Failed TB Vaccines Raise Questions and Mistrust

Oxford University researchers have been creating and testing the MVA85A vaccine, meant to serve as a booster to the Tuberculosis (“TB”) vaccine. In the course of the research, it was discovered that the researchers falsely portrayed pre-clinical results of the booster in order to gain funding for clinical trials. The researchers misrepresented information in both applications for funding and in information given to parents whose children would receive the booster. They claimed that the booster was both safe and more effective at protecting against TB than the regular vaccine alone. The researchers also falsely claimed that the booster had been safely tested in multiple animal studies, which had never occurred. In fact, researchers at Stellenbosch University in South Africa later performed an animal study and the results did not support use of the booster as a way of increasing the effectiveness of the TB vaccine.

The misrepresentations made by the Oxford University researchers have raised questions about the safeguards in place for pre-clinical research. Unlike the extensive requirements for clinical trials, pre-clinical trials do not have to be registered with appropriate authorities, which increases the likelihood that errors and omissions go unnoticed.  Many believe that a registry should be established for pre-clinical trials to provide proper oversight and ensure that unsafe drugs do not reach the marketplace.

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Stem Cell Therapies: U.S. Changing Lanes

The U.S. Food and Drug Administration (“FDA”) has been vocal about their efforts to curtail stem cell programs. Yet, in a surprising turn of events, the FDA commissioner, Dr. Scott Gottlieb, and the director of FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks, have recently co-authored a paper that promotes more accurate research regarding the use of stem cell therapy in medicine. The paper sets forth a detailed plan for assessing the effectiveness of stem cell therapy.

Stem cells have the abilities to mimic other cells in the human body, cells that may not be working properly or at all in patients with various diseases and, therefore, can have significant impacts on the outcome of health. Most promising about Drs. Gottlieb and Marks’ paper is that it opens the door for expanded use of stem cell therapy in the U.S. which was long thought to be closed. In short, it appears that stem cell programs will no longer be given a cold hard “no,” in both the medical and regulatory context.

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Tags: Science, Stem cells, Health, Law, FDA

To Donate or Destroy: Embryo Donation Practices in Australia Shed Light on Ethical Dilemmas

Embryo donation raises a series of challenges. In Australia, the market for embryo donation is comprised of high demand and low supply. In addition, embryos cryopreserved for future reproduction are only kept frozen for a maximum of ten years; then the family must decide whether to destroy or donate the embryos. However, there is no legislation in Australia to direct this decision or to protect the interests of families who choose to donate.

While the thought of destroying an embryo feels unethical to many individuals, the decision to donate may not seem acceptable either. Australian law prohibits anonymous donations and presumes that, at the age of 18, a person is entitled to know the identity of those who donated gametes from which he or she was conceived. Yet, Australia has no legislation that requires people who conceive using donated embryos to inform their children of the embryos’ origins or to inform the donors about the children their embryos helped conceive.

Although the law does not clearly protect the interests of donors, some Australians have found positive experiences when deciding to donate rather than destroy their embryos. Koby and David Argall, for example, explain that the possibility of an embryo staying “frozen in time” was not an option for them and believe that the decision to donate is one of the most important and positive decisions an individual can make.

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Sweden Dismisses Investigation of Stem Cell Scientist

Swedish authorities have dismissed claims against Dr. Paolo Macchiarini, an Italian stem cell scientist, who had been under investigation for voluntary manslaughter in connection with the death of three of his patients following windpipe transplants that were made partly from the patients’ own stem cells. The procedure is considered experimental by many researchers and experts. Yet, many scientists and physicians believe it could revolutionize medicine, particularly in regards to organ renewal and growth of new organs in laboratory settings.

The Swedish authorities argued that the use of “artificial” windpipes is negligent and medically unjust. However, there is very little consensus from medical experts regarding treatment and standard protocols that should be implemented with stem cell research. In addition, the Swedish authorities could not establish a direct connection between Dr. Macchiarini’s actions and the deaths of his patients. Without sufficient causation or standard of care protocols, the claims against Dr. Macchiarini were dismissed.

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Cuba Discovers Cancer Treatment, Yet Embargo Keeps It Out of Reach for U.S. Patients

The fast-growing biotechnology industry in Cuba has created a new cancer drug called Cimavax. The drug targets epidermal growth cells and allows the body to attack the cancer on its own. Cancer patients who use the drug are expected to live 3 to 5 months longer.  Yet, patients in the United States have limited access to the new treatment. The United States has imposed a trade embargo on Cuba that prevents the importation of goods such as medication and, therefore,  requires patients to travel to Cuba in order to receive the new treatment.

