Dr. David Healy, автор книги Pharmageddon (Pharmaceutical companies have hijacked healthcare in America, and the results are life-threatening) опубликовал важный призыв ко всем врачам и пациентам — действовать против сокрытия информации. Как вы знаете, сейчас идет борьба за раскрытие информации, полученной в клинических испытаниях. В то время как одни фармкомпании пытаются предложить промежуточные варианты, почти полное, постепенно, ограниченное раскрытие информации, другие — в первую очередь AbbVie (получающая большие прибыли от продажи humira) противодействуют напрямую, подав иск в европейский суд против EMEA (европейского лекарственного агентства).  Оригинал на (http://davidhealy.org/abbvie/).

Lets do the AbbVie again.

July 15, 2013 1 Comment

The idea of a Boycott is an Irish invention. During the Land Wars in 1880, when Colonel Boycott on behalf of Lord Erne unscrupulously evicted tenants who didn’t pay rent following a bad harvest, no one moved in to rent the vacant farms. Everyone refused to talk to Boycott. He was ostracised completely. The tactic worked so well that within months the Times of London was talking about Boycotts as a form of protest. A new non-violent form of resistance was born.

As outlined in Witty A: Report to the President, the structure and functions of company boards means that the only thing a Pharmaceutical Company behaving egregiously has ever listened to has been a Boycott.

Humira: Half-Truths by Billiam James

AbbVieing is the opposite of Boycotting

It’s time for another invention – the AbbVie. AbbVieing is named after the pharmaceutical company AbbVie (NYSE:ABBV) — the recent spun-off entity of  Abbott Laboratories. It is almost the opposite of Boycotting. Far from shunning and not mentioning AbbVie or their drugs, we call on everyone taking an AbbVie or InterMune drug, listed below, to talk loudly about them by reporting to RxISK.org any side effects they may be having on these medications. We want you to talk about these drugs and to their companies.

We need to AbbVie to undo company AbbVieCating. AbbVieCating is marketing under the banner of science without adhering to the norms of science.

In 2010 Peter Goetszche from Copenhagen who took a case for access to clinical trial data to the European ombudsman won a ruling that the European Medicine’s Agency (EMA) should make the data from clinical trials submitted to them for regulatory purposes generally available. This was a wonderful breakthrough. Last November EMA convened meetings to work out the ground rules for what was expected to be the new way of doing things.

This is not a European issue. More Americans applied for data from EMA than anyone else. This is a global issue. Americans and Canadians stand to lose more than anyone if access gets overturned.

In February, a legal action was taken in the European Court against EMA’s data access by two American companies. AbbVie Inc. (NYSE:  ABBV) —which is the former medicine’s division of Abbott – and InterMune Inc. (NYSE: ITMN). Other companies like GSK came out offering something sold as transparency but in fact possibly a more devious form of AbbVieCation. (C-389/13 P, EMA v. AbbVie, C-390/13 P, EMA v. InterMune U.K. and Others).

The risks to patients and science were so high that in a post at the end of April Brand Fascism I suggested we might be better off if access to trial data was blocked – at least that way we might more easily be able to see what we are up against.  The same day the European Court issued an interim judgement, in favor of AbbVie and InterMune , suspending data access. (This decision was appealed July 5 by EMA).

AbbVie applied to block access to two clinical study reports that focused on the safety and efficacy of their blockbuster Humira, responsible for 70% of the company’s profits. The reports were on its use for the treatment of Crohn’s disease. Another clinical study report concerned safety risks linked to combinations of Humira and corticosteroids. This is an AbbViecation from scientific norms. Just as Roche did with Tamiflu, AbbVie expects to be able to get insurance companies and governments to cough up huge amounts of money supposedly because the science shows a favorable risk benefit ratio – when in fact they want the data buried where the sun don’t shine.

In InterMune’s case, the company took issue with disclosure of data on its new drug Esbriet, an anti-inflammatory drug it hopes to push for the treatment of a lethal – largely drug induced condition – idiopathic pulmonary fibrosis. Esbriet might weirdly become the first drug to become a blockbuster out of managing an adverse effect caused by other drugs.

A breach of privacy?

AbbVie and InterMune have claimed that the decision to provide access to all non-clinical and clinical data violates their ‘fundamental right to the protection of confidential commercial information’, and their ‘legitimate expectations’, and copyrights they hold. The bottom line is company rights to privacy are being breached.

There was widespread dismay when the interim ruling of the Court supported the companies and when access to clinical trial data was suspended – at least temporarily.

The final ruling from the European Court will take time – months perhaps longer. The pharmaceutical manufacturers associations of the US and Europe have weighed in in support of the companies. The forces arguing for access have far less fire-power or resources. Few if any have the resources or legal standing to participate in this case. But there is something that everyone reading this post can do. You can AbbVie.

How to AbbVie: Step 1.

