HHS and NIH must act to define standards for ‘march-in’ implementation to help lower drug prices as part of comprehensive national policy

The publisher of RxforAmericanHealth says that the Department of Human and Health Services (HHS) and National Institute of Health (NIH) must act to define standards for implementation of ‘march-in’ rights to help lower prescription medicine prices.  

In an open letter to Secretary Sylvia Burwell posted on RxforAmericanHealth, Daniel Hines says such action coupled with other initiatives including price negotiation for medicines, reciprocal Memorandums of Understanding between regulatory agencies of Tier One Countries as validation of the safety and efficacy of the oversight of personally imported medicines from those countries, criminal penalties for abuse of pricing practices based on a ‘what the traffic will bear’ philosophy, greater transparency in Pharma pricing practices, and an end to direct-to- consumer advertising for prescription medicines, will ensure a ‘stakeholder’ role for the American public that supports so much of Pharma R&D, by an increased presence of consumers,  advocates and private citizens in policy development and hearings.

He notes that HHS Secretary Burwell recently denied a request from 50 members of Congress to implement march-in provisions leading to a number of Senators joining in support of the request aimed at cost increases of the Cancer drug Xtandi.

“While this issue has surfaced again as a request for similar action from even more Congressmen and advocacy groups regarding the Xtandi patent, it is the failure of HHS and NIH to face up to their responsibilities to take action in the public interest that is the greater concern,” Hines explains.

He says the “requests themselves are an exercise of the authority of Congress, as they are based upon long-standing (30 years) existing legislation that makes it evident that it is incumbent upon the agencies to take action when Congress believes it is appropriate.” 

He cites a number of reasons in support of his contention:

·       The function of the Health and Human Services is to ostensibly protect the health and well-being of Americans, while the National Institute of Health is the primary agency of the United States government responsible for biomedical and health-related research.

·       A major responsibility of each is that is must address not only the safety and efficacy of medicines, but their availability as well since if a medicine is unavailable for any reason it creates a health care crisis for those patients who are derived of the potential benefit of the denied medicine;

·       As the Congressional letter notes: ‘march-in rights’ should be asserted under 35 U.S.C. § (203) (a)(2) “when action is necessary to alleviate health and safety needs are not being reasonably satisfied” or “benefits of a patented product are not available to the public on reasonable terms”;

·       The current pricing crisis of vital medicines clearly not only do not ‘reasonably’ alleviate health and safety needs of Americans, but are actually contributing to endangering the health of patients who are denied the benefits of access to the benefits to be derived from a regimen of vital medicines;

·       Likewise, this means that the “benefits” of a patented medicine are not available to the public since a product that is unaffordable is, in and of itself, unavailable and is “not available to the public on reasonable terms”;

·       The linchpin for implementation of ‘march in’ action is the definition of ‘extraordinary circumstances’.  Webster’s defines extraordinary as unusual or different from the usual.  We can only hope that so many Americans being denied access to unaffordable medicines, the disastrous burden upon individual health, outrageous price increases over the past few years, and Direct-to-Consumer advertising of medicines that exceeds pharmaceutical industry research and development, are not considered to be usual, and that, instead, an ‘extraordinary’ situation does indeed exist.

“This places the responsibility upon HHS and NIH not to decide whether a circumstance is ‘extraordinary’ based upon personal whim and observation, devoid of any factual studies that represent standards,” Hines says.

“With that in mind, we urge steps be taken to clearly define standards that would constitute an ‘extraordinary’ situation, not only for higher-priced specialty medicines but for vital lower-priced maintenance prescriptions that have been priced beyond the reach of untold numbers of Americans leading to adverse health complications.”

An Open Letter to Secretary Burwell: What 'extraordinary circumstances' demand HHS 'March-In' action to lower prices?

Sylvia Mathews Burwell,
Secretary of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Secretary Burwell:

I am writing in my capacity as publisher of TodaysSeniorsNetwork, a long-standing and widely followed group of blogs dealing with issues facing aging Americans, and RxforAmericanHealth, which deals with the pricing abuses of Pharma and supports steps to ensure availability of vital affordable medicines for all American patients, to express my chagrin—and that of countless others—over your denial from Congress to the request for the Department of Health and Human Services and The National Institute of Health to implement ‘march-in rights’.

