iStockphoto/Thinkstock(NEW YORK) -- When Richard Kaminski had an unusual mole removed from his cheek in 1998, he thought it was the end of his experience with melanoma.
But more than 10 years later, Kaminski developed a cough that didn't go away. Medical tests confirmed the diagnosis: metastatic melanoma that had spread to his lungs.
Melanoma is a form of skin cancer that kills 85 percent of its victims within five years if it has spread. It is responsible for about 9,000 deaths in the United States a year, according to the American Cancer Society.
Kaminski was floored. "I had this awful thing working in my lungs," he said.
Doctors treated Kaminski with a drug typically used against this form of cancer, but without success. It was only when his oncologist put him in touch with Dr. Anna Pavlick at New York University, who enrolled him in a clinical trial of a medication called vemurafenib, that he began to turn the corner on the deadly illness.
Before treatment, Kaminski recalled, "I had great difficulty breathing. I couldn't put sentences together because I couldn't get a deep breath. I had pain in my chest." Three weeks after beginning the drug, "A lot of that was greatly diminished," he said.
Within three months, Kaminski's symptoms disappeared. Scans showed his tumors starting to regress. By the end of 2010, the tumors were gone.
Kaminski, now 65, is understandably thankful.
"In two weeks, I will be two years on this drug," he said. "It was a lifeline."
On Wednesday, the results of the clinical trial in which Kaminski was enrolled appeared in the New England Journal of Medicine. In the study conducted at 13 centers in the U.S. and Australia, researchers followed 132 patients with Kaminski's type of melanoma who had failed to respond to standard treatment. In about half of them, vemurafenib shrunk their tumors. For another third of the patients, the tumors showed no progression once the drug regimen had kicked in. Dr. Lynn Schuchter at the University of Pennsylvania, another of the study's authors, called these numbers "unprecedented."
"I've treated patients [with melanoma] for almost 25 years and never seen a drug with this kind of activity," Schuchter said. "It's so much better than the therapies that have been available to us before."
Also impressive was the improvement in survival; patients on the drug lived, on average, for an additional 15.9 months after treatment began, compared with the six to 10 months typically seen with the disease. A larger trial, also published this year in the New England Journal of Medicine, showed that the drug brought about improved survival at six months. But the authors of the new study were able to follow some of their patients much longer -- for more than a year after they'd started treatment.
For patients like Kaminski who fail standard treatment, the new drug offers hope. Unlike many other cancer drugs, vemurafenib was just as effective in patients who had failed a previous treatment as it was in patients who had received the drug right off the bat -- a rare finding when it comes to cancer treatments.
The drug is not without its limits. In targeted therapy, cancer cells can mutate slightly and stop being a target, a process called resistance. In this study, cancer tended to recur in patients after about seven months of treatment. Dr. Kelly McMasters, chairwoman of surgery at the University of Louisville who treats melanoma patients, points out, "It can cause the tumors to shrink, but they will recur on average in about six months."
That being said, McMasters said, "In some patients...vemurafenib offers the hope to shrink the tumors enough to allow [surgical removal]."
So far, resistance hasn't been an issue for Richard Kaminski. Two years into treatment, he continues to enjoy a relatively normal life. He loves to garden, although he does have to take precautions out in the sun since one of the side effects of the medication is sun sensitivity.
FDA/iStockphoto/Thinkstock(WASHINGTON) -- A U.S. Food and Drug Administration Advisory Committee Wednesday recommended approval of the weight loss drug Qnexa, a treatment many hope will help millions of Americans who struggle with obesity.
In voting 20-2 for approval, the committee said Wednesday that Qnexa’s weight-loss benefits for the chronically obese outweighed the risks of birth defects and cardiovascular problems that have been associated with the drug. An FDA advisory panel recommended against approval in 2010 over concerns about the drug’s side effects, and the FDA rejected it shortly after that. Vivus, the drug’s manufacturer, recently submitted additional research.
The committee Wednesday recommended that the manufacturer take a number of steps to prevent the drug from causing birth defects like cleft palate, including a possible warning label targeted toward women of childbearing years.
