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A Conspiracy Conspiracy?

First, let’s start with some fax humor… because you don’t see fax humor very often!

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During football watching on Sunday afternoon, multiple times a FedEx television commercial ran from a supposed Conspiracy Bookstore. The employees in the commercial were explaining their theories on a recent hike in online book sales. It wasn’t funny the first time. Not funny the 20th time; which might explain why you don’t remember it.

One of the employees credits galactic entities for buying all the books to conceal their alien secrets. The other worker credits FedEx because of their affordable deliveries. The FedEx guy just shrugs at the conspiracy theory.

By the way, do you buy into the conspiracy of Apple slowing down old phones with their constant updates? For several years, the Internet has been warning (as I use the Internet like a person identifier) that Apple keeps sending updates, to cause your old phone to slow down enough to irritate you and make you buy the new phone.

All I know is that I am tired of having constantly being asked by my phone and iPad whether I want to download my update now or at midnight. No is my answer. I was perfectly happy with my phone and iPad until your constant pestering. But I digress!

The real conspiracy that recently grabbed my attention (Reuters News)  relates to a pharmaceutical company. The New Jersey Attorney General has accused Insys Therapeutics  of engaging in a fraudulent scheme to boost the sales of their fentanyl-based cancer pain drug. Recently, Massachusetts announced a $500,000 settlement with Insys to resolve similar allegations.

The New Jersey attorney is claiming that the drug company had created a fraud scheme to encourage the prescriptions of a fentanyl-based pain medication, usually reserved for cancer patients. The intent was to get doctors to prescribe it broadly to many of their patients; not just those suffering great pain.

The New Jersey filed lawsuit alleges that Insys paid kickbacks to doctors, including sham speaker fees to induce them to prescribe the drug, defraud insurance companies into paying for it.

The lawsuit states that Insys’ greed put hundreds of lives in jeopardy and led to the 2016 overdose death of a New Jersey woman, who was prescribed a fentanyl-based medication to treat fibromyalgia. “The conduct alleged in our lawsuit is nothing short of evil,” Porrino said in a statement.

The NJ lawsuit was filed on the heels of the Massachusetts Attorney General Healy announcing that Insys would pay $500,000 to resolve similar allegations of schemes and kickbacks. (Doesn’t sound like much of a punishment. Right?) The political rhetoric would lead us to believe that this drug company is just plain evil and needs real punishment.

Fentanyl is a powerful and highly addictive drug with deadly consequences, yet this opioid maker aggressively marketed its product and made illegal payments to providers to boost sales,” Healey said in a statement.

Now that’s what I call a conspiracy. Just not one that really surprises me.

And finally for pic o’ day, here’s one from the past that always makes me laugh. Some explanation for that conspiracy?

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5 Monkeys and Their Ladder

Can monkeys figure out how to use a hotel key? The real question is whether they can figure out which room the key goes to… but I digress.

The real lesson from monkeys (for our monkeys’ blog) is told in an article from PsychologyToday.com in an article titled  What Monkeys Can Teach Us About Human Behavior: From Facts to Fiction.

The article is based on a story that goes like this:

A group of scientists placed five monkeys in a cage, and in the middle, a ladder with bananas on top. Every time a monkey went up the ladder, the scientists soaked the rest of the monkeys with cold water.

After a while, every time a monkey would start up the ladder, the others would pull it down and beat it up. After a time, no monkey would dare try climbing the ladder, no matter how great the temptation.

The scientists then decided to replace one of the monkeys. The first thing this new monkey did was start to climb the ladder. Immediately, the others pulled him down and beat him up.After several beatings, the new monkey learned never to go up the ladder, even though there was no evident reason not to, aside from the beatings.

The second monkey was substituted and the same occurred. The first monkey participated in the beating of the second monkey. A third monkey was changed and the same was repeated. The fourth monkey was changed, resulting in the same, before the fifth was finally replaced as well.

