Health Policy Solutions

By Katie Kerwin McCrimmon

Once certain that he would die young, the man born with the deadly disease now dreams of growing old.

“I’m going to be a grandfather someday. I’m going to have a really long life,” says Bill Elder, a 25-year-old Stanford graduate who is now applying for medical school.

That’s because of a blue pill and a new trend in drug development called venture philanthropy.

Elder has cystic fibrosis (CF). It’s known as an “orphan disease” because so few people have it — only about 30,000 in the U.S. and about 70,000 worldwide — so there is little incentive for drug companies to seek a cure.

Developing a single new drug can cost a billion dollars, so pharmaceutical companies want to create blockbusters for common diseases like Alzheimer’s or cancer to maximize the return on their investment.

‘Best of business, best of philanthropy’

For many years, lack of interest from Big Pharma left families of those afflicted with rare diseases facing a bleak future.

When Piper Beatty was born 30 years ago and diagnosed with CF at 6 weeks, health workers gave her parents a heartbreaking message: “Take her home and love her as long as you have her,” Beatty recalled from stories of her infancy.

At that time, the best the family could hope for was that she would live to be a teenager. Today, the official life expectancy for a child born with CF is 37 years.

Beatty, now 30 and a law school graduate from Colorado who is living in New York, has high hopes for improved therapies for CF patients and others born with rare genetic diseases. She is alive thanks to a double lung transplant she received in 2010, but expects many younger CF patients to be able to take drugs to prevent the lung damage she suffered.

“From a patient perspective, venture philanthropy is a remarkable strategy,” Beatty said. “It’s the best of business and the best of philanthropy coming together. It allows us to be very active in the drug development process. It allows people with a stake in the disease to get involved to partner with the drug companies. You take an active role at the forefront of the fight.”

The outlook for some CF patients just improved dramatically thanks to the little blue pill called Kalydeco, which was approved by the FDA in January. Because the nonprofit Cystic Fibrosis Foundation knew that no drug maker would take the financial gamble to find a cure for their relatively obscure disease, it took the initiative. The foundation raised money, partnered with a pharmaceutical company called Vertex Pharmaceuticals Inc., poured about $75 million into the development of Kalydeco, and will get royalties from drug sales to fuel more research.  Other charities including the Michael J. Fox Foundation, which is fighting for a cure for Parkinson’s, are following the CF model.

Kalydeco is the first drug that addresses the underlying cause of CF, a faulty protein. It doesn’t work for all CF patients,

Kalydeco

just for those who have a particular gene mutation. And since FDA approval in January, stock prices for Vertex have been up and down. In June, the stock price plummeted after Vertex revised reports on a Phase 2 study of another medicine being developed for CF. That medicine, VX-809, targets a much more common gene mutation. In the U.S., nearly 90 percent of people with CF are believed to have at least one copy of this mutation.

Then, in July, the stock price rose after the European Union fast-tracked approval of Kalydeco for patients there.

Piper Beatty must wait to be a candidate for Kalydeco or future drugs that can reverse her CF. She doesn’t have the specific gene mutation that would make her eligible for the first round of Kalydeco treatments. But Bill Elder, the 25-year-old pre-med student, is taking the drug.

‘It’s working!’

“It’s a brand new day for everyone who can take this drug,” Elder said.

He was one of the first patients to receive Kalydeco. His first shipment arrived via FedEx in February at the Colorado home where he lives with his parents.

Just before bed that night, Elder took his first pill. He was stunned when he woke up at 2 a.m.

“Wow, something feels different,” he thought. “Oh my God. It’s the first time in 15 years that I’m able to breathe through both nostrils. I haven’t had a sense of smell in years.”

Elder studied human biology at Stanford and has extensive experience as both a research subject and a researcher himself. So, he forced himself to slow down and evaluate what was going on.

“I was very, very skeptical. I sat there for about a half hour and took some notes.”

Then the kid in him bolted to his parents’ bedroom, where he woke them up and shared his news.

“Kalydeco is working! It’s working!” he said.

Tears streamed from his parents’ eyes. Born in Nebraska where there was no newborn screening, Elder was not diagnosed with CF until age 8. He suffered from debilitating stomachaches as a child. But, his family lived for a time in Conifer where he played soccer and other sports at high altitude, giving his lungs good workouts and keeping him relatively healthy.

In high school, Elder’s symptoms escalated, but aggressive treatments at Children’s Hospital Colorado kept him on track. He suffered setbacks again in college when he lived in the dorms and was a magnet for every germ that circulated among the students.

Elder moved home to Cherry Hills Village with his parents after graduation. On the night he first took Kalydeco, he marveled at his new-found sense of smell, thrilled to breathe in a pine scent from candles in his home.

Since taking that first pill, Elder has fine-tuned the regimen to maximize the drug’s benefits. He has health insurance through his family that covers the steep cost: about $294,000 per year.

At first, Elder found that he wasn’t taking enough fat with the drug and his body wasn’t absorbing it well. Now he takes it with heavy doses of high-fat foods like bacon, and is having excellent results. He’s breathing well and hasn’t needed hospital treatments for years. He now runs for about an hour every day.

Since he was diagnosed as a child, Elder understood that he would stay healthy if he took good care of himself. To this day, he’s religious about taking his medications and completing time-consuming daily therapies, and wearing a vest that pounds his chest, keeping his lungs clear of harmful mucous.

Bill Elder doing treatment with vest.

The man who instilled that sense of responsibility in Elder and who has helped extend his life is Dr. Frank Accurso. Accurso is Elder’s doctor at Children’s Hospital Colorado and a pediatrics professor at University of Colorado School of Medicine. He  has become a key mentor for Elder and a leader in the CF community for his  research on a disease that few ever cared about. Accurso led the Phase 2 clinical trials in the U.S. for Kalydeco.

“The day I was diagnosed, he sat me down, and said, ‘Bill, these are your pills. You’re going to be in charge of your medicine.’ He put that level of responsibility on me. He made me very independent and very strong,” Elder said.

Curiosity as med student led to  CF dedication

The national Clinical Research Forum honored Accurso earlier this year for his pioneering research that helped win FDA approval for Kalydeco. The New England Journal of Medicine published the research in January.

Accurso says it was a team effort.

“The discovery of the gene and the abnormal protein was made by academic researchers all over the world with a lot of support from the National Institutes of Health (NIH). You had to get to a certain point before the drug companies could (find a drug),” Accurso said.

The CF Foundation also was critical, he said.

“They had the ear of the NIH. They pointed out that this was basically a fatal disease. So, even though the number of patients is small, the impact is significant. The NIH realized that something had to be done.”

Accurso’s work in CF came almost by accident because of a lecture during medical school.

“I can remember walking out of the first lecture and being puzzled by the whole thing,” Accurso said.

Dr. Frank Accurso

His curiosity piqued, Accurso dedicated himself to a career as a pediatric pulmonologist. He leads the CF center at Children’s, which treats about 700 patients a year, making it the largest CF center in the U.S. Accurso also helped push for screening to detect CF at birth. Colorado became the first state in the nation to adopt newborn CF screening in 1982. The last state implemented it in 2009. Accurso fought for early detection because he was intent on preventing potentially irreversible lung damage in children with CF.

The discovery of the gene that causes CF came in 1989 and opened new possibilities for someday finding a cure.

“That was super critical. Once they identified the gene and the protein, all sorts of things could happen,” Accurso said.

Still finding the ingredients for Kalydeco was not easy. Accurso said there are essentially two paths to creating a new drug. First, you can figure out everything that goes wrong with a cell and try to correct it.

