RxforAmericanHealth Publisher: Time for Action to Lower Prescription Prices, Stop Pharma Abuses

August 31, 2016--Daniel Hines, publisher of RxforAmericanHealth has written and sent the following letter to Senators calling for an investigation of the pricing abuses of Mylan's EpiPen:

I am writing in my capacity as the publisher of the TodaysSeniorsNetwork blog sites that include TodaysSeniorsNetwork, RxforAmericanHealth, and AmericanRxBillofRights.

I applaud your efforts in calling for investigations into the outrageous pricing practices of Mylan’s EpiPen Auto-Injector.

Hopefully, this or some series of the many investigations that have occurred as a result of public outrage over not just this instance, but a  of pattern of Pharma pricing abuses, will somehow finally lead to true reform.

However, it is undeniable that Pharma has a philosophy of charging what the traffic will bear, irrespective of how many investigations are launched.  Regrettably, the investigations have a familiar outcome:  A group of ‘experts’ testify, questions are asked, statements made, and within weeks, Pharma once again not merely raises prices, but does so to such a level as to threaten the very health and well-being of Americans.

The major problem is that,  as in the old country saying, the horse is out of the barn by the time the investigations are held,  and investigations in and of themselves are brushed aside by Pharma, which continues with its abusive pricing practices.

The EpiPen price increases also illustrate the willingness of Pharma to attack the most vulnerable members of our society.  Its long-standing opposition to Personal Importation became and remains a major issue even with Part D passage as an attack upon America’s Elderly.  At a press conference after a Pfizer Board meeting, then CEO Henry McKinnell commenting on remarks by Minnesota Governor Tim Pawlenty said that efforts to lower prescription prices were nothing more than   “a Prairie Fire that breaks about every four years as an election issue and then burns out.’’

Those  comments underlie the attitude that Pharma practices today, more than a decade later.  It acts, Congress reacts, hearings are held, statements issued—and we all brace for Pharma’s next abuse.

The EpiPen price increases were an attack upon the parents and children of America, and those others for whom allergies are not merely a ‘seasonal’ nuisance, but actually potentially life-threatening conditions.

Because of that, rather than merely attempting to find out why or how such predatory pricing occurs, it is time for Congress to take action to introduce and pass comprehensive legislation that will make prescription medicines readily available and affordable for the literally millions of Americans that are denied access to the health benefits possible only through access to a regiment of such safe, effective and affordable medicines.

It is time to face the truth:  irrespective of the potential health benefits from a medicine, an unaffordable medicine is unavailable in and of itself because of its price, and a medicine that is not available and is not taken, is ‘ineffective.’

With that in mind, I am including the articles of the RxBillofRights with this letter.  It includes a series of proposals, many of which you have supported. It is time for a new approach which will have a synergistic favorable impact upon availability, access, price and health benefits.

For the record, I am a long-time supporter of and communications consultant of the  personal importation of safe, affordable brand-name medicines from licensed, registered pharmacies in Tier One countries whose standards of safety and efficacy meet or exceed those of the US.

 

I support immediate favorable action by Congress to allow personal importation as a part of the comprehensive strategy of the AmericanRxBillofRights, since even with investigations, study groups being formed, and the reliance upon generics (which have also undergone outrageous price increases), personal importation offers the only immediate relief to millions of Americans who simply cannot afford their medicines.

The EpiPen issue illustrates that personal importation is the only immediate relief for Pharma pricing practices is, even with the questionable ‘staging’ of the introduction of price reduction certificates and a ‘new’ generic EpiPen, the cost of Epi Pen from Canada is still as much as two-thirds less that the exact authentic product in the U.S.

This and other examples of the benefits of access to safe, authentic medicines show why it  is time to take a new approach towards drug pricing legislation that offer solutions to the  challenges to Americans’  health and well-being from pricing abuses of Pharma.

Thank you for your consideration of this letter. I  look forward to your response, and the opportunity to share it with the many visitors to our sites.

Respectfully,

Daniel Hines

Daniel Hines

Senators Decry Mylan’s EpiPen Price-Lowering Tactics As ‘Complex Shell Game’

 Kaiser Health News 

August 31, 2016--In a show of force, 20 Democrats send a letter to the allergy drug maker, demanding answers. They say that the generic price that will be offered by Mylan “is still three times higher than the cost of the branded EpiPen in 2007.”

