Ephedra and The best Senator money can buy?

March 5, 2003

This article appeared in today's LA Times. I think the issue here is

more than Ephedra. The FDA can't regulate dietary supplements

because Hatch (and a few others, if memory serves me correctly) have

protected the dietary supplement industry. In terms of the chemical

changes produced in the body, there's really no difference between

a " dietary supplement " and a drug. What this means to everyone on

this list is that we're on our own. We have to research dietary

supplements because our government can't and won't protect us. I've

had a fairly high opinion of Orrin Hatch, so his role in this

situation is especially disturbing to me.

BTW, you have to register to get the fulltext of the LA Times, but

it's free. I think it offers good information about health and

nutrition, and I think it's worth the trouble to register.

March 5, 2003

Senator, His Son Get Boosts From Makers of Ephedra

Orrin Hatch has kept regulators at bay and benefited via campaign

donations. Lobbyists linked to his son have received $2 million.

By Chuck Neubauer, Judy Pasternak and T. , Times Staff

Writers

WASHINGTON -- For more than a decade, the dietary supplements

industry has counted on Sen. Orrin G. Hatch to fend off tighter

regulation of products such as ephedra, the controversial stimulant

linked to more than 80 deaths — most recently a young Baltimore

Orioles baseball player.

Among other things, the Utah Republican co-wrote the 1994 law that

lets supplement makers sell products without the scientific premarket

safety testing required for drugs and other food additives. That law

has proved a major obstacle to federal control of ephedra.

For its part, the supplements industry has not only showered the

senator with campaign money but also paid almost $2 million in

lobbying fees to firms that employed his son .

From 1998 to 2001, while Hatch worked for a lobbying firm with

close ties to his father, clients in the diet supplements industry

paid the company more than $1.96 million, more than $1 million of it

from clients involved with ephedra.

Since Hatch opened his own lobbying firm last year in

partnership with two of his father's close associates, the firm has

received at least $30,000 in retainers from a supplements industry

trade group and a major manufacturer of ephedra. Both clients came

from the old firm.

Sen. Hatch said the new firm, , & Hatch, was formed with

his personal encouragement. He said he sees no conflict of interest

in championing issues that benefit his son's clients. Neither Senate

rules nor federal laws forbid relatives from lobbying members of

Congress.

" I would have no qualms talking to " about his clients, Hatch

said in an interview. " I wouldn't do anything for him that wasn't

right. "

The debt owed to the senator by the makers of diet supplements comes

close to being unique. Supplements, like prescription drugs, belong

to a relatively small category of products for which federal laws and

regulations are the defining factor in a whole industry's business

equation.

And since at least 1992, Sen. Hatch — along with Sen. Tom Harkin (D-

Iowa), co-author of the 1994 law — has played a decisive role in

helping the industry fend off restrictive oversight by the Food and

Drug Administration.

Indeed, the Hatch-Harkin act defined dietary supplements as a special

category outside drugs and other food additives, and did so in a way

that has helped supplements mushroom into what the Nutrition Business

Journal says is an industry with $17.7 billion in annual U.S. sales.

Many of the companies are based in Utah, which describes itself

as " the Silicon Valley of the supplements industry. "

Before the 1994 legislation, the FDA would classify supplements as

either food additives or drugs on a case-by-case basis. It had taken

at least four supplements off the market because they had not been

proved safe.

The Hatch-Harkin law shifted the burden of proof, requiring the FDA

to make the case that each supplement was unsafe — and preventing the

agency from holding the product off the market until tests were

completed.

On Friday, federal officials reopened consideration of steps to

increase regulation of ephedra — including a warning label pointing

to the possible risk of heart attack, stroke and death, as well as a

ban on advertising that suggests ephedra could enhance physical or

athletic performance.

The FDA also raised the question of whether it had sufficient

authority to regulate diet supplements effectively.

Based on an Asian herb called ma huang, ephedra is sold as an aid to

bodybuilding, enhanced physical performance and weight loss.

Sometimes called " legalized speed " because of its power as a

stimulant, ephedra has been widely used by athletes, despite reports

linking it to heart attacks, strokes and other severe medical

problems.

Most recently, it has been cited as a possible contributing factor in

the death of 23-year-old Orioles pitcher Steve Bechler on Feb. 17. It

was also reported as a possible factor in the training camp death of

Minnesota Vikings football player Korey Stringer in 2001.

In all, ephedra has been cited as a possible factor in more than 80

deaths nationwide, a contention the supplements industry vigorously

disputes.

Yet the history of efforts to rein in ephedra — which is stringently

regulated by the FDA when used in prescription and over-the-counter

medicines — illustrates how difficult that is to do, given the terms

of the Hatch-Harkin law.

