The 13 Diagnoses That Were Built for Their Drugs

An Essay on How Human Experience Became a Market

This essay tracks a documentary record. FDA approval dates, DSM diagnostic revisions, patent expirations, congressional investigations, and marketing campaigns all sit in the public archive. The clinical categories examined here (major depressive disorder, hypoactive sexual desire disorder, mild cognitive impairment, fibromyalgia, and the rest) appear in the vocabulary the manuals and package inserts use, because the argument concerns what those manuals did and when they did it. The mechanism being exposed is the mechanism the establishment built into its own paperwork. Readers who work from a terrain framework will notice the language of “disorders” and “conditions” is not endorsed here; it is being examined in its own words, because the record shows what those words were built for.

The Confession

The industry has a phrase for what it does.

“Every marketer’s dream is to find an unidentified or unknown market and develop it. That is what we were able to do with social anxiety disorder.”¹

Barry Brand, product director for Paxil at SmithKline Beecham, said that to Advertising Age. Paxil had received its FDA indication for social anxiety in May 1999. The condition existed in the diagnostic manual before the drug arrived. The market did not.

What follows are thirteen of these markets. Each began as an ordinary feature of human life: nervousness, sadness, aging, eating, sleeping, mourning, aching. Each acquired a clinical name at or near the moment a drug reached the shelves. The name created the patient. The patient created the prescription.

The suffering is real. The question is who named it a disease.

Every entry is verifiable in FDA approval records, DSM revisions, peer-reviewed research, and congressional reports. The pattern is not inference. It is a business model documented in its own paperwork.

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Related

The 12 Diagnostic Thresholds That Were Lowered to Create Millions of New Patients

The 12 Screenings That Manufacture the Patients They Claim to Find

The 12 Recommended Ages That Were Lowered to Make More Patients

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1. Impulsive Eating → Binge Eating Disorder / Vyvanse (2015)

Shire Pharmaceuticals began developing lisdexamfetamine for binge eating in 2011.² The DSM did not yet recognize binge eating as a diagnosis. The DSM-5 promoted it from an appendix category to a standalone disorder in May 2013.³ In the eighteen months before FDA approval, Shire spent approximately $4 million on physician education about BED while cutting its ADHD education budget as that market exclusivity expired.⁴ The FDA approved Vyvanse for moderate to severe BED in January 2015, the first drug ever indicated for the condition.⁵

Jung and Fugh-Berman later documented in the Journal of the American Board of Family Medicine that all twenty-seven BED continuing-education modules in 2015 were Shire-funded, with seven of sixteen presenters disclosing financial ties to Shire. The modules framed Vyvanse as highly effective and quietly pitched it for weight loss, an off-label use for which amphetamines carry documented risks of addiction, cardiac events, and death.⁶ Shire hired tennis star Monica Seles to front the public awareness campaign.⁷ The authors of the peer-reviewed paper concluded that BED “may be an example of a disease created to sell a drug.” Overeating had become a diagnosis requiring a Schedule II amphetamine.

2. Puberty Distress → PMDD / Sarafem (2000)

Eli Lilly’s patent on Prozac was scheduled to expire in August 2001. In July 2000, Lilly received FDA approval for Sarafem, marketed for premenstrual dysphoric disorder.⁸ Sarafem was fluoxetine, the same molecule that had been Prozac since 1987, recolored pink and lavender in a new capsule with its own patent and sold in seven-day blister packs to help women “track” the condition.⁹ A Lilly marketing associate explained the brand split in simple terms: women did not look at their PMDD symptoms as depression, Prozac was closely associated with depression, and women told Lilly they wanted a treatment with “its own identity.”¹⁰

MIT held the use patent for fluoxetine in PMDD and had licensed it through Interneuron to Lilly, with royalties flowing back to the university.¹¹ PMDD had sat as a “provisional” category in DSM-IV’s appendix since 1994; it was promoted to a full diagnosis in DSM-5 in 2013.¹² The pink capsule did its work. Lilly retired the Sarafem brand once Prozac’s generic exposure was no longer the problem. The molecule, the manufacturer, the price, and the diagnosis had all served their purpose for the length of time the business required.

