Addurl.nu Onblogspot News: February 2012

Saturday, February 25, 2012

Ryan Braun Wins Appeal, But Defense Raises More Questions Among Doping Experts


The cloud over Ryan Braun's acquittal has only gotten thicker as his case has turned into a cold war between Major League Baseball and its reigning National League MVP.


His case has broken a number of precedents, starting with the reporting of his initial positive test by ESPN in December, then with his successful appeal Thursday, followed by MLB's surprising rebuke of respected arbitrator Shyam Das.
Braun addressed his case at length for the first time Friday when he spoke to reporters at the Brewers' training camp, but in his passionate denial that he ever intentionally or unintentionally doped, Braun raised a number of issues that only further complicate his situation.
AP Photo/Jae C. Hong
Milwaukee Brewers outfielder Ryan Braun, center rear, speaks as his teammates gather to support him during a news conference at spring training in Phoenix, Friday.
This much is not in dispute: Braun gave a urine sample after the Brewers' Saturday, Oct. 1 playoff game against the Arizona Diamondbacks. The sample collector did not take the sample directly to a FedEx/Kinko's location as proscribed by MLB's policy. He reportedly testified that he didn't believe the package would be shipped until Monday, two days later, and that the sample would be more secure at his home than at a FedEx facility. On that Monday, he shipped it to the Olympic anti-doping lab in Montreal, considered one of the best, if not the best, in the world.
When the sample was tested, it showed Braun had a greater than 20-to-1 ratio of testosterone to epitestosterone, two hormones that should appear in roughly equal amounts. Anything above 4-to-1 is considered a positive result. His sample was then put through a second test, an Isotope Ratio Mass Spectrometry test, which determines whether the testosterone in someone's urine was made by his body or an outside, or "exogenous," source. It determined that Braun had exogenous testosterone.
Major League Baseball was prepared to move ahead with a 50-game suspension for one of the most popular and successful players in the game. Braun was informed of the positive result, and his fight to clear himself began.
Almost everything else is in dispute.
Braun insists he is innocent and he never doped. Major League Baseball argues that he did dope, he just avoided a suspension because of a technicality that it says Das misapplied to the case. Braun suggested in his news conference that the unnamed sample collector somehow tainted the result, and his surrogates have told reporters that there were problems with the samples.
In the 24 hours since news broke that Braun had won his appeal, here are some of the critical questions and issues that have emerged, some of which have left anti-doping experts skeptical of Braun's defense:

The first test

Standard procedure is to take a player's sample and measure a number of metabolites in the urine. The tester then compares the level of testosterone to epitestosterone. The average person produces the same amount, but if a person has four times the amount of testosterone -- a 4-to-1 t/e ratio -- then the sample is flagged for the more sophisticated IRMS test.
So what does it mean that Braun's level was 20-to-1? Only that the sample needed further testing.
Braun and his attorneys have said that his ratio was "three times higher" than had ever been recorded, noting that in itself was a sign that there was something wrong with the test.
It's possible that no one has ever tested that high in baseball, but Don Catlin, the former director for the Olympic lab at UCLA who is considered the father of performance-enhancing drug testing, said he has seen cases that exceeded 100-to-1. A 20-to-1 ratio, he and others said, is not unusual in a positive test.
AP Photo/Damian Dovarganes
Dr. Donald Catlin, considered the father of performance-enhancing drug testing.
A sample left unrefrigerated for two days could begin to break down, Catlin said, which could alter the ratio one way or the other. That's why, whether a player's sample shows a 4-to-1 or 100-to-1 ratio, it's more important to determine whether the testosterone in his system was his own.
The IRMS test determined that the testosterone in Braun's sample was synthetic. Catlin and other experts said they do not believe it is possible that a sample could somehow develop exogenous testosterone, unless it were tampered with.
Braun did not dispute the positive IRMS test in his defense in front of the arbitration panel, according to two sources with knowledge of the hearing.

