Post Reference 10- re: American Cancer Society

CANCER SOCIETY'S DEADLY MEDICINE
By MICHAEL TANNER
September 10, 2007 -- THE American Cancer Society announced recently that it will spend its entire advertising budget next year not on urging Americans to stop smoking or get mammograms, but on campaigning for a government takeover of the U.S. health-care system. This is perverse: It's hard to imagine anything worse for cancer patients than government-run health care.

For all its faults and all the criticism that it has received, the United States' free-market health-care system has made America the place you want to be if you have a serious illness.

Cancer patients understand this. The overall five-year survival rate for all types of cancer for men in America is 66.3 percent, and 62.9 percent for women, the best outcome in the world.

We shouldn't be surprised. The one common characteristic of all national health-care systems is that they ration care.

Sometimes they ration it explicitly, denying certain types of treatment altogether. More often, they ration more indirectly - imposing global budgets or other cost constraints that limit the availability of high-tech medical equipment or imposing long waits on patients seeking treatment.

In the United States, there are no such government-set limits, meaning that the most advanced treatment options are far more available. This translates directly into saved lives.

Take prostate cancer, for example. Even though American men are more likely to be diagnosed with prostate cancer than their counterparts in other countries, we are less likely to die from the disease. Fewer than 20 percent of American men with prostate cancer will die from it, against 57 percent of British men and nearly half of French and German men. Even in Canada, prostate cancer kills a quarter of men diagnosed with the disease.

A big part of the reason is that, in most countries with national health insurance, the preferred treatment for prostate cancer is . . . nothing.

Prostate cancer is a slow-moving disease. Most patients are older and will live for several years after diagnosis. Therefore it is not cost-effective in a world of socialized medicine to treat the disease too aggressively. The approach saves money - but at a high human cost.

Similar results can be found for other forms of cancer. For instance, only 30 percent of U.S. citizens diagnosed with colon cancer die from it, compared to fully 74 percent in Britain, 62 percent in New Zealand, 58 percent in France, 57 percent in Germany, 53 percent in Australia and 36 percent in Canada.

And less than 25 percent of U.S. women die from breast cancer. In Britain, it's 46 percent; France, 35 percent; Germany, 31 percent; Canada, 28 per- cent; Australia, 28 percent, and New Zealand, 46 percent.

Even when there is a desire to offer treatment, national health-care systems often lack the resources to provide it. In Britain, for example, roughly 40 percent of cancer patients never get to see an oncology specialist. Delays in receiving treatment under Britain's national health service are often so long that nearly 20 percent of colon cancer cases considered treatable when first diagnosed are incurable by the time treatment is finally offered.

In Canada, the Society of Surgical Oncology recommends that cancer surgery take place within two weeks of preoperative tests. Yet one study indicates that median waiting time for cancer surgery in Canada ranged from 29 days for colorectal cancer to more than two months for urinary cancers. Radiation treatment and new therapies, such as brachytherapy, are also far less available than they are in the United States. Consider this: seven out of 10 Canadian provinces report sending prostate-cancer patients to the United States for radiation treatment.

But the advantages of free-market health care go far beyond an absence of rationing. With no price controls, free-market U.S. medicine provides the incentives that lead to innovative breakthroughs in new drugs and other medical technologies. U.S. companies have developed half of all the major new medicines introduced worldwide over the last 20 years.

In fact, Americans played a key role in 80 percent of the most important medical advances of the last 30 years. Eighteen of the last 25 winners of the Nobel Prize in Medicine either are U.S. citizens or work here.

If the American Cancer Society got the government-run national health-care system it wants, we would eliminate consumer choice and put a stop to the innovations we count on to improve our health. It would condemn thousands of cancer sufferers to waiting lists and denied care. In the end, it would cost lives.

If the Cancer Society truly wants to help Americans suffering from that complex array of diseases called cancer, it will get back to campaigning for mammograms and quitting smoking, and keep the government out of the picture.