3. Shyness → Social Anxiety Disorder / Paxil (1999)

Paxil received its social anxiety indication in May 1999.¹³ SmithKline Beecham hired the public relations firm Cohn & Wolfe to run an awareness campaign built around the slogan “Imagine being allergic to people,” working through patient advocacy groups the firm helped organize.¹⁴ Social anxiety disorder had entered DSM-III-R in 1987 as a rare condition reserved for severe cases. The DSM-IV in 1994 broadened the criteria so dramatically that the American Psychiatric Association itself had to warn clinicians not to confuse the diagnosis with normal shyness.¹⁵

Prescriptions of Paxil for social anxiety rose from under 100,000 in 1998 to over one million within three years.¹⁶ The campaign placed stories about social anxiety in major newspapers and on television and set up help lines routing patients to physicians prepared to prescribe. A drug launch and a public relations campaign converted a rare diagnostic category into a condition carrying tens of millions of Americans and placed Paxil at the center of a new mass market. The condition existed in the manual before the drug arrived. The market did not.

4. Everyday Worry → Generalized Anxiety Disorder / Cymbalta (2007)

The GAD-7 screening tool was published in Archives of Internal Medicine in May 2006.¹⁷ Its seven questions include feeling nervous, worrying too much, and being unable to relax. A positive screen begins at five points out of twenty-one. In February 2007, Eli Lilly received FDA approval for Cymbalta in the treatment of generalized anxiety disorder.¹⁸

Lilly launched a direct-to-consumer campaign built around the phrase “Depression Hurts” and pushed the target population through primary care, where the GAD-7 could be administered in two minutes before the physician entered the room.¹⁹ Cymbalta reached annual sales exceeding $5 billion by 2013.²⁰ The screening tool and the indication arrived within nine months of each other. What both invited the physician to recognize was worry at a threshold most humans clear before breakfast.

5. Baldness → Androgenetic Alopecia / Propecia (1997)

Merck’s finasteride 5mg was approved as Proscar for enlarged prostate in 1992.²¹ In December 1997, Merck received a separate approval for finasteride 1mg as Propecia for male pattern baldness.²² The same molecule. One-fifth the dose. Substantially higher price per milligram than the identical drug for the prostate indication.²³ Going bald was reframed as androgenetic alopecia, a progressive medical condition requiring lifelong pharmaceutical management.

Post-finasteride syndrome, involving persistent sexual dysfunction, cognitive changes, and depression that continue after discontinuation, has been documented in the peer-reviewed literature since 2011.²⁴ A support foundation for post-finasteride syndrome maintains a registry of men who have died by suicide while suffering from it. Merck’s internal knowledge of the sexual side effect profile has been the subject of extended litigation.²⁵ The condition the drug was prescribed for was aging. The prescription was for life.

6. Male Aging → Low T / AndroGel (2000, DTC 2011)

AndroGel testosterone gel was approved by the FDA in February 2000.²⁶ Sales remained modest for a decade. In 2011, Abbott Laboratories launched the “Is It Low T?” direct-to-consumer campaign; Abbott spun off its pharmaceuticals as AbbVie in 2013.²⁷ The campaign was deliberately “unbranded,” meaning it never named AndroGel, while routing viewers to a quiz on IsItLowT.com whose results linked to the AndroGel website.²⁸ The ADAM questionnaire the quiz was built on had been developed by researchers funded by testosterone manufacturers; three yes answers out of ten suggested low testosterone.²⁹

Testosterone sales rose more than 1,800 percent in the three years after the campaign launched, reaching $1.9 billion in 2012.³⁰ A 2014 PLOS ONE study found a doubling of heart attack risk in men over sixty-five within ninety days of starting testosterone therapy.³¹ The FDA added a cardiovascular warning to testosterone product labels in 2015. AbbVie has paid substantial settlements through the testosterone products liability MDL.³² Getting older became a disease of the endocrine system.

