October 21

Americans Hostage to Profit-Driven Healthcare System

Recent independent reports analyzing various barometers measuring the effect of American medical practice guidelines and consequent treatment outcomes confirm an   inconvenient, but undeniable truth: America’s for-profit model
in healthcare has resulted in a highly profitable business for providers–but for consumers, it is a prescription for disaster. 

The dirty secret that holds Americans hostage to a failed profit-focused healthcare system which leaves 50 million without insurance is the naive belief that healthcare providers are working to find and deliver medical cures.  To do so, would simply present a conflict of interest.

The healthcare industry profits from overdiagnosing and selling treatments for illness and perceived illnesses–not from providing cures.

But, as Dr. Barnett Kramer, associate director for disease prevention, National Institute of Health, acknowledges: "Overdiagnosis is pure, unadulterated harm."

Three recent articles encapsulate various aspects demonstrating what’s wrong with America’s market-based medicine: 

1. Front page article, "Cancer Group Has Concerns On Screenings," by Gina Kolata, The New York Times (below) reports about an epidemiological analysis in the Journal of the American Medical Association that should give pause to both the American public and public healthcare policy officials, about the cost and dubious value of medical screening guidelines.

The JAMA article focuses on breast cancer and prostate cancer screening results:

Since screening for breast cancer was introduced, "The researchers report a 40% increase in breast cancer diagnoses and a near doubling of early stage cancers, but just a 10% decline in cancers that have spread beyond the breast to the lymph nodes or elsewhere in the body."

The increase in diagnoses does not translate into fewer deaths. Instead, the researchers found, that innocuous cancers are being detected and aggressively treated without justification–as they pose no life-threatening risk.

Screening for prostate cancer and breast cancer have hugely increased the diagnosis of cancer but has done little to help those whose cancer is truly in need of treatment. "Both have a problem that runs counter to everything people have been told about cancer: They are finding cancers that do not need to be found because they would never spread and kill or even be noticed if left alone….At the same time, both screening tests are not making much of a dent in the number of cancers that are deadly." 

"The very idea that some cancers are not dangerous and some might actually go away on their own can be hard to swallow, researchers say.

“It is so counterintuitive that it raises debate every time it comes up and every time it has been observed,” said Dr. Barnett Kramer, associate director for disease prevention at the National Institutes of Health.

Another reason the idea that a disease "might actually go away on their own can be hard to swallow" is that it collides with the profit-driven medical paradigm that holds Americans hostage.

2. "A Lifesaver Out of Reach, For Want Of a Profit," appeared in the Metropolitan section of Sunday’s New York Times:

The reporter, Jim Dwyer, makes a most important observation about America’s healthcare debacle that neither Republican or Democrat Administrations have dared to confront: "There is no easy way to make money from the cures of [ ] illnesses."

The Times article focuses on the failure to utilize therapeutic value of blood from the umbilical cord of some, four million new born babies: umbilical chord blood is acknowledged to be an effective a treatment for lymphoma (a cancer of the blood– that affects, perhaps 40,000 people a year ).

But for lack of profit–"It’s not a business"–  these therapeutically valuable, ethically uncontestable umbilical chords from newborn babies are discarded. Instead, bone marrow is sought from healthy donors who are  asked to put themselves at risk…It makes absolutely no sense.

"The reason for this squander is simple.  No one has figured out a way to make money by salvaging the blood and making it available for therapeutic use….For these life- saving therapies there is no business model."

3. A report by the Institute of Safe Medication Practices, QuarterWatch (October 8, 2009) found a 25% Increase in Serious Adverse Drug Event Reports to the FDA during the fourth Quarter of 2008. [Executive Summary below] 

The key findings:
1.  The largest ever increase in reported deaths and serious injuries (25% in a three month period).
2.  The biggest single factor contributing to these deaths and injuries was defective generic drugs which were ultimately recalled AFTER they killed.
3.  Increased reporting of injuries by consumers.

