Editing Embryos: Scientist Begins Research Involving Modifying Genes of Human Embryos

In an article dated September 22, 2016, it was revealed that a Swedish scientist has become the first known researcher to begin attempts to modify genes in healthy human embryos—a practice which has been, and for many still is, considered “taboo.” Critics are concerned that people will begin to use such technology to create “designer” babies, or that such research could unintentionally create a new genetic disease; however, the scientist involved says he plans to use the embryos for no more than 14 days, in which time he may be able to discover new ways to treat infertility, prevent miscarriages, and use stem cells to treat various diseases.

From NPR.org, “Breaking Taboo, Swedish Scientist Seeks to Edit DNA of Healthy Human Embryos”

Excerpt from article:

“Lanner is planning to methodically knock out a series of genes that he has identified through previous work as being crucial to normal embryonic development. He hopes that will help him learn more about what the genes do and which ones cause infertility.”

Read Full Article.

 

Advertisements

FDA Takes the Advocates’ Advice: Approves Drug from Muscular Dystrophy

In an article dated September 19, 2016, Muscular Dystrophy patients and advocates, with the help of select members of Congress, celebrated the FDA’s approval of Eteplirsen, a drug manufactured by Sarepta Therapeutics for treatment of a type of muscular dystrophy that predominantly affects boys in their childhood. Advocates fought heavily for the approval even though there are limited clinical trials to confirm the drug’s effectiveness. While the drug may help up to 12,000 Americans affected by the disease, critics worry that the FDA has set a “dangerous precedent” by its decision.

From NYTimes.com, “F.D.A. Approves Muscular Dystrophy Drug That Patients Lobbied For”

Excerpt from article:

[I]t was taken as a deeply troubling sign among drug policy experts who believe the F.D.A. has been far too influenced by patient advocates and drug companies, and has allowed the delicate balance in drug approvals to tilt toward speedy decisions based on preliminary data and away from more conclusive evidence of effectiveness and safety. . .

To read full article:   F.D.A. Approves Muscular Dystrophy Drug That Patients Lobbied For

 

 

The Link Between C-Sections and Obesity

This article reports on a study showing that the method of childbirth might affect that child’s weight well into adulthood. Babies who were delivered by caesarean have a 15% higher risk of being obese than babies who were delivered vaginally. The article suggests causative links, but the study did not prove that a caesarean section is a cause of obesity.

From TheGuardian.com, “Babies born by caesarean more likely to be obese as adults, study suggests”

Excerpt from article:

“Birth by caesarean was linked to a 15% higher risk of obesity in children compared with vaginal birth.”

 To read full article: Babies born by caesarean more likely to be obese as adults, study suggests

Innovative or Experimental? Brain Surgeon Tests Rumored Treatment on Three Patients

Under what circumstances is it acceptable for doctors to treat a patient, particularly one with a very poor prognosis, with an untested or experimental treatment? Dr. Paul Muizelaar confronted this problem firsthand a few years ago, when he performed three surgeries based on a long-lasting hospital rumor.  The rumor was that for a certain type of brain tumor, called glioblatoma multiforme, an infection of the wound site during surgery could actually extend a patient’s life significantly. A few studies on the method led to divergent results.  At present, there is no scientific consensus on the procedure’s effectiveness.

Despite this lack of data and previous failure to secure funding for animal research on the topic, Dr. Muizelaar first tested this treatment on a friend of his who was diagnosed with the deadly tumor and had exhausted all standard treatments. The treatment would include surgery on the tumor, during which Muizelaar would intentionally infect the brain with a type of bacteria found in fecal matter. Muizelaar had been given limited approval to conduct the surgery from the hospital’s review board, as it could probably be classified as “innovative treatment” rather than human research. The outcome was just enough to give some hope, and so Muizelaar quickly wanted to try it on another patient. This led to a second surgery, on another patient who had already exhausted the usual treatment options.  The hospital’s administration was much more hesitant about this second surgery. Muizelaar was told that if he planned to do any more of these surgeries he should submit a formal application to the FDA and hospital. However, Muizelaar performed one more surgery. He said that at the time it didn’t even occur to him that he wasn’t following those instructions, and he was just trying to treat the patient. This last patient was newly diagnosed, hadn’t had any standard treatments yet, and ended up passing away within a few weeks of the surgery.

Muizelaar was widely scrutinized for these surgeries and was eventually forced to retire from his high-ranking position at the hospital. Did Dr. Muizelaar go too far? He claims that his goal was only to help patients and that these patients had almost no other hope for survival. Any formal research progress in this area would have taken many years after these patients’ deaths. Should doctors be able to test ideas on patients without following the usual protocols for human research? Is this type of regulation stifling innovation or protecting patients from dangerous experimentation?