If you are taking, or know anyone who is on:

Depakote (another AbbVie drug, for which the company was fined $1.3 Billion for mismarketing).
Kaletra (for HIV/AIDs)
Androgrel for low Testosterone
Lupron used for prostate cancer, breast cancer and endometriosis

Report any events happening on these drugs to RxISK.org by clicking on the name of the drug. This will take you to the research pages for the drug. The drug name will be automatically entered when you click on Report a Drug Side Effect from the research pages. An exception is for Androgel which needs to be entered manually and for which there is no research pages yet. For Androgel, you will be taken directly to the reporting page.

Disease mongering & successful marketing

Humira, adalimumab, is a Monoclonal Antibody (MAB) used for the treatment of arthritis, Crohn’s disease and other auto-immune conditions. This and other “MABs” and “biologicals” such as Remicade, Enbrel, Erbitux, Prolia, Simponi, Tysabri, Herceptin and others can be wonderful and life transforming for sufferers of Rheumatoid Arthritis, Crohn’s Disease and other conditions, including some cancers.

These are medicines we need. But as with disease mongering for less important medicines, the companies producing MABs have been very good at producing advertisements showing fit young men who might have a back twinge at the end of a game of squash, planting the suggestion that this might be ankylosing spondylitis, and you just ask your doctor. None better at marketing than AbbVie.

The marketing has been so good that in many places this drug has become the frontline treatment for rheumatoid arthritis or Crohn’s disease – with young patients ending up on it rather than looking to lifestyle approaches or trying safer drugs after their very first clinic visit.

The rub is safety. Just like AIDS, Humira can affect the immune system and can activate dormant infections like Tuberculosis, Candidiasis,  Histoplasmosis, Cryptosporidium, Cytomegalovirus, Toxoplasmosis – names last heard with any frequency in the early days of the HIV epidemic. Humira and other MABs can cause a range of cancers including lymphomas and the cancer that AIDs made famous – Kaposi’s sarcoma.

Go into RxISK.org, enter Humira, and look under the Reported Side effects tab.

The Tag Clouds for Humira at the bottom of this post – come up under the Frequency and Severity tab.

All the side effects including Kaposi’s Sarcoma come up under the A-Z Side Effects tab.

Using the Location tab you can see where these come from.

How AbbVieCation affects you

There are many of us with bad Rheumatoid Arthritis or Crohn’s Disease who would gladly take these risks, especially if the drug produced a real benefit. We might be much less inclined to do for milder conditions. But in all cases the trade-off should be ours. Ideally we should be helped by our doctors and pharmacists, but doctors and pharmacists who truly know what the problems can be.

When AbbVie hide their clinical trial data, they make anyone who was involved in a clinical trial of their drug or a doctor prescribing it or pharmacist dispensing it into a potential accomplice to injury and perhaps homicide because the missing data is used to argue that ‘we’ve done trials and look there is no risk’.

There are more ways to establish whether drugs cause a problem than through clinical trials. We can put on the map what it is that AbbVie and InterMune are seeking to hide. If we mobilize quickly we might be able to provide data that the European Court will be forced to take into account.

AbbVieing is the opposite to Boycotting. We want you to pay close attention to these drugs – shine a spotlight on them – and communicate with them and each other rather than shun them. Step up as AIDs activists once did and ask the company ‘Can We Talk’.

If you are part of a patient organization dealing with Crohn’s Disease or Ulcerative Colitis, Arthritis, Psoriasis, Multiple Sclerosis or other conditions you may be able to spread the word rapidly and mobilize many people.

A good medicine is a chemical plus good information

Unlike the tenant farmers who had to endure the hardship of not earning a living off Boycott’s farms, doing the AbbVie will not hamper your treatment or access to treatment in any way. Just the opposite – it will improve your treatment. A good medicine is a chemical plus good information. AbbVie want to degrade the quality of your medicine in particular and all our medicines in general. We need to help them have better medicines – despite themselves.

How to AbbVie: Step 2

To AbbVie, go into RxISK.org.

File a report on any adverse events you have had on treatment on these or other Biologicals.

If possible outline the economic impact of these events.

Generate a RxISK Report and take it to your doctor or pharmacist.

Letting your doctor know this is about two things. One is is about an adverse event you may be having on treatment that you want help with. The second is about company behavior that she more than anyone else is well placed to influence. She can do this by adding to your report and filing reports on other patients she sees or encouraging them to file reports.

As soon as reports come in to us, we will create HeatMaps showing where the reports are coming from and this may help generate media stories that will put a campaign on the map. We will post these HeatMaps at regular intervals and at all times the data will be available for free

Wherever you come from write anywhere on your RxISK report or email us if you want us to include your name in a petition we will make available to Guido Rasi, Executive Director of the European Medicines Agency, supporting him in his action to get  the Court to uphold the ruling of the European Ombudsman that there should be access to clinical trial data. The Adverse Effects  are the most global issue in healthcare, and companies are doing all they can to silo countries off from each other.  We need a global response.

Humira Heatmap

Humira 1

Humira 2

Humira 3

Humira 4

Illustration: Humira: Half-Truths, © 2013 created by Billiam James