Pow­er­ful Dems or­ches­trat­ed cam­paign at FDA to pro­vide Bio­gen drug to a dy­ing, high-pro­file fundrais­er

Back in 2008, Dal­las tri­al lawyer and high-pro­file De­mo­c­ra­t­ic Par­ty fundrais­er Fred Baron was dy­ing of mul­ti­ple myelo­ma. Des­per­ate to gain ac­cess to Bio­gen’s Tysabri, an MS drug then be­ing test­ed for myelo­ma in ear­ly-stage stud­ies, his wife Lisa Blue Baron reached out to the com­pa­ny but ran di­rect­ly in­to a brick wall of re­sis­tance.

“[Bio­gen] won’t ap­prove for fred be­cause he is too sick and if it fails him, it could skew the out­come of the tri­als(this told to me by his wife),” not­ed a fam­i­ly friend in the er­ror-rid­den post in­clud­ed in the batch of hacked emails from John Podes­ta — the chair­man of Hillary Clin­ton’s pres­i­den­tial cam­paign — dumped by Wik­iLeaks on Sat­ur­day.

In­censed, Baron’s wife reached out to in­flu­en­tial friends in the De­mo­c­ra­t­ic Par­ty.

If I am un­able to get drug I will take out full pg add in boston globe to ceo and board mem­bers.vFred is run­ning out of time. He’s so sick and needs this drug. Thanks so much.

In short or­der, a whole line­up of high-pro­file of­fi­cials rang­ing from for­mer Pres­i­dent Bill Clin­ton to Sen­a­tor John Ker­ry and then FDA Com­mis­sion­er An­drew von Es­chen­bach were di­rect­ly lob­by­ing for­mer Bio­gen CEO Jim Mullen to pro­vide the drug for com­pas­sion­ate use.

One seg­ment of the Podes­ta email ex­change in­cludes:

I got through to Mullen.  He had al­ready had ex­ten­sive con­ver­sa­tions with Sen­a­tor Ker­ry and Lance Arm­strong and had heard from Pres­i­dent Clin­ton, too.  The an­swer he gave in every case was [no].  I be­lieve that I un­der­stood it cor­rect­ly that Ker­ry had or­ga­nized a con­fer­ence call with Mullen and FDA Com­mis­sion­er Von Es­chen­bach.  I hear that Von Es­chen­bach said it was fine with him for the drug to be used in Fred’s case.  How­ev­er, Bio­gen be­lieves that Von E does not have that au­thor­i­ty giv­en the strict FDA con­di­tions on the use of the drug.

And in the next sec­tion:

I just had a dis­ap­point­ing call with Dr. Von Es­chen­bach. FDA had a phone con­fer­ence with the med­ical and sci­ence of­fi­cers from Bio­gen. FDA told them there would be no prej­u­dice to the clin­i­cal tri­al if this drug were used for Fred. They were ap­pre­cia­tive but gave no in­di­ca­tion they would change their po­si­tion, which is that a cor­po­rate de­ci­sion has been made they would not go out­side the clin­i­cal tri­al. I am re­al­ly up­set about this, per­son­al­ly, since FDA has been great to help. I have not had the time to­day to reach out to some on the board of Bio­gen, but hope to do so yet to­day. I felt last night, af­ter talk­ing with Andy von Es­h­en­bach, that with clear­ance from FDA, the com­pa­ny would be ok.

Look­ing back over Luke Tim­mer­man’s cov­er­age at the time for Xcon­o­my, it’s in­ter­est­ing to note that Baron got the drug be­cause the FDA and the Mayo Clin­ic pro­vid­ed it to him af­ter the agency found a le­gal ba­sis to do so in an emer­gency sit­u­a­tion.

Bio­gen, though, had con­tin­ued to in­sist that any use of Tysabri for myelo­ma in Baron’s case could cre­ate a sit­u­a­tion that would cause reg­u­la­tors to re­strict its use. This was two years af­ter the FDA had al­lowed Bio­gen and Elan to put the drug back on the mar­ket af­ter it was pulled fol­low­ing the death of sev­er­al pa­tients due to PML.

The de­bate over ac­cess to drugs un­der com­pas­sion­ate use poli­cies has helped spur a whole se­ries of “Right to Try” laws around the coun­try. For many pa­tients, it can be a frus­trat­ing ex­er­cise, try­ing to con­vince a bio­phar­ma com­pa­ny to pro­vide a drug to them in their last dy­ing days. For many biotechs, though, com­pas­sion­ate use re­mains a vex­ing is­sue as well. These pro­grams can be ex­pen­sive and al­so rais­es the threat that an un­ex­pect­ed ad­verse event can force a com­pa­ny to sus­pend work on a drug.

Fred Baron got the drug, but there was no hap­py end­ing. The be­hind-the-scenes strug­gle end­ed with his death on Oc­to­ber 30, 2008, soon af­ter the con­tro­ver­sy erupt­ed.

Fangliang Zhang (Imaginechina via AP Images)

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

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Paul Hudson, Sanofi CEO (Getty Images)

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File photo (Endpoints News)

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