Dr. Nanette Santoro Explains Veozah: Episode Link

 

TRANSCRIPT:

Welcome  back  guys.  We  are  talking  to  Dr.  Nanette  Santoro  and  we,  Bridgett  and  I  have  been  waiting  for  this  interview.  We  are  thrilled  to  talk  to  you.  Welcome  to  the  show.
 Thank  you.  Pleasure  to  be  here.  Well,  it’s,  we  appreciate  your  time.  We  know  you’re  very  busy  and    and  I  started  to  do  some  research.  on  these  non -hormonal  medications  that  are  in  phase  three  trials  with  the  FDA  and  your  name  kept  coming  up.

Before  we  get  started  on  talking  about  kind  of  these  change -making  medications  that  are  going  to  be  available  hopefully  soon  for  women,
I  wanted  to  talk  to  you  about  the  article  that  came  out  recently  in  the  New  York  Times  called  Women  Have  Been  Misled.  Misled  About  Menopause  and  you  were  quoted  in  it  and  one  of  the  things  that  I  thought  was  really  interesting  was  that  you  kind  of  were  on  the  front  line  when  the  report  came  out  from  the  Women’s  Health  Initiative  in  2002  about  kind  of  the  negative  information  and  risks  and  I  wanted  to  find  out  from
you  what  was  it  like  being  a  physician  at  that  time  with  patients  who  are  taking  hormonal  therapy?  – Well,  I  think  since  that  time,  we’ve  seen  a  lot  of  sort  of  wacky  information  campaigns  where  stuff  that  seems  neutral  immediately  goes  south  and  becomes  this  polarizing  situation.
And  that  was  really  one  of  the  very  first  times  I  had  experienced  that  because  I  personally  wasn’t  prescribing  hormone  therapy.  for  the  sole  purpose  of  preventing  heart  disease.
I  think  that  some  clinicians  may  have  been  doing  that.  And  I  think  with  that  came  this  profound  sense  of,  oh  my  goodness,  that  wasn’t  a  good  idea.  Some  people  went  into  regret  mode.
Other  people  went  into  hostile  denial  mode.  No,  that  can’t  be  true.  The  study  was  wrong.  And  people  got  still  stuck  in  prevention.  world.  And  we’re  unable  to  just  take  themselves  out  of  that  and  go  to  people  are  having  hot  flashes, we  need  to  treat  them.  Now  we  have  a  very  good  assessment  of  what  risks  may  accrue  to  them  with  hormone  therapy.  Nothing  was  earth  shattering,  except  the  fact  that  it  wasn’t  protective.
Most  of  us  expected  it  to  be  protective,  but  it  wasn’t.  So  move on, you  know,  nothing  to  look  at  here,  people  move  on,  give  hormones  when  they’re  indicated,  and  don’t  give  them  when  they’re  not.
So,  you  know,  the  communication  of  risk,  and  I  really  thought  that  the  reporter  on  this  article  said  it  well,  I  mean,  it  was  just  a  mess.
And  no  one  could  have  predicted,  I  think  at  the  time  how  it  was  going  to  go  so  badly.  Many  doctors  had  to  calling  in  an  absolute  flop  sweat  panic.
You  know,  oh  my  goodness,  you  know,  I’m  taking  poison.  And  I  mean,  just  none  of  that’s  true.  And  now  that  we  have  18  year  follow -up  on  the  women  who  took  these  hormones  for  the  most  part  overall,
there’s  just  no  difference  in  long -term  health  outcomes.  There  are  nuances  to  that  data,  but  it  again  confirms  that  that  this  is  pretty  low  risk  stuff  once  you  accept  the  fact  that  nothing,
there’s  no  free  lunch  and  everything  has  some  risk  attached  to  it.  So  you  kind  of  answered  part  of  my  question,  what  were  your  thoughts  on  that  article  because  rich  and  I  found  it  incredibly  comprehensive,
as  far  as  telling  the  history  of  hormone  therapy,  how  the  media  has  misled  a  lot  of  women  into  absolute  panic  and  fear  over  taking  medication  that  is  hormone  therapy.