“That has proven very difficult,” he said.

Or, you can try chemical after chemical on the faulty protein and see if anything helps.

“It’s random. You’re shooting in the dark,” he said.

But those wild shots eventually succeeded. After trying more than 250,000 different chemicals, Accurso said researchers found four or five that appeared to work for CF. The next step was tweaking “a molecule here and there.”

Altogether, Vertex scientists have spent 14 years discovering and developing Kalydeco. A scientist at Vertex’s San Diego site discovered Vertex in 2004. The first clinical trials began in 2006. Dr. Accurso led the Phase 2 study in 2007. Vertex initiated Phase 3 trials in 2009 and in January of this year, the FDA approved Kalydeco for people with CF ages 6 and older who have at least one copy of a faulty mutation called G551D. Approximately 1,200 people, or 4 percent of those with CF in the United States, are believed to have this mutation.

Accurso said researchers began with that mutation because they believed it would work best.

“We picked our best shot,” he said. “Ultimately, it has the potential to help somewhere between 50 and 90 percent of people with CF. We’re not done learning.”

Megan Goulart, a spokeswoman for Vertex, cautioned that current studies of Kalydeco show that it could help about 10 percent of CF patients.

For  Accurso, the discovery of Kalydeco was so vital because it finally targets the root cause of CF. In the past, he felt like he was constantly swimming upstream. All he could do was find better ways to deal with the onslaught of damage on patients’ lungs and digestive systems. Children with CF often have to spend weeks in the hospital each year receiving high doses of antibiotics and having harmful mucous pounded out of their bodies. Accurso had to watch as the disease wreaked its havoc, mostly on children.

While the median life expectancy is now 37, Accurso said the average age of death is 27, and “in any given year, of the people who die, one quarter are younger than 18.

New discoveries now make him optimistic.

“For me, and for the families, I believe we have a way forward. There’s an intense amount of hope,” Accurso said. “Within four years, I think it’s likely that there will be one or two combination treatments that will help most people with CF. In 10 years, I have a good feeling that almost everyone with CF will have a drug that will be like their insulin.”

Editor’s note: An earlier version of this story misstated the reason that Vertex’s stock price declined in June. The cause for that decline was not based on reports about Kalydeco alone, but rather a new medicine that could work as a combination therapy with Kalydeco. Also, this version of the story updates details about the discovery of Kalydeco and its prospects for helping patients with CF.

By Chris Lindley

Most pregnant women across the United States listen to and rely on sound medical advice from their doctors and other health experts when determining how to protect the health of their unborn babies. “Don’t drink during pregnancy” is a message based on evidence that resonates with most expectant mothers and contributes to the health of future generations.

The Colorado Department of Public Health and Environment would like to reinforce that message with a critique of a recent study that suggests moderate drinking during pregnancy is not harmful to young children.

On June 20, a Danish research article titled, The Effects of Low to Moderate Alcohol Consumption and Binge Drinking in Early Pregnancy on Executive Function in 5-year-old Children, written by Skogerbo, et.al., was published in the British Journal of Obstetrics and Gynecology. The study drew media attention after the U.S. Department of Health and Human Services posted a news item on its website titled, “Moderate” Drinking During Pregnancy Has No Effect on Young Children. These findings and the accompanying media coverage sent a confusing and potentially dangerous message to pregnant women.

Before that message permeates society and risks the health of young children, the following limitations to this recent study should be considered:

• Study investigators themselves caution that the findings should not be taken as proof that light drinking during pregnancy is safe or that a safe level of alcohol use during pregnancy exists.
• Small sample sizes of moderate and heavy drinkers were not statistically sufficient.
• Half (51 percent) of the children born to mothers participating in the study were tested for cognitive and developmental deficits. Researchers acknowledge that mothers of children not functioning at age level might have been more likely to decline participation in deficit testing.
• The study relied on self-reporting of alcohol consumption during pregnancy.  Research shows that self-reporting of alcohol consumption frequency and quantity is often underestimated.
• The Kesmodel study clearly states that deficits related to fetal alcohol exposure may emerge after age 5 years.

Years of research and numerous epidemiological and clinical studies show harmful effects to a growing embryo from alcohol exposure. These effects may be present immediately after birth, at infancy or later in life, especially if the damage involves the central nervous system.

Studies show that there is a 6-to-10 percent chance that a fetus exposed to very high repetitive doses of alcohol will develop prenatal and postnatal growth deficiency, specific craniofacial dysmorphic features, mental retardation, behavioral changes and a variety of major anomalies.  With lower repetitive doses there is risk of slight intellectual impairment, growth disturbances and behavioral changes.  Prenatal exposure to alcohol also is associated with higher levels of conduct disorder symptoms in offspring.

Colorado women may not review or critique studies when deciding whether to drink during pregnancy. Instead, they rely on what they hear from their families, friends and doctors, and what they read, hear or see in the media to guide their decisions. Most would agree that excessive drinking is bad for their babies, but may not know if an occasional glass of wine crosses the line.

Studies like these blur that line and cause women to question their conscience.

The U.S. Surgeon General, the American Congress of Obstetricians and Gynecologists and other health experts advise abstinence for pregnant mothers who want to protect their children from fetal alcohol spectrum disorders. Until research conclusively contradicts that good advice, CDPHE will continue to clearly communicate to Colorado women that alcohol and motherhood do not mix.

Chris Lindley is director of the prevention services division at the Colorado Department of Public Health and Environment.

By Ben Young and David Cohn

The first seven cases of acquired immune deficiency syndrome (AIDS) diagnosed in Colorado were discovered in 1982. By the end of 2011, almost 17,000 people in Colorado had been diagnosed with human immunodeficiency virus (HIV), the virus that causes AIDS, and more than 5,000 had died from complications of the disease.

These are not just numbers. They represent people – our children, mothers and fathers, brothers and sisters, partners, friends, neighbors and colleagues.

Today, we know more about HIV. Many of these advances over the past 30 years can be linked to Colorado’s role in HIV treatment, prevention and education, earning our state a respected and prestigious reputation within the global HIV community.

The historic 1983 Denver Principles asserted for the first time the fundamental rights of those living with AIDS to participate in the decision-making for their care. The Colorado AIDS Project and other organizations were founded to facilitate and supplement care and education. The Governor’s AIDS Coordinating Council and Denver HIV Resources Planning Council brought many to the table to collaborate as advisory bodies on advocacy and public policy, and eventually, in decision-making on equitable distribution of much-needed federal funds for care and treatment.

In the 1980s, researchers at Denver Public Health (DPH) and National Jewish Hospital (NJH) studied the epidemiology and immunology of the then-mysterious disease, and both DPH and the University of Colorado participated in early prevention programs in at-risk populations.

In the 1990s, faculty members from CU’s Division of Infectious Diseases led the National Institutes of Health’s AIDS Clinical Trials Group and Community Programs for Clinical Research on AIDS, providing novel and experimental treatments to many patients, paving the way to the development of successful combination treatment regimens against HIV.

Through collaborations with the Centers for Disease Control and Prevention (CDC) and community clinicians at Rose Medical Center and NJH, in 1998 came the first reports of reduction in the death rate from AIDS. Most recently, critically important work led by doctors at DPH has brought needed attention to important gaps in accessing HIV medical care. All of these discoveries came about because of the Coloradoans who volunteered for clinical studies.

The world is indebted to these many individuals.

