06/07/2013 03:30 EDT | Updated 08/07/2013 05:12 EDT

Saudi paperwork demands delay work to research to find MERS source: CDC

TORONTO - Last October, scientists from the U.S. Centers for Disease Control went to Saudi Arabia to help investigate a newly discovered virus that had killed one Saudi man and left another from Qatar gravely ill.

The CDC scientists are still waiting for a chance to test the samples they took during that investigation. Those specimens remain in Saudi Arabia, tied up in prolonged negotiations for a material transfer agreement the Saudi government has insisted the American agency sign.

The situation is frustrating the American scientists and impeding efforts to find the source of a virus which has now infected 55 people, killing 31 of them.

It's also ironic. Dr. Ziad Memish, the Saudi deputy health minister, has complained bitterly and publicly because Erasmus Medical Centre, the Dutch laboratory that first identified the MERS coronavirus, applied for a patent on its genetic sequence and has been requiring labs that want virus samples to sign a material transfer agreement, known in research lingo as an MTA.

The scientist who heads the CDC division which is waiting for the Saudi samples said it is uncommon for the agency to be asked to sign an MTA to study samples taken during the course of an outbreak investigation. The team was in Saudi Arabia at the invitation of the kingdom's government.

Mark Pallansch, who is director of the CDC's division of viral diseases, said it is also unusual for it to take this long to negotiate and sign an MTA. He would not comment on what the sticking points have been, though he did say that in MTA terms, the wording of the proposed document is actually relatively standard.

"We are told at this point that we are close," Pallansch said. "So I do have some degree of hope that we will indeed have this completed in the near future."

Pallansch acknowledged the delay is frustrating. But he suggested the numerous outstanding questions about MERS are more pressing at this point, as public health agencies find themselves hampered in efforts to assess the risk posed by the new virus, a cousin of the coronavirus that caused the 2003 SARS outbreak.

"We are certainly in discussion with WHO, the European CDC and other key partner public health agencies. And I think there is very little disagreement among all of those agencies in terms of what are the important epidemiologic and virologic questions that need to be addressed. So I think that we all are trying to find out how that information can be made more readily available," Pallansch said.

The fact that the CDC is still waiting to test samples collected last October came as a shock to an international health law expert who has been following the issues related to intellectual property claims on the Middle Eastern Respiratory Syndrome virus, or MERS.

"The fact that negotiations are still going on about an MTA ... is very surprising," David Fidler, who teaches at Indiana University, said Friday when informed of the situation.

Fidler wrote an analysis on the coronavirus situation, entitled Who Owns MERS?, that was published Friday on the website of Foreign Affairs, the publication of the U.S. Council on Foreign Relations.

In an interview, he noted Memish had complained at the recent World Health Assembly — the annual meeting of the World Health Organization — that the need for laboratories to sign an MTA with Erasmus Medical Centre was slowing down scientific research on the MERS virus.

"Well here we have apparently a Saudi MTA with the CDC, the negotiation of which is causing delays in terms of getting samples and getting scientific research done," he said, adding it raises questions about whether "decisions that Saudi Arabia has made are themselves one of the key obstacles to getting research done on the coronavirus."

"We need to dig into that as well as these other questions that have been thrown around."

It's not clear why the Saudi government is requiring the CDC to sign an MTA or whether it is making the same demand of other international laboratories with which it is partnering on MERS research. Memish did not reply Friday to an emailed request for an interview.

Nor did Dr. Ian Lipkin, a Columbia University scientist famed as a "virus hunter" who has been working with the Saudi government to try to find where the coronavirus hides in nature.

Lipkin, who is the director of the Center for Infection and Immunity at Columbia's Mailman School of Public Health, has had a team in Saudi Arabia on at least two occasions collecting samples for study. Lipkin did not reply to emailed questions Friday asking whether his lab too has had to sign an MTA with the Saudi government and whether, if he has, the process has been similarly protracted.

But even if Lipkin has been able to skip the MTA step, or to work through it more quickly, his efforts to isolate the source of the virus face another major hurdle, experts say.

The U.S. Department of Agriculture would move to block entry to any samples from Saudi Arabia that came from animals like sheep, goats or camels. That's because Saudi Arabia is not free of foot-and-mouth disease, a severe and highly contagious livestock disease. The U.S. prohibits importation of animals or animal byproducts from countries affected by foot-and-mouth disease.

That prohibition wouldn't apply to human samples from Saudi Arabia, or samples taken from bats, which are thought to be where the virus probably originates. But it's believed bats aren't infecting people directly; some intermediate animal species are probably playing a bridging role.

And specimens from the types of animals people have wondered about — goats and camels in particular — would fall under the USDA's ban, Pallansch said.

"I am aware that negotiations are underway in trying to find out how there can be an arrangement made for either the USDA involvement or some other approved way for the USDA to grant a permit," Pallansch said, expressing doubt that the agriculture department would budge.

The WHO and several national public health agencies have expressed concern that the lack of information flow from Saudi Arabia is limiting the world's ability to assess the risk posed by MERS.

While infections have occurred in several other Middle Eastern countries — Jordan, Qatar and the United Arab Emirates — and cases have been exported to Britain, France, Tunisia and Italy, the lion's share of cases have occurred in Saudi Arabia. According to the WHO's tally, 41 cases have occurred or emerged from the kingdom, and 26 of them have been fatal.