Author Archives: rkhamsi

SNL imagines HPV-vaccine-administering doll

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Meet Lil’ Poundcake, “the first doll approved to administer the human papillomavirus vaccination to girls under ten”.

If she sounds like the bizarre-twisted creation of a comic’s mind, she is. A skit in this weekend’s Saturday Night Live — no doubt in response to the recent controversy over human papillomavirus immunization stirred by a Republican presidential debate in the US — imagines this doll, which will definitely not be the must-have gift this Christmas . “Lil’ Poundcake protects against HPV with a series of three injections over a period of six months AND she’s got her own phone.” Creepy!

Experts diverge on stock price flux ahead of cancer trial results

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Posted on behalf of Madhumita Venkataramanan

The stock prices of companies that report positive results for cancer drug trials tended to increase before the first public announcement of the findings, according to a study published today in the Journal of the National Cancer Institute. But experts are split as to whether the trend points to illegal ‘insider trading’ by people who know the results of these trials in advance — including physicians and scientists — or simply reflect a bias in the analysis.

In the study, a team led by pharmacoeconomist Allan Detsky of Mount Sinai Hospital in Toronto identified 59 cancer drugs in US phase 3 trials and those awaiting FDA approval from January 2000 to January 2009. Of these, 23 trials were positive and 36 were negative. The scientists retrospectively examined the stock prices of the pharmaceutical companies for 120 days before and after the first public announcement of the drug trial outcome.

The results of the study showed a surprising trend. “Companies that made a positive announcement showed a trending up in [stock] prices 60 days prior that was different from companies with a negative announcement,” says Detsky. “And the difference is statistically significant.” The stock price for companies that were due to report positive trials showed an increase of 9.4% while prices for those anticipating negative results showed a decrease of 4.5%.

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Our news internship

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Pass it on: Nature Medicine is currently accepting applications for its science writing internship.

The intern will be closely involved in the editorial process and write news articles and briefs, as well as blog entries. This is not a paper-pushing internship! The person selected for the position will be reporting stories and working on editorial content full-time.

Applicants should have completed one year in a graduate program in journalism or have equivalent work experience in journalism. Additionally, a strong understanding of biology and current issues in medicine is required. The six-month, paid internship will start in late November and be based in New York City.

The deadline for applications is 14 October 2011. Please send an email to r.khamsi@us.nature.com with “Nature Medicine news internship” in the subject line and include 1) a cover letter, 2) your resume and 3) three published writing clips.

NEWS FEATURE: Taking tissue engineering to heart — a look at the first US trial of tissue-engineered blood vessels

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More than a decade after Japanese scientists implanted the first bioengineered blood vessel into a child with a congenital heart defect, the experimental treatment has finally made its way into clinical testing in the US. Elie Dolgin asks what took so long and what lessons have been learned along the way.

Click the image above for a PDF of the full story from the September 2011 issue of Nature Medicine.

Last week, a team of around a dozen doctors and nurses in Connecticut performed a 12-hour operation to insert a cigar-shaped plastic tube, seeded with bone marrow cells, around the heart of a toddler born with only a single functioning ventricle. The delicate surgery, performed at the Yale-New Haven Hospital, represents the first time that surgeons have implanted a tissue-engineered blood vessel into someone on US soil. It could radically alter the future treatment of this type of congenital heart defect — which affects around 3,000 babies born each year in the US — and could have implications for more common heart procedures down the road.

For the trial investigators, the surgery has been more than a decade in the making. “See the black binders,” says Christopher Breuer, gesturing to a bookshelf in his small, sunlit office. Breuer, a pediatric surgeon at the Yale University School of Medicine who has spearheaded the experimental surgery, stands up and pulls out one of more than a dozen thick binders lining the wall. “All but three of these constitute a single copy of the first application” to the US Food and Drug Administration (FDA) to approve the clinical protocol, submitted in August 2009. “Things moved along very slowly,” he admits. That’s especially true when you consider that the same surgery had already been performed on 25 people, starting ten years earlier, by Toshiharu Shinoka and his colleagues at the Tokyo Women’s Medical University Hospital in Japan.

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Experts hash out guidelines for HIV trials involving men who have sex with men

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ROME — Last week’s encouraging results from two trials showing that prophylactic use of AIDS drugs in HIV-negative people can help prevent infection has underscored the value of studying new preventative treatments, particularly in high-risk groups. And one of the highest risk groups remains men who have sex with men — a term used to include men who might not self-identify as gay.

In the US, for example, men who have sex with men (MSM) represent about 2% of the population, but they accounted for 59% of new HIV diagnoses in 2009. Strikingly, a global review estimated that only 3.3% of HIV prevention spending goes to address the needs of the MSM community in parts of the world where the epidemic is concentrated.

In hopes of facilitating more work in this area, experts from groups such as the Foundation for AIDS Research (amfAR) and the International AIDS Vaccine Initiative held a session at the International AIDS Society meeting here this week to discuss a draft set of guidelines. Although the World Medical Association and UNAIDS have published research principles for biomedical trials in the past, the authors of the newly drafted guidance say it’s the first of its kind to specifically advise on HIV research among individuals who fall into the MSM and LGBT (gay, lesbian, bisexual, transgender) categories.

The draft guidance stresses that consensual same sex practices are illegal in some countries and stigmatized, sometimes by the findings of HIV research itself. “That is a real obstacle to the response,” says Chris Beyrer, director of the Johns Hopkins Center for Public Health & Human Rights in Baltimore, Maryland, an institute involved in drafting the document. He adds that the problem is “really troubling” in former Soviet states such as Uzbekistan and Ukraine where the epidemic is intensifying.

