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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Study: Colonoscopy cuts colon cancer death risk

LOS ANGELES (AP) — Millions of people have endured a colonoscopy, believing the dreaded exam may help keep them from dying of colon cancer. For the first time, a major study offers clear evidence that it does.

Removing precancerous growths spotted during the test can cut the risk of dying from colon cancer in half, the study suggests. Doctors have long assumed a benefit, but research hasn't shown before that removing polyps would improve survival — the key measure of any cancer screening's worth.

Some people skip the test because of the unpleasant steps need to get ready for it.

"Sure, it's a pain in the neck. People complain to me all the time, 'It's horrible. It's terrible,'" said Dr. Sidney Winawer, a gastroenterologist at Memorial Sloan-Kettering Cancer Center in New York who helped lead the study. "But look at the alternative."

A second study in Europe found that colonoscopies did a better job of finding polyps than another common screening tool — tests that look for blood in stool. Both studies were published in Thursday's New England Journal of Medicine.

Colorectal cancer is the second leading cause of cancer death in the United States and the fourth worldwide. More than 143,000 new cases of cancers of the colon or rectum are expected in the U.S. this year and nearly 52,000 people will die from it, according to the American Cancer Society.

Deaths from colorectal cancer have been declining for more than two decades, mostly because of screening including colonoscopies and other tests, the organization says. People of average risk of colon cancer ages 50 to 75 should get screened, but only about half in the U.S. do.

A government-appointed panel of experts recommends one of three methods: annual stool blood tests; a sigmoidoscopy (scope exam of the lower bowel) every five years, plus stool tests every three years; or a colonoscopy once a decade.

In a colonoscopy, a thin, flexible tube with a tiny camera is guided through the large intestine. Growths can be snipped off and checked for cancer. Patients are sedated, but many dread the test because it requires patients to eat a modified diet and drink solutions the day before to clear out the bowel. It usually costs more than $1,000, compared with a $20 stool test.

Researchers at Sloan-Kettering previously showed that removing polyps during colonoscopy can prevent colon cancer from developing, but it was not clear whether it saved lives.

The new study followed 2,602 patients who had precancerous growths removed during colonoscopies for an average of 15 years. Their risk of dying from colon cancer was 53 percent lower than what would be expected among a similar group in the general population — 12 patients followed in the study died, versus 25 estimated deaths in the general population.

The study was not a randomized trial that's the gold standard in medical research. But Robert Smith, director of screening at the American Cancer Society, said it's the first direct evidence that removing polyps can reduce the risk of colon cancer death.

"There's no question that these are findings that we can take to the bank," said Smith, who had no role in the research.

The National Cancer Institute and several cancer organizations paid for the study.

Government and private cancer groups also funded the second study in the journal, led by researchers in Spain. About 53,000 participants were given a colonoscopy or a stool blood test. Both tests found similar numbers of colon cancer cases — about 30 in each group.

However, colonoscopies found advanced growths in twice as many people — 514 versus 231 of those given the stool test. Colonoscopy also found 10 times more people with less serious growths than the stool test did.

Neither test proved very appealing — only a quarter of patients offered a colonoscopy had one. Similarly, only a third agreed to the offered stool test.

The Spanish study is continuing and similar research in the U.S. and Norway that began recently is looking at the long-term impacts of colonoscopy.

Stephen Raquet, of Mount Kisco, N.Y., finds the test reassuring even if the preparation is unpleasant. He had his first colonoscopy 13 years ago at age 41, earlier than usual because of a family history of colon cancer.

The sudden death of his 45-year-old sister from the disease prompted Raquet to get checked out. He had a precancerous growth removed at Memorial Sloan-Kettering in 1999, and has had the test every three years since.

During his last appointment four months ago, doctors said he can come back in five years.

"It's given me peace of mind," said the 54-year-old business executive.

__

Online:

Guidelines: http://www.uspreventiveservicestaskforce.org/uspstf/uspscolo.htm

___

Follow Alicia Chang's coverage at http://www.twitter.com/SciWriAlicia

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Colon cancer study backs blood stool screening test

NEW YORK (Reuters Health) - Although colon cancer screening is recommended by many organizations, less clear is which method is best to detect tumors and precancerous lesions. A new study in the New England Journal of Medicine suggests that a relatively inexpensive and non-invasive test may be just as effective as a colonoscopy.

Meanwhile, a 23-year study, also published in the journal, has confirmed that removing precancerous polyps, known as adenomas, during a colonoscopy can reduce the risk of death from colorectal cancer by half.

In an editorial in the Journal, Dr. Michael Bretthauer of Oslo University Hospital and Dr. Mette Kalager of Telemark Hospital, both in Norway, said that based on the results, "an appealing concept would be to use colonoscopy as a triage screening test, offering it once for everybody at 60 years of age" and using it to classify people into high- and low-risk categories. Low-risk people would not need further screening while those with adenomas would be evaluated regularly.

