Whistleblower Cases: Worst Offenders

Worst Offender Profiles:

1) Vast increases in REPORTED pharma company U.S. sales for an "old" blockbuster drug since Medicare Part D began

 2) ALL U.S. brand drug sales growth is driven by massive 5-to-10-fold U.S. price increases…

 3) While clinical use of the U.S. brand drug by physicians and patients is SHARPLY DECLINING due to severe competition 

THIS CANNOT HAPPEN IN A LEGITIMATE U.S. PHARMACEUTICAL MARKET!!!

U.S. Multiple Sclerosis (MS) Market:

• Uniform massive U.S. brand price increases in the MS category from $15,000 to $100,000 per patient/year since Medicare Part D began
• Despite severe competition and many new similar MS drugs reaching the U.S. market
  • 2005: 4 similar U.S. MS drugs - each cost about $15,000/patient/year
  • 2019: more than a dozen similar U.S. MS drugs - most now cost more than $100,000 patient/year
  • Link to Whistleblower table of  massive uniform U.S. MS drug price increases
• MASSIVE PRICE INCREASES FOR "OLD" U.S. MS BRAND DRUGS DESPITE PLUMMETING USE AND MARKET SHARE
• Severe pricing harm ONLY for Americans; competition prevented MS price increases outside the U.S.
  • Link to Whistleblower chart of U.S. vs. European MS prices

Biogen’s Avonex (MS, on U.S. market since 1996)

• 2005 Reported U.S. Sales: $939 million
• 2017 Reported U.S. Sales: $1.9 billion
• U.S. Clinical Use/Prescriptions DOWN 60-70% since 2005
• 2017 U.S. Sales WITHOUT Price Increases: $322 million
• 2005 U.S. “List”/“Sticker” Price: $15,000/patient/year
• 2018 U.S. “List”/“Sticker” Price: $100,000/patient/year
• Cumulative harm since start of Part D: $12.5+ billion
  • Link to Avonex’s Whistleblower cumulative harm chart 

Teva’s Copaxone (MS, on U.S. market since 1996)

• 2005 Reported U.S. Sales: $782 million
• 2017 Reported U.S. Sales: $3.0 billion
• U.S. Clinical Use/Prescriptions DOWN -40-50% since 2005
• 2017 U.S. Sales WITHOUT Price Increases: $530 million
• 2005 U.S. “List”/“Sticker” Price: $15,000/patient/year
• 2018 U.S. “List”/“Sticker” Price: $100,000/patient/year
• Cumulative harm since start of Part D: $20 billion
  • Link to Copaxone’s Whistleblower cumulative harm chart         

U.S. Insulin Market 

• Uniform massive 5-10-fold U.S. insulin price increases in the decade-plus since Medicare Part D began
• Despite severe competition among numerous similar products
  • Many insulins on the U.S. market for decades
• Severe U.S. patient and family harm
  • Diabetes is the highest spending U.S. brand drug category
  • Rising U.S. deaths from unaffordable insulin
  • Diabetics traveling to abroad for cheaper black market insulin

Sanofi's Lantus (long-acting insulin, on U.S. market since 2000)

• 2005 Reported U.S. Sales: $846 million
• 2017 Reported U.S. Sales: $4.0 billion
• 2017 U.S. Sales WITHOUT Price Increases: $1.8 billion
• A top-spending drug in Medicare Part D
• Cumulative harm since start of Part D: $21.0+ billion
  • Link to Lantus' Whistleblower price 6-FOLD price increase table 
  • Link to Lantus' Whistleblower cumulative harm chart

Eli Lilly’s Humulin (on U.S. market since 1982)

• 2005 Reported U.S. Sales: $411 million
• 2017 Reported U.S. Sales: $885 million
• U.S. Clinical Use/Prescriptions DOWN -60% since 2005
• 2017 U.S. Sales WITHOUT Price Increases: $173 million
• Cumulative harm since start of Part D: $4.1 billion
  • Link to Humulin Whistleblower 6-FOLD price increase table
  • Link to Humulin’s Whistleblower cumulative harm chart 

U.S. Rheumatoid Arthritis/Autoimmune Market 

• Uniform massive 5-10-fold U.S. price increases in the decade-plus since Medicare Part D began
  • from about $15,000 patient/year before Part D to the $75,000 patient/year range now
• Despite rising competition from numerous similar new drugs reaching the U.S market
  • U.S. market still dominated by AbbVie's Humira and Amgen's Enbrel
  • AbbVie's Humira is the world's top-selling drug, with 70% of its 2018 sales ($13.7 billion) in the U.S., driven by far higher U.S. prices
  • Link to Whistlelblower table showing severe and lockstep Humira and Enbrel U.S. price inflation

Amgen’s Enbrel (on U.S. market since 1997)

• 2005 Reported U.S. Sales: $2.47 billion
• 2017 Reported U.S. Sales: $5.2 billion
• U.S. Clinical Use/Prescriptions DOWN -25% since 2005
• 2017 U.S. Sales WITHOUT Price Increases: $1.9 billion
• 2005 U.S. “List”/“Sticker”: $15,000/patient/year
• 2018 U.S. “List”/“Sticker”: $75,000/patient/year
• Cumulative harm since start of Part D: $19.1+ billion
  • Link to Enbrel’s Whistleblower cumulative harm chart 

Abbvie’s Humira (on U.S. market since 2003)

• 2005 Reported U.S. Sales: $560 million
• 2017 Reported U.S. Sales: $12.4 billion
• 2017 U.S. Sales WITHOUT Price Increases: $3.8 billion
• 2005 U.S. “List”/“Sticker”: $15,000/patient/year
• 2018 U.S. “List”/“Sticker”: $75,000/patient/year
• Cumulative harm since start of Part D: $32.3+ billion
  • Link to Humira’s Whistleblower cumulative harm chart 

U.S. Cancer Market: Novartis' Gleevec (Leukemia, on U.S market since 2001) 

• Massive 5-Fold U.S. price after Part D began
  • Majority of Gleevec use in Medicare Part D prior
  • Early 2016 U.S. patent expiration

• 2005 Reported U.S. Sales: $524 million
• 2015 Reported U.S. Sales: $2.5 billion
• 2015 U.S. Sales WITHOUT Price Increases: $700 million
• 2005 U.S. “List”/“Sticker”: $30,000/patient/year
• 2015 U.S. “List”/“Sticker”: $150,000/patient/year
• Cumulative harm since start of Part D: $7.4+ billion
• Link to Whistleblower table showing severe Gleevec price increases
• Link to Gleevec Whistleblower cumulative harm chart

Other Major U.S. Brands 

Pfizer’s Lyrica (seizures/diabetics, on U.S. market since 2004)

• 2005 Reported U.S. Sales: $717 million
• 2017 Reported U.S. Sales: $3.5 billion
• 2017 U.S. Sales WITHOUT Price Increases: $1.16 billion
• Cumulative harm since start of Part D: $10.0+ billion

Other major U.S. Pfizer brands:

• Strong U.S. sales growth driven by severe prices increases
  • As clinical use sharply declined
• Premarin (hormone replacement)
• Viagra: (impotence)
• Celebrex (arthritis, pain)
• Chantix (smoking cessation)
• Link to U.S. Pfizer severe price increase and declining prescription trends