The FDA has considered numerous anti-obesity drugs in the past 20 years, but most have failed to meet the agency’s standards for safety and effectiveness. But so far, data on Qnexa suggests that the drug is the most effective in helping patients shed up to 10 percent of their body weight. Those changes, along with diet and exercise modifications, could go a long way toward alleviating some of the health problems associated with obesity, such as diabetes and high blood pressure.
Critics say the risk of potentially dangerous side effects of Qnexa, which include increased heart rate, heart attacks and arrhythmias, are too great to make the drug available to millions of people, especially because long-term effects of the drug are still largely unknown.
“Public health cannot tolerate another diet drug approved that has not been accepted for cardiovascular risk especially in light of the suggested findings of Qnexa,” said Dr. Sidney Wolfe, director of the health research group at Public Citizen, an advocacy group.
Obesity currently plagues one-third of Americans and has been linked to high blood pressure, diabetes and a range of other chronic, expensive health problems. Doctors and dietitians routinely recommend changes in diet and exercise as the safest and most effective way to shed pounds. But some acknowledge that these strategies just don’t work for a large number of obese patients. Bariatric surgery, though largely successful in producing weight loss, is not a viable option for many people.
Dr. Melina Jampolis, an obesity specialist in San Francisco, said the current options for treating obesity are “frustratingly limited,” and said it would be helpful if patients had additional tools to aid their weight loss.
“I think that combination therapy is essential as there are numerous individual and overlapping mechanisms that make weight loss difficult,” she said. “So the more of them that you can address with medication therapy when necessary, the more effective a regimen will be.”
iStockphoto/Thinkstock(NEWPORT BEACH, Calif.) -- A California plastic surgeon is keeping it in the family by performing multiple cosmetic procedures on his own young daughters.
Dr. Michael Niccole, founder of the CosmetiCare Plastic Surgery Center in Newport Beach, Calif., gave his daughter Brittani, now 22, breast implants when she was 18. Brittani also had a rhinoplasty. Niccole performed surgery on his daughter Charm, now also 22, when she was 10 to turn her “outtie” belly button into an “innie.”
Dr. Niccole said he has performed surgery on other family members as well and felt comfortable operating on his daughters, both of whom are adopted.
“Who would give them the time -- that extra little look during surgery more than I would?” the surgeon said.
Brittani told 20/20 she wanted breast augmentation surgery to “build my self-esteem.”
“I didn’t have large breasts when I was younger, and all my friends did…I felt very self-conscious about it,” she said.
Both Brittani and Charm also receive regular injections of Botox to prevent wrinkles and undergo other cosmetic procedures.
Though critics say women Brittani and Charm's age have no business undergoing cosmetic procedures, Dr. Niccole defends his work on his daughters as “maintenance.”
“I’m not changing their looks in any means. They want maintenance,” he said. "They don’t want to get old. They want to stay young.”
Hemera/Thinkstock(BOSTON) -- According to a new study, women with a history of migraines are 41 percent more likely to develop depression than their migraine-free counterparts.
"Our study shows that migraine is a potential risk factor for depression," said study author Dr. Tobias Kurth, a neuroepidemiologist at Brigham and Women's Hospital. "If you have a chronic intermittent pain condition, you may be more likely to develop depressive symptoms or even depression because you're so bothered by the pain. And it's also possible the conditions share similar pathophysiological features in the brain."
The study followed 36,154 women, 6,456 of whom had a history of migraines. Over an average of 14 years, 3,971 women developed depression -- a diagnosis much more common among migraine sufferers. Kurth and colleagues will present their results in April at the American Academy of Neurology's 64th Annual Meeting in New Orleans.
Dr. Joel Saper, director of the Michigan Headache and Neurological Institute, said the study confirms a long-suspected link between migraines and depression.
"They can intermingle with each other, and they can masquerade each other," said Saper, adding that both conditions have genetic routes. "And having one makes the other one worse."
Previous studies have found people with depression are more likely to get migraines, suggesting the risk goes both ways.
"It emphasizes the importance of treating both conditions at the same time," said Saper. "Sometimes we can treat both with the same medication."
Migraine and depression are more common in women than in men, which Saper attributes to fluctuations estrogen levels.
