Thursday, May 20, 2010

Synthetic Biology on the Loose!

As biotechnology advances, so do the safety issues. Synthetic biology poses additional threats to public health and safety as biocontainment in private companies remains unregulated.

Craig Venter and company have built the genome of a bacterium from scratch and incorporated it into a cell to make what they call the world's first synthetic life form. Although this is a startling scientific advancement with ethical and safety issues, Ventor naturally downplays safety risks. For more on this story see this link with a great video:

See also:

Wednesday, May 19, 2010


In light of all the recent biosafety issues, another biotech worker has become infected by an infectious microorganism while working in an infectious disease laboratory at University of Wisconsin-Madison. The University has been fined and a Professor of Infectious Disease has been punished by removal of his laboratory privileges.

University of W-Madison Professor Gary Splitter worked on Brucella, a microorganism which can cause Brucellosis, a major zoonotic disease. The disease can infect animals and can also cause a contagious disease in humans. Brucella is considered a bioterrorist agent. A biotech worker had become infected while working in Splitter's laboratory.

The Wisconsin State Journal states: "His lab created antibiotic-resistant strains of brucellosis and inserted them into mice in 2007 and possibly earlier, university officials said, without approval from local or federal agencies. The concern is that if someone contracted the antibiotic-resistant version of the disease created in the lab, treatment might have been more difficult." "

Splitter will lose his laboratory privileges for five years due to this serious biosafety incident and since his laboratory was not within recombinant DNA NIH standards. The university was fined $40,000 for their role also in violations of laboratory and public health and safety standards.

Biosafety is a current worker safety and public health and safety issue. Injured biotech workers can remain ill and untreated in the United States since diseases from genetically modified organisms or laboratory strains are difficult to diagnose. In addition biotech workers have no legal rights to appropriate exposure records for treatment after incurring an exposure.

Although academic labs such as University of Wisconsin are mandated to follow NIH guidelines, private industry is under no such constraint, leaving a big gap in public health and safety standards.

The biotech worker in Splitter's lab who became infected with Brucella remains unidentified.


Tuesday, May 4, 2010


Kendall from Wall Street Journal writes about a big win for investors against Pfizer, Inc for fraud. Big News!

High Court Rejects Pfizer Appeal in Investor Suit

WASHINGTON—The U.S. Supreme Court on Monday rejected an appeal by Pfizer Inc. that sought to thwart a securities lawsuit alleging the drugmaker misrepresented the safety profile of the blockbuster pain drug Celebrex.
The plaintiffs alleged that Pfizer's Pharmacia unit deliberately withheld the full results of a medical study that showed no safety advantage to using Celebrex over less expensive anti-inflammatory drugs.
Pfizer argued that investors missed a two-year statute of limitations to bring the lawsuit. The investors said there was no evidence of a possible fraud until the Washington Post published ...

for more go to WSJ link:

Geneticist Dies from Work-related Plague

University of Chicago geneticist may have died of an infection linked to the plague
Erin Podolak

