"Where there is no vision, the people perish: but he that keepeth the law, happy is he."
-- Proverbs 29:18, King James Bible (KJV)

Saturday, March 19, 2016

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 Latvian Inventor of meldonium (also known as mildronāts, Mildronate, Quaterine, MET-88, or THP) has defended the safety of the allegedly performance-enhancing drug that has brought Russian tennis star Maria Sharapova into an alleged doping crossfire, very likely unjustly, because, as Ivars Kalvins of Latvia's Institute of Organic Synthesis has stated, there is no clinical evidence that taking meldonium improves athletic performance per se.

Meldonium is a curious case because the substance was only put on the athletically prohibited list of drugs this year, in 2016, whereas the medication was already invented in the 1980s and used for livestock. Clinical trials on humans were conducted in 2005 for its use as a heart medication. As written by Eric Niiler at Wired (yes, two i's) in The Quirky History of Meldonium, From a Latvian Lab to Maria Sharapova:
"The [Latvian Institute of Organic Synthesis] demonstrated meldonium’s ability to treat effects of heart failure, myocardial infarction, arrhythmia, atherosclerosis, and diabetes, as well as how it boosts the sexual prowess of boars."
As Niiler writes further, the World Anti-Doping Authority (WADA) has stated off the record that meldonium was put on the prohibited list because it is allegedly "an energy efficiency catalyst that increases oxygen uptake, enhancing stamina and endurance." WADA is being careful in its statements on the record because they are in hot water legally, having no evidence that meldonium improves athletic performance, nor is there any evidence that meldonium is harmful to athletes -- quite the contrary, all available evidence indicates that meldonium, as a CYTOPROTECTIVE SUBSTANCE -- is beneficial for health -- perhaps for everyone!

In his Wired article, The Original Users of Meldonium, Sharapova’s Banned Drug? Soviet Super-Soldiers, Niiler points out that the drug has been used for many years, and quotes Kalvins, a European Patent Office finalist for the European Inventor Award in 2015 for his work on meldonium, as follows:
"Kalvins says the [Sharapova] ban is literally a crime. “It’s a violation of human rights,” he says. “The sportsmen should be able to protect their health. We are living in an era of evidence-based medicine, so there are not any other new data supporting the ban.” He calls the prohibition “sudden” and “a surprise.”" [emphasis added]
In fact, meldonium is a registered drug in Latvia, Russia and East European countries and has been prescribed for heart patients for years because -- if taken as indicated under the supervision of a physician -- it has proven beneficial not only for heart indications but for health in general, as detailed at the end of this posting.

The slow-moving U.S. Food and Drug Administration has not approved it yet.  See Flash - Inventor defends safety, questions ban on Sharapova drug - France 24. It is also not yet approved in Germany, in spite of clinical trials that were published already in 2010 in Seminars in Cardiovascular Medicine, 2010; 16:3. That failing in the USA and Germany, of course, may have much more to do with big money and pharmaceutical politics rather than the honest attempt to provide the best medicine to citizens via new substances, especially if the patents to those substances are owned by foreign firms.

At any rate, as a legal matter, it simply can not be the case that substances that are beneficial to the heart and the circulatory system are put on lists of substance prohibitions for athletes -- just because athletes use them beneficially. That is really quite absurd.

Many athletes surely stress their hearts more than your average person and thus taking vitamins or other medications to protect their hearts and health surely is not "doping" per se at all. We should in fact rather encourage athletes to take supplements which are beneficial to them and their organs and which make them stronger, presuming the drugs are not harmful.

Better heart health could of course result in better athletic performance in any sport, and especially so in tennis, which puts a lot of stress on the circulatory system, but to ban substances that improve an athlete's overall health can not be the purpose of prohibitory athletic doping laws. That simply goes too far in terms of sports officials interfering with people's free choice and, paradoxically, likely HARMING their health through prohibition.

There must be a line drawn between permissible supplements that improve the health of athletes as opposed to drugs such as steroids that are used primarily to enhance muscle size and thus to gain an unfair athletic advantage in strength sports. Moreover, steroid abuse has been shown to be dangerous to the health of athletes. But what about other "supplements"?

We ourselves find that eating honey and peanut butter sandwiches prior to tennis matches or other athletic endeavors appears to be beneficial for winning or losing -- for us. Calories to burn as it were. Dehydration can also be a severe problem for athletic performance and we swear by Coca-Cola (R) in such cases. Who is anyone to prohibit us from doing that?! In other words, there must be sensible limits to drug doping law prohibitions.

The world is constantly moving forward and new discoveries are being made every day that have the potential to improve human health. There is no way that all such new discoveries can be prohibited for athletes. That would be unsupportable discrimination against athletes. Indeed, the athletes may be serving in the course of their competitions as models for the rest of us, who down the road may in fact find ourselves taking the same substances to lead a better life. Meldonium certainly looks like one of those substances.

