Townsend's New York observer: presidential campaign plans for universal health insurance: what they should cover--and won't Part 1.
National health insurance
National health insurance (Economic aspects)
National health insurance (Usage)
|Author:||Cohen, Marcus A.|
|Publication:||Name: Townsend Letter Publisher: The Townsend Letter Group Audience: General; Professional Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2008 The Townsend Letter Group ISSN: 1940-5464|
|Issue:||Date: June, 2008 Source Issue: 299|
|Topic:||Event Code: 970 Government domestic functions|
|Product:||Product Code: 9105216 National Health Insurance NAICS Code: 92312 Administration of Public Health Programs|
|Persons:||Named Person: Clinton, Hillary Rodham; Obama, Barack|
|Geographic:||Geographic Scope: United States Geographic Code: 1USA United States|
Americans will elect a new President this year, and providing
medical insurance for the one in seven persons in the US unable to pay
for coverage will be among the toughest challenges to confront the
Democrat or Republican who wins the election. As I write this column,
Senator John McCain has sewn up the Republican nomination, and Senators
Hillary Clinton and Barack Obama are still contending for the Democratic
Clinton and Obama have proposed plans for health insurance, and in formulating their plans, I imagine they've hearkened to people with political or academic expertise in heath care. But their plans may also reflect information in the nation's premier newspapers on medical research, practice, politics, and insurance; browsing through these papers is a handy way of staying in touch with the latest developments in these areas.
This column is in two parts; the second will appear in July, the next issue of Townsend Letter. Both parts of this column examine factors likely to preclude provision in the Clinton/Obama plans for complementary and alternative medicine (CAM)--as primary rather than "integrative" therapy. Both parts draw heavily on a review of health care news in The New York Times I began last winter, when the State primary elections and caucuses to determine the Democratic and Republican nominees for President kicked into gear. The selection of Times articles I present here flush and flesh out some of the factors above. The Times articles here also illustrate some of the more daunting problems that plans for universal coverage should address in a rational, not patchwork, way.
Cost-Ineffective Cancer Drugs
As a writer whose column in Townsend Letter has called attention to alternatives to prevalent modes of prevention and treatment of disease, I get depressed by the high percentage of articles published in the Times and other bellwether papers that report on conventional therapy that seems to me cost-ineffective.
An editorial in the Times on March 10, 2008, "The High Cost of a Cancer Drug," supplies an excellent specimen, one that's sickening as well as depressing. (1) The drug--called Avastin" by Genentech, the company developing it--had been approved by the Food and Drug Administration (FDA) for colorectal and lung cancers. Recently, the FDA granted Avastin "accelerated approval" for use in metastatic breast cancer.
Colorectal and lung cancer patients survived a few months longer on Avastin. A clinical trial in advanced breast cancer patients showed that the drug slowed progression but did not significantly extend survival. It also caused more serious side effects, including, according to the editorial, "perhaps half a dozen deaths" in patients with breast cancer. To the credit of the Times, the editorial questioned, "whether an extra five and a half months of holding tumor progression at bay is worth toxic side effects."
Genentech charges $92,000 a year per patient for Avastin. It caps the charge at $55,000 for women with annual family incomes under $100,000. The company, the editorial notes, "does not claim that the drug is cost-effective for advanced breast cancer but believes it will be clearly worth the cost if shown effective in earlier stages of breast cancer."
The FDA granted fast-track approval pending additional clinical trials. Oncologists have already prescribed Avastin off-label for 11,000 patients with advanced breast cancer, and the recent FDA approval would widen its use nearly fourfold--to 43,000 patients.
Salient among the sickening particulars for Avastin are the comparatively meager benefits and the unconscionable price for a year-long supply. (Okay, less than half a year, if one goes by average length of survival, cutting the cost in half.) Implicitly, Genentech laid blame for the exorbitant charge on the doorstep of the FDA: "Avastin emerged from many years of costly research." (1)
True, the FDA approval process admits only applicants who can ante up the money and time required to pass a single drug through it--hundreds of millions of dollars over more than ten years. But what was the FDA up to in accelerating Avastin's approval for breast cancer, aware that half a dozen deaths from adverse effects had already occurred, while encouraging Genentech, in effect, to continue experimenting with this perilously toxic drug in early breast cancer? Isn't the FDA process designed to minimize harm to patients who test new drugs?
