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| EpiPen Maker Quietly Steers Effort That Could Protect Its Price | |
| (about 4 hours later) | |
| WASHINGTON — Against a growing outcry over the surging price of EpiPens, a chorus of prominent voices has emerged with a smart-sounding solution: Add the EpiPen, the lifesaving allergy treatment, to a federal list of preventive medical services, a move that would eliminate the out-of-pocket costs of the product for millions of families — and mute the protests. | WASHINGTON — Against a growing outcry over the surging price of EpiPens, a chorus of prominent voices has emerged with a smart-sounding solution: Add the EpiPen, the lifesaving allergy treatment, to a federal list of preventive medical services, a move that would eliminate the out-of-pocket costs of the product for millions of families — and mute the protests. |
| Dr. Leonard Fromer, a clinical professor of family medicine at the University of California, Los Angeles, just promoted the idea in the prestigious American Journal of Medicine. A handful of groups are preparing a formal request to the government. And Tonya Winders, who runs a patient advocacy nonprofit organization, reached out late last month to crucial lawmakers on Capitol Hill. | Dr. Leonard Fromer, a clinical professor of family medicine at the University of California, Los Angeles, just promoted the idea in the prestigious American Journal of Medicine. A handful of groups are preparing a formal request to the government. And Tonya Winders, who runs a patient advocacy nonprofit organization, reached out late last month to crucial lawmakers on Capitol Hill. |
| “We can save lives by ensuring access to these medications,” said Ms. Winders, chief executive of the Allergy and Asthma Network. | “We can save lives by ensuring access to these medications,” said Ms. Winders, chief executive of the Allergy and Asthma Network. |
| A point not mentioned by these advocates is that a big potential beneficiary of the campaign is Mylan, the pharmaceutical giant behind EpiPens. The company would be able to continue charging high prices for the product without patients complaining about the cost. | A point not mentioned by these advocates is that a big potential beneficiary of the campaign is Mylan, the pharmaceutical giant behind EpiPens. The company would be able to continue charging high prices for the product without patients complaining about the cost. |
| An examination of the campaign by The New York Times, including a review of documents and interviews with more than a dozen people, shows that Mylan is well aware of that benefit and, in fact, has been helping orchestrate and pay for the effort. | An examination of the campaign by The New York Times, including a review of documents and interviews with more than a dozen people, shows that Mylan is well aware of that benefit and, in fact, has been helping orchestrate and pay for the effort. |
| The journal article says it was “drafted and revised” by a medical writing consulting firm paid by Mylan, in consultation with Dr. Fromer. And Dr. Fromer himself has served in the last year as a paid Mylan consultant — which he discloses as part of the journal article. The company has also contributed money to many other groups behind the effort, and it has met with them — and Ms. Winders’s organization in particular — to coordinate its strategy, the participants said. | The journal article says it was “drafted and revised” by a medical writing consulting firm paid by Mylan, in consultation with Dr. Fromer. And Dr. Fromer himself has served in the last year as a paid Mylan consultant — which he discloses as part of the journal article. The company has also contributed money to many other groups behind the effort, and it has met with them — and Ms. Winders’s organization in particular — to coordinate its strategy, the participants said. |
| The effort has accelerated in recent weeks, just as Mylan has faced a flood of criticism about its pricing of EpiPens. The retail price for the standard two-pack has jumped nearly fivefold since 2010, hitting $608 this year. Multiple lawmakers and regulators have opened investigations into the pricing of the product, which has virtually no market competition. | The effort has accelerated in recent weeks, just as Mylan has faced a flood of criticism about its pricing of EpiPens. The retail price for the standard two-pack has jumped nearly fivefold since 2010, hitting $608 this year. Multiple lawmakers and regulators have opened investigations into the pricing of the product, which has virtually no market competition. |
| The idea being advanced is simple: If the EpiPen makes the federal preventive list, most Americans would have no insurance co-pay when getting the product. That means they could obtain the medication with no direct cost, regardless of its retail price. Mylan could keep the EpiPen at the current price, or perhaps raise it more, while keeping patient anger at a minimum. | |
