Our September 2010 issue featured an Opinion piece written by Jeb White, a partner with the national whistleblower law firm of Nolan & Auerbach, P.A. in Philadelphia, Pennsylvania. The title was pretty self-explanatory: Masterminds behind pharmaceutical fraud deserve prison time.

It seems as though regulators are following this train of thought. The week Drug Topics has a piece about how the US Food and Drug Administration “has a new target in its continuing efforts to clean up pharmaceutical industry abuses: ”https://drugtopics.modernmedicine.com/drugtopics/article/articleDetail.jsp?id=713115&sk=29aa4165af6185f84b80f4992efe0b55">individual corporate officials".

Recently, the agency targeted two VPs at McNeil Consumer Healthcare, a Fort Washington, Pennsylvania-based unit of Johnson & Johnson, following the massive recall of its over-the-counter pain reliever Tylenol. “[I]t appears the FDA spared [J&J CEO Bill Weldon] and other c-suite players because of the decentralized organization encompassing the many J&J units,” according to the Pharmalot blog.

That echoes a point made by Jeb White’s Opinion piece: “The complex organizational structure of most large corporations prevents government prosecutors from readily building a criminal case against a particular employee. Modern corporations are highly compartmentalized. For example, in the pharmaceutical or biotechnology industry, the research and development divisions operate largely separately from the marketing divisions that promote the resulting drugs.”

What do you think? Should the FDA be taking individuals to court or the companies they work for? Share your thoughts here in the comments section.

Two new papers in Nature this week — one from the Max Planck Institute for Medical Research in Heidelberg, Germany and the other from a collaborative effort between researchers at Harvard and Carnegie Mellon — provide a stunning view into how brain cells communicate. Seeing is believing, as this video demonstrates.

Salmonella is the kind of microbe people make a special effort to avoid. Long gone are the days of eating raw eggs. Instead we make sure they’re well cooked, and while we’re at it we triple-wash our spinach and handle raw chicken like a biohazard in the kitchen.

But, as reported in a news feature in this month’s Nature Medicine, scientists are reworking Salmonella to be able to infiltrate the hard-to-reach centers of tumors. A press release from the University of Minnesota Masonic Cancer Center in Minneapolis yesterday points to a clinical trial there in which scientists have engineered a weakened version of the microbe that also carries the immune signaling compound interleukin-2 (IL-2). According to the press release, “The salmonella IL-2 cocktail is mixed with water and taken as a liquid.” Recruitment is ongoing.

Image by Rocky Mountain Laboratories/NIAID/NIH via Flickr Creative Commons

The announcement yesterday that Seth Berkley will be taking the job of chief executive officer of the GAVI Alliance in August pulsed though the global health community. The GAVI Alliance, which faces a coming hurdle in raising the estimated $3.7 billion it needs to continue its global immunization efforts, has been without a CEO since the departure of Julian Lob-Levyt in October.

Berkley began developing the International AIDS Vaccine Initiative (IAVI) in 1994, and he has led the charge at the New York-based organization since it formally launched two years later. He’s seen the field through highs and lows, ranging from the disappointing STEP trial in 2007 to the more recent good news from the so-called RV 144 trial in Thailand, which in 2009 reported as much as 30% protection against HIV.

Nature Medicine caught up with Berkley today to hear what he has learned in his quest for a protective shot to stop the spread of HIV. What follows is a condensed version of the conversation:

This must be a bittersweet moment for you. What are your thoughts on how the HIV vaccine field has evolved?

I would say that I’m very excited about the field now, not only because of the Thai results, but we’ve [also] made enormous advances in the area of neutralizing antibodies over the last 18 months and now have many, many targets on the virus as well as antibodies that neutralize all of the strains at incredibly low doses. The science is in fabulous shape.

Looking back, how would you guess that we should start thinking about combining approaches to HIV vaccination?

At the end of the day, what you want is a vaccine that provides both neutralizing antibodies and cellular immunity. That’s what the best of other vaccines do, and certainly given the variability of this organism if you could only have one of those you’d probably want neutralizing antibodies because of the fact that neutralizing antibodies can block acquisition. Of course, to do good neutralizing antibodies you have to have T helper cells. But in terms of having an ability that if some of the virus was to get through, to have a way to mop that up with cell-mediated immunity would be important.

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Spread the word: 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 May and be based in New York City.

The deadline for applications is 4 April 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.

