Ephedra Scrutiny

[ROID WARRIOR]

Ephedra comes under Congressional scrutiny
House examines dietary supplement's safety
Wednesday, July 23, 2003 Posted: 11:03 AM EDT (1503 GMT)



The debate over the herbal supplement ephedra heated up after pitcher Steve Bechler died February 17.

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• FDA plans warning labels for ephedra


WASHINGTON (AP) -- Many people who followed guidelines for using the herbal stimulant ephedra still reported health problems, congressional investigators found.

In addition, many complaints came from users under 30, the General Accounting Office said in testimony prepared for Wednesday's hearing on dietary supplements before the House Energy and Commerce oversight subcommittee.

Marcia Crosse, the GAO's acting director of health care-public health and science issues, said the reports of health problems made to drug-maker Metabolife International included heart attacks, strokes and seizures. Five deaths also were reported.

Crosse also noted the Food and Drug Administration has received more reports of problems from taking supplements with ephedra than any other ingredient.

Crosse said the problems reported to Metabolite "are consistent with the types of adverse events reported to FDA and with the documented physiological effects of ephedra." In addition, she said, the records of calls to Metabolite "contain reports of serious adverse effects in consumers who were young and among those who used the product within the recommended guidelines."

She said the average age of those who included an age when they called was 38, and ranged from 17 to 65. More than one-third were under 30.

In a statement submitted to the subcommittee, Metabolite said the company "strongly believes in the science supporting the safety and efficacy of dietary supplements that contain ephedra when used as directed."

The House subcommittee is holding two days of hearings on ephedra, which was thrust into the spotlight in February following the death of Baltimore Orioles minor league pitcher Steve Bechler, who had taken a dietary supplement containing ephedra.

Congress in 1994 severely limited federal oversight of dietary supplements.

"Based on all the evidence we have seen, the industry has not adequately addressed the safety of ephedra-based diet products," said Ken Johnson, a spokesman for House Energy and Commerce Committee Chairman Billy Tauzin, R-Louisiana.

Bans and court cases
The FDA is sifting through 16,000 comments responding to its March proposal to order warning labels on bottles of ephedra. The FDA has not tried to ban the product, despite reports of more than 100 deaths being linked to the herb, citing the 1994 law.

In May, Illinois Gov. Rod Blagojevich signed the nation's first statewide ban on ephedra.

Kiley Bechler, the pitcher's widow, filed suit in federal court last week against the manufacturer and distributor of the supplement containing ephedra that was found in her husband's locker. The lawsuit names Cytodyne Technologies and its president, Robert Chinery, who also is on the House committee's witness list.

Medical Examiner Joshua Perper in Fort Lauderdale, Florida, where Bechler died, said ephedra in the weight-loss supplement Xenadrine RFA-1 contributed to the heatstroke that killed the pitcher. Toxicology tests confirmed that "significant amounts" of the over-the-counter supplement and other factors led to the attack.

Cytodyne officials released a letter to the House committee from forensic pathologist Dr. Michael Baden, former New York City chief medical examiner, who says that ephedra didn't cause Bechler's death.

"At the time Mr. Bechler collapsed from heat stroke, much of the ephedrine he had swallowed was still in his stomach and had not yet entered his bloodstream," Baden wrote. The unabsorbed ephedrine "could not have caused or contributed to Mr. Bechler's death."

Ephedra is banned by the National Collegiate Athletic Association, the National Football League and the International Olympic Committee but not major league baseball.

 

[Rick Collins]

From the NY Times:

July 23, 2003
Expert Panel Finds Flaws in Diet Pill Safety Study
By CHRISTOPHER DREW and FORD FESSENDEN

As a growing number of deaths and illnesses have raised questions about their diet pills, some ephedra companies have promoted a medical study as showing that their product is safe and helpful for losing weight.

But documents released yesterday by a House subcommittee show that a panel of scientists has found flaws and shortcomings in the study. Some government officials said those problems could undercut its safety findings at a time when federal regulators are trying to decide if they should ban ephedra, an herbal stimulant, or restrict its sales.

