DOSSIERS: Big Pharma ripoffs make headlines, but EpiPen’s greed is normal, systemic, not an aberration.

Below an excerpt from the Wikipedia page dedicated to this topic.
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Medical uses

Epinephrine autoinjectors are hand-held devices carried by those who have severe allergies; the epinephrine delivered by the device is an emergency treatment for anaphylactic reaction.^[2]

Units that have exceeded their expiration date can still be used in an emergency if an unexpired unit is unavailable and the solution is neither discoloured nor contains precipitates.^[3]

Design

The devices contain a fixed dose of epinephrine and a spring-loaded needle that exits the tip or edge of the device and penetrates the recipient’s skin, to deliver the medication via intramuscular injection.^[2]

History

The first modern epinephrine autoinjector, the EpiPen, was invented in the mid-1970s at Survival Technology in Bethesda, Maryland by Sheldon Kaplan.^[1][4] In 1996 Survival Technology merged with a company called Brunswick Biomedical and the new company was called Meridian Medical Technologies Inc..^[5] The EpiPen was marketed and distributed for Medical Technologies by Dey LP, a subsidiary of Merck KGaA.^[6]

In 2001 Meridian introduced a two-pack version of the EpiPen; at that time the device had $23.9 million in annual sales and accounted for 75% of the market in the United States.^[7] In 2002 King Pharmaceuticals acquired Meridian for $247.8 million in cash;^[8] the deal was completed in January 2003.^[9] (King was later acquired by Pfizer in 2010 for $3.6 billion in cash.^[10]) Kaplan continued to improve his designs over the years, filing for example US Patent 6,767,336 in 2003.^[11]

In 2003 Hollister-Stier received approval from the FDA to market an epinephrine autoinjector called Twinject that could deliver two shots of epinephrine, which it had spent ten years developing.^[12][13][14] In 2005 it sold the product to Verus Pharmaceuticals,^[12] which launched the product the same year.^[15] In March 2008 Sciele Pharma acquired Twinject from Verus^[16] and later that year, Sciele was acquired by Shionogi.^[17]

In 2007 Mylan acquired the right to market the EpiPen from Merck KGaA as part of a larger transaction.^[18] At that time annual sales were around $200M.^[19]

In 2009 Teva Pharmaceuticals filed an ANDA to market a generic EpiPen in collaboration with Antares Pharma Inc, a maker of injection systems; King sued them for infringing US Patent 7,449,012 that was due to expire in 2025;^[20] Pfizer, Mylan, and Teva settled in April 2012 in a deal that allowed Teva to start selling the device in mid-2015, pending FDA approval.^[21]

In 2010 Sciele/Shionogi faced a recall of Twinject devices^[22] and launched Adrenaclick, a modified version of the Twinject that could only deliver one dose.^[23][24]

In 2010 King sued Novartis‘ Sandoz generic unit after Sandoz submitted an ANDA to sell a generic EpiPen.^[25]

In the 2009 Intelliject, a US startup developing a new epinephrine autoinjector, licensed their product to Sanofi.^[26] In 2011 King sued Intelliject and Sanofi after the companies filed a 505(b)(2)^[27] New Drug Application for the product, then known as “e-cue”;^[28] Pfizer, Mylan and Sanofi settled in 2012 under a deal that allowed the device to enter the market no earlier than November 2012, pending FDA approval.^[29] On August 13, 2012, the FDA approved the autoinjector, called “Auvi-Q” after the FDA required a name change from “e-cue”.^[30] The device is equipped with a sound chip to provide electronic voice instructions to guide the user in the proper use of the device.^[31][32]

In 2010, European regulators approved Twinject,^[33] and also approved a new epinephrine autoinjector made by ALK and sold under the brand name Jext.^[34][35] Jext was launched in the European Union in September 2011.^[36]

And so it goes. Read the rest of this tawdry tale HERE.

THIRD:  VIDEO MATERIALS

FARRON COUSINS
Dem Senator’s Daughter Responsible For EpiPen Price Hike

ABC News

Even the contemptible right has its uses when it comes to exposing a crook like Hillary Clinton. Here’s Fox’s bulldog Lou Dobbs focusing attention on Hillary’s foundation’s links to EpiPen—I am shocked, shocked!

EpiPen manufacturer’s link to the Clinton Foundation

PAGE 2. Repository below

BUSINESS DAY|  NOTE: This is a repository post, making sure our readers always have access to this story. Just in case the NYTimes decides to delete it from circulation or make it less accessible. 

Painted as EpiPen Villain, Mylan’s Chief Says She’s No Such Thing 

Heather Bresch, chief of Mylan, which has a reputation for bare-knuckled tactics that have angered competitors and investors. Credit Andrew Hetherington/Redux

By KATIE THOMAS, The New York Times
AUG. 26, 2016

America has a new pharmaceutical villain. Her name is Heather Bresch.

As the chief executive of Mylan, the owner of the severe allergy treatment EpiPen, Ms. Bresch is at the center of the latest public outrage over high drug prices, excoriated for overseeing a fourfold price increase on EpiPen while taking a huge pay raise.

From talk shows to Twitter, her name is being mentioned alongside Martin Shkreli, the so-called Pharma Bro who ignited anger last fall over raising the price of the drug Daraprim, and J. Michael Pearson, the onetime McKinsey consultant who took over Valeant Pharmaceuticals International and sharply raised prices on lifesaving drugs.

But Mr. Shkreli and Mr. Pearson were outliers trying to upend the industry. At one point, the pharmaceutical industry’s main lobbying group disavowed them.