What  were  your  thoughts  on  the  article?  – Yeah,  and  I’m  not  sure  I  would  blame  the  media.  I  don’t  know  that  there’s  any  one  person  that  or  party  that  should  be  blamed.  I  think  there  were  just  a  lot  of  things  that  were  communication  missteps  that  could  we  have  done  it  better?
Yes.  Many  clinicians  were  angry,  you  know,  that  they  weren’t  told  about  it  beforehand,  but  yet  you’re  running  the  study,  how  can  you  tell  them  beforehand  without  telling  the  women  who  are  doing  it?
So  I  thought  that  that  was  captured  pretty  well  by  Susan  Dominus  in  the  article,  some  of  that  chaos.  And  I  think  that  some  of  the,  you  know,
some  of  the  ways  that  everything  got  interpreted  really  have  left  us  in  a  tough  position.  position.  Many  other  treatments  have  come  out  that  are  bogus  and  that  purport  to  be  better.
They’re  uncontrolled  studies  and,  you  know,  we  still  have  good  old  hormones  that  I  have  many  patients  that  come  in  and  just  say,  oh,  I’m  not  going  to  take  those.  Still  to  this  day.
Yes.  And  I  find  physicians  to  this  day  are  not,  not  every  but  many  and  some  that  have  happened  to  me  personally.  personally  when  I  go  and  ask  about  this  and  I  remember  the  first  time  I  asked  about  this  I  was  47  years  old  and  I  was  having  hot  flashes  unbelievably  just  at  night  at  least  15  times  a  day  you  know  sometimes  three  times  an  hour  hot  flashes  I  asked  about  it  and  it  just  wasn’t  even  considered  for  me.
She  thought  I  was  too  young  she  did  the  follicle -stimulating  hormone  blood  test  with  that  and  said,  “Oh  yeah,  okay,  it  looks  like  you  are.”  I  was  probably  perimenopausal  because  I  wasn’t  12  months  out,
but  was  denied.  I’m  finding  this  to  be  a  situation.  I  did  find  another  physician  that  was  very  open  to  discussing  this  with  me,  and  I  wanted  a  hormone  replacement.
Some  people  don’t  want  it.  Do  you  find  that  it’s  really  hard  to  get  the  word  out  to  different  physicians  that  maybe  this  is  not  as  risky  as  it  had  initially  seen?  – I  think  that  that  was  also  addressed  in  the  Times  article.
I  think  there’s  a  training  gap  that  we’ve  just  had  this  turning  away  from  hormone  therapy  so  that  the  level  of  comfort  with  it  is  reduced.  So  a  lot  of  people  just  don’t  get  enough  training.
in  OB /GYN.  They  get  maybe  six  weeks  of  training  and  reproductive  hormones  and  that  includes  menopause.  There’s  some  training  modules  that  they  can  take.
So  you  have  to  go  out  of  your  way  to  do  it.  And  you  know  for  example  my  colleagues  in  Family  Medicine,  we  have  many  here  at  the  University  of  Colorado  who  I  inadvertently  insulted  with  my  quote  in  the  article,
which  I  didn’t  mean  to  do,  but  but  what  I  really  meant  to  say  is  most  family  medicine  doctors  have  15  minutes  to  spend  with  a  patient.  And  if  you’re  going  to  have  a  lengthy  discussion  about  hormone  therapy,  you  really  need  a  lot  of  extra  skill  training  experience  to  be  able  to  have  that  conversation  and  you  probably  need  to  make  another  visit.
I  have  a  reproductive  endocrine  practice  where  I  do  a  lot  of  what  we  call  evaluation  and  management  for  menopausal  patients.  And  those  are  not  very  well -paying  visits.
So  there’s  a  time  disincentive  and  there’s  a  financial  disincentive.  And  many  doctors  choose  not  to  go  there.  Many  fearless  doctors  still  will  do  it.
And  there  are  the  North  American  Menopause  Society,  for  example,  has  certified  practitioners.  These  are  people,  they’re  physicians,  nurse  practitioners,  midwinter  doctors.
PAs  who  have  taken  a  specific  interest  in  menopause  and  have  gone  to  the  trouble  to  learn  it  to  go  through  the  guide  for  learning.  And  those  are  places  where  women  can  find  information  that  may  help  direct  them  to  doctors  who  will  be  more  sympathetic  but  you  know  you’re  not  the  only  person  that  I’ve  heard  say  that  I’ve  gone  to  someone  and  they  were  just  steps  we  were  not  just  let’s  not  go  there.
