Tune in to our radio show on your local public radio station, or sign up for the podcast and listen at your leisure. Here’s what it’s about:

Last year, millions of Americans wondered whether their cholesterol-lowering drug was safe. The giant Indian drug maker Ranbaxy had recalled its atorvastatin, the generic equivalent of Lipitor, because it was contaminated with ground glass.

Earlier this year, Ranbaxy pleaded guilty to “seven federal criminal counts of selling adulterated drugs with intent to defraud, failing to report that its drugs didn’t meet specifications, and making intentionally false statements to the government,” as our guest reported in her expose. The company was fined $500 million, but Ranbaxy drugs are still on pharmacy shelves. Do Ranbaxy’s misdeeds suggest weaknesses in FDA’s oversight of the generic drug industry? 

A few days ago we learned that another Indian generic drug company, Wockhardt, also got into trouble. In addition to problems with record keeping and manufacturing, FDA investigators found problems with a bathroom close to sterile facilities:

“For example, our investigators found that the washing and toilet facility located approximately twenty (20) feet (approximately 6 meters) from the entrance/gowning area to the Sterile Formulation (b)(4) manufacturing facility was found to have urinals that lacked drainage piping.  The urine was found to fall directly onto the floor, where it was collected in an open drain.  Stagnant urine was observed near the open drain.  In addition, the investigators also observed what appeared to be mildew or other mold(s) in this toilet facility. The facilities used in the manufacture of drugs should be appropriately maintained and repaired, and remain in a clean condition.”

Learn about foreign drug manufacturing and oversight on this week’s show with:

Guest: Katherine Eban is an investigative reporter who writes for Fortune and other national magazines. Her book is titled Dangerous Doses: How Counterfeiters are Contaminating America’s Drug Supply. Her article on Ranbaxy, “Dirty Medicine,” was published in the May 15, 2013, issue of Fortune.

The podcast of this program will be available the Monday after the broadcast date. The show can be streamed online from this site and podcasts can be downloaded for free for four weeks after the date of broadcast. After that time has passed, digital downloads are available for $2.99. CDs may be purchased at any time after broadcast for $9.99.

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  1. SM

    Great show! Ms. Eban’s investigation highlights the importance of oversight of both foreign and domestic companies…in many sectors that deal with public welfare (pharmaceutical, food, finance). I completely agree that India’s drug regulatory system needs major reform and oversight, but would like to point out that this is not a West vs. “rest of the world” sense of ethics only.
    The Europeans are typically appalled at the lack of oversight and complicity that the USDA has with the meat industry and food lobby about the dangerous chemicals, hormones, pesticides industrial factory farming that goes into our food. How do we allow school lunches with pizza, fries, and tater tots to be considered food, let alone a balanced meal?
    Our governments should be there to be protect public welfare, the common interest – not corporations and bottom line – be they foreign or domestic.
    I think there should also be an assessment of fair pricing of branded medicines that reasonably balances the costs of R&D and the long process for drug approval to patents and the exorbitant prices we consumers pay. This may mean paying a lot more than generic brands, but not so much that the cost of medicines and healthcare pushes Americans into poverty.
    Thanks again for a great show as usual!

  2. L R Dillon

    Very good program as always, but why no mention of the pretty rigid pedigree standards that already exist that soon appear to be getting even stricter? By this I mean, any pharmacy whether retail, hospital, home infusion, etc. has to be able to track the source of all drugs back to the manufacturer. I suggest a clarifying comment to this effect on a future program.
    Personally I think that prescription and OTC drugs should only be allowed into the US from the most well regulated economies, e.g. the EU, Canada, Japan.

