Rick Perry isn’t the only one getting pharmaceutical donations

pilldollars.jpgRepublican presidential candidate Rick Perry has not received his vaccination against controversy. At a debate earlier this week, the presidential-hopeful Minnesota Congresswoman Michele Bachman criticized the Texas governor’s 2007 mandate requiring all 12-year old girls to receive Merck’s Gardasil vaccine against the cancer-causing human papillomavirus (HPV). Among a list of reasons, she accused Perry of signing the mandate to please a campaign contributor — the vaccine’s maker, New Jersey-based Merck. Since 2000, Merck has donated nearly $30,000 to Perry, according to the Texas Tribune, and Perry’s former chief-of-staff used to lobby for the drugmaker.

But let’s be fair, here: Rick Perry isn’t the only one receiving political donations from pharmaceutical companies. Bachmann herself has received nearly $150,000 from pharma over the course of her career, and that’s just the tip of the iceberg. The pharmaceutical industry contributed more than $30 million to political causes during the 2010 election cycle alone, according to data compiled by Washington, DC’s Center for Responsive Politics. Pfizer, based in New York, tops the list of contributors, giving more than $1.6 million during the 2010 election cycle, evenly split between Republicans and Democrats, and topping $475,000 for this year alone.

However, these figures are not necessarily complete. Corporations are only required to disclose those donations that go directly to campaigns or lobbyists; contributions to trade associations or interest groups can remain secret. To encourage greater transparency, New York City’s Baruch College released the Baruch Index of Corporate Political Disclosure yesterday, ranking S&P’s leading 100 public companies on a scale from ‘transparent’ to ‘opaque’. The report judged companies on how much and what type of information about political donations they disclose, their contribution policies and how easy it is to find the relevant information on their websites.

As a group, pharmaceutical firms were amongst the most transparent companies, and mega-contributor Pfizer was one of only seven companies rated ‘most transparent.’

“For pharmaceutical companies, reputation is important because they really are consumer companies: they have more interaction with the public,” says Bruce Freed, president and founder of the Center for Political Accountability in Washington, DC. “They recognize that keeping donations mysterious can create problems because it’s something that the public is very sensitive to.”

While the Baruch Report gave Pfizer, Amgen and Merck high transparency ratings, not all pharmaceutical companies fared so well. Notably, Illinois-based Abbott Laboratories was on the low end, in the bracket just above ‘opaque.’ Abbott donated over $1.1 million to campaigns for the 2010 cycle. Additionally, drug distributors CVS and Walgreens were both categorized as ‘opaque.’

The Center for Political Accountability will release its own disclosure report at the end of October, and Freed says the rankings will differ from the Baruch Index. He considers Merck a more transparent company than Pfizer, for example. But Baruch Index author Don Schepers, director of the college’s Robert Zicklin Center for Corporate Integrity, thinks that the more reports that come out, the better. “This will force companies to have a governance conversation, and gives shareholders the opportunity to ask companies much more directly [about donations],” he says. “When indexes start to pop up, companies really do start to alter their behaviors.”

Image: by Flickr user Ano Lobb under Creative Commons

Patent protection brings hope to insurers

By Georgina Kenyon

Insurance companies are stepping up their marketing of damage-protection products to pharmaceutical and life science companies, some say in response to a June report by the US Food and Drug Administration laying out a collaborative strategy to more closely track the quality of goods globally.

In response to increasing regulatory activity, UK-based JLT Specialty, part of the Jardine Lloyd Thompson Group, has begun marketing such ‘nondamage’ products more aggressively this past summer—and they’re dropping their prices.

The price of the insurance depends on a variety of conditions—for instance, the size of the company seeking insurance, the limits bought and the triggers chosen. However, over the past year the cost of coverage has dropped more than threefold, from approximately 5% to 1.5% of the estimated coverage. For example, previously, $5 million could have covered a company worth $100 million, whereas now it costs $1.5 million to cover the same-sized company.

(Click here to continue reading.)

NIH student training overhauled after HHMI pulls funding

herzoginthelab.jpgAs an undergraduate student at the University of Wisconsin–Madison, Amanda Herzog worked in a number of different research laboratories where she studied everything from cartilage growth to pediatric tonsillectomy techniques to fruit fly behavior. So, when she started medical school at UW’s School of Medicine and Public Health in 2007, she figured she’d keep up with her research activities. Yet, other than a three-month stint assisting oncologist Mark Albertini in his melanoma lab for a summer research program between her first and second years, Herzog has struggled to fit research into her schedule. “I had to devote my time to my studies,” she says.

Herzog’s passion for lab work inspired her to apply for a unique research program funded jointly by the US National Institutes of Health and the Howard Hughes Medical Institute. She succeeded, and became one of the 42 students chosen from hundreds of applicants for the program’s 2010-2011 academic year. As a HHMI–NIH Research Scholar, she was able to defer her third year of medical school and instead study an experimental head and neck cancer drug in cellular and animal models at the NIH in Bethesda, Maryland.

