Friday, August 26, 2011

Layton inspires cancer patients

What an inspirational letter by Jack Layton, and kudos to The Journal for publishing it. Even when Layton knew that his battle with cancer was not to be successful, he kept his party, Canadians and the future of this country in his uppermost thoughts. He also reminded us that we should not take life for granted, nor our loved ones.
My family has a long history with cancer. Both my mom and dad died because of this disease. More recently, my daughter died from a brain tumour. Her first-year memorial will take place on her parents' 40th wedding anniversary.
Like Layton, my daughter never gave up. She fought hard and tried to help others through fundraising for the Brain Tumour Foundation of Canada.
I think the most important part of Layton's letter is his message to others who are fighting cancer themselves. We all know many people who have won their personal battles with cancer - people who say they are better people because of their trials, people who have learned to appreciate life and family more because of their struggles and successes.
Some of you may have seen the Fringe show This Is Cancer, where the audience gets to personally meet Mr. Cancer. The array of emotions the spectators feel is awesome: anger, fear, sadness and shock. Yet there is laughter and joy, especially when the audience gets to help "beat" cancer and look forward to eventually eradicating this earthly scourge.
Layton's message is clear: "Love is better than anger. Hope is better than fear. Optimism is better than despair. So let us be loving, hopeful and optimistic."
Ralph Waldo Emerson said, "The purpose of life is to be useful, to be honourable, to be compassionate, to have it make some difference that you have lived and lived well." This is Jack Layton's legacy.

Cut-off penis case has people talking penile cancer

The case of the Kentucky man who had his penis cut off has people talking about an organ that is seldom mentioned in polite conversation.

Philip Seaton and his wife sued the doctor who removed his manhood, seeking millions of dollars in damages for "loss of service, love and affection," as CBS News reported. But the jury in the case sided with the surgeon, who claimed it had been medically necessary to remove Seaton's penis because it was cancerous.

Penile cancer is rare in the U.S. - especially in circumcised men - but the diagnosis can be emotionally devastating, according to Medscape. And successful treatment can be a real challenge, since up to half of guys who have penile carcinoma are too embarrassed, fearful, or neglectful to consult a doctor right away. Delaying treatment can allow a localized cancer to spread, in some cases necessitating a partial or total "penectomy."

What can guys do to hang on to their penises? Circumcision early in life seems to offer strong protection but circumcision in adulthood may not, according to the society. Uncircumcised men should see a doctor if they experience phimosis, a condition in which the foreskin becomes tight and hard to retract. They should also keep the penis clean. Doctors believe that smegma, a buildup of secretions under the foreskin, can cause irritation that sets the stage for cancer.

Other risk factors for penile cancer include smoking, exposure of the penis to ultraviolet light (as during treatment for psoriasis), and infection with the AIDS virus and human papillomavirus (HPV).

The American Cancer Society estimates that in 2011, about 1,360 new cases of penile cancer will be diagnosed and about 320 men will die of the disease. Its website offers more on penile cancer.

New Tool Predicts How Long Cancer Patients Will Live

A cancer survival scale based on readily available clinical and laboratory variables reliably predicted whether patients in palliative care had days, weeks, or months to live, British investigators found.
Models designed to predict survival of less than 14 days, 14 to 55 days, or 56 days or longer showed good correlation with actual survival for the three prognostic categories, reflected in an area under the curve range of 0.79 to 0.86, researchers reported online in BMJ.
The models performed as well as or better than physician and nurse estimates of survival.
"The [Prognosis in Palliative care Study] PiPS-A score [based only on clinical data] can be calculated for any patient with advanced cancer who is no longer receiving disease-modifying treatment, and it is at least as good as, but not significantly better than, a clinician's estimate of survival," Patrick C. Stone, MD, of St. George's University of London, and coauthors wrote in conclusion.
Prognostic information is important to terminally ill patients and their physicians. However, clinician predictions of survival tend to be inaccurate and overly optimistic, the authors noted in their introduction.
Several studies have identified clinical and laboratory variables that predict survival in advanced cancer, and prognostic scoring systems based on the variables have been developed. A limitation of all the instruments, however, is that none has been "benchmarked" against clinicians' survival estimates, the authors continued.
So they sought to develop a prognostic scale that "did not rely on clinicians' estimates of survival but was at least as accurate as their best predictions."
To develop the prognostic system, the investigators recruited participants from 18 palliative care services in England. Data were collected on all participating patients from March 2006 to August 2009, and all patients were followed for at least thee months after enrollment in the study.
The investigators obtained clinical data from patients' medical records, and participants' mental status was assessed by a 10-item scale. For each patient, physicians and nurses involved in the care were asked to predict the patient's survival, using one of four categories: days (<13), weeks (two to less than eight), months (two to less than 12), and years (12 months or more).
Each patient's illness severity was determined using the Charlson Comorbidity Index, and the researchers asked permission to obtain a blood specimen from all patients judged competent to make decisions.
The final analysis included 1,018 patients, three-fourths of whom were competent to make their own decisions. The study group had a median survival of 34 days.
Multivariate analysis revealed 11 core variables that independently predicted two-week and two-month survival.
Four variables (dyspnea, dysphagia, bone metastases, and alanine transaminase) predicted only two-week survival. Eight variables predicted only two-month survival (primary breast cancer, male genitourinary cancer, fatigue, weight loss, lymphocyte count, neutrophil count, alkaline phosphatase, and albumin).
Prognostic models were developed for patients who did not have laboratory data (PiPS-A) and those who did (PiPS-B). Within each model, investigators developed separate models to predict survival of 14 days or more (PiPS-A14, PiPS-B14) and survival of two months (56 days) or longer (PiPS-A56, PiPS-B56)
Within each model, patients' estimated survival was designated as days, weeks, or months/years. The median survival across the three categories was 5, 33, and 92 days for the PiPS-A models and 7, 32, and 100.5 days for the PiPS-B models.
The investigators combined the 14-day and 56-day models within PiPS A and B to address the question of whether a patient would survive for more than two weeks but less than two months.
The PiPS-A models agreed with actual patient survival 59.6% of the time, compared with 56.3% for physician estimates, 55.2% for nurses', and 57.5% for the two professions combined. The results showed that PiPS-A models performed as well as clinician estimates.
Combining the PiPS-B models resulted in agreement with actual survival 61.5% of the time, which proved to be significantly better than estimates of physicians (52.6%, P=0.0135) or nurses (52.3%, P=0.012). The combined-professional estimate was in agreement with actual survival 53.7% of the time, which did not differ significantly from PIPS-B.
Limitations of the study included selective recruiting, since not all evaluable patients were studied, and inability to assess the tool in an independent cohort.
Prognosis "needs to be restored as a core clinical skill, to optimize the patient's treatment and planning." Paul Glare, MD, of Memorial Sloan-Kettering Cancer Center in New York, wrote in an accompanying editorial.
"A new science of prognosis is emerging in palliative care," Glare wrote. "There are two components to the skill of prognosis -- formulating the prediction and communicating it to the patient."
Although helpful, however, prognostic tools should not be applied arbitrarily, Glare continued. As an example, a predicted survival of days might be accurate for natural death at home but would probably be inaccurate for a patient admitted to a hospital for aggressive life-sustaining treatment in an ICU.
Moreover, even the most evidence-based prognostic tool will often be inaccurate in estimating a patient's survival, Glare wrote. New and more reliable prognostic factors are needed. Until prognostic strategies' inherent inaccuracy can be corrected, most physicians will resist prognostication, and those who do not will be accused of "playing God."
"Patients' preferences for prognostic information vary during the course of the illness, so communicating the prediction to the patient is as important as forecasting it," Glare concluded.

The Shortage of Vital Drugs

A widespread shortage of prescription drugs is hampering the treatment of patients who have cancer, severe infections and other serious illnesses. While some Republican politicians have railed against the imaginary threat of rationing under health care reform, Congress has done nothing to alleviate the all-too-real rationing of lifesaving drugs caused by this crisis.

The Food and Drug Administration says that some 180 medically important drugs have been in short supply, many of which are older, cheaper generic drugs administered by injection that have to be kept sterile from contamination.
A survey of 820 hospitals in June by the American Hospital Association found that almost all of them had experienced a shortage of at least one drug in the previous six months and that nearly half had experienced shortages of 21 or more drugs. As a result, more than 80 percent of the hospitals delayed needed treatments, almost 70 percent gave patients a less effective drug, and almost 80 percent rationed or restricted access to drugs.
Although there is limited data on how many patients have been harmed, a survey of 1,800 health care practitioners last year by the Institute for Safe Medication Practices found that a third of the physicians and a fifth of the pharmacists knew of adverse patient outcomes because of shortages, including some deaths from microbes resistant to the backup drugs. Cancer patients receiving less effective drugs may well face increased risks in the future.

