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Jun 17, 2014
Lost a loved one
Alzheimer's research scandal?

Researchers from Swedish Karolinska institution may have found an all new pharmaceutical treatment for Alzheimer's disease, but the drug company Apodemus have been keeping results secret. An Alzheimer's treatment is worth billions, and researchers are threatened with fines of $60000 if they speak out about the new treatment. "This study should be published ASAP, knowledge about possible Alzheimer's treatment must be made public", says KI-professor Lars Lindqvist.

Alzheimer's may be caused by a viral infection - and stopped through antiviral drugs. This is the hypothesis for a study of a new drug treatment tested by swedish pharmaceutical company Apodemus, but a conflict between the company and the researchers involved has so far prevented results from being published.

Doctor and virologist Bo Niklasson started both the study and company Apodemus, having long argued that picorna virus infection may be the cause of many diseases, including Alzheimer's and ALS.

The study was started three years ago and was finished summer last year, publication of results still pending. The reason is a conflict between the Apodemus company and the researchers, in particular with the former vice president Bo Niklasson. The company has through court decision prohibited Niklasson to speak about the effect of the treatment or use the tested drug on patients. The company also filed a charge against Niklasson to the healthcare and treatment inspection (IVO). IVO critized Niklasson for treating patients with an unregistered drug outside of a clinical study. Police have also searched Niklassons house on accounts of several charges for computer intrusion and industrial espionage. First two charges were dropped, one remain open.

The conflict has spread to the Karolinska institute where three of the researchers involved work. Swedish IRS attempted to confiscate medicine belonging to the company, and the company also wants to access patient journals. Initial small scale tests on human subjects with Alzheimer's were positive and paved way for the larger study of 60 patients. Apodemus witheld the results for an extended time, and when the reasearchers wanted to write a scientific article about the first smaller scale study - the company made lawsuit threats against them.

"I've never had to deal with anything like this before. A company that doesn't even have the right to manage healthcare should not gain access to neither patient data or own information coming from patients having been treated in our regular healthcare system. That's putting aside both regulations and patient confidentiality", says professor Lars Lindqvist.

Professor Lars-Olof Wahlund concurs:

"It's completely absurd - the worst I've ever seen. At least they could've called us and discussed with us instead of communicating through a lawyer's office"

Apodemus claims publication of data breaches contract between the institute researchers and the company, suggesting researchers have used the drug manufactured by the company without permission. "A publication at this point risks causing Apodemus great damage", the company states. Head of institute, Henrik Grönberg, is of another opinion and says researchers did in fact kept to their contract agreements and did nothing wrong, and adds that "Apodemus communication has been performed rudely - hardly resulting in future cooperation".

Researchers have filed complaints to the government pharmaceutical authority, making statements that the Apodemus company have been hiding information about the study, expressing concern for the patients that had positive results from treatment but is now unallowed to continue treatment.

Peder Ribbing, 74, Stockholm, knows a female friend with Alzheimer's disease who got to try treatment:

"Her friends reported a clear and noticable improvment when she was put on medication. She got infinitely better - got her life back, became her old self, began taking care of herself again and taking own initiatives".

Last year the company wrote letters to patients, telling them they were no longer allowed to accept treatment from Bo Niklasson. Professor Lindqvist hopes for continued antiviral dementia research:

"We see great possibilities of moving forward. This is just the start."

The company has excluded researchers from being cited as authors of the study and from writing the scientific article, and hired external writers instead.

"It's rare and weird that researchers who have conducted the study are excluded like this. It's completely absurd. The company acts very unprofessionally. Deciding when and if results are to be published happens due to profit interest", says professor Lars-Olof Wahlund.

(Translated from several swedish newspapers)
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