7. Thinning Bones → Osteopenia / Fosamax (1995)

In 1992, a WHO study group meeting in Rome defined osteopenia as bone density between 1 and 2.5 standard deviations below the mean of a healthy thirty-year-old woman.³³ The comparison guarantees that virtually every woman over fifty falls short. “Osteopenia was never meant to be a disease in itself to be treated,” said Anna Tosteson of Dartmouth, who attended the Rome meeting.³⁴ Merck received FDA approval for Fosamax (alendronate) in September 1995.³⁵

Fosamax did not sell well at first because few women were being scanned. Merck hired a consultant named Jeremy Allen, created a nonprofit called the Bone Measurement Institute with Allen as its sole employee, financed the placement of portable DEXA scanners in physician offices, and lobbied through to passage the Bone Mass Measurement Act making the scans Medicare-reimbursable.³⁶ Diagnoses of osteopenia increased sevenfold.³⁷ Merck then launched a lower-dose Fosamax specifically for osteopenia.³⁸ Bisphosphonates cause osteonecrosis of the jaw and atypical femur fractures; absolute fracture reduction across major trials is one to two percent.³⁹ A statistical category became a diagnosis. The diagnosis became a drug that breaks the bones it was prescribed to protect.

8. Widespread Aches → Fibromyalgia / Lyrica (2007)

Fibromyalgia had been a contested rheumatology category since 1990, when the American College of Rheumatology established its diagnostic criteria.⁴⁰ Frederick Wolfe, who led that committee, later concluded fibromyalgia was a somatic response to emotional distress rather than a disease, and by 2008 was publicly calling it the product of “disease mongering.”⁴¹ Pfizer’s Lyrica (pregabalin), approved for epilepsy in 2004 and nerve pain in 2005, received the first FDA fibromyalgia indication in June 2007.⁴² Lilly’s Cymbalta followed in 2008 and Forest’s Savella in 2009.⁴³

Pfizer spent $138 million advertising Lyrica in 2008; Pfizer and Lilly together donated over $6 million to patient advocacy groups teaching physicians to recognize the diagnosis.⁴⁴ Daniel Clauw, the University of Michigan professor who became fibromyalgia’s leading academic voice, consulted for all three manufacturers.⁴⁵ Lyrica is a Schedule V controlled substance with documented withdrawal and dependence effects, as well as weight gain, dizziness, and edema.⁴⁶ It reached annual sales above $4 billion by 2012.⁴⁷ The man who wrote the diagnostic criteria had called it a label the drug companies made real.

9. Occasional Urgency → Overactive Bladder / Detrol (1998)

The term “overactive bladder” was popularized by Pharmacia & Upjohn’s marketing team in the late 1990s.⁴⁸ Detrol (tolterodine) received FDA approval in March 1998.⁴⁹ The condition was defined broadly enough that anyone experiencing sudden urges to urinate more than eight times daily could qualify.

The “Gotta Go” campaign for Detrol LA in 2001 taught the public to recognize the diagnosis in themselves and placed the question “Do you have overactive bladder?” into prime-time television slots.⁵⁰ Anticholinergic drugs like tolterodine have been associated with increased dementia risk in older adults in a dose-dependent relationship.⁵¹ Detrol became a billion-dollar franchise at its peak.⁵²

When Detrol’s patent expired and the anticholinergic dementia research grew clearer, newer OAB drugs took its place. Pfizer’s Toviaz and the first-in-class Myrbetriq promised fewer side effects than the drugs they replaced.⁵³ Each required the same diagnosis to prescribe. The urge to urinate, which every human recognizes without instruction, had become a syndrome requiring whatever drug the industry was selling that year.

10. Restlessness → Restless Legs Syndrome / Requip (2005)

GlaxoSmithKline received FDA approval for Requip (ropinirole) for restless legs syndrome in May 2005.⁵⁴ The condition described by Karl-Axel Ekbom in 1945 had sat in relative obscurity for sixty years before the launch. GSK spent $27 million advertising the new indication in the following year and funded the RLS Foundation with at least $850,000 between 2001 and 2006.⁵⁵ A prevalence survey funded by GSK reported that RLS affected one in ten adults; researchers unaffiliated with the company estimated actual prevalence well below three percent.⁵⁶

Requip sales doubled from $165 million in 2005 to nearly $330 million in 2006.⁵⁷ Ropinirole is a dopamine agonist. Its documented side effects include augmentation, in which the drug worsens the condition it was prescribed to treat, as well as impulse control disorders including pathological gambling and hypersexuality that have been the subject of extended litigation against the manufacturer.⁵⁸ A syndrome described in 1945 and left alone for six decades became a billion-dollar franchise within eighteen months of its first drug.