The allegations of tampering

During his news conference Friday, Braun suggested that his sample must have been tampered with to have resulted in a positive test. He said that he had no idea why he would have tested positive for elevated levels of testosterone (and he was never asked during the news conference why he might have had synthetic testosterone in his system).
According to multiple sources with knowledge of the hearing, possible tampering of the specimen was not raised as a defense, and Montreal lab director Christiane Ayotte testified that she saw no signs of tampering when the lab received the specimens.
"Neither Mr. Braun nor the MLBPA contended in the grievance that his sample had been tampered with or produced any evidence of tampering," said MLB executive vice president Rob Manfred in a statement released Friday afternoon.
The collection process would have played out this way: Braun would have urinated into a sample cup, in full view of the doping control officer or DCO. The DCO would have then taken the cup and poured the sample into two other sample cups, one marked "A," and one marked "B."
A lid would have been placed on both cups, with forensic chain-of-custody tape used to seal both cups, while Braun watched. The cups would have been turned upside down to show no leakage. A source with knowledge of the case and doping issues told "Outside the Lines" that if someone tried to lift the tape or tear it off, it would be reflected on the bottle because the tape sticks.
"There's no way to replace it without that showing," said the source. "You can bet that if there was suggestion this guy intentionally sabotaged the sample, the case never would have gone forward. If that were the case, MLB's 13-man investigative unit and the FBI should have been called in."
Catlin also said that if the sample had been tampered with, it would have been evident when the sample itself was tested. "[Ayotte] would have caught that," he said.
Ayotte did not return messages left for her.

The collector and the rules

Perhaps the greatest and most unexpected mystery to emerge from the Braun saga is the role played by an unnamed Wisconsin man whose job last Oct. 1 was to collect a urine sample from Braun and two other Brewers in his role working for Comprehensive Drug Testing.
The actions or inactions of that man over the course of the following two days have emerged at the center of the case. Between Braun's defense team and Braun's news conference statements, it has been suggested the collector's son was with him at the time of the collection, and that the man worked part-time for CDT. (Experts said such collectors typically have other, full-time jobs.)
Selig
AP Photo/Bebeto Matthews
Major League Baseball commissioner Bud Selig, flanked by MLB vice president of labor relations Rob Manfred, left, and MLB Players Association executive director Michael Weiner.
Braun said the man, inexplicably, took his samples back to his home that afternoon rather than take them to any number of FedEx/Kinko's stores still open to take delivery of the samples. During his news conference, Braun stated the man didn't drop off the samples until around 1 p.m. Monday, implying that a 44-hour window provided an opportunity for the samples to be tampered with.
Addendum A, Section V, Subsection 7 of the collective bargaining agreement states that "Absent unusual circumstances, the specimens should be sent by FedEx to the Laboratory on the same day they are collected." As well, language in the CBA states, "If the specimen is not immediately prepared for shipment, the Collector shall ensure that it is appropriately safeguarded during temporary storage." It also directs the collector to keep the "chain of custody intact" and to "store the samples in a cool and secure location."
According to sources with knowledge of Braun's case, the collector believed the FedEx/Kinko's pickup time for shipments had passed and the samples would sit at FedEx until Monday, the next business day. Because of that, he took the samples, already secured and sealed for shipping, and placed them in the basement of his home. MLB believed that decision fit with the language in the contract and should not have been grounds to toss the result.
"The extremely experienced collector in Mr. Braun's case acted in a professional and appropriate manner," Manfred said in a statement Friday. "He handled Mr. Braun's sample consistent with instructions issued by our jointly retained collection agency. The arbitrator found that those instructions were not consistent with certain language in our program, even though the instructions were identical to those used by many other drug programs -- including the other professional sports and the World Anti-Doping Agency."
About the same time Manfred's statement was released, union chief Michael Weiner issued his own statement, which read in part, "As has happened several times before with other matters, this case has focused the parties' attention on an aspect of our program that can be improved. After discussions with the commissioner's office, we are confident that all collections going forward will follow the parties' agreed-upon rules."

The offer to test his DNA

Braun's team suggested Friday that after learning of the positive test result, it requested the player's sample undergo DNA testing to determine whether it was truly his urine.
MLB declined this request, according to Braun's camp. While MLB agreed Braun's camp requested the DNA request initially, a source with knowledge of the case said MLB told Braun and his lawyers it didn't believe such a test was necessary but that they were welcome take up the issue with the arbitrator if they wanted the test conducted.
Ultimately, the source said, the DNA issue was not raised during the hearing by Braun's team.

