Posts Tagged 'Big Pharma'

Pharmaceutical flimflam: drug advertising in medical journals is a global issue

Advertising may be described as the science of arresting human intelligence long enough to get money from it.  ~  Stephen Leacock, Garden of Folly (1924) ‘The Perfect Salesman’

A recent systematic review in PLoS One demonstrates quite effectively something that shouldn’t surprise any intelligent high school student: pharmaceutical advertising in medical journals often provides “poor quality information.” This strikes me as the authors’ excessively polite way of saying that drug ads, even those that appear in authoritative periodicals widely read by physicians, are unregulated, manipulative, meretricious and mendacious. Selling the latest SSRI is not really different from shilling shampoo, with the difference, of course, that there is superior evidence of shampoo’s efficacy.

Othman N, Vitry A, Roughead EE. Quality of pharmaceutical advertisements in medical journals: a systematic review. PLoS One. 2009 Jul 22;4(7):e6350. PubMed PMID: 19623259; PubMed Central PMCID: PMC2709919.

The article, buffed to a high scholarly polish with any hint of libellous language or ethical disdain well suppressed, warrants close reading. Here are some highlights:

Advertising in medical journals is one of the techniques used by pharmaceutical companies to promote their products to medical doctors. During the first four years of a new medicine on the market, pharmaceutical companies may gain approximately US $2.43 for each dollar spent on medical journal advertisements for a medicine. The return on investment has been reported to increase to more than US $4 after that period.

We found that pharmaceutical advertisements in medical journals usually provided brand and generic name and indication. Other essential information required for rational prescribing including contraindications, interactions, side effects, warnings and precautions were less commonly provided. The majority of references cited to support pharmaceutical claims were journal articles. However, less than two-third [sic] of the claims were supported [emphasis mine] by a systematic review or a meta-analysis (110/1375, 8%) and randomised control trial (455/1500, 30%).

This review noted that references used to support pharmaceutical claims were often of low quality. The inappropriate use of references in journal advertising suggests that the availability of references does not always guarantee the quality of claims.

Information on medicines is essential to help doctors ensure the optimal use of medicines. However, studies show that doctors who use journal advertisements as a source of information may prescribe less appropriately. In addition, reliance on journal advertising for information is associated with increased costs of prescribing. Even doctors who think that they obtain their knowledge from the scientific literature can be influenced by promotional sources without being aware of it. As information provided in journal advertising has the potential to change doctors’ prescribing behaviour, our review indicates that ongoing efforts including complaints and recommendations by researchers, health professionals and policy makers to improve the quality of advertisements in medical journals are crucial.

Governments may need to take more proactive action such as engaging independent experts to help in designing regulation for journal advertising where self regulatory codes are limited. In addition to that, effective regulatory system may complement pharmaceutical litigation to ensure accuracy and reliability of information in journal advertising.

Our review found that the low quality of journal advertising was a global issue. Poor quality advertising has been observed in developing countries and post-Soviet Russia where controls might be weak and limited as well as in developed countries which have stricter regulations.

Globally, pharmaceutical advertising in medical journals often provides poor quality information. The impact of this problem on doctors’ prescribing behaviour might be even greater in developing countries and post-Soviet Russia where access to industry-free medicine information is limited. The results from our review suggest the need for a global pro-active and effective regulatory system to ensure that information provided in medical journal advertising is supporting the quality use of medicines.

It is the most extraordinary thing, but I never read a patent medicine advertisement without being impelled to the conclusion that I am suffering from the particular disease therein dealt with in its most virulent form.  ~  Jerome K. Jerome, Three Men in a Boat (1889)
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Would Nietzsche have taken Prozac?

migraine-voodoo-doll

My existence is a dreadful burden: I would have rejected it long ago, had I not been making the most instructive experiments in the intellectual and moral domain in just this condition of suffering and almost complete renunciation — this joyous mood, avid for knowledge, raised me to heights where I triumphed over every torture and all despair.  On the whole, I am happier now than I have ever been in my life. And yet, continual pain; for many hours of the day, a sensation closely akin to seasickness, a semi-paralysis that makes it difficult to speak, alternating with furious attacks (the last one made me vomit for three days and three nights; I longed for death!). F. Nietzsche, Letter to Dr. O. Eiser, January 1880

Would Nietzsche have taken Prozac? The intensity and frequency of his migraine attacks would certainly make him a candidate for modern preventive therapy. [1] Virgina Woolf, Miguel de Cervantes, Lewis Carroll, and Peter Tchaikovsky might also be given the nod. According to a review article published in the May 2009 Mayo Clinic Proceedings [2] preventive therapies are commonly underused in patients who may be appropriate candidates and who may benefit from treatment. The American Migraine Prevalence and Prevention survey states that 38.8% of migraineurs “should be considered for preventative treatment.” However, the Mayo Clinic article makes no mention whatsoever of Prozac and goes on to praise the anticonvulsant topiramate for headache prevention.

