Oxycodone Takes Another One Down

nicholas kaczur

Another athlete has fallen victim to prescription drug addiction. Starting New England Patriots offensive lineman Nicholas Kaczur was arrested in April on a charge of illegal possession of prescription painkillers. Following his arrest, Kaczur secretly cooperated with the DEA in a sting operation that resulted in the indictment of his alleged drug supplier. According to one news article, Kaczur was busted for purchasing oxycodone illegally from a Massachusetts man identified as Daniel Ekasala.

The number of people that get in trouble for trying to get this drug is clearly a testament to how powerfully addictive it is. Of course, I can’t help but wonder how athletes like football players can stay in the game when they are all dosed up on painkillers. And did they start taking painkillers because of injuries received during play, or was it an already existing habit? Either way, it’s sad that a prescription drug can ruin someone’s athletic career in one fell swoop.

Death In The Mail

pills

The problem with ordering prescription drugs from online pharmacies, is that you have no idea what you’re getting. Just ask the woman from this recent CNN Health article.

“Every night before her husband went to bed, he would open a prescription bottle of the muscle relaxant Soma and swallow the eight or nine pills it took for him to fall asleep, said the woman.”

The truth of the matter is, there are no shortage of online pharmacies out there from which to order. So the question becomes, what drives people to order from them? Do we need to make certain drugs more accessible here in the United States, or will that only exacerbate the existing problem? It almost seems like it would be better to take these drugs under the supervision of a doctor, even if they are habit-forming – especially if people can just get their hands on them elsewhere.

It’s just so easy for people to learn about various drugs from sites like rxlist.com and webmd.com and the go order those drugs from foreign pharmacies. And while U.S. Customs does what it can to control the influx of illegal prescription drug orders, the sheer volume is simply overwhelming. I’m not sure what the solution is, but there is no question that people are engaging in risky behavior when they are ordering online. There is no guarantee that you are even getting the drug that you think you are getting, and you don’t have a doctor to supervise any potential negative reactions or bad drug interactions. And yet, despite these glaring risks, people order online 24 hours a day, seven days a week.

Recent New Drug Applications

Here are the most recent drug applications submitted to the FDA for approval. I always find it interesting to see what’s coming our way.

