FDA: New suppliers to ease 2 cancer drug shortages

TRENTON, N.J. (AP) — Federal regulators said Tuesday that they've approved new suppliers for two crucial cancer drugs, easing critical shortages — at least for the time being — that have left patients and parents frightened about missing life-saving treatments.

The news brings a light at the end of the tunnel for some patients, but not for thousands of others, given that there are currently 283 separate drugs in short supply or totally unavailable in this country.

On Tuesday, the Food and Drug Administration said it will temporarily allow importation of a replacement drug for Doxil, a drug for ovarian and other cancers that hasn't been available for new patients for months.

The agency also has approved another supplier for a preservative-free version of methotrexate, a crucial drug for children with a type of leukemia called ALL and for high-dose treatment of bone cancer. The version with preservatives can be toxic or cause paralysis in children and other patients getting the drug either via injections into spinal cord fluid or at very high doses.

The FDA also has approved the release of a batch manufactured by Ben Venue Laboratories Inc., shortly before it closed several factories at its complex in Bedford, Ohio, due to serious quality problems. That closing is what turned the on-again, off-again methotrexate shortage that began in late 2008 into a crisis almost overnight, with fears that patients would begin missing treatments as soon as the end of this month.

"We have made real progress ... We believe that (suppliers) will be able to meet the demands of patients in the U.S. market" for the two drugs indefinitely, FDA Dr. Commissioner Margaret A. Hamburg told The Associated Press in an exclusive interview. "It's a huge relief for us."

The FDA increasingly has been able to prevent drug shortages, mainly due to a sixfold increase in manufacturers voluntarily notifying the FDA when they anticipate shortages, Hamburg said.

Thanks to such notice, the agency prevented 195 drug shortages in 2011, mostly late in the year after President Obama issued an executive order giving FDA additional powers to address the shortages. Between that order on Oct. 31 and this week, the agency has prevented a total of 114 drug shortages.

Hamburg said that when FDA's much-expanded drug shortages team is notified about impending shortages and contacts other manufacturers, those companies have been "very responsive" as FDA worked with them on finding ways to boost production.

In the latest case, the FDA said it has temporarily allowed importation of an alternative to Doxil called Lipodox, made by Sun Pharma Global FZE. The Indian drugmaker is already known to the agency, and its factory and the production line for Lipodox have been inspected.

The FDA also has given approval to APP Pharmaceuticals LLC to begin making a preservative-free version of methotrexate in addition to its current drug that includes preservatives. The company had made a preservative-free version years ago, but needed to update paperwork and meet other requirements, which the FDA expedited. It's expected to start shipping the medication by the middle of March.

Another maker, Hospira Inc., expected today to start shipping about 31,000 vials of preservative-free methotrexate, more than enough to meet a month's demand, to hundreds of hospitals and treatment centers.

Still, hundreds of other drugs remain in short supply, including many other cancer medicines.

"I don't think we can ever close the book on drug shortages," Hamburg said. "I think we will always have to be vigilant."

Drug shortages have increased dramatically in the U.S. over the past six years, particularly for generic injected drugs. They are the workhorses of hospitals but are difficult to make and produce little profit for drugmakers. At least 15 deaths since 2010 have been blamed on the shortages, which have set a record high in each of the last five years.

So far this year, 27 new shortages have been reported, and about 215 that began in 2010 or 2011 remain unresolved, according to Erin R. Fox, manager of the University of Utah Drug Information Service, which tracks shortages.

"At this time last year, we were on a pace of about one new shortage per day. Thanks to FDA's hard work, that pace is cut in half for this first part of 2012, when we have counted 27 new shortages" in nearly two months, Fox said.

The shortages are caused primarily by problems with sterility and other serious issues that have led to shutdowns of production lines and occasionally entire factories.

In addition, consolidation among generic drug manufacturers, as well as manufacturers deciding to end production of marginally profitable drugs, has led to decreased capacity. That means when one manufacturer suddenly stops production, the small number of others making a drug can't quickly pick up slack.

The inability to get crucial medicines has disrupted not only carefully timed chemotherapy regimens, but surgery and care for patients with infections, pain and other serious conditions.

Meanwhile, some unscrupulous smaller distributors, dubbed "gray marketers," have been exacerbating shortages by charging hospitals many times the normal price for drugs that can't be acquired through normal suppliers. Several bills in Congress are pending that would establish penalties for drugmakers that don't give notice of impending shortages, or by setting penalties for price gouging on prescription drugs.

Of late, the cancer drug shortages have attracted the most attention, partly because missing multiple treatments can sharply reduce the chances of curing the disease. In the case of methotrexate, its use as part of the treatment for acute lymphoblastic lymphoma results in nearly 90 percent of children being cured, so parents and doctors were particularly upset at the prospect of it not being available.

___

Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma

View the original article here

Hugo Chávez Says His Cancer May Have Returned

The announcement comes at the start of what could be Mr. Chávez’s most challenging re-election campaign since he first took office in 1999, and it seemed bound to unsettle the political landscape. Although he previously said that he had beaten cancer, questions about Mr. Chávez’s health have continued, including whether he would be able to campaign or stay in office if he were re-elected.

“I am in good physical condition to face this battle,” Mr. Chávez said on Tuesday, appearing to tear up as he spoke of not wanting his supporters to suffer on hearing the news of his setback. He spoke in a live television broadcast while touring a truck factory in his native state of Barinas, in western Venezuela.

During his remarks, the socialist president did not mention the political campaign or the election, which is scheduled for October, but he sounded a warning to critics who might take pleasure at his misfortune.

“Let no one be alarmed, and, I would say, let no one be happy, because independent of my personal destiny, this revolution, as Bolívar said one day, has gotten its start, and nothing and no one can stop it,” he said.

He denied reports and rumors that his cancer had spread to his liver or other parts of his body, or that he was dying.

“On the contrary, and it is good news,” he said. “I do not have metastasis anywhere.”

Mr. Chávez, 57, was given a diagnosis of cancer last June and underwent two operations in Cuba, followed by chemotherapy. His illness forced him to be absent from the country for long periods and tamped down his fiery presence, leading many to wonder whether he would be able to hold off the opposition during its electoral challenge.

Luis Vicente León, a political analyst, said that Mr. Chávez had built his political strategy around convincing the public that he had recovered from cancer. If he is able to keep campaigning, Mr. León said, he will in one sense be at a disadvantage against the opposition candidate, Henrique Capriles Radonski, 39, whose youth and energy will be accentuated in comparison with a weakened Mr. Chávez.

The president has never said exactly what kind of cancer he had, and his illness and treatment have been shrouded in mystery, which has fueled more doubts about his health. Those rumors spiked in recent days, as opponents of Mr. Chávez speculated on Twitter that he had been rushed to Cuba for an emergency operation. While the government made no official statement before Mr. Chávez’s appearance, the information minister, Andrés Izarra, called the rumors a “dirty war” in a Twitter post. Mr. Chávez said that he was responding to those rumors by making his announcement a day earlier than planned.

He said that he flew to Cuba over the weekend for a regular medical exam and that doctors had found a lesion about two centimeters in diameter in the same place that the tumor was found last year. He has said in the past only that his operation was in the pelvic region. Mr. Chávez said that the new operation should take place in the next few days and that doctors would perform tests to determine whether the lesion was malignant. He said Tuesday night that the procedure would take place in Cuba.

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FDA Moves to Head Off Shortages of 2 Cancer Drugs

TUESDAY, Feb. 21 (HealthDay News) -- The U.S. Food and Drug Administration announced Tuesday what it called a series of steps to ensure the continued availability of vital cancer drugs that have been in dangerously short supply.

One of the drugs, methotrexate, is used in combination with other drugs to combat -- and in many cases cure -- acute lymphoblastic leukemia (ALL), the most common type of cancer in children. It typically strikes kids aged 2 to 5.

And another drug, Lipodox, will be temporarily imported from a pharmaceutical company in India to ease a shortage of the chemotherapy drug Doxil (doxorubicin), which is used to treat ovarian cancer, multiple myeloma and AIDS-related Kaposi's sarcoma. Lipodox is similar in chemical makeup to Doxil; there are no generic versions of Doxil.

"Through the collaborative work of [the] FDA, industry and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need," FDA Commissioner Dr. Margaret A. Hamburg said in a news release.

The FDA also said it was issuing guidelines to the drug industry that spell out detailed requirements for "both mandatory and voluntary notifications" to the agency of potential problems that could result in a drug shortage or supply disruption.

