By Merrill Goozner, The Fiscal Times
This story comes from our partner 

Julie Grabow, an oncologist at the Fred Hutchinson Cancer Center in Seattle, recently prescribed an exciting new therapy for a 60-year-old woman with metastatic breast cancer.

Three-and-a-half years into her battle against the disease, the patient had already exhausted three different anti-estrogen therapies, each of which only put a temporary check on the spreading tumors.

The newly prescribed drug, Novartis’ Afinitor, is one of the recently approved targeted therapies that have generated a lot of excitement among cancer patients and oncologists in recent years.

Drugs that target just the cancer cells promise the same or better results as toxic chemotherapy, but with far fewer side effects.

There was a catch, though. Like many of the latest cancer drugs, Novartis is charging exorbitant amounts for the treatment – in this case, $10,000 per month.

That quickly put an end to that possibility for Grabow’s patient. Her monthly co-payment, even after her insurance company agreed to pay its share of the off-label use the drug (the Food and Drug Administration has only approved Afinitor for kidney and pancreatic cancer, not breast cancer), was $2,900.

“She can’t afford this, even though it’s potentially a less toxic and potentially equally effective regimen,” Grabow said. “Chemo will help her, and it’s a reasonable choice. But that choice is 100 percent driven by economics.”

Over the past year, official Washington and candidates on the campaign trail have locked horns over the best way to curb rising health insurance costs. The public has been bombarded with dueling slogans – Republicans vowing to fight the “death panels” and “rationing” of Obamacare while Democrats promise “guaranteed access” and “affordability” with the Affordable Care Act.

But an economic drama that neither side wants to confront is playing itself out in cancer wards and oncologists’ offices across the country.

Unaffordable new drugs, even when they’re covered by insurance, are being rationed by price as patients, doctors and hospital officials struggle with what is likely to be the most pressing problem for the nation’s health care system over the next decade: how to pay for the spectacular rise in the cost of cancer care, especially drugs and diagnostic tests.

“In the real world of private practice where most care is delivered, it would be a mistake to say rising costs haven’t affected care,” said Eric Nadler, a head, neck and lung cancer specialist at Baylor University Medical Center.

The growing cost of cancer care will impose its greatest burden on the nation’s Medicare system, since 55 percent of all cancers are diagnosed in individuals 65 or older.

A recent study by the National Cancer Institute projected the cost of treating the 29 most common cancers in men and women will rise 27 percent by 2020, even though incidence of the disease is going down due to successful public health campaigns like the war on smoking.

The study pointed out that its projections were based on 2006 Medicare claims data, which predated the development of most of the latest targeted therapies.

There’s no doubt that there will be many new therapies for cancer coming to market in the years ahead. The nation’s $150 billion public investment in understanding the biology of cancer – the science side of the War on Cancer launched by President Richard Nixon in 1971 – is beginning to bear fruit.

The pharmaceutical industry, which draws on that publicly funded science to develop drug candidates, now has 887 new cancer drugs in development, over 30 percent of its total portfolio of new drug candidates, according to the Pharmaceutical Research and Manufacturers of America, the industry trade group. That’s up from 646 or 26 percent of the total devoted to cancer in 2006.

The industry is pouring increased research and development resources in cancer therapeutics in hopes that it will replace the revenue being lost from the expiration of patents on blockbusters like Lipitor.

However, since there are fewer cancer patients than there are people with chronic conditions like elevated cholesterol, and many don’t live very long, the prices needed to support the industry’s current size and structure, and profits must be substantially higher.

“They’re trying to maximize profits given their incentives,” said Peter Neumann, director of the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center, which receives funding from the drug industry.

Possible solutions, he said, include letting Medicare set prices based on the medical value of adding extra months to life. That’s a variation on Great Britain’s cost-effectiveness model, which has been roundly condemned by most U.S. politicians and the press.

The other path is to turn to a bundled payment for every for every episode of cancer care and let the health care delivery organizations and private insurers sort it out. (Bundled payments account for all medical services associated with a given episode of care—doctors, nurses, technicians, etc.) That approach, in essence, would force the marketplace to execute the rationing.