Cross posted from Nature’s The Great Beyond blog.

The strange tale of Woo Suk Hwang keeps getting more bizarre.

The former Seoul National University cloner surprised the world in 2004 by claiming to have established a stem cell line from a cloned human embryo. In November 2005, he shocked colleagues by admitting, after denying, denying and then denying again, that he had knowingly used his graduate students’ eggs to achieve that feat. (Nature had reported this first a year and a half before.) The greater shock came the following month when it turned out that that feat had been faked. The sad trial in which he was eventually convicted of embezzlement produced other incredible stories. For example, when he could not explain some missing research expense receipts, he defended himself by claiming that he had had to pay off Russian mafia to get access to mammoth DNA.

With a 2-year delayed sentence pending, Hwang has tried to rebuild his career, and private sources helped him to build the Sooam Biotech Research Foundation.

But rumors that Hwang would rise again to great heights in faraway lands keep popping up. There have been rumors that Harvard and other top US universities were recruiting him. There were rumors that Thailand was recruiting him.

Now, in the latest twist of the Hwang tale, Korean media is reporting that Libya was trying to nail down a W153 billion (US$1=W1,127) collaboration with Hwang.

Read the rest of the post on The Great Beyond.

In the past, we’ve covered the growing anxieties about the painkiller acetaminophen, which can cause liver problems and is often taken to excess. We’ve also reported on scientists’ worries that consumers are relatively unaware of the dangers of drug combinations. Today, the US Food and Drug Administration (FDA) made an announcement that might lead people who harbor both concerns to let out a sigh of relief.

The agency has asked drug makers to limit the amount of acetaminophen to no more than 325 milligrams per pill when included in drug combinations. “Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death,” Sandra Kweder of the FDA’s Center for Drug Evaluation and Research (CDER) said in a statement.

But even if this recent regulatory move addresses the problem of unintended acetaminophen overdose, the FDA still faces hurdles in the area of painkillers. The debate over opioid dosing, for one, certainly isn’t going away anytime soon.

Image from woodleywonderworks via Flickr Creative Commons

By Asher Mullard

In July, the global health financing mechanism UNITAID established an intellectual property–sharing scheme focused on scaling up access to new and lower-priced antiretroviral drugs in the developing world. The initiative—called the Medicines Patent Pool (MPP)—aims to streamline licensing processes, drive the combination of multiple HIV medicines into one pill and foster the development of drug formulations for children. In September, the US National Institutes of Health (NIH) became the first contributor to the venture, licensing a suite of patents related to protease inhibitors that are used to treat HIV. The task of bringing drug firms and other key stakeholders into the fold now falls on Ellen ‘t Hoen, a lawyer who became MPP’s executive director last month after previously heading up Médecins Sans Frontières’ Campaign for Access to Essential Medicines. Asher Mullard spoke to Hoen about the challenges of encouraging companies to share their intellectual property in a normally guarded sector.

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Image by ©IAS/Marcus Rose/Workers’ Photos

By Elie Dolgin

Humans are the products of millions of years of evolution through natural selection. Yet when it comes to the treatment of disease, physicians and biomedical researchers have long neglected our evolutionary pasts. Now, a number of research institutes are attempting to remedy that by launching new research centers dedicated to the burgeoning field of evolutionary medicine.

The newly minted Center for Evolutionary Medicine at the University of Zurich opened its doors in late October. Backed by a $10 million donation from the private Zurich-based Mäxi Foundation, the center will focus on analyzing ancient DNA and bones as well as dissecting microevolutionary changes in human morphology to better understand modern diseases. “It’s medical research, but it’s looking from an evolutionary perspective,” says the center’s director Frank Rühli, a physician who has studied ailments such as atherosclerosis in Egyptian mummies.

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By Stu Hutson

The first-line regime of tuberculosis drugs has remained virtually unchanged for a half century. But instead of improving on these medications, some researchers say it’s time to scour the lists of already-approved drugs for other indications or start from scratch to curb the more than 1.7 million deaths from tuberculosis (TB) each year.

In early November, for example, the New York–based TB Alliance announced the launch of a clinical trial to test a radically different drug cocktail. “We see this as a paradigm shift in methodology,” says Ann Ginsberg, the organization’s chief medical officer, “And it’s been one that industry as well as regulators at institutions like the [US Food and Drug Administration] have been very supportive of.”

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