Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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Speed or health
- Albert Figueras (26 November 2004)
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Is regulation of testosterone and progesterone use failing?
- Ellen C G Grant (29 November 2004)
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Commercial influence on prescriptions
- Martin D Leyland (30 November 2004)
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drug industries and doctors
- Vaidyanathan Gowri (1 December 2004)
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Save the FDA !
- Alexander SD Spiers, Cookham Dean, Berkshire (4 December 2004)
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Scientific Credibility is based upon Transparent Debate
- Stefan P. Kruszewski, M.D. (4 December 2004)
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Albert Figueras, International Cooperation Area Fundació Institut Català de Farmacologia. E-08035 Barcelona (Spain)
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Dear Editor, To those interested in the double cutting edge sword of “evidence- based-medicine”, a couple of examples are clearly shown in the News section of this 27 November BMJ issue. Dr Moynihan explains a new example of a common situation raised at a clinical problem level by drug industry in order to quickly offer a dramatic (and very profitable) solution; unfortunately, it seems that high quality evidences on testorenone patches are scarce, at best. On the other hand, there is additional information on the Vioxx story, in which, as repeatedly published this autumn, lack of appropriate evidences have been argued by the manufacturer when asked about its delay in recognizing cardiovascular effects. The double-standard message can be summarised as follows: weak evidences to approve a new drug and strong evidences to withdraw it from the market. It could be useful to remember the Editorial paper by Sackett et al.(1), in which he wrote that good doctors use both individual clinical expertise and the best available external evidence, and neither alone is enough. In the present fast-track days, the duality “speed vs. health” seems to impose. If rapid drug approval continues to be the rule of thumb, strong postmarketing surveillance is mandatory, and perhaps new impulse (and credibility) should be given to the spontaneous reporting systems and to the much more classical description of suspected adverse drug reactions as case-reports in medical journals. Perhaps this text could have been entitled as: “Whistleblowers must be all!”, in order to highlight the importance of the appropriate amplification of daily clinical observations and suspicions, often silenced or interfered in the name of "strong evidences". Perhaps the protection against another Vioxx is not to reinvent the wheel, but just to use the breaks to slow down the regulatory processes and to give ourselves the opportunity to have a quiet look at the clinical landscape. (1) Sackett DL, et al. Evidence based medicine: what it is and what it isn't. BMJ 1996;312:71-72. Competing interests: None declared |
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Ellen C G Grant, physician and medical gynaecologist 20 Coombe Ridings, Kingston-upon-Thames, , KT2 7JU.UK,
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Kamran Abbassi is young enough to be surprised that senior NHS policy makers see the drug industry as an essential financer of research and development with barely an acknowledgment of the issues of transparency, competing interests, and disentangling the relationship between drug companies and drug regulators. It is absurd that 2 million men in the USA are taking testosterone which increases the risk of aggressive behaviour, cardiovascular disease and prostate cancer. Exogenous sex hormones are immunosuppressive with both testosterone and progesterones likely to suppress antibody production. Progesterones are more carcinogenic for the breast than oestrogens. The web site of the late Dr John Lee, who died of a sudden heart attack, still promotes both testosterone and progesterone, provided they are “bio-identical”. What is the evidence that progesterone and testosterone receptors respond differently according to the source of the hormones? Progestogens can have extra actions but they predominantly stimulate progesterone receptors. Breast cancers and their blood vessels are stimulated by progesterone and treatment involves the removal of both endogenous and exogenous progesterone. Major causes of loss of libido are zinc and essential fatty acid deficiency and use of progesterone-dominant/low dose oestrogen oral contraceptives or combination HRT in women. Hormone use increases conditions like bleeding, fibroids and endometriosis, which often lead to premenopausal and postmenopausal hysterectomies. I hope the FDA continues to refuse to offer over the counter high- dose progesterone emergency contraceptives but also has the sense to restrict the availability of testosterone. How can we regard the increasing spread of sexually transmitted diseases and HIV infections among women as a crisis and still want to artificially increase libido in both sexes to the point of aggression? The regulators have certainly failed to prevent the increasing use of hormones. At present it is only the randomised double-blind trials of HRT which have been prematurely terminated. Hormone promotions and unmonitored use continue almost unabated. Abbassi K. Editor’s choice. Is the drug regulator failing? BMJ 2004;329 (27 November), doi:10.1136/bmj.329.7477.0-g Competing interests: None declared |
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Martin D Leyland, Consultant Ophthalmologist Royal Berkshire Hospital RG1 5AN
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The European Directive on Good clinical Practice in Clinical Trials (2001/20/EC, which came into force on May 1st this year, imposes a complex regulatory and administrative framework on clinical trials involving medicines. It is administered in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA),and is so complex that all trials on medicines will in the future be run by, and for, pharmaceutical companies. Individual clinicians will not have time to complete the forms, still less meet the stringent legal requirements of the Directive. These industry-sponsored trials will in turn be the 'evidence-base' informing clinical guidelines and NICE judgements, to which General Practitioners will be forced to adhere in odrer receive quality framework points and therefore remuneration under the new GP contract in the UK. With the independence of the MHRA from pharmaceutical industry bias now called into question (Abbasi;2004,BMJ),it is increasingly likely that prescribing patterns in the UK will be driven by commercial rather than clinical considerations. Competing interests: None declared |