For several years, the industry had refused to give the regulators all the data from the study, which was conducted at medical centers in New York and Boston in the late 1990's. But last February, the Food and Drug Administration made an unusual deal to gain access to the data, officials say.

The agency had to make the deal, the officials say, because it was in a bind. While drug companies are required to prove the safety of their products and must turn over safety data and consumer complaints to the F.D.A., the agency, under a 1994 law, has no such authority over the makers of dietary supplements like ephedra.

The notion that a federal regulatory agency had to make a deal to investigate a health threat also goes a long way, critics say, to explaining how the ephedra companies have been able to keep the government at bay through nearly a decade of complaints about their products. And while the companies are now removing the ephedra from many of their diet pills, these critics say they remain concerned because so little is known about the other herbal ingredients being used as substitutes.

Under the deal, administration officials said, the F.D.A. agreed to hire outside experts to help review the data. It also allowed the industry to veto several of the possible choices before agency officials picked the scientists who did the critiques.

Top agency officials said they agreed to the deal to counter industry concerns that the agency's scientists were biased against ephedra. Representative James C. Greenwood, a Republican from Pennsylvania and the chairman of the House subcommittee that will hold a hearing on ephedra today, said the deal made sense because the outside experts ended up showing that the study was "seriously flawed."

Mr. Greenwood said this also could mark a breakthrough in the agency's effort to regulate ephedra. "This is the study that was being held up by the industry as the gold standard," he said. "And now the evidence shows that it was anything but that."

Documents released by Mr. Greenwood's subcommittee show that the three scientists hired to review the data all ended up criticizing the study. One of the agency's experts noted that through a mix-up, some of the participants who were supposed to receive placebos were given a mixture of ephedra and caffeine similar to what is in most of the diet pills, thus making the study "impossible to rely on."

Another F.D.A. expert, Dr. Norman Kaplan, a hypertension specialist at the University of Texas Southwestern Medical Center at Dallas, said that with only 87 participants completing the six-month study, the group was too small to assess safety. He also said the researchers had played down increases in heart rates and blood pressure among study participants that could translate into a 20 percent to 40 percent increase in strokes and heart attacks among ephedra users.

In addition, the reviewers said the study would be a poor predictor of what might happen to the general public. Two reviewers noted that the study enrolled only people in near-perfect health, using a series of rigorous tests to eliminate 11 percent of the volunteers before the trial began.

Metabolife International, the largest maker of the ephedra diet pills, sponsored the study with other companies, and referred all questions about it to the researchers who conducted it. In a statement, Metabolife said its products were "safe and effective" when used as directed.

The chief researcher, Carol N. Boozer, a nutrition scientist at St. Luke's-Roosevelt Hospital Center in New York, did not respond to calls for comment yesterday. But in an interview last week, she said the six-month study represented the best science on the subject because it was the most extensive clinical trial ever done. She also said she believed the mix-up in the drugs involved relatively few participants and would not have affected the results.

Still, she acknowledged that the study had not proven that ephedra was safe for everyone, but only that healthy people seem to be able to safely lose weight if they do not exceed the recommended dosages.

"A lot of people would like me to say it's safe, and I'm not going to do that," she said in the interview. "I'm very careful what I say."

Industry lobbyists and some of their supporters in Congress have frequently cited the study in urging the drug agency to hold off on taking any action against ephedra.

Current and former agency officials said the ephedra companies have also been able to use the 1994 law as a shield to avoid regulation, particularly in beating back two efforts by the Clinton administration to restrict ephedra sales.

Given the age-old uses of many natural remedies, the law allows vitamins, health foods and herbal products to be sold, like foods, without prior safety testing, and does not require the companies to report consumer complaints or other safety data to the F.D.A. Instead, the law places the burden on the agency to prove that a dietary supplement is dangerous before it can take the product off the market.

