Masters Series: How Drugs Used to Cure Are Actually Harming You

 

How Drugs Used to Cure Are Actually Harming You

By Dr. David Eifrig, Jr, editor, Retirement Millionaire

 

Karen Bartlett spent months recovering in the hospital after losing two-thirds of her skin and needing a medically induced coma.

 

She is now legally blind and has trouble swallowing because of scarring in her throat. She lives off disability payments... all because she took a generic drug.

 

In 2004, Karen's doctor prescribed her Clinoril – an anti-inflammatory drug – for shoulder pain. When she went to fill the prescription, the pharmacy gave her the generic version of Clinoril, called sulindac. Soon after taking sulindac, she developed Stevens-Johnson Syndrome (SJS) – a rare and life-threatening skin disorder caused by certain medications, infections, or cancer.

 

Karen sued the generic-drug maker, and in 2010, won a $21 million judgment. However, last summer, the Supreme Court overturned the ruling because of a much-debated legal point: Generic manufacturers can't be sued.

 

You see, the FDA requires generic drugs to carry the exact same labeling as their name-brand counterparts (not including the brand name or trademark). All of the safety precautions, warnings, and related text must be copied exactly.

 

As it was, the name-brand drug did not specifically warn patients about SJS, so the generic drug didn't either. The generic-drug maker had no further legal obligation...

 

The FDA is currently working on changing this rule to force generic drugs to include their own safety warnings, which would allow people to sue generic-drug makers over harmful side effects.

 

Regardless... Karen's story isn't unique. And it underscores a hidden danger of generic drugs: They aren't as safe as you think...

 

Most people assume generic drugs are identical to the branded drugs they're meant to replicate. They figure that makes them as safe as the name-brand stuff. And they're protected if they experience serious side effects.

 

But none of that is correct. Generics are not identical... and you're not safe.

 

Big government and big businesses aren't looking out for the individual. It's up to you to make the best decisions for your health.

 

So today, I want to empower you to make knowledgeable decisions the next time you're at your doctor's office or the pharmacy.

 

Generic drugs account for more than 80% of all prescription drugs filled in America. And that number is expected to rise over the next five years to 87%, thanks, in part, to the U.S. government.

 

The Obama administration is pushing the Federal Drug Administration to approve more generics to increase competition and decrease prices. Some estimates say the value of the pharmaceutical industry will soar from $359 billion in 2012 to $476 billion by 2020, due to increases in the number of people insured (including those covered by Medicaid).

 

Insurance companies all push the use of generics as lower-cost substitutes for brand-label drugs... Because makers of generic drugs don't have to put all their money into research and development, they can charge less. Of course, the insurance companies receive incentives from the makers to encourage generics.

 

The momentum behind generics is so strong, it's likely your pharmacist or insurance company has switched a prescription of yours to a generic alternative without you realizing it. And switching your drug to a generic – without your consent – is perfectly legal.

 

In theory, this makes sense...

 

Generics are supposed to work the same way and have the same effects as the name-brand drug. Something called "bioequivalence" means things like the dosing, strength, method of administration, and intended use should be the same.

 

Measuring bioequivalence is a difficult process to explain, but it is the crux of the problem. So bear with me...

 

Basically both drugs – the name brand and the generic – are given to patients over a certain time interval, say for 72 hours. The amount of the drug in each patient's bloodstream is measured hourly. This is called the "plasma concentration."

 

The concentrations of each patient are averaged, giving the mean concentration for that time period. This gives something we call a metabolic pattern – how the mean concentration changes over time in a set percentage of people. As long as the pattern for the generic is close enough to the brand name, it can hit the market.

 

But here's the scary part: The FDA won't release the bioequivalence studies that determine their judgment.

I encourage you to write the FDA and let them know we want transparency from the government. You can write them at:   Food and Drug Administration 10903 New Hampshire Ave. Silver Spring, MD 20993-0002

Worse... even if the bioequivalence is close, that doesn't always mean the generic will act the same way as the name-brand drug. What's advertised as the same drug with the same dosage may have anywhere from 15% less to 25% more of the drug's activity in the body... This means the generic could be slightly more or less effective than the brand-label version.

 

The ingredients can also be different. The only ingredient that generics need to have in common with the name-brand drug is the active ingredient. That means all preservatives, binding materials, coatings, dyes, and flavorings are fair game. The generic-drug maker will often switch to lower-cost ingredients (another reason generics are cheaper).

 

This is all legal and approved by the FDA...

 

But these differences in inactive ingredients – called "excipients" – lead to possible side effects not found taking the brand-label drug. For example:

 

Excipient	Possible Side Effect
Ethanol	Harmful for those with alcoholism, liver disease, or epilepsy
Formaldehyde	May cause upset stomach, diarrhea
Heparin	Allergen – can cause an allergic reaction
Arachis oil	Allergen for those with peanut allergies
Source: World Health Organization Pharmaceutical Excipients – An Overview Including Considerations for Paediatric Dosing, Dr. Simon Mills, June 2010

 

The FDA doesn't test for these substances. And even if it did, around 40% of the drugs taken in America are from outside the country.

 

According to the U.S. Government Accountability Office, at the rate global laboratories have grown in the generic market, it would take the FDA 13 years to see every foreign laboratory just once. Don't count on the safety or efficacy of that generic drug.

 

And some of the foreign laboratories have already displayed safety issues.

 

Ranbaxy Laboratories (owned by pharmaceutical giant Daiichi Sankyo Co.) recalled atorvastatin (the generic of Lipitor) in November 2012 when reports of possible glass particles in the capsules made their way into headlines.

 

Eventually, Ranbaxy's atorvastatin made its way back onto the market. But the drug was recalled again in February 2014 when a pharmacist in the U.S. spotted a 20-mg tablet in a clearly sealed 10-mg bottle.

 

Last May, the manufacturer pleaded guilty to charges made by the FDA that it had filed false claims and had been producing adulterated drugs. It had to pay $500 million in fines.

 

One of Ranbaxy's labs in Toansa, India just failed a January 2014 FDA investigation. In the sample preparation room, the flies were "too numerous to count," and many windows could not be shut. A refrigerator with samples had filled with water and leaked onto the floor, as well. Workers also did not run proper screening tests for sample quality. The FDA prohibited the plant from producing and distributing drugs.

 

Unfortunately, dozens of labs have safety issues. You can see a full list of labs that haven't passed FDA inspection here.

 

In tomorrow's essay, I'll show you what you should do before taking any generic drug... and – if you'd rather stick with the name brands – how to do so as cheaply as possible. Stay tuned.

 

Here's to our health, wealth, and a great retirement,

 

Doc Eifrig

 

 

Editor's note: In his "Retirement Cheat Sheet for the U.S. Health Care System" special report, Doc suggests three cost-cutting tips for getting your prescription medicines cheap. With these insights, you can stop relying on drug makers, insurance companies, and self-important physicians to act in your benefit. You can take control of your own health.

 

Doc also recently released a research report on three cheap, clever, and critical items and gadgets that can help you survive almost any natural or manmade crisis, no matter how long it lasts. For more details on this report – and to gain access to Doc's "Cheat Sheet" – click here.