C . A . G . E .
Citizens Against Government Encroachment -- Citoyens Anti Gouvernement Envahissant
 

 

 

 

NICOTINE REPLACEMENT THERAPY


Somehow, elected representatives in both the U.S. and the Canadian federal governments have gotten it into their heads that it is safer for pregnant mothers be forced to receive a newly developed and expensive Nicotine Replacement Therapy (NRT) then to allow her to decide for herself if she will quit smoking, reduce her smoking, or continue.

Never mind that this therapy has not yet been adequately tested nor monitored on willing recipients. Once again, a well-paid pharmaceutical lobbyist has convinced some overpaid government technocrats that this makes sense. Well, we know it makes sense for the pharmaceutical company that has a guaranteed sale for every smoker who gets pregnant.

Below you have the paper trail being created by a C.A.G.E. member as she tries to raise some warning flags about this hair-brained, highly invasive and possibly dangerous scheme.

Enjoy the ride, as round-and-round we go!


 

First attempt - January 9, 2007 – Letter to the research ethics board at Health Canada:

To the Research Ethics Board

 

We are hearing more and more talk about experimenting with nicotine replacement treatment (NRT) on pregnant women.  The University of Calgary and Manitoba are conducting studies in animals using NRT and state that the next step is testing them on pregnant women.  Although these preliminary results are inconclusive, doctors may be encouraged to suggest to expecting mothers unable to give up their habit, to switch to NRT.  Case in point, we have recently read about Australian medical authorities giving pregnant mothers two weeks to give up smoking after they become pregnant, or be prescribed NRT. 

Using nicotine replacement therapy (NRT) in early pregnancy increases the risk of birth defects, according to data from a study published in the January issue of Obstetrics and Gynecology.  In view of the facts that NRT has not been around long enough for responsible scientists to draw any conclusions about its effects from real life experience rather than theories and statistics, and that children are in reality experiencing more health problems today, particularly asthma and respiratory problems, than they did in the 60’s, 70’s and 80’s when smoking was far more prevalent among pregnant women and in the population in general, we consider experimentation with NRT in pregnant women at this stage to be premature, dangerous and irresponsible. 

We are well aware that the pharmaceutical industry finances many of the epidemiological studies and that an ever increasing body of scientists are very concerned about biases due to the funding sources.  We are equally aware that the pharmaceutical lobby is very powerful and ready to create increasing opportunities to sell their products in the present hostile context to anything that has to do with smoking.  In light of these facts we wish by the present notice to caution Health Canada about this issue and demand that they seek independent scientists to conduct unbiased studies before experimenting with NRT on pregnant women. 

We hereby also request that Health Canada indicate to us in writing what steps will be taken to avoid potential harm done to pregnant mothers and their infants through a premature approval of the testing of NRT on these civilians.

References:  http://www.pjonline.com/editorial/20060107/news/p3pregnancy.html

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=529272

http://www.motherisk.org/JFAS_documents/JFAS_6003_e4.pdf

http://www.news.com.au/story/0,23599,20953951-36398,00.html

 


 

When we saw we were not getting any acknowledgement or reply, we sent a 2nd request on February 20th:

To the Research Ethics Board

 

In reference to the request we sent you on January 9th of this year, and to which we never received an acknowledgement to our concerns nor Health Canada's policies on this issue, we hereby bring to your attention a new study that just appeared urging against nicotine replacement therapy used on pregnant women. 

J Health Psychol 2007; 12; 215   Rolf Schulte-Hermann and Theodore A. Slotkin  K. H. Ginzel, Gert S. Maritz, David F. Marks, Manfred Neuberger, Jim. R. Pauly, John R. Polito,

Critical Review: Nicotine for the Fetus, the Infant and the Adolescent? which is published in the Journal of Health Psychology at: http://hpq.sagepub.com/cgi/content/abstract/12/2/215

We once again urge Health Canada's Research Ethics Board to give this matter a priority attention before testing on pregnant women begins and doctors make it the ''norm'' to prescribe NRT to expectant mothers.  


 

They replied on February 21st.

Would you kindly redirect your request to the following Health Canada
programme:
                                                                             
                                                                             
 Tobacco Control Programme                                                  
 P.L. 3507A1                                                                
 Ottawa , Canada                                                            
 K1A 0K9                                                                    
                                                                            
                                                                            
 Telephone:                                                                 
                                                                            
                                                                            
 1-866-318-1116 (staffed Monday through Friday 8am to 4pm ET; voice-mail    
 available at all other times)                                              
                                                                            
                                                                            
 Fax:                                                                       
                                                                            
                                                                            
 (613) 954-2284                                                             
                                                                            
                                                                            
 E-mail:                                                                    
                                                                            
                                                                            
 
TCP-PLT-questions@hc-sc.gc.ca                                               
                                                                             
                                                                            
Have a great day, Yvette



Yvette Parent
Senior REB Officer
L' agente principale du CER
Research Ethics Board
Comité d'éthique de la recherche
Office of the Chief Scientist
Bureau de l'Expert scientifique en chef
#410 - 1600 Scott, Ottawa, ON K1A 0K9
(613) 941-5199
Fax: (613) 948-6781
Web:
http://www.healthcanada.gc.ca/reb
http://www.santecanada.gc.ca/cer


 

So we then turned around and on the same day (February 21st) we sent a letter to the Tobacco Control Program in Ottawa:

Sir/Madam, 

 

We have recently expressed legitimate concerns on the use of nicotine replacement therapy on pregnant women to the Research Ethics Board at Health Canada. 

