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Posts Tagged ‘anemia drugs’

Anemia drugs hasten death in some cancer patients

Posted by medconsumers on July 13, 2009

For seven years Johnson & Johnson ran deceptive ads on prime time TV and in magazines with this recurring theme: A cancer patient cannot continue working because of debilitating fatigue due to chemotherapy. The ads told people in similar circumstances to ask their doctors about Procrit, which always quickly put an end to the fatigue. There is no published evidence to support the cure-for-fatigue claim, according to a 2007 press briefing at the FDA. Eventually, the agency required warning labels for Procrit, Aranesp, and Epogen —- all drugs widely prescribed to treat anemia in cancer patients. Warning label refers to the black box warning that appears in the 20 or so pages of information that comes with the drug (sometimes). The warnings for Procrit, Aranesp, and Epogen now list a higher incidence of potentially fatal blood clots, heart damage and increased tumor growth.

Now they can add “decreased survival” to the list. This week, the Cochrane Collaboration, the independent, international organization that evaluates research, published a meta-analysis of the information generated by the care of nearly 14,000 cancer patients entitled, “Anti-anemia drugs shorten survival for some cancer patients.” This meta-analysis is co-authored by Maryann Napoli, Center for Medical Consumers. For background on how their drugs came on the market and how financial incentives encouraged oncologists to overprescribe them, see her testimony on this topic before the FDA’s Oncologic Drug Advisory Committee in 2007 and one year later in 2008.

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Anemia Drugs For Cancer Patients

Posted by medconsumers on March 13, 2008

Testimony Submitted to FDA Oncologic Drugs Advisory Committee Meeting
March 13, 2008

Maryann Napoli, Associate Director, Center for Medical Consumers

As a consumer advocate who attended the May ODAC meeting, I came away wondering why these drugs remain on the market. They cause some patients to die sooner. They have many other risks that are severe and well documented, and any quality-of-life benefit has yet to be proven. The FDA approved the first ESA because it reduced the percentage of patients transfused. But the agency has since acknowledged that the infectious disease risks of a blood transfusion are far lower now than they were in 1993.

No doubt there are many cancer patients who see these drugs as an instant cure for chemotherapy-induced fatigue or as the means of allowing chemotherapy to continue. The former indication was fostered by Johnson & Johnson’s fraudulent ad campaign for Procrit, which continued for seven years in the mainstream TV and print media. I urge ODAC to discuss the misconceptions imparted by these ads and to consider recommending that the FDA require J&J to run a corrective ad campaign.

The ability of a cancer patient to make a truly informed decision with the help of her oncologist is seriously compromised by J&J’s and Amgen’s reprehensible practice of offering rebates—that is, kickbacks—to oncologists. Patients are always encouraged to discuss their treatment decisions with their doctors. Yet it’s hard for patients to believe oncologists’ recommendations are unbiased when they are “reaping millions” from the prescription of anemia drugs, as The N.Y. Times reported last May. (1) Companies that give kickbacks and other financial incentives intended to manipulate oncologists into using the most expensive drugs are poisoning the doctor/patient relationship.

Where can people turn for unbiased information? It should be the FDA, but it’s not clear to me that black box warnings are the way to go. The changes in the product labeling in 2004 did not change clinical practice. (2) And what do we know about the effects of black box warnings on the ones who need them the most—the cancer patients? The cancer patient should be given scientifically accurate, written information about ESA well before she needs it. The time to weigh the risks and benefits is not when she’s awaiting her next chemo treatment and just learned that her hemoglobin is too low for the next round.

Patients cannot make truly informed decisions unless they are given quantitative information to help them decide whether ESA is appropriate. They need to know, for example, the chances of…1) needing a transfusion; 2) suffering harm by foregoing a transfusion, 3) experiencing a serious adverse effect from the transfusion itself, and 4) having a severe adverse effect from the ESA. Patients need to know the magnitude of each of these four risks. Telling them that ESA will reduce their risk of having a blood transfusion is simply too vague. It gives them no way to compare this purported benefit with the other risks of taking ESA. If the FDA will not remove these drugs from the market, it must find the best ways to get clearly written, accurate quantitative ESA information to cancer patients.

(1) Berenson A, Pollack A. “Doctors Reap Millions for Anemia Drugs.” N.Y. Times, May 9, 2007

(2) Blau AC. “Erythropoietin in Cancer: Presumption of Innocence?” Stem Cells 2007; 25;2094-2097; originally published online Apr 26, 2007.

