The Scoop: Many cancer drug developers have put their faith in compounds focused on one misfit gene. However, Epizyme's technology might enable the firm to influence several cancer-related genes with a single small molecule--as well as affect genes that have evaded previous drug regimens. That's part of the promise of the firm's research into targeting certain epigenetic enzymes, which are like conductors whose activities affect entire sections of genes among the proverbial genetic orchestras involved in cancer. Over the past year, the firm has struck lucrative partnerships with several outfits--including major drug players Eisai and GlaxoSmithKline ($GSK)--to help underwrite its research in the hot class of epigenetic enzymes called histone methyltransferases. What Makes It Fierce: Epigenetics, which involves causes of altered gene expression other than changes in the DNA code, made the cover of Time magazine last year for its importance in understanding diseases. But Epizyme, which has raised $54 million in two venture rounds, deserves credit for significant progress in transforming epigenetic research into potential drugs. Even more, the company has banked more than $30 million in upfront cash from a sting of partnership deals this year.
Since Robert Gould (pictured) took the top spot at the biotech in early 2010, the business has grown up from a venture-funded research effort to a company with financial ties to Big Pharma outfits and disease groups. He joined the biotech around the same time as Jason Rhodes, a former dealmaker for Alnylam ($ALNY), who's been driving the successful partnership activities as chief business officer.
They've built nicely on the foundation developed with the help of chief scientist Robert Copeland and early CEO Kazumi Shiosaki, the managing director at MPM Capital who's still on the upstart's board of directors. The company also boasts high-profile academic co-founders H. Robert Horvitz, a Nobel Prize-winning biology professor at MIT, and Yi Zhang, a professor of biochemistry at the University of North Carolina Chapel Hill.
Talking to FierceBiotech during this summer's World Epigenetics Summit in Boston, Gould explained there's been intense interest in the company among clinicians even though the firm hasn't begun human testing of its drugs. That's because its compounds are being designed to serve very specific patient populations based on their genetics.
Think of kids with a rare and lethal form of leukemia. The firm is now advancing a small-molecule blocker of an epigenetic enzyme known as DOT1L, which is a culprit in mixed lineage leukemia (MLL), a deadly and small subset of acute leukemias. While the cancer develops in adults, it's notorious for poor prognoses in children. And, in a mouse study published in Cancer Cell in July, researchers showed that Epizyme's small molecule iced MLL cells without having the same killer effects on non-MLL leukemia cells.
"We had a clinical investigators meeting at the ASH (American Society of Hematology) meeting last December to educate the people who treat these patients [with MLL]," Gould said, "and we had all the world's leading leukemia docs who are treating patients in the same room...it's that specific of a population."
The Leukemia & Lymphoma Society agreed in June 2011 to provide up to $7.5 million to bankroll Epizyme's drug for MLL through Phase I. Big drugmakers have joined the party, too. Epizyme's research deal with GlaxoSmithKline announced in January 2011 brought the biotech $20 million upfront and gives the London-based drug giant the ability to develop drugs against a certain number of HMT enzyme targets for cancer and other diseases.
Epizyme's pact with Eisai, which was revealed in March, brought a lesser sum at the front end ($6 million). However, the Japanese powerhouse also agreed to fund all R&D costs for drugs involved in the deal through human proof-of-concept studies. That partnership focuses on molecules against the EZH2 enzyme, which plays a role in certain forms of lymphoma and other cancers.
Epizyme is working toward completing the preclinical work necessary to advance its molecules against EZH2 and DOT1L, its lead projects, into initial clinical trials. Its chiefs wouldn't give a specific date on the start of human trials, but the nature of the IND-enabling studies they're doing now could land the firm's first candidate in the clinic sometime in 2012.
Venture backers: Amgen Ventures, Astellas Venture Management, Bay City Capital, Kleiner Perkins Caufield and Byers and MPM Capital.
Tuesday, September 6, 2011
Jets coach feels responsible to win Sept. 11 opener
“Anytime you got cancer again, it’s a huge concern,” Rex Ryan said.
And the health and well-being of his father isn’t all that is weighing on Ryan’s mind as he begins his third Super-Bowl-or-Bust season as head coach of the Jets. The NEW YORK Jets, who will be representing New York on the 10th anniversary of Sept. 11 when America watches them against America’s Team on the grand Sunday night stage.
