Most of you don't know the USA is the only country in the free world that prohibits Big Pharma's from having to competitively bid for their business. When traveling in Egypt with a young Internist from Columbia University, he was having a bit of stomach upset and said we needed to locate a pharmacy is in this moderate sized city. We found one and the Egyptian guy said his name was Dr. something - I doubt he had more than a high school education if that. But every Big Pharma including all the big Swiss Pharma's had their products represented.
The leader of the world wide Big Pharma is the CEO of Eli Lilly, David Ricks. The USA spends almost 19% of our GNP on healthcare. The French have an excellent system and spend less than 1/2 the rate we do. The French trained all of our best physicians during the Revolutionary War among them Benjamin Rush.
The AMA is the most powerful lobby group on earth - think about that - will it ever change - not till the money barrier is solved.
52
Significant and huge Big Pharma PACs have existed in Washington since at least the 1960s. Government oversight of Pharma has been poor for 30-50 years; and it’s no surprise to learn that Pharma’s manufacturing processes have become as corrupt as the rest of their operations. But it is certainly discouraging.
Poor pathetic Pharma is inflicted with enormous cost in the process of developing a new medication: that processing includes chemical identification of a potential med; plus testing (usually animal and then human); scientific review and so on; finally potential product is submitted to FDA, apparently yet another corrupt government agency.
A new book is needed, one that offers remedies for change, for safe manufacturing practices, for reduction of greed and such driven profit motive.
12
If this is true, we are all in trouble.
Since corporate American owns us (thank you, Citizens United) and since people like the Koch Brothers (who spend millions and millions on Congressional, State and Local campaigns) believe that no government is the best government, we are unlikely to see a turnaround any time soon. And isn't it pathetic that corporate profits in all industries have more priority in our laws and government than people's lives?
The love of money is the root of all evil. Still true. Very prevalent and perhaps, until Trump, somewhat camouflaged, but not new.
Every agency -- the FDA, the EPA, the FAA, is CPA -- even the IRS -- have been decimated by cuts under the Republicans. Why? So corporations can make more money for the shareholders (not the workers, who do not share in the increased profit margins and the CEOs.)
How much money is enough? There is no limit. If you are mentally ill, no amount of money will satisfy your craven need. That disease pervades our leadership.
The people who are most harmed by this do not understand why or how and likely do not know or care. Thank FOX and Sinclair. Thank McConnell and Trump.
Vote for Warren, vote for Dems across the board. We are all dying, poisoning the earth and our bodies, thanks to unbridled greed, lies, hubris. The easily duped MAGA people who believe everything the see and hear on FOX and elect these thugs is applauding their own demise.
Really, really frightening.
134
Wow this is a bombshell report.
31
In parallel to the scandal outlined in "A Bottle of Lies," another overseas, under inspected crisis looms on the horizon. U.S. commercial airlines are thronging to outsource aircraft maintenance to the far corners of the Earth. All carriers, even the big three, send much of their heavy maintenance overseas, out of the easy access to FAA inspectors. When overworked FAA inspectors do get to visit foreign maintenance facilities, the host nations require advance notice for visits.
50
The speed and production have indeed become desirable features over accuracy and quality but this phenomenon is not limited to pharma industry. It has become a norm of excellence in a wide range of activities. Medical industry is fortunate to detect the direct cost of this approach, perhaps, because we pay it with our own lives.
12
There are many ways this story could have been told (weakness of US regulators, poor practices in India, etc.) The choice to make it about the "Generic Drug Industry" has me wondering if the "non-fiction" book isn't just a piece of big pharma marketing fiction rather than an accurate portrayal of a massive global industry with hundreds/thousands of factories around the world.
There is a mystique about branded drugs, perpetuated by great advertising, heavy investment in giving freebies to health care professionals, and other techniques for generating positive vibe. The reality is a bit different. Producing a branded drug is not much different from making a generic. Both cost cents per pill and have similar manufacturing processes around the same identical molecule (bio-equivalency is a requirement for generics). Problems that arise in production and distribution of generics can also occur in branded names.
Americans are one of the most overdosed people in the world. All drugs have side-effects, and many are of questionable value. Considering the huge expenditure on both branded and generics, it is worth reconsidering all drug treatments.
35
Carefup what you wish for with single payer. Do you honestly think our resource constrained government will allow us brand name drugs when generics are available? We will be forced to use these problematic generics produced overseas in southeast Asia. Personally, I will be able to afford the $1000 a month to buy my brand names out of pocket. Can the rest of you say the same?
7
The Generic companies should be charged licensing fees payed to the FDA that go directly toward regular testing and oversight. If a company continues to fail tests have them lose their license to sell in the US.
There should also be publication - like recalls in major news outlets that regularly lists companies and their drugs that fail tests. In part as a public shaming and impart as warning to Dr's and customers and also as a notice to these companies to get their act together.
Lets get serious.
The US government/ Insurance companies and Dr's organizations should put pressure on the Indian and Chinese governments to pressure their generic companies to comply with regulated quality control or the US will stop ordering generics from them.
Write your Senators and Congresspeople
55
Its not just Drugs. It is everything else we buy. 12 years ago Colgate toothpaste was being sold in the US which was contaminated by poisonous antifreeze. I had a tube of this stuff and had used most of it up. I contacted Colgate and they were eager to get the tube back from me and to send some coupons. The tube was destined for the South Africa market and some how made its way to the US. It was manufactured in China. Colgate insisted the product itself was counterfeit. More likely Colgate licensed the product for manufacture in South Africa so they would indeed be liable.
Adding to the confusion, I was hospitalized a year later in the US and I was given a small tube of toothpaste similarly recalled.
https://www.supermarketnews.com/nonfood/counterfeit-colgate-toothpaste-recalled-possibly-poisonous
30
I have some serious health issues, including two auto-immune disorders. So I checked out the five prescriptions that I must take daily; NOT ONE is made in the United States, nor by a US company, nor a US subsidiary of a US company. Every single one is made overseas by an overseas manufacturer. The common denominator is that all are made in the least expensive markets in which businesses can obtain an educated labor force and inexpensive real estate and capital improvements.
The real question is not whether a prescription medication is branded or generic. The question is whether a medication is made by a reputable company or not. The problem is that a consumer cannot get reliable information about manufacturing safety overseas, but neither can we get it in the United States.