Nobody is sure just what is causing the shortages because drug manufacturers are not required to report any reasons to the F.D.A. But several factors are likely to be involved: contamination problems at some manufacturing plants, forcing unexpected production shutdowns; difficulties in getting pharmaceutical ingredients from suppliers, especially those abroad; reluctance to invest in production-line improvement for low-profit generics when high-priced brand-name drugs bring in far higher profits. Sweeping consolidation in the generic drug industry means that fewer companies are left in that market to make up for a shortage.
The shortages are forcing health care providers to buy more expensive products in the absence of cheap generics. Unscrupulous wholesalers have made matters worse by scooping up scarce drugs and offering them to hospitals at markups that often reach 20 times the normal price or more, according to a recent survey.
Beyond limited responses, like using the F.D.A.’s discretionary powers to expedite temporary imports of drugs that are sold overseas but not here, there are very few ways to ease the crisis. For the longer term, bipartisan bills in Congress would require drug makers to give the F.D.A. six months’ warning of problems that might disrupt supplies. For that to work, the penalties for noncompliance would need to be stiff.
Other proposals include a national stockpile of critically important drugs, incentives to encourage the manufacture of generic drugs, and broader powers and additional resources for the F.D.A. to head off looming shortages. Some, perhaps many, Congressional Republicans will inevitably oppose an expansion of the F.D.A.’s regulatory authority. This cannot and must not be a fight over ideology. For many Americans, it is a fight for their lives.

Groups unite to educate community about prostate cancer

George Goodman, president of Men For Living Prostate Health Awareness Group, Inc., and MFL officer and prostate cancer survivor, David Miller, have been working closely with the Cabarrus County Board of Commissioners, the local mayors and the American Cancer Society to educate the community on prostate cancer.

September is Prostate Cancer Awareness Month, and the group is planning events to help get the word out about the risks associated with prostate cancer and the importance of early detection.

“We are making prostate health awareness a countywide thing. It has never been observed in Cabarrus County as such,” Goodman said.

“We are starting out this year to be united in bringing awareness,” Concord Mayor Scott Padgett, said. “We want to encourage men to be screened, and encourage mothers, wives and sisters to encourage males they know to be screened.”

One in six men will be diagnosed with prostate cancer, the most common cause of cancer death among men. One in 36 men will die from this form of cancer, but as with all cancer, early detection is the best tool for survival. A proclamation declaring September Prostate Cancer Awareness Month will be signed by Cabarrus County and the mayors of Concord, Kannapolis, Harrisburg and Mount Pleasant.

MFL was established in 2004 to promote prostate health, and the members are survivors and advocates of the disease. Miller was diagnosed 12 years ago at the age of 51. He went to see his doctor to have his blood pressure checked, and they found a small lump on his prostate. Miller’s father died from prostate cancer at a young age, so Miller’s odds were high. He had not been screened before that visit.

A prostate exam and a prostate–specific antigen test (PSA) can detect prostate cancer in its early stages before symptoms appear.

Having men speak out about the disease is the best weapon against it, advocate said.

“A survivor is really a success story,” Goodman said. “That’s the best success story for early detection, a survivor.”

MFL meets monthly at Price Memorial A.M.E. Church in Concord, and holds an annual breakfast in September to raise awareness. Early on, the group focused awareness in the African-American community, but it is now taking the fight to the whole community.

Goodman is working with local businessman Robert Burrage to hold a quarterly meeting that will be more accessible to all men in the community.

He notes women are relentless in battling cancer, pointing out the various breast cancer awareness groups, but men are different. Their approach to awareness is not as aggressive, but needs to be stronger.

“Men are more laid back,” he said.

Cabarrus Health Alliance has always been a partner in early detection of prostate cancer, but budget cuts and fights to reduce government spending has impacted the public health department. Free prostate cancer screenings have fallen victim to the funding cuts.

“There is a once-a-year prostate screening held by CMC-NorthEast that is a free screening,” said Dr. William Pilkington, chief executive officer and director of public health.

CHA was able to do the screening on a more regular basis throughout the year, educating the community on early detection. Breast and cervical cancer programs by CHA were also cut, due to state cuts.

“I certainly understand budget cuts, but I think it is so short-sighted. The effect on families could be devastating,” Padgett said.

“We hope there won’t be a rise in cancer numbers. I am a prostate cancer survivor, so it was important to me to get the program started,” he said. “There will be cases of prostate cancer that won’t be found.”

Pilkington explained that there are still a few places to get low-cost or free screenings.

“There is the community free clinic, community health center and other places that they can get health care services either free or subsidized basis to receive those kind of screenings,” Pilkington said.

Padgett questions the logic in budget cuts that affect the health of community at large, and wonders if in the long run, they will truly save money.

“I think we all want to pay the least taxes possible, but there are certainly things like this that don't make any sense even from a cost perspective,” Padgett explained. “From a health perspective, when a person has cancer, it affects everyone around them. Ultimately they will get treatment, but we all will be paying for it.”

The joint effort within the county aims to bring together the resources needed to reach out and educate men in the community regardless of funding by the state and federal government.

“This has been one of our goals for many years,” Goodman said.

For more information on Men For Living Prostate Health Awareness Group, Inc. or the 8th Annual Breakfast on Saturday, Sept. 24, call 704-792-2166.

Contact reporter Robin L. Gardner: 704-789-9140.

HPV vaccinations increase in state but lag nation's

Oklahoma's teen vaccination rate against human papillomavirus, which causes deadly cervical cancer, has been rising. The rate for the first of the three-dose vaccine reached 47 percent in 2010

The rate of teens immunized with the first of the three-dose vaccine reached 35.5 percent in fiscal year 2008, 40 percent in 2009 and 47 percent in 2010, said Ken Cadaret, registered nurse and interim chief of the state Health Department's immunization service. Last year's national rate is about 49 percent.

Rate may rise more

The Oklahoma rate for all three doses was 16 percent in 2008, no report in 2009 and 31.1 percent in 2010. Nationally, the rate was 32 percent in 2010.

Cadaret said the HPV vaccination rate is likely to rise because for the first time this year, Oklahoma is requiring a Tdap vaccination of all students entering seventh grade.

Because the children will be in county health departments or other health care providers' offices anyway, more of them are expected to get the HPV vaccine, as well.

“We're excited because it's going to save lives,” Cadaret said.

“Ten or 15 years from now we're going to see less cervical cancer.”

Both boys and girls may take the HPV vaccinations.

The vaccine costs the state Health Department $100 per dose but the vaccine is free at county health departments for families without health insurance covering the vaccine.

The Tdap vaccine protects against tetanus, diphtheria and pertussis or whooping cough, a disease that has re-emerged in Texas, Idaho, Michigan, South Carolina and California, where 1,500 children have been diagnosed in what is called the worst outbreak in 50 years.

Steve Jobs Has Rare Pancreatic Cancer

Is Steve Jobs At The End Of Battle?

Steve Jobs, Apple’s former CEO, has neuroendocrine tumor in his pancreas, a rare type of pancreatic cancer. He survived for years by undergoing aggressive treatment and even a liver transplant. However, experts say his decision to resign as Apple’s chief executive could be a sign that the disease is advancing beyond the means of medicine. Gastrointestinal oncologist Zev Wainberg of UCLA’s Jonsson Cancer Center, who has no personal knowledge of the case, claims that the Apple executive might not have more years behind him. University of California-San Francisco pancreatic cancer expert Margaret Tempero, says people diagnosed with more common pancreatic cancers to that of Steve Jobs usually die within a year.

Steve Jobs Undergone Aggressive Surgical Treatment

Steve Jobs has undergone aggressive treatment which was first announced in 2004. He underwent pancreatic surgery to remove the cancer then a liver transplant in 2009. The finding suggests that the tumor has metastasized from his pancreas to his liver in spite of the surgery. Liver transplants are rarely successful for cases like that of Steve Jobs, Margaret Tempero says.

Causes Of Neuroendocrine Tumors Still Unknown

Doctors are still studying what really causes neuroendocrine tumors to develop. However, the most common types are correlated to smoking and obesity. A diet full of red meat and fat is also a possible risk factor. African-Americans, diabetics, men and those who are above fifty years are highly at risk of pancreatic cancer.  Those whose families have a medical history of pancreatic cancer are highly at risk as well.  Chronic inflammation of the pancreas and exposure to certain chemicals also cause the disease.

Early Diagnosis Is Key

Researchers are actively finding ways to diagnose pancreatic cancer in its early stages, when the disease they believe might be more curable. Scientists are searching for genes that may be linked to the disease by  studying families who have members that developed the cancer. Researchers from Johns Hopkins University in Baltimore announced in January this year that they had uncovered the genome responsible for neuroendocrine tumors. The discovery could lead to better treatments, the scientists hoped.
In this article, you learned that Apple chief executive Steve Jobs has a rare form of pancreatic cancer called neuroendocrine tumor.  Steve Jobs have undergone treatment in 2004, a pancreatic surgery and a liver transplant in 2009. It is reported that doctors are still unsure of the cause of pancreatic cancer. However, the disease is linked to obesity and smoking. To prevent the spread of the disease, early diagnosis is key especially when it is still in a curable stage.

