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Is there a cure for corporate crime in the drug industry?
BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f755 (Published 6 February 2013) Cite this as: BMJ 2013;346:f755 1. Courtney Davis, senior lecturer in sociology, 2. John Abraham, professor of sociology Author Affiliations 1. firstname.lastname@example.org; J.W.Abraham@sussex.ac.uk
off label prescriptions for gabapentin (Neurontin) increased dramatically. However. too late. meaning that patients were exposed to the potentially harmful side effects of a drug when there was no scientific evidence to support a therapeutic effect in the condition for which it was prescribed. This has led to calls for sanctions to be strengthened. Whistleblowers’ and other “insider” accounts in the US typically include allegations that companies systematically planned complex marketing campaigns to increase drug sales. Recent research suggests that violation of the law continues to be widespread. These included active promotion of off label. or otherwise inappropriate. this may be insufficient to protect the public because legal resolution of complex criminal and civil investigations takes years.1 as of July 2012. regulators could take over control of future clinical trials and charge offending companies for the cost of doing so.1136/bmj. which involved illegal and fraudulent activities. so promotion plays a huge role in achieving market share.e8462). but courts might be reluctant to impose penalties that would threaten the financial survival of companies.4 Corporate integrity agreements could also serve as more effective vehicles for corporate probation by imposing escalating restrictions on company freedom appropriate to the offences committed. there is growing evidence that little has changed. Multi-million dollar fines imposed under US settlements seem to have failed to deter companies from violating regulations. Although stronger sanctions are needed to deter drug companies from wrongdoing. In a crowded and competitive marketplace the temptation for companies to resort to misleading claims is great. this may be too little. According to Gøtzsche (doi:10. during all phases of the US Justice Department’s seven year investigation of Warner.Effective enforcement of regulations requires more resources and determination to impose robust sanctions Nearly 30 years ago. which has raised suspicions that the firm’s off label promotion persisted throughout. during which time unethical and illegal behaviour may continue unabated. despite company knowledge that such use could seriously harm patients. Imposing bigger fines is one option. have governments responsible for protecting citizens been in curbing illegal activity by the transnational research based drug industry? The recent introduction of Regulation 658/2007 in the European Union empowers the EU Commission to impose financial penalties for corporate violation of EU legislation on medicines. use of drugs. Sadly. For example.2 3 How successful. Most new medicines offer little or no therapeutic advantage over existing products. nine of the 10 largest drug companies were bound by corporate integrity agreements under civil and criminal settlements or judgments in the United States.Lambert’s promotion of the drug’s unapproved use. For instance. then. 5 WarnerLambert. Braithwaite’s Corporate Crime in the Pharmaceutical Industry showed that unethical and corrupt behaviour was endemic in the sector. if companies hide clinical trial data. . pleaded guilty to charges of promoting gabapentin for the non-approved use. of which Pfizer is a parent company. The corporate activity that has led to recent government investigations has involved unethical and unlawful practices that are well beyond mere administrative offences. It was subsequently established that gabapentin was not efficacious for the non-approved indication. given that several companies are repeat offenders. Other sanctions being debated include removing companies’ patent rights and holding senior managers criminally liable.
