Health Policy Solutions

By Katie Kerwin McCrimmon

The American Academy of Pediatrics (AAP) has reversed decades of advice on circumcision and now says that the benefits of the procedure outweigh the risks.

The first policy statement on circumcision since 1999 has triggered angry reactions from opponents who called on the influential group to immediately retract the policy recommendation.

Since the 1970s, the AAP had said circumcisions were not medically necessary. Removing the foreskin of the penis from infant boys is an ancient Jewish and Islamic tradition, but circumcision rates have been declining in the U.S. and even in Israel. An increasing number of global health officials has raised concerns about the health impacts of circumcision and the thorny ethical problem of removing an infant’s body part when he is too young to consent.

The AAP statement, however, said that new research shows circumcising infants can decrease the risks of those boys being infected with HIV, genital herpes, HPV and syphilis. The influential group that represents 60,000 U.S. pediatricians stopped short of recommending routine circumcision, but called on public and private health insurance programs to cover the procedure for families who choose it.

In Colorado, the largest private health insurance company in the state, Anthem Blue Cross and Blue Shield, which has about 950,000 members has always covered circumcisions and will continue to do so, said company spokeswoman, Joyzelle Davis.

“Ultimately, this is a decision that parents will have to make,” said Dr. Susan Blank, chair of the task force that authored the AAP policy statement. “Parents are entitled to medically accurate and non-biased information about circumcision, and they should weight this medical information in the context of their own religious, ethical and cultural beliefs.”

It’s unclear whether pediatricians and family physicians, many of whom have strong opinions on circumcision, will heed the advice of the AAP task force.

A spokeswoman for the AAP in Colorado did not return calls on Monday to comment on how pediatricians here would respond.

In 2011, Colorado joined 17 other states in barring Medicaid funding of circumcisions. A bill introduced in the Colorado legislature earlier this year would have reinstated funding, but was defeated after a coalition of budget hawks, anti-circumcision activists and health professionals successfully argued that circumcision is cosmetic and potentially harmful and that taxpayers should not fund it.

Because of the AAP’s new recommendations, the debate over public funding of circumcisions could resurface in the 2013 session, but lawmakers in cash-strapped states have not been eager to increase their spending on public health programs. Legislative fiscal analysts had estimated that restoring Medicaid funding circumcisions would cost Colorado taxpayers about $230,000 a year.

Gillian Longley, an anti-circumcision activist, says HiV studies on adults in Africa aren’t relevant to discussions on whether infants in the U.S. should be circumcised.

Gillian Longley, a registered nurse from Louisville and an anti-circumcision activist with the Circumcision Information Resource Center of Colorado (NOCIRC), believes many health professionals will ignore the AAP statement and that increasing concern about the practice will spur reconsideration.

“The AAP is very out of step with what the rest of the world is saying,” Longley said. “Multiple medical, legal and human rights bodies in Europe and Australia are discussing the ethically problematic nature of circumcision. They are looking at the same evidence that the AAP has (reviewed).  And they have concluded that there is no convincing reason to do this either for health prevention or for hygiene.”

Longley said the AAP based the new policy recommendations about the health benefits of circumcision on studies of adult men in Africa, where studies by the Bill and Melinda Gates Foundation have found that circumcision can prevent HIV transmission.

Longley believes it’s totally inappropriate to extrapolate results from adult Africans to newborns in the U.S.

“It’s irrelevant to us in the U.S.,” Longley said.

First, HIV transmission in Africa is generally the result of heterosexual sex whereas in the U.S., transmission is still most common among men who have sex with men. Second, she said very few studies have been done to better understand the functions of the foreskin or to analyze adverse reactions from botched circumcisions.

In Colorado, some low-income families are delaying circumcisions until they can come up with the cash to pay for the procedures. Doctors at hospitals in the Denver metro area are seeing some cases of babies who have been circumcised older than usual — at about a month or six weeks of age — and are seeing some who are returning to hospitals with excessive bleeding.

Longley said no one in the U.S. tracks the negative impacts of circumcision.

“It’s very disingenuous and ethically unsupportable for a policy-making body to make such a strong statement that the benefits clearly outweigh the risks when we don’t know the risks. No one is looking for the risks,” Longley said.

Physicians in Colorado spoke out both for and against circumcision when public funding was debated earlier this year. Among those who supported it were Sen. Irene Aguilar, D-Denver, who is also and internal medicine doctor for Denver Health. Aguilar framed circumcision as a social justice issue, saying that if wealthy parents have the ability to get their babies circumcised, the poor should also have that right.

“As a physician, I don’t try to influence parents one way or the other,” Aguilar said. “People make this decision based on religious and cultural reasons.”

She said she found some of the evidence convincing that infant boys who don’t get circumcised have higher rates of urinary tract infections and that adult men who are uncircumcised and live in poverty have higher rates of sexually transmitted disease.

Another physician testified against circumcision. Dr. Jennifer Johnson is a family physician who works with Medicaid and uninsured patients at Clinica Family Health Services. She used to do circumcisions and recently stopped doing them.

“This is not a necessary procedure,” Johnson said. “It’s a healthy, normal body part.”

“There are a lot of medical needs in our population. We have no business using limited health care dollars on a medically unnecessary cosmetic procedure.”

Longley of Colorado NOCIRC said perhaps the most persuasive new argument against circumcision is coming from opponents of genital mutilation who have been fighting to protect adolescent girls in Africa and who now believe male children deserve the same protection.

“It all comes down to the same ethical bottom line,” said Longley. “The child is a human being and has the same human rights as any other human adult. That includes the right to have a whole human body.”

By Katie Kerwin McCrimmon

An unusual summer spike of whooping cough cases in Colorado has prompted health experts here to declare an epidemic and call for both children and adults to get immunized.

A strong anti-vaccine movement in Colorado has meant that the state has lagged behind the rest of the country on many immunizations. Only about 85 percent of children and adults who should be protected from whooping cough are fully vaccinated.

So far this year, Colorado health officials have tracked 715 cases of whooping cough, also known as pertussis. That compares to an average of just 158 cases during the same period in each of the previous five years. Other states that have declared epidemics are Washington and Wisconsin. In 2010, 10 babies died in California from an outbreak there.

Babies, adults who live and work around infants and toddlers, and children heading back to school who are 11 to 14 years old should all be immunized, health experts said.

The epidemic is most severe in the Denver area with the highest number of cases emerging in Adams, Arapahoe, Boulder, Denver and Jefferson counties.

