A consensus has emerged during the last few years on the definition of research misconduct in science and medicine, according to a a leading bioethicist.

David Resnik, a bioethicist at the National Institute of Environmental Health Sciences (NIEHS), said a broader understanding of falsification of medical research has resulted from several high-profile cases over the last two decades at the National Institutes of Health (NIH), including research on infectious diseases.  “The new definition really covers a lot of areas of research. It now states that ‘research misconduct means the fabrication, falsification or plagiarism for proposing, performing or reviewing research, or in recording research results.’ Misconduct does not, however, include honest error or differences of opinion.”

Speaking recently at the University of Delaware, Resnik said that generally when a misconduct finding happens, the government stipulates that the researcher or researchers will not receive funding for a specific duration of time — another five years,” said Resnik. But, some scientists could be held liable for civil fraud or criminal fraud, because basically what they are doing is deceiving the government.

Resnik elaborated on this by citing the historical case of research misconduct by nationally recognized drug therapy researcher, Stephen E. Breuning, who in 1988 became the first scientist to be prosecuted, fined and incarcerated for falsification of scientific research, according to press reports.

As a large part of research funding for major scientific experiments typically comes from government-affiliated agencies, such as the National Science Foundation (NSF) and the NIH, Resnik said that as more high-profile cases of flawed research came to light in recent years, the government began to look more closely at its definition of misconduct. Examples include the following:

* The 1986 Thereza Imanishi-Kari case.

* The 2006 convictions of American medical scientist Eric Poehlman.

* South Korean biomedical scientist Hwang Woo-Suk.

These three research misconduct incidents in recent years that caused the U.S. government to tighten its definitions of–and its penalties for–fraudulent research.

“In terms of South Korea, this was a problem for them, because they didn’t really have a proper procedure in place for investigating research misconduct,” Resnik said.

Since the journal Science had been the first to publish Hwang Woo-Suk’s findings, however, Resnik said, and because all major scientific breakthroughs have a worldwide impact, Hwang Woo-Suk’s research caused the American Association for the Advancement of Science (AAAS) to rethink its policies.

“They were ashamed that something as obvious as should have slipped through,” he said. “And so their new policy stated that really high-impact papers would be given extra scrutiny.”

NIH also adopted a more cautious approach, Resnik continued, and in the wake of Poehlman’s debunking, a debate ensued in the U.S. about the definition of research misconduct and about preventive measures.

The federal definition of research misconduct, finalized three years ago, and accepted by almost all federal agencies, Resnik emphasized, now not only is more comprehensive, but also covers more ground, including at the outset in grant proposals, where the rules also apply.

“The new definition really covers a lot of areas of research,” Resnik said.

– by Gene J. Koprowski, Editorial Director

Bioethics now a key concern for scientists.

Posted: April 23rd, 2008 under Feature Stories.
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A proliferation of parasitic worms is leading to a dramatic increase in chronic infections in Africa and Asia. Over a quarter of the world’s population is infected with parasites, leading to sub-clinical cases, clinical intervention, and, often, death. Globally, there are a quarter million deaths caused annually by parasites, according to World Health Organization official, Jackie Maison, based in the U.K.

This makes parasitic worms a leading common cause of chronic infections in human beings.

The most commonplace infection is geohelminthiases, which includes round worms, whipworms, hookworms, schistome, flukes and guinea worms. Poor diagnosis of helminthes in developing countries leads to malnutrition in children, and retardation of growth and destruction of tissues.

This leads to impairment and poor mental ability hence poor performance in children in school. China is reporting a massive helminthes infection, while Africa has seen increased clinical cases, according to the WHO.

Common presenting symptoms include abdominal pains, malnutrition, loss of appetite, destruction of tissues and organs, intestinal obstruction, anemia and ulcers are the arising clinical conditions in adults as well as in children.

According to Dr. John Nderu, a science lecturer in Nairobi University in Kenya, helminthes that suck blood also cause “anemia and mucosal damage.”

According to Dr. Daniel Elias, a medical practitioner at a Manchester U.K. clinic, chronic parasitic infections also reduce immunity against tuberculosis, Malaria and HIV/AIDS. He says that preexisting helminthes infections influence “sequestration and obstructive jaundice as well as acute tubular necrosis.”

Parasitic infections are transmitted through consumption of infected water, food or fruits, and through the skin.

Dr. Beatrice Mansfield, at Agha Khan Hospital in Nairobi, says some 44 million pregnancies are currently complicated by maternal hookworm infection, placing both mothers and children at higher risk of death during pregnancy and delivery.

