Clinical Trials Helped One Woman's Fight Against Cancer

By Barbara Bronson Gray
HealthDay Reporter

THURSDAY, April 18 (HealthDay News) -- Monica Barlow, a 35-year-old from Maryland, was training for a half-marathon when she noticed she couldn't shake a bad cough and ongoing fatigue. After a couple of rounds of antibiotics from an urgent care clinic didn't work, she sought another opinion.

A CT scan brought wrenching news: There was a tumor in her left lung.

"I never smoked, I eat well, exercise and had never had any medical problems prior to this," Barlow said. "To say it was a shock doesn't even begin to describe it."

Four years later, Barlow has been through a series of ups and downs. After learning the cancer had spread to her lymph nodes and liver, she started chemotherapy, which only shrunk the tumors temporarily. She then joined two consecutive clinical trials, each offering to help control her cancer with novel drugs.

Barlow, who is director of public relations for the Baltimore Orioles baseball team, credits her participation in those clinical trials with prolonging her life.

Clinical trials test potentially promising treatments for a wide range of challenging diseases. But it can be difficult to find a good match for your particular situation and tough to know where to start looking. Even when you join a suitable trial, the outcomes are far from a sure thing.

Such has been the case for Barlow.

After she found out the lung cancer had spread to her lymph nodes and liver, she started an 18-week course of intravenous chemotherapy -- carboplatin, pemetrexed (Alimta) and bevacizumab (Avastin). Then there was some good news: The treatment had stabilized or shrunk all of the tumors.

A year later, her doctor found that the liver tumors were back. Because he discovered Barlow carried the ALK gene mutation, he suggested she join a clinical trial for a medication called crizotinib (Xalkori).

Initially, she didn't know if she was taking the real drug or a placebo. "That was a concern," she said. "It wasn't great to hear; it was stressful." Later in the trial, all patients were able to get the actual drug and placebos were no longer given to anyone, she said.

Barlow took Xalkori for two years, but last year the cancer returned yet again, requiring three ablations (localized methods to destroy a tumor without removing it) and two chemoembolizations (which deliver chemotherapy directly to the liver tumor while minimizing exposure to healthy tissues). Those procedures were not effective, and the next step was surgery to remove almost half of her liver.

Then, when tumor growth appeared in the new liver tissue that had grown back after the surgery, her doctors suggested she try a second clinical trial for a drug called LDK 378, which is being developed by Novartis.

The treatment continues to be tough. "This drug is a lot more difficult for me to take [than the drugs in the first clinical trial]," she said. "There are a lot of side effects, like nausea and vomiting."

Although the medication seems to be shrinking her liver tumors, just recently she had problems with a lung infection and a collapsed lung after a bronchoscopy. That has forced her to take a break from the trial; she hopes to restart as soon as the infection is gone.

Barlow continues to work, traveling with the team when she can. When she's sidelined by her illness, she's frustrated. "I can't believe I had to miss opening day [for the Orioles] this year," she said.

Because she has what she calls "excellent insurance," Barlow hasn't had to face serious medical bills. There is no charge for the care associated with her clinical trial, she said. But she and her family pay for the cost of traveling to her clinical trial site in Philadelphia, including hotel and meals, which can add up when she has an occasional hospital stay there, she added.

The drug Barlow is taking now wasn't available when she was diagnosed three years ago, she said.

"There are so many new things coming out, changing how cancer is being treated, so it's really important to be your own advocate or have someone who is advocating for you," she said. "The Internet can be a huge way to help you stay on top of the latest resources."

Barlow's fight highlights the potential value of a new system to help people more easily access clinical trials, both near and far from home.

A new Internet resource, MyClinicalTrialLocator.com, has just been launched to make it easier for people to find clinical trials that fit their needs.

Dr. Bruce Moskowitz, an internist in West Palm Beach, Fla., gave $100,000 from the Bruce and Marsha Moskowitz Foundation to help support the development of the free website.

"We made this site to be easy to use and understandable to anybody: patient-centric, not doctor-centric," Moskowitz said. "Hopefully, anyone will be able to receive help if they need it."

The website is designed to help visitors search for trials available by medical condition, treatment, location, medical center or other terms. It's accurate, updated frequently and includes information from clinicaltrials.gov (sponsored by the U.S. National Institutes of Health) and academic medical centers, Moskowitz said.