Thank  you.  Currently,  there  are  two  non  hormonal  medications  that  appear  to  be  in  phase  three  trials,
if  I’m  correct,  that  could  help  women  with  half  flashes.  And  that  can  be  a  change  maker.  I  know  that  you  have  been,  your  current  research  in  menopause,
it  was  involved  with  one  of  them.  I  thought  the  best  way  for  our  listeners  to  understand  would  be  would  be  to  break  down  first,  what  is  happening  in  your  brain  with  a  hot  flash?
What  research  has  shown  with  a  hypothalamus  and  hot  flashes?  Could  you  break  down  and  explain  exactly  what  is  happening  in  the  brain  when  a  woman  has  a  hot  flash?  – Well,
I  can’t  explain  it  exactly  ’cause  it’s  not  fully  known,  but  I  would  say  that  10  or  15  years  ago,  there  was,  whoa,  estrogen  goes  away,  there’s  this  black  box  in  the  brain.  brain.  We  have  no  idea  what  the  wiring  is.
And  people  get  this,  that  we  called  it  the  thermoregulatory  center  in  the  brain.  And  we  had  a  vague  idea  that  it  was  located  in  the  hypothalamus.  So  for  those  of  you  who  haven’t  heard  of  the  hypothalamus  ’cause  not  many  people  have,  it’s  sort  of  a  waste,  it’s  a  waste  station  in  the  midbrain  and  pretty  much  connects  to  everything  else  in  the  brain.  So  it’s  a  waste  station  in  the  midbrain.  it  was  not  particularly  helpful  to  have  that  location  of  where  it  was  until  we  came  up  with  the  candy  neurons  and  by  we  I’m  talking  about  Naomi  Rance  who  was  a  neuropathologist  in  Arizona  she  noted  that  in  animals  and  in  humans  that  had  had  their  ovaries  removed this  specific  neuron  in  the  brain  the  Kandy  neuron  it  stands  for  Kispeptin,  Neurokinin,  and  Dynorum.  dinorphin.  So  chispeptin  is  one  of  the  molecules  that  governs  the  reproductive  system.
Neurokinin  is  sort  of  a  pro  inflammatory  molecule.  And  there’s  many,  there’s  a  family  of  them.  So  that  receptor  was  related  to  inflammatory  processes  and  some  connected  to  different  nerves.
And  dinorphin  governs  the  endogenous  opioid  system  in  the  brain.  So  these  are  all  sort  of  pretty  basic.  basic  functions  and  again  in  that  midbrain  that  has  many  many  inputs  and  many  outputs  but  that  finding  led  her  to  do  some  further  experiments  and  there  were  beginning  some  other  research  that  was  coalescing  saying  these  tachykinins  which  also  can  interact  with  neurokinin  receptors  were  related  in  some  women  to  a  higher
risk  of  hot  flashes  and  epidemiologic  studies  so  the  interest  was  accruing.  She  blocked  that  receptor  with  an  antibody  and  found  in  animals  that  it  seemed  to  eliminate  hot  flashes.
You  can’t  ask  an  experimental  rodent  if  they’re  having  hot  flashes  or  not,  but  there  are  ways  to  be  able  to  tell.  And  in  one  particularly  clever  experiment  done  by  another  scientist,  they  created  a  tube  where  part  of  the  tube  was  cold part  of  the  tube  was  warm,  and  the  animals  had  their  ovaries  out,  If  you  had  blocked  the  neurokinin  receptor,  the  animals  who  had  their  ovaries  out  were  all  over  the  tube.  They  didn’t  care  where  they  went  as  long  as  that  receptor  was  blocked.

The  animals  that  weren’t  blocked  were  all  huddled  at  the  colder  end  of  the  tube  because  they  were  having  hot  flashes.  So  it  was  a  great  way  to  tell  that  this  was  the  problem.  This  is  where  it  worked.