Ryan searched for the right words to describe how he feels about the responsibilty of coaching the NEW YORK Jets on this night, the significance this game in the shadows of where the Twin Towers once stood brings for him.
“I feel a . . . like a . . . I don’t know, it’s different. . . . Like a responsibility . . . and every week it’s my responsibilty to make sure our team’s prepared, and all that kinda stuff, but I don’t know, it just feels different to me. . . . The significance of it. . . . I think it’s stronger than any game I’ve ever felt,” Ryan said.
“I feel more pressure on this game for whatever reason than any game I’ve ever coached, seems like.”
His twin brother, Rob, on the other sidelines, is chasing the same dream he chases. His 80-year-old father, stiff-arming surgery, will be in the stands to watch his boys. And a city that nothing and no one can keep from standing tall as twin towers both mourning and honoring the memories of the lives that were lost and celebrating our way of life as well.
Rex Ryan has coached in Super Bowl XXX against the Giants, he has coached in the past two AFC Championship games and he has coached aganst his brother. But he has never coached a NEW YORK team on the 10-year anniversary of Sept. 11. That is why he feels more pressure to win this game than any game he has ever coached.
“This whole region, this whole area . . . and I know it’s football, we’re not talking about life or death or anything like that,” Ryan said. “I don’t know, that’s kinda how I’m taking it. It’s my job. My job’s to get this team ready to go, and we will but . . . I can’t explain it, why I feel this way or whatever, but I just do.”
All of us remember the morning of
Sept. 11, 2001. Ryan was the Ravens defensive line coach at the time.
“I was in Baltimore, and Pat Moriarity that — and I was walking by his office, he’s like, ‘Oh my goodness!’ “ Ryan recalled. “And I looked in there, and we were getting ready to practice, so I’m watching it, and then right when I was watching, the other plane hit the second tower. . . . I’m like, ‘Oh my goodness,’ you know? I was thinking about my cousin [Matthew Russo], who was a New York City fireman, and all that . . . so, a lot of thoughts about those times.”
He comes from a tiny place called Ardmore, Okla., but he has never sounded like anything but a New Yorker from the minute he blew into town.
“Everybody deals with their own issues and things,’ Ryan said, “but my job is to coach football and that’s exactly what I’m gonna do.”
He loves coaching the Jets, and never stops loving his team’s chances, in case you haven’t noticed. His players sure have.
“It’s Super Bowl-or-Nothing,” Matt Slauson said. “With us, it is a losing year if we don’t go to the Super Bowl.”
A sense of excitement and anticipation swept across the Jets locker room with the real games finally on the horizon.
“This has been a long time coming . . . having a lockout has made getting here feel like years,” Slauson said. “Brandon Moore? Was out at practice running sprints during practice, and that wasn’t part of his rehab stuff or snything. He was just doing it. Guys are stoked. They want to have the most successful year that we can possibly have.”
Maybe no one appreciates the moment more than Plaxico Burress, three months to the day removed from prison, nearly three years removed from his last regular-season game.
“It’s the start to a long journey,” Burress said.
A journey that maybe only he could see from inside his tiny cell inside the Oneida Correctional Facility.
“I kinda go over in my mind what it’s gonna feel like, but I don’t even know,” Burress said. “When I get out there, whatever happens, if I shed a few tears or whatever that may be, then the world’ll see it. I’m excited, and I don’t want to just start pressing. Just kinda let it come to me.”
Rex-tra special night for Plaxico Burress. For the head coach of the NEW YORK Jets. For all of New York and America.
Giants' Mark Herzlich makes NFL roster not long after beating cancer
Herzlich then spent his afternoon at a local Chili's, sitting by himself while watching Boston College’s season opener. While a student at BC, Herzlich was one of the nation’s top defensive players in 2008. One year later, he was being treated for cancer and faced the possibility of never playing football again.
Herzlich his since recovered from his 2009 diagnosis of Ewing’s sarcoma, a rare bone cancer, in his left leg. He returned to college football last season. More than two years later, he still has the leg and still has a football career.
Both were in doubt at one point.
Herzlich’s NFL career continued after 6 p.m. on Saturday when his phone never rang, signaling that he officially became a member of the Giants — at least for now. He’s one of 10 rookies on the Giants roster, including all four that attended Saturday’s breakfast.