Delta College event hopes to make strides in breast cancer research

Few people like to admit they're getting older. But when you're living with a diagnosis of breast cancer, any reservations about aging fly out the window.
A new event coming to Stockton this fall has adopted the lofty goal of creating a world with less breast cancer and more birthdays.
Making Strides Against Breast Cancer, coming to San Joaquin Delta College at 9 a.m. Oct. 1, is a three- to five-mile noncompetitive walk that organizers say is "as unique and special as the story that motivates you."

It's for breast cancer survivors, those who want to honor a cancer survivor and those who want to remember someone lost to cancer. It also serves as a vehicle to raise funds to support breast cancer research.
Between 1990 and 2009, 1,438 women in San Joaquin County lost their lives to breast cancer, according to the California Cancer Registry. That's an average of just under 72 women per year, and that number has held pretty steady. The good news is the county's female at-risk population grew by almost 100,000 women during those same 20 years, knocking the mortality rate down from 31 deaths per 100,000 women in 1990 to 23 deaths per 100,000 women in 2009.
Much of that can be attributed to advances in breast cancer detection, medications and treatment, but also to greater awareness among vulnerable populations.
"Bringing Making Strides to Stockton is very important, because this event will bring less cancer, which means more birthdays. And the American Cancer Society is helping breast cancer patients locally by providing direct patient services," said Sandy Stoddard, community services director for the Cancer Society's Stockton field office.
Stoddard said the longer a woman with breast cancer lives, "By creating more birthdays, there are new treatments coming out. That is our hope, that again we will be able to give that hope to more women. There are more new drugs on the horizon to extend more lives and decrease those mortality rates."
Stoddard encouraged those interested in participating in Making Strides to get involved as soon as possible by signing up online at makingstrides.acsevents.org. Information: (209) 941-2679 or (800) 227-2345 or makingstridesstockton@cancer.org.
Contact reporter Joe Goldeen at (209) 546-8278 or jgoldeen@recordnet.com. Visit his blog at recordnet.com/goldeenblog.

Monday, August 22, 2011

Prostate Cancer Treatment: The Good, The Bad and The Ugly

Many Patients Say Treatments Can Be Worse Than the Disease

In an extensive article reviewing the most popular prostate cancer treatments available to men today, South Florida urologist Dr. Bert Vorstman takes a critical view on manufacturers, hospital systems and some colleagues who minimize the after effects of radical surgeries while continuing to endorse the procedures as a viable option. "I believe that the radical surgical/robotic treatment option has single-handedly increased the incidence of impotence and incontinence worldwide, and physicians would do well to consider the Hippocrates affirmation: As to diseases, make a habit of two things--to help, or at least, to do no harm," challenged Vorstman in his article. "Men who choose these treatments without reviewing alternative, less invasive options are playing Russian Roulette with the quality of life prospects following the surgery."
The article is available today for review at http://www.hifurx.com/prostate-cancer/prostate-cancer-after-effects/
Dr. Vorstman, a nationally recognized prostate cancer specialist with more than 30 years treatment expertise, advocates that men—one in six men in the U.S. will be diagnosed with prostate cancer in their lifetimes—and their partners "do their homework" prior to selecting treatment for prostate cancer that could cause severe, lifelong quality of life issues.
"For some, these issues are worse than the disease itself," said Vorstman.
Today's men have four main definitive treatment options for localized prostate cancer, and these are high intensity focused ultrasound (HIFU), cryoablation (freezing), radiation and surgical options. In most instances, all of these four treatment options are designed only for localized prostate cancer. The survival benefits are similar, yet the complications, including life altering impotence or incontinence, vary tremendously between treatments.
"I want patients to realize that prostate cancer is not an emergency diagnosis," stated Dr. Vorstman. "When we hear the word cancer, we assume fast, aggressive treatment is required. Most prostate cancers are slow growing, which means patients and their partners have time to do their research and make a fully informed decision about treatment. As long as the cancer is not growing aggressively, patients can wait before seeking treatment."
Dr. Vorstman urges men and their partners to get very involved in understanding the disease, treatment options and potential complications. "Men should seek written information they can review after their meeting with their doctor. They should also seek several opinions on the various treatment options available. Sadly, there is a lot of questionable information out there, as well as a propensity for medical spin and inflated egos."
The bottom line for patients facing this diagnosis is this, according to Dr. Vorstman, "Prostate cancer does not have to be cut out to offer a cure. There are minimally invasive treatments besides surgery that preserve quality of life and give men a better outlook in the future."
About Dr. Bert Vorstman, MD, MS, FAAP, FRACS, FACS
Dr. Bert Vorstman has a passion to help men and their spouses fully understand the treatment available to them for prostate cancer, as well as the possible complications they face when seeking treatment. He works to promote the acceptance and use of minimally invasive options. To further those endeavors, he has developed a Center for Minimally Invasive Treatment Options for localized prostate cancer, as well as a website highlighting HIFU, www.hifurx.com.  To contact Dr. Vorstman, please call 877-783-4438.

Seattle Genetics: The Next Litmus Test for High Priced Cancer Drugs

Dendreon ran into a buzz saw of opposition last year when it priced its new prostate cancer drug at $93,000 per patient. Genentech has loads of critics who say it has overreached on price with its antibody drugs for cancer, especially in cases where the data supporting the drug is controversial, as with bevacizumab (Avastin) for breast cancer. But despite all the pressure from insurers, elected officials, patients, and doctors, drugmakers are showing no signs of backing off.

Many times, I’d say the critics are right to complain about excessively high drug prices. But in a few cases, the drugmakers are right to stand firm, and today we’re going to see an interesting test case.

Today, we’ll see a new player emerge in the great cancer drug price debate: Seattle Genetics (NASDAQ: SGEN). The company won FDA clearance on Friday to start selling its new antibody drug for Hodgkin’s disease and another rare lymphoma. Seattle Genetics plans to reveal the price of this new drug, called brentuximab vedotin (Adcetris), on a conference call with analysts at 8:30 am Eastern/5:30 am Pacific today. Wall Street is expecting it to cost about $109,800 per patient for a course of treatment, based on the average estimate of five Wall Street analysts I surveyed last week.

Most Americans will never make that much money in a single year of their life, so this could be an easy target for critics of high drug prices. But this is one case in which a drug is worth a six-figure price tag.

Here’s why: For starters, the Seattle Genetics drug is being aimed at a small group of patients. About two-thirds of the 8,500 patients diagnosed in the U.S. with Hodgkin’s disease are successfully treated with chemotherapy, leaving about one-third who eventually get relapsed, treatment-resistant forms that make them candidates for the Seattle Genetics drug. The other group of anaplastic large cell lymphoma patients who are eligible is even smaller. Insurance companies do most of their watchdogging on price with much more common medicine. They usually, or at least should, have better things to do than mess with a tiny handful of customers in their risk pool.

Those who are afflicted with this disease aren’t just dealing with some minor annoyance, or theoretical risk. Many patients with relapsed Hodgkin’s disease are in their primes (their 30s and 40s), and are being threatened with an illness that offers a life expectancy of just two to three years. These patients have no other options left. The Seattle Genetics drug is bringing innovation to a moribund field of cancer drug development. It is the first product approved for Hodgkin’s disease since 1977, and the first ever for anaplastic large cell lymphoma.

And most importantly, the data to support this drug’s approval was simply superb. About 75 percent of patients with Hodgkin’s disease had significant tumor shrinkage, and 86 percent did that well with anaplastic large cell lymphoma (ALCL). About a third of the Hodgkin’s patients and more than half of the ALCL patients went into complete remissions. These are the kinds of tumor shrinkage rates that you rarely see in the cancer drug business.

There’s no major rub here in terms of side effects, which are pretty typical for other compounds in this drug’s class. Patients get depletion of infection-fighting white blood cells, nerve damage in the fingers and toes, fatigue, nausea.

One big question here is still about survival. Nobody knows how much longer patients can expect to live if they are among the lucky ones to go into complete remission, or if their tumors shrink by half. We do know there are so many patients from clinical trials who are still alive it will take years to really answer that question. There are much worse kinds of uncertainty to have.

It’s hard to have an open and honest conversation about the factors that go into pricing a cancer drug today, because this stuff is so politicized, but I tried last week in an interview with Seattle Genetics co-founder and CEO Clay Siegall and the company’s commercial chief, Bruce Seeley. They clearly need to thread the needle very carefully on this pricing question.

Think about it. There’s risk in pricing a drug too high, and risk in pricing it too low. Price it too high, and you invite “pushback,” as Siegall puts it, from insurers and patient advocates, which could mire the drug in red tape, protests, and various pencil-pushing challenges, discouraging doctors from prescribing the drug to eligible patients. Price it too low, and you might fail to generate enough sales to satisfy the investors who supported the company through 14 long years of development, and more than $545 million of R&D spending just to get this far.

