The debate about generic drugs

So you did your homework on Generic equivalence? Sure, there is confusion. Yes, generics can work. Remember that the 90% confidence interval is based on the branded medication. So, what is the variability going from 1 generic to another? What if you get a different generic each month? How does that effect the clinical response? If stabilized on a generic that is lower side of branded and the next month gets a generic on the high side of the branded medicine, could they now have side-effects due to the difference? Remember, the pharmacies change to whichever generic they get for any given medicine. They may not always get the same brand of generic month to month. So, remember the name of ‘BIO’equivalence does not necessarily mean ‘THERAPEUTICALLY’ equivalent? Show me 10 generics that have equal pharmacokinetics and levels in patients? Would be hard to find that data…

What most people do not understand is the influence generics have on the price of brand name drugs. It all comes down to ROI (return on investment). With shortened patent life and constant patent threats form generic companies on brand name drugs, the time to make back your investment is shorter and your costs are higher. Yo need to make your ROI or you don’t have a business anymore. The only outcome to this is to increase the price. In addition, most patients and prescribers would naturally gravitate towards newer classes of drugs with oftern better outcomes and safety profiles. Therefore, the concept of shortened patent life and easier access for generics does not solve anything, it only makes the problem of cost worse. This is an example of poorly conceived political/government intervention plain and simple. Thank you Henry Waxman.

What most do not understand is how generic competition and hatch-waxman siding with generics actually increase drug costs. It comes down to ROI (return on investment). Branded companies need to make their ROI. Shortened patten life and plenty of patent challenges, only does one thing: increase brand name drug costs. Additionally, since newer, better drugs will continously come to market (and subsequently more expensive), patients and prescribers tend to gravitate towards newer and better classes of drugs. So, savings from generics never really works out unless you have government intervention that forces everyone to use older drugs and not newer drugs. In conclusion, if the federal government didn’t mess with it in the first place, brand name drugs would not be so expensive today. Thank you Henry Waxman.

Obviously the generic companies can sell generics for a fraction of the cost of branded medications, generic companies have no research and development costs to uphold. There is a place for generics, but the public should be made aware of a couple of key pieces of information that will make them better consumers. One is that they should note the time they switch to a generic to be aware if they begin having new side effects or health issues, it may be due to the lack of regulation of the generic manufacturer. The second is that many pharmacists get paid a bonus for switching branded medications to generics, because the pharmacy they work for makes more money on generics versus the branded medications. I would encourage everyone to read the article I have linked, which explains why the quality and regulation of generics may have deteriorated in the past few years due to a huge increase in the number of medications that have lost their patent and the large number of generic manufacturing plants that have moved overseas. Do not be fooled into thinking that the regulation and inspections of generics is equivalent to that of branded drugs.http://www.msnbc.msn.com/id/30940044/

In regard to earlier postings, of course Ms. Kosecoff is self interested in this article. As with any CEO she has a job to do and that is to keep her company competitive. Contrary to earlier comments, health plans and PBMs are like any business in that they are tasked with holding costs down while keeping their customers happy. They claim to drive hard bargains on both branded and generic drugs as well as the prices from the pharmacies dispensing these drugs. In a study by the General Accountability Office reviewing discounts of prescription costs achieved by PBMs contracted to the Federal Employee Program the GAO found that PBMs brought the health plans an average of 18% discounts at retail and greater than 25% at mail order. This aggressiveness by the PBMs also makes them a target for unhappy pharmacies and drug makers who resent losing margin. If, as suggested, they are fooling large employers and the government who contract for their services into paying them as worthless middlemen, I guess they must be pretty good at their deception.

If the hawking of less costly generic drugs keeps healthcare affordable and allows my employer to continue to provide medical and prescription benefits for me and my family, I am willing to listen.

Too bad Ryan from San Diego did NOT do his homework. The 20-25% he speaks about is relative to a statistical confidence interval not an absolute difference in blood levels. FDA did two studies and showed the average difference is in the range of 3.5-4% which is the same difference one would expect if one lot of the brand name drug was tested against itself!

Thanks for your response to the postcard comments. With all due respect, the sources you referenced have a stake in reassuring everyone that the system is fine. Like any subject, the truth is somewhere in the middle ground. Please check out the following link, from Consumer Reports, that gives some discussion of the shades of gray relating to this subject. I am sure that there are other credible sources with similar information. I remember, in med school, being told that one of the popular asthma meds had the right, effective ingredient, but the coating of the pill included a dye that was recognied to trigger asthma. (if the link does not work, go to the Consumer Reports website and searth “generic drugs.”

http://blogs.consumerreports.org/health/2009/06/generic-drugs-not-as-effective-as-brands-today-show-generic-drugs-as-good-at-brand-names.html?resultPageIndex=1&resultIndex=1&searchTerm=generic%20drugs

1997 is a bit dated for the generics that were available then versus now. Do some more homework and look and the number and types – you will be amazed.

JAMA and NEJM have had serious issues with studies funded by Pharma. Not the place to get all your facts.

Many of the more recent generics are “mirror” molecules, that is there is a physical structure of the molecule is a mirror image of the other. And in some people this has a profound effect on bioavailability. Most often in psychotropics.

Many generic manufacturers are in deed the brand manufacturer and the only difference is the last step of the process whereby the logo is stamped on the pill is omitted. Why the difference in price? I suspect the ink doesn’t cost that much.

Initial patent protection is that is needed to produce plenty of incentive for R&D.

Lastly, why does the USA have to pay for the worlds R&D? That is the effect of our patent/gov’t hand off pricing model.