The Scary Thing About Drug Side Effects and Recalls

FDA

Source: rawforbeauty.com

Today is Saturday, September 7, 2013.

When I was about to undergo chemotherapy for cancer, I was asked if I wanted to participate in a “study.”  It was explained to me that I could either choose to do the “standard treatment,” which had at least demonstrated a certain level of effectiveness, or I could participate in a study using a new treatment that had not yet come on the market.  I would not be told whether I was actually being given the test drug or a placebo, and they could give me no guarantees that the new treatment would work, beyond saying that it was a “promising” drug.

I said no, thank you.

Later, I found out that even the so-called “standard” chemotherapy treatment, actually a mixture of several different drugs given in a certain proportion,  was not effective in all cases.  I found that almost all drugs contain some level of risk in their use, and that patients will generally accept some level of risk, depending on how effective the treatment is reported to be.  I found out, as well, in the fullness of time, that doctors have been guilty of over-prescribing chemotherapy for breast cancer patients.   But I’m getting ahead of the story.

As an example of the concept of “acceptable risk,” starting last December, took a particular antibiotic that is not commonly given to patients, because the type of infection I had was microbacterial, which is, in itself, uncommon.  (As an aside, I believe that infections of this nature may be on the rise, and people should keep their eyes and ears open for news about microbacterial infections.)  I was told that this particular drug had a “100% cure rate,” but that it worked very slowly, due to the nature of the infection itself, and that I would have to take this drug for at least 6 months.  I ended up taking for 8 months.  Blood tests revealed that my body is no longer dealing with infection, so although my leg still doesn’t look totally cured – there was a lot of discoloration of the skin – the drug did indeed cure the infection.  The side effects for me included a constant metallic taste in my mouth and recurrence of yeast infections.  I’m also convinced that the drugs were hampering my efforts to lose weight, although that wasn’t something I could prove, other than not losing weight during the period in question, despite my efforts.  In my case, it was worth chancing the risks associated with the drug, in order to get the certain cure.  (The infection itself was horrendous, and landed me in the hospital, not once, but twice.  My skin felt as if it were on fire, and it looked like it, too.)

OK, so back to the chemo drugs.  I was advised to do the chemotherapy simply because the lab had discovered a very small speck of cancerous material in the one “sentinel” lymph node that they had extracted during my mastectomy.  I was told that if they found a speck in that lymph node, that there were probably other specks of cancerous material that they couldn’t yet see, and that I should undergo chemotherapy “just in case.”  I asked myself what might happen if I got the placebo instead of the drug, or what might happen if I got the drug and it didn’t work on me.  Then I asked myself what might happen if I took the so-called “standard treatment” and it failed, and what might happen if I took the standard treatment and it worked, but I had some side effects.  I was given a few numbers to play with, but basically, I realized that I was participating in a giant crap shoot.

The major side effects were described as nausea, fatigue, dryness, and hair loss.  Whoever hasn’t heard of these has been hiding under a rock somewhere.  These sound mostly acceptable if you realize that they are ultimately temporary.  What people don’t understand is there is no way to truly understand these side effects until you actually experience them.

We are talking about a level of nausea that makes eating impossible, for days.  We are talking about being sick as a dog for a week because you ingested something (such as onions) that doesn’t agree with the drug, which remains in your body long after the actual infusion.

We are talking about fatigue that is so intense that you cannot do anything but lie in bed, but sleep eludes you anyway.  We are talking about fatigue that makes it necessary to spend days vacuuming your living room in small increments, because you can’t accomplish it all at once.

We are talking about hair loss not only on your scalp, but also in your nose and pubic area.  Lack of nose hairs means whatever fluids are draining from your nose drip right on out and you spend months sniffling.   Lack of pubic hair means the moist skin in that area begins to stick together, which is not just uncomfortable, but painful in the extreme.

We are talking about dryness so intense that your eyes are practically glued shut in the morning.  You have trouble swallowing food.  You cannot cry.  You have trouble with bowel movements.  (I began to scream during mine, just to bear the pain and get them over with.  I detested having to do one in a public bathroom, because I couldn’t scream.)

The side effects that they did not tell me about affected me the most, however, and they are still with me.  I do not recall the doctors and nurses saying that the drugs would ruin my vascular system to the point where the valves in the veins in my legs were ruled “incompetent.”  Yes, that’s a medical designation.  It means the valves don’t work to create enough pressure to pump the blood back to the heart, so the blood pools in the legs, causing varicose veins and swelling in the legs and ankles.  Ultimately, this condition causes the veins to deteriorate, and skin color begins to be affected.  When blood can’t get back to the lungs to be refreshed with more oxygen and to the heart to be pumped around again, the person feels tired all the time.  I had two surgeries to correct this problem.

