Showing posts with label Patent. Show all posts
Showing posts with label Patent. Show all posts

Sunday, 26 May 2013

Questions about MERS, MTAs and mistakes.

Edited by Dr. Katherine E. Arden

This is a story that stretches back to June 2012-nearly 12 months ago. That's when virologist Prof Ali Mohamed Zaki reportedly notified (or not, depending on the article) the Saudi Arabian Ministry of Health about a fatal case of severe acute respiratory infection in a 60-year old man for which the standard laboratory tests yielded no answers. He sent a sample to researchers at the Erasmus Medical Center (EMC) and followed that up with more testing. He and the Dutch researchers found a new coronavirus (CoV). What seems to be missing from this process was any formal release of that sample by the Saudi Arabian Ministry of Health (MOH). Prof Zaki's ethical position could be seen as murky at best.

On September 20th, an eMail Prof Zaki sent to ProMED was published notifying the world of his process (including how he detected the virus using PCR and grew the virus in culture-processes he conducted while working in Saudi Arabia) and his findings.
ProMED was subsequently dressed down by Deputy Minister for Saudi Arabian Public Health, Prof Ziad Memish for publishing the eMail about which the Ministry was unaware. Prof Zaki signed off his eMail from the Dr Fakeeh hospital Jeddah Saudi Arabia, a private hospital.

Prof Zaki's eMail served as a trigger for the testing of another ill male from Qatar who had been airlifted to the UK September 12th - that test yielded the second case of the novel coronavirus.

If Prof Zaki did not follow protocol and sent a specimen without the knowledge or permission of the Kingdom it is interesting, in light of the expected harsh consequences, to speculate on his reasons for doing so. Did Prof Zaki have the supervisory and ethical approval to send a clinical sample out of the country? Did the EMC challenge him on this before accepting the sample(s)? Had Zaki taken the approved steps (if he did not, that is) to notify his superiors and request permission to send a specimen for further characterisation, would he have received timely permission? Would he ever have received permission?

As a result of this situation, an article was published this week that, although lacking in clarity due to machine translation issues, vilifies Prof Zaki for his actions.WHO spokesperson Gregory Hartl was quoted during September 2012 as saying that the coronavirus "is now an international issue"; a comment that raises some questions in light of this latest article about Prof Zaki's actions. Some have expressed frustrationin recent days about the slow provision of information on new MERS-CoV cases. Would the new coronavirus have been made into an international issue if not for the actions of Prof Zaki? Is the Kingdom capable of characterizing a novel CoV? If the Kingdom did proceed with announcing the MERS-CoV and inviting international experts to advise, would it have done so in time to precede one of the most successful hajj gatherings ever? Nearly 4 million pilgrims attended that gathering in 2012. A real concern exists that cases of this unknown virus could disseminate globally because of just such a gathering. That did not happen but at the time no-one could be sure it wouldn't - the risk was evident and remains so for the coming hajj.

Also this week another cause for argument arose when National Microbiology Laboratory researchers in Canada stated that they were not allowed to pass on samples of the MERS-CoV to other laboratories (40 labs have received the virus from the Erasmus researchers to date). This restriction was stipulated in the Material Transfer Agreement (MTA) that accompanied the sample from the Dutch researchers at Erasmus Medical Center (who characterized HCoV-EMC, now known as the MERS-CoV). The comment that China "gave away" H7N9 samples has been used as an example of a better way to conduct collaborative research on emerging pathogens.

MTAs are a pain in the neck. They slow things down. They are not necessarily crafted by the researchers themselves but by the legal advisory team and administrators to protect new knowledge and discoveries. They can also manage and record where and to whom a putative pathogen is sent and what is done with it by the recipient. Is that a bad thing? MTAs are not uncommon in science. They protect many things. Yes, they can protect intellectual property-with the potential to make some money. Good luck with that - there are as many scientists who have found riches in this endeavor as there are Tony Starks and Bruce Waynes.In this case the MTA, among other things, reportedly limits the distribution of what iscurrently a virus with a case fatality rate of 50%. That sort of virus needs to be worked with by experts using expert facilities with suitable restrictions and pre-existing ethical, genetic manipulation and biocontainment standards in place. We observed the uproar among scientists recently when a recombinant influenza pathogen that had the (unproven) potential to be as lethal was created in secure laboratory environment.

Why has no such uproar accompanied the shipping of observably lethal viruses around the world in the absence of MTAs and tighter restrictions?

If other labs would like the virus, they can also apply to the lab that has gone to the effort to detect, characterize, isolate, grow, purify and store it - just as the NML did. The US CDC noted similar caveats on sharing MERS-CoV were put upon it by the UK laboratory that provided it with samples, presumably form the Qatar case.How long will the attacks on Prof Zaki continue? Hard to know. He is no longer working for the Kingdom. Is losing one's job enough punishment for his putative protocol breach?

It is encouraging to read that samples from various potential animals will be sent to researchers in the US who have the expertise to conduct the studies necessary to track down a possible host.

The first human case of MERS-CoV was in June 2012 - it's now May 26th 2013.

Saturday, 25 May 2013

Patenting MERS-CoV: no hindrance to diagnosis at all.

Edited by Dr. Katherine E. Arden

This is not the first newly identified virus that researchers at Erasmus, or elsewhere, have patented.

They did the same for human metapneumovirus (HMPV; an endemic respiratory virus and kin to respiratory syncytial virus) after describing its discovery and characterization in 2001.
Another broad-ranging patent also listed on Google is for the human coronavirus (HCoV) NL63, discovered in 2004 by other researchers. Patenting is part of business and today a portion of science research requires proof of the ability of researchers to work with business to help produce real outcomes. Mass-produced diagnostic kits are one outcome - they are made to high standards of quality and distributed worldwide. Research scientists can't do that alone.


Also, the existence of a patent does not prevent or even impede the medical research or public health efforts being undertaken for MERS-CoV now. It also didn't hinder research on HCoV-NL63 or HMPV back when they were discovered. Have a look atPubMED (the Google for scientific research articles) and see how for yourself. There are hundreds of papers there that cover all aspects of each virus - virological, clinical, immunological impact and epidemiology. As a publisher of some of those papers I can assure you I was not asked to pay a cent to the "inventors" and the slowest part of the publication process was my own writing.

Comments to the World Health Assembly today have been interpreted to suggest that a patent on the MERS-CoV has delayed the development of diagnostic tests.

In fact, the necessary parts for leading edge diagnostic testing - sequences for polymerase chain reaction primers - were made available by the researchers (easily contactable thanks to a ProMED posting) as soon as they were developed. They were next made public to the entire scientific community through very rapid publications in leading journals. There are more than 20 papers on the MERS-CoV, or HCoV-EMC as it was known, listed on PubMED already. All a professional, PCR-enabled, public health or research diagnostic laboratory has to do is eMail the discoverers or read the manuscripts and order the reagents.

A true absence of information is unquestionably an impediment to infectious disease research. We saw some great examples of unfettered information from China during the H7N9 outbreak this year. When key information is freely available, as it has been from Prof Zaki and the Dutch researchers at Erasmus for the MERS-CoV, we can rest assured that diagnostic developments are unhindered. Diagnostics are most useful though when they are used to report when and how cases of infection by a new virus occur and spread. Could that area be the next target for more public criticism?