While this issue has surfaced again as a request for similar action from even more Congressmen and advocacy groups regarding the Xtandi patent, it is the failure of HHS and NIH to face up to their responsibilities to take action in the public interest that is the greater concern.

The requests themselves are an exercise of the authority of Congress, as they are based upon long-standing (30 years) existing legislation that makes it evident that it is incumbent upon the agencies to take action when Congress believes it is appropriate,  The reasons for this are:

·       The function of the Health and Human Services is to ostensibly protect the health and well-being of Americans, while the National Institute of Health is the primary agency of the United States government responsible for biomedical and health-related research.

·       A major part of responsibility of each must address not only the safety and efficacy of medicines, but their availability as well since if a medicine is unavailable for any reason it creates a health care crisis for those patients who are derived of the potential benefit of the denied medicine;

·       As the Congressional letter notes:  ‘march-in rights’  should be asserted under 35 U.S.C. § (203) (a)(2) “when action is necessary to alleviate health and safety needs are not being reasonably satisfied” or “benefits of a patented product are not available to the public on reasonable terms”;

·       The current pricing crisis of vital medicines clearly not only do not ‘reasonably’ alleviate health and safety needs of Americans, but are actually contributing to endangering the health of patients who are denied the benefits of access to the benefits to be derived from a regimen of vital medicines;

·       Likewise, this means that the “benefits” of a patented medicine are not available to the public since a product that is unaffordable is, in and of itself, unavailable and is “not available to the public on reasonable terms”;

·       The linchpin for implementation of ‘march in’ action is the definition of ‘extraordinary circumstances’.  Webster’s defines extraordinary as unusual or different from the usual.  We can only hope that so many Americans being denied access to unaffordable medicines, the disastrous burden upon individual health, outrageous price increases over the past few years, and Direct-to-Consumer advertising of medicines that exceeds pharmaceutical industry research and development, are not considered to be usual, and that, instead,  an ‘extraordinary’ situation does indeed exist.

·       This places the responsibility upon you, HHS and NIH not to decide whether a circumstance is ‘extraordinary’ based upon personal whim and observation, devoid of any factual studies that represent standards.

·       Rather, it is incumbent up governmental agencies to meet their responsibilities to do their job as Congress has determined them in legislation and called for in the recent Congressional requests, as well as those of the advocacy groups whose latest appeal is now being ‘considered.’

·       With that in mind, we urge steps to clearly define standards that would  constitue an ‘extraordinary’ situation, not only for higher-priced specialty medicines but for vital lower-priced maintenance prescriptions that have been priced beyond the reach of untold numbers of Americans leading to adverse health complications, making them available to the American public and allow stakeholders—including patient/clients—to present comments.  Such action coupled with other initiatives including price negotiation for medicines, reciprocal Memorandums of Understanding between regulatory agencies of Tier One Countries as validation of the safety and efficacy of the oversight of personally imported medicines from those countries, criminal penalties for abuse of pricing practices based on a ‘what the traffic will bear’ philosophy, greater transparency in Pharma pricing practices, and an end to direct-to- consumer advertising for prescription medicines, will ensure a ‘stakeholder’ role for the American public that supports so much of Pharma R&D, by an increased presence of consumers,  advocates and private citizens in policy development and hearings. 

Sincerely,

Daniel Hines
Publisher
TodaysSeniorsNetwork
RxforAmericanHealth

More elderly using dangerous drug combinations

March 28, 2016--One in six older adults now regularly use potentially deadly combinations of prescription and over-the-counter medications and dietary supplements — a two-fold increase over a five-year period, according to new research at the University of Illinois at Chicago.

Dima Mazen Qato, assistant professor of pharmacy systems, outcomes and policy, and her colleagues examined changes in medication use in a nationally representative sample of older adults between the ages of 62 and 85.

In contrast to many existing studies of medication use by the elderly, these investigators conducted in-home interviews to accurately identify what people were actually taking.

According to the study, older adults using at least five prescription medications (a status known as polypharmacy) rose from 30.6 percent in 2005 to 35.8 percent in 2011.

Factors that may account for the rise include the implementation of Medicare Part D, changes in treatment guidelines, and the increased availability of generics for many commonly used drugs.

