March 28, 2024

Drug Makers Increasingly Join Fight Against Doping

Now, a growing number of pharmaceutical companies are trying to prevent their drugs from the same fate by joining with antidoping officials to develop tests to detect the illegal use of their drugs among athletes.

Two major drug makers, Roche and GlaxoSmithKline, have begun evaluating every new drug candidate for its potential to be abused by athletes and have agreed to share information about those products with the World Anti-Doping Agency, known as WADA, which polices drug use in international sports. Several other smaller companies have provided proprietary information about specific drugs. A conference in Paris in November dedicated to the topic drew 250 participants.

The development reflects a significant shift from the days when drug makers paid little attention to how their products could be abused by athletes, said David Howman, the director general of the antidoping agency. In the past, drug makers “felt that any publicity in relation to antidoping control would be negative,” he said. “But what they discovered is the opposite happened.”

Instead of shying away from such stories, Roche and Glaxo have promoted their involvement as an example of good corporate citizenship. Last year, Glaxo went so far as to sponsor the testing laboratories for the London Games, the first time in Olympic history that an antidoping laboratory had a named corporate sponsor.

Pauline Williams, who leads the team at Glaxo that runs the antidoping initiative, said the cooperation with WADA grew out of that sponsorship. “What the London 2012 involvement led to was a real pride and willingness, and a positive attitude toward this continued engagement,” she said. Since the start of the program, the company said it has shared information about four of its projects, and development of a test for one drug is under way.

Antidoping officials have long sought information from drug companies. For instance, Amgen, which developed EPO, helped develop a test for Aranesp, another of its drugs that has been used in doping, in advance of the 2002 Salt Lake Olympics. But such arrangements were ad hoc and fairly simple, said Olivier Rabin, the antidoping agency’s science director. “It was almost more by chance when it was happening,” he said.

Relationships between antidoping officials and pharmaceutical companies have sometimes been tense. In 2006, Amgen was criticized for sponsoring the Tour of California at a time when EPO abuse was rampant among cyclists. Although the company said it had sponsored the race to raise awareness about doping, it was later revealed that the organizers had failed to test for EPO, short for erythropoietin, a synthetic hormone that, like Aranesp, stimulates the production of red blood cells.

“They were associated with some things in the past which we felt were probably inappropriate,” Mr. Howman said. “What we had to do was start the conversation from scratch, and say let’s see how we can work together.”

Steven Elliott, the Amgen scientist who invented Aranesp, said the misperceptions went both ways. He said some believed, wrongly, that biotechnology companies were developing drugs that could be misused by athletes as a way to increase sales. “There was this uneasiness about that,” said Mr. Elliott, who recently retired but continues to work as a liaison between biotechnology companies and the antidoping agency. “There had to be this realization that it was a win-win for both sides.”

Antidoping officials began to work more closely with drug makers after 2004, when Dr. Rabin heard that athletes were talking about a new version of EPO, called CERA, that was being developed by Roche, and asked the company for help.

“We were shocked when they first contacted us,” recalled Barbara Leishman, who oversees the antidoping program there. She said company scientists had not realized that athletes were following the drug’s development so closely. “This is not the sort of thing we like to hear about our compounds.”

Roche then worked with the antidoping agency to develop a blood test for the new drug, turning over proprietary compounds, called reagents, that would help officials test for their drug. Because of the complex nature of the drug, which mimics the body’s own hormones, and the development of the test, the project took years.

In 2009, blood samples from six athletes taken during the Beijing Olympics tested positive for CERA. Other drug makers took note of the media attention Roche received for the collaboration, Mr. Howman said. “Once there’s a foot in the water, then you can follow and walk right in,” he said.

Roche broadened its agreement with WADA, expanding the project to screen all of its drugs in development. Glaxo followed suit and around the same time, two major industry groups representing biotechnology and pharmaceutical companies adopted policies encouraging their members to cooperate.

Halting the abuse of new prescription drugs is only part of the antidoping picture. Athletes today are believed to use a variety of methods to gain an advantage, from transfusing their own blood to taking tiny quantities of tried-and-true doping agents. And some performance-enhancing drugs gain life in illicit laboratories, as was the case with “the clear,” the designer steroid developed in the Bay Area Laboratory Co-operative that toppled star athletes like Marion Jones.

Still, pharmaceutical companies have an important role to play given how complex new drugs have become, and how athletes are increasingly using substances that closely mimic the body’s natural processes, officials said.

“Developing detection methods to show that the substance taken in a synthetic form is different than your natural substance is more challenging,” said Matthew Fedoruk, the science director for the United States Anti-Doping Agency.