What's next for MLB testing

MLB's contention that Braun beat it on a technicality may be accurate, but to the players' association, that isn't the point.
When the players agreed to testing, they agreed to a system that makes them sacrifice their civil liberties to prove their innocence, and to do so in a way that very few professions require.
Ryan Braun
AP Photo/Morry Gash
Braun's case has broken a number of precedents.
They have to stand naked and urinate in front of a stranger on command, at any random time. The union's position is if players have to endure that testing and are subject to bans from 50 games to a lifetime, then there should be an ironclad system that protects their rights.
So maybe the wording in the program about how quickly the collector had to get the sample to FedEx was vague, but the procedures are there to safeguard against abuses, as they are in the criminal law system.
In his news conference, Braun described MLB's testing system as "flawed" and "broken."
Both MLB and the MLBPA issued statements late Friday afternoon saying they have one of the best systems in any sport, but that they have work to do.
Do not expect fundamental changes in the program, but do expect the two sides to address potential loopholes. Expect to see new language that specifies when and how a collector is required to ship the samples, with specific requirements about where and how he should store them in the event he is unable.
MLB isn't thrilled about having to address the issue at all; its argument is that while Braun questioned the integrity of his sample in public, he did not do so in his hearing. So if the sample was secure and its integrity wasn't compromised, then why should it matter whether it took the collector 10 minutes or 48 hours to ship the sample?
But Das didn't buy that argument, so the two sides will return to a bit of collective bargaining to tidy the language.


Tags: among, Appeal, Braun, Defense, Doping, Experts, Questions, Raises

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Thursday, February 23, 2012

Qnexa Proponents Ask U.S. Experts To Back The Obesity Drug

Qnexa




* Qnexa helped patients lose weight
* One ingredient tied to birth defects
* Uncertain effect on the heart
* FDA advisory panel to vote on drug Wednesday afternoon
* Vivus shares halted pending vote


By Anna Yukhananov

SILVER SPRING, Md., Feb 22 (Reuters) - Proponents of a new obesity medication from Vivus Inc told U.S. reviewers on Wednesday that the drug's health benefits exceed heart and birth defect risks.

A panel of outside experts to the Food and Drug Administration will vote later on Wednesday on whether to recommend approval for what would be the first new prescribed drug for obesity in 13 years.

The FDA first rejected Vivus' Qnexa in 2010 because of safety problems, along with two other obesity pills that are also seeking a second round of consideration.

The FDA usually follows panel recommendations, although it is not required to. It will make a final decision by April 17.

Qnexa, which combines the appetite suppressant phentermine and anti-seizure drug topiramate, helped patients lose at least 10 percent of their weight after a year of treatment, the company said .

Obesity, a leading cause of diabetes, heart disease and other serious health problems, has reached epidemic proportions in the United States, with about a third of the population obese and more than half overweight.

"Back in medical school, I was taught that when the risk of not treating the condition exceeds the risk of treating it, we should treat," said Dr. Arya Sharma, a chair in obesity research at the University of Alberta in Canada and paid consultant to Vivus.

"We have an obligation to change how we measure obesity. Qnexa addresses an urgent and substantial unmet medical need for our patients," he told panelists.

The FDA has set a high approval bar for weight loss drugs because such a large portion of the general population is likely to want to take them, and has not approved a new obesity drug since 1999.

Also, many diet pills have been linked to serious heart-related risks.

But patient groups say the FDA is holding obesity drugs to a higher standard than other treatments because of views that it is a choice, not a disease. They are urging the FDA to approve new obesity drugs that would give patients another option between lifestyle changes and surgery.

Shares of Vivus were halted on Nasdaq on Wednesday pending the outcome of the FDA panel meeting. They closed at $10.55 on Tuesday, well above the stock's low around $4.70 after the pill was first rejected.


SAFETY RISKS

FDA staff presenting on Wednesday said the key issues with Qnexa were about safety, not efficacy.

Staff reviewers have said patients taking the drug had more safety problems, including memory loss and higher heart rates, than those on a placebo, and some of these problems could get worse over time.

They have also noted that exposure to one of the ingredients in Qnexa has been linked to a higher rate of birth defects.

A Vivus study showed topiramate caused a higher rate of oral clefts in infants of women taking the drug during pregnancy, and the company said it would limit Qnexa to women who are not pregnant.

The FDA has said the rate of potential birth defects is about two to five times higher with topiramate than with placebo.

Vivus officials said obesity, and its common symptom diabetes, come with their own risks to pregnancy, such as stillbirth, premature birth and other complications.

The FDA and the company generally agreed on a program to mitigate the drug's risks to pregnant women, including limiting the drug to certified pharmacies and training doctors who would prescribe it.

Panelists will discuss whether they think the program is stringent enough to protect patients from the risk of birth defects.

In clinical trials, Qnexa also increased patients' heartbeats, leading to fears it may have negative effects on the heart. However, Vivus said the drug also reduced blood pressure, and a link between heartbeat and heart health was not conclusive. (Reporting by Anna Yukhananov; Editing by Tim Dobbyn)








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Monday, February 20, 2012

Nuclear officials meet Iranian leaders as war talk looms (VIDEO)


Tehran, Iran (CNN) -- Officials with the U.N. nuclear watchdog agency begin a second round of talks Monday with Iranian officials over the country's nuclear program, a day after Tehran cut off crude exports to British and French companies in retaliation for a new round of sanctions imposed on the regime.


