Case Number: AUTH/2424/8/11 and AUTH/2425/8/11
Case Ref: General Practitioner v Boehringer Ingelheim and Lilly
Description: Sponsored article on linagliptin
Breach: Lilly No breach, Boehringer Ingelheim Breaches Clauses 2, 3.1, 7.2, 7.4, 7.9, 7.10, 9.10 and 12.1
Appeal: Appeal by complainant - AUTH/2425/8/11
Review: Published in the February 2012 Review
Complaint Received: 03 August 2011
Complaint Completed: 04 October 2011
Case Summary:
A general practitioner complained that an article on linagliptin published in Future Prescriber represented the exaggerated, misleading and disguised promotion of linagliptin before a UK marketing authorization had been granted.
The article ‘Linagliptin: new class of DPP-4 [dipeptidyl peptidase-4] inhibitor in the treatment of T2DM [type 2 diabetes mellitus]’ was written by two diabetes and endocrinology physicians. A declaration of the authors’ interests was given in the final paragraph which stated ‘Placement of this article has been funded by Boehringer Ingelheim and Lilly. The content has been independently commissioned by Future Prescriber and has been checked by Boehringer Ingelheim and Lilly for factual accuracy only. Editorial control of this article remains with Future Prescriber’.
The complainant stated that the authors had previously received support from the companies which suggested that their opinions were likely to be known by both the companies which were likely to have been involved in their selection and briefing.
The complainant noted that the article stated that linagliptin was now approved and due to launch in the UK; this was not so. Linagliptin had only received a positive opinion from the European Medicines Agency (EMA .
The complainant alleged that the title of the article was misleading and exaggerated. He knew of no recognised or accepted sub-class of DPP-4 inhibitors. The title suggested an unqualified and unsubstantiated superiority over currently licenced DPP-4 inhibitors, comparisons with which were made throughout the article. The complainant asked if it was accurate to compare the maximal efficacy and potency of linagliptin with other DPP-4 inhibitors or claim that, in relation to use with concomitant medicines, linagliptin was safer than saxagliptin (Onglyza ; especially given that there were no head-to-head data with other DPP-4 inhibitors to substantiate this.
The complainant alleged that the claim that linagliptin might have a positive and long enduring effect on beta-cell function and therefore glycaemic control was misleading and inaccurate; this was not a fact nor could it be substantiated. The complainant stated that an unbalanced anddistorted promotional message was also elaborated with regard to renal acceptability. Saxagliptin was currently the only DPP-4 inhibitor with a UK licence for use in moderate/severe renal impairment. The complainant further alleged that the discussion of the possible cost of linagliptin compared with other DPP-4 inhibitors was not factual and potentially misled about cost-efficacy.
The complainant alleged that the decision to fund the development of this article and the evident lack of proper scrutiny of the facts suggested that the companies were keen to promote linagliptin prior to licence.
The detailed responses from Boehringer Ingelheim and Lilly are given below.
The Panel noted that it was acceptable for companies to sponsor material. It had previously been decided that the content would be subject to the Code if it was promotional in nature or if the company had used the material for a promotional purpose. Even if neither of these applied, the company would be liable if it had been able to influence the content of the material in a manner favourable to its own interests. It was possible for a company to sponsor material which mentioned its own products and not be liable under the Code for its contents, but only if it had been a strictly arm’s length arrangement with no input by the company and no use by the company of the material for promotional purposes.
The Panel noted that the publishers of Future Prescriber has proposed inter alia, two complementary articles (one of which was the article in question as part of the ‘managed entry programme’ for linagliptin ‘to support the product’ and ‘prepare the market’. It was proposed that the article in question would examine current and future treatment options with particular focus on the DPP-4 class and forthcoming products. The proposal also stated that the article would be independently commissioned, peer reviewed and published within the main pages of the journal. There would be no input from the company other than for medical accuracy. Reprints would be made available following publication. Minutes of a meeting between Boehringer Ingelheim the publishers and Lilly once the complaint had been received stated, inter alia, that the agreement with the publisher was that it would take all responsibility for generation of the article, choosing of authors (although it could requestinput from Boehringer Ingelheim, as it had done in relation to the article in question, but the publishers had made the final choice , managing the writing and review process and publication of the final article.
