The Cold-Medicine Racket
theatlantic.com
theatlantic.com
> The difference in price between brand names and generics accounts for tens of billions of dollars "wasted" every year by Americans in pharmacies, according to the economics researchers.
> Consumer confusion, or misplaced trust, is compounded by the fact that a drug store is likely to have upwards of 300 cold-and-flu products
> One myth is that "brand-name drugs are made in modern manufacturing facilities, and generics are often made in substandard facilities." But, the FDA counters with the reminder that it "won't permit drugs to be made in substandard facilities."
Imagine how much consumers would overspend on branded medications if they couldn't count on the FDA as a backstop.
EDIT: By "backstop" I mean the FDA's role in ensuring that generics are bioequivalent and meet manufacturing standards. Imagine how much more effective brand advertising would be if some of the choices on the shelf really were manufactured in a dirty factory in Mexico.
In January, FDA inspectors paid a surprise
visit to the facility in Toansa, in a rural
area north of New Delhi, and found broken
equipment, windows stuck open and flies
“too numerous to count,”
...
Workers ran quality tests over and over
until they got the results they wanted
Just google around and you will find many many many stories like this. It's been an ongoing problem with generics (mostly from India) for quite some time.I don't know if brand-name drugs are any better, probably many of the same ingredients are sourced from the same suppliers. But at least the brand-name drug has a reputation, i.e. a "brand name" to protect.
Edit: Just wanted to add: RTFA I linked to. My one quote doesn't do the situation justice. The culture at some companies is IMO really really bad.
[1] http://www.bloomberg.com/news/2014-03-06/flies-found-by-fda-...
http://www.iodine.com/blog/do-people-prefer-under-patent-dru...
The best example is generic Wellbutrin[1]. Many patients complained of side-effects from generics that they didn't experience with the brand-name drug. The FDA did testing and realized that the generic Wellbutrin extended-release resulted in much high blood concentrations than the branded version. The generics in questions were withdrawn from the market.
The interesting thing is that to get approval for an "AB-rated" (therapeutically equivalent) generic drug, you don't have to be identical. The FDA only requires that the generic drug deliver 80-125% of the drug the branded drug does[2]. Normally that range is fine, but for some drugs (antiepileptics are a good example) the differences can produced a less than equivalent therapeutic outcome.
[1]http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInfo...
[2]http://www.nature.com/clpt/journal/v94/n4/full/clpt2013104a....
http://www.fda.gov/Drugs/DrugSafety/ucm422568.htm
As consumers, we don't really have much of a way to test for placebo effects or when generics are actually subpar other than complaining until someone listens... so... it's a bit of a chicken/egg problem.
Even if it is a placebo, if two medications that are supposedly the same cause different effects on me, e.g. one has much more manageable side effects than the other, then why shouldn't I take the one that makes my life better?
In the industry, we call it "patient education."
People without some prior knowledge of the basic drugs must have a very difficult time walking into a store and choosing the product with the drugs they need without some of the ones they don't. I imagine many people are totally overwhelmed by the product selection and they just pick something, which they then turn to each time they're feeling sick. It's more difficult than normal to perform an assessment of products at the store when you're sick, and the store presentation only makes things more difficult. Even knowing something about these products and knowing exactly what I want, I sometimes find it time-consuming to locate the single-ingredient products among all the endless combinations, especially when they're out of stock.
Things would be so much simpler if stores posted some type of reference. I'm not an expert in the field, but it's such a pet peeve of mine that I've memorized the basics. Here's a start:
Fever/pain -> Relieve:
ibuprofin
acetaminophen [avoid if you have liver problems]
naproxen
aspirin
Nasal congestion -> Reduce:
pseudoephedrine [quite effective, but the pharmacy must be open; prepare to provide identification, sign, possibly be questioned / receive a dirty look, and have your purchase be entered into a federal database]
phenelyphrine [of questionable effectiveness]
Coughs -> Make more productive at clearing congestion:
guaifenesin
Coughs -> Suppress:
dextromethorphan
Trouble sleeping / allergic sensitivity -> Relieve:
doxylamine [slightly better for sleeping than allergies]
diphenhydramine [slightly better for allergies than sleeping]
The store could have a nice section of the products that contain just one of these drugs, making it easy to mix and match, with reference to the list.I don't think there's anything inherently wrong with the combination products, but it really seems their general effect confuses rather than clarifies, which seems to me to be part of the reason for the design and proliferation.
