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Enbrel and Remicade Companies
Sued for Infections and Deaths
Cost Of Enbrel Treatments
Drug Wars: A Capitol Prescription
by James Hall
"The plan is sound. It is in Medicare, it is an entitlement program and
it is a guaranteed benefit." Rep. Bill Thomas, R-Calif., architect of GOP plan
"This provides more political coverage for the Republicans who voted for it than
insurance for seniors who need to buy medicine."
-President Bill Clinton
Not all drug wars take place in the distant jungles of Columbia or on the mean city streets. Some of them take place between politicians battling for powerful interests. Right now it's war in Washington as Republicans and Democrats scrap over the size and extent of Medicare's new prescription drug entitlement. Yes, I did say entitlement, for neither party is shrinking from calling it that. Democrats, for their part, have never backed away from federal entitlement programs and Republicans don't either-not when they include large blocks of committed voters. Seniors at or near Medicare age constituted 25% of the vote last election cycle. That's enough clout to make any party toss out its "Contract With America." Last week the House voted along party lines to pass the Republican prescription drug program, a bill that now goes to the Senate. The question is whether the Republican entitlement program will do much good for seniors or simply serve as a fig leaf to cover the GOP's leadership's unwillingness to permit a vote on a clearly superior Democratic plan.
Democrats favor an across-the-board prescription drug program as part of Medicare itself that would cost $100 billion over five years. It would cost more by keeping costs to seniors down-lower monthly payments, a lower deductible, and lower ceilings on total yearly prescription drug payments. Republicans want a smaller, $40 billion program to fill in some of the gaps that force some seniors to choose between filling prescriptions or paying for frills like food, rent and electricity.
While both plans are voluntary, the Democratic plan would feature deductible payments from Social Security checks while the Republican plan would require that insurance companies run the plans, paid with federal funds plus premiums, copayments, and deductibles that seniors would pay themselves.
With prescription drug costs rising through the roof, a prescription drug program of some kind is now necessary. While Medicare pays for doctor's visits, tests, and diagnoses, it doesn't pay for the advanced medications physicians currently prescribe. The cost of today's prescription drugs eats up a significant amount of most retirees' fixed incomes. Consider the cost, if you will, of a drug called Embrel for rheumatoid arthritis, a crippling, painful disease. Embrel is extremely effective, but at $12,000 a year for a prescription, is well above the means of retired men with the median incomes of $18,155 or retired women with median incomes of $10,155. Even less expensive drugs, when taken in numbers as many seniors must, can add up to large annual bills.
But it's this expense that pits the Republicans against the Democrats. On the Republican side are the prescription drug companies themselves, who have had it all their way when it comes to price increases that have far exceeded inflation in recent years. These drug multinationals are spending over 200 million dollars (Guess who picks up the tab for that?) on ads and lobbyists to persuade voters not to go with the Democratic Medicare solution. Their reason: they don't want to face an organization like Medicare with enough clout to dictate drug price reductions.
Republicans want private insurance companies to run the their plan, but so far the insurance companies themselves are unwilling to commit to run it for what the Republicans want to pay. The insurance companies figure that only seniors who need prescription drugs are likely to enroll in a drug insurance program, making it a money-losing proposition for them. Even if Republicans can find companies willing to extend coverage, figures by the nonpartisan Congressional Budget Office also indicate that the Republican plan would be so expensive for seniors that one-quarter of them may not be able to afford to enroll in it.
While partisan bickering is certainly par for the course this close to November, leaders of both parties ought to stop playing politics with this issue and do something to meet the needs of older Americans living on fixed incomes. It only makes sense to include a voluntary prescription drug benefit as part of the Medicare itself and make it as simple and inexpensive as is reasonable. The Democratic plan, while more expensive, is practical, while the Republican plan is based on uncertainties-will the insurance companies be interested in it? Will it offer sufficient coverage to make a difference? However, the Republican leadership may not care whether its program is unworkable or not. The advantage for the Republicans now is that they can say they have a prescription drug program and that they all voted for it, even if it's the lesser plan available. Meanwhile the drug wars continue on, with older Americans as their first casualties.
Copyright © May 20, 2008 6:26 AM by Karl Loren on behalf of Vibrant Life, ALL RIGHTS RESERVED. Permission is granted for non-commercial downloading, copying, distribution or redistribution on two conditions: One, that some form of copyright notice is included in every copy distributed or copied, showing the copyright belonging to Vibrant Life, Burbank, CA, at www.oralchelation.com . The second condition is that the material is not to be used for any purpose contrary to the purposes and objectives of this site. This permission does not extend to materials on this site which are copyrighted by others.
Bad News About Embrel
Rheumatoid Arthritis- TNF- Part II
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.