Treatment methods often used by clinicians are prescription of ivermectin, albendazole or mebendazole for intestinal helminthes or tropical deltamethrin for ectoparatsites. This is a procedure prescribed by WHO

– By David James, East Africa Correspondent

Basic infection protection practices that can keep parasites away include the following:

* Cleaning fruits thoroughly before eating them.
* Cooking food properly.
* Meat inspection.
* Boiling water before use.

Source: The World Health Organization

                       

Posted: April 1st, 2008 under Diseases, Feature Stories, Parasites and Lice.
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Silicon Valley-based KaloBios Pharmaceuticals, Inc., a privately held bio-pharmaceutical company, this week announced the initiation of a clinical trial of KB001, a high-affinity antibody fragment that the firm is developing for the treatment of P. aeruginosa lung infections. The trial is being conducted in conjunction with the Cystic Fibrosis Foundation, and others

The blind, placebo-controlled trial is being conducted at over 10 sites across the U.S., and will enroll up to 48 patients with cystic fibrosis who will receive either one of two dose levels of KB001 or placebo. Goals for the trial include determination of safety, reduction of P. aeruginosa bacteria, and inflammatory markers.

“KB001 is a very novel approach that targets the principal mechanism by which P. aeruginosa becomes pathogenic,” said Geoffrey Yarranton, chief scientific officer.

Researchers demonstrated in both laboratory and rodent studies that KB001 is active against drug resistant strains of this bacterium.

P. aeruginosa is an opportunistic pathogen that rarely causes disease in healthy people, but is a significant problem for critically ill or immunocompromised individuals. These include the approximately 70,000 worldwide patients with cystic fibrosis where P. aeruginosa is a major causative agent in the progressive loss of lung function resulting from recurrent and chronic respiratory tract infections.

This is a phase 1/2 clinical trial, which means that the data from a small previously conducted human trial of healthy volunteers indicated that there were limited or no side effects, and so KB001 is now being tested in cystic fibrosis patients between 18 and 45 years of age with P. aeruginosa in their lungs. KB001 is a fragment of a monoclonal antibody — a biologic drug.

The drug must be given intravenously or as an injection, but its effects may last for weeks.

The technology developed by KaloBios is a proprietary method for converting non-human antibodies into engineered human antibodies.

– by Gene J. Koprowski, Editorial Director

P. aeruginosa infection can be quite harmful for those with CF.

Posted: March 31st, 2008 under Antibiotic Resistant, Feature Stories.
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Scientists, public health workers, and police have worked together to stop alleged traders of fake “anti-malarial drugs” in southern China, according to foreign media reports. The project led to the seizure of a large quantity of counterfeit drugs. The seizure demonstrates the growing threat posed by fake pharmaceuticals and the complexities of tracking down those responsible its proliferation.

Called Operation Jupiter, the investigation was coordinated by the International Criminal Police Organization (INTERPOL), the World Health Organization’s Western Pacific Regional Office, and the Wellcome Trust-University of Oxford Southeast Asian Tropical Medicine Research Program, in close cooperation with Chinese authorities.

Scientists from five other laboratories analyzed the composition of the fake drugs and their packaging. The results of this collaboration are published today in the medical journal PLoS Medicine.

Counterfeit anti-malarial drugs are an increasingly serious problem, particularly in South-East Asia and Africa. In countries with a large burden of malaria, such as Burma, Laos, Cambodia, and Vietnam, as many as “half of all artesunate” tablets—one of the most effective anti-malarial drugs—are counterfeit.

Most of the counterfeits examined as part of Operation Jupiter contained no artesunate. Some contained a wide range of potentially toxic wrong active ingredients. Counterfeiters sometimes included small amounts of artesunate in the tablets. This is to evade screening tests of drug quality, but these doses are too low to be effective, yet potent enough to contribute to malaria parasites becoming resistant to this class of drugs.

“Artesunate, as part of artemisinin-based combination therapy, is vital for malaria treatment and is one of the most effective weapons we have against this terrible scourge,” says Paul Newton of the Wellcome Trust-University of Oxford South East Asian Tropical Medicine Research Program. “If malaria becomes resistant to artesunate, the effect on public health in the tropics will be catastrophic.”

The evidence suggests that at least some of the counterfeit artesunate came from southern China, and this was supported by examination of the mineral calcite, found in some of the samples.

One suspect is alleged to have traded 240,000 blisterpacks of counterfeit artesunate, enough to “treat” almost a quarter of a million adults with a medicine with no activity against a potentially fatal disease. Whilst the Chinese authorities were able to seize 24,000 of these packs, the remainder are alleged to have been sold at crossings on the border of Yunnan and Burma, almost a half of all blisterpacks of artesunate sold to the region.

