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Posts Tagged ‘Advocacy’

We support Obama’s choice to head Medicare

Posted by medconsumers on June 29, 2010

This press release explains why we have joined 90 organizations in supporting Dr. Donald Berwick, who is President Obama’s choice as administrator of the Centers for Medicare and Medicaid Services. Click into the link to our letter of support at the end of this press release. Read what the New England Journal of Medicine has to say about Berwick and the hurdles he faces.

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What about the negotiated drug discounts?

Posted by medconsumers on September 11, 2009

President Obama just gave a powerful speech about health care reform, but notably absent was something crucial to people on Medicare—that is, giving the government the power to negotiate discounts for prescription drugs. Other industrialized countries use the power of numbers to reduce their drug costs. In our case, it would be the 44 million Medicare enrollees. The U.S. pharmaceutical industry would have us believe that the European countries are getting a free ride because our high drug costs are paying for innovation in new drugs, something that supposedly occurs only in the U.S. This view has gone unchallenged by the mainstream media.

Donald Light,
PhD, the Lokey visiting professor in comparative health care at Stanford University, has recently taken up this issue in the academic journal Health Affairs. He analyzed the new drugs discovered between 1982 and 1992 and concludes that Europeans have discovered more important new drugs, dollar for dollar, than Americans. When Dr. Light was asked to elaborate by e-mail, he said that the greater share of U.S. research funds go to what’s called me-too drugs or drugs that offer little or no advantage over existing ones. “Only 1 in 7 new drugs offer significant clinical advantages for patients,” he added.

Unfortunately, only excerpts are available from the subscription-only Health Affairs analysis and the recent Lancet editorial that supported Dr. Light’s findings. You may, however, read the entire 2005 article on the same topic, co-authored by Dr. Light, “Foreign free riders and the high cost of U.S. medicines.” Read also the pharmaceutical industry’s rebuttal and the authors’ reply in the Rapid Responses at the end of the article.

Why no mention of drug discounts in President Obama’s speech? Representative Henry A. Waxman (D-CA) answered the question before the speech in an interview with our local public radio station. “The White House made a deal with the pharmaceutical industry that is not in the interest of senior citizens,” said Waxman. “The drug manufacturers poured money into an ad campaign promoting health care reform in return for not allowing Medicare to negotiate drug discounts. The industry anticipates windfall profits from the 47 million new customers [the formerly uninsured]. ” He went on to explain the deal industry made with the White House and one of the key Congressional committees [the one headed by Senator Max Baucus] regarding the “doughnut hole,” which is the $2,700 point where Medicare stops paying for drug coverage and people must pay out of pocket for the next $4,000 until coverage kicks in again. The drug industry agreed to give discounts, but here’s the catch…only for the brand name drugs, i.e., the most expensive drugs. “The pharmaceutical industry got just what it wanted,” said Waxman.

Maryann Napoli, Center for Medical Consumers(c)

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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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New Malpractice Report Contradicts Conventional Wisdom

Posted by medconsumers on July 10, 2009

The Center for Medical Consumers, working together with the New York Public Interest Research Group, has just released a report refuting the basis for the oft-repeated claim that “out of control” medical malpractice lawsuits are contributing to inflation in health care costs.

The report finds that, while liability insurance premiums in New York State have risen over the past several years, there has actually been a drop in medical malpractice payouts made by New York doctors. The report analyzed publicly available data obtained from the federal government’s National Practitioner Data Bank. The report findings include:

  • Despite the overheated claims, doctors are not fleeing the state.  New Yorkers enjoy one of the highest per capita number of doctors in the nation, including those in one of the so-called high-risk specialties.
  • There was a need for a forensic review of the business practices of malpractice insurers to identify why premiums have jumped, while payouts are stagnant.

