Tag: Gilead

  • Congress should overhaul drug patent laws to ensure Americans access to medications

    Congress should overhaul drug patent laws to ensure Americans access to medications

    Anyone who thinks that the pharmaceutical industry should continue to be able to gouge Americans with their near-monopoly pricing power should recognize that this power is preventing people from filling prescriptions and keeping important drugs from both coming into the market and from being manufactured. Mounting evidence suggests the need for the government to intervene to ensure that people get the medications they need.

    A story in The New York Times about a lawsuit against Gilead, a pharmaceutical company, for failure to bring a critical drug to market quickly, speaks volumes about how drug company profits come before patient health. The delay in bringing a new HIV drug to market allowed Gilead to maximize revenue on another drug with possibly more dire side effects.

    The people at Gilead believed the new drug would have less harsh side effects on people’s kidneys and bones. But, the drug likely would bring down revenue on Gilead’s patent-protected drug. So Gilead’s executives  decided to delay bringing the new drug to market until the patent-protected drug lost its protection. Based on a review of Gilead’s internal documents, the New York Times reports that Gilead was “gaming the U.S. patent system to protect lucrative monopolies on best-selling drugs.”

    Stories also abound about drugs that are not available because pharmaceutical companies are not able to make big profits selling them. These drugs are not outliers. They can treat cancer and heart disease and basic infections. And, there are drug shortages of more than 300 of them.

    Geoffrey Joyce, Director of Health Policy at the USC Schaeffer Center, explains in The Express that drug shortages have been around for some time. But, we are seeing shortages of more drugs of late and we are seeing drug shortages for longer time periods. Amoxicillin to treat ear infections, for example, is hard to get, as is lidocaine and albuterol, which many Americans depend on for treating their asthma. Ironically, the problem is that these drugs come with a low price tag, so pharmaceutical companies don’t see the financial value of producing them.

    Because of US patent laws, pharmaceutical companies can pretty much call the shots on what they charge for brand-name drugs for a long period of time. That means big bucks for them. They can charge many times more for these drugs in the US than in any other wealthy country because every other wealthy country negotiates drug prices. And, drug companies generally can charge high prices for at least 20 years or until their patent expires, which could be even longer. Once a drug is off patent, they face generic competition and prices tend to fall, along with profits.

    Even when drug companies outsource generic drugs for manufacture, they do so to cut costs and, in the process, sometimes undermine quality and supplies. Interestingly, though the FDA struggles to inspect foreign drug manufacturing facilities, it allows the sale of these drugs in the US but still does not allow drug importation.

    And, when several companies manufacture a generic, quality and supplies can suffer. The supplier of key ingredients might be the same for all of them. If the supplier stops producing, no generics are produced. Or, the supplier might be responsible for a harmful ingredient in all the generics. Who knows the consequences in any given situation, but people can die.

    Joyce proposes that the US produce more generic drugs, as California has proposed to do.

    Here’s more from Just Care:

  • Small non-profit helps lower price of some ineffective drugs

    Small non-profit helps lower price of some ineffective drugs

    Caroline Humer reports for Reuters on the value of the Institute for Clinical and Economic Review (ICER) in holding drug prices down. ICER is a small not-for-profit research organization that determines the value of particular drugs and what they should cost. ICER has been effective at helping to lower the price of some prescription drugs.

    Most other wealthy countries partner with independent research organizations like ICER to set prices for virtually all prescription drugs. The US government does not have its own agency or a partnership with an independent agency that determines the value of drugs. In this research vacuum, ICER has developed influence.

    For example, some people thought that Gilead could charge as much as $10,000 for remdesivir because it was found to be helpful in treating COVID-19 patients. But ICER said that the drug did not justify a price of more than $5,000. Gilead ended up charging $5,700 for a ten-day supply.

    ICER’s budget is not large enough to establish the value of all drugs or even most drugs. But, some say it has helped reduce the cost of almost 100 drugs. And, some health insurers keep off of their formularies certain drugs that ICER deems do not offer good value.

    Drugs that ICER has determined cost way too much and are not cost-effective include Aubagio, for the treatment of multiple sclerosis, Ninlaro, for the treatment of multiple myeloma, Austedo, for the treatment of Huntington’s disease, and Rebif, an anti-inflammatory for the treatment of multiple sclerosis.

    Not surprisingly, the pharmaceutical industry is not accepting ICER’s influence, which is reducing its profits. It is attacking the non-profit any way it can. Often, it relies on non-profits that are funded by pharmaceutical companies to attack ICER.

    ICER’s goal is simply to help insurers and other prescription drug purchasers choose drugs that are cost-effective for a given condition, assessing the drug’s price and benefit to quality of life. To establish the fair value of a drug, it relies on a time-tested formula, QALY or quality-adjusted life year, what it costs to extend someone’s life with one year of good health. That is what other countries’ health systems do.