From January 1984 to July 1988, I was media and political liaison for the patients of the late Dr. Emanuel Revici, a pioneer in clinical research on lipids. Revici's unique treatment for cancer, based on his scientific findings, provoked New York's Office of Professional Medical Conduct into temporarily revoking his medical license. Repeatedly, I witnessed how precious any extension of survival time was to patients staring at death, how determined some patients were to try any treatment that might extend life. (Revici's method, anecdotally, appears to have afforded a significant number of patients who failed on conventional therapy not merely extra weeks or months, but years of good quality life.) In no way am I belittling the five-and-a-half months of survival time that Avastin may add to metastatic breast cancer patients. Still, it upsets me that the Times would devote an editorial to hand-wringing over a drug that delivers so little yet costs so much, while leaving unquestioned the FDA's approval for expanded fast-track trials of this drug despite its fatal side effects.
Nipping at the heels of its editorial on Avastin, two stories on anemia drugs for cancer patients appeared in the Times.(2) The first of these drugs, Epogen, by Amgen, hit the market in 1990, and oncologists have since used them to manage the anemia caused by chemotherapy, mostly in patients with advanced cancer. Now, eight clinical trials have flashed on orange caution lights; the trials suggest the anemia drugs might worsen cancer or hasten death in some patients.
As it often does, the FDA threw this therapeutic hot potato to one of its advisory committees, panels usually stocked with academic experts. The panel considered three anti-anemia drugs: Epogen and Aranesp from Amgen and Procrit from Johnson & Johnson. Instructive history about these drugs surfaced in the first Times story.
All are synthetic forms of erythropoietin (Epo, for short), a human hormone that stimulates production of red blood cells. An FDA advisory committee had reviewed conflicting evidence on these drugs a year ago because enough evidence had accumulated to support three hypotheses about how Epo acts in cancer: it may spur production of blood vessels that can feed cancers; it may directly cause cancers to grow; and it protects cancers against chemotherapy. Flaws in the studies constituting this evidence created the uncertainty, and the data gathered from these studies were contradictory. Studies in animals, for instance, generally did not demonstrate cancer-stimulating effects for Epo.
Amgen had defended its drugs at a workshop held by the National Cancer Institute (NCI) last December. The company believes that the deaths in human trials of Epo can be attributed to blood clots. The trial patients had received drug doses that increased red blood cell levels beyond the recommendation on the label, and at such levels, blood clots are a recognized side effect.
The NCI workshop reached no consensus on whether Epo causes human cancers to grow. More studies were needed, said the NCI in a summary of its workshop. But one crucial question remained open: are the anemia drugs really "Miracle-Gro for cancer?" (This is precisely the way an FDA advisor, quoted by the Times in its first story, had phrased it.) The second Times story, on the front page of the paper's business section, reported that the new FDA advisory panel, responding to swelling concerns about the safety of the drugs in doses typically administered by oncologists, recommended additional restrictions.
Here are the main additional restrictions recommended by the panel. Patients with breast and head and neck cancers should not receive the drugs; the evidence to date indicates that the drugs may be risky for them. Ditto for patients "being treated with the intent of curing their cancers." (2) (This quote is from the Times reporter; the emphasis is added.) The panel had in mind patients receiving chemotherapy after surgical removal of their cancer, where oncologists hope the patients are rid of the disease. For other patients, most of them with advanced cancers, the committee "also recommended that patients be made to sign consents in order to obtain the drugs. But the panel voted against "carefully controlling distribution" of the anemia drugs.
At the meeting of the advisory panel, the third the FDA has held on these drugs since 2004, a representative of the Colorectal Cancer Coalition, speaking for patients, expressed frustration: "'There is a perceived lack of progress,' exclaimed the representative. The drugs 'have been on the market for many years, billions of dollars have been spent by insurers, millions of patients have been treated, and yet we still have many of the same unanswered questions.'"
Perhaps that third meeting will turn out to be the charm. I found the recommendations issuing from it mere expedients. The Times reporter stated up front that Amgen and Johnson & Johnson "avoided the outcome they most feared: a recommendation that the drugs not be used by any cancer patients. That probably would have meant the loss of at least $1 billion in sales for each company."
'"They dodged the really big bullet,' remarked a biotechnology analyst, referring to the two drug companies, 'but they still took some damage.'" Another analyst, speaking for the investment division of a prominent bank, said, "figured Amgen would lose about $125 million in Aranesp sales if the recommendations were enacted." (This analyst estimated Amgen's loss would amount to 25% of already reduced projections for sales to American cancer patients in 2008.)
The Business of Medicine
Reading and rereading the Times editorial about Avastin, I grumbled to myself: "A terminal breast cancer patient, with annual income over $100,000, pays over 20 grand in hopes of extending her existence in this world five-and-a-half months--and that extension isn't guaranteed. Or an insurance company, pressured by advocates for patients and politicians, reluctantly pays for her treatment until she succumbs within the timeframe of her prognosis. That's a devilish small bang for the buck!"
