Scientists are working on a technology that would eliminate genetic disease in newborns by combining the DNA of three people instead of two in a single embryo.
However, the announcement of the study raised the alarm that the scientists would open the door for people to create “designer babies” with special features such as eye color, hair color or skin.
Food and Drug Administration officials are meeting over the next two days with the scientists in the project to see if they will allow testing on humans. The process is currently only approved to be used on monkeys.
“Once you make this change, if a female arises from the process and goes on to have children, that change is passed on, so it’s forever,” Phil Yeske, chief science officer of the United Mitochondrial Disease Foundation, told Bloomberg. “That’s uncharted territory; we just don’t know what it means. Permanent change of the human germline has never been done before, and we don’t know what will happen in future generations.”
Four monkeys have been created using the process and have been healthy through their first three years.
A new report from the Government Accountability Office says that drug shortages are continuing to hamper doctors nationwide.
The GAO report is mandated by a 2012 law that gives the Food and Drug Administration the power to manage drug shortages. The GAO was to determine if the FDA has improved responses to the problems.
The report concludes the FDA is preventing more shortages than in the past but that the total number of shortages is increasing. In 2012, the FDA managed 154 potential shortages compared to 35 in 2010. However, the number of drugs in shortage in 2012 was 456 compared to 154 in 2007.
Some of the drugs in the “shortage” category include nitroglycerine for heart issues and cisatracurium, the drug used to paralyze muscles for surgery.
The U.S. Food and Drug Administration released a statement on Tuesday saying they are working with three companies that produce intravenous saline to combat a shortage at American hospitals.
Valerie Jensen, FDA’s Associate Director for Drug Shortages, says that the product manufacturers, Baxter International, Hospira and B. Braun Medical, have committed to stepping up production.
“We have not heard of anyone running out of the IV solutions at this point,” Jensen said, “but we know the hospitals are not comfortable with the low supplies.”
Manufacturers had notified the FDA at the end of 2013 they anticipated delays in filling orders but a significant increase in flu cases have magnified the shortages.
Healthcare providers are reportedly saving saline only for the most seriously ill patients and in many cases using smaller bags to extend the supply.
The Food and Drug Administration issued a warning Friday that over the counter laxatives could be a threat to health.
The release from the FDA said that laxatives are potentially dangerous if consumers don’t follow dosing instructions.
At least 13 deaths have been reported to the FDA because of laxative use.
The FDA said that adults over 55 or anyone with kidney disease should be very careful to use laxatives without a doctor’s approval.
“The bottom line is that these products are safe for otherwise healthy adults and older children for whom dosing instructions are provided on the Drug Facts label as long as they follow these dosing instructions and don’t take the product more often, or in greater amounts, than the label instructs,” Dr. Mona Khurana of the FDA said.
A 17-year-old’s attempt to accelerate weight loss ended up causing so much liver damage he is now awaiting a transplant.
Christopher Herrera had bought concentrated green tea extract at a nutrition store as a “fat burner.” Herrera ended up weeks later at Texas Children’s Hospital with his chest, face and eyes so yellow that his doctor called it almost “highlighter yellow.”
A new study is showing that dietary supplements not regulated by the FDA account for almost 20 percent of liver injuries in hospitals. The number is more than double the 7 percent rate from a decade ago. Investigators say they were only counting “severe” cases of liver damage and were deliberately undercounting the total number of cases.
The FDA is banned from approving or evaluating most supplements before they enter the market because of the 1994 Dietary Supplement Health and Education Act. The FDA can only act until the items are on sale and in many cases only if people have been reported to be harmed by a supplement.
The FDA estimates 70 percent of dietary supplement companies do not follow basic quality control standards.
A study from Consumer Reports shows that about half the chicken breasts sold in U.S. grocery stores contain antibiotic resistant bacteria.
The study shows that if someone were to become ill because of the bacteria on the chicken, it would lead to potentially more difficult cures and possibly hospitalization.
Consumer Reports tested for six types of bacteria in 316 raw chicken breasts purchased at U.S. retailers in July. Almost all of the chicken breasts contained some kind of potentially harmful bacteria and 49.7 percent of the chicken breasts had a former of bacteria resistant to at least three different antibiotics.
The most common antibiotic resistant bacteria were forms that are associated with the antibiotics given to chickens to help increase their growth and fight disease.
The FDA announced last week they will call on meat producers to phase out the use of antibiotics in their animal breeding and growth.
In an attempt to find federal workers who were cheating the government, U.S. agencies ended up examining people who had no direct connection to the U.S. government and had only purchased books on an alert list.
Federal investigators reportedly gathered a list of 4,904 people from the records of two men who were being examined for teaching people how to pass lie detector tests. The officials then gave the list to 30 federal agencies including the IRS, CIA, NSA and Food & Drug Administration. The government hoped to find employees or applicants who tried to use techniques to beat lie detector tests required for security clearances.
McClatchy News Service reports that many of the people investigated by the government agencies after the release of the list had only bought books or DVDs from one of the men being investigated and received no one-on-one training from the suspects.
A source says that federal agencies are under increasing pressure from the White House to find “insider threats” in the wake of the Edward Snowden NSA scandal.
The Food and Drug Administration is announcing plans to force the phasing out of trans fats from the American diet.
The FDA will be requiring the food industry to phase out all trans fans, calling them a direct threat to public health. The FDA believes the elimination of trans fats will prevent 20,000 heart attacks a year and 7,000 deaths.
Health professionals have long cited trans fats as a detriment to good health. Some major cities such as New York have already banned their use.
The agency would not put a timetable on the requirement to remove all trans fats saying they wanted to work with various food markets to lessen the overall economic impact. The plan will take two months for public comment before any final action could be taken on the measure.
Trans fats are found mainly in processed foods like microwave popcorns, frozen pizzas and ready-to-use frostings.
A federal judge struck down key parts of a law in Texas aimed at improving health conditions for women seeking to end their child’s life via abortion.
U.S. District Judge Lee Yeakel blocked the part of the law that requires doctors to have admitting privileges at a nearby hospital because it “places a substantial obstacle in the path of a woman seeking an abortion of a nonviable fetus and is thus an undue burden to her.”
The judge also blocked a part of the law that deals with medication-induced abortions but allowed restrictions to remain. The provisions include requiring the drugs to be used in strict compliance with FDA requirements and making follow up visits mandatory.
Pro-life groups said that the blockage of the law puts women’s lives in danger.
“Blocking this law only puts vulnerable women in greater danger. We are very disturbed that a judge would partially block a law that is grounded in the latest science and in common sense,” Anna Higgins of the Family Research Council told CNN.
The Alliance Defending Freedom is calling for an investigation into Planned Parenthood of Northern New England after saying they are ignoring FDA regulations by distributing abortion inducing drugs past the time approved by the FDA.
Planned Parenthood had been advertising that they can provide the drugs for 14 days longer than the approved time period given by the FDA. Continue reading →