When companies can - and do - pay millions of dollars to game the system to extend their patent rights to drugs; when they buy off the developers of generic drugs to keep them off the market; and when they extend patents through unneeded changes in delivery systems, etc. how can a consumer EVER believe that they have his/her interests in mind? Quite simply, they do not.
One of the worst changes in US policy in my lifetime is allowing pharmaceutical advertising. "Ask your doctor..." could be stricken from the lexicon of commercial speech to save us billions.
107
We should start a movement on change.org to ban drug ads to consumers. Patients shouldn't be telling doctors what to prescribe or informing their doctors of their medical history--it should be the other way around.
35
As someone commented below, we are facing a collapse of ethics. This severely restricts our collective ability to function as a civil society. The quality problems in the drug industry and the success of corrupt know-nothing politicians on all sides are merely symptoms of this collapse. We’ve been here before in our rich and long history, and have managed to eventually adjust from within the system without experiencing any revolutions. We are now under severe socio-economic stress once again and our system’s ability to survive is being tested as never before. So don’t just sit there reading about it. Do something!
50
I sometimes wonder which is better for an illness - a generic medicine made overseas which does not work OR a US made medicine which works but costs ten times what it should and drives me bankrupt.
It is time for Big Pharma to get off their high horse and abandon their holier than thou attitude.Both the options are equally bad.
26
How many arguments have I had with doctors about the difference between a brand drug and its so-called generic equivalent? "Oh, it's the same thing, but at a fraction of the cost!" Well, no, my body says it isn't.
I have taken a med very sparingly for 20 years—about twice a month when I have trouble sleeping—and I have to pay 10 times the copay for the brand as I do for the generic because my insurance will only cover the cost of generic.
No matter that I wake up hungover and feeling rocky after taking the generic and I wake up feeling rested after taking the brand—they're "the same."
I suddenly developed an allergic rash which I finally narrowed down to the generic thyroid med I had been taken for decades and I learned that the generic had switched to a different distributor. I got a prescription for the brand med and the rash went away. Why was that? The generic manufacturer assured me that they hadn't changed anything, just the distributor. An amazing coincidence.
The whole of medicine, every aspect of it, relies on trust. What choice do we have but to trust the people who make a living off our ailments?
119
@dutchiris
the choice we have is to take health care out of the realm of profit making enterprise.
the choice we have is to vote into office at every level of local, state and federal government those who will take health care out of the realm of profit making enterprise.
69
Not funding effective FDA enforcement has consequences.
112
@Stomach acid
This. This right here.
Bingo.
20
That book and that review make me angry, but not for the reason their authors intended. Talk about "bottle of lies" - what an ample title. The lies being the stated equivalencies between "generic" and "dangerous", and "brand-name" and "safe". One can clearly see the origin of both the book and the review, both being parts of the same corporate propaganda campaign by the Big Pharma directed at discrediting the competition and protecting the value of its brands. Most generic drugs are perfectly safe and they saved untold millions of lives in Africa and elsewhere. It is not generic nature of a drug (generic simply means non-brand-name, as some of them are made in the same factories using the same processes as the branded medicines) which makes it dangerous, but the lack of proper safety controls and regulations. That should have been the real story. And this issue is not limited to pharma industry, as the examples of Takata airbags and VW fuel emission scam amply demonstrate. When profit is the king, without constant vigilance and safety enforcement, corners will always be cut and public will be put at risk for an extra buck. That has nothing to do with "generic" vs "patented" - in that argument the Big Pharma has no leg to stand on. So they decided to smear competition and scare the public, so that they could continue to extort exorbitant prices out of sick people. Shameful,Katherine Eban, and shameful, NYT. But lucrative for both, no doubt.
35
@David Dear David,
I share your experience of anger ... but assuredly not for the same reason that you express.
Alas, now somewhat aged, I happen to be a person who experiences "reactions" to, "sensitivities" to many things in the surrounding world, especially to almost any chemical concoction that represents itself as a medication or a drug. Brand name or generic, any of them are very dangerous to me and my body.
What is worse is your evocation of airbags. For me any airbag is potentially murderous, for the same reason that children of a certain age must sit in the back seat of a vehicle. Guess why!—airbags would kill them [or me] unless they [we] are of a certain weight and size.
So many faulty products and faulty remedies are a heartbreak. I am sure you and I can agree on that.
6
who would have thought that we're back to the era of corrupt practices exposed by Upton Sinclair in The Jungle?
The Pure Food and Drug Act was passed by Congress to protect Americans from risks like these. In 1906.
81
Several facts help elucidate the trends in the pharmaceutical industry that facilitate the proliferation of unsafe generic drugs. The first is the Draconian cutback of the FDA under Republican administrations, going back to Reagan. Cuts were made to staffing and funding, with Newt Gingrich playing a heavyweight, cutting chunks away from the FDA. Just since Bush the minor, over 1,300 jobs have been removed.
The second factor, according to OpenSecrets, a nonpartisan, independent research group tracking money in US politics, individual companies within the pharmaceuticals and health products sector spent $194.3 million on lobbying as of October 24, 2018 over and above the amount disclosed by PhRMA. They are lobbying to encourage fewer inspections, and less enforcement of what little is left.
It's very difficult to get a brand name in any drug or medical device today, and one finds lots of problems with the generics--many made in India and China where there is virtually no supervision of quality. Americasn lives are being threatened by the greed of the powerful pharmaceutical industry--so what else is new these days?
66
This is my temporary, personal solution to this horrible systemic problems described in this book, After many in my extended family experienced ineffective generics, I found a neighborhood pharmacy willing to order our generic drugs from specified American manufacturers. Although this book reveals that those drugs I thought were manufactured in the USA may be from overseas, we haven't noticed any problems. I do my best to keep that pharmacy in business by purchasing their OTC and other items at their slightly prices (admittedly a selfish luxury I can afford).
13
Most of us count on safe generics and brand name drugs hoping we are purchasing products we trust. Years ago, I began purchasing name brand non-prescription drugs, believing I was getting higher quality and more reliable medications. I believed the active ingredients in the more expensive brand name drugs were not diluted. Not anymore. Yet, knowing the many companies and drug chains that offer foreign made generics - Walmart, CVS, Walgreens, etc. I continue to purchase,Tylenol assuming a probability that the name brand might be 'safer'.
Thank you, David Dobbs for this informative and timely article. BOTTLE OF LIES, by Katherine Eban should be on everyone's book list.