The report notes that the Data Bank numbers showed an increase in the average size of malpractice payments but that it was consistent with the overall increase in inflation during the period.  The Data Bank does not identify the specialty of the doctor making the payments, but does track the nature of the injury that led to the malpractice payout, and includes both jury verdicts and settlements.

While the report is limited to New York’s experience, the fight over tort “reform” continues to be waged in many other states and at a national level in Washington.  A number of states have succumbed to the propaganda and enacted so-called reforms that limit the right of recovery of victims of medical negligence while doing nothing to make patients safer.  Lobbyists for the physician trade associations use the same specious arguments everywhere:  Malpractice costs are driving doctors out of practice and are negatively impacting the affordability of health care.

Even President Obama appears to have succumbed to unsubstantiated claims that the medical malpractice system need to be changed to favor doctors and other providers.  Consumer advocates, on the other hand, contend that reforms should be about making the health care system safer, not by putting up barriers to those harmed by poor care. Read the new report called Contraindication[1]

Nine consumer advocacy organizations express the reasons for their opposition to the Medical Malpractice Alternatives Act of 2009 in a July 16 letter to Congressman Henry A. Waxman.

Arthur A. Levin, Center for Medical Consumers(c)

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Harry and Louise Ad Campaign Revisited

Posted by medconsumers on July 8, 2009

The $20 million national ad campaign, sponsored by Conservatives for Patients’ Rights (CPR), continues on TV, the Internet, and radio. CPR wants the U.S. medical care system to remain largely as is, but calls for reforms like allowing more competition among insurance companies, posting prices of medical treatments, and more consumer responsibility for personal health behaviors. CPR is backed by the same public relations firm that did the Swift Boat Veterans for Truth ad campaign, which turned presidential candidate Senator John Kerry, the war hero, into John Kerry, the liar.

Initiated in March, the CPR campaign is widely viewed as today’s version of the insurance industry-backed “Harry and Louise” ad campaign which had a major role in sinking the Clinton Administration’s attempt at health care reform. It’s time to pick apart the CPR campaign.

Central Message: A government-run health plan [the purported goal of the Obama Administration] will limit your choice of doctors, dictate your treatment decisions, and ration care.

Facts: The health plans now before Congress indicate that the health insurance industry will continue to dictate your treatment decisions, ration care, and limit your choice of doctors. Furthermore, U.S. medical care is already rationed in the worst possible way—based on income. All industrialized countries are grappling with the need for rationing based on cost-effectiveness (e.g., a treatment may be marginally effective but not worth the high cost — see cancer drug example below).

Poor Care Implied: Canada and the U.K. provide “government-run healthcare.”

Facts: Both systems are taxpayer funded. Of the two, only the U.K.’s is government-run because the government provides and pays for medical care. Most hospital doctors are on salary and GPs are paid on the basis of how many patients they see. Canada has a socialized medical insurance system, otherwise known as single-payer. The provincial governments pay the medical bills, but delivery of care remains largely private. Most doctors are in private practice and their fees are paid by the government. Fees are set by negotiations between the provincial governments and the medical associations.

Canada vs. U.S.: Subtext of the ads is your life will be terrible if Congress passes a health plan similar to that of Canada.

Facts: Canada’s health care system is similar to the U.S. Medicare system but without the need for Medigap or other out-of-pocket expenses. Surveys show that most elderly Americans are satisfied with Medicare. A recent national Commonwealth Fund survey compared Medicare beneficiaries with younger Americans covered by private health plans. The Medicare beneficiaries reported greater overall satisfaction with their health coverage, better access to care, and fewer problems paying medical bills than people covered by employer-sponsored private plans.

Doctor Choice: A government-run healthcare system will restrict your choice of doctors.

Facts: As with Canadians, elderly Americans on Medicare can choose their own doctors. Many non-elderly Americans with private health insurance do not have this option.

Tragic Stories: Anecdotes from patients and doctors are offered as proof of how bad things are in the U.K. and Canada. For example: “If you have cancer in the U.K., you will die quicker than any other countries in Europe.”