One in 20 Americans will develop colorectal cancer. About 140,000 cases are diagnosed in the United States each year, resulting in about 49,000 deaths, according to the National Cancer Institute. It is the third most common cancer worldwide.

Currently, the U.S. Preventive Services Task Force, a government-backed agency, recommends screening for people age 50 to 75 years by one of three methods: a colonoscopy every 10 years; annual stool testing; or a less-thorough look into the colon (known as flexible sigmoidoscopy) every five years in conjunction with stool testing every two to three years.

People often find the tests unpleasant, however.

For example, in the new study that compared stool testing with colonoscopy, only 34 percent went along with stool testing. The participation rate was even lower when colonoscopy was offered, even though doctors can use it to cut away those suspicious precancerous adenomas.

In theory, adenoma removal saves lives by preventing a tumor. Ann Zauber of the Memorial Sloan-Kettering Cancer Center in New York, chief author of the long-term evaluation of polyp removal, and her colleagues said their work demonstrates that.

"This study is showing both a reduction in colon cancer incidence and colon cancer deaths by removing the adenomas, and it's a long-term effect" she told Reuters Health in a telephone interview. "This is reassuring for people to come in for screening."

The conclusion is based on people who were sent for a colonoscopy between 1980 and 1990. The Zauber team compared their death rate to the estimated death rate from the Surveillance Epidemiology and End Results (SEER) program.

Over a period as long as 23 years, the rate from colorectal cancer among the 2,602 people who originally had adenomas removed was 53 percent lower than estimated from the SEER data. In all, 12 died from cancer in the removal group, while 25 had normally been expected to die of colorectal disease.

The lower rate includes the fact that 81 percent of the patients who had polyps removed continued to have periodic colonoscopies to check for growths.

Bretthauer and Kalager cautioned in their editorial that "the study mimics a situation in which 100 percent of the population complies with screening, which is not a real-life scenario."

CHEAPER, LESS INVASIVE TEST PERFORMS WELL

The COLONPREV study, being conducted in Spain, is designed to compare 10-year death rates in two groups: volunteers who received a one-time colonoscopy and volunteers who are being screened every two years using fecal immunochemical testing (FIT), a form of blood stool testing. A positive FIT test led to a colonoscopy.

After the first round of testing, the researchers report in the New England Journal of Medicine, colorectal cancer was found in 30 people in the 26,703-member colonoscopy group and 33 in the 26,599-person FIT group.

Colonoscopy uncovered twice as many advanced adenomas, about two percent of the sample vs. one percent.

But the chief author of the Spanish study, Enrique Quintero of Hospital Universitario de Canarias, told Reuters Health by phone that it was encouraging that the cheaper fecal test "detected half the advanced adenomas just in the first round."

The next round of FIT tests will uncover more growths, he predicted.

Death rates will not be examined until the 10-year followup is completed in 2021.

Quintero and his team also found that the people assigned to the FIT group were more likely to participate in screening than those who were in line for a colonoscopy.

The participation rates were 34 percent with the stool-sampling test compared to 25 percent for colonoscopy.

At this point in the study, the researchers concluded, "the numbers of subjects who needed to be screened to find one colorectal cancer were 191 in the colonoscopy group and 281 in the FIT group, and the numbers who needed to be screened to find any advanced (cancer) were 10 and 36."

That's important when the FIT test is so much cheaper than a colonoscopy, Quintero said. "This simple, non-invasive and cheap test is equally good at detecting colorectal cancer and identifying the high-risk individual that should undergo a colonoscopy."

And the complication rate, including bleeding, low blood pressure and slow heartbeat, was nearly five times higher in the colonoscopy group.

SOURCES: http://bit.ly/xJBNxg and http://bit.ly/xPLSv4 New England Journal of Medicine, February 23, 2012.

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Colon cancer study backs blood stool screening test

NEW YORK (Reuters Health) - Although colon cancer screening is recommended by many organizations, less clear is which method is best to detect tumors and precancerous lesions. A new study in the New England Journal of Medicine suggests that a relatively inexpensive and non-invasive test may be just as effective as a colonoscopy.

Meanwhile, a 23-year study, also published in the journal, has confirmed that removing precancerous polyps, known as adenomas, during a colonoscopy can reduce the risk of death from colorectal cancer by half.

In an editorial in the Journal, Dr. Michael Bretthauer of Oslo University Hospital and Dr. Mette Kalager of Telemark Hospital, both in Norway, said that based on the results, "an appealing concept would be to use colonoscopy as a triage screening test, offering it once for everybody at 60 years of age" and using it to classify people into high- and low-risk categories. Low-risk people would not need further screening while those with adenomas would be evaluated regularly.