Methotrexate is a cornerstone in the treatment of children with acute lymphoblastic leukemia. In high doses, the generic drug has been successful in curing patients and beneficial in preventing recurrence. Without the drug, a patient's chance for a cure is reduced while the risk of recurrence rises, oncologists said.

Some cancer doctors had warned last week that supplies of methotrexate could be exhausted within two weeks.

To offset the shortage of methotrexate, the FDA said Tuesday that it has worked with several drug manufacturers to help maintain supplies to meet all patient needs. Preservative-free methotrexate is needed for the intrathecal (injection into the fluid surrounding the brain and spinal cord) treatment of children with ALL, the agency said.

The FDA said the steps taken with methotrexate included approving a preservative-free version of the generic drug manufactured by APP Pharmaceuticals, of Schaumburg, Ill. Those supplies should become available in March and continue indefinitely, the agency said.

Second, Illinois-based Hospira Inc., which already manufactures methotrexate, has sped up additional supplies, producing 31,000 new vials of the drug -- enough for more than one month's supply. Those additional vials are being shipped Tuesday to hundreds of U.S. hospitals and treatment centers, the FDA said.

The FDA also noted that it continues to work with other manufacturers of methotrexate that have also stepped up production. Those manufacturers include Mylan Inc., of Canonsburg, Pa., and Sandoz US Inc., of Princeton, N.J.

At a midday news conference Tuesday, one of the speakers was Sara Stuckey, mother of 6-year-old Nate Stuckey, who has been on methotrexate since he was diagnosed with ALL in 2009.

"It is hard enough to hear your child has cancer, but to hear that the treatment that is successfully working is suddenly not available is devastating," she said. "My husband and I pray the recommended drugs to fight his cancer will be available when it's time for Nate's next treatment. And we hope that in the future no more families have to go through the stress of wondering whether proven, lifesaving treatments will be out of reach when they need it the most."

Speaking at the news conference, Hamburg said: "There are too many families like the Stuckeys who worry they won't have the medication they need for their next treatment and are understandably anxious about switching to a medication that may have more side effects or may be less effective. Clearly this is not acceptable."

"We are making progress," Hamburg added. "There were 195 drug shortages prevented in 2011 and 114 drug shortages prevented since October 2011 when we made the call for early notification" of potential shortages.

As for the ovarian cancer drug Lipodox, the FDA said it will allow the temporary importation of the drug made by Sun Pharma Global FZE. The agency said in its news release that "temporary importation of unapproved foreign drugs is considered only in rare cases when there is a shortage of an approved drug that is critical to patients and the shortage cannot be resolved in a timely fashion with FDA-approved drugs."

The shortages of methotrexate and Doxil are just the latest in a series of drug shortages that have existed for several years.

In 2011, prescription drug shortages in the United States hit an all-time high. Last fall, some 200 drug shortages had been reported, compared to 178 in all of 2010, the FDA reported.

Many of the scarce drugs are injectables, such as cytarabine and cisplatin, used to treat serious conditions such as cancer. Some are only given in hospitals and are "absolutely critical," Valerie Jensen, associate director of the FDA's drug shortage program, said during a news conference last September.

More than half (54 percent) of shortages in 2010 were due to quality issues, such as drug impurities. Some were caused by delays or manufacturing capacity problems, while 11 percent were caused by discontinuation of a drug and 5 percent resulted from raw material shortages, Jensen said.

Jensen also said the shortages tend to occur in drugs that aren't "economically attractive." This could mean that only one company produces the drug, making it harder to find alternatives if the supply dries up.

A lot of the problems are tied to generic drugs, health experts explained, because few manufacturers make them and profit margins aren't as high as for brand-name drugs still under patent protection.

On Oct. 31, 2011, President Barack Obama signed an executive order designed to help ease the drug shortages. The order directed the FDA to "take action" to prevent and reduce worsening prescription drug shortages.

In response to Tuesday's announcement, Dr. Armand Keating, president of the American Society of Hematology (ASH), said in a statement: "ASH is encouraged by the steps FDA is taking to alleviate drug shortages that have significantly affected so many patients with hematololgic malignancies under our members' care. The measures announced today are consistent with the Society's recommendations to FDA, Congress and the Obama Administration to expand the agency's authority to prevent drug shortages by requiring manufacturers to provide early notification of impending shortages and importing drugs in critical supply."

"While ASH applauds the specific actions announced today," Keating added, "we also realize that these measures represent only a portion of a solution to a much larger problem. In addition to these steps, additional measures -- such as developing a national drug registry and providing economic incentives to manufacturers to produce a steady supply of generics -- must be implemented to permanently prevent shortages. Until a complete solution is in place, treatment will be delayed and care will be rationed for critically ill patients."

More information

For more on drug shortages, visit the U.S. Food and Drug Administration.

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FDA: New suppliers to ease 2 cancer drug shortages

TRENTON, N.J. (AP) — Federal regulators said Tuesday that they've approved new suppliers for two crucial cancer drugs, easing critical shortages — at least for the time being — that have left patients and parents frightened about missing life-saving treatments.

The news brings a light at the end of the tunnel for some patients, but not for thousands of others, given that there are currently 283 separate drugs in short supply or totally unavailable in this country.

On Tuesday, the Food and Drug Administration said it will temporarily allow importation of a replacement drug for Doxil, a drug for ovarian and other cancers that hasn't been available for new patients for months.

The agency also has approved another supplier for a preservative-free version of methotrexate, a crucial drug for children with a type of leukemia called ALL and for high-dose treatment of bone cancer. The version with preservatives can be toxic or cause paralysis in children and other patients getting the drug either via injections into spinal cord fluid or at very high doses.

The FDA also has approved the release of a batch manufactured by Ben Venue Laboratories Inc., shortly before it closed several factories at its complex in Bedford, Ohio, due to serious quality problems. That closing is what turned the on-again, off-again methotrexate shortage that began in late 2008 into a crisis almost overnight, with fears that patients would begin missing treatments as soon as the end of this month.

"We have made real progress ... We believe that (suppliers) will be able to meet the demands of patients in the U.S. market" for the two drugs indefinitely, FDA Dr. Commissioner Margaret A. Hamburg told The Associated Press in an exclusive interview. "It's a huge relief for us."

The FDA increasingly has been able to prevent drug shortages, mainly due to a sixfold increase in manufacturers voluntarily notifying the FDA when they anticipate shortages, Hamburg said.

Thanks to such notice, the agency prevented 195 drug shortages in 2011, mostly late in the year after President Obama issued an executive order giving FDA additional powers to address the shortages. Between that order on Oct. 31 and this week, the agency has prevented a total of 114 drug shortages.

Hamburg said that when FDA's much-expanded drug shortages team is notified about impending shortages and contacts other manufacturers, those companies have been "very responsive" as FDA worked with them on finding ways to boost production.

In the latest case, the FDA said it has temporarily allowed importation of an alternative to Doxil called Lipodox, made by Sun Pharma Global FZE. The Indian drugmaker is already known to the agency, and its factory and the production line for Lipodox have been inspected.

The FDA also has given approval to APP Pharmaceuticals LLC to begin making a preservative-free version of methotrexate in addition to its current drug that includes preservatives. The company had made a preservative-free version years ago, but needed to update paperwork and meet other requirements, which the FDA expedited. It's expected to start shipping the medication by the middle of March.

Another maker, Hospira Inc., expected today to start shipping about 31,000 vials of preservative-free methotrexate, more than enough to meet a month's demand, to hundreds of hospitals and treatment centers.

Still, hundreds of other drugs remain in short supply, including many other cancer medicines.

"I don't think we can ever close the book on drug shortages," Hamburg said. "I think we will always have to be vigilant."

Drug shortages have increased dramatically in the U.S. over the past six years, particularly for generic injected drugs. They are the workhorses of hospitals but are difficult to make and produce little profit for drugmakers. At least 15 deaths since 2010 have been blamed on the shortages, which have set a record high in each of the last five years.

So far this year, 27 new shortages have been reported, and about 215 that began in 2010 or 2011 remain unresolved, according to Erin R. Fox, manager of the University of Utah Drug Information Service, which tracks shortages.

"At this time last year, we were on a pace of about one new shortage per day. Thanks to FDA's hard work, that pace is cut in half for this first part of 2012, when we have counted 27 new shortages" in nearly two months, Fox said.

The shortages are caused primarily by problems with sterility and other serious issues that have led to shutdowns of production lines and occasionally entire factories.

