Wednesday, March 12th, 2014
A 7-year-old Memphis boy who is suffering from heart and kidney failure has been denied an experimental drug that could very well help improve his condition. The drug company, in denying the drug to Josh Hardy, says its efforts to get the drug to market–with full FDA approval–will be severely impeded if the medication is given to patients at this stage. More from CNN:
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Here’s the way it works: According to the Food and Drug Administration, if someone has a serious or immediately life-threatening disease and has tried and failed other available treatments, they can ask a drug company for an experimental drug, one that they’re still studying and has not yet been approved by the FDA.
Companies often say yes: The FDA approved 974 compassionate use arrangements in fiscal year 2013.
But pharmaceutical companies often say no, as they did to Josh Hardy.
“Our son will die without this drug,” said Todd Hardy, Josh’s father. “We’re begging them to give it to us.”
So now, like many families, the Hardys have turned to the media, Facebook, and change.org to pressure the drug company to change its mind.
Countless members of “Josh’s army” have responded with angry tweets to @chimerix, telling them to “open their hearts,” asking the executives how they can sleep at night.
“Everyone is watching,” one tweeter warned the company. Others have tweeted out the e-mail addresses of the company’s board members. Chimerix executives say they’ve received physical threats.
Moch, the company president, has read these tweets and said he is heartbroken, but the issue is complex and unsuitable for a 144-long character debate.
At its very simplest, this is it: Chimerix is going full speed ahead to get the drug on the market hopefully by the end of 2016, and if they spend time and money on compassionate use cases, it would greatly hinder their effort to get the drug, brincidofovir, on the market and available to everyone.
The company would have to dish out $50,000 per compassionate-use patient, since insurance doesn’t usually pay for experimental drugs, Moch said. And perhaps even more important than the money, it would divert manpower in this 50-person company, since they’d have to handle the requests and then get the patient’s records and follow up with them, as required by the FDA.
Thursday, March 6th, 2014
A baby girl born in Los Angeles with the HIV virus may soon become the second newborn to have the infection put into remission and, hopefully, cure with a new type of very early treatment. Last year, it was reported that a 3-year-old Mississippi girl had remained in remission 18 months after going off her medication for HIV. Though doctors are hesitant to use the word “cure,” they called that a case of “clear remission.” More from the Detroit News on the Associated Press:
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A host of sophisticated tests at multiple times suggest the LA baby has completely cleared the virus, said Dr. Deborah Persaud, a Johns Hopkins University physician who led the testing. The baby’s signs are different from what doctors see in patients whose infections are merely suppressed by successful treatment, she said.
“We don’t know if the baby is in remission … but it looks like that,” said Dr. Yvonne Bryson, an infectious disease specialist at Mattel Children’s Hospital UCLA who consulted on the girl’s care.
Doctors are cautious about suggesting she has been cured, “but that’s obviously our hope,” Bryson said.
Most HIV-infected moms in the U.S. get AIDS medicines during pregnancy, which greatly cuts the chances they will pass the virus to their babies. The Mississippi baby’s mom received no prenatal care and her HIV was discovered during labor. So doctors knew that infant was at high risk and started her on treatment 30 hours after birth, even before tests could determine whether she was infected.
The LA baby was born at Miller Children’s Hospital Long Beach, and “we knew this mother from a previous pregnancy” and that she was not taking her HIV medicines, said Dr. Audra Deveikis, a pediatric infectious disease specialist at the hospital.
The mom was given AIDS drugs during labor to try to prevent transmission of the virus, and Deveikis started the baby on them a few hours after birth. Tests later confirmed she had been infected, but does not appear to be now, nearly a year later.
The baby is continuing treatment, is in foster care “and looking very healthy,” Bryson said.
Wednesday, February 26th, 2014
Women who take the over-the-counter medication aceitaminophen during pregnancy may have babies with a greater risk of being diagnosed with attention deficit hyperactivity disorder (ADHD) later in childhood, a new study has found. More from The Huffington Post:
The findings, published in JAMA Pediatrics on Monday, are preliminary and do not establish cause and effect. However, they do intensify questions about the risks and benefits of taking the medication while pregnant.
Aspirin and ibuprofen — nonsteroidal anti-inflammatory drugs, or NSAIDs — are generally not recommended as pain relievers for pregnant women, particularly during the last three months. Acetaminophen-based medications such as Tylenol, however, have generally been thought to be safe, and estimates suggest that more than 50 percent of women in the United States take acetaminophen at some point while pregnant.
