Senator Charles Grassley is not the only one working to reveal financial ties between doctors and pharmaceutical companies. In November, a group of more than 200 students and faculty at Harvard Medical School asked the administration to expand the school’s conflict-of-interest policies. Students had already convinced the school to require professors and lecturers to disclose relevant financial ties to pharmaceutical companies when discussing drugs in class. In November, the group asked that professors at the teaching hospitals and institutes affiliated with Harvard also disclose their ties to industry. Today, The New York Times reported that a 19-member committee organized by the school’s dean will meet to re-evaluate these policies on 5 March.

In addition to the students' demands, Harvard is facing external sources of pressure. In 2008 The American Medical Student Association, which grades medical schools on how well they track and curtail industry interaction with faculty and students, gave Harvard an F. Unlike schools such as the University of Pittsburgh Medical Center and Mount Sinai School of Medicine, who received A’s, Harvard does not currently ban faculty from accepting personal gifts from pharmaceutical companies. We’ll have to wait to see if Harvard makes substantial policy changes and whether more medical schools follow suit.

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Posted by Kirsten Dorans at 02:00 PM | Permalink | Comments (1)

Scientists are not the only ones conducting experiments these days: Governments around the world are experimenting with various ways to stimulate their sagging economies, including plans aimed at strengthening biomedical research. Here is a summary of budget-related headlines from the past week:

-- The Norwegian government unveiled a NOK 20 billion ($2.84 billion) stimulus package that included around NOK 3 billion of support for biotechnology, designed to protect half of the country’s biotech companies from bankruptcy.

-- The 2009 Canadian budget will invest millions into research infrastructure over the next two years. On the downside, Genome Canada, which funds large-scale genomics and proteomics research, will receive no new money this year. Moreover, the three government councils that provide grants to scientists (including the Canadian Institutes of Health Research) will see their collective budgets reduced by $113 million CAD ($91 million) over the next three years.

-- The US House of Representatives passed an $825 billion stimulus bill, with $10 billion of that going to science facilities, research, and instrumentation. The Senate is currently debating the bill.

What do you think of the plans that have come out so far?

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Posted by Kirsten Dorans at 02:50 PM | Permalink | Comments (1)

Now that the US is no longer the undisputed world technology leader, rules devised during the Cold War to prohibit the export of certain technologies and restrict foreign scientists from immigrating to the US are outdated and harmful to economic competitiveness, the US National Research Council (NRC) reported last Thursday.

Back in 2003, the scientific community protested the strict post-9/11 visa rules, citing that many students and scholars could not obtain visas. While it is now comparatively easier for students to obtain visas, professional researchers applying for US work visas still face many regulatory obstacles, the NRC report notes.

The report urges the president to issue an immediate executive order that—in addition to easing high-tech export restrictions—would also expedite the visa process for foreign scientists and engineers. The report also suggests new rules that would automatically allow foreign students to remain in the US for a year after obtaining advanced scientific or technical degrees.

An executive order to fix these visa woes might help foster innovation in the US. However, in addition to the executive order that the NRC suggests, I think the next US Congress should devise permanent legislation—that will stay in place during future presidential administrations—that eases export and visa restrictions, in order to promote US-foreign collaboration in the long-term. Do you think it's time the US rework its visa rules for biomedical researchers?

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Posted by Kirsten Dorans at 06:00 PM | Permalink | Comments (0)

Prescription drugs occasionally have unintended and devastating outcomes—think Vioxx, the blockbuster painkiller that was pulled from the market when research suggested it might increase the risk of heart attacks and stroke .

Until now, patients have had legal recourse against pharmaceutical companies that they believe failed to provide adequate warnings on product labels: they can sue these companies in state courts. But a new case facing the Supreme Court threatens to scrap this privilege and broaden the legal shield protecting pharmaceutical companies. The Court is expected to hear Wyeth v. Levine on 3 November. The case concerns a woman who lost part of her arm to gangrene following an injection with the company's anti-nausea drug Phenergan. She claims that Wyeth’s product labeling failed to adequately discourage patients from administering the drug through injection.

