The Collision of Sports and Politics: Russian President Putin Views Meldonium as Not Being an "Athletic-Performance-Enhancing" Drug

One of the most interesting stories currently is the collision of sports and politics on the question of Latvian-invented meldonium. US News carries an AP story reporting that Russian President Vladimir Putin has gone on record as stating that Meldonium is not an athletic-performance-enhancing drug.

See the following link to a video at the above US News article which contains an excellent interview of Dr. Michael White, UConn School of Pharmacy, regarding meldonium, trade-named as Mildronate:

See video

We posted about this topic previously at LawPundit at Sports Law Pharmaceuticals & the Maria Sharapova Tennis Case: The Latvian Inventor of Meldonium Defends the Safety of the Allegedly Performance-Enhancing Miracle Drug aka Mildronāts, Mildronate, Quaterine, MET-88, THP (not Available in the USA or Germany).

The simple fact is that a 20-capsule package of meldonium at 250 mg per capsule is an OTC (over-the-counter) medication that can be purchased without a prescription in pharmacies in Latvia (perhaps in Russia too, we do not know). Meldonium is in our view quite comparable to ubiquitous vitamin and nutritional supplements and has been available for purchase for many years.

There is no evidence that taking meldonium somehow magically "enhances" athletic performance. It may make your heart healthier, just as some vitamin or similar supplements, or even certain foods, also claim to do, but that is by no means "drug misuse" of the kind that should be prohibited in athletics.

In the interview cited above, Dr. Michael White, who otherwise gives a straightforward, very informative interview, asks why Sharapova, who spends much of her time in the USA, does not take a "comparable" USA-FDA (Food & Drug Administration) approved "heart medication" rather than meldonium. Why should she do that if she has been taking meldonium without side effects for years? Nationalistic provincialism should not mark the pharmaceutical field.

As someone who worked for years in the pharmaceutical industry, here is our very personal but we hope instructive take on a further answer to Dr. White's question about what substances we can take. It is all about money.

We ourselves will hit the age of 70 this year and occasionally see signs of the wear and tear that advanced maturity can bring, so that we have occasionally taken a modern non-generic prescription-only state-of-the-art angiotensin II receptor blocker for our high blood pressure. It costs about €30 a month when taken in normal dosage and has some potential very undesirable side effects, so we have taken it sparingly. Who needs drug-induced difficulties? Not us.

We are a high energy individual, so that when meldonium first came to our attention, it looked to us like an interesting alternative substance that appeared capable of strengthening the heart and had no known side effects, so we obtained meldonium as the product Mildronāts - Grindeks, perfectly legally, prescription-free, and OTC from Latvia, a European Union Member State. We have no qualms about using it in Germany, another EU Member State, which in our view can not prohibit us from using such a medication freely available in the EU, even if the substance itself may not be approved for sale in Germany itself. That would otherwise contradict the "single market" principle. We are here, after all, not dealing with some kind of illegal drug.

In our short experience we can report that meldonium seems to have a very positive effective on lowering our high blood pressure and thus far shows no negative side effects whatsoever. There may even be a positive side effect.

We point here to a study which indicates that long-term high-dosage of meldonium intake may increase sexual performance in boars. See at PubFacts (which leaves out the diacritical markings), Zigmunds Bruveris, Vita Antane, Ilga Misane, Jazeps Rimeicans, Ivars Lusis, Alberts Auzans, Mara Mangale, Aleksandrs Mednis, Ilmars Stonans, Effects of meldonium on sexual performance, sperm motility, testes morphology and blood biochemical markers in boars. Anim Reprod Sci 2013 Jan 22;136(4):303-9. Epub 2012 Nov 22. [Author's Affiliation: Clinical Institute, Faculty of Veterinary Medicine, Latvia University of Agriculture, 8 K. Helmana Street, Jelgava, LV 3004, Latvia.]

To our knowledge, no comparable study has been published on humans, and there may be no comparable effect. Who knows.

And here is the rub, perhaps answering Dr. Michael White's question above.