“We are alerting the public to an epidemic number of pertussis cases in Colorado and are urging Coloradans to get vaccinated against pertussis,” said Dr. Chris Urbina, chief medical officer and executive director of the Colorado Department of Public Health and Environment.

Colorado has not had a fatality from whooping cough this year. But the disease is extremely dangerous for infants. About half of infants who get whooping cough will need to be hospitalized and one or two of every 100 babies who get it will die, said Dr. Rachel Herlihy, a preventive medicine physician and director of Colorado’s immunization programs.

She said there have been cases of newborn babies who have been exposed in the first days of their lives to the disease by infected adults or children.

“It’s not just moms. It could be health care workers or grandparents, visitors or siblings,” Herlihy said.

“We’ve been very fortunate in Colorado not to have had a death (from whooping cough) in a few years, but it is certainly possible,” she said.

Typically cases increase in the fall, winter and early spring.

“We’re seeing quite a bit right now occurring in the summer and that’s unusual,” Herlihy said.

She also said there’s been an age shift this year.

The highest number of cases typically occurs in infants. But health officials are also seeing a spike among school-age children. In part, Herlihy believes that’s because immunity in older children is waning as they age. That’s why it’s vital for children who are about 12 years old to get another dose of the TDaP vaccine, which immunizes against tetanus, diphtheria and pertussis.

Infants under six months are too young to have received all the vaccine doses necessary to protect them from pertussis. So, it’s critical for people who live and work around them to be immunized.

The Tdap vaccine is recommended for the following groups:

• Pregnant women in the third or late second trimester
• Parents of infants under 12 months of age.
• Caregivers of infants, including grandparents, babysitters and child care workers.
• Health care workers
• Others who plan on having close contact with an infant
• All adults need a tetanus booster if they have previously not received TDaP.

Pertussis is a bacterial infection of the respiratory tract that can easily spread through the air when an infected person coughs or sneezes. The illness often starts with cold-like symptoms, including sneezing, a runny nose and a mild cough. Often there is no fever or just a low-grade fever. The cough becomes more severe during the first week or two and people who are ill can have coughing fits, followed by a high-pitched “whoop” or a coughing fit so severe that the person vomits. The cough may last for a couple of months and is more frequent at night.

Since symptoms in adults and adolescents can be relatively mild, individuals may not realize they have pertussis and can easily spread it to others. Young infants with pertussis often do not have a cough but gasp or struggle to breathe.

For more information on pertussis, click here.

For more information on immunizations, click here.

For box:

About PERTUSSIS (Whooping Cough) causes coughing spells so bad that it is hard for infants to eat, drink or breathe. These coughing spells can last for weeks. It can lead to pneumonia, seizures (jerking and staring spells), brain damage and death. It is spread when an infected person coughs or sneezes and spreads germs.

Children should get five doses of DTaP vaccine, one dose at each of the following ages:

◦   2 months

◦   4 months

◦   6 months

◦   15-18 months

◦   4-6 years

◦   11-12 years

Anyone who comes in contact with your baby – parents, grandparents, caregivers, siblings, plus extended family and friends – should receive the adult booster (TDaP) to help shield newborns from whooping cough. In January 2011, the CDC and the Advisory Committee on Immunization Practices (ACIP) updated the TDaP vaccine recommendations to also include certain adults 65 years of age and older and under-vaccinated children aged 7 – 10 years.

By Linda Gorman

The selection of Paul Ryan as Mitt Romney’s running mate holds out hope that people in public life are finally beginning to appreciate the fact that market-oriented health care reforms offer the best potential for finally giving elderly Americans the ability to get better medical care at a lower cost. They do this by giving people an incentive to use health care more wisely.

Individuals and their physicians know more about the health care that they need and what adds value to it than any number of officials in Washington, D.C., and various state capitols working on “value-based” health care plans. Because individuals know more, they can economize in a multitude of small ways that outsiders would never dream of.

The essence of market-oriented reform is making people feel like they are spending their own money on health care, letting them choose where to reduce expenditures, and providing real accountability by allowing the development of real choices.

Ryan proposes to reform Medicare by giving people a choice of plans. Only those under 55 would be required to participate. In a scheme similar to that used by the Federal Employees Health Benefits Plan, insurers would be invited to provide annual bids for guaranteed issue policies covering a specific set of conditions with a given actuarial value. The cost of the services, another “bid,” would also be calculated using fee-for-service Medicare. The government would set the Medicare subsidy rate equal to the second highest bid.

People covered by Medicare would be able to choose a plan with the second-highest price and have all costs paid for by the federal government. They would be able to choose a plan with a lower price and receive a rebate for the difference between the second highest bid and their plan.

They would be able to choose a more expensive plan if they were willing to use their own money to make up the difference, or stay in fee-for-service Medicare if none of the plans suited their needs.

As is currently the case, the amount of individual support provided would vary by income, health status and geographic location. While there is no predetermined formula for calculating payments, taxpayers are protected by limiting the growth in the accepted bid price to nominal GDP growth plus 0.5 percent.

Ryan’s Medicare reform plan has a program design that is similar to that of Medicare’s Part D prescription drug program.

Part D may be unique among long-functioning government programs in that it was designed to be consumer-directed from the outset. It is also unique in that its current annual expenditures are about 30 percent less than were projected by the Congressional Budget Office in 2003.

For comparison, Medicare’s Part A, a centrally-planned program that anything but consumer directed, was about 7.5 times more expensive than projected. The bureaucratically controlled Medicare home health care benefit and end-stage renal disease programs were more than twice as expensive as projected, and Medicaid’s disproportionate share program was 17 times more expensive than projected.

Ryan’s plan stands a good chance of success because, like Part D, it lets people who need health care control the funds used to purchase it. They can communicate with people in the business of selling medical care by buying or not buying various benefit selections at various prices.

Unlike Obamacare, Ryan’s plan does not waste enormous resources dictating exactly how doctors, hospitals, insurers and patients must behave by spewing forth tens of thousands of pages of incomprehensible regulations designed by well-meaning bureaucrats and academics who have never managed any kind of health care business. It does not foist new and untested organizations, like Accountable Care Organizations, health insurance exchanges and Navigator Programs on people unable to signal that they neither want them nor are willing to pay for them.