Today, with access to medical treatments and care, HIV need not lead to AIDS and death. Indeed, people living with HIV can expect a high quality of life and normal life span.

But decreased death and better medicines have led to false perceptions that HIV isn’t a serious health threat or that people are no longer at risk.

We are concerned that these beliefs and other societal barriers have kept our state’s diagnosis rate, averaging 430 Coloradans per year, from declining over the past decade. Although these represent a rate of new infections that is three times less than 20-25 years ago, we still need to address the “plateau.”

Stigma, discrimination and prejudice prevent many people from getting tested. Perhaps even more alarming is that among those who do test positive, many never enter medical care or fail to stay successfully engaged with potentially life-saving treatments.

As advocates, activists and concerned citizens who have joined the fight to end HIV/AIDS, we must do more. Today, one new person becomes infected with HIV every 9.5 minutes in the United States, and an estimated 1-in-5 individuals don’t know that they are HIV-positive.

The first step anyone can take to help in this fight is to get an HIV test (the CDC recommends regular testing for anyone 13-64). Getting tested is not time-consuming, complicated or painful. Most tests involve a simple finger prick, and results are available in less than 12 minutes. Last week, the Food and Drug Administration approved the first over-the-counter HIV test, allowing people to test themselves at home and get preliminary results in less than 30 minutes.

We can all be HIV/AIDS advocates. So we call on everyone to learn about HIV and start this discussion with family members and friends. By creating a robust public discourse, we can help make discussions about HIV/AIDS less taboo.

After all, HIV awareness shouldn’t just take place one month a year, but each and every day.

Dr. Benjamin Young is medical director of Rocky Mountain Cares and chief medical officer of the International Association of Physicians in AIDS Care. Dr. David Cohn is the former associate director of Denver Public Health and founder of the Denver Health Infectious Diseases/AIDS Clinic.

By Diane Carman

Peering into the controversy over routine use of the blood test to screen for the prostate-specific antigen is like falling down, down, down into the dark and bewildering rabbit hole that is the health care system in the United States. In many ways the debate over the PSA test illustrates why the system is so confounding, expensive, unmanageable and resistant to change.

As men, their providers and policy experts wrestle with the PSA conundrum, recent battles over mammography and hormone replacement therapy illustrate key lessons. When women learned that there was potential harm from annual breast screening and hormone therapy, far fewer demanded mammograms and hormone sales tanked.  Evidence shows informed consumers could actually save millions of dollars by realizing that when it comes to health care, less often may be more.

Last month, the U.S. Preventative Services Task Force recommended against the routine use of the PSA test, citing data from clinical trials in Europe and the U.S. saying that statistically the risks outweigh the benefits.

“One man in 1,000 – at most – avoids death from prostate cancer because of screening,” the task force report said. Meanwhile, for every 1,000 men screened, 30 to 40 will develop erectile dysfunction or urinary incontinence; two will experience a serious cardiovascular event, such as a heart attack; and one will develop a serious blood clot in his leg or lungs due to treatment. For every 3,000 men screened, one will die of complications from surgery.

On the other side of the debate were doctors who treat prostate cancer,  prostate cancer survivors, patients and the patients’ nervous wives or partners who feared that leaving any cancer untreated was simply too risky.

Few on either side mentioned the economic considerations, but practitioners who diagnose and treat prostate cancer, hospitals that compete for patients, and pharmaceutical companies that produce drug therapies for prostate cancer and side-effects resulting from its treatment have a vested interest in maintaining the status quo. The annual cost for PSA screening alone is estimated at $3 billion. Just how much that vested interest influences medical protocols is a question few dare even ask.

Dr. Allan S. Brett and Richard J. Ablin raised the issue in a commentary in the New England Journal of Medicine  last November. They said that when it comes to “responsible stewardship of health care resources … policymakers cannot ignore economic aspects of screening.”

They cited an estimate that at a minimum, $5.2 million is spent on screening and prostate cancer intervention for every life saved. “We believe that the current PSA-based screening paradigm does not compare favorably with competing health care priorities.”

Unless it’s your prostate.

Despite the fact that health care spending in the U.S. in 2010 reached $2.6 trillion, nearly 18 percent of the GDP,  when it comes to their own health care, the public clamors for more.

“We do not have a system that tries to buy value right now,” Atherly said.

Benefits of test unclear

Never mind issues relating to cost, from a purely personal standpoint accepting the task force recommendation to forgo PSA screening is tough for most men to wrap their heads around.

Dr. Tim Byers

“The idea that detecting cancer earlier is better than detecting it later is indelibly etched into our consciousness because that seems to hold true for pretty much all cancers,” said Dr. Tim Byers, an epidemiologist and professor at the Colorado School of Public Health. “Generally, the earlier the diagnosis, the better the outcome.”

The trouble with the PSA test and most of the other diagnostic tests that are used to screen for prostate cancer is that they don’t accurately determine how dangerous the specific cancer is.

“We really need to educate our patients more about how common prostate cancer is and that there are benign or fairly inconsequential types of cancer,” said Byers.

For men over 85, an estimated 75 percent have prostate cancer that poses little or no risk to their health

“People think all screening is good,” said Dr. Ned Calonge, president and CEO of The Colorado Trust and a member of the U.S. Preventative Services Task Force that produced the PSA test recommendation.

The “champion all-time winner” of cancer screens is the Pap test, which “reduces the risk of dying of cervical cancer by as close to 100 percent as we can ever get,” Calonge said. Mammography, by comparison, reduces the risk of death from breast cancer by 25 percent and the PSA test “at best is one in a thousand.

“It’s not a good test,” he said. “We’ve oversold the public on it.”

Dr. Ned Calonge

Richard Ablin, the inventor of the PSA test, has called it “a hugely expensive public health disaster.”

Still, the American Cancer Society estimates that 28,170 men will die of the more aggressive forms of prostate cancer this year.

And yet, the potential side-effects of prostate cancer treatment, including incontinence, impotence or both, are serious considerations for most men as well.

“It’s a hard thing to make a recommendation on,” said Byers. “I know men who have had screening complications and I’ve had friends who have died from the disease.”

Calonge has no hesitation about recommending against the test.

“I think prevention needs a higher bar of evidence,” he said. “Remember, you are an otherwise well and asymptomatic person and now I’m going to reach out and do something to you. I need absolutely the best evidence that it will be helpful.”

For those who are diagnosed with prostate cancer, treatments range from surgery or radiation to active surveillance, an increasingly common recommendation that involves monitoring the cancer over months or years instead of treatment.

Not all patients can handle the less invasive option though.

Some patients “get anxious,” Byers said. “You feel like you’re sitting on a time bomb — or else your wife does.”

Calonge counseled patience.

“It’s important to recognize that the fusion of information takes time.”

Screening, treatment a booming industry

Since the test was approved by the U.S. Food and Drug Administration in 1986, the PSA blood screen has been used on millions of men, many of whom were uninformed about it when they submitted to the test. Doctors simply checked off “PSA” on the lab form for blood analysis along with cholesterol screens and other routine tests. Then, if the PSA numbers were high, the doctor broke the news to the patient and outlined his options.

The American Cancer Society estimatesthat 242,000 new cases will be diagnosed in 2012  and most will result in some form of costly treatment.

Adam Atherly

Atherly explained that under Medicare and most private insurance plans, “the financial incentive is always to do more for patients.” And cancer survivors become walking, talking advertisements for aggressive intervention.

“There are literally millions of men who are prostate cancer survivors who have become strong advocates” for screening, Byers said. For those who have undergone treatment for early-stage prostate cancer, the belief that it saved their lives is nearly unshakable.

