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Tag: Merck

  • Merck sues Medicare over negotiated drug prices

    Merck sues Medicare over negotiated drug prices

    Merck just filed a lawsuit challenging the legality of the Inflation Reduction Act‘s provision allowing Medicare to negotiate some drug prices with pharmaceutical companies. The administration is holding firm to doing so, notwithstanding. The law is intended to lower drug prices in Medicare.

    Merck claims that if negotiated drug prices take effect, it will keep drug manufacturers from innovating new drugs. It wants a court to say that it does not have to take part in drug price negotiations with the federal government. If the issue is innovation, the question becomes how much profit do the pharmaceutical companies need to generate to ensure they innovate and innovate for drugs that we need. Last year, Merck profited $14.5 billion.

    In response to the lawsuit, Secretary of Health and Human Services Xavier Becerra said, “We’ll vigorously defend the President’s drug price negotiation law, which is already lowering health care costs for seniors and people with disabilities. The law is on our side.”

    The IRA drug price negotiation provision is not set to take effect for another two and a half years. And, in its first year, only 10 drugs that have been on the market for several years without competition will have lower negotiated prices.

    Merck is claiming the drug price negotiation law is unconstitutional because it is taking of property for the public without fair compensation. In this country at this time, Merck could win. But, the law is not on Merck’s side.

    The IRA drug price negotiation provision is designed to withstand constitutional challenges. It allows Merck to turn down Medicare’s final negotiated price. Merck would then be subject to a tax. But, the tax could end up being hundreds of millions of dollars a day over time, according to Merck’s complaint.

    We still don’t know which drugs are included among the 10 the government intends to negotiate prices for in 2026. But, one of Merck’s drugs, Januvia, which some diabetes patients use, could be among them. And, in future years, another Merck drug, Keytruda, which some cancer patients use, could be another.

    Public Citizen President Robert Weissman issued the following statement:

    “Merck is claiming the U.S. constitution requires the U.S. government and people to be suckers. That’s not true.”

    “There’s no Sucker Clause in the 1st Amendment, 5th Amendment, or anywhere else in the Constitution.”

    “This lawsuit is a desperate attempt by the industry to beat back popular legislation that would curtail Big Pharma’s ability to price gouge Medicare and secure monopoly profits. Full stop.”

    “While Big Pharma’s litigation gambit plays out, it is critical that the federal government continue its preparation for price negotiations. Delay in the commencement of long overdue negotiations will result in billions of dollars in excess costs for taxpayers and consumers.”

    Touche!

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  • Merck charged with blocking generic competition

    Merck charged with blocking generic competition

    Paige Minemeyer reports for FierceHealthcare on a lawsuit filed by two insurers against Merck for using its power to block generic competition to its cholesterol drugs, Zetia and Vytorin. A third insurer filed a separate lawsuit alleging the same. Until Congress steps in to negotiate drug prices, pharmaceutical companies will game the system every which way they can to protect and increase their profits.

    What is the allegation against Merck? After many years of marketing a drug without competitors, Merck lost its exclusivity for Zetia, a cholesterol-lowering drug. As a result, Merck should have lost its monopoly pricing power for Zetia since generic drugs could be sold that worked as well as Zetia. But, to keep its monopoly pricing power and its enormous profits, the plaintiff insurers claim that Merck paid a generic competitor not to sell a generic version of Zetia for five years. This practice of pharmaceutical companies is called “pay for delay.”

    The insurers argue that, as a result of Merck’s pay-for-delay agreement with the generic competitor, the insurers overpaid hundreds of millions of dollars for their enrollees’ cholesterol-lowering drugs.  They further argue that Merck profited from its wrongful behavior to the tune of billions of dollars.

    The generic drug manufacturer also reaped significant revenue for delaying production of a generic drug like Zetia.  Merck paid it handsomely to hold off. But, the insurers and their enrollees paid big time.

    What is to be done? The way to fix this pay-for-delay problem and all the other gaming that the pharmaceutical corporations engage in to maximize profits is for the government to regulate drug prices. Regulating drug prices would also save tens of thousands of lives a year, enabling people who currently go without lifesaving medicines because they can’t afford them to fill their prescriptions.

    At this moment, the Democrats in Congress are trying to find a way to bring down drug prices. But, so many Democrats, along with Republicans, are in the pockets of the pharmaceutical companies. It’s still not clear what they will be able to accomplish.

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  • If Merck knew that Fosamax causes bone fractures and kept silent, shouldn’t it be liable?

    If Merck knew that Fosamax causes bone fractures and kept silent, shouldn’t it be liable?

    How would you feel if you were harmed by a medicine you took as prescribed and then learned that the drug company wasn’t liable — even though it knew about the risk and didn’t tell you or your doctor?

