Sanders, Other Lawmakers Urge FDA Approval of Generic Crestor

Two months ago, AstraZeneca gained approval for the use of Crestor in children suffering from homozygous familial hypercholesterolemia (HoFH) and, under the Orphan Drug Act (ODA), the drug then qualified for extended market exclusivity for the treatment of this new condition. With the impending loss of patent protection for Crestor’s common use in adults, AstraZeneca has filed a lawsuit accusing the FDA of illegally interpreting a federal law that will allow generic medications to exclude indications for HoFH on their labels. Without the ruling, generic manufacturers would be required to include HoFH dosing and instructions on their labels, therefore violating the exclusivity granted by the ODA and extending AstraZeneca’s market hold. Bernie Sanders, along with several other lawmakers, are petitioning the FDA to approve the generics and offer a lower cost alternative to consumers.

Read the Stat News article on it here.

[Podcast from 2 Docs Talk] Direct-To-Consumer Marketing - Letting the Fox Guard The Henhouse

Summary: Direct-to-consumer drug marketing has, historically, been a controversial topic. In 2002, Merck spent $160 million on a marketing campaign for the new pain medication, Vioxx. Later, the drug was found to increase the risk of stroke and heart attacks and was being used, largely, by individuals who were well-suited for alternative drugs (like ibuprofen). In addition to the increased potential for misuse, many ad claims are misleading for consumers: A reported “significant” increase in length of life for patients on a treatment for lung cancer is actually three months. As pressure builds to regulate, or even halt, these advertising practices, the pharmaceutical industry has a proposed solution. They recommend giving the FDA approval rights for all prescription drug ads prior to their release, funded by manufacturers through a per ad ‘user fee.’ This approach is already used for drug approvals, with manufacturers funding over half of the FDA’s budget; prior to the implementation of these fees in 1993, drug company investment accounted for less than 10% of funds received by the FDA. Opponents of the measure are concerned how the impact of additional pharma industry funding will jeopardize the ultimate efficacy of the FDA’s practices.

Here the podcast from 2 Docs Talk here.

'Cross Protection' Occurs Between Bacterial Strains

Scientists recently discovered a mutually beneficial relationship occurring between bacterial strains: cross protection. In a new study, researchers grew two types of E. coli, each resistant to a different antibiotic, in the same test tube. The environment also contained the two antibiotics to which the strains were resistant. Instead of being eliminated, both bacteria deactivated “their” antibiotic, providing protection for the other strain. While not occurring in this study, experts suspect that, over time, this stable environment could lead to the exchange of resistance genes – making both strains of bacteria resistant to both antibiotics.

Listen to Scientific American's podcast about it here.

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GlaxoSmithKline CEO On Why Drugs Cost So Much

Sir Andrew Witty, the CEO of Britain’s GlaxoSmithKline (GSK), the sixth largest pharmaceutical company in the world, discusses the current period of ‘extreme challenge’ in the industry and acknowledges the disconnect between the global push for affordable healthcare and the current cost of needed medications. Specifically, he points to the U.S.’s lack of transparency requirements as a major driver for the issues that our country is facing today – an inability to determine the actual price of a drug makes it impossible to determine a realistic cost-benefit analysis for the system. Ultimately, he suggests, the system needs to balance cost, value and innovation to ensure shareholders remain invested and patients have access to the drugs they need.

Hear the podcast on it here.

New 'Scarier' Zika Warnings in the U.S.

The CDC recently released a broader range of Zika-related complications beyond microcephaly, including stillbirth, placenta damage, prematurity, etc., as well as potential links to additional non-pregnancy conditions. In this comprehensive discussion about the existing and anticipated impact of the virus, experts explain the developing understanding of transmission, effects and prevention. Although there is evidence that the disease is not in the continental US (beyond those that traveled to infected countries), experts estimate the range of the carrier mosquito to include parts of at least 30 states – with an additional potential carrier type extending as far north as Minnesota. Combined with the difficult of containment, due to the uniqueness of the mosquito (including breeding, biting habits, etc.), experts suspect that an outbreak in the United States would be the “public health version of [Hurricane] Katrina.”

Listen to the podcast about it from On Point with Tom Ashbrook.

Podcast: "How Wall Street Reacts When a Patient Dies in a Clinical Trial"

Summary

There exists an important link between scientifically proving a drug’s efficacy and safety and maintaining the confidence of investors who fund the clinical trials; one without the other likely means the drug will fail. When the drug company Zafgen entered the third stage of clinical trials for their drug, Beloranib (originally used to treat cancer, then tested for weight loss efficacy and, ultimately, the treatment of the rare Prader-Willi Syndrome which causes insatiable hunger in children), the death of two patients lead to investors pulling out and stock prices plummeting from $35/share to $7. Despite proof that both deaths were caused by a common condition to Prader-Willi patients not receiving treatment, investor confidence appears to be shaken and share prices have not returned to their original value. For small drug companies, like Zafgen, who do not have multiple high-dollar revenue streams or alternative, ongoing research opportunities, the results of a patient death (including long-term holds placed on future trials and subsequent loss of investor support) often mean the end of the business and the drugs for which patients throughout the country have been waiting.

Link to Podcast: https://www.statnews.com/2016/04/04/podcast-clinical-trial-death/