One in 20 Americans will develop colorectal cancer. About 140,000 cases are diagnosed in the United States each year, resulting in about 49,000 deaths, according to the National Cancer Institute. It is the third most common cancer worldwide.

Currently, the U.S. Preventive Services Task Force, a government-backed agency, recommends screening for people age 50 to 75 years by one of three methods: a colonoscopy every 10 years; annual stool testing; or a less-thorough look into the colon (known as flexible sigmoidoscopy) every five years in conjunction with stool testing every two to three years.

People often find the tests unpleasant, however.

For example, in the new study that compared stool testing with colonoscopy, only 34 percent went along with stool testing. The participation rate was even lower when colonoscopy was offered, even though doctors can use it to cut away those suspicious precancerous adenomas.

In theory, adenoma removal saves lives by preventing a tumor. Ann Zauber of the Memorial Sloan-Kettering Cancer Center in New York, chief author of the long-term evaluation of polyp removal, and her colleagues said their work demonstrates that.

"This study is showing both a reduction in colon cancer incidence and colon cancer deaths by removing the adenomas, and it's a long-term effect" she told Reuters Health in a telephone interview. "This is reassuring for people to come in for screening."

The conclusion is based on people who were sent for a colonoscopy between 1980 and 1990. The Zauber team compared their death rate to the estimated death rate from the Surveillance Epidemiology and End Results (SEER) program.

Over a period as long as 23 years, the rate from colorectal cancer among the 2,602 people who originally had adenomas removed was 53 percent lower than estimated from the SEER data. In all, 12 died from cancer in the removal group, while 25 had normally been expected to die of colorectal disease.

The lower rate includes the fact that 81 percent of the patients who had polyps removed continued to have periodic colonoscopies to check for growths.

Bretthauer and Kalager cautioned in their editorial that "the study mimics a situation in which 100 percent of the population complies with screening, which is not a real-life scenario."

CHEAPER, LESS INVASIVE TEST PERFORMS WELL

The COLONPREV study, being conducted in Spain, is designed to compare 10-year death rates in two groups: volunteers who received a one-time colonoscopy and volunteers who are being screened every two years using fecal immunochemical testing (FIT), a form of blood stool testing. A positive FIT test led to a colonoscopy.

After the first round of testing, the researchers report in the New England Journal of Medicine, colorectal cancer was found in 30 people in the 26,703-member colonoscopy group and 33 in the 26,599-person FIT group.

Colonoscopy uncovered twice as many advanced adenomas, about two percent of the sample vs. one percent.

But the chief author of the Spanish study, Enrique Quintero of Hospital Universitario de Canarias, told Reuters Health by phone that it was encouraging that the cheaper fecal test "detected half the advanced adenomas just in the first round."

The next round of FIT tests will uncover more growths, he predicted.

Death rates will not be examined until the 10-year followup is completed in 2021.

Quintero and his team also found that the people assigned to the FIT group were more likely to participate in screening than those who were in line for a colonoscopy.

The participation rates were 34 percent with the stool-sampling test compared to 25 percent for colonoscopy.

At this point in the study, the researchers concluded, "the numbers of subjects who needed to be screened to find one colorectal cancer were 191 in the colonoscopy group and 281 in the FIT group, and the numbers who needed to be screened to find any advanced (cancer) were 10 and 36."

That's important when the FIT test is so much cheaper than a colonoscopy, Quintero said. "This simple, non-invasive and cheap test is equally good at detecting colorectal cancer and identifying the high-risk individual that should undergo a colonoscopy."

And the complication rate, including bleeding, low blood pressure and slow heartbeat, was nearly five times higher in the colonoscopy group.

SOURCES: http://bit.ly/xJBNxg and http://bit.ly/xPLSv4 New England Journal of Medicine, February 23, 2012.

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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

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My battle with breast cancer: Reconstruction after mastectomy

I am currently undergoing breast reconstruction after my mastectomy. In January 2012, my left breast was removed. I opted for a mastectomy over a lumpectomy for cosmetic reasons. My plastic surgeon said that I would achieve better cosmetic results this way. Is reconstruction an option for every woman?

The law

The Women's Health and Cancer Rights Act of 1998 (WHCR) states that if you undergo a mastectomy for any reason and your health insurance covers the procedure, then the insurance company must cover the cost of breast reconstruction. Any deductibles and co-payments still apply. The insurance company must also cover the cost of a prosthesis--if you choose to use one instead of having reconstructive surgery. Some insurance companies will cover both--check your policy or call for specific mastectomy and reconstruction benefits.

If you are on Medicaid or Medicare, there may be some limitations. Certain government sponsored insurance policies and some church based insurance policies are exempt from the WHCR. Most individual policies, employer-based policies and COBRA policies must abide by WHCR.