Many pharmaceutical companies already have the tools to create a doping test for their products because the Food and Drug Administration and other regulatory bodies require them to show how the drug passes through the body. During the development process, the companies design reagents to help identify the drug. Amgen and other companies, like the biotechnology company Affymax — which makes a competing anemia drug called Omontys — have given WADA some of these reagents for use in developing tests.

Still, Dr. Rabin and others said some companies needed persuading and did not return his calls. In those cases, he said, he uses peer pressure, reminding them that other companies are also participating.

“We know the progress of their drugs, and we know that at some point collaboration will naturally come,” he said. “We are a bit stubborn.”

Article source: http://www.nytimes.com/2013/02/19/business/drug-makers-increasingly-join-fight-against-doping.html?partner=rss&emc=rss

DealBook: Gundlach Says 2009 Firing Had Roots In 2001

Jeffrey Gundlach, chief of DoubleLine.Jessica Rinaldi/ReutersJeffrey Gundlach, chief executive of DoubleLine.

The bond fund manager Jeffrey E. Gundlach’s clash with his former employer, Trust Company of the West, began as early as 2001 and intensified in the months leading up to his firing, he testified on Tuesday.

In his third day of testimony in his trial against TCW, as Trust Company of the West is better known, Mr. Gundlach said he had clashed with TCW executives years before he was fired in December 2009. TCW is suing Mr. Gundlach and seeking more than $375 million in damages, contending that he used trade secrets and proprietary information from the firm to set up his new company, DoubleLine Capital.

Mr. Gundlach said he began questioning his future at TCW when its parent company, the French bank Société Générale, announced in January 2009 that it was combining its asset-management businesses with those of Crédit Agricole, another French bank, and that it was planning to list TCW on a stock exchange within five years.

Several months before that announcement, Frédéric Oudéa, the chief executive of Société Générale, told a group of TCW portfolio managers that “the asset-management business, I don’t know if I want to be in it,” according to Mr. Gundlach, who adopted a broad French accent while recounting the September 2008 meeting.

But despite his certainty that TCW would be sold, Mr. Gundlach maintained that he had never wanted to leave the firm.

“It would make no sense whatsoever for me, or my team, or my clients, or anyone,” he said, according to a live feed of the Los Angeles court proceedings provided through CourtroomView.

Mr. Gundlach is seeking more than $500 million in a countersuit asserting that he is owed fees from the fixed-income funds he ran at TCW.

On Tuesday, under questioning from his own lawyer, Mr. Gundlach gave a brief overview of his life. He told jurors about his “lower middle-class” upbringing in Buffalo and his decision to enroll at Dartmouth, where he graduated with highest honors in 1981. After graduating, he said, he briefly enrolled in a Ph.D. program in mathematics at Yale but dropped out and moved to California to play drums with his rock band.

After giving up his dreams of music stardom, Mr. Gundlach decided to become an investment banker, inspired by an episode of “Lifestyles of the Rich and Famous” that listed it as a top-paying job. He looked through the Yellow Pages for investment banks, but found only asset-management firms and stumbled into a job interview at TCW, where he began working in 1985.

In his testimony on Tuesday, Mr. Gundlach said that his problems with TCW began in 2001, when the firm was acquired by Société Générale. Mr. Gundlach’s equity stake in TCW was reduced, he said, asserting that this was something that Marc I. Stern, the firm’s chief executive, had promised would never happened.

“I’ve never yelled so much in my life,” Mr. Gundlach said of the incident.

On Tuesday, even while explaining his business conflicts, Mr. Gundlach’s aggressive personality was restrained considerably. He explained that he did not truly think of himself as “the pope,” as has been widely reported, but insisted instead that the nickname was “a third-party term meant as shorthand” within his fixed-income team.

Mr. Gundlach also responded to claims that he had used proprietary data from TCW at DoubleLine, saying he told employees repeatedly that any data taken from TCW should be removed and threatened “serious disciplinary measures, up to and including termination” for those who did not comply.

When Mr. Gundlach was fired, more than 40 of his TCW colleagues went to work for him at DoubleLine.

Earlier in the trial, Cris Santa Ana III, a current DoubleLine employee and one of Mr. Gundlach’s co-defendants in the suit, testified that Mr. Gundlach had told him to begin backing up information in case he was fired from TCW.

Mr. Gundlach will resume his testimony on Wednesday.

Article source: http://feeds.nytimes.com/click.phdo?i=fa77564b5e511b7687e35b450efca2d5