by skeeter1 7 Replies latest watchtower medical
Did you know that some of the "blood fractions" actually KILL people?
Anderson_Info brought this up in another thread (but the thread was hi-jacked)
This is dangerous medicine the Watchtower Society is touting, and not telling people the risks.
Please write your comments & experiences.
RECOMBINANT ACTIVATED FACTOR VIII is very deadly.
Normally, it's great for treating patients with hemophilia. Today, the Watchtower Society is pressuring doctors to use it on non-hemophiliacs. Factor VIII clots non-hemophliac's blood.
This past week, a Watchtower lawyer questioned a doctor who took the stand as to why the doctor did not give Factor VIII to woman who was bleeding after giving birth to twins. The woman already had a dangerous blood clot that needed an immediate operation. Doesn't it seem like malpractice to give a non-hemophiliac a drug that would cause her blood to clot...especially when she already had clots?
Please read the following. WE NEED TO BE AWARE THAT BLOOD FRACTIONS ARE NOT "Safe" CURE-ALL SUBSTITUTE FOR BLOOD.
Trauma Care May Be Killing Soldiers
ROBERT LITTLE
The Baltimore Sun
American military doctors in Iraq have injected more than 1,000 wounded troops with a potent and largely experimental blood-coagulating drug despite mounting medical evidence linking it to deadly blood clots that lodge in the lungs, heart and brain.
The drug, called Recombinant Activated Factor VII, is approved in the U.S. for treating rare forms of hemophilia that affect about 2,700 Americans. In a warning last December, the Food and Drug Administration said that giving it to patients with normal blood could cause strokes and heart attacks. Its researchers published a study in January blaming 43 deaths on clots that developed after injections of Factor VII.
The U.S. Army medical command considers Factor VII to be a medical breakthrough in the war, giving physicians a powerful way to control bleeding that can be treated otherwise only with surgery and transfusions. Guidelines at military field hospitals encourage its liberal use in all casualties with severe bleeding, and doctors in Iraq routinely inject it into patients upon the mere anticipation of deadly bleeding.
"When it works, it's amazing," said Col. John B. Holcomb, an Army trauma surgeon and the service's top advisor on combat medical care. "It's one of the most useful new tools we have."
Yet the Army's faith in the $6,000-a-dose drug is based almost entirely on anecdotal evidence and persists despite public warnings and published research suggesting that Factor VII is not as effective or as safe as military officials say.
Doctors and researchers at civilian hospitals, including major medical centers such as Johns Hopkins and Massachusetts General Hospital, have largely rejected it as a standard treatment for trauma patients. Other hospitals say they have grown increasingly cautious about administering it because of clots found in their patients, including some that have caused deaths.
Meanwhile, doctors at military hospitals in Germany and the United States have reported unusual and sometimes fatal blood clots in soldiers evacuated from Iraq, including unexplained strokes, heart attacks and pulmonary embolisms, or blood clots in the lungs. Some have begun to suspect Factor VII.
At the Walter Reed Army Medical Center in Washington, D.C., doctors said they tried to determine last year whether a seemingly high incidence of blood clots in their patients was related to Factor VII use in Iraq. However, they found that the Army was not collecting sufficient information about its use of the drug to draw any conclusions.
Doctors at the Landstuhl Regional Medical Center in Germany said they planned to track complications among war casualties who got Factor VII, after concluding that a heart attack in a patient last August was probably caused by the drug.
Fear of unwarranted risk
During one 24-hour period in May, while journalists for the Baltimore Sun were at the 10th Combat Support Hospital in Baghdad, three U.S. Army soldiers arrived in the emergency room with traumatic injuries, and all of them were injected with Factor VII. Two subsequently died, not from their battlefield injuries but from complications related to blood clots, according to medical records and interviews with doctors.
Some trauma and blood specialists outside the armed services think the military is taking an unwarranted risk with wounded soldiers because the drug has never been subjected to a large-scale clinical trial to verify that it works and is safe for patients without hemophilia.
"It's a completely irresponsible and inappropriate use of a very, very dangerous drug," said Jawed Fareed, director of the hemostasis and thrombosis research program at Loyola University in Chicago and a specialist in blood-clotting and blood-thinning medications.