Reconstruction options

Deciding to have breast reconstruction is a very personal decision. Some women want immediate results and opt for a tram-flap or other reconstruction technique using body tissue. Any type of flap surgery involves removing fat, skin and sometimes muscle from one area of the body--like the abdomen or buttocks--and using that tissue to reconstruct the breast. Flap surgery is complicated and has risks, including possible necrosis of the transplanted tissue due to flap failure.

Implants are another option. I decided on implants after doing a lot of research. The recovery time and length of surgery a flap required did not appeal to me. With implants, immediate reconstruction is sort of a misnomer. For me, it meant tissue expanders were put in place during my mastectomy. I will have 10 weekly sessions to fill the expanders. After that, the expanders will be exchanged for implants.

Deciding not to reconstruct is another option many women decide on. Instead of having breasts reconstructed, a prosthesis is used. Special bras have pockets to hold the prosthesis in place. I am currently using a soft, foam and fiber-filled prosthesis until it is time for my expander exchange. Instead of a special bra, I use one from Victoria's Secret that has foam cups. Even under snug fitting shirts, you cannot tell unless you are looking for it. If you choose to go the prosthesis route, explore all of your options. Amazing results can be achieved with the use of silicon or other materials. Some breast prosthesis actually glue on. Specialized prosthesis for swimwear can be worn in the water.

The decision to reconstruct does not have to be made immediately. It is OK to wait until after adjuvent treatments are completed to make this decision. Breast cancer patients requiring radiation therapy or chemotherapy may want to postpone the decision to reconstruct until after they recuperate both physically and emotionally from the treatments. The best time to reconstruct is after you have researched your options and are comfortable with what you want to do.

More from Yahoo! Contributor Network

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Factbox: Leaders treated for cancer

(Reuters) - Venezuela's Hugo Chavez said he will undergo another operation in Cuba in the coming days, months after surgeons removed a large cancerous tumor.

Here are details of some world leaders who have had cancer while in office.

* VENEZUELA'S CHAVEZ:

- The 57-year-old socialist president declared himself free of cancer in October, four months after surgery to remove a malignant tumor from his pelvis.

He is due to return to Cuba for a new operation to remove a small lesion in the same place where the tumor was removed. Doctors have not disclosed the type of cancer he suffered from.

* PARAGUAY'S FERNANDO LUGO:

- Lugo was diagnosed in August 2010 with non-Hodgkin's lymphoma, a cancer that originates in the lymphatic system, the disease-fighting network throughout the body. The president underwent four months of chemotherapy and the cancer is in remission.

* BRAZIL'S LUIZ INACIO LULA DA SILVA:

- Brazil's popular former president, Luiz Inacio Lula da Silva, 66, was hospitalized this month for exhaustion resulting from chemotherapy, complicating his swift recovery from throat cancer and casting doubts on when he might return to political life.

Lula led the country between 2003 and 2010, a period of robust economic growth in which more than 20 million Brazilians were lifted out of poverty and joined the middle class.

* BARBADOS' DAVID THOMPSON:

- Thompson was diagnosed in Sept 2010 with pancreatic cancer, an often fatal illness. The prime minister received medical treatment in the United States but died in October 2010. He was 48.

* CZECH REPUBLIC'S VACLAV HAVEL:

- Vaclav Havel, a heavy smoker, had surgery in 1996 to remove part of his cancerous right lung. He was re-elected president two years later and stepped down in 2003 at the conclusion of his term. Havel died last December.

* FRANCE'S FRANCOIS MITTERRAND:

- Mitterrand was diagnosed with cancer not long after being elected president in 1981. He did not reveal the information until after an operation in 1992. In 1994 Mitterrand underwent a second prostate operation followed by chemotherapy. He said he would resign if the pain became overwhelming.

Although forced to reduce his activities from September 1992 and very weak in his last nine months in office, Mitterrand remained in full possession of his mental faculties. He completed two seven-year terms in office to become France's longest-serving president.

* UNITED STATES' RONALD REAGAN:

- In 1985, Reagan underwent surgery to remove cancerous polyps from his colon. This caused the first-ever invocation of the acting president clause of the U.S. Constitution's 25th Amendment. The surgery lasted just under three hours and Reagan resumed the powers of the presidency later that day.

In August 1985, he underwent an operation to remove skin cancer cells from his nose. In October, more skin cancer cells that were detected on his nose were removed. Reagan completed two four-year terms in office in 1989 and died in 2004.

* IRAN'S SHAH MOHAMMAD REZA PAHLAVI:

- Rioting prompted the shah to leave Iran in January 1979. Gravely ill, he sought refuge abroad and later was treated for lymphatic cancer in the United States. The shah died in exile in Egypt in July 1980. Exiled cleric Ayatollah Ruhollah Khomeini returned to Iran in triumph.

