Du­bi­ous Doses

Newsweek - - NEWS - BY RICK SCHMITT @Fair­warn­ingnews

A FEW YEARS ago, mo­ti­vated by a fam­ily his­tory of de­men­tia, Bea Pena-reames be­gan us­ing a di­etary sup­ple­ment that promised im­proved mem­ory and brain health. It was ad­ver­tised as safe and ef­fec­tive—but that was not her ex­pe­ri­ence. “I’m typ­i­cally a joy­ful per­son, but I couldn’t shake this de­pres­sion and in­tense sense of sad­ness,” says Pena-reames, a for­mer high school bi­ol­ogy teacher who lives in north Texas. “I was get­ting an­gry at the drop of a hat.”

Loosely reg­u­lated di­etary sup­ple­ments of the sort Pena-reames took have found a rich vein of ac­cep­tance among mid­dle-age and older Amer­i­cans in­creas­ingly wor­ried about los­ing their

men­tal acu­ity. Thanks to health­ier life­styles and ad­vances in treat­ment for some can­cers, heart dis­ease, stroke and di­a­betes, peo­ple are liv­ing longer. But some also are liv­ing long enough to face the scourge of brain-wast­ing dis­eases such as Alzheimer’s, and they’re look­ing for help.

That of­ten-des­per­ate pur­suit of reme­dies has cre­ated a lu­cra­tive mar­ket­ing op­por­tu­nity. Prod­ucts aimed at con­sumers wor­ried about brain health and mem­ory have con­trib­uted to a more than ten­fold in­crease in the num­ber of sup­ple­ments mar­keted in the U.S. over the past two decades. It’s not known ex­actly how much of that in­crease is due to health and mem­ory sup­ple­ments, but re­tail­ers on the in­ter­net and at the mall are brim­ming with sup­posed brain-boost­ing op­tions.

Much of that growth has been fu­eled by mar­ket­ing that may be ex­ploit­ing the fears of some of so­ci­ety’s most vul­ner­a­ble peo­ple. The Govern­ment Ac­count­abil­ity Of­fice is in­ves­ti­gat­ing the mar­ket­ing of brain and mem­ory sup­ple­ments and the prob­lems reg­u­la­tors face in rein­ing in mis­lead­ing claims. The GAO ex­am­i­na­tion was re­quested by Sen­a­tor Claire Mc­caskill (D-MO.), for­merly the rank­ing mi­nor­ity mem­ber on the U.S. Se­nate Com­mit­tee on Ag­ing. She has called out re­tail­ers for de­cep­tive pro­mo­tions of mem­ory and brain sup­ple­ments, and sees reg­u­la­tory over­sight of the sup­ple­ment in­dus­try as “alarm­ingly in­ad­e­quate.”

On Jan­uary 9, U.S. and New York state au­thor­i­ties sued one of the na­tion’s largest sell­ers of brain sup­ple­ments, Quincy Bio­science of Madi­son, Wis­con­sin, al­leg­ing that the com­pany made false and un­sub­stan­ti­ated claims about its flag­ship prod­uct, Pre­vagen. “The mar­keters of Pre­vagen preyed on the fears of older con­sumers ex­pe­ri­enc­ing age-re­lated mem­ory loss,” Jes­sica Rich, di­rec­tor of the Fed­eral Trade Com­mis­sion’s con­sumer pro­tec­tion bureau, said in a pre­pared state­ment. “Yet de­spite the de­fen­dants’ claims, there is no sci­en­tific proof that use of the prod­uct will im­prove mem­ory or pro­vide any other cog­ni­tive ben­e­fit.”

In Septem­ber, the U.S. Food and Drug Ad­min­is­tra­tion pro­posed to ban the sup­ple­ment that Pena-reames took, vin­poce­tine (pro­nounced vinPoe-suh-teen). The FDA said the prod­uct was syn­the­sized in a lab­o­ra­tory and thus failed to meet the le­gal def­i­ni­tion of a di­etary sup­ple­ment—that it con­sists only of nat­u­ral in­gre­di­ents. But the pro­duc­tion method should have been known to the agency nearly two decades ear­lier, when sev­eral com­pa­nies made reg­u­la­tory fil­ings say­ing they were go­ing to mar­ket the sup­ple­ment. The pro­posed ban comes after tens of mil­lions of dol­lars of the prod­uct have been sold to the pub­lic.

