This case study describes the history of Bayer's anti-cholesterol medicine Baycol/Lipobay from its early development to its withdrawal from the market. Initially available only in low doses, sales of the aggressively priced Baycol/Lipobay picked up when the product was marketed at higher doses, especially in the large US market. On course for €1 billion sales, the product was suddenly withdrawn worldwide in response to reports of a number of deaths associated with its use. The withdrawal resulted in public criticism of the pharmaceutical industry and the company, multiple lawsuits against Bayer and a decline in the sales and profitability and strategic repositioning of its pharmaceutical division.
ThemistocleousT.HaireG.BramhamE. (2000). Bayer Healthcare — All Eyes on Delivery, UBS Warburg Global Equity Research, London, UK.
2.
Other brand names for cerivastatin included Lipobay, Lipoban, Lipogis, Liposterol, Certa, Cervasta, Cholstat, Eltina, Staltor, Stativa, Vaslip, Vazqol and Zenas.
3.
ChongP. H.SeegerJ. D.FranklinC. (2001). Clinically relevant differences between the statins: Implications for therapeutic selection. Am. J. Med.111, 390–400.
4.
RosensonR. S. (2004). Current overview of statin-induced myopathy. Am. J. Med.116, 408–416.
5.
FDA Advisory Committee Meeting Briefing Document NDA21–366, 11th June, 2003.
6.
ChongP. H.SeegerJ. D.FranklinC. (2001). Clinically relevant differences between the statins: Implications for therapeutic selection. Am. J. Med.111, 396.
7.
Letter by Professor Dr Schlüter, Professor Kühlmann and Dr Ziegler, Bayer AG, Geschäftsbereich Pharma, Forschung und Entwicklung, Medizin und Entwicklung, Wuppertal, Germany, to Dr MacCarthy, MILES Inc, Pharmaceutical Division, West Haven, Conn., 8th February, 1991. Haltom v Bayer Corp. 699L Plaintiffs' Exhibits.
8.
ClimacoJ.R.ArsenaultR.J.ZimmermanC.S.AndrusV.R. (1995) Letter by Professor von Keutz and Dr Schlüter, 22nd November, 1995. Source: Climaco, J. R. et al., Baycol Discovery Status, Mealey's Baycol Litigation Conference, Amelia Islands, Florida, 2–3 June, 2003.
9.
In Japan, 0.15 mg was Baycol's highest approved dosage strength. All statins were limited in their dosage strength in Japan. For example, Lipitor's highest dosage strength was 10 mg, whereas it was 80 mg in the US.
10.
FarmerJ. A. (2001). Learning from the cerivastatin experience. Lancet358, 1383–1385.
11.
Baycol withdrawal gives boost to pravachol; will crestor NDA be affected?The Pink Sheet, August 13, 2001, p. 5.
12.
Calculated from business wire. The pharmaceutical industry: More reps and more promotion fuel new launches, June 21, 1999, http://www.businesswire.com accessed 3rd December, 2004.
13.
Bayer documents, cited in PsatyB. M.FurbergC. D.RayW. A.WeissN. S. (2004). Potential for conflict of interest in the evaluation of suspected adverse drug reactions: Use of cerivastatin and risk of rhabdomyoysis. JAMA292(21). 2622–2631.
14.
PsatyB.M.FurbergD.D.RayW.A.WeissN.S. (2004) 2–6 cases per 100,000 patient years for Baycol compared to 0.2 to 0.6 cases for the other statins. Source: Bayer documents, cited in Psaty et al., JAMA292(21), 2622–2631.
15.
PsatyB. M.FurbergC. D.RayW. A.WeissN. S. (2004). Potential for conflict of interest in the evaluation of suspected adverse drug reactions: Use of cerivastatin and risk of rhabdomyoysis. JAMA292(21). 2622–2631.
16.
Notes of the Baycol teleconference on 27th June, 2000, by Rajeshwar Sharma (Assistant Director of Drug Safety). In addition to Rajeshwar Sharma, the seven teleconference participants included the VP of Drug Safety Assurance, Associate Director of Drug Safety, Baycol Senior Product Manager, Director of Medical Research.
17.
E-mail from Gerald Faich to Ernst Weidmann (Director of Global Drug Safety) and Felix Monteagudo (VP of Drug Safety Assurance), 7th July, 2000. Haltom v Bayer Corp. 588 Plantiffs' Exhibits.
18.
ThompsonGilbert R.Professor, Imperial College. Comments on ‘Cerivastatin Clinical Expert Report: Sixth Addendum for 800 mcg dose registration’, 12th January 2001. Haltom v Bayer Corp. 1651 Plaintiff Exhibits.
19.
FDA approves new 0.8 mg baycol dosage and important HDL-C indication for the brand. PR Newswire, 24 July, 2000 http://www.prnewswire.com accessed 17th August, 2004.
20.
E-mail from Craig Simpson to Hartmut Schmied, 8th December, 2000, Haltom v Bayer Corp. 1665 Plaintiffs' Exhibits.
21.
E-mail from Eric Pauwels to Hartmut Schmied, 11th December, 2000, Haltom v Bayer Corp. 1665 Plaintiffs' Exhibits.
22.
E-mail, from Ernst Weidmann to Eric Pauwels, 12th December, 2000, Haltom v Bayer Corp. 1665 Plaintiffs' Exhibits.
23.
Agence Française de Sécurité Sanitaire des Produits de Santé (Afssaps) (2001) Rapport sur les conditions de retrait du marché des spécialités contenant de la cérivastatine (Staltor® & Cholstat®) le 08 août 2001 et obligations de pharmacovigilance, Paris, p. 9.
