Drug Regulators and Companies are Feuding over a Ban in India

More than 300 combination drugs have been banned in India since 2016.  This is the result of an argument between Pharmaceutical companies, citizen groups, the government and, I believe, patients.  It has the potential to be far reaching.  I'll try to keep this article from rambling, but it touches on many themes I often write about.

Citizen's groups say that the combinations of drugs (similar to combination nausea/diarrhea medication, and cough/cold combinations) are sometimes irrational and sometimes dangerous.  Patients say they are useful and say it with their hard earned money.  Pharmaco's say they are just providing a needed product.  The government says their experts say most of the formulations are problematic. You might be surprised, but I'm with the Pharmaco's on this one!  I think in this case, they really are just providing a service, as they say. 

Patients find combination drugs to be helpful apparently, because they're popular.  Now, the Indian government has banned many of them, and the Pharmaco's have partially won a repeal via a petition campaign.  The patients in all articles have been treated as if knowledge of science outweighs patient experience.  That troubles me. 

It also troubles me that after the petition process, the government hired independent experts to look into the matter and the drug companies were not allowed to comment or offer any data to the panel.  This is worrisome because I know that the lion's share of science on drugs is not ever published.  Keeping the drug companies out of this process ensures that the panel was working with limited information. I'm not sure how much patient/customer input was sought, but I didn't read about any, so I'm assuming there wasn't any.

People with a lifelong illness of any kind, especially one that causes malnutrition (more on that below;  yes I mean Celiac Disease) should be paying attention to this debate because it's going to affect them more than those who rarely require OTC or prescribed drugs to function, and only use a few drugs in late life. That's why it bothers me that patients are left out.  The average time to be diagnosed with Celiac is more than a decade!  During the undiagnosed period, patients should be allowed to do what they can to make life bearable.

Many pharmaceutical companies are multinational, and so this will affect what they do in the US as well as many other countries. I will address a current article on the matter, but an older article mentions a few of the larger Pharmaceutical companies involved.  It should be clear that this decision is not only about India, but about what options should be available to people everywhere.   Quote from older article:  "Over 150 petitions by pharma majors such as Pfizer, Glenmark, Procter and Gamble (P&G) and Cipla, have challenged the government’s March 10 [2016] decision, of banning the 344 FDCs." 

One of the pharmaco's, Cipla has already triggered my 'three strikes you're out 'rule. That means, I've taken three different drugs made generically by Cipla and none of them worked right, so they're on my 'do not fill" list at the pharmacy. No doubt some of the companies are engaging in faulty assumptions, if not shenanigans, when it comes to OTC and generic drugs.

My working assumption is that my genetics or epigenetics renders some drug manufacturer's assumptions to be faulty for me. Simple Occam's razor.

 But, on the whole, I'm on the Pharmaco side on this one. Not out of fawning respect for business, but because austerity in this situation can be crippling to people with chronic illness. I'll try to explain why in the rest of this article.

I think it's important to acknowledge what we don't know about the human body.  And out of respect for our scientific limitations, we should tread carefully in this area. Home remedies can and do work, and science is working finding out why.  India has made respectable strides in validating Ayurveda concepts and herbs.  One of the most visible results of that is that some American rheumatologists (like mine) now suggest Turmeric as an anti-inflammatory adjunct to care.

We didn't know something, we had a suspicion based on tradition, and science found it out.  But this takes time.  It's not instant.  And the rewards, for pharmaco's can only be potential drug targets, since they can't patent Turmeric. So let's take a look at this new drug war and make a few observations.


India Moves to Ban Cocktail Drugs

What's a cocktail drug?

Well the most prominent in most people's memory is the propofol combination that unfortunately killed Michael Jackson, but that's not the sort of thing they mean.  Cocktails like that are custom made by pharmacists.  What they mean is the kind of thing you might buy for a bad cold:  NyQuil or similar combinations are found all over the world.

If you've ever taken a cruise, and stopped in a convenience store in the Caribbean, you might have been delighted to note that mild antibiotics are sold over the counter as cough drops, for example.  Since I always get a bit of a cold when I travel, it really helped me out.  To think that such things may disappear from more than just India's store shelves is troubling.  Being on a cruise ship exposes people to crowded conditions and potential food poisoning, not to mention the stress caused by being caught too close to a Hurricane. Combination drugs can affect whether you've had an "adventure" on such a cruise, or a "disaster."

Is it political?

Drug companies are fighting the ban of course but the recent articles are hinting that the argument is political:

(excerpt) "The companies are actually waging an open war because they are worried about setting precedents’, says Aisola. ‘Its like opening a can of worms. Their worry is, if the government succeeds in banning a number of them now, what comes next?"