Recommendations can affect profits

If the recommendations of the U.S. Preventative Services Task Force were rigorously followed, the economic impact to health care providers and drug companies would be serious.

When the task force called for less routine mammography screening among women in 2009, providers began to see a drop in the numbers of women seeking the tests. A survey conducted by the Avon Foundation  found that within three months of the task force announcement, 24 percent of providers surveyed reported a decrease in the number of women requesting mammography.

The response to findings released in 2002 by the Women’s Health Initiative that challenged the safety of routine use of hormone replacement therapy for post-menopausal women offers another a case in point.

In 2001, before the release of the Women’s Health Initiative findings, 61 million prescriptions were written for the two most popular forms of hormone replacement therapy, Wyeth’s Prempro and Premarin. An estimated 6 million women took the drugs. The two pharmaceutical compounds produced $2 billion in sales for Wyeth that year.

When the Women’s Health Initiative findings were announced, the company’s stock fell by 24 percent.

By 2004, the number of prescriptions for Prempro and Premarin dropped to 21 million.

(Last month, the U.S. Preventative Services Task Force issued a recommendation advising against routine use of hormone replacement therapy for women over 50. It said, as it did with PSA screenings, that the risks outweigh the benefits. The task force cited findings of increased incidence of dementia, stroke and other serious conditions among women using hormone replacement therapy.)

Calonge said during his tenure from 2004 to 2011 as a member and a chair of the task force, cost was never a factor considered in determining recommendations.

“It did come up,” he said. The members held entire meetings on whether to include economic considerations in their recommendations. “Repeatedly, members voted that down.”

Other task force recommendations, such as those calling for screening and intervention for treatment of obesity, were destined to cost the health care system, proving that the task force wasn’t just out to save the health care system money.

“We separated our recommendations from the issue of cost,” Calonge said. “They were based entirely on science.”

Richard Lamm

Managing costs a minefield

While health care providers have much to lose by changing treatment protocols, it would seem that the national economy would benefit by any such changes that might lower health care costs. But few policymakers have the temerity to broach the subject of cost control in health care out of fear of being accused of rationing care or advocating for death panels.

Politicians nearly always rail about the runaway costs of Medicare, Medicaid and health care in general as they campaign across the country, but with the exception of cutting reimbursement rates to providers, they seldom propose concrete policies for reducing health care costs.

“I understand the political volatility,” said former Gov. Richard Lamm, co-director of the Institute for Public Policy Studies at the University of Denver and the author of “The Brave New World of Healthcare.” “But so much of public policy is driven by cost-benefit analysis, why does health care have no limits?”

Taxpayers pay for more than 50 percent of health care in the U.S., he said, which means that a system without serious cost-containment measures is “a fiscal black hole.”

“There’s definitely a belief that we over-treat in this country,” said Athlerly, who pointed to studies showing high numbers of diagnostic scans and images ordered by doctors in the U.S. compared to those in other countries.

Yet, evaluating medical protocols to identify unnecessary treatments is almost unthinkable.

“The Affordable Care Act includes language ruling out that sort of cost analysis,” Atherly said, and when it comes to the American public, there is little support for cost controls in health care.

“I see a million avenues” for controlling costs, Atherly said. “Tell me what system you want, and I’ll tell you how to control costs. There is no problem getting health care costs under control.

“The trouble is we as a society haven’t been willing to allow anyone to control costs,” he said. “There are plenty of tools available. It’s purely a matter of the public not being willing to have that happen right now.”

Good medicine is the bottom line

The PSA test recommendation flare-up reveals medicine as science, art and industry.

The data from the clinical trials are persuasive: the screening finds lots of men with prostate cancer but cannot yet identify which cases are harmless and which are deadly. The pathology of cancer cells is one of the critical frontiers in science, but the answers remain elusive. As a result, many men are treated unnecessarily and many will suffer lifelong consequences.

“Both here and in Europe, we’re seeing the same kinds of complications or side-effects,” Byers said. “A not insignificant proportion of men treated for prostate cancer are ending up with complications of one kind or another affecting urinary or sexual functions and problems with their rectum related to surgery or radiation.”

Counseling men to help them make good decisions about whether to undergo PSA screenings or prostate cancer treatment is not easy. It’s an art. Not all doctors have the time or the ability to do it well, and not all patients are willing to accept any level of risk when it comes to cancer.

At the same time, across most of the U.S. health care system, the financial incentives argue for more – not less – testing and treatment. The only patients inclined to consider costs first in deciding whether to undergo a PSA test are the uninsured.

Still, Byers said, “if the angle is that economic self-interest can outweigh objective evidence, even though I think that’s true, it’s probably an oversimplification.”

In the case of the PSA test, he said the goal really is good medicine.

Atherly agreed.

“I don’t think the PSA discussion is at all about economics,” said Atherly. The task force is “essentially saying that the clinical benefit doesn’t justify the clinical risks. There are no dollar signs attached to it.”

Calonge is adamant that the task force recommendation on the PSA test is a powerful reflection of the science and the data — and nothing else.

“Doing something that doesn’t work and that overall is harmful just to do something is a bad strategy for prevention,” he said.

The debate over PSA tests won’t be the last to put established cancer screening and treatment practices under the risk/benefit/cost microscope.

As clinical trials continue, Byers said researchers have begun to wonder, “How good is the evidence that finding and treating small cancers really does save lives?”

Until scientists crack cancer’s genetic code and find the way to identify which cancers kill and which ones are harmless, the question will remain.

By Virginia A. Moyer, M.D.

Amid the many messages you will hear about screening for prostate cancer in the coming days, I hope these stand out most prominently: Science finds that there is at a best a small potential benefit from prostate cancer screening and there are substantial known harms. We need a better test, and we need better treatment options. We can do better.

The panel that I chair, the U.S. Preventive Services Task Force, has just issued a recommendation against screening men of any age for prostate cancer using the prostate-specific antigen (PSA) blood test. The draft of this recommendation was posted for public comment in October. Since then, we have read the many comments received, reviewed newly released evidence, and arrived at this conclusion:

Many men are harmed as a result of prostate cancer screening and few, if any, benefit. The evidence shows that at most 1 man in 1,000 screened will avoid a prostate cancer death over the course of 10 years, and in the best and largest study done in the U.S., no benefit was shown. Of the same 1,000 men screened, two to three will have a serious complication of treatment such as a blood clot, heart attack or stroke, or even death, and up to 40 will have erectile dysfunction, urinary incontinence or both. About 30 to 40 men in 1,000 will also have less serious but bothersome harms from a prostate biopsy, such as infection.

We need a better test, and we need better treatment options.

Cancer is a frightening word, but not all cancers are deadly. Prostate cancer is rarely aggressive enough to cause death within the course of a man’s natural lifespan. Three-quarters of men older than 80 and a third of men between ages 40 and 60 have cancer cells in their prostate, and yet men have only a 2.8 percent lifetime risk of dying from the disease. Currently, there is no way to know which men have a cancer that may benefit from treatment.

Until we have a better test and better treatment options, the USPSTF has recommended against screening for prostate cancer. Whether or not to be screened for any condition is a decision each person must make with his or her clinician based on individual values and preferences, but we are urging all health care professionals to be forthcoming about the facts around prostate cancer risk, the relatively small benefit of detecting the cancer, and the significant known harms of screening and treatment.