The Panel considered that it was clear from the proposal that the article would support linagliptin, and that Boehringer Ingelheim would have known this at the outset.
It appeared that although Boehringer Ingelheim did not pay for the article per se, it in effect commissioned it through an agreement to pay for 2,000 reprints. The Panel considered that Boehringer Ingelheim was inextricably linked to the production of the article and the company was responsible under the Code for the content.
Turning to the article itself, the Panel noted that the only mention of Boehringer Ingelheim was at the end of the article, after citation of all the references. The Panel considered that the article did not clearly indicate the involvement of the company, and ruled a breach of the Code. As the content was promotional, the Panel considered that it was disguised in that regard and ruled a breach of the Code.
The Panel noted that the article stated that linagliptin was approved in the UK. When the article was published, the product had not received a marketing authorization. The statement in relation to its licence was therefore inaccurate, and a breach of the Code was ruled. In addition, the article promoted a medicine prior to the grant of a marketing authorization and the Panel ruled a breach of the Code. As linagliptin did not have a marketing authorization, and therefore did not have a summary of product characteristics (SPC at the time of publication, the Panel did not consider that the article promoted the medicine outwith the terms of its marketing authorization or inconsistently with its SPC, and ruled no breach of the Code.
On the evidence before it, the Panel did not consider that linagliptin represented a new class of DPP-4 inhibitors. The title of the article implied that the medicine had some special merit, which could not be substantiated, and the Panel ruled breaches of the Code.
The article made it clear that there were currently no head-to-head trials of linagliptin with other DPP-4 inhibitors. The Panel did not consider that the article made misleading comparisons of the efficacy of linagliptin and other DPP-4 inhibitors as alleged and ruled no breach of the Code.
The Panel noted that the article stated that as linagliptin did not interfere with CYP450 it was ‘safer to use’ concomitantly with certain medications than saxagliptin. Given that there was no head-to-head trial of linagliptin and saxagliptin, the Panel considered that this claimdid not reflect available evidence and was not capable of substantiation by clinical experience, and ruled a breach of the Code.
The Panel noted the complainant’s comments in relation to the effect on beta-cell function of linagliptin and renal acceptability of the medicine. The Panel did not know whether any of these claims were correct. The Panel noted that the complainant bore the burden of proof. The Panel also noted its comment above that the company was responsible for the article. The Panel considered that as the product did not have a marketing authorization at the time the article was published, its ruling above of a breach of the Code covered these allegations.
With regard to the allegation that the information about possible cost of linagliptin compared with other DPP-4 inhibitors was not factual and potentially misled in relation to the cost-efficacy of the medicine, the Panel noted that the complainant had not explained why the claim at issue was inaccurate. There was no actual or implied cost-efficacy claim. No breach of the Code was ruled. This ruling was unsuccessfully appealed by the complainant.
The Panel considered that Boehringer Ingelheim would have been aware at the outset of the promotional content of the article. For the company to consider it anything other than a promotional item demonstrated a serious lack of understanding of the Code. High standards had not been maintained and ruled a breach of the Code. The Panel considered that Boehringer Ingelheim’s involvement with the publication brought discredit upon and reduced confidence in the pharmaceutical industry, and ruled a breach of Clause 2.
In relation to Lilly’s involvement with, and responsibility for, the article, the Panel noted that at the time the content of the article was agreed, Lilly and Boehringer Ingelheim had not formed a co-marketing alliance. The proposal for the article in question was sent only to Boehringer Ingelheim and only Boehringer Ingelheim was mentioned in the title of the proposal. Lilly was not aware of the article until it was contacted by Boehringer Ingelheim. Given the exceptional circumstances the Panel did not consider that Lilly was responsible for the article at issue, and ruled no breach of the Code.
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Ganapati Mudur
India’s controller of patents has granted the country’s first compulsory licence on a patented drug, allowing a domestic drug company to manufacture a generic version of Bayer’s sorafenib tosylate (marketed as Nexavar , used in chemotherapy for hepatic and renal cancers.