I would also highly recommend Rosemary Gibson's, CHINA RX - published in 2018 as another important book that examines our dependency on foreign made drugs. Ms Gibson's book focuses on the booming drug industry in China. Most important, Gibson's book highlights the inefficiency and lack of our government's oversight of regulatory procedure on the drugs that flood our market.
"Bottle of Lies" is an appropriate phrase we should keep in mind when choosing our medications.
30
Whether or not the book is funded by name brand drug manufacturers is almost irrelevant. Either way it shows a very dark side of unregulated capitalism.
39
My employer based insurance originally paid for along with a copay for six Cialis per month. not cheap but possibly a marriage saver. Than they stopped paying. The price shot up over and over until they became totally out of reach at about $22. per pill. I decided to try a generic overseas shipment. They were Tadicip by Cipla. Ten years latter I still enjoy a healthy sex life because at $2. a pill ,I can take them at ease and , trust me, they undoubtedly do the trick.Shame on Big pharma for charging prices that keep poor and middle class citizens unable to pay.
10
Is the purpose of this book to scare people into buying the much more expensive name brand drugs??
9
@Robin No it isn’t. The purpose is to enlighten us to the high levels of corruption in the dug industries of India and China. Did you miss that 80% of the active ingredients of ALL drugs in America, generic and non-generic, come from India and China?
34
We don't make many shoes in this country anymore. The President seems keen on made in America. Is there some reason generic drugs can't be made here at competitive prices with guaranteed quality controls? I wonder where my generic Tylenol is made. The bottle only provides a U.S. distributor.
24
Kaiser recently switched my generic Tegretol (carbamezepine) from Teva (Israeli) to Torrent Pharmaceuticals (East Indian). The first few days on that med, I could barely keep my eyes open. I did eventually habituate to it, however, and my blood levels are therapeutic. But still ...
12
How are we supposed to know this book isn't part of a scheme by drug companies to stay away from generic drugs. And that's how crazy the world has become.
19
@zb Speaking from personal experience, my family have had horrific and frightening problems with some of our generics. I’m very grateful someone is finally bringing light to this issue! I have no connection to the pharmaceutical industry — I’m just chronically sick person married to someone with an advanced neurodegenerative disease. I’m fed up with paying too much for my medications as everyone else.
18
@zb
An easier to answer question is - how do we know that it is part of such scheme? Because NYT printed a glowing review of it - that's how. Because the Big Pharma would not leave anything to chance in such corporate propaganda campaign. So a follow-up review in NYT to promote the book and its argument against generic drugs is the only way to go.
6
I do not share the everyone is out to get us worldview. Thankfully.
It must be very debilitating to do so.
8
We need to bring back all drug manufacturing to the U.S. and get the heck out of China and India where there is lax (if any) regulatory oversight, and where there are hundreds of incidents of mislabeling, counterfeiting, adulteration with poisonous substances, and toxicity laced products, bad branded and generic drugs, vaccines, dog food and treats, fish, food, candy and infant formulas.
THE CHINESE do not trust the drugs, vaccines, food and even DOG and CAT FOOD produced in China. They get it from other countries - like Taiwan, NZ, America and Australia.
It should be illegal for any American company to produce and market anything in CHINA that is intended for Americans and our pets.
68
Or India?
Not that I disagree with you. But it's not just China that has shoddy production.
23
Whenever I hear Republicans complaining about "job-killing regulations", I think of issues like this article. Such regulations are probably out there somewhere, but most are more like "life-saving supervision and oversight"
239
@Michael Ando thank you. Without my daily asthma inhaler I would not have enough air, and without my Wellbutrin I would speed the dying process. It doesn’t matter if my prescription meds “shorten” my life compared to those without asthma and depression because the drugs extend my personal life compared to not having the meds.
13
@Michael Ando
Why have job-killing regulation when you can have human-killing deregulation? /s
47
@Michael Ando Better to have job-killing regulations (if that's even a thing) than people-killing deregulation.
23
Hey everyone, let's call overseas manufacturers unethical while our 'regulation-abiding' pharmas illegally proliferate painkillers and start an opioid epidemic. So by showing me worse companies, am I to think that our pharmas are any better? Oh overseas manufacturers should have better regulation and inspections we all say? And what of our supplement pills industry and the complete lack of oversight there? This article just raises a mirror to our industries and selectice lack of regulation
21
Overpay for poison, this is America.
11
"60 Minutes" just did a great -- and infuriating -- segment on how generic manufacturers are conspiring and colluding (yes, there's that word again!) with each other to fix prices on generics, limit competition, divide the market amongst themselves. etc.
Couple that with previous work from them plus this book, and much other fact-finding on the lousy to dangerous 'quality' of these generics, the many recalls, the constant jerking around of consumers who rely on medications ... and it's just mind-bending.
36
I take a prescription medicine for migraines. About two years, my pharmacy switched to Ranbaxy as the supplier. The medicine was totally ineffective, which had never happened previously. I contacted the pharmacy, who of course insisted that everything was fine. I changed pharmacy and got a refill from another supplier. The drug worked as expected. I was convinced back then that the drug was either not the correct dosage or a total fraud. Everyone insisted this wasn't possible. Now I'm learning that I probably wasn't imagining it.
130
Two words: tort reform.
So-called tort reform has insulated manufacturers from responsibility for the products they produce. It has assured that victims will not be adequately compensated and that manufacturers won't be deterred from shoddy manufacturing and design processes.
If a manufacturer knows that it can earn $10M on a product but will face $2M in liabilities to people that are hurt, one hopes that ethical managers would opt not to produce that product. Unfortunately, where ethical managers decide not to tread, there are unethical ones to take their places.
And the unethical ones earn all of the profits, gain all of the promotions, and buy all of the politicians. FDA approval now is a shield to liability, but certainly no assurance of quality or even safety.
The problem with India and China is that they have never had effective civil liability systems. Our problem is that we've allowed ours to be undermined.
48
I worked in a hospital pharmacy in the early 1990's just when the profit making was taking off in the generic drug trade. The pharmacists were frequently getting recall notices on batches of generic drugs. We would have to pull those medicines from the inventory. There would be problems of particulate contamination of "sterile" vials of medications, etc. Or the ingredients of generic tablets did not match the formulary. You would think when such problems were frequent then that they would have been cleaned up by now.