The author of this piece seems to have similar feelings:
> ...I can't see myself using it, because I usually keep generic single-drug products around. A family, or a sickness-inclined person living alone, could very reasonably keep the five aforementioned individual generic medications in their medicine cabinet and address the symptoms as they arise. I think that's easier than messing with combination products, and usually cheaper. Especially if you consider that you're not taking medications you don't need.
> I tried to convince Angelotti that's the way to go, but she was adamant that many or even most people really like to take one pill that addresses all of their symptoms. "I don't know if people will be likely to have their own inventory of generic over-the-counter medications in their homes," she said.
I think a simple list like this, preferably easily visible in the store, and some better organization in stores would do people a much greater service than the app the article discusses.
My problem with this approach: As I'm quoted as saying in Jim's article, I just think it's a non-starter for most people to do this, ie keep an inventory of sorts in their medicine cabinet and recombine them as needed. Jim is thinking like a doctor, not like your average, non-medically-trained person. There's a reason pharma makes combo products — people do like getting multiple ingredients in one pill. It's convenient! Most people have neither the patience nor the medical education to recombine individual generic ingredients on their own. And trying to do so could actually put them at higher risk for drug interactions or other human error. You have to read and reconcile warnings and directions labels from 3 or 4 different product packages, instead of just one.
I don't see how "combined" pills that are vetted by pharmaceutical companies or the FDA stop unwanted interactions from drugs. People don't read the entire huge and tiny-font booklet that comes with most medicine and cross-reference the ingredients from each with all the other medicine they're taking. Sure, they rely on doctors to help them out (if they know/can anticipate), but that's just as much a disaster waiting to happen as what you're arguing against.
So what ends up happening is that the drug interactions occur anyways even though people took approved combinations of ingredients. I'd rather we not promote this whole approved combinations prevent unwanted interactions as people mix different pills anyways.
Many (likely most males under 60) people take zero pills on a given day when not sick.
I certainly agree with you that some people are not going to keep a small inventory of common drugs, others can't be bothered to take more than one pill, and a few cannot successfully manage that sort of combination.
On the other hand, though, I think there are a lot of people who would like to learn more in order to make the best choice about what drugs they take, and the branded combination solutions really end up muddying their conceptions of these medicines. I know a number of people who just buy whatever they've decided is their favorite variety of DayQuil when they're feeling sick during the day (you're quoted relating similar experience in the article), and I know a number more who don't realize there are major differences between traditional Alka Seltzer and the proliferation of their cold products. The brands and the proliferation undermine people's ability to concentrate on the drugs they're taking, and they mentally give up on figuring the situation out and determining the best medical choice (especially if they also consider the cost and branded/generic elements of the equation).
The identification with brands rather than the actual drugs is likely the largest problem, especially now that each long-existing drug manufacturer sells combinations of the various drugs under their own name. I wouldn't mind seeing these companies have to devote the top 1/3 of the front of their boxes to a large, unadorned list of the product's active ingredients.
I think people who would like to be more informed consumers, but who struggle because of the current setup, are underaccounted for. I think there are many people who would love an inexpensive pack of 50 of each of these generic drugs to keep a small inventory at home, and who would be perfectly capable of managing it.
While it may be easy for a doctor who is familiar with these medicines to erroneously assume that they are very familiar to others, I think it is also easy for a doctor to not give patients enough credit in being engaged with their health treatment and being willing to spend a small amount of time and effort becoming familiar with a few extremely common drugs.
How often are people, on average, mildly sick in their adult lives? About once per year? How often do they care for others who are sick? These drugs are incredibly common, they are relatively simple, and people are likely to have a lot of contact with them over a lifetime. I think greater familiarity with them would be very useful in the average life, and I think an education effort would provide a lot of health value, even so little as starting with a simple reference in the store.