4.  Two drugs, Pfizer’s anti-smoking drug, Chantix, and Merck’s antihistamine, Singulair, pose serious psychiatric risks–including violence, aggression, hallucinations, and suicide. The Department of Defense has banned Chantix from use by aircraft and missile crews. However, the authors of QuarterWatch call for a ban on Chantix to all active duty military personnel as well as police and emergency personnel.  The FDA, by contrast has approved a Pfizer’s defective MedGuide that underplays the risks posed by Chantix.

Whatever the risks posed by smoking, they do not include the risk of assaultive behavior toward others.  That a drug such as Chantix is permitted to be marketed despite the danger it poses, is an illustration of business considerations trumping safety.

The fact is that no administration–Democrat or Republican– has been willing to challenge the false premise that for-profit businesses were working to find and deliver medical cures.

As a former Pharma marketing executive observed: "Do you really believe that a drug manufacturer would bring to market a cure for cancer…or AIDS…or diabetes?”

To do so, would be contrary to their financial interest!

Indeed, one must confront the fact that there is NO INCENTIVE for those who make up the American healthcare academic-industrial consortium to find and sell a cure for  disabling chronic diseases. Indeed, diagnosing and treating chronic illness is their source of greatest profit!

Healthcare reform requires a radical change or it will merely increase profits for the stakeholders.

By Vera Sharav

October 21, 2009
In Shift, Cancer Society Has Concerns on Screenings

The American Cancer Society, which has long been a staunch defender of most cancer screening, is now saying that the benefits of detecting many cancers, especially 
breast and prostate, have been overstated.

It is quietly working on a message, to put on its Web site early next year, to emphasize that screening for breast and prostate cancer and certain other cancers can come  with a real risk of overtreating many small cancers while missing cancers that are deadly.

“We don’t want people to panic,” said Dr. Otis Brawley, chief medical officer of the cancer society. “But I’m admitting that American medicine has overpromised when it  comes to screening. The advantages to screening have been exaggerated.”

Prostate cancer screening has long been problematic. The cancer society, which with more than two million volunteers is one of the nation’s largest voluntary health  agencies, does not advocate testing for all men. And many researchers point out that the PSA prostate cancer screening test has not been shown to prevent prostate  cancer deaths.

There has been much less public debate about mammograms. Studies from the 1960s to the 1980s found that they reduced the death rate from breast cancer by up to 20  percent.

The cancer society’s decision to reconsider its message about the risks as well as potential benefits of screening was spurred in part by an analysis published Wednesday  in The Journal of the American Medical Association, Dr. Brawley said.

In it, researchers report a 40 percent increase in breast cancer diagnoses and a near doubling of early stage cancers, but just a 10 percent decline in cancers that have  spread beyond the breast to the lymph nodes or elsewhere in the body. With prostate cancer, the situation is similar, the researchers report.

If breast and prostate cancer screening really fulfilled their promise, the researchers note, cancers that once were found late, when they were often incurable, would now be  found early, when they could be cured. A large increase in early cancers would be balanced by a commensurate decline in late-stage cancers. That is what happened with  screening for colon and cervical cancers. But not with breast and prostate cancer.

Still, the researchers and others say, they do not think all screening will — or should — go away. Instead, they say that when people make a decision about being  screened, they should understand what is known about the risks and benefits.

For now, those risks are not emphasized in the cancer society’s mammogram message which states that a mammogram is “one of the best things a woman can do to  protect her health.”

Dr. Brawley says mammograms can prevent some cancer deaths. However, he says, “If a woman says, ‘I don’t want it,’ I would not think badly of her but I would like her to  get it.”

But some, like Colin Begg, a biostatistician at Memorial Sloan-Kettering Cancer Center in New York, worry that the increased discussion of screening’s risks is going to  confuse the public and make people turn away from screening, mammography in particular.

