Category: Colombia

Colombia drug regulator halts clinical research at US-funded facility

Following an inspection earlier this month, Colombia’s FDA has suspended all human research at a facility that until this summer had been receiving U.S. funding to develop a malaria vaccine.

The Malaria Vaccine and Development Center, in the city of Cali in western Colombia, is part of the Caucaseco Scientific Research Consortium, which is run by husband-and-wife team Myriam Arévalo-Herrera and Sócrates Herrera. The couple has secured more than $17 million from the U.S. National Institutes of Health (NIH) since 2003. 

As we reported in April, an investigation by the group People for the Ethical Treatment of Animals (PETA) exposed a host of serious problems at the facilities, including widespread animal abuse and falsified research approvals. The NIH defunded the facilities in June, as first reported by STAT.

According to a statement released on August 5 (in Spanish), the Colombian National Institute of Drug and Food Surveillance (Invima) made the following findings during its inspection of the Malaria Vaccine and Development Center:

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US-backed researchers in Colombia accused of experimenting on animals, humans without approval

On January 16, inspectors from an environmental agency in western Colombia made some troubling findings. At a U.S.-funded facility supposed to be doing cutting-edge malaria research, researchers were keeping dozens of monkeys in dirty cages in poorly ventilated, over-lit enclosures. Several animals were smeared with feces. Some looked sick, and one was missing an eye. A fetid smell hung in the air. On the floor of a cage, a baby monkey lay dead.

It wasn’t the first time Fundación Centro de Primates (FUCEP) had run afoul of local authorities. In 2021, inspectors had turned up signs of “animal abuse” at the facility, located a few miles from the city of Cali, and found no veterinarian on site. Perhaps more damning, the researchers in charge did not have the permits required to experiment on or keep lab animals.

But the problems may run even deeper. According to an 18-months investigation by People for the Ethical Treatment of Animals (PETA), a U.S.-based animal-rights group, FUCEP’s parent organization, Caucaseco Scientific Research Consortium, apparently also conducted research in people without valid ethics approvals. These allegations have not previously been described in the media.

Continue reading US-backed researchers in Colombia accused of experimenting on animals, humans without approval

Methodology of paper linking vaccine to behavioral issues “seriously flawed,” says retraction

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After temporarily removing a paper that suggested a link between the vaccine for the human papillomavirus (HPV) and behavioral issues, the journal has now retracted it.

Vaccine says the reason is “serious concerns regarding the scientific soundness of the article,” including flawed methodology and unjustified claims.

Christopher A. Shaw, a co-author on the paper and a researcher at the University of British Columbia, told us he has seen the notice, but doesn’t know the specific issues the journal had with the paper:

We still don’t know why [Editor in Chief] Dr Poland removed the article.

Here’s the retraction notice for “Behavioral abnormalities in young female mice following administration of aluminum adjuvants and the human papillomavirus (HPV) vaccine Gardasil:”

Continue reading Methodology of paper linking vaccine to behavioral issues “seriously flawed,” says retraction

Journal temporarily removes paper linking HPV vaccine to behavioral issues

1-s2.0-S0264410X16X00084-cov150hThe editor in chief of Vaccine has removed a paper suggesting a human papillomavirus (HPV) vaccine can trigger behavioral changes in mice.

The note doesn’t provide any reason for the withdrawal, although authors were told the editor asked for further review.

Two co-authors on the paper — about Gardasil, a vaccine against HPV — have previously suggested that aluminum in vaccines is linked to autism, in research a World Health Organization advisory body concluded was “seriously flawed.”

Approximately 80 million doses of Gardasil were administered in the U.S. between 2006 and 2015. Both the the WHO and the Centers for Disease Control and Prevention have ruled the vaccine to be safe — the CDC, for instance, calls it “safe, effective, and recommended.”

The journal published an uncorrected proof of “Behavioral abnormalities in young female mice following administration of aluminum adjuvants and the human papillomavirus (HPV) vaccine Gardasil” online on January 9th, 2016. In its place now is a note that says:

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Paper on the adhesiveness of a material doesn’t stick

1-s2.0-S0169433215X00213-cov150hApplied Surface Science has retracted an article that looks at the structure of thin tungsten-titanium coating, because it was submitted without all of the co-authors’ consent.

According to the introduction of the paper, “Structure adhesion and corrosion resistance study of tungsten bisulfide doped with titanium deposited by DC magnetron co-sputtering,” such thin films are “widely used as a surface treatment for optimizing base material properties.”

Here’s the retraction note in full, published in the September issue of the journal:

Continue reading Paper on the adhesiveness of a material doesn’t stick