Research misconduct, Unispital Zürich

These news came up years ago. At the time, every event was framed as “allegedly”…and not much happened for years.

Earlier today, the hospital management made a press conference whey they admitted responsibility and asked people for forgiveness, what?

70 excess deaths under former heart surgery clinic director Francesco Maisano

A report shows serious misconduct by the ex-clinic chief. The university hospital has informed the criminal authorities, apologizes to relatives and patients and sets up a counselling centre for them.

As far as I understand this is textbook case of research misconduct during clinical trials of a new device. Even for research with animals there’s an ethics committee that oversees the experiments and sometimes has the tough job of telling “please stop”. Allegedly, the ethics committee did not act because:

  • Data manipulation: data from the clinical trials was manipulated to make the death be caused by something else.
  • Conflicts on interest: apparently, the person performing the trial had partial ownership of the company manufacturing the device being tested.

If this had happened in the biology department at random Uni while working with rats, it would be a scandal. The surprising thing is that hospital management and ethics committee did nothing until a whistleblower came up. The hospital management started an investigation and fired the whistleblower in the meantime.

Well, the past is the past. It’s time to do better and try to right the wrongs as much as possible:

  • The hospital management stops the narrative of recent years of “no harm to anyone” and switches to “we will cooperate with investigators”.
  • Hospital management shared the documents of 24 deaths with the Zürich prosecutor office.
  • 3 member of the hospital council (management) resigned today and apologized for the harm and distress.

Of course, this is the story of an individual (and the team behind) manipulating data, hiding information, and other stuff. But, it’s also the story of other people whose task is precisely to oversee experiments (clinical trials) and allegedly did nothing until a whistleblower came up. And the system punished the whistleblower :frowning:

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Maybe the first time it comes out on the news – here in Switzerland, but it is unfortunately not unheard of in the scientific community.

Too many vested interests, too much money involved.

For anybody interested, large scandals of the type took place in Africa involving clinical trials some 10-15 years ago, in which the TAE (Therapy Adverse Effects) were not reported, or ill-reported, or dismissed. Not to forget the (in)famous case of Vioxx…

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Big pharma is the boogeyman in many stories. It seems this time it was about much smaller startups and manufacturers.

Of course vested interests, but the money at a smaller scale. It’s hard to scale up very specialized surgical methods compared to scaling up the sales of a pill.

Personally, I know little about the science behind the story. The fascinating part if the human side of the story, how the system works, how the safeguards in place did not work, etc.

I’m an idiot.

I just realized this is bigger than Unispital Zurich, it’s about a medical device company with 1 billion USD valuation.

In March 2026, a new binding code of conduct and a whistleblowing reporting office were introduced, to which employees can also contact anonymously to report grievances or risks to patient safety. In the future, cadre employees will have to declare their secondary employment and interests in a public register.

In the second big sale this week of an Israeli medical-device firm, Edwards Lifesciences Corporation said Tuesday it has agreed to buy Valtech Cardio in a deal whose value could reach $1 billion.

The California-based company said it would pay $340 million in stock and cash up front, plus up to $350 million more in performance-based milestone payments over the next 10 years.

Before the sale’s completion, slated for early 2017, Valtech is to spin off its early-stage transseptal mitral valve replacement technology program. Edwards has an option to buy it. That could add $300 million to the deal, for a total of $1 billion.

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