In addition, consolidation among generic drug manufacturers, as well as manufacturers deciding to end production of marginally profitable drugs, has led to decreased capacity. That means when one manufacturer suddenly stops production, the small number of others making a drug can't quickly pick up slack.

The inability to get crucial medicines has disrupted not only carefully timed chemotherapy regimens, but surgery and care for patients with infections, pain and other serious conditions.

Meanwhile, some unscrupulous smaller distributors, dubbed "gray marketers," have been exacerbating shortages by charging hospitals many times the normal price for drugs that can't be acquired through normal suppliers. Several bills in Congress are pending that would establish penalties for drugmakers that don't give notice of impending shortages, or by setting penalties for price gouging on prescription drugs.

Of late, the cancer drug shortages have attracted the most attention, partly because missing multiple treatments can sharply reduce the chances of curing the disease. In the case of methotrexate, its use as part of the treatment for acute lymphoblastic lymphoma results in nearly 90 percent of children being cured, so parents and doctors were particularly upset at the prospect of it not being available.

___

Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma

View the original article here

Contagious Cancer: Genome Study Reveals How Tasmanian Devil Cancer Has Spread

tasmanian_devil_cancer_genome Image courtesy of Save the Tasmanian Devil Program

A killer cancer that is threatening to wipe Tasmanian devils off the map for good has been spreading from an original infected female 15 years ago via live cancer cells, according to evidence from genome sequences of the cancer and the animal, published online Thursday in Cell. Finding out how this happened could help save this species from extinction and it could also prepare researchers for the unlikely event that a contagious cancer ever appeared in humans.

The facial cancer, which is spread through bites, has plagued this animal’s precarious population for more than a decade. Tasmanian devils (Sarcophilus harrisii) are the largest surviving carnivorous marsupials and live on Australia’s island state Tasmania. [Read more about this scourge in "The Devil's Cancer," from Scientific American's June 2011 issue.] All of the tumors afflicting the animals today contain cells from one original devil, genetic sequences show. “I call her the immortal devil,” Elizabeth Murchison, a researcher at the Wellcome Trust Sanger Institute and co-author of the new paper, said in a prepared statement. “Her cells are living on long after she died.”

An earlier version of the Tasmanian devil genome was published last year in Proceedings of the National Academy of Sciences and revealed some secrets about why the cancer hasn’t killed off the species already. One of the two devils sequenced, named Cedric, showed resistance to at least two strains of the cancer, although he later succumbed to a third.

“The Tasmanian devil cancer is the only cancer that is threatening an entire species with extinction,” Murchison said. After the first tumor appears on the doomed animals face, it will likely die within three months.

But by turning to genetics, researchers and conservationists hope to be able to find clues to at least slow the cancer’s spread. The researchers studied tumors from 104 tumors collected from Tasmanian devils from various locations on the island and found that there were separate geographic groups of cancer types but that all of them contained cells from the original female. “Sequencing the genome of this cancer has allowed us to catalogue the mutations that caused this cancer to arise and to persist,” Murchison said. More detailed genetic details could point the way to targeted cancer drugs. It might also suggest how the cancer is able to sneak past the immune system and start its explosive growth so quickly.

“Tracing the evolutionary history and spread of this cancer helps us to understand not only what caused this disease but also to predict how it might behave in the future,” David Bentley, chief scientist at Illumina Cambridge, Ltd. and study co-author, said in a prepared statement.

The Tasmanian devil’s cancer has more than 17,000 mutations. “This is fewer mutations that are found in some human cancers and indicates that cancers do not need to be extremely unstable in order to become contagious,” Bentley said. Only one other type of contagious cancer is known a venereal tumor that infects dogs and wolves. The next step is “to use the genome sequence to understand more about how this cancer became transmissible,” Michael Stratton, director of the Wellcome Trust Sanger Institute and study co-author, said in a prepared statement. “Cancers that transmit through populations are obviously incredibly rare, he said, but we should use the Tasmanian devil example to be prepared in the extremely unlikely event that such an epidemic ever occurs in humans.”

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US couple get 8 years each in son's cancer death

CLEVELAND (AP) — The parents of an 8-year-old boy who died from Hodgkin lymphoma after suffering for months from undiagnosed swollen glands were sentenced to eight years in prison Thursday following their guilty pleas to denying him medical treatment.

Attorneys for Monica Hussing, 37, and William Robinson Sr., 40, had said the parents had financial problems and tried to get checkups for their son but couldn't afford it.

The couple was given the maximum sentence by Cuyahoga County Judge Michael Astrab, who accepted their guilty pleas last month to attempted involuntary manslaughter in a last-minute plea deal before their trial was about to begin. They were handcuffed and taken into custody immediately. Both plan to appeal the sentence.

"I loved my son," Robinson told the judge, occasionally wiping his eyes with a tissue. He said he was sorry.

"I tried to help my son," Hussing said as family members in the courtroom quietly sobbed.

Hussing's sister, Shelia Slawinski, cried as she stood before the judge and gave voice to her nephew, Willie Robinson.

"I told my sister," Slawinski said. "I offered to help my sister."

According to the prosecution's pre-sentencing memo to the judge, at least eight family members noticed Willie's deteriorating health over a period of more than two years and most spoke to the couple about it. One relative described the boy's swollen neck glands as the size of a softball.

"Twenty-nine months he suffered," Slawinski said. "Twenty-nine months they had to do something and they chose not to."

Asked outside court why her sister hadn't taken care of Willie and hadn't enrolled him or three siblings in school, Slawinski said it was easier for Hussing to stay in bed during the day and do drugs. Both parents have abused drugs, their attorneys earlier told the judge.

Hussing's oldest daughter, Lillian, 18, defended her mother in court and said Willie was able to do the same things other 8-year-olds do. "He was able to play, go outside," she said.

The judge looked surprised and asked the teen if she would be willing to repeat her statements under oath and possible penalty of perjury. She did.

The judge compared the autopsy photo of Willie's emaciated body to concentration camp victims. "If anybody, anybody, didn't know this kid was sick, they are seriously, seriously disturbed," Astrab said.

Two doctors told the judge before the sentencing that no sick child would be turned away from a hospital.

Willie Robinson collapsed at his home on March 22, 2008. Prosecutors say he had begged his parents to take him to see a doctor but was rejected. Hodgkin lymphoma is a highly treatable cancer.

Lillian Hussing said earlier the family didn't have money for medical care and tried repeatedly to get help from social services and visited a free clinic but left when told they would have to pay $180.

The family soon moved to Cleveland and the boy died within weeks.

Prosecutors say that while the boy was suffering, the parents claimed financial hardship but paid $87 to have a pit bull treated for fleas. Hussing's defense attorney, John Luskin, said the dog belonged to Hussing's parents and her parents paid for the treatment.

Trumbull County Children Services says it had worked with the family to provide Willie health care, getting involved after receiving a phone call in July 2007. Agency officials said a case worker visited the family at least monthly and pushed the parents to have a medical follow-up on his swollen neck but they didn't.

However, Robinson's attorney Thomas Rein said previously that a social worker who visited the family in January 2008 "indicated the kids were healthy and happy." He said no one knew the boy had cancer until he died and an autopsy was performed.

And Lillian Hussing said a case worker had told the family the boy's lump looked like a swollen gland and to hold off until they could secure financial assistance before getting it checked.

About two weeks after they moved to Cleveland, she said, her brother came down with something. Her mother treated him with cold medicine and he died within three days.

View the original article here

Women in the U.K. May Lose Access to Important Breast Cancer Drugs

SALT LAKE CITY (Reuters) - Elizabeth Smart, who was kidnapped at age 14 from her Utah home and held for what she described as "nine months of hell," exchanged vows on Saturday with her boyfriend of the past year at a private wedding in Hawaii, her uncle told Reuters. Smart, 24, and Matthew Gilmour, whom she met while she …

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Ohio couple get 8 years in in son's cancer death

CLEVELAND (AP) — The parents of an 8-year-old boy who died from Hodgkin lymphoma after suffering for months from undiagnosed swollen glands were sentenced to eight years in prison Thursday following their guilty pleas to denying him medical treatment.

Attorneys for Monica Hussing, 37, and William Robinson Sr., 40, had said the parents had financial problems and tried to get checkups for their son but couldn't afford it.

The couple was given the maximum sentence by Cuyahoga County Judge Michael Astrab, who accepted their guilty pleas last month to attempted involuntary manslaughter in a last-minute plea deal before their trial was about to begin. They were handcuffed and taken into custody immediately. Both plan to appeal the sentence.