The site offers information about clinical trials worldwide, provides a mapping function to pinpoint the location of a trial and will notify users when trials matching their needs become available. It also allows patients to email clinical trial researchers directly, and academic medical centers can update and correct information on the site in real time.

Despite her many challenges, Barlow thinks clinical trials will help extend her life. "I know this drug won't work forever. But there will be other drugs out there, drugs [that are now] in the early stage of development, and when I need them, I'll switch to those drugs," she said. "The answers are out there; it's just a matter of researchers finding them."

Copyright © 2013 HealthDay. All rights reserved. SOURCES: Monica Barlow, Ellicott City, Md.; Bruce Moskowitz, M.D., internist, West Palm Beach, Fla.; March 27, 2013, press release, Biomedical Research and Education Foundation and the Bruce and Marsha Moskowitz Foundation

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Clinical Trials Helped One Woman's Fight Against Cancer

And new tool for finding the right match may help others get novel treatments

By Barbara Bronson Gray

HealthDay Reporter

THURSDAY, April 18 (HealthDay News) -- Monica Barlow, a 35-year-old from Maryland, was training for a half-marathon when she noticed she couldn't shake a bad cough and ongoing fatigue. After a couple of rounds of antibiotics from an urgent care clinic didn't work, she sought another opinion.

A CT scan brought wrenching news: There was a tumor in her left lung.

"I never smoked, I eat well, exercise and had never had any medical problems prior to this," Barlow said. "To say it was a shock doesn't even begin to describe it."

Four years later, Barlow has been through a series of ups and downs. After learning the cancer had spread to her lymph nodes and liver, she started chemotherapy, which only shrunk the tumors temporarily. She then joined two consecutive clinical trials, each offering to help control her cancer with novel drugs.

Barlow, who is director of public relations for the Baltimore Orioles baseball team, credits her participation in those clinical trials with prolonging her life.

Clinical trials test potentially promising treatments for a wide range of challenging diseases. But it can be difficult to find a good match for your particular situation and tough to know where to start looking. Even when you join a suitable trial, the outcomes are far from a sure thing.

Such has been the case for Barlow.

After she found out the lung cancer had spread to her lymph nodes and liver, she started an 18-week course of intravenous chemotherapy -- carboplatin, pemetrexed (Alimta) and bevacizumab (Avastin). Then there was some good news: The treatment had stabilized or shrunk all of the tumors.

A year later, her doctor found that the liver tumors were back. Because he discovered Barlow carried the ALK gene mutation, he suggested she join a clinical trial for a medication called crizotinib (Xalkori).

Initially, she didn't know if she was taking the real drug or a placebo. "That was a concern," she said. "It wasn't great to hear; it was stressful." Later in the trial, all patients were able to get the actual drug and placebos were no longer given to anyone, she said.

Barlow took Xalkori for two years, but last year the cancer returned yet again, requiring three ablations (localized methods to destroy a tumor without removing it) and two chemoembolizations (which deliver chemotherapy directly to the liver tumor while minimizing exposure to healthy tissues). Those procedures were not effective, and the next step was surgery to remove almost half of her liver.

Then, when tumor growth appeared in the new liver tissue that had grown back after the surgery, her doctors suggested she try a second clinical trial for a drug called LDK 378, which is being developed by Novartis.

View the original article here

New Method May Help Pinpoint Woman's Final Menstrual Period

Title: New Method May Help Pinpoint Woman's Final Menstrual Period
Category: Health News
Created: 3/26/2013 10:35:00 AM
Last Editorial Review: 3/26/2013 12:00:00 AM

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New Method May Help Pinpoint Woman's Final Menstrual Period

Doctors could use information to start preventive treatment for bone loss, researcher says

By Robert Preidt

HealthDay Reporter

TUESDAY, March 26 (HealthDay News) -- A new formula to predict a woman's final menstrual period could help menopausal women fight bone loss and reduce their heart disease risk, a new study reports.

The formula is based on the changing levels of two hormones: estradiol, which is found in the ovaries; and follicle-stimulating hormone, which is present in the brain and gives instructions to the ovaries.

Estradiol levels fall and follicle-stimulating hormone levels rise as women go through menopause, the University of California, Los Angeles, researchers explained in a news release from the Endocrine Society.