“I want to try to go from being a feel-good story to making an impact on the field,” Herzlich said. “That’s kind of the process, the transition now.”
Because as much as Herzlich has received attention for overcoming cancer, he wants to be viewed as another member of the team. There’s been an ongoing narrative since Herzlich returned to the football about whether he’d ever reach the NFL, and he understands the appeal to the story.
He was invited by the league to the April draft, butwas not selected. Because of the lockout, Herzlich could not sign with the Giants until the week training camp opened. His signing was encouraged by team president John Mara, a Boston College alum, but Mara emphasized that the team viewed Herzlich as a prospect.
Once the ACC defensive player of the year and a surefire first-round pick, Herzlich offered the talent that prompted general manager Jerry Reese to reveal the Giants hoped “to catch lightning in a bottle” by signing Herzlich.
On the first day of practice, Herzlich said reaching an NFL camp provided “a little bit of closure” to his story. The Giants tried Herzlich at each linebacker spot, and Herzlich spent August digesting the playbook. Head coach Tom Coughlin witnessed Herzlich improve “literally week by week.”
In four preseason games, Herzlich forced a fumble, grabbed an interception to prevent a touchdown and recorded a sack. His biggest influence on the team will likely come on special teams, unless injuries ravage the Giants starting linebackers. Herzlich is the only player on the roster besides Kiwanuka to play strongside linebacker during camp.
There’s a sense of relief for Herzlich that he will be viewed as an NFL player and not just a cancer survivor playing football. If he misses a tackle, he knows he’ll be criticized. If he recovers a fumble, he knows he’ll be praised.
“I expect (fans) to be (unhappy) if I make a bad play,” Herzlich said. “I’ll be (unhappy) at myself.”
Sash, whose locker is next to Herzlich’s, knew about Herzlich’s history when he arrived at camp. Sash drew inspiration from his locker mate, knowing he cannot complain on a bad day. But when he thinks about Herzlich now, he doesn’t think about the cancer. Sash has not heard Herzlich discuss the recovery from cancer because “in his mind, he’s over that, too.” And though Herzlich’s history will remain attached to his name, yesterday’s first practice on the 53-man roster started the next chapter in his comeback.
“Your story’s never over because when you talk about the story, that’s actually my life,” Herzlich said. “Maybe the book is getting toward the end of the chapter. But that’s my life. And that’s going to keep on going and lots of changes are going to happen whether it’s related to football or what.”
Thursday, September 1, 2011
Prostate Cancer Awareness Month
This month, the American Cancer Society reminds men of the importance of prostate cancer awareness.
Beginning at age 50, men should have the opportunity to make an informed decision with their health care provider about screening for prostate cancer after receiving information about the uncertainties, risks, and potential benefits associated with screening. African-American men, or men with a family history of prostate cancer, should receive this information at age 45.
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Excluding skin cancer, prostate cancer is the most frequently diagnosed cancer in men and the second leading cause of cancer death in men. Knowing the facts about prostate cancer and early detection is important, particularly this month, Prostate Cancer Awareness Month.
An estimated 240,890 cases of prostate cancer will occur in the U.S. during 2011. The disease accounts for about 29% of newly diagnosed cancers each year in U.S. men. In Nebraska alone, an estimated 1,290 men will hear the words, “you have prostate cancer” and an estimated 280 will die from the disease.
For reasons that remain unclear, incidence rates are significantly higher in African-Americans than in whites. Age is the most important risk factor for prostate cancer and prostate cancer incidence rates increase in men until about age 70 and decline thereafter. The American Cancer Society currently funds 89 research grants relating to prostate cancer. These multi-year grants are for $47 million. Ten of these grants are in the High Plains Division (seven in Texas and two in Missouri), totaling $6.9 million.
Beginning at age 50, men should have the opportunity to make an informed decision with their health care provider about screening for prostate cancer after receiving information about the uncertainties, risks, and potential benefits associated with screening. African-American men, or men with a family history of prostate cancer, should receive this information at age 45.
ADVERTISEMENT
Excluding skin cancer, prostate cancer is the most frequently diagnosed cancer in men and the second leading cause of cancer death in men. Knowing the facts about prostate cancer and early detection is important, particularly this month, Prostate Cancer Awareness Month.
