Generic Drugs Are Poisoning Us

A New Book Argues That Generic Drugs Are Poisoning Us – New York Times  – By David Dobbs – May 13, 2019

This is a review of a recently published book exposing the seamy side of the “profit above all else” generic drug industry:

The Inside Story of the Generic Drug Boom
By Katherine Eban

I’ve always been suspicious of generic drugs because I’ve noticed that my body sometimes reacts slightly differently to a new batch, and often reacts very differently to a switch from brand-name medications to generic. This book validates my concerns and even adds new ones. 

I knew that generics are manufactured overseas in Third World countries where corruption is a problem, but I assumed that the FDA was monitoring foreign facilities to assure our drug supply was at least safe, even though these drugs often seem ineffective.

I’m horrified at what this book exposes. And it’s not just about pain medication, which is actually a very straightforward chemical compound. I’m more worried about things like anti-depressants and hormones which I take.

I’ve tried stopping all my drugs at various times, But then I feel even worse, so I know they’re helping at least a little bit.

But as I hear about this atrocity, I might pay more attention to which generic drugs from which manufacturers I’m currently taking, so that when the pharmacy switches their suppliers I will know why the medication is causing weird side-effects or isn’t working anymore.

There he is, early in Katherine Eban’s “Bottle of Lies,” barefoot in his Ahmedabad ashram, urging the chemist Khwaja Abdul Hamied (a fellow Indian nationalist) to copy Western drugs as a way to bring affordable medicine to India’s masses. Thus the generic drug industry began.

At first, things went nicely. Hamied’s business, Cipla, founded in 1935, quickly grew adept at reverse-engineering drug formulas, and by midcentury it was supplying India and other countries with low-cost versions of important Western medicine

In the 1980s, when the United States began allowing the import of such generics, Cipla and other generic makers became heroes to critics of Big Pharma.

Cipla, almost a tenth the size of Merck, has kept its nose clean. But much of the wider generics industry is harming and sometimes killing patients by making drugs quick and dirty and erecting facades of legitimacy to fool regulators.

This booming industry, with most production coming out of lightly regulated plants in India and China, is pumping bad medicine into unsuspecting patients in every corner of the globe.

Eban’s gripping book lays bare how Gandhi’s well-intentioned local action became hellish global fraud.

The book’s central thread is a David and Goliath whistle-blower story, as a young engineer and executive named Dinesh Thakur tries to stop Ranbaxy Laboratories, the Indian generics giant that employs him, from continuing (and covering up) its careless drug manufacture.

Eban skillfully unspools the slow, intricate, cat-and-mouse investigation that follows, as well as an armed raid of corporate headquarters (“Step away from your desk”), the discovery of astounding levels of deceit and damage, and finally a three-front legal battle, as Ranbaxy fights the F.D.A., the United States attorney Rod Rosenstein and the lawyer Thakur retains so he won’t get skinned alive

Thakur’s story stuns with how utterly corrupt an entire company can become. Both his and the book’s broader account of the industry, meanwhile, show how a quieter sort of corruption — an erosion of will and mission — has neutralized the industry’s overseers.

Unlike American plants, which matured in an environment where constant oversight made shortcuts risky, the Indian industry evolved in a culture in which outwitting inefficient bureaucracies was an essential skill.

There the most rational approach was to stress speed and production over accuracy and quality — and deal with the occasional inspector with some sleight of hand and greasing of palm.

The F.D.A. was utterly unprepared for this, and largely blind as well to the implications of both its own and the Indian industry’s cultural assumptions.

These high jinks read like farce but hit like poison, as tainted drugs daily enter patients’ bloodstreams worldwide.

In Africa, which the companies consider the safest place to send faulty drugs, doctors regularly find that drugs for AIDS, bacterial infections and other conditions are underpowered.

In the United States,

  • imports from India now make up 40 percent of all generics used, and
  • 80 percent of the active ingredients used in both generic and brand-name medications come from India and China.

In 2007, when scores of kidney patients across the United States died from allergic reactions after dialysis, experts traced the cause to a contaminant in the blood thinner heparin provided by a Chinese plant contracted by Baxter, the leading American supplier.

The F.D.A. had never inspected this plant. Someone there, it seems, had intentionally added a chemical to stretch the drug’s yield and profitability.

Eban quotes inspector after inspector saying that they themselves fill only the most essential prescriptions — and will pay anything to avoid taking a drug made overseas. They’ve seen how those drugs are produced, and they live in fear of them.

Author: David Dobbs is the author of “My Mother’s Lover,” a memoir of his mother’s long-secret wartime affair.

13 thoughts on “Generic Drugs Are Poisoning Us

  1. Kathy C

    The FDA was undermined years ago. Pharma lobbyists, and corrupt politicians underfunded certain positions. The same kind of targeted under-funding and dismantling occurred at numerous state and federal agencies. The Neoliberal idea that the industries could regulate themselves, while the corporate media did not cover it and instead ran a false narrative about “Big Government.” We saw brand new airplanes fall out of the sky, because key positions at the FAA were done away with, and the industry was allowed to do it’s own safety testing.