"Estrogen makes both of these worse," he said, describing the headaches and mood changes often triggered by the menstrual cycle. "Women are more prone to depression and more prone to migraines, and women who take oral contraceptives are often worse off."
Chris Polk/FilmMagic(LOS ANGELES) -- Rihanna debuted her sexually charged “Birthday Cake” remix Monday, and the man who bloodied and bruised her three years ago, Chris Brown, appears on the new version, rapping about how he wants to “f***” her and “give it to her in the worst way.” Listeners can also hear Rihanna’s vocals featured on the new version of Chris Brown’s “Turn Up the Music,” which was released Monday.
While some fans have expressed acceptance and even excitement about the collaboration, others are outraged, announcing their loss of respect for the pop princess for what seems like welcoming her former abuser back into her life.
Without having treated Rihanna or knowing the full details of the continuing saga of Rihanna and Chris Brown, experts weighed in on the rekindled music relationship. While some said the revived pair is inappropriate and dangerous, others suggest that Rihanna may have healed from the experience and now feels empowered to separate business and personal relationships.
“It is always a little worrisome to see an abused woman readmit her abuser into her life,” said Alan Hilfer, chief psychologist at Maimonides Medical Center in Brooklyn. “This is, however, quite common and we often see women willing to forgive men for some of the awful things that they have done. As psychologists, we are always working to get people to change their behaviors and hope we can be successful. We advocate the ability to forgive, but not necessarily forget.”
The cycle of domestic abuse can be a confusing one for all those involved or witnessing it, said Dr. Sudeepta Varma, clinical assistant professor of psychiatry at New York University’s Langone School of Medicine and a member of the American Psychiatric Association. While common sense tells most people to permanently stay away from something so damaging, victims can fall back into their abuser’s web of charm, promises of change and grand gestures of apology.
“The highs the abusers provide their victims are like no other, and the memory and potency of the positive experiences draws the victim back in for more,” said Varma. “The victim is often someone who is psychologically vulnerable to this type of charm, deceit and grandiose behavior. Underneath the debonair exterior of the abuser lies a person with gross lack of empathy, disregard for rules and norms of society. [These are] many qualities we see in people with personality disorders.”
Rihanna seemed to allude to the situation with her former flame Tuesday while accepting best international female artist at the Brit Awards. “At times when I feel misunderstood, my fans always remind me that it’s O.K. to be myself,” she said during her speech.
Varma said society doesn’t expect women who are beautiful, talented, wealthy, and who have many options surrounding her to fall prey to such behavior, but, “domestic violence is an equalizer.”
It is more about psychological dependence, low-self esteem, and believing that this person, who is good to you sometimes, is really your best and only option out there, Varma continued.
“You are willing to overlook the bad, because the good feels so good,” said Varma. “It sends a confusing message to concerned parties and continued contact with a former abuser sends a message that you have accepted, tolerated and maybe even condoned this type of behavior.”
Nevertheless, Martin Binks, clinical director & CEO of Binks Behavioral Health, said women who are victims of abuse do not have to remain victims of their abuser forever.
“Why must we insist on disempowering victims by questioning their judgment without all the facts?” said Binks. “People may be forgetting that perhaps she has recovered and is a strong independent woman who is empowered enough to make this decision thoughtfully and without there being some pathological explanation. Only she and her therapist are qualified to have an opinion on this topic, in my opinion,” he said.
Don Arnold/WireImage(NEW YORK) -- Kim and Khloe Kardashian may have gotten themselves into legal hot water with their promotion of the diet drug QuickTrim.
According to the New York Post, the New York City law firm Bursor & Fisher has filed a class-action against QuickTrim’s manufacturers, Windmill Health Products in New Jersey, for the product’s promotion and marketing claims, which include the Kardashian sisters as celebrity users of QuickTrim.
In an email sent to Quick Trim customers, the Post reported, the company noted, “The active ingredient in QuickTrim weight loss products is a large dose of caffeine...The FDA has determined that caffeine is not safe or effective for weight loss.”
QuickTrim was hitched to Kim and Khloe’s star in 2009 when the duo became the product’s celebrity endorsers. In January 2010, Kim claimed that she used QuickTrim and dropped 15 pounds. Khloe professed a similar weight loss a few months later. Since then, the product has earned Windmill Health Products $45 million windfall in revenue.