“Bundled payment isn’t a panacea, but it does create incentives,” Neumann said. Some private insurers are experimenting with bundled payments for cancer care.

A quick review of the new cancer drugs approved by the Food and Drug Administration last year reveals how fast drug prices are rising.

Most of the older chemotherapy regimens for cancer, some of which have been around since the 1950s, are generic and relatively inexpensive.

But among the six new drugs approved in 2011, the cheapest – Johnson & Johnson’s Zytiga for advanced prostate cancer – cost $44,000 a year. The drug extended life by an average of less than 5 months to 16 months, according to a company spokesperson.

At the high end of the spectrum was Adcetris, a biotech product from Seattle Genetics that treats recurrences of Hodgkin’s lymphoma. A highly curable disease when initially treated in the 8,830 mostly middle-aged patients who get the disease every year, it is usually fatal if a drug-resistant strain emerges later in life.

Adcetris, the first new treatment to come along since 1977, kept the cancer in check for nearly 7 months in the single small trial that led to its quick FDA approval. It’s price tag: $216,000 for a full course of treatment.

Skin cancer specialists had a lot to cheer about in 2011 with two new therapies coming on the market for metastatic melanoma, which is fatal within one year for about 75 percent of the 10,000 people stricken each year.

But Roche/Genentech’s Zelboraf cost $61,400 a year and Bristol-Myers Squibb’s Yervoy, which nearly doubled the one-year survival rate from 25 percent to 46 percent, cost $120,000 for a four-month course of treatment.

“We price our medicines based on a number of factors including the value they deliver to patients and the scientific innovation they represent,” said Sarah Koenig, a spokeswoman for Bristol-Myers. “We have one of the most robust patient assistance programs for cancer patients in the industry.”

Most drug companies have patient assistance programs for poor or struggling patients, but many only come into play if patients are poor or families have exhausted their savings.

And since many of the latest therapies, like the older chemotherapies they are replacing or supplementing, extend life for brief periods of time, patients wind up weighing whether they want to deplete their children’s inheritances for a couple extra months of being very, very sick.

A study released at last June’s annual conference of the American Society of Clinical Oncology, which represents the nation’s 25,000 oncologists, revealed that patients with co-payments over $500 a month were four times more likely to refuse treatment than those whose co-payments were under $100 a month.

“The price of drugs can’t be set so outrageously high,” study author Lee Schwartzberg told Reuters. Schwartzberg is the chief medical officer at Acorn Research, which conducted the study.

“All stake holders have to get together and compromise to translate this great science into great patient care without breaking the bank.

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

The talks will be held 7 p.m. to 8:30 p.m. every Thursday of the month.

What’s Stress Got to Do with It? — February 2

Dr. Bonnie McGregor is a behavioral medicine pioneer interested in how psychological factors affect the health of our bodies and our minds. Hear how stress influences our vulnerability to disease, and how stress management techniques can help you reduce your own disease risk.

Stem-cell Therapy: The Hope, the Hype and the Real Potential – February 9

Join Drs. Beverly Torok-Storb, Tony Blau, Phil Horner and Chuck Murry in a discussion of stem-cell research. Learn about the different types of stem cells, common misunderstandings about stem-cell work, clinical therapies being explored and what these researchers envision for the future.

Cancer and Infectious Diseases: Making a Global Impact – February 16

Did you know that nearly a quarter of cancers around the world are infection caused or related? Meet Dr. Corey Casper, the force behind the Hutchinson Center’s research on infection-related cancers in Uganda. By focusing efforts in a country with a higher disease burden, we hope to understand how chronic infections lead to cancer, including why this happens in some of us and not in others.

Influenza: A Study in Evolution – February 23

Soon personal genomic sequences will be cheaper than personal computers. But genomic sequences don’t come with instruction manuals, so revealing what they tell us about evolution and disease remains a challenge. Dr. Jesse Bloom will take us on a journey along the evolutionary path followed by one influenza gene over the last 40 years, and reveal the obstacles and forces that shape genetic change as we attempt to understand evolution at the molecular level.

When:

Thursdays
February 2-23
7-8:30 pm

 Where:

Fred Hutchinson Cancer Research Center
1100 Fairview Ave. N., Seattle
Thomas Building
Pelton Auditorium

To Register go HERE.