If the drug company prevails, consumers will be denied legal redress, the pharmaceutical industry will be off the hook, and the burden of ensuring proper product labeling will fall almost entirely on the Food and Drug Administration (FDA). With all due respect, isn’t this a lot to expect from the FDA, an agency known for being underfunded and backlogged with products awaiting approval? As editors of the New England Journal of Medicine have pointed out, FDA approval is typically based on short studies that fail to reveal long term health consequences. Furthermore, the agency relies heavily on the goodwill of drug companies to reveal potential safety problems, lacking the subpoena power required to make them tell all. If Wyeth rules in favor of the industry, will this not redirect lawsuits onto the FDA?

Drug companies know the most about their drugs—after all, they developed and tested them—so they should be responsible for informing patients of risks. What do you think?

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Posted by Coco Ballantyne at 12:28 PM | Permalink | Comments (1)

The world is watching US SenatorJoe Biden today. The the new hopeful for vice president will speak tonight at the Democratic National Convention in Denver. Through his previous legislative proposals, though, he has already said volumes about what global health issues he views as important.

Last summer, Senator Biden introduced the Global Pathogen Surveillance Act of 2007 (S. 1687), which would expand overseas infectious disease laboratories run by the Centers for Disease Control and Prevention (CDC). Experts say the risk of an avian flu pandemic is as great as ever. But according to Biden, the US government is only "one-third" prepared for an outbreak.

A report submitted by Biden urging passage of the Global Pathogen Surveillance Act calls developing nations the “weak links in a comprehensive global surveillance and monitoring network” and cites research suggesting that about one-third of countries may not even have the tools required to diagnose avian flu in humans. It's no surprise then that the proposed legislation would also provide assistance to developing nations that need better tools for recognizing and containing infectious disease outbreaks.

Forgive the pun, but in my opinion this legislation kills two birds with one stone. In addition to offering increased protection from natural pandemics, it would help prepare the global community for launching a coordinated response against a biowarfare attack; biological agents, manmade or natural, are likely to spread through human populations in similar ways. If passed, the act would cost each American family about $1—a small sum compared with the approximate per-family cost of $300 for the United States Global Leadership Against HIV/AIDS, Tuberculosis and Malaria Reauthorization Act of 2008 (also known as PEPFAR), recently signed by US President George W. Bush.

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Posted by Coco Ballantyne at 01:24 PM | Permalink | Comments (1)

The relationship between pharmaceutical makers and physicians has come under close scrutiny lately. In recent weeks Congressional leaders have accused Harvard physicians of failing to properly disclose large payments from drug companies; meanwhile, other reports have highlighted the industry ties of certain experts who helped write the American Society of Pediatrics’ new recommendations for managing childhood cholesterol.

One way to facilitate greater transparency in biomedical research is to adopt a universal policy for reporting conflicts of interest in the scientific literature, according to the Center for Science in the Public Interest, a nonprofit health advocacy group based in Washington, DC.

The group has released a model disclosure policy, which requires authors to tell editors about all potentially relevant financial relationships from the past three years. This means all types of employment, consulting gigs, patents and patent applications for products related to the research, travel grants, speaking fees, writing fees, membership to science advisory boards, stock ownership (including investments by immediate family members) in funding by firms that have anything at stake in the research, and perhaps even strong personal, intellectual or political convictions relating to the study. The authors would also submit formal conflict-of-interest statements to be published along with the paper, which editors would evaluate against the scientists’ private declarations.

Transparency always seems to be the best policy, but will everyone agree upon what constitutes a potentially relevant conflict of interest? Some people are exceptionally good at convincing themselves that they are immune to bias, and since the policy relies on an honor system it will be hard to keep track of those who defy it. The other question is whether a uniform policy is better than having each journal frame its own policy, one that is tailored to the particular set of issues affecting its field. For example, patent issues seem to be particularly germane to biotechnology but not so much to geoscience, and pharmaceutical consulting fees are intensely to relevant to medicine but much less so to the physical sciences. Would a universal policy even be practical?

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Posted by Coco Ballantyne at 04:30 PM | Permalink | Comments (2)

Life scientists sometimes work with dangerous pathogens and chemicals capable of causing grave damage to human health; they engineer novel organisms and conduct high-stakes clinical trials. These scientists are also under incredible pressure to produce results, publish papers and get ahead in their fields. One would hope that all researchers, especially those in the life sciences, adhere to the highest ethical standards. But a recent study by the US Department of Health and Human Services suggests this might not always be the case. The survey by the agency’s Office of Research Integrity found that 9% of US scientists believed they had observed possible research misconduct, such as fabricated research records and misleading grant applications.