Un­der the law, man­u­fac­tur­ers and dis­trib­u­tors also are barred from say­ing their sup­ple­ments can cure dis­eases like de­men­tia. But the dis­play and con­text of the mes­sages com­ing from many re­tail­ers at least in­sin­u­ates as much. A Lex­ing­ton, Vir­ginia, com­pany, Green Val­ley Nat­u­ral So­lu­tions, has been pro­mot­ing a 12-part video series, “Awak­en­ing From Alzheimer’s,” with tips for “what you can do to­day to halt and re­verse Alzheimer’s and de­men­tia.” Among the sug­ges­tions: Pur­chase the video series for $319 along with sup­ple­ments the com­pany sells, prod­ucts with names like “Ad­vanced Brain Power” and “Max­i­mum Mem­ory Sup­port.”

A New Zealand com­pany, Xtend-life, mar­kets a sup­ple­ment called Neuro-nat­u­ral Re­call, and it has an ar­ti­cle on its web­site about treat­ments for Alzheimer’s and de­men­tia and how a “pow­er­house” in­gre­di­ent in Neuro-nat­u­ral Re­call can help.

A spokes­woman for Xtend-life says the com­pany was re­vis­ing the ar­ti­cle to make it clear that “while we be­lieve that this prod­uct can be ef­fec­tive at sup­port­ing mem­ory func­tion, we do not claim to mit­i­gate, treat or cure de­men­tia or Alzheimer’s, which is very dif­fer­ent.” Green Val­ley did not re­spond to re­quests for com­ment.

‘DON’T AS­SUME SOME­THING WORKS’

Ex­perts say that there is no sim­ple so­lu­tion for treat­ing de­men­tia and that sell­ers do a grave dis­ser­vice to the pub­lic by sug­gest­ing oth­er­wise.

GREEN VAL­LEY NAT­U­RAL SO­LU­TIONS HAS TIPS FOR “WHAT YOU CAN DO TO HALT AND RE­VERSE ALZHEIMER’S AND DE­MEN­TIA.”

Some of these ex­perts say that while sup­ple­ments may not cause wide­spread phys­i­cal harm or in­jury, they can end up be­ing a huge waste of money. “You have peo­ple who are mak­ing some pretty spec­tac­u­lar claims, and you also have a large co­hort of peo­ple who want to find an an­swer,” says Ruth Drew, di­rec­tor of fam­ily and in­for­ma­tion ser­vices for the Alzheimer’s As­so­ci­a­tion. “I think we would all love to have that sil­ver bul­let. We just don’t see that.… The sci­ence is just not that far along.”

The in­dus­try has en­joyed ex­plo­sive growth since 1994, when Congress en­acted the Di­etary Sup­ple­ment Health and Ed­u­ca­tion Act. It al­lowed sup­ple­ments to be sold to the pub­lic with­out the ex­ten­sive test­ing and FDA ap­proval re­quired for drugs. At the time, the FDA was crack­ing down on sales of un­ap­proved drugs, con­duct­ing well-pub­li­cized raids. Among the tar­gets: the Life Ex­ten­sion Foun­da­tion, a Fort Laud­erdale, Florida, com­pany that bankrolls anti-ag­ing re­search and a hu­man cry­on­ics fa­cil­ity.

The raids be­came a touch­stone in the de­bate that led to the adop­tion of the sup­ple­ment law. In sign­ing the bill into law, Pres­i­dent Bill Clin­ton called the leg­is­la­tion a “com­mon sense” so­lu­tion to the reg­u­la­tion of sup­ple­ments.

To­day, sales of di­etary sup­ple­ments in the U.S. to­tal an es­ti­mated $37 bil­lion a year, and the num­ber of sup­ple­ments on the mar­ket has shot up from 4,000 to more than 55,000, ac­cord­ing to the FDA. Many hun­dreds of sup­ple­ments prom­ise brain and mem­ory en­hance­ment. GNC, the giant re­tailer of health and nu­tri­tion aids, lists more than 350 prod­ucts on its web­site with the word brain and some 130 with the word mem­ory.