Michael Tanner is director of health and welfare studies at the Cato Institute.

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A Canadian Doctor Describes How Socialized Medicine Doesn't Work
By DAVID GRATZER | Posted Thursday, July 26, 2007 4:30 PM PT

I was once a believer in socialized medicine. As a Canadian, I had soaked up the belief that government-run health care was truly compassionate. What I knew about American health care was unappealing: high expenses and lots of uninsured people.

My health care prejudices crumbled on the way to a medical school class. On a subzero Winnipeg morning in 1997, I cut across the hospital emergency room to shave a few minutes off my frigid commute.

Swinging open the door, I stepped into a nightmare: the ER overflowed with elderly people on stretchers, waiting for admission. Some, it turned out, had waited five days. The air stank with sweat and urine. Right then, I began to reconsider everything that I thought I knew about Canadian health care.

Dr. Jacques Chaoulli faces the media in Montreal in June 2005, after he got Canada's Supreme Court to strike down a Quebec law banning private insurance for services covered under Medicare — a decision the rocked the country's universal health care system.
I soon discovered that the problems went well beyond overcrowded ERs. Patients had to wait for practically any diagnostic test or procedure, such as the man with persistent pain from a hernia operation whom we referred to a pain clinic — with a three-year wait list; or the woman with breast cancer who needed to wait four months for radiation therapy, when the standard of care was four weeks.

Government researchers now note that more than 1.5 million Ontarians (or 12% of that province's population) can't find family physicians. Health officials in one Nova Scotia community actually resorted to a lottery to determine who'd get a doctor's appointment.

These problems are not unique to Canada — they characterize all government-run health care systems.

Consider the recent British controversy over a cancer patient who tried to get an appointment with a specialist, only to have it canceled — 48 times. More than 1 million Britons must wait for some type of care, with 200,000 in line for longer than six months. In France, the supply of doctors is so limited that during an August 2003 heat wave — when many doctors were on vacation and hospitals were stretched beyond capacity — 15,000 elderly citizens died. Across Europe, state-of-the-art drugs aren't available. And so on.

Single-payer systems — confronting dirty hospitals, long waiting lists and substandard treatment — are starting to crack, however. Canadian newspapers are filled with stories of people frustrated by long delays for care. Many Canadians, determined to get the care they need, have begun looking not to lotteries — but to markets.

Dr. Jacques Chaoulli is at the center of this changing health care scene. In the 1990s, he organized a private Quebec practice — patients called him, he made house calls and then he directly billed his patients. The local health board cried foul and began fining him. The legal status of private practice in Canada remained murky, but billing patients, rather than the government, was certainly illegal, and so was private insurance.

Eventually, Chaoulli took on the government in a case that went all the way to the Supreme Court. Representing an elderly Montrealer who had waited almost a year for a hip replacement, Chaoulli maintained that the patient should have the right to pay for private health insurance and get treatment sooner. A majority of the court agreed that Quebec's charter did implicitly recognize such a right.

The monumental ruling, which shocked the government, opened the way to more private medicine in Quebec. Though the prohibition against private insurance holds in the rest of Canada for now, at least two people outside Quebec, armed with Chaoulli's case as precedent, are taking their demand for private insurance to court.

Consider, too, Rick Baker. He isn't a neurosurgeon or even a doctor. He's a medical broker — one member of a private sector that is rushing in to address the inadequacies of Canada's government care. Canadians pay him to set up surgical procedures, diagnostic tests and specialist consultations, privately and quickly.

Baker describes a man who had a seizure and received a diagnosis of epilepsy. Dissatisfied with the opinion — he had no family history of epilepsy, but he did have constant headaches and nausea, which aren't usually seen in the disorder — he requested an MRI.

The government told him that the wait would be 4 1/2 months. So he went to Baker, who arranged to have the MRI done within 24 hours — and who, after the test revealed a brain tumor, arranged surgery within a few weeks. Some services that Baker brokers almost certainly contravene Canadian law, but governments are loath to stop him.