What was left was a group of five monkeys that – without ever having received a cold shower – continued to beat up any monkey who attempted to climb the ladder.

This story has been repeated in many motivational talks through the years, to stand for the premise that if it was possible to ask the monkeys why they beat up on the other monkeys, what would they say? The reason the monkeys continued to beat up any new monkey trying to climb the ladder is because, “I don’t know, it’s just the way we do things around here”.

Now… that’s a wonderful life lesson. However, it just never happened. There was some studies on monkeys, but none that were this specific. I guess they could have told us stories about monkeys who eat swordfish, and we would believe it.

When I read this story… and the fiction of the story, I thought of metaphors involving pharmaceutical companies or politicians. Pharma, because they pitch drugs for headaches that they claim have been tested with, “ask your doctor if this drug is right for you” and then they go on to say that this headache pill causes everything from hives to death.

As to politicians, they tell us stories about poverty or pain that make for good stories… but just aren’t based in fact. Anything to get elected, and we are tired of it.

I said all that to say, let’s let the monkeys enjoy life.  They don’t effect us. Do they really need to teach us a lesson?

 

And for pic o’ day, here’s another lesson from animals… when there is too much TV watching:

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OxyContin in Kentucky

In a story that sounds more like, “We thought you were making a pain pill… not heroin”,  The makers of OxyContin have agreed to settle a lawsuit brought by the Kentucky Attorney General, that claimed that Purdue Pharma had misled the public about their powerfully addictive drug. (InsuranceJournal.com)

The lawsuit was filed by the state of Kentucky back in 2007. It alleged that Purdue Pharma was “marketing the prescription painkiller as not addictive because it was a pill that, when swallowed, slowly released the drug over 12 hours.” However, users soon discovered that it was as addictive as heroin.

The state of Kentucky claimed that medical costs across the state began to rise because of the effects to those that were now addicted to the drug. This particularly became a problem in the eastern part of the state where injured coal miners were regularly prescribed the medication. So, the Kentucky Attorney General filed suit.

In response to the lawsuit, Purdue Pharma agreed to take that form of OxyContin off the market, and replaced it with a newer 2010 version, where it claims that such issues have been resolved.

The manufacturer of the drug will also pay $24 million to the state of Kentucky over the next eight years. That’s to be used to assist with addiction programs within the state.

Of course, here’s the part that probably is no surprise to you. In entering into the settlement, Purdue Pharma admitted no wrongdoing. And I conclude the blog with what the company spokesman said in the news release about the settlement:

The company entered into the settlement to allow it to “focus on bringing innovative abuse-deterrent medicines to patients and our other efforts to combat prescription drug abuse and overuse”. (shaking head!)

And for pic o’ day, this just seemed to be down that same “responsibility alley”:

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A Settlement Story

I recently finished up a pharmaceutical settlement with a group of women. Our claim related to cancer from hormone therapy.  Most of the time, I don’t discuss settlements or their amounts because I consider it a private matter for my clients. Sometimes, a letter or story comes along that makes me want to share.

I recently received a letter that specifically mentioned that it would be ok if I shared a bit of her story. I have intentionally left out the specific names and places.  I think that if insurance adjusters and defense lawyers were able to see the result of the settlements years after the cases end, it might change how they view cases during the process.  The following is a portion of that letter which discusses the impact of a settlement  far better than I ever could:

I am a former elementary teacher who eventually had a word processing business in my home and also worked as a temporary in a city attorney’s office. In 2003, three years after my diagnosis of cancer, I had the opportunity to move to the mountains (in another state) and work as a permanent employee and pay into their retirement system.

     I remember thinking that if I lived five years without the cancer coming back, I would break even financially as a result of the move. I also thought that if the cancer did come back, at least I would have a beautiful view of the mountains while I was sick. Thankfully today, I remain cancer free.