The Associated Press: 20 Democratic Senators Blast Steep Price Hike For EpiPens
In a sign of growing concern in Congress, 20 Democratic senators are demanding answers about steep price hikes for the life-saving EpiPen injector device. The senators said in a letter Tuesday that price hikes of more than 500 percent have jeopardized access to emergency allergy shots for many Americans. The letter was addressed to Heather Bresch, CEO of the pharmaceutical company that makes the devices, Mylan N.V. Bresch is the daughter of Sen. Joe Manchin, D-W.Va. Manchin did not sign the letter. (Daly, 8/30)

The Wall Street Journal: Senators See ‘Shell Game’ In EpiPen Maker Mylan’s Bid To Ease Access To Allergy Drug
A group of 20 senators called the recent price-lowering overtures from the company that makes the EpiPen emergency auto-injector a “well-defined industry tactic to keep costs high through a complex shell game.” The sheer number of senators – 19 Democrats plus independent Sen. Bernie Sanders – represents a ratcheting-up of the stakes over the dramatic price increases of the emergency epinephrine product from Mylan NV. Mylan has sought recently to quell criticism by announcing discount programs and, on Monday, other plans soon to offer a generic version at half price. (Burton, 8/30)

Morning Consult: Senate Democrats Blast Mylan’s Affordability Moves
The senators, 19 Democrats and independent Sen. Bernie Sanders of Vermont, wrote that the company’s decision to offer a generic version of EpiPens and offer a discount coupon for patients paying the full list price out-of-pocket still results in high costs for patients through insurance premiums. (McIntire, 8/30)

The Star Tribune: Franken Joins Mounting Criticism Of EpiPen Manufacturer 
U.S. Sen. Al Franken of Minnesota has added his voice to the congressional outcry against price increases Mylan pharmaceutical company made to its epinephrine auto-injector that treats potentially deadly allergic reactions. Last week, Sen. Amy Klobuchar of Minnesota called for a Senate Judiciary Committee hearing and asked the Federal Trade Commission to investigate possible antitrust violations by Mylan, which raised the price of a two-pack of its EpiPen product from $100 in 2008 to $500 to $600 in 2016. (Spencer, 8/30)

Los Angeles Times: State Senator Introduces Resolution To Condemn EpiPen Price Hikes
State Sen. Ed Hernandez's attempt to push through a drug pricing transparency bill sputtered this year, but the West Covina Democrat still wants his colleagues to weigh in on the latest controversy in the cost of prescription drugs: the surging price of EpiPens. Hernandez is introducing a resolution that excoriates the anti-allergy device's manufacturer, Mylan, joining a chorus of federal lawmakers who have accused the company of price-gouging. (Mason, 8/30)

St. Louis Public Radio: Epi Pen Price Spike Leaves St. Louisans With Few Options 
So far, [Maureen] Walkenbach’s meticulous monitoring of her son’s food intake has kept her from having to use an EpiPen. But the injectors expire every year, and have to be re-purchased. The Walkenbachs have health insurance, but recently switched to a high-deductible plan. Even with a patient assistance coupon from Mylan, Walkenbach was on the hook for more than $500 for one EpiPen set — a cost she said she’s willing to pay, because going without it would be unthinkable. Instead of three pairs of EpiPens, Walkenbach said the price is forcing her to make do with two — switching one from her kitchen cabinet to her purse whenever she leaves the house. When she forgets it, as she did on a recent trip to the grocery store, she rushes home in a panic.  (Bouscaren, 8/30)

Mylan, PhRMA 'play' Congress and the American Public

by Daniel Hines
Publisher, RxforAmericanHealth

Even before reading this article,  I suggested that perhaps Mylan was implementing a ‘play’ upon the American pubic…first with the price increases, then with the  rapid price decreases, and now the move with a ‘new generic’ ...seems to me to be actions designed to allow Mylan to take the steps necessary to enter the market with a ‘generic’ and Teva must wait until 2017 with approval and a new review,  by which time Mylan will control the generic segment of this market. While the introduction of the generic is not included in this story, the article deals with the PhRMA PR campaign and mind-set of an industry that has ‘played’ the American Public and Congress for decades...
http://www.rawstory.com/2016/08/the-epipen-scandal-runs-deeper-than-most-of-us-realize/

Senator Grassley calls for explanation of EipPen price increases

August 25, 2016--On Monday, Sen. Chuck Grassley wrote to the manufacturer of the EpiPen, used for emergency treatment for life-threatening allergic reactions, to explain a steep price increase in the product in recent years. 

Grassley’s letter came after Iowans expressed concern to him about the prices.  

On Wednesday, Grassley led a letter from five senators to the Food and Drug Administration, seeking details on whether alternatives to the EpiPen are in the works. 

Grassley made the following comment on the announcement today from the EpiPen maker, Mylan pharmaceuticals, that it will expand patient assistance programs for the product.