More importantly, Ryan’s plan does not include Obama’s price controls, the ones that the Medicare Trustees say will bankrupt 15 percent of hospitals, skilled nursing facilities and home health agencies by 2019. Nor does it cut physician reimbursements by approximately 31 percent in 2013.

Although the Obama Administration says that these reimbursement cuts have “strengthened Medicare,” the trustees note that “Medicare payment rates for inpatient hospital services are about 67 percent of those paid by private health insurance” and that “providers could not sustain continuing negative margins and would have to withdraw from serving Medicare beneficiaries.”

The Obama plan turns Medicare into a plan that will pretend to pay for the medical care that it will pretend to provide. The Ryan plan builds on prior successes. It offers a realistic alternative to the Obama plan, one that is likely to provide better care.

Linda Gorman is the Director of the Health Care Policy Center at the Independence Institute in Denver.

By Katie Kerwin McCrimmon

LAKEWOOD — As Medicare has leapt into the top-tier of issues that will decide the presidential contest, Colorado’s population of older adults is ballooning.

Colorado now boasts the fourth fastest-increasing population of seniors in the country and these aging baby boomers — who vote in large numbers — could help drive election results in key swing counties of this crucial swing state.

Mitt Romney’s pick of U.S. Rep. Paul Ryan, R-Wisconsin, for his running mate has put Medicare at the center of the national debate. Ryan supports dismantling the public health insurance program for seniors and replacing it with a voucher program for future Medicare recipients, those now under age 55.

During his first visit to Colorado as the vice-presidential candidate last week, Ryan didn’t utter a single word about Medicare, but the budget hawk revved up more than 2,000 fans at Lakewood High School by promising to usher in a new era of belt-tightening.

Then over the weekend in Florida, with his 78-year-old mother at his side, Ryan accused President Obama of raiding Medicare to divert more than $700 billion into funding for the Affordable Care Act. Ryan claimed Obama’s plan could shutter one out of six hospitals and nursing homes.

Obama shot back during an appearance in New Hampshire saying that the Republicans are the ones who want to gut Medicare in order to give tax breaks to the super-rich. Obama said the only changes to Medicare now are that preventive services like cancer screenings will be free. Obama told voters that the $716 billion comes from reducing reimbursements to hospitals and reducing waste and fraud which would make Medicare solvent for an additional eight years.

Colorado has a significantly smaller percentage of seniors — about 11 percent — than traditional magnets for retirees like Florida, where about 22 percent of the population is 65 and older. But the unprecedented population growth among older adults is far outpacing other population growth across Colorado. Between 2000 and 2010, the population of adults ages 60 to 64 who were on the cusp of Medicare eligibility, increased by a whopping 86 percent in Colorado, while the population as a whole grew by 17 percent.

Colorado’s state demographer, Elizabeth Garner said the boom in Colorado’s population of older adults is hitting now.

“This is a boom and it’s hitting right now. This decade is where we’re going to have the fastest growth,” said Elizabeth Garner, Colorado’s state demographer, who released a report in July on the unprecedented increase among aging Coloradans. Garner says Colorado has never had a large population of older adults, but the young ski bums, federal workers and East Coast transplants who flocked to Colorado in the 1960s and ’70s and stayed are now aging and retiring in Colorado.

The trend is most pronounced in some of the Front Range counties where Colorado’s presidential race could be decided. Arapahoe, Douglas, El Paso, Jefferson and Larimer counties led the state during the last decade in growth among people ages 65 and older. Altogether, Colorado’s population of baby boomers, born between 1946 and 1964, is expected to increase the state’s population over 65 by 150 percent between 2010 and 2030.

Seniors were among those who turned out to see U.S. Rep. Paul Ryan, R-Wisconsin, during his first trip to Colorado after Republican presidential contender, Mitt Romney picked Ryan for his running mate.

“Medicare issues will definitely be hitting now. The impact will be significant in Colorado, Garner said.

Altogether, Colorado has more than 665,000 Medicare recipients and costs for their care exceeded $5.3 billion in 2009, the last year for which data are available. Nationwide, according to data from the Centers for Medicare and Medicaid Services, 49 million people are on Medicare now. That number is expected to grow to about 75 million by 2025.

With so many seniors invested in the popular government program and so much money at stake, “Mediscare” tactics are in full swing on both sides of the political debate.

A poll conducted by the Kaiser Family Foundation and the Washington Post has found that a majority — 55 percent — of Republicans oppose changing Medicare. Of Democrats, 68 percent said “Medicare should continue as it is today”; among independents,  53 percent  preferred the status quo. The poll was conducted in late July and early August before Romney selected Ryan.

In Colorado, seniors on both sides are pleased that health issues have risen to the top of the nation’s agenda, but they differ sharply on their views of the candidates.

Henry Barlow, 77, moved to Highlands Ranch with his wife last year to be closer to their two young grandchildren. A volunteer with the Colorado Senior Lobby and a member of the National Committee to Protect Social Security and Medicare, Barlow is a former professor at Cleveland State University who was director of the schools’ gerontology program.

Barlow said the ads claiming that the Affordable Care Act is draining money from Medicare are patently false and that cost-savings for Medicare in the health law actually help extend Medicare’s solvency. He’s dismayed by Ryan’s voucher plan, comparing it to the disastrous strategy from the Vietnam War: “destroying a village to save it.”

“What’s at stake here is the preservation of Medicare. My reaction to the voucher idea is you get less, you pay more and you die quicker,” said Barlow, a Democrat who supports Obama.

“No doubt about it,” Barlow said. “(With vouchers) one is left in a position where not only is Medicare greatly damaged, we in effect greatly damage the whole health system. We open the floodgates for the private health insurance system to charge whatever they want.”

Barlow wants health reforms that rein in health costs.

“I don’t mind the for-profit insurance companies being in the arena, but we need a level playing field,” Barlow said.

He said the Medicare debate brings crucial issues into sharp focus.

“It raises a nasty question. What are older people for? They are here not to be dependent, not to be moochers. They’re here to stand up and provide a moral example for everyone else. You pay attention to future needs and you care about future generations.”

At Paul Ryan’s campaign rally in Lakewood, Irv Doty, 75, was so thrilled with the addition of Ryan to the GOP ticket that he literally danced out of the high school gym after Ryan’s 20-minute speech.

“I like Romney a lot better now,” said Doty, a Republican.

Health issues are on the front burner for Doty.

“Medicare needs to be revamped. It’s become more expensive and less available.

“You can’t throw grandma off the cliff, but you have to solve the problem,” Doty said.