Critics say that while most of the nutritional supplements appear to be safe, the law has placed the drug agency in a difficult legal hole when it comes to regulating powerful stimulants like ephedra, which acts like amphetamine in speeding up the body's metabolism and has been linked to heart attacks and strokes.

David A. Kessler, who was F.D.A. commissioner from 1990 to 1996 and who opposed the 1994 law, said it "tied the agency's hands" on substances like ephedra that, he said, are really drugs "masquerading as nutritional supplements."

"The problem is that the supplement industry doesn't have to report adverse events, so the F.D.A. doesn't have the data," Dr, Kessler said. "How do you prove something is unsafe if you don't have the data? It's the ultimate Catch-22. It's also a colossal failure of protecting the public health."

But Senator Orrin G. Hatch, the Utah Republican who is a chief sponsor of the 1994 law, responded, "It is extremely hard to take action if you never try." He said the agency had folded too quickly in its previous attempts to regulate ephedra. If it had gone further and actually imposed restrictions, he said, then the issue of whether the law works — "as I believe it can" — could have been settled in the courts.

Still, the political climate has changed since a Baltimore Orioles pitcher, Steve Bechler, 23, died on Feb. 17. The local medical examiner linked his death to weight-loss tablets with ephedra.

Two weeks after Mr. Bechler's death, Tommy G. Thompson, the secretary of health and human services, and Mark B. McClellan, the F.D.A. commissioner, proposed tough new labels to warn consumers about the dangers of ephedra, and the F.D.A. ordered a number of companies to stop advertising ephedra as a way to build muscles or enhance athletic performance, saying there was no scientific evidence for the claim.

Dr. McClellan added that once the agency finishes evaluating scientific data, probably later this summer, "we will take action." Whether that is likely to mean a ban on sales or new restrictions on the labels and marketing, is unclear.

F.D.A. officials said that at one point in mid-1990's, the industry seemed willing to compromise over ephedra and substantially lower the recommended dosages in the weight-loss pills. But when the agency proposed a rule in 1997 with still-lower dosage limits, the industry derided it as unscientific and criticized the agency for relying too much on anecdotes about deaths and illnesses.

The General Accounting Office, the investigative arm of Congress, later agreed with some of that criticism, which forced the drug agency to withdraw the proposal. A second agency effort to crack down also fizzled in late 2000.

At that time, agency officials said, they were also trying to gain access Dr. Boozer's study, which was similar in structure to the clinical trials used to test pharmaceutical drugs. But it involved far fewer people than most drug studies do.

Dr. Boozer said in the interview that she was reluctant to give any data to the F.D.A. before her article summarizing the study's results was published last year. Afterward, she said she was still hesitant because she did not trust the agency to analyze it in a "responsible way."

One drug agency reviewer, Dr. Richard Atkinson, editor of the International Journal of Obesity, which had published Dr. Boozer's article about the study, wrote to the F.D.A. that the study was "severely compromised" by the mix-up involving placebos and ephedra pills, which was discovered after the study was completed.

Dr. Boozer said she tested 326 leftover bottles, finding 5 incorrectly labeled. But Dr. Atkinson said the study should be redone because she was unable to account for the contents of about 1,200 other bottles.

 

[Rick Collins]

Today's NY Times story on yesterday's Ephedra hearing.
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July 24, 2003
Complaints and Support for Diet Pill at Congressional Hearing
By CHRISTOPHER DREW

ASHINGTON, July 23 — A nurse who used to work for Metabolife International, the country's largest seller of weight-loss pills containing the stimulant ephedra, told a House subcommittee today that he had taken 5 to 10 calls a day from customers complaining of side effects and that one-fifth of the callers had reported symptoms of cardiac problems.

"Some said their hearts were pounding in their chests right then," the nurse, Michael Vasquez, said, describing how he and nine co-workers had handled complaints on a toll-free line set up by Metabolife International, which is based in San Diego.