“We want to make sure we price this drug so that we can maximize the impact on patients, and maximize the effect for the company as well,” Siegall says. “What we are excited about doing is making sure we can treat as many patients as possible, and also do well for our shareholders.”

Seattle Genetics’ officials say they have spent months of work talking with doctors and insurers about the “value proposition” of the drug, essentially trying to suss out how valuable customers think the drug is, and how much they’d be willing to pay.

Feedback from these talks has been positive. One of the big reasons is that this drug is scientifically designed to hit a target known as CD30 that is overabundantly expressed on tumors of patients with these cancers. A simple lab test can tell doctors when a patient’s tumor has a lot of these CD30 targets. And when they do, there’s basically a 75 to 85 percent chance that the patient will see a significant improvement.

That’s different from a lot of cancer drugs on the market today, in which doctors play a guessing game that goes something like this: Prescribe a $100,000 cancer drug, and give the patient a 100 percent chance of suffering from side effects, and a one-fourth to one-third chance of seeing any benefit. That’s not what most people consider a good deal. When you start talking about a three-in-four chance a patient with a death sentence will really benefit, with minimal side effects, now you’re talking about something that’s worth a six-figure check.

The key here is this: If you’re a drugmaker who can show doctors and patients that the odds are obviously in their favor, that they will see a really big benefit from one of these new drugs, then you’ll probably get less pushback. Roche/Genentech and Daiichi Sankyo/Plexxikon’s vemurafenib (Zelboraf), a drug for patients with metastatic melanoma, has followed a similar pattern with striking effectiveness in a specific group of people. The price is $56,400 for a six-month course of treatment. I haven’t seen a peep of complaint.

It may be hard for those in the biotech business to swallow, but nobody outside the industry cares that drugmakers spent a lot of money and took a lot of risk and need to be rewarded when they get an FDA approval. It’s all about getting paid for the value you bring to patients. And if your drug better deliver the goods. Because if it doesn’t, maybe it’s time to listen to the patients and back off a bit on price.

Women Who Stop HRT Skip Screening Mammo Too

Some women under age 64 who ditched hormone replacement therapy (HRT) because of its potential links with breast cancer also stopped screening mammography, researchers found.
Women ages 50 to 64 had lower breast cancer screening rates after they stopped taking HRT, Nancy Breen, PhD, of the National Cancer Institute in Rockville, Md., and colleagues reported online in Cancer.
Yet there was no association between HRT and mammography screening in women 65 and older, they wrote, indicating that "age was strongly associated with mammography use."
In 2005, mammography rates in the U.S. dropped for the first time among eligible women. The increased risk of cancer related to hormone therapy detected in the Women's Health Initiative had been reported just three years earlier, in 2002, leading to a significant decline in use by 2005, the researchers said.
Screening likely declined as well because women on therapy needed to consult their physicians to renew their prescriptions; doctors, in turn, probably used that consultation to talk about the benefits of screening mammography. Fewer visits led to fewer opportunities for discussion, Breen and colleagues said.
So to examine whether the declines in hormone therapy and screening mammography were related, the researchers looked at data from the 2000 and 2005 National Health Interview Survey (NHIS) on over 14,000 patients.
They found that women, ages 50 to 64, were more likely to report a recent screening mammogram if they had higher levels of education; had a usual source of care; were covered by private health insurance; were any race except Asian; talked with a doctor in the last year; or were currently on HRT.
Women 65 and older were more likely to report having been screened if they were younger (age 65 to 74); had more education; had a usual source of care; were on Medicare Part B or another supplemental Medicare insurance; were in excellent health; were any race except Asian; had spoken with their doctor in the last year; or were currently taking HRT.
Breen and colleagues said these factors explained 70% to 80% of the change in screening mammography use.
The researchers said there was no significant interaction between current HRT use and the survey year, which suggested that HRT and breast cancer screening were related, at least in women ages 50 to 64. In this group, those who stopped HRT had lower screening rates after quitting than when they were on the therapy, the researchers said.
Ultimately, they reduced their screening mammography compliance to rates of those previously observed in women who didn't use hormone therapy, they added.
For women 65 and up, however, hormone therapy use and screening mammography weren't related, the researchers said. Those currently on HRT had lower rates of mammography in 2005 than in 2000. Those who didn't currently use HRT had similar rates of the breast cancer screening test in 2005 and 2000.
That suggests the "change in hormone therapy use had less effect on mammography use in older women compared with younger women."
Though the study was limited by self-reported data, Breen and colleagues concluded that the findings are "consistent with the preponderance of evidence from other studies indicating that the decline in incidence [in breast screening] is accounted for largely by a reduction in risk caused by hormone therapy cessation."
The findings also "continue to raise the possibility that reduced mammography use may also have played a role in the relation between hormone therapy and [breast cancer] incidence in the population."

Tuesday, August 16, 2011

Cancer Drug Supply

I commend Dr. Emanuel for highlighting the importance of generic drugs in assuring cost-effective access to quality health care. He recognizes that his approach may slightly increase prices for generic oncology drugs, to stimulate production in times of shortage. Fortunately, the federal government could recoup these costs several times over.
First, Congress should enact legislation that would put an end to anticompetitive “pay for delay” agreements. Branded-drug manufacturers are paying their generic competitors to stay off the market, making consumers wait years for less expensive generic alternatives. Stopping these sweetheart deals could save as much as $3.5 billion a year.
Second, Congress should amend the rules governing drugs, including oncology treatments, subject to “restricted distribution” safety controls. Some branded companies appear to be exploiting the safety rules by denying research samples to would-be generic competitors, who are blocked at the Food and Drug Administration’s entry gate because they cannot conduct bioequivalence studies.
Facilitating this additional generic competition would reap substantial savings — potentially billions of dollars — which would more than compensate for cost increases triggered by Dr. Emanuel’s proposal and help reduce the budget deficit.

Tanorexia': Study Shows UV Light Activates Addictive Parts of Brain

Even though she has been diagnosed with skin cancer five times in the past 11 years, Lori Greenberg says she still dreams about tanning.

"You need it almost on a daily basis," the Wayland, Mass., woman said today. "If you don't ... you feel like you go through withdrawals. It's almost like Xanax or Valium."

She's convinced that she has "tanorexia," or an addiction to tanning. And a new study suggests that she might be right.

Researchers have believed for several years that tanners exhibit similar behavior to alcoholics and drug addicts.

"Certain regions of the brain we know are responsible, partially responsible for drug and alcohol addiction seem to have increased blood flow when you put UV [ultraviolet] light in front of these individuals who are known for frequent tanning," Dr. Charles Samenow, a psychiatrist and professor at George Washington University, said Saturday.

Nearly 30 million Americans tan indoors every year and more than 1 million visit tanning salons every day.

Now scientists say they've seen that addiction firsthand, by peering into the brain.

According to findings due to be released in the journal Addiction Biology, scientists at University of Texas' Southwestern Medical Center examined a group of tanners undergoing a regular, indoor tanning session.

Sunbathers' Feelings Similar to Other Addictions

When the ultraviolet light, which tans the skin, hit the tanners' bodies, the parts of their brains associated with reward and addiction lit up, indicating increased blood flow.

When researchers blocked the UV light, without telling the tanners, the same parts of the brain dimmed and became less active.

"We've found 50 percent of frequent tanners, sunbathers report feelings similar to other addiction," said study author Dr. Bryon Adinoff, an addiction psychiatrist at the University of Texas' Southwestern Medical Center. "They're unable to cut down their tanning. Life focused around getting tan. They get skin cancer and they still tan. These are the kinds of things that we see in people with other kind of addictions."

The researchers' conclusion: UV light revs up addictive urges. They say that the addiction is likely not limited to tanning indoors but also outdoors.

Greenberg, 40, said she was cancer-free, even though doctors last month had found a recurring site for malignant melanoma. She said she still couldn't resist the urge to tan. "I'd say no [to laying out] but I would be lying," she said.

"I smoked before," she said. "I stopped, and I don't have lung cancer. ... Sun-tanning? I have skin cancer and yet I still go."

Gilead Takes Drug-Cocktail Approach to Cancer

Gilead Sciences Inc. (GILD) is on a mission to make cancer more like AIDS -- an illness that can be kept at bay over the long term, rather than a lethal disease.
The company, which leads the market for AIDS drugs, is re- entering the market for cancer medicines a decade after selling its oncology unit. Since December, Gilead has spent $600 million for two companies developing experimental therapies and signed a research deal with Yale University, just as scientists are suggesting that drug cocktails may work as well against cancer as they do against HIV.
Gilead seeks to capitalize on advances in cancer research that help pinpoint the way to fighting tumors, letting it repeat the company’s success in matching combinations of medicines to prolong the lives of AIDS patients. The return to oncology, the world’s top-selling drug category, is a smart move for the Foster City, California-based company because it can expand its portfolio and boost revenue, said Joel Sendek, an analyst at Lazard Capital Markets in New York.
“They have a very strong balance sheet, their HIV business is generating a lot of cash, and they have a clear plan for the next generation of HIV drugs,” Sendek said. “They’re at a stage in their maturity where they need to do more.”
Cancer-drug sales generated almost $56 billion in 2010 and will expand 12 percent to 15 percent annually, reaching as much as $80 billion by 2012, according to Norwalk, Connecticut-based IMS Health.