Since the mid-1990s, the in­dus­try has also be­come a po­lit­i­cal power, spend­ing $44.1 mil­lion to lobby law­mak­ers and fed­eral agen­cies. An ad­di­tional $24.5 mil­lion went to fed­eral can­di­dates, party com­mit­tees and out­side spend­ing groups, in­clud­ing $9.2 mil­lion in the 2016 elec­tion cy­cle, ac­cord­ing to the non­profit Cen­ter for Re­spon­sive Pol­i­tics. Among in­dus­try cham­pi­ons: Sen­a­tor Or­rin Hatch (R-utah), an orig­i­nal spon­sor of the 1994 sup­ple­ment bill, who has re­ceived $413,237 in cam­paign con­tri­bu­tions from the in­dus­try since the law was en­acted.

With such in­flu­ence, the in­dus­try has had its way in­side the Belt­way, thwart­ing pe­ri­odic calls for reg­u­la­tion to put more in­for­ma­tion about risks and side ef­fects on sup­ple­ment la­bels. In the courts, the in­dus­try has de­feated ef­forts by reg­u­la­tors to re­quire more sci­en­tific proof be­fore sup­ple­ments can be mar­keted to the pub­lic.

It is fur­ther aided by some well-con­nected lead­er­ship. Daniel Fabri­cant, a for­mer head of the FDA’S sup­ple­ment di­vi­sion, is now CEO of the in­dus­try’s lead­ing trade group, the Nat­u­ral Prod­ucts As­so­ci­a­tion.

Agen­cies that are sup­posed to ex­er­cise over­sight of­ten find them­selves over­matched. The Fed­eral Trade Com­mis­sion, which mon­i­tors the in­dus­try for false ad­ver­tis­ing, has but 20 peo­ple track­ing all of the di­etary sup­ple­ments sold in the U.S. “I am the first one to say, ‘Don’t as­sume some­thing works just be­cause it is on the mar- ket,’” says Rich Cle­land, the as­sis­tant di­rec­tor in charge of the FTC ad­ver­tis­ing bureau. “There are just so many [di­etary sup­ple­ments], it is im­pos­si­ble un­der this type of reg­u­la­tory scheme to look at ev­ery­thing.”

The few cases reg­u­la­tors bring don’t do much to pro­tect con­sumers. In 2015, as part of a set­tle­ment in U.S. District Court in Los An­ge­les, the FTC won a $1.4 mil­lion civil penalty from the mar­keters of Pro­cera AVH, which once claimed the sup­ple­ment could re­store up to 15 years of lost mem­ory in 30 days. By the time reg­u­la­tors got on the case, how­ever, Pro­cera had racked up nearly $100 mil­lion in sales, the FTC al­leged. Pro­cera is still sold, although the cur­rent owner, Keyview Lab­o­ra­to­ries of Tampa, Florida, says it has re­vamped its mar­ket­ing prac­tices and ex­ec­u­tive team.

Ac­cord­ing to the fed­eral law­suit filed by the

EX­PERTS SAY THAT WHILE SUP­PLE­MENTS MAY NOT CAUSE WIDE­SPREAD PHYS­I­CAL HARM OR IN­JURY, THEY CAN END UP BE­ING A HUGE WASTE OF MONEY.

FTC and the New York state at­tor­ney gen­eral, Quincy has sold more than $165 mil­lion of Pre­vagen since 2007. Ac­cord­ing to the com­plaint, bot­tles of 30 reg­u­lar-strength tablets of Pre­vagen have re­tailed for up to $58.53.