 

We received a reply from them today advising us that our concerns should be addressed to the Tobacco Control Health program, therefor we are forwarding to you the original correspondance on the issue as it appears below.  

 

We hope that our requests will be given your prompt attention as we are sure you will agree that the issue at hand is one of utmost importance. 


Par for the course, we didn’t get any acknowledgement or reply so we sent a second request on April 10th:

Sir/Madam,

 

We are yet to receive a reply to our e-mail dated February 21st that you will find hereafter.  Perhaps our e-mail has been misplaced or deleted in error? 


We received a reply the following day (April 11th) that read as follows:

Thank you for your email in regards to Nicotine Replacement Therapy and
pregnancy.

The Tobacco Control Programme is responsible for the administration and
enforcement of the Tobacco Act  which governs the manufacture, sale,
labelling and promotion of tobacco products.  Therefore, I have forwarded
your email to Health Canada's Office of Clinical Trials.

We sincerely apologize for the delay in responding.

Regards,

Suzie
A/Information Officer
Health Canada
Tobacco Control Programme
Tel.:  (866) 318-1116
www.gosmokefree.ca


On May 7th, Mr. Yadvinder Bhuller, Manager - Clinical Group II/, Office of Clinical Trials, sent us the following message which in essence does not answer our questions.  It only gives us the general guidelines of procedures before clinical trials are given the green light.  We still don’t know if independent research was conducted and if clinical trials were indeed approved.  To trust our doctor, is about all we can make out of this e-mail.  It does not tell us on who’s information our doctor relies, or if there was conflict of interest involved.   We are presently still trying to determine how and to who we can address our questions so that we can get a clear answer. 

 

As per my v-message, your original email was re-directed to my attention

and I do apologize for the delay in providing you with a response. With

respect to your inquiry, please note that Health Canada oversees the

regulation of health products at the federal level, which includes

regulating clinical trials, authorizing the sale of a product for the

Canadian market and emergency treatment via the special access programme

(SAP).  In addition, HC also ensures that the product monograph and label

have all the relevant information such that the consumer can make an

informed choice.  Using nicotine replacement therapies (NRT) as an example,

the use of all marketed non-prescription NRT that currently hold DINs

(e.g. gum, inhaler and patch) are contraindicated for use in pregnant or

nursing women.  Additionally, product monographs for these products advise

women of childbearing age to take adequate precautions to avoid becoming

pregnant while using these products.

 

Please note that while it is generally recognized that smoking is worse

than nicotine alone, no safe dose of nicotine in pregnant women has been

established.  Therefore, pregnant women should be encouraged to use

behavioural approaches before considering taking NRT's. However, if

pregnant women who smoke do use NRTs as an aid to quitting smoking, they

should be apprised of the potential hazard to the fetus, within or outside

a clinical trial setting.  For the later, the decision to use NRTs during

pregnancy should be made in consultation with a health care provider and

should consider the relative risks and benefits of using NRTs.

Furthermore, a physician's decision to use a particular product, such as

NRT, in the treatment of an individual who has a specific condition is part

of the "practice of medicine," which is an area regulated by the local,

provincial college of physicians and surgeons.

 

With respect to clinical trials, under the Canadian clinical trial

regulations, prior to initiating a clinical trial a sponsor must submit a

clinical trial application to Health Canada for review and authorization.

As you probably are aware, clinical trials are conducted to investigate

whether the use of a drug is safe and effective, what dosages are most

effective and what side effects may be associated with the use of the drug

in humans.  However, I am not certain if you are aware of the clinical

trial application process and thus, I have briefly described it below for

your convenience:

 

   Under the current regulations governing clinical trials in Canada, a

   scientific review of all clinical trial applications is required, by

   Health Canada, before a drug can be sold or imported by a sponsor for

   use in a trial.  Health Canada evaluates the appropriateness of all the

   available evidence for the safety, efficacy and quality of the product

   and the design of the trial protocol that is provided in a clinical

   trial application.  The main objective of this review is to ensure that

   the sponsor has the appropriate parameters in the application such that

   known risks to participants are: identified and minimized; detailed and

   communicated via the Informed Consent Form; detailed in the

   Investigator’s Brochure; and are acceptable within the context of the

   medical condition to be treated, the alternative treatments available,

   and study population identified in the protocol;