Mr. Vasquez worked for Metabolife for four months in 1999, and during that time, he said, he also took 10 calls from emergency room doctors who were trying to treat patients who had taken ephedra.

Mr. Vasquez's comments are important because the Justice Department is investigating the company's handling of the complaints in the late 1990's. Department officials have said they are trying to determine whether Metabolife's founder, Michael Ellis, lied when he told the Food and Drug Administration in 1998 that the company had never received notice of "any serious adverse health event" among users of Metabolife 356, its flagship product, which contains ephedra.

Mr. Ellis, along with a former Metabolife chief executive, David Brown, and the company's head nurse, Daniel Rodriguez, all refused to testify at the hearing today, invoking their Fifth Amendment right to avoid compelled self-incrimination.

K. Lee Blalack II, a lawyer for Mr. Rodriguez, said his client declined to testify because he was cooperating with Justice Department investigators. Mr. Blalack said Mr. Rodriguez has received immunity from prosecution.

The hearing, held by a subcommittee of the House Energy and Commerce Committee, came as the F.D.A. tries to decide whether to ban ephedra, an herbal stimulant similar to amphetamine that has been connected to a growing number of deaths and illnesses.

Russell Schreck, Metabolife's current chief executive, said at the hearing today that nothing had shaken "our firm belief in the safety and efficacy of our products."

The latest effort to crack down on the drug began after a 23-year-old Baltimore Orioles pitcher, Steve Bechler, died in February, and a medical examiner later linked his death to Xenadrine RFA-1, an ephedra product then made by Cytodyne Technologies.

The pitcher's parents, Ernie and Pat Bechler, also testified today, with Mrs. Bechler tearfully asking how many others "will have to die to prove these products are not safe?"

Cytodyne has since quit selling Xenadrine RFA-1, and the company is now known as Nutraquest Inc. Its president, Robert Chinery Jr., said that while "our hearts go out" to the Bechlers, he was confident that all the company's products are safe.

Several scientists criticized studies paid for by the dietary supplements industry, contending that, given the possible dangers, it would now be unethical to ask anyone to take ephedra as part of a clinical trial.

Documents released this week showed that experts hired by the F.D.A. had found shortcomings in a study led by Dr. Carol Boozer, a nutrition scientist at St. Luke's-Roosevelt Hospital Center in New York. Industry officials had promoted the study as suggesting that ephedra diet pills are safe.

Dr. Boozer testified today that she would not draw such a sweeping conclusion from her study, which studied their use only in healthy people. Asked if she would recommend the pills to any friend, she said, "I personally would not."

Representative James C. Greenwood, a Pennsylvania Republican who is the subcommittee chairman, also questioned the qualifications of some of the supplement company executives.

Robert Occhifinto, the president of NVE Pharmaceuticals of Newton, N.J., acknowledged that he had twice been convicted of federal crimes, including selling raw materials to a maker of illegal drugs, — and that his company had never employed a doctor or chemist in creating the ingredient formulas for its products.

 

[mikes]

Regarding Kiley Bechler law suit-

Its about people refusing to take responsibilities for their actions! If anyone should be sued its the Orioles for not monitoring his health situation more closely.
Heres the laundry list of health problems, that contridicted use of ephedra products, which this Steve Belcher had:

-Bodyweight at autopsy-320
-Previous bout with Heat Stroke (makes you much more likely for a reoccurance).
-Family history of heatstroke (death of brother).
-High blood pressure
-Liver problems
-Abnormal heart problems
-Unsafe diet (hadnt eaten solid food in 2 days).
-Wearing multiple layers of clothing in attempt to lose weight during excersise.

Where does this dumpy chinned, choppy haired bitch come up with $600million for a fatass who'd never in his dreams make the major leagues? I wouldnt give $600 for that slob! Roll the dice take your chances-even as the deck is stacked against you-you have noone to blame but yourself. Included are the fact that he exceeded the recommended doseage. I hope Cytodyne fights this lawsuit tooth and nails, instead of giving in and settling to avoid public backlash. I dont see how Cytodyne could lose-but then again look at the tobacco law suits. This is one fucked up country!