I think there's a much larger issue at stake.  We're prisoners of the phrases "evidence based" or "scientifically proven."   The hubris of science is that it assumes everything can be proven (so far, there's no proof of that), and that if something is done that isn't proven yet, it's a scam.  This severely limits the value of patient experience.

Patient experience is symptom oriented.  Someone feels tired, in pain or sick to their stomach.  If you go to a doctor enough times and say that, but have negative lab tests,after a while, you get labeled a hypochondriac and ignored.  If that person is an undiagnosed Celiac, or undiagnosed ME/CFS sufferer, they can lose their entire livelihood trying to be just well enough to work and care for kids.

When I was younger I discovered that combination cold medicines work on tooth pain from dentistry work.  In fact, they work better for that purpose than hydrocodone which is often prescribed for that.  It could be that it's just my unusual genetics that causes that.  But all of these things are not yet 'proven' by science to a level where it has entered the clinical practice guidelines by which doctors make decisions.We haven't made use of our new knowledge that people's genetics can be affecting mainstream care. Not yet.

Much later, I was part of a support group for people with Migraines. The support group met in a small medical library at a University and we were surrounded by books on the neurology of pain.  I happened upon a passage in a book about how antihistamines assist pain reduction and how there is a combination of prostaglandins, Cox 1 and 2, and other cytokines that work in combination to produce the signal that something is wrong.  In short, it takes a combination of chemicals to oppose this process.  I had my explanation of why cold medicine would help toothache better than tylenol alone, or even hydrocodone.

Many Combinations are Used for Pain

Many of the combinations banned by India are for pain.  And pain is a very subjective thing.  You can never prove that I actually do have pain, you'd have to take my word for it.  Perhaps you will see my blood pressure changes (if you're charting it daily), you will notice my general agitation, the tightness around my mouth, the flinching when you shine a light at me, my reporting that I am too painful to move very much.  Or you can brush this all aside and say that I'm overdramatizing and lazy.

I've had a long experience of pain, I was a toddler when I first experienced kidney pain and yet I couldn't say anything to communicate it.  For nearly two years I suffered agony, fevers and hallucination from an unknown source. until someone realized that I had one failing kidney and why. A surgery fixed the blockage, but it took years for me to recover and feel normal.

To me, 'normal' is the most blissful physical state.  No temptations of 'getting high' can ever compare with the simple absence of pain and a feeling of wellbeing.  

My recovery after that early surgery led to me discounting my basic malnutrition until I moved to the US and had reactions to nutritious fresh foods.  The reactions were minor, and my body recovered from malnutrition too, but I'll never forget the sudden breakout of rashes from too much citrus fruit, and the zenlike state someone has when they've been starved and they're eating watermelon for the first time.

For years I ate every bit of food obsessively, cleaning bones completely, and then breaking them to get the marrow.  It was instinctive and I didn't realize how odd it was until I married.  I got a chance to compare eating habits up close.  I'm fascinated by this self reflection, and my mother's silence.  She never once pointed out that I ate like I'd been starved.  I think she was glad it worked out and we survived it.  I like to think I have recovered emotionally also, but it still takes a bit of effort to allow any scrap of food to remain on my plate.

Epigenetic Changes Due to Malnutrition

According to a new article from a famous nutrition scientist, chronic illness can be triggered by malnutrition, and usually is.  His proposed mechanism is in the basic changes made by the body to ensure survival and reproduction.  These changes are mainly in the form that enzymes take, and the 'survival' forms are less efficient in the long run, causing an increase in reactive oxygen species (ROS, or the reason why you should take antioxidants).  Again, patient experience has been that low levels of antioxidants aren't effective for some people, and higher doses of antioxidant vitamins are needed by some people.  Science is only now starting to hear patient experiences about vitamins, investigate it, and believe us.

I suggest that the real reason this argument exists in India and elsewhere, over combination drugs, is that science is a wonderful tool, but it hasn't fully elucidated everything yet.  For a long time, bromides were what you took if you were nervous, but today that's unthinkable.  We've come up with more effective and less toxic ways to deal with nerves.  In the same way, someday some of these questionable combinations will become obsolete as we discover what drives chronic illness.  But until that day, have mercy on those suffering and trying to maintain a daily workload.  

I'm hardly ever on the side of pharmaceutical companies, but in this case, I agree with them mostly.  An overzealous attempt toward austerity in drug combinations will only lead to people buying 4 drugs instead of one, and being exposed to more fillers (which we tend to ignore).  Fillers in liquid drugs are often hydrogenated fats (check the label on Delsym), fillers in tablets are often stearates (check the controversy around magnesium stearate and many other tablet fillers).  All of life is a risk, but now the risk will be multiplied. For someone with Celiac, especially in the undiagnosed period, the risk is even higher that some filler will contain gluten or be contaminated with it. 