Malcolm Casadaban was researching the genetics of harmful bacteria, including a weakened strain of the bacteria that causes the plague, when he became infected.
On Sept. 13, University of Chicago geneticist Malcolm Casadaban died from an infection which has been attributed to a weakened laboratory strain of Yersinia pestis, the bacteria that causes the plague. Sixty- year-old Casadaban was working with Y. pestis, and other unspecified bacteria, for a genetic study.
According to a statement from the University of Chicago Medical Center, the laboratory strain of Y. pestis was found in blood samples taken from Casadaban after he was admitted to the Medical Center’s Bernard Mitchell Hospital. The finding suggests the possibility that Casadaban died from a form of infection known as septicemic plague, which can lead to death before any other physical symptoms of the disease develop.
Kenneth Alexander, chief of pediatric infectious disease at the medical center, described the case as a mystery. In a statement from the medical center, Alexander said that the bacterium is not typically fatal. The laboratory strain is engineered to lack the key proteins that cause it to be harmful to humans. The strain is considered so safe that it has even been used in some countries as a live-attenuated vaccine against the disease. The strain is approved by the Centers for Disease Control and Prevention (CDC) for routine laboratory use.
The infection control team at the medical center is working with the Chicago Department of Public Health (CDPH), the Illinois Department of Public Health, and the CDC to investigate Casadaban’s death. According to the Medical Center, no other illnesses related to the case have been reported.
Officials are looking into the possibility that an underlying medical condition may have contributed to Casadaban’s death. However, the medical center has reported that the initial autopsy indicated no obvious cause of death except for the presence of the bacteria in blood cultures. According to the medical center, conditions like high levels of iron in the blood can increase susceptibility to infection.
Though the strain is not known to be deadly, officials are taking all precautions. Casadaban’s lab has been sealed off in accordance with the investigation, and on Sept. 18, the medical center began notifying family, friends, colleagues, and health care personnel who had contact with Casadaban prior to his death. "While the death of this individual researcher is terrible and tragic, there is currently no indication that his case of illness spread to anyone else," the CDPH said in a statement.
Symptoms of the plague usually develop within 2-10 days of exposure. The University has reported that none of those who had contact with Casadaban have reported any illness. The typical treatment for the disease is a course of antibiotics.
Casadaban held degrees from Harvard, Stanford, and the Massachusetts Institute of Technology. He was also a member of the University of Chicago’s Institutional Biosafety Committee, which regulates research protocols for the use of biohazardous substances.
A memorial for Casadaban was held at the University on Sept. 16. A funeral service is planned for November. “This death is a tragic loss to our community,” James L. Madara, dean of the Biological Sciences Division and Pritzker School of Medicine, and CEO of the Medical Center, said in a statement. “We are all saddened to lose a valued colleague.” Those wishing to make donations have been asked to contribute to the American Diabetes Research Association.
The plague appears in three forms, septicemic, pneumonic, and bubonic. The bubonic plague infects the lymph nodes and is infamous for the outbreak in Europe in the 1300s. Pneumonic plague infects the lungs. Septicemic plague is an infection of the blood. It is the rarest of the three forms, but considered the most lethal.
Infection due to the modified strain of Y. pestis is so rare that data regarding infection rate is unavailable. In the United States about 20 cases of plague are reported each year due to unmodified strains of Y. pestis. Plague remains a significant problem in developing countries where up to 3,000 cases are reported yearly.

Monday, May 3, 2010

New Deadly Emerging Disease Caused By A Fungus

Killer fungus from Oregon could spread across the West Coast 30 April 2010, 2:27 pm

Researchers have identified a highly fatal emerging disease caused by the spores of a fungus known as Cryptococcus gattii, or C. gattii. Because the fungus may spread in lumber, wind, water, and animals— including those as disparate as birds, dogs, farm animals, and even dolphins—researchers expect that the fungus will eventually spread to Northern California, where the climate is similar, but will be stopped from eastward expansion by freezing winters.
The researchers involved in the study began looking at animal deaths caused by the fungus, and noticed they were dealing with a new, more virulent strain closely related to another—and still quite dangerous— C. gattii species found in nearby British Columbia.
“This novel fungus is worrisome because it appears to be a threat to otherwise healthy people,” said co-author Edmond Byrnes III, in a release from PLoS Pathogens, the journal that published the study. “We more often see this fungal disease associated with transplant recipients and HIV-infected patients, but that is not what we are seeing yet.”
The fungus cannot spread from person to person, or from animal to person. A recent paper from the Centers for Disease Control and Prevention reported that people appear mostly likely to become infected near their homes, and that the disease is most prevalent in forested, rural, or semi-urban areas where older trees are common, but it has also been found in urban areas. Mature trees, especially eucalyptus, are thought to provide a breeding ground for the fungus.
While the new strain of the disease has killed one in four people who have been known to come down with it, so far it has affected very few Americans. The researchers analyzed 21 cases and found 5 deaths, though there are almost certainly more cases.
While the study sample is small, an analysis of the pathogen in mice confirmed that the new species of C. gattii was more virulent than the British Columbia strain. Still, no special precautions or travel restrictions have yet been recommended, likely due to the low risk of acquiring C. gattii—even for people living in the endemic areas, according to the Oregon state health authorities.*
Most people who do encounter the fungus never develop symptoms, but those who do usually develop pneumonia—an infection of the lungs—two months to about a year after the initial exposure. The signs of pneumonia include, a cough lasting weeks, sharp chest pains, shortness of breath, headache, fever, nighttime sweats, and weight loss, among others.
Approximately 20 percent of C. gattii cases result in meningitis—an inflammation of the brain and spinal cord. The symptoms of meningitis may also include fever, headache, a stiff neck, nausea, vomiting, sensitivity to light, confusion, sleepiness and seizures, among others.
Both meningitis and pneumonia can be serious, whatever the cause, so see a doctor if you have symptoms for either. If your physician is having trouble treating your condition and you live in the Pacific Northwest or have visited there within the previous year, it may be worthwhile to raise the possibility of a fungal infection. Your doctor may have several screening options and medical treatments, including antifungal drugs.
The researchers said that further study of the disease is necessary to fully understand where it spreads and how to treat it most effectively. Environmental factors are thought to be behind the emergence of the tropical fungus into temperate regions. Whatever the cause, the disease does not seem widespread enough to cause you to alter your travel plans. But know the symptoms, and see a doctor if you develop signs of pneumonia or meningitis.
For more, see the CDC's page on cryptococcus.
—Kevin McCarthy, associate editor