An estimated 240,890 cases of prostate cancer will occur in the U.S. during 2011. The disease accounts for about 29% of newly diagnosed cancers each year in U.S. men. In Nebraska alone, an estimated 1,290 men will hear the words, “you have prostate cancer” and an estimated 280 will die from the disease.
For reasons that remain unclear, incidence rates are significantly higher in African-Americans than in whites. Age is the most important risk factor for prostate cancer and prostate cancer incidence rates increase in men until about age 70 and decline thereafter. The American Cancer Society currently funds 89 research grants relating to prostate cancer. These multi-year grants are for $47 million. Ten of these grants are in the High Plains Division (seven in Texas and two in Missouri), totaling $6.9 million.
Lung Cancer Pill Holds Promise For Those Who Pass Test
From Pfizer, a drugmaker known best for medicines to treat millions, there is now a twice-a-day pill to treat lung cancer that will be prescribed for only a few thousand people each year.
The Food and Drug Administration approved Pfizer's Xalkori to treat patients with a particular form of non-small cell lung cancer, one that is marked by a genetic variation called ALK.
Only people with tumors that test positive for ALK — about 3 to 5 percent of NSCLC patients, or around 6,500 to 11,000 U.S. patients a year — are candidates for the treatment. By comparison, last year more than 45 million prescriptions were dispensed for Lipitor, the cholesterol-fighter that is Pfizer's biggest seller.
The FDA approved the pill in combination with a genetic test to detect the ALK variation to figure out who has the best chance of responding to the medicine.
The new, highly targeted cancer pill won't come cheap at about $9,600 a month. But the benefits for those with the ALK-positive cancers appear to be substantial. Half or more of patients in the studies cited in the FDA approval responded well to treatment with Xalkori. Their tumors shrank or disappeared.
But there are no definitive data so far on whether the drug extends life, though that's expected to be the case. The FDA approved the drug quickly, under a priority review approach reserved for drugs that have special promise. Pfizer has to perform more studies of the drug to confirm the agency's assessment of Xalkori.
Common side effects from Xalkori include vision problems, nausea and diarrhea. More rarely, in less than 2 percent of cases, patients experienced life-threatening inflammation of the lungs.
One high-profile patient who took Xalkori in clinical trials is former Microsoft engineer Andy Hill, a state senator in Washington. Diagnosed with NSCLC in early 2009, he started taking the pill in October of that year. Since Feb. 2010, he's shown no signs of lung cancer. "It's pretty miraculous," he told the Redmond Reporter. "I am doing things I never thought I would ever be able to do again."
For more on Hill's case and how cancer patients can make the best use of the Internet and medical professionals in making treatment decisions, watch the video below of Dr. Jack West, a lung cancer specialist at Seattle's Swedish Medical Center. (Hat tip on video to Sally Church at Icarus Consulting.)
The Food and Drug Administration approved Pfizer's Xalkori to treat patients with a particular form of non-small cell lung cancer, one that is marked by a genetic variation called ALK.
Only people with tumors that test positive for ALK — about 3 to 5 percent of NSCLC patients, or around 6,500 to 11,000 U.S. patients a year — are candidates for the treatment. By comparison, last year more than 45 million prescriptions were dispensed for Lipitor, the cholesterol-fighter that is Pfizer's biggest seller.
The FDA approved the pill in combination with a genetic test to detect the ALK variation to figure out who has the best chance of responding to the medicine.
The new, highly targeted cancer pill won't come cheap at about $9,600 a month. But the benefits for those with the ALK-positive cancers appear to be substantial. Half or more of patients in the studies cited in the FDA approval responded well to treatment with Xalkori. Their tumors shrank or disappeared.
But there are no definitive data so far on whether the drug extends life, though that's expected to be the case. The FDA approved the drug quickly, under a priority review approach reserved for drugs that have special promise. Pfizer has to perform more studies of the drug to confirm the agency's assessment of Xalkori.
Common side effects from Xalkori include vision problems, nausea and diarrhea. More rarely, in less than 2 percent of cases, patients experienced life-threatening inflammation of the lungs.
One high-profile patient who took Xalkori in clinical trials is former Microsoft engineer Andy Hill, a state senator in Washington. Diagnosed with NSCLC in early 2009, he started taking the pill in October of that year. Since Feb. 2010, he's shown no signs of lung cancer. "It's pretty miraculous," he told the Redmond Reporter. "I am doing things I never thought I would ever be able to do again."