So  it’s  thought  that  there’s  two  places  that  have  those  neurokinin  neurokinin  receptors.  One  is  in  that  area  where  the  chispeptin  neurons  are  in  the  hypothalamus,
and  there’s  a  second  set  of  neurons,  interneurons  that  interact  with  that  that  seem  to  also  have  this  neurokinin  receptor.  So  we  know  that  those  neurons  go  increase  with  menopause,
they  go  up,  if  you  block  them,  you’re  going  to  be  able  to  block,  theoretically  would  be  able  to  block.  hot  flashes.  And  it  looks  like  it’s  highly  specific  that  it  works  as  well  as  estrogen.
And  that’s  really  what  has  doctors  and  clinicians  really  excited  about  it.  Because  the  only  other  FDA  approved  medication  for  hot  flashes  is  peroxitine  mesolate.
It’s  a  long -acting  salt  of  peroxitine,  also  commercially  known  as  Paxil,  but  this  compound  is  bristelle.  And  it  works,  but  it’s  not,
it  just  barely  edged  out  the  placebo  effect,  so  it  wasn’t  of  that  order  of  magnitude.  And  every  other  treatment  we  have  that  we  use  off -label  works  a  little  bit,
but  for  most  women,  not  nearly  as  well  as  estrogen.  So  now  that  they  made  this  connection,  scientists  made  this  connection  and  presented  it  as  an  option,
first  of  the  term  non -hormonal  is  going  to  peak  women’s  interest  because  of  the  fact  that  they  are  so  afraid  to  take  hormones.  Why  did  you  get  that  to  go  into  phase,
because  I  know  that  we  were  saying  that  it’s  phase  through  trials,  but  how  do  you  even  get  it  to  a  phase  one  trial?  Well,  phase  one  is  where  you,  that’s  when  you’re  looking  most.  at  that.  Those  are  the  very  first  experiments  in  humans  for  toxicity.
So  you  give  it  to  a  very  limited  number  of  people  in  phase  one,  and  you  just  make  sure  that  it  doesn’t  have  any  awful  side  effects.  You  go  through  a  different  doses.  And  you’ve  already  done  all  your  animal  research  where  you’ve  shown  that, you  know,  what  dose  kills  half  of  the  animals.  So  you’re  kind  of  in  the  ballpark,  you  look  at  pregnancy  outcomes  in  the  animals.  and  you  look  at  the  molecular  structure  and  try  to  figure  out,
you  know,  is  there  going  to  be  a  problem  with  this?  Does  it  have  any  particular  configuration  that  it  may  be  toxic  to  the  kidney,  to  the  liver,  wherever,  where  do  we  have  to  look?  So  the  many,
several  compounds  actually  have  gone  through  that,  and  there’s  many  others  right  now  that  are  also  in  testing.  Phezolinitant  is  ahead  of  the  others.  It  is  now  actually  with  the  FDA  pending  approval.
approval  so  we  could  hear  any  day  now  that  it’s  approved  we  could  also  hear  that  it’s  not  approved  but  I  am  a  consultant  for  the  company  and  on  their  scientific  advisory  board  the  data  looks  good  that  I  know  of  and  I’m  hoping  that  it  will  be  approved  and  we’ve  just  published  a  couple  of  new  papers  on  it  showing  the  safety  and  the  effectiveness  you  know  so  many  women  they  are  like  Colleen  said  just  they  they  hear
the  word  hormones  and  they  go  back  to  the  2002  study  and  they  are  terrified.  I  would  love  to  really,  you  know,  wrap  my  head  around  who  is  really  at  risk  for  hormone  replacement.
>>  Yeah,  important  question  because  there  are  some  women  that  should  not  take  it.  And  most  women  are  actually  pretty  low  risk.  in  the  50  to  60  age  group,
age  range.  But  for  some  women  who  have  had,  for  example,  a  blood  clot  of  venous  thromboembolism,  that  would  be  a  deep  vein  thrombosis  in  the  calf  or  a  lung  pulmonary  embolus,
those  women  should  not  take  estrogen.  It’s  generally  recommended  they  don’t.  Women  who  cannot  take  estrogen  at  all  are  women  with  breast  cancer.  The  mainstay  of  treatment  for  breast  cancer  is  giving  an  aromatase  inhibitor, which  which  wipes  out  your  estrogen  levels  and  any  estrogen  exposure  is  thought  to  help  encourage  the  cancer  to  mutate  and  grow.  Women  with  endometrial  cancer,
so  there  are  some  other  rare  estrogen  dependent  cancers  where  we  don’t  want  to  give  hormones.  Those  are  the  biggest  contraindications  by  far.

