抗癌专利本质上不道德吗?

IF 3.2 3区 生物学 Q2 BIOCHEMISTRY & MOLECULAR BIOLOGY
BioEssays Pub Date : 2024-04-17 DOI:10.1002/bies.202400081
Dave Speijer
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(iii) There is no great “conceptual idea/inventive step” (which is often used as an excuse for the extra financial rewards linked to patenting) to speak of. All of the underlying knowledge and the possible application are so mainstream that undergraduate biology or medicine students can (and will have, I am sure) already come up with it. (iv) The vast majority of researchers are still steeped in the “ethics of science”, which means that they know scientific progress depends on open discussion and exchange of ideas. It also means most scientists are much more interested in such progress and the common good than in any financial gain. Alas, such attitudes, so beneficial to science and medicine, are precisely what makes them such easy prey for those who use their scientific literacy in less altruistic ways. Regarding patents, I hope to have made it clear why I consider this specific instance “patently absurd”. However, I must admit that it reflects a wider concern of mine: overall, we should do more to “get the market out of medicine”. So, what could be done? Some of these suggestions might not be popular, but here goes. Government employees should not get patents, unless with specific dispensation. Going further, third parties working with academics should also <i>not</i> get patents regarding such work unless they get consent from, and compensate society via, the appropriate authorities. Most importantly: medical patents should be severely limited in number, scope, and duration of applicability. 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引用次数: 0

摘要

我有可能会因为下面的一些看法而惹上麻烦,但我认为值得对公共开支、专利、"知识 "产权和不必要的高昂救命治疗费用之间的相互关系进行一些思考。[1]《自然-科学报告》发表了一篇有趣的文章,详细描述了肿瘤特异性分子的可能来源。[2]这种分子当然会引起极大的临床兴趣,因为它们可以作为肿瘤特异性抗原,潜在地释放我们自身免疫系统对抗恶性肿瘤的力量,同时将自身免疫并发症的几率降到最低。所谓的嵌合抗原受体(CAR)-T 细胞疗法[3],以及使用针对免疫检查点蛋白(如 PD-1/PD-L1 和 CTLA-4)的抗体来实现更有效的癌症免疫疗法[4],都说明了激活免疫系统在对抗癌症方面的重要性。在公开的大型数据集中,确实可以找到大量这种新的、癌细胞独有的开放阅读框。这意味着,将编码的肽作为抗原,可以帮助患者对抗肿瘤,是有效的个性化医疗的一个微妙实例。可能会让读者感到惊讶的是,这篇文章还附有一份利益冲突声明,内容涉及一项专利:"......基于新开放读框肽数据库制备受试者特异性免疫原组合物的方法"。与此同时,该专利已被高价卖给了德国生物技术公司 CureVac。这可能意味着,由于涉及到额外的费用,这种可能挽救生命的治疗方法在未来可能会受到限制。你可以说我是老古董,但这种令人遗憾的结果怎么能说得通呢?考虑一下(i) 正如我所提到的,分析是利用大量公开的数据集进行的。(ii) 所有这些重要的、高水平的生物信息分析都是由 Plasterk 的合著者完成的,他是一名公务员,受雇于一家学术医院,也就是纳税人。值得注意的是,这位研究员(可能是老派研究员)根本没有参与专利工作。(iii) 没有什么伟大的 "概念性想法/发明性步骤"(这常常被用作与专利有关的额外经济 回报的借口)可言。所有的基础知识和可能的应用都是非常主流的,生物学或医学专业的本科生都可以(而且我相信他们已经)提出来。(iv) 绝大多数研究人员仍然深受 "科学伦理 "的熏陶,这意味着他们知道科学进步取决 于公开讨论和思想交流。这也意味着大多数科学家对这种进步和共同利益的兴趣远远超过对任何经济利益的兴趣。唉,这种对科学和医学如此有益的态度,恰恰使他们很容易成为那些不那么利他地利用自己的科学素养的人的猎物。关于专利问题,我希望我已经说得很清楚,为什么我认为这个具体例子 "明显荒 谬"。不过,我必须承认,它反映了我的一个更广泛的关切:总体而言,我们应该做更多的工作来 "让市场退出医学"。那么,可以做些什么呢?其中一些建议可能不受欢迎,但还是要提一下。政府雇员不应该获得专利,除非有特殊的豁免。更进一步说,与学术界合作的第三方也不应该获得有关此类工作的专利,除非他们得到有关当局的同意,并通过有关当局补偿社会。最重要的是:应严格限制医学专利的数量、范围和适用期限。但是,在这些以及其他法律和社会框架发生根本性改变之前,我们只能提出这样一个重要的警告:"请记住,专利定价是用患者的生命换来的!"
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Are anti-cancer patents intrinsically immoral?