Beyond Chemotherapy

While traditional cancer treatments use radiation and chemotherapy in an attempt to kill the disease’s spread, that approach can damage healthy tissue. The ability to sequence genomes rapidly has allowed researchers to discover mutations in certain cancers that may be targeted by new drugs without damaging other parts of the body.
Gilead, which sold its oncology business in 2001 to OSI Pharmaceuticals Inc. for about $200 million, is betting it can use these advances to find new medicines.
“Ten years from now, if you have any cancer, or pre- cancer, you will be sequenced, and based on the genetic changes identified, you will be assigned treatments,” Norbert Bischofberger, Gilead’s chief scientific officer, said in an interview.
The company’s most advanced experimental cancer drug is GS- 1101, which blocks the so-called PI3 kinase pathway. Phosphoinositide-3 kinases, or PI3K, are enzymes linked to tumor growth and survival.

Blood Cancer

The drug, acquired with the $375 million takeover of Calistoga Pharmaceuticals Inc. announced in February, is in the second of three stages of clinical trials. It’s being tested on patients with different types of blood cancer.
Still, expanding into different areas may be difficult, said Alan Carr, a Needham & Co. analyst in New York.
“When you spread yourself out like that, you can create some challenges: Can you have expertise in all these different indications?” Carr said. “With their oncology, we’ll have to wait and see how this plays out. It’s very early and they don’t have a track record in this area.”
Gilead also isn’t alone in seeing the potential for new oncology treatments. Companies such as Pfizer Inc. (PFE), Amgen Inc. and Roche Holding AG are testing at least 18 experimental drugs targeting the PI3 kinase pathway.
They’re also using drugs developed from DNA sequencing as part of treatment combinations. Daiichi Sankyo Co., Japan’s third-largest drugmaker, acquired closely held Plexxikon Inc. of Berkeley, California, earlier this year for about $935 million. Plexxikon’s medicine targets the BRAF gene, a cancer-causing mutation expressed only in tumor cells.

Melanoma Experiments

London-based GlaxoSmithKline Plc (GSK) is studying a combination of two experimental medicines in melanoma -- one that tries to block a protein spurring the spread of the disease, the other that thwarts a protein that helps the cancer evade drugs.
Another focus for Gilead is monoclonal antibodies that stimulate a patient’s immune system to attack disease-causing cells. Its acquisition of Arresto Biosciences Inc. for $225 million, gave the company a drug that targets the LOXL2 protein believed to aid in the early spread of tumors. The experimental therapy, GS-6624, is in the first stage of clinical testing. Earlier this month, Gilead purchased a 70,000-square-foot lab from Roche Holding AG (ROG)’s Genentech to make GS-6624.
“We really shied away from being in cancer because typically Phase I studies are about as non-predictable as they can be,” John Milligan, Gilead’s president and chief operating officer, told analysts in March. “What we’ve been doing over the last year or so is we started looking at areas where the biology and the chemistry had matured to the point where parts of human disease were very much well, more well understood.”
More Acquisitions?
Other novel approaches may come from its collaboration with Yale, and through more acquisitions, Bischofberger said.
“We have looked at a number of commercial products that are potentially for sale, or available for licensing,” he said. “We’re getting a huge amount of proposals and requests and we’re spending a fair amount of time sifting through them.”
Future developments may lead to a cocktail of drugs that add years to a cancer patient’s life -- similar to how HIV was transformed from a death sentence 15 years ago. HIV is manageable today with medicines such as Gilead’s two-therapy combination Truvada, Bischofberger said.
“I am absolutely convinced the same will be applicable in cancer,” he said. “That’s where we think the field is going.”
Even after the acquisitions, Gilead will need to boost spending on research and acquisitions to expand into oncology, Bischofberger said. The company spends about 13 percent of its revenue in research, compared with the industry average of about 24 percent, according to Bloomberg data.
“The absolute intent, desire and ambition is that 10 years from now, and hopefully sooner, we will be a major player in oncology,” Bischofberger said. “If we don’t screw it up, and things continue to go well, I think we can do that.”
To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.

For Cancer Patients, Help Navigating the Maze

Hospitals are offering a new service to cancer patients: navigators to help them steer through the often-overwhelming maze of decisions, doctor visits and treatments, today’s Informed Patient Column reports.
Researchers across the country have been studying patient navigator programs for several years in an attempt to determine how best they can help patients — and how exactly they should be designed and staffed. A new supplement to the journal Cancer is devoted to the issue.
The National Consortium of Breast Centers offers a certification program for patient navigators focusing on the unique challenges faced by breast cancer patients, who may see several types of specialists and face multiple decisions on surgery, radiation and follow-up care.
While many of the programs are dedicated to helping underserved and racial and ethic minorities with poor access to care, even the savviest patients who have medical insurance can often be daunted by the complexities of cancer care, and benefit from the help of a navigator, says Martha Hare, program director of the National Cancer Institute’s Center to Reduce Cancer Health Disparities. “Patients may be overwhelmed by family issues, job issues, and even questions about whether they can get an appointment at a reasonable time,” she says.
The NCI’s Patient Navigation Research Program is currently analyzing results of a five-year study of thousands of patients at nine centers around the country, comparing those who used patient navigators to those who did not. Preliminary results are “encouraging” about the benefits, according to Karen Freund, a Boston University physician and chair of the design and analysis committee.
Several studies, starting with a project in Harlem for minority women in the 1990s, have already shown that patient navigation services increase participation in cancer screening and adherence to follow-up care after detection of an abnormality in minority groups and economically disadvantaged patients.
While funding for such programs has largely come from government grants, private foundations and cancer advocacy groups, more hospitals are expected to add the services thanks to revised standards from the American College of Surgeons’ Commission on Cancer, which accredits more than 1,400 cancer centers in the U.S. caring for 71% of all newly diagnosed cancer patients. By 2015, centers accredited by the commission must offer patient navigation services as a condition of accreditation.
Stephen B. Edge, chair of the commission and an oncologist at the Roswell Park Cancer Institute, tells the Health Blog there are many interpretations of navigation. The commission is requiring “that each program do an assessment of their community and develop programs to address barriers to access and smooth cancer care,” he says. The group plans to provide assistance in developing the programs, including a repository of best practices so all programs can learn from each other, he adds.
While commission accreditation isn’t used for reimbursement, accreditation “will be increasingly a requirement for any organization holding itself out to the public as a quality cancer program,” he says.
Research shows show patient navigators can also be helpful in getting patients to be screened for cancer in the first place – such as getting that mammogram or colonoscopy that many avoid. A study published in May in the Archives of Internal Medicine found that black and non-English speaking patients working with  navigators at Cambridge Health Alliance, a Boston-area public health-care system, were more likely to undergo colorectal cancer screening than control patients without navigators, more likely to be screened by colonoscopy, and more likely to have abnormalities detected.
Laureen Gray, program director of special projects at Cambridge, says the service is now being offered to all patients, many of whom are low-income and speak languages such as Portuguese or Spanish. Navigators “guide them through the whole process” of preparing for a colonoscopy, make sure the patients understand the preparatory instructions and then that they show up for the procedure.
At Presbyterian Healthcare Services in Albuquerque, where four nurses and a social worker comprise the navigation team, Dava Gerard, a breast surgeon and administrator in the cancer program says patient navigation services need to reflect the needs and concerns of the community, which can vary greatly.
Presbyterian is compiling data that shows the cost-benefit of professional navigators who can assess and adapt to a spectrum of needs.  However, “a basic competence is for navigators to know their boundaries,” Gerard says, so a navigator without medical knowledge or medical social worker isn’t providing inaccurate or dated treatment information.

Hospitals Promoting Bargain CT Scans For Smokers

Trumpeting a landmark study released recently, hospitals around the country have started offering deeply discounted CT scans for smokers worried about lung cancer. But some experts question whether the strategy is a marketing ploy that could bring more harm than good.

St. Luke's Hospital in Bethlehem, Pa., put out a single-page flyer with a headline that a "10-second scan could be life-saving" and a clip-out coupon for a $49 procedure.  University Hospitals in Cleveland has a slick video on its website promoting its $99 scan, noting that some experts say this could be the "new hope needed to help save lives."

