HD Blog

According to Knight-Ridder "8,000 people became seriously ill last year" from popular drugs off-label. That sounds horrifying..lets stop this practice now! Oh, wait...that's out of 115 million off-label prescriptions they analyzed? That works out to (doing the numbers).... a 1 in 14,375 chance of becoming seriously ill from the off-label medication. For comparison...you're 30% MORE likely to be struck by lightning!

But wait! What about this horrible use of Thalidomine? After all it causes all those horrible birth defects and 99% of its use is off-label! Well, if you don't prescribe it to women who can become pregnant than there is no risk at of birth defects. Its on-label use is leprosy, but it's showing great promise in treating normally fatal diseases such as AIDS and certain cancers.

Doctor's prescribe off-label because there isn't a good on-label alternative. Since insurance companies generally don't cover off-label use there is already a big incentive to stay on-label if there is an alternative. Scare stories like this one are an embarrassment to the newspaper business and Knight-Ridder should issue a retraction and an apology (but they won't)!

Off-label use is an important issue to the Huntington's Disease community. It would take seven or more years for a potential treatment to make its way through the testing process and be approved as on-label. However, there are existing medications (such as an HDAC inhibititor and TUDCA) that may be very effective treatments for Huntington's Disease and they are being investigated now. Off-label availability is speeding up research and, if they prove effective, will be available years sooner than if only on-label prescriptions were allowed. This would save thousands of lives.

Based on their press release, Knight-Ridder placed little or no emphasis on the benefits of off-label prescriptions in order to make a more alarming story. Shame on them.

Here's their press release:

Knight Ridder (ticker: KRI, exchange: New York Stock Exchange) News Release - 11/2/03
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Knight Ridder Exclusive: Off-Label Drug Prescriptions Skyrocket in U.S.

Thousands Became Ill Last Year After Taking Nation's Most Popular Drugs
Off-Label
WASHINGTON, Nov. 2 -- A three-part investigative series by Knight Ridder Newspapers has found that patients nationwide are being injured and killed as doctors routinely prescribe drugs in ways the Food and Drug Administration has never approved as safe and effective. The study, based on a sample of top-selling drugs, found that the number of off-label prescriptions has nearly doubled in five years. The Knight Ridder analysis released today is perhaps the most comprehensive ever done of off-label prescribing.

The series by investigative reporters Alison Young and Chris Adams is based on interviews with patients, doctors, researchers and drug companies, and the review of thousands of records from lawsuits, government hearings and regulatory actions, medical records and scientific studies. The complete results will run over the next three days in Knight Ridder newspapers across the country.

Off-label prescribing is legal, widely accepted and defended by doctors and the American Medical Association. Victims of off-label prescribing interviewed by Knight Ridder have suffered heart attacks and strokes, had permanent nerve damage or lost their eyesight. Based on the FDA's own data, the report estimates that at least 8,000 people became seriously ill last year after taking some of the nation's most popular drugs for off-label purposes.

Among the report's findings on prevalence of off-label prescribing:
-- 21 percent of the prescriptions examined were for off-label uses
-- 115 million off-label prescriptions for the drugs analyzed by Knight
Ridder were written in the U.S. last year, nearly double the number of
five years ago
-- As many as 90 percent of the prescriptions for some drugs were
off-label uses.
-- Three-quarters of anti-seizure medications are prescribed off-label,
as are nearly two-thirds of antipsychotics and about one-quarter of
antidepressants

Some Drugs Sold Mostly for Unapproved Purposes
The report tracks some of the most widely prescribed drugs in the U.S. It found that doctors are giving their patients epilepsy drugs for depression, hot flashes and to help them lose weight. They use antidepressants to treat premature ejaculation and pain, and powerful antipsychotics for insomnia and attention deficit disorder. High blood-pressure pills are prescribed for headaches and anxiety; antibiotics are used to treat viruses.

Eight out of 10 prescriptions for the epilepsy drug Topamax aren't for epilepsy. Thalidomide, the morning-sickness drug that caused horrible birth defects and ushered in today's FDA drug-safety rules, even is on the market, and 99 percent of its prescriptions are off-label.

Methodology

To calculate how often drugs are prescribed off-label, Knight Ridder analyzed the three top-selling drugs in 15 classes of medications, comparing what doctors said they prescribed them for with the FDA's approval for each. The analysis looked at 900 million prescriptions written in 1998 and 2003 for more than 1,000 different ailments. Its estimate of the prevalence of off-label prescribing excluded cancer treatments or pediatric off-label uses, because they already are known to have a large percentage of off-label use.

To estimate how often patients are harmed by this practice, Knight Ridder reviewed the FDA's database of adverse drug reactions. The FDA estimates that only 1 to 10 percent of reactions are reported. Knight Ridder identified more than 800 reports filed during 2002 of serious reactions involving off-label prescriptions for its sample of 45 drugs. Experts say that means anywhere from 8,000 to 80,000 people probably were affected.

About Knight Ridder's Washington Bureau

The Knight Ridder Washington bureau serves Knight Ridder newspapers and the more than 350 client newspapers of the Knight Ridder/Tribune News Services, with Washington and international coverage. Bureau correspondents cover the White House, Congress, national security issues, the economy, legal affairs, law enforcement, science and other beats. Eight foreign correspondents are posted in major capitals around the world to bring international news home to Knight Ridder readers.

SOURCE Knight Ridder