Facts: The U.K. does have a lower cancer survival rate than other European countries, according to a 2007 study that also showed the highest cancer survival rates are in Sweden, which has a single-payer health insurance system. See Michael Moore’s 2007 movie “SICKO” for tragic stories from Americans dumped by their insurance companies once an expensive illness was diagnosed.

Drugs Rationed: In one ad a British woman says, “There are expensive new drugs coming up for cancer and other things. It’s hard to get hold of them without a big struggle…. It’s heartbreaking, especially when people can’t afford to buy the drugs.”

Facts: Costly cancer drugs are a worldwide problem no matter the type of health care system. Too often effectiveness is not fully addressed, just as it isn’t in this ad. A recent issue of the U.S. Journal of the National Cancer Institute published a cost/benefit analysis of a drug for non-small cell lung cancer, Erbitux (generic name: cetuximab), which has been hailed as “practice changing”. It concluded, “18 weeks of cetuximab treatment for non-small cell lung cancer, which was found to extend life by 1.2 months, costs an average of $80,000.”

Rationing by Delay: Government-run healthcare will lead to long waiting lists for care.

Facts:
There is truth to this charge in some countries for certain tests and procedures, as well as visits to specialists. In Ireland, however, a country with both private and public systems, people who paid more to be in the private system reported longer delays in getting care than the people in the public system. According to a 2008 PBS Frontline show (see end of this article), the British government has instituted reforms expected to alleviate the problem of delayed care.

More accountability and competition: Prices of medical treatments should be up front and people should be rewarded for good health behaviors. “These ideas will lower costs without taking away your right to make your own medical decisions.”

Fact: No well-designed studies back up the cost-lowering benefit of these worthy suggestions.

CPR’s Driving Force: Health care entrepreneur Richard Scott, the former CEO of Columbia/HCA Healthcare, who made millions in the for-profit hospital industry.

Fact: Scott was forced to resign amid fraud charges against this giant health care company in 1997, according to Forbes magazine.

Scott’s Defense: “[My detractors] are running TV ads attacking me personally because they don’t want to debate the substance of what we believe vs. the substance of what they want, which is government-run healthcare.” Choosing his words carefully, Scott says, “I was never charged with any wrongdoing.”

Facts: True. His company settled. According to a June 26, 2003, U.S. Department of Justice press release, “HCA Inc. (formerly known as Columbia/HCA and HCA—the Healthcare Company) settled in 2003 and agreed to pay the U.S. $631 million in civil penalties and damages arising from false claims the government alleged it submitted to Medicare and other federal health programs.” In an April 1, 2009 New York Times article about Scott’s role in the scandal, reporter Jim Rutenberg wrote, “Though Mr. Scott was not directly implicated in the fraud scandal — with whistle-blower suits filed against some hospitals before his acquisition of them — critics said his drive for profits had created incentive for fraud.”

Information About Other Health Plans:

-Sixty percent of U.S. physicians favor a single-payer health insurance system. Go to Physicians for National Health Program to learn why. Here’s one reason from the organization’s Web site: “The term socialized medicine is often used to conjure up images of government bureaucratic interference in medical care. That does not describe what happens in countries with national health insurance where doctors and patients often have more clinical freedom than in the U.S., where bureaucrats attempt to direct care.”

-“Sick around the world: Five Capitalist Democracies and How They do it.” The excellent 2008 PBS Frontline program is freely available online.

Maryann Napoli, Center for Medical Consumers(c)
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Hospital-Acquired Infection Report

Posted by medconsumers on July 1, 2009

New York State Releases 2008 Hospital-Acquired Infection Report

June 30, 2009. The long awaited New York State 2008 report on hospital-acquired infections was released today at a press conference held at Roosevelt Hospital. The law requiring the report took effect in mid-2006, but the first report issued in 2007 did not by design provide the names of hospitals. The 2007 report did provide aggregate rates for the state by region and type and size of hospital, thus establishing a baseline for trending purposes. Arthur A. Levin, MPH, Director of the Center for Medical Consumers, was instrumental in writing the law and steering it through the legislative process.