Also see:


The Genetic Information Nondiscrimation Act Is Tested

The NYT recently wrote an article about Pam Fink from Connecticut who alleges she was fired for genetic discrimination of having a predisposition for breast cancer. The article states that there has been already 80 complaints filed under the new law, GINA, (the Genetic Information Nondiscrimination Act of 2008) which prohibits such discrimination.

The toubling fact of the matter, however, is that there has been no reports stating that any of the 80 complaints have been successful using GINA to protect against genetic discrimination.

“Peggy R. Mastroianni, the commission’s associate legal counsel, said most of the 80 complaints filed since the genetic law took effect five months ago seemed to involve cases in which employers had improperly acquired or disclosed genetic information. But Ms. Fink’s case alleges a more serious offense: an improper firing because of it.”

Let us hope that Ms. Fink is successful. But GINA is a weak law making the probability slim. If she does win, it will make GINA stronger and help protect others against genetic discrimination.

See the NYT article here:

Cows Genetically Modified with Human Genes Die

Well, the picture is a bit far-fetched...but the story is not.

Mutant cows die in GM trial
By Eloise Gibson May 1, 2010
Genetically modified cows were born with ovaries that grew so large they caused ruptures and killed the animals.
The bungled experiment happened during a study by AgResearch scientists at Ruakura, Hamilton, to find human fertility treatments through GM cows’ milk.
AgResearch is studying tissue from one of three dead calves to try to find out what made the ovaries grow up to the size of tennis balls rather than the usual thumbnail-size.
Details of the deaths – in veterinary reports released to the Weekend Herald under the Official Information Act – have reignited debate over the ethics of GM trials on animals.
AgResearch’s applied technologies group manager, Dr Jimmy Suttie, said he did not see the deaths as a “big deal”, and they were part of the learning process for scientists.
But GE-Free NZ spokesman Jon Carapiet said details of the calf trial showed the animal welfare committee overseeing AgResearch’s work was “miles away from the ethics and values of the community”.
The calves died last year, aged six months. They were formed when human genetic code injected into a cow cell was added to an egg from a cow’s ovary and put into a cow’s uterus.
The scientists hoped that the genetic code, a human follicle stimulating hormone (FSH), would enable the cows that were produced to produce milk containing compounds that could be used as a human fertility treatment.
Under permits issued by the Environmental Risk Management Authority last month, AgResearch can put human genes into goats, sheep and cows for 20 years to see if the animals produce human proteins in their milk.
The proteins could eventually be used to treat human disorders.
Anti-GM groups said the cost to animal welfare was too high, citing cases of aborted and deformed fetuses, deformed calves and respiratory conditions among animals bred at Ruakura.
The Official Information Act documents show a Ministry of Agriculture and Forestry (MAF) investigation found deformities and respiratory problems among animals at the facility – something AgResearch had been open about – but said that was a foreseeable by-product of the project.
Overall, the investigator found cows were better cared for by vets at Ruakura than they would be on a standard dairy farm.
Scientists noticed that four calves carrying the FSH gene grew more quickly than their clone sister, which did not have the gene.
The FSH calves had bigger abdomens and thicker necks but seemed otherwise healthy, apart from one that easily grew short of breath, said a vet’s report.
Dr Suttie said the abnormalities were reported to the animal ethics committee, which told the company to monitor the calves.
Tests five months later found three of the four calves had abnormally large ovaries.
When the calves were six months old, one died suddenly of a haemorrhage to her uterine artery, probably because of stretching and distortion caused by her deformed ovaries.
Five days later, a second calf died, after her ovary became twisted and separated from her uterus.
The third calf with over-sized ovaries was killed the same day so scientists could study her tissue.
Dr Suttie said the root of the trouble was that the human FSH genes had affected the whole calf and not the mammary glands only, as was intended – a problem that did not show up in trials on mice.
“This was not intended to happen. But, bluntly, this is what research is all about.”
Emails between AgResearch and MAF reveal Agriculture Minister David Carter sought more information about animal welfare when he learned of the calves deaths last year.
He said yesterday that he was satisfied with AgResearch’s response.