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Anemia Drug Update

Posted by medconsumers on June 1, 2007

On May 10, 2007, the FDA held an emergency meeting of its Oncologic Drugs Advisory Committee to discuss the anemia drugs that supposedly help people cope with chemotherapy. But several recent studies were halted prematurely because these drugs—Epogen, Procrit, Aranesp—caused an increased death rate, cancer progression, deep-vein blood clots and heart damage (see last month’s newsletter). Ultimately, the FDA advisory committee asked for better studies and voted to put more stringent warnings on the labels for these drugs, known collectively as EPO. Unfortunately, few doctors ever read warning labels (one in ten, according to one survey), and the FDA has no authority over how they prescribe drugs.

As is often the case with drugs found to be risky long after they came on the market, the future of EPO comes down to money. There are huge financial incentives for oncologists to overprescribe EPO. Amgen and Johnson & Johnson, makers of EPO, sell their drugs directly to doctors and thanks to rebates (a.k.a. kickbacks) from the drug companies, many oncologists are making a fortune.

That was made clear the day before the FDA meeting in a front-page New York Times article entitled, “Doctors Reaping Millions for Use of Anemia Drugs.” A former business manager for a six-oncologist practice in the Pacific Northwest provided the Times with documentation showing that the six doctors received $2.7 million from Amgen for prescribing $9 million worth of its drugs last year. The rebates are available for cancer drugs other than those self-administered by the patient. The rebates are in addition to the reimbursements doctors get from Medicare and private insurers.

Normally, the FDA steers clear of drug costs, sticking solely to safety and efficacy issues, but the Times article loomed over the FDA meeting. When the advisory committee discussed how to inform patients of the adverse effects of EPO, one oncologist said it should be left to doctors. But another committee member Otis Brawley, MD, head of Atlanta’s Grady Hospital, objected. “The problem is at my hospital doctors get $1200 for every dose they give patients. And they don’t have to sign conflict-of-interest statements like we do,” he said, referring to the FDA requirement that each committee member reveal any financial ties to drug companies prior to participation.

Another oncologist on the committee expressed fury about the uncertainties regarding the safety of the doses currently in use. “Yes, we have a burning question: Are these drugs killing people?” asked Silvana Martino, MD. “What are the doses that are reasonable and appropriate?”
The misleading EPO advertising aimed at the public would never have come up at this meeting were it not for consumer advocates. Five advocates attacked Johnson & Johnson’s ads for Procrit, which fraudulently sold the drug as the cure for chemotherapy-induced fatigue in an ad campaign that ran from 1998 to 2005. They pushed the FDA to force Johnson & Johnson to mount a corrective ad campaign because there is no proof for its claim.

There is no proven quality-of-life benefit for EPO. The drugs were initially approved as a safer alternative to blood transfusions for a chemotherapy-induced drop in red blood cells. But transfusions are not as risky as they were 15 years ago when the first EPO was approved. One basic question lingered: What is the purpose of this drug?

Answers will take years, but Wall Street reacted immediately. Within days of the FDA meeting, Amgen shares dropped more than 15%.

Maryann Napoli, Center for Medical Consumers© June 2007

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Anemia Drugs for People on Chemotherapy

Posted by medconsumers on May 10, 2007

Testimony Submitted to the FDA Oncologic Drugs Advisory Committee Meeting , May 10, 2007
Maryann Napoli, Associate Director,
The Risks of Erythropoiesis-stimulating Agents For Use In The Treatment Of Anemia Due To Cancer Chemotherapy

I’m Maryann Napoli, associate director of the Center for Medical Consumers in New York City. We have never taken pharmaceutical industry funding. (No drug company has ever wanted to give us any.) I write often about cancer and drugs because our mission, as an organization, is encouraging people to look for and to understand the evidence that supports their treatment decisions.

The story of these anemia drugs and how they were oversold to the public and how financial incentives encouraged oncologists to overprescribe them is truly outrageous. Like me, many Americans probably first became aware of them while watching the evening news. Those ubiquitous Procrit TV ads all had the same scenario – the cancer patient undergoing chemotherapy cannot continue the work he or she loves because of disabling fatigue. Procrit quickly turns things around, and the cancer patient is back on track enjoying work again.

Who among us on chemotherapy would not ask their doctors for this drug? And even if you didn’t have cancer at the time of this ad campaign—very likely the message would stay with you. There is a drug that quickly cures chemotherapy-caused fatigue.

