ASH Clinical News June 2016 | Page 15

UP FRONT
We asked applicants , “ Where do you see yourself in five or 10 years ?” Predictably , most said something along the lines of , “ a clinician-scientist at a university .” Any other answer would have been seppuku . We next asked their wives ( at that time most applicants were men ), “ Where do you see your husband in five or 10 years ?” Their answers were rather different ; usually something along the line of , “ I think he will be in private practice in Pebble Beach .” We tracked down the applicants a decade later to see where they were . Readers will not be surprised to learn many were in Pebble Beach .
Today , over one-half of applicants are female , so we have to change the approach . I have found that men are far less insightful and less realistic ! But the point is , spouses , partners , life partners , or significant others are often a better judge of career trajectories than the applicants themselves .
What is the strangest interview question you ’ ve ever been asked ? My career has touched on many different areas besides traditional hematology . I ’ ve been an expert in dealing with the aftermath of nuclear accidents and the role of nuclear energy on an international level .
Immediately after the Chernobyl accident 30 years ago , Mikhail Gorbachev invited me to a press conference with the international press corps in Moscow . The press had been kept in the dark about the accident for two weeks ; I was the only foreigner who knew the medical details of the accident . Wild claims of hundreds or even thousands of deaths had been published – some by seemingly trustworthy news sources .
The interview room was filled with about 1,000 journalists from around the world . I went up to the podium and was handed a stack of supposedly spontaneously written questions . ( In the Soviet Union , a press conference is not an open-ended question-and-answer situation .) I took the first question from the top of the stack and read it to myself : “ Why are Western countries taking advantage of this tragedy in the Soviet Union ?”
I realized I was alone on the podium , the only person with a microphone ( well , the only person in front of more than 100 microphones ), and the only person who could see the question . I looked at the slip of paper for about 30 seconds ( a long time in a press conference ) and said , “ The first question is : ‘ Why are the Western countries helping the Soviet Union cope with
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this terrible tragedy ?’” Needless to say my KGB handlers were not happy . But what could they do ? The U . S . delegation and I had shared several vodkas when it was over !
Has helping the victims of nuclear accidents always been an interest of yours ?
PROVEN PROPHYLAXIS

+

SIMPLE ,* TWICE-WEEKLY DOSING SCHEDULE

= conversations THEIR WAY

Proven results with ADYNOVATE
+ Zero median ABR for joint or spontaneous bleeding episodes while on prophylaxis † 1
+ 98 % of patients ( n = 120 ) remained on their starting dose and did not need a dose adjustment . Only 2 people increased their dose to 60 IU / kg during prophylaxis due to bleeding in target joints 1
* ADYNOVATE allows patients to infuse on the same 2 days every week . 1
Joint : 0.0 ( Q1 : 0.0 ; Q3 : 2.0 ) median vs on-demand 38.1 ( Q1 : 24.5 ; Q3 : 44.6 ); 2.9 ( SD 8.0 ) mean vs on-demand 34.7 ( SD 15.1 ). Spontaneous : 0.0 ( Q1 : 0.0 ; Q3 : 2.2 ) median vs on-demand 21.6 ( Q1 : 11.2 ; Q3 : 33.2 ); 2.9 ( SD 7.1 ) mean vs on-demand 26.0 ( SD 19.6 ). 1 , 2
The safety , efficacy , and pharmacokinetics ( PK ) of ADYNOVATE were evaluated in a multicenter , open-label , prospective , nonrandomized , 2-arm clinical study ( N = 137 ) that compared the efficacy of a twice-weekly prophylactic treatment regimen to on-demand treatment and determined hemostatic efficacy in the treatment of bleeding episodes . 1
ADYNOVATE [ Antihemophilic Factor ( Recombinant ), PEGylated ] Important Information
Indication
ADYNOVATE , Antihemophilic Factor ( Recombinant ), PEGylated , is a human antihemophilic factor indicated in adolescent and adult patients ( 12 years and older ) with hemophilia A ( congenital factor VIII deficiency ) for :
• On-demand treatment and control of bleeding episodes
• Routine prophylaxis to reduce the frequency of bleeding episodes
ADYNOVATE is not indicated for the treatment of von Willebrand disease .
DETAILED IMPORTANT RISK INFORMATION CONTRAINDICATIONS
ADYNOVATE is contraindicated in patients who have had prior anaphylactic reaction to ADYNOVATE , to the parent molecule ( ADVATE [ Antihemophilic Factor ( Recombinant )]), mouse or hamster protein , or excipients of ADYNOVATE ( e . g . Tris , mannitol , trehalose , glutathione , and / or polysorbate 80 ).
WARNINGS & PRECAUTIONS Hypersensitivity Reactions Hypersensitivity reactions are possible with ADYNOVATE . Allergic-type hypersensitivity reactions , including
Baxalta , Advate and Adynovate are trademarks of Baxalta Incorporated . USBS / MG159 / 16-0048
I ’ ve spent much of my life on several different fronts : Soviet / American relations ; nuclear issues , including nuclear weapons and nuclear energy ; and bone marrow transplantation . The interaction between these spheres is what I like to call “ atomic hematology .”
I was born in 1945 , just after the atomic bombing [ of Japan ]. My generation grew up during the Cold War and the idea that either the United States or Soviet Union could launch a nuclear attack . This was not an abstract theory ; the basement of my apartment building in New York was designated a bomb shelter ( not that it would have been useful ). It was also suggested you put newspapers over your head in the event of a nuclear
For patients 12 years and older with hemophilia A
anaphylaxis , have been reported with other recombinant antihemophilic factor VIII products , including the parent molecule , ADVATE . Early signs of hypersensitivity reactions that can progress to anaphylaxis may include angioedema , chest tightness , dyspnea , wheezing , urticaria , and pruritus . Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur .
Neutralizing Antibodies Formation of neutralizing antibodies ( inhibitors ) to factor VIII can occur following administration of ADYNOVATE . Monitor patients regularly for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests . Perform an assay that measures factor VIII inhibitor concentration if the plasma factor VIII level fails to increase as expected , or if bleeding is not controlled with expected dose .
ADVERSE REACTIONS Common adverse reactions ( ≥1 % of subjects ) reported in the clinical studies were headache and nausea .
Please see the following page for the Brief Summary of ADYNOVATE .
References : 1 . ADYNOVATE Prescribing Information . Westlake Village , CA : Baxalta US Inc . 2 . Data on file . Baxalta Incorporated .
For more information , visit www . ADYNOVATEPRO . com
ABR = annualized bleeding rate .