Russia removes the ban on medical specimen exports. Sort of.

Russian authorities all but admitted that the ban on export of all biological specimens from Russia was a flop. Well, not officially, of course.  Officialdoms do not make mistakes let alone flops. However, as the Kommersant Business Daily reported today,

Two weeks after the ban was initially imposed, leaving a legislative vacuum on the issue, the Ministry of Health and the FTS have issued new regulations governing biological specimens being sent out of the country. In essence, the document repeals the ban on the transport out of the country of three basic categories of biological specimens: those being used in clinical studies of new drugs, as part of an international scientific exchange, and for laboratory analysis as part of the treatment of patients in Russia.

Finally, after promises to resolve the issue within hours, Federal Customs Service and Ministry of Health pulled the ban, you think, right? Well, again, not exactly. Unlike the ban that had been immediately imposed without any explanations and any procedures, the repeal of the ban have not yet taken place. Just like it did on May 28th the Federal Customs Service sent out directives this past Saturday.

"We found out on Saturday that the customs posts had received letters concerning the new regulations for exporting biological materials," said TNT's coordinator for clinical studies, Maria Astanina. "Now the customs officials should pass these rules along to the couriers. So far we haven't received them." Ms. Astanina also said that, in conjunction with possible changes in the permission-granting process, the company is currently not accepting any new orders for the transport of such materials abroad.

In the caption of the article, Kommersant offers a figure of 40 thousand Russians whose health was threatened by the ban. It would be just great to let these people off the bureaucratic hook, but the natural instinct for self preservation trumps patients once again.

Pharmaceutical companies expect to wait at least another week for the real removal of the ban. A representative of one such company told Kommersant that "some time will elapse while the decree is registered with the Ministry of Justice or until information is received indicating that the decree will go into force without registration."

Even when according to the same Kommersant article,

In essence, the regulations can be considered "new" only with regard to laboratory analyses "for patients' medical conditions."

Well, there is another "new" feature that had many people puzzled.

The only unanimous reaction to the document among experts concerned the rule that the permit must be in the name of the patient. According to Svetlana Zavidova, a former legal advisor for the Association of Pharmaceutical Manufacturers, the rule violates patient confidentiality. Specifically, outside agencies - in this case, the customs offices where permits for the export of biological specimens are sent - will have access to patients' confidential medical histories.  

Once again, bureaucratic thinking meets reality. In search of a mild, saving face retreat without casualties among bureaucrats, at least some regulations needed to be imposed. What could possibly be easier and more benign then simply require a patient's name specified? What possible harm could it do? There is no need for it and there is already an existing system of coding that protects interests of patients, but would a saving face bureaucrat do any kind of research on consequences of his actions?

In no way am I suggesting that Russian bureaucrats are somehow different from bureaucrats elsewhere or here in the US. A planning department in some over bureaucratized county in California, like Santa Cruz can easily drag a business owner through several years of a grinding ordeal for no other reason then to show its power. Bureaucrats just have more power, more control over people's lives in Russia. They are more entrenched and are more likely to operate with impunity no matter the consequences of life and death to tens of thousands of people. Unfortunately, Russia is not moving away from the overreaching power of bureaucracy. The course of building "vertical power structures", the course of de facto nationalizations, the course of "managed democracy" its current president had embarked Russia onto leads to more day to day dependence of its citizens on bureaucracy.

The more people depend on the state the less likely they are to oppose it in any way. Across the globe in Santa Cruz, one of the most lefty cities in the US, people are less likely to vote its incompetent leaders out simply because government in one form or another is the largest city employer. Bureaucracy is the foundation of any lefty rule, its bread and butter, its milk and honey, its line, hook and sinker; it is the cage it forces people into. The only way to break the stranglehold bureaucracy has over lives is to privatise and deregulate as much as possible. In Maxist terms, to move away from state ownership of means of production to private ownership of means of production. And that is a very long road indeed.

Putin doubts clinical test specimen exports ever helped anyone.