Some important findings from the new report are as follows:

- No one hospital was found to have a high hospital-acquired infection rate across the board.

- Colon surgical-site infection rates decreased significantly in 2008 and were lower than 2006-2007 national rates.

- Coronary Artery Bypass Graft chest infection rates declined from 2007 and were significantly lower than 2006- 2007 national rates.

-Hip replacement surgical-site infections in 2008 were unchanged from the previous year.

-Central line-associated bloodstream infection rates in intensive care units for 2008 were the same or higher than the 2006-2007 national rates. The report breaks down intensive care units into categories, such as surgical, medical, pediatric and newborn.

As a result of including the auditing requirement in the law, New York State likely has the most reliable information of any state hospital infection reporting system. A Department of Health team of infectious disease specialists visited each of the reporting hospitals at least once during the year to review the accuracy of their identification and reporting. The Department of Health teams conducted sample chart reviews as part of their routine audit process. While in 2007, eight hospitals were identified as out of compliance with reporting requirements and eventually cited by the department; by 2008 all hospitals in New York State were in compliance with the law.

Consumers should understand that infection rates alone might not be a sufficient reason to go to or stay away from any one hospital. If the report had found that one or more hospitals with higher rates across all the measures, a prudent consumer would have had reason to avoid that facility. However, that was not the case in 2008.  Furthermore, the results are mixed for each hospital.

The department has said it will work with hospitals with higher than average infection rates on one or more measures to find ways to improve patient safety.

Here are some tips on how to best understand the report. The graphical presentation of results starts on page 55 with the results for colon surgical-site infection rates and the other measures follow. On page 26 of the report you will find an explanation of the tables. A summary of all the results for each hospital begins on page 123 (Table XXIII). The absence of any result in any cell (box) of the table means that the hospital does not provide that service (for example only 40 hospitals perform CABG surgery). Where “NA” appears in the cell, the hospital did less than 20 procedures in 2008, a number too small for statistical significance.

Contact Arthur A. Levin at medconsumer@earthlink.net

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Health Care Reform

Posted by medconsumers on July 1, 2009

Opponents of President Obama’s health reforms are not above misrepresenting the quality of health care in other countries. In my experience, critics of progressive efforts to reform health care are also quick to tout American medical care as “the best in the world.” They raise fears that the proposed reforms will make our health care “second rate.” Unfortunately, findings from studies comparing health outcomes like longevity and patient experiences in the U.S., U.K. and Europe tell us that our health care is already second rate.

What I have found even more frustrating than such politically motivated distortion of the truth is the willingness of learned policy makers, pundits and even friends to accept at face value unfounded assertions of U.S. health care superiority. To be fair, there clearly has been growing public recognition of a U.S. crisis in affordability and polling data suggests that a growing majority of Americans support universal access. However, I remain concerned that public opinion can still be too easily swayed. Opponents of reform have already confused the national debate by implying that the President’s plans, which would require a role for government in prioritizing research and technology development, will result in denial of care to sick people.

In a recent essay, “Medical Progress – Unintended Consequences” Daniel Callahan PhD, president emeritus of The Hastings Center, a well regarded bioethical think tank, describes American culture as having a long and unique romance with medical research and new technology. Few new medical technologies are ever assessed for their comparative effectiveness, safety and cost. But that does not seem to deter their enthusiastic adoption by doctors and patients alike.

A British oncologist was asked by the authors of a 1984 book on rationing of medical care why chemotherapy of unproven benefit was used in the U.S. at rates therapy of unproven benefit was used in the U.S. at rates far in excess those in the U.K. His response: “Americans confuse activity with progress.”

