Talk:Aprotinin

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We have not heard the end of this. Dr Mangano has suggested that the research community has been lax in not following up renal side effects reported in 1993[1] in the FDA approval nota bene[2]. I smell blood. JFW | T@lk 02:18, 4 June 2006 (UTC)

What is your opinion on this? Is there a nephrology expert (I thought there was on the MD page) who could weigh in on this? While I abhor attempts to use Wikipedia for advertising, I wonder Monheit's statement about safety was true:

"Aprotinin doubles a patient's risk of kidney failure, heart failure, and heart attack in heart bypass patients as well as the number of patients needing kidney dialysis. A research by Ischemia Research and Education Foundation and the McSPI Research Group, led by Dennis T. Mangano, advises replacing Aprotinin by other, safer generic drugs."

Is this an accurate statement? IT seems shorter and clearer for the statement to be at the beginning of the paragraph. The way it is now is muddy, and rather cumbersome.jgwlaw 22:43, 8 July 2006 (UTC)

Sources

I need the title of the 1928 German paper, in German preferable. I'm also looking for the earliest mention of the amino acid sequence, which I've presently inserted without a cite. JFW | T@lk 07:43, 30 June 2006 (UTC)

There seems to be some information regarding the determination of aprotinin's structure by NMR here: [3]; Relevant papers regarding that discovery: "G. Wagner and K. Wuthrich. J. Mol. Biol. 155 (1982), pp. 347–366." and "C. Stassinopoulou, G. Wagner and K. Wuthrich. Eur. J. Biochem. 145 (1984), pp. 423–430." 85.138.11.182 (talk) 13:59, 23 January 2009 (UTC)

Recombinant

PMID 2423515 reports production of a correctly folded form by E. coli. Is Trasylol actually still extracted from cow lung? JFW | T@lk 12:29, 2 July 2006 (UTC)

Rewrite badly needed

This is a confusing sentence. Perhaps, JFW, you could rewrite to be a bit more comprehensible?

"Anaphylaxis occurs at a rate of 1:200 in first-time use, but serology (antibodies against aprotinin) is not advocated to prevent anaphylaxis on reexposure due to metholodological problems[2]." From this sentence, it appears that the writer means that serology is an antibody, and that it is not advocated to prevent anaphylaxis (although I don't think that is what you mean)... Wikipedia should be written for the general population, not medical professionals. Even if the audience were medical professionals, the sentence is still awkward.jgwlaw 02:00, 6 July 2006 (UTC)

Update

Apart from the way this article has ended up in legal circles, it needs the two articles from todays NEJM to bring it up to date. This drug has a murky history, and I would lso include Dean Fergusson's paper in Clinical Trials (2005; 2: 218–232) on the ethical issues.
Mgoodyear 23:51, 22 November 2006 (UTC)

The drug does not have a "murky history". What has gone wrong is that the FDA and Bayer disagree on whether the safety data has been underreported. The Fergusson paper does document some important points, but whether that concerns aprotinin alone or whether this is something that permeates all clinical research has yet to be established. I'd personally rather use a drug that has been tested in larger numbers of patients, even if there has been some duplication. Yet, this should preferentially be in larger trials to make the data generalisable. Some chemotherapy regimens are used only in trial context (e.g. in The Netherlands all patients with Hodgkin's lymphoma are in clinical trials). JFW | T@lk 04:16, 21 December 2006 (UTC)

Relevant articles:

• PMID 17124026 Jeffrey Drazen on Mangaro's data and the FDA.
• PMID 17124013 William Hiatt on discrepancies between observational studies and Bayer's handling of the 67,000 patient study
• PMID 17124031 FDA claims Mangaro restricted access to data

The gist seems to be a reiteration of the FDA's poor handling of postmartketing surveillance, an issue already exposed by the rofecoxib case. While we should mention the fact that these clashes have taken place, the NEJM articles do not provide new data on the safety of trasylol. JFW | T@lk 04:26, 21 December 2006 (UTC)

What about the recent claim that "up to 22,000" preventable deaths have occurred due to Trasylol? At least it caused Bayer stocks to plummet. Dysmorodrepanis (talk) 19:42, 15 February 2008 (UTC)

Legal Circles

As discussed on my usertalk page with JFW, I believe that there are substantial sources of information involving the litigation surrounding this drug. The Judicial Panel on Multidistrict Litigation heard arguments in March of 2008. This hearing took place after Bayer requested that the Federal Court cases be consolidated in front of one judge. see: LexisNexus. Thereafter, on April 7, 2008, the [Judicial_Panel_on_Multidistrict_Litigation] granted MDL [Multidistrict_litigation] status to the litigation surrounding this drug. See: JPML Order for MDL 1928. On the front line reviewing the millions of pages of documents to be produced by Bayer is a court appointed plaintiffs steering committee in MDL. All cases filed in Federal Court will be tranferred to Florida where they will be part of this consolidated effort to get to the bottom of what occurred. (MonheitLaw (talk) 15:20, 28 July 2008 (UTC))

Merge with BPTI

It looks like there is a parallel page called BPTI on the same protein. These should of course be merged. But what should the article be called. Personally I'm used to calling this protein BPTI, but I guess the more clinically interested would object to this... Thoughts anyone...? Kjaergaard 22:02, 20 December 2006 (UTC)

• From a pure policy view, BPTI would be against WP:NC (prefer spelled out names), but well, if BPTI is the name the community knows this drug under, that's fine with me. Another guideline says the INN-name? But as I said, pure policy. I know not a lot about these things. I'll see where it ends up. --Dirk Beetstra ^{T C} 22:05, 20 December 2006 (UTC)

The name is used interchangeably, but aprotinin and trasylol (each 2,000,000) both outgoogle BPTI[4]. I have completed the merge and done some other tidying up. I will need to read the NEJM articles to see whether they are clinical or political papers. JFW | T@lk 04:10, 21 December 2006 (UTC)

NEJM this week

Two trials: first and second, out this week, both showing increased mortality and renal impairment. Perhaps it is safe to say that aprotinin's days are well and truly numbered. JFW | T@lk 06:56, 21 February 2008 (UTC)

doi:10.1056/NEJMoa0802395 - and another one. Aprotinin is dead. JFW | T@lk 22:59, 14 May 2008 (UTC)

PMID 2446091 was the trial that started its use in major surgery. JFW | T@lk 13:17, 15 May 2008 (UTC)

Rewrite done, including scientific as well as clinical importance

I concede that probably more total people care about the drug than about the actual protein, so the merge and title are OK, given the redirect. But since BPTI is also very important to the history of scientific research on protein structure, I've added more facts and citations and an image, and rearranged the article somewhat to end with a section on BPTI as a protein. Dcrjsr (talk) 04:01, 11 April 2010 (UTC)

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• Added archive https://web.archive.org/web/20140201214751/http://www.nordicpharmagroup.com/art-4-4-38-the-nordic-group-acquires-rights-to-trasylol-from-bayer-healthcare.html to http://www.nordicpharmagroup.com/art-4-4-38-the-nordic-group-acquires-rights-to-trasylol-from-bayer-healthcare.html

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Suggestion for external links - https://www.aprotinin.co.uk/ - the official website in UK. — Preceding unsigned comment added by 2A00:23C7:D880:9C01:301E:1244:2FAA:4E20 (talk) 11:48, 6 February 2021 (UTC)