Each year, about 70,000 young people in the U.S. aged 15 to 39 years are diagnosed with cancer.

In the series, a group of teens and young adults from Children’s Adolescent Young Adult Oncology Program talk about their experiences with the disease – from treatments and hair loss, to dealing with school, friends and family.

Producers of the series hope that seeing other teens and young adults with cancer talk about their experiences will help other young patients struggling with the diagnosis of cancer cope.

“It is so important for these teens and young adults with cancer to know that there is a peer out there that understands what they are going through and that support is available,”  Dr. Rebecca Johnson, medical director of the Adolescent and Young Adult Oncology Program at Seattle Children’s Hospital.

The discussion group was facilitated by Teen Talking Circles, a nonprofit organization that offers teens “a safe place to tell their truth,” and trains adults to start Teen Talking Circles in their communities.

• To view the complete series go to:  ”Good Times and Bald Times” or click on individual episodes listed below.

• To learn more visit the website of the Children’s Adolescent Young Adult Oncology Program.

To learn more about the challenges facing teens and young adults with cancer read our series from the NCI Cancer Bulletin.

Series Episodes:

• Good Times and Bald Times – Meet the Circle
• Good Times and Bald Times – Family, Friends & Cancer
• Good Times and Bald Times – How Did it Feel?
• Good Times and Bald Times – Treatment and Medication
• Good Times and Bald Times – Eggs
• Good Times and Bald Times – Fertility Preservation
• Good Times and Bald Times – Food, Appetite & Cancer
• Good Times and Bald Times – Feeding Tubes
• Good Times and Bald Times – Losing Your Hair
• Good Times and Bald Times – PICC Lines, Hickman Lines & Ports, Oh My!
• Good Times and Bald Times – Dealing with School
• Good Times and Bald Times – What If

By Dr. James Kublin

Today, December 1st, is World AIDS Day, and to mark the occasion the HIV Vaccine Trials Network, which is headquartered at Fred Hutchinson Cancer Research Center in Seattle, would like to debunk the top 10 myths about HIV vaccine research.

Myth No. 1: HIV vaccines can give people HIV.

HIV vaccines do not contain HIV and therefore a person cannot get HIV from the HIV vaccine. Some vaccines, like those for typhoid or polio, may contain a weak form of the virus they are protecting against, but this is not the case for HIV vaccines. Scientists make HIV vaccines so that they look like the real virus, but they do not contain any HIV. Think of it like a photocopy: It might look similar, but it isn’t the original. In the past 25 years more than 30,000 volunteers have taken part in HIV vaccine studies worldwide, and no one has been infected with HIV by any of the vaccines tested – because they do not contain HIV.

Myth No. 2: An HIV vaccine already exists.

There is no licensed vaccine against HIV or AIDS, but scientists are getting closer than ever before to developing an effective vaccine against HIV. In 2009, a large-scale vaccine study conducted in Thailand called RV144 showed that a vaccine combination could prevent about 32 percent of new infections. Researchers are starting to understand why this vaccine combination worked and how to improve upon it.

Researchers around the world continue to search for an HIV vaccine that is even more effective. Leading this effort is the HIV Vaccine Trials Network, the largest publicly funded group of HIV vaccine researchers in the world. The HVTN is an international effort to find a safe and effective vaccine to stop the spread of HIV. It is funded by the U. S. National Institutes of Health.

Myth No. 3: Joining an HIV-vaccine study is like being a guinea pig.

Unlike guinea pigs, people can say yes or no to participating in research. All study volunteers must go through a process called informed consent that ensures they understand all of the risks and benefits of being in a study, and those volunteers are reminded that they may leave a study at any time without losing rights or benefits. The HVTN takes great care in making sure people understand the study fully before they decide whether or not join. All HVTN research adheres to U.S. federal regulations on research, as well as the international standards for the countries in which it conducts research.

Myth No. 4: A person must be HIV positive to be in an HIV vaccine study.

Not so. While some research groups are conducting studies of vaccines that might be used in people who are already infected with HIV, the vaccines being tested by the HVTN are preventive vaccines. They must be tested on volunteers who are not infected with HIV.