The FDA has granted approval to Abbott Laboratories to sell its rheumatoid arthritis treatment Humira, formerly designated D2E7. 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.
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.
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.
Abbott's drug Humira, also known as D2E7, is expected to win approval by the FDA early next year. Abbott developed the drug with Cambridge Antibody Technology of Britain. 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.
Abbott Laboratories new rheumatoid arthritis drug D2E7 achieved some very promising results according to some figures released by the company. 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. This would indicate that they hope to receive approval to market it in the spring of 2003.
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.
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 & Women’s 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 can’t
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. O’Dell, 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 aren’t
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:
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 A
See: Rheumatoid
Arthritis-Part III-Vioxx, Celebrex and the Elderly who Have Ulcers.
See: Rheumatoid
Arthritis-Part IV-General Overview-Part B
Harold Rubin, MS, ABD, CRC, Guest Lecturer
Allan Rubin
Updated January 31, 2002
By Jon L. Gelman[1]
In August one of the first cases was filed against the manufacturer of the biological product, Enbrel (etanercept). Enbrel (etanercept) was approved by the U.S. Food and Drug Administration on November 2, 1998, as a second-line agent for the treatment of juvenile rheumatoid arthritis. At the time Enbrel was co-marketed by Immunex, Corp. (in 2001 Amgen, Inc. bought Immunex Crop. of Seattle and Enbrel for some $16 billion, the largest biotech buyout ever) and Wyeth-Ayerst Pharmaceuticals. Although Enbrel has been touted in the press and through marketing as a wonder "drug", it is a potent product whose long term effects and mechanism of action are not known or fully understood. The adverse effects that are known, are serious and fatal. Patients have neither been warned adequately of these risks nor their severity.
Embrel Is Injected
Subcutaneously
Enbrel Is Injected
Subcutaneously Enbrel is a biological product (a genetically engineered
antibody), which reduces the actions of chemicals in the body that are involved
in inflammatory and immune responses. Specifically, Enbrel inhibits the action
of tumor necrosis factor, a component of the body's natural defenses against
serious infection. Enbrel is injected subcutaneously twice weekly by trained
patient. Although the scientific literature to date demonstrates a positive
response by many sufferers of rheumatoid arthritis prescribed Enbrel, in post
marketing reports serious infections and sepsis, nervous system disorders such
as multiple sclerosis, seizures, blood disorders, tuberculosis, SLA,
inflammation of the nerves of the eyes, and fatalities, have all been reported
with the use of Enbrel. The long-term effect of TNF antagonists in the
development of infection, malignancy and autoimmune disease is currently
unknown.
Serious Infections &
Deaths
Serious Infections &
Deaths In just the initial five months following licensure of Enbrel,
post-marketing reports documented thirty serious infections including six
deaths. Subsequently, on
May 10, 1999, a
"Dear Health Care Professional" letter was sent out which added to the
warnings section of the labeling, a warning about infections and sepsis and
advised, among other things, not to give if there is a new infection and to use
caution if there is a history of recurring infections, and to stop Enbrel if
serious infection arises. On
October 10, 2000, a
second "Dear Health Care Professional" letter was sent out to health care
professionals providing inter alia, that "[r]are cases of central nervous system
disorders, including demyelinating disorders such as multiple sclerosis,
myelitis, and optic neuritis; have been reported in patients with rheumatoid
arthritis who have received Enbrel therapy… [and that] rare cases of
pancytopenia, including aplastic anemia, some with a fatal outcome, have been
reported in patients with rheumatoid arthritis who have received Enbrel
therapy." The FDA followed suit, and in January 2002, it issued a warning about
serious nervous system problems that could be caused by Enbrel, involving
demyelination, producing MS and other conditions; patients were warned to watch
for vision changes. We intend to pursue cases on behalf of individuals seriously
injured by both Enbrel and Remicade, a similar biological product, manufactured
and sold by Centocor, Inc.
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You can reach Karl Loren at www.PainStudy.com by mail at 1831 N. Bel Aire Drive, Burbank, CA 91504. Within the US and Canada, use the toll free number: (800) 523-4521, the local number: (818) 558-1799, the FAX: (818) 558-7299, eMail to karl@painstudy.com
Copyright © May 20, 2008 6:26 AM by Karl Loren on behalf of Vibrant Life, ALL RIGHTS RESERVED. Permission is granted for non-commercial downloading, copying, distribution or redistribution on two conditions: One, that some form of copyright notice is included in every copy distributed or copied, showing the copyright belonging to Vibrant Life, Burbank, CA, at www.oralchelation.com . The second condition is that the material is not to be used for any purpose contrary to the purposes and objectives of this site. This permission does not extend to materials on this site which are copyrighted by others.