Los Angeles Times

Bitter pill from Hatch’s legacy

- MICHAEL HILTZIK

Sen. Orrin G. Hatch (RUtah) last made a public splash during the debate over the GOP’s tax cut bill in December, when he threw a conniption over the suggestion that the bill would favor the wealthy (who will reap about 80% of its benefits by 2027).

Hatch subsequent­ly announced his retirement from the Senate as of the end of this term, writing finis to his 40 years of service. In that time, he has shown himself to be a master of the down-is-up, wrong-is-right method of obfuscatin­g his favors to rich patrons. That was especially the case with his sedulous defense for 23 years of his deadliest legislativ­e achievemen­t.

We’re talking about the Dietary Supplement Health and Education Act of 1994, or DSHEA (pronounced D-shay). Hatch introduced DSHEA in collaborat­ion with then-Sen. Tom Harkin (D-Iowa), but there was no doubt that it was chiefly his baby. The act all but eliminated government regulation of the dietary and herbal supplement­s industry. Henceforth, the Food and Drug Administra­tion could not block a supplement from reaching market; the agency could take action only if it learned of health and safety problems with the product after the fact.

In other words, supplement­s were assumed to be innocent until proven guilty. The obvious problem is that the proof often takes the form of death among users. The harvest has been a

public health disaster.

In 2013, for example, Hawaii health authoritie­s discovered seven cases of acute hepatitis and liver failure among users of a supplement known as OxyElite Pro that had slipped easily through DSHEA’s porous regulatory screen. By February 2014, the Centers for Disease Control and Prevention had linked 47 hospitaliz­ations, three liver transplant­s and one death to the diet product. Eventually it was taken off the market.

The Government Accountabi­lity Office found the marketing of herbal supplement­s, especially to the elderly, to be rife with deceptive and dangerous advice; marketers were heard assuring customers that their products could cure disease and recommendi­ng combinatio­ns that were medically hazardous. The FDA told the GAO that, yes, those marketers shouldn’t be saying these things, and they’d get right on it.

DSHEA did more than prevent the FDA from regulating convention­al supplement­s, which provide essential nutrients not available from someone’s normal diet. As Stephen Barrett, who writes the authoritat­ive Quackwatch blog, observed, it added to the privileged group “vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrat­e, metabolite, constituen­t, extract, or combinatio­n of any such ingredient­s.”

DSHEA is the source of what’s often been called the “quack Miranda warning.” You’ve probably seen it on websites or labels from businesses hawking supplement­s or treatments that have no known grounding in science. At StemGenex, a clinic offering supposed stem-cell therapies for conditions such as multiple sclerosis and Parkinson’s, the website disclaimer states that its treatment “is not a part of FDA approved stem cell therapies and is not a considered a cure for any medical condition.” (What are you paying for, then?)

Herbalife, perhaps the nation’s leading marketer of nostrums covered by DSHEA, claims that its Niteworks product, to choose just one example, will “help the body create more life supporting nitric oxide,” which “supports healthy blood pressure levels already within a normal range and blood vessel elasticity,” and will also help “support a healthy cardiovasc­ular system.” These statements are marked with asterisks that refer to this line: “These statements have not been evaluated by the Food and Drug Administra­tion. This product is not intended to diagnose, treat, cure or prevent any disease.”

You get the picture. “DSHEA was created specifical­ly to allow these companies to make claims that would otherwise be of questionab­le legality,” Dr. Peter Lipson, an assiduous pursuer of bogus medical claims, observed back in 2009. “DSHEA, as it was written and as it was intended, facilitate­s the legal marketing of quackery.”

When the FDA comes calling to say, “You’re illegally marketing cures for disease,” the businesses can respond, “No, we’re not — it says right here that we’re not curing anything.”

Orrin Hatch’s upsidedown defense of his noxious offspring has been that DSHEA actually enhanced public safety. That was the headline version, as he put it in a 2014 speech marking DSHEA’s 20th anniversar­y — delivered (where else?) at a dietary supplement industry conference. Amazingly, he claimed that “DSHEA establishe­d a rational framework for the regulation of dietary supplement­s.”

But one didn’t have to drill down too deeply in the speech to discern what really drove the law’s enactment. It wasn’t the desire for “rational regulation,” but that most common political drug of all, money. The dietary supplement industry had set up shop in Hatch’s home state and plied him with pantsfuls of campaign cash; in 2010, for instance, Utah-based Xango LLC, which markets dietary supplement­s among other products, was Hatch’s second-biggest contributo­r. (Herbalife ranked third.) Hatch’s son, Scott, has worked as a lobbyist for the industry.

Thanks to DSHEA, the supplement­s industry grew from $9 billion in 1994 to more than $50 billion today. In Utah alone, it’s worth more than $7 billion.

Over the years, Hatch pulled out all the stops to make sure no one ever messed with his DSHEA, fighting off even Sen. John McCain (R-Ariz.), who tried in 2010 to enact a law mandating reports on illnesses associated with supplement use. McCain backed down.

Hatch’s defense has been so valuable that the supplement industry is now fretting over who will have the power and vigor to take his place in Congress. The industry probably shouldn’t worry. As his lasting legacy, Hatch has made it so rich that it won’t have any problem finding senators and members of Congress to take their money to serve their interest, the public be damned.

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 ?? Carolyn Kaster Associated Press ?? SEN. ORRIN G. HATCH plans to retire this year. The Dietary Supplement Health and Education Act of 1994 was his baby. The act all but eliminated government regulation of the dietary and herbal supplement­s industry.
Carolyn Kaster Associated Press SEN. ORRIN G. HATCH plans to retire this year. The Dietary Supplement Health and Education Act of 1994 was his baby. The act all but eliminated government regulation of the dietary and herbal supplement­s industry.

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