The MHRA currently vets print advertisements for around 50 medicinal products each year. but none involved a large research based drug company. the Medicines and Healthcare Products Regulatory Agency (MHRA) initiated 101 prosecutions for breaches of medicines legislation between 2005 and 2012. with additional funding granted for FDA fraud detection and prosecution alongside other signals from Congress that the agency should increase its enforcement activity. enforcement.10 There are some signs that change is afoot in the US. Notes .6 9 Such timid regulatory behaviour may be symptomatic of the extent to which regulators have been encouraged by governments to be responsive to the commercial interests of industry and to view large drug firms as clients whose fees increasingly fund these agencies. and human capital.In such cases. with current resources. benfluorex (Mediator). However.8 Because of the complex and varied ways in which companies promote their drugs. there was only one (unsuccessful) referral for potential prosecution of such a company—GlaxoSmithKline regarding paroxetine (Seroxat).7 Why have drug regulatory agencies played such a small role in prosecuting large companies given the evidence of extensive illegal activity uncovered in recent cases in the US that were brought by other prosecuting or investigating bodies? The reality is that. Both the MHRA and the FDA claim that they can generally achieve compliance through informal communication and negotiation with large firms.13 Individual instances of corporate malfeasance are indicative of wider systemic problems. US government investigations indicate that even when faced with evidence of serious wrongdoing or persistent violation the FDA may be reluctant to initiate formal investigations or escalate its response against individual companies. on whether regulators can develop credible systems of detection. none was referred by the FDA. medicines regulators can police only a fraction of the industry’s ever expanding promotional activities. Increased resources and expanded legal authority may need to be backed up by a more probing regulatory culture. money. but regulators seem to treat evidence of non-compliance as isolated incidents rather than signals that firms may be engaged in extensive offending.2 gathering evidence of systematic illegal marketing requires far greater commitment in terms of time. Of the 11 civil or criminal cases involving off label promotion by major drug companies settled by the US Justice Department between 2003 and 2007. prompt action by regulatory agencies to prohibit further violation of the law is also needed to protect public health.11 A similar shift in the UK is less likely given successive governments’ determination to “reduce burdens on business. in part.” Whether government authorities in the EU are willing to take enforcement action against large drug companies will become clearer on resolution of the European Medicines Agency’s investigation of Roche for safety reporting violations 12 and a French manslaughter investigation o f Servier Laboratories’ former president in relation to the antidiabetes drug. and punishment. Whether companies continue to “get away with it” depends. Indeed. it is striking that the Food and Drug Administration has played a marginal role in detecting cases of fraud or enforcing compliance with the law. In addition.6 In the United Kingdom.
PLoS Med2011. Mello MM. Levin R.com/news/washington/story/2012-03-05/penaltiesdrug-companies/53372918/1.346:f755 Footnotes Personal view.30:2318-27. 2012.Cite this as: BMJ 2013. Big pharma often commits corporate crime.gov/opa/pr/2012/July/12-civ-842. Darby D. FREE Full Text 2.icmje. ↵ US Department of Justice. Strategies and practices in off-label marketing of pharmaceuticals: a retrospective analysis of whistleblower complaints. USA Today2012 March 5. 4. ↵ Kesselheim AS. Studdert DM.justice. no other relationships or activities that could appear to have influenced the submitted work. Press release. False Claims Act prosecution did not deter off-label drug use in the case of Neurontin. doi:10. not externally peer reviewed. ↵ Kennedy K. 3. 5. no financial relationships with any organisations that might have an interest in the submitted work in the previous three years.org/coi_disclosure. GlaxoSmithKline to plead guilty and pay $3 billion to resolve fraud allegations and failure to report safety data. Experts seek alternatives to excluding drug companies. BMJ2012. http://usatoday30.usatoday.8:1-9. Studdert DM. and this must be stopped. Avorn J. Glynn R. Health Affairs 2011. www. FREE Full Text .1136/bmj.e8462 Competing interests: Both authors have completed the ICMJE uniform disclosure form at www. ↵ Kesselheim AS. References 1. ↵ Gøtzsche PC.345:e8462.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work.html. Provenance and peer review: Commissioned.