“Criminal investigations and legal action are important in disrupting and inhibiting the trade in fake medicines, but to be effective these will require financial support and resources,” says Newton.

– by Gene J. Koprowski, Editorial Director

Fake anti-malaria drugs proliferate in China, Africa.

Posted: March 31st, 2008 under Feature Stories, Malaria.
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A Kansas man who died two months ago had a Mad Cow-like disease, called the Creutzfeldt-Jakob disorder, a relative reportedly told The Wichita Eagle.“They don’t know where he got it, but they’re trying to figure it out,” he told the local newspaper.According to Frank Rebarchek of Scott City, Kan., the National Prion Disease Pathology Surveillance Center had confirmed that the rare disease, which turns brain tissue spongy, caused the death of his brother Milton Eugene Rebarchek of Monument, Kan.The incubation period for the disease can be several decades, and its presence can’t be confirmed until brain tissue is tested. The disease is always fatal, the report said.The deceased, Milton Eugene Rebarchek, worked at a packing plant about 15 or 20 years ago. It is possible that he did not undertake proper infection protection precautions — use of gloves and masks and disinfectants — when working at the plant, and encountered tainted meat. One variation of the disease is mad cow disease. The human form has never been seen in the U.S. in someone who hadn’t had exposure overseas.Creutzfeldt-Jakob can also come from blood transfusions.– by Gene J. Koprowski, editorial director

FDA poster touting Mad Cow disease prevention, control.

Posted: March 28th, 2008 under Developing Diseases, Feature Stories.
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A Russian doctor said during a global bird flu conference that the virus will cause a “pandemic resulting in thousands of deaths.”Lecturing at the 6th International Bird Flu Summit in Bali, the deputy director of the Russian Health Ministry’s Institute of Epidemiology, Viktor Maleyev said: “Diseases know no borders and when they are transmitted by birds, it is twice as true,” Maleyev said.No cases of human-to-human transmission of the deadly H5N1 strain of bird flu have yet been reported,  but scientists worry the virus might mutate into a strain that could pass easily between people.”Bird flu is a global problem,” the scientist said.No human fatalities or cases of humans infected with the virus have been reported in Russia. But, the first outbreaks of bird flu there were reported in southern areas of the country and Siberia in 2005. The latest outbreak occurred near Moscow last month. “Every incident raises tension, as there is still a lot we do not know. We are only aware of 1% of all the micro organisms that are in our environment, and 99% of them we know nothing about,” the doctor said.Each year 25 million severe respiratory infections are recorded in Russia But, doctors know the etiology of just 10% of these incidents. We think there was a lot that can be done to fight the virus and avoid widespread panic, including public health awareness campaigns, training for medical staff, drawing up a vaccination action plan and development of rapid testing for the disease.– by Gene J. Koprowski, editorial director

 

Russian doctors eying bird flu diagnostics.

Posted: March 28th, 2008 under Developing Diseases, Feature Stories.
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Taipei, Taiwan’s Department of Health (DOH) confirmed this week the “first case” of whooping cough to be reported there this year.According to Lin Ting, deputy chief of the DOH Centers for Disease Control, the patient was a one-month-old baby boy who displayed the symptoms of intermittent coughing and wheezing on Feb. 27.  The diagnosis was reported as a suspected case of whooping cough when he was admitted to hospital on March 5. The boy’s condition stabilized after treatment.The youngster was not old enough to have been vaccinated and the DOH suspects he was infected by his mother, Lin said. “The mother had a cough during the Lunar New Year holiday in early February, but the patient’s father and six-year-old brother had no similar symptoms,” Lin added.Whooping cough generally affects infants in their first year, and the children can suffer complications such as pneumonia, which can be fatal.Children are usually given four shots of DPT — a three-in-one vaccine — to immunize against diphtheria, whooping cough, and tetanus before they reach the age of 18 months. But, the DOH still finds about two dozen whooping cough cases every year.Immunity against whooping cough diminishes between five and 10 years after vaccination. The center has already purchased additional vaccine.”If everything goes well, first graders in elementary schools will be able to get the additional vaccines as early as September,” he said, noting that the whooping cough can be caught any time of the year, not just during the winter.– by Gene J. Koprowski, editorial director

A baby with whooping cough. Source: National Health Service, U.K.