To address this issue, the Institute of Medical Science at the University of Toronto has its students recite an oath before embarking upon their graduate studies. The oath is short and pithy; students pledge, among other things, to “pursue knowledge and create knowledge for the greater good, but never to the detriment of colleagues, supervisors, research subjects or the international community of scholars.” They swear never to allow “financial gain, competitiveness, or ambition” cloud their judgment in research and scholarly endeavors.

This strikes me as an excellent idea. Providing students with an opportunity to proclaim their good intent in front of peers is a great way to cultivate a responsible culture. I think all life science graduate programs should be doing this. What do you think?

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Posted by Coco Ballantyne at 09:19 AM | Permalink | Comments (1)

Last week, a Texas woman named Michelle Kimzey made headlines when she suggested that Gardasil, the Merck vaccine for human papillomavirus (HPV), had caused her 14-year-old daughter to develop epilepsy. Kimzey claimed that she found some 5,000 other reports of adverse side effects in the federal government’s vaccine safety surveillance database, the Vaccine Adverse Event Reporting System (VAERS).

This is not the first time VAERS has been invoked in news stories about the safety of the HPV vaccine. Last year, the National Vaccine Information Center published an analysis of VAERS data suggesting that Gardasil could cause serious side-effects including the development of an autoimmune disorder, Guillain-Barre Syndrome (GBS). While VAERS is a valuable tool for monitoring vaccine safety—both the Centers for Disease control and Prevention (CDC) and the Food and Drug Administration (FDA) analyze information in the database—the reports can cause alarm when taken out of context.

The public should know that VAERS collects only unverified reports of health events. The CDC and FDA encourage parents, vaccine manufactures, health care providers and others to report all adverse events following vaccinations, regardless of whether the vaccination is the suspected cause. Thus some of the purported vaccine side-effects actually reflect underlying diseases or conditions completely unrelated to the vaccination. VAERS does not keep tabs on groups who have not received vaccinations, so there are no control groups to compare incidence rates of various health events.

Given these issues perhaps the government should revamp the database to prevent the VAERS reports from being misconstrued as verified cases of vaccine deaths and complications. What do you think?

Posted by Coco Ballantyne at 02:40 PM | Permalink | Comments (1)

They say that knowledge is power, and some 15 US states are poised to apply that philosophy in tackling the obesity epidemic. These states are considering legislation that would require fast food chains and certain restaurants to provide consumers with nutritional information such as calorie, fat and sodium content of food items. New York and California may be the first to pass laws mandating statewide menu labeling, which could set the trend for other states to follow. The public seems to be embracing the idea, particularly in New York, where a recent poll found that 80 percent of people want nutritional tables posted in fast food eateries. The point of these laws is to encourage consumers to make informed – and thus presumably healthier – decisions about what they are eating. Ultimately, the new laws aim to curb America’s obesity epidemic – which is at an all-time high (34% of adults are obese, and 32% of school-aged children are overweight or obese) – and lower the rate of diseases associated with obesity, such as diabetes, hypertension, and certain types of cancer.

But will people actually use the information to modify their eating habits? Perhaps the best place to inquire is New York City, where a menu-labeling rule is already in place (ahead of the possible statewide regulations). In January, the city’s Board of Health voted in favor of a regulation requiring restaurant chains (businesses with more than 15 units nationally) to prominently list calories on menus and menu boards. The industry group New York State Restaurant Association has challenged the regulation, and the 2nd US Circuit Court of Appeals will probably deliberate the case for another few weeks, according to a Restaurant Association representative. Meanwhile, the FDA has sided with New York City.

I conducted an informal survey in lower Manhattan and found that, although people seem to be noticing these calorie counts, they way it drives their behavior is variable.

“For me personally, it doesn’t change what I do,” said a man I met in a fast food chain, noting that he is not concerned about his weight. “But I think with other people it does.”