↵ .gov. Delivering high standards in medicines advertising regulation.com/sites/default/files/publications/FDA_Revamps_Crimi nal_Prosecution_Guidelines_0. CrossRef 11. Ketek clinical study fraud: what did Aventis know?’ 2008. ↵ Medicines and Healthcare Products Regulatory Agency.gao.pdf. www. ↵ US Government Accountability Office.pdf. Technol Anal Strategic Manage2007. 2012. Sixth annual report JanuaryDecember 2011. 2008.6.gov/products/GAO-08835.gov/fdsys/pkg/CHRG-110hhrg48587/pdf/CHRG-110hhrg48587. ↵ Medicines and Healthcare Products Regulatory Agency. Davis C. FDA Revamps Criminal Prosecution Guidelines and Expands Health Care Fraud-Related Investigations. House of Representatives.uk/home/groups/commsic/documents/websiteresources/con143738.ema.pdf. 13. ↵ Skadden. EMA/405725/2012. 10. FDA’s oversight of the promotion of drugs for off-label uses. www. GAO-08-835. 2008.19:387-402.gov.eu/docs/en_GB/document_library/Press_release/2012/06/WC 500129047.mhra. Interpellative sociology of pharmaceuticals: problems and challenges for innovation and regulation in the 21st century. ↵ US Committee on Energy and Commerce. www.pdf.skadden.pdf. 2011.gpo. 12. MHRA investigation into Glaxosmithkline/Seroxat. European Medicines Agency acts on deficiencies in Roche medicines-safety reporting. ↵ Abraham J. ↵ European Medicines Agency. https://www.mhra. www. 7. 9. 8.europa. www.uk/home/groups/espolicy/documents/websiteresources/con014155.
but as sales were $2. The most common recent crimes were illegal marketing by recommending drugs for non-approved (off label) uses. agreed in 2009 to pay $430m to resolve charges related to illegal marketing of gabapentin (Neurontin). However. Rigshospitalet. DK-2100 Copenhagen. exceeding $1bn (£620. Nordic Cochrane Centre.doi.1 All cases were related to the United States and involved huge settlements or fines. according to the US Justice Department.org/10. I googled the names of the 10 largest drug companies in combination with the term “fraud” and looked for offences on the first page for each company. €769m) each for four companies. pcg@cochrane. 2012.com/article/2012/12/11/france-mediatoridUSL5E8NBGI520121211 Personal View Big pharma often commits corporate crime.6m.Reuters.7bn in 2003 alone.345:e8462 1. the standard response from the industry is that there are bad apples in any enterprise. for example. misrepresentation of research results. in July 2012 only Roche was not bound by such an agreement. the company entered into a corporate integrity agreement with the US Department of Health and Human Services to detect and avoid such problems in future.1 As the crimes were widespread and repetitive. Pfizer. and this must be stopped BMJ 2012. such fines are far too small to have any deterrent effect. hiding data on harms. they are probably committed deliberately—because crime pays.1136/bmj. was the most pervasive and harmful criminal antitrust conspiracy ever uncovered. It was easy to find additional crimes committed by these same companies and committed outside the US. www. Denmark 1.reuters. Peter C Gøtzsche.2 Of the top 10 drug companies. Pfizer had previously entered into three such agreements in the past decade.3 Roche . also in 2009.3bn for off label use of four other drugs. professor. When Pfizer was fined $2. Blegdamsvej 9. Sure. 345 doi: http://dx.dk When a drug company commits a serious crime.e8462 (Published 14 December 2012) Cite this as: BMJ 2012. and Medicaid and Medicare fraud. France Servier founder investigated in drug deaths. but the interesting question is whether drug companies routinely break the law. high level executives in Roche had previously led a vitamin cartel that. over 10 years in the 1990s. and as about 90% was for off label use.
