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Trouble With Generics

Is the "Same" Drug Really the Same?

They’re Not The Same

“I used to be taking blue pills but now they’re orange. And I don’t think this pill is working.” The patient had been given the “same” medication. But it was a different generic drug.

This “generic” story is now a general story.

In America, generic medications are off-patent versions of FDA approved drugs. They are made all over the world. They are fabricated by many different manufacturers – often producers of patented drugs. They contain the same ingredient – most often in the same amount – as the FDA approved patented drug. They are often cheaper, sometimes vastly more inexpensive than patented versions.

But they are not the same. Which is why the oligopolistic pharmacy benefit companies, with their burgeoning economic power, now must be actively watching to prevent harm. By shifting different generics onto patients, sometimes month by month, and not telling or explaining what they are doing to patients or physicians, greed can overcome good.

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How are Generics Different? 

Generic drugs are the same compound inside different packaging, binding and dissolution agents. The drug inside may be the same, but how it gets absorbed and used by the body is often different.

Sometimes very different.

The FDA allows drugs that provide data demonstrating “bioavailability” is between 80-120% of the patented drug. For a “relevant” population.

Most of the public does not understand such population statistics. What the statistics say is that in the population studied – which may not be like the population which gets the drug - most will actually absorb between 80 to 120% of the patented drug dose.

However, in any given individual the splay can be much, much bigger – ranging from near zero usable compound to multiples of the standard, patented drug.

Does This Change the Effect of the Drug? 

Yes. Medical school teaching describes a 20 fold – that’s 2000% difference – in how quickly and completely people render drugs inactive. Now add that difference to the different biological affects of one patented drug versus a generic – or between one generic and another – and the effect difference can become huge.

Next consider the additional effects from two other factors – allergic or immunologic reactions, which are poorly studied, and the immensely complicated interactions of different drugs.

And recognize that drugs change the metabolism of other drugs. They change how they are metabolized and used. Taking drug A can, for example, may cut the bioavailability of drug B in half. With most elderly folks on 10, 12 or more medications, swiftly changing from one generic to another can change everything.

And worse, often neither doctor nor patient is aware of that change.

Does Changing the Formulation Always Matter? 

Fortunately no. The human body is extraordinarly resilient. Great differences in bioavailability may still allow clinical effectiveness. 

But there are many drugs with quantum - threshold effects. Go below – or above – a certain threshold and they don’t work – or cause unpalatable side effects. Antidepressants are one class of drugs that sometimes demonstrate threshold effects. Ninety-five percent of the blood concentration dose may do nothing, while 101% will give you what you want. 

Changing generics willy-nilly from one to another can be very problematic with people on drugs like antidepressants, chemotherapeutic agents, and others. Antidepressant effects often take a very long time to appear – and may take a long time to come off. 

Which means you won’t know if symptom worsening three months down the road was the result of changing the drug.

Are Generics Always Properly Absorbed?

Sadly, no. There are so many – and supposedly so much competition – that stated bioavailability may not prove real. Recently wellbutrin XL made by Impax Pharmaceuticals was taken off the market for not showing “proper” absorption and availability. 

But drug companies have been performing such antics for decades. For a fuller recounting of what the “ethical” drug manufacturers routinely do, look to Ben Goldacre’s “Bad Pharma” which should be appear in the US soon.

Wellbutrin XL is an interesting case, for it is just one of three differently absorbed forms of bupropion, an antidepressant also commonly used for smoking cessation. Problems with wellbutrin XL were noted for years via comments to Joe and Terry Graedon of the People’s Pharmacy, a popular and useful NPR show and website. It can take a long time for government to act.

Why Are Generics Being Switched by Pharmacy Benefit Companies?

Money. Generics can save companies – and individuals – lots of money - a generally good thing. And the dominating pharmacy benefit companies tend to have special relationships with certain manufacturers.

That may explain why one generic costs pennies per pill with one drug insurer – and dollars with another. Patients also can’t understand why the same drug is twice as costly at Walgreen’s than Walmart – even though it’s supposedly “the same.”

What Should Be Done? 

1. Start regular testing. Lots of generics are being thrown on the market, and after the compounding pharmacy mess somebody better start testing their real bioavailability. Self-regulation is sometimes non-regulation. As occurs in most of the rest of the world, the government has a critical role here. 

2. If someone is doing well on a generic it has to be explained to both physician and patient why they are being switched to another.

3. Organizations like Britain’s NICE (National Institute of Clinical Effectiveness in Britain) should be established federally and in US states to look at “standard” medical practices – like rapid substitution of generics – and possess the ability to change them.

New Times

American physicians are becoming fed up spending extra hours every day “discovering” patient information inside competing electronic medical record systems. Outpatient records don’t talk to inpatient ones even in the same hospital system – and may absolutely refuse to communicate with other “dedicated” systems. It’s a real mess when looking at what drugs people are – and have been – taking.

But physicians are also writing prescriptions that are disregarded with impunity by the “fine print” of their pharmacy benefit contracts. Patients complain we have not written refills – though they were written for a year. Drugs are “substituted” without consent. Incessant faxes are sent to “verify” medications – though the prescription has been written out, handed to the patient, sent electronically, or both. Changes are made without explanation. And the pharmacies are making a pretty penny sending private prescribing information to drug companies – though the pharmacy benefit companies know more.

Woe to the doctor who wants a certain medication given to their patient – even supercheap generics – that does not appear on an insurer’s “preferred list.” You will spend hours on the phone giving the same information four or five times to different individuals who will pass you on again and again until you reach the “authoritative individual” who will listen and tell you “yes, something will be done.”

Which is to send you another fax.

People better know what they’re paying for. And what they’re really getting in the pills they take.

Matthew Edlund, M.D. researches rest, sleep, performance, and public health; he is the author of Healthy Without Health Insurance and The Power of Rest.

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