As an example, the use of simvastatin (Zocor) — the most commonly used prescription medication in the older adult population, which became available as a generic in 2006 — doubled from 10.3 percent to 22.5 percent, Qato said. Zocor is used to treat high cholesterol and may reduce the risk of heart attack and stroke.

Despite limited evidence of their clinical benefit, dietary supplements are being used by a growing number of older individuals, the study found — an increase from 51.8 percent to 63.7 percent over the same time period, with nearly a 50 percent growth in the number of people using multiple supplements. The largest increase was found in the use of omega-3 fish oils — a dietary supplement with limited evidence of cardiovascular benefits — which rose from 4.7 percent of people surveyed in 2005 to 18.6 percent in 2011.

Fifteen potentially life-threatening drug combinations of the most commonly used medications and supplements in the study were also identified. Nearly 15 percent of older adults regularly used at least one of these dangerous drug combinations in 2011, compared to 8 percent in 2005.

More than half of the potential interactions involved a nonprescription medication or dietary supplement, Qato said. Preventative cardiovascular medications such as statins (cholesterol-lowering drugs, particularly simvastatin), anti-platelet drugs (such as clopidogrel and aspirin, used to prevent blood clots), and supplements (specifically omega-3 fish oil) accounted for the vast majority of these interacting drug combinations.

Cardiovascular prevention efforts and treatment guidelines promoting primary prevention may be undermined by these interactions, Qato said.

“Many older patients seeking to improve their cardiovascular health are also regularly using interacting drug combinations that may worsen cardiovascular risk,” she said.

“For example, the use of clopidogrel in combination with the proton-pump inhibitor omeprazole, aspirin, or naproxen — all over-the-counter medications — is associated with an increased risk of heart attacks, bleeding complications, or death. However, about 1.8 percent — or 1 million — older adults regularly use clopidogrel in interacting combinations.”

Health care professionals should carefully consider the adverse effects of commonly used prescription and nonprescription medication combinations when treating older adults, Qato said, and counsel patients about the risks.

“Improving safety in the use of interacting medication combinations has the potential to reduce preventable, potentially fatal, adverse drug events,” she said.

While it is not known how many older adults in the U.S. die of drug interactions, Qato said, “the risk seems to be growing, and public awareness is lacking.”

Co-authors of the research, published in JAMA Internal Medicine, are Jocelyn Wilder of UIC; L. Philip Schumm and Victoria Gillet of the University of Chicago; and Dr. G. Caleb Alexander of the Johns Hopkins School of Public Health.

The National Social Life, Health and Aging Project is supported by grants R01AG021487 and R01AG033903 from the National Institutes of Health, including the National Institutes on Aging, the Office of Women’s Health Research, the Office of AIDS Research, and the Office of Behavioral and Social Sciences Research.

NHeLP Urges Action on High Drug Pricing

WASHINGTON, March 7, 2016--The National Health Law Program (NHeLP) sent a letter to Senators Ron Wyden and Chuck Grassley supporting the Senate Finance Committee's investigation into high prices for hepatitis C prescription drugs and barriers to access for Medicaid beneficiaries. 

The committee requested public comments in January 2016 on its investigation into biopharmaceutical company Gilead and Sovaldi and Harvoni, Gilead's breakthrough hepatitis C treatments. 

"As we have seen with HIV treatments, drug company profiteering and high costs prevent people from getting the care they need," said Wayne Turner, NHeLP staff attorney who led the successful 2014 HIV anti-discrimination complaint against four insurance companies. 

"When people with chronic diseases like hepatitis C are unable to afford treatments due to state restrictions or discriminating company policies, federal action is necessary."

In 2014, The AIDS Institute and NHeLP filed a complaint with the U.S. Department of Health and Human Services' Office for Civil Rights (OCR) charging four Florida health plans with unlawful discrimination against people living with HIV and AIDS by placing all HIV medications, including generics, on the highest cost sharing tier, thus requiring enrollees to pay as much as 50 percent co-insurance for every HIV drug. 