Other private-sector health options are blossoming across Canada, and the government is increasingly turning a blind eye to them, too, despite their often uncertain legal status. Private clinics are opening at a rate of about one a week.

Canadian doctors, long silent on the health care system's problems, are starting to speak up. Last August, they voted Brian Day president of their national association. Day has become perhaps the most vocal critic of Canadian public health care, having opened his own private surgery center and challenging the government to shut him down.

And now even Canadian governments are looking to the private sector to shrink the waiting lists. In British Columbia, private clinics perform roughly 80% of government-funded diagnostic testing.

This privatizing trend is reaching Europe, too. Britain's Labour Party — which originally created the National Health Service — now openly favors privatization. Sweden's government, after the completion of the latest round of privatizations, will be contracting out some 80% of Stockholm's primary care and 40% of its total health services.

Since the fall of communism, Slovakia has looked to liberalize its state-run system, introducing co-payments and privatizations. And modest market reforms have begun in Germany.

Yet even as Stockholm and Saskatoon are percolating with the ideas of Adam Smith, a growing number of prominent Americans are arguing that socialized health care still provides better results for less money.

Politicians like Hillary Clinton are on board; Michael Moore's new documentary, "Sicko," celebrates the virtues of Canada's socialized health care; the National Coalition on Health Care, which includes big businesses like AT&T, recently endorsed a scheme to centralize major health decisions to a government committee; and big unions are questioning the tenets of employer-sponsored health insurance.

One often-heard argument, voiced by the New York Times' Paul Krugman and others, is that America lags behind other countries in crude health outcomes. But such outcomes reflect a mosaic of factors, such as diet, lifestyle, drug use and cultural values. It pains me as a doctor to say this, but health care is just one factor in health.

Americans live 75.3 years on average, fewer than Canadians (77.3) or the French (76.6) or the citizens of any Western European nation save Portugal. Health care influences life expectancy, of course. But a life can end because of a murder, a fall or a car accident. Such factors aren't academic — homicide rates in the U.S. are much higher than in other countries.

In The Business of Health, Robert Ohsfeldt and John Schneider factor out intentional and unintentional injuries from life-expectancy statistics and find that Americans who don't die in car crashes or homicides outlive people in any other Western country.

And if we measure a health care system by how well it serves its sick citizens, American medicine excels. Five-year cancer survival rates bear this out. For leukemia, the American survival rate is almost 50%; the European rate is just 35%. Esophageal carcinoma: 12% in the U.S., 6% in Europe. The survival rate for prostate cancer is 81.2% here, yet 61.7% in France and down to 44.3% in England — a striking variation.

Like many critics of American health care, though, Krugman argues that the costs are just too high: health care spending in Canada and Britain, he notes, is a small fraction of what Americans pay. Again, the picture isn't quite as clear as he suggests. Because the U.S. is so much wealthier than other countries, it isn't unreasonable for it to spend more on health care. Take America's high spending on research and development. M.D. Anderson in Texas, a prominent cancer center, spends more on research than Canada does.

That said, American health care is expensive. And Americans aren't always getting a good deal. In the coming years, with health expenses spiraling up, it will be easy for some to give in to the temptation of socialized medicine. In Washington, there are plenty of old pieces of legislation that like-minded politicians could take off the shelf, dust off and promote: expanding Medicare to Americans 55 and older, say, or covering all children in Medicaid.

But such initiatives would push the U.S. further down the path to a government-run system and make things much, much worse. True, government bureaucrats would be able to cut costs — but only by shrinking access to health care, as in Canada, and engendering a Canadian-style nightmare of overflowing emergency rooms and yearlong waits for treatment.

America is right to seek a model for delivering good health care at good prices, but we should be looking not to Canada, but close to home — in the other four-fifths or so of our economy. From telecommunications to retail, deregulation and market competition have driven prices down and quality and productivity up. Health care is long overdue for the same prescription.