The products are sold nationwide at such chains as Walmart, CVS and Walgreens. The company’s website claims that QuickTrim products, which range from pills to powdery drinks, can help burn calories, cleanse the bodies, curb appetite and boost energy. The website also warns that, “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Rob Carr/Getty Images(BOSTON) -- Tom Martinez, the man credited for grooming New England Patriots quarterback Tom Brady for his NFL career, died of a heart attack while undergoing dialysis Tuesday on his 66th birthday.
The retired football coach had been awaiting a kidney transplant for two years, but he had not succeeded in finding a donor. Three months ago, Martinez's doctors told him he had mere months left to live.
"I've been told I'm out of here, and I don't accept that," Martinez told ABC News in January. "I'm going to fight to the end."
Martinez's wife, Olivia, had dropped him off at the Satellitte Dialysis Center in Redwood City, Calif., for a routine appointment. Shortly after, she was called back to the center and was told by staff members that her husband had had a heart attack.
Martinez told ABC News in January that if there was ever a key to success on the field, it's this: Don't quit.
"I tell the kids I don't care who it is, I don't care where we go, I don't care where we play, we don't whine about officials' calls, we don't whine about weather conditions," said Martinez. "You play hard and you play right to the end."
Brady adopted that no-quit attitude to help his longtime mentor Martinez connect with a donor.
Brady spread the word through a banner he circulated online over the past month through MatchingDonor.com, a nonprofit organization that helps interested living organ donors find those who need transplants.
"We don't like to promote one person or another," Dr. Jeremiah Lowney, medical director at MatchingDonor.com, told ABC News in January. "If Tom Martinez is helping people get to this site, then that's great."
Martinez started coaching Brady when he was a 13-year-old at a quarterback football camp Martinez ran at the College of San Mateo in California, and the relationship lasted through Brady's NFL career.
"He's one of the fiercest competitors I have ever known," said Martinez. "He wants to do things 100 percent."
But Brady and Martinez's relationship was better than a great throw.
"He obviously is the summation of everything you attempt to teach," Martinez said.
ABC News(NEW YORK) -- Environmental activist Erin Brockovich has corrected misinformation regarding her investigation into the medical mystery in an upstate New York town where a group of teenagers has displayed symptoms similar to Tourette syndrome, saying that her research is still preliminary.
Nearly two dozen people, including one 36-year-old, in the upstate New York village of LeRoy are now experiencing uncontrollable tics, seizures and outbursts that might have been caused by a chemical spill in the town more than 40 years ago.
In a statement released Tuesday, Brockovich said she is still investigating a plume from a 1970 train derailment in LeRoy, which dumped cyanide and trichloroethylene (TCE) -- a chlorinated hydrocarbon used to de-grease metal parts -- within three miles of the village's high school.
The Environmental Protection Agency says that TCE can affect the central nervous system, and cause dizziness, headache, sleepiness, nausea, confusion, blurred vision and facial numbness. It is suspected of being linked to the symptoms among LeRoy's local teens.
Brockovich associate Bob Bowcock reportedly said on Feb. 11 that samples taken from the wells of private residences had not migrated west and south -- toward LeRoy High School -- as some had feared. Although at the time Browcock said that the investigation would continue for the next several months, Brockovich on Tuesday said that the tests he referred to were preliminary.
"Contrary to an erroneous news report, I want to make clear that my investigation into possible sources of environmental contamination in LeRoy, New York that may or may not be linked to the serious illnesses suffered by various members of the community is not complete," Brockovich said in a statement. "In fact, it appears the number of people in the area displaying alarming health issues that can be caused by TCE is growing."
"It took the EPA 40 years to investigate the contamination from the train derailment and it will take us more than 40 days to get to the root of the problem in LeRoy. I want to further stress that we have not ruled out the TCE plume from the train derailment as a source of contamination at LeRoy High School," she added.
Brockovich, 51, added that her team has many more areas of LeRoy to test, including the local quarry, six fracking wells at the high school and the Methyl tert-butyl ether (MtBE) contamination in local wells, while stressing that thoroughness is key in her investigation.
iStockphoto/Thinkstock(NEW YORK) -- Men and women who shoehorn themselves into skin-tight jeans, battle to button their trousers or knot their neckties too tightly might unknowingly suffer nerve damage, digestive disturbances and even potentially deadly blood clots.