11. Low Libido → HSDD / Addyi (2015)

The FDA’s advisory committee voted unanimously against flibanserin in 2010 and again rejected the application in 2013.⁵⁹ Sprout Pharmaceuticals responded with a public relations campaign titled “Even the Score,” framing the rejections as a matter of gender equity and recruiting a coalition of twenty-six women’s organizations to lobby Congress and the FDA.⁶⁰ In August 2015, the FDA approved Addyi for hypoactive sexual desire disorder in premenopausal women.⁶¹

In the pivotal trial, women taking flibanserin daily reported approximately one additional sexually satisfying event per month over placebo.⁶² The alcohol interaction study submitted to the FDA used twenty-three men out of twenty-five participants, despite the drug being approved exclusively for women.⁶³ Addyi carries a black-box warning for severe hypotension and syncope with alcohol use. Two days after the approval, Valeant acquired Sprout for $1 billion.⁶⁴ Within two years Valeant handed Sprout back to its original shareholders as a failed asset.⁶⁵ A reluctant desire had been converted into a diagnosis requiring a drug the market itself refused.

12. Grief → Major Depression / SSRIs (DSM-5, 2013)

Before May 2013, the DSM excluded bereavement from major depressive disorder for the first two months following a loss.⁶⁶ A grieving widow could not be diagnosed with depression until she had grieved for at least eight weeks. The DSM-5 removed this exclusion.⁶⁷ A person who had just buried someone close could now be diagnosed with depression at the funeral and prescribed an SSRI on the way home.

Allen Frances, chair of the DSM-IV task force, had warned: “Making grief a mental disorder will be a bonanza for drug companies, but a disaster for grievers.”⁶⁸ Eli Lilly was already running clinical trials of Cymbalta for a proposed bereavement-related depression indication.⁶⁹ Antidepressant prescribing in the United States had already risen sharply through the 1990s and 2000s; the removal of the bereavement exclusion opened the newly bereaved to another decade of expansion.⁷⁰ The condition being treated is death.

13. Forgetfulness → Mild Cognitive Impairment / Aduhelm (2021)

Mild cognitive impairment was formalized as a diagnostic category through Mayo Clinic research in the late 1990s.⁷¹ In May 2019, after Biogen had abandoned its Alzheimer’s drug Aduhelm (aducanumab) over failed trials, Biogen’s chief scientist Al Sandrock met FDA neuroscience chief Billy Dunn off the books at a Philadelphia conference.⁷² Biogen then launched an internal campaign named “Project Onyx,” which produced at least 115 recorded contacts with the FDA over the following year.⁷³ In June 2021, the FDA granted accelerated approval to Aduhelm for Alzheimer’s disease including MCI.⁷⁴

None of the eleven members of the FDA advisory committee had recommended approval; three resigned in protest. Aaron Kesselheim called it “probably the worst drug approval decision in recent U.S. history.”⁷⁵ A congressional investigation later concluded that the FDA had “inappropriately collaborated” with Biogen on the briefing document the advisory committee had reviewed, and that Biogen had priced Aduhelm at $56,000 per year to “make history.”⁷⁶ Brain swelling and microhemorrhages appeared in roughly 40% of treated patients.⁷⁷ Biogen withdrew Aduhelm from the market in 2024. Billy Dunn had already resigned from the FDA in 2023.⁷⁸ The diagnostic category remained.

The Pattern

The mechanism behind these thirteen rebrands is a machine with three moving parts. A committee changes a definition. A drug arrives. A campaign teaches the population to recognize the diagnosis in themselves.

The committees are not independent. Cosgrove and Krimsky documented in PLOS Medicine in 2012 that 69% of DSM-5 task force members reported financial ties to the pharmaceutical industry, up from 57% on the DSM-IV task force before it.⁷⁹ Three-quarters of the DSM-5 work groups drafting the manual had majorities with such ties. The FDA that approves the drugs operates on pharmaceutical user fees that fund roughly two-thirds of its drug review budget.⁸⁰ The committees that invent the diagnoses and the agencies that approve the drugs are substantially paid by the same companies that sell them. This is not conspiracy. It is disclosed financial architecture.

The Aduhelm investigation showed what the architecture produces when it operates at full capacity. The FDA co-wrote with Biogen the briefing document that the advisory committee reviewed, met with Biogen more than a hundred times in a year, and approved the drug over the unanimous rejection of its own experts. The drug then failed in the market, Biogen withdrew it, and the diagnostic category it was approved to treat remained in the manual. That sequence is the pattern at full volume. The quieter cases in this essay are the same pattern at lower volume.