Every time someone buys a single drug, they take on the risk of that drug being contaminated or defective.  Multiply by 4 or 6 and you can see how the risk grows. And it's not always true that any of a class of drugs is equivalent to any other.  Pharmacy Benefit Managers engage in this false assumption all the time when they try to publish a 'formulary' and enforce it on insured people.  We all have examples of how wrong that assumption is, if not in our own lives, then in the lives of our friends or relatives.

Some of the pharmaceutical combination changes are due to the permission governments give to businesses that produce science.  They allow them to not publish information unless they want to.  This has complicated reasons behind it, but mainly it's to protect trade secrets.  As  a result, we can't see the proof that some of these things work, or why.  Especially why.  How often have you heard "mechanism is not fully elucidated" or "mechanism unknown"?  Yeah, well I read that as "mechanism hidden."  Several times I came across analytical science that "elucidates" the mechanism just fine, it just wasn't published by the pharma company.

It's hard for doctors to function in such a situation.  Their workloads keep increasing, new data tracking software keeps their staff too busy to think about people, and they're frequently on call.  When do they get a chance to read the pharmaceutical inserts of the drugs they prescribe?  Even if they do, when do they get a chance to look for the mechanism in scientific articles published after-market?  Even if that is possible for them, when do they read the genetics variations that affect the enzymes required for activating these drugs in the human body?  Or study the changes to said enzymes based on epigenetic changes?

I think that medical centers should have a team of people capable of interpreting science and keeping up with changes.  To some extent, hospitals do this.  You can often go to the reading library of a hospital and get help finding answers.  You can visit the social worker and get help when you don't know where to look for answers.  In the very least, a doctor's office should have a 'clipping service' to alert them to changes and potential exceptions to mainstream care.  It might have made the ME/CFS crisis less invisible if we'd had that.

But insurers would never allow it.  The trouble is, that insurers can overrule good medical care and even drop doctors who provide it.

Do 'cocktail drugs' fulfill an unmet need?

Many people are suffering from something they can't find a diagnosis for.  When you remove combination drugs, they have to adjust.  Those adjustments can be more dangerous than the combination. It would be ideal to find the correct diagnosis efficiently and get better treatment, but for many that's not their reality.

It's all well and good to cite health risks, and want to give a blow to the bullying tactics of multinational corporations.  I'm usually banging my tambourine along those lines myself. But this particular salvo is set to do a lot of harm to people, especially women with chronic illness or obesity.  They are the most likely to be ignored in the current medical climate. Sure, patient experience is anecdotal.  And so it should be.  Anecdotes are how anyone's curiosity has ever been aroused.  To call patient experience anecdotal by way of dismissing it, particularly about pain control, is an act of negligence at best.  I would call it an act of abuse. Patient experience is what keeps science honest.

Here's a quick anecdote for you:  If you look into studies done on Multiple Sclerosis, you'll find a series of articles written about Biotin in high doses used to treat MS.  I kept reading them over and over trying to find what I knew would be the number 1 side effect:  headache.  And it was never mentioned.  But go to any "hair growing" website and their dosage of biotin is much lower, yet they suffer headaches.  Eventually I decided to try a high dose, and bingo.  Headache.  The omission of headaches as a side effect in that series of studies is probably deliberate.  Yet, you'll notice that you probably haven't heard of biotin for MS until I just mentioned it.  How long do you think it will be before a synthetic biotin is produced as a drug to do the same without headache? This is the kind of thing that makes me read studies!

There's some proof of malicious intent on the part of insurers and biotech companies when it comes to proper diagnosis and cure.  That won't change overnight, though.  There's been a deafening silence around that article online. 

Finally, it will take years to process the suggestion that Dr. Bruce Ames has made, (nutrition link, same as above) that people with suboptimal nutrition status have epigenetic changes that may result in chronic illness because the body makes different enzymes.  Since enzymes are relied upon to make medications work, this should be a central finding.  But once again, I'm hearing a deafening silence about it.


Post Script:  I noticed in the news today that Stan Lee has passed away at age 95.  He is best known as the publisher of Marvel Comics.  I'm really broken up about it. The retrospectives so far have provided me with two facts I didn't know:  He was a second generation Romanian from a Jewish family.  That explains why I loved Marvel comic books throughout my childhood and early adulthood, the human rights and dignity issues were right there among the flashy costumes.I wish I could've made him ciorba just once.  Maybe as a tribute I'll make it and publish a recipe.

The second surprise was that he had been married for 70 years!!  One has to feel awe for such a loving life.  He was asked what his superpower is, and he said it was Luck.  That's exactly what my mom would've said.  Noroc si bani, Stan Lee, thank you for a legacy of stories and an exemplary life.


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