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, )

U.S. Rep Introduces Bill to Limit Drug Advertising

February 25, 2016--A Connecticut representative has introduced a bill that would restrict direct-to-consumer advertising by pharmaceutical companies. Rosa DeLauro, a Democrat representing Connecticut’s third Congressional district, has introduced the “Responsibility in Drug Advertising Act,” which would require a delay of three years on any advertising of newly approved prescription drugs. 

Direct advertising to consumers by pharmaceutical companies has also been opposed by Democratic presidential hopeful Hillary Clinton and by the American Medical Association (AMA).

“At the end of the day, we should allow informed medical professionals, not advertising executives, to guide our healthcare spending,” said DeLauro in an official announcement of the bill. 

The Congresswoman added that the moratorium on advertising would minimize the perpetuation of inaccurate drug information and control costs by limiting the number of drugs that consumers can ask their physicians about directly, thereby putting more control in doctors’ hands to determine treatment options. DeLauro cited a 13% increase in prescription drug spending in 2015 to $374 billion.

The legislation would also bar ads from running after the three-year delay if the Department of Health and Human Services determines a new drug comes with “significant” side effects.

However, there has been fervent disapproval of the bill. “What [Ms. DeLauro] is saying is that if you come up with a drug that is lifesaving, you could not tell people about it for two or three years,” said Dan Jaffe, the top lobbyist for the Association of National Advertisers, in a statement to Advertising Age. 

“Cutting people off from truthful, valuable and lifesaving information is not only deceptive but unconstitutional.” Jaffe added that the ban “would paternalistically roll the clock back decades to the days when only doctors could be ‘trusted’ to receive information about important health issues.”

DeLauro’s proposed legislation is the most recent major development in an ongoing debate over the appropriateness of direct-to-consumer drug advertising. 

At the Interim Meeting of the AMA in Atlanta in November 2015, a majority of attendees voted to back a total ban on direct-to-consumer advertising and called on Congress to prohibit the practice. They stated that drug ads geared towards consumers drives demand for expensive treatments when more affordable alternatives are available.

“Today’s vote in support of an advertising ban reflects concerns among physicians about the negative impact of commercially-driven promotions, and the role that marketing costs play in fueling escalating drug prices,” said AMA Board Chair-elect Patrice A. Harris, M.D., M.A., at the Interim Meeting. 

“Direct-to-consumer advertising also inflates demand for new and more expensive drugs, even when these drugs may not be appropriate.”

On the presidential campaign trail, Hillary Clinton has stated that, in an effort to lower drug expenses, she, if elected, would not allow pharmaceutical companies to deduct their direct-to-consumer advertising costs, and would require them to invest in deeper R&D rather than marketing strategy in exchange for taxpayer support.

Before the mid-1980s, pharmaceutical companies could only advertise their products to healthcare professionals. That practice changed when the FDA approved direct-to-consumer advertising, though the agency continues to regulate ads to confirm they are not misleading. To this day, only the United States and New Zealand allow for pharmaceutical companies to advertise directly to consumers.

RxforAmericanHealth publisher says personal importation of brand-name medicines from Tier One countries. including Canada, a key element of comprehensive approach to lowering prescription medicine costs in the U.S

The publisher of RxforAmericanHealth says that a recent article in the Harvard Business Review that claims that ‘cheap drugs’ from Canada will not reduce prescription drugprices fails to acknowledge the harm to Americans’  health and well-being, as well as that of society overall,  by Pharma charging what “the traffic will bear” based solely upon its profit motives for prescription medicines.

Daniel Hines  notes in his blog at http://rxforamericanhealth.blogspot.com/2016/02/harvard-review-author-ignores-very.html  that the conclusion that ‘cheap drugs’ from Canada won’t lower prices simply because no one believes that Pharma will “lean back” and “allow” personal importation simply because they are “selling drugs at a terrific discount to Canada and other countries” does not address the harm done by the long-running opposition by Pharma to personal importation of brand-name medicines, and gives it a ‘license’ to continue its pricing abuses in the name of profit.

“Pharma has no inherent authority to either ‘allow’’ or ‘disallow’ Americans from personally importing their medicines,’ Hines notes, explaining that this is clearly the prerogative of the U.S. Congress. 

“That is why over the past 15 years, Congress has passed or considered many bills in support of personal importation of medicines, only to see behind-closed-door deals with PhRMA, the trade group of the Pharmaceutical industry leading to the passage of the Affordable Care Act (Obamacare); ‘poison-pill amendments from legislators,  who are recipients of Pharma’s  contributions,  to require ‘certification’ by the Secretary of  Health and Human Services of each and every medicine personally imported; Pharma-led efforts directed at personal importation claiming to protect product safety or intellectual property rights that were turned aside because of public outcry that the legislation would have trampled on individual liberties.”

Hines says the extent of the healthcare crisis that has been generated by the excessive costs of prescription medicines making them a major driver of rising health care costs, calls for a comprehensive, coordinated approach to lower drug prices. 

“There is a distinct role for personal importation of medicines as part of strategies that will help end the crisis caused by the pricing practices of Pharma that have denied millions of Americans access to their prescribed medicines simply because they are unaffordable.”

He also noted that there must be a recognition of the potential of the harmful effects upon society when ‘profitability’ far exceeds the basic requirements that will earn a business the funds that are necessary to guarantee its ability to maintain its operations, and to enter into new products and markets, rather than allow Pharma to continue charging what the traffic will bear.

He calls for a number of actions:

• ·         A recognition that a medicine that is unaffordable is, in and of itself, unavailable;
• ·         Brand name medicines imported from Canada—and other Tier One Countries-- are not ‘cheap drugs’. They are instead valid medicines that can provide a vital lifeline of maintenance medicines that would otherwise be denied to millions of Americans;
• ·          No one, not even the most fervent supporters of personal importation of safe, affordable prescription medicines from licensed, registered pharmacies in Tier One Countries (not just Canada) has ever suggested that personally imported medicines are the sole answer to lower medicine prices in the U.S.;
• ·         The role of personal importation prescription medicines is not an inherent authority of Pharma not the Food and Drug Administration (FDA), but is within the province of the U.S. Congress to establish the direction of prescription medicine policy, including but not limited to personal importation;
• ·         Congressional support of personal importation, is evidenced by continuing Congressional initiatives on a number of fronts including appeals to the HHS Secretary to grant waivers, as well as bi-partisan bills on behalf of personal importation;
• ·         Tell Pharma that when it threatens to curtail its Research and Development, that much of the cost of that R&D is borne by the U.S. Taxpayer, whom, after supporting such R&D, is subject to the highest prices in the industrialized world for their medicines;
• ·         Take action on the political front. Americans have traditionally expressed their dissatisfaction with the status quo at the ballot box, leading to historic changes in national policies (i.e., social security, anti-trust legislation, Medicare);

Hines noted that the 2016 Election is of watershed proportions.  He calls for voters to make sure that they now where candidates stand on the cost of prescription medicine, the right and the ability of Americans to determine the safety and efficacy of personally imported medicines and the right to have access to those vital medicines. 

To that end, he offers the ‘planks’ of a platform that he believes will lower prescription prices;

1.       Price negotiation for Medicare and other programs;

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 penalize Pharma if it 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.       Passing legislation that allows personal importation of brand-name medicines from licensed registered pharmacies in Tier One Countries whose standards of safety and efficacy meet or exceed those of the U.S.;

5.      Impose 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

“When these steps are taken—and only then—will we remove the burden of paying the highest prices in the industrialized world for our medications,” Hines concludes.