     As someone who was the first in my family to finish college and paid for my education, I was alwsys extremely cost conscious. Now, because of my settlement, I am able breathe alot easier now and enjoy life more. I am also thankful that the settlement served to hold the drug company accountable for what they did.

     One of the most fulfilling activities that I am now involved in is a Women’s Cancer Survivor Group. It is a privilege to give back by assisting women diagnosed with cancer. In addition, I have also had the opportunity to take an art class and have pursued a passion by producing note cards with my art, and framed prints. I never imagined that while healing from cancer, my life would lead me down this interesting and exciting path. I look forward to each day of the journey.”

DID YOU KNOW that the man and woman who were the original voices for Mickey Mouse and Minnie Mouse got married in real life.mickey

For pic o’ day, a good reminder:

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Here Comes Qnexa

     One of my favorite commercials from the Super Bowl was the car commercial… What, you don’t remember a car commercial? Well, I’ll bet you’ll remember it when I describe it.

     A fat dog keeps seeing a car drive by that he wants to run outside and chase. The first time he tries, he can’t get through the opening in the door. So, he sits and looks at himself in the mirror to figure out what to do. He is sad. The violin music is playing.

                                                                                                                                                                          

     Off of a sudden, the voice of James Brown kicks in with, “Get Up Offa That Thing”. Heavy dog decides to go on a massive workout program to lose weight. He throws his ball down the steps, so he has to chase it. He runs on the treadmill. He ignores the food being dropped on the floor: He even goes out to the pool to swim.

   In thirty seconds, you feel a part of the accomplishment. Yes, he is through the door doggy hole and out chasing the VW Beetle. All because he decided to exercise and do it. He takes no shortcuts to weight loss.

  The New York Times did a story on the making of the ad, because so many people picked it as their favorite Super Bowl ad. YouTube even has “The Making of:The Dog Strikes Back” commercial.

     They decided to create a metaphor of “letting ourselves go” by showing Fat Dog. Originally, the director of the commercial was looking for two dogs. But, they decided that “Bolt”; the dog in the commercial, was such a good actor that they would just use special effects to accomplish the weight loss.

     Bolt wore a “fat suit” built out of fake fur. As the reporter of the Times put it, “No animals were harmed in the making of this fat suit”.

     We all can feel a bit challenged by this ad because it ends in accomplishment. Unfortunately, drug companies know that people aren’t inclined to exercise and would rather just take a pill to lose weight. They have been focusing on finding “that pill” and getting it approved for marketing.

      It’s why the diet drug, fen-phen, was so widely prescribed. Then, when it was shown to cause pulmonary hypertension and heart valve problems, the drug was taken off the market; and it led to damage lawsuit payouts of about $13 Billion dollars.

     Other drugs have failed to get approval. Even Qnexa was rejected in 2010. But, maybe enough time has gone by where the effects and dangers of fen-phen are fading from our minds.       

     Last week’s big pharmaceutical news is the potential arrival of  Qnexa to market. Vivus is the Mountain-View based drug company to create it. When the FDA gave tentative approval last week by a 20-2 vote, Vivus stock (VVUS) jumped 98 percent on its first day of trading.  At close on Friday, it is now trading at $22.13 and moved to $22.45 in after hours trading.

     I will briefly describe ingredients and warnings. No need for exercise with what they are touting.   

     In terms of weight loss, Qnexa’s study participants loss an average of 10 percent of their body weight. One analyst predicts that such results will make this drug “the next Lipitor” with millions of prescriptions being written.

     If you analyze the drug, you’ll find that it’s really a cocktail creation. It’s a combination of two previously approved FDA drugs. The first is phentermine, which is really an appetite suppressant. It was the “phen” of fen-phen.     The second part of Qnexa is topiramate, which is an anti-convulsant.  

     Phentermine is already known to have two heart-related side effects: tachycardia, which is an increased heart rate, plus it has been shown to elevate of blood pressure. It has been around for over 40 years.