What  about  family  history?
Because  we  hear  from  a  lot  of  listeners,  “Oh,  my  mother  had  breast  cancer,  my  aunt.”  had  breast  cancer,  I  can’t  take  it.  What  about  people  like  that  that  have  a  family  history  of  it?
Yeah,  and  it’s  not  in  every  case  that  you  need  to  be  afraid  of  hormones  for  that  reason.  So  there’s  a  few  objective  ways  that  women  can  estimate  the  breast  cancer  risk.
Family  history  is  one  piece,  the  age  at  first  birth  is  another  major,  major  determinant  of…  and  how  many  family  members  have  it  also  makes  the  difference  whether  there’s  any  genetic  mutations  associated  with  it  because  it  might  prompt  genetic  testing.
And  the  amount  of  risk  that  hormones  add  to  already  high  breast  cancer  risk  is  not  always  as  high  as  people  think  it  is.
So  some  women  will  still  choose  to  take  that  risk  because  their  their  hot  flashes  are  so  miserable.  miserable.  So  it  is  not  an  unreasonable  thing,
and  I  will  usually  work  with  my  patients,  we’ll  look  at  an  objective  breast  cancer  risk  model,  because  then  we’re  just  talking  about  a  disease  they  do  not  have.  Once  they  get  a  disease,
that’s  a  different  story.  >>  With  the  trials  in  the  phezo,  I  want  to  make  sure  I  said  that  right,  phezo  and  the  phezo  medication,
it  was  between  women  between  the  phezo  and  the  phezo.  ages  of  40  and  70,  correct?  – I  think  it  was  40  to  65.  – 40  to  65,  okay,  let  me  try  that  again.  So  in  the  Phezo  trials,
the  women  were  between  40  and  65  and  they  had  at  least  seven,  I  think  the  average  was  seven  hot  flashes.  Were  there  any  side  effects  that  were  noted  during  the  phase,
during  the  trials?  trials?  They  had  at  least  seven  hot  flashes  a  day  and  amine  of  at  least  50  a  week  because  that’s  the  FDA  guidance  for  hot  flash  studies.
So  if  you  want  to  show  that  something’s  effective  against  hot  flashes  you  need  to  test  it  in  sort  of  the  biggest  baddest  hot  flashers.  So  these  women  are  they’re  just  on  fire.  I  would  have  been  a  great  candidate.
I  would  have  been,  yes.  So  they  have  to  be  tested,  and  I’m  sorry,  I  forgot  the  other  piece  of  your  question.  No,  I  was  saying,  what  side  effects,
if  any,  were  noted  during  the  trials?  Yeah,  because  the  trial  was  done  during  COVID,  we  had  a  lot  of  COVID  related  side  effects,  headache,  body  aches,
nausea,  things  like  that.  They  seem  to  be  distributed  equally  among  the  people  taking  placebo.  placebo  and  Phezo,  so  really  no  side  effects.  There  was  noted  in  the  early  studies  with  similar  related  compounds  and  also  with  Phezo  at  higher  doses  that  women  reported  back  that  they  were  sleeping  better.
So  in  some  of  the  newer  studies  sleep  was  incorporated  and  it  does  look  like,  we’ve  presented  that  as  an  abstract,  that  there  were  some  improvements  in  sleep  and  a  paper  is  being  prepared.
for  publication  on  that.  – That’ll  be  great  news  because  we  hear  that  from  so  many.  – So  many.  – That’s  another  thing  that  comes  along  with  menopause  is  the  disturbance  of  sleep.
– Yeah,  so  that  would  be  huge.  And  in  one  of  the  very  early  studies  with  a  different  compound,  it  looked  like  women  were  even  losing  weight  with  this  type  of  compound.  So  I  think  I  was  high -fiving  with  one  of  my  colleagues  in  the  back  of  the  room.