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Vaidyanathan Gowri, assistant professor SQu, muscat,oman,PO box 35;code 123
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Sir It is time Institutions and individuals alike should stop getting research funded by drug companies solely. Gowri V Competing interests: None declared |
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Alexander SD Spiers, Professor of Medicine Retired, Cookham Dean, Berkshire
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The United States Food and Drug Administration (FDA) performs a largely thankless task. Patients and their families wish the latest new drugs to be available immediately and they exert powerful political pressure to bring this about. A dramatic example was the lobbying, agitation and even violence that promoted the early release of anti-HIV drugs. On the other hand, the public wishes all its medicines to be guaranteed safe - an unattainable aim - and blames the FDA when an approved drug has to be withdrawn because new toxic effects have been observed. Some medical researchers consider the FDA and its regulations to obstruct their clinical investigations and swamp them in a sea of form- filling. The pharmaceutical industry seems to regard the FDA as an adversary to be overcome, not as a helper and protector. During a twenty-year residence in the United States I encountered many FDA agents. A few seemed to revere FDA regulations for their own sake and appeared to have no regard for Science or Medicine. Such people are irksome, but without strict regulation the pharmaceutical scene in the United States would be horrendous, with valueless and frequently toxic agents being marketed. A prime example is laetrile, a useless and poisonous drug promoted for the treatment of cancer. The FDA, supported by the National Cancer Institute, successfully resisted extreme pressure to allow the marketing of laetrile, and doubtless saved many lives and prevented millions of dollars going into the pockets of the unscrupulous. Now the FDA is under attack for some serious faults. First, the attempt to suppress David Graham's whistleblowing on the subject of rofecoxib suggests an assault on scientific honesty and academic freedom. Second, the FDA's refusal to allow over-the-counter sales of emergency contraception suggests that unacceptable political pressure was exerted by the religious right, and successfully, too. Third, there is more than a suggestion that sometimes relations between the FDA and the pharmaceutical industry are too cosy, and some fast track reviews and marketing approvals are inappropriate. I believe that the FDA is worth saving: how should this be done? First, the department that orders withdrawal of a drug should be made independent from the department that approves a drug for marketing. Second, the FDA could be insulated from political pressures by making it a quango rather than an organ of the government. Third, conflicts of interest involving employees of the FDA and consultants to the FDA should be rigorously scrutinised, even more severely than editors scrutinise the interests of contributors. Closer to home, the Medicines and Healthcare Products Regulatory Agency is now being accused of industry bias. Housecleaning there, as well as at the FDA, will benefit patients, physicians, and ultimately the pharmaceutical industry itsef. Competing interests: None declared |
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Stefan P. Kruszewski, M.D., Psychiatrist Harrisburg, Pennsylvania USA
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I savored the comments of Albert Figueras in response to Kamran Abbassi’s editorial (1). To paraphrase Dr. Figueras, he suggested that individual practitioners consider accepting a greater role and responsibility in airing their clinical observations to protect the regulatory process of drug approval and post-marketing surveillance. He added that individual and collective ‘whistle-blowing’ could enhance the accumulation of scientific evidence---and therefore should not be the exception to the process, but the rule. I concur. Scientific credibility is powered by transparency but disemboweled by conflicts of interest. In the debate about drug safety, those political, cultural and/or financial alliances that exist other than for the purpose of protecting and improving the public welfare are at odds with the pursuit of scientific discipline and the rigorous honesty that is necessary for its success. This debate reminds me of a quote attributed to Dorothy Thompson (b.1893), an early-mid 20th century American political commentator and journalist. She said, “There is nothing to fear except the persistent refusal to find out the truth, the persistent refusal to analyze the causes of happenings. Fear grows in darkness; if you think there’s a bogeyman around, turn on the light.” I’m guessing that both Abbassi and Figueras agree that turning up the lights in order to curtail ignorance and misinformation is a good thing. It is---with one clarification. Earlier this evening, I spoke with two colleagues who work for our US Food and Drug Administration (FDA). They are out of the spotlight and in the trenches. They are hurting because they have persevered under the umbrella of suspicion while certain administrative members and/or legal counsel to the FDA have been the target of media censure. Not unlike their counterparts at agencies such as the MHRA, many--if not most--of these scientists have done what’s asked of them, with conviction and diligence. Their dedication should not go unnoticed. Optimistically, the efforts of these exemplary men and women can be more fully realized when vigorous and transparent leadership returns to steward the protection of our foods and pharmaceuticals. 1. Abbassi K. Editor’s choice. Is drug regulation failing? BMJ 2004; 329 (27 November), doi:10.1136/bmj.329.7477.0-g Competing interests: None declared |
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