There is still no resolution for the eight day ban on medical specimen exports from Russia and some 100,000 patients in have been affected, according to Gazeta.ru:

These are people taking part in two-year clinical tests. In their cases we are talking about hours. 8 days, 200 hours, doctors have to cancel visits

Kommersant offers a list of 17 children that have been saved by the program which the Russian President doubts there were any need for at all. Gazeta.ru also quotes an anonymous source from clinical therapy field:

We already have 17 women with breast cancer and 14 HIV infected patients that do not receive adequate therapy.

Government officials have been promising a speedy resolution. I have reported on last week's promises from Mr. Belyannikov, The Federal Customs Head. Nothing happened since. More from Gazeta.ru: 

On Tuesday evening, Mikhail Zurabov, Deputy Minister of Heath Care and Social Development stated that the problem with export of medical specimen from Russia would be resolved "within hours". According to Zurabov, a joint directive from Federal Customs Service and Ministry of Health Care and Social Development would outline the regulatory process of obtaining export permissions. This however would only apply to clinical samples related to actual treatment, not clinical tests.

Needless to say, nothing has happened within hours yet. Claiming to have enough time to ponder, the good minister decided he had a couple of weeks to come up with regulations pertaining to export of clinical test samples. Also according to the same article in the Gazeta.ru, even deputy chair of the State Duma Committee on Science and Education is in the dark:

We are still in information vacuum. Nobody has seen the actual text of the ban. It has never been published. We do not know who issued it and what its Issue Number was,  while the Customs Service adheres to it nonetheless.

There is apparently an internal struggle going on and probably within the top echelons of Russian state power. Kommersant notes an interesting quote from Mr. Putin's Friday interview to international mass media where he also threatened Europe with missiles and compared himself with Mahatma Ghandi. When someone did ask Russian President about the medical specimen export ban, his reply was, at best strange:

"Если вы говорите, что эти образцы вывозятся для того, чтобы оказать людям какую-то помощь, у меня, конечно, возникает вопрос: кому и какую помощь до сих пор оказали? Есть такая статистика? У меня такой статистики нет. И вообще, у меня сомнения, что кому-то оказана какая-то конкретная помощь после вывоза каких-то биоматериалов"

If you are saying that these specimens are exported in order to provide people with some help, I naturally have a question: what kind of help has been provided so far and to whom? Is there any statistical data? I do not have any. In general, I doubt there has ever been any specific help provided to anyone based on export of some bio samples.

I think this is the most revealing quote and it actually points directly to where this ban came from and why is it so difficult to resolve it. This ban is the product of the retrograde, paranoid and ignorant mentality of FSB/KGB apparatchiks. There is no other explanation anymore. Now, with such an abysmal competency level, do we still want to believe that Kremlin would never have anything to do with Litvinenko murder because it did nothing but hurt it? They would never do something like that to themselves, would they?

Putin's government seems to become the epitome of gross miscalculations.  

 

 

More about Russian ban on clinical medical specimen exports.

Smoke clears a bit around the  bizzare decision of Russian Federal Customs service to ban all  exports of human medical specimen. Kommersant Daily that initially reported the story is trying to figure out both how it happened and why. There is still no clear answer, but it looks like there was a combination of potential explanations I have outlined in my previous post on the subject. Let's rehash and keep them in mind:

  • Anti-terrorism concerns and belief that the West is working on the anti-Russian ethnic-specific weapon. It is after all a case of grandiose obscurantism on governmental level where paranoid bureaucrats are really exposing their convoluted world view.
  • It is a beginning of a PR campaign to counter dismal health care and public health record of the current administration. After all the dreadful life expectancy figures can not be helpful and blaming the West has always worked like a charm in Russia.
  • Somebody within Putin's coterie is eyeing medical field. I can't fathom how this ban could help improve the field but them vultures think in different terms.
  • There is an internal struggle within Putin's coterie and someone with financial interests in medical field is being squeezed.
  • The Federal Customs service is setting up a new racket - new opportunities for bribery or extortion.
  • Gross Incompetence in implementing regulations.
From the Kommersant account [link in Russian], Federal Customs Head Mr Belyaninov was not very clear. His press conference had to be canceled and only a statement was available later. In that announcement, Belyaninov presented new customs regulations as "some restrictions" rather then a "ban". Which flies in the face of reality, since there are no exports through Moscow and St Petersburg ports of entry. The Customs Head indicated that the "new regime" stops "uncontrolled border crossing by organs and tissues." There is no explanations of what could be wrong with "uncontrolled border crossings by organs".