39
I am dealing with the issue of trying to preserve and encourage development of affordable housing here in Miami among the least affordable places to live in the nation. You may not realize it but the lack of affordable housing is among the most serious issues facing the nation.
A line in this review struck my attention:
"Her portrayal of Thakur’s plight will set crawling the skin of anyone who has alerted regulators to horrid misdeeds only to find those regulators not just timid but outright protective of the villains."
Sadly, this is true of my own experience in dealing with the politicians, officials, developers and all the other rich and powerful interests who run this community.
What has become of us or is this the way it has always been? The battle is not over yet but from our president on down and even the ones i thought were on the side of doing right it surely seems that everywhere we look evil is winning the war.
44
Between insurance companies fiddling with prescription coverage and doctors focused on checkboxes instead of actual individual patients, I feel that the few medications I take help on the one hand and hurt on the other, so that I never really get better, which is just what big pharma and the insurance industry wants—people well enough to function and pay for drugs but not be cured.
15
This is the best information yet for people to start taking their health and wellness seriously, to eat right and move their bodies more to avoid the poison that is prescribed like candy.
15
Drs have always known that generics drug versions of medication are unpredictable and not always as good. Try mentioning this to the FDA. They have been throwing their arms up in the air saying "generic drugs work just as well as brands" and in many or most cases it just isn't true. Patients can have different reactions switching from one generic manufacturer to another, of the SAME drug. The fillers, formulas and manufacturing are different. They are also, as you can see from this book, made in shady places by shady companies. Brand name drugs have reached a point where nobody can afford them and insurance won't pay for them. Great system...
27
This is a good moment to acknowledge John le Carré, whose 2001 novel "The Constant Gardner" pretty much nailed the problem of profiteers' passing off fatal medicines to unsuspecting – or badly corrupted – nations.
The book was mostly set in Africa, which the review of Ms. Eban's book says today's "companies consider the safest place to send faulty drugs." Mr. le Carré has a long record of prescience for changes in worldwide espionage, new dangers to nations, and now it would seem for an important part of our deteriorating health care systems.
14
One of the pieces of disinformation that's been spread to the American patient/consumer is we're not allowed to order pharmaceuticals from Canada to protect our safety - the implication being that drugs from Canada are less safe then those purchased here. The problem, of course, is that drugs purchased here - particularly generics - are likely manufactured overseas. As this book points out, in many cases in countries such as India where there is little to no oversight or appropriate inspection by the FDA. Most Americans are unaware of the fact that our health and safety are potentially being compromised every time we're prescribed generic drugs. Yet another reminder that generic drugs are not identical to brand name drugs. This is a very dangerous oversight on the part of the FDA - and is misleading all of us into believing generics are safe and effective, when they very well may not be. I'd much rather take my chances with our neighbor to the north - with the added benefit of significant cost savings for many drugs
28
And this is different from the non-generic drug world how?
6
Is this book an expose' or another conspiracy theory like vaccines?
As a physician myself, I cannot but disagree. There will always be examples of corruption and wrongdoing, but most often when brand name drugs patents' expire I find that patients benefit by having that drug in generic form that is easier to get covered for.
Yes, we depend on our government to be the watchdog to prevent fraud. But most of the time it works.
There are regulations with generics and most of the time they work very close to what the brand name does.
I get my own meds in generic form.
If we all do then the expense of medical care goes down.
And brand names can have their own issues as well.
I often feel that when a drug goes generic it starts getting a bad rap. Perhaps the opposite of what is said about them is true and their newly found "risks" are pushed by the brand names, but I do not want to sound paranoid about it either.
Lets be responsible about our medical expenses.
35
@Lili B
This is hardly the first expose on both generic and prescription drugs (i.e. China RX and others).
Have you read any of these books? Have you checked their references?
As a doctor, you know that 'facts' need to be checked. And I'm sure that you have encountered corruption in the medical/health industry.
We can't blindly believe/hope that companies are acting in our best interests anymore. Our health is at stake.
A doctor in Phoenix died from contaminated heparin from China. His wife, also a physician, sued the company (per her husband's wishes) that was having the drug produced in China and won.
Dr. NL
37
@Lili B I would encourage you to go the the FDA website-www.fda.gov-and type "Ranbaxy warning letter" (technical title is a 483 letter) into the search field and see what comes up. Yes, Ranbaxy's Toansa plant was manufacturing API (active pharmaceutical ingredients) that was repeatedly retested until it passed and failing results were not documented. The associated press release states that Ranbaxy products from the Toansa facility were banned from the US market. Ranbaxy has subsequently been purchased by Sun Pharma. So no, this isn't a conspiracy theory. FDA oversight in ex-US facilities is spotty at best.
37
Where are the brand name drugs manufactured?
Is there any guarantee that brand name drugs are manufactured in better conditions?
The conditions described in article are really horrifying, but are generic drugs makers oversea the only culprits?
128
@NYC60
per the article "80 percent of the active ingredients used in both generic and brand-name medications come from India and China"
22
Good luck with that. insurance companies won't pay for brand name drugs if generic is available.
12
@NYC60 Depends if the pharma company accepts the manufacturer's certificate of analysis at face value and how diligent their quality team is about auditing the manufacturer (many pharma companies outsource the manufacturing of the active pharmaceutical ingredient to third party manufacturers known as a CMO-contract manufacturing organization. The CoA may contain actual test results on the batch, which a pharma company could verify through third party testing. Whether they do the third party testing or not is another question. I hate to say it depends, but it depends.
11
Can one sue generic companies? Or do consumers not have even that priviledge? This is a frightening scenario for most people lulled into thinking the FDA is looking after their safety. I will be sure to stay off generics from now onwards.
34
@Meena
Unfortunately, a 5-4 ruling by the Supremes in Pliva v. Mensing, 2012, had the effect of immunizing most generic drugmakers from liability suits. Congress could fix this, but likely won't.
22
While I am thinking of using the same strategy, I have serious concerns the innovative companies may be off-shoring production and possibly purchasing raw materials (organic reagents) from lowest price global markets where production is not “hampered” or “strangled” by excessive regulations.
8
The US should impose a special tax on generic manufacturers to fund a regulatory regime to protect US citizens from rapacious generic manufacturers. This past weekend 60 Minutes reported on a price collusion conspiracy among our domestic generic manufacturers. This industry looks criminally dirty, top to bottom, domestically and abroad. Let the industry pay for the oversight needed to protect us from being harmed by these “health providers”.
