Editorials

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  • The production setbacks for Genzyme's rare-disease drug Fabrazyme are tragic for the people who need the medicine. But a petition to break the company's patent exclusivity could do far more harm than good.

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  • The US Food and Drug Administration (FDA) wants to create a way to fast-track approval of new medical devices, but they must first address the problems of the existing accelerated process for bringing devices to market that are substantially equivalent to ones already in commercial distribution.

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  • Cancer drugs often impair quality of life and fail to extend patient survival. Mandating increased efficacy and promoting efforts to target tumor metastasis may improve outcomes for patients with cancer.

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  • A joint statement from 17 funding agencies urges biomedical researchers to openly share data obtained from population-based studies. Although this will foster more collaboration, new web technologies need to be harnessed, and the attribution of credit must change to facilitate this transition.

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  • Online science blogs are a valuable forum for commenting on published research, but their present importance lies in complementing rather than replacing the current system of peer review.

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  • Budget crises are forcing many countries to make unprecedented spending cuts. Scientists must engage with their governments to protect funding for science.

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  • Nature Medicine's relationship with the press is probably not what you think it is.

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  • The US Food and Drug Administration (FDA) is increasingly conservative in its assessment of data in new drug applications derived from noninferiority trials. Such caution might be similarly warranted in approving generic biologics.

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  • Singapore's current investment in science is remarkably strong, but it isn't yet clear if the resulting knowledge and innovation will go on to fuel economic growth, as the country expects.

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  • The National Cancer Institute is the most important cancer funding agency in the US. Yet criticism of some of its programs underscores the need for change and modernization of this institute. With the recent appointment of a new NCI director, the time for change has arrived.

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  • A more transparent drug approval process has the potential to reduce cost and duplicated effort, as well as ultimately improve access to effective treatments for patients.

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  • Major pharmaceutical firms are regularly slapped with huge fines for illegally promoting off-label drug use. But as long as the sales of these drugs dwarf the size of the fines, companies will continue to skirt the law.

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  • A program at the US National Science Foundation (NSF) has tackled the problem of the under-representation of women in academic bioscience by providing grants to foster institutional change. A recent study shows that more progress is needed—but universities and other research centers can make a big difference in sometimes small ways.

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  • A growing number of clinics are offering cell therapies that remain untested in rigorous clinical trials. Although the scientific community has chided the use of unproven treatments, we need less talk and more action in regulating stem cell therapies.

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  • Lax laws mean that drug counterfeiters often receive light punishments and companies can remain silent when they suspect bogus medicines in the supply chain. Winning the fight against fakes requires getting tough.

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  • The path of drug development is fraught with hurdles. Gaining a clear understanding of how a drug works before it enters clinical trials is the intelligent route to drug discovery and could increase the likelihood for drug success.

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  • The peer review process can be frustrating to researchers eager to get their work published. Changes to the process might be warranted—but only if they are based in fact, not conjecture.

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  • Everybody agrees that ensuring the integrity and accessibility of research data is crucial for scientific progress. Agreeing on the best way to do so is the hard part.

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  • Molecular medicine has undergone profound changes since the publication of the first issue of Nature Medicine 15 years ago this month. To keep up with these changes, we strengthen our commitment to publishing the best research and the most topical newsand commentary on translational medicine by adding more pages to the journal.

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  • Innovation in translational research has often emerged from the biotechnology industry. In a climate in which it is increasingly hard to found a successful company, direct technology transfer from academia to the pharmaceutical industry poses an additional threat to small biotechs.

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