Editors warn of, but don't retract, implant study

The editor of a chemistry journal has warned his readers to be cautious when assessing the results of a paper published in May on platinum levels in women with breast implants. Critics of the paper say the journal was right to urge caution, but not retract, the paper, which contains data that has been called into question.

The paper is flawed, Analytical Chemistry editor Royce Murray told The Scientist, but he decided not to seek a retraction as there was no evidence of deliberate misconduct.

"I think a retraction is done for reasons of fraud and I don't have any evidence of that here," Murray said. "It's simply a matter of what I, and others I consulted, considered was an example of publishing something substantially below the standard of the journal."

In a paper in the May issue of the journal, authors Susan Maharaj and Ernest Lykissa used ion chromatography-inductively coupled plasma-mass spectrometry to measure the platinum concentration and platinum oxidation states in the blood, urine, hair, nails, sweat, and breast milk of women exposed to silicone and saline breast implants.

Maharaj and Lykissa said that the urine of women with silicone breast implants contained significantly more platinum than that of people with no known exposure to platinum, and that platinum used in the manufacture of breast implants was converted to highly oxidized platinum species, up to and including Pt⁶⁺.

The paper was peer reviewed, but on publication triggered several critical letters, including one from Thomas Lane of Dow Corning Corporation, which formerly manufactured implants. "The authors' primary conclusions are not supported by their own data," he wrote.

After receiving the correspondence, Murray said, he consulted experts on the chemistry of platinum who told him that platinum 6+ is an extremely strong oxidizing agent that "probably wouldn't have made survived the chromatography column, let alone the workup."

That and other issues such as the lack of an appropriate control group prompted him to pen an editorial for the August issue jointly with section editor Catherine Fenselau, urging readers to use "caution in evaluating the conclusions drawn in the paper."

This is the first time the journal has taken this kind of step in the 15 years that he has been editor, Murray said.

The publication of the paper came at a sensitive time, with the Food and Drug Administration in the midst of considering applications to market silicone implants by two manufacturers, Inamed and Mentor. Lykissa and Maharaj acknowledged support from Chemically Associated Neurological DisOrders (CANDO), a group that opposes the marketing of breast implants.

Purnendu "Sandy" Dasgupta, a professor of chemistry and specialist in ion chromatography at Texas Tech University, told The Scientist he thought the journal editors had done the right thing by alerting their readers to the problems with the paper.

"I don't think they should have made the authors retract the paper," said Dasgupta, who was also critical of the article, and said he has not received any money from the breast implant industry. "All in all I think they have made the right decision."

Dow's Thomas Lane agreed, saying he was very satisfied with what the journal had done. "The really did step up ... and do a lot of extra work to understand the situation," he told The Scientist. "The journal was very responsive ... and did a wonderful job."

As for the authors, Lane said he "would invite them to address the concerns that have been expressed and resubmit their work for publication."

Murray, who works at the University of North Carolina Chapel Hill, said he had invited Maharaj and Lykissa to submit a rebuttal for peer review in response to the editorial. This they did, "rather late," he said.

The rebuttal does not appear in the August issue, however, and Murray said it was not going to be published in the next. He would not comment on whether it had been rejected for publication, referring questions to the authors.

Study author Maharaj told The Scientist via Email that Murray said he wouldn't publish their rebuttal. "The Editor has refused to publish a response paper from us -- this is unconscionable. The standard practice at journals is to publish comments about a paper, together with the author's response. This was obviously not done, and now they are refusing to let me air my side of the debate. This is not the scientific way. Any scientist would agree."

Maharaj's co-author Lykissa added in a separate Email that the study used certified standards, and some critics may have "skewed" facts if they base their knowledge on data from newer implanted devices, which may have different effects than older implants.

Maharaj added that she should be able to revise her submitted response and publish it. "This more than anything else reveals the improprieties that we have been up against in publishing on this controversial topic."

Stephen Pincock
spincock@the-scientist.com

Links within this article

A. McCook, "Scientists protest Cell retraction," The Scientist, September 29, 2005.
http://www.the-scientist.com/article/display/22782/

Analytical Chemistry
http://pubs.acs.org/journals/ancham/index.html

Royce W. Murray
http://www.chem.unc.edu/people/faculty/murrayrw/rwmindex.html

D. Payne, "Researcher admits faking data," The Scientist, March 21, 2005.
http://www.the-scientist.com/article/display/22630/

E. Lykissa and S. Maharaj, "Total Platinum Concentration and Platinum Oxidation States in Body Fluids, Tissue, and Explants from Women Exposed to Silicone and Saline Breast Implants by IC-ICPMS," Anal. Chem., 2006;78:2925-2933.
PM_ID: 16642977

Expertox
http://www.expertox.com/

T. Lane, "Comments on Total Platinum Concentration and Platinum Oxidation States in Body Fluids, Tissue, and Explants from Women Exposed to Silicone and Saline Breast Implants by IC-ICPMS," Anal. Chem., 2006 Aug 1;78(15):5607-8.
PM_ID: 16878903

Thomas Lane
http://www.chemistry.org/portal/a/c/s/1/acsdisplay.html?DOC=elections%5C2004candidates%5Clane.html

Purnendu Dasgupta
http://www.depts.ttu.edu/chemistry/faculty/dasgupta/dasgupta.html

R. Walgate, "Retracted Ecstasy paper an 'outrageous scandal,'" The Scientist, September 16, 2003.
http://www.the-scientist.com/article/display/21593/