Not so with Ms. Bresch. In many ways, she is an ultimate insider. Her father is a United States senator. She runs one of the largest generic drug companies in the world. She also oversees the Generic Pharmaceutical Association — the generic industry’s lobbying group.

Now the question is whether her different position will give her a different result. Both Mr. Shkreli and Mr. Pearson were forced out of their companies.

Already, Ms. Bresch, 47, has moved more quickly than they did to quell public furor over prices. On Thursday, she announced that the company was increasing financial assistance to patients to reduce their out-of-pocket costs. But the company did not say it would lower the list price — which has risen to about $600 for a pack of two EpiPens, from about $100 when Mylan acquired the product in 2007.

In an interview, Ms. Bresch said the price increases on EpiPen weren’t even in the “same hemisphere” as what Mr. Shkreli did when he raised the price of Daraprim by 50 times overnight.

Over the years, her brash leadership style has bruised egos but also, some say, improved access to drugs and raised quality standards. Her company, Mylan, also has a reputation for bare-knuckled tactics that have angered competitors and investors alike.

“I think we mean what we say: You can do good and do well, and I think we strike that balance around the globe,” Ms. Bresch said. Still, she was unapologetic that Mylan’s actions were driven by profit. “I am running a business. I am a for-profit business. I am not hiding from that.”

How the company, and Ms. Bresch, strikes that balance seems to be quickly changing. Generic drug companies once dealt almost exclusively in making cheap copies of pills and railed passionately against the anticompetitive tactics of brand-name competitors. Now, through a series of acquisitions and mergers, the handful of large generic companies that are left are increasingly investing in expensive brand-name drugs and in doing so, are embracing many of the tactics they once scorned.

“It’s like talking out of both sides of your mouth,” said Dinesh Thakur, an advocate for generic drug quality. “To me, I think, it’s opportunistic.”

In the interview, Ms. Bresch said the company’s latest actions would do the most to help patients where it mattered, by reducing their out-of-pocket costs. And she said that the $600 list price was necessary for the company to recoup its investment in the EpiPen, which includes raising awareness for severe allergic reaction and making improvements to the way the product works.

But she also sought to shift blame away from Mylan, saying that patients are feeling the pain in part because insurers have increased the amount that customers must pay in recent years.

“What else do you shop for that when you walk up to the counter, you have no idea what it’s going to cost you?” she said. “Tell me where that happens anywhere else in the system. It’s unconscionable.”

To some, the company’s response seemed to ring hollow. “It’s a real challenge to understand how a management team sits around a board table and makes a decision to raise the price of a lifesaving medication over and over and over, and when the P.R. storm hits, decides to blame someone else for that price increase,” said David Maris, an analyst for Wells Fargo. He had warned investors in June that Mylan’s price increases on EpiPen and other drugs could soon draw unwanted media scrutiny.

The company is not a stranger to controversy. Robert J. Coury, Mylan’s chairman who served as chief executive until 2011, came under scrutiny in 2012 for using the company’s corporate jet to travel to his son’s music concerts. And last year, The Wall Street Journal reported that one of the board members had undisclosed ties to the land where the company built its new Pittsburgh offices.

Ms. Bresch has also weathered her share of controversy, like when it was discovered that West Virginia University awarded her a business degree 10 years after she had attended the school, even though she had completed only about half of the coursework. A report by the university later concluded that officials wrongly awarded her the degree because she was the daughter of the then-governor Joe Manchin, now a Democratic senator representing West Virginia. Mr. Manchin and Ms. Bresch have said they did nothing wrong.

The company also angered shareholders when it switched its headquarters to the Netherlands, and then used a little-known provision in Dutch law to block a takeover by the pharmaceutical giant Teva, which many investors had favored. The move to the Netherlands in 2014, called an inversion, also reduced the company’s tax rate. Mylan is one of a string of pharmaceutical companies that have done inversions in recent years, prompting outcry in Washington and calls to limit the practice.

Ms. Bresch’s rising salary has also fueled anger over the EpiPen price increase. Since 2007, when EpiPen was acquired and she was the company’s chief operating officer, she earned about $2.5 million in total compensation. In 2015, her compensation was nearly $19 million. Mylan’s board has said in company filings that it believes her pay is justified because she has contributed significantly to the company’s growth in recent years.

Ms. Bresch, who has worked at Mylan for 25 years, said her West Virginia upbringing had informed her approach to serving as chief executive. “There is a work ethic and grit about that that allows me to help make a difference,” she said.

Some of the chafing at her style, she said, is because people are resistant to change. Her top accomplishments, she said, include getting a federal law passed that required more inspections of overseas drug manufacturers, and improving access to AIDS drugs for patients overseas. “To make change happen, to make a difference, mediocrity doesn’t get you there.”

Even as they have ruffled feathers within the industry, Ms. Bresch and Mylan have earned measured praise from consumer advocates, who said she wielded her influence in ways that helped consumers.

James Love, director of the consumers group Knowledge Ecology International, said Ms. Bresch opened doors at the Office of the United States Trade Representative when his group and others were working to change provisions in the proposed Trans-Pacific Partnership that they said would have limited access to drugs by people overseas. Mylan, as a seller of generic drugs, shared their interest, he said.

“They came in with some very talented people in the negotiations, and they knew what was going on politically,” Mr. Love said.

Still, he said, he opposes their position on the EpiPen and said his group was composing a letter of complaint to the Federal Trade Commission.

“I’m appalled at the price increase,” he said. “I don’t want to sugarcoat that.”

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