They're victims of fashion's hidden health hazards. Even some favorite accessories, like waist-cinching belts, can compress delicate nerves in the abdomen or constrain breathing and deprive the heart and brain of needed oxygen.
"Who hasn't tried to squeeze into a too-small pair of shoes, or wriggle into too-tight jeans?" said Dr. Orly Avitzur, a neurologist in Tarrytown, N.Y., who started warning about too-constricting skinny jeans on her Consumer Reports blog back in 2009. "Sometimes we realize right away that our choice of wardrobe or fashion is the culprit; other times, it only dawns on us when we begin to really suffer."
When patients seek medical help for pain radiating into the thigh, or feelings of numbness or tingling, it's unlikely they suspect that the cut of their jeans might be the problem. But sharp-eyed physicians like Dr. Malvinder S. Parmar, medical director of Timmins & District Hospital in Ontario, Canada, might recognize the hallmarks of meralgia paresthetica, the compression of a nerve running from the pelvis into the outer thigh.
In 2003, Parmar published a description of "tingly thighs" in three "mildly obese" women who wore low-rise jeans throughout the previous few months. Their discomforts resolved after four to six weeks "avoiding hiphuggers and wearing loose-fitting dresses," according to Parmar's 2003 correspondence in the Canadian Medical Association Journal.
Some clothing-related maladies go by mundane-sounding names that hardly hint at their potential to sicken. For example, a middle-aged or older man whose belly hangs below the waist of his pants may suffer from "tight pants syndrome," a term coined in a 1993 article by Dr. Octavio Bessa, an internist in Stamford, Conn.
Bessa described a collection of gastrointestinal symptoms including abdominal pain, heartburn and reflux a few hours after meals that he would see in 20 to 25 men every year. The common thread: All wore ill-fitting pants with waistbands several inches smaller than their bellies, Bessa reported in the Archives of Internal Medicine.
Three years later, two diagnostic imaging specialists from Wales described a "sporting variant" of tight-pants syndrome that they linked to tight Neoprene bike shorts worn to prevent muscular injury.
Wearing tight neckties and shirts with constricting collars can also impede blood flow through neck veins and arteries and may affect vision. In a 2003 study of 40 men, half with glaucoma, three minutes with a tightened tie raised eye pressure among the majority of those with and without the disease. Elevated eye pressure is a key element of diagnosing and monitoring glaucoma, a leading cause of blindness.
David De Lossy/Thinkstock(LOS ANGELES) -- Women with a history of endometriosis are at a significantly increased risk of developing several types of ovarian cancers, according to a new study published in Lancet Oncology.
Endometriosis occurs when the cells from the lining of the uterus grow in other areas of the body, according to the National Institutes of Health. About 10 percent of women in their childbearing years experience it. It can cause pain and irregular bleeding and make it difficult to conceive.
The new research found that women with endometriosis have a three times higher risk of developing clear-cell ovarian cancer (which accounts for less than five percent of all ovarian cancer cases) and twice the risk of developing endometrioid tumors.
"Our data, taken with the other published data on the link between ovarian cancer and endometriosis strongly suggests a causal relationship, with endometriosis being a precursor lesion for these three types of ovarian cancer," Dr. Celeste Leigh Pearce, lead author of the study and a preventive medicine researcher at the University of Southern California, told ABC News.
Researchers analyzed the link between endometriosis and ovarian cancer rates from data compiled by the Ovarian Cancer Association Consortium, a forum of investigators of case-control studies on the cancer. Tuesday's published study included data from more than 23,000 women with ovarian cancer.
"This excellent study brings home the point to all primary care physicians that women with endometriosis, surgically proven or self-reported by symptoms, deserve to have available all options to limit this ectopic endometrial growth," said Dr. Diane Harper, director of the Gynecologic Cancer Prevention Research Group at the University of Missouri-Kansas.