The suit fol­lows more than a year of com­plaints from con­sumer groups that the com­pany has falsely stated that clin­i­cal stud­ies have shown Pre­vagen im­proves hu­man mem­ory. It also says the com­pany’s claims ig­nored the fact that the main in­gre­di­ent is di­gested be­fore it could af­fect the brain. “It is bi­o­log­i­cally in­con­ceiv­able that tak­ing a pro­tein [like Pre­vagen] by mouth would have any ef­fect on mem­ory,” says David Seres, di­rec­tor of med­i­cal nu­tri­tion and as­so­ci­ate pro­fes­sor at Co­lum­bia Univer­sity Med­i­cal Cen­ter. Seres eval­u­ated Quincy’s claims for Truth in Ad­ver­tis­ing Inc., a Madi­son, Con­necti­cut, non­profit ad­vo­cacy firm that filed a com­plaint with the FTC about Pre­vagen in Septem­ber 2015.

In a state­ment, com­pany of­fi­cials said they “ve­he­mently dis­agree” with the al­le­ga­tions in the law­suit, which they said was “an­other ex­am­ple of govern­ment over­reach and reg­u­la­tors ex­tin­guish­ing in­no­va­tion by im­pos­ing ar­bi­trary new rules on small busi­nesses.”

The FDA has been in a bat­tle with Quincy, which has touted the fact that the key in­gre­di­ent in Pre­vagen was dis­cov­ered in a rare jel­ly­fish. In fact, the com­pany makes the in­gre­di­ent in a lab, be­cause har­vest­ing enough jel­ly­fish would be un­eco­nom­i­cal and might lead to toxic side ef­fects, the com­pany says in a patent ap­pli­ca­tion de­scrib­ing the process.

In a 2012 warn­ing let­ter, the FDA al­leged that the com­pany was in ef­fect sell­ing an un­ap­proved drug rather than a sup­ple­ment, which un­der the law is re­quired to be all-nat­u­ral or found in the hu­man diet. The FDA also chal­lenged tes­ti­mo­ni­als on a com­pany web­site claim­ing Pre­vagen cured Alzheimer’s and iden­ti­fied more than 1,000 ad­verse events like seizures and strokes that Quincy had failed to re­port to reg­u­la­tors. The com­pany took down the of­fend­ing claims from its web­site and over­hauled its reg­u­la­tory re­port­ing, but it has de­clined to com­ment on the FDA in­quiries. The FDA also de­clined to com­ment, say­ing Quincy was in­volved in “an open com­pli­ance mat­ter.”

The 1994 sup­ple­ment law’s main jus­ti­fi­ca­tion was that sup­ple­ments, found in na­ture, are more like food than drugs and should re­quire less reg­u­la­tory over­sight. The hope was that the pub­lic would ben­e­fit from the avail­abil­ity of cheaper

al­ter­na­tives to tra­di­tional drugs.

But con­sumer or­ga­ni­za­tions say that the in­dus­try has harmed con­sumers by ag­gres­sively stretch­ing fed­eral rules for di­etary sup­ple­ments and that the FDA has done lit­tle to stand in its way. Un­der the law, for ex­am­ple, com­pa­nies must no­tify the FDA if they plan to use new in­gre­di­ents in their prod­ucts. But the FDA says there may be vast num­bers of in­gre­di­ents that have not been prop­erly dis­closed.

The FDA’S han­dling of vin­poce­tine, the sup­ple­ment Pena-reames took and a pop­u­lar treat­ment for stroke vic­tims in Europe and Asia, also raises ques­tions about over­sight. Vin­poce­tine gained no­tice in the U.S. in the 1980s as a pos­si­ble treat­ment for Alzheimer’s and de­men­tia. Clin­i­cal tri­als were in­con­clu­sive, and vin­poce­tine was never cleared for sale as a drug. In the late 1990s, how­ever, it found new life un­der the di­etary sup­ple­ment law. An in­dus­try magazine dubbed it “Vi­a­gra for the brain” be­cause of its sup­posed abil­ity to in­crease blood flow. To­day, vin­poce­tine is found in nearly 400 prod­ucts, as a stand-alone sup­ple­ment and in blends, in­clud­ing Pro­cera and Neuro-nat­u­ral Re­call. To­day, $20 mil­lion to $40 mil­lion of vin­poce­tine is sold ev­ery year, in­dus­try of­fi­cials es­ti­mate.

