Drug ex­ecs be­hind fe­male li­bido pill have run afoul of US agency

The China Post - - LIFE - BY MATTHEW PER­RONE

A small drug­maker in the U.S. may suc­ceed next week where many of the world’s largest phar­ma­ceu­ti­cal com­pa­nies have failed: in win­ning ap­proval for the first drug to boost women’s sex­ual de­sire.

The hus­band-and-wife team that founded Sprout Phar­ma­ceu­ti­cals is not new to the phar­ma­ceu­ti­cal busi­ness or even to mar­ket­ing drugs to peo­ple frus­trated with their sex lives. The cou­ple’s pre­vi­ous com­pany, Slate Phar­ma­ceu­ti­cals, sold an im­plantable testos­terone pel­let to men with low lev­els of the hor­mone.

But Slate’s mar­ket­ing push ran afoul of U.S. rules, mak­ing mis­lead­ing, un­sup­ported state­ments about the ben­e­fits of testos­terone ther­apy while down­play­ing risks. In fact, when the U.S. Food and Drug Ad­min­is­tra­tion (FDA) held a meet­ing ex­am­in­ing the over­pre­scrib­ing of testos­terone last year, it played Slate’s com­mer­cial as an ex­am­ple of in­ap­pro­pri­ate mar­ket­ing.

That record wor­ries Sprout’s crit­ics, who see a trou­bling pat­tern in the ag­gres­sive tac­tics it has used to urge the FDA to ap­prove the women’s de­sire drug, which was pre­vi­ously re­jected twice be­cause of lack­lus­ter ef­fec­tive­ness and side ef­fects such as nau­sea, dizzi­ness and faint­ing.

The search for a pill to in­crease women’s li­bido has been some­thing of a holy grail for the phar­ma­ceu­ti­cal in­dus­try since the block­buster suc­cess of Vi­a­gra for men in the late 1990s. Pfizer, Bayer and Proc­ter & Gam­ble all stud­ied — then aban­doned — po­ten­tial treat­ments for fe­male sex­ual de­sire dis­or­der.

“This com­pany al­ready has a history of un­eth­i­cal mar­ket­ing,” said Dr. Adri­ane Fugh-Ber­man of Georgetown Univer­sity. “If ap­proved, I think this drug will be widely pre­scribed, and we would see an epi­demic of ad­verse ef­fects.”

Af­ter a year of lob­by­ing by Sprout­backed sup­port­ers, the drug won a sur­pris­ing 18-6 rec­om­men­da­tion from a panel of FDA ad­vis­ers in June. The FDA is sched­uled to make its de­ci­sion on the drug by Tues­day.

Sprout’s drug was ac­tu­ally ac­quired from Boehringer In­gel­heim in 2011. The Ger­man drug­maker shelved the pill af­ter a unan­i­mous vote against its ap­proval by FDA ad­vis­ers in June 2010.

CEO Cindy White­head and her hus­band, Bob White­head, who pre­ceded her as CEO, paid for the drug, dubbed Ad­dyi, by selling off their testos­terone busi­ness, which had grown to nearly 100 em­ploy­ees.

These days, the ex­ec­u­tives like to em­pha­size their com­pany’s small size. In in­ter­views, CEO Cindy White­head jokes that Sprout’s en­tire staff of 25 could fit in an el­e­va­tor.

There is lit­tle fi­nan­cial in­for­ma­tion avail­able about Slate or Sprout be­cause they have both been pri­vately held. The White­heads say their hor­monal im­plant, Testopel, grew into the sec­ond most­pre­scribed testos­terone treat­ment among urol­o­gists, ahead of com­pet­ing gels and in­jec­tions.

Pro­mo­tional Ef­forts

Went Too Far

In March 2010, the FDA sent Slate an 11-page warn­ing let­ter, high­light­ing a host of mis­lead­ing, un­sup­ported and in­ac­cu­rate state­ments in its brochures, web­sites and a video. In a rare step, the FDA held a tele­con­fer­ence with the com­pany to out­line its “se­ri­ous con­cerns.”

Among the many prob­lems, the com­pany’s web­site sug­gested Testopel could ben­e­fit pa­tients with de­pres­sion, di­a­betes and HIV.

“The FDA is un­aware of any data to sup­port these claims,” the let­ter said.

In a video, Slate fea­tured Har­vard Med­i­cal School pro­fes­sor Abra­ham Mor­gen­taler, claim­ing that testos­terone could boost men’s energy and li­bido.

“Their strength may im­prove. Their work­outs at the gym may get bet­ter. They start chas­ing their wives around the room a lit­tle bit. They just feel like guys again,” Mor­gen­taler said. The FDA said his claims were un­proven.

This past May, the FDA di­rected all testos­terone drug­mak­ers to clar­ify that their drugs are in­tended only for men with low testos­terone due to dis­ease or in­jury — not nor­mal ag­ing. And new warn­ing la­bels also stress the risk of heart at­tack and stroke with the hor­mone.

When Slate mar­keted Testopel, that in­for­ma­tion was not yet re­quired. But the com­pany’s ma­te­ri­als failed to dis­close a laun­dry list of other known risks, in­clud­ing prostate can­cer, swelling, nau­sea, vom­it­ing, acne, liver prob­lems and headaches.

“I can’t re­mem­ber see­ing a warn­ing let­ter with so many ex­am­ples of mis­brand­ing in it,” said Fugh-Ber­man, who re­cently signed a pe­ti­tion urg­ing the FDA to re­ject Ad­dyi, cit­ing min­i­mal ben­e­fits and dan­ger­ous side ef­fects.

Cindy White­head said Slate im­me­di­ately dis­con­tin­ued the ma­te­ri­als cited by the FDA. And she in­sists the com­pany will pro­mote Ad­dyi care­fully, fo­cus­ing on ed­u­cat­ing doc­tors about who is likely to ben­e­fit from the drug.

AP

In this June 22 photo, Sprout Phar­ma­ceu­ti­cals CEO Cindy White­head works in her of­fice in Raleigh, North Carolina.

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