For more on Hill's case and how cancer patients can make the best use of the Internet and medical professionals in making treatment decisions, watch the video below of Dr. Jack West, a lung cancer specialist at Seattle's Swedish Medical Center. (Hat tip on video to Sally Church at Icarus Consulting.)
Seizure Drug May Extend Lives of Brain Cancer Patients
Study Shows Benefits of Valproic Acid for Patients With Glioblastomas
As many as half of all people with a common and potentially lethal type of brain cancer known as a glioblastoma will have a seizure at some point during their illness.
Doctors often prescribe a drug to help control these seizures. But until now little was known about which drug, if any, is the best choice.
When added to standard treatment, an older seizure drug, called valproic acid (sold with the brand names of Depakote, Depakene, and Stavzor) may extend the lives of people with this type of tumor by an average of three months, a study shows.
The study is published in Neurology.
"Three months could be a big deal," says Keith L. Black, MD. Black is the chair of the neurosurgery department at Cedars Sinai Medical Center in Los Angeles. He reviewed the study for WebMD.
Glioblastomas are the most common type of brain cancer seen in adults. On average, people live 15 to 18 months after they are diagnosed with this cancer, Black says.
Standard treatment may include:
* Surgery to remove as much of the tumor as possible.
* Radiation therapy to the brain to shrink tumors.
* The chemotherapy drug temozolomide (TMZ), which slows cancer cell growth. An anti-seizure drug is often added for those individuals who also have seizures.
"First, do no harm," Black explains. The hope was that the drugs would control seizures without dampening the effects of the other treatments.
Certain seizure drugs, called enzyme-inducing anti-epileptic drugs, may interfere with chemotherapy. These drugs include carbamazepine, oxcarbazepine, phenobarbital, and phenytoin.
Until now, no one was thinking that any seizure drug could actually extend the lives of people with brain cancer. "Valproic acid may actually offer an additional benefit besides protection from seizures," Black says.
Impact of Valproic Acid
The study originally set out to compare whether or not chemotherapy provides a survival edge when added to radiation among 573 people with brain cancer. It did.
Of 398 people who were also taking seizure medications, the 97 who took valproic acid lived three months longer than those who took other types of seizure medications. They also lived longer than those who had seizures but were not taking any medication to control them.
There were some side effects seen with valproic acid. These included a drop in the number of white blood cells that could increase a person's risk of getting an infection and a drop in blood platelets that could increase risk of bleeding. The survival benefit was only seen among people who received both radiation and chemotherapy. This suggests there may be a synergy between the chemotherapy drug and the seizure medication.
"It is now very important to go back and try to confirm and understand the mechanism," Black says.
"It is a curious observation," says Cormac O'Donovan, MD. O'Donovan is an associate professor of neurology at Wake Forest Baptist Medical Center in Winston-Salem, N.C. He is also a member of the Brain Tumor Center of Excellence Advisory Board at Wake Forest.
"The science behind it needs to be verified before suggesting this is the drug of choice for people with brain cancer and seizures," he says.
As many as half of all people with a common and potentially lethal type of brain cancer known as a glioblastoma will have a seizure at some point during their illness.
Doctors often prescribe a drug to help control these seizures. But until now little was known about which drug, if any, is the best choice.
When added to standard treatment, an older seizure drug, called valproic acid (sold with the brand names of Depakote, Depakene, and Stavzor) may extend the lives of people with this type of tumor by an average of three months, a study shows.
The study is published in Neurology.
"Three months could be a big deal," says Keith L. Black, MD. Black is the chair of the neurosurgery department at Cedars Sinai Medical Center in Los Angeles. He reviewed the study for WebMD.
Glioblastomas are the most common type of brain cancer seen in adults. On average, people live 15 to 18 months after they are diagnosed with this cancer, Black says.
Standard treatment may include:
* Surgery to remove as much of the tumor as possible.
* Radiation therapy to the brain to shrink tumors.
* The chemotherapy drug temozolomide (TMZ), which slows cancer cell growth. An anti-seizure drug is often added for those individuals who also have seizures.
"First, do no harm," Black explains. The hope was that the drugs would control seizures without dampening the effects of the other treatments.
Certain seizure drugs, called enzyme-inducing anti-epileptic drugs, may interfere with chemotherapy. These drugs include carbamazepine, oxcarbazepine, phenobarbital, and phenytoin.