I am not a medical doctor or a pharmacist, and my list above is from memory (except for spelling). Perhaps I have engaged in the care of illness slightly more than average, but it didn't take a medical text to learn this stuff. It just took some concern over what I was giving myself/others and whether it was appropriate for me/them, and then a small bit of reading. This is an issue I care about because it seems to me the ill are victims in a corporate marketing game where the outcome is often someone sick ending up with an inappropriate product.
Another part of what bothers me about the combination setup is that many people are getting acetaminophen when they don't need it, or even when it could be bad for them. For instance, when I enter "stuffy nose" and "trouble sleeping" into the site, I get products with diphenhydramine, phenylephrine, and... acetaminophen, even though it's not needed for the symptoms. When it is needed for the symptoms, I bet a lot of people take extra tylenol when they have a headache, anyway. Many would be better off with ibuprofin, but in many combinations it's not an option.
I think your project is a very helpful improvement over the status quo, and I'm glad you made it and that it's available! I'll certainly recommend it to my "DayQuil" friends, and someone looking for relief in the store is much more likely to find it with your site than by a first-time confrontation with the cacophony on the cold shelf. My suggestion would be not to discount that people might like--and be capable of--getting down to the basics of each medicine. It's really not hard, and I hold out hope that, contrary to Internet rumors, some people still have some patience and the ability to remember a few things!
There are some pseudoephedrine products on the market which are supposed to be diversion-resistant for methamphetamine production but it seems if you stop people from making meth they will just order up some other sympathicomimetic amine from China.
It would be like ripping out the perfectly functional seatbelt in my car and replacing it with a home-made duct-tape based mechanism for reduced side effects.
I grow a lot of medicinal herbs and have never had to worry about dangerous impurities or quality control, except for the occasional spider web. I'm not a homeopathic nut, but certain things (mint, ephedra, thyme, sage, peppers) are easy to grow and provide tangible, scientifically confirmed benefits.
http://www.iodine.com/cold-and-flu
I work at Iodine (our Cold and Flu tool is featured in this article) and we're watching this thread. Feel free to ask medication related questions of our clinical team or technical questions of our engineering team.
It's too bad the 'Food Allergen Labeling Consumer Protection Act of 2004' didn't cover medication. Sounds like a worthy congressional lobbying cause. Proper labeling really isn't too much to ask.
Putting it another way: I understood that you are indexing off of the active ingredients, I was wondering why you chose to emphasize the brand name products (or how intentional that was...).
OK, it's back up. You tell people they can save money by buying generic, but your site is all about the brand names, not the active ingredients. I think you're going about it backwards. Then by adding reviews on top of it all -- it just perpetuates the entire brand-name mythos. What's there to "review" about a bottle of Guaifenesin?! It's Guaifenesin!
What people really need to be educated about is; 1) the only thing that matters is active ingredient, and 2) what active ingredients do I want to take for these symptoms?
To that end, I think you want to explain the difference between Guaifenesin and Dextromethorphan, and why you would take one over the other, or both at once. But on your site, I click 'Cough', and I'm just hit with big shiny brand names, and nothing to explain how to decide. So I'm sorry to say I think you're failing entirely on your stated goal.
Edit: OK, I'm basically echoing @maxerickson 12 hours late.
Is there going to be some way to ask for and filter out information for effectiveness etc. depending on the use that you're trying to address? For example, I just looked up gabapentin, which was basically ineffective for treating my non-shingles/diabetic neuropathic pain.. and I can only break down the info by age and sex. Same story with montelukast, great for my asthma but far from a one-pill wonder for my allergic rhinitis despite being marketed/approved for it. Would love to see data like that without having to dig around in the individual comments or for studies!
Iodine doesn't provide medical advice, diagnosis, treatment, or prescriptions. Read our terms of use for more info.
