group even without painkiller treatment.(12/14/05)- After deliberating for a total of about 18 hours on Thursday, Friday and Saturday, the jurors in the Irvin case, which was the first case to go to a federal trial on the Merck-Vioxx matter could not reach a unanimous verdict. Unlike state court civil trials, federal civil court trials require a unanimous verdict. The nine-member panel had voted 8-1 in favor or Merck, after an initial vote of 7-2 in favor of Merck. The judge therefore declared a mistrial, and will set a date for a retrial to take place early in 2006 U.S. District Court Judge Eldon E. Fallon of the Eastern District of Louisiana, who presided over the two week trial in Houston will set a new trial date sometime in February, at which time the New Orleans court system is expected to be fully operational. As of September 30, there were about 2,900 federal lawsuits pending. Judge Fallon will set additional trial dates for some of the other cases in February, March and April.Carol E. Hughes, the New Jersey state court judge overseeing the Vioxx trials in that state has asked both sides to prepare to try two lawsuits in a consolidated trial that is expected to start February 27, a proposal that Merck opposes. The next trials in New Jersey will involve plaintiffs who had been taking Vioxx for longer than 18 months.(12/10/05)- U.S. District Court Judge Eldon E. Fallon of the Eastern District of Louisiana has delivered on his promise to have the Irvin case jury decide the case within two weeks after the trial began. The court, which is sitting in Houston, because of the flood from hurricane Katrina, had a curve ball thrown at it by the plaintiff's lawyers, in the form a motion to declare a mistrial that may delay the decision.The reason for the motion arose as a result of an editorial in the New England Journal of Medicine entitled "Expression of Concern". The editorial cited "inaccuracies and deletions" in Merck's Vigor study the results of which were published in the Journal in November 2000. Although the study stated that 17 patients who were taking Vioxx had heart attacks, in fact 20 patients had heart attacks. Merck claimed that these 3 heart attacks occurred after the study had ended, but the Journal asserted that this was untrue.The Vigor study began in early 1999 and was paid for by Merck. The study was intended to look at gastrointestinal problems such as internal bleeding and ulcers that arose as a result of taking this Cox-II medication compared to the painkiller naproxen, which is sold under the brand name of Aleve. The study was not officially designed to look at the issue of heart attack comparisons, but only 4 of the naproxen patients suffered heart events compared to the 17 Vioxx users who suffered heart attacks.Gregory Curfman, executive editor of the Journal said that all three of the new cases came from the group of supposed lower cardiac risk patients. Merck said that the data about the heart attacks was provided to the FDA, presented to an FDA advisory panel, disclosed to physicians, and included in news releases later issued by the company. Merck further asserted that the three additional heart attacks "did not materially change" the conclusions of the study.The jury of five men and four women will have to answer 12 questions about the roles of Merck, the son-in-law emergency room doctor who prescribed the Vioxx to Mr. Irvin, the physical condition of Mr. Irvin himself and the dangers posed by the medication. If Merck is found liable, jurors will have to consider what would be fair compensation to Mr. Irvin's children and widow for the suffering and the loss of his income and companionship.(12/8/05)- U.S. District Court Judge Eldon E. Fallon of the Eastern District of Louisiana, who is presiding over the "third" Vioxx trial in Houston, Texas has ruled that the plaintiff in the case can introduce evidence showing that Merck knew of the short term risks involved with the usage of Vioxx as well as the longer term usage of the drug. This is the first Vioxx trial being held in the federal court, since both earlier trials involved the state court of Texas and New Jersey. The case has been moved to Houston because of the flood that resulted from hurricane Katrina in New Orleans.Earlier evidence has shown that usage of Vioxx over an 18 months period of time increased the risk of heart attacks and strokes. In the Houston case lawyers for Evelyn Irvin Plunkett will argue that Merck is responsible for the death of her then husband Richard Irvin, even though he used the drug only for 24 days before his death.Judge Fallon denied Merck's request at a pretrial hearing to limit testimony about Vioxx's short-term risks. Plaintiff's attorneys plan to introduce evidence showing that Merck knew of the short term risk of the drug through internal memos from its own scientific staff. By his ruling, in effect it means that all the pending federal cases can introduce evidence of the short term risk of Vioxx, as well as its longer term risk.If Merck were to lose the so called "stronger cases" involving short term risk of the drug, the company would be in a much weakened position in defending itself against the longer term usage cases. If they win the short term cases, it does not improve their chance of winning the longer term usage cases.Judge Fallon stated that he hopes to conclude the case within a 2 week period of time, even if it means holding court sessions in the evening and on weekends.(11/21/05)- New Jersey Superior Court Judge Carol E. Higbee, the judge who is overseeing the Vioxx cases in New Jersey announced that she would select the next case that would go to trial in that state on November 28. The trial will begin on January 30, 2006. There are at last count 3,254 cases pending in New Jersey in the Vioxx matter.The judge will make her selection from one of seven cases that have been selected by plaintiff and defendant attorneys as the potential next eligible case. All of the seven potential cases involve patients who were taking the drug for longer than 18 months. One of the seven potential cases involves a plaintiff who has died. Of the cases filed in New Jersey, plaintiffs' attorney say some 61% involve patients that are believed to have been taking the drug for 18 months or longer.