"I loved my son," Robinson told the judge, occasionally wiping his eyes with a tissue. He said he was sorry.

"I tried to help my son," Hussing said as family members in the courtroom quietly sobbed.

Hussing's sister, Shelia Slawinski, cried as she stood before the judge and gave voice to her nephew, Willie Robinson: "I am so in pain ... please take me to the doctor ... the last four weeks have been the most painful."

"I told my sister," Slawinski said. "I offered to help my sister."

According to the prosecution's pre-sentencing memo to the judge, at least eight family members noticed Willie's deteriorating health over a period of more than two years and most spoke to the couple about it. One relative described the boy's swollen neck glands as the size of a softball.

"Twenty-nine months he suffered," Slawinski said. "Twenty-nine months they had to do something and they chose not to."

Asked outside court why her sister hadn't taken care of Willie and hadn't enrolled him or three siblings in school, Slawinski said it was easier for Hussing to stay in bed during the day and do drugs. Both parents have abused drugs, their attorneys earlier told the judge.

Hussing's oldest daughter, Lillian, 18, defended her mother in court and said Willie was able to do the same things other 8-year-olds do. "He was able to play, go outside," she said.

The judge looked surprised and asked the teen if she would be willing to repeat her statements under oath and possible penalty of perjury. She did.

The judge compared the autopsy photo of Willie's emaciated body to concentration camp victims. "If anybody, anybody, didn't know this kid was sick, they are seriously, seriously disturbed," Astrab said.

Two doctors told the judge before the sentencing that no sick child would be turned away from a hospital.

Willie Robinson collapsed at his home on March 22, 2008. Prosecutors say he had begged his parents to take him to see a doctor but was rejected. Hodgkin lymphoma is a highly treatable cancer.

Lillian Hussing said earlier the family didn't have money for medical care when they lived in Warren, tried repeatedly to get help from social services and visited a free clinic but left when told they would have to pay $180.

The family soon moved to Cleveland and the boy died within weeks.

Prosecutors say that while the boy was suffering, the parents claimed financial hardship but paid $87 to have a pit bull treated for fleas. Hussing's defense attorney, John Luskin, said the dog belonged to Hussing's parents and her parents paid for the treatment.

Trumbull County Children Services says it had worked with the family to provide Willie health care, getting involved after receiving a phone call in July 2007. Agency officials said a case worker visited the family at least monthly and pushed the parents to have a medical follow-up on his swollen neck but they didn't.

However, Robinson's attorney Thomas Rein said previously that a social worker who visited the family in January 2008 "indicated the kids were healthy and happy." He said no one knew the boy had cancer until he died and an autopsy was performed.

And Lillian Hussing said a case worker had told the family the boy's lump looked like a swollen gland and to hold off until they could secure financial assistance before getting it checked.

About two weeks after they moved to Cleveland, she said, her brother came down with something. Her mother treated him with cold medicine and he died within three days.

She said the boy never complained about his neck.

"He played, he went outside, he wrestled, he played video games," the boy's sister said. "He was the happiest kid you could imagine. It never seemed like he was suffering."

The emotional aftermath from their son's death led the couple to split, according to Luskin.

The couple's four other children under 18 were placed in the custody of a family member. Luskin said Lillian Hussing, upon turning 18, decided to return to live with her mother.

Rein said Robinson agreed to plead guilty so his children could be spared any further grief and wouldn't have to suffer by testifying. Lillian Hussing said her mother took a plea bargain because of the uncertainty of a trial and fear she could be sent to prison for a long time.

As part of the deal, the prosecution agreed to drop four counts each against each parent, including child endangering. Prosecutors didn't agree to a sentence recommendation. Both Luskin and Rein had said they hoped the judge would consider probation.

"There's not a day my client ... starts without shedding a tear for his son," Rein said.

The coroner ruled that the boy was a victim of medical neglect and died from pneumonia due to Hodgkin lymphoma.

Hodgkin lymphoma is a highly treatable cancer, with as many as 95 percent of patients in early stages of the disease surviving for five years or more with treatment. It's one of the most common forms of cancers among children.

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FDA Warns Health Officials About Counterfeit Cancer Drug

The FDA announced on Tuesday that a counterfeit version of the drug Avastin has made its way into the U.S. market. Doctors, hospitals, and pharmacists are being urged to check their supply of the drug to make sure it was manufactured by Roche Group partner Genentech, the maker of the real Avastin.

What is Avastin?

Avastin is a "designer drug" created to treat cancer by isolating a protein known as vascular endothelial growth factor, or VEGF, according to Genentech. VEGF helps the body create new blood vessels, which in a person with cancer, can help feed the cancerous cells. By blocking VEGF, Avastin theoretically can "starve" cancer cells and kill them off, according to NPR.

Avastin has only been approved to help treat certain kinds of cancers, including colorectal, brain, kidney, and lung cancer. It was initially approved late last year for treating breast cancer as well, but the FDA withdrew the approval while it is re-evaluating the drug's effectiveness in treating advanced cases of the disease.

How did the FDA find out about the counterfeit?

CNN reports that the FDA tracked purchases made from Quality Specialty Products, which in the U.S. appears to also go under the moniker Montana Health Care Solutions. The company is alleged to have been sourcing counterfeit drugs from overseas distributors and then selling them to U.S. practitioners.

Genentech themselves tested the suspected counterfeit version of the drug and found it to be not merely repackaged but fraudulent. Some 19 different potential buyers have been identified. The FDA warned all of them individually about the counterfeit drug before releasing a more general press statement on Tuesday.

Is the counterfeit version dangerous?

Yes, in that it is missing the active ingredient bevacizumab, the key component in the real Avastin medication. Therefore, anyone who has been treated with the counterfeit would not have been getting needed cancer therapy. Roche and Genentech released a statement on Tuesday giving details on how to identify fake medications, as well as warning practitioners that the counterfeit should not be considered either safe or effective.

Does the FDA know if anyone has actually been given the counterfeit?

Not at this time. The path of the counterfeit drug once it hit American shores is still being investigated, according to MSNBC. Because the agency is still unsure just how much of the counterfeit was purchased and distributed, the FDA hasn't been able to determine whether anyone was actually administered the faux treatment.

Vanessa Evans is a musician and freelance writer based in Michigan, with a lifelong interest in health and nutrition issues.

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Astra takes brand cancer drug straight to patients

(Reuters) - AstraZeneca Plc is selling breast cancer drug Arimidex directly to U.S. patients, offering an option for people who want to pay for the brand instead of generic versions.

Under the drugmaker's new program, patients with a prescription can pay $40 a month for Arimidex to be mailed to their homes.

That is less than patients would generally pay for the brand, but is typically more than the co-payment for generic versions of the drug, also known as anastrozole.

AstraZeneca said it started the program in response to patients asking for options to buy the brand, which are prohibitively more expensive compared with generics since the cheaper copies became available in mid-2010.

"We definitely got lots of calls every month to our information center on how they could get a branded option," said Steve Davis, Astra's executive director overseeing its mature brands in the United States. "There are patients that prefer not to be on the generic option."

Health plans generally try to steer patients to generic versions once they become available because they are significantly less expensive.

AstraZeneca's move is similar to one by Pfizer Inc, which has offered delivery of brand versions of its Lipitor drug to patients after the big-selling cholesterol treatment lost U.S. patent protection in November.

Arimidex was once a big seller for Astra. In 2009, the last full year before generics arrived, Arimidex sales reached $1.9 billion globally and about $880 million in the United States alone. Last year, Astra's U.S. sales of the drug fell 91 percent to $42 million, reflecting the toll taken by generic rivals.

In Arimidex's class of drugs, known as aromatase inhibitors, some 96 percent of prescriptions are generic, Davis said.

A major wrinkle in the Arimidex Direct program is that patients do not use their health insurance to get their pills, but pay out of pocket. AstraZeneca is contracting with Express Scripts Inc, a pharmacy benefit management company that mails the prescription to patients.

At $40 a month, the price is more than the usual $10 co-pay for generics, but less than insured patients would otherwise pay for the brand, which may only be available at close to the full price, according to Express Scripts.

Drugstore.com lists a one-month supply of Arimidex at $458.97 and anastrozole at $186.01.

"Given the seriousness of the condition, there may be individuals who are willing to pay $40 for the brand," said Everett Neville, chief trade relations officer Express Scripts. "That's completely different than you might see with some less emotionally charged conditions."

Aromatase inhibitors are used to treat breast cancer or help keep breast cancer from recurring after surgery, according to the American Cancer Society.