  • Sancuso (granisetron) Transdermal Patch Company: ProStrakan Group; Treatment for: Nausea/Vomiting – Chemotherapy Induced. Sancuso (granisetron) is an anti-emetic transdermal delivery system in development for the treatment of chemotherapy-induced nausea and vomiting without the need for injections or swallowing pills.
  • Promacta (eltrombopag): Company: GlaxoSmithKline; Treatment for: Idiopathic (Immune) Thrombocytopenic Purpura. Promacta (eltrombopag) is an investigational oral platelet growth factor therapy for the short-term treatment of previously treated patients with chronic idiopathic thrombocytopenic purpura (ITP) to increase platelet counts and reduce or prevent bleeding.
  • Liraglutide Company: Novo Nordisk; Treatment for: Diabetes Mellitus Type II. Liraglutide is a once-daily human GLP-1 analogue in development for the treatment of people with type 2 diabete
  • Rezonic (casopitant): Company: GlaxoSmithKline; Treatment for: Nausea/Vomiting – Chemotherapy Induced, Nausea/Vomiting – Postoperative. Rezonic (casopitant) is an investigational NK-1 receptor antagonist in development as add-on therapy for the prevention of chemotherapy-induced nausea and vomiting, and also for the prevention of postoperative nausea and vomiting.
  • Surfaxin (lucinactant). Company: Discovery Laboratories, Inc. Treatment for: Respiratory Distress Syndrome. Surfaxin, an engineered version of natural human lung surfactant, represents a potential alternative to the commercially available animal-derived surfactants used for the prevention of Respiratory Distress Syndrome in premature infants.
  • OTG (oxybutynin hydrochloride) Topical Gel. Company: Watson Pharmaceuticals, Inc. Treatment for: Overactive Bladder
  • Viviant (bazedoxifene). Company: Wyeth Pharmaceuticals. Treatment for: Prevention of Osteoporosis. Viviant (bazedoxifene) is a selective estrogen receptor modulator (SERM) in development for the prevention of postmenopausal osteoporosis.
  • Davanat Company: Pro-Pharmaceuticals, Inc. Treatment for: Targeted Drug Delivery. Davanat is a polysaccharide polymer comprised of mannnose and galactose in development for the targeted delivery of drugs used in the treatment of cancer.
  • Reloxin (botulinum toxin type A) Company: Ipsen and Medicis. Treatment for: Aesthetics. Reloxin (botulinum toxin type A) is a neurotoxin in development for the temporary improvement in the appearance of some facial wrinkles.
  • Iclaprim Intravenous Injection. Company: Arpida Ltd. Treatment for: Skin and Structure Infection. Iclaprim is a broad-spectrum diaminopyrimidine antibiotic in development for the treatment of complicated skin and skin structure infections.
  • Sublinox (zolpidem) Sublingual Tablets. Company: Orexo and Meda AB. Sublinox is a sublingual tablet formulation of the widely used drug zolpidem. Sublinox is being developed to provide fast, effective absorption for the short term treatment of insomnia.
  • Entereg (alvimopan) Capsules. Company: Adolor Corporation. Treatment for: Postoperative Ileus. Entereg (alvimopan) is a peripherally-acting mu opioid receptor antagonist used to help patients regain gastrointestinal (GI) function earlier following bowel resection surgery.
  • Cinryze (C1 inhibitor). Company: Lev Pharmaceuticals, Inc. Treatment for: Angioedema. Cinryze is a C1-esterase inhibitor being developed as a comprehensive replacement therapy for the treatment of hereditary angioedema (HAE).
  • Naturlose (tagatose). Company: Spherix Incorporated. Treatment for: Diabetes Mellitus Type II. Naturlose (tagatose) is a unique sugar undergoing clinical trials as a treatment for Type 2 diabetes.
  • Imagify (perflubutane). Company: Acusphere Inc. Imagify is an investigational new drug developed to assess perfusion using ultrasound (or echocardiography) for the detection of coronary artery disease.
  • MK-0524A (niacin ER and laropiprant) – formerly Cordaptive. Company: Merck & Co., Inc. Treatment for: Hyperlipoproteinemia Type IIa (Elevated LDL), Hypertriglyceridemia. MK-0524A is an investigational compound containing extended-release niacin and laropiprant, a novel flushing pathway inhibitor designed to reduce flushing often associated with niacin treatment. MK-0524A is used either alone or with a statin, as adjunctive therapy to diet for the treatment of elevated LDL cholesterol, low HDL cholesterol and elevated triglyceride levels.

Cloretazine Shows Some Promising Results

vion banner

Vion Pharmaceuticals announced the interim data results of its pivotal phase II trial of cloretazine, an anticancer agent drug that is intended to treat elderly patients with de novo poor-risk acute myelogenous leukemia (AML) today. 35 percent of the 85 patients evaluated in the study responded to the drug treatment, and 90 percent of those responses occurred after the first induction treatment.

“While follow-up is still ongoing, the median of overall survival for responders was 6.3 months (1.7-16.4 months) and for all patients was 3.2 months (0.1-16.4 months). The induction death rate within 30 days of first induction treatment was 14 percent. The majority of first induction deaths were either due to progression of disease or infection.”

In a Vion Pharmaceuticals press release, Dr. Gary Schiller, Professor of Medicine at the David Geffen School of Medicine, and a lead investigator on the study, said “The responses observed in this trial represent a clinically meaningful outcome for many of these difficult-to-treat AML patients. As a single-agent, single-infusion therapy, Cloretazine has the potential to be an important new treatment option for older patients with poor-risk AML.”

Alan Kessman, Chief Executive Officer of Vion Pharmaceuticals, said the company plans to file an application for new drug approval with the FDA some time this year.

AML is the most common type of leukemia, and more than 11,900 new cases occur in the United States each year, mostly in older adults. My grandmother died from this cancer when she was only 63, so I know she could have had many more good years in her life, had there been an effective treatment available. So here is another example of the kind of drug research that could potentially perform miracles.

A Little Scary…

xiadafil

On May 27, the FDA alerted consumers and healthcare professionals not to buy or use Xiadafil VIP Tablets sold in bottles of 8 tablets or blister cards of 2 tablets. The product is marketed as a dietary supplement and is promoted and sold over the internet for sexual enhancement and to treat erectile dysfunction.

“The product contains a potentially harmful, undeclared ingredient that may dangerously affect a person’s blood pressure and can cause other life-threatening side effects. Xiadafil VIP Tablets contain hydroxyhomosildenafil, an analog of sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for erectile dysfunction. The undeclared ingredient may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels.”