It’s  like it’s  the  menopause  polypill.  But,  you  know,  we  need  to  see  what  happens  when  it  gets  out  in  clinical  use.  And  we’re  using  it  in  all  of  our,  the  patients  we  typically  will  treat.
The  women  in  the  pheasant  linotant  studies  do  look  like  they  were  pretty  much  representative.  About  20 %  were  African -American,  about  20,  25 %  were  Latina,
and  about  a  quarter  had  African -American.  hysterectomy.  So  that’s  pretty  and  based  on  their  BMI  was  around  28,  which  is  about  the  average  BMI  for  women  in  that  age  group.
They  seem  pretty  representative  of  American  women.  So  that’s  good  to  see.  What  about  women  that  are  already  on  hormone  replacement?  Would  it  be  okay  if  they  switched  if  they  said,
oh,  this,  if  this  becomes  approved,  do  do  you  know  if  it  would  be  okay  if  they  said,  oh,  I  want  to  try  this  instead?  Well,  sure.  I  think  it’s  a  completely  reasonable  thing.  We’re  giving  hormones  to  alleviate  symptoms.
So  when  we  have  another  treatment,  and  often  when  I  have  a  patient  who  has  been  on  hormones  for  long  enough  that  we  feel  like  she’s  kind  of  timed  out,  and  she’s  beginning  to  get  risks  that  we  don’t  want  her  to  have this  may  be  something  to  switch,  switch  her  to.  – Once  it’s  approved,  and  we’re  putting  out  in  the  universe  that  it  will  be  approved.  So  we’re  not  even  saying  if,  when  it’s  approved,
how  do  doctors  find  out  and  prescribe  the  medication?  Because  it  seems  like  the  doctors  are  a  little  delayed  on  information,
on  menopause.  How  do  we  make  sure  that  not  only  our  listeners  can  ask  for  it,  but  that  it’s  an  option  that  they’re  given.  There’s  a  number  of  ways  that  it  gets  delayed.
So  first  of  all,  it  gets  approved,  but  then  it  has  to  be  costed  out.  Arrangements  are  made  with  insurance  companies.  Are  you  going  to  pay  for  this?  If  so,  how  much  are  you  going  to  pay?
What’s  the  patient’s  co -pay  going  to  be?  And  then  it  has  to  get  on  the  formulary.  So  a  hospital  formulary  committee,  like  we  have  in  our  hospital  in  Colorado.  or  whatever,  wherever  it’s  going  to  be  prescribed  by  the  insurance  companies, they  have  to  put  it  on  their  formulary.  And  that  can  take  months.  So  that  can  delay  it  further.  Cost  can  be  a  big  issue.  You  know,  I  am  a  scientific  advisor  to  Ustela’s.
The  company  is  going  to  market  it,  but  I  do  not  have  the  capacity  to  advise  them  on  cost.  I  have  made  my  sentiments  clear.  I  really  hope  this  is  going  to  be  a  further  discussion.  for  women.  But  we  have  noted  in  the  menopause  field  that  many  menopause  treatments  are  not  picked  up  by  pharmacies.
Or  if  you  you’re  not  the  average  patient  and  the  simple  stuff  doesn’t  work  for  you  and  you  need  a  slightly  more  complicated  treatment,  it’s  wildly  expensive.  So  those  things  are  pretty  disappointing.
And,  you  know,  we  just  don’t  know  yet  where  that’s  how  that’s  going  to  fall  out.  So  that  can  take  time.  Sometimes  there’s  there’s  issues  with  physicians  not  learning  about  it.
And  that’s  part  that’s  part  of  that’s  on  the  burden  on  the  company  is  to  get  the  information  out.  And  that’s  why  they  will  bring  detail  people  to  doctors  offices  and  practitioners  to  to,
you  know,  acquaint  them  with  the  compound  and  give  them  more  information.  But  a  lot  of  times  those  that  that  access  has  been  restricted  because  there’s  always  worry  about  conflict  of  interest  and  giving  physicians,
you  know,  to  incentives  to  prescribe  new,  more  expensive  drugs.  So  those  things  can  be  barriers  to  getting  the  information  out,  but  some  of  the  reasons  or  the  reasons  behind  it  are  good,
but  it  may  make  it  take  longer.  – Are  there  any  people,  are  there  contraindications  or  contraindications?  for  the  medication  women  who  should  not  be  taking?  There  are  no  contraindications  at  present.
