I think it is time for something I wrote a few years ago. Would love your opinions. 7/7/2013 What if the FDA was looking at Thalidomide Today? By Robert Douglas Walden I awoke this morning thinking about an encounter I had long ago, when I was 14 or 15 (1963 or 1964). At that time the Thalidomide scare had just passed, this drug had been tested on an unsuspecting public with disastrous results. But in 1962 or 1963, for most of us life was back to normal, the people of this country had been protected from the majority of the damaging effects of this drug on pregnant women and their babies. Life was not back to normal and never would be for the many children with disabilities caused by this drug. For these children, life would never be normal they would face a life greatly disadvantaged, suffering under the burden of incredibly damaged bodies. There were 10,000 of these damaged children throughout the world, we here in the United States had been spared the brunt of this man made epidemic which unfortuately Germany and some other countries were destined to face, thanks to a brave pharmacologist who had just started working at the FDA, her name was Frances Oldham Kelsey M.D., who fought Richardson-Merrells push to introduce this drug into the US. Sadly we were not spared completely, the drug had been distributed here for ‘Clinical Trials”, but there were only 17 children born in the US with “Seal Limbs” (as the abnormalities caused by Thalidomide were often described). The encounter I remember was with a victim of this drug I happened to walk by on a sunny summer day in the San Fernando Valley. I lived in Woodland Hills at the time and was walking alone in front of the Plate Ave shopping center from the Thrifty Market down towards the Thrifty Drug store. I was just passing the barber shop and liquor store when I walked by a young boy with his mother. He looked to be about 2, maybe 3 years old and was wearing a safety helmet strapped to his head. He was seated in the child seat of a shopping cart smiling as any little boy would be, enjoyed his ride. Where his arms should have been were only small fingers sprouting from his shoulders and I think his legs were malformed as well but my attention was mostly directed to his hands and head. I felt sad, I knew the story of Thalidomide, this tragedy had been in the news everywhere, everyone knew the story back then and we all knew this man made horror worked could have been avoided. This child’s future of suffering, the difficult challenges now uniquely his and that of thousands of other children whose mothers had trusted their doctor’s advice and taken Thalidomide, now all of them lived with new challenges to their daily survival. This was the legacy and the results of this inadequately tested drug, Thalidomide. This child’s life and the lives of others would never be the same as other children’s, how could they? They wouldn’t, their lives would forever be managed by other people caring for them. This terrible crippling of their lives, forced upon them through the mistakes of a mother trusting her doctor and a doctor trusting a drug company, and a drug company anxious to profit from this new “Wonder Drug”. My casually passing by this small helpless person now impacted my life and my thinking. History is such a great teacher to those who wish to understand the evolution of culture and society, the cause and effect which every change makes in the lives of people. Looking back we can see not just an action but the results of that action in the present. Obviously looking at any problem from the rubble of its aftermath is more insightful to knowing how they have improved or diminished our society. We see the entire story right up to the present with clarity of vision which easily evades those looking into the future from the past. I am not writing here against Thalidomide, it is still in use but not by pregnant women, we now have labels warning pregnant women against the use of Thalidomide. What I am trying to point out is that every action has a result, a reaction. Every change creates a new riddle of changes which cannot always be predicted along with other possible problems often not even considered, as was the case with Thalidomide. There is more to the Thalidomide story and a “what if” I chose to ask. The story in short as it happened: Thalidomide was developed by German pharmaceutical company Grunenthal obtaining a patent in 1954, in 1957 Thalidomide was proclaimed a wonder drug for insomnia, coughs, colds, and headaches, and was also effective in inhibiting morning sickness. Unfortunately in industries hast to market this new wonder drug they had not tested its effects for potential harm to the fetuses of pregnant women. In 1960 Richardson-Merrell a US company applied for approval to the FDA here in the United States, Thalidomide had already been distributed in large quantities to doctors for clinical testing on patients. Only one person stood between Richardson-Merrell’s desire to market Thalidomide in the United States, one Frances Oldham Kelsey. Not willing to rely on the limited information from Richardson-Merrell which did not include test results, she refused approval of the drug, not once but 6 times. Drug companies are if nothing else, persistent, when there is a profit to be made. The results: An estimated 10,000 children were born with Thalidomide caused deformities world wide. Frances Oldham Kelsey’s refusal did not prevent the test samples being sent out and used here in the US, but her refusal to give in to Richardson-Merrell’s application and give it FDA approval without proper testing resulted, lead to only 17 of those 10,000 children being born here in the US with Thalidomide deformities. In 1962 in recognition of her great service to the nation John F. Kennedy awarded Frances Oldham Kelsey the Presidents Award for Distinguished Federal Civilian Service. She had saved 100’s if not 1,000’s of American newborn children’s lives from being ruined by this new “wonder drug”. This story had a relatively happy ending, few of our citizens were damaged and Thalidomide was not allowed to be pushed into mass marketing and distribution. Now I ask, what might have happened if in 1960 under the current deregulating administrative practices of the US? With a deputy commissioner reviewing the request who has divided loyalties because from time to time he is employed by and gets a big pay check from the industry he is expected to regulate and protect us from? “What if” we had the same kind of crony, swinging door staff in the FDA, a congress which strongly supports a company’s rights over the people’s well being and a SCOTUS with overly strong leanings towards business as we do today back in 1960 instead of Frances Oldham Kelsey? That is the “what if” I am to ask now. What if for instance it had been the favored corporation Monsanto asking for approval? With both houses of congress and members of both parties showing favoritism towards Monsanto through laws and very lax regulations, the SCOTUS showing favoritism in its legal findings and with Michael Taylor an ex and most likely future employee