Top executives should be held personally accountable so that they would need to think of the risk of imprisonment when they consider performing or acquiescing in crimes. These proclamations are not shared by the companies’ employees or experienced by the public.7 and laws that not only allow but require drug agencies to publish what they know. It is hard to imagine that so many Americans can be so mentally disturbed that these sales reflect genuine needs. we need laws that protect whistleblowers and ensure they get a fair proportion of the fines. both legal and illegal marketing leads to massive overtreatment of the population. as happened with rosiglitazone 9—with the consequence that the public was not informed that the drug causes myocardial infarction.1 The disconnect between the drug industry’s proclamations—of the “highest ethical standards. Many crimes would be impossible to carry out if doctors weren’t willing to participate in them. It is time to introduce tougher sanctions. Last but not least. An internal survey of Pfizer employees in 2001 showed that about 30% didn’t agree with the statement. “Senior management demonstrates honest.” 6 When 5000 Danes ranked 51 industries in terms of the confidence they had in them. not the detection rate. all legal requirements. the drug industry came second to bottom. . seems to be increasing. drug companies can pretend they are innocent. We also need to avoid the situation that. A US poll also ranked the drug industry at the bottom. by settling accusations of crimes. Antidepressants came fourth. together with oil and tobacco companies. beaten only by automobile repair companies. including the unnecessary deaths of thousands of people and many billions in losses for our national economies every year.8 Fines need to be so large that companies risk going bankrupt. To bring the crimes to light also outside the US. Doctors are often complicit in these crimes. which they often do. equivalent to about one year’s revenue from its US vitamin business. ethical behavior.agreed to pay $500m to settle charges. as the number of crimes. Thus. as kickbacks and other forms of corruption were common. without hiding under some absurd “proprietary nature of companies’ trial results” clause. doctors and their organisations should recognise that it is unethical to receive money that has been earned in part through crimes that have harmed those people whose interests doctors are expected to take care of.7 As doctors have access only to selected and manipulated information. 1 10 11 12 13 Notes . they were induced to use expensive drugs and paid to lend their names to ghostwritten articles purporting to show that a drug works for unapproved conditions. after lipid lowering drugs and proton pump inhibitors. The consequences of these crimes are huge.” and providing “most accurate information available regarding prescription medicines” 4 5—and the reality of the conduct of big pharma is vast. In the US. .” of “following . the most sold class of drugs in 2009 (in US dollars) was antipsychotics. We also need laws requiring firms to disclose all knowledge about their drugs and research data. they believe drugs are far more effective and safe than they really are.
www. ↵ Pharmaceutical Research and Manufacturers of America (PhRMA). New York Times. externally peer reviewed. no other relationships or activities that could appear to have influenced the submitted work. A fuller account is at www. 10 May 2012.com/1999/10/10/business/tearing-down-the-facade-of-vitaminsinc. 4.cochrane. no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years. ↵ Tanne JH. Pfizer pays record fine for off-label promotion of four drugs. FREE Full Text 3. 2. www. ↵ Kelton E.p df. www. BMJ2009. . join the “dishonor roll” after Abbott settlement.cochrane.339:b3657.com/sites/erikakelton/2012/05/10/more-pharma-companies-to-join-thedishonor-roll-pay-billions-for-fraud-following-abbotts-settlement.forbes.phrma. Forbes.Cite this as: BMJ 2012. www. Tearing down the facade of ‘Vitamins Inc. 5. Corporate crime in the pharmaceutical industry is common.icmje.org/sites/default/files/108/signatory_companies_phrma_code_061112.html.345:e8462 Footnotes Competing interests: the author has completed the ICMJE uniform disclosure form at www. PhRMA code on interactions with healthcare professionals —signatory companies.’ 10 Oct 1999.pdf (available on request from the corresponding author) and declares: no support from any organisation for the submitted work. ↵ Barboza D. More drug companies to pay billions for fraud. ↵ Gøtzsche PC.nytimes. References 1.dk/research/corporatecrime.org/coi_disclosure. serious and repetitive.dk/research/corporatecrime. 11 June 2012. 2013. Provenance and peer review: Not commissioned.