The DSM does not remove diagnoses. The FDA does not reverse indications. When a drug fails or its manufacturer withdraws it, the category remains in the manual. Physicians trained during the launch keep prescribing. The children whose parents were told they had ADHD grow up believing they have adult ADHD, and their children will be diagnosed with binge eating disorder. What began as a marketing campaign becomes clinical common sense within one professional generation.

Accepting any of these rebrands forces the frame across the rest. If PMDD and social anxiety and Low T and overactive bladder and fibromyalgia were built to sell drugs, the diagnostic labels a person holds about themselves are no longer observations. Some are advertising residue.

The pattern is not hidden. FDA approval dates sit in public databases, and DSM revision timelines and pharmaceutical patent schedules are a search away. The Barry Brand confession is in Advertising Age, and the Project Onyx documents are in the congressional record. The Jeremy Allen interview on how Merck’s Bone Measurement Institute built the osteopenia market was broadcast on NPR. The Jung and Fugh-Berman paper on how Shire paid for every continuing-education module on binge eating disorder in the year of Vyvanse’s approval is in the Journal of the American Board of Family Medicine. Frederick Wolfe’s disavowal of fibromyalgia as a disease was reported on the front page of the New York Times.

The next time a doctor offers a new name for something ordinary, look up when the name entered the manual and what drug reached the market that year. When the two align, the diagnosis is telling you what it was built for.

A companion essay, “The Thresholds That Weren’t,” examines the parallel mechanism of lowering numerical cutoffs for existing diagnoses (blood pressure, cholesterol, blood sugar, bone density) to manufacture millions of new patients overnight. The present essay examines the invention of names. The two mechanisms work the same way.

How to Explain It to a Six-Year-Old

Imagine you own a factory that makes umbrellas. You have too many umbrellas, and nobody is buying them because it is not raining much where you live. The umbrellas are stacking up in your warehouse. Your bills are coming due. You need to sell your umbrellas, and you cannot change the weather.

So you decide to change the weather in people’s heads instead. You start walking around telling people that a little drizzle is actually a very dangerous storm. You give it a scary name: Storm Anxiety Condition. You put up posters. You go on television. You get doctors to agree that Storm Anxiety Condition is real and that an umbrella is the only treatment. Soon your neighbors line up at your factory and buy your umbrellas, because they are afraid of the dangerous storm you told them about.

The drizzle did not change. Your factory did not change. The umbrellas did not change. You just gave the ordinary thing a scary new name and convinced everyone it was dangerous. That is what happened thirteen times in the pages above. Somebody had a new pill. Somebody gave the ordinary thing a scary new name. Everybody bought the pill. The drizzle was never the problem.

In Print

The Unbekoming library is available in paperback, printed to order through Lulu and shipped worldwide. The shelf begins with the paradigm question underneath everything else — No Virus, the isolation problem, the collapse of virology’s foundational claims, and a disease-by-disease reappraisal — and moves through the suppressed compounds mainstream medicine set aside: The DMSO Book, Chlorine Dioxide: The Forbidden Remedy, The Iodine Book, and The Hydrogen Peroxide Book. Two more recover what’s still on the kitchen shelf: Baking Soda and The Castor Oil Book. Two more recover the minerals modern soil, water, and processing quietly stripped from the diet: The Magnesium Handbook and The Boron Book. Sitting alongside these is No Contagion, co-authored with Jamie Andrews — the case against germ theory itself, catalogued through 258 failed contagion experiments.

The critique books cover what medicine, dentistry, psychiatry, and veterinary practice have become. The Unvaccinated treats the completely unvaccinated as a comparison group across twenty chapters and five appendices. Medicalized Motherhood follows a woman through 123 documented interventions from teenage pill to postpartum discharge. Drilling for Profit treats cavities, gum disease, and crooked teeth as the dietary problem they are. What Your Vet Can’t Tell You applies the same critique to pets. Escape from Psychiatry documents the fabrication of the DSM and the specific damage of every major psychiatric drug class. The Vitamin K Injection covers what happens in the first hours of a newborn’s life.