  3. dl

    Thank you for this program [Dirty Medicine] and your ongoing work in educating the public about medications.
    I highly suspect Walgreen’s switch from generic wellbutrinSR made by Mylan recently to generic made by Wockhardt caused my elderly relative to suffer a relapse into depression and display other distressing symptoms. I was suspicious of the pills initially because of the terrible smell of the pills.
    After seeing the depression return I looked up the manufacturer Wockhardt and found the FDA had recently taken action against them. Compounding my distress was the failure of Walgreens (or at least its local store) to even be concerned, stating over a series of calls and in person visits that alot of pills smell bad, or that the FDA monitors manufacturing so they would know if there was a problem, implying that my concerns were not valid.
    I found out later after telling them I would switch to another pharmacy that they could go outside their supplier if a customer is concerned with quality of what their supplier is providing, but they like to use their supplier because it is cheaper.
    I am outraged at the lack of concern and action by the FDA re: Wockhardt drugs (why no alert to the public at least to look for symptoms of possible problems with bad drugs) and by Walgreens to listen to my concerns and voluntarily stop obtaining drugs from this company, given what was found there. How can patients’ safety and well being be placed below profits?
    if you have an elderly family member or other person you are caring for who is on medication and suddenly displays a change or return to symptoms, check into where the drugs they are taking come from and better still, as advised in this program, be proactive and make sure your pharmacy respects your desire to get your medications from a company located in a country where standards and access make it possible to prevent or discover any problems with production.
    I shudder to think how many people like my family member are hospitalized or forced to undergo additional or unnecessary medications to solve a problem, that, if not for intentinal or negligent drug production processes, would never have happened.

  4. liddell

    All drug companies are causing harm, foreign or not. This brave researcher has to focus on the one aspect, fraudulent or counterfeit drugs, to peruse her important work.
    But all drugs have harmful side effects. These are often misdiagnosed because they seem unrelated, like back pain, muscle pains, joint and chest pains, poor balance, poor vision, obesity, fatigue, depression, loss of sexual function, loss of appetite, etc. The drug literature (PDR) is remarkably honest about these side effects, trusting MD’s not to read about them, or to believe they are very rare, or largely imagined by the clients. And clients are embarrassed to share some problems; being unaware of the drug connection.
    Little effort is made to find underlying causes. Nutritional deficiencies are common, as our food supply is problematic. Adequate vitamin D alone could reduce the numbers of some common Cancers and a host of other ills as well. Ditto trace elements, enough Magnesium, etc. Easily eliminated toxins like MSG, Red-40, Chlorine, Toxic cosmetics and cleaning products, Gluten, Cassiene, High Fructose Corn Syrup, etc. are causing all manner of disease, as are the drugs themselves.
    Each side effect creates the “need” for yet another drug. I’m a 35 year RN, and have seen first hand the devastation drugs cause. (And I only see the folks who lived.) Happily, I’ve been able many many times, to “solve” problems of long-standing, some were severe, by checking my $20 drug book!
    MD’s are busy and confused, and drug Companies are about one thing only, profits. So, counterintuitavely, they perpetuate disease and so the fear of disease. Remember also, that the big charities depend on the disease and on the fear, which they are pleased to call “awareness”, as millions of dollars in contributions are at stake. But all this awareness and “early detection” have not produced the expected results. There’s been no change in mortality or morbidity rates. Mammograms are now known to produce a 25% over-diagnosis rate (people who were treated but were never actually sick. Check this out, at whatever sources you trust.) A more accurate test exists but isn’t widely used.(thermography) The “business” section of the paper, shows the (sometimes shockingly callous) investors’ view of drugs, also note the number of full-page, color drug ads. These create dependency on drug company money, and perhaps lead to toning down coverage of information which might be offensive to the advertiser.
    FDA inspectors can often expect profitable jobs with the companies they regulate. This has long been known in many industries, as “the revolving door”.
    Oddly, in the abstract, assuming a counterfeit drug were inert and could, “do no harm” it might be preferable.

  5. KazooGuy

    Political decisions have personal consequences. The political movement to “defund” the “big” government includes starving regulatory agencies such as the FDA and the EPA that we have put in place to defend us against the impersonal and corrosive affects of stock-price-driven corporate decisions. We cannot afford to be disinterested in how our country is run – if we don’t make informed decisions, then our medicine cabinet’s contents get decided by market forces.

  6. cjm

    I agree!!!!!

  7. LA

    Thanks to Katherine Eban and to the whistleblowers who have tried to alert the public to these outrageous offenses to our public health system. Unfortunately I believe it will take a huge attack by way of adulterated drugs to get any concerted action on the part of our government, since the trend is to depower our only weapon, the FDA.
    The larger calamity is that we as a nation are suffering a totally unnecessary assault on our mostly already disfunctional health care system.