CrossRefMedline 8. Wolfe S. Bitter pills for drug companies. Why we need easy access to all data from all clinical trials and how to accomplish it. FREE Full Text 10. 2005.pdf. FREE Full Text Drug Regulation . 2006. Public Citizen’s Health Research Group.org/documents/rapidlyincreasingcriminalandcivilpenalties. ↵ Cohen D. ↵ Angell M. 16 December 2010.6. ↵ Kassirer JP. 12. ↵ Rost P. ↵ Almashat S. ↵ Braithwaite J. Routledge. Waterman T. 11. Preston C.341:c5095. Soft Skull Press. Random House. Rapidly increasing criminal and civil monetary penalties against the pharmaceutical industry: 1991 to 2010. 2005. Oxford University Press. 9.12:249. The truth about the drug companies: How they deceive us and what to do about it. On the take: how medicine’s complicity with big business can endanger your health. 13. ↵ Newman M. 7. 1984.citizen. www. ↵ Gøtzsche PC. The whistleblower: confessions of a healthcare hitman. Corporate crime in the pharmaceutical industry. Trials2011. BMJ2010. Rosiglitazone: what went wrong? BMJ 2010.341:c4848.
1 The company was also accused of paying incentives or “kickbacks” to doctors to prescribe the drugs. and pregabalin— for uses that the US Food and Drug Administration had not approved. unapproved conditions. assistant director of the Federal Bureau of Investigation’s criminal investigative division “a clear message” to drug companies that they would not be allowed to “peddle their prescriptions or products for uses beyond their intended—and federal government-approved—purpose.5bn.Bitter pills for drug companies BMJ 2010. said Kevin Perkins. Melanie Newman.3bn (£1. because they mean government healthcare programmes are paying for drugs that may not work effectively or are unnecessary.341:c5095 1. €1. Warner-Lambert. the New York Times pointed out that $2.1136/bmj. Melanie Newman reports It was the biggest fine ever imposed in America.org/10. 2 And US authorities admitted that Pfizer was illegally marketing its drugs at the same time as it was negotiating settlement terms for a similar. reporter Author Affiliations 1.3 Seven years earlier it had been fined $355m for . gabapentin. melanienewman@tbij. which was approved for arthritis and menstrual pain. ziprasidone. previous offence.” Pfizer had just agreed to be fined a record $2. It was.8bn) for illegally promoting four drugs—valdecoxib. the US government is turning to more radical enforcement measures. AstraZeneca paid out $520m in 2010 to settle civil charges of illegally marketing its anti-psychotic drug quetiapine. And Pfizer is not alone in failing to change its behaviour in response to large fines. the largest healthcare fraud settlement in Department of Justice history. and the largest civil fraud settlement ever paid by a drug company. Repeat offending and unenforceable penalties In 2004 Pfizer agreed to pay $420m to settle charges that its newly acquired subsidiary. had marketed an epilepsy drug.c5095 (Published 17 September 2010) Cite this as: BMJ 2010. linezolid.3bn amounted to less than three weeks of Pfizer’s sales. 341 doi: http://dx. for unapproved purposes. Both practices are considered fraudulent in the US.doi. But at the same time its sales representatives were marketing the anti-inflammatory drug valdecoxib. for other. The company’s lawyers assured prosecutors that Pfizer and all its subsidi aries would cease this practice immediately.com After criticism that massive fines are failing to dissuade drug companies from engaging in fraudulent business practices. a charge that was also resolved under the terms of the settlement. On the day after the fine was announced.
