Allen Tower as seen by Pediatric Cardiologists

Re: Mr Allen Tower (NuMED Inc) Mr Jim Bessette, We understand that there is a case in progress between the US FDA and Mr Allen Tower of NuMED Inc.  We further understand that apart from financial penalties, there are possibilities of a custodial sentence.  We have grave concerns on behalf of our patients with congenital heart defects and wish to make representation to you.  Therefore, we are all signatories for the petition below and wish you to pass on our concerns to the FDA and to the magistrate dealing with this case.   1)  There is unanimous agreement amongst paediatric cardiologists around the world that Mr Allen Tower and NuMED have committed themselves to helping to provide for the desperate needs of children with congenital heart defects.  Since the late 1980s, NuMED have always acted in good faith to address these needs consistently.  They have listened to the paediatric cardiologists closely and developed products based on clinical need rather with an eye on financial profit.Mr Tower and NuMED, on grounds of sincere consideration for the quality of life for children born with congenital heart disease, decided to develop niche products, which have been life saving for the patients. These include Tyshak, Mini-Tyshak balloons, atrio-septostomy balloons, BIB balloons and bare and covered Cheatham-Platinum stents.   2)  It is a recognised fact that, except for the NuMED products, the vast majority of invasive and interventional products used in the diagnosis and treatment of congenital heart disease, were not developed for use in children.  We, as paediatric cardiologists, by necessity have had to improvise with adult equipment; a fact which, even to the lay person, will indicate that this can only be considered as suboptimal, as purely on clinical grounds, products developed specifically for use in children are considered safer than those modified from adult practice.  NuMED have fulfilled this need of paediatric cardiology consistently over the last two decades.  Other large companies have focussed their attention to adult cardiology products on financial grounds and have consistently ignored children with congenital heart disease.   3)  There are countless patients with congenital heart defects, who have benefited from the NuMED products mentioned above.  BIB balloons and Cheatham-Platinum stents are widely used all around the world.  In Europe, NuMED have complied with every legislation and the products have received the regulatory approval (CE Mark).  There are patients who have the potential for rupture of vessels such as the aorta and indeed cases of rupture and death have been reported in the literature in the past following the use of conventional balloons and stents.  The availability of the covered Cheatham-Platinum stent has been lifesaving for patients considered at high risk for this complication.  This has resulted in these devices being considered as state-of-the-art devices to the extent that there is no competition from other companies, a majority of whom have shown no interest in developing products for congenital heart defects.  4)  Mr Tower from the start has maintained his commitment to develop more specialised devices for standard and custom use, including the percutaneous pulmonary valve and the provision of unique products such as the covered stents. He, therefore, has extensive knowledge of congenital heart disease and the working practices of the catheter lab teams throughout the world. 5) Mr Tower and his dedicated and supportive team at NuMED have provided a very personal service to the paediatric cardiology community. There is hardly a paediatric cardiology team in the world, who have not benefited from his willingness to ship products without delay to treat sick and dying children, whose lives have been saved and transformed as a consequence of his actions.  Many interventional paediatric cardiologists have appreciated NuMED's willingness to modify devices for specific patient needs on a priority basis without any discussions about finances.  We perceive from this that the commercial side of his business is of considerably less importance to him than the appreciation of the individual patient needs.  6)  Mr Tower has made major contributions to the general educational support of the specialty of paediatric cardiology throughout the world. He has facilitated and supported meetings, which have embraced the breadth of highly technical small groups from local groups such as the British Congenital Cardiac Association, to more prestigious meetings in Europe and the rest of the world, something to which other larger companies have been reluctant to commit their support. His endorsement of scientific meetings has facilitated education of nurses, technicians and junior doctors who, in the current climate of Health Service funding in many parts of the world, would have not had such opportunities.  7)                 His contributions to the specialty of paediatric cardiology were appreciated by the profession to such an extent that just over two years ago, he was awarded the PICS Outstanding Achievement Award, hitherto only awarded to pioneering interventional paediatric cardiologists.  This was the first time an individual from industry was given this prestigious award, a unique recognition of his service. 8)  A law case resulting in a custodial sentence would be perceived in the rest of the world as a grave injustice, as it would jeopardise the functionality of the company and impact on its maintaining the very important contribution to saving lives of children with congenital heart defects.  It would be a devastating loss to patients requiring invasive treatment should Mr Tower be relieved of his freedom or ability to continue his work.  He is a great asset to our specialty and to our patients.  The patients are our main concern and without Mr Tower's commitment and ability to continue with developing products, our patients will be left exposed to a lack of suitable equipment to treat their defects and expose them to unnecessary increased risks from the use of equipment not specifically designed.  We believe that the patients or parents of those children all over the world, who have benefited from the use of NuMED devices would be prepared to endorse the sentiments of support expressed in this letter.  We urge you to take the above facts into consideration when making any decisions against a man whose commitment and actions have saved the lives of thousands of babies, children and adults worldwide, who, through no fault of their own, were born with congenital heart disease.