There seems to be a great deal of confusion about the best preventive medications for migraine. Prozac (fluoxetine) is just one of many drugs that have been and are being tried on suffering patients, everything from feverfew to ergotomine to botulinum toxin. Research is ongoing, of course. But despite gaps in the literature and promising evidence for some of the competition, Prozac is commonly prescribed for migraine prophylaxis. [14] A little casual investigation reveals that hard evidence to support its use is, in fact, lacking. Moreover, what evidence there is comes from a few studies done more than a decade ago.

The two most relevant Cochrane reviews are inconclusive. Cipriani, et al. (2005) found statistically significant differences in terms of efficacy and tolerability between fluoxetine and certain other antidepressants, but concluded that the clinical meaning of these differences was uncertain and that no definitive implications for clinical practice could be drawn from them. [3] Moja, et al. (2005) found that selective serotonin re-uptake inhibitors (SSRIs) like Prozac were no better than placebo for preventing migraine. [4]

One of the leading headache textbooks, the aptly named Wolff’s Headache, takes no heed of the Cochrane information and confidently asserts the prophylactic efficacy of Prozac. The studies it cites are from the early 1990s. [5,6,7] Curiously, in its own review of Prozac for migraine prevention, the US Headache Consortium cites completely different studies from the same decade. [9,10] The Consortium’s guideline [8] cautiously approves the use of Prozac based on some favourable outcomes from the cited studies.

Borkum’s Chronic Headaches (2007) barely mentions fluoxetine prophylaxis. [11] Another text, Migraine and Other Headache Disorders (2006) merely nods in the direction of SSRIs, [12] admitting that the mechanism by which antidepressants work to prevent headache is uncertain (p. 319). The editors of The Headaches (2006) also make a brief mention of the 1994 Saper study [7] which “found fluoxetine 20 to 40 mg/d more effective than placebo in the last month of a 3-month study.” [13] In his chapter on chronic migraine in Advanced Therapy of Headache (2005) Silberstein asserts that Prozac is “coming into wider use for daily headaches” (p. 104). [14]

But here is the summary from BMJ Clinical Evidence:

Compared with placebo SSRI antidepressants may be no more effective at reducing headache symptoms (very low-quality evidence).

Compared with amitriptyline We don’t know whether SSRI antidepressants are more effective at reducing headache duration (very low-quality evidence).

I could go on …

So why is Prozac being prescribed to thousands for relief of their migraine headaches? Beats me. Especially when harms associated with the use of Prozac are well described. (See the alerts published on the FDA website.) What would Nietzsche do?

David Healy’s warning is still relevant:

Since the development of anesthesia, physicians have been prepared to do harm to a few patients in order to benefit a majority of patients. The de facto Hippocratic Oath has always been: Do no harm to a majority of your patients. In the case of the SSRIs, the clinical trial evidence indicates that we may benefit some patients. None of this evidence shows us what proportion of patients benefit from SSRI treatment and what proportion are harmed by it. In the case of anesthesia, much less than 1% of takers are at risk. In the case of the SSRIs, there is a serious risk to far more than 1% of takers, but neither society nor the psychiatric profession has expressed a view as to what constitutes an acceptable minority of harmed patients. [15]


References

1. Hemelsoet D, Hemelsoet K, Devreese D. The neurological illness of Friedrich Nietzsche. Acta Neurol Belg. 2008 Mar;108(1):9-16.

2. Buse DC, Rupnow MF, Lipton RB. Assessing and managing all aspects of migraine: migraine attacks, migraine-related functional impairment, common comorbidities, and quality of life. Mayo Clin Proc. 2009 May;84(5):422-35.

3. Cipriani A, Brambilla P, Furukawa T, Geddes J, Gregis M, Hotopf M, Malvini L, Barbui C. Fluoxetine versus other types of pharmacotherapy for depression. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD004185.

4. Moja L, Cusi C, Sterzi R, Canepari C. Selective serotonin re-uptake inhibitors (SSRIs) for preventing migraine and tension-type headaches. Cochrane Database of Systematic Reviews 2005, Issue 3. Art. No.: CD002919.

