The Truth is Out There
Just brought Jacob to his first austism assesment. He visited with a speech therapist, behavioral therapist, and my favorite; the psychologist. I spent over an hour discussing my concerns with Jacob with her.
I explained that I was on antidepressants throughout my pregnancy with him. He was a severe low birth rate baby. He was unresponsive at birth. His 10 days in NICU in the oxygen enriched environment to keep him alive. I even gave her a copy of his birth record and subsequent hospital stay for all his issues. Mostly regarding his problem absorbing oxygen and losing conciousness. All the symptoms point directly to PPHN, a side effect of exposure to antidepressants within the womb. My fear that the lack of oxygen to his brain may have caused some permanent brain damage.
She was listening very well until I let her know my concerns about it being PPHN and that his sleep problems all tie into my exposing my baby to antidepressants. This “professional” told me she never heard of any links of birth and or child problems with exposure to antidepressants. I asked her if she knew of the links to illigal street drugs and the neonate? Of course she had. Has she heard that these illicit drugs pass through to the baby? Of course she has. But she couldn’t understand that if those drugs pass through to the baby, that legal drugs do too. Then she let me know that there is no evidence they are harmful. Really? Where is she getting her information? The drug rep? She told me that we have to take into consideration that the benefits outweigh the risks. I know I’ve said that if someone else said that to me I would punch them in the face. And I really wanted to. But I don’t need an assuault charge. I told her I know all too well what the risks are. But nobody can give me scientific proof of the benefits. She tried backpedaling that she doesn’t know too much about Effexor and that she heard that Wellbutrin was the safest to take while pregnant. Now I can’t seem to wrap my brain around professionals, choosing medication based solely on what gives their patient the least amount of side effects. How about meds that are safe and actually work? She tried to explain to me that if the drugs were not safe, they would not be prescribed. Now just for Effexor alone, the FDA has been giving warnings to the medical community on the dangers of these drugs during pregnancy since at least by 2002. Yet these professionals have not seen them, or bothered to read the warnings. They are there. I’ve read them. And yet when I bring it up to these professionals, they all seemed shocked. Why? Why can’t they do their job? Why me, the lay person am I able to find all these facts out? Is it because I look for my information from more than one place. By looking beyond the drug company. I’ve been given the spiel about how the drugs were tested and okayed. But they have no idea how those numbers work.
We bought a book from a man whose daughter died from a “safe” drug. He lives in Toronto, surrounded by people who work with the system every day. He’s met and talked to the ones who know the truth. The author is Terrence H. Young. MP and founder of Drug Safety Canada. His book is called, “Death By Prescription. A Father takes on his Daughter’s Killer – the Multi-Billion-Dollar Parmaceutical Industry.” Here is some information our so-called professionals should know.
Some excerpts from his book that have rattled us are;
“If drugs have to be proven ‘safe and effective’ to get on the market,” I asked *Michele, “What is the definition of ‘effective’?”
“In clinical tests ‘effective’ means compared to placebo – a sugar pill. A drug can be only slightly more effective than a sugar pill and still get approved. The problem is that doctors assume and believe that new drugs are better than older drugs. They rely on what the industry tells them. But they often aren’t.”
It was appalling to hear that doctors are that naive. “Why do our regulators even approve drugs that aren’t as effective as the ones already on the mareket?” I asked.
“Commercial rights. The law doesn’t require new drugs to be better, because drug companies have a right to make money. The drug companies don’t have to compare a new drug in clinical tests to any other drug. Effective does not mean more effective than the drugs already on the market.”
“But every new drug has new risks. The least they could do is make sure the risks are for a good reason.”
Michelle smiled. “I agree.”
“Let me get this straight,” I summarized. “A drug declared safe and effective by Health Canada might actually be life-threatening to some patients, yet only slightly more effective than water. So there’s no way the benefits could outweight the risks?”
“How often does that happen?”
“So who is protecting the public?” I asked.
“By statute it is the duty of the Minister of Health through the department to uphold the Food and Drugs Act. The minister is supposed to protect the public from health hazards and fraud in the sale and use of foods, drugs, cosmetics, and medical devices. That is not happening.”
“What about the drug companies,” I asked. “Don’t the risk-management practice help protect the patients?” Michele’s reply was an awakening.
“Risk management is not patient protection. Risk mangement is corporate terminology for making money with responsibility.” (Pgs. 127-128)
*Michele Brill-Edwards. From 1988-1992 Michele was Health Canada’s senior physician in charge of prescription drug approvals.
If you take any new drug, even free samples, you are joining a giant drug trial, becoming part of a giant Big Pharma experiment – Phase IV of testing. Doctors never tell patients that. Rare and very rare dangers aren’t recongnized until tens of thousands of patients take the drug. A lot of injuries can occure before a bad drug is withdrawn. Here’s the math: if one in ten thousand people will suffer liver damage from a new drug – and a million people take the new drug, that’s a hundred people who will need a new liver, or die.