"It's insane, using it that way. Absolutely insane," said Dr. Rodger L. Bick, a University of Texas hematologist and editor of the Journal of Clinical and Applied Thrombosis/Hemostasis.
Army trauma specialists say that blood clots in severely injured patients can be caused by many things and that using Factor VII is worth the risk.
But some civilian doctors who have worked with the drug say its clotting capabilities are so profound that they have to assume it is responsible for deaths among military casualties who have received it.
"Of course some of them are dying from it," said Dr. Louis M. Aledort, a professor of hematology at the Mount Sinai School of Medicine in New York who specializes in clinical research and who has studied Factor VII safety. "If you give people this kind of dangerous coagulating product, some of them are going to have [blood clots]."
Yet he and other civilian specialists were less troubled by the potential dangers, which they said might be justified given the severe injuries in Iraq, than by the lack of scientific evidence that war casualties are getting any benefit from taking the risk.
"If you don't have that," Aledort said, "then you're just experimenting on people with a dangerous drug."
Weighing side effects
Deciding what rate of complications is acceptable is a decision generally left to individual doctors. Officials at Novo Nordisk, the drug's manufacturer, say evidence of clot-related complications doesn't mean that Factor VII is too dangerous to use, only that the side effects need to be weighed against its potential to help a patient.
"It's really not a question of an absolute safety level, but rather a ratio of benefit to risk that has to be established," said Dr. Michael Shalmi, Novo Nordisk's vice president of biopharmaceuticals.
Military officials are unapologetic about moving aggressively toward a new treatment for the types of deadly bleeding they see frequently in Iraq. Wounded troops requiring transfusions of 10 or more units of blood have a 25% to 50% chance of dying from their injuries, they say, so anything that helps to stop severe bleeding is worth exploring.
"We're making decisions, in the middle of a war, with the best information we have available to us," said Holcomb, commander of the Army's Institute of Surgical Research.
As the trauma advisor to the Army surgeon general, Holcomb is largely responsible for establishing what types of drugs and equipment are used to treat wounded American soldiers. It was his decision, with the support of Army leadership, to begin using Factor VII as a standard treatment in Iraq.
The decision was made in February 2004, Holcomb said, after he saw results from the largest clinical trial conducted so far of Factor VII's use in trauma -- an international study of 277 people, sponsored by Novo Nordisk. It concluded that trauma patients who got Factor VII had the same likelihood of suffering blood clots as those who didn't. Those results, and data from a few much smaller studies that did not focus on trauma patients, made Holcomb comfortable that the drug was safe enough, he said.
The same study also suggested that Factor VII didn't work particularly well in trauma patients, especially those with penetrating injuries. But military doctors say they've since gathered enough hands-on evidence of the drug's effectiveness to continue promoting its use.
"I've seen it with my own eyes," said Air Force Lt. Col. Jeffrey Bailey, a trauma surgeon and senior physician at the American military hospital in Balad, Iraq. "Patients who are hemorrhaging to death, they get the drug and it stops. Factor VII saves their lives."
Doctors in Iraq's emergency rooms, however, almost never care for their patients long enough to see firsthand whether blood clots or other complications have developed. A typical war casualty treated at the hospital in Baghdad is flown to Balad within hours, then to Landstuhl in a day or less, then to the United States within another three or four days.
"I haven't noticed any complications, but then I wouldn't see them anyway," said Army Capt. David R. Steinbruner, an emergency room doctor who served at the Baghdad hospital. "They're usually gone by the next day."
Clots in the veins, including pulmonary embolism and a precursor called deep vein thrombosis, or DVT, are occasional complications of severe trauma regardless of whether Factor VII is used.Injured soldiers and Marines are particularly susceptible to such clots because they spend hours immobilized and unconscious flying from Iraq to Germany and the United States. Clots in the arteries, which flow outward from the heart and can lead to stroke and heart attack, are much less common.
But in the hospitals away from the front lines, military doctors tell anecdotes about patients with strange clots in their lungs or brains that defy obvious clinical explanation. Factor VII has become a prime suspect.