Oh  That’s  great.  That  is  great  to  know  because  that’s  just  the  the  most  frightening  thing  for  women  and  And  another  point  that  I  want  to  make  too  that  I’ve  seen  in  some  of  your  talks  that  I’ve  looked  watched  on  YouTube  or  the  internet  is  that  the  treatment  just  of  menopause  that  how  it  shouldn’t  be  really.
It’s  not  really  a  disease  that  it  is  a  natural  phase.  Can  you  talk  a  little  bit  about  that  about  how  that  can  be  an  issue.  Sure,  I  mean,  you  know,
there’s  a  lot  of  concern  about  the  medicalization  of  menopause,  and  there’s  also,  you  know,  the  messages  that  I  feel  are  anti  woman  and  anti  feminist,  and  it’s  highly  gendered  like  oh  women  and  their  hormones,
you  know.  I  think  Rebecca  Thurston  said  it  well  in  the  Times  article,  we  seem  to  be  comfortable  and  more  comfortable  with  women  suffering  in  our  society  than  we  perhaps  should  be.
And  women  don’t  always  speak  up  and  agitate  and  advocate  for  themselves  as  much  as  they  could.  So  I  do  think  that  having  advocacy  in  this  area  would  really  be  helpful.
–

Do  you  think  that  the  FDA  will  make  some  type  of  decision  soon  or  you  just  have  no  idea?  (laughs)  – If  I  could  predict  the  FDA’s  behavior,
I  would  be  at  the  racetrack  right  now  betting  ’cause  I  could  be  at  the  middle  of  the  time.  (laughs)  – Is  it,  I  know  the  phase,  I  was  reading  about  the  phase  two  trials  were  in  2015,
2016.  and  then  phase  three,  if  I’m  understanding  correctly,  started  in  2019.  Is  it  normal  to  take  this  long  or  do  you  think  the  COVID  might  have  delayed?  I  think  that’s  actually  pretty  fast.
This  is  one  of  the  encouragingly  fast  translations  of  the  basic  science  into  something  that’s  clinically  useful.  That’s  something  I  wouldn’t  know  because  I  don’t  know  how  that  works.
And  that’s  what  we  want  to  know.  you  know,  our  listeners  are  your  patients,  are  the  women  that  come  in  and  say,  “I’m  afraid  to  take  hormonal  medications.”  And  I  wish  I  knew  that  there  were  medications  that  are  going  to  be  offered  hopefully  soon  that  can  help  my  hot  flashes.
And  I  think  just  finding  out  more  about  the  fact  that  the  hypothalamus  and  the  neurons  obviously  were  laid  people,  so  it  sounds  a  little  Latin  to  us,  but  the  more  you  know,
the  more  information  we  can  give  our  listeners.  Yeah,  and  we  will  learn  a  lot,  you  know,  in  post -marketing  is  sometimes  where  we  learn  a  lot,  and  we  do  also  learn  about  the  weird  and  rare  side  effects  that  can  happen.
So  as  of  now,  I  would  say  probably  we’re  up  to  thousands  of  women  that  have  been  studied,  but  we’re  not  up  to  tens  of  thousands,  and  that’s  when  you  can  pick  up  anything  that  might  be  unusual  or  rare,
that  may  lead  to  further  precautions  or  contraindications  for  the  medication.  But  as  of  now,  we  have  a  good  one  year  of  safety  on  women  and  it  looks  quite  safe.
Thank  you  so  much  for  telling  us  about  this  and  everything  that  you’re  doing.  And  thank  you  for  what  you’re  doing  because  it  is  is  the  physicians  and  the  researchers  that  are  coming  out  with  this  stuff  that  is  actually  going  to  make  such  a  difference  in  women’s  lives.
So  thank  you  for  everything  that  you’re  doing.  Oh,  you’re  very  welcome.  It’s  really  fun  to  do  because  it  does  make  a  difference  in.  It  does.  It  absolutely  does.  And  absolutely  does.
And  all  of  us  who  have  lived  through  menopause  appreciate  all  of  this  research.  Yes.  – Thank  you  so  much  for  coming  on.  – All  right.

 

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