The hospitals – including the University of Pittsburgh Medical Center, Swedish Medical Center in Denver, Abbott Northwestern Hospital in Minneapolis, Rhode Island Hospital in Providence and Pomona Valley Hospital Medical Center in California – say they are responding to the study by the National Cancer Institute. It  found annual low-dose CT – or computerized tomography – screening of asymptomatic current or former smokers could cut the death rate from lung cancer by 20 percent by identifying the disease earlier than X-rays.  The results were so striking that federal officials last November ended the study early to announce their findings.

The nearly decade-long study of more than 50,000 current and heavy smokers showed 354 lung cancer deaths had occurred among those with CT screening compared to 442 deaths among those who were screened only with an X-ray.

“The data is pretty compelling,” said Dr. Christopher Faber, medical director of the University of Pittsburgh Comprehensive Lung Center.

Most lung cancers are detected when they cause symptoms such as shortness of breath, by which time the disease is more likely to be advanced and less curable.

William Burfeind, a cardiothoracic surgeon at St. Luke’s, said the goal of offering the low-cost scans is to identify patients with earlier stages of lung cancer who have better chance of being cured by treatment. “The vast majority of my patients show up with stage 3 or 4 which is treatable, but rarely curable,” he said. “Once we learned the results of the national study, we felt compelled to offer this to our patients.”

Hospitals have marked down the CT scan – which typically costs as much as $1,000 –to help cash-paying customers. The test is not covered by Medicare or private insurers. Neither the American Cancer Society nor the U.S. Preventive Services Task Force, an independent panel of medical experts that examines the effectiveness of preventive tests, has recommended the screening, although both groups are studying the issue.

“You have to ask the question whose interests are being served here,” Dr. H. Gilbert Welch, a Dartmouth researcher who studies cancer screening, said of hospitals’ sales pitches. “Screening tests are a great way to recruit new patients that produce revenues with follow up biopsies and procedures.”

Welch and other experts worry that hospitals pushing the low-cost CT scans will focus on promoting the benefits of the lung cancer study to patients rather than warn about its costs and complications.

The biggest risk of the test is the possibility of false positives — a scan that finds an abnormality in the lung that turns out not to be cancer. Nearly one in four people in the national study had a false positive from the CT scans, which often can lead to a biopsy or other invasive procedures that carry their own health risks.  Another concern is added radiation exposure from scans.

In addition, there are economic considerations: The results of the study suggest that more than 300 heavy smokers will need to be screened to prevent just one death from lung cancer over a five-year period.

Dr. Peter Bach, a researcher at Memorial Sloan-Kettering Cancer Center in New York who evaluates testing for the cancer society, said the hospitals offering the low-cost CT scans may be unfairly inducing patient to have a test they don’t need.

“It is troubling behavior,” he said. While some hospitals see a public health benefit to the testing, others may see it as a profit strategy. He notes the scans won’t make anyone better. “It’s not like they are giving away a flu shot or a nicotine patch,” he said.

Lung cancer is the leading cause of cancer-related deaths in the United States, with more than 94 million current or former smokers at elevated risk of the disease. Each year more than 222,000 people nationwide will be diagnosed with lung cancer and approximately 157,000 will die from the disease.

Leslie Greissing, 64, of Brunswick, Ohio, who had the test last month at University Hospital in Cleveland, said she was attracted by the $99 price and the chance to catch a cancer before an X-ray. She said her doctor told her about the problem with false negatives, but she decided to have the test anyway.

“As a heavy smoker on and off since I was 16, and my father died of lung cancer, I figured I was playing with a loaded deck,” she said. Her test was negative and she plans to have another scan next year.

This is not the first time the health industry has pushed screening tests before major medical groups endorsed their use. In the 1990s, hospitals promoted PSA blood tests as a screen for prostate cancer. But because of concern over false positives that could lead to high risk surgery, neither the cancer society nor the Preventive Services Task Force recommends the test.

A low dose CT scan of the entire chest takes about 10 seconds. The technology uses a coordinated series of X-rays taken from many different angles to create a three-dimensional image allowing physicians to see smaller details than those that show up on a traditional X-ray. “This screening scan could make a real difference for people considered high-risk for developing lung cancer,” says Dr. Andrew Halpern, a St. Luke’s radiologist.

At St. Luke’s, 72 patients have taken advantage of the offer since early July. Fourteen of the patients have been recommended for follow-up screening in less than a year to check on abnormalities. Patients can only get the test with their doctor’s permission and they have to meet the same requirements as those in the national study: Current or former smokers age 55 to 74 who had an average of a pack a day habit.

Dr. David Midthun, a pulmonologist at the Mayo Clinic in Minnesota, said the national lung cancer screening study proves that on an individual basis the CT is a good idea. “We now have the evidence that the test is effective in mortality reduction,” he said.

But what’s not known is whether considering the cost of the test, it makes sense to recommend for millions of people.  “We’re at the intersection now of what’s good public policy and individual patient decision making,” he said.

A Need For Health Care Reform: Cancer Care Costs And The Patient Perspective

We recently completed a nationwide study assessing the impact of out-of-pocket expenses on cancer care. As a part of this survey-based study, we asked insured patients with cancer to comment on the experience of having to pay out of pocket for health care despite having insurance coverage. Their comments were unsettling. One participant wrote, "I have had to go without groceries in the house just to get my medicine." Another wrote, "My parents pay my medical bills which is humiliating when I worked 27 years as a teacher." A third patient commented, "I became homeless, and our entire family has had to live with a friend several times."
These comments are especially poignant when we take into consideration today's financial climate. The health reform discussion has been focusing on the systemic impact of health care costs, but somewhere in the bar graphs detailing trillions of dollars in projected spending, the daily experience of the cancer patient has been lost. We know that the experience of receiving cancer treatment can result in a physical toxicity, but recent data suggest that cancer treatment might also cause financial toxicity that affects the daily lives of patients and their families.
How are patients impacted by the cost of cancer care? Our recent study begins to shed light on the relatively novel concept of financial toxicity. We surveyed 216 patients nationwide receiving treatment for cancer. We asked participants how much they spent out of pocket on their cancer care. We asked them what strategies they used to cope with these expenses. Finally, we asked them about their level of satisfaction with the health care they have received. The mean age of our participants was 64 years, and most were retired. Ninety-nine percent of our study participants were insured, and 83 percent carried prescription drug coverage. Despite this insurance coverage, participants were still paying mean expenses of more than $700 a month for their cancer care. Thirty percent described bearing a significant financial burden as a result of their cancer care. Eleven percent described bearing a catastrophic financial burden.
We found that out-of-pocket expenses for cancer care impacted patients' lifestyles: 51 percent of patients reduced spending on basics like food or clothing to pay for their medications; 70 percent reduced spending on leisure activities to cope with cancer-care related expenses; and 18 percent sold possessions or property. Forty-eight percent used all or a portion of their savings -- a particularly striking figure because most were retired.
In addition, out-of-pocket expenses might impact the quality of care patients receive as well as their satisfaction with care. Among our participants, 26 percent did not fill prescriptions for medications and 22 percent filled only part of a prescription. Nine percent spread out appointments, 6 percent missed appointments altogether and 9 percent declined recommended tests -- all were strategies patients used to save money. Meanwhile, study participants who used these strategies to cope with cancer care expenses were also more likely to be dissatisfied with the care they received.
What can be done to relieve this significant cost burden that cancer patients' experience? The responsibility lies with patients, physicians and policymakers.
Patients should take the initiative to describe their experiences with doctors and should not hesitate to initiate a discussion about the potential cost of care, with an understanding that being mindful of expenses does not necessarily preclude the highest quality care. For their part, physicians must be open to discussing the cost of care at the bedside. Data suggest that physicians are uncomfortable discussing health care expenses, possibly because of a lack of time, perceived lack of solutions and a fear that advocating for less expensive care might compromise the quality of care a patient receives. But this discussion should play an important role in the medical decision-making process.
A simple question like, "Do you have prescription drug coverage?" might save a patient thousands of dollars over the course of treatment. For example, in many instances, patients might benefit equally from either intravenous fluorouracil or its oral equivalent, capecitabine. However, oral capecitabine might cost thousands of dollars to a patient without prescription drug coverage.
Finally, policymakers must recognize the impact of cost sharing on the financial burden carried by patients. Insurance providers are shifting more of the costs of cancer care to patients, and patients are decreasing the amount of care for which they are willing to pay. We can only wonder if, in the long term, this incomplete care will increase the overall cost to the health system.
While health care reform must occur in broad strokes, we must work to keep in mind the daily experiences of the patient with cancer.