Davis said AstraZeneca started the program late last year, initially marketing it through brochures left in oncologists' offices and wanted to make sure it was working smoothly before publicizing it. About 300 patients are enrolled so far.

"This is a very emotional disease and it brings a lot of patient concerns," Davis added. "There is brand loyalty."

(Reporting By Lewis Krauskopf; editing by Andre Grenon)

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Ohio couple get 8 years each in son's cancer death

CLEVELAND (AP) — The parents of an 8-year-old boy who died from Hodgkin lymphoma after suffering for months from undiagnosed swollen glands were sentenced to eight years in prison Thursday following their guilty pleas to denying him medical treatment.

Attorneys for Monica Hussing, 37, and William Robinson Sr., 40, had said the parents had financial problems and tried to get checkups for their son but couldn't afford it.

The couple was given the maximum sentence by Cuyahoga County Judge Michael Astrab, who accepted their guilty pleas last month to attempted involuntary manslaughter in a last-minute plea deal before their trial was about to begin. They were handcuffed and taken into custody immediately. Both plan to appeal the sentence.

"I loved my son," Robinson told the judge, occasionally wiping his eyes with a tissue. He said he was sorry.

"I tried to help my son," Hussing said as family members in the courtroom quietly sobbed.

Hussing's sister, Shelia Slawinski, cried as she stood before the judge and gave voice to her nephew, Willie Robinson: "I am so in pain ... please take me to the doctor ... the last four weeks have been the most painful."

"I told my sister," Slawinski said. "I offered to help my sister."

According to the prosecution's pre-sentencing memo to the judge, at least eight family members noticed Willie's deteriorating health over a period of more than two years and most spoke to the couple about it. One relative described the boy's swollen neck glands as the size of a softball.

"Twenty-nine months he suffered," Slawinski said. "Twenty-nine months they had to do something and they chose not to."

Asked outside court why her sister hadn't taken care of Willie and hadn't enrolled him or three siblings in school, Slawinski said it was easier for Hussing to stay in bed during the day and do drugs. Both parents have abused drugs, their attorneys earlier told the judge.

Hussing's oldest daughter, Lillian, 18, defended her mother in court and said Willie was able to do the same things other 8-year-olds do. "He was able to play, go outside," she said.

The judge looked surprised and asked the teen if she would be willing to repeat her statements under oath and possible penalty of perjury. She did.

The judge compared the autopsy photo of Willie's emaciated body to concentration camp victims. "If anybody, anybody, didn't know this kid was sick, they are seriously, seriously disturbed," Astrab said.

Two doctors told the judge before the sentencing that no sick child would be turned away from a hospital.

Willie Robinson collapsed at his home on March 22, 2008. Prosecutors say he had begged his parents to take him to see a doctor but was rejected. Hodgkin lymphoma is a highly treatable cancer.

Lillian Hussing said earlier the family didn't have money for medical care when they lived in Warren, tried repeatedly to get help from social services and visited a free clinic but left when told they would have to pay $180.

The family soon moved to Cleveland and the boy died within weeks.

Prosecutors say that while the boy was suffering, the parents claimed financial hardship but paid $87 to have a pit bull treated for fleas. Hussing's defense attorney, John Luskin, said the dog belonged to Hussing's parents and her parents paid for the treatment.

Trumbull County Children Services says it had worked with the family to provide Willie health care, getting involved after receiving a phone call in July 2007. Agency officials said a case worker visited the family at least monthly and pushed the parents to have a medical follow-up on his swollen neck but they didn't.

However, Robinson's attorney Thomas Rein said previously that a social worker who visited the family in January 2008 "indicated the kids were healthy and happy." He said no one knew the boy had cancer until he died and an autopsy was performed.

And Lillian Hussing said a case worker had told the family the boy's lump looked like a swollen gland and to hold off until they could secure financial assistance before getting it checked.

About two weeks after they moved to Cleveland, she said, her brother came down with something. Her mother treated him with cold medicine and he died within three days.

She said the boy never complained about his neck.

"He played, he went outside, he wrestled, he played video games," the boy's sister said. "He was the happiest kid you could imagine. It never seemed like he was suffering."

The emotional aftermath from their son's death led the couple to split, according to Luskin.

The couple's four other children under 18 were placed in the custody of a family member. Luskin said Lillian Hussing, upon turning 18, decided to return to live with her mother.

Rein said Robinson agreed to plead guilty so his children could be spared any further grief and wouldn't have to suffer by testifying. Lillian Hussing said her mother took a plea bargain because of the uncertainty of a trial and fear she could be sent to prison for a long time.

As part of the deal, the prosecution agreed to drop four counts each against each parent, including child endangering. Prosecutors didn't agree to a sentence recommendation. Both Luskin and Rein had said they hoped the judge would consider probation.

"There's not a day my client ... starts without shedding a tear for his son," Rein said.

The coroner ruled that the boy was a victim of medical neglect and died from pneumonia due to Hodgkin lymphoma.

Hodgkin lymphoma is a highly treatable cancer, with as many as 95 percent of patients in early stages of the disease surviving for five years or more with treatment. It's one of the most common forms of cancers among children.

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FDA Thinks Shortage of Cancer Drug for Kids Can Be Averted

TUESDAY, Feb. 14 (HealthDay News) -- The U.S. Food and Drug Administration said Tuesday that it was cautiously optimistic that a feared shortage of a life-saving drug used to treat a form of childhood leukemia will be averted.

The drug, methotrexate, is used in combination with other drugs to combat acute lymphoblastic leukemia (ALL), which typically strikes children ages 2 to 5 and is the most common type of cancer in children.

Methotrexate is a linchpin in the treatment of children battling acute lymphoblastic leukemia. In high doses, the generic drug has been successful in curing patients and beneficial in preventing recurrence. Without the drug, a patient's chance for a cure is reduced while the risk of recurrence rises, oncologists report.

"We are seeing the [three] companies [that make methotrexate] respond to this shortage and they are planning on some very large releases, and we are planning on having the situation resolved," said Valerie Jensen, associate director of the FDA's drug shortage program.

"Right now, from what we are understanding from the companies, the releases will resolve these shortages. So we are watching this very closely," Jensen added. "We are expecting some good releases at the end of this month and continuing into March and beyond."

Oncologists are worried that supplies of methotrexate could be gone in as little as two weeks.

One of the three makers of methotrexate, Hospira Inc., based in Lake Forest, Ill., said Tuesday that it had increased production to "make up for the supply gap."

Thomas Moore, president of U.S. Hospira, said in a news release: "Hospira is doing everything it can to help bring more product to market. This includes working with the U.S. Food and Drug Administration to qualify a second supplier of the drug's active ingredient to enable increased production. Hospira believes that it can increase its supply to the market if it can secure additional methotrexate active ingredient supply."

The other two manufacturers are Mylan Inc., of Canonsburg, Penn., and Sandoz US Inc., of Princeton, N.J. Both said they are working to head off a shortage of the drug.

Mylan, in a Tuesday news release, said it has "ramped up its production in order to try to meet the resulting increased demand. We are working both on the manufacturing and regulatory fronts to expedite the FDA regulatory approvals necessary to further increase capacity to the extent possible to support the additional demand."

Dr. Elizabeth Raetz, an associate professor of pediatric hematology/oncology at NYU Langone Medical Center in New York City, said methotrexate is a "critical component of ALL therapy."

The concern is that there is a 90 percent chance for cure of acute lymphoblastic leukemia, but that's based on the total drug regimen including methotrexate, Raetz said. "There is a deep concern that if that key component is eliminated there would be a reduced chance for cure," she said.

There hasn't been a shortage of the drug at her hospital, Raetz noted, but many other hospitals across the country have reached a critical point, and some centers don't have any at all, she said.

Acute lymphoblastic leukemia is the most common type of cancer in children. It's a disease that affects white blood cells, which help to fight infections in the body. Blood cells are produced in bone marrow. But in leukemia patients, the bone marrow produces abnormal white blood cells, which crowd out healthy blood cells. In acute lymphoblastic leukemia, the excess white blood cells are called lymphocytes or lymphoblasts, according to the U.S. National Library of Medicine.

The potential shortage of methotrexate is just the latest in a series of drug shortages that have existed for several years.

In 2011, prescription drug shortages in the United States hit an all-time high. Last fall, some 200 drug shortages had been reported, compared to 178 in all of 2010, the FDA reported.

Many of the scarce drugs are injectables, such as cytarabine and cisplatin, used to treat serious conditions such as cancer. Some are only given in hospitals and are "absolutely critical," Jensen said during a news conference in late September.

