加拿大广播公司记者凯莉·克劳(Kelly Crowe)报道说，多达几十个外国制药公司被加拿大、美国和欧盟国家的药物监管部门发现伪造药品试验数据。
在一次多国药监部门开展的 常规检查行动中，执法人员在某海外制药公司发现了被藏起的几页重要数据，但电脑记录已经被删除，制药公司还伪造了人体血液化验数据，而他们目所能及的这 些，仅仅是冰山一角。这样的数据造假，在跨国医药制造行业已经并不是什么新鲜事，甚至成为了不公开的行业共识。
国际制药公司的弄虚作假行为对加拿大人的健康影响很大，因为加拿大每年消耗的药品中有80%是从外国进口的。这个进口比例在美国是50%。
加拿大卫生部药品质检部门的负责人Etienne Ouimett指出，药品实验数据的可靠性是一个越来越严重的问题。
虚假数据并不一定意味着药物是危险的，但如果没有可靠的数据，我们无法确保并相信药物的安全性。
“当你不能相信某药物包含了它应当包含的有效成分且分量正好时，如果该成分分量太少，它可能无效;如果分量太大，它很有可能很危险。”加利福尼亚州医药产业顾问芭芭拉·昂格(Barbara Unger)解释道。
大门紧闭的储藏室
去年美国药品监管局(FDA)曾对一个印 度制药公司进行检查，公司雇员在看到督察员的当下，就立刻携带一个U盘离开了现场。十五分钟后，经理携带另一个一模一样的U盘回到公司接受检查。“但已经 无法判断是否与之前是同一个U盘，即使是同一个，是否被删除了重要信息也不得而知”，督察员汇报说。
另一个典型案例，是去年6月，一家 中国制药公司拒绝让意大利的督察员检查制药配料和成品药，理由是它们“被放置在一个非官方和不可控的地方”。更有甚者，该公司强行关闭了储藏室的门。督察 员由此得出结论，该公司的制药材料处于“质量保证体系”之外，且有伪造数据的极大可能。
今年2月，在印度塔拉普尔(Tarapur)一个制药公司的垃圾堆中，法国督察员发现了一些被丢弃的抗生素原始数据。这家公司早前宣布他们生产出了一种有效的家用抗生素，然而事实上，他们购买的是中国某制药公司禁止在欧盟销售的药物。
印度制药业问题严重波及加拿大
今年4月份，美国药品监管局和世界卫生组织的药检专家发现，印度班加罗尔的一个私营药品研发公司赛穆勒(Semler)故意更换血液样本，修改和伪造药 品实验数据，以让其用新方法制造的品牌药品的疗效看起来与原来的品牌药品一样好，而且，这种在药品研发中对实验数据弄虚作假的做法在印度制药界是常见的事 情。
加拿大卫生部已经证实，有一家加国本地医药公司马肯(Marcan)正是进口了赛穆勒公司的药品并沿用了对方的假数据。被进口的药品证实为莫西沙星(Moxifloxacin)，是一种用于治疗鼻窦炎、支气管炎、肺炎等细菌感染病症的抗生素。
目前，在加拿大药品市场上，有五个不同品牌药品在销售马肯公司的莫西沙星。不过，即使查到了某公司的某种药品实验数据虚假，想要根据一颗小小的药片去追踪整个制药业的产业制造链，其难度无异于是蚂蚁走迷宫。
加拿大和美国的药品监管部门正在采取措施打击这种在药品实验数据方面弄虚作假的制药公司。加拿大卫生部除了禁止几十种外国制药公司的药品进入加拿大市场之外，还把另外二十多个成品药和半成品药制药公司列入需要加强监管的问题公司的名单上。
神秘的制药业
“我们知道我们的衬衫产自哪里，知道我们的鞋子产自哪里，却不知道与我们生命健康息息相关的药物产自哪里。”来自制药业网站PharmaCompass的梅塔(Behrat Mehta)表示忧虑。
虽然各方做出各种努力，试图保证用药安全，但想要找出哪些药物被控制被隔离，又有哪些药物仍然在售卖、被谁售卖，几乎是不可能的事情。
因为，药品制造信息这类的细节，从来不会提供给加拿大公司。加拿大卫生部虽然列举了一些数据跟踪的样本，但这份清单并没有包括所有的药品，表述也非常不完整。
整个制药产业制造链处于保密状态，只有企业内部清楚，且加拿大卫生部拒绝解除保护。这种让人恼火的结果，究其原因，是全球供应链的日益复杂化。
专家们指出，几个知名国际制药巨头公司越来越多得把制药原料的生产、半成品药的制造、药品的临床试验等合同外包给印度、中国等许多国家的私营制药公司，再加上以商业秘密为理由不公布药品的哪个程序是在哪个国家完成的，这使得对药品质量的检查和监管成为很困难的工作。
“这些医药公司们可能今天从美国买一些原料，明天从法国买一些原料，后天又转向瑞士的制造商，最后在另一个国家包装出成品。这一切，都取决于谁提供更好的服务。” Etienne Ouimett如是说。
来自达尔豪斯大学(Dalhousie University)的卫生政策研究学者马修·赫尔德表示，这样的情况意味着加拿大的制药公司成为全球性企业，“真正了解这些药物的生产后，我们就知道这里面的风险有多大”。
虽然这些不可靠的进口药品还没有在加拿大造成严重问题，但2008年有19位美国人被怀疑由于使用了用来自中国的原料制造的防血凝药品而死亡，另有几百人由于使用了这批药品而发生严重健康问题。
海外华文媒体老是胡乱搞标题。这里是cbc原文章的原文章。说得是全球，非要说成加拿大。 不读英文的华人就这样被忽悠了。
http://www.cbc.ca/news/health/drug-companies-caught-faking-data-1.3620483
ANALYSIS
Secrets and lies: Faked data and lack of transparency plague global drug manufacturing
Consumers can't find out where their drugs are made
By Kelly Crowe,
CBC News Posted: Jun 10, 2016 6:18 PM ET Last Updated: Jun 13, 2016 3:20 PM ET
Faked drug data and destroyed corporate records 2:21
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About The Author
Kelly Crowe
Medical science
Kelly Crowe is a medical sciences correspondent for CBC News, specializing in health and biomedical research. She joined CBC in 1991, and has spent 25 years reporting on a wide range of national news and current affairs, with a particular interest in science and medicine.
