News in Brief

Breakthrough research in the science of cancer

Mina Bissell, a Distinguished Scientist at the Lawrence Berkeley National Laboratory, has delivered a talk on TED about her groundbreaking research which has proven that cancer is not only caused by cancer cells, it is caused by an interaction between cancer cells and the surrounding cellular micro-environment. She shares the two key experiments that proved the prevailing wisdom about cancer growth was wrong. Watch the TED video:

RMSI donates to under-resourced Kabul hospital

RMSI, a Dubai-based medical solutions company, donated critical medical supplies to Ibne Sina Emergency Hospital in Kabul. The donation is welcome relief for the under-resourced and under-staffed hospital which can see up to 800 patients a day. RMSI is the exclusive alliance partner in hostile territories of International SOS – the world’s largest integrated medical assistance company.

WHO tries to contain Ebola outbreak

The WHO reported on 6 August that an Ebola outbreak in Uganda that killed 16 people has set in motion a global effort to contain the disease. Among the dead are a healthcare worker and several members of the same family. Six more suspected patients were admitted to hospital, raising fears that the outbreak could be more widespread. On 20 August the WHO reported 9 people had died from the Ebola virus in neighbouring Democratic Republic of Congo. The Ebola virus is highly contagious and infections carry a high fatality rate. Hallmarks of Ebola infection include internal and external bleeding. There is no vaccine or specific treatment.

H3N8 flu could pose threat to humans

CIDRAP News reports that a research team that analysed the strain of H3N8 influenza linked to a baby seal die-off in New England last year found that it originated in birds and has adapted to mammals, signalling a possible threat to humans and animals alike. The study, which appeared 31 July 2012 in mBio, the online journal of the American Society for Microbiology, also revealed mutations that are known to make flu viruses more transmissible and able to cause severe disease.

NDM-1 found in cholera

Promed Mail quotes Indian media as saying there is major cause for concern for a new strain of cholera bacteria which is resistant to 3rd generation antibiotics and found to be circulating in India. This cholera bacterial strain contains two super bug genes including the New Delhi Metallo beta-lactamase- 1 (blaNDM-1). The other super bug gene is plasmid-mediated betalactamase- 1 (blaDHA-1). Due to these two super bug genes, the new cholera bacterial strain (O1 El Tor Ogawa) has developed resistance to most known antibiotics. The blaNDM-1, discovered a couple of years ago was then found in Escherichia coli strains. This is the first time that doctors have found blaNDM-1 in the cholera bacteria Vibrio cholerae.

First African case of antimicrobial-resistant NDM

A man from Cameroon may represent the first reported African case of infection with bacteria carrying [a novel variant of] New Delhi metallobeta- lactamase [NDM]-4, an enzyme that blocks many antimicrobials, according to a 14 August 2012 letter in Emerging Infectious Diseases. According to a ProMed-mail, the letter details the case of a man with Hodgkin lymphoma who was treated with chemotherapy 1 year before his current 1 month hospitalisation for an inflammatory disorder with kidney failure. After transfer to a hospital in France, a rectal swab revealed NDM- 4 [-carrying] Escherichia coli. The strain was resistant to all beta-lactam antimicrobial drugs, including imipenem, meropenem, ertapenem, and doripenem, and to fluoroquinolones.

Legal bid fails to stop plain packaging for cigs in Australia

The WHO has welcomed the landmark decision from Australia’s High Court on 15 August this year to dismiss a legal challenge from the tobacco industry, and calls on the rest of the world to follow Australia’s tough stance on tobacco marketing. Several major tobacco companies challenged Australia’s legislation to require cigarettes and other tobacco products to be sold in plain packaging without any branding. But the industry’s attempt to derail this tobacco control measure failed. As of December 2012, Australia will be the first country to sell cigarettes in drab, olive-green packaging without branding.

Saudi to enforce smoking ban

The Saudi Arabia Interior Minister, Prince Ahmed bin Abdulaziz, announced at the end of July that the kingdom will begin enforcing the royal decree banning smoking in public places. Under the official order, smoking, including shisha, is banned in all government facilities and most commercial areas, including restaurants, supermarkets, and shopping malls. The order also prohibits the sale of tobacco to those under the age of 18.