* FRANCE'S GEORGES POMPIDOU:

- In April 1974, Pompidou died in office of a rare form of cancer called Waldenstrom macroglobulinemia. His death was a shock to the public, who had been told the president was suffering from recurrent bouts of flu. Pompidou died in an era when talk of the president's health was taboo.

(Sources: Reuters/www.britannica.com) (Reporting by David Cutler, London Editorial Reference Unit)

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Researchers Spot New Gene Mutation Linked to Breast Cancer

A new drug to treat advanced skin cancer, or metastatic melanoma, has been shown to nearly double average survival time in a study of more than 130 patients, researchers said Wednesday.

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FDA acts to stem shortages of two cancer drugs

SILVER SPRING, Maryland (Reuters) - The U.S. Food and Drug Administration said it will resolve a potentially life-threatening shortage of two leading cancer drugs by allowing one of them to be imported from abroad and rushing approval for a new manufacturer to make the second.

The moves announced on Tuesday mark the latest government effort to address severe drug shortages. More than 200 medicines were in short supply in 2011 and doctors and patient advocates say the crisis has forced providers to postpone care or use second-best or costlier alternatives.

The FDA will allow imports of an alternative to the cancer drug Doxil, which in the next few weeks should meet all patient needs, the agency said. The drug is called Lipodox and has the same active ingredient as Doxil, doxorubicin.

Late on Friday, the FDA also approved a new company, APP Pharmaceuticals, to make preservative-free methotrexate, a drug used to treat children with leukemia. APP is a unit of German healthcare group Fresenius.

"We believe we can meet the needs of patients on a continuing basis," FDA Commissioner Margaret Hamburg said at a news conference. "This should resolve the shortages."

Doxil, a cancer drug marketed by Johnson & Johnson, has been in persistent short supply since manufacturing problems surfaced at a plant of Ben Venue, a unit of German drugmaker Boehringer Ingelheim that has been making the drug under contract.

The injectable drug, which has annual global sales of about $500 million, is used to treat ovarian cancer and multiple myeloma. About 7,000 patients used the drug in the United States before Johnson & Johnson announced a possible supply disruption last June. The company said in January it was able to allocate the drug to 4,400 patients.

The FDA said it reached a limited, temporary arrangement to import Lipodox from Indian drugmaker Sun Pharmaceutical Industries Ltd and its distribution subsidiary, Caraco Pharmaceutical Laboratories Ltd.

Ben Venue's problems have also contributed to a shortage of methotrexate, leading U.S. lawmakers to call for action last week from the FDA and manufacturers amid fears U.S. medical practices were close to running out of the drug entirely within a few weeks.

The medicine has been on the shortage list since last year. It helps treat about 3,500 children a year with acute lymphoblastic leukemia and has cure rates close to 90 percent.

In response, Ben Venue also said last week it would release reserves of methotrexate made before it shut down the plant last November.

MORE TO DO

President Barack Obama made shortages a national priority with an executive order in October and the FDA said it has prevented 114 shortages since then, mainly by working with manufacturers.

The FDA has said the number of drugs in short supply, which include cancer, anesthesiology and nutrition medications, had risen to 220 in 2011 from 56 in 2006 - the year a clear trend started emerging. Many of the drugs are generic, sterile injectable medications.

FDA officials say a number of industry factors have created the shortages, including a consolidation of generic drugmakers, manufacturing problems that have shut down plants or production lines and the decision by some manufacturers to stop producing a treatment when profit margins erode too far.

Patient advocates and doctors who also spoke at the FDA said helping patients who need Doxil and methotrexate was a positive step, but does not address the needs of others whose treatments remain in short supply.

They called for longer-term action that could prevent drug shortages.

"It's a shame to have to put our children at risk to bring attention to this problem," said Dr. Peter Adamson, chair of the Children's Oncology Group.

"While today was good news, the fact is that the (drug shortages) list is not getting smaller, and may be growing."

Adamson also called on Congress to speed passage of legislation that could help address the issue of shortages by forcing manufacturers to notify the FDA about looming supply disruptions. Now, by law companies only have to tell the agency they are stopping supply when they are the only maker of a drug.

The legislation has been stuck in a divided Congress for more than a year, despite support from both political parties.

The agency said it will also release guidelines for manufacturers to inform the FDA about looming shortages, as early notification can help prevent them.

Sandy Kweder, the deputy director of the FDA's Office of New Drugs, said the agency began working on increasing supply of methotrexate last year, since they became aware of persistent issues at the Ben Venue plant.

The FDA said in September 2011 that it sped up the application from APP for methotrexate, which had been languishing in the FDA's overcrowded waiting list for generic applications since August 2010.

It also asked to ramp up production at other makers of methotrexate: Hospira Inc, Mylan Inc and Sandoz, a unit of Novartis.

