Big Pharma $$$$ by PBT Consulting
In addition to the billions of health care dollars drug companies waste on disease mongering -- convincing the public that everyday human problems are actually illnesses requiring treatment -- 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 an existing drug that is already on the market. The main downside of me-too drugs is that they are a primary factor in skyrocketing health care costs, which in turn, are the main reason hundreds of thousands of Americans can't afford to see a doctor when they are ill. Other drawbacks of Big Pharma's fixation with copycat drugs include the neglect of hundreds of untreatable fatal and disabling 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
I first learned about me-too drugs when Ralph Nader raised the issue in his 2000 presidential campaign. Dr Marcia Angell, Harvard Senior Lecturer in Social Medicine 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 http://www.cmaj.ca/cgi/content/full/171/12/1451
According to Angell, it's quite common for a drug company to manufacture their own copycat drugs when their patent is about to expire on an older drug (which means most doctors and patients will opt for the cheaper generics that become available). She gives the example of AstraZeneca reformulating the ulcer drug Priloxec to bring out Nexium, a nearly identical replacement and then increasing the price of the Prilosec to get people to switch.
She then gives the example of three identical cholesterol lowering drugs - Provochol, Zocor and Lipitor - being introduced a few years apart following the immense success of Movochol. As of December 2010, we now have eight extremely virtually identical medications for the exact same indication: lowering cholesterol levels.
Billions Spent on Marketing Identical Drugs
Angell goes on to point out that of all the drugs the FDA approved between1993 and 2003, 78% were similar to already marketed drugs. Even more shocking was that 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 (in psychiatry this is a common ruse to extend a patent on a brand name drug)
Angell is also extremely concerned about 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. This is done without a shred of scientific evidence to back up their claims, as the FDA only requires pre-approval trials to compare me-too drugs to placebo and not to existing medications. Occasionally drug companies will do a head-to-head trial with a competitor's drug, but this is only years after approval. AstroZeneca, for example, spent $500 million persuading doctors to substitute Nexium for Prilosec.
Refuting Drug Company Allegations
The drug companies and pharmaceutical industry analysts that pimp them claim that me-too drugs are beneficial for the US health care system in two ways. First they allegedly lower prescription costs by increasing competition. Secondly they provide doctors 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, as 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. The reality is that the price for brand name prescription drugs continues to soar through the roof. Only the ready availability of quality generics has kept prescription costs affordable for the vast majority of patients.
Moreover it makes no sense to apply free market competition principles to the prescription drug costs, as drug prescribing is never a standard market transaction. Nearly all prescriptions are at least partially subsidized, either by insurance or Medicaid. The heaviest users of prescription drugs are vulnerable geriatric, mentally ill and disabled patients who hold virtually no sway in making a price-driven choice between competing products. Even their doctors, who ultimately make the choice, must go to a lot of extra effort to ascertain price differences between brands, as drug companies don't voluntarily provide it.
The Sad Saga of SSRI Copycats
To justify the value of providing doctors a range of similar drugs to choose from, most analysts give the example of all the copycat SSRIs available to treat depression. In doing so, they claim that some patients who fail to respond to Prozac, may respond to Paxil, Zoloft, Celexa, Przac, Priligy, Lexapro, Zelmid, Viibyrd or Upstene. This is yet another marketing claim with no scientific data whatsoever to back it up. After prescribing SSRIs for twenty years, I, like most of my colleagues, have never found a differential response to different brands. My own clinical experience coincides very closely to recent meta-analyses of three decades of SSRI efficacy studies: about 35-40% of patients (only slightly higher than the placebo response) get a positive response to any SSRI, while 60% fail to improve or experience horrible side effects (http://www.oregoncounseling.org/ArticlesPapers/Documents/TherapyVsRx.htm).
I agree with Angell's view that having one therapeutic equivalent for a patient who develops and allergic reaction to the first drug invented in a therapeutic class - but approving eight is enormously wasteful (especially in view of the billions of dollars spent on marketing them), as well as posing major safety risks.