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Panel Swedish hospital should never have hired star surgeon

first_img Country * Afghanistan Aland Islands Albania Algeria Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia, Plurinational State of Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos (Keeling) Islands Colombia Comoros Congo Congo, the Democratic Republic of the Cook Islands Costa Rica Cote d’Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands (Malvinas) Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See (Vatican City State) Honduras Hungary Iceland India Indonesia Iran, Islamic Republic of Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati Korea, Democratic People’s Republic of Korea, Republic of Kuwait Kyrgyzstan Lao People’s Democratic Republic Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, the former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Martinique Mauritania Mauritius Mayotte Mexico Moldova, Republic of Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Norway Oman Pakistan Palestine Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Qatar Reunion Romania Russian Federation Rwanda Saint Barthélemy Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Martin (French part) Saint Pierre and Miquelon Saint Vincent and the Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Sint Maarten (Dutch part) Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and the South Sandwich Islands South Sudan Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania, United Republic of Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates United Kingdom United States Uruguay Uzbekistan Vanuatu Venezuela, Bolivarian Republic of Vietnam Virgin Islands, British Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe The Karolinska University Hospital and the Karolinska Institute (KI) in Stockholm ignored warning signs when they hired surgeon Paolo Macchiarini in 2010, an independent panel concluded this week. The investigation was commissioned by the hospital’s director in the wake of an ongoing misconduct scandal surrounding Macchiarini and the artificial tracheae he implanted in three patients at the hospital. Two of the patients died, and a third has been hospitalized since receiving an implant in 2012. “Macchiarini’s transplant activities have damaged clinical research not only at Karolinska University Hospital, but also in Sweden in general,” the panel noted.The procedures did not have proper ethical approval, were not based on adequate science, and failed to follow Swedish regulations regarding new medical products, the panel says in its 31 August report. (An English summary is here. The full report in Swedish is here.) The investigation was led by Kjell Asplund, professor emeritus in medicine at Umeå University in Sweden, chairman of the Swedish National Council on Medical Ethics in Stockholm, and former director general of the Swedish National Board of Health and Welfare, also in Stockholm.The report highlights mistakes made during Macchiarini’s tenure at the hospital. But it also notes that the hospital terminated Macchiarini’s employment in late 2013, successfully resisting pressure from KI, where Macchiarini remained a senior researcher until March. Whistleblowers raised questions about Macchiarini’s work in 2014, but KI stood by the surgeon, extending his contract even after an independent investigator found that the allegations had merit. He was dismissed after a television documentary in January raised additional questions about the surgeon and his work. Managers from KI and the hospital recruited Macchiarini, according to the report, based on favorable publicity surrounding his work on trachea transplants and the technical skills he demonstrated during a “test operation” in Stockholm. KI managers took the lead, and the hospital did not collect independent information on Macchiarini’s clinical qualifications until late in the recruitment process. “The warning signs that arose then were suppressed,” the panel writes.Once Macchiarini took up the dual appointments, the report says, it was not always clear who was supervising his activities. At the hospital, he was officially part of the ear-nose-throat clinic, but he performed the surgeries in the thoracic clinic, located at a different campus. The report says this left ambiguous who was responsible for the “independent” and “difficult-to-manage” Macchiarini and gave him “an opportunity to move between the two clinics too freely.” Macchiarini also failed to provide adequate follow-up care when the implant recipients developed complications, the report says.The hospital and Macchiarini have argued that the surgeries did not require ethical review because they were not clinical research but were performed as life-saving measures on patients with no other treatment options. But the panel said the patients who received the transplants did not have life-threatening conditions and that the surgeries should have been subject to ethical review as clinical research. There were no animal studies that had tested the specific combination of materials Macchiarini used on the patients at the time of the transplants, the report says.“We find it to be very unlikely that the transplants would have been approved by an ethical review board based on the scientific information that was available in 2011,” the panel writes. The panel warns that continuing to argue that the surgeries were not clinical research risks undermining future research at the hospital.The report recommends that the hospital implement a range of measures to address the problems the panel identified. It notes that the hospital has already set up a procedure for whistleblowers to express concerns and established a task force to address the overlap between patient care and clinical research. It calls for the hospital to be more independent from KI, especially in hiring decisions, and recommends additional training for staff on regulations surrounding ethics approval and new medical products. Sign up for our daily newsletter Get more great content like this delivered right to you! Countrycenter_img Click to view the privacy policy. Required fields are indicated by an asterisk (*) Emaillast_img read more

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