Neurontin Case to be Settled by Pfizer

In April of 2014, U.S. pharmaceutical company Pfizer agreed to a settlement of $190 million dollars to end a lawsuit that charged them with a variety of violations of federal law concerning the drug Neurontin. The company will also pay interest on the amount, while denying any wrongdoing. The settlement ends a 12-year legal battle in the New Jersey court.

Neurontin

Neurontin, generic name gabapentin, is a popular drug used to treat seizures and some types of pain conditions. It is used to treat epilepsy and an anticonvulsant, affecting the chemical transmission of messages to the nerves. Neurontin is sometimes used in combination with other medications to treat these conditions. It is also sometimes used for unrelated conditions. The U.S. Food and Drug Administration first approved the drug in 1994 to control seizures. Later, it was also approved for use for the relief of neuropathy pain from shingles. However, it is illegal for pharmaceutical manufacturers to promote their drugs for uses not approved by the FDA, an accusation also alleged by the lawsuit.

The Charges

The lawsuit charges Pfizer with willfully delaying the entry of the generic version of the drug Neurontin to the market. The lawsuit also charges that the company promoted the sale and prescribing of Neurontin for a number of unapproved uses, as well as for filing and maintaining several sham patent lawsuits. Their actions put them in direct violation of antitrust laws, making them vulnerable to monopoly and anti-competitive conduct charges, which can be shown by either direct or indirect evidence. The suit began in 2002 charging Pfizer with carrying on a comprehensive scheme to monopolize the market for the drug. Neurontin sales reached $2.3 billion annually in 2013.

The Settlement

Pfizer has admitted no wrongdoing in the case and continues to contend that the settlement of the lawsuit only reflects the company’s commitment to concentrating on the needs of the patients and providers that depend on their company to continue its efforts to produce effective medications to treat disease and relieve pain. However, the company’s actions caused patients who used Neurontin over the past decade to pay inflated prices for the drug. The company may be the target of additional lawsuits regarding the overcharging of these patients.

Reference:
http://www.reuters.com/article/2014/04/21/usa-antitrust-pfizer-idUSL2N0ND1EK20140421

Illegal Pharmaceuticals: Part of Google’s New Clampdown

Almost everyone depends on Google’s search engine for finding information about products, services, and everything in-between. While most people’s intentions are true and good, criminals and illegal companies have been using Google’s tools to buy and sell illegal drugs. Until recent years, Google has been lenient on such practices and has faced much scrutiny because of it. The tech giant has admitted to selling ad space to rogue online pharmacies, which led to the company being fined $500 million a few years ago. While Google has changed some of its policies, many attorney generals are still not satisfied.

Changes Google Has Made

Executives from Google have conducted meetings with approximately two dozen state prosecutors as an attempt to resolve the issue. In 2013, Google reported that it disabled 4.6 million ads that were placed by rogue pharmaceutical and health companies. In addition, since 2010, the tech giant reports that nearly all illegal pharmacies have stopped placing ads. In addition, Google has agreed to hire over 100 new workers to crawl ads and videos in search for rogue and potentially dangerous sites. Google has even tweaked its auto-complete suggestions by removing over 1000 suspect phrases. With all this success and change, state leaders still want more.

What Lawmakers Are Demanding

State leaders applaud Google for its efforts, but they still believe more can be done. Attorney generals argue that the changes have removed ads and have removed auto-complete phrases, but users can still find illegal content if they explicitly searched for it. Attorney general Jim Hood of Mississippi believes that the restrictions should extend to copyright infringement and all other illegal activities as well. As of now, Google has not agreed to make changes on that level, and many question whether such changes are even practical.

What This Means for Users

The average user is mainly affected by the auto-complete feature. The auto-complete feature analyzes what millions of people have already searched for and gives you suggestions based upon what you are typing. These suggestions could lead you down an unintentional, yet educational, path you would not have considered otherwise. With the new changes, if you are not searching for anything illegal, you will be virtually unaffected. However, if you are looking for a new career and search for “How to be a…” “How to be a drug dealer” will not be suggested unless you explicitly search for it.

Sources:
http://www.geek.com/apps/google-cracks-down-on-legal-searches-about-illegal-things-1591496/
http://www.washingtonpost.com/politics/google-faces-new-pressure-from-states-to-crack-down-on-illegal-online-drug-sales/2014/04/15/6dfc61fa-be6d-11e3-b195-dd0c1174052c_story.html
http://www.slate.com/articles/technology/future_tense/2013/08/words_banned_from_bing_and_google_s_autocomplete_algorithms.html

Suprax Infection Prevention Drugs Recalled

On April 14, 2014, Indian pharmaceutical company Lupin announced a voluntary recall of 9,210 bottles of Suprax, a drug used to treat bacterial infection. According to the U.S. Food and Drug Administration, the medication failed purity tests done in the United States and were not eligible for sale here. However, this is a class III recall, meaning there have been no adverse health consequences. Suprax is typically prescribed for ear infections, sinusitis, tonsillitis, strep throat, bronchitis, and pneumonia; so it is a common drug in the U.S.

This is not the first time that drugs produced by Lupin have been recalled over a purity issue. In January 2013, more than 65,000 bottles of Suprax were pulled from shelves in the U.S. over a discoloration issue. In September of that year, the company recalled 53,000 bottles of Quinapril, a drug used to treat high blood pressure.