A package of 20 such 250mg capsules of meldonium costs about €6, so let us say ca. €10 per month if taken as we take them, at one capsule a day, even though 2 are recommended as the normal dosage. That is a cost of ca. two-thirds less than what we would have to pay out of pocket for our non-generic angiotensin II receptor blocker, since insurance covers only cheap generics -- in our experience not always comparably effective. The annual cost is thus $120 instead of $360. Quite a bit of money for an average person.

As a sample of the prices in force for a high blood pressure medication such as e.g. Micardis -- that is the brand version while the generic is called Telmisartan -- see PharmacyChecker.com, which also appends the following footnotes significant for money questions and borderline legal issues:

""*The total price includes shipping fees which typically cover an entire order....
**U.S. Law and Drug Safety: U.S. government officials have stated that individuals who order non-controlled prescription drugs from Canada or other foreign sources (up to a three-month supply) for their own use are not being pursued or prosecuted. However, it is technically not legal for individuals to import most prescription drugs. The U.S. FDA regulates the safety and efficacy of medications sold in U.S. pharmacies. Medications dispensed from outside the U.S. are regulated for safety and efficacy by pharmaceutical/pharmacy regulatory authorities in other countries. Read how regulations may differ by country.
Coverage by Insurance: For a drug to be reimbursable from a health reimbursement account or flexible spending account it must be approved for sale in the U.S. and prescribed by a licensed U.S. physician, although drugs which you personally import are typically not reimbursable. If you have pharmacy insurance coverage, you may want to check with your benefits administrator to determine whether drugs ordered from outside the U.S. will be covered or reimbursed."

Why is meldonium not available for sale in Western nations? There appears to be a simple explanation. It is not a home-grown product and is priced reasonably. Hence, profits via meldonium would be much lower for indigenous pharmaceutical companies who would have to pay patent royalties on a licensed product sold much more cheaply than their own overly priced, patented, but perhaps nevertheless inferior remedies. We are reminded here of the many actions taken by Apple, Inc. to keep competing, in part, better, smartphones and tablets out of the country. The monopoly principle is the same. Keep competition out.

The meldonium controversy is thus conceivably not a medical issue at all, but rather an issue of institutional power, money and monopoly pharmaceutical markets.

The USA's FDA and similar institutions elsewhere function as "economic barriers to entry". Even if a drug has been clinically tested and approved elsewhere, every nation persists on making their own studies in determining the licensing of substances, a costly ever-duplicating process paid for by the taxpayers, who have no say in the matter, and who may even be paying top dollar for inferior pharmaceutical substances at their own local pharmacies.

When institutions such as the World Anti-Doping Agency (WADA) start blacklisting substances just because they are being used -- blacklisting without any evidence that they do in fact increase athletic performance unfairly, then things are askew in the systems of control that govern competitive sports, as we already know from negative examples at the NCAA, the FIFA and the Olympic movement.  Competitive sports are dominated by self-serving monopolies, often abetted by clueless lawmakers and courts who accord such sports organizations special advantages, to which they should not be entitled at all. EVERYONE is "in business". EVERYONE.

We note that in what looks to us like a retaliatory measure against the Russians, by the way, that WADA just revoked accreditation of the Moscow Laboratory. It all appears to be part of "the game" of monopoly in sports.

The competitive sports world has become -- or perhaps it always has been -- a golden goose for too many organizations and their officers at the cost of the competing athletes. The private WADA is surely no exception in this regard, as its monopolistic practises have come under increasing scrutiny (see the Wikipedia for examples).

Moreover, all of these organizations try to expand their powers as much as possible so that they can tell other people what they are supposed to do. Why people have that need for power is something we have never understood.

Indeed, it is the athletes who are usually being punished by these "ruling bodies" and not those who run athletics. It is a bizarre system of top-down injustice in which the ruling organizations and institutions control the lives of athletes for their own selfish self-serving and self-sustaining ends.

And now perhaps someone in Brussels or Berlin can explain to us why in the alleged "single market" of the European Union, it is virtually impossible to order prescription-free meldonium online, as it is not delivered by Latvian pharmacies outside of the territory of Latvia, as far as we have been able to determine. Mildronate used to be available through Amazon.de. No longer. Its sale is conceivably being blocked on the orders of someone.

