Tuesday, October 23, 2012

Faulty medical implants investigation: 'Sometimes we cross the line'

6:55AM BST 23 Oct 2012
The Telegraph
(More details on the story)
The offices of the firm in a former Communist town in Slovakia were lined with burnt-out kettles and toasters, testimony to the “safety” tests which take place in the building.
EVPU is one of the private companies given the task of assessing, on behalf of the Slovakian government, whether electrical products are safe to be sold throughout the European Union.
But the company’s activities are not restricted to licensing domestic appliances to see if they blow up when plugged in. Under European rules, the firm is also authorised to license medical implants such as artificial hips and knees.
The European system of regulation has prompted widespread concern over whether medical experts are really at the vanguard of deciding which devices can be implanted in patients.
The Daily Telegraph and the British Medical Journal therefore decided to investigate the rigour of the licensing process, amid allegations that dozens of private companies are competing with one another to offer licences for medically questionable devices. Was profit being put before patient safety?
Undercover journalists from this newspaper approached EVPU, claiming to represent a fictitious Chinese company that wanted to get a new hip implant approved for use in Europe.

In order to test the system, the “new” hip implant was in fact based on a device now withdrawn throughout the world which had been produced by DePuy.

DePuy had to recall thousands of hip implants after it emerged that it wears down and deposits potentially toxic metal deposits in the blood. The company has put aside £2 billion in case of compensation claims.

Medical experts advised this newspaper that any regulatory body seeing a supposedly new artificial hip of the metal-on-metal variety should immediately raise concerns about approving the product. In the meeting in Nova Dubnica, executives from EVPU were happy to “sell” the benefits of seeking EU-wide approval using their services.

Describing their approach as a “very fast and easy, easy process,” they explained the procedure for gaining approval. The representatives pointed out the company had only closed, or rejected, four cases in five years “without success”.

Instead of carrying out independent research on the device, the fictitious Chinese company could simply submit a “literature review” on the planned materials using information from similar devices already on the market.

“They can even prepare the clinical evaluation report according to literature review. Take some journals, make research and prepare some reports. Make comparative study, read the product used from article and make comparative study,” Lubica Skrovanova, an EVPU executive said.

EVPU would not even have to see an example of the proposed hip implant when its representatives reviewed the dossier — and would be able to rely on drawings of the device.

Notified bodies are strictly banned from acting as consultants to companies on how to gain approval and are meant to assess the dossier as it is presented.

Peter Luley, one of the company’s representatives, indicated that the rule was not watertight.
“We kind of can give them [the Chinese company] advice and some push on … this certification process, but with some borders, often, sometimes we cross the line,” he said, “and say just do this and it will be OK.”

This is how they had a “high rate of successful certification”, he said.

EVPU would charge €2,750 (£2,241) to carry out the approval. As Miss Skrovanova explained in the meeting, although the rules are meant to be applied identically throughout the EU, “each notified body has different requirements”.

After the meetings with the notified bodies, the reporters sent an email outlining some of the device’s specifications, including the materials used to make the product and the sizes available.
Peter Luley responded the following day, asking the company to complete an application form so that he could provide a quotation.

On Aug 9, he emailed, saying: “So I have finally the total costs of certification. Please find attached price offer and let me know whether are you [sic] interested.”

After contracts had been signed and money paid, the reporters submitted a full technical dossier, prepared with the help of medical experts, at the end of August. Alarm bells should have sounded and the product been immediately rejected because the medical studies that were cited were those for the banned hip implant.

But Miss Skrovanova emailed her comments, which were unexpectedly positive. Miss Skrovanova marked the sections “product features” and “principle features of the device” as “OK”.

She said her company needed to see the companies’ “risk analysis” and information on the manufacturing process. She also said that the clinical evaluation “must be approved by responsible person” – but this was a minor administrative point.
In a telephone call last week, Miss Skrovanova confirmed again that the firm was happy with the design of the device.
A medical company is only supposed to submit its application to one notified body, but there is no system in place to prevent a company from “forum shopping” around different countries, until eventually approval is granted. This issue was raised when The Daily Telegraph also visited a company called Szutest in Brno in the Czech Republic.

Michal Bauer of Szutest said that his company had raised concerns about other notified bodies and admitted the sub-standard products were being approved.

“Some manufacturers do it so that they come to one notified body and they have very poor dossier, very poor technical file or their system is not working well and something,” he said. “So they [say] okay, 'you won’t do it for us,’ and they go to another one.

“When I have seen some certificates issued for some products, it was horrible,” he said.

At ITC, another notified body, based in Zlin in the Czech Republic, its representative Tomas Zavisek was open about where its loyalty lay. “We are on the side of the manufacturer and their products, not on the side of patients,” he said.

The company insisted that the approval would be as straightforward as possible.
“We normally do not have big obstacles to not issue certificate,” he said.

It also boasted about its success rate — in ITC’s case the pass rate was 90 per cent: “We try, we try to solve it and to complete.”

Following the meeting, the undercover reporters sent an email to ITC confirming again the key details of the product for which approval was sought. Again, no safety concerns were raised — just a quotation was provided for licensing the artificial hip.

EVPU refused to comment. ITC said it complied “in full accordance with the law”.

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