Archive for January 2009
EC, don’t let drug companies give information to the public
28/01/2009 by admin.
That pharmaceutical companies may be given permission to provide information about their prescription medicines in Europe1 is troubling.
Thankfully, the ban on direct to consumer advertising stands. This sort of engagement with consumers has not always benefited patients: in the case of Vioxx strong patient interest generated in the drug by its producer Merck translated into “blockbuster” status. Merck’s later withdrawal of the drug came after perhaps thousands of preventable adverse events.2
Monitoring is obligatory and will be carried out by member states before dissemination. However, the industry has found its way around monitoring systems before: the Food and Drug Administration’s vetting of US pharmaceutical advertisements has often been ineffective, resulting in dissemination of false and misleading advertising material.3 4
Patients require unbiased and objective information, and have the right to the highest quality information. However, the description of information in the European proposals is inadequate and may come with some of the negative side effects of direct to consumer advertising. The profile of profitable branded drugs may be increased, which will increase spending on prescription medicines by patients and the NHS. Unbiased and objective information would be best provided by healthcare professionals, who are trained to appraise and interpret the evidence on clinical and cost effectiveness.
Healthcare professionals are increasingly aware of the potential conflicts of interest in having close ties with the pharmaceutical industry and its subsequent impact on patient safety and care.5 It would be very unfortunate if the influence of the pharmaceutical industry’s marketing apparatus instead refocused on patients, perpetuating the industry’s influence yet longer.
We call on the European Commission to abandon its proposals and explore options for providing a more impartial and unprejudiced system of high quality peer reviewed information.
Cite this as: BMJ 2009;338:b290
Jonathan A Currie, 4th year medical student1, Helen Preston, intercalating medical student2, Sudath Weerapperuma, 4th year medical student1
1 University of Bristol Medical School, Bristol BS2 8DZ, 2 Nuffield Centre for International Health and Development, Leeds Institute of Health Sciences, University of Leeds, Leeds LS2 9LJ
Competing interests: None declared. HP is president and JAC campaigns director of Medsin, a student global health network. SW is a representative of Pharmaware, a UK campaign aiming to maximise ethical interactions between healthcare professionals and pharmaceutical companies.
References
- Watson R. Proposal to allow drug companies to give information to public sparks outcry. BMJ 2008;337:a3043. (16 December.)
[Free Full Text] - Topol EJ. Failing the public health—Rofecoxib, Merck and the FDA. N Engl J Med 2004;351:1707-9.
[Free Full Text] - Government Accountability Office. Prescription drugs: improvements needed in FDA’s oversight of direct-to-consumer advertising. Washington, DC: GAO, 2006.
- Angell M. The truth about drug companies. New York: Random House, 2004.
- Sweet M. Australian health professionals warned against featuring in advertisements. BMJ 2008;337:a2951. (11 December.)
[Free Full Text]
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Eli Lilly pays record $1.4bn for promoting off-label use of olanzapine
26/01/2009 by admin.
The drug giant Eli Lilly has agreed to pay $1.4bn (£1bn; 
1.1bn) in settlement for the marketing of its antipsychotic drug olanzapine (Zyprexa) for off-label uses. It is the largest individual corporate fine in history.
The drug, which is licensed for the treatment of schizophrenia and bipolar disorder, was widely promoted by Eli Lilly between September 1999 and November 2003 to treat more common disorders, such as dementia, agitation, aggression, depression, and sleep problems, said the US Department of Justice in a statement.
The company began its promotion by encouraging doctors who treated people in nursing homes and assisted care facilities to prescribe olanzapine, because one of the drug’s side effects is sedation. It claimed that “this side effect was a therapeutic benefit, not an adverse event.” The sales force used the slogan “5 at 5,” meaning that 5 mg of olanzapine at 5 pm would help patients sleep, said the department’s statement.
Eli Lilly expanded its “illegal” marketing strategy to primary care doctors in 2000 with the “Viva Zyprexa” campaign, whose goal, the statement said, was to make the drug “an everyday agent in primary care, even though the company recognized that schizophrenia and bipolar disorder were not viewed as conditions typically treated by primary care physicians.”
The department said that the off-label marketing campaign “raised safety issues and posed potential risk to patients.”
Eli Lilly knew that olanzapine could cause significant weight gain and obesity and increase the risk of hyperglycaemia and diabetes, “yet despite written caution from the FDA [US Food and Drug Administration], Eli Lilly continued to promote these adverse events as therapeutic benefits of Zyprexa use, particularly in the elderly.”
The statement added, “Eli Lilly’s management created marketing materials promoting Zyprexa for off-label uses, trained its sales force to disregard the law, and directed its sales personnel to promote Zyprexa for off-label uses. When promoting Zyprexa to health care providers, Lilly emphasised that the weight gain of the drug was a therapeutic benefit for patients who had trouble maintaining their weight.”
Eli Lilly pleaded guilty to one misdemeanour violation of the Food, Drug, and Cosmetic Act and agreed to pay a total of $615m.