When researchers at Walter Reed studied cases of blood clots in 2003, before Factor VII was introduced in Iraq, they concluded that war casualties had the same frequency of complications as victims of civilian trauma.
A year later, the New England Journal of Medicine published a report on military care for the wounded, including the nine-month period after the Army had begun using Factor VII, and noted a "startling" rate of pulmonary embolism and DVT.
Doctors at Landstuhl began injecting every battlefield patient with an anti-coagulant drug in early 2005 because of the perplexing incidence of blood clots. They say that seemed to reduce the rates of pulmonary embolism, DVT and other clots in the veins.
But doctors say they also have seen war casualties in the last two years with unusual clots in their hearts and arteries that resemble complications found in elderly patients -- troubling, given that most patients at Landstuhl are in their 20s or 30s.
"We see some weird strokes," said Lt. Col. Warren Dorlac, director of trauma surgery and critical care at Landstuhl. "You can't draw any conclusions from one patient, but when you start to see [multiple cases], after a while you have to ask if something is wrong."
Even doctors who suspect a link between Factor VII and clot-related complications in a patient say they can't determine if there is a larger trend because the military doesn't keep enough information to study it.
Unexpected episodes
The Sun was able to identify a handful of wounded soldiers, either by witnessing their treatment in Iraq or reviewing their medical records weeks later, who were injected with the drug and later suffered unexpected episodes related to blood clots, including stroke, pulmonary embolism and heart attack.
Capt. Shane R. Mahaffee, wounded by a roadside bomb near Hilla, Iraq, on May 5, was injected with the drug in the emergency room and during surgery in Baghdad. Four days later, he suffered a pulmonary embolism -- a PE, in medical jargon. He died May 15 of infection and respiratory problems.
Pfc. Caleb A. Lufkin, 24, injured by a bomb May 4 in southern Baghdad and given Factor VII at the Baghdad hospital, suffered a blood clot in his lung two weeks later during surgery on his leg. The procedure was stopped; he was revived and placed on anti-coagulant drugs.
Lufkin died a week later during surgery. His autopsy report, obtained from his mother, says he might have died from an air bubble in his heart, but tests were not performed to confirm it and the surgery records indicate that doctors suspected a clot.
His official cause of death was "complications of blast injuries."
Doctors say that determining the precise cause of blood clots is rarely possible, making it difficult to establish definitively whether Factor VII is responsible for later complications. And military doctors caution against drawing any conclusions from individual cases.
"A year ago we had a 25-year-old patient, a burn patient, who had a heart attack, and he didn't get Factor VII," said Holcomb, considered one of the world's authorities on the use of Factor VII in trauma cases. "There are lots of complications occurring in this group of significantly injured young people. They have devastating injuries."
Military doctors in Iraq often inject Factor VII into injured patients in anticipation of coagulopathic bleeding later, but in hospitals in the United States it is more often used later in treatment, after other options have been tried, and only after case-by-case consideration.
"I want to hear about [the patient's] history, I want to know if they're at risk for thrombotic complications, and I want to know whether more routine measures that are medically appropriate have been exhausted," said Dr. Paul M. Ness, director of the transfusion medicine division at Johns Hopkins Hospital and a "gatekeeper" for Factor VII use there. "The problem is that we haven't seen any kind of good, randomized, controlled study showing us that the drug is safe and that it works."
"I think everyone has an anecdotal experience where it seemed to work dramatically in a patient," said Dr. John M. Harlan, chief of hematology/oncology at Seattle's Harborview Medical Center. "It's just that without the large, randomized trials, you can't identify those patients most likely to benefit. And, obviously, there are questions about adverse complications."
At Shock Trauma
Doctors at the R Adams Cowley Shock Trauma Center in Baltimore have been among the more prominent advocates for Factor VII in trauma patients, publishing several papers about the drug and documenting almost 300 uses since 2001.
When the FDA study questioning the drug's safety was published in January, the Shock Trauma doctors wrote a rebuttal letter and began sifting through their own data, expecting it to show that the potential for complications was overstated.