“I am concerned that the complex view of a changing landscape will be distilled by the public into yet another ‘screening does not work’ headline,” Dr. Begg said. “The fact  that population screening is no panacea does not mean that it is useless,” he added.

The new analysis — by Dr. Laura Esserman, a professor of surgery and radiology at the University of California, San Francisco, and director of the Carol Frank Buck Breast  Care Center there, and Dr. Ian Thompson, professor and chairman of the department of urology at The University of Texas Health Science Center, San Antonio — finds that  prostate cancer screening and breast cancer screening are not so different.

Both have a problem that runs counter to everything people have been told about cancer: They are finding cancers that do not need to be found because they would never  spread and kill or even be noticed if left alone. That has led to a huge increase in cancer diagnoses because, without screening, those innocuous cancers would go undetected.

At the same time, both screening tests are not making much of a dent in the number of cancers that are deadly. That may be because many lethal breast cancers grow so  fast they spring up between mammograms. And the deadly prostate ones have already spread at the time of cancer screening. The dilemma for breast and prostate  screening is that it is not usually clear which tumors need aggressive treatment and which can be left alone. And one reason that is not clear, some say, is that studying it has not been much of a priority.

“The issue here is, as we look at cancer medicine over the last 35 or 40 years, we have always worked to treat cancer or to find cancer early,” Dr. Brawley said. “And we  never sat back and actually thought, ‘Are we treating the cancers that need to be treated?’

The very idea that some cancers are not dangerous and some might actually go away on their own can be hard to swallow, researchers say.

“It is so counterintuitive that it raises debate every time it comes up and every time it has been observed,” said Dr. Barnett Kramer, associate director for disease prevention at the National Institutes of Health.

It was first raised as a theoretical possibility in the 1970s, Dr. Kramer said. Then it was documented in a rare pediatric cancer, but was dismissed as something peculiar to  that cancer. Then it was discovered in common cancers as well, but it is still not always accepted or appreciated, he said.

But finding those insignificant cancers is the reason the breast and prostate cancer rates soared when screening was introduced, Dr. Kramer said. And those cancers, he  said, are the reason screening has the problem called overdiagnosis — labeling innocuous tumors cancer and treating them as though they could be lethal when in fact they  are not dangerous.

“Overdiagnosis is pure, unadulterated harm,” he said.

Dr. Peter Albertsen, chief and program director of the urology division at the University of Connecticut Health Center, said that had not been an easy message to get across. 
“Politically, it’s almost unacceptable,” Dr. Albertsen said. “If you question overdiagnosis in breast cancer, you are against women. If you question overdiagnosis in prostate  cancer, you are against men.”

Dr. Esserman hopes that as research continues on how to advance beyond screening, distinguishing innocuous tumors from dangerous ones, people will be more realistic about what screening can do.

“Someone may say, ‘I don’t want to be screened’ ” she said. “Another person may say, ‘Of course I want to be screened.’ Just like everything in medicine, there is no free  lunch. For every intervention, there are complications and problems.”

Copyright 2009 The New York Times Company


October 18, 2009
About New York
A Lifesaver Out of Reach, for Want of a Profit

Scrambling to get 60 seconds out of every minute, Katie Meacham finally got the boyfriend to take her for a carriage ride in Central Park. He hated it, she reports. “He said, ‘You know this is a pity ride, don’t you?’ ” she said, laughing.

Even though she is just 26, her days and time are at a premium. Ms. Meacham lives on the Upper East Side of Manhattan, but she is also a citizen of another country: cancer land. She has a kind of aggressive lymphoma, a disease that ruins the blood.

Her journey is worth a moment or two of reflection. For Ms. Meacham and thousands of others with similar illnesses, the best chance for a cure would be a transplant of cells from the bone marrow of a living person, or from the umbilical cord blood of a newborn. One way to sign up as a possible donor for Ms. Meacham or others is through the Web site of the National Marrow Donor Program, at join.marrow.org/4katie.