Cutting them out of the market and depriving patients of drugs. provides life saving drugs.” Lewis Morris. and thereby avoiding criminal conviction by a court. running a little. Pfizer also side stepped a rule that companies convicted of major fraud against the government should be barred from working for government programmes. “A big drug company hires tens of thousands of people. The law is one of a series of statutes introduced to strengthen the Department of Health’s ability to puni sh fraud. they say. any organisation convicted of healthcare fraud at state or federal level must be excluded from Medicare and state healthcare programmes. The penalties. the government could still have debarred the company. complains that the fines have had little effect beyond “moving a few numbers on the New York stock exchange. They’re roaring a little. If we’re going to affect change. . Under a section of the US Social Security Act that came into force in 1996. with major consequences for the drug industry. which helps whistleblowers to expose fraud against the government. are treated as just another cost of doing business. Although Pfizer settled the case. chief lawyer at the US Department of Health and Human Services. we have to increase the calibre of the bullet. even such hefty fines are not hard pills to swallow. “They paid $2.” He adds: “We’re shooting 22s—little bullets —into the arse of a rhino. A Pfizer subsidiary was permitted to plead guilty to the crimi nal charges. is now turning to more radical measures that will make the stock market and the shareholders sit up.4 So why are the fines not working? Critics argue that for the multibillion dollar drug industry. it is actually the public that ends up paying for them. There are too many people that use Pfizer drugs.” New sanctions But all this could be about to change. Patrick Burns. Worse. Mr Burns says that “The problem with that portion of the law is that Pfizer’s too big to fail. it’s a critical component of the health system. putting a lot of innocent employees on the street—that’s not a very attractive option.5 leaving the parent company free to continue working for the government.” Pfizer made around $180bn out of the 12 drugs that were the subject of the federal investigation.” By settling the case. reveals Mr Morris. as the companies make up their lost profits by hiking future drug prices. he points out. suggests that’s true. But the company’s lawyers managed to wriggle free of these commercially damaging restrictions.criminal and civil charges relating to the same offence — this time involving the prostate cancer drug gosarelin.3bn—that’s a good business plan. The government. communications director at the campaigning organisation Taxpayers Against Fraud. and then they’re going back to business.
“The parent company can no longer own that part of the company. and all its assets. chief legal officer. Officials have already used this approach in a handful of cases. “That would have an enormous impact on the financial bottom line. You had the responsibility and the authority to stop it and you didn’t. As part of resolving the allegations with the parent company. In 2006 the Tenet Healthcare chain settled several civil fraud allegations for $900m. we took over General Motors and forced a change at the top of the company … it’s time we started to force a change at the top of certain healthcare corporations. your compliance officer. argues Burns. “Five years ago [before the Tenet case] people would have said you’re never going to get a hospital [chain] to sell off an asset. we invaded Afghanistan for regime change. to be sold off to a third party. He explains: “This responsible corporate official doctrine will allow us to go to a chief executive and say ‘I don’t even need to have proof that you specifically hatched this scheme. your finance officer.” Executives found guilty will be banned from working for the state. will not be enough unless executives are held personally accountable for their companies’ wrongdoing. and their sacking could be a condition of the company’s negotiated settlement.” he says. those two hospitals had to be sold off to an independent third party. “The US invaded Iraq for regime change.” Accountability Even this.” says Mr Burns. and former chief medical officer of drug company Purdue Frederick pleaded guilty to charges of misbranding prescription painkiller OxyContin (modified release oxycodone) as part of a $634. you’re never going to be able to force that kind of change. or you are done with us. “The pain has to be personal. why should it continue to benefit from the exclusivity that you get as a brand name?” Mr Morris asks. so you have to leave the company.” Mr Morris says. We need to say: get rid of your chief executive. You could have stopped it. The company would be allowed to keep the drug but it would have to compete as a generic.6 “We found that in two different instances a particular hospital had paid kickbacks to doctors and had provided medically unnecessary cardiac services to patients. and we think it would probably cause some of these executives to think twice about illegally marketing drugs.” Confiscation of the company’s patents is another penalty under consideration. If a company abuses a patent by marketing a drug for a purpose it has no t be approved or tested for. .” Mr Morris says the department is planning to make more use of a strict liability rule to hold executives to account. In 2007 the president.5m settlement after the company had claimed that the drug was less addictive and less likely to be abused than rival medications.“In the drug industry we have a case that is moving to final resolution where we are going to be requiring a subsidiary.” It’s a radical move but one that the department has used before in a different area.
