The Me-Too Drug Ripoff

In addition to the billions of health care dollars drug companies waste on disease mongering (see earlier posts), billions more are wasted on developing and marketing hundreds of “me-too” drugs. By definition, a “me-too” or “copycat” drug is a very slight variation of a drug already on the market.

The main downside of me-too drugs that they drive up health care costs  – the exorbitant cost of medical care is the main reason millions of Americans can’t afford a doctor when they’re ill. Other drawbacks of Big Pharma’s fixation with copycat drugs include the neglect of hundreds of potentially treatable illnesses and hundreds of cases of premature death and/or permanent disability related to inadequate safety profiling. Nearly all the major drug recalls in the last few years have involved copycat drugs that were assumed safe because they were chemically similar to medications already on the market.

An Issue First Raised by Ralph Nader

To the best of my recollection, Ralph Nader was the first to raise the issue of “me-too” drugs in his 2000 presidential campaign. Dr Marcia Angell, Harvard Senior Lecturer in Social Medicine, also covers the subject extensively in The Truth About the Drug Companies: How They Deceive Us and What To Do About It (2004) and in “Excess in the pharmaceutical industry” in the Canadian Medical Association Journal

According to Angell, it’s quite common for a drug company to manufacture their own copycat drugs when their patent is about to expire. The idea is to persuade doctors not to opt for cheaper generics when brand named drugs lose their patent protection. She gives the example of AstraZeneca reformulating the ulcer drug Priloxec to bring out Nexium, a nearly identical replacement. The company also shrewdly increased the price of Prilosec to get people to switch.

Three virtually identical cholesterol lowering drugs, Provochol, Zocor and Lipitor were introduced soon after Lipitor (introduced in 2002) became the best selling pharmaceutical in history . The latter was the first statin, a class of drugs that inhibits cholesterol formation in the liver. There are now eight virtually identical statin medications, excluding combination medications that contain it.

Billions Spent on Marketing Identical Drugs

OF all the drugs the FDA approved between 1993 and 2003, 78% were similar to already marketed drugs. Even more shocking, 68% weren’t even new compounds but a reformulation (change from capsule to tablet, short to long acting, etc) or a recombination of existing drugs.

Angell also laments the billions of dollars drug companies spend persuading doctors (and now patients through direct-to-consumer advertising) that their new me-too drug is more effective or safer than the older versions on the market. In most cases, they do this without a shred of scientific evidence. The FDA only requires pre-approval trials to compare me-too drugs to placebo and not to existing medications.

Big Pharma’s View on Me-Too drugs

Pharmaceutical companies want us to believe that me-too drugs enhance health care delivery. They allege that copycat drugs lower prescription costs by increasing competition. They also assert that doctors need a range of back-up drugs when the first-line medication doesn’t work or isn’t tolerated.

The claim about lowering prescription costs is utter rubbish. Copycat drugs are always priced the same or higher than the older drugs they supposedly compete with. And drug companies never, ever market their me-too drugs to doctors or patients on the basis of cost savings. As the price for brand name prescription drugs soars through the roof, only the easy availability of quality generics keeps prescription costs affordable for patients.

To justify the value of providing doctors a range of similar drugs to choose from, drug industry analysts give the example of the numerous copycat SSRIs available for treating depression. In doing so, they claim that some patients who fail to respond to Prozac, may respond to Paxil, Zoloft, Celexa, Priligy, Lexapro, Zelmid, Viibyrd or Upstene.

This is yet another marketing claim unsubstantiated by scientific research. After prescribing SSRIs for 25 years, I, like most of my colleagues, have never found a differential response to different brands. In fact my clinical experience coincides very closely to a recent literature review of SSRI effectiveness. This meta analysis revealed that only 35-38% of patients (only slightly higher than the rate of placebo response) get a positive response to any SSRI. The other 60+% fail to improve or experience horrible side effects.

What the Congressional Budget Office Found

In 2004, Angell could only estimate what drugs companies were spending on marketing, as this is considered proprietary corporate information. However in 2008, the Congressional Budget Office investigated and came up with the following findings:

• Drug companies spent approximately $20.5 billion on promotional activities (10.8% of total revenue) in 2008.
• Drug marketing costs, which grew rapidly between 1988 and 2006 had slowed and had been steady for three years at 10-11%. The CBO felt this was directly related to decreased rate of new drugs coming to market.
• In 2008 drug companies spent only slightly more on promoting new drugs than they did marketing copycat drugs.

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