I Want a New Drug

I recently watched a heartbreaking documentary about thalidomide and the devastating birth defects if spawned in the late 1950s and early 1960s. Some 10,000 children worldwide were affected, half of those in West Germany where the drug was first patented and most widely used. I was appalled to learn that the man who created thalidomide was a known Nazi doctor whose past, like that of so many men making their way in various occupations after the Second World War, was completely overlooked for the sake of expediency. The US alone secretly gave safe haven to an estimated 1,600 Nazi scientists, engineers and technicians after the war, most notably Warner Von Braun, the Nazi rocket scientist who got America to the moon before the Russians.

I don’t have room to get into the whole Nazi mishegoss here, so I’ll continue with thalidomide. The number of children affected was horrifying, but would have been far greater were it not for one woman. Frances Oldham Kelsey worked for the American Food and Drug Administration. The US drug manufacturer and distributor Richardson-Merrell was very keen to get thalidomide approved, as it had been a huge cash cow in Germany and England. Mrs. Oldham Kelsey, feeling that their proposal contained questionable science, said no. By the end of 1960 the company had submitted six requests to have the drug sanctioned, but as they still had not done adequate testing in Mrs. Oldham Kelsey’s estimation, she said no six times. Imagine, one lowly FDA official withstood the wrath and pressure of a large and powerful company for the sake of her morals, and in the process saved countless Americans enormous suffering and their health care system massive expense. Mrs. Oldham Kelsey’s contribution was acknowledged with the Presidential Award for Distinguished Service, the highest honour an American civilian can receive.

In those countries where thalidomide was approved (including Canada), it was responsible for many horrible outcomes such as the deformed and missing limbs for which it is infamous, and also for many newborn deaths. A lot were stillborn, but parents and health care professionals in the documentary who were in the delivery rooms at the time heavily intimated that some deformed babies were allowed to die after birth or, and this is where they became more evasive, were actively killed. The thinking was that the children’s deformities were so profound as to preclude them from any semblance of a normal life and therefore they were better off out of it. I try not to judge these people as society was very different then, and the best these children could hope for given the times was a solitary life in a locked institution.

It turns out that drugs were only tested on lab animals in the 1950s, with no clear protocol for human testing. Not only that, but doctors truly believed that nothing the mother ingested could cross the placental barrier and therefore there was no way a drug taken to control morning sickness could possibly have any bearing on fetal development. In other words, thalidomide met all of the existing medical and legal requirements.

Now there are more stringent protocols in place before drugs are approved, including double-blind human experiments, but I would argue from personal experience that the criteria still fall short of adequacy. About six years ago I started experiencing a weird, stinging pain in my shins and forearms. I went to my doctor, who was baffled and sent me to a rheumatologist in case it was arthritis or some other autoimmune disease. When he found nothing I was send to an OB-GYN in case my symptoms were related to perimenopause, and she found nothing.

A month later the burning pain had spread over my entire body, and I mean entire, from the tips of my toes up to my ears, which stung so badly I wanted to rip them off! A couple other horrifying symptoms had kicked in as well because I now had intractable insomnia and crippling nausea. My doctor was perplexed but suggested that maybe they were side effects of the statin I was taking to lower my cholesterol. My pain was clearly nerve related and statins were mostly associated with muscle pain, but I was ready to try anything. I subsequently stopped taking my Crestor, and when I saw the doctor two weeks later with my symptoms as bad as ever, he said I would be noticing a difference if the drug was responsible. The search for a cause continued.

By this time I was desperate for help and booked an appointment with a doctor of Chinese medicine recommended by a colleague. There were two things this doctor did for which I will be eternally grateful. First, our initial appointment was a full ninety minutes, meaning I had time to go into all the details of my illness and was really heard. It is hard to articulate how very healing it is to have a medical professional’s full attention and concern for an extended period. Second, she gave me a book and a couple videos about cholesterol and statins. She firmly believed that all of my problems stemmed from the Crestor.

I greedily consumed everything she gave me and was convinced by the end of it that she was right. The incredible revelation for me in all of that research was that the governmental agencies responsible for approving new drugs in the States and here in Canada base their decisions on science provided by the pharmaceutical companies themselves. No independent corroboration is necessary. The statin documentaries I watched featured several European scientists who worked for unaffiliated labs, all of whom said that they could find no evidence that there is a clear link between elevated cholesterol and heart disease (as the pharmaceutical companies had claimed).

Which brings me to the current and most devastating legal drug catastrophe – the opioid epidemic. Right now in the States there is an opioid overdose every nineteen minutes, and this legally prescribed drug accounts for more deaths than heroin and cocaine combined. The thing is, however, this is the third opioid addiction crisis the US has faced in the past one hundred years. The first came around the turn of the last century when they put heroin in children’s cough syrup, and the second came home with returning Vietnam soldiers. This means the powers that be were well aware of the highly addictive nature of opioids, or at least could easily have found it out had they asked any addiction specialist or looked at their own recent history, yet they blithely accepted Purdue’s claim that this miracle drug was not addictive and consequently unleashed a tsunami of heartbreak and death on their citizenry.

Heart disease continues to be the number one killer in North America despite statins having been used for the past twenty five years, which begs the question of their efficacy. They certainly bring down cholesterol, but to what end? I maintain that the only reason they are still on the market is because the statin industry rakes in $29 billion a year. I personally endured two years of debilitating symptoms because of this drug and hold the government bodies charged with overseeing the licensing of new pharmaceuticals responsible. There is no way they are being sufficiently rigorous when they base their decisions on self-serving corporate science. I also feel for the many millions of others who have experienced similar or worse health problems because of this shortfall in due diligence, as well as those suffering because of the opioid epidemic. Surely the legislation regarding drug licensing needs to be augmented to include independent verification of the drug companies’ findings concerning any medicine they put forward for approval.