Moreover, we have found a few links here and there online that seem to point to meldonium "teasers" -- you are warned -- i.e. websites not actually selling meldonium but purporting to do so, and perhaps acting on behalf of other parties to discover who is taking meldonium and who is not.

What goes on here as a matter of law, sports and politics?

Digital Rights: New European Union (EU) Data Protection Rules Passed by the European Parliament as the General Data Protection Regulation (GDPR)

We reproduce here a press release from the European Union Parliament on new rules regarding digital rights, the General Data Protection Regulation (GDPR)  ["REGULATION (EU) 2016/… OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL ... of ... on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)"]

European Parliament PLENARY SESSION Press Release of April 14, 2016
Police cooperation / Citizens' rights / Justice and home afairs

"Data protection reform - Parliament approves new rules fit for the digital era

New EU data protection rules which aim to give citizens back control of their personal data and create a high, uniform level of data protection across the EU fit for the digital era was ["were", sic] given their final approval by MEPs on Thursday. The reform also sets minimum standards on use of data for policing and judicial purposes.

Parliament’s vote ends more than four years of work on a complete overhaul of EU data protection rules. The reform will replace the current data protection directive, dating back to 1995 when the internet was still in its infancy, with a general regulation designed to give citizens more control over their own private information in a digitised world of smartphones, social media, internet banking and global transfers.

"The general data protection regulation makes a high, uniform level of data protection throughout the EU a reality. This is a great success for the European Parliament and a fierce European 'yes' to strong consumer rights and competition in the digital age. Citizens will be able to decide for themselves which personal information they want to share", said Jan Philipp Albrecht (Greens, DE), who steered the legislation through Parliament.

"The regulation will also create clarity for businesses by establishing a single law across the EU. The new law creates confidence, legal certainty and fairer competition", he added.

The new rules include provisions on:

• a right to be forgotten,
• "clear and affirmative consent" to the processing of private data by the person concerned,
• a right to transfer your data to another service provider,
• the right to know when your data has been hacked,
• ensuring that privacy policies are explained in clear and understandable language, and
• stronger enforcement and fines up to 4% of firms' total worldwide annual turnover, as a deterrent to breaking the rules.

New rules on data transfers to ensure smoother police cooperation

The data protection package also includes a directive on data transfers for policing and judicial purposes. It will apply to data transfers across borders within the EU as well as, for the first time, setting minimum standards for data processing for policing purposes within each member state.

The new rules aim to protect individuals, whether victims, criminals or witnesses, by setting out clear rights and limitations on data transfers for the purpose of prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including safeguarding against and preventing threats to public security, while at the same time facilitating smoother and more effective cooperation among law enforcement authorities.

"The main problem concerning terrorist attacks and other transnational crimes is that member states’ law enforcement authorities are reluctant to exchange valuable information", said Parliament's lead MEP on the directive Marju Lauristin (S&D, ET)."By setting European standards for information exchange between law enforcement authorities, the data protection directive will become a powerful and useful tool which will help authorities transfer personal data easily and efficiently, at the same time respecting the fundamental right to privacy", she concluded.

More details on the general data protection regulation and the directive in our Q&A here.

Next steps

The regulation will enter into force 20 days after its publication in the EU Official Journal. Its provisions will be directly applicable in all member states two years after this date.

Member states will have two years to transpose the provisions of the directive into national law.

Due to UK and Ireland's special status regarding justice and home affairs legislation, the directive's provisions will only apply in these countries to a limited extent.

Denmark will be able to decide within six months after the final adoption of the directive whether it wants to implement it in its national law.

REF.: 20160407IPR21776
Updated: 14-04-2016 - 16:23"
[this is the snipped end of the press release and what follows is EU Pundit text]

Contact for the press release: Rikke Uldall at the European Parliament Press Service ... please go to this link: the EU original page of the press release.

The European Data Protection Supervisor (EDPS) has a posting about this new Directive at One giant leap for digital rights.