{ "docId": "019dd923-5ca1-7489-b639-45501f4b359b", "docSlug": "158df8627a0b9aca", "documentTitle": "Opioid Conflicts Majority Staff Report", "authorId": "McKinsey", "authorName": "U.S. House Committee on Oversight and Reform", "documentKindSlug": "consulting-deck", "documentKindLabel": "Consulting deck", "sourceTypeSlug": "strategy_consulting", "sourceTypeLabel": "Strategy consulting", "presentationDate": null, "orientation": "portrait", "aspectRatio": 0.773, "pageNumber": 37, "pageCount": 53, "prevPage": 36, "nextPage": 38, "slideType": "appendix_disclosure", "function": "appendix", "density": "dense", "nDataPoints": 1, "notes": "This is a page from a legal or investigative report, containing footnotes and legal citations.", "elementsJson": [ "paragraph", "footnote" ], "metadataConfidence": 1, "imagePath": null, "slideHref": "/slides/019dd923-5ca1-7489-b639-45501f4b359b/37", "deckHref": "/decks/019dd923-5ca1-7489-b639-45501f4b359b", "deckJsonHref": "/decks/019dd923-5ca1-7489-b639-45501f4b359b.json", "deckAnchorHref": "/decks/019dd923-5ca1-7489-b639-45501f4b359b#slide-37", "components": [ { "bbox": null, "kind": "callout", "text": "McKinsey's contracts for a federal regulator and a regulated entity could lead a reasonable person to question whether the firm's \"ability to render impartial advice to the government [was] undermined by the firm's competing interests.\"", "attrs": null, "subkind": null, "toolName": "Visual emphasis", "toolSlug": "visual-emphasis", "confidence": null, "componentId": "019dd951-cdec-74db-b49d-369c82f376fb", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.105, "w": 0.764, "x": 0.118, "y": 0.568 }, "kind": "paragraph", "text": "McKinsey’s practice of staffing consultants on FDA projects who also consulted opioid manufacturers appeared to impair its objectivity. Some of the FDA and Purdue contracts on which McKinsey staffed consultants had seemingly conflicting aims. For instance, in 2009, McKinsey staffed a consultant on a project in which the firm recommended Purdue “defend against strict treatment by the FDA” in the agency’s opioid-REMS safety program or otherwise “Raise legal claims alleging FDA impropriety.” Yet in 2011, McKinsey staffed that same", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "20945752-37b0-4e42-8776-133f8180eeed", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.065, "w": 0.764, "x": 0.118, "y": 0.313 }, "kind": "paragraph", "text": "Despite the clear requirements in federal law, McKinsey appears to have repeatedly created serious, undisclosed conflicts of interest by consulting for both the FDA and opioid manufacturers, including on related matters and with overlapping staffing of consultants who shared information between clients.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "38e6195a-a38f-464a-a863-bb8b70bb32e2", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.165, "w": 0.764, "x": 0.118, "y": 0.378 }, "kind": "paragraph", "text": "As described above, McKinsey worked on several contracts at FDA regarding the safety and monitoring of dangerous drugs, including the 2011 contracts in the Office of Surveillance and Epidemiology and the three Sentinel Contracts from 2014 through 2018. During the same periods, McKinsey was working for or attempting to win additional business from Purdue to measure and compile findings about OxyContin’s safety for FDA’s review. McKinsey advised FDA on the structure and priorities of its surveillance offices and systems while simultaneously advising one of the nation’s largest opioid manufacturers how to demonstrate the safety of its opioids to FDA. McKinsey’s contracts for a federal regulator and a regulated entity could lead a reasonable person to question whether the firm’s “ability to render impartial advice to the government [was] undermined by the firm’s competing interests.”", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "f0b29529-6e5b-4d36-87df-9c05026748de", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.15, "w": 0.764, "x": 0.118, "y": 0.72 }, "kind": "source-note", "text": "177 Department of Justice, The False Claims Act: A Primer (Apr. 22, 2011) (online at www.justice.gov/sites/default/files/civil/legacy/2011/04/22/C-FRAUDS_FCA_Primer.pdf). 178 Congressional Research Service, Selected Legal Tools for Maintaining Government Contractor Accountability (Sept. 26, 2018) (online at www.crs.gov/Reports/R45322); Federal Register, Civil Monetary Penalty Inflation Adjustment (Jan. 13, 2022) (online at www.federalregister.gov/documents/2022/01/13/2022-00506/civil-monetary-penalty-inflation-adjustment). 179 See 18 U.S.C. § 287. 180 See 48 C.F.R. §§ 9.505-3, 9.505(a); Aetna Gov’t Health Plans, Inc.; Foundation Health Fed. Servs., Inc., B-254397 et al., July 27, 1995, 95-2 CPD 129 at 13; Leidos, Inc., B-417994, Dec. 17, 2019, 2019 CPD ¶ 425. 181 MCK-HCOR-0340667, Slide 1; MCK-HCOR-0339718; MCK-HCOR-0225929.", "attrs": null, "subkind": null, "toolName": null, "toolSlug": null, "confidence": null, "componentId": "c2055b1e-97e7-4080-a765-d778df490828", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.045, "w": 0.764, "x": 0.118, "y": 0.238 }, "kind": "title", "text": "2. McKinsey Had Extensive Conflicts of Interest in Apparent Violation of the Federal Acquisition Regulation and Contract Terms", "attrs": null, "subkind": "headline", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "d0a1f069-257b-4042-a62d-4d0d6c0fd174", "frameworkName": null, "frameworkSlug": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [ { "to": 53, "from": 29, "beatId": "1170eac2-9202-4b41-a53c-edbd934ded10", "arcName": "Problem-Agitate-Solution", "arcSlug": "problem-agitate-solution", "beatName": "Impact & Next Steps", "beatSlug": "consultants-gambit-impact-next-steps", "evidence": "The document concludes with implications of McKinsey's actions and potential next steps for regulatory action.", "position": 2, "confidence": 0.8, "parentBeatName": "Resolution", "parentBeatSlug": "resolution" } ], "loops": [ { "to": 53, "from": 1, "name": "Cost Of Inaction", "slug": "27-cost-of-inaction", "bestFor": "Urgent budget requests, compliance, risk mitigation", "matchId": "ee9686db-f8b5-4bc9-bf6e-2d29966ee033", "evidence": "The document implies the cost of inaction through its presentation of McKinsey's conflicts of interest and their potential impact on the opioid epidemic.", "position": 0, "objective": "What is the cost of inaction in addressing McKinsey's conflicts of interest?", "structure": "The Status Quo -> The Hidden Costs Accumulating -> The Future State of Inaction -> The Tipping Point", "confidence": 0.7, "description": "Quantify what happens if the audience does nothing" }, { "to": 40, "from": 24, "name": "Voice Of Customer", "slug": "51-voice-of-customer", "bestFor": "Product strategy, customer experience, market research", "matchId": "308c22ef-34f3-45b8-b50d-c273c6edeb88", "evidence": "The document presents the concerns of regulatory bodies through examples of McKinsey's actions and lack of disclosure.", "position": 1, "objective": "What are the concerns of regulatory bodies regarding McKinsey's conflicts of interest?", "structure": "What Customers Say (Verbatim) -> The Pattern Across Voices -> The Insight -> The Response", "confidence": 0.6, "description": "Let customer quotes and feedback drive the narrative and validate the insight" } ], "imagePathAlt": null, "thumbSrc": null, "thumbSrcAlt": null, "locked": true }