DOSSIERS: Big Pharma ripoffs make headlines, but EpiPen’s greed is normal, systemic, not an aberration.
FROM VARIOUS SOURCES. DOSSIER EDITED AND PREPARED BY PATRICE GREANVILLE
SUCKER NEWS: Clinton Calls For Lower Price On Allergy Drug Epipen The fault is certainly with the appalling politicians that capitalism puts in power, and naturally the equally prostituted corporate media scarcely help matters by giving this and similar systemic issues spotty coverage. But not even the mainstream media can be fully blamed for this latest scandal, for it would really require a certifiable idiot to live in the US as an ordinary citizen, be continually confronted with a machinery of multi-tiered ripoffs and restricted access to medical services, and not realize there’s something horribly wrong, putrid with the healthcare system. Below we present a sampler of materials on this case. The first is a Reuters dispatch on Clinton’s worthless pronouncements on the EpiPen outrage, still being defended by industry hacks and the company’s CEO herself, a daughter of West Virginia Senator (D) Jim Manchin. The second is an excerpt from Wikipedia’s page on Epinephrine autoinjectors. We suggest you examine this page in detail, as it is an education. What you will see is not so much a story about a medical solution to a serious condition, but a document that will remind any alert reader to what extent drugs in capitalist society are nothing but commodities to make oodles of money from. Hardly an earth-shattering revelation in the US, a nation soaked in capitalist values, endemic corruption and propaganda, but it still needs to be said that this state of affairs should be an anomaly in any healthy society, yet in America it is regarded as normal. The page is a long recital of sales and purchases by various pharmaceutical combines, all buying and selling the rights to market this drug with no thought whatever to the public interest. The recitation of EpiPen’s tortured journey, from its development to this day, also strongly suggests the nefarious role played by the FDA, not as a friend of the public, but as a politically manipulable player making the entry of competing drugs far more difficult than warranted, and thereby strengthening existing monopolies like EpiPen. Lastly, we also include some video discussion that is self-explanatory. The New York Times, by the way, filed an interesting article on EpiPen’s CEO, H. Bresch, a veritable portrait in the reigning pathology.—PG
As usual when it comes to corporate scoundrels, US politicians invoke “voluntary restraint and good behaviour.” Yea, that’s gonna cure what is in truth a deeply systemic problem caused by capitalist ethics—hum, no, make capitalism’s lack of any ethics. Anyone who believes in Clinton’s sanctimonious posturing about this outrage will believe anything. After all, she’s not called Wall Street’s darling for nothing. Meanwhile, the Big Uncle Tom at 1600 Pennsylvania Ave., has kept basically mum about this. It’s clear that Mylan, the maker of EpiPen, a virtual monopoly, is a despicable corporation, but so is the rest of the industry, as Big Pharma has long been a key player in that huge ripoff scheme that goes by the name of US national healthcare system. (See our post elsewhere by Robert Weissman on Big Pharma et al’s corruption of the US political process.)
FIRST: THE REUTERS REPORT
Thursday, Aug 25, 2016 / By Reuters
Democratic presidential candidate Hillary Clinton called on pharmaceutical company Mylan NV to voluntarily drop the price of its severe allergy treatment drug EpiPen, which has increased in price by more than 400 percent in the past decade.
“That’s outrageous – and it’s just the latest troubling example of a company taking advantage of its consumers,” Clinton said in a statement. “It’s wrong when drug companies put profits ahead of patients, raising prices without justifying the value behind them.”
Clinton frequently said during the primary that she would fight pharmaceutical companies – part of an attempt to counter criticism that she was too closely tied to the insurance industry. She has released a proposal that she says will lower drug costs for consumers.
Mylan spokeswoman Nina Devlin did not respond to inquiries about Clinton’s criticism of the company. Mylan acquired the product in 2007, and the price increased from $100 in 2008 to its current cost of $600.
Shares of Mylan closed down more than 5 percent at $43.15 on the Nasdaq.