“I don’t pay attention to it,” said a woman sitting nearby. “I don’t believe that a plain bagel has 300 calories,” she added, referring to the posted calorie content.

But according to the employee working behind the register, the nutritional tables are deterring customers from buying high-calorie foods—to the detriment of business. "The people, when they ask about the muffins’ calories, they don’t buy them,” said the employee, pointing at the 400-calorie ‘reduced fat’ item. “It’s affecting my sales.”

A few blocks away at a fast-food restaurant where king-sized chocolate milkshakes pack over 840 calories, patrons stopped to scan the nutrition table on the wall before approaching the register. One young woman studied the information but claimed that it would not influence her decision; she would have that bacon-double-cheeseburger no matter what. But a traffic policeman said he would chosse menu items based on caloric and fat content. “It’s very important to know the nutritional value of the food,” he told me. A couple from Argentina agreed; they used the nutritional tables to avoid the excessive amount of carbohydrates that characterizes the North American diet.

I could not help but notice that the people who said they used nutritional tables to make decisions appeared lean and fit. All this made me wonder whether menu-labeling will simply reinforce good eating habits in those who already have healthy lifestyles, rather than reform those who most need it. Critics of menu labeling have pointed out that Americans have continued to get more obese despite two decades of nutritional labeling on packaged food. Perhaps better calorie labeling will not change things. What do you think?

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Posted by Coco Ballantyne at 11:30 AM | Permalink | Comments (4)

The AAAS meeting last weekend was abuzz with events related to the US elections, including a forum where representatives of the Clinton and Obama campaigns presented their viewpoints of science policy.

I've been having trouble figuring out the difference between the two candidates' positions on any issue, so was eager to learn something from from the source.

Perhaps reflecting the stereotypes of the two campaigns, the Clinton representative, Tom Kalil, presented a more detailed, wonky set of proposals. Kalil was Deputy Assistant to former President Bill Clinton for Technology and Economic Policy. He said Clinton would double the budgets of specific agencies, including the National Institutes of Health, the National Science Foundation and the National Institute of Standards and Technology. She also would establish a $50 billion "Strategic Energy Fund" in part to promote renewable energy.

Obama's representiative, Alec Ross, looked about 20 years old and is the exective vice-president of One Economy, a nonprofit corporation that seeks to expand broadband technolgy. Perhaps in keeping with that, he emphasized computer technology advances, such as an expansion of high speed internet access. But he also said Obama planned to double funding of basic research and establish a $150 billion ten-year energy program.

Both candidates proposed programs to create electronic medical records--something that could also aid researchers conducting clinical trials.

I must admit I left still wondering essentially what the difference is between the two candidates. And I also wish someone from the McCain campaign could have been there (his campaign said they had scheduling conflicts). So I'm all for an effort to get the candidates together for a "Science Debate" an idea that is gaining a lot of momentum (although maybe not among the candidates themselves).

What do you think? Is science important enough for it's own debate? Are you ready to get behind the effort?

http://www.sciencedebate2008.com/www/index.php

Posted by Charlotte Schubert at 12:41 AM | Permalink | Comments (0)

Sorry we haven't been posting anything for the past few weeks. Blogging requires a degree of discipline that I have yet to develop. We'll try to be a bit more disciplined, though, as there's always interesting stuff happening that it's worthy of comment.

This time is Europe's decision to launch the Innovative Medicines Initiative, a joint effort of the European Union and big pharma to inject cash into Europe's biopharmaceutical industry.

The Initiative correctly stated that investment in Europe has lagged behind what the Americans spend in research and development, and the growth of the industry is nowhere near what you see in countries like China. Part of the solution is to increase investment, sure. But, as we stated in our February Editorial, one wonders if the kind of projects they intend to fund -- which they call "pre-competitive research" (research aimed not at directly developing a drug, but at generating tools that speed up the drug discovery process) will be all that helpful to the biopharmaceutical sector.

In addition to this question, there are other points that may be problematic as the IMI moves forward -- questions about funding, intellectual property and bureaucracy, some of which we discussed in the Editorial. As we wrote there, more money is always a good idea but, when it comes to the actual implementation of the IMI, the devil will be in the details.

Posted by Juan Carlos Lopez at 12:00 PM | Permalink | Comments (2)