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Rapid Responses: Rapid Responses published:
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Influence of drug companies
- M N Shah, N A Shah (24 October 2004)
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Re: Influence of drug companies
- susanne mccabe (25 October 2004)
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Thank God, patient compliance is very low
- BM Hegde (25 October 2004)
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Is the BMJ influenced by drug companies?
- Wendy Holden (25 October 2004)
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WHY INDUSTRY AND DOCTORS NEED TO WORK TOGETHER
- Richard S Tiner (9 November 2004)
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Trials in 'big' journals can't be believed?
- Margaret C Haugh (9 November 2004)
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The solution is deregulation.
- Richard G Fiddian-Green (11 November 2004)
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M N Shah, SpR obs and Gyn Wigan Wn12NN, N A Shah
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It is frightening to read about how drug companies have managed to gain so much influence over doctors and patients alike.There is no doubt that clever marketing under the guise of "awareness campaigns" persuades patients to see their doctors and insist on medications. It is also not difficult to see why doctors would be persuaded to hand out prescriptions for these medicines, given the constant bombardment of favourable data from companies and visits by company representatives, notwithstanding the fact the the so called "evidence" is actually corrupted and falsified. It is of even more concern to read that papers published in major respected journals from respected authorities are ghost written by drug companies without revealing the raw data.Also unfavourable results are prevented from getting into journals by using various inducements or indirect coercion.Even an agency as respected as the FDA, does not seem to immune to these inducements. Now that these corrupt practices have been exposed are any strong measures going to be introduced to prevent another "rofecoxib" from happening? Are the drug companies liable for compensation for harmful side-effects arising from use of drugs where data about serious harmful effects has been supressed? Are the journals going to institute any measures to actually investigate the raw data from "studies" sponsored by drug companies before publishing them? Or is the strong need to make money and put profits before patients on the part of drug companies going to override patient safety? Competing interests: None declared |
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susanne mccabe, cf24 3pf retired
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The October edition of British Journal of Psychiatry has 1/3, ie 17 full colour pages out of 52, covered by advertisements by drugs companies. Other submissions, career adverts,offensive adverts for ECT machines, notices of meetings, etc, which will have been paid for out of less lucrative budgets presumablly, are in black and white. What are the priorities? Surely after so many scandals, scientific journals should stop this practice....Drug companies would not set up this kind of partnership with medical Colleges if there was no pay off. Competing interests: None declared |
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BM Hegde, Retd. Vice Chancellor Mangalore-575004,India
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Dear Sir, The drug companies would continueto do what they have been doing so far with greater vigour in future as their profit levels drop. So there is no way we can build a perfect method to check fraud in this area. Most of the papers written are written to mislead the doctors, whether ghost written or not. The book written by the former editor of NEJM recently on how the drug companies take us for a ride and what to do about it is a step in the right direction. At the end of the day what keeps many patients alive is their low compliance. When more than three drugs are prescribed together it was estimated that about 25% of patients only comply. So society is still insulated from the real danger. I hope someday we will be able to expose the drug company fraud in greater detail. yours ever,
Competing interests: None declared |
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Wendy Holden, SpR Rheumatology Stoke Mandeville Hospital HP21 8AL
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I was heartened to hear Dr Kamran Abbassi, acting editor of the BMJ comment on an inquiry into the influence of the pharmaceutical industry heard by the health select committee earlier this month – “The BMJ takes the issues of transparency and accountability very seriously” (BMJ News 23rd October 2004 page 937). Perhaps he could explain how just a week before his remarks, Pfizer were able to place their advertisement for celecoxib (the main rival of rofecoxib) on the facing page adjacent to the BMJ’s editorial article on the withdrawl of rofecoxib (1). Was this a coincidence or an example of how even the BMJ can be manipulated by the pharmaceutical industry? Reference List (1) Dieppe PA, Ebrahim S, Martin RM, Juni P. Lessons from the withdrawal of rofecoxib. BMJ 2004; 329(7471):867-868. Competing interests: None declared |
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Richard S Tiner, Medical Director ABPI, 12 Whitehall, London SW1A 2DY