I also don’t recall being told that my hearing would be affected, but it was. I thought my aging hearing aids were at fault, but my audiologist confirmed with testing that I had experienced a major loss of hearing.  This particular office had my records dating back a couple of decades and my congenital hearing loss had not been markedly worse in all that time.  It wasn’t until I underwent chemotherapy that I experienced a sharp loss.  By this time, I was in debt management and could not afford new hearing aids, so I limped along until the debts were paid off.  This meant that for about four years, I did not really hear well enough to do my best at my teaching job.  (I had to tell the staff  and parents not to call me, because I could not hear their phone messages.)  I was not able to get new hearing aids until just weeks before I retired.  The first day I wore the new hearing aids, one of the kids asked me why I was talking so softly, and I realized with chagrin that I had been yelling at them.  For years.  I felt awful.

When the original chemotherapy (four rounds of infusion given at the hospital) was over, I took supplemental chemotherapy (drugs given by mouth, at home).  I started with Tamoxifen, which had a stated side effect of blood clots.  My veins were already forming pools of blood, and now the blood was clotting.  At one point, I had a blood clot in one leg that ran from the back of my knee halfway down my calf, and my legs were swollen to almost twice their normal size.  A trip to the ER confirmed the blood clot, and my oncologist switched me to Arimidex immediately afterwards.  It was up to me to tell him about the swelling and the trip to the ER, though.

Arimidex had its own side effects; the main one was that the drug leached the calcium out of the bones, and I ended up with osteoporosis of the spine, established by a baseline DEXA Scan before using the drug and another one a couple of years down the road.  Because the bones were getting weaker, they were not doing the work of holding up the muscles, which meant extreme pain on an ongoing basis.  I chose to stop the drug before the course of treatment was finished, and I sought chiropractic treatment, which helped, but most of which was not covered by insurance.

I knew that my body would be especially susceptible to infections while I was receiving the infusion chemotherapy treatment.  What I didn’t realize was that my immune system has been permanently compromised, which is why I had the microbacterial infection that I described earlier.  The microbacteria that caused the infection are prevalent worldwide, in both fresh and salt water, and the only reason they affected me is that 1) they were able to enter the body through a scratch on my leg and 2) my body was unable to deal with them.

There have been other side effects, the like of which doctors are only now beginning to acknowledge and understand.  One of these is “chemo brain,” a condition where the brain literally loses its ability to function.  Researchers are only now realizing that this condition not only exists, but persists long after infusion chemotherapy is finished.

**** **** ****

So what does it take for a drug to be recalled?  Drugs can be recalled by the manufacturer, by FDA “request,” or by order of the FDA (mandatory recall).

Class I Recalls are for dangerous or defective products.  Some are found to contain toxins due to contamination.  Some are simply defective batches of a product that is normally safe to use.  Some have “undeclared allergens” that have resulted in severe reactions or deaths.  Some are recalled because of label mix-ups, especially if the drug is considered a “life-saving” drug.

Class II Recalls are for drugs that might pose a temporary health problem.  This might include a drug that was produced “under strength” necessary to treat the problem.

Class III Recalls are for drugs that violate FDA standards but do not cause adverse reactions.  This might include drugs that are off-taste or off-color, or drugs in a container that does not seal or a container that is otherwise defective.

Drug recalls happen about once a month in the United States, but fortunately most of them are not Class I recalls. There were 1,734 recalls between the years 2004 and 2011.  91 of them were Class I.  Of these 91 drugs, 34% (about one-third) of them involved more than 100,000 units of the drug, and about 64% (two-thirds) had been distributed nationwide.  40% of the drugs (two-fifths) were recalled for contamination, and 25% (one-fourth) were recalled for having wrong doses or release mechanisms.  The rest were recalled for product mix-ups and mislabeling.

Drugs approved by the FDA must go through a series of clinical trials.  Before trials on people, they go through animal testing.  Clinical trials involving humans are often done with patients who have specific health conditions (such as the trial being conducted among cancer patients who had been prescribed chemotherapy).  Often the people tested are healthy volunteers who are paid for their inconvenience. They generally remain at the testing site for one to forty nights, and sometimes longer. One problem with this is that some side effects take longer than forty days to materialize.

A major problem with drug testing in the United States is that the elderly, who consume over 33% of the drugs, comprise only 14% of the population, and they are often excluded from drug trials because of their complex health issues.  Also, women and children are generally excluded from trials, which means that doctors don’t really know how some drugs might react on women or children until people start taking them.  As well, people who have unrelated health conditions are excluded from studies, which means that researchers have no idea how patients who have other, unrelated conditions might be affected by the drug under consideration.

Phase 0 (zero) testing is done with small groups, and establishes what the drug does to the body and what the body does to the drug.  Phase I testing establishes drug safety and an effective dose; this is where side effects are noted.   Phase II testing establishes “effectiveness” of the drug.  (This is where some people are given a placebo to see if the effects are due to the drug being tested or to something else.)  Phase III testing compares the drug to other treatments for the same ailment and collects information about how the drug can be used safely.  Phase IV studies are actually done once the drug is already on the market.  These are called “sentry” studies and these are the ones that can lead to a drug recall.  :-/

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