U.S. medical care: A critique with proposals for change

It has taken a long time to sink in. The United States does not have the best medical care in the world. We are spending far more than other industrialized countries and showing poorer outcomes. And if that’s not bad enough, at least one-third — $750 billion — of our medical care spending in 2009 went to unnecessary services, excessive administrative costs, fraud, and other problems, according to a new report from the Institute of Medicine.

This report, entitled “Best Care at Lower Cost,” clearly presents the situation as dire and unsustainable:  “America’s health care system has become far too complex and costly to continue business as usual. Pervasive inefficiencies, an inability to manage a rapidly deepening clinical knowledge base, and a reward system poorly focused on key patient needs, all hinder improvements in the safety and quality of care and threaten the nation’s economic stability and global competitiveness.”

The report draws on a large body of existing research that documents the health care system’s failures from the patients’ perspective. The result is lots of sobering statistics that serve as impetus for change. The rate of health care related injury, for example, is illustrated with this statistic: “One-third of all hospitalized patients are harmed by their care.” Similar back-up statistics appear with this list of italicized recommendations for improving the quality, efficiency, and cost of care:

–Use information technology [e.g., digital transfer of test results and medical records] more effectively: 20% of patients said their test results or medical records were not transferred from one place to another in time for an appointment; 25% said their health care provider has had to re-order a test to get accurate information for diagnosis.

-Improve transparency [e.g., hospitals and provider should make the cost of treatment publicly available]: 63% percent of patients do not know the cost of their care until they get the bill; 10% never find out the cost of their care.

–Promote teamwork and communication among health care providers: 50% of adults report problems with care coordination, notification of test results, and communication among their doctors.  Less than half of all patients receive clear information on the benefits and trade-offs of treatments for their conditions.  Less than half are satisfied with their level of control in medical decision-making.

The IOM report was compiled by a panel of experts, which includes my colleague Arthur A. Levin, MPH, the director of the Center for Medical Consumers, who has long been involved with patient safety issues. It takes broad view of the different ways people receive health care in the current U.S. system from small groups of physicians to large integrated delivery systems, each with different strengths and weaknesses. How can we learn from the good and the bad of these different systems? This is the crucial question taken on by the report’s authors.

Though written in the style of a health policy wonk, the chapter entitled “Creating a new culture of care” is worth reading.  Like it or not our health care system is going to change—no matter who is president after election day. It makes sense to start giving some thought to how you want to adapt. Unhappy with health care that is fragmented and diffusely organized?  This chapter describes large pioneering, integrated health care delivery systems (e.g., Mayo Clinic, the VA system, Kaiser Permanente).

These systems have many characteristics in common, such as use of electronic medical records, incentives for providers to adopt “best practices,” physicians on salary (my personal favorite), and bundled payments. An example of the “new culture” of care delivered by these systems: Readmission to the hospital would be regarded as a failure (as opposed to more income for the hospital), and the relevant staff members would come together to see how it could have been avoided.  “A culture of teamwork is fundamental to building a learning organization and ensuring a continuity of care that yields better outcomes for patients.”

Nothing like these systems is available in my neck of the woods, but I have hope for the Accountable Care Organizations, which are already up and running in some areas of the country. ACOs are pilot projects funded by the Affordable Care Act signed into law two years ago by President Obama.  ACOs are described recently by the N.Y. Times as “collections of medical providers who band together under one business umbrella. The organization can include primary care doctors, specialists, social workers, pharmacists and nurses. The difference is in how these providers are paid: Instead of an insurance company or the government reimbursing each provider for each service provided to each patient, the ACO is paid simply to care for a group of patients.”     read more

You can read the 360-page IOM report online for free.  This excellent interview from ProPublica is not part of the IOM report, but is definitely worth reading:  Why Patient Harm Is One of the Leading Causes of Death in America

Maryann Napoli, Center for Medical Consumers©

Breast cancer and radiation

Want to know the best way to reduce your chances of developing breast cancer? Avoid inappropriate CT scans of the chest. This is the refreshingly blunt conclusion of a new study funded by the U.S. National Cancer Institute. The radiation exposure from this imaging procedure is huge,  the damage is cumulative, and the breast is known to be one of the most radiation-sensitive organs of the body. There has been an alarming five-fold increase in the use of CT scans over the last two decades.

