Why You Should Report to RxISK rather than Health Canada or FDA

Editorial Note: This post by John Scheel follow on his Sticks in the Throat and Sticks in the Throat: Boxology posts. The driving force behind these posts – a demand that people should be accountable – can be seen in greater detail in his book Someone gives a S**t (www.johnscheel.com).

What John outlines here can be found time and again in the adverse events field – report your problem to a company and they ask you more questions, not aimed to establish how their drug might have caused a problem but rather to find any possible way to discount a link between their drug and your problem. See American Woman and American Woman 2. Reporting independently to RxISK and getting your doctor to report also is the best possible way to raise the profile of any problem that happens to you or someone you know.

The myth of protection

Mezavant is made by Shire plc and intended for gastro-intestinal disorders. It was prescribed off-label to me for radiation proctitis – damage of the colon wall through radiation treatments for cancer.

I started Mezavant (1.2G) on January 1, 2010. By January 8 I felt very ill. That afternoon I had heavy flu-like symptoms – headache, chills and sore muscles. That evening I felt very nauseous and had high fever. During the night I had large temperature swings and chills. I stopped Mezavant the next day for reasons of possible allergy and reaction. My only other drug reaction had been penicillin 45 years earlier.

By that evening my symptoms had worsened to violent chills, shaking uncontrollably, a temperature (41C) and sweats. I omitted the Mezavant again the next day (Sunday( and at noon I went to a walk-in clinic and was diagnosed as “toxic” and “septic” and told to go to ER at the closest hospital.

I arrived at ER around 2:15PM January 10 and was admitted. By 10PM that evening I had no doctor input. I was only formally admitted to a hospital stay the following morning.

About 2PM while still in ER I was approached by the ER staff who said I was to resume the Mezavant. This is referred to as “re-challenged” in medical lingo. My own doctor showed up about 5PM and told me to stop the Mezavant immediately because I had had a serious adverse reaction to it. He admitted that my symptoms, which included many which were not on the drugs’ alert sheet, were real and that ER had made an error in re-prescribing the drug.

I was discharged January 14 with suspected pneumonitis and a urinary tract infection, both acknowledged side effects of Mezavant. I was completely depleted and at about 10% physical strength and capacity. Having been given the drug a second time apparently was conclusive that Mezavant had caused my symptoms.

Side effects of Mezavant

When I had the prescription filled, the Shoppers Drug Mart drug fact sheet on Mezavant said it “may cause” mild headaches, diarrhea, stomach ache, dizziness, nausea (rarely vomiting) and a sore throat. That was given to me on a single sheet of paper which is also available on Shoppers web site. I didn’t expect any problems because I had never had a bad reaction to any drug since the 1962 penicillin incident.

After this episode, a subsequent visit to Shoppers produced a second “adverse effects” drug sheet for Mesalamine on which Mezavant is based. This second under-the-counter sheet was quite scary and listed 28 effects (e.g. headache 35% of users, dizziness 8%, pain 14%, fever 7%, etc.). Had I seen this I doubt I would have purchased the drug.

Shire seems to have a different picture of Mezavant than Shoppers (see http://www.medicines.ie/medicine/13022/SPC/Mezavant+XL).

Here is what Shire says about Mezavant in its own words. This is pretty serious stuff:

“Like all medicines, Mezavant XL can cause side effects, although not everybody gets them.”

“Common side effects, occurring in less than 3 in 100 patients (<3%), are headache, flatulence (passing wind) and nausea (feeling sick).” (note %’s in Shoppers information)

“Uncommon side effects, seen in less than 1 in 100 patients (<1%) are: a reduced number of platelets (a blood clotting cell); dizziness; feeling sleepy or tired; trembling or shaking; ear pain; racing heartbeat; changes in blood pressure; throat pain; bloated or painful stomach; colitis; diarrhea; indigestion; an inflamed pancreas or colon (associated with pain in upper abdomen and back and feeling sick); rectal polyp (a non-cancerous growth in the back passage causing symptoms such as constipation and bleeding); being sick; abnormal liver function test; acne; hair loss; itchy skin with or without a rash; hives; joint aches or pains; back pain; weakness; swollen face; fatigue (feeling extremely tired); fever (high temperature).”

Reporting to Health Canada

My adverse reactions were certainly serious so I decided to report my experience to Health Canada (“HC”) and its on-line Adverse Reaction Reporting system. My input, collaborated with my gastroenterologist, became Report Number 000336878 in the HC “Canada Vigilance Adverse Reaction Online Database”. It refers to a 66 year old male and ascribes descriptive terms such as asthenia, chromaturia, dyspnoea, pruritus, and pyrexia to my symptoms. No Canadian will understand how these relate to my fever, nausea and real life measures of illness. Nevertheless, I was booked in the data file and hoped the information was useful.

I insisted that Shire be exposed about its drug failing so badly in my case. I called the company’s web advertised contact number the day after I was released from hospital. A Montreal-based representative took detailed information. I was told a company representative would call that afternoon. He didn’t.

A call the next day, Saturday, got me to someone in Cincinnati and no results.

Another call on Monday got an apology from the Montreal rep. A Philadelphia-based “nurse” called Tuesday and took more detailed information. Few of my questions (e.g. what are the longer term effects?) received direct answers with the excuse that the nurse was not a doctor.

Shire wanted the names and contact points of all doctors involved. It was my impression that Shire’s only real concern was to protect itself. Since the drug was for ulcerative colitis, the ‘nurse’ said that the doctor had misapplied it for my radiation proctitis. Shire is off the hook for what they refer to as “off-label use”. The nurse said he would be filing a report which I presumed was to the same data base that I had fed.