“It is important we follow up [on] the potential health risks that acetaminophen may cause,” Zeyan Liew, a Ph.D. candidate with the UCLA Fielding School of Public Health and an author on the study, told The Huffington Post. “ADHD incidence has been noticed to be increased in the last decades, and we are interested in searching for avoidable environmental factors that may contribute to the trend.”
Liew and his co-authors looked at data on more than 64,000 women and their children taken from the Danish National Birth Cohort. They found that children whose mothers took acetaminophen while pregnant had a 13 percent to 37 percent greater risk of later being diagnosed with hyperkinetic disorder (which is similar to ADHD, but uses different diagnostic criteria), taking medications for ADHD, or displaying ADHD-like behaviors at age 7.
That link was stronger among women who took acetaminophen in multiple trimesters or who used it more frequently. For example, the risk of behavioral issues was elevated by 50 percent or more in children whose mothers took the pain reliever for more than 20 weeks while pregnant.
Image: Pregnant woman, via Shutterstock
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Tuesday, August 27th, 2013
A new report from the American Academy of Pediatrics (AAP) finds that breastfeeding women can safely use many medications without harming their infants.
Experts from the AAP Committee on Drugs also noted that some doctors give moms inaccurate advice that they must quit nursing or stop taking certain medicines to keep their babies safe. From Reuters:
“Sometimes people are told that, because physicians may be worried about the risks the drug may pose … and aren’t necessarily thinking about the potential benefit of breastfeeding,” Dr. Hari Cheryl Sachs, the lead author on the report, said.
That benefit includes a lower risk of ear infections, asthma and sudden infant death syndrome, according to the U.S. Department of Health and Human Services.
Sachs said properties of the drug itself, whether it’s being used on a long- or short-term basis and the age and health of the infant all affect how safe it is to use medication while breastfeeding.
“It’s hard to make a blanket recommendation on what drugs are fine for the mother, because it’s going to depend on multiple factors,” Sachs, from the Pediatric and Maternal Health Team in the Food and Drug Administration’s Center for Drug Evaluation and Research, told Reuters Health.
If breastfeeding women have questions about specific medications, Sachs recommends that they talk with their doctors and check LactMed, a website run by the National Institutes of Health. Again from Reuters:
[LactMed] includes the most up-to-date scientific knowledge on how much of a given drug is passed to an infant during breastfeeding, its effects on babies and possible alternatives to consider.
In its report, published Monday in Pediatrics, the committee focused on a few classes of drugs, including antidepressants, narcotics and smoking cessation aids.
Limited information is available on the long-term effects of antidepressants on babies, it wrote, and because the drugs take a long time to break down, levels could build up in infants’ bodies.
“Caution is advised” for certain powerful painkillers such as codeine and hydrocodone—but others including morphine are considered safer when used at the lowest possible dose and for the shortest possible time, pediatricians said.
Nicotine replacement therapy, especially gum and lozenges, is typically considered safe to use during breastfeeding, according to the committee. However the FDA discourages the use of stop-smoking drugs such as varenicline, marketed in the U.S. as Chantix, among women who breastfeed.
The risk of exposure to any drug for babies needs to be weighed against the drug’s importance for the mother as well as the benefits of breastfeeding, researchers noted.
Image: Prescription medication via Shutterstock
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American Academy of Pediatrics, antidepressants, breast milk, breastfeeding, LactMed, medications, narcotic painkillers, National Institutes of Health, smoking cessation | Categories:
Child Health, Must Read, New Research, Parents News Now
Thursday, March 22nd, 2012
Since the late 1970s, the number of accidental child poisoning deaths has nearly doubled, a new study conducted by Safe Kids Worldwide has found. In that same period of time, the number of overall poisoning deaths has fallen drastically, but 64 percent of the current number of deaths are due to the misuse of medications.
“About 165 kids — or roughly four school busloads of children — are seen in emergency rooms for medication-related treatment every day in the U.S.,” said Kate Carr, president and CEO of Safe Kids Worldwide, in a statement. “Every one of those trips was preventable. We can and must do better.”
The group offered some safety tips to prevent medication-related poisoning, including:
- Always put medicines and vitamins away after every use. Never leave them on the counter between dosings. Don’t be tempted to “keep them handy” in a purse, backpack, or briefcase, or in an unlocked cabinet or a drawer within a child’s reach.
- Always read and follow label instructions when giving medicines to children.
- Only use the dosing device that comes with the medication. Never use a household utensil, such as a teaspoon or tablespoon, to measure medication.
- Up to 20 percent of pediatric poisonings involve a grandparent’s medication.9 Make sure that all medications in the child’s environment are stored out of reach and out of sight.
- Program the nationwide poison control center number (1-800-222-1222) into your phones.
Image: Prescription drugs, via Shutterstock.
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