Imagine my surprise when I read two months ago of a FDA press briefing about the new warnings to be added to the labels of all anemia drugs. Dr. Richard Pazdur announced that there has never been any evidence to support the claims that anemia drugs can increase energy or ease fatigue in patients undergoing cancer chemotherapy.

Why, then, did the FDA allow Johnson & Johnson to run those Procrit ads?

I’m glad that the FDA sent warning letters to members of professional organizations, but what about the cancer patients? There are numerous cancer patient groups across the country. Surely, they should have been notified, too.

I’m glad the FDA held that press briefing. But what about the TV-watching public? That is the majority, after all. As a result of the press briefing, some articles appeared in the print media. But the newly identified risks of anemia drugs and the circumstances in which they are likely to occur are simply too complicated for TV medical reporters. They would have to explain off-label use; and how the greatest harm appears to be associated with off-label use; that raising hemoglobin isn’t equivalent to reducing fatigue; how anemia can be caused by chemotherapy or the cancer itself; that deep-vein blood clots and heart damage occur when anemia drugs are given in excessively high doses.

Weigh these complicated concerns against that simple TV message about Procrit. No Procrit ad that I ever saw had a cancer patient saying, “This drug helped me avoid a blood transfusion.”

Johnson & Johnson was allowed to train current and future cancer patients to demand these expensive drugs for what we now know is an evidence-free indication. Given what we now know about the increase in deaths, deep-vein blood clots, and heart damage associated with anemia drugs, the FDA should require J & J to run a corrective ad campaign. These ads should be run on prime time TV—shows with the same demographics as the evening TV news and at the same frequency.

The huge expense and the range of pricing of these anemia drugs are troubling, especially since the FDA views the three as equivalent. From what we have known for years about financial incentives—that is, the deep discounts offered by the drug companies for the most expensive drugs to oncologists in outpatient practices —it is likely that these discounts have fueled the inappropriate use of anemia drugs, which are among the 20 highest-expenditure drugs covered by Medicare

And we know from a 2006 study in Health Affairs that these deep discounts achieved what the drug companies had in mind. They increased the use of the most expensive drugs. This is due to the fact that the most costly drugs came with the largest discounts, and therefore the most generous profit margins for oncologists in outpatient practice.

Federal laws may prohibit drug companies from paying doctors to prescribe drugs given in pill form that are purchased by patients at the pharmacy. But companies are allowed to rebate part of the price of the drugs given by injection or intravenously in doctors’ offices. Doctors receive the rebates after they buy the drugs from the companies. In other words, they receive reimbursement from Medicare or private insurers for the drugs, often at a large markup over the doctors’ purchase price. And on top of that, the oncologists get rebates (i.e., kickback) based on the amount of drugs they have purchased.

Oncologists are, in effect, running their own pharmacies. Consumers would naturally be suspicious of the herbalist recommending and selling his own herbal medicine or the vitamin doctor selling vitamins to her patients. It’s time for the public to understand that things are far worse at the oncologist’s office.

Fifteen years after these anemia drugs went on the market, we learn that they can hasten death and cause severe injuries. Why did it take so long to know this?

The situation points to the necessity of major changes. The FDA should be given the power to require better safety studies in the pre-approval process, and the agency must have the power to exact a large penalty on any drug company that does not follow through on FDA recommendations, such as those made at the Oncologic Drug Advisory Committee’s 2004 meeting.

Thank you for giving me this opportunity to speak.

1. GAO Report-01-1118 Medicare payments for drugs exceeds providers’ cost. September 2001.
2. Jacobson, Mireille. Does reimbursement influence chemotherapy treatment for cancer patients? Health Affairs, Mar/Apr 2006
3. Berenson A, Pollack A. Doctors reaping millions for use of anemia drugs. New York Times, May 9, 2007.

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Anemia Drugs Increase Risk of Death, Blood Clots and Heart Damage

Posted by medconsumers on May 9, 2007

Serious doubts surround the expensive anemia drugs widely prescribed for the fatigue associated with cancer chemotherapy and kidney dialysis. They were initially approved to decrease the need for blood transfusions. But the latest studies show that these injectable drugs, sold under the brand names of Aranesp, Procrit and Epogen (Eprex in Canada), increase the risk of death, deep vein blood clots and heart damage. Several recent trials had to be stopped prematurely because the drugs either caused the cancer to progress more rapidly or the cancer patients to die sooner. In some trials, the harms are caused by excessively high doses.