Really, did you have any concerns or regulatory speed bumps in that way when starting the company? Do you figure it's handled by the qualifications of your medical team, or have you actually interfaced with FDA in some way?http://summaries.cochrane.org/CD001364/ARI_zinc-for-the-comm...
http://www.webmd.com/cold-and-flu/news/20100719/study-links-...
edit: Link to original study: http://archotol.jamanetwork.com/article.aspx?articleid=49648...
It talks about "homeopathic zinc gluconate gel" and some patients reported a burning sensation while applying it.
Are you aware of any information on the mechanism by which zinc works? I'm content knowing that it does, but it would be cool to understand what's going on with it.
1. http://www.ncbi.nlm.nih.gov/pubmed/15542347 2. http://en.wikipedia.org/wiki/White_blood_cell#Overview
Of course here's my disclaimer that this is not medical advice, and you should talk to a pediatrician. :)
>The effect of branding--that is, the labelling and marketing--of a well-known proprietary analgesic used to treat headaches was studied in a sample of women given a branded or unbranded form with either an inert or an active formulation....The findings showed that branded tablets were overall significantly more effective than unbranded tablets in relieving headaches.
*EDITED:
Of course that would cut into pharma's profits, so it would never in a million years actually happen.
http://fortune.com/2013/05/15/dirty-medicine/
I'd be very hesitant about buying medicine from such companies. But I agree that if the regulators could assure quality, then yes, pointing out equivalence would help a lot of people.
Is there a data source for companies & drugs that are known bad?
I would love to pull up an app, tap a few buttons, and ask the pharmacist to change the meds to brand name when they are selling me products produced by $sketchy_fraudulent_company.
When do they find out they drop the hammer. Most (all?) Ranbaxy plants are banned from importing product into the US and many products were recalled.
Sun Pharma, which is buying (or bought?) Ranbaxy, recently got a plant ban for the same types of issues. (They delete test info if it isn't in their favour, and have terrible hygiene at the labs.) It's obviously endemic. And Sun quickly noted that the ban only affects 1% of their revenue.
It seems unbelievable that this deep level of corruption is exposed, and the FDA does limited bans and recalls. Instead of, say, completely banning the company and high-level individuals involved, until a complete end-to-end audit is completed. It's simply counterfactual to think these limited bans are accomplishing anything, or that a company is going to utterly and completely change the way they conduct themselves from individual techs all the way up to the board.
The Fortune article says none of the FDA inspectors would ever personally buy drugs from Ranbaxy, ban or not.
Interesting, I looked it up and yes, the FDA is banning each plant separately. One could argue that the FDA can only ban the plants they find problems at, however, I would agree with you that Ranbaxy's behavior is bad enough to stop all shipments into the US. Not sure why the FDA decided to be more lenient. Maybe the law governing the FDA limits how far it can go? I don't know.
It's simply not possible to see how such a company can be redeemed; it's rotten to the core.
I'm trying to phrase that politely, but yes, there seems to be much reason to trust the main name brands over those generic companies.
But additionally, it's part of corporate culture. In fact, the article I linked to says that Ranbuxy had a manufacturing plant in the US, and that plant ended up making pills containing glass fragments. So it seems more of who is "in charge". That said, I'd trust stuff manufactured by a EU company in a EU location more than manufactured in a less controlled location.
I have noticed that local companies of a global corp will misbehave in incredible ways. And some US companies might not realise just how bad it can get on-site, in country. They are big on deferring things to their local subsidiaries, figuring they know best. For instance, MS has had huge problems with local companies in Latin America. From misrepresenting the success and adoption, to pure outright theft. It's unlikely you'd see the same thing happening on the same scale at MS's North Carolina or Toronto office, for instance -- just because there's a higher chance of someone speaking up.
I'm not saying the US or EU are infallible or better, just that people might not be acutely aware of how "flexible" other countries can be at breaking laws. (And not that I blame "the locals" entirely, the risk/reward is so excellent, in addition to a generally poor background situation, that I'm not sure I'd necessarily do better put in the same position. (Same for crime: If I could pull a gun on someone with low risk of being caught, and make off with several months' salary, it'd be a large temptation if I didn't have steady housing/food/etc.))
