Exploiting science? A systematic analysis of complementary and alternative medicine clinic websites' marketing of stem cell therapies.

OBJECTIVE: To identify the frequency and qualitative characteristics of stem cell-related marketing claims made on websites of clinics featuring common types of complementary and alternative medicine practitioners. The involvement of complementary and alternative medicine practitioners in the marketing of stem cell therapies and stem cell-related interventions is understudied. This research explores the extent to which they are involved and collaborate with medical professionals. This knowledge will help with identifying and evaluating potential policy responses to this growing market. DESIGN: Systematic website analysis. SETTING: Global. US and English-language bias due to methodology. MAIN OUTCOME MEASURES: Representations made on clinic websites in relation to practitioner types, stem cell therapies and their targets, stem cell-related interventions. Statements about stem cell therapies relating to evidence of inefficacy, limited evidence of efficacy, general procedural risks, risks specific to the mode of therapy, regulatory status, experimental or unproven nature of therapy. Use of hype language (eg, language that exaggerates potential benefits). RESULTS: 243 websites offered stem cell therapies. Many websites advertised stem cell transplantation from multiple sources, such as adipose-derived (112), bone marrow-derived (100), blood-derived (28), umbilical cord-derived (26) and others. Plant stem cell-based treatments and products (20) were also advertised. Purposes for and targets of treatment included pain, physical injury, a wide range of diseases and illnesses, cosmetic concerns, non-cosmetic ageing, sexual enhancement and others. Medical doctors (130), chiropractors (53) and naturopaths (44) commonly work in the clinics we found to be offering stem cell therapies. Few clinic websites advertising stem cell therapies included important additional information, including statements about evidence of inefficacy (present on only 12.76% of websites), statements about limited evidence of efficacy (18.93%), statements of general risks (24.69%), statements of risks specific to the mode(s) of therapy (5.76%), statements as to the regulatory status of the therapies (30.86%) and statements that the therapy is experimental or unproven (33.33%). Hype language was noted (31.69%). CONCLUSIONS: Stem cell therapies and related interventions are marketed for a wide breadth of conditions and are being offered by complementary and alternative practitioners, often in conjunction with medical doctors. Consumer protection and truth-in-advertising regulation could play important roles in addressing misleading marketing practices in this area.

Process change evaluation framework for allogeneic cell therapies: impact on drug development and commercialization.

AIMS: Some allogeneic cell therapies requiring a high dose of cells for large indication groups demand a change in cell expansion technology, from planar units to microcarriers in single-use bioreactors for the market phase. The aim was to model the optimal timing for making this change. MATERIALS & METHODS: A development lifecycle cash flow framework was created to examine the implications of process changes to microcarrier cultures at different stages of a cell therapy's lifecycle. RESULTS: The analysis performed under assumptions used in the framework predicted that making this switch earlier in development is optimal from a total expected out-of-pocket cost perspective. From a risk-adjusted net present value view, switching at Phase I is economically competitive but a post-approval switch can offer the highest risk-adjusted net present value as the cost of switching is offset by initial market penetration with planar technologies. CONCLUSION: The framework can facilitate early decision-making during process development.

Stem cell-based therapies: promises, obstacles, discordance, and the agora.

Stem cell research has entered the public consciousness through the media. Proponents and opponents of all such research, or of human embryonic stem cell research specifically, engage in heated exchanges in the modern public forum where stakeholders negotiate, the agora. One common claim that emerges from the fray is that a particular type of stem cell research should be pursued as the most promising path toward the reduction of suffering and untimely death for all of humanity. Upon evaluation, experimental data regarding the potential role of stem cells in regenerative therapies for three conditions-spinal cord injury, type 1 diabetes, and cardiovascular disease-tell distinct, complex, and inconclusive stories. Further analyses in this article incorporate realistic considerations of a broad range of relevant factors: limited funding for biomedical research, media motives, the discordance hypothesis of evolutionary medicine, the relationship between religion and science, medical care in developing nations, and culture wars over abortion. Holistic investigation inspired by the current agora conversation supports the need to drastically change interactions regarding stem cell research so that its potential to benefit humanity may be more fully realized.

The unregulated commercialization of stem cell treatments: a global perspective.