Myth No. 5: Vaccine researchers want study participants to practice unsafe behaviors so they can see whether the vaccine really works.

Not true. The safety of study participants is the No. 1 priority of HIV vaccine researchers and study site staff. Trained counselors work with study participants to help them develop an individual plan on how to keep from contracting HIV. Participants also are given supplies such as condoms and lubricant as well as instructions on how to use them properly. HIV efficacy trials enroll thousands of participants over several years, and with even with the best counseling some participants will still become infected through their risky behavior. Changing human behavior is never easy; after all, many people still smoke, even though it is widely known that smoking is the major cause of lung cancer. An AIDS epidemic would not exist if prevention was as simple as counseling people to change their risky behavior.

Myth No. 6: Now that there are pills that can prevent HIV infection, an HIV vaccine is no longer necessary.

HIV-negative people who are at high risk can take antiretroviral medication daily to try to lower their chances of becoming infected if they are exposed to the virus. This type of therapy – called PrEP, short for PreExposure Prophylaxis – has been shown to be effective among those at high risk. However, it has not yet been recommended for widespread use. PrEP is unlikely to be an option for everyone because the pills are expensive and are not always covered by insurance, may cause side effects, and not everyone has access to them. Remembering to take a pill every day is also challenging for some people. The most effective way to eliminate a disease is by using an effective vaccine. It was a vaccine that eliminated small pox and has almost eliminated polio. Most likely it will be an HIV vaccine that eliminates HIV from the world. Vaccines are an effective, affordable and practical option.

Myth No. 7: An HIV vaccine is unnecessary because AIDS is easily treated and controlled, just like diabetes.

While treatment for AIDS has dramatically improved over the last 30 years, it is no substitute for prevention. Current HIV medications are very expensive, and there are also many side effects. Sometimes people develop drug resistance and have to change the regimen of pills they take. Access to these drugs for the uninsured in the U.S. and those in the developing world is also very limited.

Myth No. 8: The search for an HIV vaccine has been going on for a long time and it’s just not possible to find one that works.

The science of HIV-vaccine development is challenging, but scientific understanding continues to improve all the time. In just the past two years there have been promising results from the RV144 study in Thailand as well as exciting laboratory work, such as the discovery of new broadly neutralizing antibodies against HIV. HIV is a powerful opponent, but scientists are constantly learning from one another and using advanced technology to fight it. Science has come a long way in the 30 years since AIDS was discovered. In comparing preventive HIV vaccine work to other vaccine development, the time it has taken is not so surprising; the polio vaccine took 47 years to develop.

Myth No. 9: Vaccines cause autism and just aren’t safe.

This is not true. Numerous studies in the past decade have found this claim to be false. The British doctor who originally published the finding about vaccines and autism has since been found to have falsified his data. There is actually no link between childhood vaccination and autism. It is true that vaccines often have side effects, but those are typically temporary (like a sore arm, low fever, muscle aches and pains) and go away after a day or two. The value of protection to vaccinated individuals and to the public has made vaccines one of the top public health measures in history, second only to having a clean water supply.

Myth No. 10: People who aren’t at risk don’t need an HIV vaccine.

A person currently may not be at risk for HIV, but life situations can change along with disease risk. Such a vaccine also may be important for one’s children or other family members and friends. By being knowledgeable about preventive HIV vaccine research, a person can be part of the solution by educating friends and family about the importance of such research and debunking the myths that surround it. Even if a person is not at risk, he or she can be part of the effort to find a vaccine that will hopefully save the lives of millions of people worldwide.

To learn more or find out how to get involved in an HIV vaccine study, please visit www.hvtn.org

WBBA President Chris Rivera said the upbeat report on state’s life sciences industry was “conservative” — but added there were challenges that threatened the sector’s growth, including burdensome regulation and increased competition from competitors both here in the U.S. and abroad.

The report “Trends in Washing’s Life Sciences Industry 2007–2011”, which was prepared for WBBA by the Washington Research Council, found that the life sciences was now the fifth largest employment sector in the state, after transportation and equipment manufacturing, agriculture, software, and food and beverage manufacturing.