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Scaled-up study of soldiers points to doubled risk of dementia from head injury

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PARIS — A massive review of the medical records of nearly 300,000 US veterans lends weight to the notion that traumatic brain injury might contribute to the risk of cognitive impairment later in life. Neurologist Kristine Yaffe of the University of California–San Francisco and her colleagues reviewed seven years’ worth of data from the files of the former military troops, and found that these types of head injuries were linked to a doubled risk of dementia.

Yaffe, who presented the findings here today at the Alzheimer’s Association International Conference, says that it’s the largest analysis of its kind to date. All of the 281,540 veterans included in the analysis were aged 55 years or older and free of dementia at check-up visits before 2001. However, during seven years of follow up, 2% of the older veterans had a diagnosis of traumatic brain injury (TBI). Of those with TBI, 15.3% developed dementia, as opposed to 6.8% of those who were free of this type of head injury. After adjusting for other possible contributing factors, such as post-traumatic stress disorder — which previous research has hinted might contribute to impaired cognitive function — the scientists calculated that TBI is linked to a 2.3-fold increased risk of dementia.

Based on the limitations of the medical records, Yaffe and her colleagues were unable to determine the severity and extent of the head injuries among the veterans who had a TBI diagnosis. “We couldn’t delve down and say whether it was repetitive or not,” she explains. She adds that while her team was able determine the type of TBI the veterans sustained, ranging from skull fractures to concussions, the dementia risk did not seem to vary much between the kinds of head injury.

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AIDS map gives reason to hasten Hastings’ bill

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The idea that HIV affects people living in the southern US far worse than their neighbors to the north is not new. Back in 2008, a report grabbed headlines by showing that the rate of infection in some pockets of the country rivaled that of the most heavily affected parts of Africa.

So now, even though the notion of this disparity within the US comes as no surprise, it’s hard not to be struck by the stark contrast as visualized by the AIDSVu map, a project launched online yesterday by Emory University and its affiliated Rollins School of Public Health, both in Atlanta. The interactive image is based on 2008 data from the US Centers for Disease Control and Prevention (CDC).

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“Knowing the areas most affected by HIV is critical for meeting the goals of the National HIV/AIDS Strategy, which calls for significantly reducing new HIV infections and improving care for people living with HIV,” Emory epidemiologist Patrick Sullivan said in a statement.

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WHO defers decision on smallpox stocks

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Crossposted from Nature’s newsblog.

The World Health Organization’s top-decision making body, the World Health Assembly, said today it would defer until 2014 any decision on the destruction of the two last known remaining stocks of the virus that causes smallpox. A US-resolution calling for the stocks to be maintained for at least another five years ran into opposition led by Iran, resulting in deadlock last night after a day of negotiations.

A consensus to defer the decision was only reached after further negotiations this morning (today is the last day of the World Health Assembly). Shortly after the assembly decided to not decide, I spoke with Nils Daulaire, director of the Office of Global Health Affairs at the US Department of Health and Human Services, and head of the US delegation to the Geneva meeting. He says that Iran opposed in particular a clause in the US resolution that would have demanded that all countries affirm to WHO that they do not currently hold undeclared stocks of the virus.

Continue reading on Nature’s newsblog.

Shall I compare thee to another drug?

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Posted on behalf of Meera Swami

In 2009, the US Congress pledged $1.1 billion to improve comparative effectiveness research, a field dedicated to side-by-side evaluations of how drugs perform. The key question is whether new medicines really offer any improvements over the current standard of care at their time of approval. Without this information, are clinicians equipped to make the best treatment decisions?

Such concerns are reinforced by a study published yesterday in the Journal of the American Medical Association indicating that over the past decade approximately half of the new drugs approved by the US Food and Drug Administration (FDA) did not have publically available information on their comparative effectiveness when they were approved.

The authors of the study, Nikolas Goldberg and his colleagues at Brigham and Women’s Hospital and Harvard Medical School in Boston, suggest that increasing the proportion of drugs with this data and improving the accessibility of this information are crucial for making informed decisions. “Strategies are needed to enhance the accessibility of, and ultimately the use of, this information, particularly in the early marketing experience, when comparative effectiveness data from other sources are scarce or nonexistent,” they conclude.

Notably, these findings come a time when the future of the National Institute for Health and Clinical Excellence (NICE) — a UK agency that decides how best to allocate the country’s health spending — is under threat. So clearly this push for comparative effectiveness data has received a pushback. Given these cuts, and the situation revealed by Goldberg’s paper, those who believe comparative effectiveness data is a good thing need to make their voices better heard. Pouring money into the field doesn’t mean that the comparative effectiveness information it produces will necessarily be evaluated by regulators.

Tale of two twins highlights role of chance in HIV infection

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HIV is notoriously unpredictable. The virus can prove fatal rather quickly in some individuals, while it remains at bay in a rare group of people known as elite controllers. Doctors have puzzled as to why some patients can fend off the virus better with drugs, while others progress despite receiving the best antiviral medications available.

A new study from a group led by Keith Crandall of Brigham Young University just south of Salt Lake City offers some explanation as to why HIV infection can produce such variable effects. Crandall’s team analyzed blood samples from a pair of identical twins who were both accidentally infected with HIV when receiving a contaminated blood transfusion at birth. “They were infected in 1983 — that was before most people knew HIV existed,” Crandall explains.

The virus mutates in the body over time. So Crandall and his colleagues scrutinized how the virus evolved in each of the twins using blood samples taken from birth up until 1998. They found that the viral sequence in the twins was about 1% genetically different by the end of that 15 year period. “That’s quite a significant difference,” Crandall says, noting that the genes of humans and chimpanzees differ by only about 2% to 4%.

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