Gratzer, a physician, is a senior fellow at the Manhattan Institute. This article is adapted from the forthcoming issue of City Journal.

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Avastin® (bevacizumab)
Avastin was the first anti-angiogenesis therapy approved by the U.S. Food and Drug Administration (FDA) and is currently approved for the treatment of two of the three largest cancer killers in the U.S.:1, 2

Colorectal cancer: In combination with intravenous (IV) 5-fluorouracil (FU)-based chemotherapy for first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum (February 2004, June 2006)
Lung cancer: In combination with carboplatin and paclitaxel for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC) (October 2006)

"Firsts" in Patient Survival
Avastin with IV chemotherapy is the first and only FDA-approved biologic therapy proven to extend overall survival in metastatic colorectal cancer (mCRC) and advanced NSCLC.1 In NSCLC, Avastin plus chemotherapy is the first drug combination in 10 years to improve upon standard first-line treatment, and the first targeted therapy ever to extend overall median survival beyond one year in a large, randomized clinical study.

Targeting VEGF/Mechanism of Action
Avastin is a therapeutic antibody (not a chemotherapy) designed to bind to and inhibit human vascular endothelial growth factor (VEGF), a protein believed to play an important role in the formation of new blood vessels (angiogenesis) and the maintenance of existing blood vessels throughout the lifecycle of a tumor.3 By inhibiting VEGF, Avastin may interfere with the blood supply to a tumor, which is thought to be important to a tumor's ability to grow and spread (metastasize) to other parts of the body. The effects of Avastin on tumor blood vessels may also enhance the delivery of chemotherapy drugs to the cancer.4-6

Clinical Trial Data

First-Line Treatment in Metastatic Colorectal Cancer
The Avastin FDA approval for first-line treatment of patients with metastatic carcinoma of the colon or rectum is based on data from two trials. The pivotal trial was a large, placebo-controlled, randomized study that demonstrated a prolongation in the median survival of patients treated with Avastin plus the IFL (IV 5-FU/Leucovorin/CPT-11) chemotherapy regimen by approximately five months, compared to patients treated with the IFL chemotherapy regimen alone (20.3 months versus 15.6 months). In addition, this study demonstrated an improvement in progression-free survival (PFS) of more than four months (10.6 months in the Avastin/IFL arm compared to 6.2 months in the IFL-alone arm).1

Second-Line Treatment in Metastatic Colorectal Cancer
The second-line approval for Avastin is based on results of a randomized, controlled, multicenter Phase III trial (E3200) of 829 patients with advanced or metastatic colorectal cancer who had received previous treatment with irinotecan and IV 5-FU as initial therapy for metastatic disease or as adjuvant therapy. The study showed that patients who received Avastin plus the IV 5-FU-based chemotherapy regimen known as FOLFOX4 (oxaliplatin/5-FU/leucovorin) had a 25 percent reduction in the risk of death (based on a hazard ratio of 0.75), the primary endpoint, which is equivalent to a 33 percent improvement in overall survival, compared to patients who received FOLFOX4 alone. Median survival for patients receiving Avastin plus FOLFOX4 was 13.0 months, compared to 10.8 months for those receiving FOLFOX4 alone.1

First-Line Treatment in Metastatic NSCLC
The FDA approval for this indication was based on results from E4599, a randomized, controlled, multi-center trial that enrolled 878 patients with unresectable, locally advanced, recurrent or metastatic non-squamous NSCLC. Results showed that patients receiving Avastin plus paclitaxel and carboplatin chemotherapy had a 25 percent improvement in overall survival, the trial's primary endpoint, compared to patients who received paclitaxel and carboplatin alone (based on a hazard ratio of 0.80). One-year survival was 51 percent in the Avastin plus chemotherapy arm versus 44 percent in the chemotherapy-alone arm. Median survival of patients treated with Avastin plus chemotherapy was 12.3 months, compared to 10.3 months for patients treated with chemotherapy alone.1

