Costimulation Blockade Holds Emerging Hope for Patients in Large Markets Only
Bibliographic record
Abstract
To the Editor: We were excited to read of the long-term results and emerging applications of belatacept in the articles by Durrbach et al (1Durrbach A Pestana JM Florman S et al.Long-term outcomes in belatacept- versus cyclosporine-treated recipients of extended criteria donor kidneys: Final results from BENEFIT-EXT, a Phase III Randomized Study.Am J Transplant. 2016; 16: 3192-3201Abstract Full Text Full Text PDF PubMed Scopus (95) Google Scholar), Wen et al (2Wen X Casey MJ Santos AH Hartzema A Womer KL Comparison of utilization and clinical outcomes for belatacept- and tacrolimus-based immunosuppression in renal transplant recipients.Am J Transplant. 2016; 16: 3202-3211Abstract Full Text Full Text PDF PubMed Scopus (21) Google Scholar), Ebcioglu et al (3Ebcioglu Z Liu C Shapiro R et al.Belatacept conversion in an HIV-positive kidney transplant recipient with prolonged delayed graft function.Am J Transplant. 2016; 16: 3278-3281Abstract Full Text Full Text PDF PubMed Scopus (11) Google Scholar), and others (4Krezdorn N Murakami N Pomahac B Riella LV Immunological characteristics of a patient with belatacept-resistant acute rejection after face transplantation.Am J Transplant. 2016; 16: 3305-3307Abstract Full Text Full Text PDF PubMed Scopus (15) Google Scholar) in the November 2016 issue of the American Journal of Transplantation. These exciting advances prompt us to raise the issue of the lack of access to belatacept in Canada. We might cynically suggest that a special Canadian version of the cover was needed, entitled, “Costimulation Blockade Emerges—Except in Canada.” The United States has long been the testing ground for development and commercialization of new therapeutics. This infrequently poses a significant barrier for access to new therapies for common conditions, but it is a problem for therapeutics with smaller target patient populations such as immunosuppressant drugs. We anticipate this will be a bigger issue in the future, as establishing a market foothold for new transplant therapeutics in the U.S. market is likely to be more difficult with the availability of generic immunosuppressant drugs. We are sensitive to the challenges that Bristol-Myers Squibb (BMS; New York, NY) has encountered in advancing belatacept in transplantation in the United States that may render consideration of expanding access to the drug in smaller markets such as Canada financially unattractive at this time. Nevertheless, it is difficult to accept the ongoing inequity in access to belatacept for Canadian patients. We believe the responsibility to change this is not solely that of industry: Governments in smaller markets need to be engaged in ensuring patient access to important new therapeutics such a belatacept. For our part, we would invite BMS to engage with clinicians in smaller markets such as Canada to develop an advocacy strategy to address the barriers in our country that currently exclude our patients from gaining access to belatacept. We also believe this issue needs an international perspective; otherwise, we will have to accept that the decreased flow in the immunosuppressant pipeline will never trickle down enough to be relevant for those of us who care for patients in smaller markets. The authors of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplantation.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.006 | 0.051 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.002 | 0.002 |
| Scholarly communication | 0.005 | 0.005 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.013 | 0.020 |
| Insufficient payload (model declined to judge) | 0.010 | 0.005 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".