But there was a fun­da­men­tal prob­lem. The sup­ple­ment has long been mar­keted as a botan­i­cal ex­tract, de­rived from the lesser peri­win­kle plant, a flow­er­ing shrub. Yet it is ac­tu­ally a syn­thetic deriva­tive of an al­ka­loid found in the plant. Trans­la­tion: It is made in a lab, which dis­qual­i­fies it as a sup­ple­ment un­der fed­eral law.

That fact should have been dis­cov­ered nearly 20 years ago, when sev­eral sup­ple­ment mak­ers no­ti­fied the FDA they were plan­ning to start sell­ing vin­poce­tine. But for rea­sons that are still un­clear, the agency did not take ac­tion.

In an Oc­to­ber 2015 ar­ti­cle pub­lished in the jour­nal Drug Test­ing and Anal­y­sis, re­searchers at Har­vard Med­i­cal School and the Univer­sity of Mis­sis­sippi re­ported wide­spread la­bel­ing er­rors in a sam­ple of 23 brands of vin­poce­tine pur­chased at GNC and Vi­ta­min Shoppe re­tail stores. The prob­lems in­cluded the fact that la­bels did not dis­tin­guish be­tween syn­thetic vin­poce­tine and its nat­u­ral cousin.

GNC and Vi­ta­min Shoppe de­clined to com­ment on the study, but GNC is­sued a state­ment say­ing it be­lieves vin­poce­tine is a le­gal di­etary in­gre­di­ent. “The FDA ac­knowl­edged the safety of vin­poce­tine nearly 20 years ago, and the in­gre­di­ent has been safely sold in di­etary sup­ple­ments since then,” the com­pany stated.

The study was for­warded to the FDA by Mc­caskill—and in Septem­ber the agency pro­posed that the sup­ple­ment be banned. “The idea that com­pa­nies can just put vin­poce­tine into sup­ple­ments and sell it to any­one al­ways was crazy,” says David Schardt, se­nior sci­en­tist at the Cen­ter for Sci­ence in the Pub­lic In­ter­est, a Wash­ing­ton, D.c.–based ad­vo­cacy and in­for­ma­tion or­ga­ni­za­tion. “But this also shows how lax FDA’S en­force­ment has been,” says Schardt, who calls vin­poce­tine “Vi­a­gra for the profit mar­gin.”

Pi­eter Co­hen, a pro­fes­sor at Har­vard Med­i­cal School and an au­thor of the la­bel­ing study, says it is im­por­tant that the FDA up­hold the ban. “If vin­poce­tine can be sold as a sup­ple­ment,” he wrote in an email, “then a back­door ex­ists to in­tro­duce new drugs di­rectly to con­sumers as sup­ple­ments.” Of the de­layed re­ac­tion, he says FDA was “asleep at the wheel.”

FDA of­fi­cials have been hard-pressed to

ex­plain why they did not reach these con­clu­sions ear­lier. “Be­cause nearly 20 years have passed, we are not aware of the spe­cific cir­cum­stances sur­round­ing the eval­u­a­tion of the NDI [new di­etary in­gre­di­ent] no­ti­fi­ca­tions FDA re­ceived for vin­poce­tine in the late 1990s,” an agency spokes­woman says.

The pro­posed ban has mo­bi­lized the in­dus­try and its al­lies. The Life Ex­ten­sion Foun­da­tion, the com­pany the FDA raided years ago, is fight­ing back again. It has cre­ated a spe­cial page where cus­tomers and oth­ers can down­load a let­ter to the FDA and mem­bers of Congress call­ing the pro­posed ban “un­sci­en­tific and il­le­gal” and urg­ing the agency to with­draw it.

The agency mail­bag also in­cludes tes­ti­mo­ni­als from chil­dren of Alzheimer’s pa­tients and a let­ter from a Cal­i­for­nia vet­eri­nar­ian who said he has used vin­poce­tine in geri­atric ca­nine pa­tients with “ob­serv­able suc­cess.” Other writ­ers ac­cuse the FDA of do­ing the bid­ding of drug com­pa­nies so they can even­tu­ally take over mar­ket­ing of vin­poce­tine and raise prices.