The next paragraph in the Kommersant article is perplexing. It claims that the Federal Customs Service "indirectly" confirmed that the "main explanation" after all were the concerns among "power structures" [an ugly Russian euphemism for defense, security and law enforcement entities all wrapped in one neat little package] regarding existing theories of biogenetic and ethnic specific weapons development.

Further, during his announcement Mr. Belyaninov indicated that "FCS together with Ministry of Health and Social Development will shortly present new border crossing rules for law abiding exporters". This sort of suggests that no new regs were defined when the initial ban suddenly fell from above like a ton of bricks.

So it appears that reality lies in a combination of the first and the last explanations from my earlier list. Well, add to this the second explanation from the bottom and you have a fairly good picture of how things work in Russia. Some top boss, maybe Putin himself, expressed displeasure with the situation, in light of the report accusing the West of planning to kill all Russians, causing a knee jerk reaction among subordinate professional brownnosers and nobody along the way thought about consequences, except for the customs officials that now have yet another racket opportunity.

My refusal to believe obscuramtism was the core reason behind the ban turned out to be short lived. But realization of how seriously retrograde some people at the top of Russian officialdom are also brings back another point I have yet to get tired of making.

Limiting press freedoms, limiting free flow of conflicting opinions, limiting critical thinking in any way will invariably result in those at the top, limiting themselves from information necessary to make appropriate decisions. That was the downfall of the USSR expressed so vividly by Raisa Gobachev trying to "gotcha" Americans in Minneapolis for showing her Potemkin villages in a drug store.

Quite often if not always, those that adhere to conspiracy theories reveal inner working of their minds more then anything else. They all but shout to the world of what they would have done if they were in a position to.

For now contrary to blatantly contradicting statements from the Customs Head, there is no easing of the ban. Kommersant reports that courier services that specialize in  transporting  medical samples for clinical tests are not taking any orders. Managers of 11 major clinical test companies have sent a letter to Russian Prime Minister Fradkov stating that health of tens of thousands of patients can be threatened. However, it is Saturday in Russia. Is anyone willing to take a flying guess whether there will be a change over the weekend tens of thousands of people be damned?


 

Why in the world would Russia ban exports of biological specimen?

[Added some followups below] 

[Also, the story continues here.

I have to admit, I do not understand  this. My first reaction did fit a common Internet acronym WTF.  So far only Forbes picked up on this subject among the Western media. Read for yourself and see if your reaction is different:

MOSCOW (Thomson Financial) - Russia has banned the shipment of medical specimens abroad, threatening hundreds of patients and complicating drug trials by major companies, the Kommersant newspaper reported...

Kommersant said the Federal Customs Service had started the ban on Monday, blocking the shipment of all biological material, including hair and blood, beyond Russia's borders.

What Forbes' news wire reprint does not mention is that one of the explanations offered for this absurdity is
 
Western development of an ethnic based anti-Russian biological weapon.

Here is more from the Kommersant article, once again only available on the Russian side of its web site (translating in a hurry, fairly loose, so be nice):

Neither Federal Customs Service, nor Ministry of Health, nor Russian Public Health Service (Росздравнадзор) could offer exact reasons for the ban on export of biologic sample material, that is otherwise necessary for clinical or clinical patient tests. We do know that in the past several months several major medical institutions conducting clinical research for big pharmaceuticals have become targets of routine searches by the Customs Service that was looking for names of medications, research time frames, partners and funding sources [my highlighting]...