Until now, no one was thinking that any seizure drug could actually extend the lives of people with brain cancer. "Valproic acid may actually offer an additional benefit besides protection from seizures," Black says.
Impact of Valproic Acid
The study originally set out to compare whether or not chemotherapy provides a survival edge when added to radiation among 573 people with brain cancer. It did.
Of 398 people who were also taking seizure medications, the 97 who took valproic acid lived three months longer than those who took other types of seizure medications. They also lived longer than those who had seizures but were not taking any medication to control them.
There were some side effects seen with valproic acid. These included a drop in the number of white blood cells that could increase a person's risk of getting an infection and a drop in blood platelets that could increase risk of bleeding. The survival benefit was only seen among people who received both radiation and chemotherapy. This suggests there may be a synergy between the chemotherapy drug and the seizure medication.
"It is now very important to go back and try to confirm and understand the mechanism," Black says.
"It is a curious observation," says Cormac O'Donovan, MD. O'Donovan is an associate professor of neurology at Wake Forest Baptist Medical Center in Winston-Salem, N.C. He is also a member of the Brain Tumor Center of Excellence Advisory Board at Wake Forest.
"The science behind it needs to be verified before suggesting this is the drug of choice for people with brain cancer and seizures," he says.
In film and on TV: 'The terror that is cancer'
Hollywood is exploring the topic of cancer.
Mia Wasikowska is a terminally ill cancer patient who meets a guy who crashes funerals. On Sept. 30, Joseph Gordon-Levitt grapples with a potentially deadly form of spinal cancer in 50/50. In next year's Now Is Good, Dakota Fanning plays a girl dying of leukemia and going through her bucket list.
Mia Wasikowska is a terminally ill cancer patient who meets a guy who crashes funerals. On Sept. 30, Joseph Gordon-Levitt grapples with a potentially deadly form of spinal cancer in 50/50. In next year's Now Is Good, Dakota Fanning plays a girl dying of leukemia and going through her bucket list.
They join TV's Laura Linney, who is battling melanoma on Showtime's The Big C (Mondays, 10:30 p.m. ET/PT), and AMC's Breaking Bad, renewed for its fifth and final season and starring Bryan Cranston as a meth dealer with lung cancer. And on Lifetime, Jennifer Aniston and Demi Moore helped direct Five, interconnected short films about breast cancer airing in October.
The parallels between the projects? Realism, as opposed to overwrought sentimentality, coupled with a little surrealism and hefty dollops of black humor.
"That is what making movies is about, finding the truth and telling it the best way you know how," Fanning says. "I was really moved by the thought of a young girl knowing that there are so many things she will never achieve and truly making the most of what's left of her life."
The mandate for cast and crew: no histrionics or handwringing.
"The biggest challenge is tone. Because the stakes are so high, it's very easy to go into a place of melodrama," says Bryce Dallas Howard, who produced Restless and stars in 50/50. "There's not a higher stake than someone having to face their own death. That's what these movies deal with in different kinds of ways."
A little levity goes a long way. "It helps bring the terror that is cancer home. Let's face it: There's nothing funny about that disease," says Linney's C co-star John Benjamin Hickey.
In 50/50, Gordon-Levitt's best friend uses the disease to pick up girls; Linney's once-estranged husband on The Big C decides to become her personal concierge after he learns of her diagnosis.
"I had cancer, so I know the absurd things that can happen. You always want to be true to the emotional state of the character, and not go into wackiness," says Big C executive producer Jenny Bicks. "We're constantly monitoring ourselves. It's a very fine line."
And a very relatable topic. Nearly everyone has known a person with cancer. More broadly, the concept of life and death is a universal one. "It's something everyone can identify with," says 50/50 director Jonathan Levine.
Steele spikers raising funds to beat cancer
When it takes to the court next Friday, the Steele Lady Knights volleyball team will be counting on its fans to help them defeat a disease that afflicts thousands of women each year.
The Lady Knights will host the New Braunfels Canyon Cougarettes in their third annual Digs for a Cure game at 7 p.m. Sept. 9 in the Steele High gym. Proceeds from the game, which include tickets for door prizes and a silent auction, will go toward fighting breast cancer.
Steele assistant coach Adrienne Kindt, the event organizer, said the goal of this year's fundraising campaign is to raise $7,000 for the Alamo Breast Cancer Foundation, a local non-profit that provides outreach and education programs on breast cancer and free screenings to women who can't afford them.