(11/08/05)-There are still about 2,750 Vioxx lawsuits pending against Merck in the state courts of New Jersey, which is Merck's home state, and a total of about 6,400 actions pending in the Vioxx matter throughout the court systems of this country. The next case to go to trial in this matter will be in the federal court in Houston on November 29. Incidentally, this case originally was scheduled for the federal court in New Orleans, but because of the hurricane and flood it has been moved to Houston.Many legal experts feel that the next case is one of the weakest cases against Merck of the many that are still pending. In the Houston case, Evelyn Irvin Plunkett is suing Merck after her husband, Richard Irvin, 53 died of a heart attack 24 days after beginning to take Vioxx. Mr. Irvin was an emergency medical technician who died in May 2001. Andy Birchfield will represent the plaintiff in this action. Phil Beck, a prominent trial lawyer, will lead Merck's defense team in this case..According to court filings by Merck, Mr. Irvin had high blood pressure and high cholesterol levels. His autopsy showed that he had "advanced heart disease." Merck is seeking to have its marketing material excluded at this trial, because Mr. Irvin did not get his prescription for the drug from a doctor who had received such material from Merck. He got the prescription from his son-in-law, an emergency room physician who had not been visited by any Merck sales people.You may be wondering how it is determined as to which case proceeds to trial first in these Vioxx matters. The next trial in New Jersey is set for a trial date of January 7 before Judge Carol Higbee, who presided over the Humeston case. The determination as to which case should be next is set under an agreed upon agenda for determining the order of trial plaintiffs. W. Mark Lanier, the plaintiff's attorney who won the Texas case against Merck will be the lead attorney in this case.A plaintiff's steering committee and Merck each provide a list of five cases they would like to try next. Each side can strike three of the cases selected by the other side. This procedure is for the state of New Jersey only, and Judge Higbee has indicated that she may at some point soon send some of the cases to other judges in the state.There were two questions that were decided by the jury in the Humeston case in New Jersey. On the first question the jury of 3 men and 6 women voted 8-1 that Merck either did not know that Vioxx carried cardiovascular risks at the time that it was prescribed for Mr. Humeston in 2001, or that the company adequately warned physicians about those risks.On the second question the jury voted that Vioxx had not violated consumer fraud rules and did not use "unconscionable practices" in marketing the drug to physicians.Incidentally Merck and federal officials are discussing the possibility of returning Vioxx to the marketplace, although it will be many months before that matter is finalized. (11/4/05)- After a seven-week trial, it only took eight hours of deliberation by a New Jersey state court jury to find for the defendant in the second of the so-called "Vioxx trials". Unlike the first trial in the state court in Texas which found for the plaintiff and against Merck the New Jersey decision represented a complete victory for Merck. The next case in the "Vioxx trials" now moves on to the federal court in Houston, with the scheduled starting date for the trial being November 28.In the New Jersey case, the plaintiff Humeston allegedly took the drug Vioxx for only a two-month period of time in 2001. The plaintiff who is now 61 years of age, was overweight, had a family history of heart problems and was under a great deal of stress in connection with his job. The attorneys for Merck questioned whether or not Mr. Humeston took the drug for even the two months that was alleged in the complaint.Merck was cleared of the allegation that it failed to warn consumers about the drug's risk and engaged in "unconscionable commercial practices." Most legal experts believed that the case was a weak one to begin with, and that the facts of this particular case were in Merck's favor. Merck voluntarily removed Vioxx from the market in September 2004.The greatest increased risk for having a heart attack after taking Vioxx seems to be for those who took the drug for more than an 18-month period of time(9/22/05)- The FDA has turned down for approval Pfizer Inc.'s injectable pain reliever called Dynastat, a member of the Cox-2 class of drugs. The drug had been developed by Pharmacia Corp., which was taken over by Pfizer in 2003. The FDA had first turned down the drug for approval in 2001, but Pfizer had submitted additional data, which the company hoped, would cause the FDA to change its mind.Dynstat, known generically as parecoxib, is sold in many countries, including those in the European Union, for the short-term treatment of surgical pain in hospitalized patients. Some studies have shown that the drug can reduce patients' need for narcotic medications for pain. The drug is converted by the body into Bextra, or valdecoxib, after injection. Pfizer had withdrawn Bextra from the market at the request of the FDA in April.(8/29/05)- The following item came from the Dow Jones News tape:- The "Therapeutic Products Directorate (TPD), the Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use, released a report of the Expert Advisory Panel on the Safety of Cox-2 inhibitors. The panel ruled unanimously (vote: 13 vs 0) that Pfizer's Celebrex should continue to remain on the market in Canada and Merck's Vioxx be reintroduced to the market (vote: 12 vs 1). However, the panel voted eight to five that Bextra not be allowed back on the market, indicating CV risk and rare skin disorders outweigh potential benefits of the drug. The reasons cited for keeping Celebrex and Vioxx on the market include 1) the increased risk of CV disease appears similar to that of most NSAIDs, 2) GI risk appears less than most NSAIDs, and 3) benefits from having a variety of drugs available for pain relief. With Bextra, the panel felt that potential rare skin disorders and CV risks associated with Bextra outweighed the benefits received from the drug. As a reminder, in Febrary 2005, the FDA Advisory Panel ruled 17:15 in favor of MRK's Vioxx to be sold in the U.S."(8/20/05)- A Texas jury awarded Carol Ernst, the widow of Robert Ernst $24.5 million for mental anguish and economic losses and $229 in punitive damages in the first case tried and decided against Merck's Cox-2 pain inhibitor drug Vioxx. The case was tried in a state court in Brazoria County, Texas.Texas law caps punitive damages so that part of the award will be limited to $1.6 million, meaning the overall award would not exceed $26.1 million.Merck announced that it would appeal the decision. The company said that the court made several erroneous rulings that will form the basis for its ap
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