Every few months, stories like Ms. Meacham’s are broadcast on television and radio, or appear in newspapers. This year, a drive was held to recruit potential donors for Jasmina Anema, a 6-year-old girl in Greenwich Village who has leukemia. Perhaps 40,000 people a year come down with blood cancers.

As much as their personal struggles engage us, they also tell us about the hard limits of market-based medicine.

There is no easy way to make money from the cures to these diseases. Millions of people are willing to donate cells from their bone marrow, but commercial blood banks are not interested in bearing the cost of figuring out who wants to do it or in tracking them down when they are needed.

“It’s not a business,” said Robert Baitty, the director of the blood stem cell transplantation program at the Health Resources and Services Administration.

Similarly, more than four million babies are born every year in the United States, each one with an umbilical cord containing blood that is highly prized because it is less likely to be rejected when cells are transplanted.

“Most of the cord blood is just thrown in the garbage,” Ms. Meacham said.

The reason for this squander is simple. No one has figured out a way to make money by salvaging the blood and making it available for therapeutic use. It is expensive to collect the names and tissue types of millions of people, or tens of thousands of units of umbilical cord blood. For these lifesaving therapies, there is no business model.

Over the last four years, the federal government has stepped into the vacuum and taken on greater responsibility for the blood transplant programs. It financed an expansion of the National Marrow Donor Program, which has a registry called Be the Match.

And for the first time, a coordinated program was started to collect cord blood. In the four years since it began, the federal program has collected a little more than 40,000 units of cord blood, at a time when 16 million babies were born.

The main obstacle, Mr. Baitty said, is cost. The collection and storage of each unit of cord blood costs $1,500 to $2,500.

None of that money can be recouped until the cells are provided to a patient for transplant. “You incur all the cost of recruiting donors, shipping it to the bank, putting it in the freezer,” Mr. Baitty said. “Then you wait for someone to need it. It’s not attractive to private companies.”

The federal appropriation for collecting cord blood is about $12 million annually, which covers the cost of about 10,000 new units. If the national banks had 400,000 units of cord blood, that inventory could provide matches for 90 percent of the people with dozens of serious blood diseases, Mr. Baitty said. It would be ideal. It would also cost 40 times as much as is now being spent.

In New York City, mothers can donate their newborn’s cord blood at many hospitals, although they are urged to make their wishes known by the eighth month of pregnancy.

And then there are the drives inspired by individuals like Ms. Meacham, who, besides taking a horse carriage ride through Central Park, ran five miles a few weeks ago and is known as a person of great verve. She works in public relations.

The bone marrow registry programs typically ask for contributions of $50 to $100 to cover the costs of listing a person as a possible donor.

But Ms. Meacham’s friends and relatives have raised money so that anyone who goes to the National Marrow Donor Program site will be able to sign up without paying. And the information about their cells will be available not only to Ms. Meacham but to anyone else who might be able to use it for a transplant.

“We don’t want any obstacles,” she said. “For me or anyone else.”

E-mail: dwyer@nytimes.com

Copyright 2009 The New York Times Company


QuarterWatch: 2008 Quarter 4
October 8, 2009
Serious Adverse Drug Event Reports Increase 25% in 2008
Executive Summary

Fatal, disabling and serious adverse drug events reported to the Food and Drug
Administration increased by 25% for the full year of 2008, compared to the previous year.

The FDA received domestic reports of 100,789 cases of severe injury in 2008, compared to 80,598 reports in 2007. This was the largest one-year increase since the beginning of our historical data in 1998, although large increases were also reported in 2002 and 2003.
The biggest identifiable safety factor behind the 2008 increase was reports
associated with massive generic drug recalls in 2008 because of product quality assurance
problems that according the FDA posed a “reasonable probability” of serious injury or
death.1 The consumer-level recalls included more than half of the nation’s supply of
heparin in vial form, about 50% of the nation’s supply of the heart drug digoxin, and still
undetermined quantities of morphine, isosorbide and propafenone.