of Monsanto as a deputy commissioner to the FDA (“Taylor has moved for decades between working for Monsanto, the FDA and the USDA” ~ Wikipedia). Would this product today have been stopped in its tracks without the needed testing or would it have received fast track approval and hit the shelves as the new “Wonder Drug” it was proclaimed to be in 1957, then distributed and prescribe by doctors across the land? If so we know this story would have had a more tragic ending for our nation. The nation would have been peppered with human tragedy from one end to the other. Fortunately we will never know this ending because a fellow citizen stood up for us all and refused to compromise the regulations designed for the protection of our people. But here now reside my concerns. We have educated people who voice concerns and yet are ignored by less knowledgeable politicians: “Nine FDA scientists appealed to then president-elect Barack Obama over pressures from management, experienced during the George W. Bush presidency, to manipulate data, including in relation to the review process for medical devices. Characterized as corrupted and distorted by current FDA managers, thereby placing the American people at risk, these concerns were also highlighted in the 2006 report on the agency as well.” ~ Wikipedia. “However, in an indicator that the FDA may be too lax in their approval process, in particular for medical devices, a 2011 study by Dr. Diana Zuckerman and Paul Brown of the National Research Center for Women and Families, and Dr. Steven Nissen of the Cleveland Clinic, published in the Archives of Internal Medicine, showed that most medical devices recalled in the last five years for serious health problems or death had been previously approved by the FDA using the less stringent, and cheaper, 510(k) process. In a few cases the devices had been deemed so low-risk that they did not need FDA regulation. Of the 113 devices recalled, 35 were for cardiovascular health purposes.”” ~ Wikipedia en.wikipedia.org/wiki/Food_and_Drug_Administration So what would happen today if it were Monsanto applying for approval of Thalidomide and Michael Taylor were making the big decision as to approve or not, would we be protected from such a disaster again? Michael Taylor is a deputy commissioner of the FDA, with mixed loyalties as a sometimes employee of Monsanto, the FDA and the USDA. Again I ask if he would have the personal integrity not to approve something that was deemed to have been inadequately tested. We can’t know, but a shadow falls upon the land, the SCOTUS gives support to Monsanto’s law suits against farmers, often after the farmer has been damaged by Monsanto’s genetically modified products. We watch as legislation specifically favoring Monsanto passes both houses of congress by both parties. We have to wonder what dangers are being introduced into our food supply as other nations legislate against GMO’s. In our nation information is more often kept secret from us to protect the guilty, to preventing our knowing, our having a chance to make some kind of informed choice. Protective laws are passed to prevent our knowing while even our smallest request for labeling is denied. We know the goals of every industry in the US, it is to get new products into production as soon as possible, regardless, this attitude might be good for industry but it is not the wisest or safest course for our people. Might more independent commissioners, agencies not headed by those with confused allegiances save us a safer future and save us from needless suffering? GMO’s are rapidly altering the structure of our food stuff at a genetic level, foods that humans have adapted to over many millennia. Toxins that plants produce to protect themselves from insects are being genetically increased, the speed of growth is being genetically increased, size, shape and taste are being altered and what effect these changes will have on some or all of our people can only be guessed at, possibly new allergies or toxic effects, like peanuts for some people. Meanwhile those manufacturing GMO’s are only concerned with its production; the speed of growth, the ease of getting it to market all nice and pretty in the greatest volume possible, but all boils down to two things that really concern companies, the control of the product (preferably a monopoly) and the profits from the patent monopoly rights (something cheap to make that can be sold for a lot). In truth though, there is only one real concern, profits. Profits above all else. The wreckage left behind was just the cost of doing business and if it is big enough a disaster the government can pick it up for you. As long as there is a bigger pile of money in the bank after the dust settles than there was at the beginning, then it was a good deal. For the corporation we have enshrined in law the mandate to maximize profits, this without any concern for well being of anything else. This one clause of incorporation is the demon which haunts us, harms us and will destroy us if we allow the amoral behavior it brings to the market place to continue. It justifies criminal behavior of CEO’s and board members who without responsibility, protected by the amoral corporate entity from responsibility for their choices (and I really don’t understand how they get this privilege) which effect us and our nation and under these prescriptions they manipulate their product, their customers, their labor and our government to one end, greater profits at a cost to everything else. I ask you today, how does this serve us? And how might it have changed what happened to us in 1960? It makes a certain sense to look to successful people in industry for advice on matters pertaining to that industry, but to the point of allowing them to head those regulatory agencies which protect our people from their manipulations. In a nation within which the economic system is based on greed, the greediest rise to the top. The system we have allowed to grow here, within which fraud, cheating and swindling are all business practices upon which no justice system seems willing to tread in the pursuit of justice for the people. In such a system who really can be trusted? Those who benefit from their own decisions? How are we to find the unique people with honesty and integrity who have served us in the past? These important traits seem to have vanished from our political system as well as our economic system and become highly managed by the corporations these industrial politicians rely on to finance their campaigns. It is becoming increasingly obvious we the people can trust no political party to do the right thing for the people of this nation. They are bought before they are even voted on. As politicians and corporations work in collusion ignoring concerns of scientists and many of our people. All the while industry uses similar science to change a known into an unknown with unknown consequences to the world around us. Do we have to sit silently by and wait for the next Thalidomide disaster?
Posted on: Thu, 23 Jan 2014 04:07:26 +0000
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