Qatar’s Sheikha Moza signs organ donor pledge

To show support for Qatar’s newly developed organ transplantation programme Her Highness Sheikha Moza bint Nasser of Qatar signed up to be an organ donor in the country’s organ donation drive which started in August. Following her lead, a number of other dignitaries who were present made the same gesture. “Our aim in Qatar is to become self-sufficient as a country and every single one of us must reflect seriously, as our religious duty demands, on how we can play a part in this effort,” said Her Highness Sheikha Moza, adding that the Qatar Organ Donation Center is dedicated to the promotion of organ donations and the maintaining of a national donor register.

Massachusetts General Hospital listed as top in US

Massachusetts General Hospital in Boston, United States, has earned the top spot on the United States’ most prestigious list of hospitals as ranked by US News and World Report which recently released their annual Honor Roll of America’s Best Hospitals.

Finland develops first brain mapping device

Researchers at Aalto University in Finland have developed the world’s first device designed for mapping the human brain that combines whole-head magnetoencephalography (MEG) and magnetic resonance imaging (MRI) technology. MEG measures the electrical function and MRI visualises the structure of the brain. The merging of these two technologies will produce unprecedented accuracy in locating brain electrical activity noninvasively.

Professor Risto Ilmoniemi, said: “We expect that the new technology will improve the accuracy of brain mapping of patients with epilepsy. It may also improve the diagnosis of cancer patients.”

The innovative MEG-MRI device will allow brain imaging for new patients, such as those with metal implants. Also, the silent and open device will not scare children or make people feel claustrophobic. In the future, this development can also reduce costs as images can be obtained in one session rather than two.

Issues with MEG include the fact that when the techniques are used separately, the image accuracy can be compromised because of the movement of the brain. Also, the image it provides may not be accurate enough for precise brain surgery. In the past, it was not possible to combine high-field MRI and MEG because their magnetic fields interfered with one another. Extremely sensitive magnetic field sensors have now been developed, so scientists can now use the new low-field MRI with a magnetic field strength of only a few hundred-thousandths of that of the high-field MRI device. Fusing these two technologies produces localisation accuracy that was not possible with MRI or MEG alone. doi: 10.1002/mrm.24413

BMS spends $5.3bn for diabetes medication

Bristol-Meyers Squibb (BMS) has acquired Amylin Pharmaceuticals in a complex three-part deal that included AstraZeneca (AZ). Under the deal, BMS will pay US$5.3 billion in cash ($31/share) to Amylin shareholders and assume the $1.7 billion in debt and future royalties owed to Eli Lilly as part of the agreement the two companies came to when they split over Bydureon (exenatide) last November. In turn, AZ will make a payment of around $3.4 billion to Amylin as a wholly-owned subsidiary of BMS, continuing a longstanding partnership between BMS and AZ for diabetes therapies. Both BMS and AZ will take equal rights to profits and losses, with AZ having the option to take equal share of governance for another $135 million.

Amylin currently markets three diabetes drugs, none of which pose a threat to the BMS/AZ diabetes portfolio. Amylin’s product Byetta (exenatide), which was the first GLP-1 receptor agonist to reach the market, is a twice-daily injectable that had gross revenues of almost $518 million in 2011. Bydureon (exenatide weekly injection) is Amylin’s more updated and longeracting version of exenatide, and some analysts believe that it will reach sales of over $1 billion in the next few years. However, Bydureon had a difficult twoyear extension of the approval process, where Amylin had to prove that the drug did not cause cardiac arrhythmias. A week prior to the agreement, a former regulator at the US Food and Drug Administration (FDA) surfaced to announce that Amylin had dragged its feet to provide safety data from Bydureon trials, leading to a complete response letter. The FDA is also requiring Phase IV studies to show that Bydureon does not cause heart attacks or other cardiovascular complications, thyroid cancer, or pancreatitis.

In 2011, Amylin entered into litigation and eventually severed ties with its marketing and development partner, Eli Lilly. This resulted in an upfront payment of $250m plus up to $1.2 billion in sales royalties on the back end in order for Amylin to procure exclusive marketing rights for the diabetes drug.

GSK acquires Human Genome Sciences

GlaxoSmithKline (GSK), the British pharmaceutical giant, has acquired Human Genome Sciences (HGS) in a deal worth about $3.6 billion. However, the final deal size was approximately $3 billion net of cash and debt. GSK paid a premium of 99% from when it offered its initial private offering of $13/share in April. HGS was trading at $7.17/share prior to that. GSK believes they will be able to realise $200 million in cost synergies from the deal.