Gregory G Katsas, assistant attorney general for the civil division of the Department of Justice said, “Off-label promotion of pharmaceutical drugs is a serious crime because it undermines the FDA’s role in protecting the American public by determining a drug is safe and effective for a particular use before it is marketed.”
In a separate civil settlement agreement Eli Lilly agreed to pay nearly $800m to the US government and to state Medicaid programmes for payment for unapproved off-label uses of olanzapine.
Four former sales representatives who blew the whistle on Eli Lilly for the off-label practices and who were either fired or resigned filed lawsuits against the company, said the Department of Justice statement. They will share $80m of the civil settlement, in a bid to encourage whistleblowers. Federal law permits whistleblowers to share in the money recovered.
Kim Rice, special agent in charge at the FDA’s Office of Criminal Investigations, said, “The unprecedented terms of this settlement demonstrate the government’s increasing efforts aimed at pharmaceutical companies that choose to put profits ahead of the public’s health.
“The FDA will continue to devote resources to criminal investigations targeting pharmaceutical companies that disregard the safeguards of the drug approval process and recklessly promote drugs for uses for which they have not been proven to be safe and effective.”
Eli Lilly has agreed to cease off-label marketing and must send doctors letters advising them of the settlement, give them a way to report questionable conduct of sales representatives, list payment to doctors on its website, and ensure that the company complies with the law.
John C Lechleiter, chairman, president and chief executive officer of Eli Lilly, said in a statement, “We deeply regret the past actions covered by the misdemeanor plea. At Lilly we take seriously our responsibilities to abide by all the laws governing our business practices, and we realize that we have a tremendous responsibility to the patients and healthcare professionals we serve. Every day and with every interaction we strive to operate in a responsible and compliant manner. Doing the right thing is non-negotiable at Lilly, and I remain personally committed to all of us at Lilly maintaining the highest standards of conduct.”
BMJ 2009;338:b217
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January DTB
15/01/2009 by admin.
The January 2009 issue of Drug and Therapeutics Bulletin (DTB) has a new colour design, and from this month, the number of pages per month increases from eight to twelve. This issue includes an editorial (the first for DTB) and three articles. The editorial gives a background to the changes to DTB. The issue also includes a review of herbal therapies for menopause, a review of the prescribing trends of minocycline for acne and an explanatory article about the use of test for the TPMT enzyme before starting the drug azathioprine.
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Changes to the regulation of drug prices in the UK
12/01/2009 by admin.
On 11 December 2008 the Department of Health and the Association of the British Pharmaceutical Industry jointly published details of an agreement they had reached after nine months’ negotiation for the pricing of brand name drugs sold to the NHS.1 The new terms, which came into effect on 1 January 2009 and will run for five years, are the latest in a continually evolving Pharmaceutical Price Regulation Scheme.
Under the framework of this scheme, which was originally known as the Voluntary Price Regulation Scheme, government and industry have been negotiating “voluntary and non-contractual” terms for drug pricing since 1956, and the previous set of terms—which started in 2005—was due to run until 2010. However, in 2007 a market report from the Office of Fair Trading argued that the scheme was outdated, perverse, and not fit for purpose, and demanded that it be reformed.2 The government unilaterally withdrew from the 2005-10 scheme in February 2008 despite resistance from the drug industry.3 To what extent does the current scheme allay the Office of Fair Trading’s criticisms?
Much has been reformed in the pricing agreement, although an opportunity for a new start, with new structures and new relations, has not materialised. So, through the Pharmaceutical Price Regulation Scheme, the Department of Health will remain the “sponsoring” department for the drug industry in the United Kingdom, and the scheme will still be voluntary and non-contractual. As before, a profit margin will be calculated annually for each company according to its fixed assets (for example, its land, buildings, plant, and machinery), with monies repaid to government if the margin is exceeded and vice versa; and in calculating the profit margin, allowances will continue to be made for research and development, innovation, promotion, and the provision of information.
However, the new scheme contains key changes, among which are the way individual drug prices are set and modified, the central role that the National Institute for Health and Clinical Excellence (NICE) will play in the pricing process, and a more determined effort by the department to ensure that NICE’s recommendations are fully implemented. In addition, and as part of the new deal, government has negotiated a 5% overall cut in the cost of drugs sold to the NHS, estimated to be equivalent to £350m (415m; $520m) in 2009-10 and £500m for each year thereafter.1 4 Separately, but crucially, generic substitution is to be allowed in the community. So, from January 2010 pharmacists in the community will be able to substitute generic equivalents for drugs prescribed by their brand names. This has happened in hospitals for years and is a welcome change because it weakens the hold of brand name products.