The sector, which does not include hospitals and other health services, employs 33,519 individuals directly, whose employment, in turn, supports as many as 57,000 other jobs indirectly for a total of nearly 91,000 overall, the report said.

In general, life science jobs are well paid, with an annual average wage of $77,490, compared to the state’s average private sector wage of $48,519 a year.

Overall, the sector adds $10.4 billion to the state’s gross domestic product of $340.5 billion in 2010.

Chris Gregoire

In her address to the conference, Gov. Christine Gregoire said collaboration has been the key to the success of the state’s life science sector.

“Our growing life sciences sector is built on three strong pillars: our educational institutions, our private businesses, and our nonprofit organizations,” she said, which “unlike many around the world are all working together.”

Gregoire cited a number of promising programs designed to support the sector, in particular small start ups, but warned that cuts to education due to the budget crisis threatened the sector.

“We cannot afford to continue to compromise our education system in this state and yet expect that we be on the cutting edge of the knowledge economy,” she said.

Speaker Highlight: Eli Lilly CEO John Leichleiter

Eli Lilly CEO John Leichleiter told the conference that while the U.S. Life sciences and biopharmaceutical sector was the “envy of the world” the sector is “facing today nothing short of a innovation crisis.”

Leichleiter blamed the high cost of research and development, burdensome regulation at home, and increased competition abroad, particularly from China and India.

Leichleiter noted that it now takes $1.3 billion to develop a new drug. At the same time, due to expiration of patents for a large number of top-selling drugs, the industry faces the loss of $150 billion in annual revenue. This means there will be less to invest in “next generation of medicines,” Leichleiter said.

These and other pressures are forcing a “wave of defensive consolidation” among “arge cap pharmaceutical companies, resulting in a “dwindling number of entities capable of taking a discovery to a medicine.”

At the same time,  China and India are “producing more scientists and engineers than we are and are intensely focussesing on developing their innovation capacity,” Leichleiter said.

Leichleiter proposed five policy remedies:

1. Improve science and math literacty by improving K througn 12 education.
2. Immigration reform that “allows and encourages top scientists to choose to work in the U.S.”
3. Strong and sustained federal support for research: Medical research is a long process, he noted, “the funding must be consistent, predictable and sustained” in order to attract researchers and keep them engaged.
4. Tax reform: Lowering corporate tax rates to the 20 to 25 percent range, more in line with the rates seen in competitor nations.
5. Regulatory reform: Make drug approval quicker and more predictable and that better balances risks against potential benefits. “The pressure on regulators is to err on the side of avoiding risks, when some patients might accept those risks for the treatments potential benefit,” he said.

University of Washington President Michael Young echoed Gregoire’s and Leichleiter’sconcern about the effect state and federal budget cuts may have to the education system.

Young argued that there were three elements needed for a successful regional high-tech sector: an “innovative, imaginative business community that is willing to take risks”, a university that included “economic development in its mission,” and a supply of well-trained, “entrepreneurial students.”

That third leg was under threat due to budget cuts to public education, he warned.

WBBA also announced 2011 winners of their Innovation Award.

Seattle Genetics was recognized for its work on Adcetris (brentuximab vedotin), approved for the treatment of patients with relapsed Hodgkin lymphoma, and for the treatment of patients with relapsed systemic anaplastic large cell lymphoma.

Amgen was recognized for the FDA approval of Prolia (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fractures, as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer, and as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer.

“Success in today’s economy is most directly tied to a region’s ability to grow, retain and attract human capital,” Young said.

Young argued that reason why the U.S. has been able to thrive as as the world economy have evolved from an economy based on first, agriculture, then industry, then services and now knowledge, was that it had an economic and regulatory environment that allowed businesses to adapt, a cutting-edge research infrastructure, and the “mechanisms for the best and the brightest to rise to the top,”

“The mechanisms that has allowed the best and the brightest to rise to the top have been the universities,” Young said, particularly the public universities, which educate the vast majority of America’s young.

To learn more:

• Read the Washington Research Council’s report: Trends in Washingotn’s Life Sciences Industry 2007 – 2011