After reviewing each use at Shock Trauma over the last five years, however, doctors there realized that the data revealed an 8.7 percent rate of major clot-related complications.
Two young patients developed mesenteric ischemia, an interruption of blood flow to the intestines rarely found in patients younger than 60.
A woman developed a clot in the deep veins of an otherwise healthy leg.
One woman died of a heart attack minutes after being injected with the drug, and doctors later found a massive clot in her heart.
The survey identified 12 patients whose deaths were due, in part, to blood clots they suffered after getting Factor VII.
Doctors at Shock Trauma are still exploring Factor VII, but they say they are more cautious about who gets it. They have come to believe that Factor VII can cause cerebral and abdominal blood clots that they don't fully understand and that it should be used sparingly in patients without hemophilia.
"If you'd asked me a year ago, I would have told you the complication rate wasn't anywhere near 8 percent. But the data doesn't lie," said Dr. Thomas M. Scalea, the center's physician-in-chief.
Holcomb said that without a control group for comparison, the Shock Trauma data offers no new perspective on the safety of Factor VII. And he agrees that only a trial where patients are randomly given either the drug or a placebo can determine Factor VII's true rate of complications.
But Scalea thinks his results are "troubling," particularly considering the scarcity of sound research available and the lack of statistical evidence that Factor VII actually works.
"The data is the data, and nobody, to date, has been able to show an increase in survival," said Scalea.
"I think John Holcomb is an incredibly talented, tremendously bright guy who's had experiences I haven't had, and it's very possible that if I worked in John's environment I'd make the same decisions he's making.
"But I've had experiences he hasn't had. And in this environment we've become circumspect about Factor VII, in terms of its cost, its effectiveness and the rate of complications."
'Step back and ask'
The U.S. military has never performed the kind of retrospective analysis that the Shock Trauma center did, because it doesn't have the data available to do it.
Doctors in Iraq, Germany and the United States hold a conference call every Thursday to discuss patients they treated in recent days, in hopes of spotting issues and improving the system.
But with dozens of casualties evacuated from the war zone each week, the information can be overwhelming, particularly given the demanding nature of the work that military medical teams do every day.
When The Sun interviewed Gina Dorlac in late August, she had just awakened from a brief nap after an all-night shift during which nine war casualties were admitted to Landstuhl's intensive care unit. She joked that the workload and the long hours were reminiscent of her residency training. And she equated the perspective on patient care that the pace sometimes affords her to that of looking at the system through a microscope.
"You need someone outside of this kind of setting to be able to step back and ask those questions" about Factor VII, Dorlac said. "I don't know if they're doing that. I hope so."
ANOTHER WATCHTOWER cure-all is EPO (erythropoitein). The HLC's promote this fraction to increase the number of red blood cells.
But, this drug in the wrong doses or to people who are not severly anemic can be DEADLY. **************************************************** May 9, 2007By ALEX BERENSON and ANDREW POLLACK
Two of the world’s largest drug companies are paying hundreds of millions of dollars to doctors every year in return for giving their patients anemia medicines, which regulators now say may be unsafe at commonly used doses.
The payments are legal, but very few people outside of the doctors who receive them are aware of their size. Critics, including prominent cancer and kidney doctors, say the payments give physicians an incentive to prescribe the medicines at levels that might increase patients’ risks of heart attacks or strokes.
Industry analysts estimate that such payments — to cancer doctors and the other big users of the drugs, kidney dialysis centers — total hundreds of millions of dollars a year and are an important source of profit for doctors and the centers. The payments have risen over the last several years, as the makers of the drugs, Amgen and Johnson & Johnson, compete for market share and try to expand the overall business.
Neither Amgen nor Johnson & Johnson has disclosed the total amount of the payments. But documents given to The New York Times show that at just one practice in the Pacific Northwest , a group of six cancer doctors received $2.7 million from Amgen for prescribing $9 million worth of its drugs last year.