CT scans of the chest are ordered for diagnosing diseases of the heart, the lungs, and even screening symptomless people for these diseases. And it is not yet clear whether the improvements in diagnostic accuracy outweigh the cancer-causing harm of radiation exposure.

Among the reasons given for the inappropriate use of CT scans are: financial incentives, especially for hospitals and physicians who own their CT equipment; expanding indications for appropriate use; fear of malpractice lawsuits; and public demand fostered by hospital advertising campaigns. Too often, radiation exposure is unnecessarily high due to poorly trained technicians, the lack of universally agreed-upon standards for minimal exposure, and failure to calibrate the scanning equipment to the size of the patient.

The National Cancer Institute-funded study was conducted by Rebecca Smith-Bindman, MD, a professor of radiology and biomedical imaging, epidemiology and biostatistics at University of California, San Francisco, and published yesterday online in the Journal of the American Medical Association (JAMA).  She has focused on the breast because of an Institute of Medicine report that was published at the end of last year. Commissioned by the high profile foundation called Susan G. Komen for the Cure, this report disappointed many breast cancer advocates who wanted to know which pesticides and toxic substance in consumer products are the most likely to cause breast cancer.

The Institute of Medicine found insufficient evidence for any of these potential health hazards, but singled out “avoidance of medical imaging as one of the most important and concrete steps that women can take to reduce their risk of breast cancer.” Dr. Smith-Bindman used the National Cancer Institute funding to document the rise in CT scanning between 1996 and 2010 based on the care of patients at six U.S. health plans with 1-2 million enrollees altogether. She found a tripling of the number of CT scans, and a doubling of per capita radiation dosage over the study period. It should be noted that this finding could understate the magnitude of the problem because physicians practicing in managed health plans do not have a financial incentive to overdo the ordering of tests.

Acknowledging the media attention given previous studies documenting CT scan overuse, Dr. Smith-Bindman noted in an online video provided by JAMA: “There is a belief that we’ve solved the problem about radiation dose due to increased awareness over the years, but I’m not convinced that we’ve gotten the doses down, particularly in children and young adults, which are much higher than I would like to see.”

People should ask for the radiation dose before agreeing to a CT scan and make sure the dose is listed in their medical records, she advises, hoping that a groundswell of consumers asking pointed questions will improve the current situation. “Many ordering physicians are insufficiently informed about radiation doses and the cancer risks attributable to medical images,   and yet this information is crucial to weigh risks and benefits and provide appropriate justification for the use of CT and other high-dose imaging studies to patients and families.” Testifying before Congress last week about radiation safety, Dr. Smith-Bindman reportedly said, “Some people have worried about the X-rays at our airports to screen passengers, but one CT scan is equal to approximately 200,000 airport screens.”

When this study was reported yesterday by Medpage, an information source for physicians and journalists, one of the first comments came from an anonymous expert who appears to be a medical physicist, which is a specialist in the health effects of radiation on the human body:

“One issue is the variation in image quality caused by differences in expertise and experience amongst equipment operators, maintenance and calibration protocols, and servicing intervals. Another is the variation in image quality caused by the use of older versus newer, mid-range versus high-end equipment. When I researched this area in some depth about ten years ago, I discovered that the top-end equipment was being built by Japanese firms and only being used in Japan. It simply wasn’t available in the USA, in the EU or elsewhere. I have yet to speak to a specialist in medical imaging technology, or a pathologist or oncologist, let alone a typical medical generalist, who has more than an entry level understanding of the medical physics employed in this area. Accurate images, taken from multiple angles, can be a real boon. But the average physician doesn’t know how to interpret them, and most radiologists refuse to discuss medical imaging results directly with patients.