Arizona. And although the department has traditionally focused on the company offering the kickback. They still have to pay a substantial fine. Harvard Medical School banned its faculty from accepting industry sponsored travel and meals and from giving sponsored speeches. Like drug companies.” 7 . has the right to impose a $50 000 penalty for every kickback received plus three times the amount of the kickback and exclude the doctor from working for the state again. “A kickback can be as crass as twenty dollar bills in an envelope or something more subtle—perhaps putting the doctor on an advisory committee where she doesn’t do any work but gets paid $20 000 or taking the doctor on all expenses paid trip to Phoenix. but the department monitors their behaviour rather than throwing them out of state programmes. The Department of Health’s Office of the Inspector General. Another of the department’s relatively new lines of attack is to pursue individual doctors suspected of receiving kickbacks from industry in return for prescribing or using certain practices. it is now turning its attention to the recipients —the doctors. The medical profession is waking up to its responsibilities here. . in the winter. In white collar crime responsibility for illegal acts is usually spread across many individuals at all levels in the organisation: there is rarely one person who has made a critical decision on which the prosecutors can hang their case. . the authorities won’ t accept a settlement unless the company cooperates with a secondary investigation into the doctors concerned. “The company has to turn over the call notes . we’ll know which doctors said to a drug rep. But enforcement is equally important. ‘If you don’t give me that $50 000 consulting agr eement I’m moving all my artificial hip patients to your competitor. And in March. where Mr Morris is chief counsel.” Mr Morris says.” Mr Morris says. “Nonetheless.’” says Mr Morris. When a company is charged with paying kickbacks to doctors.” Consumer advocates have called for executives to be given jail terms. This February Florida based surgeon Harvey Montijo agreed to pay $650 000 after the Department of Health and Human Services alleged he “solicited and received remuneration in the form of consulting payments from two medical device manufactures in exchange for using their orthopedic hip and knee products. This July. Morris says. they were convicted of misdemeanour and excluded from our programme for 12 years. But Mr Morris argues that the criminal burden of proof is hard to meet. Stanford University extended its conflict policy to ban all adjunct faculty (volunteer teaching staff) from participating in drug company speakers’ bureaus.“That was strict liability—they did not admit to any personal engagement in the fraudulent conduct. doctors usually settle the cases rather than allow them to continue to the exclusion stage.
2. References 1.nytimes. “You would see the bones and you’d know that if you committed a crime there. Pfizer pays $2. and no other relationships or activities that could appear to have influenced the submitted work. That’s the message we need to send to the people who are green-lighting the fraud.com/2009/09/03/business/03health. not externally peer reviewed. no financial relationships with any organisation that might have an interest in the submitted work in the previous three years.html. “In medieval times people used to put the bodies of criminals in cages and hang them to rot outside the town.icmje. Provenance and peer review: Commissioned.hhs.html. you weren’t going to be slapped aro und. ↵ . www.341:c5095 Footnotes Competing interests: The author has completed the unified competing interest form at www. and doctors that illegal behaviour is just too risky. even though the profits to be made are so huge? It’s too soon to tell.org/coi_disclosure. as many of the fines currently being dished out are for offences that happened four or five years ago. But Mr Burns isn’t convinced the deterren t is strong enough yet.3 billion to settle marketing case.pdf (available on request from the corresponding author) and declares no support from any organisation for the submitted work.Will this combination of new measures convince companies. The Bureau of Investigative Journa lism’s documentary on the drug industry is available at http://thebureauinvestigates.com/2010/08/11/documentary-revealsthe-unhealthy-profits-of-the-pharmaceutical-industry/. www. ↵ US Department of Health and Human Services. executives.” he says. 2 Sep 2009.gov/news/press/2009pres/09/20090902a. you were going to be done. 3.” Notes Cite this as: BMJ 2010. ↵ Gardiner H. who think that fraud is a good business plan. New York Times 2009 Sep 2. Justice department announces largest health care fraud settlement in its history.