| Instead, the federal government, health insurers and employers would pay the bill. Those costs, in turn, could be passed on to consumers in other ways, as in higher premiums or higher co-pays on other drugs. | Instead, the federal government, health insurers and employers would pay the bill. Those costs, in turn, could be passed on to consumers in other ways, as in higher premiums or higher co-pays on other drugs. |
| “In a way, it is brilliant,” said Rachel E. Sachs, a law professor who specializes in public health policy at Washington University in St. Louis. “We are all seeing them for what they are — the poster child for high drug prices right now, but they don’t want to be. And this tactic is nothing but a self-serving move, not a public-regarding one.” | “In a way, it is brilliant,” said Rachel E. Sachs, a law professor who specializes in public health policy at Washington University in St. Louis. “We are all seeing them for what they are — the poster child for high drug prices right now, but they don’t want to be. And this tactic is nothing but a self-serving move, not a public-regarding one.” |
| Mylan, in a statement, acknowledged financing “research, resource development and travel” by the nonprofit coalition Ms. Winders formed in collaboration with the company to help push for the change. But, the company said, “we were clear in our corporate sponsorship agreements that the coalition would maintain control.” | Mylan, in a statement, acknowledged financing “research, resource development and travel” by the nonprofit coalition Ms. Winders formed in collaboration with the company to help push for the change. But, the company said, “we were clear in our corporate sponsorship agreements that the coalition would maintain control.” |
| The company also pointed to steps it had taken to lower the price of the EpiPen. Mylan has announced more rebates for some patients and it is preparing to release a less expensive generic version. | The company also pointed to steps it had taken to lower the price of the EpiPen. Mylan has announced more rebates for some patients and it is preparing to release a less expensive generic version. |
| The decision about whether to label EpiPens a preventive drug will fall to the United States Preventive Services Task Force, a federally appointed group of physicians and public health experts. The group reviews disease screenings, counseling and other treatments to determine if they are sufficiently effective to make the list. Under the Affordable Care Act, certain recommendations from the task force must be adopted by almost all insurers. | The decision about whether to label EpiPens a preventive drug will fall to the United States Preventive Services Task Force, a federally appointed group of physicians and public health experts. The group reviews disease screenings, counseling and other treatments to determine if they are sufficiently effective to make the list. Under the Affordable Care Act, certain recommendations from the task force must be adopted by almost all insurers. |
| The EpiPen is an epinephrine auto-injector, meaning it contains a portable supply of epinephrine that can be quickly administered to a person suffering from an allergic reaction. Proponents of adding EpiPen to the federal list argue that it can prevent a fatal allergic reaction, by stopping anaphylactic shock from progressing, if taken immediately. | The EpiPen is an epinephrine auto-injector, meaning it contains a portable supply of epinephrine that can be quickly administered to a person suffering from an allergic reaction. Proponents of adding EpiPen to the federal list argue that it can prevent a fatal allergic reaction, by stopping anaphylactic shock from progressing, if taken immediately. |
| Getting the designation could be difficult, since there are no prescription medications for diagnosed illnesses on the preventive list. The task force has recommended at least one over-the-counter medication: aspirin. But generally it lists treatments for a patient only if there are “no signs or symptoms of the specific disease or condition,” the agency said — like a cancer screening. The task force chairwoman, in a statement, appeared to all but rule out adding EpiPens to its list of recommendations. | Getting the designation could be difficult, since there are no prescription medications for diagnosed illnesses on the preventive list. The task force has recommended at least one over-the-counter medication: aspirin. But generally it lists treatments for a patient only if there are “no signs or symptoms of the specific disease or condition,” the agency said — like a cancer screening. The task force chairwoman, in a statement, appeared to all but rule out adding EpiPens to its list of recommendations. |
| But a review of Mylan’s lobbying history makes clear that the company has an exceptional track record at influencing government policies, both in Washington and in state capitals. Heather Bresch, Mylan’s chief executive, called the effort “our unconventional approach to growing this franchise” in remarks to Wall Street analysts last year. | But a review of Mylan’s lobbying history makes clear that the company has an exceptional track record at influencing government policies, both in Washington and in state capitals. Heather Bresch, Mylan’s chief executive, called the effort “our unconventional approach to growing this franchise” in remarks to Wall Street analysts last year. |