27
Hey, class action lawyers, this one’s made for you !
Get to work: unite law firms to share the cost of big data on the differences in outcomes, find someone who gives you an easier causality path (tough, but not impossible) to be named plaintiffs, and bring out the whistle blowers! Send investigators to find them in India and China, and the whistleblowers get quite a pay day, too.
I think with the corruption in all of government, only class action lawyers (remember tobacco) can help us now.
47
@Lily
Didn't you read the waiver you signed when you picked up your last generic prescription. In it, you agreed to binding arbitration of all quality issues with the drugs you received, with arbitration from the Association of Friends of the Generic Drug Manufacturers' Association. And the Supreme Court agrees we can give away our right to access our legal system at the click of a mouse, after all!
11
Be sure to read this in conjunction with Sunday's Article, also here in the NY Times, "Americans Need Generic Drugs, But Can They Trust Them?" and you will never want to take another generic drug again.
I just took my 1 year old son to get vaccines last week. I am a big proponent of vaccination, but after these articles, I wonder what he was injected with. I don't know if it was a generic or not, I don't know where it was manufactured. But stories like this add momentum to the anti-vaxxer movement, and then everybody loses.
21
@Alex Wood
Ask the nurse to show you the label of the vaccine that is to be administered. It will have the manufacturer and the lot number.
14
My Losartan has been switched twice now because of recalls. I don’t know if the ones I’m taking now are safe or not.
44
@Cindy Mackie
The CVS hasn't filled my most recent Rx for Losartan... no reason given but it's "not available."
17
The US government should manufacture generic drugs, a new arm of the NIH. Period. There is no downside.
97
@A J There is a huge downside, if it is under the oversight of an administration such as our current one.
21
@A JHow quickly we forget... the government cannot even keep itself open how is it supposed to manufacture lifesaving drugs at affordable cost?
https://www.bloomberg.com/news/live-blog/2019-01-24/u-s-enters-day-35-of-government-shutdown
6
@Sarah D.
As far as I can tell, the worst case scenario for underfunded oversight of a nationalized pharmaceutical industry by a corrupt administration would merely amount to a return to the present-day status quo of being supplied by unaccountable, profiteering private industries.
7
What you see here is the collapse of ethics. The doom of humans.
51
The article focuses on generics, as if they're the problem, but near the bottom of this piece comes this sentence: "At the same time, even brand-name companies are increasingly hiring poorly regulated Indian and Asian plants to make their ingredients or formulations."
The focus on generics in the rest of the article then seems a misleading red herring -- to the benefit of no one except the insanely expensive brand-name drug industry.
83
Excellent review of a book I will definitely put on my Must Read list. Another example of human greed chomping away at human morals and ethics like termites. Does Ms. Eban mention that the US Supremes ruled that generic versions
of a drug have zero liability to warn consumers of dangers, unlike the original ? I think it happened years ago. Along with the Navy wins/Whales Lose decision. (It had to do with Sonar.)
14
I’d be curious to see an actual article on this issue rather than just a book review. It sounds like it deserves some in depth investigative journalism.
19
@Eric Here's one from 2010 about Ranbaxy, the company described in the review.
https://www.nytimes.com/2010/03/13/business/13generic.html
5
@Eric
you can read the book
4
What we are seeing is the collapse of our systems of checks and balances. Notice how this is the underlying "news" in each article you read today: "We can no longer ensure your safety." There are so many systems that have been in effect, limping along for 50-100 years, and they are now starting to fail. Buckle up folks, this is just the beginning.
70
The writer Katherine Eban wrote an Op-Ed a few days ago so you can read directly too what she thinks:
https://www.nytimes.com/2019/05/11/opinion/sunday/generic-drugs-safety.html
And for comment readers like me, interestingly, Dinesh Thakur wrote some comments on that article if you scroll down enough. I often learn as much from comments as the article.
16
Same! And thank you!
5
Please contact the FDA and your congressional representative, senators, and the House and Senate FDA authorizing and appropriations committees.
FDA, the IRS, EPA, and other regulatory agencies have been underfunded for years. See this 2007 workshop summary from the NIH:
https://www.ncbi.nlm.nih.gov/books/NBK52926/
https://appropriations.house.gov/subcommittees/agriculture-rural-development-food-and-drug-administration-and-related-agencies-116th
Here are the links to the congressional committees:
https://appropriations.house.gov/subcommittees/agriculture-rural-development-food-and-drug-administration-and-related-agencies-113th
https://www.appropriations.senate.gov/subcommittees/agriculture-rural-development-food-and-drug-administration-and-related-agencies
https://energycommerce.house.gov/subcommittees/health-116th-congress
https://www.help.senate.gov
And here's the "contacts" website for FDA:
https://www.fda.gov/about-fda/contact-fda
17
Stop buying drugs from India and china.
9
I do remember reading an article on a science website a couple years ago that stated that as many as 40% of all "brand name" prescription medications are fakes from China - that is just placebos, sugar pills, etc. packaged to look like well known brands of prescription medicines.
12
I worked in generic pharmaceuticals for 10 years including nearly 3 for an Indian company. The 2 US based manufacturers were pretty ethical in their manufacturing and quality protocols and processes. One in particular was exceptional in their emphasis on safety and quality as well as regulatory compliance.
The Indian company always went into production slowdowns prior to and during FDA inspections. Up until a few years ago they knew well in advance of an inspection and cleared out all incriminating evidence. Once notified of an adverse event they tested and tested until they came up with in spec results. The issues were known across the company from the higher levels on down. The fundamental cause was cultural, the Indian culture does not appear to define honesty in same terms as the West. My colleagues would lie to my face, I’d know they were lying, they knew that I knew, and all would job head bobble awaiting the next disaster.
I’ve been wondering when this would become public knowledge am am relieved it has. The US is poised to endure a drug supply crisis with the closing of US production and the instability of Asian production. The shift of API manufacturing from Europe & Israel to Asia is frightening. There is the same disciplined approach to production, testing, and shipping.
74
@Schimsa
Corrections to my post
“ and would job head bobble” should read “and would just head bobble”
“There is the same disciplined approach to production, testing, and shipping.” Should read as “There is NOT the same approach to production, testing, and shipping.”
My apologies.