The Shire report

I waited several weeks and seeing no report from Shire I enquired with HC as to its arrival and status. I was told that I had to use the Freedom of Information (FOI) system to get a copy. Obviously whatever Shire submitted never went to the public database.

Two weeks after my problems and at my request, HC sent me notice that Shire had reported a no-name case (which looked like mine!) on a confidential basis. After filing the FOI papers, I received a 4 page report (form CIOM3) via HC’s Access to Information and Privacy Division. It was entitled “Suspect Adverse Reaction Report” – obviously Shire was accepting no blame.

Mezavant was referred to as a “Suspect Drug”, again no direct attachment to my situation. It was registered under a Manufacturer’s Control Number SPV1-2010-00098. Its only link to me and my report was my initials “J.S.”, my country “Canada” and my age, weight and sex. This cannot possibly be audited or linked to me, my doctor, etc. In other words, nothing will ever stick on Shire.

Some of my discussion with the nurse carried into the report but wow, with some misinformation and entries totally denying any possible fault. For example, my orange urine ended up as a hernia. Many of my previous operations were noted. What does an appendectomy in 1950 have to do with Mezavant in 2010? It noted that my left testicle was removed; it was my right testicle. It refers to me having had a bronchial tube (totally untrue). There is a comment that “additional information was requested”. I have no idea as to who was asked.

Shire summarizes its input as follows:

“The company’s Pharmacovigilance Physician has assessed all of the events of dysnoes, chromaturia, abnormal urine odour and tremor as unlisted per CCDS and not related to therapy with Mezavant, but due to a pre-existing conditions (sic) worsening. The events of pruritus, asthenia, pyrexis and nausea are listed per CCDS and possibly related. However, it should be specified that the patient has multiple cancers which might have played a role in the occurrence of asthenia, pyrexia and nausea. Therefore they cannot be ruled out.”

This is followed by a HC redacted line, i.e.XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX.

Some comment is in order. Yes, I once had testicular cancer (1976) and prostate cancer (2007). The report says I have multiple cancers. My insurance companies never had a problem with these past cancers of which I am 200% cured. How can such bumff be written and then accepted by HC? How does a large corporation actually write this shit? Regardless, HC accepts word for word whatever the drug company submits and into a secret repository. How trusting!

Health Canada

• What data file did Shire feed its report to?
• Is there a real file?
• Is it crossed with the one that is on-line?
• How is my information linked to the Shire input?
• Is it ever linked?
• How is the main on-line databank information used by HC?
• How do I know that there aren’t three or four Thalidomides building their data in some of these data banks right now?
• How did HC police Shire and assure that its entry, wherever it is, was sound?

I tried to get HC to tell me what the redacted line said and to whom it was addressed. It responded that I had to go to the HC Information people again. I did and here is the reply:

“As per our telephone conversation on July 8, 2014 the noted information protected on the third page of your privacy request (P2009-00369) is considered third party information and therefore continues to be protected.”

In other words, “get lost”. So there is a private below-the-surface and not-available-to-the-public flow of information between HC and drug manufacturers. There are even special forms for this but the input is not shared with Canadians. Had I known what Shire wrote about me and my case I would have gone ballistic.

A little more on Health Canada

Early on, I had called HC’s Vigilance Regional Office and learned that calls were treated passively. My message was answered 7 hours later. The human’s suggestion was to fill in a complaint form available on their web site. There was no urgency there as this is a user driven system. Privacy was an issue as it was difficult to leave my name and telephone number to record the call.

I asked what the reaction would be if I had said my aunt died yesterday of a prescription drug reaction and was told to fill in the forms. You have got to be kidding – we pay people to tell us to fill in forms when people are dying. I also found that reported reactions were logged but that the actual drug sales were not contrasted with the reactions. So how could the frequency of adverse reactions be determined?

Here is HC’s mandate:

“Health Canada plays an active role in ensuring that you have access to safe and effective drugs and health products. The Department strives to maintain a balance between the potential health benefits and risks posed by all drugs and health products. Our highest priority in determining the balance is public safety.”

Fence-sitting lessons are available here. They are free but supported by your taxes. Because of the simultaneous expiration of many key “big drug” patents, drug companies are scrambling looking for their next blockbusters from a lean crop. That means many marginal drugs are being brought forward without the accustomed due diligence and off-label uses are increasing. This puts extra pressure on HC to rush the release the drugs to market or just turn a blind eye.

Turning a blind eye to the adverse reaction databank complements a sloppier front end due diligence process. Through my threat of an FOI request, I was sent Shire’s submission which was full of errors and a couple of misleading statements. Lax, to the extreme! The government lets you think you are protected. My guess is that 99% of cases like mine end without proper follow-up and controls which is good for Big Pharma. Much valid and very useful information just dissipates into thin air.

HC is misrepresenting its role to Canadians. Its Adverse Reaction databank has to be under total suspicion because of its parallel secret drug company databanks which they protect through legislation intended to protect individuals.

Email from HC to J Scheel:

“For the purposes of the Canada Vigilance Program, information related to the identify of a patient and/or reporter (Shire) of an adverse reaction is protected as personal information..

Health Canada does not modify marketed authorization holder (pharmaceutical company) reports based on patient follow-up. Should you wish to bring modifications to the original report, please contact Shire directly”.

Editorial Note: Most people reading the above will think it’s atypical. This cannot be the way things are. This is absolutely 100% typical. As an editor it’s difficult to refrain from interjecting and say you’d better believe what you read here.