Hospira said it shipped 31,000 vials of methotrexate in the last 24 hours, which represent a month's worth of demand in the United States. Hospira CEO Michael Ball also said the company would be releasing another 34,000 units next week and 55,000 units in mid-March, all produced at its plant in Australia.

(Reporting by Anna Yukhananov in Washington; editing by Lisa Von Ahn, Gerald E. McCormick and Andre Grenon)

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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

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Female Cancer Survivors Report Worse Health Habits: Survey

MONDAY, Feb. 20 (HealthDay News) -- Female cancer survivors are more likely to smoke and have other unhealthy behaviors than women who have never had cancer, a new study finds.

Researchers compared nearly 20,000 women ageD 35 and older with no history of cancer to more than 2,700 female cancer survivors. Both groups were undergoing mammography screening for breast cancer.

Cancer survivors aged 30 to 49 had higher rates of smoking than women with no cancer history. Cancer survivors were also less likely to engage in strenuous exercise, and were more likely to rate their health as "poor."

Cancer survivors were less likely, however, to drink alcohol at least once a month.

Body-mass index (a measure of body fat based on a person's height and weight) did not differ between the two groups, but cancer survivors reported less weight gain than the noncancer group over the previous five years, according to study author Sarah Rausch, a clinical psychologist and director of integrative medicine at the Moffitt Cancer Center in Tampa, Fla., and her colleagues.

The study was published in a recent issue of the American Journal of Clinical Oncology.

It's possible that women who have survived cancer could benefit from programs to encourage them to adopt healthier habits, the researchers said.

"The differences in health behaviors between cancer survivors and those with no cancer history afford a 'teachable moment' in which a cancer survivor may be motivated to change behaviors to promote a healthier lifestyle and prevent cancer recurrence," Rausch said in a Moffitt news release.

"As the population of cancer survivors increases, the importance of health status and quality of life of cancer survivors is even more critical," Rausch said. "Approximately 10.5 million people in the United States have been diagnosed with cancer. Because of the progress in cancer diagnosis and treatment, there is a growing population of cancer survivors."

More information

The U.S. National Cancer Institute has more about cancer survivorship.

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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.

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7 reasons breast cancer survivors shouldn’t be afraid of menopause

I've watched the breast cancer struggle of a close friend over the past few years. She was diagnosed with breast cancer in her early 30s. She fought the toughest fight I've ever watched and she beat that cancer into the ground with a smile on her face and a hop in her step. Now, she has to face the threat of her cancer recurring because she has not passed into menopause. Typically, breast cancer survivors are encouraged to undergo a complete hysterectomy to reduce the risk of relapse or new cancer, but my friend has chosen to keep her womanhood intact. I often wonder, as a woman in her early 30s and in menopause, if there is a fear associated with menopause that stops some breast cancer survivors from having a hysterectomy. Menopause is easy compared to fighting cancer, so here are seven reasons breast cancer survivors shouldn't be afraid of menopause.

Hot flashes don't last forever. I've been in menopause for about five years and I have very few hot flashes. For the first few years I suffered late night hot flashes nearly every night, but they fade.

There are alternatives to estrogen therapy. Estrogen therapy is not an option for breast cancer survivors, but other treatments are available. Doctors can prescribe antidepressants, blood pressure medications and seizure medications to treat hot flashes and other menopause symptoms.

You'll still want to have sex. Many women worry that they'll lose their sex drive after menopause. Nope, I can attest to the fact that you still want to take a trip between the sheets, but sometimes it takes a little more coercion to feel as hot as you did before menopause.

You can still have an orgasm. This was the myth I was worried about when my doctor told me he would be removing my cervix. During an orgasm the cervix moves up and down and I thought this had something to do with the feeling of an orgasm. I was quickly convinced that your cervix is not needed to have an orgasm and I learned for myself in the months following menopause.

Vaginal dryness is painful. Yes, vaginal dryness can be annoying, especially during sex, but there are over the counter lubricants that work wonders. Choose one in a cute bottle that heats or cools to increase sensitivity.

You're still a woman after menopause. I was scared that I would never feel like a woman again, but I was even more scared of turning into a man. Without estrogen I thought my breasts would shrink, I'd start growing facial hair and my voice would lower. That silly thought was soon proven wrong when none of those things happened.

You will be able to lose weight and stay fit. I asked my doctor about testosterone production, as some women in menopause have trouble with low testosterone, which can cause side effects like reduced sex drive. I was told the adrenal gland picks up testosterone production for most women, so I wouldn't lose my ability to build muscle, maintain muscle and feel sexy.

Breast cancer survivors are some of the bravest people in the world, especially my friend and secret muse. I watch her struggles with mammograms and wonder what is keeping her from taking that final step to protect her from another bout of breast cancer. Hopefully, if she is reading, she'll feel a little better about menopause.

More from Summer on Menopause

Is Black Cohosh the Biggest Scam in Natural Menopause Treatment?