Yesterday, the Food and Drug Administration added to concerns about the drugs, releasing a report that suggested that their use might need to be curtailed in cancer patients. The report, prepared by F.D.A. staff scientists, said no evidence indicated that the medicines either improved quality of life in patients or extended their survival, while several studies suggested that the drugs can shorten patients’ lives when used at high doses. Yesterday’s report followed the F.D.A.’s decision in March to strengthen warnings on the drugs’ labels.
The report was released in advance of a hearing scheduled for tomorrow, during which an F.D.A. advisory panel will consider whether the drugs are overused.
The medicines — Aranesp and Epogen, from Amgen ; and Procrit, from Johnson & Johnson — are among the world’s top-selling drugs, with combined sales of $10 billion last year. In this country, they represent the single biggest drug expense for Medicare and are given to about a million patients each year to treat anemia caused by kidney disease or cancer chemotherapy.
Dr. Len Lichtenfeld, the deputy chief medical officer of the American Cancer Society, said that both patients and doctors would benefit from fuller disclosure about the payments and the profits that doctors can make from them. “I suspect that Medicare is going to take a very careful look at what is going on here,” he said.
Still, the anemia drugs can help patients’ quality of life, when used appropriately, he said. “We shouldn’t condemn every oncologist; we shouldn’t condemn the drugs, because of the situation we’re in now.”
Federal laws bar drug companies from paying doctors to prescribe medicines that are given in pill form and purchased by patients from pharmacies. But companies can rebate part of the price that doctors pay for drugs, like the anemia medicines, which they dispense in their offices as part of treatment. The anemia drugs are injected or given intravenously in physicians’ offices or dialysis centers. Doctors receive the rebates after they buy the drugs from the companies. But they also receive reimbursement from Medicare or private insurers for the drugs, often at a markup over the doctors’ purchase price.
Medicare has changed its payment structure since 2003 to reduce the markup, but private insurers still often pay more. Combined with those insurance reimbursements, the rebates enable many doctors to profit substantially on the medicines they buy and then give to patients.
The rebates are related to the amount of drugs that doctors buy, and physicians that agree to use one company’s drugs exclusively typically receive higher rebates.
Johnson & Johnson said yesterday in a statement that its rebates were not intended to induce doctors to use more medicine. Instead, the rebates “reflect intense competition” in the market for the drugs, the company said.
Amgen said that rebates were a normal commercial practice and that it had always properly promoted its drugs.
“ Amgen is dedicated to patient safety,” said David Polk, a spokesman. “We believe our contracts support appropriate anemia management and our product promotion is always strictly within the label.”
Both companies’ stocks fell yesterday after release of the F.D.A. report. Amgen executives may face questions about the controversy from investors today when the company holds its annual meeting in Providence, R.I.
Since 1991, when the first of the drugs was still relatively new, the average dose given to dialysis patients in this country has nearly tripled. About 50 percent of dialysis patients now receive enough of the drugs to raise their red blood cell counts above the level considered risky by the F.D.A.
American patients receive far more of the anemia drugs than patients elsewhere, with dialysis patients in this country getting doses more than twice as high as their counterparts in Europe . Cancer care shows a similar pattern. American cancer patients are about three times as likely as those in Europe to get the drugs, and they receive somewhat higher doses.
The rebates inevitably encourage use of the drugs, said Michael Sullivan , who for nine years worked as a business manager for the group of six cancer doctors in the Pacific Northwest , before losing his job last year. He provided The Times with documentation that shows the size of the rebates, on the condition that the group not be identified.
“Personally, I think rebates should go away,” said Mr. Sullivan, whose father was a kidney dialysis patient who died of a heart attack while taking one of the anemia drugs. “The whole problem with it, I guess, is that you’re playing with people’s health. It’s not the same as buying widgets.”
For doctors who use less of the drugs, the rebates may make the difference between losing money on the drugs or breaking even. Mr. Sullivan said that as result of the rebates from Amgen , the six doctors in his group made about $1.8 million in net profit on the drugs they prescribed.
Unlike most drugs, the anemia medicines do not come in fixed doses. Therefore, doctors have great flexibility to increase dosing — and profits. Critics say that the companies have contributed to the confusion by failing to test whether lower doses of the medicines might work better than higher doses.
