最近，一家大型制药公司（Astra-Zeneca，阿斯利康）报告说，他们的新鱼油产品大规模的III期临床试验失败了。我一点也不惊讶。 实际上，这不是第一次这样的失败尝试。 让我在这里预测，这也不会是最后一次这样的失败。 直到医学界和药物开发界发生根本变化。
我不知道任何慢性疾病是由于一个单一原因造成的。我知道我对医学了解不够，尽管我整个成年生活都在医学领域里，已经40多年了。
大多数（如果不是全部）慢性疾病都有增加了的氧化压力（OS）作为其主要特征。这个慢性疾病清单包括但不限于动脉粥样硬化性心血管疾病、糖尿病、癌症、自身免疫性疾病等等，这个单子很长。实际上，所有对氧化压力有过研究的慢性疾病都显示增加了的氧化压力。相信我，我研究了很多。实际上，我会挑战任何人, 找出一个没有氧化压力升高的慢性病。
氧化压力定义为氧化剂/抗氧化剂的比例。（还有所谓氮化压力，但是现在文献中一般并入氧化压力慨念中）。氧化压力并无好坏之分，只有高低不同。就像血压一样。 血压过高对你有害，但血压过低也会杀了你。因此，氧化剂和抗氧化剂的平衡是关键。今天，我们生活在一个被丰富的氧化剂包围的环境里（所有的毒素都是氧化剂），我们的食品的营养价值下降，包括抗氧化剂的减少（我在本文中不会对此进行扩展）。
要真正改变氧化压力升高的状况，人们需要采取多管齐下的方法：一方面，我们需要限制氧化剂的摄入量，另一方面，我们需要增加抗氧化剂的摄入量，以达到临床上有意义的氧化压力平衡，通过只改变氧化剂/抗氧化剂比的一侧，通常不会导致有意义的氧化应激重新平衡。上述Astra-Zeneca的失败，我敢断定，原因在此。
整个医疗和制药行业需要重新思考他们的做法。目前全球奖励制度主要以单一药物专利机制为基础。很多时候，制药公司会改变一个新药的分子结构，使其具有专利性。 这种方法有一个固有的主要问题：改变的，不自然的分子往往有副作用。著名的美国”妇女计划“ (Women’s Initiative) 发现人工合成激素有害，就是一个典型的例子。但是，如果制药公司不改变分子结构，他们便不能申请专利。这是一个二难的困境。因为，没有经济动机来推此类研究。这是我对整体医学（integrative medicine）或功能医学（functional medicine）总结的新三观“整体观“”自然观“”平衡观”中之自然观之反应。慢病防治，养生长寿离不开这新三观。
这需要改变。需要建立一个更完整和更有意义的奖励机制，以鼓励大型制药公司对药物开发进行系统性投资。药物组合或系统的疾病管理平台应可申请专利保护。天然形式的制剂（未改变对人体的异物分子）可以保存在这些更全面的药物开发方法中，然而这些综合形式也可以申请专利。 随着医学领域的觉醒（如整体医学, 功能医学的日益普及），这种新的药物开发模式应该而且将越来越普遍地在可预见的未来。 这最终将使行业和消费者受益。
Recently, a giant pharma (Astra-Zeneca) reported that their new fish oil product failed a large scale Phase III clinical trial. I am not surprised at all. Actually this is not the first time of such failed attempt. Let me predict here, this won‘t be the last such failure either. Until a fundamental change in medicine and drug development occurs.
I don‘t know any chronic disease that is due to a single cause. I know I don’t know enough about medicine, albeit I have been in medicine my entire adult life of over 40 years.
Most, if not all, chronic diseases have increased oxidative stress (OS) as its key hallmark. This list of chronic diseases includes, but not limited to, atherosclerotic cardiovascular diseases, diabetes mellitus, cancer, autoimmune diseases and many many more. Actually all chronic diseases that have such research on oxidative stress that I have studied have increased oxidative stress. Believe me, I have studied a lot. Actually I will challenge anyone to show me a report where scientists looked into oxidative stress and didn’t find it elevated in a chronic disease state.
Oxidative stress is defined as the ratio of oxidants/antioxidants. (There is also a nitrasative stress which in the literature is often included in the OS these days). Oxidative stress is not a good thing or bad thing, just like blood pressure. Too high a blood pressure is bad for you, yet too low a blood pressure will also kill you. so the balance of oxidants and antioxidants is the key. Today we live in an environment where we are surrounded by the abundant oxidants (all toxins are oxidants), and where our foods have decreased nutritional value including decreased antioxidants (I will not expand into this in this article).
To truly change the elevated oxidative stress status, one needs to take a multi-pronged approach: on the one hand, we need to limit the intake of oxidants and on the other, we need to increase the antioxidants intake to reach a clinically meaningful balance, by changing just one side of the oxidant/antioxidant ratio often will not result in meaningful oxidative stress re-balance.
The entire medical and pharmaceutical industry needs to re-think of their approach. The current worldwide reward system in primarily based on single drug patent mechanism. Often times a drug company would alter a potential drug molecule to make it patentable. This approach has an inherent major problem: an altered, unnatural molecule often have long time side effects to human body. Harmful synthetic hormones found in women‘s Initiative are such a typical example. But if a drug company doesn’t alter it, they can‘t patent it. This is a dilemma: there is no financial incentive to invest in such research.
This needs to be changed. A more complete and meaningful reward mechanism needs to be in place to encourage big pharma to invest in systemic approach to drug development. Combination of agents, or propriatory disease management platforms can be patented. Natural forms of agents (not altered foreign molecules to human body) can be kept in these more comprehensive approach to drug development and yet these comprehensive forms can also be patented. With the wakening in the medical field (such as the ever increasing popularity of integrative/functional medicinee), this new model of drug development should and will be more and more common in the forseeable future. This will ultimately benefit both the industry and the consumer.