A woman with a mother or sister with endometriosis is significantly more likely to contract endometriosis than other women, according to the NIH. Other risks of developing the condition include beginning menstruating at an early age, never having children and frequent and long-lasting periods. The most telling sign of endometriosis is pain -- during and before menstruation, sexual intercourse, and found in the abdomen, lower back and pelvic area.
While this is not the first time that a link between endometriosis and ovarian cancer has been studied, Dr. Mark Einstein, director of gynecologic oncology at Montefiore Medical Center, said the combining of studies offers a better understanding of the strength of the association between endometriosis and ovarian cancers.
Authors warned that most women who suffer from endometriosis never develop ovarian cancers, but the findings should alert patients and physicians of the high risks.
Dr. Diane Yamada of the Society for Gynecologic Oncology Communications Committee said that while the study should not be a cause of alarm for women with endometriosis, the research "may allow for an opportunity to identify symptoms associated with another disease process, which may help identify these patients."
Recent studies have even found that ultrasounds and blood tests intended to screen for ovarian cancer actually did more harm than good by undergoing unnecessary follow-up treatments and surgeries. At this point, Yamda said it would be a "leap of faith" to recommend that women should undergo rigorous screening, but the information offers new clues on how and who to screen to prevent the cancer, which causes about 15,000 American deaths each year, according to the American Cancer Society.
Stockbyte/Thinkstock(NEW YORK) -- Talk about adding insult to injury. More and more U.S. emergency rooms won't admit patients until they pony up a fee of $100 dollars or more for non-emergencies.
The fees are meant to discourage people suffering from nothing worse, say, than a sore throat or a skinned knee from taking up time and resources better reserved for the seriously ill.
Both for-profit and non-profit hospitals are levying the charge.
Ed Fishbough, spokesman for the nation's biggest for-profit chain, HCA Healthcare in Nashville, Tenn., says the company first started imposing such fees in 2004, at one of its Houston-area hospitals.
The practice has since spread to 76 other hospitals in the 163-hospital chain. The purpose, he says, is to "help reduce crowding in the ER and to educate people about appropriate use of ER resources."
Critics of ER fees include the American College of Emergency Physicians, which says that two to seven percent of patients determined to have non-emergency conditions are admitted to a hospital within 24 hours.
Patient advocacy groups, likewise, blast the policy, saying it discourages the sick from seeking help. "It seems the point of the policy is to put a financial barrier between the patient and care," Anthony Wright, executive director of advocacy group Health Access California, told Kaiser.
Either way, here's how it works at HCA:
You show up at the ER wanting treatment. A clinician checks you out, and decides whether your case qualifies as a true emergency. If it doesn't, but if you want to stay in the ER and get treated there anyway, you are asked to pay a fee, which at HCA runs between $100 and $150.
Pregnant women, children younger than 6 and people older than 64 are exempt.
HCA says it had six million emergency room visits at its hospitals last year. Of those, 314,000 (about five percent) were from people who, after screening, were determined not to have an emergency condition. They were offered the choice of paying the fee and remaining in the ER for treatment, or leaving and seeking treatment at what HCA calls a "more appropriate setting," such as a clinic or doctor's office. About 233,000 patients chose to stay and pay. About 80,000 didn't, and took a hike. It's unknown where they ended up.
Such ER fees are common now at other big, for-profit chains (including Health Management Associates of Florida, and Community Health Systems of Tennessee) and nonprofit hospitals, as well.
Tomi Galin, vice president for corporate communications at Community Health Systems, says patients who choose to leave "are provided with information about other community health resources for their non-emergency medical conditions." Imposing a fee, she argues, helps reduce costs for the patient and the hospital alike because "the ER is the highest cost environment to receive non-emergency care."
The U.S. Centers for Disease Control and Prevention says patients with non-urgent problems account for about eight percent of ER visits. Other studies have put the figure considerably higher. One by Health Affairs policy journal in 2010 concluded it was closer to 27 percent.
The non-profit Midland Memorial Hospital in Texas implemented a $150 ER fee in 2009, as part of an exercise in cost-control, according to a Kaiser Health News story. Kaiser says the hospital had lost $14 million in 2008, in part because of millions of dollars in ER bills left unpaid.
