15 December News

FDA Urged to Consider Ban on Cow Brain Products

26 October (Reuters Health [Ori Twersky])— The US Food and Drug Administration (FDA) may soon consider banning the sale of any product containing cow brains or spinal tissue, whether made abroad or here in the US.

Expert advisors to the FDA voted 18 to 1 on Friday in favor of urging the federal agency to begin assessing the necessity and feasibility of passing regulations to either ban or restrict the use of products containing these tissues, due to the theoretical risk of “mad cow” disease (BSE).

These products range from soup stock and sausage casings to cosmetics, drugs, medical devices, and dietary supplements.

The FDA's Transmissible Spongiform Encephalopathies Advisory Committee's vote was based largely upon the potential risk products containing cow brain or spinal tissue could pose to Americans.

The FDA already has already banned the importation of products containing cow-derived material from countries with documented BSE cases. It has also asked blood collection centers to defer donors who spent 6 months or more in the UK between 1980 and 1996. However, no case of vCJD or CJD transmission via blood or blood products has ever been documented or reported.

The FDA committee said its primary concern in making its recommendation was the lack of a definitive, real-time test to identify incubating infections. The committee added it was also concerned that the US could inadvertently import contaminated products, especially dietary supplements. The FDA had previously issued an advisory on importing dietary supplements from countries with documented BSE cases, but not from those that appear to be BSE-free.

Should the FDA follow its committee's recommendation, which the agency generally does, it will undoubtedly face criticism.

Critics have charged that the FDA has already overstepped its bounds and created the perception of a public health threat when there was none by passing precautionary regulations and advisories. These critics have also charged that the FDA could be creating a slippery slope by distorting the meaning of a real public health threat versus a minimal individual risk.

But if the FDA should follow its committee recommendation, there are unlikely to be any immediate consequences. The FDA's rule-making process could take months and even years to complete, while the agency reviews the available data and upcoming studies.

Editor's comment. It was news to me—and somewhat disconcerting—that tissues from cow brains and spinal cords are found in so many products, including soups.

Health Care Workers' Long Nails May Carry Bacteria

26 October (Reuters Health [Melissa Schorr])—Health care practitioners with long fingernails may be more likely to harbor bacteria that can lead to patient infections than those with shorter nails, researchers reported here Friday at the annual meeting of the Infectious Diseases Society of America.

“The longer your nails are, the more pathogens you have,” lead author Dr. Shelly A. McNeil, an assistant professor of internal medicine at Dalhousie University in Halifax, Nova Scotia, told Reuters Health. “Longer nails may pose an increased risk to patients.”

The researchers conducted the study after several newborns died during an outbreak of Pseudomonas infection in an Oklahoma hospital. The outbreak was linked to two nurses who carried the bacteria on their hands—one who had long natural nails and one who had long artificial nails.

Previous work had found that artificial nails are more likely than natural nails to harbor bacteria, and many hospitals now ban their staff from wearing them. The researchers wanted to see whether nail length was a cause for concern as well.

The investigators found that, before hand washing, all 7 of the nurses with nails longer than 3 millimeters had dangerous bacteria on their nails, compared with only 2 of the 11 health care workers with nails 3 millimeters or less.

Overall, the researchers estimated that the nurses with nails longer than 3 millimeters were more than 5 times as likely to carry pathogens as the nurses with nails shorter than 3 millimeters.

Assuming a larger study confirms these findings, the researchers advise health care workers in especially vulnerable areas of the hospitals, such as the intensive care unit, should keep their fingernails clipped to less than 3 millimeters in length.

Us Decides to Issue Anthrax Vaccine

29 October (Reuters)—Decontamination personnel and hundreds of state and private laboratory workers on the front line of the anthrax scare will be eligible for vaccination against the germ warfare agent, the Centers for Disease Control and Prevention said on Friday.

The spokesman, who spoke on the condition of anonymity, said the proii gram, the first broad use of the vaccine among civilians, would cover an estimated 800 lab workers and an unknown number of decontamination specialists.

The spokesman could not, however, confirm an earlier report by CNN that criminal investigators and even postal workers could also be eligible for the vaccine, now restricted to members of the US armed forces and a small number of lab technicians.