More than half (54 percent) of shortages in 2010 were due to quality issues, such as sterility or drug impurities. Some were caused by delays or manufacturing capacity problems, while 11 percent were caused by discontinuation of a drug and 5 percent resulted from raw material shortages, Jensen said.

Jensen also said the shortages tend to occur in drugs that aren't "economically attractive." This could mean that only one company produces the drug, making it harder to find alternatives if the supply dries up.

A lot of the problems are tied to generic drugs, health experts explained, because few manufacturers make them and profit margins aren't as high as for drugs still under patent protection.

On Oct. 31, 2011, President Barack Obama signed an executive order designed to help ease the drug shortages. The order directed the FDA to "take action" to prevent and reduce the worsening prescription drug shortages.

Specifically, the order directed the FDA to take steps to require drug manufacturers to report any impending shortages or discontinuances six months ahead of the shortage. The agency should also speed up its review of new manufacturing sites, new suppliers and new manufacturing protocols, and also add more staff to its drug-shortage office, the order stated.

More information

For more on drug shortages, visit the U.S. Food and Drug Administration.

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Higher Cancer Rate Seen in Children With Juvenile Arthritis

MONDAY, Feb. 13 (HealthDay News) -- The cancer rate in children with juvenile arthritis is four times higher than in other children, a new study says.

This increased risk of cancer isn't necessarily linked to arthritis treatments, such as tumor necrosis factor (TNF) inhibitors, according to the study published online Feb. 13 in the journal Arthritis & Rheumatism.

In the United States, TNF inhibitors carry a "black box" warning about the potential cancer risk associated with the drugs.

In this study, the researchers analyzed 2000-2005 Medicaid data from more than 7,800 children with juvenile arthritis and comparison groups of about 650,000 children with asthma and nearly 322,000 children with attention-deficit hyperactivity disorder (ADHD).

The incidence rate of probable and highly probable cancers in children with juvenile arthritis was 4.4 times higher than in the other groups of children.

Juvenile idiopathic arthritis (JIA) in children is a general term covering different types of chronic arthritis. Symptoms, similar to adult arthritis, include joint pain, swelling, tenderness and stiffness.

"While our findings show children with [juvenile idiopathic arthritis] have a higher incidence of cancer compared to peers without JIA, the greater frequency of malignancy does not appear to be necessarily associated with treatment, including use of TNF inhibitors," concluded Dr. Timothy Beukelman, of the University of Alabama at Birmingham, in a journal news release.

"This highlights the critical importance of appropriate comparator groups when evaluating the safety of new medications. Further confirmation of our findings with large-scale and long-term investigation of the association between cancer and [juvenile arthritis] and its treatment is needed," he added.

Most of the children with juvenile arthritis in the study were treated with injections of etanercept, a soluable TNF-receptor blocker. Other anti-TNF drugs that work by different mechanisms may yield different results, Dr. Karen Onel and Dr. Kenan Onel from the University of Chicago noted in an accompanying journal editorial.

But, "By focusing on the possible cancer risk associated with the use of TNF inhibitors, the underlying cancer risk associated with [juvenile arthritis] may have been understated, and it is important to make patients, families and physicians aware of the possible late consequences of this disease," they added in the news release.

More information

The U.S. National Institute of Arthritis and Musculoskeletal and Skin Diseases has more about juvenile arthritis.

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No Cancer Benefit From Vitamin B, Omega-3 Supplements in Heart Patients

MONDAY, Feb. 13 (HealthDay News) -- Patients with a history of heart disease will most likely not reduce their risk for developing cancer by taking vitamin B and/or omega-3 fatty acid supplements, a new French analysis suggests.

"In the population we studied, we found no beneficial effects of either B vitamins or omega-3 fatty acids taken over five years on cancer occurrence or cancer-related death," noted study author Valentina Andreeva, who is with the nutritional epidemiology research unit at the University of Paris XIII in Bobigny, France.

Andreeva and her colleagues report their findings in the Feb. 13 online edition of the Archives of Internal Medicine.

To explore the protective potential of B vitamins and fatty acid supplements, the authors did a secondary analysis of data that had been collected in a previous study involving almost 2,000 French men and 500 women.

All were between 45 and 80 years of age, and all had experienced cardiac trouble (heart attack, unstable angina or ischemic stroke) in the year leading up to the start of the study.

In turn, the participants were divided into one of four different groups that consumed a daily supplement regimen involving various types of vitamin B and omega-3 fatty acids at "relatively low supplementation doses."

By the end of the original five-year study, 7 percent of the participants had gone on to develop some form of cancer, and just over 2 percent ultimately died of cancer. The vast majority of cancer cases (including prostate, lung, bladder and colorectal cancer) and deaths occurred among men (81 percent and 83 percent, respectively).

The team unearthed no evidence that any form of vitamin B or omega-3 fatty acid supplement improved cancer outcomes in any way.

The investigators noted that there were some indications that cancer risk might have actually gone up, specifically among women taking vitamin B and/or omega-3 fatty acid supplementation. However, the authors stressed that this observation was based on too few cases to substantiate a firm conclusion, and called for further research involving a larger pool of participants.

"The results of our study suggest that individuals should exercise caution when deciding to take dietary supplements, especially over a long period of time and without a physician's advice," advised Andreeva. "Such supplements constitute active substances and might have adverse effects in some populations. To be on the safe side, individuals should strive to achieve dietary recommendations via healthy, balanced diets."

Joseph Su, the Washington, D.C.-based program director of the division of cancer control and population science within the U.S. National Cancer Institute's epidemiology and genomics research program, said that nothing about the findings struck him as surprising.

"So far, study findings have been very inconsistent," he noted. "But most supplement studies, if anything, have shown no beneficial effect whatsoever. Just like this one. So, I don't think there's anything that can really back up the idea that these supplements can prevent cancer."

However, Vicky Stevens, strategic director of laboratory services at the American Cancer Society in Atlanta, expressed some reservations about the French analysis.

"Compared with other trials, they used much lower levels of supplements," she noted. "From the B-vitamin point of view, dramatically lower. So, it could be argued that they just weren't using high enough levels of supplements to see any effects," Stevens suggested.

"And they used a natural form of folate [vitamin B supplement], whereas other trials use a synthetic form," Stevens added. "But the real problem in being able to evaluate the effects they do see is that they don't have enough people. And it's not really a long enough follow-up period to really see an effect of these supplements on cancer onset. Five years isn't really enough. It can take 10 or 20 years in most cases. So, what they may be seeing is an effect on preexisting abnormalities, but not the impact on cancer onset itself."

Duffy MacKay, a naturopathic doctor and vice president of scientific and regulatory affairs for the Council for Responsible Nutrition in Washington, D.C., agreed.

"When you look at an intervention like this, you're definitely not looking at the role of the supplements at preventing tumors, because the tumors likely started well before the trial," he noted. "So really what the trial is about is giving vitamin B and omega 3 and seeing if they altered the outcome, the progression, of these cancers," MacKay explained.

"And with that you have to realize that cancer is a very complex multi-factorial disease," MacKay stressed. "And two supplements would never be expected to be a successful treatment on their own. I would say, however, that proper nutrition is one of your best allies in terms of wellness, period. And while no one ever claimed these were cancer drugs, if you will, supplements make sense, cancer or no cancer."

More information

For more on vitamins and cancer, visit the American Cancer Society.

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Aspirin could beat cancer spread: Australian study

Aspirin and other household drugs may inhibit the spread of cancer because they help shut down the chemical "highways" which feed tumours, Australian researchers said Tuesday.

Scientists at Melbourne's Peter MacCallum Cancer Centre said they have made a biological breakthrough helping explain how lymphatic vessels -- key to the transmission of tumours throughout the body -- respond to cancer.

"We've shown that molecules like the aspirin... could effectively work by reducing the dilation of these major vessels and thereby reducing the capacity of tumours to spread to distant sites," researcher Steven Stacker said.

Doctors have long suspected that non-steroidal anti-inflammatory drugs such as aspirin may help inhibit the spread of cancer but they have been unable to pinpoint exactly how this is done.

By studying cells in lymphatic vessels, the researchers found that a particular gene changed its expression in cancers which spread, but not when the cancer did not spread.

The results published in Cancer Cell journal reveal that the gene is a link between a tumour's growth and the cellular pathway which can cause inflammation and dilation of vessels throughout the body.

Once these lymphatic vessels widen, the capacity for them to act as "supply lines" to tumours and become more effective conduits for the cancer to spread is increased.