In the complaint, the groups contend that such practices discourage people with HIV/AIDS from enrolling in the plans and violate the Affordable Care Act's (ACA) non-discrimination provisions. The ACA bans plans from discriminating against individuals based upon disability and prohibits them from discouraging enrollment by people with significant health needs.

"Since the passage of the Affordable Care Act, we have monitored Medicaid enrollment efforts across the country to ensure states are making every effort to help residents obtain adequate health insurance coverage, which should include affordable prescription drugs," said Jane Perkins, NHeLP legal director. 

"Restrictions on breakthrough treatments are blatantly illegal and violate federal Medicaid requirements and the ACA's non-discrimination provisions."

"Low-income individuals so often are the most in need of breakthrough treatments and are the least likely to afford them," said Abbi Coursolle, NHeLP staff attorney. "It is inherently unfair for Medicaid beneficiaries to be both denied treatments simply because they are expensive and unable to afford the two most widely used medications because of the company mark-up."

How will prescription medicine prices be determined in the Future? Time for Congress to step up in the interest of the American people!

(Publisher’s Note:  This is Part One of a two-part series examining how Pharma is using Congress’ failure to enact comprehensive legislation to lower prescription medicine prices as an opportunity to advance Pharma’s model of ‘the value of medicines’ as adding to life-spans as the basis for prescription drug pricing with Pharma itself being the ‘determinator’ of the value and cost of medicines.)

There are significant national events taking shape in this country, and not just the Presidential Election.

As important as the elections are to the American future, the moves by Pharma and its front groups to ensure that it will be the ‘determinator’ of how prices for virtually all medicines will be established should spur Congress to step-up and develop a policy based on consensus that can lead to a clearly defined policy that will finally end the predatory pricing practices of Pharma.

Admittedly, the issue of the cost of vital prescription medicines has received ‘extraordinary attention’ from Congress, drawing the ‘wrath’ of Senators and Representatives with hearings, statements of outrage, and the introduction of a number of stand-alone bills to address one or another of many strategies that could and should be a part of a comprehensive approach to lower prescription drug prices.

Unfortunately, the many bills themselves ultimately hinder the chance of lowering prescription drug prices through legislation. 

As important as it is that individual Senators and Representatives take a stance on lowering prescription drug prices, it is time for Congress to develop a consensus that incorporates the key, workable elements of each proposal to create a synergy that could lead to legislation to lower prices. This includes:

1.               Price negotiation based on recognition that a medicine that is unaffordable is, in and of itself, unavailable;

2.              A ‘stakeholder’ role for the American public that supports so much of Pharma R&D, by an increased presence of consumer advocates and private citizen in policy development, hearings, and opportunities for public comment;

3.              A revised patent policy that ensures the public investment in R&D is protected in legislation that will provide penalties if Pharma is abusive in its pricing practices;

4.              Reciprocal Memorandums of Understanding between regulatory agencies of Tier One Countries as validation of the safety and efficacy of the oversight of personally imported medicines from those countries;

5.              Criminal penalties for abuse of pricing practices based on a ‘what the traffic will bear’ philosophy;

6.              Greater transparency in Pharma pricing practices;

7.              An end to direct to consumer advertising for prescription medicines.

Without such Congressional action, even though we have witnessed a tremendous public outcry (finally) over the predatory pricing practices in which Pharma thumbs its nose at patients, policy-makers, and the American public generally with prices that are based on ‘what the traffic will bear’, there will continue to be virtually not even the slightest chance to actually lower prescription drug prices.

This has opened the door for Pharma to launch a public relations and lobbying campaign to establish its stance that medicines should be priced as a function of the ‘value added’ from the medicine itself, with Pharma itself determining the ‘value’ and, therefore, the price of the medicine.

The million-dollar campaign features one ad showing an infant with a voice-over reminding the viewer (the campaign is targeted towards Congress) that “Time is Precious” and that new medicines give us “hope.”

It would, of course, be wonderful if Pharma truly believes that its primary mission is to offer ‘hope’ through the improved health of the American public.  

But when it uses ‘hope’ as a vehicle to continue to price its medicines at unaffordable prices, it is nothing less than a cruel facade played out at the expense of patients. (to be continued)

(In Part Two, we will examine the claims about the ‘flaws’ that have been unfairly attributed to legislative efforts both past and current to lower prescription medicine prices, )