“The announcement today doesn’t appear to change the product price.  The price is what Medicare, Medicaid and insurance companies pay.  It’s what patients who don’t get assistance cards pay.  And when drug companies offer patient assistance cards, it’s usually not clear how many patients benefit.  Regardless of today’s announcement, I look forward to a written response, as specifically requested in my Monday letter, to my questions on the EpiPen cost increases.”    

Government-Protected ‘Monopolies’ Drive Drug Prices Higher, Study Says

 Scientific research that leads to new drugs is usually funded by the National Institutes of Health via federal grants, the researchers found. (Heidi de Marco/KHN)

By Sydney Lupkin Kaiser Health News.

August 23, 2016--The “most important factor” that drives prescription drug prices higher in the United States than anywhere else in the world is the existence of government-protected “monopoly” rights for drug manufacturers, researchers at Harvard Medical School report today.

The researchers reviewed thousands of studies published from January 2005 through July 2016 in an attempt to simplify and explain what has caused America’s drug price crisis and how to solve it.

They found that the problem has deep and complicated roots and published their findings in JAMA, the journal of the American Medical Association. The study was funded by the Laura and John Arnold Foundation with additional support provided by the Engelberg Foundation.

“I continue to be impressed at what a complex and nuanced problem it is and how there are no easy solutions either,” said lead study author Dr. Aaron Kesselheim, a professor who runs the Program on Regulation, Therapeutics and Law at Harvard Medical School and Brigham and Women’s Hospital.

“As I was writing, the enormity of the problem continued to shine through.”

Five key findings in the JAMA review:

1. Drug manufacturers in the U.S. set their own prices, and that’s not the norm elsewhere in the world.

Countries with national health programs have government entities that either negotiate drug prices or decide not to cover drugs whose prices they deem excessive. No similar negotiating happens in the U.S.

When a Republican-majority Congress created the Medicare drug benefit in 2003, they barred the program that now covers 40 million Americans from negotiating drug prices. Medicaid, on the other hand, must cover all drugs approved by the Food and Drug Administration, regardless of whether a cheaper, equally or more effective drug is available.

And private insurers rarely negotiate prices because the third party pharmacy benefits managers that administer prescription drugs, such as Express Scripts and CVS Health, often receive payments from drug companies to shift market share in their favor, according to the study.

2. We allow “government-protected monopolies” for certain drugs, preventing generics from coming to market to reduce prices.

In an effort to promote innovation, the U.S. has a patent system that allows drug manufacturers to remain the sole manufacturer of drugs they’ve patented for 20 years or more. The FDA also gives drug manufacturers exclusivity for certain products, including those that treat people with rare diseases.

But sometimes, drug companies deploy questionable strategies to maintain their monopolies, the study says. The tactics vary, but they include slightly tweaking the nontherapeutic parts of drugs, such as pill coatings, to game the patent system and paying large “pay for delay” settlements to generics manufacturers who sue them over these patents.

And this is a serious problem, the study concludes, because drug prices decline to 55 percent of their original brand name cost once there are two generics on the market and to 33 percent of original cost with five generics.

3. The FDA takes a long time to approve generic drugs.

Application backlogs at the FDA have led to delays of three or four years before generic manufacturers can win approval to make drugs not protected by patents, the study says.

4. Sometimes, state laws and other “well-intentioned” federal policies limit generics’ abilities to keep costs down.

Pharmacists in 26 states are required by law to get patient consent before switching to a generic drug, the authors wrote. This reportedly cost Medicaid $19.8 million dollars in 2006 for just one drug: a statin called simvastatin whose brand name is Zocor. Costs ran higher because pharmacists didn’t get patient consent and Medicaid had to pay for the costlier brand name drug even though a cheaper product was available.

5. Drug prices aren’t really justified by R&D.

Although drug manufacturers often cite research and development costs when defending high prescription prices, the connection isn’t exactly true, Kesselheim and his team found, citing several studies. Most of the time, scientific research that leads to new drugs is funded by the National Institutes of Health via federal grants. If not, it’s often funded by venture capital. For example, sofosbuvir, a drug that treats hepatitis C, was acquired by Gilead after the original research occurred in academic labs.

“Arguments in defense of maintaining high drug prices to protect the strength of the drug industry misstate its vulnerability,” the authors wrote, adding that companies only spend 10 percent to 20 percent of their revenue on research and development.

“The biotechnology and pharmaceutical sectors have for years been among the very best-performing sectors in the U.S. economy.”

