You Can Teach an Old Drug New Tricks

Drug discovery is a laborious process.

From initial discovery of a promising target to the final medication becoming available, is an expensive, and lengthy process. At present, the costs of bringing a single new drug to market is around $1.2 billion, an amount that doubles every five years.

Aside from the cost, it takes, on average, 12 years for an experimental drug to progress from bench through FDA approval to market.

Annually, North American and European pharmaceutical industries invest more than $40 billion to identify and develop new drugs. Even so, for every 5,000 compounds that enter pre-clinical testing, only five, on average, are tested in human trials, and only one of these five receives approval for therapeutic use.

So, it’s hardly surprising that many pharmaceutical companies are choosing to take a closer look at old drugs. Last week, SRxA’s Word on Health brought you news of a host of potential new uses for aspirin.

And aspirin is not alone.  Old drugs often get a surprising second shot at life. In the past few weeks, the news has buzzed about the skin cancer drug – bexarotene – that may cure Alzheimer’s; a common antimalarial drug – hydroxychloroquine – that may help to destroy cancerand, a leukemia drug that inhibits the Ebola virus.

Then, of course, there’s the personal favorite of many women – Latisse.  Originally developed as a glaucoma treatment , it was found to have the desirable side effect of making eyelashes fuller and longer and is now FDA approved for this purpose.

Testing drugs already approved for one use to see if they can treat other conditions, can reduce time and money. Since these known drugs have already undergone toxicology and safety testing, the clinical development program can be streamlined.

Sometimes it’s pure serendipity.

Take Viagra for example. Although these days it’s the stuff of pharmaceutical industry legend , in the early 1990s, it was just a chest pain drug that wasn’t performing very well in clinical trials. So how did the little blue pill go from heart to crotch?  Pfizer was ready to call it quits when they decided to look into one unexpected but common side effect: long-lasting erections. Then came the drug patent and the rest is history.

The discovery that lithium could be used to treat manic episodes in bipolar patients was equally fortuitous. In 1949, Australian psychiatrist John Cade was injecting guinea pigs with urine extracts from schizophrenia patients to try and isolate a compound that caused mental illness. By accident he happened to use a compound with lithium – which at the time was used as a treatment for gout, as the control. Although he didn’t find the compound that caused mental illness, he did find one that treated it!

Back in 2010 we reported on the repurposing of thalidomide. Although the drug caused serious birth defects when it was launched in the 1960’s as a morning sickness pill it has since been found to be useful in reducing severe and frequent bleeding in patients with  hemorrhagic telangiectasia (HHT); in the treatment of patients with newly diagnosed multiple myeloma when taken  in combination with dexamethasone; and for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum

The National Institutes of Health (NIH) recently established The Learning Collaborative (TLC) to study how to more easily repurpose known drugs to treat rare forms of blood cancers.

TLC is a dedicated collaboration between the NIH Chemical Genomics Center (NCGC) and its Therapeutics for Rare and Neglected Diseases (TRND) program, The Leukemia & Lymphoma Society (LLS), and Kansas University Cancer Center (KUCC) to discover and develop new drug therapies for rare blood cancers. TLC is creating a pipeline of new therapies to treat leukemia from both the discovery of new treatments as well as identifying new uses for approved and abandoned drugs.  For example, Auranofin, a drug originally used for rheumatoid arthritis, is now in clinical trials for treating chronic lymphocytic leukemia.

Word on Health will continue to follow the drug recycling trend and bring you news as it breaks. In the meantime if you have noticed any beneficial side effects from the medicines you’re taking, we’d love to know.

Fake drugs hurt patients and pharma

Your Word on Health bloggers suspect that there’s probably not a single one of our readers who hasn’t, at one time or another, received a spam e-mail promising erectile dysfunction drugs at bargain prices.  While annoying, we can get rid of these with fast and judicious use of the delete button.Counterfeit drugs, made in Asia and other emerging markets, are however a more serious and growing problem.  According to the Pharmaceutical Security Institute (PSI), last year, almost 1,700 incidents of counterfeit drugs were reported worldwide –  triple the number in 2004.Estimates for the size of the counterfeit drug market range from $75 billion to $200 billion a year.  The World Health Organization suspects that more than 50% of the medicine bought from certain illegal websites are fake. As frightening as that figure is, the market is probably much bigger because many cases are hard to detect…and the problem is expected to get worse.

Fake drugs are a “money machine.” Sales are growing at twice the rate of legitimate pharmaceuticals, says Peter Pitts, president of the Center for Medicine in the Public Interest.  A weak economy along with rising drug prices are likely leading consumers to seek out cheaper products online or from unauthorized providers.

However, others believe that it’s not cheaper prices that drive consumers to counterfeit medicine, but their “lack of education and awareness of the dangers.” Counterfeit medicine may include too much, too little or none of the ingredients found in the real product, causing injury and, in extreme cases, death.

While fake drugs have been around for decades, the Internet’s growth and the popularity of Pfizer’s erectile dysfunction drug Viagra in the 1990s created the “perfect storm” to fuel this underground industry.

Today, drug rings in Asia, particularly in China and India, are increasingly churning out fake versions of popular brands and generics, then selling them to consumers online or in the black market.

Counterfeiters are now able to fake drugs so well, even experts find it hard to distinguish the copies from the real deal. And they’re able to replicate security devices such as holograms only a few months after pharmaceutical companies put these features on their packages.

You can make more money in counterfeit drugs than heroin,” says Tom Kubic, CEO of PSI. “There’s a major financial incentive for criminals because of the low risk of detection and prosecution.”

Now, drugmakers are fighting back.  Most pharmaceutical companies routinely gather information about fake drugs and pass it along to authorities. Some are even sharing such information with their competitors, sometimes leading to raids of suspected manufacturing facilities.

Fake medicines put both the reputation of the industry and, even more importantly, patients’ lives at risk.  They also divert consumers away from the legitimate products.

The FDA has produced some great resources to educate people about dangers of fake drugs.

Along with tips for buying medicines, the Agency’s website offers summaries of recent safety alerts and how to spot and report fraudulent or dangerous products.

One example of this is their “Warning Signs” of an unsafe drug web site.

They advise consumers to stay away from any site that:

  • offers prices that are dramatically lower than the competition
  • may offer to sell prescription drugs without a prescription—this is against the law
  • sends you drugs with unknown quality or origin
  • gives you the wrong drug or another dangerous product for your illness
  • doesn’t provide a way to contact the web site by phone

Seems the old adage “you get what you pay for” applies to drugs too