The anthrax vaccine is made by Lansing, Michigan-based BioPort Corp., which is awaiting Food and Drug Administration (FDA) approval to resume shipping the vaccine. The FDA stopped production at BioPort in 1998 because of quality concerns.

Virtually all the US stockpile of the vaccine is under the control of the Pentagon, which has long worried that its soldiers will face enemy use of anthrax on the battlefield.

Hopkins Professor to Help in Bioterrorism Response

2 November (Reuters Health [Ori Twersky])— Department of Health and Human Services (HHS) Secretary Tommy Thompson has named the founding director of the Center for Civilian Biodefense Studies at the Johns Hopkins Bloomberg School of Public Health to help coordinate the agency's response to bioterrorist attacks, including the current anthrax incidents.

In naming Dr. Donald A. Henderson, who currently also serves as the chairman of the HHS advisory council on public health preparedness, Thompson also essentially created a new HHS office, the Office of Public Health Preparedness.

Thompson said the new office would work to ensure that HHS has a coordinated response.

Henderson will not have decisionmaking responsibilities. But he is among a number of experts that have now been recruited by HHS as a result of the anthrax incidents and the attacks on the World Trade Center in New York and the Pentagon building in Washington, DC.

Another example is Phillip Russell, a retired US Army major general, who recently joined the department as a special advisor on vaccine development and production. Prior to retiring, Russell served as the director of the Army's Medical Research Institute of Infectious Diseases.

Henderson began his public health career with the World Health Organization (WHO), as the director of the organization's global smallpox eradication campaign. In that role, he served an instrumental role in initiating WHO's global immunization program, which is now responsible for vaccinating about 80% of the world's children against the six prevalent childhood diseases.

Henderson joined the Johns Hopkins Bloomberg School of Public Health in 1977 as a dean. After leaving for a short period of time to serve as the associate director of the White House Office of Science and Technology and later as a senior science advisor to HHS, he rejoined the faculty in 1995 as a distinguished professor.

Editor's comment. We are very pleased by this appointment and would like to point out that Dr. Henderson is both a member of the editorial board of CID and Special Section Editor of the section “Confronting Biological Weapons.” He has also contributed important articles to CID in his area of expertise.

Russian Germ Warfare Experts Raise Smallpox Alarm

5 November (Reuters [Adam Tanner])— Former Soviet germ warfare scientists, warning that rogue powers could lure underpaid Russian researchers, called Monday for wide reintroduction of worldwide vaccination against the now extinct smallpox virus.

“It is a very dangerous weapon in the hands of terrorists and...you don't need some clever way of delivering it,” said Lev Sandakhchiev, director of Russia's Vektor Institute, which holds one of the world's two official samples of smallpox.

“All you need is a sick fanatic to get to a populated place,” he told a news conference in Moscow. “The world health system is completely unprepared for this.”

Sandakhchiev said scientists at Vektor earn just about $100 a month and so some could—in theory—be tempted financially by outsiders looking to acquire germ warfare expertise.

But he added that the institute's collection of germ warfare agents was protected: “We do have a security system against terrorism and attacks on the collection and our site and we have a controlled entry. People don't just show up there by chance.”

Anatoly Vorobyov, a former Soviet general and a leader of Moscow's secret bioweapons program in the 1980s, said smallpox posed the greatest health risk among biological weapons because it is highly contagious once one person is infected.

“In principle, the whole population needs to be vaccinated, not only in the United States but in Russia and everywhere in the world,” he said.

In a recent book on Soviet germ warfare research, one of Moscow's former top bioweapons scientists, Ken Alibek, says the Vektor Institute tested a smallpox weapon in 1990.

Since 1994, Sandakhchiev's laboratory in Siberia has held one of the world's two sanctioned smallpox samples. The Centers for Disease Control and Prevention in the United States has the other, in Atlanta, Georgia.

Western intelligence services suspect some nations including Iraq and North Korea may also have stocks of the smallpox virus.

Editor's comment. These warnings by men who are extremely knowledgeable about the Russian biowarfare program reinforce existing suspicions that both the technical know-how and the products may have leaked to other countries and perhaps terrorist groups.