6
Best case scenario Government agencies under strict supervision make and provide drugs for free as part of a Universal healthcare system, but for the time being, regulators like the F.D.A keep regulating them and Generic drugs
8
I hope our American Medical Association acts ethically on this matter and demands change from the F.D.A. (chance to change the AMA’s in-the-toilet current public image).
For years I have said to doctors, “the generic doesn’t work the same as the brand”, only to be told, as though I were a child (and sometimes with hostility), “the generic has the exact same components as the brand”.
Immense gratitude the author tackled this disgraceful matter so authoritatively.
It’s also time for us voters to deluge our government representatives demanding change.
170
If only there would be like in the sixties the passion of the public to effect changes. I realize living today technology and all raising families is much harder and young people are working hard to get a start.
8
Most of the drugs, including branded ones, sold and consumed in USA are made either in India or China. Why is the country of manufacture not stamped on the drug package? And what is the patient to do?
137
@MW MD
I'd guess that the country of origin is mostly irrelevant here. Iphones are made in China, and they are in my experience over multiple versions and years of use, near flawless. I am more interested in manufacturing quality measurements, purity measurements, etc.
Let's put a simple ABCDEF rating like the ones that restaurants in California get put on the windows of those establishments. That rating goes on the label of any prescriptions made and sold. I realize that the inspections have to be better (not a farce) but do that and at least I would think twice about taking something with an "F" rating.
12
I am a doctor and I am from India. When I grew up in India milk was adulterated with water, rice with stones and rocks that could kill your teeth--there was no guarantee you wouldn't find heavy metals in your water or in your cosmetics or you won't find fecal bacteria in your fruits and your veggies. Now I say America is in the same state. I don't trust the FDA at all. The FDA inspection teams are understaffed, overworked and muzzled in order that they may keep their jobs. I am forced to use generics in my practice. The results are poor for anti depressants, for generic thyroid, for anti hypertensives and anti diabetics. As a physician you're always confused whether the lab results and physical exams are not up to par because of patient non compliance or is that because of the generics not being potent enough or being contaminated with toxic by products. The recent recalls of anti hypertensives is not inspiring of trust. I am fed up of the global market for generics. This market has no transparency and no accountability. It might well be pro disease and toxicity rather than anti disease.
303
@Usha Srinivasan
If you can stay off prescription drugs until Trump is out of office in 2020, there is hope that regulation in the United States will again be valued.
17
Would it be too cynical to inquire where is the greater harm? Is it in poor regulation of overseas generic manufacturers and occasionally contaminated drugs? Or, is it in the over-hyped, over-prescribed, and over-expensive name-brand drugs (thereby creating a market for generics)? Greedy corporations have seduced so many people into poor nutrition, unhealthy lifestyles, with concomitant ailments, and seduced them again into the delusion that pills, pills, and more pills will make it all better. All for profit.
29
@Mynheer Peeperkorn
How many of the drugs these generics are intended to imitate are either poor performers, or perform no better than a cheaper medication that has been on the market for decades? There's much more incentive to manufacture a hair growth creme, which has to be used in perpetuity, than a lifesaving antibiotic used for a couple of weeks.
7
If one votes republican, then this is exactly what one should expect: deregulation and a “drowned in the bathtub” under resourced government that cannot carry put proper inspections.
151
@Me myself I--please stop these biased attacks based on politics. If this is the fault of Republican govt, how do you account for the fact that, prior to trump, 16 of the past 24 years have been democratic presidents and nothing happened to fix this problem then.
6
@bored critic Funding decisions are made by congress, and Republican congressfolk have been more hostile towards government regulation than Democratic congressfolk, on average, as well as proponents of deregulation. That's been a pillar of the Republican Party's agenda for several years.
29
@bored critic
I think that "16 of the past 24 years have been democratic presidents and nothing happened to fix this problem" is a simplification.
1. How do you know that this problem has persisted for 24 years? In the past, more generic medication was produced domestically. For example, NJ has been host to many generic drug plants. Unfortunately, many have closed (e.g., West-Ward Pharmaceuticals) because it is cheaper to produce drugs abroad. As noted here, drugs produced domestically have passed regulations.
2. Considering that the FDA was not operational during the recent month-long government shutdown as well as the Trump administration's actions to cut back on drug regulations and approve record-setting numbers of new drugs (without the same record of drug trials and tests as previous years), it is impossible to believe that Trump or members of his administration care about whether any American's drugs work or are uncontaminated. Do you think Trump has ever taken generic meds in his life?
The reality is that the quality of our meds and the quality of our healthcare is a political issue that requires taxpayer money. We cannot rely on private healthcare and drug manufacturing companies to do the right thing.
27
Serious Presidential candidates are talking about government controls and the Sacklers are being called to account for addicting America to opioids.
Then, suddenly comes this pervasive media buzz on the theme of “generic drugs are dangerous.”
Golly, I wonder who might be funding it?
15
@JL Williams
Almost every advertising dollar on TV now seems to come from Big Pharma. It's no longer just the nightly news, or a major network, even the niche networks who once subsisted on selling garden hoses and non-stick pans are vehicles for this non-stop promotion. The message should be that the drug companies have money to burn which is not being used on R&D, retain carte blanche from Congress to gouge the market, and are happy to rub the fact in your face several times an hour.
17
@JL Williams
Interesting point indeed.
2
@JL Williams
You have articulated nothing more than a conspiracy theory to cast doubt on a consumer protection story. Far from encouraging the public to purchase name-brand medications, the author also expresses her concern that they also include active ingredients sourced in India and China.
Unless you have some proof that Eban is in the pocket of Big Pharma, you owe her - and us - an apology.
12
If anyone hasn’t figured it out yet, we are doomed! Never before has it been more important, than to maintaining good health! There is fraud throughout the medical community! The next revealing book should investigate why hospital food is so awful! When you become a patient, all you are is a cash cow! Being ill is a boon to the whole medical community! The most feared enemy of the medical world, is not a disease, but a human being in excellent health!!!
36
@Counter Measures - I spent the winter visiting a friend in the hospital and her dinners looked (and smelled) pretty yummy.
1
Blown away to read about this in a book review. Had heard about various recalls but unaware of systemic nature of problem. NYT really should do more on this - given how ties into other national issues like the ACA/ Medicare for All- or this administration’s general approach to weakening oversight, including FDA.
54
Brand name wellbutrin xl is superior to generic wellbutrin. I will never take generics again. Sometimes the fillers in these drugs can alter a drug's mechanism of action despite containing an identical active ingredient.