Posted: March 27th, 2008 under Feature Stories, Whooping Cough.
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A team of tropical disease control experts has urged the global health and development community, and particularly the leaders of the G-8 countries, to create a “new financing mechanism” to combat so-called neglected tropical diseases (NTDs).These diseases include intestinal worms, schistosomiasis, elephantiasis, and river blindness. They represent the most common infections of the world’s poorest people, and are often more deadly than malaria.A “Global Fund to Fight Neglected Tropical Diseases,” say Professor Peter Hotez, of the Sabin Vaccine Institute and George Washington University, Washington, D.C., and colleagues, say, would  meet “an urgent need to support NTD control and elimination.”Affliction with any of these diseases prevents the poorest people from escaping from a vicious, downward spiral of poverty. That is a injustice, the doctors argue.”We are now in a unique position to control or eliminate some of the highest burden NTDs through integrated use of donated drugs,” researchers say.The debut of a dedicated fund to scale up research and clinical activities would be “one of the most cost-effective and urgently needed approaches for sustainable poverty reduction,” the researchers say.The doctors say that funding of $2 billion, over five years, would be enough to initiate the program. – by Gene J. Koprowski, editorial director

Reference: Hotez PJ, Molyneux DH, Fenwick A, Savioli L, Takeuchi T (2008) A Global Fund to Fight Neglected Tropical Diseases: Is the G8 Hokkaido Tokyo 2008 Summit Ready? PLoS Negl Trop Dis 2(3): e220. doi:10.1371/journal.pntd.0000220

Image source: The World Health Organization.

Posted: March 26th, 2008 under Developing Diseases, Feature Stories.
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A debate article in the clinical journal PLoS Medicine says that “deferred treatment” of children infected with HIV is now the best medical option. The debut of effective therapies for treating HIV dramatically improved the outlook for both adults and children infected with HIV who had access to treatment. The proper timing for starting treatment remains “controversial,” particularly in children, according to the article.According to Dr. Steven Welch, a consultant in pediatric HIV and infectious diseases department, Heartlands Hospital, Birmingham, U.K., it is quite rational to consider an individual child’s and family’s wishes and circumstances as well as the child’s risk of disease progression in deciding when to start treatment. “The hasty and injudicious use of antiretroviral medications in children,” he says, “risks creating a cohort that has learned poor adherence habits, is infected with multi-drug-resistant viruses, and has been exposed to unnecessary cumulative drug toxicities.”There are contrary beliefs, however, in the medical community. Professor Di Gibb, a consultant pediatrician at the Medical Research Council Clinical Trials Unit, London, U.K., says that “deferring treatment initiation for as long as possible is no longer an option.” She believes kids will “grow better” if they receive antiretroviral medication.The authors note that there has never been a clinical trial conducted on determining when to start antiretroviral medications in children.

– by Gene J. Koprowski, editorial director

Journal reference: Welch SB, Gibb D (2008) When should children with HIV infection be started on antiretroviral therapy? PLoS Med 5(3): e73.

First Lady Laura Bush visits a pediatric AIDS treatment center.  Doctors wonder what the right time for treatment of HIV/AIDS is for kids.

Posted: March 26th, 2008 under Feature Stories, HIV.
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A new study has revealed a dramatic rise in the past 15 years in tuberculosis cases in Africa. According to the New England Journal of Medicine, Africa is facing the “worst tuberculosis epidemic since the invention of antibiotics.”Africa is home to 11 percent of the world’s population, but carries 29 percent of the world’s TB cases and 34 percent of all TB-related deaths. From 1990 to the year 2005, the incidence of TB more than doubled, mainly in southern, eastern and central African nations.According to the head of HIV research at Johannesburg’s Witswatersrand University, Francois Venter, a major cause is HIV/AIDS which weakens a person’s ability to fight disease. “There’s so much TB floating around in this community that conventional approaches to prevention and treatment are not going to win,” Venter said.TB is spread through the air usually by the cough of an infected person. More than three million people in Africa are living with TB and a half-million die from it each year. Tuberculosis is treatable, but diagnosis can take such a long time, a period during which the victim is in the community spreading the affliction. Doctors say that many TB victims die before they are diagnosed and many who are diagnosed die anyway “because they begin treatment too late.”But, health care systems in many countries have difficulty responding to the threat because of a lack of funding, personnel, drugs, and laboratories.”The numbers of patients with TB are astronomical,” said Venter. “Every morning we do a ward around here and it’s just TB, TB, and more TB, a dozen different forms, but all of it TB. It’s scary to me that there doesn’t seem to be a plan.”Other aggravating factors:* The emergence of TB strains that are resistant to most drugs.* The victims of these strains are HIV positive and few of them are ever cured.Venter says current TB programs are not working and as a result governments and policy makers need to declare a TB emergency similar to that for HIV/AIDS.– by Gene J. Koprowski, editorial director

Posted: March 25th, 2008 under Feature Stories, Tuberculosis.
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