To be sure, there are gaps in the existing evidence on this topic. One particular area of concern is that African-American men have a higher risk of developing prostate cancer and dying from it. The same is true for those with a family history of the disease. There is no evidence to suggest, however, that these men have an increased benefit from current prostate cancer screening or that the balance of benefit and harms is any different for them. We need more research to improve the health of men at high risk for prostate cancer and to eliminate health disparities.

Some critics of our recommendation have suggested that we based our decision on an urge to cut costs for insurance companies and government programs such as Medicare. Cost is not a consideration in our evaluation of the scientific evidence. Our mission is to improve the health of all Americans by sharing evidence-based recommendations with them and empowering them and the clinicians who serve them to make informed decisions.

The members of the USPSTF are human; we face the same concerns and fears about health challenges that you do. This topic is not something we take lightly, and this decision was not reached in a cavalier fashion. It is based on science and rooted in the knowledge that while we all want to help prevent deaths from prostate cancer, we need to recognize that current methods of PSA screening and treatment of screen detected cancer are not the answer.

We can do better.

Dr. Virginia A. Moyer is chair of the U.S. Preventive Services Task Force, an independent panel of experts in prevention that reviews and makes recommendations for clinical preventive health services.

By Katie Kerwin McCrimmon

The Denver mother keeps EpiPens and Benadryl in her fanny pack, in three places in the car and in every room of the house.

Skye Barker Maa lives on the front lines of a battle that is escalating in the world’s richest countries and unheard of in some of the most poverty-stricken parts of the globe.

She has two severely allergic children and no explanation for why seemingly normal foods could kill her kids.

“It doesn’t make sense to me. I’m not allergic to anything. There are no allergies on my side of the family,” she said.

Her husband has some milk intolerance, but it’s not a big deal.

Yet, their older child, Sebastian, now 3, can’t drink a quarter of a teaspoon of milk without going into shock.

The problems began at just three months when Barker Maa was breastfeeding and noticed that Sebastian got rashes and became very fussy if she ate dairy products. So, she cut them out of her diet. Then, at age 2, he ate a tiny piece of banana bread with walnuts in it and started to go into anaphylactic shock. Doctors at National Jewish Health later determined that he was severely allergic to tree nuts, peanuts, milk and shellfish.

“Oh, and there was a brief stint with amoxicillin,” Barker Maa said, describing what appeared to be an allergy to antibiotics.

Their daughter Sloane, 2, has severe asthma and a peanut allergy.

The family lives in the urban chic Stapleton neighborhood and Barker Maa has become the kind of parent who’s omnipresent at her son’s preschool. Before every birthday party or school celebration, she springs into action like a super hero fending off danger.

“Please don’t give my kid a cupcake,” she tells parents and teachers. “It could kill him.”

Researchers at the nation’s premier hospital and research center for asthma and allergies, National Jewish Health, are puzzled by the mysterious epidemic that strikes wealthy countries where sanitation and food supplies are best.

Hay fever, eczema, asthma and food allergies, which were mostly unheard of 100 years ago, have doubled in prevalence, says Dr. Erwin Gelfand, chair of pediatrics department at National Jewish.

Hay fever, eczema, asthma and food allergies, which were mostly unheard of 100 years ago, have doubled in prevalence, says Dr. Erwin Gelfand, chair of pediatrics department at National Jewish.

New data from the U.S. Centers for Disease Control and Prevention recently revealed that the percentage of adults and children with asthma has climbed to its highest point ever, growing from 7.3 percent in 2001 to 8.4 percent in 2010.

And a mild spring across the U.S. has created a spike in seasonal allergies triggering a rash of sneezing and itchy, red eyes.

Researchers don’t know yet why the developing world is inundated with allergic diseases and asthma while these conditions are rare in places like rural Africa.

“Why the western world and not the developing world? Are we too clean? Are we getting all these vaccinations? Have we shifted the balance?” Gelfand wonders.

He and others are hunting down possible culprits that range from suspicious links between acetaminophen and asthma, to environments for babies that could be too clean, to waiting too long to introduce new foods to babies. Perhaps the super-doses of folic acid, which have dramatically helped reduce birth defects, have inadvertently increased allergies.

Even obesity may be to blame since extra pounds are linked to increased inflammation and higher allergy rates.

Regardless, says Gelfand, prevention is key. That’s why researchers around the world are working to solve the allergy-asthma mystery.

One consistent finding is that children who grow up on farms drinking fresh, non-pasteurized milk seem to have some protection from allergic diseases. A simple visit to a farm or purchasing farm-fresh milk is not enough. The mothers and newborns have to spend significant time in that environment.

“What is in on farms with livestock?” Gelfand said. “Is it related to exposure to the (livestock) droppings? Is there a different bacterial content that somehow has a protective effect?”

Studies in Kenya of the Masai people reinforce the protective effects of contact with bacteria.

“When they’re out in the rural areas, living in dung huts, allergy is lower than if they live in the city,” Gelfand said. Rural people certainly experience other health problems,  including parasites.

But, for allergy researchers, rural locales may hold a piece of the puzzle.

“It would be very nice to know how to harness that to newborns and prenatal mothers,” he said. “Through vaccinations, one might do something.”

In cities, our houses are more airtight and our diets have changed.

“Have we somehow changed the flora in our guts to avoid some protective effects?” Gelfand said.

A study by Dr. Gideon Lack of King’s College London, who previously studied and worked at National Jewish, compared 10,000 Jewish children who lived in similar communities in London and Tel Aviv. Peanut allergies were ten times more common among children in the United Kingdom. When Lack explored the disparity, he found that Israeli parents frequently give their infants a peanut-flavored snack called Bamba.

Lack then theorized that early exposure to peanuts may be protective rather than harmful, a notion that turns typical allergists’ advice on its head. American mothers learn to introduce new foods one at a time and delay allergic foods such as dairy, fish, peanuts and tree nuts until toddlers are older.

The National Institutes of Health is now funding a new study of babies at high risk for allergies. Half are avoiding peanuts while the other half are eating them regularly from 11 months to age 3.

Answers will be vital for a growing population of sufferers.

Gelfand said more than 40 percent of people in the U.S. will develop some sort of allergic disease in their lifetime. The most common is rhinitis, but food allergies, eczema and asthma are all on the rise. Medications for asthma have improved dramatically, but require careful compliance from patients. On the other hand, medications to treat seasonal allergies and eczema aren’t particularly effective, Gelfand said.

“The issue for us now is understanding enough to intervene and prevent these diseases,” he said. “Drugs are never going to catch up with the diseases. There’s no cure and nothing works 100 percent of the time. We need to answer the question, ‘are we doing things that are inappropriate in the early years?’ ’’

For instance, grandmothers used to say that a little dirt was good for kids. But, some parents determined to keep their kids safe and healthy have become obsessed with hand-washing, Clorox wipes and anti-bacterial soap. Could an ultra-clean environment be harming us?

“You can almost trace this epidemic to 50 years ago,” said Gelfand. “With civilization and advancement, we’ve gained so much. But along with it, we have probably paid a price too. How do we affect the balance?”

As Skye Barker Maa pushes her daughter, Sloane, on the swings at Stapleton’s Central Park, she says she’s eagerly awaiting answers that explain the allergy epidemic.

“There have to be better ways to mitigate allergies than stabbing 50 jolts of adrenaline into your child,” she said.

Not a fan of overmedicating her children, she nonetheless is giving them medications for reflux, seasonal allergies and asthma and said she knows countless parents in the same boat.

Her wish for her children: “I would hope they wouldn’t have to medicate their kids so much,” Barker Maa said. “It’s crazy.”