Said his wife, JoAnne Doty, 70, “We have to do something about entitlements.”

The couple said they are financially secure and would be willing to pay a greater share of their health costs.

Dorothy and Ernest Light with their grandson, Daniel Dorchuck,18. All three support Ryan. Says Dorchuck: “Change is better than bankruptcy.”

Dorothy Light, who is in her 70s, brought her husband, Ernest, who is in his 80s to the rally, pushing him in a wheelchair.

“I’m not alarmed,” Dorothy Light said of Ryan’s plans to reform Medicare.

“I think we’ve got to do something about Medicare. We have to raise the age (of eligibility), limit benefits and clean up the fraud,” Light said. “If we don’t do something, Medicare is gutted.”

Her grandson, Daniel Dorchuck, 18, who is headed to Duke University as a freshman this fall, joined his grandparents at the rally and shares their enthusiasm for Ryan.

“Change is better than bankruptcy,” said Dorchuck, who welcomes Ryan’s honesty about the need to cut federal spending.

The AARP, the lobbying group for adults ages 50 plus, is not making an endorsement in the presidential contest, but is urging members to speak up about Medicare through a new campaign called You’ve Earned a SAY .

“We want Social Security and Medicare to be there for our children and our children’s children. We’ve earned these benefits and we feel they are major safety nets. We know that these programs keep people out of poverty,” said Angela Cortez, communications director for AARP Colorado.

The group is conducting a national listening tour with older adults and plans to make a splash at the University of Denver when one of the presidential debates is held there on October 3.

The National Committee to Preserve Social Security and Medicare is also stepping up critiques of the Ryan budget.

“Choosing Paul Ryan as Mitt Ryan’s vice presidential candidate has changed the whole dynamic of this campaign,” said Dan Adcock, director of policy and government relations for the group.

He said Republicans are now using a “divide and conquer” strategy where they try to convince older seniors that Ryan’s proposed changes won’t affect them.

“That’s just not true,” said Adcock. “The way the newest version of the Ryan plan is structured, you get a voucher and you compete. You can use that on a traditional Medicare plan or a private plan.”

He said policy experts expect private companies to try to cherry-pick the younger and relatively healthier older adults, which could then send traditional Medicare into a “death spiral.”

The new conversation about Medicare will be especially relevant in states like Florida, Iowa, Nevada and Pennsylvania, Adcock predicted.

Colorado’s senior surge means that policymakers here will need to pay close attention to the needs and the political views of this ever more powerful group.

“Currently, we’ve got a very ‘young old’ population,” Garner said. “They are basically 65 to 70.”

But health costs surge with age and people ages 65 and older could eventually represent nearly 1 of every 5 Coloradans.

Garner cites data in her report on aging that show health costs increasing from an average of about $1,800 a year for young adults in their 20s and early 30s to more than $4,800 for those over 65.

“The fastest growth industry in Colorado over the last 10 years has been health care. That is due in large part to the aging of the baby boomers. That’s when things start hurting a little. Even at 55, you can have problems with hips and knees. That’s when you start  needing a little more health care.”

By Bob Semro

The latest debate over the Affordable Care Act is whether the new law cuts Medicare funding by more than $700 billion and then uses the money from those cuts to cover the cost of reforms that have nothing to do with American seniors. The implication is that the ACA will hurt Medicare without offering anything in return. The debate has received a great deal of attention because Medicare is a very popular program, not just with seniors but with most Americans.

Historically, Medicare has been extremely successful in providing health care for America’s seniors. Before Medicare existed, many seniors had limited access to health insurance or regular medical care. Even in our current polarized political environment this “government-run” public program is popular with both Republicans and Democrats. In a 2011 Washington Post/ABC poll, 53 percent of those surveyed said that they would prefer to raise taxes on all Americans in order to avoid cutting Medicare, compared to 21 percent who supported cutting Medicare as part of a deficit-reduction plan.

The claim that Medicare would be “cut” by $716 billion comes from a July 24, 2012, analysis concerning the Affordable Care Act by the non-partisan Congressional Budget Office. However, the report does not say that the ACA cuts Medicare; rather it states that if the ACA were repealed, “spending for Medicare would increase by an estimated $716 billion” between 2013 and 2022.

The Affordable Care Act does, indeed, reduce the growth in Medicare spending, but those reductions are based on efforts to improve efficiencies and reduce waste and fraud, all of which are designed to extend the solvency of the program. There is no provision in the law that either rations or eliminates any Medicare benefit. In fact, sections of the law specifically prohibit any action that would take away Medicare benefits, restrict eligibility or increase costs to middle- and low-income seniors.

Under the ACA, Medicare expenditures are still projected to grow an average of 6.8 percent per year from 2015 through 2021.  In order to control Medicare spending, the law also caps spending growth at the growth rate for GDP (Gross Domestic Product) plus 0.5 percent.  The budget passed – twice – by the U.S. House of Representatives, largely formulated by Wisconsin Rep. Paul Ryan, uses the exact same formula to cap Medicare spending growth.

So, how does the Affordable Care Act reduce Medicare spending? The Washington Post reports that 65 percent of the $716 billion in reductions comes from two sources: reducing reimbursement rates for hospitals and Medicare Advantage plans. For hospitals, those reductions will be offset, in part, by the increase in newly covered patients as a result of other insurance reforms in the ACA.

Medicare Advantage plans (a private insurance alternative to traditional Medicare, also known as Medicare Part C) were introduced as part of the Balanced Budget Act of 1997.* The goal was to create greater competition among private insurance companies for the 65+ age market and drive down costs. In practice, however, Medicare Advantage plans have not been as successful at reducing costs as had been hoped. By 2010, the average Medicare Advantage per-patient cost was 17 percent higher than regular Medicare fee-for-service, according to The Washington Post.

In response, the Affordable Care Act reduces payments to those plans and ties reimbursement to improved efficiencies, quality of care and customer satisfaction. And that strategy may be working. According to the Department of Health and Human Services, Medicare Advantage premiums are projected to be 4 percent lower in 2012 than in 2011, and enrollment is expected to increase by 10 percent under the ACA.

Other spending reductions involve lowering the rate of growth in provider payments, improving administrative efficiencies and reducing waste, fraud and abuse in the claims and reimbursement process.

