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Bladders Built in the Lab

Rating

3 Star

Bladders Built in the Lab

Our Review Summary

This story discusses a small observational study of 7 patients who underwent transplantation of a reconstructed man-made bladder. The organ was constructed in a laboratory and the patients' cells were added to the inner and outer layer of the bladder. Cells then attached themselves to the new bladder and it was sutured into the defective bladder, along with a blood-rich tissue to nurture the new organ. The results of this small observational study were published in the British medical journal, The Lancet, though the reporter here chose to focus on anecdotal evidence from one person who underwent the procedure. Surgeons and experts in the field of tissue regeneration are quoted, and they talk positively about the reconstructed bladder and the possibility of other man-made organs; however, there is no quantitative data provided on outcomes of patients who undergo this very new organ transplantation. Reconstructed bladders are not yet approved for commercial purposes, as FDA standards for approval of tissue-based products are similar to those for drugs or medical devices. There is discussion that conventional surgery–intestinal tissue used to reconstruct a bladder– "threatens further health complications". These complications are briefly discussed, and include clogging of the bladder with intestinal mucus or formation of kidney stones, yet there is no mention of potential health problems after surgery for a reconstructed organ, or the possibility of a patient rejecting this organ. This is still a very new procedure and there is not much long-term data on health outcomes from humans with reconstructed bladders. This study is very small (9 recruited, 7 had the transplant), and so results would not be generalizable to a larger population. The cost of the surgery was free to patients in this experimental group. There is no estimate of what the reconstructed bladder procedure might cost outside a clinical trial, however, the reporter made an attempt to get this information from the company that made the bladders for this study, but the company declined to respond. There is no mention of sources' potential conflict of interest or sources of funding for this study. The cost may be free to the patients currently undergoing the transplantation, but someone is paying for the research and surgeons� efforts.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story explains that there was no cost to patients in this experimental group. The story gave no estimate of what the procedure might cost outside a clinical trial, however, the reporter made an attempt to get a cost estimate from the company, which declined comment.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

The story makes it clear that this is still a very new procedure and there is not much long-term data on outcomes from humans with reconstructed bladders. There is no quantitative data from the results of this study. This study also is very small (9 recruited, 7 had the transplant), and so results would not be generalizable to a larger population. The story discusses this limitation

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

No mention of the potential harms of the new man-made bladder.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The study in Lancet was observational, but no data on incidence of side effects or improvement (compared with functioning prior to surgery) are reported in the news story. Only anecdotal reports were given.

Does the story commit disease-mongering?

Satisfactory

No evidence of disease mongering. Patient population needing reconstructed bladders is very targeted.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

No mention of sources' potential conflict of interest or sources of funding for this procedure. The cost may be free to the patients currently undergoing the transplantation, but someone is paying for the research and surgeons' efforts.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

There is discussion that conventional surgery–intestinal tissue used to reconstruct the bladder– "threatens further health complications". These are briefly discussed, and include clogging of intestinal mucus or formation of kidney stones. There is no mention of disadvantages and potential health problems of the surgery with a reconstructed organ, or the possibility of the patient rejecting this organ.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story notes that this transplantation has only been done in a very small number of people and it is still very experimental. FDA approval has not given because tissue-based products need to be manufactured to standards similar to those for drugs or medical devices.

Does the story establish the true novelty of the approach?

Satisfactory

The story makes it clear that transplantation of reconstructed man-made bladders is still very new.

Does the story appear to rely solely or largely on a news release?

Satisfactory

There is no evidence this is taken directly from a press release. The reporter makes an effort to interview several surgeons and experts in the field of tissue regeneration.

Total Score: 6 of 10 Satisfactory

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