老药会比新药好吗？

readok2009

Are Old Drugs Better than New?
The release of a new drug is a pretty big deal in the world of medicine. The company that made it will throw a lavish party. The stock market will react to the news. Doctors will be inundated with freebies and trial samples. And now that the Food and Drug Administration has lifted its restrictions against direct advertising, the public too will be assaulted with ad campaigns in newspapers, magazines and television.
发布一种新药在医学界是件大事。医药公司需要投入大量的资金。股票市场也会对此做出反应。医生能获得大量的免费赠品和实验样本。现在，食品和药品管理委员会提高了对直接药品广告的限制，报纸、杂志、电视大众媒体的广告也将被检查。

As a physician, I often hear from patients who have read about a new medication and want me to write a prescription. To them, I must sound like a stick in the mud. Unless the medication they're taking is not working, however, I'm generally reluctant to change. They assume that newer drugs are better; I assume the old ones are fine.
作为一名医生，当病人看到一些新药的广告，就会要求我开这些新药的处方给他们。对于他们来说，我看起来对这些新药并不感兴趣，但是，一般来说，这种情况很难改变，除非他们吃这些新药没有任何作用。病人都认为新药疗效要好一些，而我则觉得老药好。

So I felt somewhat vindicated last week by a report in the Journal of the American Medical Association about the safety problems associated with new medications. Of 548 drugs approved by the FDA over the past 25 years, fully 20% turned out to have serious or life-threatening effects that were unknown or undisclosed at the time of approval, according to an analysis directed by the Harvard Medical School. Sixteen drugs were subsequently withdrawn from the market, but not before millions of people had been exposed. Seven of those drugs had side effects so serious they were cited as possible contributing factors in 1,002 deaths.
因此上周美国医学联合会报道新药使用安全问题的那期期刊，我觉得非常有价值。根据哈佛大学医学院的研究表明，在过去25年里，FDA批准的548种新药里，足足有20％的药品在刚刚批准使用的一段时间内无法证实是否有严重的或者威胁生命的副作用。16种药物后来被撤出市场，而在此之前，已经有数百万的患者受到影响。其中7种药物已经被证实其严重的副作用与1002例死亡有关。

How could this happen? I put the question to Dr. Karen Lasser, the lead author of the study. Basically, she says, \"the drugs aren't adequately studied before being released to the public.\" As she points out, new drugs are tested first on relatively small numbers of users, who in the past tended to be men. It's only when the drugs are marketed to the general population and taken by large numbers of women, children and the elderly that more obscure side effects emerge.
这种情况为什么会发生呢？我问该项研究的带头人Karen Lasser博士，她说：“药物上市前没有完全进行充分的研究。”她指出，新药首先在小部分试药者中应用，过去，这些人多数是男性。只有当药物进入市场，应用于普通人群，有大量的女性、儿童、老年人使用，那些不易被发现的不明显的副作用才会显现出来。
The Pharmaceutical Research and Manufacturers Association took issue with the study, releasing a statement that called it \"misinformed and misleading.\" All medications involve some risk, the drugmakers point out, and some new medications have significant additional benefits that are discovered only after they are approved.
药物研究和制造协会对该项研究发表声明，称其是“错误和误导”。制药者说，所有的药物应用起来都有危险，有些新药被发现的重要的副作用是经过批准才上市的。

But the drug companies, by marketing their newest products so aggressively, are part of the problem. \"They push the public and doctors to use new drugs that are more profitable but also more dangerous,\" says Dr. Paul Allen, one of the study's co-authors.
但制药公司十分积极的销售其新产品也是问题的一个方面。该项研究的合作者Paul Allen博士说：“他们鼓励公众和医生使用新药，这样利润更大，但却十分的危险”。

That's a message patients should take to heart. Don't assume because you see a lot of ads for a new drug that the one you are taking is obsolete. And if you switch to a new medication, be attuned to any unexpected side effects. The most common adverse reactions include liver toxicity, heart problems and fetal damage.
这个讯息病人应该重视。不要因为你看到一个新上市的药品广告就假定你正在吃的药物是过时的。如果你转而去吃新药，就需要去适应任何你意想不到的副作用。最常见的副作用包括引起肝毒性、心脏病和畸胎。

This is not to say that there aren't plenty of important new drugs in the pipeline. I am sure that if there's a sound reason for doing so, I will still prescribe newly released medications for my patients. But only when absolutely necessary. And then I will keep a very close eye out for any adverse effects.
这并不是说，现在正在研制的药物中就没有作用重要的药物。我确信如果监管机制合理，我也会给病人开使用新药的处方，当然了，这只是在绝对必要的时候才这么做。并且我会密切关注是否有副作用产生。

只有当药物进入市场，应用于普通人群，有大量的女性、儿童、老年人使用，那些不易被发现的不明显的副作用才会显现出来。
看来要是没有特殊原因，还是用老药比较安全！