The acquisition of HGS gives GSK full rights to three main drugs: Benlysta (belimumab), albiglutide, and darapladib. The catalyst of the deal is Benlysta as it is the first approved therapy for systemic lupus erythematosus in more than 50 years. Unfortunately, as the US FDA noted during the approval process, only 30% of lupus patients saw a benefit in clinical trials, and adverse events due to the depressed immune response were higher in Benlysta-treated patients. Consequently, sales for Benlysta have disappointed in its first year on the market. Benlysta saw a 77% increase in sales during Q2 of 2012. However, sales remain substantially below what was originally forecast.

Albiglutide, which requires only weekly, or bi-weekly, dosing is scheduled for US FDA filing in early 2013 in the treatment of type 2 diabetes. Despite this advantage, head-to-head trial results to date have been split; albiglutide was not as efficacious as liraglutide, but beat sitagliptin (Januvia). Results from several other headto- head studies are pending. Current consensus is that albiglutide will struggle in the competitive diabetes market, with peak sales near the $500 million mark.

Biologics licence for regeneration of insulin-producing cells

German drug laboratory Evotec has licensed a portfolio of small molecules and biologics designed to trigger the regeneration of insulin-producing beta cells to Janssen Pharmaceuticals. The molecules and biologics were initially identified by scientists at the Harvard University Laboratory of Douglas Melton, and were then analysed by Evotec as part of the CureBeta research and development programme.

The agreement starts with an upfront payment of US$8 million. Upon achievement of certain pre-clinical, clinical, regulatory and commercial goals, Janssen will make future milestone payments of up to about $200 million to $300 million per product. In addition, Janssen will pay royalties on future sales of any products that result from this collaboration. All payments will be shared by Evotec and Harvard according to pre-agreed terms.

Dr Cord Dohrmann, chief scientific officer of Evotec, said: “Our collaboration has been extremely successful on multiple levels. We have not only achieved our scientific goals of creating a superior beta cell drug discovery platform and generating a deep pipeline of novel and exciting targets, but we have also established a new model of collaboration between academia and industry that has proven highly efficient and effective in accelerating innovative scientific development.

British nanomaterials team receives grant

Scientists at The University of Nottingham have won a £1.2 million (about US$1.88 million) grant for research into the engineering of nanomaterials. Nanotechnology is already being used in the healthcare sector. For example, hospitals use fabrics with silver nanoparticle coatings, which give them an anti-bacterial and anti-fungal effect.

New studies will develop a way to produce medical polymer-based (plastic) nanocomposites for use as surgical implants that eventually break down to be absorbed safely by the body when they have done their job. In this way they could replace metal implants in bone surgery, for example.

The funding was awarded by the UK’s Engineering and Physical Sciences Research Council and will run for four years from October 2012. By the end, the researchers expect to be able to manufacture demonstration models so the research can progress to the clinical trials stage.

WHO offers guidance for preventative HIV drugs

The World Health Organisation (WHO) has issued its first guidance to countries that are considering offering HIV antiretrovirals (ARVs) to protect people who do not have the virus but who are at high risk of HIV infection.

The guidance is based on clinical trials indicating that HIV-negative people taking a daily dose of oral antiretroviral medication, known as pre-exposure prophylaxis (PrEP), to reduce the risk of infection, is both safe and effective in preventing HIV. The study shows that use of PrEP can reduce HIV infection by around 40% among men who have sex with men; this figure goes up to 73% among those who took the medicine regularly. The Partners PrEP study found 75% protection among serodiscordant couples (couples in which one person is HIV positive) in Kenya and Uganda.

The range of results in these studies highlights the potential benefits of PrEP, but also emphasises the importance of taking medicines every day. Many people who are at high risk for HIV may not easily be able to incorporate the diligent treatment regimen required, so the next challenge is to ascertain how best to deliver PrEP to those who would benefit from it in ‘real life’ settings in order to achieve the necessary adherence and maximum public health gains.

To better understand how PrEP can best contribute to a combination HIV prevention programme, WHO is encouraging countries wishing to introduce PrEP to first establish small projects to help public health workers to better understand and realise its potential benefits. The results will help determine the best way to integrate PrEP guidance in future consolidated WHO guidelines on the use of antiretrovirals for preventing and treating HIV infection, which are expected in the summer of 2013.

