Lantus致癌事件：市场竞争的牺牲品
2009-07-08 20:09:27   来源：丁香园   作者：  评论：0 点击：

考虑到我将要写的内容，对标题我感到一丝内疚。但这个敏感的题目正是问题关键，最近一些日子各大媒体就Lantus胰岛素的致癌可能性议论纷纷。

流言起于上个礼拜，媒体捕风捉影的得到一些消息，一位著名的糖尿病研究者预报了一个关于lantus胰岛素安全性的震撼消息。2周后在欧洲Diabetologia杂志正式发表相关数据。

对于学术界和制药行业，泄露这样的消息是不负责任的！为什么？疯狂的反文迪雅媒体恐吓病人离开这些药物，而没有确切证明其潜在的危险。在研究数据仍没有发布的情况下，仍然使用了类似我的标题，使用“… ….的原因”这样的字眼意味着更多更多。

现在这些数据发布了，对于这个故事而言我们有一些重要的事情要了解。

1)没有证据。“没有证据表明Lantus胰岛素导致肿瘤，但它可能导致现存的肿瘤细胞快速生长和分裂。” 欧洲糖尿病研究协会主席Ulf Smith说。

2)并非和大家想象的常采用的研究形式，一组为药物组，一组为安慰剂组。研究者而是采用了对英国、德国、瑞典、苏格兰等国家的127 031名患者的数据记录进行研究来寻找癌症与病因之间的联系。

研究过程是将众多相关胰岛素与各种类型肿瘤进行联系，数据本身就是非结论性的，美国糖尿病协会就对此发表声明“这些研究的数据本身就是矛盾和紊乱的”。

3)ADA和其他专业组织建议使用的Lantus的患者不必停止使用胰岛素，如果还是存有顾虑，那可以咨询你的医生。我同意糖尿病系统分析学家David Kliff的观点，这个研究方法本身就是不全面的。

虽然患者不应该将胰岛素抛在一边，我想知道的是这个国家的内科医生没有什么时间进行数据分析，如何准备为他们的糖尿病患者进行咨询，在阅读了这些矛盾的研究之后除了告诉患者“Lantus与肿瘤可能有联系”之外，还能怎样有效的告知患者。

4)Jenny对这些最新的糖尿病研究指出，针对癌症起因，众多高危因素的研究起于多年之前的对于高血糖的研究，在开始使用Lantus之前许多人已经采用鸡尾酒式的方式口服降糖药物。因此，将癌症的原因单一的认为与Lantus是有误导的。

然而，Jenny总结说，最近的造成恐慌可能还是件好事，因为它激发了许多认真的学者就癌症和胰岛素类似物甚至是口服降糖药物之间的关系进行研究。

我个人观点与其有所不同，我敢打赌，经历了众多研究者和公司专家的折腾之后，对说明已经有或正有高危致癌因素的患者轻微风险的数据，我们可以结束了；同时，对患者的伤害已经造成，在以后使用胰岛素时他们会产生恐惧心理。

之所以这样说，最新的知识表明，更多的结论性证据表明，口服药Januvia会刺激胰腺癌发生。

回到胰岛素上，胰岛素的副作用轻微，患者将会平衡反对者和赞成者的意见来决定是否使用胰岛素，如果你马上就需要它，为什么不用？

不管Lantus和癌症的关系是否有结论，恐慌已经伤害了赛诺菲-安万特公司，对患者也没有好处，药物价格可能会上涨，还可能会减少药物发展。

“唉”最终，受最重伤害的还是患者。

外网原文： http://www.dxy.cn/bbs/post/view?bid=116&id=15048661&sty=1&tpg=1&age=0

Does Lantus Cause Cancer?

Considering what I am about to write, I feel a little guilty about the post headline here. But these sensational headlines are just the point: the media is abuzz the last few days with the possibility that Lantus insulin “may be linked” to cancer.

The rumors started late last week, when the media got wind that a prominent diabetes researcher forecasted that an “earthquake” event was about to hit that would compromise the safety profile of Lantus. This leak came nearly two weeks before the data was actually published in the European journal Diabetologia.

For both academia and the pharma industry, a leak like this is just so irresponsible! Why? Because it kicks off just the kind of anti-Avandia media frenzy that frightens patients off their meds, without real substantiation of the potential danger. In this case, the research data wasn’t even out yet, and already headlines like mine, above, using the “C-word” (cause) were appearing far and wide.

Now that the data is actually out, there are a few Important Things to Know About This Story:

1) No cause was shown! “There was no evidence that Lantus actually causes cancer, but it might possibly cause any existing cancer cells to grow and divide more rapidly,” according to Ulf Smith, president of the European Association for the Study of Diabetes (EASD).

2) Backing up for a moment, the study conducted here was not your usual kind, where one group takes the drug and another gets a placebo (unethical in a case like this, of course). Rather, researchers took recorded data (housed in databases) from 127,031 patients in the UK, Germany, Sweden and Scotland and “crunched the numbers” to look for associations with instances of cancer.

Given that it’s just a bunch of numbers correlating insulin use with a handful of different types of cancer, the data is pretty inconclusive. Even the American Diabetes Association has come out with a statement that “the data within these studies and between these studies are conflicting and confusing.”

3) The official recommendation to patients using Lantus now by the ADA and other expert groups is not to stop using insulin, and also to “consult your doctor” if you have concerns. I have to agree with the much-quoted diabetes analyst David Kliff that this approach is a bit lame.

That is, while I agree that it’s important for PWDs not to toss aside their insulin, I’d also like to know how the many physicians across this country are supposed to be prepared to consult with their diabetes patients when they’ve had no time to analyze the data? And how, after reading these confusing studies, can they effectively tell their patients anything other than “there might be a link between Lantus and cancer?”

4) As eloquently pointed out by Jenny over at Diabetes Update, the population studied was most likely a very high-risk group for cancer due to a number of other factors, leading with running consistently high blood sugars for many years — most likely long before being prescribed Lantus. Many had probably also been taking “cocktails of powerful oral drugs for years before starting Lantus.” Therefore, to pin the cancer correlation solely on Lantus insulin is probably misleading at best.

Nevertheless, Jenny concludes that “this latest alarm… is probably GOOD news, because it will trigger some serious research into the cancer profile of all the analog insulins and perhaps, even, of the oral diabetic drugs.”

Personally, my prediction is a bit different: I’m betting that after a lot of bantering about by various researchers and industry experts, we’ll end up with data illustrating a TINY risk in people who already had or are already very high-risk for cancer. Meanwhile, the damage has been done in the sense that people who really need it are afraid to take their insulin.

I say this even with the knowledge of new, more conclusive evidence that the oral drug Januvia may indeed spur pancreatic cancer.

When it comes to insulin, as long as the risk of side effects is tiny, which I’m assuming it will be, we patients will have to weigh the pros and cons: the consequences of not taking insulin when you need it are more immediately damaging, are they not?

Whether the cancer risk with Lantus proves significant or not, the scare is surely hurting drugmaker Sanofi-Aventis, which is not good for us either, in terms of rising price-points and possible curtailing of drug development.

*Sigh* In the end, it’s always the patients who suffer most.