Music therapy may ease anxiety in cancer patients

Music therapy might help lower anxiety and improve mood in people with cancer, say researchers who analyzed past studies.
It's not entirely clear from those studies what kind of music-related treatment -- going to sessions with a music therapist, or listening to pre-recorded CDs during hospital visits -- might help patients most.
But music therapist Debra Burns, from Indiana University-Purdue University Indianapolis, said therapists especially can help patients relax during stressful treatments and think through their tension.
"We can use the different music interventions to target the in-the-moment symptoms -- pain, anxiety. But we can also look at longer-term interventions," such as improving communication with family members, said Burns, who was not involved in the review.
For the analysis, creative arts therapist Joke Bradt from Drexel University in Philadelphia and her colleagues reviewed data from 30 past studies that looked at the effect of music therapy or music listening in close to 2,000 cancer patients.
Compared to patients who only received standard cancer treatment, the combined data from the studies suggested that patients who also had music treatment rated their anxiety and pain lower and had higher mood scores. In addition, their heart rates were lower by about four beats per minute, on average.
There was no effect, however, on how patients rated their depression or fatigue.
That's probably because most of the studies only tested the effect of listening to music in the hospital for a single session, and didn't give patients much choice about what type of music they listened to, Bradt said.
"If someone's really depressed, one music listening session is not going to reverse that," she told Reuters Health.
While there wasn't enough data to determine if going to a music therapist helped patients more than listening to CDs, Bradt said she suspects that's the case. With a music therapist, patients are usually involved in making music by singing or playing instruments, she explained, and therapists can design a treatment program for each particular patient.
"The patient can become an active participant," she said. "It can be really empowering, and can help patients feel more in control over the situation."
Burns agreed. Therapists can adapt treatment "as they need to depending on the patient's needs. It gives you some flexibility and a wider breath of tools," she said.
"We cannot forget that making music is a lot of fun as well," Bradt added.
It can be hard to objectively compare anxiety and depression in patients getting music therapy and those not getting any extra treatment, the authors explained in the new review, published in the Cochrane Library. That's because researchers can't keep music therapy a secret from patients -- so if patients think music therapy will help them, they could feel better just because of that extra optimism and expectation, rather than the because of the therapy itself.
But Bradt said despite that limitation, the potential positive effects of music treatment -- especially with a trained music therapist -- should be taken seriously, and that it's not "just about listening to some music."
"Certainly it's not for everybody," said Burns, who's on the staff of Indiana University's Melvin and Bren Simon Cancer Center.
"Somebody at least has to be open to the experience," she told Reuters Health.
Burns concluded that research should continue to look at what type of music therapy might help different patients at different stages of their cancer treatment.

Cancer’s Secrets Come Into Sharper Focus

For the last decade cancer research has been guided by a common vision of how a single cell, outcompeting its neighbors, evolves into a malignant tumor.

Through a series of random mutations, genes that encourage cellular division are pushed into overdrive, while genes that normally send growth-restraining signals are taken offline.

With the accelerator floored and the brake lines cut, the cell and its progeny are free to rapidly multiply. More mutations accumulate, allowing the cancer cells to elude other safeguards and to invade neighboring tissue and metastasize.

These basic principles — laid out 11 years ago in a landmark paper, “The Hallmarks of Cancer,” by Douglas Hanahan and Robert A. Weinberg, and revisited in a follow-up article this year — still serve as the reigning paradigm, a kind of Big Bang theory for the field.

 But recent discoveries have been complicating the picture with tangles of new detail. Cancer appears to be even more willful and calculating than previously imagined.

Most DNA, for example, was long considered junk — a netherworld of detritus that had no important role in cancer or anything else. Only about 2 percent of the human genome carries the code for making enzymes and other proteins, the cogs and scaffolding of the machinery that a cancer cell turns to its own devices.

These days “junk” DNA is referred to more respectfully as “noncoding” DNA, and researchers are finding clues that “pseudogenes” lurking within this dark region may play a role in cancer.

“We’ve been obsessively focusing our attention on 2 percent of the genome,” said Dr. Pier Paolo Pandolfi, a professor of medicine and pathology at Harvard Medical School. This spring, at the annual meeting of the American Association for Cancer Research in Orlando, Fla., he described a new “biological dimension” in which signals coming from both regions of the genome participate in the delicate balance between normal cellular behavior and malignancy.

As they look beyond the genome, cancer researchers are also awakening to the fact that some 90 percent of the protein-encoding cells in our body are microbes. We evolved with them in a symbiotic relationship, which raises the question of just who is occupying whom.

“We are massively outnumbered,” said Jeremy K. Nicholson, chairman of biological chemistry and head of the department of surgery and cancer at Imperial College London. Altogether, he said, 99 percent of the functional genes in the body are microbial.

In Orlando, he and other researchers described how genes in this microbiome — exchanging messages with genes inside human cells — may be involved with cancers of the colon, stomach, esophagus and other organs.

These shifts in perspective, occurring throughout cellular biology, can seem as dizzying as what happened in cosmology with the discovery that dark matter and dark energy make up most of the universe: Background suddenly becomes foreground and issues once thought settled are up in the air. In cosmology the Big Bang theory emerged from the confusion in a stronger but more convoluted form. The same may be happening with the science of cancer.

Exotic Players

According to the central dogma of molecular biology, information encoded in the DNA of the genome is copied by messenger RNA and then carried to subcellular structures called ribosomes, where the instructions are used to assemble proteins. Lurking behind the scenes, snippets called microRNAs once seemed like little more than molecular noise. But they have been appearing with increasing prominence in theories about cancer.

By binding to a gene’s messenger RNA, microRNA can prevent the instructions from reaching their target — essentially silencing the gene — and may also modulate the signal in other ways. One presentation after another at the Orlando meeting explored how microRNAs are involved in the fine-tuning that distinguishes a healthy cell from a malignant one.

Ratcheting the complexity a notch higher, Dr. Pandolfi, the Harvard Medical School researcher, laid out an elaborate theory involving microRNAs and pseudogenes. For every pseudogene there is a regular, protein-encoding gene. (Both are believed to be derived from a common ancestral gene, the pseudogene shunted aside in the evolutionary past when it became dysfunctional.) While normal genes express their will by sending signals of messenger RNA, the damaged pseudogenes either are mute or speak in gibberish.

Or so it was generally believed. Little is wasted by evolution, and Dr. Pandolfi hypothesizes that RNA signals from both genes and pseudogenes interact through a language involving microRNAs. (These signals are called ceRNAs, pronounced “sernas,” meaning “competing endogenous RNAs.”)


His lab at Beth Israel Deaconess Medical Center in Boston is studying how this arcane back channel is used by genes called PTEN and KRAS, commonly implicated in cancer, to confer with their pseudotwins. The hypothesis is laid out in more detail this month in an essay in the journal Cell.

Fueled by the free espresso offered by pharmaceutical companies hawking their wares, scientists at the Orlando meeting moved from session to session and browsed corridors of posters, looking for what might have recently been discovered about other exotic players: lincRNA, (for large intervening noncoding), siRNA (small interfering), snoRNA (small nucleolar) and piRNA (Piwi-interacting (short for “P-element induced wimpy testis” (a peculiar term that threatens to pull this sentence into a regress of nested parenthetical explanations))).

In their original “hallmarks” paper — the most cited in the history of Cell — Dr. Hanahan and Dr. Weinberg gathered a bonanza of emerging research and synthesized it into six characteristics. All of them, they proposed, are shared by most and maybe all human cancers. They went on to predict that in 20 years the circuitry of a cancer cell would be mapped and understood as thoroughly as the transistors on a computer chip, making cancer biology more like chemistry or physics — sciences governed by precise, predictable rules.

Now there appear to be transistors inside the transistors. “I still think that the wiring diagram, or at least its outlines, may be laid out within a decade,” Dr. Weinberg said in an e-mail. “MicroRNAs may be more like minitransistors or amplifiers, but however one depicts them, they still must be soldered into the circuit in one way or another.”

In their follow-up paper, “Hallmarks of Cancer: The Next Generation,” he and Dr. Hanahan cited two “emerging hallmarks” that future research may show to be crucial to malignancy — the ability of an aberrant cell to reprogram its metabolism to feed its wildfire growth and to evade destruction by the immune system.

Unwitting Allies

Even if all the lines and boxes for the schematic of the cancer cell can be sketched in, huge complications will remain. Research is increasingly focused on the fact that a tumor is not a homogeneous mass of cancer cells. It also contains healthy cells that have been conscripted into the cause.

Cells called fibroblasts collaborate by secreting proteins the tumor needs to build its supportive scaffolding and expand into surrounding tissues. Immune system cells, maneuvered into behaving as if they were healing a wound, emit growth factors that embolden the tumor and stimulate angiogenesis, the generation of new blood vessels. Endothelial cells, which form the lining of the circulatory system, are also enlisted in the construction of the tumor’s own blood supply.

All these processes are so tightly intertwined that it is difficult to tell where one leaves off and another begins. With so much internal machinery, malignant tumors are now being compared to renegade organs sprouting inside the body.

As the various cells are colluding, they may also be trading information with cells in another realm — the micro-organisms in the mouth, skin, respiratory system, urogenital tract, stomach and digestive system. Each microbe has its own set of genes, which can interact with those in the human body by exchanging molecular signals.

