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Tamiflu: Over $20bn of public money has been spent on stockpiling drugs of uncertain benefit...

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
British Medical Journal Editor's Choice

The missing data that cost $20bn

April 11, 2014

Kamran Abbasi, international editor

Marketing is what you do when your product is no good, said Edward Land, scientist and inventor of the Polaroid instant camera.

The same notion filled Tom Jefferson’s head when he began to reappraise his initial conclusions about neuraminidase inhibitors and the risk of influenza complications and hospital admissions (doi:10.1136/bmj.g2227).

Keiji Hayashi, a Japanese researcher, alerted him to the existence of unpublished trials, trials that were not included in his Cochrane review of 2006.

From trusting the literature, researchers, and companies, Jefferson moved to a position of deep scepticism.

Many trials were unpublished, data weren’t shared, and decisions on purchasing, stockpiling, and using the drugs were based on a slim and skewed representation of the total evidence base.

This week is the culmination of a five year campaign led by Jefferson’s Cochrane research team, supported by The BMJ, to ensure the release of the full clinical trial data on neuraminidase inhibitors (doi:10.1136/bmj.g2630).

The studies, analyses, and editorials in this issue strike like a hammer blow. Oseltamivir (Tamiflu) has generated sales in excess of $18bn (£11bn; e13bn) for Roche since 1999, something more than the "nice little earner" that a City of London financial analyst described it as (doi:10.1136/bmj.g2524).


The United States stockpiled 65 million treatments for a cost of $1.3bn. The United Kingdom spent £424m on a stockpile of 40 million doses. By 2009, 96 countries possessed enough osteltamivir for 350 million people.

GlaxoSmithKline’s drug zanamivir (Relenza) was less successful but still generated sales in the region of $2bn.

The revised Cochrane reviews, which were based on the full clinical trial data, conclude that the benefits of the drugs don’t outweigh the harms (doi:10.1136/bmj.g2547; doi:10.1136/bmj.g2545).

An analysis of the observational studies finds that they are inconclusive (doi:10.1136/bmj.g2371). So, over $20bn of public money has been spent on stockpiling drugs of uncertain benefit, and decisions were based on incomplete data.

It isn’t hard to see who benefits here, and it clearly isn’t patients. Informed choice requires comprehensive and credible information, writes Harlan Krumholz (doi:10.1136/bmj.g2548).

Patients, he argues, might choose differently if data owners released all the relevant information and independent scientists were able to properly analyse and communicate the results.

Worryingly, the welfare of patients seems a secondary consideration for all stakeholders. Drug company executives champion their work for the benefit of patients. Regulatory authorities are responsible for protecting patients. Politicians make decisions for the public good.

Yet, when faced with the sudden threat of pandemic H1N1 flu, a threat that ultimately did not materialise, each party behaved opportunistically and irresponsibly. Drug companies exploited a window for rapid sales. Regulators approved drugs with insufficient scrutiny, exposed now by the forensic approach of the Cochrane researchers. And politicians were desperate to act, to do something in the face of a perceived crisis, whether it was based on evidence or not.

Patient welfare didn’t matter, although it was the excuse for these decisions.

The crux of the saga remains the ability of independent analysts to quickly access the full clinical data on any product or device. Initiatives supported by regulators and the industry are being introduced to try to prevent future scandals, but data on existing drugs remain hidden (doi:10.1136/bmj.g2579, doi:10.1136/bmj.g2632).

"Everything for me is marketing and publicity, unless proven otherwise," says Jefferson. Companies, regulators, politicians, and researchers might consider the lessons of Tamiflu and put patients first and marketing a nice little earner a distant second.


Related links Cite this as: BMJ 2014;348:g2695
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
Many trials were unpublished, data weren’t shared, and decisions on purchasing, stockpiling, and using the drugs were based on a slim and skewed representation of the total evidence base.

This is pervasive throughout medicine. Further, its a key factor in psychogenic medicine and ME .. slim and skewed evidence bases.
 

barbc56

Senior Member
Messages
3,657
LOL! I just logged on to post an article about the same subject.

The lack of transparency as well as unpublished data about Tamiflu misled the medical community which in turn impacted patients. This is an excellent example why transparency is essential for Science based studies.:)

Another article:

The absence of a full data set on Tamiflu (oseltamivir) and the other neuraminidase inhibitor Relenza (zanamivir) became a rallying point for BMJ and the AllTrials campaign, which seeks to enhance the transparency and accessibility of clinical trials data by challenging trial investigators to make all evidence freely available
.
http://www.sciencebasedmedicine.org


Barb.
 