WHO PReP Guide

World Hepatitis Day 2012

World Hepatitis Day was held on July 28. This year the WHO launched a new global framework to tackle the disease, describing four areas of work to prevent and treat hepatitis infection. These are: Raising awareness, promoting partnerships and mobilizing resources; transforming scientific evidence into policy and action; preventing transmission; and screening, care and treatment.

The WHO is urging governments to strengthen efforts to fight viral hepatitis, an inflammation of the liver that kills about 1 million people every year. In addition, an estimated 500 million people experience chronic illness from their infection with hepatitis; it is a major cause of liver cancer and liver cirrhosis.

Dr Sylvie Briand of WHO’s Pandemic and Epidemic Disease Department, said: “Only by increasing awareness of the different forms of hepatitis, and how they can be prevented and treated, can we take the first step towards full control of the disease and save thousands of lives.”

WHO – Hepatitis, framework for global action

US FDA’s ethics questioned

Ethical challenges are central to persistent “critical weaknesses” in the United States’ system for ensuring drug safety, according to a commentary by former US Institute of Medicine (IOM) committee members published in the New England Journal of Medicine.

With a caution against “reactive policymaking,” committee co-chairs Ruth Faden, Ph.D., M.P.H., and Steven Goodman, M.D., M.H.S., Ph.D., with fellow committee member Michelle Mello, J.D., Ph.D., revisit the controversy over the antidiabetic drug Avandia that led to the formation of their IOM committee on monitoring drug safety after approval.

The Avandia postmarket trial, halted in September 2010, was “a lesson in how our current approach to the oversight of drugsafety and postmarketing research can fail both the public and the research participants,” the authors write. With those lessons in mind, their independent commentary follows the May 2012 IOM report with a focus on the ethical challenges ahead.

The authors detail the IOM report’s recommendations for maintaining the delicate balance of drug innovation and drug safety. Increased “fast-tracking” of drug approval for medical conditions with no effective treatment necessitates a counterbalance of increased postmarket oversight, the authors argue. They echo the IOM report’s call for an independent ethics advisory board to the Food and Drug Administration (FDA), focused on postmarket research and safety surveillance.

“As the pace of the translation of discoveries from bench to bedside continues to intensify, so too does the imperative for thoughtful ethical governance throughout the lifecycle of a drug,” the authors write.

The authors also amplify one of the IOM report’s key ethics points – the responsibility of the FDA to participants in postmarket research, particularly in randomized trials that determine which treatment they receive. The FDA has a unique ethical obligation to the welfare of research participants when requiring a postmarket study, the authors assert, which “cannot be handed off to contractors or the industry sponsor”.

“The FDA is uniquely positioned to ensure ethical postmarket research, including a proper informed consent process,” says Faden, director of the Johns Hopkins Berman Institute of Bioethics. “Because some postmarket trials are required specifically to address mounting concerns that the drug’s risks may outweigh its benefits, there are heightened obligations to ensure that potential research participants understand the risks of enrolment.”

The authors also note that the volume of postmarket studies is increasing, due not only to FDA-ordered research but also the growing field of academic comparative-effectiveness research. The ethical issues involved can vary widely, the authors say, which makes clarity about the context for the research crucial. “Depending on who is initiating the research, for what reasons, and when, the same study design may have very different ramifications for the benefit–risk balance of the study and what patients need to know in order to provide meaningful informed consent,” the authors write.

MRSA infections in the US double in five years

Infections caused by methicillin-resistant Staphylococcus aureus (MRSA) doubled at academic medical centres in the US between 2003 and 2008, according to a report published in the in the August issue of Infection Control and Hospital Epidemiology. The findings run counter to a recent US Centers for Disease Control and Prevention study that found MRSA cases in hospitals were declining.

Researchers from the University of Chicago Medicine and the University HealthSystem Consortium (UHC) estimate hospitalisations increased from about 21 out of every 1,000 patients hospitalised in 2003 to about 42 out of every 1,000 in 2008, or almost 1 in 20 patients. Michael David, assistant professor of medicine at the University of Chicago and one of the study’s authors, said: “The rapid increase means that the number of people hospitalised with recorded MRSA infections exceeded the number hospitalised with AIDS and influenza combined in each of the last three years of the survey.” 


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