The various “wars” on disease over the last decades have been fought with huge investments in research and new technology, some of which have managed to prolong survival, but have mostly failed to produce curative victories. As a result there are growing numbers of people now living with unremitting chronic disease that years ago would likely have been fatal.

Most experts agree that our health care system generally does a poor job of taking care of such patients. To complicate matters further, many have multiple chronic conditions requiring multiple treatment regimens. To address this serious and growing problem, Callahan suggests redirecting significant research funding away from its current focus on cures towards finding ways to more effectively coordinate medical care and better integrate social and family support for people living with chronic disease.

Callahan’s essay offers a unique perspective on the current national reform debate. He concludes by calling on policy makers to reexamine how we as Americans value and define medical progress. “Serious progress would mean turning back the clock: learning to take care of ourselves, to tolerate some degree of discomfort, to accept the reality of aging and death (not to mention the near-death experience of erectile dysfunction) and to see our personal doctor as someone as likely to talk with us as to have us scanned. That cluster of backward-looking ideas is what I think of a common sense, affordable progress.”

His advice merits serious consideration by us all.

Arthur A. Levin, MPH, Center for Medical Consumers(c)

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Supreme Court Rules Against Pharmaceutical Industry

Posted by medconsumers on March 5, 2009

New York Times, March 5, 2009: The Supreme Court, by a 6-to-3 vote, upheld a jury verdict of $6.7 million in favor of a musician from Vermont whose arm had to be amputated after she was injected with an anti-nausea drug. The drug’s manufacturer, Wyeth, had argued that its compliance with the Food and Drug Administration’s labeling requirements should immunize it from lawsuits. Days after the Supreme Court decision was announced, Democrats in Congress reintroduced a bill called the Medical Device Safety Act, which would permit lawsuits against companies that made medical devices that injure people.

As of May 13, 2009, H.R. 1346, sponsored by Frank Pallone, Jr. (D-NJ), has picked up 79 co-sponsors, and S.540, authored by Senator Ted Kennedy (D-MA) has 21 co-sponsors.

For context on this important issue, read this Center for Medical Consumers 2008 position statement.

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Pharmaceutical Industry to Public: Drop Dead

Posted by medconsumers on May 1, 2008

The Pre-emption Shield Explained

The scenario has become depressingly repetitive: A heavily promoted drug prescribed to millions over the years is found to have potentially fatal adverse reactions; a hundred or so deaths are linked to the drug; the drug maker acts as if it just learned of the harm; a lawsuit precipitates the release of in-house documents showing that company officials knew of the dangers long before its drug went on the market; the injured patients have their day in court.

The last phase of this scenario, the one where people go to court to seek compensation for their injuries, will be eliminated if the pharmaceutical industry gets its way. The industry takes the position that a drug’s safety must be proven to the FDA’s satisfaction before it is allowed on the market; therefore, the drug maker should be held harmless for anything that happens thereafter. “The FDA should not be second guessed by the courts” goes the pharmaceutical industry’s legal argument for what is called pre-emption. Not surprisingly, it has the strong backing of the Bush Administration.

Proof of Safety Inadequate

The presumption that the FDA approval process guarantees safety is absurd. The two clinical trials required by the FDA are usually short-term and always conducted by the drug makers themselves. Rare or uncommon serious adverse reactions to drugs are typically not apparent until hundreds of thousands of people take the drug over the course of many years. Worse of all, drug companies are known to withhold negative trial results from the FDA.

And if that’s not bad enough, a bipartisan Congressional panel recently confirmed what has been known for years: The FDA’s ability to protect the public’s interest is obstructed by the fact that it is seriously underfinanced. This affects everything from the agency’s inability to vet all drug advertising for misleading claims to its drug-safety monitoring system that, according to the nonpartisan Government Accountability Office, captures less then 10% of all serious adverse reactions to drugs after they go on the market.