If you have ever bought a major lottery ticket, like 6/49, your odds of winning were about 1 in 14 million. But you could only lose $2. If you take a new drug on the market that turns out to have a dangerous side effect, your odds of losing could be 1 in 10,000 – 14,000 times greater. But you are betting your life. Taking a new drug is your lottery ticket. (Pgs. 181-182)
Film maker Erna Buffie called me. Health Canada had refused to give her key documents she’d requested, like the 1990 new drug application for Prepulsid. “They said it was proprietary information that belonged to Johnson & Johnson,” she explained. “How can saftety information be a commercial secret?”
Good question. The information that drug companies give our regulators to get their drugs approved is simply not available. So the terrific researchers like Joel Lexchin who are focused on safety can’t look for evidence of risk in their early trials.
Yet we were to learn that keeping new drug applications secret is normal at Health Canada, and Erna had to hire specialists in using the Freedom of Information(FOI) process to get the documents. In the U.S. they are made available on the Internet for the same drugs! Every public statement Health Canda officials made was about how concerned they were with safety, and evey action they took blocked our progress. I no longer had any doubt that Health Canada was Big Pharma’s partner.
Some of the things we’ve read have really hit Amery and myself in how this whole thing works. I reallize now that I was just a guinea pig and that Matthew is just another statistic in Phase IV.
Human testing is done in four phases.
Phase I is usaully done on twenty to eighty healthy young adult males who are paid, looking mostly at safety; what the drug does to their bodies, and at what dose it either works, or intolerable side effects appear. This is risky. For example, in March 2006 six young men were rushed to hospital in London, England, with multiple organ failure after participating in such a trial for an experimental drug.
Phase II is usually twenty to three hundred volunteers some of whom have the conditon being addressed, looking mostly to see if the drug works on the targeted symptom, but also toxicity.
In Phase III the drug is administered to three hundred to three thousand patients, most of whom have the condition being targeted and who might be on other drugs (in randomized-controlled way). Some subjects get the drug, others will ge a placebo.
If after Phase III the drug appears to be safe and effective, all the documentation is compiled into a new drug application (NDA), usually delivered to the FDA and Health Canada in numerous boxes filling one or more large trucks. Then some lucky doctor-drug reviewer is assigned the responsibility to pore over all these documents and say yes or no; they can sell it for that condition, or they can’t
But Phase IV is the drug being sold to the public. This is where children, pregnant women, millions of people on other drugs, and anyone taking the drug for a longer term become canaries in a mine for Big Pharma. No one knows what will happen. That’s why doctors like David Knox and the people at Public Citizen suggest you stay away from new drugs for at least seven years. (pgs191-192)
Before approval in 1993, more than 2 per cent of patients who took Prepulsid in the U.S. studies experienced “heart rate and rhythm disorders.” One out of fifty.
During the same studies, eight children aged six and under had died while on Prepulsid. An FDA report claimed “no clear evidence” implicated Prepulsid, but neither could its role be excluded. Naturally I wondered how often children die during trials for drugs that treat non-life threatening conditions. And I thought children were rarely included in drug trials? Nevertheless, this is the kind of critical saftey information that Health Canada should have known about, but were they still keeping it secret to protect Johnson & Johnson’s “commercial rights?” (pg209)
Lots of this information is available to the medical community through FDA warnings. Even just googling a specific drug and side effects. There are sites dedicated to people who have died because of certain medications. It just seems doctors don’t care to read them. Yes, they recieve all kinds of information and that they just don’t have time to read everything. But people are put at risk. There needs to be some kind of guidelines to follow concerning the prescribing of drugs. There needs to be in place some laws on how the drug reps relay their information to their clients. Instead, we are put into the testing phase and being studied. Unfortunately for the real testing to occur, all the side effects need to be given to the FDA for accurate numbers. But less than 10% of side effects are ever reported. And in our case, we can’t complain of the side effects being my Seretonin Syndrome, long term problems for my 3 living boys and the deaths of my last two boys. As the evidence isn’t clear that the drugs I was on caused them even though we can’t rule out that they didn’t. It doesn’t matter if they do anyway as I live in a Province that does not put value on Matthew’s or Simon’s lives. They will just continue to be a statistic. And the drug companies will continue to test on others at the risk of their lives. Who knows how many more Matthew’s there will be.
We as responsible human beings, need to be made aware of the truths, the risks and actually take it seriously. Being compliant isn’t working. Too many people are dying. And more are put at risk by laws trying to be implicated to diagnose more people with so-called disorders all for the sake of making money.