The FDA has taken the unusual step of calling a special meeting of its Oncologic Drugs Advisory Committee to review the new data on these drugs. Aranesp, Procrit and Epogen are all versions of erythropoietin, or EPO, which is a synthetic form of a protein produced by the kidneys that stimulates production of red blood cells. EPO drugs were approved by the FDA for the treatment of anemia in patients with kidney failure and in cancer patients undergoing chemotherapy. Anemia, a deficiency of red blood cells, is a common side effect of chemotherapy, which suppresses red blood cell production. EPO drugs are good at elevating and maintaining red blood cell levels, but now their effectiveness in treating fatigue has been called into question.

Yet fatigue in cancer patients undergoing chemotherapy was the heavily advertised reason for the TV ad campaign for Procrit. If you’re over the age of 55, these ads will be quite familiar because they appeared regularly during the Network evening news and other venues likely to have an older audience. In the standard scenario for a Procrit ad, the cancer patient cannot continue the work he or she loves because chemotherapy has produced disabling fatigue. Procrit quickly turns things around, and the cancer patient is back on track enjoying life.

At a March press briefing about the new warnings to be added to the labels of all EPO drugs, the FDA’s Richard Pazdur, MD, announced that there has never been any evidence to support the claims that EPO can increase energy or ease fatigue in patients undergoing cancer chemotherapy.

EPO drugs are heavily marketed worldwide, accounting for more than $11 billion in combined sales last year. Amgen, the world’s largest biotechnology company, makes both Aranesp (the most expensive of the three EPO drugs at $1,300 to $2,000, a shot) and Epogen. Clinical trial results announced just in the last eight months alone generated enough alarm and FDA warning letters (to health professionals) to warrant the aforementioned FDA meeting this month.

Off-Label Uses Prove Deadly

These recent trials were intended to expand the market for EPO drugs for uses beyond those initially proven according to FDA pre-approval requirements. Off-label use, as it is known in FDAspeak, refers to the prescribing of a drug for an unproven indication—a common, though questionable, practice. EPO drugs, for example, are already prescribed off-label to treat anemia unrelated to chemotherapy. (Anemia can be caused by chemotherapy or the cancer itself.) It is in a drug company’s interest (sometimes) to prove an off-label use in a clinical trial because that would allow it to openly and aggressively promote the use to doctors and the public; expand the market; and make more money.

Unfortunately, the newer trials testing off-label uses have produced disastrous results. In January, Amgen reported preliminary results from a large randomized trial that found Aranesp hastened death by 23%. The 851 participants were anemic cancer patients not currently under treatment with either chemotherapy or radiation. There were 250 deaths in the Aranesp group and 215 in the placebo group.

Another trial, conducted last year in Denmark, showed that cancer progressed sooner in the Aranesp-treated study participants undergoing radiation therapy for advanced head and neck cancers. Amgen failed to publicly disclose that this long-awaited Danish trial was stopped prematurely last fall. In February, the Journal of Clinical Oncology published an online paper about a Canadian trial in which 70 lung cancer patients on Eprex (Epogen in the U.S.) were dying sooner. Most of the participants were not receiving chemotherapy.

These recent trials are not the first to show deadly EPO-induced harms for off-label uses. The first hint that EPO causes cancer to progress faster showed up in a 2003 German trial testing whether the drug enhances the effects of radiation therapy. The next year, a trial of women with metastasized breast cancer was stopped after four months when a higher rate of death and fatal “thrombotic events” was shown in those on Epogen and chemotherapy compared to those on chemotherapy alone. This trial was testing two off-label uses: 1) higher than normal doses of EPO; 2) in patients who weren’t anemic.

Bottom Line

All EPO trials will be reviewed this month by the FDA, which will likely generate new prescribing guidelines. The newly revised warning labels now tell doctors to use the lowest doses needed to avoid blood transfusions. Potentially fatal deep-vein blood clots and heart problems appear to be related to the administration of EPO in excessively high doses. These drugs were originally introduced to reduce blood transfusions, a procedure that was riskier in the early years of EPO use (early 1990s) than it is today.

To access the newly revised warning labels for EPO drugs on the Internet, type the words label Aranesp or label Procrit into the search box. These 22- to 42-page documents start with the new warnings to doctors. The Aranesp label describes some of the trials that had to be stopped prematurely.

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