Katherine Eban, well-known author of Dangerous Doses, is back with another drug industry shocker called "Are generic drugs a bad bargain?"
The subtitle should get your attention: "All of us want cheaper medicine — but not if it costs us our health." (Cue scary music…)
What do you think? Responsible muckracking or irresponsible fearmongering?
Eban writes:
But a yearlong investigation by SELF — including more than 50 interviews and records leaked from one of the world's largest generic-drug companies, Ranbaxy Laboratories — raises questions about whether some new generics are as safe or effective as the brand names.
Eban focuses on the experiences of three women who claim to have had problems with generic drugs. (The plural of anecdote is data?) She also uses the problems at Ranbaxy to implicate the entire generic drug industry, the FDA, pharmacists, insurers, and just about anyone with scientific data that conflicts with the article's thesis.
I found the tone of the article to be unnecessarily sensationalistic and pejorative. She summarily dismisses any scientific evidence from peer-reviewed medical journals in favor of the comment board at the People's Pharmacy website. Example. (BTW, does anyone know more about the People's Pharmacy organization?)
Check out the snarky tone of this paragraph:
Anxious to cut costs, health insurers are stampeding to switch patients to drugs that are cheaper to make, test and ultimately buy because their manufacturers can piggyback on the research and marketing already done by brand-name-drug companies. Pharmacists in most states are also free to give patients whichever version of a drug is cheapest for them to supply, without telling the prescribing doctor; in some states, pharmacies are required to make this switch.
"stampeding"? "piggyback"? "without telling the prescribing doctor"?
And to make sure that SELF readers get the point:
Women who wouldn't dream of substituting Diet Pepsi for Diet Coke, simply because of the taste, eagerly swap vital medications, because the change can cut co-pays in half.
Last time that I checked, Diet Coke and Diet Pepsi had different ingredients, whereas generic drugs are chemically identical to branded drugs. Whatever.
FYI, Dangerous Doses started as an article in SELF magazine, so anyone with a vested interest in generic drugs should keep an eye on the anti-generics trend.
Hey Playahata..
ReplyDeleteThere are plenty of irresponsible articles written across the industry. Why has this one gotten under your skin so much as to evoke your dark side? Have you secretly wished to publish in SELF magazine?
There are a lot of complicated issues that shouldn’t be decided by the general public but public opinion is the basis for political platforms and what ultimately gets people elected. I’m fine with the fact a debate is at least starting in the general public – it will eventually become a better one and perhaps lead to better solutions.
don't hate the playa..
I think its appropriate to raise questions about the sources of generic drugs. I believe they are mostly safe, but the article is right that the FDA needs to step up with more foreign inspections.
ReplyDeleteFirst of all, small-molecule drugs (e.g. chemical drugs) are supposed to be interchangable, the same is NOT true for biopharmaceuticals. However, the FDA has been dragging its feet on guidance for even those biopharmaceuticals that are governed by the Federal Food, Drug, and Cosmetic Act (such as insulin, human growth hormone, etc.) for more than a decade, so for the moment, this is a non-issue.
ReplyDeleteAssuming we're talking about small-molecule drugs, while I do believe that quality standards vary, the largest provider of generics is Teva, and that company has an excellent safety record. Another with similarly excellent track record is Novartis' Sandoz unit, so you're right about implicating a whole industry based on the actions of a single supplier.
At issue is that third-party pharmacy benefits managers (PBMs), at least when we talk about mail-order which is growing increasingly dominant for maintenance medications, choose which generic manufacturer they use, but are not obliged to share this information with the patient. There is slightly more transparency from retail pharmacies on which suppliers they use for generics would be appropriate (if you don't like Walgreen's supplier, then you could theoretically go to CVS) but again, there is a veil of secrecy we should be demanding from the FDA. Ultimately, consumers must be more involved in their purchases, but as long as decisions are made by one or more third-parties, we will not have the level of accountability we really deserve.
Perhaps this article does try to be a little sensationalistic, but anyone who remembers the recent Leiner Health Products product safety fiasco and the ensuing bankruptcy can certainly relate.
ReplyDeleteThis shouldn't come as a surprise at all. Given the new administration's affinity for generics (as well as the Democrat-controlled Congress' stated support), I'd be curious what her impetus for this article was. That is, I am curious, why, all of a sudden, are generics bad??? Who is in Eban's ear promoting this angle?
ReplyDeleteShe did the same thing to the secondary distributors in "Dangerous Doses" -- i.e., used some bad apples as basis to smear an entire industry. Luckily, Congress has/is rejected/ing the argument that the secondary sector is fundamentally dangerous and is moving forward with legislation that reflects the need for and value presented by this small-business industry (read: Buyer-Matheson; and Importation bills).
Does anyone remember how the FDA shut down Glaxo's Paxil Cr factory (YES, a BRAND name drug) because after multiple warnings, the company was found to not have had appropiate amounts of drug and faulty delivery systems? Hmmmmm, where is the book on the danger of Brand name medication!
ReplyDelete“The plural of anecdote is data?” God I love it. You come up with some GREAT lines!
ReplyDeletePlayahata?
ReplyDeleteMr/Ms Anonymous(1) asserts that this article in SELF is helpful in that is spurs debate in the general public. It certainly does that. Challenge: Look around you at the people who love Statistics. From that sample, select those who understand anything about pharmacokinetics and/or clinical endpoints. Finaly, compare that individual (if you even know one...I do), to the general public. Dr. Fein's quip that the plural of anecdote is data is well made and undoubtedly lost on most. The confirmation bias is alive and well. The public has long assumed that Big Pharma is out to get them and that the Pharmacist is the agent of that agenda. This article is shifting that same colored spotlight onto the generic industry which, incidentally, is more Big Pharma every day. the public would be better served by an artice in SELF (or even Prevention!) describing how they can and should participate in the FDA MedWatch program. This program includes a statistically valid mechanism for compiling anecdotal evidence.
ReplyDeleteSo after reading the article you referenced from the People's Pharmacy website, and also the more detailed article from the Washington Post "FDA Scrutiny Scant In India, China as Drugs Pour Into U.S." (http://www.washingtonpost.com/wp-dyn/content/article/2007/06/16/AR2007061601295.html), I did a bit more research and found out that on top of the two major drugmaker(Ranbaxy and Wockhardt) in India who received warning letters from the FDA, Lupin Limited has also recently received one from FDA.
ReplyDeleteThe article includes a prediction that finished generic drugs are India's future, moving up from importing only active ingredients. And that it is difficult for FDA to inspect most firms there due to "lack of resources". Also, based on your importation blog posts about its support from President Obama and the Secretary of HHS. Should we be incredibly worried about the quality of our drug prescriptions orders here since it is simply impossible for individual consumers to trace the origin of each ingredient and steps made to produce the final product. Is there a solution to this?