The full shelf is at lulu.com/spotlight/unbekoming. A physical book reaches the person a Substack post never will — the skeptical relative, the friend who won’t click a link but might open a book, the visitor whose eye lands on a coffee table. Buy one to keep, and one to give away.

References

1. Brendan Koerner, “Disorders Made to Order,” Mother Jones, July/August 2002; Christopher Lane, Shyness: How Normal Behavior Became a Sickness (Yale University Press, 2007); Barry Brand quote to Advertising Age cited in both.

2. Public Citizen Health Research Group, “Vyvanse for Binge Eating: Old Pill, New ‘Disease,’” Health Letter, July 2015.

3. American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), 2013. Binge Eating Disorder promoted from Appendix B to a standalone diagnostic category.

4. Public Citizen Health Research Group, Health Letter, July 2015.

5. FDA News Release, “FDA expands uses of Vyvanse to treat binge-eating disorder,” January 30, 2015.

6. Jinhyun Jung and Adriane Fugh-Berman, “Marketing Messages in Continuing Medical Education (CME) Modules on Binge-Eating Disorder (BED),” Journal of the American Board of Family Medicine 33, no. 2 (March 2020): 240–251.

7. Shire plc press materials, January–February 2015, documented in Public Citizen Health Letter, July 2015.

8. FDA Approval Package for Sarafem (fluoxetine hydrochloride), NDA 21-107, approved July 6, 2000.

9. Melody Petersen, “Lilly’s Boost For Fluoxetine, With A Twist,” New York Times, October 22, 2000.

10. Nathan Greenslit, “Depression and Consumption: Psychopharmaceuticals, Branding, and New Identity Practices,” Culture, Medicine and Psychiatry 29, no. 4 (2005): 477–501; Lilly marketing associate quoted therein.

11. MIT News Office, “MIT-patented treatment approved by FDA for severe form of PMS,” July 2000. MIT held U.S. patent on serotonin-reuptake-inhibitor use for PMDD, licensed through Interneuron to Eli Lilly.

12. American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), 1994, Appendix B; DSM-5, 2013.

13. FDA Approval Package for Paxil (paroxetine hydrochloride) for Social Anxiety Disorder, NDA 20-031/S-024, approved May 11, 1999.

14. Brendan Koerner, “Disorders Made to Order,” Mother Jones (2002); Christopher Lane, Shyness (2007). Cohn & Wolfe campaign documented in both.

15. American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), 1994, Social Phobia criteria and clinician guidance.

16. IMS Health data cited in Koerner (2002) and Lane (2007).

17. Robert L. Spitzer et al., “A Brief Measure for Assessing Generalized Anxiety Disorder: The GAD-7,” Archives of Internal Medicine 166, no. 10 (May 22, 2006): 1092–1097.

18. FDA Approval Package for Cymbalta (duloxetine hydrochloride) for Generalized Anxiety Disorder, NDA 21-427/S-015, approved February 26, 2007.

19. Eli Lilly direct-to-consumer campaign materials for Cymbalta, 2007–2013; “Depression Hurts” tagline.

20. Eli Lilly and Company, Annual Report 2013.

21. FDA Approval Package for Proscar (finasteride 5mg), NDA 20-180, approved June 19, 1992.

22. FDA Approval Package for Propecia (finasteride 1mg), NDA 20-788, approved December 19, 1997.

23. Retail pricing comparison for Proscar and Propecia at launch, documented in Martha Rosenberg, Born With a Junk Food Deficiency (Prometheus Books, 2012).

24. Michael S. Irwig and Swapna Kolukula, “Persistent Sexual Side Effects of Finasteride for Male Pattern Hair Loss,” Journal of Sexual Medicine 8, no. 6 (June 2011): 1747–1753; Post-Finasteride Syndrome Foundation registry.

25. In re: Propecia (Finasteride) Products Liability Litigation, MDL No. 2331 (E.D.N.Y.).

26. FDA Approval Package for AndroGel 1% (testosterone gel), NDA 21-015, approved February 28, 2000.

27. “2013 All-Star Large Pharma Marketing Team of the Year: AndroGel,” Medical Marketing & Media, January 2013; corporate history per Abbott Laboratories and AbbVie Inc. Form 10-K filings; AbbVie spin-off completed January 1, 2013.