And another comment from the same Medpage forum:

“For each non-emergency situation, ask your physician or dental  professional, ‘Is this imaging procedure going to change the  treatment plan?’  If they can’t provide an intelligent answer,  then I refuse or delay the test until I speak to someone who can.   Every time my <10 yr old child goes to the Orthodontist, the  assistant immediately says, ‘let’s get some x-rays’ (or even a whole  facial scan) and then gets mad when I question her.  They’ve never  actually recommended any treatment/action taken for my child’s  teeth; she is just being observed yearly so why take x-rays  additional to the ones she has at the regular Dentist?  On the  other hand, my ~40 yr old husband hit his head tubing in the  Smokies.  At the ER, I agreed on a head CT because having a brain  bleed, although highly unlikely, could be fatal.  So, each patient  needs to question the risk to benefit ratio and consider age at the  time of exposure.”

Maryann Napoli,Center for Medical Consumers(c)
Related posts:
Tests to avoid CT scans appear frequently on the specialists’ list of inappropriate tests.
CT scans: lots of radiation, little research Explains why CT Scan radiation dose is so much higher than that of a conventional x-ray. And how to determine when a scan may be inappropriate.
Another way to cut your risk of breast cancer:  Explains how mammography screening  increases your chances of  being  diagnosed with breast cancer and  treated unnecessarily for a cancer that did not need to be detected.

Whistleblower’s story: New book reviewed

“Blood Feud: the man who blew the whistle on one of the deadliest prescription drugs ever” (NY: Dutton, 2011)  by Kathleen Sharp 

This is the true story of an expensive anti-anemia drug that came on the market for one purpose; was heavily promoted for several unproven uses; and how the drive for profits led two drug companies to commit fraud. Kathleen Sharp, a veteran investigative reporter, describes what happened from the perspective of a drug salesman whose company pressured him into achieving higher and higher sales targets. The drug maker provided a playbook of tactics known to manipulate physicians into writing more prescriptions and at higher, more dangerous, doses. Eventually, the drug salesman-turned-whistleblower comes to the horrifying conclusion that over a half a million people have died as a result of this drug. Its benefits, if any, remain unclear; its safety never established.  It is still on the market.

Central to the story is one of the first biotech drugs to go on the market. Erythropoietin is the man-made version of human erythropoietin, which is produced naturally in the body and stimulates the bone marrow to make red blood cells. Epo, as it is called, became known as a “blood booster,” sold by Amgen and Johnson & Johnson under the brand names: Procrit, Epogen, Aranesp, and Eprex (Europe).

Epo received FDA approval in 1989 to reduce cancer chemotherapy patients’ need for blood transfusions after it became known that the nation’s blood supply was infected with the HIV virus. In time, epo would be heavily promoted as an instant cure for chemotherapy-related fatigue and for anemia in kidney dialysis patients. (Disclosure: I am quoted in the book, speaking before the FDA Oncologic Drug Advisory Committee against J&J’s fraudulent direct-to-consumers advertising campaign for Procrit.)

The whistleblower ‘s story begins in 1992 when Mark Duxbury became a Procrit sales rep at J&J’s new biotech division, Ortho. Initially, Duxbury believed that he was selling an important quality-of-life enhancing drug for cancer patients suffering the debilitating effects of chemotherapy. Procrit, so he thought, would allow them to complete the treatment regimen.

The methods used by J&J to get its sales reps to turn Procrit into a blockbuster drug make for fascinating, though appalling, reading. Doctors were easily manipulated into prescribing more epo with rebates, secret discounts, honoraria, and other kickbacks.  In time, the entire Procrit sales force was encouraged by J&J to break the company’s own product license agreement with its partner Amgen. This agreement stipulated that J&J would stay away from the kidney dialysis market. (Amgen, maker of Aranesp, was the start-up company that did the original epo research.)

By 1993 Duxbury was a company award-winner for the greatest overall growth in sales in the western region of the U.S. He was rewarded with a higher income and an all expenses paid trip to a luxury resort. Still, J&J didn’t let up on the pressure to increase sales, making Duxbury conclude that the only way to meet his escalating quota was to “steal dialysis business”.