Natco Pharma asked for the right to manufacture sorafenib tosylate, saying that it would make available a generic version that would cost patients 8800 rupees (?110; ˆ135; $175 a month rather than the 280?000 rupees a month it costs for Bayer’s product. The controller granted the licence and ruled that Natco Pharma should pay Bayer a royalty fee of 6% on sales of the generic version.
Experts in public health who have been campaigning for better access to inexpensive generic drugs have hailed the controller’s decision, but sections of the pharmaceutical industry have said that compulsory licensing should be invoked only in public health emergencies and not to reduce the prices of drugs.
Bayer, which has the right to appeal, has said it is disappointed by the decision.
However, patient support groups are looking forward to more compulsory licences in other therapeutic areas. Yogendra Sapru, chief executive of the Cancer Patients Aid Association, said in a statement released after the controller’s decision this week, “Many other cancer medicines are sold at exorbitant prices in India.”
A single vial of patented trastuzumab (Herceptin , which is used in combination with paclitaxel to treat metastatic breast cancer, costs about 132?000 rupees in India, says a report from the Centre for Trade and Development, a policy think tank in New Delhi.
Malluparambil Santhosh, associate fellow at the think tank, said, “Herceptin chemotherapy in India is currently beyond the reach of the vast majority of patients who need it.”
A patented version of interferon used to treat hepatitis C virus infection is another example of a drug that most patients can’t afford, he said.
A senior health economist said that India will need to use all available tools to reduce prices of drugs given the government’s plans to introduce universal healthcare, including free drugs, announced last year (
BMJ
2011;343:d6774, doi:
10.1136/bmj.d6774 .
Sakthivel Selvaraj, an economist with the Public Health Foundation of India, New Delhi, said, “Compulsory licensing fits in with the goal of government procurement of drugs and distribution of free medicines for inpatient and outpatient healthcare.”
India changed its patent laws in 2005 to allow product patents on drugs, including the provision of compulsory licensing—as have other countries, as this is allowed under World Trade Organization rules. Brazil and Thailand have already used compulsory licences to make available antiretrovirals and anticancer drugs to their populations.
“India has been lagging behind on compulsory licensing despite huge expenses on drugs,” Dr Selvaraj told the
BMJ
. A nationwide survey of healthcare spending has shown that expenditure on drugs had accounted for about 68% of total personal spending on healthcare in India between April 2009 and March 2010.
The Organisation of Pharmaceutical Producers of India, which mainly represents international drug companies, has said that it has no objection to the use of compulsory licensing in a national emergency but believes that broadening its scope for “affordability” could result in the abuse of this provision.
India’s Association of Biotechnology Led Enterprises has said that it supports strong protection of intellectual property and opposes compulsory licences on “frivolous” grounds. “The government should clearly specify the criteria for issuing compulsory licences,” said Nandita Chandavarkar, its director of operations.
But health groups say that such reactions are predictable. “The idea that compulsory licensing should be limited only to emergencies is a myth promoted by multinational companies,” said Anand Grover, a director of Lawyers Collective, a non-government organisation that has represented cancer and HIV patients’ groups in court.
Mr Grover said that members of the World Trade Organization, including the United States and the European Union, had signed the Doha Declaration in 2001, which recognises the right to grant compulsory licences and the freedom to determine the grounds on which such licences are granted.
“India is likely to experience intense pressure from the developed countries and multinational corporations in the coming weeks to go slow on compulsory licensing,” said the Centre for Trade and Development’s Mr Santhosh.
Notes
Cite this as:
BMJ
2012;344:e2132
A claim for restitution filed by Pennsylvania's attorney general caused a last-minute delay in the sentencing of
Merck & Co. (MRK for its violation of a federal drug law in connection with its marketing of former painkiller Vioxx.
At a hearing Friday in federal court in Boston, U.S. District Judge Patti Saris delayed Merck's sentencing until April 19 to allow for more time to consider the Pennsylvania claim. Merck was originally scheduled to be sentenced Friday.
Merck, of Whitehouse Station, N.J., agreed in November to pay $950 million and plead guilty to a misdemeanor charge of marketing a misbranded drug, to resolve government allegations that the company illegally promoted Vioxx and deceived the government about the drug's safety.