But aspirin acts to shut down the dilation of the vessels.

"So it seems like we have found a pivotal junction point in a biochemical sense between all these different contributors," Stacker said.

The discovery could lead to new and improved drugs which could help contain many solid tumours, including breast and prostate cancer, as well as potentially provide an "early warning system" before a tumour begins to spread.

Last year, a study published in medical journal The Lancet found that rates of cancer of the colon, prostate, lung, brain and throat were all reduced by daily aspirin use.

Many doctors recommend regular use of aspirin to lower the risk of heart attack, clot-related strokes and other blood flow problems. A downside of extended daily use is the risk of stomach problems.

mfc/mp/jms

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For pregnant women with cancer, chemo possible

LONDON (AP) — Researchers have encouraging news for women who find themselves in a very frightening situation: having cancer while pregnant. Studies suggest that these women can be treated almost the same as other cancer patients are, with minimal risk to the fetus.

Only about 1 in 1,000 pregnant women face this dilemma, but doctors fear that more will because the risk of cancer rises with age, and more women are delaying having children until they're older.

Doctors have long worried about how to balance treating a pregnant woman with cancer and the need to protect her fetus from the effects of toxic cancer drugs and radiation treatments, and whether it is safe to continue a pregnancy in certain situations. A series of papers in the journals Lancet and Lancet Oncology published Friday make several key contributions:

— A Belgian-led study of 70 children in Europe exposed to chemotherapy while they were in the womb found they developed just as well as other children, according to tests on their hearts, IQ and general health. They were assessed at birth, 18 months, and every few years until age 18.

— Chemotherapy after the first trimester is possible, using extra ultrasounds to ensure the baby is developing properly. Radiation therapy is best done in the first two trimesters, when the baby is small enough to be covered with a lead blanket, according to a review of previous studies, led by Belgian researchers.

— Ending the pregnancy doesn't improve chances for the mother, the same study found.

— The type of cancer seems to matter: An Israeli analysis of past research suggested pregnant women with blood cancers might want to terminate an early pregnancy when chemotherapy can't be delayed.

— Another review of previous studies by French and American researchers concluded doctors should aim to preserve pregnancy in women with cervical or ovarian cancers where possible.

"Many (doctors) aren't keen to give chemotherapy to pregnant women and may even recommend termination," said Dr. Frederic Amant of the Leuven Cancer Institute in Belgium, an author of two of the papers. "But treating a pregnant woman with cancer doesn't have to be so different from treating a cancer patient who isn't pregnant."

Amant, who led the study of 70 children, said most of the children with cognitive problems were born premature, and that was probably the primary cause of their delayed development.

"Doctors will often err on the side of caution and deliver a baby early to avoid the effects of chemotherapy," said Dr. Catherine Nelson-Piercy, an obstetric physician and spokeswoman for Britain's Royal College of Obstetricians and Gynaecologists.

"These data don't say that chemotherapy is completely safe, but the baby is better off being in (the mother) as long as possible," she said. Nelson-Piercy was not linked to the Lancet series and often works with pregnant women diagnosed with cancer or other illnesses.

Dr. Richard Theriault, a professor of medicine at the MD Anderson Cancer Center in Texas, said he hoped the papers would change how doctors treat pregnant cancer patients.

"Terminating a pregnancy is not always necessary," said Theriault, who heads a program to treat pregnant women with cancer. He said a minority of pregnant women with cancer still get abortions.

He said the placenta seems to act as a kind of filter for chemotherapy drugs, restricting their effects on the fetus. "There's the phenomenon of the bald mother who gives birth to a baby with a full head of hair," he said. "It seems to suggest not as much gets to the baby as we thought."

That was certainly Caroline Swain's experience, who was diagnosed with breast cancer while pregnant with her second son. She had her left breast and many lymph nodes removed and had to wait until her fetus was 12 weeks old before starting chemotherapy.

"I was just so grateful it was possible to have treatment and keep my baby," said Swain, 45, who lives near London. "I was scared that my child wouldn't remember me if something happened to me."

Her son Luke, now 9, weighed in at 7.4 pounds (3.35 kilograms) when he was born, only slightly lighter than his older brother Max a year earlier.

"We had celebrations all around when Luke came out absolutely fine," Swain said of her and her husband Rowland's relief at the birth. "Luke is no different from his brother," she said. "They both love Legos and X-Box."

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For pregnant women with cancer, chemo possible

LONDON (AP) — Researchers have encouraging news for women who find themselves in a very frightening situation: having cancer while pregnant. Studies suggest that these women can be treated almost the same as other cancer patients are, with minimal risk to the fetus.

Only about 1 in 1,000 pregnant women face this dilemma, but doctors fear that more will because the risk of cancer rises with age, and more women are delaying having children until they're older.

Doctors have long worried about how to balance treating a pregnant woman with cancer and the need to protect her fetus from the effects of toxic cancer drugs and radiation treatments, and whether it is safe to continue a pregnancy in certain situations. A series of papers in the journals Lancet and Lancet Oncology published Friday make several key contributions:

— A Belgian-led study of 70 children in Europe exposed to chemotherapy while they were in the womb found they developed just as well as other children, according to tests on their hearts, IQ and general health. They were assessed at birth, 18 months, and every few years until age 18.

— Chemotherapy after the first trimester is possible, using extra ultrasounds to ensure the baby is developing properly. Radiation therapy is best done in the first two trimesters, when the baby is small enough to be covered with a lead blanket, according to a review of previous studies, led by Belgian researchers.

— Ending the pregnancy doesn't improve chances for the mother, the same study found.

— The type of cancer seems to matter: An Israeli analysis of past research suggested pregnant women with blood cancers might want to terminate an early pregnancy when chemotherapy can't be delayed.

— Another review of previous studies by French and American researchers concluded doctors should aim to preserve pregnancy in women with cervical or ovarian cancers where possible.

"Many (doctors) aren't keen to give chemotherapy to pregnant women and may even recommend termination," said Dr. Frederic Amant of the Leuven Cancer Institute in Belgium, an author of two of the papers. "But treating a pregnant woman with cancer doesn't have to be so different from treating a cancer patient who isn't pregnant."

Amant, who led the study of 70 children, said most of the children with cognitive problems were born premature, and that was probably the primary cause of their delayed development.

"Doctors will often err on the side of caution and deliver a baby early to avoid the effects of chemotherapy," said Dr. Catherine Nelson-Piercy, an obstetric physician and spokeswoman for Britain's Royal College of Obstetricians and Gynaecologists.

"These data don't say that chemotherapy is completely safe, but the baby is better off being in (the mother) as long as possible," she said. Nelson-Piercy was not linked to the Lancet series and often works with pregnant women diagnosed with cancer or other illnesses.

Dr. Richard Theriault, a professor of medicine at the MD Anderson Cancer Center in Texas, said he hoped the papers would change how doctors treat pregnant cancer patients.

"Terminating a pregnancy is not always necessary," said Theriault, who heads a program to treat pregnant women with cancer. He said a minority of pregnant women with cancer still get abortions.

He said the placenta seems to act as a kind of filter for chemotherapy drugs, restricting their effects on the fetus. "There's the phenomenon of the bald mother who gives birth to a baby with a full head of hair," he said. "It seems to suggest not as much gets to the baby as we thought."

That was certainly Caroline Swain's experience, who was diagnosed with breast cancer while pregnant with her second son. She had her left breast and many lymph nodes removed and had to wait until her fetus was 12 weeks old before starting chemotherapy.

"I was just so grateful it was possible to have treatment and keep my baby," said Swain, 45, who lives near London. "I was scared that my child wouldn't remember me if something happened to me."

Her son Luke, now 9, weighed in at 7.4 pounds (3.35 kilograms) when he was born, only slightly lighter than his older brother Max a year earlier.

"We had celebrations all around when Luke came out absolutely fine," Swain said of her and her husband Rowland's relief at the birth. "Luke is no different from his brother," she said. "They both love Legos and X-Box."

View the original article here

Study on mice shows fasting weakens cancer

Early research on mice with cancer shows that fasting may weaken tumors and help chemotherapy work better, scientists said on Wednesday.

While it remains unknown if the same approach could work in humans, or if it would even be safe, researchers said the findings suggest a promising new route of study for improving response to cancer treatment.

In the mice experiments, "the combination of fasting cycles plus chemotherapy was either more or much more effective than chemo alone," said senior author Valter Longo, professor of gerontology and biological sciences at the University of Southern California (USC).