Also included as co-defendants is the unnamed place which fatso bought the Xenedrine. So now everyone will be afraid to sell it (rightfully so). Fucking bullshit.

I can see now I will be calling a talk-radio station, when some dumbass journalist gets started spouting off the bullshit on this one.

 

[ROID WARRIOR]

"Also included as co-defendants is the unnamed place which fatso bought the Xenedrine. So now everyone will be afraid to sell it (rightfully so). Fucking bullshit."

This is a products liability case. A plaintiff need not prove negligence. Section 402A of the Second Restatement of Torts allows Plaintiffs to sue anyone in the chain of distribution. In fact, an entire judgement could be collected from the retailer or distributor who did nothing more than resell the product.

RW

 

[ROID WARRIOR]

Witnesses call for greater regulation of ephedra
Congressional hearing examines dietary supplement's safety
Thursday, July 24, 2003 Posted: 1:08 PM EDT (1708 GMT)



The debate over the herbal supplement ephedra heated up after pitcher Steve Bechler died February 17.

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WASHINGTON (AP) -- Major league baseball should not ban dietary supplements containing ephedra unless the government does, an official of the players' union testified Thursday to lawmakers looking into health problems related to the herbal stimulant.

The issue is particularly relevant to baseball because of the death in February of Baltimore Orioles pitcher Steve Bechler, who was taking a supplement with ephedra.

"The position of the players' association has long been that players should not be prohibited from using any substances that the United States government has effectively determined are not unsafe for consumption by other American consumers," said Eugene Orza, associate general counsel of the Major League Baseball Players Association.

Following Bechler's death, Baseball Commissioner Bud Selig banned players with minor league contracts from taking ephedra but did not prohibit major leaguers from using the stimulant.

Robert Manfred Jr., an executive vice president of major league baseball, explained Selig's decision, saying the players' union would not agree to ban any substance that could be purchased over the counter.

Other sports leagues do ban ephedra and test players to make sure they are not using the product. They include the National Football League and Major League Soccer, both of which sent representatives to Thursday's hearing before the House panel.

They planned to call for more government regulation of ephedra.

"By taking decisive action, Congress can address many of the concerns related to the use of ephedrine by its constituency," said Adolpho A. Birch III, the NFL's counsel for labor relations.

Athlete's parents testify
Ephedra, which can be used to lose weight and boost athletic performance, has been linked to as many as 100 deaths. Health problems linked to the drug include strokes, heart attacks and seizures.

A 1994 law left dietary supplements largely unregulated. The Food and Drug Administration has said the statute prevents it from banning such products.

Health and Human Services Secretary Tommy Thompson said Wednesday that makers of dietary supplements should have to tell the FDA about potential side-effects, just as drug makers do. He urged Congress to revise the 1994 law.

"FDA is somewhat hampered," Thompson said. "We are unable to really do as effective a job as possible."

Scientists, health officials and the parents of two people who died after taking ephedra told the House panel Wednesday that the FDA should classify ephedra as a prescription drug, to be dispensed only when a doctor approves.

"Ephedrine products are not dietary supplements," said Dr. Raymond Woosley, vice president for health sciences at the University of Arizona. "They are drugs, and they should be regulated as drugs."

Manufacturers of ephedra insisted their products were safe.

"Ephedra supplements have been used by tens of millions of people in recent years," said Robert Chinery Jr., president of Nutraquest Inc., formerly Cytodyne Technologies Inc.

Bechler's parents, Ernie and Pat Bechler, and Kevin Riggins, whose 16-year-old son, Sean, died of a heart attack after taking ephedra, blamed the stimulant for the deaths.

"How many Steve Bechlers or Sean Rigginses have to die to prove that these are not safe?" Mrs. Bechler said, sitting behind a framed picture of her son in his Orioles uniform, her voice cracking. "We need to get this off the market. We need to help our children."