It is also an exaggeration to claim that these spending reductions are exclusively designed to fund non-Medicare related provisions of the ACA. On the contrary, the spending reductions will be used to extend the solvency of Medicare by eight years, create savings for beneficiaries through lower co-payments and premiums, pay full costs for preventive-care benefits and eliminate the prescription drug “donut hole.”

When evaluating the Affordable Care Act, we should also consider how the current Medicare program would be affected under the House budget proposal. Although it was not specifically designed to be an alternative to the ACA, the legislation would fundamentally alter how Medicare would work and how it would be paid for.

Kaiser Health News reports that, under that proposal, traditional Medicare would remain in place for current enrollees. However, for those 55 and younger, Medicare eligibility would eventually increase to age 67 and the program would be converted into a premium-support system where the government would provide a set amount of money annually that could be used to purchase private insurance or enroll in the traditional Medicare program. The government would pay the full premium for the private plan with the second-lowest bid, or for traditional Medicare, whichever is lower.  If costs should rise faster than the size of the annual subsidy, then seniors would have to pay the difference or move to a cheaper and possibly less comprehensive plan. Over time, that could shift more of the cost burden to seniors.

While the House budget proposal would repeal the vast majority of the Affordable Care Act, many of the cost-cutting provisions described above would remain in place. Under this plan, the prescription drug donut hole would continue to exist, allowing significant costs to be passed on to beneficiaries; and preventive services would still be subject to co-pays and deductibles.

While the current debate is focused on Medicare, an even bigger issue may be waiting in the wings.  Under the House plan, Medicaid, the only safety net available for seniors who run out of money for expensive long-term care services, would be turned into a federal block grant. That plan would reduce federal Medicaid spending by $810 billion over 10 years.  We will discuss the impact of these cuts on seniors in the future.

*That bill also introduced a new formula to calculate the Medicare provider reimbursements rate, called sustainable growth rate (SGR). That provision has been postponed on numerous occasions and if implemented next year would result in a 32 percent pay cut for Medicare doctors and providers.

By Dr. Aroop Mangalik

Accepting hard scientific facts is seldom easy. Despite more than five decades of research and mountains of data demonstrating shrinking glaciers, melting icecaps, rising seas and severe droughts across the world’s continents, climate change skeptics adamantly refuse to believe the legions of international climate scientists.

The tension between science and emotion is even more dramatic in the realm of modern medicine, when quality of life and life itself are at stake.

Most health care professionals realize that at a certain point, treatment of seriously ill patients is futile.  In some – maybe many – instances, treatment of these patients may even be harmful, producing side effects that would be acceptable if there was some benefit, but merely make the patients’ final days or weeks more painful, uncomfortable and unpleasant.

Doctors often try to dissuade patients and their families from seeking treatments they believe to be futile, and as a result, many choose instead to focus on care that enriches their quality of life.

But there are some who challenge this practice, saying that doctors who discourage further treatment and allow patients to die comfortably and in peace are killing them. The critics suggest that doctors who recommend against further treatment show a lack of respect for the elderly, the disabled and the very sick. They say (maybe even believe) that doctors and hospitals have financial incentives for not treating them.

They fail to accept that the reality is exactly the opposite.

Hospitals and doctors in the current system of fee-for-service medicine are compensated for the treatments, regardless of who the patient is and whether the patient might benefit from them.

This is especially true for the elderly on Medicare.

Medicare pays about half of its reimbursements to cover treatment of patients in the last three months of their lives. This means that more money is spent on treatments that are painful and expensive, and do not help the patient.

Over two-thirds of people say they want to die at home, but in fact, due to the excessive treatment, over two-thirds die in hospitals, hooked to machines and often separated from their family and friends.

Patients frequently are told that they should not give up; they should avail themselves of all medical technology; they should “fight.”

The deniers of death may have known of a patient who lived longer than expected, or of someone denied treatment for financial reasons. They generalize from those cases and develop a narrow perspective.

In many ways, they resemble the climate change skeptics, who cling to a mindset despite the accumulating volumes of data.

Encouraged by industries with a vested interest in the status quo, the climate change skeptics sow doubt about science and undermine sincere efforts to address the issue before damage to ecosystems around the world is irreversible.

The public, desperate for an easy answer to an overwhelmingly complex problem, is vulnerable to the climate skeptics’ message, so science and its peer-reviewed data are cast aside in favor of a more optimistic – if dishonest – appraisal.

Similarly, when it comes to health care, people may hear an extreme, often inaccurate, story about a medical miracle and seek to replicate the experience for themselves or their loved ones. The science, the data, the facts are ignored.

But, despite the emotional response to the desperation measures, the futile quest to treat a dying patient no matter what is not heroic.

That unwillingness to accept the medical reality squanders scarce medical resources for no benefit. It nurtures false hopes in both patients and their loved ones. And it deprives a frail, sick, dying person of a peaceful death in a comfortable bed with family and friends nearby.

Reality is unchanged. It is the patient who pays the price.

Dr. Aroop Mangalik is an oncologist, clinical researcher and professor of medicine at the University of New Mexico Cancer Center.

By Diane Carman

Long before five people were killed at the University of Iowa in 1991, signs of trouble were apparent to those around the former graduate student who opened fire on his colleagues. Similarly, the shooter in the Virginia Tech massacre in 2007 had a long history of psychological struggles, and people around him said he had been acting strangely in the days and weeks before he killed 32 people and wounded 17.

The refrain on both campuses was the same: If only people had known what to do or who to call for help.

These incidents were key factors in the development of threat assessment teams at Iowa State University and Virginia Tech, which were among the first institutions to create the programs designed to identify and treat persons who may be a threat to themselves or others.

Threat assessment teams have vaulted into the news following the Aurora movie theater killings last month. Accused shooter James Holmes, who had been a neuroscience graduate student at the University of Colorado Denver, was receiving care from a psychiatrist, according to court documents. Police are now probing whether his psychiatrist or other university officials reported concerns about Holmes’ behavior to the school’s threat assessment team in the weeks prior to the shooting that left 12 dead and 58 injured.

The work of threat assessment and behavioral intervention teams is little known or understood, but the FBI and other law enforcement organizations consider these teams to be crucial for reducing violent behavior on campuses, in workplaces and in other public settings.

Proving that they prevent violence is not so easy, however. “This begs the question,” says the FBI on its website. “How can a negative be proven?”

For those working with threat assessment teams, however, the benefits are obvious.