 

   Health Canada or more specifically the Minister will only authorize the

   sponsor to sell or import the product for the purposes of a clinical

   trial if the Minister has reasonable grounds to believe, based on the

   assessment of the application and all related information, that the use

   of the product in the trial will not endanger the health of a clinical

   trial subject or other person, that the clinical trial is not contrary

   to the best interests of the clinical trial subjects, and that the

   objectives of the clinical trial will be achieved;

 

   Health Canada is not responsible for evaluating the ethics of clinical

   trials or conducting the trial.  However, part of the regulations also

   includes the requirement that a sponsor obtains ethics approval for all

   trials from a properly constituted Research Ethics Board (REB) prior to

   initiating the study; and

 

   It is also the sponsor’s responsibility to conduct the trial in

   accordance to the regulations and the principles set forth in the

   internationally recognized ICH Good Clinical Practices Guidelines.  This

   would include, but is not limited to having a qualified investigator

   (i.e. a physician) who is responsible for all trial-related medical

   decisions including obtaining the informed consent of trial

   participants.

 

Finally, I hope the information provided above identifies the 'steps' that

Health Canada takes in order to review a clinical trial application and

also in relation to your concerns related to NRT.  However, should you have

any additional questions, please do not hesitate to contact me directly.

 

Kind regards,

 

Yadvinder Bhuller

________________________

 

Manager - Clinical Group II/

Gestionnaire,

Programme des essais cliniques Groupe II,

Office of Clinical Trials / Bureau des essais cliniques,

5th Floor, Holland Cross,Tower B /

5ième étage,Holland Cross, Tour B,

AL 3105A OTTAWA K1A 0K9

 

Tel: 613-941-0570

Fax: 613-952-9656


 On May 15, 2007, we addressed our questions to Health Minister Tony Clement as follows:

Sent: Tuesday, May 15, 2007 12:13 AM
Subject: For Mr. Tony Clement - Minister of Health

 Dear Mr. Clement,

On January 9th of this year, after reading that there were serious intentions to conduct clinical trial tests on nicotine replacement therapy on pregnant women and having seen studies that show that the risk factors of these therapies are more dangerous to the fetus than smoking itself, we alerted Health Canada asking for their vigilance on the matter. Knowing how influential the pharmaceutical industry has become through their grants for studies and how conflicting their interests are in the tobacco issue, we demanded that Health Canada makes sure that independent scientists conduct serious studies before giving the go ahead for these clinical tests.

After having been given the run around treatment by different departments at Health Canada as you will see by our following correspondence with the different agencies, it appears we finally got the right department to acknowledge our concerns, in the person of Mr. Yadvinder Bhuller. However, as you can see from his letter below, what he has outlined to us does not answer any of our questions.

We are at this point left with no other alternative than to get you involved in this issue. Our questions and concerns are the following:

1) Has Health Canada approved clinical trials for nicotine replacement treatment on pregnant women?

2) If so, on which studies has this decision been based?

3) Who funded these studies?

4) Has Health Canada taken serious considerations of the expert opinions and studies that do not recommend the use of nicotine replacement therapies on pregnant women?

We dare hope Mr. Clement, that this matter will be given all the attention it deserves.


 On May 27th we reminded him that we were still waiting for an answer:

Dear Mr. Clement,
We are yet to receive an answer or even an acknowledgement that you have received our letter.  Can you please advise when we can expect to hear from you.
Thank you


Well here you have it folks, on June 25th we finally received a reply.  We had to climb the hierarchy all the way up to our elected health minister Tony Clement, to be told that the information we are seeking is confidential and the only way we can get it is through the manufacturer of the nicotine replacement products!  We are totally appalled by such a policy.  The fate of our pregnant women is in the hands of the bureaucrats and the manufacturers of the products they sell, but it’s confidential to us the public.  After all it only concerns our health, why should it be our business?    Copy of the letter he has sent us will be posted on our server in the near future.  Following is a transcript of what the Chief of Staff from the Office of the Minister of Health has responded:

 

Thank you for your correspondence of May 15 and 27, 2007, addressed to the Honourable Tony Clement, Minister of Health, concerning clinical trial tests for nicotine replacement treatment (NRT) on pregnant mothers.  

 

Information related to clinical trial is confidential.  I suggest that you contact the manufacturer in order to get a response to your question about any trials for NRT on pregnant women.  I must point out however, that under the current regulations governing clinical trials in Canada, a sponsor is not required to identify the source of funding for the trial.  For more information related to the clinical trial application process, please refer to the clinical trials e-manual at http://www.hc-sc.gc.ca/dhp-mps/prodhparma/applic-demande/guide-ld/clini/cta_intro_e.html .

 

I would also like to refer you to the information provided to you by Mr. Yadvinder Bhuller in an e-mail dated May 7, 2007. 

Thank you for writing. 

 

Sincerely,

William King

Chief of Staff