“Dispense as Written” are the words found on prescriptions in the U.S. when the prescriber wants the patient to take the brand drug, not the generic. Many who read Katherine Eban’s new book – Bottle of Lies: The Inside Story of the Generic Drug Boom – will conclude that they would like to see “DAW” on their prescriptions.
Bottle of Lies teaches its readers that generic drugs are not as good as the FDA claims. It shows that poor manufacturing practices, mostly in India and China, but also in the U.S., are the leading cause of substandard drugs being sold in U.S. pharmacies and throughout the world. More ominously, India and China intentionally ship even lower quality and, in some cases, worthless drugs to poor countries in Africa and Southeast Asia where regulations are weak or non-existent.
The FDA knows this but for political and budgetary reasons doesn’t take the necessary actions to deal with it. In fact, the FDA knows that generic drugs are of poorer quality and/or not equally as effective as a brand but still allows the drug companies manufacturing those drugs to export them to the U.S.
I’m not writing a book review, just yet. Here’s the New York Times review.
Very generally, while I don’t agree with certain conclusions drawn by its author, Bottle of Lies is a great read. I highly recommend it to people who simply want to learn more about how drugs are made, regulated and distributed globally from the same plants – not just about corruption and fraud.
While I loved the dramatic narration and discussion that Ms. Eban was able to bring to this topic, her account is not new to me. The gist is that generics are not all created equal and people have gotten hurt and died because of it. I blogged about this four years ago:
One thing that’s cool about the book is the insider baseball. Ms. Eban obtained emails through Freedom of Information Act requests among FDA personnel, industry, and others, like Joe Graedon of the People’s Pharmacy, becoming justifiably outraged at the FDA ignoring problems reported by American patients.
One of the problems raised in the book is that most active pharmaceutical ingredients are foreign made and not regulated well enough by the FDA. Those APIs go into our U.S. drugs, generic and brand, so there are risks for both versions. But Ms. Eban is abundantly clear that brand name drugs are generally safer. That conclusion was drawn after hearing from practitioners, such as Dr. Harry Lever from the Cleveland Clinic of Medicine, that the brand consistently worked but the generic did not.
Dispense as Written – Code #1 – for prescribers – instructs the pharmacist:
“Brand product(s) (are) ‘medically necessary’ and therefore no substitution is allowed by the prescriber…This would be used when a brand name drug has consistently received better results than a generic version and so a specific brand name version is deemed required.”
For Americans finding themselves with DAW, what are they to do when their health insurer won’t cover the brand, or they don’t have insurance at all?
Many people won’t be able to afford the brand Lipitor or most brand drugs when paying out of pocket. Some will apply to the industry’s Patient Assistance Programs but find themselves turned down. Then they will look to Canada and farther abroad for brand name Lipitor.
Will the brand Lipitor in other countries be just as safe?
Brian Donnelly, pharmacist, former FBI agent, and head of global security for Pfizer, says yes. In this CNBC video news segment, international pharmacy store fronts are in the spotlight and accused by drug companies as being dangerous for “facilitating” sales of medicines from other countries. These storefronts are basically offices in places like strip malls where people receive assistance filling their prescriptions from Canadian and other foreign pharmacies to save money. CNBC producers conducted mystery shops of brand name Lipitor from U.S. pharmacies and foreign pharmacies. The foreign Lipitor is round in shape, not oval like the American Lipitor! Is the “foreign Lipitor” bad?
Pfizer tests it and finds that it’s in fact real Lipitor: Pfizer’s own Lipitor made for another market.
According to Brian Donnelly: “Whatever product Pfizer makes is going to be top-shelf product.”
The TV journalist states that Donnelly says, “The higher prices in the U.S. buys you the FDA and what he calls a ‘closed system’ to keep out substandard or counterfeit drugs. It happens to also keep out the less expensive overseas Lipitor.”
I really liked that reporter, but he refers to the cheaper but no less high-quality Lipitor as “overseas Lipitor,” lending to the assumption that the “American Lipitor” is made here.
Lipitor sold in the U.S. is made in Ireland and you can bet that the active pharmaceutical ingredients are made in India! Seventy-one of 100 top brand drugs sold in the U.S. are not made here.
It was just last week when we announced that generic drugs cost much less in the U.S. than in Canada, and sometimes less than even those sold in India. When using the PharmacyChecker Discount Card, 88% of popular generic drugs are cheaper in the U.S. than Canada, and at a potential average savings of 68%.
I believe that for most drugs, Americans should not import them but buy the lower cost generic here in the U.S. But if your generic medication is not working, here’s advice from Dr. Tod Cooperman, president of ConsumerLab.com, CEO of PharmacyChecker, and a minor but heroic character in Bottle of Lies:
– If a generic doesn’t work like the original drug, be concerned, particularly if it is an extended release (often called “XL”) product.
– Be aware that the labeling on a generic drug describing its performance is copied from the labeling of the original product and may not reflect the performance of the generic. This is a deception required by the FDA, perhaps to create the perception of generics as interchangeable.
– If a generic works for you, look carefully at the label and identify the manufacturer. Request the same manufacturer each time you refill that prescription. Other generics may not behave the same way.
So, for those Americans who can’t take advantage of the great savings generic drugs provide because their health care providers write “Dispense as Written” on the prescription (or e-Rx), meaning “brand-only” – there’s good news:
Those brands are available in Canada, Australia, India, New Zealand, Singapore, the UK and Turkey from international online pharmacies accredited by PharmacyChecker. According to Pfizer, they are just as safe.Tagged with: Bottle of Lies, generics, Katherine Eban