A second major factor explaining the increase was more voluntary reporting both
directly to the FDA for numerous drugs and, in specific cases by manufacturers who
learned of more events through increased contact with patients. We estimate that
approximately one-half of the 25% increase in 2008 was explained by more voluntary

In the 4th quarter of 2008 alone, we identified 24,609 reported cases of death,
disability and other serious adverse drug events, a total of 18.6% higher than the same
quarter one year earlier, and slightly less than the previous calendar quarter.
In the quarter we saw warning flags about two drug safety problems. Fentanyl, a
narcotic 100 times more potent than morphine, was the suspect drug in more cases of
preventable medication error than any other drug. Product recalls from KV Pharmaceutical

of St. Louis for possibly over strength tablets of seven different generic drugs were
associated with reports of death or serious injury in 458 cases in the 3rd and 4th quarters.
We discuss these signals in the full report.

The ISMP QuarterWatch pilot monitoring program evaluates computer excerpts of
all serious, disabling and fatal adverse drug events reported to the FDA for patients in the
United States. The US system for postmarket safety surveillance relies on voluntary
reports submitted by consumers, doctors, pharmacists and other health professionals. The
submission of a report does not in itself prove that the suspect drug caused the event
described. There are no reliable estimates of what fraction of serious adverse drug events
are ever reported, and small studies and our own investigations show wide variation
between drugs and among different types of adverse reactions. Although we have
occasionally documented instances where injuries for a drug may be over reported, the
events reported to the FDA are believed to be a relatively small fraction of the drug-related injuries actually occurring.

Varenicline (CHANTIX). In July 2009 the FDA and Pfizer greatly strengthened the
warnings regarding the risks of violence to self and others associated with this aid to
stopping smoking. But in a step backward, weak and potentially misleading language
about the risk of accidents was added to the patient Medication Guide. Given the
accumulating evidence that varenicline causes violent and aggressive behavior, its use
should be further restricted in the military, as well as for police and other emergency

Montelukast (SINGULAIR). We previously reported a large surge in adverse event
reports of psychiatric side effects, apparently in response to an FDA advisory notice
posted after Merck reported a small number of cases of suicidal behavior. In August
2009 the FDA and Merck added precautionary language to the prescribing information
for doctors. Merck also provided a clear alert for patients on its SINGULAIR web site.
The alert was also expanded to include additional psychiatric side effects including
aggression, abnormal dreams and hallucinations.

Adverse Event Reporting System
We observed substantial increases in the 4th quarter for two Biogen Idec products,
interferon beta (AVONEX brand) and natalizumab (TYSABRI). The company said one
factor in the increase was that it had begun submitting its reports electronically in the 4th
quarter and because of software compatibility problems with the FDA, duplicate reports
were being generated.

Although the dangers of fentanyl transdermal systems have been documented in
numerous reports and subject to previous FDA regulatory action, the new data show that
the risks of this high alert drug are not under adequate control. We believe measures are
needed to insure that every patient receives education on the risks and safe use of this

The FDA and Pfizer need to strengthen and clarify the accident warning for
varenicline to make clear to all patients that severe adverse effects may occur when the
drug is started, after a few weeks, or even on discontinuation. In addition, because the
drug can cause violent behavior, interrupt muscle control and cause blackouts, we believe
the Department of Defense should extend its ban from aircraft and missile crews to all
active duty military personnel. Its use should also be limited in police and emergency

We continue to have concern about the massive recalls of generic drugs, mainly
because defective quality assurance resulted in companies distributing potentially over
strength tablets for drugs in which a small overdose can be life-threatening. We have also
noted that neither the FDA nor the manufacturer will reveal the size of some large recalls,
and that manufacturers are often left to handle any public announcement.


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