5. Silberstein SD, Lipton RB, Dodick DW. Wolff’s headache and other head pain. 8th ed. New York: Oxford; 2008. p.353.

6. Bussone G, Sandrini G, Patruno G, et al. Effectiveness of fluoxetine on pain and depression in chronic headache disorders. In Headache and depression: serotonin pathways as a common clue (G Nappi, G Bono, G Sandrini, et al., eds), pp. 265-272. New York, Raven Press;1991.

7. Saper JR, Silberstein SD, Lake AE, et al. Double-blind trial of fluoxetine: chronic daily headache and migraine. Headache 1994;34:497-502.

8. Ramadan NM, et al. Evidence-based guidelines for migraine headache in the primary care setting: pharmacological management for prevention of migraine. US Headache Consortium. Available from: http://www.aan.com/professionals/practice/pdfs/gl0090.pdf

9. Adly C, Straumanis J, Chesson A. Fluoxetine prophylaxis of migraine. Headache. 1992;32(2):101-104.

10. Steiner TJ, Ahmed F, Findley LJ, MacGregor EA, Wilkinson M. S-fluoxetine in the prophylaxis of migraine: a phase II double-blind randomized placebo-controlled study. Cephalalgia. 1998;18(5):283-286.

11. Borkum JM. Chronic headaches: biology, psychology, and behavioral treatment. Mahwah NJ: Lawrence Erlbaum; 2007.

12. Lipton RB, Bigal ME. Migraine and other headache disorders. New York: Informa Healthcare; 2006.

13. Olesen J, Goadsby PJ, Ramadan NM, Tfelt-Hansen P, Welch KMA. The headaches. 3rd ed. Philadelphia: Lippincott Williams & Wilkins; 2006.

14. Silberstein SD. Chronic migraine without medication overuse. In, Purdy RA, Sheftell FD, Rapoport AM, Tepper SJ. Advanced therapy of headache. 2nd ed. Hamilton ON: BC Decker; 2005.

15. Healy D. Let them eat Prozac. Toronto: James Lorimer; 2003. p. 380

prozac-don't-worry

Dying is unequivocally the major cause of death

pills-cure-all
Milton Berle once said you know you’re old when you order a three-minute egg and they ask for the money up front. My baby boomer generation is deep in crow’s feet; and in keeping with the relentless demographics of aging in our society, interest in some, any, pharmacological fountain of youth is growing.

PharmaGossip, blogging with a sense of humour from the UK,  has posted a splendid send-up of Big Pharma propaganda to the anxiously aging. Basing itself on a report from an industry blog called BNET Pharma, it skewers the questionable drug marketing practices we have come to loathe and vituperate.

Here’s how it begins:

Phoni told the WSJ that it did not know about a study published last week in Nature that claims the life expectancy of mice was increased 9 – 14 percent if they took Heapamunee, a drug Phoni markets to suppress the immune system so that organ transplants won’t be rejected.

A Phoni spokesman called it an “interesting preclinical study” and said that the company had only just become aware of the findings.

“Phoni have only just acquired Heapamunee as a result of our hostile takeover of Whyus,” said Phoni’s President of Global Marketing, Rich Pillager, “and so we’re still working out just what assets we need to strip out of the company before we shut it down. However, following the Nature study, our marketing team is already up to speed on the case.”

Rich Pillager is a wonderful creation, worthy of Martin Amis in his eighties heyday. You can be sure that the Rich Pillagers of the world are working night and day concocting “anti-aging” drugs while convincing us that becoming superannuated is a disease that can best be treated with their magical elixir in a capsule.

PharmaGossip also makes fun of Aubrey de Grey (“Aubrey de Nutcase”), a death-defying British gerontologist and self-advertiser, only slightly altering a real quote of his: “Dying is unequivocally the major cause of death in the industrialized world and a perfectly legitimate target of medical intervention.”

De Grey strikes me as the kind of bloke who reads the obituaries every day and can’t understand why people die in alphabetical order. “It’s time to break out of our denial about aging,” he admonishes. I didn’t know I was in denial. Like Woody Allen, I’m not afraid of death. I just don’t want to be there when it happens. But I see how it’s pharmamarketing’s prime directive to feed my fears about that clean-sweeping scythe. Is it really true that when you get old your broad mind changes places with your narrow waist? Not at all. Stupidity, greed, deceit, and sheer, undiluted wankery know no age barriers.

pill-addiction


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