Posted tagged ‘drugs’

Pharma weasel games: Tales of Concerta and Auralgan

June 25, 2011

The Pediatric Insider

© 2011 Roy Benaroch, MD

I’ve been pretty hard on big pharma in the past—drugs account for a huge part of the cost of health care, and drug companies haven’t always been transparent and fair in the way they’ve priced and marketed new medications. They’re businesses, I understand that, and they exist to make a profit. But the way they game the system to take advantage of gullible docs and patients is sometimes sickening. Two recent stories illustrate their weasel games.

Auralgan is an old medication, an ear drop used to treat the pain that comes with ear infections. For decades it was made with two ingredients, and was sold inexpensively alongside several generic versions. The original product was formulated before current FDA standards for marketing prescriptions, so it was “grandfathered in,” basically allowing it to be sold and marketed “as-is” without proof of safety and effectiveness. It seemed to work well enough, and I suppose no one complained.

A few years ago, the manufacturer of Auralgan “reformulated” the product, adding two more ingredients without changing the name. Naturally, they also reformulated the price—now, cheap Auralgan was priced at over $100. Furthermore, because the ingredients had changed, docs who prescribed “Auralgan” found that pharmacies could no longer substitute inexpensive generics, even though the generics had the ingredients that Auralgan originally contained. In one swoop, the manufacturer dramatically increased the price while eluding generic substitution. Clever, huh?

Maybe too clever. This year, US Marshalls swooped into a warehouse in Kentucky, confiscating 16.5 million dollar’s worth of Auralgan. All new drugs must be FDA approved, and “new Auralgan” had never received FDA approval. It was illegal to sell, and it’s now completely off the market.

A bigger company sells a much bigger drug, Concerta. It’s one of the most popular treatments for ADHD, and one of the biggest selling brand-name medications in the USA. But its patent has expired, ostensibly allowing generic manufacturers to sell their own version of the product (presumably at a lower price.) Johnson and Johnson, maker of Concerta, has fought the expiration of their patents for years in the courts, finally losing an appeal in 2010. But get this: after losing their patent-infringement suit against generic company Watson Pharmaceuticals, J&J turned around and cut a deal with its adversary in court. J&J will now be manufacturing, in their own facilities, an “authorized generic” of Concerta to be sold by Watson. Watson, of course, will pay J&J to make their generic Concerta for them. So J&J will in effect be making the profits off of their own, off-patent Concerta, plus the profits off of the “generic”, which will actually be sold by another company pretending to be their competitor. No wholesale prices have been released, but I’m guessing that this generic Concerta will be priced quite similarly to the brand name. J&J wins. You lose.

Tired of the weasel tricks? Would you like to hear about some real ways to save on prescription drugs? Start here.

Acetaminophen safety alert

August 14, 2009

The Pediatric Insider

© 2009 Roy Benaroch, MD

Kelly posted, “After the FDA’s recent announcement about the dangers of acetaminophen overdose, I now think twice before using it for me or my family.  What’s your take on whether the drug is safe in the prescribed dosages – particularly for kids?”

In June, 2009 the FDA released information from an advisory committee studying the safety of medications containing acetaminophen (most commonly known by the brand name Tylenol.) They pointed out that acetaminophen can cause acute and chronic liver injury, which can be fatal. Since then, the manufacturer has started an advertising campaign defending the safety of their product. So who to believe?

Acetaminophen is very, very safe—when taken correctly by people who are not already at risk for liver problems. But it turns out in practice that many, many people have been injured because they didn’t take the medicine right, or didn’t realize that acetaminophen isn’t always safe for everyone.

Who shouldn’t take acetaminophen? Anyone with chronic liver damage or liver disease. The main group are adults who consume too much alcohol. It turns out that not everyone tells their doctor about their alcohol habits, so doctors haven’t necessarily warned people about this. Other causes of chronic liver problems are obesity (so-called “fatty liver” has become the most common cause of liver disease in adolescents), the use of other medicines that affect the liver, and hepatitis. For most children (excluding overweight adolescents), the chance of having liver disease is very, very small.

How do you take acetaminophen correctly? Read the label. Use the included dosing device, and if you’re not sure how to use it, ask your doctor or pharmacist. Don’t combine multiple medications that contain acetaminophen, and make sure that if your child does take other medicines every day, you know if there are interactions between that and acetaminophen (or any other over-the-counter meds you might try.)

One specific recommendation from the FDA committee was to insist that all children’s and infant’s acetaminophen products be sold at the same concentration, simplifying dosing instructions. Right now there are several different strengths of liquids, chewables, and “Junior” tablets that are unnecessary and confusing.

Also, don’t use acetaminophen (or any other medicine) unless you really need to. Fever itself doesn’t necessarily need to be treated with medication (see here and here), but if your child feels lousy, you ought to try to help her feel better.

Alternatives to Tylenol include Motrin or Advil (both are brands of ibuprofen, see here for comparisons), or a non-medical approach like cool towels to reduce a fever, or a gentle heating pad to reduce ear pain.

If your child is in pain or has a fever, acetaminophen is a good safe medication to use. Just use it carefully and correctly, and check with your doctor or pharmacist if there’s any reason to think that your child has liver disease or is on any other chronic daily medication.