If there were any reservations as to the lengths the pharmaceutical industry will go to make a profit, then the settlement agreed upon by St. Louis based KV Pharmaceutical Company may help quell those reservations.

In 2008, the Food and Drug Administration (FDA) told KV to stop making some time-release cough, cold, and gastrointestinal drugs. Yet, KV continued to make the drugs. This prompted the agency seized more than $24 million in unapproved products in July of that year.

In a statement given by KV to the Washington Post, the settlement include $25.8 million in fines and restitution, $2.3 million of which will be paid to the federal government. Ethex (a division of KV) also will not contest a $1.8 million administrative forfeiture, it said.

It sounds like a lot of money, but in the pharmaceutical business for a single company all of those figures added together amounts to about one week’s profit. Not a month or year, one single week.

Giant Pills

KV had to issue repeated recalls in late 2008 and early 2009 because some batches of products contained pills that were oversized. This lead some patients to overdose accidentally. That’s right, bigger pills that contained more than the recommended dosage.

Most of the recalled products were made by Ethex, but some were made by the Ther-Rx specialty drug division. Ther-Rx has recently become experts at recalls, having to recall 20 of its products in the last two months. But that is tiny amount compared to Ethex (not to be confused with the word “ethics”) with 156 recalls in the last month.

These products range from cold medicines to morphine to oxycodone. Some of these drugs are extremely dangerous when a person overdoses. Particularly if it is a simple cold medicine innocently administered to a child.

Do not fret though, Ethecs has been trumped by ethics and will no longer be around to harm people.

Criminal Charges

KV said Thursday that it will shut down the Ethex generic drug unit and plead guilty to criminal charges alleging Ethex failed to promptly inform regulators about dangerous manufacturing problems.

The charges concern Ethex’s failure to file field alerts, or urgent notices about potential safety threats, with the Food and Drug Administration. The alerts concern two drugs: dextroamphetamine, an ingredient in the attention deficit hyperactivity disorder drug Adderall, and propafenone, which is used to treat cardiac arrhythmia, or irregular heartbeats.

Please keep in mind that when criminal charges are filed against a large corporation people rarely go to jail.

Spin, Spin, Spin

KV is shutting down Ethex Corp. because after the plea it would probably be excluded from government programs. The company will also pay a total of $27.6 million to resolve a government investigation into its business, which has had to recall dozens of drugs because its manufacturing practices did not meet federal standards.

“This settlement marks an important milestone in our efforts to restore normalized business operations at KV, regain full regulatory and legal compliance, and set KV on a new path moving forward,” KV interim Chief Executive Officer David Van Vliet said in a statement to Business Week

Yet, there was no apology issued to either the FDA or consumers issued either in statements or on the KV website.

Forgiveness

KV is still not able to resume sales of generic drugs affected by the recalls. Along with the closing of Ethex, this will dip considerably into their profits. Yet, Wall Street still responded positively to news that the investigations are being resolved.

Shares of KV Pharmaceutical rallied in late trading, closing up 32 cents, or 11 percent, at $3.33. Good news, because beyond failing the confidence and safety of its consumers, all that really matters is KV’s stock prices.

If you or a loved one find that you have been affected by defective drugs in any way, it is important that you get representation right away. Call Phillips Webster for a consultation on your legal rights.

Tioga Pharmaceuticals Inc is a pharmaceutical company that is following the trend of the industry as a “virtual” pharmaceutical company. They are essentially a small team (one person or more) that are venture capital acquiring machines that have a concept and farm out all of the production, testing, and lab work to contractors. It is highly profitable, especially when the drug hits the market. Tioga Pharmaceuticals Inc. has just secured $18 million dollars from various sources and is going into the third trial of its new drug to treat Irritable Bowel Syndrome (IBS).

The trial, one of two registration trials required for approval in the United States, is a 600-subject randomized, double-blind, placebo-controlled, single-dose clinical trial in D-IBS patients. The trial is scheduled to begin at 120 sites in the United States next month.

Irritable Bowel Syndrome (IBS)

IBS is suffered by millions of people around the world. It is a disease that makes bowel movements painful and limits the sufferer’s comfort being away from facilities for extended periods of time. Some of the symptoms of IBS are:

• Mucus in the stool
• Bloating and gas
• Constipation
• Diarrhea, regularly or predictably
• Immediate need to have another bowel movement after you’ve already had one
• Sudden and strong urge to have a bowel movement
• Abdominal pain and cramping that diminish after the movement

What is Asimadoline?

Asimadoline is a drug that is listed as an analgesic or a certain type of pain killer. It is described by Tioga Pharmacueticals Inc. as:

“Asimadoline is an orally administered small molecule that is a highly selective, peripherally restricted, kappa opioid receptor agonist.”

A kappa opioid receptors (k-Opioid receptors) are widely distributed throughout the brain, spinal cord, and in pain neurons. They are particularly related to the central nervous system and gastrointestinal tract. Asimadoline suppresses the signals sent through the k-Opioid receptors.

What was the result of other clinical trials?

There have been many since 1998 when the drug was first starting to be tested. Animal trials had mixed results as they always do when testing proper dosage and extreme effects of over dosage.

Patient trials reported by the National Institute of Health (NIH) have been generally positive when treating IBS, but yet, the side effects of such studies were not given. Tioga Inc. also reported no side effects when they described phase 2 clinical trials:

“In a 596-subject Phase 2b clinical trial asimadoline demonstrated statistically significant results in the treatment of D-IBS patients with at least moderate pain across multiple parameters including endpoints of pain, urgency, frequency and bloating in both males and females. A therapeutic benefit was observed within the first month of treatment and was sustained for the three month duration of the trial. Asimadoline appeared to be well tolerated with no adverse events occurring in a dose-dependent manner throughout the randomized, double-blind, placebo-controlled, dose-ranging clinical trial.”

This is odd when there are currently no drugs in existence that have zero side effects, particularly a painkiller.

What are the side effects to Asimadoline?

Asimadoline is related to a whole family of drugs that act in a similar way to other forms of opioid receptors including Butorphanol, Menthol, and the popular over-the-counter party drug Salvinorin A.

In clinical trials with other similar drugs of the same family, there has been clear evidence to the tendency to cause hallucinations and other psychological effects. Hallucinations can go either way. As a hallucination is often sudden and may be perceived by the person as real there are several outcomes. They can cause a euphoric state and a sense of peace. They can also cause panic and rash sudden decisions that could be a detriment to the patient and others around them.

Though Asimadoline has not been registered with the FDA yet, the FDA may require further studies to test for the side effects under normal and adverse conditions. There has also been no trials as to the effects of the drug when taken with other medication.

Defective Drugs

If you or a family member are currently suffering from the adverse side effects of a medication that has been proscribed to you should know your legal rights. Call Phillips Webster for a consultation on how to protect yourself and your legal recourse.