![RobertWeissman--PIGpresident](https://www.greanvillepost.com/wp-content/uploads/2016/08/RobertWeissman-PIGpresident.jpg)
Weissman: spot on
“The price of EpiPen is outrageous,” said Robert Weissman, president of consumer watchdog group Public Citizen. “Mylan is endangering lives and ripping off the country.”
Weissman said EpiPen’s U.S. price should be rolled back sharply, noting the product is available for as little as $112 in Canada. (That price is also a gross ripoff, as the drug costs a couple of dollars to manufacture.—Eds) Many other drugmakers also routinely raise prices of their prescription drugs by 10 percent or more each year, and U.S. legislation is needed to prevent such “price spikes,” he added.
The White House took a more cautious tone in criticizing rising drug costs, refusing to comment on the decisions of an individual company.
“I will observe, however, that pharmaceutical companies that often try to portray themselves as the inventors of life-saving medication often do real damage to their reputation by being greedy and jacking up prices in a way that victimizes,” White House spokesman Josh Earnest said at a news briefing.
Clinton joins a bipartisan group of lawmakers who are calling for investigations into the price increase of EpiPens, which are preloaded injections of epinephrine (adrenaline) that people use if they are having a dangerous allergic reaction that untreated could result in death.
Republican Senator Chuck Grassley, chairman of the Senate Judiciary Committee, wrote Mylan earlier in the week to ask for an explanation of the price change. Senator Amy Klobuchar, the top Democrat on the committee’s antitrust subcommittee, called for an investigation by the Federal Trade Commission.
On Wednesday, Republican Senator Susan Collins and Democratic Senator Claire McCaskill requested that Mylan provide a briefing for the Senate to explain the price change.
Grassley and Klobuchar, along with Democratic Senators Patrick Leahy and Richard Blumenthal and Republican Senator Ron Johnson, on Wednesday said they had written to the Food and Drug Administration to ask about its approval process for alternatives to the EpiPen.
“Given the importance of this topic, it is imperative to understand the FDA’s role with respect to EpiPens and its approval of generic equivalents that could help to increase competition and lower prices if introduced,” the senators said in a statement.
“We have reached out to every member of Congress who has sent us a letter, and we look forward to meeting with them and responding to their questions as soon as possible,” Devlin said.
![Mylan's CEO Heather Bresch: defiantly justifying EpiPen's ripoff.](https://www.greanvillepost.com/wp-content/uploads/2016/08/EpiPen-Heather_Bresch-600x251.jpg)
Mylan’s CEO Heather Bresch: defiantly defending EpiPen’s ripoff price. Offering token remedies to the scam.
In January, Clinton admonished Valeant Pharmaceuticals International Inc, which raised the price of a heart drug. In the wake of a Clinton campaign blog post targeting Valeant, the company’s stock fell. In March, she released a campaign ad vowing to target the company specifically.
Clinton also criticized Turing Pharmaceuticals in the fall of 2015 when public ire rose after it decided to raise the price of an antiviral medication commonly used by AIDS patients and pregnant women from $13.50 a tablet to $750 each.
After a single post by Clinton on the social media website Twitter critical of Turing, the company’s stock price tumbled.
At that time, Clinton released a comprehensive drug price plan that she says would reduce costs. Her proposal includes capping monthly out-of-pocket costs, expanding generic drug access and allowing Americans to buy pharmaceuticals abroad.
Republican presidential candidate Donald Trump has said little about lowering drug prices. He has proposed increasing the amount of negotiations permitted by Medicare in order to lower prices for those using the program. Source : reuters.com
The meandering corporate (not medical) saga of EpiPen: A typically sordid capitalist story
Below an excerpt from the Wikipedia page dedicated to this topic.
….
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
Drug Maker Mylan Standing Firm on EpiPen Price Hike
Sarah Jessica Parker Quits As Spokesperson For EpiPen After Price Hike
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
![HeatherBresch-NYT](https://www.greanvillepost.com/wp-content/uploads/2016/08/HeatherBresch-NYT-267x400.jpg)
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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