I'm Too Womanly for My Own Health: The Link Between Menopause, Fat Loss, and Estrogen Overload

Early Menopause Health Risks: Osteopenia and Osteoporosis

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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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Men opting for costly new prostate cancer treatment, study shows

Lindsey Konkel

NEW YORK (Reuters Health) - Men diagnosed with localized prostate cancer are more likely to be treated with proton beam therapy, a novel form of radiation therapy, if the technology is available nearby, a new study found.

Prostate cancer is the most common cancer in men -- the National Cancer Institute estimates that more than 240,000 men in the U.S. were diagnosed in 2011.

About nine out of 10 of those cases were localized prostate cancer, meaning the cancer hasn't spread outside the prostate gland. Nearly all men diagnosed with localized tumors survive at least five years after diagnosis.

In the study, researchers examined the treatment choices of nearly 20,000 men living inside or outside of a regional market for Loma Linda University, a hospital in Southern California with a proton beam facility. All men were diagnosed with low- to intermediate-risk prostate cancer between 2003 and 2006.

Currently, there are nine proton centers in operation in the United States and eight more in development, according to the National Association for Proton Therapy.

Touted as a technological advancement over other forms of radiation therapy, proton beam therapy allows radiated particles to more tightly target and destroy tumor cells, leaving more of the surrounding tissue intact.

The treatment is often billed as having lower impotence and incontinence rates than other radiation treatment options, but there's a lack of evidence to support this, according to Dr. David Aaronson, a urologist at Kaiser Permanente Medical Group in Oakland, California, and lead author of the study.

After taking into account factors such as tumor stage and year of diagnosis, Aaronson's team found that patients living near a proton beam facility were more than five times more likely to receive proton beam treatment than those living outside of the hospital's referral region.

Nearly nine percent of the patients living within the referral region for the facility received proton beam therapy, compared to less than two percent of patients throughout the rest of the state.

The researchers also found that younger and non-Hispanic white men were also slightly more likely to receive proton beam treatment.

"It's not surprising that men are more likely to be treated with a certain technology in an area where that technology is offered," Aaronson told Reuters Health.

While most insurers, including Medicare, cover proton beam therapy, it comes at a hefty price.

Previous studies have estimated that proton beam therapy costs twice as much as intensity-modulated radiation therapy, another form of external radiation therapy and about five times more than radioactive seed implants.

And side-by-side comparisons of proton beam therapy and other prostate cancer treatments have not been done, according to Dr. Leonard Lichtenfeld, chief medical officer for the American Cancer Society.

Despite the added costs, there's no evidence to suggest that proton beam therapy results in better outcomes than other forms of prostate cancer treatment, including other forms of radiation, surgery or hormone therapy.

Although proton beam therapy has been shown to be superior in targeting tumors of the brain, eye and spine, those cancers are rare.

Institutions with proton beam facilities often look to pad their numbers by treating prostate cancer, according to Dr. Anthony Zietman, a radiation oncologist at Massachusetts General Hospital in Boston who was not involved in the new study.

"People often think that technology is synonymous with 'better,' but in some cases, it's not," said Aaronson.

"With the healthcare crisis looming and multiple treatment options available, newer, more expensive procedures for prostate cancer should be validated before they are implemented," he said.

SOURCE: http://bit.ly/yHdxqN Archives of Internal Medicine, February 13, 2012

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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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Panel favors some World Trade Center cancer claims

NEW YORK (AP) — A U.S. government panel favors expanding an aid program for people sickened by World Trade Center dust to include people who have at least some types of cancer.

Congress has set aside billions of dollars to compensate and treat people suffering from illnesses potentially caused by clouds of soot and smoke released during the Sept. 11, 2001 attacks.

But the program doesn't cover cancer, which scientists have not conclusively linked to trade center toxins.

Panel members meeting in New York agreed Thursday that some cancer patients should be covered by the program, but they were uncertain whether to extend it to all types of the disease or just some.

The committee's recommendation is due by March 2. Its advice can then either be accepted or rejected by the program's administrator.

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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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DiagnoCure gets FDA nod for prostate cancer test, shares jump

(Reuters) - Canada's DiagnoCure Inc said it received U.S. regulatory approval for a prostate cancer test that may help avoid unnecessary biopsies, sending its shares to their highest in about 18 months.

"We expect it (the approval) will increase our royalty revenues," said Yves Fradet, chief medical officer of DiagnoCure, which was founded in 1994.

Royalty revenue for the company, which has a market capitalization of about C$31 million, was C$659,120 in 2011.

The urine-based test -- named Progensa PCA3 -- will be used with other patient information to help decide on repeat biopsy in men of 50 years or older.

PCA3 is a gene that is highly over-expressed in prostate cancers -- the second most common type of cancer found in American men, according to the American Cancer Society (ACS), the company said.