From, “A Souvenir Smuggled Home From Cuba: A Cancer Vaccine”

Excerpt from article:

“The trial could take years, but American cancer patients are not waiting. Over the past couple of years, dozens have slipped into Havana and smuggled vials of the vaccine in refrigerated lunchboxes back to the United States, sometimes not even telling their doctors. Talk about Cimavax on cancer patient networks online has been escalating steadily as relations between the two countries have warmed and more patients are making preparations to go…”

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Tags: Cancer, Treatment, News, Research

Removing Fetal Tumors In Utero

According to an October 20, 2016 article, a doctors in Texas removed a sacrococcygeal teratoma (a rare tumor found on the tailbone of a newborn) from a fetus by removing the fetus from the womb, performing the surgery and then placing the fetus back into the mother’s womb. The surgery was important for the mother because she had lost the fetus’s twin during her second trimester. Without the surgery, the fetus would compete with the tumor for blood supply and may have grown increasingly ill before birth. The child was born after a full-term pregnancy, begging the question: was the baby born twice?

From, “Meet the baby who was born twice”

Excerpt from article:

“As Cass describes it, first their obstetrician tells them there’s something wrong and then they’re told there’s nothing that can be done and their babies will die and then a surgeon tells them there’s something that can be done. Amazingly, some end with a healthy baby.”

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Should Individuals who Donate their DNA and Other Biological Samples to Research Have Control Over How their Samples are Used?

An article dated, October 10, 2016, explained the growing “biorights” movement and the issues that arise when individuals refuse to donate their biological samples for free and/or demand control over how researchers can use their samples. Much of this controversy stems from the case of Henrietta Lacks, whose cells were taken without her consent or compensation and were used for decades in research that resulted in major medical discoveries. Many individuals believe they have a right to control their biological samples even after they are donated. However, researchers are concerned that this biorights movement will hinder medical advances by reducing the availability of samples they need to conduct research that can potentially make vast impacts on public health and welfare.

From the Boston Globe, “‘Biorights’ Rise: Donors Demand Control of Their Samples

Excerpt from article:

No longer are patients or donors like O’Connor remaining passive when it comes to providing blood, saliva, or tissue samples used for research — samples that are used to help researchers find treatments that can earn drug makers millions, or even billions, of dollars.

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How Sure is Sure? The Ethical Use of Neuroscience in Court

Is neuroscience ready to be used in the courtroom? Judge Jed S. Rakoff, a federal judge for the Southern District of New York, doesn’t think so. Lawyers have been attempting to use neuroscience as evidence with increasing frequency, for purposes such as showing brain dysfunction, proving pain, or acting as a lie detector. However, Rakoff and many other judges are cautious to use this still developing area of science as evidence because “[d]uring the last century, the law [has] embraced science in ways that were inhumane and harmful—and eventually discredited.” An example of harmful science being embraced by the law is the practice of eugenics, which caused several states to allow forced sterilization of women. Another example is lobotomies, which used to be regularly ordered by courts to treat psychiatric patients, some with consent and some without. And as recently as the 1990s, science with no solid basis was used to supposedly recover memories, which led to criminal convictions.

According to concerned judges, this is the danger of allowing neuroscience into evidence, as it can lead to reliance on information which may eventually be discredited, producing unethical results. The effects of these decisions may be permanent, so it is important for science to be very well founded before entering the courtroom; otherwise a fleeting, erroneous scientific theory could have life-long results. “The worst thing that can happen with neuroscience is that it gets into the courtroom before it’s ready,” said Rakoff. This of course begs the question: “how certain must scientists be before their findings can appropriately be used as evidence?” In other words, “how sure is sure?”


Three-Person IVF Possible in 2015 per UK Government

The UK is now drafting regulations for the use of “three person IVF” – a technique designed to eliminate certain mitochondrial disease.  Mitochondria produce energy within cells, and mitochondrial DNA, which comes only from the mother, determines how mitochondria function in an individual. Three-person IVF replaces “bad” mitochondrial DNA from the mother with mitochondrial DNA from a donor’s egg.

To read more, click here.