Tag: PhARMA

  • Let’s make medicines a public good again

    Let’s make medicines a public good again

    Fran Quigley writes for The Other 98 percent that it is time to make medicines a public good again. He explains that it is only recently that we began treating medicines as a commodity that could be priced at any level and kept from people who needed it. Throughout most of history it would have been “immoral and illegal” to impede access to medicines by making them unaffordable.

    How is it that we now assume that medicines should be developed, distributed and marketed by profit-driven corporations and that these corporations should have monopolies to charge what they will for them?  We have created a system in which people suffer and die because they can’t afford their medicines. Are we prepared to let these people die?

    Patents are the problem, along with the pharmaceutical corporations that own them. It was only in the second half of the 20th century that a large number of countries began giving individuals and corporations patent protections. These patent protections combined with people’s critical need for life-saving and life-improving medicines have delivered larger profits to pharmaceutical companies than any other industry in the world.

    Today, thousands of lobbyists spend tens of millions of dollars telling policymakers and the public that they need to make huge profits to develop new medicines. They want to ensure that policymakers do not once again insist that medicines are a public good. And, they are winning, internationally and domestically, nationally and at the state level.

    What is particularly galling is that taxpayer dollars are paying for a big chunk of the discoveries. Indeed, in the six years between 2010 and 2016, all 210 new drugs approved by the FDA were developed with taxpayer dollars. Drug companies spend more on marketing than on research. And, a big chunk of our taxpayer dollars is going to CEO salaries, lobbying and campaign contributions, not to drug development.

    Poll after poll show that most people see a big difference between TVs and other commodities, which are patented, and medicines. Unlike medicines, we can go without those products without risk to our health and well-being. We should be treating medicines as a public good not as a commodity.

    It does not have to be this way. If Congress stepped in and allowed negotiated drug pricing, the money we saved would more than pay for all the research currently undertaken and allow us to target research money on needed medicines. Pharmaceutical companies dedicate a lot of their research dollars to me-too prescription drugs and spinoffs of branded products that do not contribute in any meaningful way to the public good. Rather, these drugs may extend the patent life of a prescription drug or prevent the development of generic alternatives and increase Pharma profits.

    Taking a step back to the past in order to move forward and treating prescription drugs as a public good is not unheard of. We did it with the AIDs drugs. It is time we do it for all prescription drugs.

    Here’s more from Just Care:

  • Hundreds of patient advocacy groups are Pharma shills

    Hundreds of patient advocacy groups are Pharma shills

    About a year ago, a piece in the New England Journal of Medicine revealed that the overwhelming majority of patient advocacy groups that are disease organizations are funded by industry and governed by industry leaders. Since then, Kaiser Health News (KHN) has built a database tracking gifts from pharmaceutical companies to patient advocacy groups. Sydney Lufkin and Emily Kopp report for Kaiser Health News that, in 2015 alone, 594 patient advocacy groups received $116 million from 14 drug companies. Could this explain why virtually all of the large patient advocacy groups are Pharma shills and never advocate for lower drug prices?

    Many of the patient advocacy groups have significant influence with lawmakers. They generally dedicate a lot of time making the case for research money. They also often keep pressure on members of Congress not to take action to reduce drug prices, claiming that it could undermine access to drugs.  As a general rule, they do not ally themselves with organizations advocating for their members who cannot afford needed medicines.

    Pharmaceutical companies do not have to disclose donations to patient advocacy organizations. So, we do not know the full extent of pharmaceutical company donations to these “patient advocacy” groups. Several pharmaceutical companies opted not to disclose their giving to these groups, including Allergan, Baxter International, Gilead Sciences and Mylan. But, the KHN database, Prescription for Power has gathered as much information as is available.

    KHN has found that pharmaceutical companies gave more money to patient advocacy groups in 2015 than to federal policymakers.  By so doing, pharmaceutical companies can leverage their dollars, enlisting patients to speak to lawmakers, provide testimony in Congress, and organize social media campaigns on their behalf.

    The NEJM researchers studied 104 “patient advocacy” groups with revenues of at least $7.5 million. Prescription for Power takes that work to the next level, with information on 1,200 patient groups. KHN finds that nearly half (594) of them accepted drug company money. KHN further finds that some patient groups are purely shills for pharmaceutical companies, repeating their talking points in their communications without doing much else.