Of course, this might be selection bias plus some personal biases I have just poking through.
That's a cynically opinion.
When it comes to prescription drugs, most states have generic substitution requirements. That is, if your doctor writes a script for Lipitor, the pharmacist is required to fill it with the generic unless the doctor writes (DAW = dispense as written).
When it comes to OTC drugs, I think it's up to the consumer to educate themselves.
"Phenylephrine was not significantly different from placebo in the primary end point, mean change in nasal congestion score at more than 6 hours (P = .56), whereas pseudoephedrine was significantly more effective than both placebo (P < .01) and phenylephrine (P = .01)"
Ask any seasonal allergy sufferer, we all look to find out where the 24 hour pharmacies are so we can get access to the "good stuff" when sinus trouble inexplicably hits and you need the behind the counter pseudo-ephedrine to get through it.
If we all trusted the FDA implicitly, then the next logical step could be to actually ban the entire concept of applying brand names to off-patent pharmaceuticals and rework the entire cold aisle into a patient-education + active ingredient grab bag. In such a world, phenylephrine is phenylephrine, guaifenesin is guaifenesin, and all shoppers would care about is the form factor and dosages.
I've read on HN about exactly how many fucks the FDA gives these days when billion dollar pharma is forging test results while they knowingly pump crap generic meds with zero quality control out of their dirty factories. See, for example, https://news.ycombinator.com/item?id=8468099. So that leaves us with the flimsy fallback of hoping brands like Mucinex believe good QC is absolutely essential to maintaining their market position.
TFA claims American consumers waste "tens of billions" on brand name pills. I'm sure this stat isn't just cold/flu meds, but probably including blockbusters like Lipitor vs generic as well. That's like a $10 billion tax because we can't fully trusted the quality and bio-equivalence reviews the FDA is tasked to enforce?! By comparison, the total FDA budget is $4.5 billion.
Now imagine having that same level of trust in the FDA. "Guaifenesin 1200mg 24 Hour - FDA Prime" would be all I need to see, and I'm grabbing that bottle. Spend a cool $5 billion setting up that program for the Top 100 generics, and you save Americans, what, maybe about a trillion dollars over the next 30 years?
Just like with beef, this isn't about controlling production, or subsidizing the factory, but simply establishing public trust in an inspection process.
And for marketing and trademark reasons you had to study the fine print to figure out what is in each bottle. So you can't buy a bottle of ready to drink screwdriver, you have to look in the fine print for "Slammer Canadian Lite Extra Dry Extreme" to figure out its a bottle of screwdriver.
I'm not suggesting I want bulk generic powder guafenisien but life would be a lot simpler if it was more like the produce aisle, OK I got runny nose and cough so take one of pseudoephedrine and one of dextromethorphan and call it good, instead of the "confuseopoly" system we currently have, which I'm sure reduces everyone's quality of life while increasing profits.
So for your analogy, the liquor store would have to have a small shelf of mixers and giant coolers full of premixed stuff. But flavor is easier to deal with than medicine, so people won't put up with it, so liquor stores mostly sell ingredients.
"It's a press release, Mary. The iodine algorithm saved your husband from the brink of ruin. His newfound sense of consumer empowerment was so invigorating to his spirit that he no longer needed any Mucinex at all."
But really, we hear from users all the time that they get confused in the cold and flu section of the pharmacy. We hope to help address this problem.
Wether they spend $10 on symptom suppressors or $50 is besides the point. Taking medications for what your body should be capable of handling with proper nutrition and rest cannot be healthy.
Point is, treating cold symptoms can actually prevent complications, so it's not all bad.
http://globalnews.ca/news/1723414/are-your-young-kids-fighti...
In general all these cold and flu medications do is suppress your immune response, which is obviously not the smartest thing to do. You might get rid of some symptoms, but you're also hindering your body from actually getting rid of the infection.
The article above does say that in adults decongestants might be helpful. I think you need to know when it's a good idea to "help" your body treat the infection, and when you're just treating the symptoms and just hindering it. Most people just want rid of the symptoms.