| Mylan was actively involved in pushing a 2013 federal law encouraging schools nationwide to stock EpiPens. And the company takes credit for legislation in at least 10 states that require the product in hotels, restaurants and other places, and additional school-related legislation in nearly every state. It is also helping push legislation pending in Congress that would require epinephrine auto-injectors on all commercial airline flights. | Mylan was actively involved in pushing a 2013 federal law encouraging schools nationwide to stock EpiPens. And the company takes credit for legislation in at least 10 states that require the product in hotels, restaurants and other places, and additional school-related legislation in nearly every state. It is also helping push legislation pending in Congress that would require epinephrine auto-injectors on all commercial airline flights. |
| The company and its employees are major contributors to lawmakers, both Democrats and Republicans, on Capitol Hill. Ms. Bresch is the daughter of Senator Joe Manchin, Democrat of West Virginia. | The company and its employees are major contributors to lawmakers, both Democrats and Republicans, on Capitol Hill. Ms. Bresch is the daughter of Senator Joe Manchin, Democrat of West Virginia. |
| Effectively pushing such arguments through various public awareness campaigns has helped expand the epinephrine auto-injector market. The product now accounts for 99 percent of the market’s $1 billion in sales in the first six months of this year, the research firm IMS Health estimates. | Effectively pushing such arguments through various public awareness campaigns has helped expand the epinephrine auto-injector market. The product now accounts for 99 percent of the market’s $1 billion in sales in the first six months of this year, the research firm IMS Health estimates. |
| EpiPen’s market dominance is partly the result of the recall last year of a main competitor, Auvi-Q, after its manufacturer discovered problems with the dosage. | EpiPen’s market dominance is partly the result of the recall last year of a main competitor, Auvi-Q, after its manufacturer discovered problems with the dosage. |
| The drive to get EpiPens added to the preventive services list appears to have started in earnest late last year, just as the public and politicians started to focus on drug pricing. | The drive to get EpiPens added to the preventive services list appears to have started in earnest late last year, just as the public and politicians started to focus on drug pricing. |
| Mylan began to hear complaints, including some from the patient advocacy groups that it funds with millions of dollars in grants. Ms. Winders of the Allergy and Asthma Network said it was at a meeting with Mylan in November that the company proposed getting the epinephrine auto-injectors designated a preventive drug, and she agreed to help. | Mylan began to hear complaints, including some from the patient advocacy groups that it funds with millions of dollars in grants. Ms. Winders of the Allergy and Asthma Network said it was at a meeting with Mylan in November that the company proposed getting the epinephrine auto-injectors designated a preventive drug, and she agreed to help. |
| Mylan gives money to Ms. Winders’s organization to help expand treatment for severe allergies. She would not say how much the company has given, or the exact terms, citing a confidentiality agreement. But part of that money is related to this push, Ms. Winders acknowledged. | Mylan gives money to Ms. Winders’s organization to help expand treatment for severe allergies. She would not say how much the company has given, or the exact terms, citing a confidentiality agreement. But part of that money is related to this push, Ms. Winders acknowledged. |
| “I am being compensated to ensure access to epinephrine,” Ms. Winders said in an interview last week. | “I am being compensated to ensure access to epinephrine,” Ms. Winders said in an interview last week. |
| Nina Devlin, a Mylan executive, rejected a request by The Times to release these nonprofit groups from their confidentiality agreements. But she did say that the company donated a total of $1.8 million this year to nine nonprofits “in support of anaphylaxis awareness and education initiatives,” of which about $227,500 was to push for the federal listing. | Nina Devlin, a Mylan executive, rejected a request by The Times to release these nonprofit groups from their confidentiality agreements. But she did say that the company donated a total of $1.8 million this year to nine nonprofits “in support of anaphylaxis awareness and education initiatives,” of which about $227,500 was to push for the federal listing. |
| Financial relationships between pharmaceutical companies and patient advocacy groups are extremely common — and often benefit the drug company’s lobbying agendas. | Financial relationships between pharmaceutical companies and patient advocacy groups are extremely common — and often benefit the drug company’s lobbying agendas. |