The Nat­u­ral Prod­ucts As­so­ci­a­tion calls the pro­posed ban “un­prece­dented” and ques­tions the le­gal­ity of ban­ning a prod­uct that was tac­itly ap­proved by reg­u­la­tors years ago. The trade group says that many stud­ies show that vin­poce­tine is safe and ef­fec­tive, and that for the FDA to ban it now hurts sat­is­fied cus­tomers, not to men­tion the in­dus­try bot­tom line.

Hatch, the long­time in­dus­try cham­pion, also has writ­ten the agency, declar­ing the pro­posed ban “a prece­den­tial step that could shake the con­fi­dence that man­u­fac­tur­ers main­tain in the FDA process.”

“To wipe out a whole in­gre­di­ent…that tells me they are not spend­ing their re­sources on what they should be,” says Fabri­cant, the head of the Nat­u­ral Prod­ucts As­so­ci­a­tion. Ac­cord­ing to Fabri­cant, the agency is be­ing un­duly in­flu­enced by Mc­caskill, an in­dus­try neme­sis. “This means one sen­a­tor can up­set the ap­ple cart.”

Yet one ex­pert, John Mor­ley, an in­ter­na­tion­ally rec­og­nized geri­a­tri­cian at Saint Louis Univer­sity med­i­cal school, coun­ters, “I do not be­lieve that there is nearly enough ev­i­dence to get peo­ple to waste their money” on vin­poce­tine.

Con­sumers like Hank Auw­erda, 80, of Tampa, Florida, also are skep­ti­cal. Auw­erda pur­chased a bot­tle of vin­poce­tine on­line in 2015. He had re­cently suf­fered a head in­jury and had brain surgery, and he thought it might help his mem­ory. In­stead, after two days, he be­gan hav­ing what he de­scribes as “hal­lu­ci­na­tions.” He sus­pects the sup­ple­ment in­ter­acted with anti-seizure medicine he was tak­ing. But he was irked that there was no warn­ing on the la­bel. He was an­gered fur­ther when he called the seller, Source Nat­u­rals, and was sim­ply en­cour­aged to con­tact Ama­zon for a re­fund. “This was a very strange re­ac­tion,” says Auw­erda, who ex­pressed sur­prise that the com­pany wasn’t more con­cerned with the re­ac­tion he suf­fered.

Un­der FDA rules, sup­ple­ment man­u­fac­tur­ers are re­quired to re­view and in­ves­ti­gate prod­uct com­plaints and in­form the agency of all se­ri­ous ad­verse ef­fects that come to light. “A re­spon­si­ble firm will prop­erly train all their call cen­ter em­ploy­ees to rec­og­nize if some­one is re­port­ing an ad­verse event and be able to di­rect them ap­pro­pri­ately,” the FDA spokes­woman says.

Source Nat­u­rals, based in Scotts Val­ley, Cal­i­for­nia, did not re­spond to re­quests for com­ment.

For Pena-reames, the side ef­fects dis­ap­peared, and her emo­tional health re­turned, when she stopped tak­ing vin­poce­tine. (While oth­ers also have re­ported de­pres­sion after tak­ing vin­poce­tine, more com­mon com­plaints in­clude flush­ing, headaches and low blood pres­sure.) She has found other sup­ple­ments that give her some peace of mind.

Gen­er­ally skep­ti­cal of the FDA’S abil­ity to pro­tect the pub­lic, she ques­tions whether an out­right ban of vin­poce­tine is wise, but says con­sumers need to do their home­work. “There are a num­ber of de­men­tia snake oil sales­men out there. Be­ware.”

A SUP­PLE­MENTS IN­DUS­TRY MAGAZINE DUBBED VIN­POCE­TINE “VI­A­GRA FOR THE BRAIN.”

SNAKE OIL: The FTC won a $1.4 mil­lion penalty against the mar­keters of Pro­cera AVH, which claimed it could re­store 15 years of lost mem­ory and had $100 mil­lion in sales be­fore the FTC stepped in.

Ginkgo biloba, touted as an Alzheimer’s drug, is clas­si­fied as a sup­ple­ment be­cause it is nat­u­rally de­rived and thus barely reg­u­lated. POW­DER BURN:

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