For Herzog, the experience was a first step to fulfilling her budding career ambitions. “I would love to have my own lab down the road,” she says, “and this program will help me get my foot in the door.” But other aspiring medical researchers might not be so lucky. On 30 August, the NIH announced plans to replace its existing medical training programs with a new education initiative that, at least initially, will only offer around half the number of spots as were previously available.

HHMI had funded the Research Scholars Program—also known as the Cloister Program because the participants are housed in an old convent on the NIH campus—since its inception in 1985. But the goal all along had been simply to help get the program off the ground, notes William Galey, director of graduate science education program for the Chevy Chase, Maryland-based non-profit. A quarter-century later, with that mission accomplished, HHMI decided to pull its support and invest in other training efforts, such as its international student research fellowships, offered for the first time this year . “It was really time to hand the keys over to the NIH,” Galey says.

Continue reading →

OPINION: Consistent clinical research standards benefit patients around the world

By Joe Herring

joeherring.jpgAlthough the globalization of clinical trials has provided benefits to host countries, critics have focused on the rare but egregious examples of unethical practices. But large, coordinated trials by the contract research industry can encourage best practice, particularly if local countries adopt more consistent standards and oversight.

As economic prosperity comes to developing nations, diseases associated with Western lifestyles, such as cancer and diabetes, are crossing borders. Meanwhile, developing countries are quickly becoming consumers of biopharmaceutical products. With the shared burden of disease comes the need to obtain safety and efficacy profiles across worldwide populations in a way that mirrors global disease epidemiology and treatment.

Increasing access to allow for more people to participate will be instrumental in clinical trials of the future. Developed nations are home to just 15% of the world’s population, yet they host three-quarters of all clinical trials. Clinical trials in emerging regions tend to take place in large urban centers where healthcare infrastructure can support research conducted according to Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) standards. Compliance to these industry standards will strengthen the safety and quality of the research and increase public confidence in clinical trial participation.

Without further globalization, the pace of medical research would slow substantially. This is largely due to the reality that clinical trials are larger and more complex than they were ten years ago, and Western participation levels have peaked.

(Click here to continue reading.)

Joe Herring is chairman and chief executive officer of Covance, headquartered in Princeton, New Jersey, USA. Currently, he also serves as chairman of the board of the Washington, DC–based Association of Clinical Research Organizations.

French law to make conflict of interest disclosure mandatory

By Sabine Louët

France, still reeling from the Mediator scandal in which the diabetes drug (also known by its generic name, benfluorex) remained on the market until November 2009 despite earlier indications that it carried a risk of fatal heart valve trouble, is contemplating a revamp of its drug approval system. Lawmakers are due to discuss updates to the rules governing disclosures of conflict of interests by experts involved in the country’s drug approval process when the French National Assembly reconvenes at the end of September.

As part of a draft bill reforming the drugs approval and safety system, France may soon require that conflicts are publicly disclosed by directors and experts at regulatory agencies and made available publicly. Failure to do so would now incur sanctions including fines of up to €30,000 ($43,000).

Etienne Caniard, president of Mutualité Française, a federation of most of France’s nonprofit private health insurers, contends that the new rules will have a positive effect. “This proposal will help uncover the sectors where the state has given free rein to the pharmaceutical industry and where it should take its responsibility and regain control, such as continuous medical education,” he says.

To gain a clean start, the new bill also suggests renaming the country’s drug regulatory authority, from the French Health Products Safety Agency (AFSSAPS) to the National Agency for Medicine Safety (ANSM). The legislation would also make the renamed agency’s drug approval committees smaller than before to ensure that only experts with a track record in relevant therapeutic areas are involved. These experts would not be allowed to sit on drug approval committees longer than four or five years, and the decisions made by the committees would be more transparent.

(Click here to continue reading.)

Natural killer cells caught on film while attacking disease

One of the most potent players within the immune system is the so-called ‘natural killer cell’. The ‘NK’ cell attacks by emptying sacks full of destructive proteins, known as lytic granules, across its membrane into a diseased cell, causing the target to dissolve. And, in research published today in PLoS Biology, molecular immunologists from Imperial College London caught it all on film using specialized microscopy technology.

In the video below (skip to 1:20), you can watch a natural killer cell assail a target cell. The movie shows the two cells layered on top of one another; their point of contact is indicated by the green-stained ring, composed of clusters of fluorescent receptors on the surface of the natural killer cell. The contact itself activates these receptors, which in turn recruit the red-stained lytic granules to the cell membrane. In the final act, these potent granules fuse with the target cell’s membrane, and empty their contents to kill it. Cue the credits.