    So, before supporting or taking advice from a group that appears to be a patient advocacy group, understand its ties to the medical industrial complex. Dr. Adriane Fuh-Berman, the head of PharmedOut,  a Georgetown University Medical Center program critical of the way pharmaceutical companies market drugs, warns that the advice you get from many patient groups could be misleading. For example, it could steer you to high-cost drugs when low-cost alternatives might be better.

    To be sure, the patient advocacy groups taking money from pharmaceutical companies represented to Kaiser Health News that they shaped their organizations’ priorities independently of the companies funding their organizations. And the drug companies represented same. We all know, however, that money talks. Notably, the patient groups and the drug companies appear to share similar goals, goals that are very different from those of Patients for Affordable Drugs, a patient  advocacy group that takes no money from Pharma.

    In addition to “patient advocacy” groups, drug company money flows to scores of entities that can benefit pharmaceutical companies, including, doctors, researchers, thought leaders, academics, media outlets, and policymakers.

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  • States focus on drug importation as way to rein in drug costs   

    States focus on drug importation as way to rein in drug costs  

    Shefali Luthra reports for Kaiser Health News that states are looking at drug importation as a way to rein in prescription drug costs and encourage Congress to act to bring down drug prices throughout the nation. Even some Republican lawmakers in red states recognize that government intervention is needed because there is no free market when it comes to drug prices. They see addressing the outrageous price of prescription drugs as a non-partisan issue.

    One Utah legislator wants Utah to buy drugs for the state’s health system from wholesalers in Canada. Legislators in Vermont, West Virginia and Oklahoma also are looking to pass laws that would allow their states to import drugs from Canada. Today, some 11 million Americans import drugs from abroad. Although doing so is technically illegal, no American has ever been prosecuted for importing drugs for personal use.

    With a waiver from the Trump administration, states could buy drugs wholesale from abroad and then resell them to pharmacies and hospitals. Such a waiver could help states to bring down the price of drugs for their residents considerably. The drugs would be as safe as drugs available in the US; indeed, many Canadian drugs are manufactured in the same facilities by the same manufacturers as US drugs.

    A 2003 federal law grants the US Department of Health and Human Services authority to permit state drug importation when the evidence suggests importation will reduce costs without jeopardizing the public health. Because of pressure from Pharma, however, HHS has never approved a state’s drug importation program. But, given that addressing prescription drug prices is the top policy priority for Americans, there is more public pressure than ever for HHS to do so.

    Undoubtedly, if HHS were to approve a state’s Canadian drug importation program, pharmaceutical companies would cut Canada’s supply of drugs or otherwise penalize Canadian suppliers of drugs to the state. But, then, Congress finally might step in to regulate the price of drugs for everyone in the US, much like it has done for Veterans, and every other developed country has done for its citizens.

    If you want Congress to rein in drug prices, please sign this petition.

    Here’s more from Just Care:

  • Pharma blocks state law requiring disclosure of drug prices to doctors

    Pharma blocks state law requiring disclosure of drug prices to doctors

    Kaiser Health News reports on Pharma’s full court press to block a state law requiring disclosure of drug prices to doctors. Unfortunately, Pharma’s targeted investments have extraordinary influence. Pharma kept Louisiana state policymakers from passing legislation that would require pharmaceutical companies to disclose to doctors the price of their drugs at the time they market their drugs to doctors.

    The US should not allow drug companies to market their drugs to doctors without also providing doctors with objective information about the value of their drugs.. But, today, when they market to doctors, drug makers need not show doctors evidence that their drugs have greater clinical benefits and offer better value than other drugs on the market. Unless states require disclosure of this information, it will not happen. Pharma has no interest in helping doctors make objective decisions about the drugs they prescribe.

    In Louisiana, Pharma hired one lobbyist for every two state legislators–at one point Pharma had enlisted 84 lobbyists–to make sure Louisiana’s drug-price disclosure requirement bill was not enacted.  Pharma also made political contributions to 80 legislators and other politicians. And, Pharma spent thousands of dollars on entertainment for Louisiana legislators, including taking them out to fancy dinners. On top of Pharma’s contributions, pharmaceutical companies made generous contributions to political candidates and political action committees at the state level to influence them.