57
Adulterated with toxic fillers, whether from China or India.
7
If a medication prescribed is filled by generic in a pharmacy bottle, how is the patient to know the country of origin? The article doesn't say.
19
@Alan Mass
Often the pharmacies do not know. There was a chilling tv report of big name pharmacies in Florida buying generics from the trunk of cars, basically buying it from street dealers.
6
@Alan Mass - Your pharmacy will know the identity of the manufacturer. You can then at least find out on the internet where the manufacturer's plants are located. (One must be careful: some drug companies shown as US or European actually have their plants in other places like India.)
At least one generic manufacturer's web site actually shows where each of its drugs is made. (Although I guess the ingredients could be imported from elsewhere.)
11
If you want to understand many anti-vaxxer’s mindset look no further than what is described in this pieces— there is deep public distrust of the corrupt FDA and pharmaceutical companies, who source ingredients from 3rd worlds with no oversight, and their billionaire CEOs. I’m not an anti-vaxxer, but I definitely no longer trust our government, greedy corporations, insurance companies, or the unregulated pharmaceutical and “health care” industry.
36
@Misplaced Modifier - then you should NEVER vote for any Republican. If the Republicans finish their job of subverting our entire government you won't even have the right to protest this, much less change things.
24
I believe the US medical industrial insurance complex plays a role here as well. Big Pharma is able to earn obscene profits through its conspiracy with the insurance companies that allows it to charge astronomical prices for prescription drugs here. So what happens? Manufacturing shifts to Asia. Sound familiar?
36
Pointing the finger at generics is a red herring; all pharmaceutical drugs taken for prolonged periods will shorten life. The adverse effects listed in all those commercials are real. You cannot consume a synthetic chemical, which all drugs are, and expect a healthy result. Barbara Starfield authored a study published in JAMA in 2000 in which she concluded that 106,000 people in the US died each year from taking duly prescribed pharma drugs. These substance do not nourish the body; they inhibit or promote some bodily process, which in the long run cause harm. These synthetic chemicals are toxic and must be processed by the liver and kidneys for excretion, which explains in part the amount of liver and kidney disease. In her article she also concluded that adding in medical errors and hospital infection, the medical system's year death count was 225,000. Think about that when you the doctor prescribes a drug.
4
@Dan - Yes, almost all drugs can be and often are dangerous and in this country, at least, drugs are often over-prescribed. OTOH, drugs are often life-saving and can certainly improve the quality of life for many people. Melody Petersen, former NYT science writer some years ago wrote a very informative book on the subject, Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs. But we do need to be careful not to throw out the baby with the bathwater. Sometimes a drug really is the lesser of two evils.
10
@Dan
Tell Type 1 diabetics that the insulin-like drugs ( or insulin itself) they REQUIRE to live will shorten life.
Tell hypertensive patients ( and you will probably become one, Dan, as 80% of people over 80 are hypertensive, especially under newer definitions of hypertension) who take meds to decrease the chances of heart disease or stroke that their meds will shorten their lives instead of prolonging it.
No drug is 100% safe. Some drugs are necessary to maintain life.
4
"The market" isn't concerned about safety. In this case, its method of self-correction, at worst, involves deaths and at best involves people who need a medication and aren't getting the full benefits of whatever their doctors prescribed. Lives and people's health shouldn't be deemed acceptable while the "free market" supposedly does its work to stop people from being poisoned by unethical drug manufacturers. Particularly when very few U.S. consumers have an actual choice regarding the drugs actually dispensed to them by their insurance carriers.
18
I understand the need for low priced drugs. But where was the regulation against greed and corruption all these years. Lupin, an Indian manufacturer is now on the US attorney genera'ls and NY attorney general's price fixing list and is being sued. I single out this manufacturer since it was in business 1 year and produced a generic that gave me Arrhythmia. It stopped after 1 time disuse. I reported it to Express Scripts who I dropped as my Rx coverage. Their response was that FDA inspects, not true, and that they buy generics from many different manufacturers worldwide every month in bulk based on best wholesale price with almost no oversight.. Who knows whether the active ingredients really are and their strength and whether the plants used for fillers could cause adverse responses to us here in USA.
45
I started on my current blood pressure medicine about a year ago and in even that short time, there have been FOUR recalls!!! I could ask my doctor to prescribe only brand name meds (assuming I can afford them), but if even the Big Pharma companies are now trying to increase profits by moving production to India & China, what hope is there?
Ain't capitalism grand?
88
Generic use is key to cost containment of prescription pharmaceuticals. Almost all third party payers incentivize or require equivalent generics rather than branded drugs in their benefit designs and drug formularies. Several states mandate that pharmacists substitute equivalent generics for brands, unless the prescriber indicates 'do not substitute'. Over 90% of prescriptions for the top 10 therapeutic areas are dispensed as unbranded generics (slide 21 in https://www.accessiblemeds.org/sites/default/files/2019-02/Doug-Long-Access2019.pdf). Will increasing public awareness of lax FDA inspection of overseas - in particular India and China - manufacturing plants increase FDA's oversight regimen? Might public skepticism of generics reduce their use? Is there an even greater threat to public confidence in the quality of prescription pharmaceuticals, if 80% of brand-name products sold in the USA use ingredients manufactured in India and China? This presents a major and urgent challenge for pharmaceutical manufacturers, regulators, politicians - and for those of us who prescribe or dispense prescription pharmaceuticals.
40
@Elan Rubinstein
Fantastic salient points.
Where will we get the money for the necessary increase in inspections/testings/etc.?
Not from the current administration ( so far) who has decreased similar funding for other agencies....
4
@padgman1
As someone else suggested charge the generic companies a licensing fee where the monies go to the FDA to exclusively cover testing and oversight.
7
Ever since I saw some expose on some Chinese food manufacturers I don't buy food made in China. One guy was quoted as saying it didn't matter because it was being exported when he put some substance to stretch out the filling in the food. Scary to think it has the potential to be in our medicine too. Too many people cry about U.S. regulation but sometime that is the only thing keeping companies honest, both here and abroad.
45
@hilliard
With drugs its not always so easy to know where they are manufactured.
7
I don'ty adhere to any particular ideology. I'm skeptical of single-payer healh care and socialized medicine. I think there are probably aspects of the health care system that work more cheaply and efficiently through competition in a direct fee for service model than by billing either insurance companies or the government (albeit with sliding scale fee schedules or subsidies for low-income people.)