The government alleged Merck promoted Vioxx for treatment of rheumatoid arthritis before that use was approved by regulators. A portion of the $950 million settlement also was to resolve parallel civil allegations that Merck made false and misleading statements about Vioxx's safety, causing government health programs to pay for the drug's use. Merck denied the civil allegations.
Merck had withdrawn Vioxx from the market in 2004 after a study showed it increased the risk of heart attacks and other cardiovascular events.
The proposed November settlement was to resolve claims by the U.S.
Justice Department, more than 40 states and the District of Columbia.
But last week, the Commonwealth of Pennsylvania filed a so-called victim impact statement with the court. Pennsylvania's attorney general office argued that Judge Saris shouldn't impose a sentence unless Pennsylvania obtains restitution for
Medicaid payments allegedly resulting from Merck's criminal misconduct, according to a court document filed by the U.S. Justice Department.
Pennsylvania is continuing to pursue Vioxx-related claims against Merck in proceedings coordinated by a federal judge in Louisiana, according to the Justice Department.
The Justice Department argued that Pennsylvania therefore has a forum to pursue its claims, and it shouldn't hold up the sentencing in Boston.
Merck also urged Judge Saris to decline Pennsylvania's application for restitution because it would delay distribution of the settlement money to participating states.
In a written statement Friday, Merck said: "Through a last minute request the Commonwealth of Pennsylvania has attempted to derail an agreement already reached in good faith with the federal government, 44 other states, and the District of Columbia. There is no legal foundation for the Commonwealth's claim in this court and Merck will vigorously oppose it."
The Justice Department said Pennsylvania was allocated $4.5 million for alleged Medicaid losses under the $950 million settlement. States had the choice of either accepting their allocations or initiating or continuing litigation against Merck.
“Human resistance to antibiotics could bring ‘the end of modern medicine as we know it’,” according to The Daily Telegraph. The newspaper says that we are facing an antibiotic crisis that could make routine operations impossible and a scratched knee potentially fatal. Similarly, the Daily Mail’s headline stated that a sore throat could soon become fatal.
The alarming headlines follow a new report by the World Health Organization (WHO , which set out ways to fight the growing problem of antimicrobial resistance (AMR . AMR occurs when infectious organisms, such as bacteria and viruses, adapt to treatments and become resistant to them. The publication specifically addressed the long-known problem of antibiotic resistance, where increasing use of antibiotics can lead to the formation of “superbugs” that resist many of the antibiotic types we currently have. It outlined a variety of measures that are vital for ensuring we can still fight infections in the future and described how other major infectious diseases, such as tuberculosis, HIV, malaria and influenza, could one day become resistant to today’s treatment options.
However, despite the future danger posed by antimicrobial resistance, the situation is not irretrievable. As Dr Margaret Chan, director general of WHO, said: “much can be done. This includes prescribing antibiotics appropriately and only when needed, following treatment correctly, restricting the use of antibiotics in food production to therapeutic purposes and tackling the problem of substandard and counterfeit medicines.” The report also highlighted successful cases where antimicrobial resistance has been tackled, demonstrating that we can safeguard the effectiveness of important antimicrobial medicines with dedicated, rational efforts.
Where has the news come from?
WHO has just published a new report (“The evolving threat of antimicrobial resistance - Options for action” that sets out a global strategy for fighting antibiotic resistance. It explores how over past decades, bacteria that cause common infections have gradually developed resistance to each new antibiotic developed, and how AMR has evolved to become a worldwide health threat. In particular, the report highlights that there is currently a lack of new antibiotics in development and outlines some of the measures needed to prevent a potential global crisis in healthcare.
This is not the first time WHO has set out such a strategy. In the 2001, WHO published its “Global strategy for containment of antimicrobial resistance”, which laid out a comprehensive list of recommendations for combating AMR. The current report looks at the experiences over the past decade of implementing some of these recommendations, the progress made, and what else should be done to tackle AMR.
What is antimicrobial resistance?