Related Stories
Who cheats on tests? Some foreign drug makers do.
Several dozen companies have been caught in the act, fabricating data used by Health Canada and other regulators to approve drugs for sale in the Canadian, U.S. and European markets.
Western inspectors have found pages of important data buried under rubble. They've found evidence of erased computer records and falsified human blood tests. And those are just the examples they've witnessed.
The data fraud is happening across the international pharmaceutical manufacturing industry.
"Data integrity is a fairly new issue and it's an emerging issue," said Etienne Ouimett, Health Canada's director of drug establishment inspections.
And because 80 per cent of drugs on the Canadian market and almost half of those sold in the U.S. are imported, Health Canada, the U.S. Food and Drug Administration and other health regulators are increasingly trying to crack down.
Raw data crumpled on the floor
In April, the FDA and the World Health Organization independently discovered problems at one private research company in Bangalore, India. Semler Research Centre was testing pills, in humans, for a variety of international drug companies.
WHO inspectors
reported finding evidence of "deliberate sample manipulation," which they concluded was "a common practice" and an "indicator of fraud."
FDA inspectors
reported observing Semler employees tampering with bioequivalence tests. These are experiments designed to prove that new versions of old drugs have the same metabolic effect on the body.
The regulator says it caught Semler employees deliberately switching blood samples, to make it look like the the test drug was having the desired effect.
The inspectors also reported finding raw data ripped up and crumpled on the floor.
So far, the FDA has found no evidence of serious safety concerns with drugs approved using Semler data. But the agency demanded all of the tests be repeated by an independent group.
Canadian connection
Health Canada has identified one Canadian drug company that used data from Semler to have a drug approved for sale here. That company is Marcan Pharmaceuticals and the drug is moxifloxacin, an antibiotic used to treat sinusitis, bronchitis, pneumonia and other bacterial infections.
Marcan's version of moxifloxacin is marketed in Canada under five different brand names and it's an instructive example of the maze that awaits anyone who tries to
track the manufacturing chain of a single pill.
Health Canada says Marcan has been able to demonstrate the safety of moxifloxacin using other data.
But the Semler story is just the latest episode in a burgeoning data manipulation problem that international agencies are working together quietly to try to control.
Dozens of drugs are no longer being imported to Canada because of unreliable data, and more than two dozen suppliers of finished medicines and raw pharmaceutical ingredients are on a Health Canada watch list for data integrity violations.
Manufacturing shrouded in secrecy
But it's almost impossible to find out which drugs are being quarantined and who sells them.
Those details, along with information about where the drugs are made, are not routinely available to Canadians. Health Canada lists some of the examples on a
data inspection tracker. But the list doesn't name all of the drugs affected or describe the nature of the data integrity problems.
Canadians can't find out where their drugs are made. (David Donnelly/CBC)
And the entire drug manufacturing chain is shrouded in secrecy, protected by a curtain of corporate confidentiality that Health Canada refuses to lift.
It's an uncomfortable consequence of the global supply chain's growing complexity.
Everything from raw materials to human safety testing is contracted out to third parties in India, China and around the world.
These days even the regulators admit it's difficult to connect the dots.
"We know where our shirts are made, we know where our shoes are made but we don't have that level of detail over where our medicines are made"- Behrat Mehta, PharmaCompass
"Companies may one day buy an ingredient from the U.S and the other day buy the same ingredient but produced by a manufacturer in France," said Health Canada's Etienne Ouimett. "And depending on who provides the best service for money they may turn to a fabricator in Switzerland and then turn to a packager in another country."
Matthew Herder, health policy researcher at Dalhousie University, said this means as drug companies become global enterprises, "we're taking on greater and greater risks of what we really know in the manufacturing of those drugs."