The National Comprehensive Cancer Network (NCCN) recommends Avastin plus intravenous 5FU-based chemotherapy as a first-line treatment option for advanced colorectal cancer and in combination with carboplatin and paclitaxel in appropriate patients for the first-line treatment of advanced non-squamous NSCLC, two of the three largest cancer killers in the U.S.7

The most serious adverse events associated with Avastin across all trials were gastrointestinal (GI) perforation, wound healing complications, hemorrhage, arterial thromboembolic events, hypertensive crisis, reversible posterior leukoencephalopathy syndrome, neutropenia and infection, nephritic syndrome and congestive heart failure. The most common adverse events seen in patients receiving Avastin across all studies were asthenia, pain, abdominal pain, headache, hypertension, diarrhea, nausea, vomiting, anorexia, stomatitis, constipation, upper respiratory infection, epistaxis, dyspnea, exfoliative dermatitis and proteinuria.

The Avastin Timeline
1989 Napoleone Ferrara, M.D., and his team at Genentech clone VEGF and publish in Science some of the first evidence that a specific angiogenic growth factor exists.
1993 Ferrara and his team publish a study in Nature demonstrating that an anti-VEGF antibody can suppress angiogenesis and tumor growth in preclinical models.
1997 Genentech submits an Investigational New Drug (IND) Application to the FDA and begins a Phase I trial of Avastin.
1998 Phase II trials of Avastin begin.
2000 A Phase III trial of Avastin in first-line metastatic colorectal cancer (in combination with the IFL [5-FU/leucovorin/CPT-11] regimen) begins.
May 2003 A Phase III trial of Avastin and the IFL chemotherapy regimen in first-line metastatic colorectal cancer exceeds its primary endpoint of improving overall survival, and meets its secondary endpoints of progression-free survival, response rate and duration of response.
September 2003 Genentech submits a Biologics License Application (BLA) to the FDA for Avastin in metastatic colorectal cancer under the FDA's Fast Track program. The FDA grants Priority Review (a six-month review of the application).
February 2004 FDA approves Avastin in combination with intravenous 5FU-based chemotherapy for the first-line treatment of patients with metastatic carcinoma of the colon or rectum, making Avastin the first approved anti-angiogenesis treatment for cancer.
April 2004 The NCCN, an alliance of 19 of the world's leading cancer centers, updates their Colorectal Clinical Practice Guidelines and adds Avastin in combination with intravenous 5FU-based regimens — including those using oxaliplatin or irinotecan — to its list of first-line treatment options for advanced colon or rectal cancer.
May 2005 A Phase III trial of Avastin plus paclitaxel and carboplatin chemotherapies in first-line non-squamous, NSCLC meets its primary efficacy endpoint of improving overall survival.
A Phase III trial of Avastin plus paclitaxel chemotherapy in first-line metastatic breast cancer exceeds its primary efficacy endpoint of improving progression-free survival, compared to chemotherapy alone.

October 2005 The NCCN updates its Clinical Practice Guidelines in Oncology and adds Avastin in combination with chemotherapy to its list of first-line therapy for advanced NSCLC.
June 2006 FDA approves Avastin in combination with intravenous 5-FU-based chemotherapy for patients with second-line metastatic colorectal cancer.
October 2006 FDA approves Avastin in combination with carboplatin and paclitaxel for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, NSCLC.



Based on data showing that VEGF may play a broad role in a range of cancers, a global development program for Avastin currently includes more than 300 clinical trials in 20 different tumor types. Avastin is being evaluated in Phase III clinical trials for its potential use in adjuvant and metastatic colorectal, renal cell (kidney), breast, pancreatic, non-small cell lung, prostate and ovarian cancers. Avastin is also being evaluated in Phase I/II trials as a potential therapy in a variety of solid tumor cancers and hematologic malignancies, and is being studied in combination with other targeted therapy agents in the absence of chemotherapy.


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