Antimicrobial resistance (AMR occurs when microorganisms, such as bacteria, viruses, fungi or other microbes, develop resistance to the drug that is being used to treat them. This means that the treatment no longer effectively kills or inactivates the microorganism. The term “antimicrobial” is used to describe all drugs that treat infections caused by microorganisms. Antibiotics are effective against bacteria only, antivirals against viruses only, and antifungals against fungi.
The case of penicillin illustrates the AMR phenomenon well. When penicillin was first introduced in the 1940s, it revolutionised medicine and was effective against a wide range of staphylococcal and streptococcal bacteria. It was also able to treat infections that had previously been fatal for many people, including throat infections, pneumonia and wound infections. However, with increasing use of antibiotics over the decades, bacteria began to adapt and develop changes in their DNA that meant they were resistant to the actions of the once-powerful antibiotic. These bacteria would survive and proliferate, which meant their protective genes would then be passed on to other strains of bacteria. As a result, new and stronger antibiotics had to be created to combat the resistant bacteria.
AMR is driven by many factors, including overuse of antimicrobials for human and animal health and in food production, which can allow microbes to adapt to antimicrobials they are exposed to. Poor infection-control measures, which fail to prevent the spread of infections, also contribute. In particular, the WHO publication reports what it describes as the five most important areas for the control of AMR, as recognised in its 2001 strategy:
- surveillance of antimicrobial use
- rational use in humans
- rational use in animals
- infection prevention and control
- innovations in practice and new antimicrobials
How big is the problem?
As the report describes, AMR makes it difficult and more expensive to treat many common infections, causing delays in effective treatment or, in the worst cases, an inability to provide effective treatment at all. Many patients around the world suffer harm because infections from bacteria, viruses, fungi or other organisms can no longer be treated with the common medicines that would once have treated them effectively.
The report presents some startling facts on major infectious diseases worldwide:
- Malaria: malaria is caused by parasites that are transmitted into the blood stream by a bite from an infected mosquito. Resistance to antimalarial medicines has been documented for all classes of the drug, which presents a major threat to malaria control. The report describes that a change in national antimalarial treatment policy is recommended when the overall treatment failure rate exceeds 10%. Changes in policy have been necessary in many countries due to the emergence of chloroquine resistance. This means that alternative forms of combination therapy have to be used as first-line treatment.
- Tuberculosis: in 2010, an estimated 290,000 new multidrug-resistant tuberculosis (TB cases were detected among the TB cases notified worldwide, and about one-third of these patients may die annually. Inaccuracies in diagnosis also impede appropriate treatment.
- HIV: resistance rates to anti-HIV drug regimens ranging from 10% to 20% have been reported in Europe and the USA. Second-line treatments are generally effective in patients when the first-line therapy has failed, but can only be started promptly if viral monitoring is routinely available.
- Common bacterial infections: various bacteria can cause infections within the chest, skin and urinary tract bloodstream, for example, and the inability to fight these infections appears to a growing problem in healthcare. Estimates from Europe are that there are 25,000 excess deaths each year due to resistant bacterial hospital infections, and approximately 2.5 million avoidable days in hospital caused by AMR. In addition, the economic burden from additional patient illness and death is estimated to be at least ˆ1.5 billion each year in healthcare costs and productivity losses.
What can be done about AMR?
The five key areas that the report highlights could tackle the problem of AMR are as follows:
Surveillance of antimicrobial use
Tracking antimicrobial use (in particular antibiotic use and looking at the emergence and spread of resistant strains of bacteria is a key tactic in the fight against AMR. This can provide information, insights and tools needed to guide policy and measure how successful changes in prescribing may be. This can happen both locally and globally.
AMR is a global problem but, at present, there appears to be wide variation in the way regions and countries approach AMR surveillance. This means there is a long way to go before it can be carried out worldwide.
Rational use in humans
Antimicrobials can obviously be important or even lifesaving in appropriate situations, but it is just as important to prevent unnecessary use of antimicrobials, which can lead to resistance. Putting this into practice worldwide is said to be difficult, but rationalising antimicrobial use has had a demonstrable impact on AMR in some cases.
Rational use in animals
Antibiotics are said to be used in greater quantities in food production than in the treatment of disease in human patients. Also, some of the same antibiotics or classes are used in animals and in human medicine. This carries the risk of the emergence and spread of resistant bacteria, including those capable of causing infections in both animals and people.