28. “Testosterone Marketing Frenzy Draws Skepticism,” NBC News, September 9, 2012; Lisa M. Schwartz and Steven Woloshin, “Low ‘T’ as in ‘template’: how to sell disease,” JAMA Internal Medicine 173, no. 15 (August 12, 2013): 1460–1462.

29. John E. Morley et al., “Validation of a screening questionnaire for androgen deficiency in aging males,” Metabolism 49, no. 9 (September 2000): 1239–1242; industry funding disclosed in publication.

30. Schwartz and Woloshin, JAMA Internal Medicine (2013); Kantar Media advertising-spend data cited in NBC News, September 9, 2012.

31. William D. Finkle et al., “Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men,” PLOS ONE 9, no. 1 (January 29, 2014): e85805.

32. In re: Testosterone Replacement Therapy Products Liability Litigation, MDL No. 2545 (N.D. Ill.); AbbVie Inc. Form 10-K filings; FDA Drug Safety Communication, March 3, 2015.

33. World Health Organization, “Assessment of Fracture Risk and its Application to Screening for Postmenopausal Osteoporosis,” WHO Technical Report Series 843, 1994, based on 1992 study group meeting in Rome.

34. Alix Spiegel, “How A Bone Disease Grew To Fit The Prescription,” NPR All Things Considered, December 21, 2009.

35. FDA Approval Package for Fosamax (alendronate sodium), NDA 20-560, approved September 29, 1995.

36. Spiegel, NPR, December 21, 2009; Ray Moynihan and Alan Cassels, Selling Sickness (Nation Books, 2005); “Merck to support DEXA scanner sales,” Diagnostic Imaging, 1995.

37. Spiegel, NPR, December 21, 2009.

38. Fosamax 35mg once-weekly approval for the prevention of osteoporosis, FDA 2000; Moynihan and Cassels (2005).

39. Documented in Unbekoming, “The Screening Trap” (2025), drawing on bisphosphonate trial meta-analyses; see also The Architecture of Deception (2025), chapter on bisphosphonates.

40. Frederick Wolfe et al., “The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia,” Arthritis & Rheumatism 33, no. 2 (February 1990): 160–172.

41. Alex Berenson, “Drug Approved. Is Disease Real?” New York Times, January 14, 2008; Associated Press investigation of fibromyalgia promotion, 2009, quoting Wolfe calling the Pfizer and Lilly campaigns “disease mongering.”

42. FDA News Release, “FDA Approves First Drug For Treating Fibromyalgia,” June 21, 2007.

43. FDA Approval Packages for Cymbalta fibromyalgia indication (June 13, 2008) and Savella/milnacipran (January 14, 2009).

44. Associated Press investigation of fibromyalgia promotion, 2009; TNS Media Intelligence advertising-spend data cited in multiple outlets.

45. Berenson, New York Times, January 14, 2008.

46. Lyrica (pregabalin) Prescribing Information, Pfizer Inc., Schedule V designation and adverse effect profile.

47. Pfizer Inc. Annual Report 2012; Lyrica revenue data.

48. Ray Moynihan, “The marketing of a disease: female sexual dysfunction,” BMJ 326 (2003): 45–47; Moynihan and Cassels, Selling Sickness (2005), chapter on OAB.

49. FDA Approval Package for Detrol (tolterodine tartrate), NDA 20-771, approved March 25, 1998.

50. Pharmacia Corporation, Detrol LA marketing materials, 2001; documented in Moynihan and Cassels, Selling Sickness (2005).

51. Shelly L. Gray et al., “Cumulative Use of Strong Anticholinergics and Incident Dementia,” JAMA Internal Medicine 175, no. 3 (March 2015): 401–407.

52. Pfizer Inc. Annual Reports, 2005–2010, following acquisition of Pharmacia.

53. FDA Approval Packages for Toviaz (fesoterodine fumarate), approved October 31, 2008, and Myrbetriq (mirabegron), approved June 28, 2012; Myrbetriq Prescribing Information, Astellas Pharma, cardiovascular warnings.

54. FDA Approval Package for Requip (ropinirole hydrochloride) for Restless Legs Syndrome, NDA 20-658/S-010, approved May 5, 2005.