Since imposing its fee, the hospital has seen a drop in debt, according to its chief financial officer, whom Kaiser quotes. He estimates that about 75 percent of patients with nonemergency conditions leave the hospital rather than pay the fee. "More people now know," he says, "that our ER is not a walk-in clinic or a primary-care office."
iStockphoto/Thinkstock(WASHINGTON) -- The U.S. Food and Drug Administration approved new suppliers for two cancer drugs Tuesday in an effort to curb the largest nationwide drug shortage in nearly a decade.
The FDA said its approval of a new supply method would increase production of the injection form of the drug methotrexate, which is used to treat children with the most common form of childhood leukemia.
The agency also said it would allow temporary foreign imports of the cancer drug Lipodux, an alternative to the drug doxorubicin, sold under the name Doxil, which is used to treat ovarian cancer, multiple myeloma and AIDS-related Kaposi's sarcoma. Temporary foreign importation is a rare move for the agency.
"In different circumstances we have to apply different tools," said FDA Commissioner Peggy Hamburg in a statement, adding that the quality of the drug was evaluated by the agency before its temporary approval.
The FDA's actions follow President Obama's executive order issued in October 2011 to reduce the dire drug shortage. The order instructed the FDA to broaden its reporting of potential drug shortages, expedite regulatory reviews that can help prevent shortages and investigate whether potential shortages have led to price gouging.
The drug shortage has compromised or delayed care for some patients and may have led to otherwise preventable deaths, say many oncologists.
All five pharmaceutical companies that make the injection drug methotrexate, which treats acute lymphoblastic leukemia by slowing the growth of cancer cells, have either slowed or stopped manufacturing of the drug, according to the FDA. The companies have blamed shortages on high demand or manufacturing delays.
Drug manufacturers APP Pharmaceuticals and Hospira Inc. announced at the press briefing Tuesday that within four to six weeks, both companies would have made enough methotrexate, including the preservative-free form, to meet the nationwide demand.
Next week Hospira plans to release 34,000 vials of methotrexate, or a month's supply of the drug, Michael Ball, CEO of Hospira Inc., told reporters at Tuesday's briefing.
According to Michael Link, a pediatric oncologist and president of the American Society of Clinical Oncology, some hospital pharmacies reported having only a couple of weeks of supplies left.
Many oncologists are especially worried about the shortage of the preservative-free form of methotrexate, which is considered less toxic.
Only the preservative-free methotrexate can be injected into the spinal fluid of cancer patients to prevent the spread and recurrence of the disease.
"There are couple other drugs that can be injected into the spinal fluid, but none that are as effective," said Link. "As for the high dose version of the drug, there's no workaround for it."
Digital Vision/Thinkstock(VANCOUVER, British Columbia) -- New research is proving that humans are naturally pretty nice with “pro-social tendencies” and are not as “nasty” as previously thought, according to a top primate behavior expert.
Frans de Waal, a biologist at Emory University in Atlanta, told a meeting of the American Association for the Advancement of Science that new research was helping to challenge earlier beliefs -- popular until more than a decade ago -- that humans were competitive, aggressive and plain-old mean, according to the Discovery Channel.
He showed videos from laboratories of a monkey displaying emotional distress after being denied a treat that another had received as well as a rat turning down a snack to help another rat escape from a trap.
De Waal, the author of The Age of Empathy: Nature’s Lessons for a Kinder Society, said the new research revealed that animals were naturally capable of “reciprocity, fairness, empathy and consolation.”
He told the audience in Vancouver, British Columbia, on Monday that human children and most higher animals, such as primates and elephants, are “moral” because they need to cooperate with each other to reproduce and pass on their genes, the Discovery Channel reported.
But he told reporters that animals empathized with those within their “in group” but that courtesy was not so easily extended in the human world.
ABC News(MEMPHIS, Tenn.) -- David Andrews plays for his freshman basketball team at Germantown High School outside of Memphis.
He wears the number 40. He leads the pregame chant. He swishes threes. And he has Down syndrome.
When Andrews’ mother, Maureen, asked coach Wes Crump if her son could be part of the team that his brother was already on, the coach immediately agreed. But she never expected to see her son practice, let alone play.
“Maureen wasn’t asking for anything other than David maybe getting a sweatsuit, team shoes, and for him to be on the bench with the team,” Crump told ABC News.