    With many drug prices at eye-popping levels, state legislatures across the country are entertaining legislation that aims to rein in drug costs. Even if states cannot control their prescription drug costs, their efforts to do so keeps attention on these costs and helps to raise awareness of the issues at the grassroots level.

    Achieving fair prices for prescription drugs will not happen without a battle. Pharma appears willing to spend whatever it takes to combat any federal or state law that helps people better understand the prices paid for drugs in the US, let alone that brings down drug prices. Pharma spent $110 million in 2016 to defeat a California ballot measure that would have reduced the price of drugs for state agencies, easing a large burden on taxpayers. (In 2017, California enacted a law forcing pharmaceutical companies to justify price hikes in certain situations.)  It spent another $50 million to do same in Ohio.

    Although reining in drug costs remains the public’s top policy priority, it will take extreme public pressure to move Congress to regulate drug prices across the board. Americans spend way more of our income than we should on drugs, through taxes, high health insurance premiums and copays, and lower wages.

    If you want Congress to rein in drug prices, please sign this petition.

    Here’s more from Just Care:

  • GAO: Drug prices continue to skyrocket

    GAO: Drug prices continue to skyrocket

    At the request of Senator Bernie Sanders and Congressman Elijah Cummings, the Government Accountability Office recently issued a report on pharmaceutical company profits and drug prices. The GAO found that drug spending has nearly doubled since the 1990s mostly because drug prices continue to skyrocket and because of increased use of costly drugs. It shows that research and development costs do not explain or justify high drug prices.

    Why are drug prices so high? Drug patents are responsible in significant part for high drug prices, affording drug companies monopoly pricing power. Consolidation in the drug industry and lack of adequate competition in the generic drug market are also to blame.

    The GAO analyzed pharmaceutical company revenue, profit margins, and merger and acquisition deals worldwide between 2006 and 2015. It found a 45 percent increase in drug and biotech sales revenue in that period, from $534 billion to $775 billion in 2015 dollars.

    Two out of three drug companies also increased their annual average profit margins, with the largest 25 companies, seeing annual profits of between 15 and 20 percent. These margins are two to five times higher than the annual average profit margin of the largest 500 non-drug companies, which was between 4 and 9 percent.

    There is concerning industry consolidation. Ten pharmaceutical companies generated 38 percent of sales. But, within certain therapeutic classes, fewer companies controlled even more of the market. And, market pressure is leading large drug companies to acquire smaller ones to drive greater profits. Lack of competition in the drug industry, particularly for generics, fueled higher drug prices. Based on the data, the GAO also found a link between industry mergers and lack of innovation.

    While drug company profits have increased dramatically, research and development spending has not, rising just over eight percent to $89 billion from $82 billion between 2008 and 2014. The U.S. government spends about $28 billion a year on research. Tax benefits to drug companies for research and development of orphan drugs helped foster their investments.

    The FDA approved between 179 and 263 drugs each year. Between 23 and 35 of these drugs were treatments for unmet medical needs or to “help advance patient care.” The GAO does not explain this term, which may mean simply new ways of dispensing old drugs and nothing innovative from a treatment perspective.

    The GAO explains that insured consumers are often less price conscious with prescription drugs than they are with products for which they have to pay in full and that can promote price inflation and drive up spending. In addition, doctors may not be aware of low-cost alternatives they could prescribe or they simply may be inclined to prescribe the most expensive drug, which can further drive up spending. And, Medicare is often required to pay for even the expensive drugs that may offer no added value, which drives up spending further still.

    The GAO does not discuss incentives of health insurers and pharmacy benefit managers to promote high-priced drugs over lower-cost alternatives. But, there’s every reason to believe that fees to PBMs to promote high-priced drugs on insurer formularies over lower-cost alternatives are also in some way responsible for driving up drug spending.  Insurers are likely benefiting from this arrangement or they would be doing something to stop that practice.

    Senator Sanders and Congressman Cummings sent a letter to President Trump alerting him to the GAO report and urging him to make good on his promise to the American people to address skyrocketing prescription drug costs.

    If you want Congress to rein in drug prices, please sign this petition.

    Here’s more from Just Care:

     

  • Trump’s pick to head HHS drove up insulin prices at Eli Lilly

    Trump’s pick to head HHS drove up insulin prices at Eli Lilly

    Caitlyn McClure of the Other 98 reports that Alex Azar, President Trump’s pick to head the US Department of Health and Human Services (HHS), is a Pharma executive who drove up insulin prices at Eli Lilly. If confirmed, Azar can be counted on to help Pharma and disregard the public interest in having HHS ensure Americans good affordable health care.