     Topiramate is the active ingredient in Topamax. It’s side effects include confusion, memory loss, concentration problems and “difficulty in finding the right words” in conversation.

     It appears that the FDA is going to allow this to go to market, because of the positive effect in the war on obesity. The FDA  probably will require additional studies for those that are already at risk from the above two ingredients.

      Warnings probably will include cardiovascular issues. Plus, Topiramate already carries the warnings of depression, mood problems, fatigue and sleeplessness. Plus, there’s that side effect termed as “suicidal ideation”.

     The FDA will make a final determination on approval and required warnings on April 17. Vivus is asking the FDA to allow it to begin a 4-year-trial on cardiac health AFTER the FDA approves it. People will be excited with the weight loss and push to be on the drug longer. Then, history tells us that the drug company will push for a stronger version, for those that really need to lose weight.

     I suspect that you will be seeing more blogs from me on this drug, if it is approved. It would not surprise me, if this law firm becomes very familiar with this drug and drug company.

     For pic o’ day, I thought I’d post something that I think, describes this blog.

Akavar Class Action and Others

     It sounds like a great idea to be able to “Eat all you want and still lose weight”. Let’s put on our buffet pants right now. Unfortunately, you know the saying of “there’s no free lunch” . Now, we should also start saying that there is ” no all you can eat and don’t get fat lunch”. 

     A nationwide notice is being sent out, authorized by the United States District Court of Utah, relating to a class action lawsuit  that is being brought against the manufacturers of a weight loss supplement that is called Akavar 20/50.(Akavar) The lawsuit is called Miller v Basic Research LLC, et al. (Case No. 2:07-CV-871)

     In their ads for the supplement, the manufacturer made claims that the product had undergone “scientific evaluation” by a “team of doctors”.  The lawsuit alleges that there were no clinical trials; no scientific evidence that supported the claims of being able to eat anything you want and not gain weight; and that the advertisements were just making fraudulent claims.

          In 2009, Hydroxycut was recalled, because people claimed to have suffered severe liver damage injuries. I see their commercials again under the title of “Hydroxycut Advanced”. Now, they are pitching energy and weight loss in the same supplement. Notice, they hit the airwaves hard, right before swimsuit season. I wonder what change they made in the ingredients, that make it “Advanced”.

     Synerate weight loss was recalled, after more than 60 adverse events were reported. Many were deaths relating to heart attacks and strokes.

     The FDA just sent out a warning about an over the counter weight loss supplement called Fruta Planta. It is barred from the US and the warning went as far as to say that you should make sure that it gets thrown away, in a sealed container, so children and animals cannot  get to it.  

     It’s sad that people of bad character concoct some pill; set up a PO Box; and just start running TV ads that tout false claims. Meanwhile, people think that the ads are truthful and the pictures of the actors in their bathing suits, must be real. 

     The battle of the bulge lets these kinds of characters prey on the unsuspecting. History records that  Hitler believed that you should  “make the lie big; make it simple; keep saying it and eventually they will believe it”.

Dollars For Docs Follow-Up

     In my previous blog, “Drug Companies Paying Doctors” , I cited a database called “”Dollars for Docs” that has attempted to compile  information on payments, that drug companies have made to doctors.

     It is not my opinion that just because a doctor receives compensation from a drug company, that it should mean that such payment means influence over that doctor.

     Unfortunately, there is not enough funding for doctors. Many times, the difficulty in even filling out the paperwork to try to receive research grants, can be overwhelming. Plus, many doctors, that I know, are already working long hours and fighting insurance companies to even get a portion of their entitled billing.

     I just thought that I would attach the website (here) which will allow you to plug in the name of any healthcare provider, to determine what monies that they might be receiving from the Pharmaceutical Industry.

     To me, it’s no different than lobbyists interacting with legislators on Capitol Hill. We know that industries contribute to campaigns. That doesn’t mean that every legislator is being “bought” by every contribution. 