hhs. www.gov/opa/pr/2003/June/03_civ_371. 29 June 2006. company agrees to pay $355 million to settle charges. 339 doi: http://dx.gov/opa/pr/2006/June/06_civ_406.gov/fraud/enforcement/cmp/kickback.US Department of Justice. 27 Apr 2010.asp.gov/opa/pr/2010/April/10-civ-487.com/2010/HEALTH/04/02/pfizer. Press release. ↵ US Department of Health and Human Services. Pfizer pays record fine for off-label promotion of four drugs BMJ 2009.justice.html.doi. 20 June 2003.html. 6. 7. 5.bextra/index. www.org/10. Kickback and physician self-referral.cnn. Pharmaceutical giant AstraZeneca to pay $520 million for off-label drug marketing. http://oig.html. ↵ US Department of Justice. ↵ Griffin D.339:b3657 Health policy Health service research Biological agents Drugs: musculoskeletal and joint diseases More topics Article .1136/bmj. www.justice.justice. Press release. Segal A.htm. Feds found Pfizer too big to nail. http://edition.b3657 (Published 9 September 2009) Cite this as: BMJ 2009. Tenet Healthcare Corporation to pay US more than $900 million to resolve false claims act allegations. Press release. CNN2010 Apr 2. AstraZeneca pharmaceuticals pleads guilty to healthcare crime. ↵ US Department of Justice. 4.
but drug companies may not promote off-label use.3bn. the parent body of the Food and Drug Administration. the department’s publicity suggests that the Obama administration will be tougher on drug companies that market their products for unapproved indications. Pfizer agreed —for the fourth time— not to do it again.4bn. The US Department of Justice said it was the largest healthcare fraud settlement in the department’s history and the largest criminal fine ever. Drug and Cosmetic Act and to pay fines and forfeitures amounting to $1. The many charges related to Pfizer’ s promotion of the anti-inflammatory drug valdecoxib (marketed in the United States as Bextra) and other drugs for uses not approved by the FDA. “Pfizer to pay $2. and pregabalin (Lyrica). The subsidiary had promoted valdecoxib for off-label uses and at dosages that the FDA had not approved. Pfizer previously entered three such agreements. In addition.6bn) to settle charges of fraud and civil and criminal liability over its promotion of off-label use of four drugs.Related content Article metrics 1. has agreed to pay $2. an antibiotic. Janice Hopkins Tanne Author Affiliations Pfizer. The drug. In a press release Pfizer said that it had “finalized a previously reported agreement in principle with the US Department of Justice to settle an investigation regarding past offlabel promotional activities” related to four drugs. Pfizer agreed to pay $1bn to resolve charges that it promoted off-label uses of valdecoxib and also ziprasidone (Geodon). Pfizer said it had previously disclosed financial statements setting aside funds for the settlements. The New York Times noted that $2. Pfizer agreed to enter a corporate integrity agreement with the Office of the Inspector General of the Department of Health and Human Services to avoid and detect such problems. secretary of the Department of Health and Human Services.nytimes. the world’s largest drug company. the announcement of the settlement was made at a Washington press conference by Kathleen Sebelius. As part of the settlement with the justice department.3bn (£1. Unlike in previous settlements by drug companies. an anti-epilepsy drug. US doctors may prescribe any drug approved by the FDA for any indication. Although the investigation was conducted under the Bush administration. was withdrawn from the market in 2005. The Pfizer subsidiary Pharmacia & Upjohn agreed to plead guilty to a felony violation of the Food. linezolid (Zyvox). .3 billion to settle inquiry over marketing”). 3 Sep. an antipsychotic drug. a cyclo-oxygenase-2 inhibitor. €1.3bn amounted to less than three weeks of Pfizer sales (www.com.
$1bn will return funds to Medicare. Six whistleblowers. will share $105m. which supports state programmes helping crime victims and is entirely funded from fines and penalties collected by state and federal authorities. The rest will go to the Treasury Department. $635m will go to the Victim Witness Fund.Pfizer’s promotion of off-label use of these drugs caused doctors to prescribe them and thus to submit false claims to the US government’s Medicare insurance programme for elderly people and its Medicaid programme for poor people when these drugs were not approved. Medicaid. Notes Cite this as: BMJ 2009.3bn payment. including a former Pfizer salesman who quit. and other government insurance programmes. States that share Medicaid payments with the government will receive part of that $1bn. Also.339:b3657 . Of the $2.