Last year's Steele-Clark Digs for a Cure game raised $6,300, which topped the $5,500 raised when Steele hosted rival Clemens in 2009.
Kindt, diagnosed with breast cancer a few years ago but now cancer free, said the event has topped its fundraising goal each year because of the tremendous support of the local community and the Lady Knight volleyball players.
“It has really taken off,” Kindt said. “Our girls really get into it. People are always willing to help out no matter what the economy is like. Rarely do we have any of the girls say someone has turned them down.”
Kindt said several area businesses are donating gift cards as part of the door prizes. Other door prizes that will given away include an iPod and Steele T-shirts. Pink T-shirts will be sold at the game.
Jay Pogue, whose daughter plays on the volleyball team, will host a poker tournament at Freiheit Country Store in New Braunfels Sept. 10, the day after the game, with proceeds going to the breast cancer foundation. For more on the poker tourney and how to get involved, contact Kindt at akindt@scuc.txed.net.
On Aug. 31 both of the Schertz Sonic Drive-Ins on FM 78 and at Interstate 35 and FM 3009 allowed Lady Knight volleyball players to sell door prize tickets and donated 10 percent of their dinner proceeds to Digs for a Cure.
During the game, players from both teams will don pink socks and pink hair ribbons, and have temporary tattoos of the pink ribbon, symbol for breast cancer awareness. Game officials will have pink whistles and a pink ball warmup ball signed by Steele players will be presented to an Alamo Breast Cancer Foundation representative.
With thousands of women affected by the disease every year, Kindt said it is important to keep working for a cure.
“You know somebody that has been affected by this,” she said. “Nobody can turn a blind eye to cancer because it is prevalent. What it is we are trying to do is to help bring some awareness and to find that cure. We just (got) to find a cure, so many people are devastated by it.”
The Lady Knights will host the New Braunfels Canyon Cougarettes in their third annual Digs for a Cure game at 7 p.m. Sept. 9 in the Steele High gym. Proceeds from the game, which include tickets for door prizes and a silent auction, will go toward fighting breast cancer.
Steele assistant coach Adrienne Kindt, the event organizer, said the goal of this year's fundraising campaign is to raise $7,000 for the Alamo Breast Cancer Foundation, a local non-profit that provides outreach and education programs on breast cancer and free screenings to women who can't afford them.
Last year's Steele-Clark Digs for a Cure game raised $6,300, which topped the $5,500 raised when Steele hosted rival Clemens in 2009.
Kindt, diagnosed with breast cancer a few years ago but now cancer free, said the event has topped its fundraising goal each year because of the tremendous support of the local community and the Lady Knight volleyball players.
“It has really taken off,” Kindt said. “Our girls really get into it. People are always willing to help out no matter what the economy is like. Rarely do we have any of the girls say someone has turned them down.”
Kindt said several area businesses are donating gift cards as part of the door prizes. Other door prizes that will given away include an iPod and Steele T-shirts. Pink T-shirts will be sold at the game.
Jay Pogue, whose daughter plays on the volleyball team, will host a poker tournament at Freiheit Country Store in New Braunfels Sept. 10, the day after the game, with proceeds going to the breast cancer foundation. For more on the poker tourney and how to get involved, contact Kindt at akindt@scuc.txed.net.
On Aug. 31 both of the Schertz Sonic Drive-Ins on FM 78 and at Interstate 35 and FM 3009 allowed Lady Knight volleyball players to sell door prize tickets and donated 10 percent of their dinner proceeds to Digs for a Cure.
During the game, players from both teams will don pink socks and pink hair ribbons, and have temporary tattoos of the pink ribbon, symbol for breast cancer awareness. Game officials will have pink whistles and a pink ball warmup ball signed by Steele players will be presented to an Alamo Breast Cancer Foundation representative.
With thousands of women affected by the disease every year, Kindt said it is important to keep working for a cure.
“You know somebody that has been affected by this,” she said. “Nobody can turn a blind eye to cancer because it is prevalent. What it is we are trying to do is to help bring some awareness and to find that cure. We just (got) to find a cure, so many people are devastated by it.”
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.
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.
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.
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.
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.
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.
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.
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."
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.
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."
"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.
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.
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.
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.
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.
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.
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.
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.
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