By Diane Carman

The average American is fat, sedentary, drinks too many sweetened soft drinks, eats too many French fries and knows it all too well.

“Most people in the U.S. want to lose weight,” said Elizabeth Kealey, a registered dietician and professional research assistant at the Anschutz Health and Wellness Center.

The problem is they just don’t know how.

Researchers at the center are testing strategies and documenting results, and while they don’t claim to have the obesity cure at their fingertips, they have identified several approaches that appear to work for a significant population that wants to lose weight.

A sense of urgency is driving the research. A recent study forecast that by 2030, 42 percent of Americans will be obese and that the cost of treating them could add $550 billion to health care costs in the next two decades.

Elizabeth Kealey

The center’s approach “is not surprising,” said Kealey. “Moderation and variety – those are the cornerstones of a good diet.”

It’s getting there that’s the hard part.

Clinical researchers have found that the secret is baby steps, “small changes,” she said.

“We identify a couple areas that are realistic to each person.”

Kealey, who teaches classes in the Colorado Weigh program, has found that if people are genuinely interested, they can develop healthier lifestyles, lose weight and keep it off. But before they can change their habits, they have to recognize what they’re doing wrong.

Auditing food intake

Most of the time, Kealey starts by evaluating the beverage category in their diets. For some reason, most people don’t count liquid calories, whether they arrive via sweetened soft drinks, fruit juices, energy drinks or cocktails.

“If you want to lose weight, evaluating beverages is a good place to start,” she said. For many people, simply switching from cola or energy drinks to water can make a dramatic difference in daily caloric intake.

The next step is to take a hard-eyed look at portion sizes.

Kealey said one of the exercises she leads in her classes is to have participants serve themselves portions of breakfast cereals, fruit juice or other foods and then measure or weigh them. “It’s a fun exercise,” she said, because people usually are amazed at what the recommended portion size of, say, granola is compared to the usually much more generous portion they’ve poured.

“I always get a lot of comments on that lesson,” she said.

She also works with participants to help them improve their overall diets by including at least five and optimally nine servings of fruits and vegetables a day while reducing fats, starches and sweet treats.

The goal is to prepare or purchase foods that are satisfying and taste good, but are nutritious and not as fat-and-calorie dense as common restaurant or fast-food offerings.

Good taste is key

Bistro Elaia at the Anschutz Health and Wellness Center creates guilt-free foods that focus on flavor.

Kealey and other nutrition researchers worked with the staff from Bistro Elaia at the Health and Wellness Center to develop menus and adapt recipes to encourage healthier eating and enable Colorado Weigh participants and others to enjoy eating and still achieve their weight-loss goals.

“We offer food in three different categories: ultra healthy, healthy and healthier (than the usual alternatives),” said Paolo Neville, executive chef at the café located on the first floor of the center.

“We started with the concept that the food has to really taste great,” he said. “It has to be addicting. It shouldn’t have the stigma of being health food.”

Some of the guidelines were to reduce fat (“There are no fryers here,” Neville said.), reduce salt, adjust portion sizes away from the “supersized” servings that have become common in restaurants, and put the emphasis on organic grains, vegetables, fruits and plenty of seasonings.

The bistro also clearly posts calorie counts for everything on the menu. “We’re all about transparency here,” the chef said.

One example is the popular chicken corn chowder (238 calories per bowl). Neville said he purees some of the vegetables and stirs in fat-free yogurt at the end to give it the creamy taste and texture people love without using heavy cream, or thickeners like flour and butter.

Bistro Elaia Chef Paolo Neville

For sandwiches, he said, they shopped around to find whole-grain breads that weren’t too high in calories “to give us some breathing room for the fillings.” Then he revised classic recipes for aioli, using the typical olive oil and egg yolks as a base, but punching up the seasonings and flavorings “so we don’t have to put so much on the sandwich.”

With something like the “for fromage” sandwich, they used stronger cheeses, like blue cheese and goat cheese. “We cut the amount of cheese on the sandwich by close to half without sacrificing flavor.” It weighs in at 490 calories.

Breakfast items also feature plenty of vegetables. The Egg White Shuffle has spinach, dried tomatoes and feta cheese with egg whites on a whole-wheat English muffin and tops out at 264 calories.

Since the bistro opened last month, Neville said the response has been “fantastic. We’ve been doing very, very well.”

Bistro Elaia’s catering business has been operating for several months and appeals to businesses and organizations that want to encourage healthy eating among their employees and clients, director Carrie Cohen said.

Carrie T. Cohen, Bistro Elaia restaurant manager and catering director

One of the events they catered was a lunch for executives from McDonald’s, which helps fund the center. On the menu were chicken Provencal, salad and carrot cake.

“They loved it,” she said. “Everybody always asks what we served the McDonald’s people.”

Diet alone not enough

Along with encouraging greater awareness of what participants are eating, the Colorado Weigh program emphasizes regular physical activity. “It’s not just diet alone,” said Kealey. “It’s the physical activity piece, the biological piece, the motivational piece.”

For Maureen Ediger, director of external affairs for the School of Public Affairs at the University of Colorado Denver, the 12-week program has been eye-opening.

“It’s nothing radical. There’s nothing you can’t eat,” she said. “It’s a matter of adjusting portions and writing down everything.”

The simple task of keeping a log of everything she eats and all her activities each day (recorded on a pedometer she wears) provides an incentive and a level of accountability she didn’t have in the past.

It also has given her a sense of accomplishment.

When life at work or at home with her husband and four children feels overwhelming, focusing on her own health feels great, she said. “It’s one part of my life that I can control.”

“It’s a matter of making little choices throughout the day. That’s why it’s working.”

One example of a little change that has a big impact is her new coffee routine.

“I’ve always liked coffee with half and half,” Ediger said. “Now I drink it with skim milk or black. Once I realized how much fat and calories I was consuming in that daily habit alone, I started making a different choice. Now I think if I tried to drink coffee with half and half, it would be disgusting to me.”

All of the recommendations in the Colorado Weigh program are based on the latest research on obesity. Kealey said the program was developed by James O. Hill, director of the Center on Human Nutrition at the Health and Wellness Center; Dr. Holly Wyatt, a specialist in internal medicine; and Assistant Professor Bonnie Jortberg, a dietician at the University of Colorado School of Medicine.

Participants set goals for increasing their activity levels through walking, biking, dancing – or any way they choose.

“I can’t get an hour out of my day for a workout,” Ediger said, “but I can take 20 minutes in the morning, I take the stairs throughout the day at work and then do another 20 minutes of exercise in the evening.”

Maureen Ediger

She tries to incorporate activity into other parts of her life, choosing to run an errand on her bike instead of in her car and to get the kids involved in fun runs, hikes and cycling outings on weekends.

“All these new habits really benefit the whole family,” Ediger said.

Among the recent findings included in the program is research that suggests while a daily workout routine — or as health officials recommend, a 30-minute walk five times a week – is good, those activities may not be enough to counteract the damaging impact of spending eight hours a day sitting at a desk. A recent study found the risk of cardiovascular disease is 64 percent higher among men who spend more than 23 hours a week in sedentary activity (not including sleep) compared to those who spend 11 hours or less per week sitting.

“It’s not necessary to spend eight hours a day at the gym,” Kealey said, “but we all need to get up and move, not just sit.”

Results from the participants in the Colorado Weigh program are used for the studies on weight loss and obesity at the Health and Wellness Center. While the weight loss goal in the 12-week program is 8 percent, Kealey said that average weight loss for participants is 6 to 7 percent. Ediger’s weight loss in the program was 10 percent.