On Friday, as the government announced its proposed new crackdown,

Sen. Hatch issued a statement chiding the FDA for being slow to act

against a known hazard.

" It has been obvious to even the most casual observer that problems

exist, " his statement said, calling the FDA's action " long overdue. "

" As one of the lead authors of the law governing the regulation of

dietary supplements, I have long been concerned that the agency was

not seriously enforcing the Dietary Supplement Health and Education

Act, " Hatch added, referring to the law commonly known as the Hatch-

Harkin act.

In 1999, however, when the FDA was trying to reduce the recommended

dosage of ephedra in response to accumulating evidence of health

risks, Hatch was in the vanguard of industry supporters who

challenged the agency. He was joined by Harkin, who sits on the

Senate subcommittee that controls FDA budget appropriations.

In a letter to the FDA, the two senators questioned the scientific

basis for the agency's proposal to reduce the recommended single

dosage to 8 milligrams. Some states allowed as much as 25 milligrams.

The FDA said then it had received more than a dozen reports of

possible ephedra-related problems, ranging from heart attacks and

arrhythmia to strokes, psychotic episodes, dizziness and skin rashes.

It also relied on studies and advice from a range of experts, the

agency said.

Hatch and Harkin questioned whether the number of problems reported

were sufficient to warrant action, when measured against the billions

of doses consumed by users of products containing ephedra.

The pair also decried the incomplete nature of some of the incident

reports, which came from users, doctors and other sources.

The kind of detailed scientific data Hatch and Harkin were insisting

on is routinely compiled during premarket tests and clinical trials

conducted before prescription medicines are allowed on the market.

In the face of those challenges and a lobbying blitz by the industry,

the FDA backed down.

At the time, Hatch's son worked for Parry and Romani Associates Inc.,

the lobbying firm headed by the late Tom Parry, a former senior aide

to Sen. Hatch.

Before being hired at Parry and Romani, Hatch, now 41, had

finished college and worked as a government clerk in Washington. At

Parry and Romani, he worked his way up to lobbyist.

Among others, Parry and Romani had been hired by New York-based Twin

Laboratories Inc., a manufacturer of products containing ephedra, to

lobby Congress and the FDA " regarding ephedra products. "

The firm had also been hired by the National Nutritional Foods Assn.,

a major trade group representing the diet supplements industry, to

lobby on supplement regulation, including ephedra.

Last year, Hatch opened his own lobbying firm with Jack ,

a veteran of Sen. Hatch's Senate staff and a former diet supplements

lobbyist at Parry Romani. Laird , another longtime associate of

the senator, became the third partner.

One of the first clients to sign up was the National Nutritional

Foods Assn., which paid the fledgling firm $20,000 through the first

half of 2002.

The foods association particularly asked the firm to lobby on behalf

of ephedra and other supplement issues. The firm lobbied the Senate,

the House, the executive office of the president and the FDA on the

organization's behalf.

Kim , the association's legislative director, said the

Hatch firm was hired because of , not because

Hatch was the senator's son.

Twin Laboratories, called Twinlab on its labels, also left Parry and

Romani to sign up with the new firm last year. The firm was paid

$10,000 for three months of work on ephedra and other issues.

Twinlab was one of 24 companies that received a warning letter from

the FDA last week on their products containing ephedra. Those include

its Diet Fuel, Ultimate Diet Fuel and Energy Fuel.

Several months ago, as the controversy grew, the company decided to

stop making ephedra products.

The payments from Twinlab were reported on the firm's lobbying

disclosure forms, covering the first six months of 2002.

It is not known what further payments may have been made because year-

end reports have not been released.

Hatch said he does not lobby his father directly, leaving that

to his partners. said he has handled the dietary supplement

account.

The firm is being paid to monitor regulatory and legislative activity

that might affect ephedra and other supplement issues, he said.

Sen. Hatch said in an interview that he has met frequently with

to discuss dietary supplements.

" Jack worked with the FDA and has been very active in the

dietary supplements area. And of course, I am the author of the

dietary supplement authorization act, " he said. " Naturally, he has

been in and out of the office on those issues. Quite a bit. "

Industry payments to Hatch and his partners represent only part

of the supplements industry's total lobbying budget.

Hatch may be the foremost defender of the diet supplements industry

in Congress.

" I have taken dietary supplements almost my entire adult life and can

attest to the benefits they provide, " he wrote in his memoirs.

He has received nearly $137,000 in campaign contributions from the

supplements industry over the last decade, according to the Center

for Responsive Politics. It based its figures on government reports.

In addition to the contributions to the senator and lobbying fees to

his son's firms, the supplements industry has given Sen. Hatch its

Congressional Champion award and a lifetime achievement citation.

Harkin, another regular supplements user, received $119,242 from the

supplements industry from 1993 to 2002.

March 5, 2003