Customs searches were a part of "war on bio-terrorism" - let us remind you that the concept of this phenomenon yet to have a real world example was offered by Vladimir Putin in 2004. One of the Kommersant's sources inside medical establishment who claimed to have been familiar with the development, indicated that the ban came after an early May 2007 FSB report delivered by the FSB Head Nikolai Patrushev to President Putin himself. According to the source, the report described clinical research market as several Western medical centers receiving biological sample material from Russia and at the same time being involved in a program to develop a bio genetic weapon specifically against the population of Russia... [following is a list of major NGO including Harvard Public Health School, various international societies and unions, etc.]

According to Kommersant Daily, the report claims that the supposed biological weapon is designed to be ethnically specific and will target health of Russian people including causing infertility among Russian women.

The Kommersant article also offers a litany of quotes from health care professionals concerned by recent developments and predicting dire consequences to clinical research in general and to public health in particular. Clinical research funding figures in Russia are incomparable to these in the West and inability to send samples for clinical tests, in cases of bone marrow transplants for example,  will result in simply put it, deaths.

My recent trip to Russia has elevated the word "obscurantism" (мракобесие) in my day to day vocabulary. There has been way too many noticeable examples there, mostly on personal level: weird ideas of Russian exclusivity, destiny, superiority mixed in with Feng Shui, pagan worship of medicinal stones - all fermented inside superficial Christian Orthodoxy. Superficial, because during the 80 years of the Communist rule, study of religion has been mostly substituted with shamanic soul searching and cultural psychosis of hodge-podge of obscurant beliefs.

To make sure, the idea of banning DNA shipments to prevent the West from developing an ethnic-specific anti-Russian weapon is preposterous. Nikolai Yankovsky from the Russian Institute of General Genetics told Echo of Moscow radio:

Banning shipments of one's DNA aboard is impossible - I am my DNA

There got to be some other explanation. Maybe against my better judgment I flatly refuse to believe that such obscurantism can be the real cause. But I am still flabbergasted and can only offer several meager explanations in no particular order:
  • It is after all a case of grandiose obscurantism on governmental level where paranoid bureaucrats are really exposing their convoluted world view.
  • It is a beginning of a PR campaign to counter dismal health care and public health record of the current administration. After all the dreadful life expectancy figures can not be helpful and blaming the West has always worked like a charm in Russia.
  • Somebody within Putin's coterie is eyeing medical field. I can't fathom how this ban could help improve the field but them vultures think in different terms.
  • There is an internal struggle within Putin's coterie and someone with financial interests in medical field is being squeezed.
  • The Federal Customs service is setting up a new racket - new opportunities for bribery or extortion.
  • It is a trial balloon and The Kommersant Daily is in error - no such ban has been authorized.

Except for the last option, all other explanations are scary. I do not know what would bother me more - grandiose obscurantism of cosmic proportions or blatant disregard for human life for political or financial goals. Probably the former, since after spending one fifth of the last two and a half years in Russia dealing with my mother's cancer I am quite sanitized to customary insensitivity of the Russian establishment, medical or not.

I am sorry, but this is your second scary thought of the week.

A FOLLOWUP: The original Kommersant article is now available on their English language site here

MORE FOLLOWUPS:

Here are some quotes from Moscow Times:  

The Health and Social Development Ministry, meanwhile, said the new rules referred only to exports in large quantities.

"The system for the export of biological materials for sick individuals remains unchanged," the ministry said in a statement.

 Compare the above with this:

Federal Customs Service chief Andrei Belyaninov told Kommersant that all biological specimens had been banned from export.

"No foreign institution is able to destroy Russian's health more effectively than [Health and Social Development Minister] Mikhail Zurabov," Mentkevich said.

I am willing to add another bullet to the above list of possible explanations:

  • gross incompetence.

The general idea was to try to cut into the smuggling of human organs business but the only way Federal Customs and Russian officialdom in general know how to react is to ban everything outright.

НИИИИЗЗЯЯЯЯ! 

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