Follow-up on weight maintenance under Colorado Weigh is less thorough. However, a different database used at the center tracks people who have lost 30 pounds or more and kept it off for at least one year. The National Weight Control Registry tracks more than 5,000 people who meet those criteria. The average weight loss among them is 66 pounds.

Kealey said research on weight loss, nutrition and general fitness is an increasingly important field in health care, where the CDC estimated in 2008 that the annual cost for obesity-related conditions was $147 billion.

“We have a long way to go, but there is evidence that making those small changes, realistic changes is the key. We know if you make your expectations too large, you won’t succeed.”

By Gena Akers

Have you been worried about the fact that you are a mortal being?  Here’s some comfort sent by way of Seneca, some 2000 years ago: “You will not die because you are sick, but because you are alive.”  Now, don’t you feel better?

Well, Seneca almost got it right.  After reading a particularly upsetting article in the New York Times recently, I took the liberty of editing Seneca’s timeless words: “Gena, you will not die because you are sick, but because you are alive… and sitting in a chair.”

That’s right, my mere existence will account for about 94 percent of my death (humorous, non-scientific estimation.  No source necessary).  My office chair, home desk chair and kitchen stool… those four legged fiends get the remaining 6 percent.

To steal from Gretchen Reynolds, a fellow sitter, thinker of thoughts and writer of words, “ One lesson I’ve learned while writing about fitness is that few things impinge on an active life as much as writing about fitness—all that time spent hunched before a computer or puzzling over scientific journals, the countless hours of feckless, seated procrastination.”

But my writing is selfless.  I spend time sitting and writing so you, dear reader, can be thin, fit and immortal.  As a friend says, who spends her 9-to-5 life fighting childhood obesity, “all the skinny kids… that’s me.  All the fat kids… I had nothing to do with that.”

Well, you too, thin readers…  can say thanks to me and one of my occasional health-conscious ramblings for changing your life.  And for you not-soo-thin readers, I had nothing to do with those 5 extra pounds you gained last winter.

Okay, okay.  I got sidetracked. Selfless or selfish, I sit too much.  I really do.  It came with some annoyance to admit that it doesn’t matter how much I exercise, it matters how much I exercise and how much I don’t exercise—namely how inactive I am.

The University of Massachusetts did a study to see just how much a sedentary lifestyle affects overall health.  It measured the effect of physical inactivity by giving a group of healthy young men heavy platform shoes with 4-inch heals for their right feet.  The men were instructed to hobble around on their right feet with crutches for two days.  They were to leave their left feet dangling: no muscle contractions, no touching the ground.

After 48 hours, the scientists biopsied both legs and found multiple genes already being expressed differently.  The inactive left leg revealed lower insulin levels, slower metabolic activity and disrupted DNA repair in comparison to the right.  To honor Seneca, one could say “every man’s left leg was dying…” but that doesn’t get at the full truth.

A second experiment that shines light on the truth involved putting the back legs of lab animals in casts.  Soon after, the newly handicapped animals were already producing substantially less of an enzyme that dissolves fat in the bloodstream… an enzyme important for staving off cardiac disease and diabetes.

So, it’s really not the TV or TV dinners or awful commercials that are killing you.  It’s that you’re alive… and not producing enough enzymes to break down fat or a billion other things I didn’t learn about in my undergraduate philosophy courses.

You know what will help?  Standing!  A related study at the University of Massachusetts showed that when volunteers stood all day, (just standing, no walking or jogging) they burned hundreds more calories than their fellow sitters.  Standing isn’t even considered exercise, but on the scale from 1 to death, it puts you a lot closer to 1.

Well, if you’re like me, consider an office remodel.  Maybe, funnel the architectural foresight of the Shakers.  Hang your office chairs on the wall.  Then balance your computer on one of the office chairs.  Then stand, facing your freshly mounted chair and computer to send emails, edit project proposals, and whatever else you do through a keyboard to improve humanity.  After a few weeks, maybe hang up a picture of an open window next to your chair.  You don’t want to feel like you’re in timeout.

Whether you hang your chair on your office wall or take walk-around-the-office breaks every 15 minutes, you’re still going to die.  That’s nothing to be sad about.  Just make sure you can do what you want to do until then.  For most people, that involves some kind of movement, beyond pressing numbers or letters on a TV remote, smartphone or keyboard.

And don’t worry about me, this article only took two hours of sedentary writing.  I would write more but…. (the author of this article just left for a walk).

Gena Akers is the project coordinator for SanLuisValleyHealth.org, an education and advocacy website dedicated to increasing access to health for all residents in Colorado’s San Luis Valley.  SanLuisValleyHealth.org is a project of the San Luis Valley Regional Medical Center and funded through The Colorado Trust. She can be contacted at gena.leneigh@gmail.com. 

By Gena Akers

For 19 days, writer Steve Hendricks fasts.  No food.  No vitamins.  Just water.  End result: he loses 25 pounds.

Chronicling his story and the history of fasting in February’s Harper’s Magazine, “Starving Your Way to Vigor,” Hendricks inevitably poses the question: why not fast?  Why not fast and eat your vegetables too (of course at different times)?

Hendricks asserts that vanity wasn’t his only concern.  “Fat, in our era, is disease, decrepitude and death.  The odds of incurring diabetes or high blood pressure, respiratory or kidney failure, thrombosis or embolism, gout or arthritis, migraine or dementia, cardiac arrest or stroke, gallstones or cancer, all increase with one’s ballast.”

Through its history, fasting has been successfully associated by researchers to decreasing rates of obesity, seizures, diabetes and high blood pressure.  In rats, which (I know…) are not humans, it has also been shown to decrease the growth rates of some cancers and mitigate the side-effects of chemotherapy.  So why was I so surprised to hear about the benefits of fasting, outside of getting closer to God?

Hendricks writes, “… starvation, a remedy that cost nothing — indeed, costs less than nothing, since the starver stopped purchasing food — was abandoned whenever a costly cure was developed.  Decades later, studies would show that fasting followed by a high-fat diet was as effective against seizures as many modern anticonvulsants… but Americans, then and now, preferred the promise of the pill over a modification of menu.”

And that brings me to back pain.

No matter who you are, there’s an 80 percent chance that, at some point in your life, you’ll suffer from back pain.  Writing for January 2012 Wired, Jonah Lehrer reports in “Trials and Errors: Why Science is Failing Us” that at any given time, “about 10 percent of Americans are completely incapacitated by their lumbar region, which is why back pain is the second most frequent reason people seek medical care, after general check-ups.”

When doctors began encountering a surge in patients with lower back pain in the mid-20^th century, they had few explanations.  And why?  Well, the lower back is exquisitely complicated; it’s full of tiny bones, ligaments, spinal discs and minor muscles.  As a result, patients were typically sent home with a prescription for bed rest.  This simple treatment plan was extremely effective.  Lehrer writes that about 90 percent of people with back pain on the “rest” plan got better within six weeks.

This all changed in the 1970s, when magnetic resonance imaging (MRI) was introduced as the diagnostic savior, generating detailed images of the body’s interior.

With MRI scans, back pain soon became correlated with degenerated discs.  Rather than bed rest, doctors began administering epidurals for the pain or would surgically remove the damaged disc tissue.