“There’s a statistic out there that if we catch somebody early in the process of a psychotic break, there’s a 90 to 95 percent chance things won’t spiral down,” said W. Scott Lewis, a partner with the National Center for Higher Education Risk Management  and president-elect of the National Behavioral Intervention Team Association.

Lewis said that “virtually every” higher education institution has created some kind of formal or informal threat

W. Scott Lewis

assessment team in the last decade, though the concept of monitoring students and providing advice and support has been around for centuries. “It goes back to the old European models with the seminaries where monks and priests lived there and kept an eye on the students.”

The more formal team approach spread across the country in response to deadly incidents. The National Behavioral Intervention Team Association estimates it has 700 to 800 active members.

A 2008 report  on threat assessment teams calls the Virginia Tech shooting “the ‘9/11’ of higher education.” Since that day, “campus administrators and others across the country have increasingly focused on safety issues generally and, more specifically, on the management of disruptive students who may also have serious mental health issues.”

So now, instead of a meeting in the dean’s office with a couple of faculty members trying to figure out what to do, more often cases involving troubled students or staff members will be referred to a professionals who are assembled in teams that specialize in evaluating threat risks and developing treatment or other intervention programs.

Lewis, who is a fan of the proactive approach taken by behavioral intervention teams, said that some university threat assessment teams still are ad hoc organizations that meet only when a threat is identified, while behavioral intervention teams generally are full-time programs that are designed to address problems in very early stages — long before a threat might be perceived.

How teams work

Threat assessment and behavior intervention teams usually include counselors, mental health professionals, campus police officers, disability specialists and legal advisers.

They run outreach programs to teach students, faculty members, residence hall advisers and university staff members from administrators to custodians how the teams work and what kind of behaviors are considered red flags. The teams rely on the full cooperation of university community, so they work hard to teach their colleagues what to look for and how to report information.

“We’ve looked at a number of incidents over the last many years, and it’s very rare for an escalation to significant volatile behavior without exhibiting concerning behaviors before that,” said Gene Deisinger, deputy chief of police and director of threat management services at Virginia Tech. Deisinger also was involved in the creation of one of the first threat assessment teams when he was at Iowa State University in 1993.

The key to an effective threat assessment team is to identify the “concerning behaviors” early, neutralize the threat and design a response that addresses the individual’s specific needs.

Red flags might include missing class, significant weight loss, signs of cutting, strange postings on Facebook, troubling statements in term papers or class journals, covert or veiled threats either online or in person, bizarre behavior in discussion groups, treatment for alcohol or drug abuse, disassociating in class or any number of other behaviors.

Lewis said many programs use a rubric to plot the information and determine how serious the situation might be. If a person is found to be in a crisis, universities can mandate mental health treatment.

“The process is designed to provide a fair, objective and reasonable assessment and response to identified concerns,” said Deisinger.

It’s not about what teams can make people do, he said. “Our approach is to emphasize a caring, consultative approach.”

To a great extent, that is the result of some not-so-successful experience with other models.

In the aftermath of the Virginia Tech shootings, several universities emphasized that troubling behavior be reported without thinking about what the appropriate response to that information should be.

“Many tried a zero-tolerance approach,” which generally was perceived as punitive and resulted in low levels of reporting, Deisinger said.

As the programs evolved, however, emphasis on communication, counseling and solving problems increased and made the teams more effective.

Gene Deisinger

Sometimes, the incidents that are reported as potential threats are found to be simple misunderstandings. The behavior or conversations were taken out of context and are “much less ominous than initially perceived,” Deisinger said.

Other times, the problems are serious and possibly life-threatening.

Deisinger told of an international student who was exhibiting bizarre, disruptive behavior and began showing a fascination with weapons. He was having trouble with a faculty member who “didn’t have the most agreeable manner of problem-solving.”

The student was brought to the attention of the threat assessment team, which helped him get treatment for his developing mental health crisis. It also worked with the faculty member to help him develop better skills for working with students and others.

Ultimately, Deisinger said, the student returned to his home country where he received psychiatric treatment and continued his studies via distance learning programs.

Deisinger has maintained contact with the student’s family. “His health has markedly improved,” he said. He has a job and “feels grateful for the assistance he received.”

At the same time, the other students at the university were able to concentrate on their studies again without being distracted by fears for their own safety.

Not every intervention is that successful, however.

Lewis recalled two incidents in which he was involved where students with serious mental health problems came into behavior intervention programs and, despite months of counseling, treatment and intensive support, took their own lives.

Need is great

Most university programs receive hundreds of referrals a year once the threat assessment teams are well established, which usually takes two or three years. The teams follow up on information that is provided and develop intervention plans, but they also engage members of the faculty and staff to continue to monitor cases and provide support.

“My goal is to develop a consultative relationship with people who have concerns about the safety and well-being of the community,” Deisinger said. “We want people to be active agents.”

Often people will come to the threat assessment team saying, “It may be nothing, but…”

Deisinger encourages them. “When in doubt, consult,” he said. If behaviors seem outside the norm, the team can determine if they pose a threat.

What he won’t abide is what he calls “the plop effect.”

“That’s when people plop the problem on my desk and think they’re absolved of it.”

Universities are big places, Deisinger said. “We can’t afford to have you plop and run.”

Deisinger and Lewis said it’s difficult to demonstrate that the teams have prevented violent incidents, but seldom does the bizarre, threatening behavior continue or escalate once the team is involved.

“We should strive for the goal of eliminating violence on campus, but it’s an unrealistic goal in its absolute,” said Deisinger. “We can’t absolve the world of all risks. What we can do is reasonable mitigation of the risks we can influence. It’s very important for us not to over-promise and under-perform.”

Cost varies

The threat assessment and behavior intervention teams can be costly, depending on the number of cases that occur on each campus, whether the teams are full-time operations, and the size and level of staff support involved.

“It depends on who’s on the team,” Deisinger said.

But the alternative may not be cheaper.

We know that addressing the threats and concerns that arise can be expensive, he said. We also know from hard experience that “failing to do so can be very, very costly.”

By Nat Rudarakanchana and Matt Drange

I-News Network

Federal prosecutors are close to concluding a criminal investigation into last fall’s deadly listeria outbreak linked to cantaloupes grown at Jensen Farms, the I-News Network has learned.