Doctors were encouraged to prescribe Procrit in high doses, particularly for cancer patients, because this would increase sales by hundreds of millions of dollars. That the deaths of about a dozen high-profile European cyclists were already linked to high dosing with epo (accessed via the black market) should have served as a warning.

This book is a goldmine of information about how the nation’s pharmaceutical companies inflate the cost of medicines while hiding the true cost from consumers as well as the government payers. What’s more, the drug makers in this story monitor doctors’ prescribing habits to determine the marketing strategies that work best; violate patient confidentiality laws by encouraging sales reps to troll medical records for the best drug-testing candidates; and use study participation to get doctors to prescribe epo for dangerous off-label purposes. Such tactics are not confined to the selling of epo.

Duxbury’s sterling career started to go downhill when he was deposed as a result of a lawsuit initiated by Amgen against J&J. (Depositions conducted over the course of several years serve as a major source for this book.) As a result, his own in-office memos revealed J&J’s orders to encroach on Amgen’s kidney dialysis territory.

Duxbury soon became a liability to his own company, which turned on him as if he were the one who thought up the illegal sales tactics.  He was fired in 1998. Many of the reps who had been instructed to sell Procrit for dialysis were also fired or resigned. Many would not learn—until years later—that their order to promote Procrit as an anti-anemia drug for kidney patients was an off-label use (unproven) use and thus a federal crime. (The FDA had approved Procrit to treat anemia only in cancer patients.)

The rest of the story involves Duxbury’s downward spiral— unemployment, lawsuits, depression, and self-destructive behavior—as he tried to alert the public about the dangers of epo.  The sinister way the Ortho division of J&J treated its own employee who, after all, was just following orders, should confirm your worst fears about corporate misbehavior. As Duxbury put it after his own lawsuit for wrongful termination turned up information new to him. “I was shocked to learn that everything I did at Ortho was illegal. They cheated not just the government but their own people too!”

Author Sharp says that the safety tests were never conducted for epo drugs, though such testing was required by the FDA contingent on approval. By the late 1980s, she states, “scientists knew that boosting red blood cells also thickened the blood, which increased the risk of clotting. Blood clots lead to strokes, heart attacks, and brain aneurisms.” What’s more, she writes, “No one could be sure that Procrit was safe at even recommended doses, according to several sources.”

In 2007 the FDA finally got around to protecting the public. The agency issued a warning about all epo drugs which by this time were also marketed for AIDS patients. New studies showed epo drugs associated with an increase in death, heart attack, stroke and tumor growth in subgroups of people with cancer and those with chronic kidney failure. Click here

Epo drugs continue to generate billions in annual revenues.  Duxbury’s whistleblower case is still making its way through the courts.

Maryann Napoli, Center for Medical Consumers©

MD disciplinary actions: read our new report

The number of doctors sanctioned by New York State’s Office of Professional Misconduct has declined to a 15-year low, despite a substantial increase in the number of doctors practicing in the state and a dramatic increase in complaints. Read this new report co-authored by Arthur A. Levin, MPH, director of the Center for Medical Consumers. Read the [Albany] Times Union story about the topic. And here’s an editorial from The Daily News.

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We support Obama’s choice to head Medicare

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. And this explains why the Obama Administration went the recess appointment route.

Why the swine flu isn’t a major threat

For the last 15 years, physician and epidemiologist Tom Jefferson, MD, has made it his mission to conduct extensive reviews of all studies of seasonal influenza vaccines. With colleagues at the Cochrane Collaboration, Dr. Jefferson has co-authored over 10 Cochrane reviews to answer a wide range of questions such as: do these vaccines reduce the chance of getting influenza or reduce the risk of complications, hospitalizations and deaths in elderly people, children, healthy adults and asthmatics? Based in Rome, Italy, Dr. Jefferson has published extensively and is arguably the world’s leading authority on the quality of the evidence supporting seasonal influenza vaccines. As we head into winter, the U.S. media is reporting a new, more ominous viral threat that may well become a pandemic. It is, of course, the swine flu, now known as the H1N1 virus or the 2009 H1N1 virus. Dr. Jefferson is interviewed by Maryann Napoli.