Instead, the price tags are based on what the market will bear, they wrote

In general, fixing America’s drug price problems won’t be easy, the study authors concluded. Congressional gridlock and the power of the pharmaceutical lobby make allowing Medicare to negotiate Part D prices an unlikely possibility. And leaving that aside, policymakers must find a way to tighten rules and strengthen oversight surrounding patent protections and exclusivity without chilling innovation, Kesselheim said.

Those not involved in the study said the fact that it was published in JAMA is meaningful because the authors are able to speak directly to doctors.

“I think the most significant thing about this is not necessarily what he’s saying but who he’s saying it to,” said Kenneth Kaitin, who directs the Tufts Center for the Study of Drug Development.

“In part, the concern over rising drug prices is something that physicians have been more aware of lately…They’ve still been for the most part on the sidelines of these issues.”

Kaitin said the exception has been the American Society of Clinical Oncology and the physicians at Memorial Sloan Kettering Cancer Center.

Dr. Joshua Sharfstein, the Associate Dean for Public Health Practice and Training at the Johns Hopkins Bloomberg School of Public Health, said Kesselheim’s study provides a “bird’s eye view” of how the U.S. became an outlier when it comes to drug prices, without getting lost in the weeds.

“It also illustrates that there is not a single policy that is going to address the range of challenges that our health system faces around drug pricing,” Sharfstein said.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

PRESCRIPTION DRUG USE RISES, OUT-OF-POCKET SPENDING DROPS AMONG INDIVIDUALS NEWLY INSURED UNDER AFFORDABLE CARE ACT

Newswise August 22, 2016 — People who gained health coverage following the implementation of the federal Affordable Care Act's coverage expansion sharply increased their use of prescription drugs, while their out-of-pocket spending for medications dropped significantly, according to a new RAND Corporation study.

Studying the experiences of nearly 7 million prescription drug users nationally, researchers found that among those who gained private insurance there was a 28 percent increase in prescriptions filled and a 29 percent reduction in out-of-pocket spending per prescription compared to the previous year when they were uninsured.

Those gaining Medicaid — the government insurance program for low-income people — filled 79 percent more prescriptions and paid 58 less out-of-pocket per prescription after gaining coverage.

The effects were even larger for individuals with one of five chronic conditions such as diabetes and asthma that were tracked by researchers. The findings are published online by the journal Health Affairs.

“This is strong evidence that the Affordable Care Act has increased treatment rates while reducing out-of-pocket spending, particularly for people with chronic health conditions,” said Andrew W. Mulcahy, lead author of the study and a health policy researcher at RAND, a nonprofit research organization.

“Improving the treatment of people with chronic conditions is an important step in improving health outcomes.”

The study also tracked the drop in the uninsurance rate among the study population, which was adjusted to be representative of all prescription drug users nationally. Researchers found a 30 percent drop in the number of uninsured from 2013 to 2014.

In addition, states that opted to expand Medicaid by early 2014 had significantly larger declines in uninsurance rates (39 percent) when compared to states that had not (23 percent).

There is little research on the change in health care utilization caused by the ACA. RAND researchers examined changes in prescription use over a three-year period by analyzing prescription transactions for nearly 7 million individuals who had purchased medication from a retail pharmacy in January 2012 prior to the coverage expansion.

Researchers developed methods to assign individuals to insurance status categories by reviewing whether they paid for prescriptions with cash or using insurance coverage. Individuals' prescription purchase patterns were tracked from before the coverage expansion in 2013 through the end of 2014, after the ACA coverage expansion.

People who had one of five chronic condition categories studied — diabetes, high cholesterol, anxiety or depression, asthma or chronic obstructive pulmonary disease, and hormone therapy for breast cancer — sharply increased the number of prescriptions filled after gaining coverage, but had lower annual out-of-pocket expenses.

For example, individuals with high cholesterol who gained private coverage had $200 less in annual out-of-pocket spending while those newly covered under Medicaid had $359 less in out-of-pocket spending.

Support for the study was provided by the Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation. Other authors of the study are Christine Eibner of RAND and Kenneth Finegold of the Office of the Assistant Secretary for Planning and Evaluation.

RAND Health is the nation's largest independent health policy research program, with a broad research portfolio that focuses on population health, health care costs, quality and public health systems, among other topics.

AHF: Committee Sues Jon Husted, Ohio Secretary of State, Over Voter Signatures on Drug Price Ballot Measure

AHF sues to restore voter signatures in support of a ballot measure to lower drug prices for state programs in Ohio

Legal action, filed as a Complaint in Original Action in Mandamus with the Supreme Court of Ohio today over improper rejection of voter signatures by Secretary Husted, seeks to restore the signatures on a ballot measure intended to lower drug prices for state programs in Ohio.