Interviews and newly obtained documents also show:

• Conflicts of interest in food safety audits of the farm near Holly are deeper and more widespread than previously reported.
• Private inspection company Bio Food Safety has joined Jensen Farms in filing for bankruptcy, while a settlement fund established for victims of the outbreak is millions of dollars short.
• A memo obtained by I-News shows how private auditing firms might escape liability in foodborne illness cases.
• The latest food safety law, characterized as a “sweeping reform” by the Food and Drug Administration, leaves untouched the problems that allowed Jensen Farms to distribute its tainted melons. Meanwhile, new efforts by members of Congress to fix the problems have gone nowhere, leaving potentially deadly gaps in the food safety inspection system.

Dozens of civil lawsuits have been filed, but await bankruptcy proceedings before they can move forward. I-News has also learned that prosecutors initiated a grand jury investigation last fall, just weeks after the melons were recalled.

Federal investigators could file criminal charges against the farm in Southeast Colorado within the next few weeks, said a source close to the investigation.

Jaime Pena of the U.S. Attorney’s Office in Denver would neither confirm nor deny the investigation, but said the case was “an important public health” issue. However, multiple sources confirmed the criminal investigation to I-News.

One of those sources was Bill Marler, an attorney who represents 42 separate victims in lawsuits against Jensen Farms. Marler said in his experience with similar outbreaks, it took years before federal investigations came to fruition.

“So this…is far more prompt than other investigations we’ve seen,” Marler said. “I certainly got the impression they were moving forward relatively quickly.”

Despite the pace of the investigation, criminal charges could lead to only a small fine.

Sources said charges might be brought under the Food, Drug and Cosmetics Act for the adulteration of food. Under the act, knowingly selling adulterated food is a felony. But doing so without knowledge or intent to defraud consumers is a misdemeanor, penalized by up to a year in prison or a $1,000 fine.

Deadly outbreak in 2011

Last year, Jensen Farms cantaloupe were found to be tainted with the pathogen listeria monocytogenes, sickening 147 people according to the Centers for Disease Control. Another 37 deaths are believed to be associated with the outbreak, making it the deadliest in nearly a century.

On July 18, an investigator from the Office of Criminal Investigations branch of the FDA collected medical releases and health department records for victims of the outbreak.

Frontera Produce, a Texas distributor of Jensen Farms cantaloupes, also confirmed through spokesman Jim Mulhern that they were aware of a criminal investigation and were contacted about the investigation earlier this year.

I-News obtained a memo prepared after the outbreak by a law firm that advises private food safety auditing companies. The memo outlined how companies could avoid liability for sickness and death because consumers never review their auditing reports.

And even if consumers did see the reports, the memo argued, they need to take steps to protect themselves. Either way, inspectors should be able to “escape with no liability.”

No food safety auditing company has ever been found liable in litigation brought by consumers,  Marler said.

Two private food safety auditing companies were involved in the Jensen Farms case. Jensen Farms hired PrimusLabs, a California-based company, to audit the farm. PrimusLabs in turn subcontracted the work to Texas-based Bio Food Safety.

If either company is found partially responsible for the outbreak, the case could set a new legal precedent for an industry that critics say lacks accountability.

On July 27, Bio Food Safety filed for Chapter 11 bankruptcy. The company then filed a motion to consolidate its case with Jensen Farms’, which filed for bankruptcy in May.

The two companies, along with Pepper Equipment, have agreed to a settlement, Marler said. Together, they have placed roughly $4.5 million in a settlement pool.

Victims must submit claims for a portion of that money by September 14 – exactly one year after the FDA announced a recall of cantaloupe grown at the farm in southeastern Colorado.

As of July 23, medical bills amounted to more than $6.5 million for Marler’s clients alone, not counting the half dozen victims represented by other attorneys. This means that if everyone who’s eligible submits a claim, they will receive only a percentage of their total medical costs. Marler said he is considering suing retailers for the remainder.

Outside attorney Al Maxwell is overseeing the process as special claims administrator. Maxwell served a similar role in litigation involving the Peanut Corporation of America, which received a glowing audit by private inspection company AIB International shortly before a widespread salmonella outbreak in 2008.

Given the number of potential claimants, Maxwell said, “I think it’s fair to say that if there’s $4.5 million they could exceed that amount. Perhaps significantly.”

‘Just how the industry works’

Although the conflicts of interest inherent in private food inspections have been widely reported, the conflicts found at Jensen Farms go deeper. The company that inspected the operation had previously acted as a consultant to the farm.

Bio Food Safety founder Jerry Walzel audited Jensen Farms in August 2010, but afterward recommended as a consultant that brothers Ryan and Eric Jensen purchase different washing equipment. A used potato washing machine was shipped to the farm on July 20,invoice statements show – five days before Walzel sent one of his inspectors to audit the farm.

It was that very piece of equipment that federal investigators believe may have been one source of the listeria. When one of Walzel’s inspectors visited the farm again last July, he did not note any issues with the potato washer, and under federal guidelines is not required to notify the FDA of equipment changes.

Several auditors and industry experts said that to audit a food producer after consulting and recommending food safety changes is a serious conflict of interest, especially if the auditing and consulting both happen within a two-year window. In that scenario, they said, to audit is to examine and grade your own work as a consultant.

It’s unclear if PrimusLabs knew of Walzel’s dual roles.

“If Jerry was doing some consulting for them and didn’t tell us, that would make us pretty angry,” said a source familiar with PrimusLabs. “Most auditors will tell us if they’ve done work for a client in the past and will say that they cannot audit in this case.”

Reached at his Texas home earlier this year, Walzel would not comment on either his 2010 audit or his company’s audit last July, citing advice from his attorney Milton Colia. None of the four employees listed on Bio Food Safety’s website returned calls for comment.

Ryan and Eric Jensen declined to comment through their attorney.

Several contract auditors told I-News that employers rarely monitor or investigate conflicts of interest. If an auditor first recommends food safety measures as a consultant to a farm and later audits their own work, they are expected to disclose the relationship upfront.

Craig Bovee, a Texas farmer previously audited by Walzel, said that when it comes to consulting and auditing simultaneously, “it’s just how the industry works.”

Before becoming an auditor, Walzel worked for 18 years as a Texas game warden, his resume shows. He eventually became vice president of government affairs for the Texas Produce Association in 1987, and worked as a lobbyist.

On May 30, 2002, Walzel registered his auditing company, Bio Food Safety Inc., with the Texas Secretary of State, incorporation records show. Since 2009, Walzel has conducted numerous audits for the California-based PrimusLabs, including three produce facilities in Texas and an onion farm in Mexico.