MN: Thanks for sending me that September 16, 2009 letter from the Health Protection Service of Australia. It made me turn my attention to that part of the world. Now that winter is ending in the southern hemisphere, what has happened in Australia doesn’t appear to be a pandemic. There were 131 H1N1 deaths out of a population of nearly 22 million people. Is it fair to conclude that the H1N1 virus did not turn out to be a pandemic in Australia?

TJ: Yes, you may conclude that the H1N1 virus is not the threat that it has been portrayed to be.

MN: And no H1N1 vaccine was available to Australians in time for their winter season.

TJ: Yes, that’s right. But notice that I did not answer the second part of your initial question about whether Australia experienced a pandemic. That’s because the definition of pandemic has changed on the World Health Organization’s (WHO) website since May 2009. The earlier version defines pandemic as: “An influenza pandemic occurs when a new influenza virus appears against which the human population has no immunity, resulting in epidemics worldwide with enormous numbers of deaths and illness [emphasis in the original document].” In the lookalike document that currently appears on the WHO Web site, the definition of pandemic has changed to: “A disease epidemic occurs when there are more cases of that disease than normal. A pandemic is a worldwide epidemic of a disease. An influenza pandemic may occur when a new influenza virus appears against which the human population has no immunity.”

MN: The phrase “enormous numbers of deaths and illness” is gone. And we now have a lower threshold for calling something a pandemic

TJ: The definition we’re left with makes the difference between seasonal influenza and pandemic influenza a matter of debate.

MN: What do you think is going on?

TJ: I am wondering if this means that the world will always be in a pandemic. The world will always have to be doubly vaccinated and the world will always be spending a huge amount of money for vaccines, and of course, buying anti-viral drugs by the barrel load. Journalists and others have contacted WHO to find out why the change in definition, and they are always told that someone will get back to them, which never happens.

MN: What about funding? The WHO funded the osteoporosis meeting in 1993 where the definition of osteoporosis was expanded. Do you know whether the same thing may have happened here?

TJ: No, I don’t, but when you look at the WHO pandemic preparedness document, which is 62 pages long, you see in the citation count only 2 references for hand washing, 3 for masks, 1 for gloves, 23 for vaccines and 18 for anti-viral drugs. What WHO should be pushing worldwide, especially for poor countries, are these public health interventions; instead, it’s pushing pharmacologic interventions. We now have clear evidence from our reviews that pharmaceutical industry-sponsored influenza vaccine studies have risen in importance and visibility, considerably more than non-pharmaceutical industry-sponsored studies. However, this is not explained either by size or quality of the studies which is the same. The likely, and very unpalatable, explanation for this finding is that the most prestigious scientific journals are more likely to print pharmaceutical industry-sponsored studies probably because of the money they make out of selling reprints of the studies and advertising space.

MN: But Tom, many who read this will say, “Yes, maybe a lot of people are going to make money from our fear, but I’ll still get the vaccine.”

TJ: First of all, it’s not “maybe” a lot of people are going to make money. Here’s a swine and bird flu stocks index, which tells you just how much money vaccine companies made in the last six months. So if you want to know how the pandemic is going, you can consult this Web site. I call it a “pandemiometer,” the barometer of the pandemic. Don’t forget to read the comments at the end of the page and the insights from the contributing pundits.

MN: Don’t you mean that this Web site is a barometer of the fear of the pandemic?

TJ: No, I think it is a reflection of what this pandemic really is: a commercial operation.
Why else would the Australian government plan to immunize millions of people after the epidemic with a partially evaluated vaccine?

MN: The Food and Drug Administration recently announced approval for four new vaccines against the H1N1 virus. They come with the usual warnings for people with allergies to eggs and possible “unexpected or rare serious adverse events.” Do you have any other reservations about these vaccines?