Unfortunately, researchers discovered that people experiencing no back pain also exhibited “serious problems” with bulging or protruding tissue, meaning “normal” people could have even more troubling MRIs than those with pain.  The 1994 study in The New England Journal of Medicine revealed that 38 percent of patients with “serious problems” had multiple damaged discs.

And where has this wealth of facts led us?  Currently, doctors are encouraged to not order MRIs when making diagnoses.

So what does fasting have to do with back pain and vice versa?  Fasting is and back pain can be relieved by no cost remedies.  Both are important and telling stories in the history of why we have the health care system that we have.  With the power and promise of drugs and technology to fix our problems, simple solutions (for some conditions) like fasting and bed rest have been easily forgotten.

Lehrer succinctly writes, “the larger point is that we’ve constructed our $2.5 trillion health care system around the belief that we can find the underlying causes of illness, the invisible triggers of pain and disease… If only we knew more and could see further, the causes of our problems would reveal themselves.”

I’m not a doctor or a certified anything, but the current push nationally for better diets, more physical activity… more purposeful living overall, gets us back to where we should have already been.  Whether we like it or not, most of us are responsible for the decisions made about our health.  At least in this community, you decide what doctor to see; you decide what food to eat; you decide whether to be a couch potato.

Concerns about the cost of health care aren’t going away.  In an election year, the conversations will just get more heated.

However, like fasting and bed rest, some of the solutions to high health care costs are in your control and can’t be outsourced to better drugs and more expensive diagnostic tools.  The toughest part of these solutions, and why they aren’t popular, is that there is no silver bullet.  Unplug your expectations from the promises of modern technology.  It’s cheaper to open up your fridge and peer inside.

Gena Akers is the project coordinator for SanLuisValleyHealth.org, an education and advocacy website dedicated to increasing access to health for all residents in Colorado’s San Luis Valley.  SanLuisValleyHealth.org is a project of the San Luis Valley Regional Medical Center and funded through The Colorado Trust.  

By Michael Elliott and Norton Arbelaez

Staff  Sergeant Mary McNeely joined the military, went to Iraq and served her country with honor. While there, she was injured in a car bombing.

Upon returning to Colorado Springs, physicians at the Veteran’s Administration prescribed her narcotic pain medications to treat her various injuries. Nonetheless, her health kept deteriorating. The drugs did not effectively treat her pain, made her irritable, nauseous and unable to function. She grew distant from her daughter and husband.

Through Colorado’s medical marijuana system, she discovered that cannabis controlled her pain and nausea with minimal side-effects. As a result, she was able to stop taking several high-risk prescription drugs including percocet and vicodin. Medical marijuana allowed her to regain a semblance of a normal life.

Colorado’s medical marijuana program is here for Mary and the tens of thousands of patients like her. While neither pariah nor panacea, medical cannabis provides substantial relief to the sick and injured, and is void of many toxic side-effects common to prescription drugs. Regulated and taxed, medical cannabis also improves public safety and provides Colorado with a sorely needed source of revenue and jobs.

Cannabis Indica has been used as medicine for thousands of years. For most of American history, the United States Pharmacopeia recommended it for conditions as diverse as asthma, nervous disorders and insomnia. In 1937, amid propaganda steeped in institutional prejudice, all uses of cannabis were outlawed by the federal government.

In light of failed attempts at national reform, Colorado voters approved a state constitutional amendment allowing for medical marijuana in 2000. Currently, 16 states and the District of Columbia allow medical marijuana, encompassing about one-third of all Americans. Conservative estimates forecast as many as 25 states will have adopted medical marijuana laws by 2014. As reflected by an October 2010 Gallup poll in which 70 percent of Americans favor making medical cannabis legally available, Colorado’s regulated model reflects a national trend.

In 2010 and 2011, the Colorado General Assembly, in a bipartisan effort, codified the licensing, regulation and taxation of medical marijuana businesses. These regulations created a closed-loop system that requires local and state licensing, establishes “good moral character” standards for ownership and employment, and mandates rules for security and surveillance aimed at eliminating illicit activity. Nationwide, Colorado has the most comprehensive and effective medical marijuana regulatory framework.

In Colorado, regulated medical cannabis has provided medicine to 473 HIV/AIDS patients, 9,771 patients suffering from severe nausea, 14,112 patients suffering from muscle spasms, 75,424 patients suffering from severe or chronic pain, and 2,181 patients with cancer. Despite all the accusations of abuse surrounding this issue, less than 2 percent of Colorado’s population are registered patients. According to state statistics, the average age of a medical marijuana patient in Colorado is 42.

As medical marijuana becomes more accepted, its medicinal uses become more apparent. Recent studies have shown the potential of cannabis to treat premenstrual syndrome, insomnia, migraines, multiple sclerosis, spinal cord injuries, alcohol abuse, arthritis, asthma, atherosclerosis, depression, Huntington’s disease, Parkinson’s disease, Alzheimer’s disease, sickle-cell disease, sleep apnea, anorexia nervosa and many forms of cancer. With so much potential, it’s not surprising that the federally funded National Institute of Health currently holds U.S. Patent 6,630,507 B1 for “Cannabinoids as Antioxidants and Neuroprotectants.”

In addition to providing a mechanism for safe and legal access, regulated medical cannabis is a net positive for the state. It contributes to deferred prosecution and incarceration, as well as providing a source of revenue in hard budgetary times.

In total, Colorado medical marijuana businesses have paid approximately $20 million in local, state and federal taxes, and another $9 million in licensing and application fees. With regard to jobs, some estimates indicate that the medical cannabis industry has created upwards of 20,000 new jobs, as well as a boom in ancillary businesses such as real-estate, accounting, carpentry, engineering, plumbing, law, medicine and security.

With regard to health and safety, a recent University of Colorado study indicates that states which pass medical marijuana laws see on average a 9 percent reduction in traffic fatalities. In addition, a 20-year study documented in the Journal of the American Medical Association (January 2012) indicates that smoking cannabis on an occasional basis does not appear to produce adverse effects on lung function. Moreover, the increase in criminality predicted by opponents of regulated medical marijuana has simply not materialized.

Though much has been made of the supposed link between medical marijuana and teen use, new research by CU professor Daniel Rees finds no evidence that medical marijuana laws are related to the use of marijuana by minors. Other studies show that, on average, teen usage decreases after states pass medical marijuana laws.

Regardless, regulation remains the most effective way to limit unauthorized access and abuse. After all, street dealers do not check IDs. The most comprehensive solution likely involves education and prevention initiatives, restrictions on advertising and increased penalties for illicit diversion to minors.

Though Colorado Attorney General John Suthers opposes the state’s medical marijuana program, consider the alternative – the continuation of a failed policy that criminalizes patients and subsidizes a violent black market operating clandestinely out of homes and public lands. This emboldened black market would pose an immediate threat to public safety and further strain our state’s limited resources.

U.S. Attorney General Eric Holder has issued recommendations to U.S. Attorneys to use their prosecutorial discretion, in light of limited resources, to focus on those individuals and organizations who are not in “unambiguous compliance with state law.”

Meanwhile, in Colorado, the democratic process has made regulated medical cannabis the law of the land, and it is the duty of our state officials and our chief executive to implement the Colorado Medical Marijuana Code.

Patients and providers hold hope that with time the institutional resistance from the federal government and certain state elected officials will be reoriented to conform with the interests of patients, economic realities, and the values of justice, dignity, and tolerance.

Michael Elliott, Esq., is the executive director of the Medical Marijuana Industry Group (MMIG), the largest medical marijuana trade association in Colorado. Norton Arbelaez, JD, is MMIG’s board chair.