But maybe the American pharmaceutical industry should be nationalized.
Think on that one a little bit, rather than dismissing the idea out of hand.
48
@DC Reade
Brilliant. As long as the politicians who receive Big Pharma money are not involved.
18
@DC Reade - This simplistic belief in competition in just about all realms of health care is doing huge amounts of damage to many Americans. You'd know that if you paid any attention to the fact that almost all other developed countries (and some less developed ones, too) have universal health care which is often single payer or, if not, have tightly regulated insurance markets. And, surprise, surprise, they have generally better health outcomes, longer life expectancy, no or at worst far fewer people with no access to health care, and no bankruptcies from medical conditions. Yeah, let's all hear it for "competition". Don't forget to get quotes on your emergency care after your next accident.
21
@DC Reade As a physician, I often find some of the public believe a private financing system would be more efficient than a public one. However, that's incorrect. I have friends and family in other countries ( Europe (UK, Germany, France, Ireland), Canada, and Asia (Taiwan, Singapore, Japan)) and they and their doctors don't face the paperwork he** we do in this country. Most people don't realize that in many US clinics and hospitals, at least 3 staff members are needed per doctor to handle billing. In contrast, in France, some docs need 1 or less (i.e. a credit-like insurance card all French residents get) Most national healthcare systems have more simplified billing than we do.
50
Of course one needs to ask a) how many people have died or been injured from this malfeasance and b) why have there been no publicized lawsuits to emerge? Given the billions upon billions of pills Americans consume annually, one would expect a crisis of this magnitude to have had some material impact within the legal system.
Not to defend the predatory nature of the pharmaceutical industry, but of all big pharma's malfeasance, tainted supply seems a bit tangential and marginal in the US context to bribery, over-marketing and extortionate pricing.
8
@OneView - I'm sure all the people who have died and those who have lost loved ones because of bad generic meds might question your belief that the issue is "tangential and marginal". Perhaps you will be among those harmed by one of those "tangential and marginal" meds one day. Wonder if you'll still think the issue should still be dismissed as "tangential and marginal". ALL of the issues you mention need to be tackled and resolved.
8
@OneView If someone has a medical condition requiring medication and dies because the prescription didn't work, the death will be ascribed to the medical condition, not the prescription that didn't actually work. The crisis is a completely hidden one due to the medical and pharmaceutical industries' lack of willingness to examine themselves. It seems tangential and marginal because it is largely unrecognized and when it is recognized, dismissed.
4
@Annie do you know of any? The review cited one case from 2007. I’ve never read any cases of generic manufactures being sued for tainted drugs and wrongful death on any significant scale.
1
It never made sense to me that generics could be so incredibly cheaper than branded, whether prescription or over-the-counter. The answer was supposed to lie in advertising expense, but still, it just doesn't make sense - the consumer cost differential can be gigantic. And I'm so not surprised at the criminal activities of drug manufacturers, from price gouging to price setting to adulteration and impure manufacture. Thank you for this book!
63
They are not cheap.... and instead of agonizing over the fact that we are importing generics from countries that don’t give a hoot about compliance, why is it that nobody manufactures generics in the US? Maybe the government should if they care about patients having accessible medicines.
24
@debra,
Brand drugs are usually the result of years of expensive research, development, and testing; most initially promising drugs are not successful. Those drugs that make it into the market are protected by patents, in order to make a profit on the initial huge investment. Generics merely make the same drug, without all the effort to research, develop, and test them. That’s why they are cheaper. And can’t be made till the brand name drugs’ patent protection expires.
14
@debra Branded include amortizing the years of research, and trials, and failures, and more trials and failures, for the very small number that reach the market. They use their lock on the drug via patent for the years they have it, to recoup the costs. The actual cost of the chemicals in these drugs, for the most part, is pretty cheap. None of this, however, has anything to do with sloppy, dirty manufacturing. My generic BP medication, branded Diovan, was recalled due to manufacturing issues in China. For better or worse, I will only get it manufactured in India and pay more than I otherwise can through my insurance company by foregoing 90 day supply options since they won't ensure they won't source from China. Don't know if it really matters in the long run, but it's all I can do.
13
I read this and ran to read the label of my post-cancer medications that I have to take for about 10 years to help prevent its reoccurrence. My dismay - made by Intas company in India for an American company. It would be helpful if there was a follow-up article on what people can do. It’s life or death for many of us. It blows my mind that the people of this country continually votes in politicians who decimate hard won protections/regulations and defund enforcement.
225
Among so many other concerns, WHY HAS THIS ADMINISTRATION DECREASED FUNDING TO THE FDA and let more drug manufacturers write their own legislation and certify their on drug trials?
We have little government oversight left under Trump. That needs to be changed immediately. His buddies, the industrial oligarchs, are now running Washington - not US.
I do not want my life governed by incompetence and dishonesty. How about you?
237
@RealTRUTH: Don't look to the Fraud and Death administration for help. The FDA is a lapdog for Big Pharma. Your health comes first only if Pharma's interests are not involved. Why would the FDA be working so hard to discredit natural homeopathic medicine and supplements if they really cared about you. These modalities compete with Pharma and that is a no no.
13
@RealTRUTH
Trump just announced this week a rule that drug pricing must be shown in all TV ads. I hope that drives out the price fixing which they are now being sued for by 22 states.
2
@Nadine
It does not, however, address the core problem- the existence of TV ads for pharmaceuticals in the first place (which is incidentally a relatively recent development- it wasn't always like this. Especially to its current extent.)
I find it unfathomable that the drug industry is concern-trolling the general public with ads for prescription drugs, essentially inviting them to self-diagnose some medical condition- often based on the presentation of some vague profile of symptoms- and then request specific brand name medicines from their health care providers.
I've also read that the private pharma industry spends more than twice as much on ads and promotion as they do on R&D https://www.sciencedaily.com/releases/2008/01/080105140107.htm
At least the advertisements are currently mandated to include a profile of the side effects of the product- and now, the price schedule. But the ads aren't an ethically justifiable practice in the first place.
11
The scariest horror story yet. Send this book to Congress. To those who can read.
154
Some in Congress may “read” but barely any can think critically or ethically when they have so many Big Pharma lobbyist dollars blinding their vision....
36
Couldn't a candidate for president win by stirring our fears of this instead of immigrants?
122