While Walzel would not comment on his work for Jensen Farms, he estimated he had done 1,000 audits in his career, and added that he “had nothing to hide,” before declining to answer further questions.

“Nobody is going to be brought back from the grave,” if I talk to you, Walzel said.

No regulation

Little comprehensive data exist on the scope of the private auditing industry, which isn’t regulated by the FDA.

The agency doesn’t track which among its 1,800 staff investigators (tasked with both foreign and domestic inspections, among other things) are responsible solely for food safety. With an estimated 186,000 farms across the country inspecting each one is impossible, said FDA investigator Jim Gorny, who visited Jensen Farms last September.

The agency had never been to Jensen Farms prior to the outbreak.

“We can’t be everywhere all the time. It’s just not possible,” said Gorny, a private auditor before joining the FDA and a key investigator in the Jensen Farms outbreak. “Our job is not to make food safe. Our job is to set the standards and make sure that people are complying with them.”

The private auditing industry in the United States remained largely untouched by the Food Safety Modernization Act signed into law last year. While the act develops a model to approve and certify foreign food safety auditors, it does not give the FDA authority to regulate domestic auditors.

The agency doesn’t track the size of the industry, does not keep a directory of individual firms, and does not investigate private auditing firms with dubious track records, an FDA spokesman confirmed.

“Unfortunately, we’re going to see more of this,” said microbiologist Mansour Samadpour, president of IEH food testing lab. He compared a third-party audit to a person who claims to be a physician, but only takes your pulse.

“Even if they do the work properly, these are not food safety audits. They are being sold as them, but they are not.”

Finding solutions

In January, U.S. Rep. Diana DeGette of Denver and three other Democratic members of the House Energy and Commerce Committee called for the FDA to reconsider its approach to third party auditing in an open letter to FDA commissioner Margaret Hamburg. The letter emphasized that auditors often don’t require food safety flaws to be corrected, don’t conduct thorough and unannounced audits, and face serious conflicts of interest.

The lawmakers requested that the FDA reform its industry regulation and guidance in light of Jensen Farms, suggesting that the agency develop a model for U.S. auditors that could act as a standard.

Since then, the committee has done no follow up work on the issue of conflicts of interest among auditing companies, said Karen Lightfoot, spokeswoman for ranking member Rep. Henry Waxman (D-Calif.). DeGette did not respond to several requests for comment.

But one model for fixing food safety auditing may already exist. It’s called the Global Food Safety Initiative, or GFSI.

Under GFSI guidelines, auditors must be uniformly trained and qualified. Problems found during GFSI audits must be fixed before a farmer, grower or shipper can pass. Provisions safeguard against conflicts of interest like those in the Jensen Farms case.

In 2008, Walmart began requiring produce suppliers to undergo GFSI approved audits. But ensuring GFSI audits takes time, Walmart learned. As the company became more involved in implementing the new requirements, it realized the need to extend the deadline for suppliers to meet the higher standards, a spokesman said.

A letter issued by Walmart to produce suppliers in 2010 shows the retailer extended the deadline for GFSI certification to December 2011, a move that allowed Jensen Farms’ contaminated cantaloupes to reach Walmart’s shelves last year.

GFSI audits can cost thousands of dollars more than proprietary ones. In many cases smaller companies are more likely to seek a non-GFSI audit, said Bill Schwartz, a former manager at an auditing firm who now teaches an online training course for auditors.

Like other auditing companies, PrimusLabs offers both GFSI-approved audits and proprietary audits subject to their own internal standards. The latter is what Jensen Farms chose last year.

Private inspections like the one conducted at Jensen Farms are the “subprime mortgages” of food safety audits, said Benjamin Marchant, vice president of business development for private auditing firm NCSI Americas Inc., which conducts GFSI equivalent audits.

Roughly half of the audits conducted in the U.S. this year will be proprietary, Marchant said.

“They’re just accidents waiting to happen,” Marchant said. “Everyone knows that. There’s just no rules around them and there’s no consequences. There’s no one with any teeth or the ability to say, ‘No, that’s not right.’ ”

Additional reporting contributed by Jeff Green, Nathaniel Herz, Benjamin Sales and Sean Easter. All six reporters are recent graduates of Columbia University’s Toni Stabile Center for Investigative Journalism.

The I-News Network is a nonprofit newsroom collaborating with Colorado news organizations to cover important issues. Learn more at iNewsNetwork.org

Editor’s Note: This story has been updated to correct the name and the company for Benjamin Marchant. An earlier version was incorrect.

By Nat Rudarakanchana and Matt Drange
I-News Network

The deadly listeria outbreak at Jensen Farms last fall illustrates wider failures in the private food safety auditing industry, an industry that operates with little government oversight. Almost a year later, these failures remain unaddressed by lawmakers, regulators and the industry itself.

Those who ate Jensen’s cantaloupes bought them from stores including Walmart and Kroger, retailers that require audits of food producers to verify that the food they sell is safe to eat. But it is food producers – such as Jensen Farms – that pay for the audits.

Critics say this is an inherent conflict of interest, as it’s unlikely auditors would fail those who commission their services. David Acheson, former associate commissioner of foods for the FDA, said understanding the results of an audit can be especially challenging for small farms.

“If I give someone a failing grade, there’s no way they’re going to invite me back next year,” Acheson said, adding that high scores like the one Bio Food Safety awarded Jensen can instill a false sense of security.

“They (Jensen Farms) are going to think ‘Wow, we’re good,’ ” he said. “And why would they not think that? They aren’t real thirsty to hear that they have problems.”

Many inspection companies set their own standards, and do not always conduct the work themselves. Instead, they contract the work to independent auditors such as Bio Food Safety. Industry experts and contract auditors say subcontracting can be problematic because training requirements between firms and individuals vary.

For that reason, private auditing firm Steritech doesn’t rely on contract auditors, its CEO Mark Jarvis said. Based in North Carolina, Steritech conducts about 2,000 audits annually.

“What makes us different is that all of our people are full-time employees,” Jarvis said. “(Using subcontractors) is a huge Achilles heel in the whole industry.”

Several contract auditors said in separate interviews that training standards vary according to an inspection company’s internal practices. Some reported lax hiring standards, while others said they were subjected to more rigorous reviews and background checks.

New Jersey-based contract auditor David Strait, for instance, recalled how two auditing companies had only asked for his resume before offering him some contract audits, without meeting or training him personally.

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.