    Over the last 50 years, Eli Lilly has paid billions of dollar in settlements for illegal marketing of drugs, bribery, and the sale of unsafe products. Ten years ago, the FDA charged Lilly with misleading marketing of dog medicines.

    Today, Eli Lilly is embroiled in allegations around insulin price fixing. At least five states are investigating Lilly for raising insulin prices to the same level as its competitors. In addition, a federal class-action RICO (Racketeer Influenced and Corrupt Organizations Act) suit has been brought against Lilly.

    Azar was president of Lilly USA in 2012. During his ten-year tenure at Lilly, Lilly tripled its price for insulin and hiked up prices on other drugs to increase its revenue. It created no new drugs. James Elliott of The Nation reports that Lilly’s Humalog, an insulin medicine, costs more today than it did in 1996 when it came to market. In the last 10 years, while Azar was at Eli Lilly, its list price went from $74 to $269.

    McClure points out that Trump’s selection of Azar as HHS head is at odds with Trump’s alleged goal of keeping Pharma from “getting away with murder.”

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  • Reining in drug costs remains public’s top priority

    Reining in drug costs remains public’s top priority

    A new Harvard-Politico poll shows that reining in drug costs remains the public’s top priority. More than anything else, Americans want Congress to bring down prescription drug costs.

    The public opinion poll found that four in ten Americans believe that Congress needs to take action on drug costs. To be sure, a far larger percentage of  Democrats than Republicans supported this priority–more than half v. three in ten. But, Americans are far less sure about how to resolve the issue of high drug prices.

    While there has been a lot of public attention on high drug prices, at both the state and federal levels, policymakers and advocates are promoting a wide range of solutions, virtually all of which involve either helping one subpopulation–e.g., people in Maryland, people needing the Hepatitis C vaccine, people with Medicare–or, addressing one piece of the problem–e.g., lack of generic drug competition, Orphan Drug Act.

    Until there is agreement that Congress needs to rein in prescription drug prices across the board–a recognition that access to life-improving and life-saving drugs is a basic human right–Pharma will continue to spend tens of millions of dollars raising fear among different populations over how the proposal will jeopardize their access to drugs.

    Not surprisingly, almost 90 percent of people support Medicare drug price negotiation in theory. But, fewer than 40 percent support the policy once they hear that  it could mean people with Medicare lose access to certain drugs.

    Many people also support drug importation as a way to drive competition and bring down prices. More than half of Americans support importation of drugs that the FDA has not yet approved. After all, we import food with very few safety risks. Why not drugs?

    If you want Congress to rein in drug prices, please sign this petition.

    Here’s more from Just Care:

     

  • How Pharma keeps generics off the market

    How Pharma keeps generics off the market

    Brand-name drug manufacturers appreciate the value of their patents, which give them virtually monopoly pricing power. So, to keep drug prices high, pharmaceutical companies have come up with a number of ways either to ensure that their brand-name drugs continue to remain on patent or to keep generic pharmaceutical companies from manufacturing their drugs once they go off patent. The Commonwealth Fund has a new paper that explains these strategies in detail, along with recommendations for Congress to ensure fair drug prices.

    Drug company tactics for maintaining their patents and, along with them, market exclusivity for their drugs:

    1. Secondary patents: Before a drug goes off patent, the manufacturer patents the drug with a new coating, or with a new frequency of use or a new administration method.
    2. Settlements with generic drug manufacturers who are challenging their patents: In a nutshell, through a “reverse-patent settlement,” the brand-name manufacturer pays the generic drug manufacturer to drop the patent challenge and agree not to bring the generic drug to market for some defined period of time beyond the patent’s life.
    3. Preventing generic manufacturers from getting samples of their brand-name drugs, which are needed for the generic drug manufacturers to show the FDA the bio-equivalence of the generic drugs.
    4. Petitioning the FDA not to approve generic drug applications on the ground that there is an inadequate showing of bioequivalence. The brand-name manufacturers usually lose these petitions.