24.
ClimacoJ.R.ArsenaultR.J.ZimmermanC.S.AndrusV.R. (1995) Minutes of the teleconference of 26 March 2001. Presented in Climaco, J. R. et al., Baycol Discovery Status, Mealey's Baycol Litigation Conference, Amelia Islands, Florida, 2–3 June, 2003.
25.
BarkerJ.FearO.SiddiquiR.WaltonJ. (2003). Bayer: Baycol Update, Lehman Brothers Global Equity Research, March 11, 2003, p. 8.
26.
E-mail from Steve Niemcryk to Kuno Sprenger, 12th April, 2000, Haltom v Bayer Corp., 1654 Plaintiffs' Exhibits.
27.
The European Agency for the Evaluation of Medicinal Products (2002). Annex II. Scientific conclusions and grounds for withdrawal of the marketing authorisations presented by the EMEA, CPMP/811/02, London, UK, p. 7.
28.
The European Agency for the Evaluation of Medicinal Products (2002). Annex II. Scientific conclusions and grounds for withdrawal of the marketing authorisations presented by the EMEA, CPMP/811/02, London, UK, p. 1.
29.
Bayer Voice Mail Text, 27th June, 2001, Haltom v Bayer Corp. 615 Plaintiffs' Exhibits.
30.
As indicated in the FDA letter to Bayer, NDA 20-740/S-015, 3rd August, 2001.
31.
KobersteinW. (2000). Bayer crosses over: President Wolfgang Plischke tackles the US market, pharmaceutical executive, October, 42–52.
32.
Special issue: Withdrawal of Lipobay/Baycol. Bayer, Stockholders' Newsletter, 2001, p. 6.
33.
GilliesC.JenkinsG.JayarajanJ.HaylockS.EvansA. (2000). Bayer: Now is the time. Deutsche Bank AG Europe Equity Research, 6th October, 2000, London, UK, p. 40.
34.
Anonymous.Apotheker greifen Bayer massiv an, Frankfurter Allgemeine Zeitung, August 15th August, 2001.
35.
Jean-Yves.Nau Trois Questions à Pierre Costes (President of MG France, Federation of General Practitioners), Le Monde, 22nd August, 2001.
36.
Anonymous.Sind unsere Ärzte bestechlich? Reisen, Nobel-Autos, Extra-honorare — so schmieren Pharmafirmen unsere Ärzte. Bild Zeitung, 17th August, 2001. See also Anonymous. Für 25 neue Patienten durfte der Arzt in den Orient-Express. Süddeutsche Zeitung, 16th August, 2001.
37.
CarrubaM.PulazziniA.Lipobay and the media. Scrip Magazine, November 2001, 36–37.
38.
FlöhlR.Wirkungen mit Risiko, Frankfurter Allgemeine Zeitung, 20th August, 2001.
39.
Anonymous.Lipobay: Werbung bis zuletzt. Frankfurter Allgemeine Zeitung, 19th August, 2001.
40.
LangleyM.Courtroom triage: Bayer, pressed to settle a flood of suits over drug, fights back — it pays in some Baycol cases but bars a broad deal; result: A texas showdon — risk in a jury full of ‘greens’. Wall Street J., Europe 3 May 2004.
41.
CloverR.EastwoodM.PhillipsD.Bayer: Phoenix rising from the Baycol ashes?MorganStanley Equity Research Europe, 18th December, 2001, p. 43.
42.
Special Issue: Withdrawal of Lipobay/Baycol. Bayer, Stockholders' Newsletter, 2001, p. 4.
43.
CloverR.EastwoodM.PhillipsD.Bayer: Phoenix rising from the Baycol Ashes?Morgan Stanley Equity Research Europe, 18 December, 2001, p. 46.
44.
Bayer Stockholders' Newsletter, Interim Report as of 30th June, 2006.
45.
Bayer Aktiengesellschaft, Form 20-F/A filed with the United States Securities and Exchange Commission on 24th May, 2004, Washington, D.C.
46.
BayerA. G.Further step in the realignment of Bayer HealthCare: Bayer enters strategic pharmaceutical alliance with Schering-Plough. News Release, Bayer AG, 13th September 2004, Leverkusen, Germany.
47.
Presentation by Arthur Higgins, Bayer HealthCare AG, at the Goldman Sachs Global Healthcare Conference, Laguna Niguel, USA, 13th June, 2006.
JonesT.JayarajanJ.MannP. (2006). Bayer: A Roche-like margin story on a chemical multiple, Deutsche Bank Company Research, 4th August, 2006, London, UK.
50.
MayerR. (2005). No panacea for image woes: Small steps have been taken by several major pharmaceutical companies to rebuild the industry's once-stellar reputation, but intensive efforts on a number of fronts are still needed. Med. Ad. News24 (12).
51.
See, for example GAO (2006). Drug safety: Improvement needed in FDA's postmarket decision-making and oversight process, Government Accountability Office, Washington, DC.
52.
RayW. A.SteinC. M. (2006). Reform of drug regulation — beyond an independent drug-safety board. N. Engl. J. Med.254(2), 194–201.
53.
Committee on the Assessment of the US Drug Safety System, BaciuA.StrattonK.BurkeS. P. (eds.) (2006). The Future of Drug Safety: Promoting and Protecting the Health of the Public, The National Academies Press, Washington, DC.
54.
PsatyB. M.BurkeS. P. (2006). Protecting the health of the public — institute of medicine recommendations on drug safety. N. Engl. J. Med.355(17). 1753–1755.
