174. ARE GENERIC DRUGS ANY GOOD? – Surviving Healthcare

Update on Cassandra’s Memo. I have been beating on it nearly 10 hours a day since I wrote to you last. I’ve had some comments that helped me improve it, but the content is about the same. If you want the ebook, or have the time to review the final or near-final result, please feel free to download another copy HERE. Thanks much for your support and comments. You have permission to forward the download link to your friends.

The audio above is the full original “Generics: Good, Bad, or Fake?” chapter from Butchered by “Healthcare” and the full text is HERE.

Excerpt:

We have allowed our patent drugmakers to gouge us so thoroughly that we can no longer afford their products. The result is that ninety percent of America’s medications are now generics. Until recently, I believed that these were nearly equivalent to the brand names, but it stunned me to learn that I was wrong.

Generics are not exact copies of trade-name drugs. The manufacturers do not have the original recipe, and production outside the brand factories tends to be less careful. Overseas, there might be hygiene problems or extra ingredients added. These can change the way a drug works or even be harmful.

We permit new companies to manufacture drugs after the patent expires. Other companies make generics in foreign countries where patent laws are ignored. The drug’s chemical name is used to market generics rather than the original trade name, and sometimes the generic drugmaker makes up their own trade name.

Lipitor generics illustrate how it works. Richard Mason (Harvard), collected thirty-six samples of this statin drug from fifteen countries and two dozen manufacturers between 2011 to 2013. Analysis proved that thirty-three had impurities that thoroughly compromised them. This is beyond atrocious, but the backstory is worse.

When the patented version of Lipitor was originally studied during its approval process, only two small groups lived longer: those who had a previous heart attack and (possibly) those with hereditary high cholesterol. This alleged success was used to support marketing to nearly anyone with slightly high cholesterol. There are now 35 million US citizens taking Lipitor. It is not just the bestselling statin, but in 2011, it was the bestselling medication of all time.

Lipitor was an ideal drug for fraudulent generic copies because the genuine item was nearly worthless. Neither the doctors, the public, the study authors, nor the writers of the two otherwise excellent resource books I used for this chapter ever understood the irony.

Although the brand-name drugmakers are guilty of many sins, they are rarely accused of poor manufacturing standards. They get so much money from the monopoly and third-party reimbursement that they can afford to make drugs accurately. Their only recent production issues have been Gilead’s hepatitis C drug and a few cancer, migraine, and HIV medications.

The generics are another story. Because of our soaring drug prices, eighty percent of all US medications now originate in India or China, counting both ingredients and finished products. A 1970 Indian law allowed copying patented drugs. The only requirement was that the manufacturer had to alter some step in their process. Soon, they were producing forty percent of our generics. Some are close replicas, but others are weak, and some have extra ingredients that produce harmful effects. When doctors use weak (substandard) or ineffective (counterfeit) drugs for sick people, suffering and occasional death result. With antibiotics, weak ones breed resistant bacteria, the “superbugs.”

The two countries that are the primary source of US drugs are unreliable. Their issues may include miserable standards, outright frauds, and lately even designer bioweapons from China. The FDA could never monitor thousands of foreign manufacturing facilities even if they were motivated to do so.

Another source reports:

…while companies are required to get the chemical recipe of the generic drug close to the original, they aren’t required to show that the two versions are therapeutically equivalent, meaning that they don’t have to do tests to make sure that patients respond to these drugs the same way they do the brand-name version. For example, the manufacturer of a generic blood pressure medication wouldn’t need to prove that its drug also lowers blood pressure…

Some US institutions have resorted to doing their own generic testing.

As a stopgap, some US institutions are operating like a mini-FDA. For example, Cleveland Clinic detected reduced efficacy of certain generics after the cardiology patients who took them got sick or even died. Lab testing proved certain ones were inactive, so the doctors substituted brand-name drugs, and many patients improved. Since then, the Clinic developed a program to test generics. Other groups have followed suit. (Butchered by “Healthcare.”)

I have watched many of my patients respond poorly to certain generic drugs. These include:

• Beta blocker heart medicines (metoprolol) that are supposed to last 24 hours that only work for 12

• Calcium channel blockers (generic Norvasc, for example) with the same problem

• Low potency generic Tylenol and Advil

• Some brands of generic Prilosec don’t work, but you can get the real thing economically at Costco.

• These are just a few examples among many. If you assume that generics are quite different from and underperform brand names, you will often be right.

What can patients do?

• Raise your general suspicions from amber to blinking red regarding every drug.

• Lifestyle changes are always preferable, so do not depend on a foreign chemical to solve your stress, drinking, smoking, or overweight problems.

• Avoid all prescriptions if possible. If the ones you have been prescribed have severe side effects for a few people, you could easily be the unlucky one.

• If you must take drugs, patented ones are usually better quality. Some may be purchased from foreign countries at steep discounts.

• If you buy within the US, your health plan may not ordinarily cover the “real thing.” You may have to get aggressive with your insurance plan or doctor to make an exception for you.

• Watch yourself carefully at all times for side effects and to be sure medications are working properly.

• Feel free to challenge, change doctors, and get second opinions. Be courteous and respectful and never burn bridges.

• Always bear in mind that drugs are never studied in combination and any doctor that has you on too many is risking your health. I cannot give exact guidelines, but the extreme examples are the nursing home patients who are taking ten to twenty! This turns most of them into zombies, but it is profitable for Pharma.

• Certain classes of drugs—generic or not—have little or no place in rational medical care. The statins and the entire psychiatric formulary are examples. Learn about these in Butchered by “Healthcare.”

• Be careful out there. Although you can find great doctors, the healthcare system is not your friend.