According to the FDA, the undeclared ingredient may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates, and the FDA warns that consumers who have used the product should discontinue use immediately and consult their healthcare professional if they have experienced any adverse events that they believe may be related to the use of this product.

I am always highly suspicious of any ads I see for drugs claiming to be miracle weight loss pills or sexual enhancers, and after reading this, I would advise people to do their research carefully before taking random supplements.

 

Blogging About Alzheimers

Patients diagnosed with early symptoms of Alzheimer’s disease are speaking out and demanding more attention, according to an article in today’s New York Times. Some patients – like 52-year-old Kris Bakowski of Athens, Ga. – are even blogging about their personal experience. Bakowski’s blog Creating Memories documents her daily struggles and successes with the disease.

There are several drugs currently being tested to treat Alzheimer’s, and several drugs that are used to treat symptoms. Aricept is probably the drug I see the most widely advertised

The hope is that, with more people being diagnosed at an earlier stage, the more that can be discovered about this heart-wrenching disease. I think Bakowski’s blog and the others out there like it will certainly go a long way in educating and informing people about the Alzheimer’s experience.

Bill Maher On Prescription Drugs

Bill Maher

Bill Maher – one of my very favorite comedians – pokes fun at our over-dependency on prescription drugs in his stand-up routine “The Decider.” I like how Maher says we “come up with the pill before the disease.” Sometimes it certainly seems that way!

Baby Steps for Lung Cancer Patients

erbitux

I don’t want people to get the idea that I am opposed to prescription drugs and medicine. I firmly believe that there are drugs out there that have done wonders for the human race – and I think it’s amazing that there are people out there creating these wonder-meds… so I figure I should be sure to give credit where credit is due.

The drug Erbitux has been found to extend the life of lung cancer patients by as much as five weeks. Now, five weeks may not seem like much, but five weeks is five weeks when you are dying. Erbitux is already FDA-approved to treat colon cancer and head and neck cancer, and was developed by Imclone Systems (the company probably best known for being the stock that sent Martha Stewart to jail).

I guess I still have mixed feelings about drugs like this. Having had an aunt who died of lung cancer, I can appreciate how valuable five weeks is. On the other hand, when I think about the quality of life she had during her last five weeks, I wonder if she would even want that extra time. I don’t know – it’s impossible to say now. But I do think it is significant and important that scientists are working to come up with treatments for cancer. Lung cancer is the world’s number one cause of cancer death, and it is becoming particularly prevalent in women – even women who have never smoked a cigarette in their life.

So, when it comes down to it, I say more power to the scientists and researchers who are making cancer treatments a reality.

Drugstore Cowboys

Drugstore cowboy video

I was just thinking about the movie Drugstore Cowboy the other day. It’s one of my favorites, and I think it was a little ahead of its time. It was made in 1989, and while pharmacy robberies have been going on since the first pharmacy opened its doors, they probably weren’t as commonplace as they are these days. After all, there are even more drugs to choose from in 2008.

When I was a reporter for a local newspaper in Northern Virginia, I was of course on the mailing list for all of the police press releases. Pharmacy robberies were among the most common crimes committed in the area. I remember one thief even dressed up as Spiderman to steal Oxycontin from a CVS. In fact, if one does a Google search of “oxycontin robberies,” over 100,000 results pop up.

In any event, “Drugstore Cowboy” did an excellent job of portraying the subculture of prescription drug addicts, and it’s interesting to see that not much has changed since 1989.

May Drug Approvals

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So, just to keep up with my occasional updates on FDA drug approvals, I feel compelled to point out that May was a bumper month for new drugs – 166 approvals in total!

The list is way too long to go over in detail, but, wow. 166 new approvals in one month? If that is the norm (which, judging by the approvals listed out for the last few months, it seems to be), that’s almost 2,000 new drug approvals a year. Seems like a lot, doesn’t it?

On the one hand, I suppose we should be thankful that the FDA is there to review all of these drugs for potential safety hazards… but the sheer number of drugs going through the system certainly explains why the screening process is imperfect, and why some drugs slip through the FDA cracks, so to speak. So what is the solution to this? Do we cut down on the number of drugs seeking approval? Do we give the FDA more manpower and more money?

Anyone who is curious about the process for drug approval can learn more here.