The two days of talks come amid heightened tensions in the region, with Israel making clear it is pondering an attack on Tehran's nuclear infrastructure, while Iran warned it could cut off the narrow strait through which oil tankers sail in and out of the Persian Gulf.


The scheduled talks between the International Atomic Energy Agency and Iranian officials are billed as an opportunity for the watchdog agency to get more clarity about the "possible military dimensions to Iran's nuclear program," the group said.


Iran's official Islamic Republic News Agency cited the head of the IAEA mission as saying it would take time to resolve Iran's nuclear issue because it is complicated.
Mission head Herman Nackaerts is the IAEA deputy director general responsible for ensuring that countries are not secretly developing nuclear weapons.
Iran says it is producing enriched uranium to fuel civilian power plants and has refused international demands to halt its production.

But the IAEA reported in November that it had information to suggest Iran had carried out some weapons-related research.

U.N. Secretary-General Ban Ki-moon said it is up to Iran to disprove the allegation.
"The Agency is committed to intensifying dialogue. It remains essential to make progress on substantive issues," IAEA Director General Yukiya Amano said in statement following the first round of talks in January.

The talks in Tehran follow an announcement Sunday by Iran's oil ministry that it was halting crude exports to French and British companies, an order that followed a threat that Iran would cut oil exports to some European Union countries in retaliation for sanctions put in place last month by the EU and the United States.

"Iran has no difficulty in selling and exporting its crude oil. ... We have our own customers and have designated alternatives for our oil sales. We shall sell to new customers, who will replace French and UK companies," ministry spokesman Ali Reza Nikzad-Rahbar said in a statement.

But on Monday, Foreign Minister Ali Akbar Salehi said he expected relations with Europe to improve.
The two sides need each other, the semi-official Mehr news agency quoted him as saying.

"I believe that relations will return to their earlier state," Salehi said in Tehran, Mehr reported.

The sanctions put in place last month are meant to force Iran to provide more information on its nuclear program by shutting off its sales of crude oil, which generates half of Iran's revenue.

Iran exports 2.2 million barrels of oil a day, 18% of which is bound for European markets, according to the U.S. Energy Information Administration. The world consumes about 89 million barrels of oil per day.

U.S. and European sanctions are already squeezing Iran's economy, driving down its currency and driving up consumer prices.

Israeli Defense Minister Ehud Barak has called for still-tougher sanctions, saying that accelerating the pace of sanctions would force Tehran to return to nuclear talks.

Iran proposed a resumption of those stalled talks last week. U.S. and European diplomats were still trying to gauge the sincerity of the Iranian offer, but U.S. Secretary of State Hillary Clinton called it "an important step."

Meanwhile, Israel has made clear that it considers a nuclear-armed Iran a threat to its existence and has suggested it is considering an attack on Tehran's nuclear infrastructure.

The United States believes talk of military strikes against Iran's nuclear program is "premature" and has advised Israel that an attack would be counterproductive, Gen. Martin Dempsey, the chairman of the Joint Chiefs of Staff, said Sunday on CNN's "Fareed Zakaria GPS."

Dempsey said U.S. officials aren't convinced Iran has decided to pursue nuclear weapons. Meanwhile, economic and diplomatic sanctions appear to be taking a toll on the Islamic republic, he said.

"On that basis, I think it would be premature to exclusively decide that the time for a military option was upon us," Dempsey said.

Dempsey said American officials believe an Israeli strike would delay Iran's nuclear development "probably for a couple of years, but some of the targets are probably beyond their reach." He said he and others have had "a very candid, collaborative conversation" with the Israelis about the issue.

"I'm confident that they understand our concerns, that a strike at this time would be destabilizing and wouldn't achieve their long-term objectives," he said. "But, I mean, I also understand that Israel has national interests that are unique to them. And, of course, they consider Iran to be an existential threat in a way that we have not concluded that Iran is an existential threat."

Tensions between Iran and Israel have been further heightened in recent days with two Iranian warships sailing through Egypt's Suez Canal into the Mediterranean Sea.

It's only the second time such ships have crossed through the Suez Canal since Iran's 1979 revolution.
Iran's Press TV reported on Monday that the two ships had docked Saturday in the Syrian port of Tartus where the crews were to provide maritime training to Syrian naval forces.



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