    The federal government does not negotiate drug prices for Medicare or Medicaid. In fact, Congress forbade the federal government from using QALY to negotiate drug prices. ICER has been taking on that role, in a way.

    Unfortunately, the pharmaceutical industry holds so much sway over pharmacies and other health care providers that CVS Health Corp was not successful at keeping drugs, which ICER has determined are not cost effective, off its formulary for employers.

    ICER plans to look at prices for the novel coronavirus vaccine and COVID- 19 treatments with the goal of helping to ensure they are fair.

    Here’s more from Just Care:

  • Coronavirus: FDA approves emergency use of an antiviral drug treatment

    Coronavirus: FDA approves emergency use of an antiviral drug treatment

    Stat News reports that the Food and Drug Administration just approved the emergency use of remdesivir, an antiviral drug, as a treatment for COVID-19. It is not a cure. But, it could speed up your recovery.

    It’s good news that remdesivir showed promise for speeding up the recovery of patients with COVID-19 in a government clinical trial. You should also understand that it is still too early to know how well it works, any side effects, and how safe it is.

    The National Institute of Allergy and Infectious Disease studied the effects of remdesivir on 1,000 hospitalized patients with COVID-19. It found that more than three in ten patients who took the drug recovered four days faster than patients who took a placebo, 11 days v. 15 days.

    The patients in the clinical trial were all seriously ill. Questions not only remain about the safety of remdesivir but also about whether it works to help patients who are not seriously ill or as a preventive treatment.

    The FDA has a fact sheet that explains more about the drug. Remdesivir should be used only for patients who are hospitalized with a blood oxygen count less than 94 percent. The FDA is also allowing the use of two antimalarial drugs, hydroxychloroquine and chloroquine to treat hospitalized patients with COVID-19. But the evidence is not clear that they are either safe or effective

    Gilead manufactures remdesivir. It’s CEO said that the company is donating 1.5 million doses of remdesivir–its existing supply–to ensure quick access for patients. Gilead will have 140,000 treatment courses available by July. And, the CEO is assuring the world that access to the drug will not come with financial obstacles. But, many members of Congress are concerned about what Gilead plans to charge for the drug, which was developed in large part with taxpayer funding.

    Before taking remdesivir for COVID-19, be sure to tell your doctor about any serious illnesses and allergies you have, kidney or liver problems, and any prescription and over-the-counter medicines you’re taking, as well as supplements.

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  • Government’s Section 1498 authority to regulate the price of drugs

    Government’s Section 1498 authority to regulate the price of drugs

    While the federal government should be regulating the price of all drugs, as does every other developed country, Congress has been too much in the thrall of pharmaceutical companies to rein in drug prices and ensure all Americans have access to affordable drugs. Instead, Congress gives drug companies the power to charge what they please for their drugs, even when people’s lives hang in the balance.  In fact, our government refuses to use its authority to limit the prices of some life-saving drugs for the public health under 28 U.S.C. Section 1498, as Alexander Zaitchik writes in his new piece for the American Prospect.

    Right now, in Louisiana, more than 70,000 people have hepatitis C, a blood disease that is extremely contagious and fatal. But, Gilead charges close to $100,000 a person for the medicine that cures it, and Louisiana cannot afford to provide the medicine to the 35,000 Louisianans who need it.

    Hepatitis C is killing more people in the U.S. than every other infectious disease combined. It would cost about $200 billion to treat everyone in the U.S. who needs it. In Kentucky, seven percent of the state’s Medicaid budget went to treating 900 people with hepatitis C, a tiny fraction of the people who need it.

    The cost of producing the hepatitis C treatment is between $62 and $216 and bears no relation to the price of the treatment. Gilead has already reaped tens of billions of dollars in profits from its hepatitis C drug alone.

    Section 1498 gives the U.S. the right to use a company’s patent in the interest of the public health, the national security and commerce. And, according to Zaitchik, back when, the government exercised that right many times. For example, it used Section 1498 to encourage the availability of lower cost generic drugs. But, since the early 1970’s, the government has refused to exercise this right to bring down the cost of prescription drugs.

    Rebekah Gee, the Louisiana Health Secretary is considering asking Secretary of Health and Human Services, Tom Price, to use Section 1498 to spur the production of generic versions of the hepatitis C treatment for which Gilead currently holds the exclusive license. Otherwise, Gilead’s large price tag for its hepatitis C drug likely will lead thousands of people with hepatitis C to die unnecessarily.

    Under Section 1498, the government would have to pay Gilead a “reasonable price” if it infringed on its patent. But, it’s fair to assume that  Secretary Price will not grant Gee’s request. Secretary price has historically placed the rights of corporations to reap profits ahead of people’s lives.

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

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