The problems associated with the use of antibiotics in animal husbandry, including in livestock, poultry and fish farming, are reportedly growing worldwide without clear evidence of the need for or benefit from it. There are said to be major differences in the amounts of antimicrobials used per kilogram of meat produced in high-income countries, and actions need to be taken by national and international authorities to control this.
Infection prevention and control in healthcare facilities
The hospital environment favours the emergence and spread of resistant bacteria. The report highlights the importance of infection-control measures to prevent the spread of microbes in general, regardless of whether they are resistant to antimicrobials. Many facilities and countries are reported to have progressed well since 2001, implementing many recommendations on infection control and prevention, although gaps and challenges still remain.
Innovations
Lastly, the report describes how innovative strategies and technologies are needed to address the lack of new antimicrobials being produced. As the report says, while antimicrobials are the mainstay of treatment for infections, diagnostics and vaccines play important complementary roles by promoting rational use of such medicines and preventing infections that would require antimicrobial treatment. So far, new products coming on to the market have not kept pace with the increasing needs for improvements in antimicrobial treatment. However, current challenges to new research developments can be both scientific and financial.
Can these strategies really stop AMR?
While AMR poses a significant threat to health in the future, the situation does not appear to be irretrievable. The WHO report and an accompanying press release highlight some examples of success stories over the past years:
- In Thailand, the "Antibiotic Smart Use" programme is reported to have reduced both the prescribing of antibiotics by prescribers and the demand for them by patients. It demonstrated an 18–46% decrease in antibiotic use, while 97% of targeted patients were reported to have recovered or improved regardless of whether they had taken antibiotics.
- A pharmacy programme in Vietnam reportedly consisted of inspection of prescription-only drugs, education on pharmacy treatment guidelines and group meetings of pharmacy staff. These measures were reported to give significant reduction in antibiotic dispensing for acute respiratory infections.
- In Norway, the introduction of effective vaccines in farmed salmon and trout, together with improved fish health management, was reported to have reduced the annual use of antimicrobials in farmed fish by 98% between 1987 and 2004.
- In 2010, the University of Zambia School of Medicine was reported to have revised its undergraduate medical curriculum. AMR and rational use of medicines were made key new topics to ensure that graduates who enter clinical practice have the right skills and attitudes to be both effective practitioners and take a role in fighting AMR.
How can I do my part?
There are times when antibiotics are necessary or even vital. However, as patients and consumers, it is important to remember that antibiotics or other antimicrobials are not always needed to treat our illnesses, and we should not expect them in every situation.
For example, the common cold is caused by a virus, which means it does not respond to antibiotics. However, people may expect to be given antibiotics by their doctor when they are affected, even though they offer no direct benefit and could raise the risk of bacteria becoming resistant. Furthermore many common viral and bacterial infections such as coughs, throat and ear infections and stomach upsets, are “self-limiting” in healthy people, which means they will generally get better with no treatment at all.
If, on the other hand, you are prescribed an antimicrobial, it is important to take the full course as directed. Taking only a partial course of an antimicrobial may not kill the organism but may expose it to a low dose of a drug which can then contribute to resistance.
Links To The Headlines
Health chief warns: age of safe medicine is ending. The Independent, March 16 2012
Human resistance to antibiotics could bring "the end of modern medicine as we know it", WHO claim. The Daily Telegraph, March 16 2012
Why a sore throat could soon be fatal: Bugs are becoming more resistant to antibiotics, warn health chiefs. Daily Mail, March 16 2012
Links To Science
WHO: The evolving threat of antimicrobial resistance - Options for action. March 16 2012
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The top executives at Abbott see their pay packages decline by a collective 24%; also, Allezoe replaces suspect secretary White; Stereotaxis COO/CTO steps down; and iCad holds on to marketing SVP.
The top brass at
Abbott (NYSE:
ABT saw their 2011 pay packages reduced by a collective 23.9%, ranging from a 6.1% cut for chairman & CEO Miles White to a whopping 26.9% hit for pharma head Richard Gonzalez.
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