Currently, doctors monitor women's menstrual bleeding patterns to determine the menopause transition phase. However, this phase is an imprecise indicator of when the final menstrual period will occur, according to the authors of the study published in the April issue of the Journal of Clinical Endocrinology & Metabolism.

"We need a better way to answer women's questions about when to expect the final menstrual period," lead author Dr. Gail Greendale, of UCLA's David Geffen School of Medicine, said in the news release.

"If further research bears out our approach, it could be the first step to developing web-based calculators and other tools women can use to estimate where they are in the menopause transition and how far away their final period is," she added.

The ability to predict a woman's final menstrual period could prove important for their health, the researchers suggest. In the year before the final menstrual period, women experience accelerated bone loss and increased heart disease risk, the study authors said.

"For example, some researchers have proposed that an intervention begun one or two years before the final menstrual period would greatly decrease future fracture risk by preventing the very rapid bone loss that occurs in the few years before and few years after the final menses," Greendale said. "But before ideas such as this can be tested, we need to accurately predict where a woman is in her timeline to menopause."

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Woman's Tea Addiction Led to Loss of Teeth, Bone Problems

Extreme levels of fluoride from daily consumption of a concentrated brew caused pain, brittle teeth

By Barbara Bronson Gray

HealthDay Reporter

WEDNESDAY, March 20 (HealthDay News) -- Here's a cautionary tale about the value of moderation.

A case study reported in the March 21 issue of the New England Journal of Medicine shows how habitually drinking an extreme form of highly concentrated tea over almost 20 years created a hard-to-diagnose case of severe bone damage in a 47-year-old woman.

Worried that she had cancer, the patient told her primary care doctor in Lansing, Mich., that she was concerned about bone pain she had been having in her lower back, arms, legs and hips for five years. She also had had all her teeth extracted due to brittleness.

Her X-rays showed her bones were unusually dense, but there was no sign of disease. The fluoride level in her blood was also high. She was referred to Dr. Sudhaker Rao, section head of bone and mineral metabolism and director of the bone and mineral research laboratory at Henry Ford Health System in Detroit, for a bone biopsy.

The patient's intake of brewed tea was astronomically high, said Rao, who learned that the patient had been regularly drinking a pitcher a day of tea made from about 100 to 150 tea bags, which gave her more than 20 milligrams (mg) of fluoride. She had a fluoride concentration in her blood of 0.43 milligrams per liter, while the normal concentration is less than 0.10 mg per liter, Rao reported.

Fluoride is used to prevent tooth decay and is usually prescribed for children and adults whose homes have water that does not naturally have fluoride in it, according to the U.S. National Library of Medicine.

It turns out that Rao, the author of the case study, came from an area in India where fluoride levels in the water were naturally extremely high, sometimes causing a condition called skeletal fluorosis. He has also recently consulted on a few cases involving high fluoride in the blood, he pointed out.

"Most of us can excrete fluoride extremely well, but if you drink too much, it can be a problem," he said. Brewed tea has one of the highest fluoride contents of all the beverages in the United States, according to Rao. He immediately wondered if the fluoride in the concentrated tea concoction the woman was regularly drinking could be the cause of her bone troubles, he said. "There have been about three to four cases reported in the U.S. associated with ingesting tea, especially large amounts of it," he noted.

When Rao tried to perform the biopsy, the woman's bone was so hard he said his instrument could not penetrate the bone. "It was like steel," he said. "Her bone density was very high, seven times denser than normal."

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Woman's Tea Addiction Led to Loss of Teeth, Bone Problems

Title: Woman's Tea Addiction Led to Loss of Teeth, Bone Problems
Category: Health News
Created: 3/20/2013 6:35:00 PM
Last Editorial Review: 3/21/2013 12:00:00 AM

View the original article here

Woman's Tea Addiction Led to Loss of Teeth, Bone Problems

Extreme levels of fluoride from daily consumption of a concentrated brew caused pain, brittle teeth

By Barbara Bronson Gray

HealthDay Reporter

WEDNESDAY, March 20 (HealthDay News) -- Here's a cautionary tale about the value of moderation.

A case study reported in the March 21 issue of the New England Journal of Medicine shows how habitually drinking an extreme form of highly concentrated tea over almost 20 years created a hard-to-diagnose case of severe bone damage in a 47-year-old woman.