Ecoclimber

Senior Member
Messages
1,011
[B said:
Many trials were unpublished, data weren’t shared, and decisions on purchasing, stockpiling, and using the drugs were based on a slim and skewed representation of the total evidence base.[/B]]

Why stop there. Why not mention the fact that the vaccine by GlaxoSmithKline and the Pandemrix H1N1 swine flu vaccine caused serious and irreversible damage to those vaccinated.

http://www.huffingtonpost.com/2013/01/31/pandemrix-narcolepsy-swine-flu-shot-britain_n_2588859.html

http://forums.phoenixrising.me/inde...link-to-gsk-swine-flu-shot.21476/#post-327592

http://www.nbcnews.com/id/50890438/...c-says-flu-vaccine-barely-worked-over-s-year/
The flu vaccine barely worked to protect elderly people this year, and it helped prevent illness in just 56 percent of adults and children overall, federal health officials said Thursday


The flu vaccine reduced the chances of illness by just 9 percent in people over 65, the Centers for Disease Control and Prevention reports. Overall, it reduced illness by 56 percent.

Although this year’s vaccine was considered a good match for the most common circulating flu viruses, it still only provided 47 percent protection against the main virus, called H3N2, the CDC said in its weekly report on death and illness



I'm mot opposed to vaccinations per se but let's have full disclosue and transparency in all aspects of the pharma industry.

Hmmm...
 

barbc56

Senior Member
Messages
3,657
Why stop there. Why not mention the fact that the vaccine by GlaxoSmithKline and the Pandemrix H1N1 swine flu vaccine caused serious and irreversible damage to those vaccinated.

The flu vaccine is not 100% effective and I would hope medical professionals are aware of this. That being said, IMHO, the benefis outweigh the risks. I'm not saying there are no side effects/negative impact on patients, but I believe they are often overstated and not backed up by the scientific data.

The article I cited does mention the effacacy of the flu vaccine but not the side effects/impact for those getting the vaccination. However there are many blogs on the site which do discuss this. I don't have time to post these articles but they are easily accessed through the search function on the site.

Barb
 

taniaaust1

Senior Member
Messages
13,054
Location
Sth Australia
This article doesnt surprise me one bit. What drug companies are are BUSINESSES.. and businesses are out to rake in profits for themselves. So they are like sales people.

Unfortunately these businesses control the research .. put the most money into research and only publish studies when appear good to them and leave out the rest (and journals not liking to publish negative studies as much as positive ones, help them along. The drug companies control medicine itself (conning your doctors and offering gifts etc to encourage them along).
 

golden

Senior Member
Messages
1,831
Why stop there. Why not mention the fact that the vaccine by GlaxoSmithKline and the Pandemrix H1N1 swine flu vaccine caused serious and irreversible damage to those vaccinated.

http://www.huffingtonpost.com/2013/01/31/pandemrix-narcolepsy-swine-flu-shot-britain_n_2588859.html

http://forums.phoenixrising.me/inde...link-to-gsk-swine-flu-shot.21476/#post-327592

http://www.nbcnews.com/id/50890438/...c-says-flu-vaccine-barely-worked-over-s-year/
The flu vaccine barely worked to protect elderly people this year, and it helped prevent illness in just 56 percent of adults and children overall, federal health officials said Thursday


The flu vaccine reduced the chances of illness by just 9 percent in people over 65, the Centers for Disease Control and Prevention reports. Overall, it reduced illness by 56 percent.

Although this year’s vaccine was considered a good match for the most common circulating flu viruses, it still only provided 47 percent protection against the main virus, called H3N2, the CDC said in its weekly report on death and illness



I'm mot opposed to vaccinations per se but let's have full disclosue and transparency in all aspects of the pharma industry.

Hmmm...

http://articles.mercola.com/sites/a...dia-deceive-facts-regarding-flu-vaccine.aspx#!
 

jimells

Senior Member
Messages
2,009
Location
northern Maine
the welfare of patients seems a secondary consideration for all stakeholders

Burn this quote into your consciousness. It is the central organizing principle of the entire medical industry. It explains why the riddle of our illness will not be solved, or even seriously investigated, until long after I'm dead. It explains why the concept of "customer service" is so foreign to the medical industry that we can't even get a callback or real followup from doctors offices.

To the medical industry, insurance companies and government funding agencies are the "customers", not us. We are just a stack of insurance claims. Patients are a nuisance, an impediment to getting out on the golf course. And if a patient is poor, it's best to not let them in the door.

At this point I have completely given up on the idea that there is a doctor somewhere on the earth who will actually improve my life, beyond prescribing band-aids to cover up a few symptoms.
 

jimells

Senior Member
Messages
2,009
Location
northern Maine
It's called capitalism.

Yes indeed. I fought against it, for most of my life, until I got sick...

People of my generation have completely failed to even slow it down. I sure hope younger folks have more success, but I'm not optimistic it will be anytime soon.