Archive for the ‘Pharmaceuticals’ Category

By Will Neer and Anisha Sehgal

Imagine being diagnosed with a life threatening illness. The immediate reactions of shock and panic may also be mixed with relief once your doctor informs you that there is an effective treatment available. However, that relief can quickly disappear and instead be replaced with hesitation and fear once the hefty price tag associated with the treatment is revealed.  This unfair cycle of emotions is a process too many Americans and their families are forced to experience due to astronomical drug prices.

A type of drug commonly used to treat serious illnesses is a biologic. However, as prescription drug corporations often charge more than $100,000 annually for biologic treatments, many Americans are fighting insurer rationing or even turning to pill splitting.  A piece of bipartisan legislation, S. 0394 / H.R. 5573, titled the Price, Relief, Innovation and Competition for Essential Drugs (PRICED) Act aims to remedy this problem. The PRICED Act would amend U.S. law and shorten the time that prescription drug corporations have monopolies on biologic medicines – and how long they can charge monopoly prices, thereby making these treatments more readily accessible.

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By Anisha Sehgal

Pharma Part B infographicDuring election season, Americans across the country hear politicians make grand statements on how they will look out for the good, hard-working people of their state and push for progress that will benefit us all. As we watch them head off to Washington we expect or at least hope that they will deliver on their promises and act in a manner that looks out for our best interests.

However, a recent Public Citizen report on the role of corporate money in politics has revealed the strong influence donations can have on swaying lawmakers’ support on big issues. We are in the midst of a contentious debate regarding the Centers for Medicare and Medicaid Services’ (CMS) proposed Medicare Part B demonstration, a proposal strongly opposed by the pharmaceutical industry. Public Citizen’s new study reveals that members of Congress who opposed or were critical of the reform on average received 82% more in campaign contributions for the 2016 election cycle from the pharmaceutical and health products industry than rank and file members who did not take a stance against the reform.

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By Emma Stockton

Last month, The International AIDS Society’s conference in Vancouver came to a close with an announcement that gave the global AIDS community great hope. In 2011, The United Nations had set a goal of treating 15 million people by 2015. That goal, once thought unrealistic, was reached 9 months early. Now more than 15 million people around the world living with HIV are receiving treatment.

On July 14, the United Nations announced the laudable goal of ending AIDS by 2030. As U.N. Secretary-General Ban Ki-moon said, “Ending the AIDS epidemic as a public health threat by 2030 is ambitious, but realistic, as the history of the past 15 years has shown.”

One major contingency for this goal that must be addressed is access to treatment. We have conclusive evidence that starting antiretroviral treatment as soon as a patient is diagnosed with HIV is proven to vastly improve patients’ health outcomes and prevent future transmission. We also know of a French teen born infected with HIV who received treatment until age 6 and has been virus free for twelve years.  This is the first confirmed long term remission for a child born with HIV.

However, despite the need to start treatment at diagnosis to be most effective, currently we are essentially rationing out ARVs to the sickest people because of their exorbitantly high cost. According to Medecins Sans Frontieres (MSF), more than half of the 37 million people living with HIV are not receiving treatment.

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fda approved smallNo one can dispute that multidrug-resistant “superbugs” are a key public health concern for the 21st century. Better, safe and effective cures are needed. But the 21st Century Cures Act, legislation that will be voted on this week in the House, is not the solution to this problem.

Over 2 million people are infected with antibiotic-resistant bacteria each year, resulting in at least 23,000 deaths. New antibiotics have been slow in coming: No antibiotic with a truly novel mechanism of action has been discovered since the late 1980s. Yet this drought is not the fault of the Food and Drug Administration (FDA), which has long been under tremendous pressure to approve new antibiotics quickly. This pressure was increased even further by a 2012 law that accelerated review for qualifying antibiotics.

Thanks to the current review process for antibiotics, clinical development for these drugs is already quick by industry standards. A new antibiotic takes only seven years to get to market, compared with nine years for cancer drugs.

Quick approval is not without costs. Many of the antibiotics approved over the past decade have suffered from safety and effectiveness problems. For example, tigecycline (Tygacil), an antibiotic that received special accelerated FDA approval in 2005, was slapped with a black-box warning in 2013 stating that the drug increases the risk of death.

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Antibiotic Resistance Coalition - photo courtesy of ReAct

Antibiotic Resistance Coalition – photo courtesy of ReAct

Last Thursday, Public Citizen joined partners in the Antibiotic Resistance Coalition in releasing a declaration on the dire threats posed by antibiotic resistance and urgent steps that must be taken to avert its dangers.

Additionally, the coalition called on World Health Organization member states to pass a critical resolution calling for measures to combat antimicrobial resistance, including antibiotic resistance, at the 67th World Health Assembly.

The implications of the growing trend of antibiotic resistance are frightening, to say the least. Human beings rely on antibiotics for treatment of the most basic bacterial infections. Without effective antibiotics, most surgery, organ transplantation and chemotherapy would be impossible. The growing trend of antibiotic resistance is making that possibility all too real.

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