Worried that she had cancer, the patient told her primary care doctor in Lansing, Mich., that she was concerned about bone pain she had been having in her lower back, arms, legs and hips for five years. She also had had all her teeth extracted due to brittleness.

Her X-rays showed her bones were unusually dense, but there was no sign of disease. The fluoride level in her blood was also high. She was referred to Dr. Sudhaker Rao, section head of bone and mineral metabolism and director of the bone and mineral research laboratory at Henry Ford Health System in Detroit, for a bone biopsy.

The patient's intake of brewed tea was astronomically high, said Rao, who learned that the patient had been regularly drinking a pitcher a day of tea made from about 100 to 150 tea bags, which gave her more than 20 milligrams (mg) of fluoride. She had a fluoride concentration in her blood of 0.43 milligrams per liter, while the normal concentration is less than 0.10 mg per liter, Rao reported.

Fluoride is used to prevent tooth decay and is usually prescribed for children and adults whose homes have water that does not naturally have fluoride in it, according to the U.S. National Library of Medicine.

It turns out that Rao, the author of the case study, came from an area in India where fluoride levels in the water were naturally extremely high, sometimes causing a condition called skeletal fluorosis. He has also recently consulted on a few cases involving high fluoride in the blood, he pointed out.

"Most of us can excrete fluoride extremely well, but if you drink too much, it can be a problem," he said. Brewed tea has one of the highest fluoride contents of all the beverages in the United States, according to Rao. He immediately wondered if the fluoride in the concentrated tea concoction the woman was regularly drinking could be the cause of her bone troubles, he said. "There have been about three to four cases reported in the U.S. associated with ingesting tea, especially large amounts of it," he noted.

When Rao tried to perform the biopsy, the woman's bone was so hard he said his instrument could not penetrate the bone. "It was like steel," he said. "Her bone density was very high, seven times denser than normal."

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Genes May Boost Woman's Risk of Postpartum Depression

Test found specific changes to two genes predicted problem with 85 percent accuracy

By Amy Norton

HealthDay Reporter

TUESDAY, May 21 (HealthDay News) -- Pregnant women with specific alterations in two genes may be at increased risk of suffering depression after giving birth, a small new study suggests.

The researchers hope they can use the findings to develop a blood test that could help spot pregnant women who are vulnerable to postpartum depression, which affects around 15 percent of new mothers.

Their study, reported in the May 21 issue of the journal Molecular Psychiatry, uncovered specific chemical changes in two genes that predicted which women would develop postpartum depression with 85 percent accuracy.

Little is known about the genes, called TTC9B and HP1BP3, but they are somehow involved in activity in the brain's hippocampus, which regulates mood. Based on animal research, both genes seem to be "reactive to estrogen," said Zachary Kaminsky, a researcher at Johns Hopkins University School of Medicine in Baltimore who worked on the study.

The findings offer clues as to what makes some women susceptible to postpartum depression. But there is still a lot of work to be done before a screening test becomes available, according to an expert not involved in the research.

"This is a first step, but I think we're pretty far off from having a blood test," said Dr. Kimberly Yonkers, a professor of psychiatry and obstetrics and gynecology at Yale School of Medicine in New Haven, Conn.

She said the study was small -- involving only 51 women, about a dozen of whom developed depression within a month of giving birth -- so the results need to be validated in larger studies.

But beyond that, Yonkers said, there's the larger, "dicey" issue of how much benefit there would be from telling pregnant women their genes put them at heightened risk of postpartum depression.

"You may unnecessarily worry some women," Yonkers said.

"Information is power," Kaminsky said, and for some women, knowing they are at risk of postpartum depression can offer a chance to minimize that risk: Their partner, family or friends could be especially attentive and step in to ease some of the stress of being a new mom, for example.

Kaminsky acknowledged that if a blood test result actually caused distress for an expectant mom, it would not be good. But, he said, having a blood test as an option for women who want an idea of their risk could be valuable.

Kaminsky and two of his co-researchers have filed for a patent on testing for the genetic markers.

The findings are based on 51 pregnant women with a history of depression or bipolar disorder, which raises the risk of suffering depression during or after pregnancy. One group of 19 women had major depression during their pregnancies, and 12 continued to have symptoms in the first month after giving birth.

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