| With company support, Ms. Winders’s organization hosts conferences every year that bring together allergists, pediatricians, school nurses and elected officials. At the conferences, held in St. Louis, Orlando and Las Vegas this year, the attendees detail plans to help win passage of legislation intended to increase the distribution of epinephrine. | With company support, Ms. Winders’s organization hosts conferences every year that bring together allergists, pediatricians, school nurses and elected officials. At the conferences, held in St. Louis, Orlando and Las Vegas this year, the attendees detail plans to help win passage of legislation intended to increase the distribution of epinephrine. |
| For the preventive drug push, Ms. Winders has been joined by representatives from other allergy organizations, all with somewhat similar financial ties to Mylan. They include the American Latex Allergy Association, the Food Allergy & Anaphylaxis Connection Team and the Asthma and Allergy Foundation of America. | For the preventive drug push, Ms. Winders has been joined by representatives from other allergy organizations, all with somewhat similar financial ties to Mylan. They include the American Latex Allergy Association, the Food Allergy & Anaphylaxis Connection Team and the Asthma and Allergy Foundation of America. |
| Eleanor Garrow-Holding, the president of the Ohio-based Food Allergy & Anaphylaxis Connection Team, said the effort was “initiated by Mylan” and acknowledged that her group also receives annual grants from the company. | Eleanor Garrow-Holding, the president of the Ohio-based Food Allergy & Anaphylaxis Connection Team, said the effort was “initiated by Mylan” and acknowledged that her group also receives annual grants from the company. |
| After The Times raised questions about the arrangement, she added in an email this week that Mylan was “not part of this task force moving forward. Only the patient advocacy groups are actively participating.” | After The Times raised questions about the arrangement, she added in an email this week that Mylan was “not part of this task force moving forward. Only the patient advocacy groups are actively participating.” |
| In addition, Ms. Winders and Ms. Garrow-Holding both took offense to the idea that Mylan’s money had affected their organizations’ work. | In addition, Ms. Winders and Ms. Garrow-Holding both took offense to the idea that Mylan’s money had affected their organizations’ work. |
| “Mylan nor any other industry partner dictates our position,” Ms. Winders said. “They have no direct influence over our messaging.” | “Mylan nor any other industry partner dictates our position,” Ms. Winders said. “They have no direct influence over our messaging.” |
| But at least two groups declined to participate in the effort, citing the appearance of a conflict of interest, their representatives said in interviews. | But at least two groups declined to participate in the effort, citing the appearance of a conflict of interest, their representatives said in interviews. |
| Dr. Bobby Quentin Lanier, executive medical director of the American College of Allergy, Asthma and Immunology, a nonprofit group of allergy doctors, said his group had spurned Mylan’s offer of payments for a series of papers focused on “the possibility of adding the epinephrine auto-injector to the national preventive drug list.” | Dr. Bobby Quentin Lanier, executive medical director of the American College of Allergy, Asthma and Immunology, a nonprofit group of allergy doctors, said his group had spurned Mylan’s offer of payments for a series of papers focused on “the possibility of adding the epinephrine auto-injector to the national preventive drug list.” |
| “As we looked at it, we thought, ‘No way that we could do that,’” Dr. Lanier said. | “As we looked at it, we thought, ‘No way that we could do that,’” Dr. Lanier said. |
| Dr. James R. Baker Jr., chief executive and medical director of the Food Allergy Research and Education group, which has historically taken money from Mylan, said he had been offered money to lead the effort, a role Ms. Winders is now playing. | Dr. James R. Baker Jr., chief executive and medical director of the Food Allergy Research and Education group, which has historically taken money from Mylan, said he had been offered money to lead the effort, a role Ms. Winders is now playing. |
| “We just didn’t feel, given the structuring, that it fully aligned with our role as a patient advocate,” Dr. Baker said. (He would not name the organization that he said had offered him the money, citing a confidentiality agreement.) | “We just didn’t feel, given the structuring, that it fully aligned with our role as a patient advocate,” Dr. Baker said. (He would not name the organization that he said had offered him the money, citing a confidentiality agreement.) |
| As of last week, he decided to no longer accept donations from pharmaceutical companies that make products that serve his members. | As of last week, he decided to no longer accept donations from pharmaceutical companies that make products that serve his members. |