The Court had previously dismissed, without prejudice, a lawsuit seeking restoration of the voter signatures, writing at the time that the lawsuit was “premature,” pending the resolution of a separate, but related OSC lawsuit brought by PhRMA seeking to invalidate voter signatures on the ballot measure.

The Supreme Court of Ohio issued a ruling in the PhRMA case denying most of PhRMA’s claims and objections on the signatures; however, one part of the ruling now compels backers of the Ohio Drug Price Relief Act to collect an additional 5,044 voter signatures by August 25^th—making the backers’ prior legal action to restore the voter signatures urgent, and no longer “premature.”

August 22, 2016  --(BUSINESS WIRE)--Members of the citizens’ committee sponsoring the Ohio Drug Price Relief Act filed a new legal action (Case No. 2016-1235) today with the Supreme Court of Ohio against Ohio Secretary of State Jon Husted over voter signatures in support of a ballot measure to lower drug prices for state programs in Ohio that backers allege were unlawfully invalidated by Secretary Husted earlier this year.

The legal action was filed as a Complaint in Original Action in Mandamus with the Supreme Court of Ohio .

The Supreme Court of Ohio had previously dismissed (without prejudice) a lawsuit by members of the drug pricing ballot measure citizens’ committee that was seeking restoration of the voter signatures, writing at the time that the backers’ lawsuit was “premature,” pending the resolution of a separate, but related lawsuit brought in the SCO by PhRMA (the Pharmaceutical Research and Manufacturers Association, the lobbying association of large drug manufacturers) in conjunction with the Ohio Manufacturers’ Association seeking to invalidate voter signatures on the ballot measure.

On Monday, the Supreme Court of Ohio issued a ruling in the PhRMA case denying most of PhRMA’s claims and objections on the signatures; however, one part of the ruling now compels backers of the Ohio Drug Price Relief Act to collect an additional 5,044 voter signatures by August 25^th—making the citizens’ committee’s prior legal action to restore the signatures urgent, and no longer “premature.”

In its lawsuit, the Ohio drug pricing advocates assert:

“The instant action is a re-filing of State ex rel. Tracy L. Jones, et al. v. Jon Husted, et al., Case No. 2016-455, but is more limited in scope based on the Court’s August 15, 2016 decision in Ohio Mfrs. Assn. v. Ohioans for Drug Price Relief Act, Slip Opinion No. 2016-Ohio-5377 which invalidated 10,303 signatures from the petition proposing the Ohio Drug Price Relief Act to the General Assembly (“the Petition”), leaving the Petition 5,044 signatures below the constitutionally required threshold. However, the Court in Ohio Mfrs. Assn. also held that it is improper to invalidate part-petitions because they contain signatures crossed out by someone other than the circulator, signer, or signer’s attorney-in-fact. The instant action seeks to recover such signatures that were rejected by Respondent and various county boards of elections. The recovery of these signatures would more than make up the deficiency and further would moot the portion of the Court’s decision that “[i]f the secretary certifies enough valid signatures, then he shall resubmit the initiative to the General Assembly, in accordance with the terms of the Ohio Constitution, Article ii, Section 1b.” Id. at ¶47.”

The Ohio Drug Price Relief Act will amend Ohio law to require state programs to pay the same or less for prescription medications as the U.S. Department of Veterans Affairs¹.

Backers intended to have the initiative appear on Ohio’s November 2016 presidential election ballot, but obstructionist—and backers believe, illegal—moves by Secretary of State Husted have forced the ballot measure proponents to aim for the November 2017 Ohio ballot instead.

“Secretary of State Jon Husted rode roughshod over local County Board of Elections that twice certified voter signatures for the Ohio Drug Price Relief Act when he eliminated those signatures, an act that thwarted attempts to get this measure before voters and on the ballot in Ohio,” said Michael Weinstein, President, AIDS Healthcare Foundation, the sponsor and primary funder of the measure.

“Now, Monday’s Supreme Court ruling in the PhRMA case forces backers to gather an additional 5,044 signatures by August 25^th in order to compel Secretary Husted to transmit the proposed law to the Ohio legislature, as legally required under the Ohio Constitution. However, the ruling also appears to overturn Husted’s invalidation of more than 20,000 signatures previously thrown out by him.

The committee is now suing to get further clarity from the court and restore those other signatures—which are more than enough to force Husted to advance this measure for consideration and possible action by the Ohio legislature as the next step in the process of ultimately bringing this drug pricing issue before Ohio voters in ballot measure form in November 2017.”

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 614,000 individuals in 36 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook:www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare and Instagram:@aidshealthcare

¹ V.A. pricing is generally believed to be 20% to 24% lower than for almost any other government program.