“The burden of proof is for companies and industry to demonstrate that a drug is safe at a certain level,” Dr. Ajay Singh, an associate professor at Harvard Medical School . Dr. Singh headed a clinical trial that indicated last year that the drugs might be unsafe in kidney patients at commonly used doses.
Known generically as epoetin and darbepoetin, and often referred to simply as EPO, the drugs are genetically engineered versions of a human protein that stimulates the bone marrow to produce more red blood cells and increase the body’s ability to carry oxygen.
Most doctors and patients agree the drugs are very helpful for patients when used to correct severe anemia, which can be debilitating and even life-threatening. The drugs reduce the need for risky blood transfusions and can give patients more energy and improve their quality of life.
“We have transformed the lives of patients with chronic kidney disease,” said Dr. Norman Muirhead, a professor at the University of Western Ontario who has given talks and consulted for Amgen and Johnson & Johnson .
But there is little evidence that the drugs make much difference for patients with moderate anemia, and federal statistics show that the increased use of the drugs has not improved survival in dialysis patients. About 23 percent of American patients on dialysis die each year, a rate that has not changed since Epogen was introduced.
Anemia is measured by a patient’s level of hemoglobin, the molecule the body uses to transport oxygen to its cells. Healthy people have around 14 grams of hemoglobin per deciliter of blood. Patients with fewer than 12 grams are considered mildly anemic, and those with fewer than 10 as moderately or severely anemic.
The labels on the drugs, as currently approved by the F.D.A., encourage doctors to aim for a hemoglobin level of 10 to 12. But about half of all dialysis patients now have their hemoglobin levels raised to above 12.
Critics of the drugs say their increased use has been driven by profit. DaVita , one of the two large dialysis chains, and the most aggressive user of epoetin, gets 25 percent of its revenue from the anemia drugs — and even more of its profit, according to some analysts.
Dr. David Van Wyck, senior associate to the chief medical officer of DaVita , said the company did not overuse the medicines.
Doctors determine how much to use, Dr. Van Wyck said. “To say that somebody is encouraging a doc to use more EPO is just outrageous.”
Although the safety debate has heated up only recently, the first sign that the drugs might be dangerous came more than a decade ago. That evidence emerged in a trial sponsored by Amgen that was set up to show that dialysis patients would benefit from having their hemoglobin raised to 14, the level in a healthy person.
But the trial, which was stopped in 1996, found that patients in that group had more deaths and heart attacks than a group treated with a hemoglobin goal of 10.
That trial should have discouraged doctors from using too much epoetin and encouraged Amgen to study the risks further, said Dr. Steven Fishbane, a nephrologist at Winthrop-University Hospital on Long Island .
Instead, use of epoetin continued to soar. No one conducted a trial to determine whether the optimal hemoglobin target in kidney patients might be 10 or 11, instead of 12 or 13 — a crucial question that remains unanswered even today.
Dr. Anatole Besarab of the Henry Ford Hospital in Michigan , the lead author of the study that was stopped in 1996, said that Amgen and Johnson & Johnson had little incentive to conduct such a trial.
Dr. Robert M. Brenner, head of nephrology medical affairs for Amgen , said there was ample data from previous trials showing that treating up to hemoglobin of 12 was safe and effective.
Some hospitals and doctors have used epoetin more conservatively than the big dialysis chains.
Dr. Ronald A. Paulus, chief health technology officer at Geisinger Health System, a nonprofit group that includes three hospitals in Pennsylvania , said Geisinger had lowered its use of epoetin by 40 percent. Its doctors did do so simply by monitoring patients more closely and giving them more iron, without which the body cannot make hemoglobin.
Dr. N. D. Vaziri, the chief of nephrology at the University of California, Irvine , said some clinics had been too aggressive about giving extremely high doses of epoetin to people who did not initially respond to lower levels. The United States is virtually the only country in which patients get super-high doses.
“You create a toxicity situation,” said Dr. Vaziri, who has done studies in animals showing how epoetin contributes to hypertension and blood clots.