Be that all as it may, meldonium is manufactured only in Riga, Latvia by the pharmaceutical firm Grindeks (Grindex), and prescriptions of the drug have shot up considerably since the Sharapova case became public.

As written at France24 about the clever Mayor of Riga and meldonium, and we would not be surprised if tourist traffic to Riga increased as a result:

"Meanwhile, the mayor of Riga, Nils Usakovs has turned the controversy over the drug into a cheeky promotional initiative.

On his Twitter and Instagram accounts, he has mocked up a holiday-style poster, decorated with swimsuit-clad women, with the slogan: 'Welcome to Riga, meldonium home city!'"

Here is what the pharmaceutical company Grindeks (Grindex) has written recently at its website about meldonium in Meldonium should not be included in the Prohibited list [note that the company is not doing this to INCREASE sales, rather sales of meldonium have increased because of the prohibition]:

"Despite «Grindeks»’s submitted arguments, evidence and justifications, the World Anti-Doping Agency (WADA) included meldonium in the Prohibited list. In accordance with the results of the extended research, «Grindeks» has a firm conviction that meldonium should not be included in the Prohibited list. It is unclear to «Grindeks» why the WADA included meldonium in the Prohibited list, because it never gave any explanation of this decision. The company will continue to use all the options and will stand up for to the exclusion of meldonium from the WADA’s Prohibited list.

Mildronate® is a registered trademark of the JSC «Grindeks». Its active pharmaceutical ingredient (or active substance) is meldonium which is responsible for the pharmacological and therapeutic effects of Mildronate®. It should be noticed that inclusion of meldonium (Mildronate®) in the Prohibited list doesn’t change the fact that it is a medicine of high quality, safety and efficacy. Until now it has been available to everyone, including athletes, to prevent the negative effects caused by physical and psycho-emotional overload.

Mildronate® is widely used in the clinical practice. During increased physical activity, it restores the oxygen balance of tissue cells as well as activating the metabolic processes that result in lower requirements of oxygen consumption for energy production. Mildronate® is widely recognized by health care professionals and patients, and this may include athletes as well.

Mildronate® is mostly prescribed for patients to treat heart and cardiovascular diseases, including stable angina pectoris, chronic heart failure (NYHA I-III functional class), cardiomyopathy, functional cardiovascular disorders; also when there are acute and chronic ischemic brain blood circulation disorders, reduced working capacity, physical and psycho-emotional overload as well as during the recovery period after cerebrovascular disorders, head injury and encephalitis.

Depending on the patient’s health condition, the treatment course of meldonium preparations may vary from 4 to 6 weeks. The treatment course can be repeated twice or thrice a year. Only physicians can follow and evaluate patient health condition and state whether the patient should use meldonium for a longer period of time or not according to the information provided in the patient leaflet and summary of product characteristics.

Meldonium is a cytoprotective substance, which is used to prevent death of ischemic cells, and not to increase performance of normal cells. The mechanism of action of meldonium is based on limitation of carnitine biosynthesis, which leads to deceleration of fatty acid oxidation and activation of glycolysis. Unlike carnitine, meldonium doesn’t cause increase of muscle mass and physical properties. Meldonium decreases cellular damage from ischemia by reducing accumulation of detergent substances (acylcarnitine and acyl-coenzyme A) in the mitochondria. It means that meldonium reduces the ability of an organism to use fatty acids as its energy source. This is important in the treatment of pathologies associated with heart muscle ischemia (stenocardia, heart failure), because in these cases the heart is not getting enough oxygen and nutrients. Consequently, meldonium is a cytoprotective substance, which is used to prevent death of ischemic cells, and not to increase performance of normal cells. It means that meldonium cannot improve athletic performance, but it can stop tissue damage in the case of ischemia. That is why this therapeutic drug is not a doping agent.

Good safety profile of Mildronate® should be particularly emphasized. This is one of the key factors explaining its wide recognition among the doctors and patients. The Mildronate®’s safety is confirmed by its periodic safety update records and the results of published clinical studies. Based on available data, no adverse reactions related to Mildronate®’s use in athletes have been registered.
"

Meldonium looks pretty good to us, and WADA has clearly made a mistake in putting a substance on the prohibited list which has not been proven to be harmful nor has it been proven that it confers an unfair advantage in sports.

Moreover, as a personal matter and on behalf of people who might be helped to lead better lives with meldonium, we want to know why the substance is not available in the USA and Germany, where the local pharmaceutical company monopolies are reaping gigantic profits by providing us with what may turn out to be less effective cardiovascular substances than meldonium.

Hat tip to CaryGEE.


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Cave Paintings Earthworks & Mounds as Land Survey & Astronomy
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