DiagnoCure licensed Progensa to U.S.-based Gen-Probe, a diagnostic test maker, in November 2003.

The ACS estimates about 241,000 Americans were newly diagnosed with prostate cancer in 2011, and about 34,000 men died from the disease.

DiagnoCure marketed its first diagnostic test, for bladder cancer, in Europe in 1998. The product got U.S. approval in 2000.

The company said the PCA3 test will now be available for sale in the United States, Canada and the European Union.

Shares of the company were up 35 Canadian cents at C$1.06 on Wednesday morning on the Toronto Stock Exchange. They touched a high of C$1.30 earlier in the day.

(Reporting by Bhaswati Mukhopadhyay in Bangalore; Editing by Roshni Menon)

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In prostate cancer, other death risks may be higher

NEW YORK (Reuters Health) - Some men with prostate cancer may have increased risks of dying from causes other than the cancer itself, a new study finds.

Researchers found that when men had their prostate cancer diagnosed after developing symptoms -- and not after screening tests -- they had heightened risks of dying from heart problems or other cancers.

It's not clear what to make of the findings at this point. Mainly, they raise questions for future studies, said Dr. Anthony D'Amico, of the Dana-Farber Cancer Institute and Harvard Medical School in Boston.

"This is a study of associations, and does not prove cause-and-effect. It's really hypothesis-generating," said D'Amico, who was not involved in the research.

One possibility, according to the study authors, is that hormonal therapy has something to do with the increased risk of heart disease death.

D'Amico agreed that could be a factor. A number of studies, he told Reuters Health, have suggested that hormonal therapy for prostate cancer could raise the risk of heart disease death.

But, D'Amico added, that link has only been seen in men with a history of heart disease going into the therapy.

SCREENING VS. USUAL CARE

The findings, reported in the British Journal of Urology International, are based on a subgroup of men who took part in a European clinical trial on prostate cancer screening.

The men, who were ages 55 to 74, were randomly assigned to either undergo periodic prostate cancer screening or be part of a control group that stuck with "usual" health care.

The researchers followed death rates among 372 men who were diagnosed with prostate cancer through screening, comparing them with 1,488 men who'd been screened but found cancer-free.

They also followed 221 men in the usual-care group who'd been diagnosed with prostate cancer after developing symptoms. Those men were compared with 884 men from the control group who had not been diagnosed with the cancer.

Looking at that latter group, the researchers found that men with prostate cancer were more likely to die from cardiovascular disease or other types of cancer over the next six years.

Just under 12 percent died of cancers other than prostate tumors, versus 7 percent of men who had not been diagnosed with prostate cancer. And 5 percent died of heart disease or stroke, compared with just over 3 percent of other men.

In contrast, men who'd had their prostate cancer caught through screening showed no increased risk of death compared with men free of prostate cancer.

OFTEN SLOW-GROWING

Prostate cancer screening, such as with PSA blood tests, often catches very early tumors that may or may not be life-threatening. Prostate cancer is often slow-growing, and may never progress to the point of being lethal.

But when men are diagnosed because they've developed symptoms (like problems passing urine and low back pain), the cancer is often at a more-advanced stage.

For those men, one treatment option is hormonal therapy to lower a man's levels of testosterone, which can fuel prostate tumors' growth.

Several studies have linked the therapy to higher-than-normal risks of cardiovascular "events," like blood clots or heart attacks, or death from heart complications.

In this study, 27 percent of men diagnosed with prostate cancer based on symptoms ended up having hormonal therapy, according to the researchers, led by Dr. Pim J. van Leeuwen of Erasmus Medical Center in Rotterdam.

So, they say, hormonal therapy might help explain the increased risk rate of death from cardiovascular problems.

D'Amico agreed that that's a possibility, and called it the most "interesting" point from the findings.

As for the increased rate of death from other cancers, D'Amico speculated that men with more-aggressive prostate cancer may be genetically vulnerable to other cancers as well.

Or, he added, being part of a medical study may have meant they were more likely to have screening tests for other cancers.

For now, the reasons for the findings are unclear. "This is not something that would change clinical practice," D'Amico said.

Like with any treatment for prostate cancer, experts say the risks of hormone therapy have to be weighed against the potential benefits. For men with "high-risk" cancer that is likely to progress, for example, studies have shown that a combination of hormonal therapy and radiation can boost survival.

Men with early prostate cancer diagnosed through screening would not be the ones given hormone therapy, D'Amico said.

For those men, surgery may be an option -- and so may "active surveillance." That means putting off treatment altogether and monitoring the cancer over time.

According to the National Cancer Institute, about half of the more than 190,000 U.S. men diagnosed with prostate cancer in 2009 fell into the "low-risk" category -- meaning their cancer had low odds of progressing.

SOURCE: http://bit.ly/yw2VMt BJU International, online January 30, 2012.

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