"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

President Barack Obama's Option to APPOINT a Supreme Court Justice Due to WAIVER of Advice and Consent by the Senate

President Barack Obama actually has a simple solution available in handling the Senate refusal to follow normal procedures of "advice and consent" according to Article II, Section 2, paragraph 2 of the United States Constitution which provides that:
"[The President] shall have Power, by and with the Advice and Consent of the Senate, to make Treaties, provided two thirds of the Senators present concur; and he shall nominate, and by and with the Advice and Consent of the Senate, shall appoint Ambassadors, other public Ministers and Consuls, Judges of the Supreme Court, and all other Officers of the United States, whose Appointments are not herein otherwise provided for, and which shall be established by Law: but the Congress may by Law vest the Appointment of such inferior Officers, as they think proper, in the President alone, in the Courts of Law, or in the Heads of Departments." [emphasis added]
As provided in the Constitutional provision cited above, the President has the power to NOMINATE and also to APPOINT Supreme Court Justices in concert with the middle provision "by and with the Advice and Consent of the Senate". Nomination and appointment are two SEPARATE acts between which is sandwiched the "advice and consent" clause.

What would happen now if President Obama were to go on and actually APPOINT the previously nominated Merrick Brian Garland to the vacant seat on the U.S. Supreme Court?

The only recourse that the Senate of the United States would have would be to bring the case to that very same U.S. Supreme Court and to argue that the appointment is unconstitutional and thus null and void due to the failure of the President of the United States to obtain the constitutionally required "advice and consent" of the Senate.

However, the Senate would be on very shaky legal footing.

The President would argue that he had fulfilled his Constitutional duty as President, had nominated Garland to the vacant position and had submitted that nomination to the U.S. Congress for its duties of "advice and consent", but that the Congress had publicly proclaimed and categorically so, that it would not carry out its Constitutional duties of "advice and consent" REGARDLESS of the NOMINEE, i.e. by not having any contact with the nominee, by not holding any hearings on the nomination, and by not voting on the nomination to determine if the required number of Senators consented to the nomination or not.

In other words, the President could argue that the Congress WAIVED the requirement of advice and consent by categorically and publicly declining to fulfill its Constitutional duty -- and had done so for publicly proclaimed POLITICAL rather than Constitutional reasons.

Regardless of the political leanings of the individual Justices, they would be hard-pressed to support the Senate's actions as a matter of Constitutional law.

The Senate Majority Leader, Mitch McConnell, has gone on record as saying that the reason for the Senate's declining to exercise its Constitutional duties of "advice and consent" is to "Give the people a voice in filling this vacancy", something which would allegedly occur by waiting until the next President is elected. See Senator Mitch McConnell on Merrick Garland Supreme Court Nomination at C-Span.

The Constitution says NOTHING about Supreme Court positions being popular quasi-elective offices whose filling depended on prospective political elections. Rather, the procedure is clearly provided in Article II, Section 2, paragraph 2 of the United States Constitution. The people have already had their say by electing the President that they currently have. There is no issue here of the people's voice being somehow magically activated by the election of the next President, as if that voice had already not been heard previously.

Moreover, McConnell is wrong in saying that the Senate is "withholding" its consent. That is a nicely twisted falsehood. Rather, the Senate is not acting at all to determine if Senate consent is there or not. That is an entirely different matter, because the Constitution states that BOTH "advice and consent" are duties of Congress in the intermediary stage between nomination and appointment of a Supreme Court Justice. The Senate has DENIED those duties REGARDLESS of the NOMINEE, a clear Constitutional usurpation.

If the Senate WAIVES those duties by publicly proclaimed inaction, and for reasons of pure politics, seeking to make Justices quasi-elected judges, thus failing to abide by the clear provisions of the U.S. Constitution, then the Senate should be barred from raising the argument that the appointment is unconstitutional and/or that it is therefore null and void, because the Senate itself has failed to "withhold" its consent from the nominee by a proper advice and consent, and by a negative Senate vote, a result which is by no means secured until the vote is actually held.

Should the Senate argue that it can determine WHEN it is to fulfill its Constitutional duties, even if it takes years, because the Constitution sets no specific time limit, then the Supreme Court in our opinion should hold as an axiom of law, that Constitutional government DUTIES are to be fulfilled within a reasonable period of time, which in the case of confirmation or non-confirmation of Supreme Court Justices to the Court, has previously been 125 days at the maximum and has been an average of 71 days for current Supreme Court Justices. To avoid any game-playing and trickery on the part of the Senate, the Supreme Court should set a limit of 90 days. Period.

The Senate could still vote against the nominee, but it can not withhold the process of its "advice and consent", which the Constitution requires.

Those who disagree with the above scenario should consider the following hypothetical: Hillary Clinton wins the upcoming election and one of the conservative Justices passes away at the same time. The Court then has a more-or-less liberal majority and needs no more Justices, so that no more nominations to the Court are made by the new President for the duration of her administration. What then, dear obstructionists?

Frankly, we do not think that President Obama will take the option discussed here because he has simply been a very weak President in the last years of his Presidency and probably wants to go out without any greater catastrophes happening, especially a face-to-face Constitutional battle among the three branches of government. But it might be the right thing to do for the country and a proper education of its citizens about the U.S. Constitution and the impartiality of the Judiciary.

P.S. If this scenario ever actually happened, what would be the position of Justice Garland in deciding the case? Would he have to recuse himself? Or could he also cast his vote on the merits, especially if the Senate is to be held barred from bringing the action for reasons of its own WAIVER. After all, the case is not about Garland but about the publicly declared inaction of the Senate in refusing to fulfill its Constitutional duties, REGARDLESS of the NOMINEE, which is an entirely different matter.


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.