    This is exactly what has happened in the case of Fosamax (alendronate), a drug used to treat bone-thinning osteoporosis and osteopenia. After it was approved by the Food and Drug Administration and women across the country began taking the drug, the FDA and its maker, Merck, started receiving reports about spontaneous fractures of the thigh bone among women taking the drug.

    These fractures, dubbed “Fosamax fractures,” happen with no warning and usually require surgery. Although they are a rare side effect of the drug, millions of women have taken the drug. While the true number of Fosamax fractures isn’t known, about 500 women have sued Merck for failing to warn them about the risk of this painful and possibly debilitating side effect. These lawsuits are at the heart of a case, Merck, Sharp & Dohme Corp. v. Doris Albrecht, et al., that will be argued before the U.S. Supreme Court on Jan. 7, 2019.

    MedShadow Foundation, the nonprofit organization I founded in 2012 to inform the public about the side effects of medicines, along with three former FDA officials, filed an amicus curiae brief in support of Albrecht, the defendant in the case. Such “friend of the court” briefs are filed by individuals or organizations that aren’t parties in a case.

    Merck Admits Fosamax Caused The Fractures

    Merck acknowledges that Fosamax caused these fractures and that the company knew about them. In 2008, Merck started the process to get the FDA’s permission to put a warning on the drug label — the inserts that come with all medicines, providing information such as instructions on how to take a drug, what it can be used for, and warnings. The FDA reviews and must approve any information on drug labels for accuracy. These labels are generally considered fair warning to users about possible side effects or adverse events and, in that way, provides legal protection for drug companies from being sued for causing them.

    The FDA relies on manufacturers to update and make changes to drug labels throughout the lives of their drugs. That’s because approvals for new drugs are often based on small clinical trials of 1,000 or fewer people that normally last less than a year. Unusual or rare side effects and can’t be detected in such small, short-term trials. Once a drug is approved and thousands or millions of people are taking it, new side effects and adverse events can emerge.

    The spontaneous fractures caused by Fosamax didn’t begin appearing until the drug had been on the market for five years. And these fractures aren’t the only significant bone problems linked to the drug. Cases of osteonecrosis (literally “bone death”) of the jaw, a painful condition where jaw bones become exposed, were reported by people taking Fosamax. In 2013, Merck agreed to pay $27.7 million to settle 1,140 lawsuits from individuals who alleged that Fosamax caused them to develop this condition.

    Pharmaceutical companies have the best access to reports of adverse events, and they pay attention to updating drug labels as an important patient-protection safeguard.

    When Merck applied to the FDA for a label change to reflect these fractures, the FDA rejected its request. Why? Because Merck described them as stress fractures, which are minor and quite different from far more serious spontaneous fractures. A stress fracture is an incomplete bone break that is generally treated by rest and inactivity. A spontaneous fracture is a complete break that occurs in a seemingly normal bone without any trauma and must often be repaired with surgery.

    Although drug companies are responsible for updating labels, the FDA can require updates. In 2010, the FDA convened a panel to review the increasing number of reports of Fosamax-related spontaneous fractures. After reviewing the research, the panel found a clear connection between Fosamax and spontaneous thigh bone fractures. The FDA then ordered Merck to change the label.

    Women Suing Merck Claim Drugmaker Failed to Warn Them

    The women suing Merck claim that the company failed to warn them about a known adverse event. Merck is claiming that the FDA did not allow the company to change the label, making it impossible for Merck to warn women or their doctors.

    If Merck prevails, the disingenuous tactic it used for Fosamax could be replicated by other pharmaceutical companies and have far-reaching effects.

    Suppose a pharmaceutical company discovers that one of its drugs causes a serious adverse event. The company files an application for a change to the drug label, but knowingly designs the change so the FDA won’t accept it — either by minimizing the risk of the adverse event or by not accurately reflecting the risk. The drug company could then claim it isn’t liable for not warning consumers about that adverse event because the FDA denied the label change.

    If the Supreme Court allows drug companies to circumvent the law this way — which is what Merck is attempting to do in this case — it would remove the motivation for pharmaceutical companies to provide the FDA with timely and transparent information.

    MedShadow Foundation is a small nonprofit with limited resources. Yet we have taken on the costly and time-consuming process of filing an amicus brief because we believe that pharmaceutical companies cannot be allowed to obscure the risks, side effects, and adverse events of drugs — or exaggerate their benefits.

    The foundation’s mission is to protect quality of life by ensuring that people have all the known information about side effects before deciding to take a prescription or over-the-counter drug. Today, pharmaceutical companies are motivated to reveal previously unknown risks and warn the medical community so they can’t be sued for damages. The FDA and the law must maintain that obligation to protect people from unnecessary harm.

    There will always be some risk with medicines, but consumers have the right to all the information about benefits and risks of drugs — whenever that information is discovered — so they can make informed decisions about their health and well-being.

    This article originally appeared on Stat and is also on Medshadow.org.

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