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Dear Editor So many criticisms and accusations of the pharmaceutical industry were made to the last meeting of the House of Commons Select Committee inquiry (BMJ, October 23) that it seems those giving evidence may have lost sight of two most important facts: that the industry is the most highly regulated in the country; and that it produces (and is very successful at producing) life-saving, innovative medicines. Certainly it is difficult to understand the rationale behind criticism of public awareness campaigns because they encourage patients to go to GPs who then prescribe medicines. If patients suffering from a condition for which there is a treatment available are encouraged to seek medical advice, surely this is to the good? To take the view that the less patients know about treatments, the better – and cheaper – is to behave dishonestly. Naturally, once they have attended the surgery, it will always be the doctor’s decision as to whether treatment is necessary and, if so, what form of treatment. But patients must not be kept in the dark about potential treatments, and I make no apology for the fact that the pharmaceutical industry occasionally provides such information. Furthermore, disease awareness campaigns often lead to earlier diagnosis of potentially fatal conditions, eg carcinoma of the bladder in the bladder dysfunction campaign. GPs’ knowledge of treatments needs to be continuously kept up-to-date. One way in which they can ensure that they remain informed about the latest medicines is through the services of pharmaceutical representatives. I do hope that the witness who gave evidence to the committee was right when he said that representatives’ influence can lead to changes in prescribing habits, for the UK is notoriously slow at taking up new therapies, lagging behind the rest of Europe. If doctors are convinced by what they hear about the latest, innovative medicines – and any information provided by a pharmaceutical representative must be backed up by the relevant scientific data – then it would be surprising indeed if they did not change their prescribing habits. The witness seemed to believe that doctors only listen to such information if they are being wined and dined at the same time. I have a better opinion of both doctors’ and pharmaceutical companies’ probity, and the situation is in any case covered by the industry’s rigorously enforced Code of Practice. If any of the BMJ’s readers has evidence of unwarranted hospitality being bestowed on healthcare professionals, the Code of Practice’s administrators, the Prescription Medicines Code of Practice Authority, would be pleased to investigate. In this context, it may be helpful to remind doctors that, where they receive payment in excess of Ł25, whether in money or in kind, from any external source including the pharmaceutical industry then they should declare it in the locally held register set up for these activities by the NHS in 2000. Contrary to further assertions at the inquiry, the system of self- regulation works well. The ABPI Code of Practice reflects and goes beyond UK and European law, and is internationally hailed as a “gold standard” on which many other countries’ codes are based. Times change, however, and this has been recognised by the ABPI which has recently embarked on a major overhaul of the code to ensure that it continues to cover all relevant aspects of modern pharmaceutical companies’ activities. All reported cases are published even if there is no case to answer – a very transparent approach. Certainly the PMCPA would gladly investigate any evidence that can be produced to support the claim made at the inquiry that bribes have been offered by a pharmaceutical company not to publish unfavourable research results. On questioning, it appeared to emerge that the witness was referring to a single instance some 20 years ago. Nevertheless, I should like to assert strongly that flawed scientific data is of no possible use to a pharmaceutical company. We work in a long-term business, where it takes some 10-12 years to develop a single new medicine. Because the data developed in supporting a marketing authorisation application has to be provided to the regulators, provision of flawed data would soon be detected. The pharmaceutical industry aims to work in partnership with all those involved in the provision of healthcare in the UK. This ranges from the Government to the NHS, bodies such as NICE and the Scottish Medicines Consortium, through to healthcare professionals, and, indeed, patients. In that wide range of activities by many different people and many different organisations, it is perhaps inevitable that, occasionally, things may go wrong and, where that happens, it is very important that it is discovered, reported and acted upon. But it is quite another matter to draw from this the conclusion that the whole system is flawed and that we would all work more efficiently if we refused to communicate with each other. Yours sincerely Richard Tiner (Dr Richard Tiner, Medical Director, Association of the British Pharmaceutical Industry 12 Whitehall, London SW1A 2DY Email: rtiner@abpi.org.uk) Competing interests: None declared |
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Margaret C Haugh, International Project Leader Lyon, 69008, France
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I am astonished at Professor Healy's claim that at least half of articles on drug efficacy that appear in the BMJ, the Lancet, and the New England Journal of Medicine are ghost-written by pharmaceutical companies and that "the most distinguished authors from the most prestigious universities" put their names to them without ever seeing the raw data. I know that this must happen, but the level claimed is much higher than I imagined. Does this mean that we should place more faith in trials published in the less prestigious journals? Competing interests: None declared |
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Richard G Fiddian-Green, FRCS, FACS c/o anders, Temple Gdns, Moor Park.