AIDS documentary ‘We Were Here’ takes emotional trip back in time

600x500_banner_NYT.jpgAlthough all eyes and ears were on the blockbuster Contagion this weekend, another film featuring an epidemic opened in New York City on Friday. We Were Here chronicles San Francisco’s gay community in the 1980s and 1990s as it was engulfed by the very real epidemic of AIDS. Director David Weissman’s time-traveling documentary traces the disease from its surprising emergence and examines the effect it had on a community that ultimately mobilized to hasten medical treatment.

“None of my friends are around from the beginning,” says Daniel Goldstein, an HIV-positive sculptor and one of the documentary’s storytellers, in the film. “So I want to tell their story as much as I want to tell my story.”

Goldstein is one of five voices that narrate the film, all of whom lived through the epidemic in San Francisco. Goldstein’s story is perhaps the most striking for its emotional poignancy — he describes losing two partners to AIDS within a decade — but each narrator dictates a distinct angle. The storytellers embrace neither self-pity nor self-promotion, and their crisp recollections immerse the audience into their community.

Continue reading →

Q&A: Microbiologist takes helm of the European Institute of Innovation and Technology

vongabain913.jpgAlthough many of the world’s best known drugmakers hail from Europe, historically the continent’s academic institutions haven’t been as adept as their US counterparts at spinning off companies. So, in 2008, the European Commission founded the European Institute of Innovation and Technology (EIT) to bring technology and ideas developed at universities to market.

The EIT was modeled after the Massachusetts Institute of Technology in Cambridge—but it doesn’t bring its students and researchers to a common location. Instead, EIT-funded projects are based within virtual Knowledge and Innovation Communities (KICs) spread across the continent. So far, the institute has established three subject-specific KICs focused on climate change, sustainable energy and information technology, with a total of 75 collaborating universities, companies and other investors.

On 15 September, microbiologist Alexander von Gabain will take over from physicist and founding chairman Martin Schuurmans as head of the EIT. A professor at the Max Perutz Laboratories in Vienna and a cofounder of the Austrian biotech Intercell, von Gabain brings with him a new focus on advancing biomedical innovations at the institute. Hannah Waters spoke with him about how he plans to move the EIT into the biomedical arena.

(Click here to continue reading.)

FDA reorganization inspires hope for better coordination

By Mike May

In an agency-wide e-mail message on 13 July, US Food and Drug Administration Commissioner Margaret Hamburg unveiled a massive reorganization of the regulatory watchdog’s 41-year-old management structure. “The most obvious change you will see,” she wrote, “is that the Agency’s programs, in terms of a reporting chain to me, will be divided into ‘directorates’ that reflect the core functions and responsibilities of the Agency.” In addition to the existing offices, she said the FDA would also create a new Office of Operations as well as a deputy commissioner for Global Regulatory Operations and Policy “focused on grappling with the truly global nature of today’s world.”

For the pharmaceutical industry, the most important change could be the addition of the Office of Medical Products and Tobacco, which will be directed by Stephen Spielberg, who will assume the new post by the end of September. Speilberg is tasked with helping to coordinate work across the FDA’s centers for drug, biologics, medical devices and tobacco products. In the past, each of these centers reported directly to the commissioner.

(Click here to continue reading.)

Lasker prizes go to protein-folding pioneers and artemisinin originator

Two researchers who uncovered the action of molecules known as chaperonins and the scientist who characterized the ancient Chinese herbal medicine artemisinin have won the 2011 Lasker Awards for basic and clinical medical research. And, in an unusual twist, an institution, rather than any single person, won the Lasker’s public service prize.

Yale University’s Arthur Horwich and the Max Planck Institute of Biochemistry’s Franz-Ulrich Hartl took home the Albert Lasker Basic Medical Research Award for showing how protein complexes called chaperonins guide other proteins to assume their proper shape. Protein misfolding has since been linked to the accumulation of protein aggregates in many diseases, including Alzheimer’s and Parkinson’s, and biotech companies now take advantage of chaperonins to boost protein yields when producing biologic drugs. Horwich tells the “inside story” and Hartl describes the “path to discovery” in our annual Lasker special. (Click on the image to the right to go to a landing page with all of this year’s commentaries.)

This year’s Lasker~DeBakey Clinical Medical Research Award went to Tu Youyou of the China Academy of Traditional Chinese Medicine — the first-ever Chinese recipient of the $250,000 award. Although Chinese herbalists had used the leaves of the Artemisia annua wormwood plant to treat many diseases for centuries, it was Youyou who, in 1972, derived the active ingredient artemisinin, which is now a staple of malaria therapy. In her commentary in Nature Medicine, Youyou describes her discovery and other “gifts from Chinese medicine”.

Rounding out the winners circle, the National Institutes of Health Clinical Center was recognized with the newly rebranded Lasker~Bloomberg Public Service Award, named in honor of New York major Michael Bloomberg, who himself won the public service award in 2009. Clinical Center director John Gallin discusses the hospital’s myriad contributions to clinical investigations and “the future of clinical research” in his commentary.