Indian pharmaceutical companies produce up to 40 percent of drugs sold in the United States, and in recent months the FDA has been more closely scrutinizing medications produced by these manufacturers. There have been several high-profile recalls from the country, including a recall of more than 500,000 bottles of Lipitor made by Ranbaxy Laboratories. Several companies that compete with Lupin, Ranbaxy Laboratories Ltd., Sun Pharmaceutical Industries Ltd. and Dr. Reddy’s Laboratories Ltd., have also had high-profile recalls for products sold in the U.S. And earlier this year, the FDA completely banned imports of prescription drugs from Indian-based Sun Pharmaceuticals.

While no health effects have been reported in connection with those recalls, several American drug companies express concerns that Indian-made generic drugs are not as effective as the domestic name-brand versions. Problems like these may spell big trouble for Lupin, which relies on the U.S. for approximately 40 percent of its total sales since its initial entry into the market in 2003.

Since the recall occurred before these products hit shelves, there’s no reason for consumers to be concerned. However, if you are prescribed Suprax or another recalled drug, confirm with your pharmacist that the batch you are given has passed through quality control.

Sources:
http://www.reuters.com/article/2014/04/15/usa-lupin-suprax-idUSL3N0N71MM20140415
http://www.fiercepharma.com/story/lupin-recalls-more-suprax-purity-problems-adding-indian-pharmas-quality-que/2014-04-14

Viagra and Skin Cancer

According to a new preliminary study, men who use the popular erectile dysfunction (ED) drug Viagra (sildenafil) face an increased chance of melanoma, the most life-threatening type of skin cancer. Scientists revealed that men who took the drug were 84 percent more likely than their non-using counterparts to develop the deadly cancer.

Dr. Abar Qureshi, a professor at Warren Alpert Medical School’s dermatology department, says that because these are just early findings, nobody is urging men to stop using Viagra for ED. “However, men who use Viagra and are also at higher risk of melanoma might want to talk with their doctors,” he finished. Dr. Qureshi co-authored the study, which used almost 26,000 participants and was recently published in the Journal of the American Medical Association Internal Medicine.

According to Dr. Qureshi, Viagra is believed so far to raise a man’s melanoma risk because it works on the same genetic pathways that cause cancers of the skin to grow more aggressively. Fortunately, men who took sildenafil for erectile dysfunction didn’t face higher odds of any benign or less-serious skin cancer types, like squamous and basal cell carcinomas. The National Cancer Institute expects that around 76,100 new cases of melanoma will rise in 2014, killing roughly 9,710 patients, about 6,740 of which will be men.

In several areas throughout China and the United States, Dr. Qureshi and his colleagues looked at data regarding skin cancer and Viagra use provided by the Health Professionals’ Follow-Up Study. This is a long-running study on male physicians and other medical workers.

The men in the study were an average age of 65. Of these, around six percent had used sildenafil for ED. Even men who had previously taken Viagra faced nearly twice as much melanoma risk as men who had never taken it. This information remained true after scientists took other cancers, family histories of melanoma, serious illnesses and other things into consideration. They even adjusted for exposure to ultraviolet light in the participants’ home regions.

Dr. June Robinson from the Feinberg School of Medicine out of Northwestern University says, “Any doctors with patients who are older males using Viagra should keep a close eye on these individuals for evidence that skin cancer may be developing.”

In a brief editorial of the study, she also pointed out that ever since Viagra hit pharmacy shelves in 1998, the rates of increase for melanoma have actually slowed down considerably. This presents a note of caution regarding the effects of Viagra on melanoma risk and development. Dr. Robinson said, “The role of this drug in the biological effects of melanoma in older males needs to be studied further before we can get clear answers.”

Source:
http://www.nbcnews.com/health/health-news/viagra-may-boost-risk-deadly-skin-cancer-study-finds-n73976

Takeda Gets a $6 Billion Punitive Damages Penalty (Actos)

A jury has ordered Japanese drug maker, Takeda Pharmaceutical, as well as their marketing partner, Eli Lilly, to pay $9 billion after finding that the company had hidden the cancer risks of the drug Actos. The Lafayette, Louisiana jury made the decision in a lawsuit filed by a man who was diagnosed with bladder cancer after using the drug for several years.

Punitive Damages

The jury ordered the pharmaceutical company to pay $6 billion in punitive damages with Eli Lilly responsible for the remaining $3 billion, but under the contract between Eli Lilly and Takeda, the marketing company is indemnified and will not have to pay any damages. It was the seventh largest punitive damage case in United States history, but it is expected that an appeals court would likely reduce the amount or overturn the verdict. Because the Supreme Court has ruled in recent cases that punitive damages cannot be more than ten times the amount of compensatory damages, which, in this case  was approximately $1.5 million, it is likely the punitive damage award will be reduced to about $15 million.

Cancer Diagnosis

The lawsuit was filed by Terrance and Susan Allen of Attica, New York in 2011 after Mr. Allen was diagnosed with bladder cancer. He had been taking Actos since 2006, and the lawsuit claimed that the manufacturer was aware of the risks of bladder cancer, yet failed to warn physicians or patients. Mr. Allen said that he was “overwhelmed” by the verdict, but that the lawsuit was more about making others aware of the dangers of the drug. Mr. Allen has been cancer free for approximately two years, but faces possible recurrences in the future.

Actos and Cancer

In 2011, the United States Food and Drug Administration (FDA) required that the label on Actos reflect that there was an increased risk of bladder cancer in patients who used the drug. Studies have shown that patients who took Actos for more than a year have a 40 percent higher risk of contracting bladder cancer than patients who do not use the drug. Shares in Takeda stock dropped nearly six percent the day after the verdict was announced.