I run the risk of getting into hot water over a few of the observations below, but I think that some thought regarding the intersection of public spending, patents, “intellectual” property, and the unnecessarily high costs of life-saving treatments might be worth it.

The following considerations were triggered by a recent Dutch article, published in the well-respected NRC newspaper, describing how the well-known scientist/politician Ronald Plasterk became a millionaire, upon selling a cancer-treatment patent he obtained.[1] At the basis of some of the arguments over patents described in the NRC article is an interesting Nature Scientific Reports publication detailing a possible source of exclusively tumour-specific molecules.[2] Such molecules are of course of great clinical interest as they might function as tumour-specific antigens, potentially unleashing the power of our own immune systems against malignant growths, with minimal chances of auto-immune complications. How important activating the immune system can be in fighting off cancer is illustrated by the so-called chimeric antigen receptor (CAR)-T cell therapy,[3] and the use of antibodies against immune checkpoint proteins such as PD-1/PD-L1 and CTLA-4 to allow much more effective cancer immunotherapy.[4] In the publication about tumour-specific molecules,[2] the focus is on the peptides that result from frameshifts in open reading frames which could occur more often in the notoriously sloppy cancer cells. A surprisingly large number of such new, cancer cell exclusive, open reading frames can indeed be found in publicly available large data sets. This means that using the encoded peptides as antigens might help patients combat their tumours in a subtle instance of effective personalized medicine. Thus far the science.

It might surprise the reader that the article in question was accompanied by a competing interest declaration about a patent regarding a: “…method of preparing subject-specific immunogenic compositions based on a neo open-reading-frame peptide database.” The patent in question has in the meantime been sold for quite a lot of money to German biotech company CureVac. This could mean that such potentially life-saving treatment might in the future have limited accessibility, because of extra expenses involved. Call me old-fashioned but how can such a regrettable outcome be justified? Consider: (i) As I mentioned, the analysis was done using large, publicly available, data sets. (ii) All of this important, high level, bio-informatic analysis was performed by Plasterk's co-author, a civil servant employed by an academic hospital, that is, the tax-payer. Of note, this (probably old school) researcher was not involved in the patent at all. (iii) There is no great “conceptual idea/inventive step” (which is often used as an excuse for the extra financial rewards linked to patenting) to speak of. All of the underlying knowledge and the possible application are so mainstream that undergraduate biology or medicine students can (and will have, I am sure) already come up with it. (iv) The vast majority of researchers are still steeped in the “ethics of science”, which means that they know scientific progress depends on open discussion and exchange of ideas. It also means most scientists are much more interested in such progress and the common good than in any financial gain. Alas, such attitudes, so beneficial to science and medicine, are precisely what makes them such easy prey for those who use their scientific literacy in less altruistic ways. Regarding patents, I hope to have made it clear why I consider this specific instance “patently absurd”. However, I must admit that it reflects a wider concern of mine: overall, we should do more to “get the market out of medicine”. So, what could be done? Some of these suggestions might not be popular, but here goes. Government employees should not get patents, unless with specific dispensation. Going further, third parties working with academics should also not get patents regarding such work unless they get consent from, and compensate society via, the appropriate authorities. Most importantly: medical patents should be severely limited in number, scope, and duration of applicability. But until these and other legal and societal frameworks have changed fundamentally, we only have this important warning: “Please remember that proprietary pricing is paid in patients’ lives!”

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来源期刊
BioEssays
BioEssays 生物-生化与分子生物学
CiteScore
7.30
自引率
2.50%
发文量
167
审稿时长
4-8 weeks
期刊介绍: molecular – cellular – biomedical – physiology – translational research – systems - hypotheses encouraged BioEssays is a peer-reviewed, review-and-discussion journal. Our aims are to publish novel insights, forward-looking reviews and commentaries in contemporary biology with a molecular, genetic, cellular, or physiological dimension, and serve as a discussion forum for new ideas in these areas. An additional goal is to encourage transdisciplinarity and integrative biology in the context of organismal studies, systems approaches, through to ecosystems, where appropriate.
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