Research into the biological properties and clinical potential of stem cells has spurred strong public investment, industry development, media coverage, and patient interest in recent years. To date, however, few clinical applications of demonstrated safety and efficacy have been developed with the exception of uses of hematopoietic stem cells in the treatment of diseases of the blood and immune systems. This lack of an evidence basis notwithstanding, hundreds of companies and private clinics around the world now sell putative stem cell treatments for an enormously broad range of medical and quality-of-life conditions. This represents a major challenge for legitimate scientists working in the field, for authorities seeking to protect their constituencies, and for patients and consumers targeted by such companies' marketing strategies. In this review, I provide an overview of the global industry in pseudomedical stem cell treatments, with an investigation of claims in a single disease area (amyotrophic lateral sclerosis), and make recommendations for the introduction and enforcement of appropriate regulatory responses to this problem.

Stem cell stratagems in alternative medicine.

Stem cell research has attracted an extraordinary amount of attention and expectation due to its potential for applications in the treatment of numerous medical conditions. These exciting clinical prospects have generated widespread support from both the public and private sectors, and numerous preclinical studies and rigorous clinical trials have already been initiated. Recent years, however, have also seen alarming growth in the number and variety of claims of clinical uses of notional 'stem cells' that have not been adequately tested for safety and/or efficacy. In this article, I will survey the contours of the stem cell industry as practiced by alternative medicine providers, and highlight points of commonality in their strategies for marketing.

The systematic production of cells for cell therapies.

Stem cells have emerged as the starting material of choice for bioprocesses to produce cells and tissues to treat degenerative, genetic, and immunological disease. Translating the biological properties and potential of stem cells into therapies will require overcoming significant cell-manufacturing and regulatory challenges. Bioprocess engineering fundamentals, including bioreactor design and process control, need to be combined with cellular systems biology principles to guide the development of next-generation technologies capable of producing cell-based products in a safe, robust, and cost-effective manner. The step-wise implementation of these bioengineering strategies will enhance cell therapy product quality and safety, expediting clinical development.

Cost utility of allogeneic stem cell transplantation with matched unrelated donor versus treatment with imatinib for adult patients with newly diagnosed chronic myeloid leukaemia.

OBJECTIVE: To estimate, from the perspective of the German statutory health insurance, the cost utility of allogeneic stem cell transplantation with matched unrelated donor (MUD-SCT) in newly diagnosed, chronic-phase chronic myeloid leukaemia (CML) patients aged 40 years or younger, relative to the treatment with imatinib. METHODS: The incremental cost-effectiveness ratio (ICER) of the additional cost of imatinib versus MUD-SCT per quality-adjusted life year (QALY) gained was chosen as a target assessment. ICER was quantified using a Markov cohort modelling approach. The evaluation encompassed 5 years of treatment with either approach, and only direct medical costs (in euro, year 2005) were considered. RESULTS: There were incremental costs of euro77,410 for imatinib therapy per QALY gained versus MUD-SCT. No strategy was clearly dominant; on average, during 5 years, cost savings of euro63,433 were obtained and 0.82 QALY lost by SCT compared to treatment with imatinib. QALYs gained in CML patients with either treatment resulted in considerable cost to the third-party payer in Germany. The results were particularly sensitive to the price of imatinib. CONCLUSIONS: The analysis finds that imatinib is more costly but more effective (as measured in QALYs) over a 5-year time horizon. The resulting ICER of euro77,410 per QALY is higher than commonly cited thresholds. The cost utility of MUD-SCT to treat CML in patients with a European Group for Blood and Marrow Transplantation score < or = to 2 compares with that of the imatinib strategy.

Economic evaluation of treatments for cancer in childhood.

Treatment of cancer in childhood is an expensive undertaking for the health-care system and for the affected families. As there is a substantial burden of treatment-related morbidity, it is important to determine whether the effects of treatment are worth these monetary costs, especially from a societal perspective. Economic evaluation affords a comparison of the costs and consequences (effects) of relevant therapeutic alternatives. Preference-based measures of health-related quality of life are particularly useful for assessing the effects of treatment, for these tools integrate mortality and morbidity. These measures provide utility scores that can be used as weights on survival data to compute quality-adjusted life years (QALYs). Costs are incurred both within and outside of the health-care system. The former should include those in front-line patient care departments (e.g. nursing); the pro-rated share of the expenses of service departments (e.g. materials management) to those in the front line; and the fully allocated costs for capital invested in lands, building and equipment. The latter are costs borne by families that are both out-of-pocket (e.g. for over-the-counter drugs) as well as related to time spent in providing care, which may involve foregone income. Costs and consequences should be subject to discounting; a process for converting those items incurred in the future into contemporary equivalents. Economic evaluation provides estimates of incremental discounted costs per discounted QALY gained. By almost any interpretative standard this appears attractive with respect to cancer in childhood. Examples are provided with the encouragement that economic evaluation be undertaken in more clinical trials in paediatric oncology.