Health Canada can only inspect a fraction of the hundreds of foreign manufacturing sites and instead gets much of its on-site inspection information from its "trusted partners," including the FDA and the European Medicines Agency. And those reports reveal the challenges inspectors face trying to uncover data fraud.
Storage room door screwed shut
In one case, during an FDA inspection of an Indian company last year, an employee ran away with a USB thumb drive when he saw FDA inspectors. Fifteen minutes later, a manager came back with what the company claims was the same USB drive. But "it is impossible to know whether management provided the same USB thumb drive that the analyst had removed," the inspectors reported.
In another case, in June of last year, a Chinese drug company refused to let Italian inspectors see ingredients and finished drugs being kept in an "unofficial and non-controlled storage area." The company had even screwed the door shut. Inspectors concluded the material was to be used "outside of a quality assurance system" and that there was a serious risk of data falsification.
The global drug manufacturing supply chain is so complex, it's difficult to track the origins of a particular medication. (Kevin Frayer/Canadian Press)
At a manufacturing plant in Tarapur, India, in February, French inspectors found raw data about some antibiotics discarded in a pile of rubble on the other side of a wall.
The same company claimed it had manufactured the active antibiotic ingredient in-house, when instead it had purchased the product from a Chinese company not approved to sell pharmaceuticals in the European union.
The data manipulation doesn't necessarily mean the drugs are dangerous. The problem is, without reliable data, their safety can't be proven.
"If you can't trust that the drug contains the active ingredient at a concentration that it's supposed to contain, if it's too low, it can be ineffective. If it's too high, depending on what the drug is, it can actually be dangerous," said Barbara Unger, a pharmaceutical industry consultant in California.
Last year, the FDA caught an Indian drug manufacturer manipulating tests for genotoxic and carcinogenic impurities.
Tragic proof
In another case, when the FDA responded to complaints from U.S. manufacturers about impurities in raw ingredients from a Chinese company and asked to see the data, inspectors discovered it had been deleted and the audit trail disabled.
Two companies on Health Canada's watch list have been caught falsifying the source of their active pharmaceutical ingredient. Both claimed to have made the raw material, but actually purchased it from somewhere else.
There's tragic proof that data integrity matters. In 2008, 19 people in the U.S. died and hundreds more were sickened by a contaminated blood thinner made from a raw material the FDA believes had been tampered with at its source in China.
There's no way the consumer can know where the drugs are made, says Barbara Unger, pharmaceutical industry consultant. (supplied)
In January, the European Medicines Agency recommended its member states suspend the marketing authorization for 700 drugs because of data integrity violations discovered at one contract research organization in Hyderabad, India.
Risk of drug shortages
But banning drugs can cause drug shortages and that creates new headaches for regulators like Health Canada.
"They have to balance whether the risk to public health is greater if they take these medically necessary products off the market," said industry consultant Barbara Unger.
Health Canada often relies on its 'trusted partners,' including the FDA and the European Medicines Agency, to inspect foreign manufacturing facilities.
That means if a company is making medications that are deemed to be "medically necessary," Health Canada will still allow the drugs to be imported into Canada, with conditions, even if there are questions about the integrity of the data used to approve them.
"It's a case-by-case basis because it varies by the nature of the product, by the nature of the data integrity issues," said Ouimette.
"We will work with the company to design the terms and conditions that are such that will mitigate the potential risk of the product coming into the country."
"...a lot of companies are manipulating their documentation"- Behrat Mehta, PharmaCompass
In India, Bharat Mehta is one of the few people speaking out about the data manipulation problem. He spent 15 years in the Indian pharmaceutical industry and now writes an industry newsletter.
He says the reasons for faking data are clear: the companies are being hired to test drugs and ingredients, and they want to get the answer their customers are paying for.
"If you develop a reputation of being a lab which would not be able to demonstrate the equivalence, at some level why would people come to you for business?" he said.
Fake paper trail
The companies also know that Canadian, American and European inspectors want to see a paper trail for the drugs they import.
"There's a very high degree of focus in pharmaceutical quality to be able to back up whatever you say with paper," Mehta said. "And so because of that pressure a lot of companies are manipulating their documentation."
And without knowing who really makes a drug, consumers can't apply pressure or make informed decisions.
"Currently the entire system is extremely opaque," Mehta said. "We know where our shirts are made, we know where our shoes are made, but we don't have that level of detail over where our medicines are made."
"And I think consumers should have access to that type of information so it pushes the industry to hold itself to a higher quality of standards."
That's why many are calling for greater transparency. At Dalhousie University in Halifax, Matthew Herder has been pushing Health Canada to release all industry data.
"If your goal is to encourage better oversight, better data integrity in the research and development process, then I think there's good reason to have a lot more transparency about that complicated group of corporate actors that are involved," he said.
The secret world of drug manufacturing
David Donnelly/CBC
Do you know where your pills are made? Canada? The U.S.? Not likely.
80 per cent of pills sold here are made overseas in places like China and India.
But if you want to find out exactly where, good luck.
Companies refuse to disclose trade secrets and Health Canada doesn’t make them do so. So, when there’s news that foreign drug companies have been caught faking data on safety and effectiveness, how do you know if the pill you take is connected with that company?
You often don’t.