55. Steven Woloshin and Lisa M. Schwartz, “Giving Legs to Restless Legs: A Case Study of How the Media Helps Make People Sick,” PLOS Medicine 3, no. 4 (April 11, 2006): e170; funding figures from Dartmouth Medicine coverage of the paper and Washington Post reporting.

56. Richard P. Allen et al., “Restless legs syndrome prevalence and impact: REST general population study,” Archives of Internal Medicine 165, no. 11 (June 13, 2005): 1286–1292, GlaxoSmithKline funding disclosed; Woloshin and Schwartz (2006) counter-estimate.

57. Requip sales growth documented in Public Citizen Worst Pills, Best Pills newsletter and NBC News coverage.

58. Requip (ropinirole) prescribing information, augmentation and impulse control disorder warnings; dopamine agonist impulse-control litigation.

59. FDA Advisory Committee minutes on flibanserin, June 18, 2010 (unanimous vote against approval), and FDA Complete Response Letter, October 2013.

60. Sprout Pharmaceuticals, “Even the Score” campaign materials, 2014; documented in Nature Reviews Drug Discovery 14 (October 2015): 669.

61. FDA News Release, “FDA approves first treatment for sexual desire disorder,” August 18, 2015.

62. Sprout Pharmaceuticals, Addyi (flibanserin) FDA Advisory Committee Briefing Document, June 4, 2015.

63. Addyi FDA labeling and advisory committee transcript, June 4, 2015; also Ms. Magazine, June 12, 2015, documenting the trial composition.

64. Andrew Pollack, “Valeant to Buy Sprout, Maker of Addyi Female Libido Pill, for $1 Billion,” New York Times, August 20, 2015.

65. Valeant Pharmaceuticals International press release, November 2017; Genetic Engineering & Biotechnology News coverage, November 2017.

66. American Psychiatric Association, DSM-IV, 1994, Major Depressive Episode criteria, bereavement exclusion.

67. American Psychiatric Association, DSM-5, 2013, Major Depressive Disorder criteria.

68. Allen Frances, “Last Plea To DSM-5: Save Grief From the Drug Companies,” Psychology Today, January 7, 2013; and Saving Normal (William Morrow, 2013).

69. Lilly duloxetine development pipeline documented in Patricia Pearson, “When did life itself become a treatable mental disorder?” Globe and Mail, April 2013.

70. Laura A. Pratt et al., “Antidepressant Use in Persons Aged 12 and Over: United States, 2005–2008,” NCHS Data Brief No. 76 (October 2011).

71. Ronald C. Petersen et al., “Mild Cognitive Impairment: Clinical Characterization and Outcome,” Archives of Neurology 56, no. 3 (March 1999): 303–308.

72. Damian Garde and Adam Feuerstein, “Inside ‘Project Onyx’: How Biogen used an FDA back channel to win approval of its polarizing Alzheimer’s drug,” STAT News, June 29, 2021.

73. House Committee on Oversight and Reform and Committee on Energy and Commerce, “The High Price of Aduhelm’s Approval: An Investigation into FDA’s Atypical Review Process and Biogen’s Aggressive Launch Plans,” December 2022.

74. FDA News Release, “FDA Grants Accelerated Approval for Alzheimer’s Drug,” June 7, 2021.

75. Peripheral and Central Nervous System Drugs Advisory Committee, FDA, November 6, 2020 meeting minutes; Adam Feuerstein and Damian Garde, “Three FDA advisers resign over agency’s approval of Aduhelm,” STAT News, June 10, 2021; Kesselheim resignation letter.

76. House Oversight and Energy and Commerce Committees, “The High Price of Aduhelm’s Approval,” December 2022.

77. Aduhelm (aducanumab-avwa) Prescribing Information, Biogen Inc., 2021; ARIA (amyloid-related imaging abnormalities) incidence data.

78. Biogen Inc. press release, “Biogen to Realign Resources for Alzheimer’s Disease Franchise,” January 31, 2024; Billy Dunn FDA departure announced February 2023.

79. Lisa Cosgrove and Sheldon Krimsky, “A Comparison of DSM-IV and DSM-5 Panel Members’ Financial Associations with Industry: A Pernicious Problem Persists,” PLOS Medicine 9, no. 3 (March 13, 2012): e1001190.

80. FDA Prescription Drug User Fee Act (PDUFA) funding structure; see Government Accountability Office reports on FDA drug review budget composition.