Source: http://www.newyorker.com/magazine/2015/12/07/bacteria-on-the-brain?intcid=mod-most-popular

FDA Compliant Stem Cell Manufacturing Process Made Available Free of Charge

In recent years, human-induced pluripotent stem cell (“IPS cell”) research has emerged as a treatment modality that potentially avoids the ethical objections connected with embryonic stem cells.

First produced in 2007, IPS cells are differentiated so that they serve a specific function, like dopamine production, before being implanted. Undifferentiated cells can form tumors called teratomas and therefore, differentiating cells is key to enhancing safety.

Biotech company, Lonza, has published a paper detailing the company’s stem cell manufacturing process and announced the availability of its IPS cell banks. In the paper, the company states: “To our knowledge, no fully cGMP-compliant cell line has been generated where the entire manufacturing process, from tissue sourcing to cell expansion and banking processes as well as documentation, raw materials, staff training, cell therapy facility, and quality control (QC) testing, was validated.”

The design will be compliant with FDA’s Good Manufacturing Practices and the basic process is available without charge, though the detailed version (the one that produced Lonza’s cell banks) is still proprietary.

Source: http://www.sandiegouniontribune.com/news/2015/sep/24/induced-pluripotent-stem-cell-lonza-manufacturing/

Study Shows New Nerve Treatment Doesn’t Have the Side Effects of Traditional Treatments

Traditionally, doctors have relied on two techniques to treat jagged nerve injuries that cause gaps in nerves. One technique is called a “nerve autograft” which takes nerve tissue from one part of the patient’s body and uses it to repair the injured nerve. However, because the nerve used to repair the injured nerve is harvested from another part of the patient’s body, the harvest site experiences a “nerve deficit.” The other approach is to use a “nerve conduit,” a synthetic tube that fills the gap in the nerve. A nerve conduit may cause problems for the patient because implants can be rejected by the patent’s body or become infected.

However, a recent study conducted by Dr. Brian Ringer suggests that a new treatment known as a “nerve allograph” can repair the gap in a severed nerve without the side effects of the two traditional methods of treatment. An allograft uses an actual human nerve, taken from a cadaver, to repair the patient’s nerve injury. The study found less foreign body reactions and infections when compared to nerve conduit operations, and the technique does not leave the patient with a nerve deficit somewhere else in the body.

Read more here.

Stress May Be Passed Down Through Generations

BMC Medicine, an open-access, online medical journal, recently published the results of a study indicating that stress during pregnancy may stretch across generations. Researchers subjected late-term, pregnant rats to high levels of stress, which in turn caused shorter pregnancies. Then, the researchers separated the next two generations of female rats into two groups. Group one was subjected to stress during pregnancy; group two was not subjected to stress. Both groups showed shorter pregnancies than rats whose ancestors were not stressed during their pregnancies. Thus, the study suggests that stress during pregnancy can be passed along to future generations, even causing shorter pregnancies for mothers who did not suffer high amounts of stress during pregnancy.

Read more here.

“Cure” HIV by Speeding Up the Virus’ Mutation?

It has been fifteen years since MIT professor John Essigmann proposed that in order to fight HIV, drugs should be developed that drastically increase the rate of the virus’ mutation. Essigmann’s idea has lead to the current use of inhibitors (drugs that force cells to mutate so quickly they weaken) for HIV treatment. Once HIV infects a cell, it “rapidly makes copies of its genetic material.” Rapid copying causes errors allowing the virus to mutate quickly and evade the immune system. Essigmann hypothesized that the virus could be starved of essential proteins if the mutation process is increased to an even more rapid pace, eventually killing the virus. Current HIV treatments fight the virus using Essigmann’s 15-year old idea of forcing cells to mutate at unsustainable rates, but researchers have not yet been able to completely “cure” patients.

Read more here.

CDC Reviews Safety Procedures After Accidently Shipping the Deadly H5N1 Virus

The Center for Disease Control and Prevention (“CDC”) stopped shipments of samples from its “high security” laboratories following accidents with Anthrax and the deadly H5N1 flu virus. The CDC reported that many employees might have been exposed to live Anthrax after workers failed to properly “inactivate the bacteria” before shipment to other labs. Most recently, CDC workers accidentally cross-contaminated the “low-pathogenic” H9N2 virus with the highly deadly H5N1, then shipped the sample to the U.S. Department of Agriculture. The CDC said that it would be reviewing the safety procedures involving shipments from its high security laboratories.

Read more here.

Violent Video Games Can Make Players Sensitive to Real-World Moral Codes

Violent video games may not cause players to become desensitized to the “real world.”  In fact, Mathew Grizzard, PhD, assistant professor at the University at Buffalo Department of Communication, found the opposite to be true. His findings reveal “heinous behavior” in the virtual world does not lead players to become less moral but might actually increase players’ sensitivity to real-world moral codes.   The study showed that players that committed heinous acts in video games had feelings of guilt that elicit pro-social behavior in the real world.

Read more here.