As of now, the price of each new drug will be based on its clinical value (”the value the medicine provides to NHS patients”) and will no longer be determined by the company according to what it feels the market can bear. Moreover, prices will be flexible, and so could start low and increase (or decrease) depending on subsequent evidence. Prices could also increase if a new indication emerges, in which case the product could have two prices—one for each indication—with the price difference managed through a reimbursement system. Central to the arrangements will be NICE’s technology appraisals, which will now be undertaken for most new products (no longer for a selected few) and will be available within months of drug launch. Moreover, as part of the new Pharmaceutical Price Regulation Scheme, the elements of the quality adjusted life year will be reviewed, to ensure that it can be used to best reflect clinical value. Over the next three years NICE’s funding is being doubled to just over £60m (Andrew Dillon, personal communication, 2008), no doubt to help meet this expanded workload.
Knowing that a positive NICE appraisal is crucial to a product’s future in the UK, companies will need to “second guess” NICE’s recommendations when setting their prices. NICE’s decisions will certainly be crucial in the flexible pricing arrangements. Importantly, if NICE does not approve a new product, one option is for the company to work with the various health departments across the UK to establish a Patient Access Scheme. The new Pharmaceutical Price Regulation Scheme repeatedly asserts that NICE “will not negotiate or publicly set or publicly indicate prices”; however, it seems inconceivable that some “discussion” will not take place.
The terms of the new Pharmaceutical Price Regulation Scheme are welcome, even if the changes are somewhat timid. The government and the Association of the British Pharmaceutical Industry have gingerly responded to the criticisms of the Office of Fair Trading, but they go nowhere near meeting them in full. Perhaps they see this as a stepping stone and plan to make the full transition at the next round of changes in 2013. To check if the experiment (for it is just that) is successful, patients, doctors, and the public will need to have access to the workings and outcomes of the new scheme. A public debate on the achievements of the new arrangement would seem sensible. Inevitably NICE will play an increasingly important role in determining what we pay for medicines. It is essential that NICE remains true to its origins and provides advice that is intellectually independent of the government and drug companies. The risk that these new arrangements will draw the
BMJ 2008;337:a2735
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Opposition to European proposals for drug “information” dissemination
06/01/2009 by Merav.
The recent proposals for European legislation contained in the delayed “pharmaceutical package” outline that pharmaceutical companies may be given permission to provide “information” regarding their prescription medicines in Europe [1] presents a troubling prospect for the future of objective prescription, usage and funding of medicines.
Thankfully, the ban on direct-to-consumer advertising (DTCA) stands and pharmaceutical companies will not be granted the untrammelled access to consumers they enjoy in other countries. As is widely known, this sort of engagement with consumers has not always benefit patients: consider the case of Vioxx in which strong patient interest generated in the drug by its producer Merck translated into “blockbuster” status. Merck’s later withdrawal of the drug came after perhaps thousands of preventable adverse events.[2]
Monitoring is obligatory and will be carried out by Member States, prior to dissemination. However, the industry has found its way around monitoring systems before: the Food and Drug Administration’s (FDA) vetting of US pharmaceutical advertisements has for instance has often been ineffective, resulting in dissemination of false and misleading advertising material, [3] [4].
Patients require unbiased and objective information, and have the right to the highest quality of information about their health. As it stands though, the description of “information” in the EC proposals is inadequate and may come with some of the negative side effects of direct to consumer advertising. The profile of profitable branded drugs may be increased which will ramp up prescription medicine spending by patients and the NHS. Unbiased and objective information would be best provided by healthcare professionals, who are trained to appraise and interpret the evidence on clinical and cost effectiveness.
Healthcare professionals are increasingly aware of the potential conflicts of interest in having close ties with the pharmaceutical industry and its subsequent impact on patient safety and care. [5][6]. It would be very unfortunate if the influence of the pharmaceutical industry’s marketing apparatus instead refocused onto patients, perpetuating the industry’s influence yet longer. We call upon the European Commission to abandon its proposals and explore options for a more impartial and unprejudiced system of high quality peer-reviewed information provision.
[1] Watson R. Proposal to allow drug companies to give information to public sparks outcry. BMJ 2008;337:a3043
[2] Topol EJ. Failing the public health - Rofecoxib, Merck and the FDA. NEJM 2004; Volume 351:1707-1709.
[3] Prescription drugs: improvements needed in FDA’s oversight of direct- to-consumer advertising. Washington, DC: Government Accountability Office, November 2006.
[4] Angell M. The truth about drug companies. New York: Random House, 2004.
[5] Sweet M. Australian health professionals warned against featuring in advertisements. BMJ 2008;337:a2951
[6] Brennan TA, Rothman DJ, Blank L, Blumenthal D, Chimonas SC, Cohen JJ, Goldman J, Kassirer JP, Kimball H, Naughton J, Smelser N. Health industry practices that create conflicts of interest. JAMA. 2006;295:429-433.
Jonathan A Currie, Helen Preston, Sudath Weerapperuma
Competing interests: HP is President of Medsin, a student global health network. JC is Campaigns Director of Medsin. Sudath Weerapperuma is a representative of Pharmaware, a UK campaign aiming to maximise ethical interactions between healthcare professionals and pharmaceutical companies. We declare that we have no conflicts of interest.
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