TJ: Yes, I do. I am aware of only one published study. It appeared recently in the online version [September 11, 2009] of the New England Journal of Medicine. I have four problems with this study, which was done in Australia. 1) It was tiny, only 240 adults. The authors made reassuring statements about Guillain–Barré syndrome, which is ridiculous because GBS occurs in one out of 750,000 to 1 million vaccinations, and this study only had 240 participants; 2) one third of these volunteers had side effects that resembled influenza-like illness (headaches, sore throats, etc.), so they were vaccinating to prevent symptoms that they were causing; 3) there was no placebo arm in the study [a group that was injected with an inert vaccine], yet there’s no ethical excuse for not having a placebo arm because these are experimental vaccines; and 4) the description of what additive substances [ingredients that boost the immune response] were in the vaccine was unclear. We know that there is thimerosal [mercury] in this H1N1 vaccine, but its manufacturer did not say whether there are additional substances like aluminum, which can be found in many other vaccines. We just don’t know. And they are advising this vaccine for pregnant women and children over six months of age!

MN: Can you just back up and explain how vaccine studies determine whether a new vaccine should be approved?

TJ: In all our reviews of the studies involving seasonal influenza vaccines, we always looked for real outcomes, i.e., cases of influenza, bronchitis, pneumonia. [In other vaccine studies like this new one from Australia], researchers look at the quantity and quality of antibodies [in the bloodstream] of the volunteers once they are injected with an experimental vaccine. If they produce a pre-set quantity considered to be “protective,” then it is assumed that once vaccinated, people will be protected. So the key question is how these laboratory markers relate to the protection of people. To answer the question we reviewed all influenza vaccines studies from 1948 to 2007. A straight answer is made difficult by the poor quality of these studies, but vaccines have performed very poorly especially in the elderly (for which they are universally recommended). So if this is the track record, why are researchers pursuing the same old tired and fruitless road?

MN: Yes, you made that so clear when I interviewed you in 2006 after you published an extensive report in the British Medical Journal. What about that CDC-generated statistic that the media hauls out each year to scare us into getting vaccinated: 36,000 U.S. deaths each year from influenza? It never changes. And when you think of it, 36,000 out of 300 million Americans is miniscule.

TJ: We know that in the last 20 years in the U.S., the seasonal influenza-related mortality rate is flat, despite the fact that over the years a higher and higher number of people have been getting influenza vaccines.

MN: Re the seasonal influenza vaccine which the CDC usually recommends for certain populations like children under age two and the elderly…

TJ: There is no evidence whatsoever that seasonal influenza vaccines have any effect, especially in the elderly and young children. No evidence of reduced [number of] cases, deaths, complications.

MN: Obviously, there’s no Cochrane review on the horizon for the H1NI virus.

TJ: Of course not, there’s no data yet to review. There is no problem with the H1N1 virus. It’s no different from any other seasonal virus. In fact, it looks—from the Australian experience—like it’s going to be milder and it can be handled with public health measures, such as hand washing, masks.

At the end of this interview Dr. Jefferson was asked if he had any conflicts of interest to report about influenza vaccines. His response: “Yes: I am publicizing my work. But no, I have no financial conflicts.”

More articles written during and after the swine flu “pandemic” of 2009-2010:

“WHO & Pharma draw fire over H1N1 hype”

“Swine flu in the U.S.—final death count”

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What about the negotiated drug discounts?

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)

Advocacy letters

Here are links to several advocacy letters, co-signed by Arthur A. Levin, MPH, on behalf of the Center for Medical Consumers

Physician Payment Sunshine Law
Urges the Senate to keep a provision in the health care reform bill that would require disclosure of all
payments to doctors and hospitals from companies that make drugs and medical devices.

Protection of Privacy of Computerized Medical Records
Protests the proposed federal goverment regulations that would weaken some protections afforded personal computerized medical information and would limit patient notification about a breach of their privacy.

Injuries Related to Medical Devices
In support of an FDA move to speed up reporting of medical device problems.

Union of Concerned Scientists
Proposed health care reform legislation appoints a number of advisory committees to help federal agencies, like U.S. Health & Human Services, oversee certain key aspects of implementing the suggested changes. The Center has joined other advocates in urging that members chosen for these committee’s be free from conflicts of interest and that all their deliberations be fully transparent.

Anemia drugs hasten death in some cancer patients

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

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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