Most Recent Industry Crimes

Within a recent three-week period alone, the national media spotlighted three cases in which pharmaceutical giants misled the FDA about the safety of their products. Eli Lilly and Alaska agreed to a $15 million settlement on behalf of the state’s Medicaid patients who developed diabetes as a result of Lilly’s antipsychotic drug Zyprexa. The company hid the risks (e.g., deaths, strokes, pancreatitis) and exaggerated the benefits of Zyprexa while encouraging primary care doctors to prescribe it for unapproved uses.

Another case involved the bestselling pain-reliever Vioxx withdrawn in 2004 by its maker Merck because it increased the risk of heart attacks and strokes. And lastly, there’s Johnson & Johnson’s birth control patch, now known to cause blood clots, strokes and deaths. In all three cases, the dangers would have remained unknown—and people would continue to be injured—had it not been for lawsuits.

Among the e-mails, letters and other internal documents released during the Vioxx litigation was damning evidence that Merck knew of the drug’s dangers early-on. The company’s initial research made “the surprising discovery” that “Because selective COX-2 inhibitors [Vioxx, Celebrex, Bextra] do not affect platelet function whereas standard NSAIDs [aspirin, ibuprofen, etc] do, it was hypothesized that selective COX-2 inhibitors might…increase the risk of cardiovascular events.” This warning was repeated twice (at a meeting and in a memo), according to Merck documents—all dated prior to Vioxx’s approval by the FDA in 1999.

Vioxx made news again recently when the most comprehensive study of Merck’s internal documents released during the Vioxx litigation revealed the manipulation of the company’s clinical trial results. One example: Merck conducted several trials trying to prove that Vioxx slows the progression of cognitive impairment in people with dementia. The company’s early analysis of these trials showed “a significantly increased mortality risk” among the participants assigned to take Vioxx (their death rate was more than twice that of the placebo group). This, however, was not the way Merck reported the results to the FDA. Instead, Merck minimized the death risk by using a less-valid type of data analysis of the same trial results and concluded that Vioxx was “well tolerated.”

When the study of the Merck documents was published last month in the Journal of the American Medical Association, the accompanying editorial made it clear that the manipulation of trial results is not the sole purview of one company. The editors also noted that the evidence necessary to demonstrate Merck’s misdeeds became public—and publishable—only because of litigation. Last fall, Merck agreed to a $4.85 billion settlement to resolve tens of thousands of lawsuits filed by former Vioxx patients or their families.

This is not likely to be the way things will turn out for the young women injured by Johnson & Johnson’s popular Ortho Evra birth control patch. The patch delivered far more estrogen into the bloodstream than standard oral contraceptives, increasing the risk of potentially fatal blood clots. More than 3,000 women and their families have sued Johnson & Johnson claiming that the patch caused heart attacks, strokes and at least 40 deaths. Documents made public by this lawsuit showed that Johnson & Johnson’s own trial revealed these risks in 1999. The company, as The New York Times put it, “obscured the finding in a 435-page report to the FDA.”

The Pre-Emption Dodge

The Ortho Evra plaintiffs are now on hold while a similar lawsuit against yet-another drug company (Wyeth) becomes the test case for the pre-emption shield when it goes to the Supreme Court in November. The Court is expected to rule in favor of industry and make pre-emption the legal standard. A precedent was set in February when the Court ruled that the device industry is immune from damage suits filed by people injured by defective pacemakers, stents, etc.

Pre-emption is just the latest in a series of outrages perpetrated by the pharmaceutical industry against the public. At a time when criminal charges should be brought against company officials who withhold evidence of harm, the industry wants a pass. And it’s likely to get just that given the pro-business, anti-consumer Supreme Court decisions over the last few years.

In the meantime, if you are scheduled for a knee replacement or stent or a new heart valve, be aware that medical devices now come with an invisible warning from industry:

In event of a major defect or other serious harm: You’re on your own.

Maryann Napoli, Center for Medical Consumers © May 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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