Longo and colleagues previously published findings in 2008 that showed how fasting protected normal cells against chemotherapy in a study that focused on one type of cancer and a single chemo drug.

The latest study expands on that research to show that fasting makes cancer cells more vulnerable, and spanned several different types of cancer in mice.

Types of cancers studied included breast cancer, melanoma, glioma and human neuroblastoma.

All cancers studied showed that fasting combined with chemotherapy improved survival, slowed the growth of tumors and/or limited their spread.

The study appears in the journal Science Translational Medicine.

"We don't know whether in humans it's effective," Longo said, adding that for now fasting should be "off-limits" to cancer patients, although they should feel they can ask their doctors about the possibility.

In 2010, a small study of 10 human cancer patients who tried fasting cycles with their drug treatment showed that they perceived fewer side effects from chemo, according to self-reported data. The study was published in the journal Aging.

The results of a phase 1 trial assessing the safety of fasting two days before and one day after chemotherapy in patients with breast, urinary tract and ovarian cancer, conducted at the USC, have been submitted for presentation at the annual meeting of the American Society of Cancer Oncologists later this year.

"A way to beat cancer cells may not be to try to find drugs that kill them specifically but to confuse them by generating extreme environments, such as fasting that only normal cells can quickly respond to," Longo said.

ksh/rl

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Marc Garnick Answers Six Key Questions About Prostate Cancer

The latest findings about the ineffectiveness of PSA testing to screen for prostate cancer has confused many men--and their loved ones. On the one hand is the seeming chance to catch cancer early. On the other hand is the growing realization that many prostate tumors grow so slowly that they will never cause a problem in an individual's lifetime.

After closely examining all the latest data, investigators from the U.S. Preventive Services Task Force concluded in 2011 that the PSA test holds little or no value as a screening test for most healthy men.

Dr. Marc Garnick explored the pros and cons of PSA screening in a feature article in the February 2012 issue of Scientific American entitled "The Great Prostate Debate: Does Screening Save Lives?" [preview]. After writing the article, Garnick, who is a prostate cancer expert and medical oncologist at  of Harvard Medical school and Beth Israel Medical Center in Boston, agreed to speak at greater length with senior editor Christine Gorman about the following questions in the prostate cancer field.

Q: Why are medical experts questioning the value of the PSA test to screen for prostate cancer?

In 2009, two very important studies—one from Europe and one from the United States—were published that looked at whether PSA screening saved lives. "The striking thing of these studies, which included tens of thousands of individuals, was that there was no difference in the overall survival of those men who were tested, biopsied, diagnosed with cancer and then treated compared to the control population who were not offered the testing whatsoever," Garnick says.

Listen to more of Dr. Garnick's answer about why the PSA test has come under fire for prostate cancer screening:

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Q: So if you could summarize, you're saying that you don't live any longer if you get screened with the PSA test and you're subjecting yourself to really bad side effects from treatments for prostate cancer?

"That's the public health policy perspective," Garnick says. "It's obviously more difficult when you have the individual patient sitting in your office--especially a patient with a strong family history of the disease in whom perhaps their brother had the disease, their father may have had the disease and passed away from it."

Listen to Dr. Garnick explain what individuals with a family history of prostate cancer should know about the PSA test:

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Q: What is the difference between a PSA test for screening and one used after a prostate cancer diagnosis?

"The PSA test for screening says, 'Yes, your value may be elevated but we don't know yet, short of doing a biopsy, whether or not you do or do not have prostate cancer.' In a patient who has an established diagnosis of prostate cancer, the PSA is very useful," Garnick explains. "So, for example, if a patient has prostate cancer and they're treated for their cancer and the patient, for example, is treated with a radical prostatectomy in which the cancer is thought to be confined to the prostate gland, surgical removal of the prostate gland should actually result in an undetectable PSA value . . . If it's not undetectable either not all the cancer was removed or there may actually be metastatic cancer that has already spread that is causing the PSA not to come down back to an undetectable level."

Listen to more of Dr. Garnick's explanation of how a PSA test can be helpful after the diagnosis of cancer.

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Q: What is the latest thinking about what to do with a Gleason score in the middle zones?

Garnick says, "the majority of cancers that we see today are Gleason 3+3s. The other cancers are Gleason 7s (3+4 or 4+3). And then we have a group of very high-risk cancers that we call Gleeson 8 to 10 cancers, which are in general are Gleason 4+4 or 4+5 or 5+4. Those are very aggressive, what we call high-grade cancers.

"The problem is trying to distinguish what the biological behavior of a Gleason 6 cancer and a Gleason 7 cancer is going to be. A Gleeson 3+4 or a 3+3 are the real enigmas because those cancers can bifurcate into being cancers that will never cause problems in the patient's lifetime to cancers, which are going to problems months to years after being diagnosed.

"We don't really have right now a good set of molecular markers or other biomarkers that help us predict which type of behavior an individual patient's cancer is likely to experience."

Listen to Dr. Garnick discuss the Gleason score in greater depth.

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Q: What are the options if you want to get screened with a PSA test for prostate cancer but are still concerned about the potential side effects of treatment?

"The criticism has been that we're over-diagnosing prostate cancer," Garnick says. "I actually think we're not necessarily over-diagnosing prostate cancer, we're actually over-treating prostate cancer . . .

"The recent National Institutes [of Health] consensus conference took a look at these low-grade or low-risk prostate cancers and actually recommended that we more strongly consider active surveillance in a lot of these men who otherwise would have been treated and suffer the potential consequences of therapy."

Listen to Dr. Garnick explain in greater detail what active surveillance is all about.

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Q: What does the future look like for men with advanced cases of prostate cancer?

"This is actually one of the most exciting areas in prostate cancer biology," Garnick says. Over the past 30 years, "We've come from orchietctomy, which is surgical removal of the testicles, to estrogen therapy to the use of LHRH analogues—such as lupron and the anti-androgens—to first- and second-line chemotherapy to second-line hormonal therapy to immune therapy to agents that help bone health."

Listen to Dr. Garnick talk about results using recently approved drugs such as docetaxel, cabizitaxel and abiraterone, as well as some of the latest research on experimental medications like MET inhibitors and immune therapy for advanced prostate cancer. 

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Fasting Plus Chemo May Help in Cancer Fight: Study

WEDNESDAY, Feb. 8 (HealthDay News) -- Fasting, especially when combined with chemotherapy, appears to slow the growth of cancerous tumors in mice, new research suggests.

Experts note that the results of animal studies often don't hold up when tried in humans.

However, researchers have started testing whether fasting can help human patients with breast, ovarian and urinary tract cancer.

In the mouse study, published in the current issue of Science Translational Medicine, researchers found that fasting slowed the growth of growth of breast cancer, melanoma, glioma and human neuroblastoma in mice.

In some cases, fasting was as effective as chemotherapy, according to the study.

"The combination of fasting cycles plus chemotherapy was either more or much more effective than chemo alone," senior study author Valter Longo, a professor of gerontology and biological sciences at the University of Southern California, said in a university news release.

Researchers said that normal cells deprived of nutrients during fasting enter a dormant state, whereas when studied in the lab, a type of cancer cell attempted to keep growing and dividing.

That, in turn, led to a "cascade of events" that damaged the cancer cells' DNA and led to cell death.

"A way to beat cancer cells may not be to try to find drugs that kill them specifically but to confuse them by generating extreme environments, such as fasting, that only normal cells can quickly respond to," Longo concluded.

The study authors noted that results from the initial phase of a clinical trial, which involved patients with breast, urinary tract and ovarian cancer conducted at the USC Norris Comprehensive Cancer Center, have been submitted for presentation at the annual meeting of the American Society of Cancer Oncologists. This trial tested the safety of short-term fasts two days before and one day after chemotherapy.

"We don't know whether in humans it's effective," Longo said. "It should be off limits to patients, but a patient should be able to go to their oncologist and say, 'What about fasting with chemotherapy or without' if chemotherapy was not recommended or considered?"

The researchers warned that fasting may not be safe for all cancer patients, particularly those who have already lost a significant amount of weight or have other conditions, such as diabetes. They added that fasting can cause headaches and a drop in blood pressure. The study also pointed out that cancer-free survival resulting from fasting may not extend to large tumors.

According to the American Cancer Society, "available scientific evidence does not support claims that fasting is effective for preventing or treating cancer. Even a short-term fast can have negative health effects, while fasting for a longer time could cause serious health problems."

More information

The American Cancer Society provides more information on fasting and cancer.

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