Then, rereading the two stories the Times ran on safety concerns for drugs developed to handle the anemia caused by cancer chemotherapy, it very forcibly registered on my mind that the Times health care news predominantly covers the business of health care. And what a business this is in the US!
An essay the Times published in its Science section on March 11, 2008 offered a dollar amount. The author, a cardiologist, was inveighing against unnecessary procedures and testing, "often for the sake of business," and he said, "Though accurate data is lacking, the overuse of services in health care probably cost hundreds of billions of dollars last year, out of the more than $2 trillion that Americans spent on health." (3)
"Are we getting our money's worth?" he asked. His answer: "Not according to the usual measures of public health. The United States ranks 45th in life expectancy, behind Bosnia and Jordan; near last, compared with other developed countries, in infant mortality; and in last place, according to the Commonwealth Fund, a health care research group, among major industrialized countries in health care quality, access, and efficiency."
One short paragraph in this essay conveyed the cardiologist's feeling about the impact on the health-care system of over-consultation and over-testing. They "have now become facts of the medical profession. The culture in practice is to grab patients and generate volume. 'Medicine has become like everything else,' a doctor told me recently. 'Everything moves because of money.'"
A New York Times "News Analysis" about plans for health coverage for uninsured Americans proposed by Senators Hillary Clinton and Barack Obama ventured that Medicare and Medicaid would pose immediate challenges for the next President in reining in health care costs. (4) Medicare and Medicaid, began the writer of this analysis, accounted for 23% of all Federal government spending in 2007. The Congressional Budget Office projects a doubling of the cost of these two programs by 201 7, when they will account for 30% of the total budget--if there is no change in current law.
"Medicare has generally not taken costs into account in deciding which services to cover," observed the writer. "If officials even suggest that Medicare should deny payment for an expensive treatment that could produce a small improvement in a person's condition, they are accused of rationing care."
Further examining the issue of rationing, the writer pointed to findings by researchers at the Dartmouth Medical School. There are "large variations in the amount of hospital care and other services that people with the same condition receive in different parts of the country. In some regions, where doctors favor more intensive treatments, Medicare spends much more without getting better results for patients."
The analyst finished: "This research 'suggests that about 20 percent of Medicare spending could be eliminated with no adverse effects on health,' said Prof. David M. Cutler of Harvard, an advisor to the Obama campaign. Identifying that 20 percent would be 'very difficult,' he acknowledged." (4)
According to the Times articles discussed in this column, the ballooning cost of health care in the US is mostly a consequence of overuse of health services, especially unnecessary services and tests, and inconsistent payouts by Medicare for medical care, the cost and effectiveness of which vary regionally. When viewed from a business perspective, where the prime motive is to profit from patients, naturally these factors come to the fore. But minimizing questionable services and procedures--and exercising better judgment on reimbursement for care--are helpful goals that would amount to patchwork solutions, solutions supporting a system that encourages late-stage, drug-based, invasive, inherently expensive medical practice.
A more rational approach would promote prevention of disease or encourage intervention at early stages, utilizing far less drastic treatment. In my May 2008 column, I quoted Dr. Herbert Pierson on an example of this approach. I omitted the closing paragraph of his presentation, made in 1993, a few years after he had stepped down as head of the NCI's phytochemical division, when health care spending was less than half of what it is estimated to be today:
"Given that our annual health care costs now exceed $800 billion dollars, it is prudent to focus on preventive measures that are controllable in our lifestyles. Foods are one such controllable parameter, and an extensive amount of information and technology strongly suggests that our food supply can be made much more healthier and rationally preventive." (5)
Our Daily Meds
In mid-March, the Times reviewed Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs, by Melody Peterson.6 Ms. Peterson covered the drug industry for the Times for four years. The reviewer, Janet Maslin, went into detail on "the economics of creating chronic conditions for marginally necessary drugs" (Ms. Peterson's words):
Medical News Not "Fit to Print"
Townsend Letter proclaims itself "The Examiner of Medical Alternatives." Its standard operating procedure is to publish information about naturally occurring compounds that may help in avoidance of or recovery from disease. Writing my columns for Townsend Letter, I take pains to cite peer-reviewed literature showing that such substances are effective and safe, often more so than standard therapies.
Through my years as a columnist, I've written about vitamin A as cost-effective therapy for avian flu (Feb./March 2006, April 2006); nutritional approaches that lower the risk of cancer associated with human papilloma virus (June 2007); phytochemicals in dark-colored fruits and vegetables which protect against cancer, diabetes, and cardiovascular conditions (May 2008); L-carnitine to lessen cardiotoxicity from the cancer drug Adriamycin (July 2007); and AcetylL-carnitine to control sepsis (January 2008). This is a partial list.
