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Scorecard: Guidelines for dealing with adverse events during clinical trials.

        British Government        

  

         U.S. Government         

A+

Vs

D-

In Britain, when a patient in a clinical trial held by Janssen (or any) pharmaceutical has an adverse event,  Janssen immediately and voluntarily covers all of the patient's medical and personal needs.
They start a no nonsense investigation as to whether the event was caused by the clinical trial, but either way, cover the patient's needs until the investigation is complete.
The investigation hinges on one main question.  Did the patient have the symptoms of the adverse event prior to starting the trial?  If the answer is no, then in most cases, the investigation is over.
If the adverse event proves serious and long lasting, Janssen's insurance automatically provides compensation. Period. 

Comparison of American and British pharma industry and industry association positions and practices when addressing adverse events during clinical trials.

Search results of the term "Clinical Trials Adverse Events Compensation" on the leading British and American Medical association's web sites.

Don't take our word for it. Click on either image to visit the actual site with search results.
British Clinical Trials adverse Event Compensation search results American AMA Clinical trials adverse events compensation search results

British Results: 25

American Results: 0
 
 

 

In Britain, the (BHBIA) British Healthcare Business Intelligence Association , British version of the AMA (American Medical Association) and the ABPI, The Association of British Pharmaceutical Industry worked with elected representatives and the industry itself, and simply asked Janssen and all other industry leaders. to sign a common sense set of guidelines for clinical trials.

 

  

 

  

Live Links: To visit the actual site framed, in full-screen, or download the actual document referenced, click anywhere inside the image.

  

 

  
ABPI Membership Pharmaceutical companies conducting clinical trials, following a voluntary set of guidelines for thecompensation and long term care of adverse event sufferrers

Full Membership:

The top 90% of the industry are signed members of these organizations and their guidelines.

  
     
Janssen Pharmaceuticals, volutary member of ABPI and BHBIA in Britain, sign regular guidelines for clinical trials. Included are guidelines specific to adverse event compensation and medical attention when patients in Britain experience any adverse events during clinical trials  

Janssen:

Janssen pharmaceuticals is a signed member of ABPI and The BHBIA.

  

 
Clinical Trials guidelines for biologic pharmaceutical industry. Janssen signed this agreement that follows a common sense approach to adverse events compensation and all other guidelines during clinical trials

The guidelines and agreements.

These guidelines were found on the first page of results with the simple search string "Clinical Trials Guidelines". An identiccal search on the AMA web site returned 136 documents. None of them were actual guidelines, rather reports from various meetings held by doctors.

  
Sample clinical trial agreement between Janssen biologic and Britain for clinical trial of Stelara, CNTO-1275 with adverse event compensation wording and agreement.  

The Image at left is a sample.

The identical real agreement is a simple, straight forward 30 page document that governs all aspects of clinical trials.

Click on the image to see the whole genuine document

In fact, the portion that details how adverse events are handled is only 3 pages long. (pictured and linked below, left)

  
The Clinical Trials compensation guidelines, which are easily found and agreed to by all major pharmaceutical companies who carry out clinical trials in Britain. The ABPI and NHS sponsored and developed  

Image:

The compensation for adverse events portion (left) is even separated out from the whole agreement and published as its own document on their website.

Click on the image to see the entire genuine document.

 

  
       
       

So, that is how Britain, Ireland, Scotland and Wales manages clinical trials. We found nearly identical guidelines and procedures for Canada, Australia and New Zealand. We will update you as we research other countries.

Now The USA, is another matter.

In the U.S.,when a patient in a clinical trial held by Janssen pharmaceutical has an adverse event,  Janssen is under no obligation to even provide the patient with information about the drug that ruined their life, let alone provide compensation or medical expertise.


If the patient needs any sort of information, they must file a report with the FDA, wait up to six months, then file another report with Janssen and wait for the information.

 
If the patient needs any sort of compensation due to medical costs, loss of income or suffering, their only recourse is ask the FDA and the Center for Drug Evaluation and Research Division of Scientific Investigation, to start an investigation. 
The patient must wait 180 days for an investigation to begin.


If they do choose to investigate, the patient must then prove somehow that the drug was the cause of the event.


If somehow they do prove the drug caused the event, it is 100% upon the sick or dying patient to source an attorney, convince them of the financial viability of a law suit, then wait as up to seven years to see if the suit is successful or settled.

 

Why the huge difference in how the same situation is handled in 2 countries who are considered "sister" countries?

_________________________In Britain_____________________

This agreement was sponsored by and signed by each member of the (BHBIA) and ABPI, including Janssen Pharmaceutical, because the medical associations and the government ASKED THEM TO.

_________________________In The U.S._____________________

Neither the AMA nor any elected government representative has, or will ask for the same dignity and safety for it's citizen patients as is universally done not only in Britain, but in most other countries of the world.

In particular, we are focusing on an adverse event that occurred in 2008 during a clinical trial of Janssen's now $1.4 Billion blockbuster drug Stelara. 

Please visit www.helpfortony.org/action.htm to make a difference.
Typical response from a US senator when a US citizen along with 200 sypporters, write letters to the senator's office and provide a campaign petition with 5000 signatures, including 900 signatures from the senator's own state.  

This is a real life response from Dianne Feinstein of California, written to a supporter of a US citizen who suffered a severe adverse event during a clinical trial of CNTO-1275, Now called Stelara, Janssen's $1.5 Billion /year blockbuster drug.

A typical response from a US senator when a US citizen along with 200 supporters, wrote letters to the senator's office and provided a petition with 5000 signatures, including 900 signatures from the senator's own state.