I am aghast at the latest headline spin insisting that generic drugs are just as good as the more expensive brands.

Why? Because the study cited doesn’t “prove” that at all.

From the JAMA (Journal of the American Medical Association) abstract (summary):

We identified 47 articles covering 9 subclasses of cardiovascular medications, of which 38 (81%) were randomized controlled trials (RCTs). Clinical equivalence was noted in 7 of 7 RCTs (100%) of β-blockers, 10 of 11 RCTs (91%) of diuretics, 5 of 7 RCTs (71%) of calcium channel blockers, 3 of 3 RCTs (100%) of antiplatelet agents, 2 of 2 RCTs (100%) of statins, 1 of 1 RCT (100%) of angiotensin-converting enzyme inhibitors, and 1 of 1 RCT (100%) of {alpha}-blockers. Among narrow therapeutic index drugs, clinical equivalence was reported in 1 of 1 RCT (100%) of class 1 antiarrhythmic agents and 5 of 5 RCTs (100%) of warfarin. Aggregate effect size (n = 837) was –0.03 (95% confidence interval, –0.15 to 0.08), indicating no evidence of superiority of brand-name to generic drugs. Among 43 editorials, 23 (53%) expressed a negative view of generic drug substitution.

Quite a mouthful, isn’t it.

Let’s break it down. I don’t belong to the AMA so don’t have access to the gritty details, but a few things bother me.

The “survey” was not a survey of actual drugs taken randomly from your local pharmacy, but a “survey” of articles that examined generic versus brand name medicines.

The problem? This means that “headsup” articles, where medications were caught being a problem and were taken off the market, aren’t included.

But the part that worries me as a doctor it the line “..Clinical equivalence was noted in 7 of 7 RCTs (100%) of β-blockers, 10 of 11 RCTs (91%) of diuretics, 5 of 7 RCTs (71%) of calcium channel blockers..”

Translation: one of the ten studies, they found that generic diuretics, AKA “water pills”, a medicine used for water retention and high blood pressure, didn’t work as well as the name brand product; but what is more upsetting is that two of the seven studies that compared Calcium channel blockers found that the drugs were not equivalent. These medicines are mainly used for high blood pressure, but sometimes used for irregular heart beat.

Another problem in the study was that it included research papers from “ …January 1984 to August 2008…”

So what? well, in recent years with globalization, more and more of pharmacuticals come from non American factories, many in India and China. This was not true in 1984.

Most of these factories are run by honorable men who produce a high quality and cheaper product, but this is not true of every factory.

So do your generics come from a long established company, that would face lawsuits, loss of their good name, and even bankrupcy for peddling fake ingredients, or does the generic come from a “fly by night” company whose owners can take the money and run?

Of course, with globalization, even well known drug companies in the US and Europe are using ingredients or using factories in third world countries.

From the NYTimes:

Generic drug makers in the United States, where price competition is fierce, were the first to seek cheaper drug ingredients in China. Last year, generic drug applications to the F.D.A. listed 1,154 plants providing active pharmaceutical ingredients: 43 percent of them were in China, and another 39 percent were in India. Only 13 percent were in the United States. Branded drug makers, with their fatter profit margins, resisted buying ingredients from China for years, but with their businesses now suffering, even major pharmaceutical companies like AstraZeneca, Bayer, Baxter and Pfizer have announced deals to outsource manufacturing to China.

We all know the result: fake heparin ingredients. And not because of a “mistake” that inspection of paper work would have discovered, but a deliberate adulteration with an ingredient that would pass ordinary quality control drug inspection by the well known and respected American and European (and Japanese) drug companies.

So pass a law, hire some inspectors, and voila, no problem, right?

Wrong. From a WHO report:

Enacting deterrent anticounterfeiting legislation alone will not solve the problem. It needs to be enforced. Where existing laws are not enforced crime is perpetuated as criminals are not afraid of being arrested and prosecuted. Lenient punishments for offences tend to encourage criminal activities such as medicines’ counterfeiting, particularly when the penalties for counterfeiting non-medicinal products are more severe. Moreover, disregarding trademark rights may encourage large scale counterfeiting of drugs.

The efficiency of personnel is adversely affected by corruption and conflict of interest resulting in laws not being enforced and criminals not being arrested, prosecuted and convicted for their crimes

Translation: if the laws aren’t enforced, they don’t mean anything. If the laws are “enforced” with a small penalty, it is still cost effective for criminals to continue committing crime. And when you can easily bribe the local inspector or government official to look the other way, criminals can literally get away with murder.

The dirty little secret is that third world countries do not have the same infrastructure as in the US: if a factory doesn’t meet standards, a simple bribe may be able to make the local authorities look the other way (and if the inspector is your brother-in-law, you may not even need a bribe).

There is a level of corruption in many third world countries that is unbelievable to the average American. A WHO report revealing such corruption include the deliberate adulteration of products with cheaper poisonous ingredients to make a profit (e.g. melamine in baby’s milk, Diethylene glycol (used in antifreeze) as a sweetener in toothpaste, teething medicine, and cough syrup), and the manufacture of counterfeit items (fake vaccines,or drugs that have the same appearance as those made by well known companies) are criminal acts, yet the slowness in prosecution of those perpetrating the deception has been slow.

Outbreaks of deaths from poisonous ingredients are easy to track, but how many thousands have died of infections or malaria died because they were given a substandard drug?  After all, children in the third world die every day, so did your child die of Pneumonia or malaria because he was undernourished and sick for two days before you saw the doctor, or because the medicine didn’t work?

How big is the problem? The World Health Organization estimates ten percent of all pharmacuticals are counterfeit. However, they note that only one percent of the drugs in developing countries are counterfeit.

So you in the US don’t have to worry. The USDA will protect you, right?

But there is a dearth of USDA inspectors for these factories.

The US Government Accountability Office (GAO) report reveals problems:

In the fiscal years 2002 to 2007 the FDA issued 15 warning letters to overseas manufacturers citing serious deficiencies but failed to adequately follow these up, according to the report.

The GAO found that after issuing the letters the FDA re-inspected four of the facilities but not until two to five years after it had initially discovered the faults.

And, of course, if there is a conspiracy to add a hard to trace fake ingredient, as happened in the Heparin scandal, there is no evidence that inspecting the plant or the paperwork would actually detect the illegal substitution. It is all too easy to “fake” paperwork or clean up factories before inspections (even “unscheduled” inspections may result in a “heads-up” by local taxi drivers, government officials, or hotel clerks to the factory owner, so he has time to clean up his act).

So I’m happy that the JAMA and the US government bean counters are planning to tell everyone that generic medicine is just as good as the brand name product. Most of the time it is.

But the study in JAMA doesn’t prove anything.

As for me, after my husband Lolo’s bad experience with generic antibiotics (which I wrote about HERE), I hope you will excuse me if I decide to spend my own money getting the brand name here in the Philippines.

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Nancy Reyes is a retired physician living in the rural Philippines. Her website is Finest Kind Clinic and Fishmarket, and she writes medical essays at heyDoc Xanga blog.

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