That's not true at all. Over the counter cold formulations contain one of four products: decongestant, cough suppressant, pain reliever and antihistamine.
None of those suppress your immune system.
EDIT: I think know what you meant now. You mean your immune system reacts to a cold by making you cough and the drugs suppress your cough (thus your immune response)? In that case, I see your point.
Now, even assuming that the medication doesn't actually interfere with your immune system and just gets rid of the symptoms and makes you feel great, you should be aware that your immune system deliberately makes you feel crappy ("sickness behaviour") so that you'll rest and give your immune system a chance to kill the infection. This is more an issue with the flu rather than the cold.
I think the difference with cold remedies is that they tend to interfere with immune responses that are far downstream that tend to be more symptomatic, rather than major mechanisms by which the body's immune system works.
I give Acetaminophen/Paracetamol/Tylenol for pain, and a mucogenic (Guifanesin or the much better Mucosolvan/Ambroxol if I can get it from Europe) to thin out the mucus secretions.
It goes against instinct but making more mucus keeps it from building up and turning into that gunk that starts sinus/ear infections and never gets out of your lungs once the cold has passed.
I really wish Ambroxol would be approved in the USA, but apparently it's too old of a molecule to successfully recoup the FDA approval expenses.
The case I see more often is people get obvious cold symptoms and are back at work the next day. Thanks to symptom reducers they don't have to rest or eat properly for the condition, so their light symptoms persist for weeks. That also leads to complications.
Also I should have mentioned that most adults are not healthy and don't eat healthy to begin with, which creates a ripe market for band aid medications.
Typically food will reduce symptoms by stimulating the immune system to work faster. Attempts at immediate relief will be short lived. That's how people traditionally treated disease. It's still a valid approach for light ailments where modern medicine can be a harmful crutch.
Could you explain a bit more as I can think of a case where this seems to be false: While my child's body can eventually handle colds and flus, if his temperature goes above a certain level there's a significant chance for brain-damage, so I counteract the bodies natural fever with medication.
If you're running a 101 degree fever, it may be more effective not to suppress it.
Which sets up a glorious chicken and egg where due to the peculiar anatomy of my sinuses or whatever, I find it nearly impossible to rest without some form of cold medicine. By the end of a simple cold, I'm really looking forward to finally getting a decent nights sleep and not feeling miserable when I'm sitting around.
Got a cold-like thing that turned into bronchitis a few weeks before my wedding. Still had it during my honeymoon a couple weeks later and lingering symptoms for a couple more months afterwards. With the veritable arsenal of meds I had, I barely scraped by and with no ER visits even after waking up most nights of the week for a couple weeks with asthma attacks at its worst. Wooo. Not something I'd wish on my worst enemy. I'm amazed I did what I did given how tired and shitty I felt despite everything. Feeling sick really sucks.
Ate well, exercised regularly, actually just straight up stopped working for other reasons so I had plenty of time to rest. < for parent commenter who seems to care about such things.
Ahem. Anyway, here's what Wikipedia has to say:
"The symptoms of the common cold are believed to be primarily related to the immune response to the virus. The mechanism of this immune response is virus specific. For example, the rhinovirus is typically acquired by direct contact; it binds to human ICAM-1 receptors through unknown mechanisms to trigger the release of inflammatory mediators. These inflammatory mediators then produce the symptoms."
Wikipedia may not be any more reliable than me, but at least it's something. Unfortunately it looks like the cited paper is behind a paywall.
I'm not aware of anything that shows that people who take medications to alleviate symptoms take longer to recover than those who don't, while they're often more comfortable in the meantime. That seems sufficient to establish "overreaction."
Better: Generic
Best: Nothing
"If takes about 1 week to get over a cold if you don't take medicine, but only 7 days to get over a cold if you take medicine."
"It takes about 1 week to get over a cold if you don't take medicine. It still takes 1 week to get over a cold with medicine, but you'll feel much less hindered by the effects of the cold itself."