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#71 – Katherine Eban: Widespread fraud in the generic drug industry — Whalespan

Content›Video›#71 – Katherine Eban: Widesp…

#71 – Katherine Eban: Widespread fraud in the generic drug industry

Peter Attia2h 42m · 2020-01-14

Claims Made

213

Claims Supported

110

Support Rate

52%

Support rate

110 of 213 claims supported

110 supported103 partial / not

Claims from this content

40

◐Partially SupportedThe podcast content is not a substitute for professional medical advice, diagnosis, or treatment, and users should not delay seeking medical advice for any conditions.✓Well SupportedUsers should not disregard or delay obtaining medical advice for any medical condition and should seek assistance from healthcare professionals.◐Partially SupportedPeter Attia maintains an up-to-date and active list of companies he invests in or advises on his website.◐Partially SupportedPeter Attia shares updates on his activities, interesting papers he has read, and longevity science, performance, and sleep-related content via a weekly email newsletter.Well Supported

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A. Volkovreader

4h

Bookmarking — the dossier-vs-overview split is the right call. Most of the time I want overview; sometimes I want receipts.

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N. Park

2d

Would love a "what would change this verdict" RSS feed. Sign me up if it exists.

✓

Ranbaxy manipulated drug data and tested crushed brand-name drugs to generate bioequivalence data for generic products.

◐Partially SupportedInformation related to Peter Attia's podcast can be found at petertiamd.com/podcast.

◐Partially SupportedThe cost of bringing a drug from IND application to Phase 3 approval is approximately $1 billion and takes about a decade.

◐Partially SupportedAn FDA inspector recommended a plant in Zhejiang, China, be sanctioned for failing to investigate impurity spikes in its drugs.

◐Partially SupportedGeneric drugs are considered identical to brand-name drugs by the FDA, but variations in manufacturing processes and excipients can exist.

◐Partially SupportedGoodRx is a recommended app for finding prescription drug prices and locations.

◐Partially SupportedGeneric drug companies must prove similar absorption and route of administration to brand-name drugs, but other aspects can vary.

◐Partially SupportedPeter Attia prescribes Crestor over Lipitor and uses pravastatin more frequently in patients with mild CK elevations.

◐Partially SupportedPatients should investigate their own drugs by determining the manufacturer and asking their pharmacist.

◐Partially SupportedThe FDA drug approval process requires confirmation of safety and efficacy.

◐Partially SupportedProving drug efficacy became central to modern FDA drug approvals.

◐Partially SupportedAmericans have received drugs that are not bioequivalent, contain foreign particulate matter, toxic impurities, or are otherwise misrepresented.

◐Partially SupportedVetting generic drug manufacturers aims to increase the use of safer options.

◐Partially SupportedGeneric drugs are a crucial and life-saving player in public health.

◐Partially SupportedCorroded equipment used in sterile injectable cardiac drug manufacturing can leave metallic particles in the drug.

◐Partially SupportedThe FDA's origin in the 1930s was a response to public health disasters, including children dying from tainted cough syrup.

◐Partially SupportedFrances Kelsey prevented thalidomide from being approved in the US due to insufficient safety data.

◐Partially SupportedIf a drug purchased from a US pharmacy originates from an Indian or Chinese company, there is an 80% chance of misinformation regarding its potency, shelf life, or composition.

◐Partially SupportedThe FDA conducts follow-up inspections approximately every two years to ensure ongoing compliance with manufacturing standards.

◐Partially SupportedThe FDA detected three different carcinogens in recalled blood pressure medications.

◐Partially SupportedDrugstore chains may dispense the lowest cost generics from manufacturers with lower quality standards.

◐Partially SupportedNDMA, a carcinogen found in recalled blood pressure medications, is created in the production of liquid rocket fuel.

◐Partially SupportedThe six-month exclusivity period for generic drugs created a perverse incentive.

◐Partially SupportedGeneric extended-release metformin may not be as effective as brand-name Glucophage XR and can cause gastrointestinal side effects.

◐Partially SupportedGeneric drug manufacturers must demonstrate bioequivalence to brand-name drugs to the FDA.

?Limited ResearchGeneric drugs may have misinformation affecting potency, shelf life, or composition.

◐Partially SupportedThe Hatch-Waxman Act provides a six-month market exclusivity period for the first generic drug applicant to receive FDA approval.

◐Partially SupportedGeneric drug applications require data demonstrating bioequivalence to the branded product, including absorption, stability, and dissolution.

◐Partially SupportedValley Store, a mail-order pharmacy, tests every drug they dispense.

✕Not SupportedGeneric AIDS drugs sent to Africa were of poor quality and degraded in heat, failing to cure patients.

◐Partially SupportedSome cardiac patients stabilized on brand-name drugs became unstable when switched to generic versions, and heart transplant patients suffered organ rejection from generic tacrolimus.

◐Partially SupportedPhysicians should list all prescribed drugs, their generic manufacturers, and research public information on filings against these companies.

◐Partially SupportedThe Hatch-Waxman Act of 1984 created an FDA pathway for generic drugs requiring proof of bioequivalence.

◐Partially SupportedMillions of Americans took blood pressure medications containing carcinogens from Chinese and Indian manufacturing plants.

◐Partially SupportedPrior to the mid-1980s, generic drug companies had to prove both safety and efficacy, making it difficult to compete with branded drugs.

◐Partially SupportedFDA reviewer Frances Kelsey refused to approve thalidomide in the early 1960s due to insufficient safety information.