Also at Wednesday's hearing, three past or present Metabolife International officials took the Fifth Amendment and declined to testify. The San Diego-based company makes supplements that include ephedra.

The Justice Department is investigating whether the company lied about ephedra's safety. The president of the company in 1998 told the FDA that the firm had never received any consumer complaints of serious side effects, but later turned over more than 14,000 records of calls from ephedra consumers with concerns about health-related issues.

 

[plethos]

Back in high school not knowing the specifics of ephedra I used to take some before a wrestling match believing it would hopefully give me some more stamina. Afterall, what it was marketed as is an energy enhancer. Now I was 16-17, in perfect physical shape and health, but I would take more than recommended and right before a very physically draining match this caused a few problems sometimes. I remember my heart pounding in my chest after a couple matches and just resting trying to figure out what was going on. Well, needless to say I didn't know exactly how ephedra worked and using it in the manner I did was loony. I can see how someone who was a bit older and not in shape could suffer a life threatening heart attack if not using it in the right way. I think this is why some people want it banned- because people have had such problems, some of them maybe not even misusing it. Now I'm personally conflicted on the matter. I believe the risk is so low and benefits so great of this herb that it shouldn't be banned. But I can see how some people who don't fully appreciate it's mild fat burning qualities (namely old, fat, pencil pushing lawmakers) to believe it's not worth the risk of those very few people having physical problems with it. But tobacco, caffiene, alcohol, and birth control pills- sure, everybody's all for that.

 

[ROID WARRIOR]

From Sports Illustrated. I would imagine that any action against the team will be dismissed on the grounds that they are the employer, and as such, Worker's Comp is the only remedy. Interestingly, ephedra was not tested for and not implicated in Stringer's death.

RW


MINNEAPOLIS (AP) -- An attorney for Korey Stringer's widow said she will sue the NFL on Monday, alleging that the league's policies led to Stringer's heat stroke death during Minnesota Vikings training camp in 2001.

Stan Chesley said Kelci Stringer's suit would also name football helmet maker Riddell Sports Group Inc., and some NFL medical advisers. He said the federal lawsuit would include a wrongful death claim on behalf of Stringer's widow and son, and a class action claim on behalf of all NFL players.

"What's on trial here is the rules and procedures and the culture" of the NFL, Chesley said Saturday. "Frankly, it's no coincidence that the average football player in the NFL plays for 4 1/2 years. They use them up and spit them out."

Chesley declined to say publicly where the lawsuit would be filed. The planned suit was first reported by The New York Times.

Stringer collapsed during training camp on July 31, 2001, in sweltering heat and humidity. The 335-pound Pro Bowl lineman's body temperature was 108.8 degrees when he arrived at a hospital. He died 15 hours later.

Phone messages left by The Associated Press with an NFL spokesman and Riddell were not immediately returned.

Kelci Stringer had already filed a $100 million wrongful-death lawsuit against the Vikings and the team's training camp physician, David Knowles. In April, a Hennepin County District Court judge dismissed Kelci Stringer's claims against the team. She later settled with Knowles for an undisclosed sum.

Her attorneys said at the time they planned to ask the state appeals court to reinstate the claims against the Vikings.

Chesley said the issues in the new lawsuit are different. The suit against the team stumbled because the law limits how much Stringer's widow could get from his employer, the Vikings. Chesley said that while the league does not employ the players, it sets the procedures for the mandatory training camps.

Chesley said the league wanted a 335-pound player like Stringer but then did little to protect him in the heat that led to his death. He said the lawsuit is designed to change that.

The NFL has said it has already made changes.

Before training camp opened in 2002, the NFL consulted with several experts and held a series of discussions and seminars on the subject. The league banned the herbal stimulant ephedra and began random testing for it last summer after learning that dietary supplements increased the risk of heat-related illnesses.

A bottle of Ripped Fuel, which contains ephedra, was found in Stringer's locker after he died, though Stringer's remains weren't tested for the substance during investigations of his death.