    To address these issues, the Commonwealth Fund recommends:

    1. The U.S. Patent and Trademark Office should prevent brand-name pharmaceutical companies from securing secondary patents for non-material drug modifications.
    2. Congress should forbid reverse-patent settlements on the grounds that they are anticompetitive and violate antitrust laws.
    3. Congress should pass legislation that requires brand-name drug manufacturers to share samples of their drugs with generic manufacturers.

    If you believe it’s time for Congress to rein in drug prices, please sign this petition.

    Here’s more from Just Care:

     

  • Senate bill would empower Medicare to reduce drug prices

    Senate bill would empower Medicare to reduce drug prices

    Today, Medicare covers prescription drug costs under Part B–drugs that are generally administered at a hospital or in a doctor’s office–and  Part D–drugs that are self-administered. And, Medicare pays whatever price pharmaceutical companies charge for their drugs because Congress forbids Medicare from negotiating drug prices. Now, Senator Amy Klobuchar has introduced a bill which would empower Medicare to reduce drug prices.

    The price of prescription drugs has been rising rapidly in large part because there is no free market for drugs. The FDA approves drugs based on select evidence, without knowledge of their price or clinical effectiveness as compared with other drugs already on the market. Drug companies effectively have monopoly power to set prices for their patented drugs for as long as they can keep them patented. Doctors are free to prescribe these drugs regardless of their clinical benefits or costs. And, Congress requires Medicare to cover them, even without evidence of their clinical benefits relative to less costly drugs on the market.

    Klobuchar’s bill is aimed at introducing some competition into the prescription drug marketplace through Medicare drug price negotiation. In early 2017, Klobuchar introduced legislation with John McCain to allow people to import drugs safely from Canada. She has also introduced bi-partisan legislation with Senator Charles Grassley that would keep Pharma from paying generic drug companies from delaying manufacture of their drugs as generics for lower cost, “pay for delay.” And, she has introduced bi-partisan legislation with Senator Mike Lee, Creating and Restoring Equal Access to Equivalent Samples (CREATES) to allow drug companies to sell drugs in the U.S. that they have sold abroad for at least 10 years when there is little or no competition for the drug in the U.S.

    Thirty-one senators are co-sponsoring Klobuchar’s Medicare drug price negotiation bill, including Chuck Schumer, Patty Murray and Tammy Baldwin.

    If you want Congress to rein in drug prices, please sign this petition.

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  • With health insurers and Pharma setting prices, no controlling health care costs

    With health insurers and Pharma setting prices, no controlling health care costs

    Why would a health insurer pay one hospital in New York City $81,000 more for outpatient infusion treatment than another hospital one mile away–$100,000 and $19,000 respectively?  And, how is it that a pharmaceutical company can get away with charging for Avonex today almost seven times its original cost  21 years ago? These are two questions Elisabeth Rosenthal’s op-ed on CNN.com leads us to ask. Rosenthal’s op-ed makes a strong case that there’s no controlling health care costs, so long as health insurers and Pharma are setting prices.

    In Japan, an echocardiogram costs less than $100, at a Harvard training hospital it costs $1,714, and at a community hospital in New Jersey it costs $5,435. The health insurers do not appear to have the leverage to rationalize the prices for different procedures and pay a standard fair price for them. For that reason alone, the federal government should be negotiating prices, as it does with Medicare, for everyone in the U.S..

    The health care market is broken, and incentives are misaligned. When insurers pay high prices, they not only drive up premiums, they increase insurer profits. And pharmaceutical companies, accountable to their shareholders first and foremost, have every reason to charge exorbitant prices for prescription drugs so long as Congress gives them the power to do so, and insurers are willing to pay those prices.

    Tremendous price variations for the same health care services, along with sharply increasing prices for older treatments and technologies over time, should be enough to demonstrate that we cannot rely on competition in the health care marketplace to bring down prices. With insurers in the mix, doctors determining treatments regardless of cost, and patients essentially unable to know whether they are getting value, the market is broken. So, even prices for competitive treatments that have been around for decades just keep going up. Economists describe this phenomenon as “sticky pricing.”

    Japan does not permit sticky pricing. Instead, doctors, economists and politicians come together to decide how the price of a piece of technology, such as an echocardiogram will drop over time. What will it take for the U.S. Congress to step in and regulate health care prices?

    If you believe it’s time for improved Medicare for all, please sign this petition to Congress.

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