What Crump and the team soon realized was Andrews, 18, was going to have a bigger impact than anyone could have imagined. Andrews started participating in practice and during the team’s fourth game he took to the court to chants from the crowd of “We want David! We want David!”
“During the first offensive play, David ran down the left side of the floor into the deep corner. Our point guard passed David the ball, and without hesitating, he shot. Swish!” Crump wrote. “From that game on, it seemed our team had a new goal of getting so far ahead of the other team, that David would have an opportunity to play some minutes.”
Fortunately for Andrews, the Red Devil’s were more than pretty good. They lost only one game all season and he was able to play quite a bit.
Crump said Andrews has put the game into perspective for him. One time after he received a technical foul going into halftime, Andrews’ antics during warmups prior to the second half lifted his mood.
Andrews was hitting shot after shot from the top of the key and the crowd took notice.
“The CBHS parents were applauding his every basket,” Crump told ABC News. “David turned to the stands every time they applauded and flexed for them. As I watched that exchange, I realized just how little the game meant, and how much David means to me and to the people who get to be around him. It completely changed my attitude. I sat there and just smiled.”
File photo. Hemera/Thinkstock(NEW YORK) -- Tami Kemit thought she was coming down with the flu, but the 35-year-old mother of two was actually having a massive heart attack.
Kemit, who lives in Erie, Pa., waited three days before she drove herself to the hospital, where she hoped doctors would give her something for her flu symptoms. Instead, they cut open her chest and performed a triple bypass.
"I had no idea I was having a heart attack," said Kemit. "I'd had only ever seen my father have a heart attack, and he was always grabbing his chest. I had no pain in my chest."
Although chest pain or discomfort is the most common heart attack symptom, fatigue, nausea, shortness of breath and pain or numbness in the jaw, arms or back can also signal a blocked artery cutting off vital oxygen and nutrients from the heart. And according to a new study of more than one million heart attack patients, women under 55 are less likely to seek medical attention for those atypical symptoms and more likely to die in a hospital from a heart attack than men of the same age.
"Young women who have atypical symptoms might not appreciate that they're in fact having a heart attack and may be more likely to delay treatment," said Dr. John Canto, a cardiologist at the Watson Clinic in Lakeland, Fla., and lead author of the study published Tuesday in the Journal of the American Medical Association. "They think it's the flu or stress or a pinched nerve, and they don't want to come in to the hospital only to have doctors tell them it's nothing serious. But we should all err on the side of caution."
Kemit, now 46, takes 30 pills a day for heart failure. The drugs, designed to lower her blood pressure and slow her weak heart, have packed weight on her once-fit frame.
"I'm really fat, but I'm still here," said Kemit, whose doctors gave her five years to live 11 years ago.
Since her first heart attack, Kemit has had three more, signaled by a squeezing in her arm, a tingling in her hand and numbness in her jaw. She never had chest pain.
"Less than 20 percent of patients who present to a hospital with typical or atypical symptoms are in fact having a heart attack," said Canto. "But time is muscle and muscle is life. When an artery is blocked, the heart muscle begins to die after 30 to 60 minutes. We call it the golden hour of heart attacks. Every minute you wait after that golden hour, more heart muscle will die. And once you lose it, it's not coming back."
Dr. Malissa Wood, spokeswoman for the American Heart Association and co-director of Massachusetts General Hospital's Corrigan Women's Heart Health Program, said women tend to look out for the hearts of others more so than their own.
"I think women tend to worry so much about breast cancer, and I understand why," said Wood, who has survived breast cancer herself. "But heart disease is the No. 1 killer of women."
Women should "know their numbers" and risk factors, said Wood. Smoking, high blood pressure, diabetes and a family history of heart disease raise the risk of heart attack.
"The more risk factors you have, the more you really need to pay attention when symptoms strike out of the blue," she said. "It's rare for young women to have a heart attack, but the results can be devastating."
FDA/iStockphoto/Thinkstock(WASHINGTON) -- A U.S. Food and Drug Administration Advisory Committee Wednesday recommended approval of the weight loss drug Qnexa, a treatment many hope will help millions of Americans who struggle with obesity.