  8. cjm

    I am a nurse and I see the side effects of the many drugs we administer and have wondered many times if they live up to what they are supposed to be and without doing worse harm. The side effects are too often worse than the disease. Some generics ARE making people sicker… Good physicians and nurse’s collaborating with pharmacists can only do so much if the very product is faulty/fraudulent.
    I take Synthroid, the brand name drug for hypothyroidism. After years of trying the generics, with which I was having anxiety and panic attacks and word finding difficulties,etc., I am on the perfect dose, and have none of these side effects. My memory is better than when I was younger… I am so thankful for this name brand and what it does for me and will do everything in my power not to change to a generic…My very job depends on my mind being clear and able to communicate etc.
    Thank you to Ms. Eban for her hard work and collaboration to bring the truth to the fore… I tried Atorvastatin and got the famous leg aches and pains on just 5mg… I refuse to take now…
    Now we need to fund and demand the FDA regulate to the standard that all drugs are what they state they are chemically… We need every student in the US, let alone the world to have a basic understanding of chemistry and the effects of changes at the molecular level… the causes of pollution of our bodies as well as our earth…Lofty perhaps but necessary if we are to survive…
    Three poisons: Greed, Anger, Ignorance… Heal with Generosity, Compassion, and Wisdom… Let’s focus on Wisdom and the knowledge that we can say “no” to fraud by acting wisely… Let’s empower the FDA to regulate rightly…

  9. jve

    Precisely why we need a single-payer system. We may still be dictated to, but at least we can also rise up with one voice to protest poor decisions and it will be easier to demand accountability.

  10. KH

    Thank you so much for having Ms. Eban on your show to discuss this issue. She and Fortune Magazine have done a huge service for all of us in America to inform us of just how much danger we are all exposed to as long as this lack of oversight continues of foreign manufactured medications. Why can’t our representatives in Congress step up to the plate and deal with this impossible situation? If we continue to rely on generic drug manufacturers to provide medications for all of us, the FDA needs to be funded by Congress for inspectors to be able to pull drugs off of shipments into our country so they can test them to make sure they are safe and effective and be given the legal power to ban manufacturers from selling drugs in America if they have been found to be following fraudulent practices or providing unsafe medications. If the FDA cannot be trusted to perform this duty, then perhaps the US Customs Service could.
    After listening to your program, I looked up the manufacturer of a generic medication I took 2 weeks ago that was completely ineffective for my medical condition. Not surprisingly, it too was manufactured by another generic company in India. The name brand drug, which I have taken in the past and is made in the state I reside in but is considered too expensive to be paid for by my health insurance plan through my employer, was always effective within a matter of 2 days. I would love to just be able to buy the name brand drug on my own, but at $475 for a one week supply, this is impossible to afford. As long as circumstances such as this exist, Americans like me are forced to either go without or be reliant upon generics.

  11. SS

    Thank you for this program. It is scary what goes on in the pharmaceutical industry.

  12. Gail D.

    I take a generic beta blocker, Lisinopril, a generic anti-depression medication, and lorazepam. I am concerned about the fact that I might be taking ineffective fraudulent drugs from Ranbaxy or some other foreign drug mfr.. What can I do to find out if any of my prescriptions come from Ranbaxy or some other foreign drug mfr.?
    People’s Pharmacy response: Ask your pharmacist the next time you pick up a prescription refill who the manufacturer was. This is really the only way to find out, unless the pharmacy has put the manufacturer’s name on your prescription bottle label.

  13. LAF

    I took clindamycin for a root canal and continue to have issues with infection. Is it possible that it was not effective because it is a drug made by Ranbaxy?

  14. BP

    WOW!!!!! I am a pharmacist. I have been worried that something like this story would happen. Having so many of our drugs made in other countries exposes us to possible terror attacks.

  15. MS

    Don’t American companies outsource ingredients, including for their proprietary drugs? How do we know their suppliers are delivering what they’re supposed to?

  16. Sara h.

    In my perspective this all comes back to the insurance companies. I take some very expensive psych meds. They will not pay for branded drugs, usually of any kind. It makes us feel helpless. We are continually at the mercy of them in so many ways. They tell us what doctors we can and can’t see, what procedures and tests we can and can’t have, what drugs we can and can’t take…
    And the medical profession has to overcharge to compensate for the insurance companies, stupid convoluted practice of paying based on a percentage of ‘usual and customary charges’. WTH is that? I know what it is. It’s a complex formula contrived to mask avoidance with complexity that no one can negotiate, not the consumer, not the medical professionals, and many times not even the insurance companies themselves.

  17. pak

    Katherine Eban noted that one might seek safer generics by using the “authorized generic as specified by the manufacturer”…How does one find this?

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