“The signaling these microbes do is dramatically complex,” Dr. Nicholson said in an interview at Imperial College. “They send metabolic signals to each other — and they are sending chemicals out constantly that are stimulating our biological processes.

“It’s astonishing, really. There they are, sitting around and doing stuff, and most of it we don’t really know or understand.”

People in different geographical locales can harbor different microbial ecosystems. Last year scientists reported evidence that the Japanese microbiome has acquired a gene for a seaweed-digesting enzyme from a marine bacteria. The gene, not found in the guts of North Americans, may aid in the digestion of sushi wrappers. The idea that people in different regions of the world have co-evolved with different microbial ecosystems may be a factor — along with diet, lifestyle and other environmental agents — in explaining why they are often subject to different cancers.

The composition of the microbiome changes not only geographically but also over time. With improved hygiene, dietary changes and the rising use of antibiotics, levels of the microbe Helicobacter pylori in the human gut have been decreasing in developing countries, and so has stomach cancer. At the same time, however, esophageal cancer has been increasing, leading to speculation that H. pylori provides some kind of protective effect.

At the Orlando meeting, Dr. Zhiheng Pei of New York University suggested that the situation is more complex. Two different types of microbial ecosystems have been identified in the human esophagus. Dr. Pei’s lab has found that people with an inflamed esophagus or with a precancerous condition called Barrett’s esophagus are more likely to harbor what he called the Type II microbiome.

“At present, it is unclear whether the Type II microbiome causes esophageal diseases or gastro-esophageal reflux changes the microbiome from Type I to II,” Dr. Pei wrote in an e-mail. “Either way, chronic exposure of the esophagus to an abnormal microbiome could be an essential step in esophageal damage and, ultimately, cancer.”

Unseen Enemies

At a session in Orlando on the future of cancer research, Dr. Harold Varmus, the director of the National Cancer Institute, described the Provocative Questions initiative, a new effort to seek out mysteries and paradoxes that may be vulnerable to solution.

“In our rush to do the things that are really obvious to do, we’re forgetting to pay attention to many unexplained phenomena,” he said.

Why, for example, does the Epstein-Barr virus cause different cancers in different populations? Why do patients with certain neurological diseases like Parkinson’s, Huntington’s, Alzheimer’s and Fragile X seem to be at a lower risk for most cancers? Why are some tissues more prone than others to developing tumors? Why do some mutations evoke cancerous effects in one type of cell but not in others?

With so many phenomena in search of a biological explanation, “Hallmarks of Cancer: The Next Generation” may conceivably be followed by a second sequel — with twists as unexpected as those in the old “Star Trek” shows. The enemy inside us is every bit as formidable as imagined invaders from beyond. Learning to outwit it is leading science deep into the universe of the living cell.

Wednesday, August 10, 2011

Medicaid Denies Coverage for Breast Cancer Treatment in Men

The Kiss drummer Peter Criss recently brought breast cancer in men into the spotlight after he discovered he had the cancer in 2008. Since then he has been an advocate for early treatment in men.
According to the American Cancer Society, about 2,000 men are diagnosed with breast cancer each year. In comparison with women, men are 100 times less likely to develop breast cancer than women, but it is possible. In 2009, about 192,370 women were diagnosed with breast cancer. Similar to women, breast cancer in men was found to be linked to the BRCA1 ad BRCA2 gene mutations, in addition to family history records and age contributions. Heavy drinking and exposure to radiation are thought to influence this cancer development. Most recently, a breast cancer cluster in men has been potentially linked to drinking contaminated drinking water in North Carolina at Camp Lejeune. Thus there may be a link between chemical exposure and the cancer risk.

Men who develop breast cancer are in sticky situation when Medicaid coverage is denied for breast cancer treatment because they are males. In the case of most male patients, they are shocked to hear from their doctors that they have breast cancer. And they are even more shocked when they are denied coverage. With amounting bills and chemotherapy treatments working to potentially save their lives, it is hard to think about the future and how they will afford it.
According to CBS News, Raymond Johnson, a man with breast cancer who was denied Medicaid coverage, said, “Cancer doesn’t discriminate, so this program shouldn’t discriminate.” He might argue that this situation is an act of sexism within the system. The federal Medicaid system is not serving the interests of the people it was designed to help.
This situation is being addressed by the CDC and South Carolina to see if changes can be made to offer options that will resolve the problem. In the minds of most, it is important to ensure that Medicaid is helping the individuals it was designed to help. In events when this is not true, it is important to make these individuals eligible for the coverage they deserve.
In the weeks to months to come, it will be interesting to see when and how this glitch will be fixed.
In addition, former Sen. Edward W. Brooke (R-Mass) was diagnosed with breast cancer in 2002. Before diagnosis, he was feeling chest pain. This symptom of chest pain was described by other men who were later diagnosed with breast cancer.

Pharmacyclics Secures Five-Year CRADA with NCI to Develop Blood Cancer Drug

    Pharmacyclics inked a five-year Cooperative Research and Development Agreement (CRADA) with the National Cancer Istitutes (NCI), to progress development of its Bruton’s tyrosine kinase (Btk) inhibitor, PCI-32765, for the treatment of hematologic malignancies. Under terms of the deal NCI’s Division of Cancer Treatment and Diagnosis plans to sponsor Phase I and II studies with the oral drug against various blood cancers, including non-Hodgkin lymphoma (NHL) and multiple myeloma. The PCI-32765 is currently in Phase I trials for the treatment of lymphoma/CLL, and is being prepared for Phase II studies in CLL, mantle cell lymphoma and diffuse large B-cell lymphoma, either as monotherapy or in combination with other anticancer treatments. Positive data from a Phase IB/II study  evaluating PCI-32765 patients with chronic lymphocytic leukemia / small cell lymphocytic lymphoma (CLL/SLL), were presented in June. BtK is a tyrosine kinase that plays a critical role in B cell maturation and activation, Pharmacyclics explains. PCI-32765 is a small molecule inhibitor that has been shown to lead to apoptosis in multiple malignant B-cell lines, and inhibited B-cell lymphoma progression in vivo. Studies have suggested a model whereby PCI-32765 directly affects CLL cells by inducing programmed cell death, and blocking the ability of CLL cells to migrate to and to adhere to lymph nodes. Btk is also a key component of signaling Fc-gamma signaling in myeloid cells, and inhibition of Btk activity is expected to reduce two major components of autoimmune diseases: pathogenic autoantibody production by B cells, and pro-inflammatory cytokines produced by myeloid cells, Pharmacyclics adds. To this end the firm is in addition evaluating Btk inhibitors for their potential use in the treatment of autoimmune diseases. It says lead candidate PCI-45292 has been shown to be more potent in a mouse model of collagen-induced arthritis than either PCI-32765 or methotrexate. Pharmacyclics clinical pipeline is headed by its histone deacetylase (HDAC) inhibitor candidate, PCI-24781, which is in Phase II development for the treatment of lymphoma, and Phase I development for sarcoma. PCI-24781 is currently being tested in II clinical trials in the US and 5 in Europe. The HDAC inhibitor program has been partnered with Servier, under a 2009 agreement under which the French firm has an exclusive license to Pharmacyclics’ pan-HDAC inhibitors worldwide, excluding the U.S. Pharmacyclics’ radiation and chemotherapy sensitizing agent, motexafin gadolinium (MGd; PCI-0120). Is also in Phase II development. The program is being sponsored by the NCI, which is funding a Phase I/II multicenter study evaluating MGd administered in combination with radiation therapy and temozolomide, in patients with newly diagnosed glioblastoma multiforme.

New ‘biomarker’ blood test could improve prostate cancer detection

A new DNA-based “biomarker” blood test that complements the currently offered prostate-specific antigen (PSA) test, could greatly improve the accuracy of prostate cancer detection before recommending patients for an invasive biopsy, according to a new study.
University of Cincinnati (UC) researchers conducted a meta-analysis of existing published data related to DNA methylation in bodily fluids. The goal was to evaluate a specific cancer biomarker-known as GSTP1-as a screening tool for prostate cancer.
Lead author of the study and assistant professor of environmental health at the University of Cincinnati, Tianying Wu merged epidemiologic and molecular data from 22 studies conducted in the United States and Europe between 2000 and 2009. More than 2000 human biologic samples (1,635 prostate cancer cases and 573 controls) were analyzed for the current study, including whole blood, plasma, urine, ejaculates and other secretions.
Wu determined that GSTP1 was a statistically significant biomarker for prostate cancer and could increase the specificity of prostate cancer diagnosis by up to 70 percent as compared to using the PSA test alone.
"The PSA test is highly sensitive, but it cannot differentiate between prostate cancer and benign prostatic conditions such as benign prostatic hyperplasia, leading many men to have unnecessary biopsies,” says Wu.
"Measuring GSTPI in plasma or urine is an easy and non-invasive test. This biomarker will give physicians reassurance regards to whether to conduct biopsies in selected patients,” she added.
The study will be published in the British Journal of Cancer.