    Today in the Guardian, there was an article about the compounding pharmacies. After all of those meningitis cases, the industry was allowed to volunteer for FDA oversight.
    https://www.theguardian.com/tv-and-radio/2019/sep/30/john-oliver-takes-on-compounding-pharmacies

    Over 10 years ago, generic pharmaceuticals from India and China, which were manufactured and sold by big US pharma corporations here in the US, were found to be contaminated, ineffective or contain different active ingredients. Patients taking these drugs had complications and side effects. Some of the pills were found to contain wall board compound and no active ingredients. Once again the corporate media and the pharma industries covered up these stories. Politician working for the industry even cut the number of FDA investigators, to protect industry profits. Patients who experienced adverse events were Gas Lighted, physicians were told that the patients were to blame, and that they could be sued for any speech, that cast doubt on the pharma industry.

    Fifteen years ago generic Gabapentin manufactured in India was found to contain wallboard dust and no active ingredients. The media suppressed this story, and since no one died not much attention was paid to it Since then there are even less FDA inspectors, so when they claim they have “rigorous standards,” that might be true, but as the number of overseas manufacturers grew, the number of FDA inspectors dropped. The industry found that inspections would cut into their profits, so they had the lapdogs in congress remove funding for the positions they did not like.

    We are in post fact America, now. The FDA hides adverse incident reports to protect industry profits. Physicians and researchers are under gag orders and fear lawsuits. That was one of the reason the opioids, were over prescribed. The system no longer functions. All we have to do is look at the prescription drug pricing hearings, to see the massive corruption and lies that the industry runs non stop. If we had a functioning press, the people would have been informed, instead they are continuously duped.

    https://www.fdanews.com/topics/117-inspections-and-audits

    https://en.wikipedia.org/wiki/Generic_drug

    Liked by 1 person

    Reply
  2. Michelle S.

    I’m not sure where the author obtained their information but I worked in a Chain Pharmacy for almost 20 years and I saw alot.
    First off there is some really scary things that happen that you never will hear about like recalls of specific lot number because they may have had something wrong with them (like one I remember it saying “Recall Due to possible metal shards , ground metal , or metal chips” ) But the public was not notified and I don’t think it’s right. Only pharmacies are notified to return the meds. I understand it would be almost impossible to know who got those exact lot numbers but it really is wrong.
    Also one thing I wanted to mention was that lots of name brands AND GENERICS are made in the United States and in other countries , it depends where the company actually manufactures the medication and can have several plants . I remember a time noticing that the Prevacid Solutabs we had in stock at the Pharmacy had one box from China and the other box from Italy , same drug , same strength, name brand only so obviously same manufacturer and two very different places . It’s very difficult to ever really know to be very honest.
    And the name brand vs generic thing is supposed to be that the ACTIVE INGREDIENT MUST BE THE SAME BUT THE NON-ACTIVE CAN DIFFER. I always thought that was wrong because that’s like not following a recipe and expecting the same results . I saw many patients suffer from failed generics after insurance no longer covered name brand .
    TAKE CARE EVERYONE

    Liked by 2 people

    Reply
    1. Zyp Czyk Post author

      Thank you for verifying what I’ve suspected for decades: even if a generic has the same amount of “active ingredients”, the excipients and fillers can be completely different than in the approved brand medication, which can dramatically change how our individual bodies metabolize them.

      And this is even more problematic with medications manufactured overseas with who knows what ingredients (the FDA certainly doesn’t).

      Liked by 1 person

      Reply
  3. leejcaroll

    Accroding to the FDA, and you either trust them or you dont, they are the same https://www.fda.gov/drugs/questions-answers/generic-drugs-questions-answers
    The click given in the reply above lists 2 – 3 cases where the FDA stepped in to stop the behavior. Formany of us generics are all we can afford/insurance requires them. Scare tactics help no one and the consensus from what I can tell is they are perfectly safe. Not sure what conflict(s) of interest if any, the book author mayhave

    Liked by 1 person

    Reply
    1. leejcaroll

      https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002763 This is not from the FDA “In this study, we observed that use of generics was associated with comparable clinical outcomes to use of brand-name products. These results could help in promoting educational interventions aimed at increasing patient and provider confidence in the ability of generic medicines to manage chronic diseases.”

      It is also important to differentiate. I found a study “In this tudy from 10 sub-Saharan African countries, nearly one-quarter of the available generic antihypertensive drugs were found to be of poor quality. Concerted measures to improve the quality of antihypertensive drugs could lead to major improvements in hypertension control with attendant reduction of its deleterious consequences in low-income and middle-income countries.”
      However it appears that the meds were from there and used there. If someone could find a study(ies) that shows the same similar poor outcomes where the meds used in the US as well that would help prove the book author’s contention. https://www.ingentaconnect.com/content/wk/jhype/2018/00000036/00000002/art00024

      Liked by 2 people

      Reply
      1. Zyp Czyk Post author

        Yes, drug trials will not show these problems because there aren’t huge numbers of people affected. It’s just a few, but because one of them is me, I feel it’s important to make others aware of this potential issue.

        Liked by 2 people

        Reply
    2. Zyp Czyk Post author

      I’m glad to hear they’ve always worked well for you. Brand products are ridiculously expensive, so most of us are stuck with generics whether we like it or not. Besides this book, there have been other articles questioning the “equal-ness” of generics and from personal experience I know some people’s reaction to a medication can differ dramatically from brand versus generic.

      As usual, it all depends on the specific individual with their individual metabolism and the specific drug and the specific manufacturer of this specific batch of medication. My main goal in posting this is to inform people who are switched and then start experiencing all kinds of side effects or lack of efficacy. It’s just another variable to explore.

      Liked by 1 person

      Reply
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