http://www.nytimes.com/2014/11/25/world/leading-surgeon-is-accused-of-misconduct-in-experimental-transplant-operations.html?_r=0
SCIENCE
Leading Surgeon Is Accused of Misconduct in Experimental Transplant
Operations
By HENRY FOUNTAIN
NOV. 24, 2014
A prestigious medical institute in Sweden has begun an investigation of a
surgeon who is considered a pioneer in the field of regenerative medicine,
after complaints that he did not receive ethical approvals for experimental
operations on patients and misled medical journals about the success of the
procedures.
The Karolinska Institute, which awards the Nobel Prize in Medicine, said it
had asked an independent expert to look into the complaints against Paolo
Macchiarini, a visiting professor who operated on three patients at
Karolinska University Hospital in Stockholm. In the procedures, Dr.
Macchiarini removed diseased or damaged windpipes and implanted
replacements made of plastic and treated with stem cells and drugs to
encourage the growth of new tissue.
“Since the accusations against Dr. Macchiarini are serious and detailed, I
considered that they should be thoroughly investigated,” said Anders
Hamsten, vice chancellor of the institute. He said Friday that he hoped to
have the investigator’s report by mid-January.
Dr. Macchiarini’s work, which is just one of many efforts at laboratories
around the world to make human tissues that could help prolong lives and
ease organ shortages, was the subject of a Page 1 article in The New York
Times in 2012 that described the first plastic windpipe implant, on an
Eritrean man living in Iceland who had tracheal cancer.
The patient, one of the three cited in the complaints, died in January 2014
and spent the last eight months of his life in the Karolinska hospital. Of
the other patients, one, an American, died several months after his
surgery, and the other has been hospitalized since her operation more than
two years ago and requires a procedure every four hours to clean out her
airway, according to the complaints filed with the institute.
The complaints were filed in August and September by four doctors who have
been involved in the treatment and care of the three patients.
Reached in Krasnodar, Russia, where he has done his most recent operations,
Dr. Macchiarini said the accusations against him were unfounded.
“We have never ever manipulated data,” he said, adding that he had complied
with all regulations and laws regarding medical ethics. He said he was
confident that he would be cleared.
One of the doctors who filed the complaints, Karl-Henrik Grinnemo, is
himself the subject of a complaint by one of Dr. Macchiarini’s colleagues,
Philipp Jungebluth. Dr. Jungebluth has accused Dr. Grinnemo of ethical
breaches in connection with a grant Dr. Grinnemo received from the Swedish
government.
In a letter to the institute responding to Dr. Jungebluth’s complaint, Dr.
Grinnemo said that it was “lacking in substance and containing very serious
misrepresentations.”
Dr. Hamsten said the complaint against Dr. Grinnemo was being handled by
the institute’s ethics council.
The complaints against Dr. Macchiarini were lodged in the form of letters
to the institute, copies of which were obtained by The Times. They assert
that there is no evidence that the experimental operations — considered
“compassionate use” because the patients were said to have few if any
alternatives for survival — had been subject to ethical review. According
to the complaints, only one of the patients, the Eritrean man, appeared to
have signed a consent form for the operation, and in that case the form was
dated more than two weeks after the surgery, according to a copy of the
document included with the complaints.
The Eritrean man’s case was the subject of a paper, described as a “proof
of concept study,” by Dr. Macchiarini and others that was published online
in the British medical journal The Lancet on Nov. 24, 2011, five and a half
months after the synthetic windpipe was implanted.
The paper described the connections between the implant and the patient’s
own lung tissues as being open and the implant partly lined with healthy
tissue of the kind needed for the airway to function properly. It said
there were “no major complications” five months after the operation.
But according to the complaint, during a procedure on the patient several
days before the paper was published, stents had to be inserted into the
implant to keep it open and holes were seen between the implant and the
patient’s tissues. Dr. Macchiarini, the complaint said, must have been
aware of the problems, and the paper should not have been published as
written.
A spokeswoman for The Lancet declined to say whether the journal had been
notified of the allegations.
Correction: November 27, 2014
An article on Tuesday about accusations of misconduct against Paolo
Macchiarini, a surgeon who is a pioneer in the field of regenerative
medicine, misstated the timing of the complaints against him by doctors in
Sweden. The complaints were filed in August and September, not last month.
A version of this article appears in print on November 25, 2014, on page
A11 of the New York edition with the headline: Leading Surgeon Is Accused
of Misconduct in Experimental Transplant Operations.
Received on Sat Nov 29 2014 - 17:56:33 EST