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Having been closely associated with obtaining FDA approval for gastrointestinal tonometers the only overt evidence of undue influence I came across was with a highly recommended consultant who had formerly been an employee of the FDA. He seemed to know all the in-and-outs [i.e he still had inside contacts off whom he was able to bounce his draft applications before final submission]and the "weasle words", to use his phrase, he used to get the examiners to approve the application. In retrospect the company might have been far better off without his assistance even though he obtaned FDA approval for the company very quickly. The reason is that FDA approval is a supplementary means of protecting intellectual property rights. That is to say had FDA approval for tonometry been obtained for measuring the adequacy of tissue oxygenation or better yet tissue energetics, rather than simply measuring the pH, the protection obtained would have been much greater. The process would, however, have taken very much longer for approval would no longer have depended upon "substantial equivalence", that is a similarity with approved devices. In this case substantial equivalence was an approved device for measuring intraluminal pH rather than intramucosal pH, a fudge if ever there were one given the large concepetual differences. The application would have to have included evidence, not available at the time, to support claims for measuring tissue oxygnation or energetics. The critical factor for a startup company, such as ours, is the time it takes to break even. With limited funds the sooner one is able to start selling product the sooner one is likely to break even and the less the investment required and hence dilution of investors stock holdings. The downside is that the easier it is to obtain FDA approval in the first place the easier it is for competitors to obtain approval and put you out of business. The larger the company, the deeper the pocket ,the higher the hurdles that can be set to deter competitors. This is where NICE comes in. In making the hurdles even higher by, for example demanding roll out for all patients at the same time and a price much lower than that needed to break even with a much lower volume of sales, NICE plays into the hands of the biggest company with the deepest pocket. That is a huge disincentive and the antithesis of what happens in the US. The net effect is an ossified healthcare industry with an enourmous amount of inertia and products being out of date if and when NICE eventually approves them. "Andrew Herxheimer, emeritus fellow at the UK Cochrane Centre, Oxford, called the relationship between the industry and the agency "a closed, inbred community where the industry is the client and the client must be looked after" and where a "culture of secrecy" permeates"....He called for the reporting of adverse drug reactions to be separated from the business of licensing drugs. ..Witnesses also called for stronger enforcement of formularies in general practices, declaration by pharmaceutical companies of their contact with and payments to doctors, and regulation of the industry's influence on consumers"..He also believes that," the regulatory agency feels it must "look after" the drug industry"(1). Kamran Abbasi said: "The BMJ takes the issues of transparency and accountability very seriously. We believe that authors must accept full responsibility for the integrity of their research—including having the idea, collecting and analysing the data, interpreting the results, and writing the paper—and we have several policies in place to ensure this." The regulatory agency may indeed look after the big companies by helping them raise the barriers for entry by competitiors. The solution has to be deregulation to allow smaller companies with innovative products to enter the market and break even early by charging what the market will bear as soon as they are ready to enter the market. They will be forced to bring their prices down as the market expands and competitors enter the market. That is what happens in US. This is also the most effective way of getting new products into lesser deveoped countires almost all of which allow the private sector to buy new products. Transparency and accountability are appropriate but in the cut and trust of free market forces that is best left to companies and authors. Deceiving the market or one's professional collagues does nobody any good. In my dealings I have found company and investigator ethics exceptionally high even when people have had a significant financial interest. Most of the commentary I have read is uninformed and the degree of ignornance seemingly directly related to the degree of hysteria expressed. Deregulate. 1. Zosia Kmietowicz Consumer organisations criticise influence of drug companies BMJ 2004; 329: 937. Competing interests: Patens issued in my name and products based upon them have been commercialised |
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