I've also published three interviews with Stephen A. DeFelice, MD, coiner of the term "nutraceutical" (July 2007, Oct. 2007, Jan. 2008). Dr. DeFelice has proposed Congressional legislation for a nutraceutical approval process, the Nutraceutical Research and Education Act (NREA), aimed at spurring research and development of the various substances massed under his umbrella term. The NREA would make nutraceuticals available, mostly through over-the-counter sale, via a comparatively quick and inexpensive route.
My interest in nutraceuticals has centered on their potential to shift prevalent treatment paradigms toward prevention or early-stage modulation of disease, which is more cost-effective, less invasive, and generally safer than current clinical practice. Passage of the NREA should increase scientific substantiation of therapeutic benefits of nutraceuticals. I foresee this as a desirable "side effect" of enactment of the NREA. The Dietary Supplement and Education Act of 1994 (DSHEA) would have encouraged such substantiation, but in implementing DSHEA, the FDA disregarded the intent of the Act's Congressional sponsors and the broad support for DSHEA among Americans.
On the relatively few occasions the media have reported on nutraceuticals, they've concentrated on marketing possibilities and potential monetary profits. But, to put it bluntly, there ain't gonna be marketing and profits without first overcoming objections from advocates for FDA regulation of nutraceuticals as strict as those for new drugs, and that's a really hard sell.
I don't expect The New York Times, The Wall Street journal, and other bellwether US newspapers to cover developments and therapies originating in alternative medicine. They apparently feel that alternative therapy hasn't been sufficiently proven even in lab and animal studies, much less demonstrated as effective and safe for humans. So when they infrequently report on alternate care, they customarily represent it negatively, as though casting it in a positive light would raise "false hopes" among patients and their relatives desperate for remedies for illnesses unresponsive to mainstream medicine.
What's the core-attitude of these papers toward alternative care? I suppose it's expressed in the prime criterion for publication on the front page of the Times: "All the News that's Fit to Print." Dietary supplements do rate occasional coverage by these papers--especially if the latest research suggests they aren't as safe or effective as assumed. I read these reports with strong reservations about how thoroughly the reporters compared the new studies with previous studies: there are many variables in design and conduct from study to study, and one should match as many as possible before accepting the latest finding as the last, most reliable word.
Part 2 of this column will resume with my comments about coverage of the Times on diabetes, flu, heart disease, and papilloma virus. The Times coverage on heart disease included a small piece in its Science section on a review of studies indicating that Hawthorn extract eases the symptoms of heart failure, a notable exception to the paper's negative pieces on alternative and complementary medicine. The second part will conclude with my observations on plans for health care insurance by Senators Clinton and Obama, analyzing why they are unlikely to cover alternative approaches to prevention and early treatment of disease.
(1.) The high cost of a cancer drug. Editorial. The New York Times. March 10, 2008.
(2.) Pollack A. Risks of anemia drugs for patients with cancer to get more scrutiny. The New York Times. March 12, 2008; Pollack A. Panel seeks new limits on anemia drugs for cancer patients. The New York Times. March 14, 2008.
(3.) Jauhar S. Many doctors, many tests, no rhyme or reason. Essay. The New York Times. March 11, 2008.
(4.) Pear R. About those health care plans by the democrats. ... News Analysis. The New York Times. March 3, 2008.
(5.) Pierson HF Jr. Food phytochemical pharmacology: the basis for designer food development. Regulatory Affairs. 1993; 5: 219-222.
(6.) Maslin J. The case for another drug war, against pharmaceutical marketers' dirty tactics. Book review. The New York Times. March 17, 2008.
by Marcus A. Cohen
Ms. Peterson steps back to consider the long-term consequences of this shift in consumption. She notes that the first generation raised in front of ubiquitous, sunny drug-company advertisements (which became legal in 1997) has acquired the notions that prescription pills fix everything, and that they are less dangerous than street drugs. Then, looking to the elderly, she points out that increasing numbers of drugs are accumulating in these patients, with little regard to the consequences. "As older patients move through time, often from physician to physician," one doctor tells her, "they are at increasing risk of accumulating layer upon layer of drug therapy, as a reef accumulates layer upon layer of coral." And when the side effects of sleeping pills or antidepressants mean more elderly people fall down, the solution is not likely to be the scaling back of such prescriptions. "Instead," she writes, "the companies have used the statistics on falls to create a new blockbuster pharmaceutical market for drugs they claim will reduce the chances of breaking a bone." The market for just two of these drugs, Fosamax and Actonel, is expected to be worth $10 billion by 2011.
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