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I'm Rob Logan, Ph.D., senior staff, U.S. National Library of Medicine substituting this week for Donald Lindberg, M.D, the Director of the National Library of Medicine.

Here is what's new this week in MedlinePlus.

To listen to Dr. Lindberg's comments, click here

Two recent studies and a commentary in the Journal of the American Medical Association candidly reveal that some refereed clinical research sponsored by for-profit companies needs more rigor, reconsideration, and reform.

Two JAMA studies suggest a pharmaceutical company apparently misrepresented research data, plus allegedly manipulated clinical research articles and reviews that were published widely in internationally respected, refereed, medical journals (including JAMA).

The comprehensive studies also reveal that some of this published research may have been ghost-written. Or, the listed authors of some published research did not write the articles.

In some cases, the first or primary author allegedly had little to do with some studies or reviews and often did not disclose financial support from a drug company. Instead, the research apparently was conducted and articles were written by unacknowledged authors, who at times were employees of a pharmaceutical company.

In fairness, JAMA's editors note occasionally some authors who did not disclose a financial conflict of interest may not have received support -- and not all refereed journals report or require full disclosure of financial underwriting.

Although the examples cited in the two JAMA studies focus on one company (Merck) and research about a drug (sold as Vioxx and two other brands), the editors of JAMA write in an accompanying editorial, (and we quote) 'the manipulation of study results, authors, editors, and reviewers is not the sole purview of one company" (end of quote).

This suggests the practice is not limited to the examples the JAMA studies detail and represents a scenario that JAMA's top editors proclaim needs to stop.

While JAMA's editors add that information and articles published in refereed medical journals influence the education, clinical practice of physicians and other health professionals, they note the public's trust and confidence in clinical research also is at stake.  After all, one purpose of peer review is to establish the credibility of the scientific evidence that the authors (and a journal) present.

Incidentally, the release of internal documents that suggested manipulation and ghost-written articles mostly became public record during recent litigation. In the case of related research articles originally published in JAMA, the journal recently placed all the relevant documents (that were disclosed during litigation) on the Internet for public inspection.

Merck also issued a statement that said (and we quote), 'a full, unbiased evaluation….shows that many of the conclusions put forward by the authors of the JAMA papers are incorrect.'

To reform the status quo, JAMA's editors make 11 suggestions. Some of these include:

• Medical journals should require a statistical analysis of clinical trial data that is conducted by a statistician who is not an employee of a for-profit company
• Authors who fail to disclose financial relationships and conflicts of interest, or permit their names to be used for work they did not perform, must be reported to an appropriate authority or oversight body. An offending author must provide full disclosure and apologize to the journal, which may ban him or her from future publication (in the journal)
• A medical journal editor who knowingly permits a for-profit company to manipulate research in the journal should be removed from his or her post
• Physicians should be free of influence from pharmaceutical and medical device companies and should not accept funds for serving on company sponsored speaker's bureaus or accept gifts.

Although MedlinePlus does not directly address the manipulation of clinical trial research, it provides comprehensive and helpful health topic pages devoted to understanding medical research and drug safety.

MedlinePlus' health topic page on understanding medical research helps explain clinical trial processes and the information that underlies the U.S. Food and Drug Administration's (FDA's) approval of prescription medications.

A website maintained by the Family Caregiver Alliance helps you evaluate medical research findings and gives you tips on how to assess the results of clinical trials. While this is a complex topic, the Family Caregiver Alliance website tries to explain basic principles in plain language.

The Family Caregiver Alliance website is called 'evaluating medical research findings and clinical trials' and is in the 'overviews' section of MedlinePlus.gov's understanding medical research health topic page.

To find it, please type 'medical research' in the search box on MedlinePlus.gov's home page. Then, click on 'understanding medical research (National Library of Medicine).'

The drug safety health topic page adds information about how to use medications safely. Among recommended links is a well-written website provided by the FDA that introduces the safe use of prescription medications.

Another FDA website provides a clearinghouse of information about medications where the agency has issued warnings and advisories, and permits you to submit reports of adverse events (or unhealthy drug reactions) to the FDA.

Both FDA websites are located in the 'overviews' section of MedlinePlus.gov's drug safety health topic page. To find it, please type 'drug safety' in the search box on MedlinePlus.gov's home page. Then, click on 'drug safety (National Library of Medicine).'

The issues surrounding the credibility of medical research, which the JAMA studies raise, are a sobering reminder that individual and institutional health care decisions need to be based on maximally rigorous evidence. Please use MedlinePlus as a resource to help you understand medical evidence and to stay abreast of developments in research credibility and drug safety.

Before I go, this reminder……. MedlinePlus.gov is authoritative,….. free…. does not accept advertising …and is written to help you.   

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We encourage you to use MedlinePlus and please recommend it to your friends. MedlinePlus is available in English and Spanish.

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It was nice to be with you….

Dr. Lindberg returns in the future.

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