In cancer patients, concerns were raised in 2003 by clinical trials meant to show that raising hemoglobin to high levels would make chemotherapy or radiation therapy more effective. Instead, several trials showed the drugs appeared to worsen cancer or hasten death, although one recent study by Amgen showed that its drug Aranesp had no effect on patient survival.
The conflicting studies are among the issues the F.D.A. advisory committee is expected to discuss tomorrow. Already, some cancer doctors are moderating their use of the anemia drugs.
Dr. Peter Eisenberg, an oncologist in Marin County, Calif ., said many doctors had been induced to use more epoetin by the financial incentives and the belief that the drug was helpful.
“The deal was so good,” he said. “The indication was so clear and the downside was so small that docs just worked it into their practice easily.
“Now it’s much scarier than that,” he said. “We could really be doing harm.”
(By James)
In the 1990s cycling saw a number of unexplained deaths from heart attacks. It was surmised that many athletes were using/abusing EPO, the blood-boosting drug developed by Amgen in 1989. In 2007, the FDA just figured this out and is now issuing a warning about the abuse/overuse if EPO.
Are they paying attention?
The Food and Drug Administration issued strict new warnings yesterday about overuse of widely prescribed anemia drugs after a flurry of recent studies suggested they might cause heart problems or hasten the death of cancer patients.
The agency said that a “black box” warning — the strongest kind — had been added to the labels of the drugs and that doctors should use the lowest possible dose needed to help patients avoid blood transfusions.
It also said it was re-evaluating the validity of claims in the labels and in advertisements that the drugs can raise energy levels or otherwise improve a patient’s quality of life.
Almost one million Americans take one of the drugs, which are mostly used to treat anemia caused by kidney failure or chemotherapy. The drugs are darbepoetin alfa, sold as Aranesp by Amgen, and epoetin alfa, sold as Epogen by Amgen and as Procrit by Johnson & Johnson.
Both drugs are genetically engineered forms of erythropoietin or Epo, a substance made by the human kidney that increases the production of red blood cells, which ferry oxygen to the body’s tissues.
Sales of the drugs worldwide totaled about $10 billion last year, making Epo the most lucrative product ever produced by the biotechnology industry. It is also the largest drug expense for Medicare, which spent $2 billion in 2005 just for the use of Epogen in kidney dialysis patients.
Thanks for highlighting this information. As usual, the WT Society gets it wrong when dabbling in medical advice. They don't care about lives lost, they are pushing an anti-transfusion agenda replete with dubious information.
Want me to ignore the millions lives saved? I hope they improve their quality control.
Driving to the market can kill you. Should we ban motor vehicles? Yes, let's start with ambulances and fire trucks!
The drug, called Recombinant Activated Factor VII, is approved in the U.S. for treating rare forms of hemophilia that affect about 2,700 Americans. In a warning last December, the Food and Drug Administration said that giving it to patients with normal blood could cause strokes and heart attacks. Its researchers published a study in January blaming 43 deaths on clots that developed after injections of Factor VII.
Who would want to take a chance if you were prone to blood clots? I wouldn't.
The payments are legal, but very few people outside of the doctors who receive them are aware of their size. Critics, including prominent cancer and kidney doctors, say the payments give physicians an incentive to prescribe the medicines at levels that might increase patients’ risks of heart attacks or strokes
I'm not sure about that here being the case. But I do know my Dr. used to get boxes and boxes of free samples, I always got a sh#t load from him free.
Interesting info, really there are so many drugs out there and little is really known about the side effects until it is too late.
hope4others
But the trial, which was stopped in 1996, found that patients in that group had more deaths and heart attacks than a group treated with a hemoglobin goal of 10.
Results like that seems to have resulted in the removal from the market, several Rx's, by the FDA. Remember the NSAIDS ? I can understand people with very low Hemoglobin levels needing EPO, but not the others.
I have a JW daughter with chronic anemia (cause unknown), she is still very active physically, I would hate to think a Doc could be influenced by BIG money...and give her EPO, risking her life. And JW's with anemia may be more inclined to agree or even ask for EPO -- because the WT gods have blessed it's use.
Hey, it's right there in their Watchtower Advanced Directive. It must be true. They wouldn't lie or change the Truth.