| With the nonprofit groups that still take donations from Mylan, the effort to get epinephrine auto-injectors on the preventive list is moving ahead. | With the nonprofit groups that still take donations from Mylan, the effort to get epinephrine auto-injectors on the preventive list is moving ahead. |
| Ms. Winders said her group planned to send a formal submission to the United States Preventive Services Task Force in November. The patient advocates are separately planning to set up meetings with the nation’s eight largest insurers to ask them to add epinephrine auto-injectors to their own lists, even if the federal government does not make the move. | Ms. Winders said her group planned to send a formal submission to the United States Preventive Services Task Force in November. The patient advocates are separately planning to set up meetings with the nation’s eight largest insurers to ask them to add epinephrine auto-injectors to their own lists, even if the federal government does not make the move. |
| The task force could list the EpiPen in a couple of different ways: either mandating that insurers cover the auto injectors with no co-pay or putting them on a lower-priority list that many insurers still adopt, eliminating the co-pay even though the insurer is not required to do so. But Mylan, in a statement, said it was seeking the most exclusive status, on the A list. Under the Affordable Care Act, most private health insurance plans must cover certain recommended preventive service, including those on the A list, without any charge to the patient. | The task force could list the EpiPen in a couple of different ways: either mandating that insurers cover the auto injectors with no co-pay or putting them on a lower-priority list that many insurers still adopt, eliminating the co-pay even though the insurer is not required to do so. But Mylan, in a statement, said it was seeking the most exclusive status, on the A list. Under the Affordable Care Act, most private health insurance plans must cover certain recommended preventive service, including those on the A list, without any charge to the patient. |
| The article Dr. Fromer published in The American Journal of Medicine will almost certainly help the cause. It makes the exact argument that Mylan wants to push: “The recognition and classification of epinephrine as a preventive medicine by both the U.S. Preventive Services Task Force and insurers could increase patient access, improve outcomes and save lives.” | The article Dr. Fromer published in The American Journal of Medicine will almost certainly help the cause. It makes the exact argument that Mylan wants to push: “The recognition and classification of epinephrine as a preventive medicine by both the U.S. Preventive Services Task Force and insurers could increase patient access, improve outcomes and save lives.” |
| The article, published online in late August, says in an acknowledgments section that Mylan paid for medical writing consultants who “drafted and revised” the paper based on input from Dr. Fromer. But in interviews, Dr. Fromer and a Mylan spokesman said the article had not been ghostwritten and that Dr. Fromer was heavily involved in the paper. He said he intended to ask the journal to revise the language in the article to make clear that he helped write it. | The article, published online in late August, says in an acknowledgments section that Mylan paid for medical writing consultants who “drafted and revised” the paper based on input from Dr. Fromer. But in interviews, Dr. Fromer and a Mylan spokesman said the article had not been ghostwritten and that Dr. Fromer was heavily involved in the paper. He said he intended to ask the journal to revise the language in the article to make clear that he helped write it. |
| “My sole purpose in writing this article was to improve access to a lifesaving medication for millions of patients,” he said. He added that while he has served as a consultant to Mylan — with payments as recently as December — he was not paid by the company to write the article. | “My sole purpose in writing this article was to improve access to a lifesaving medication for millions of patients,” he said. He added that while he has served as a consultant to Mylan — with payments as recently as December — he was not paid by the company to write the article. |
| Senator Richard Blumenthal, Democrat of Connecticut, whose office was among those contacted recently by the nonprofit groups working with Mylan, said he was disappointed with the company’s tactics: turning to patient groups and a doctor it has retained as a consultant to try to get its drug on the preventive list. | Senator Richard Blumenthal, Democrat of Connecticut, whose office was among those contacted recently by the nonprofit groups working with Mylan, said he was disappointed with the company’s tactics: turning to patient groups and a doctor it has retained as a consultant to try to get its drug on the preventive list. |
| “This is the dark side of pharmaceutical practices in enlisting and paying professionals to pitch their profit-making drug,” he said. | “This is the dark side of pharmaceutical practices in enlisting and paying professionals to pitch their profit-making drug,” he said. |