     The reality is that medical treatment and research does cost money;  just like political campaigns cost money. I just think that it’s good to know who is paying and who is receiving.

     This website is not an exhaustive list. There are many doctors and payments still not listed. It is a good place to start. It goes along with the old saying that “information is the greatest commodity”.

Drug Companies Paying Doctors

     An astronaut was sitting in the capsule, preparing for launch. Reporters still had access to them, before closing the hatch. The reporter asked “How do you feel when you are an astronaut, ready to take off?”  The astronaut looked at the reporter with a tilted head and answered, “How would you feel if you were sitting on top of at least fifty thousand parts that were each supplied by the lowest bidder?”

     It’s a fact of life that we all believe that money does provide influence. In the past few years, opinions about doctors, have taken a “hit” , because it is suspected that they are being influenced by the money of drug companies. It is the reverse of the astronaut’s opinion that maybe, cheaper impacts quality. Maybe drug company money effects treatment.

     The Richmond Times-Dispatch   has reported that at least 10 Virginia doctors have earned in excess of 100k from drug companies, during the period of 2009-2010. It is published by a NY  non-profit group ProPublica, under its compiled “Dollars for Docs” database.

     There is a move to ban doctors from receiving compensation or gifts from drug companies. The doctors that were interviewed, as part of the reported 10 from Virginia, gave such explanations that by speaking for the drug companies,  it brought special medication and treatment  awareness; That they were not influenced by the money and that, as one diabetes doctor said, “I feel like I am in a good position to teach primary care doctors how to properly take care of type 2 diabetes”.

     I wonder how accepting money somehow causes a doctor to be in a better “teaching position”. I do think that drug ads that say “Ask your doctor if it’s right for you”, is doing no favors for the medical profession.

     People have become smarter about taking personal responsibility for their own care. Now, I think, just because a doctor says it, no longer means that it is fully believed by the public. However, isn’t that unfortunate? The good old days of going to your family physician and he or she knowing your entire family, sure sounds good today. Instead, we sit wondering whether the medicaion is being given because the doctor is being paid as a “drug consultant”.

AstraZeneca Just Moving Forward

     The title of this blog sounds boring. It’s like flipping through the channels and seeing an ad for a “Man Groomer”. It just sounds scary and who really wants to hear about someone shaving their back.

     Anyway, since we do Pharmaceutical litigation, it did grab my attention that Astra Zeneca just paid a $520 million dollar fine for illegal marketing of an anti-psychotic drug called Seroquel.  Now, before you tune away, I wanted to just outline a few curious things about this settlement and why there is such a large fine for marketing.

     Some of the false marketing just didn’t make sense. When I read some of the company comments about the settlement, I can’t help but shake my head at, “While we deny the allegations, it is in the best interests of AstraZeneca to resolve these matters and to move forward with our business of discovering and developing important, life changing medicines”.

     This reminds me of the recent handicapped-accessible water fountain that was installed in a Courthouse, as a result of a settlement with the US Justice Department, over deficiencies in complying with the Americans With Disabilities Act.   The curious thing  is where it  was installed: on the second floor of the courthouse, which is only accessible by a staircase. In that instance, the spokesman for the Courthouse, told the reporter that the fountain is not just for those who have difficulty walking, and that this fountain really is better equipped for those who have problems bending, twisting or gripping. I love a good quote that just makes me shake my head. 

     Anyway, back to the drug company settlement where they just wanted to put it behind them so they move forward and do more good.  Justice Department officials allege that Seroquel was also being marketed for Alzheimer’s disease, anger management, depression, post traumatic stress, depression, bipolar maintenance and sleeplessness. Nothing in there, though, that would make the “Man Groomer” obsolete.

     It was also alleged that this Drug company had violated the Federal Anti-Kickback Statute by offering and paying illegal remuneration to doctors it recruited, to advise the firm about marketing for unapproved uses beyond the FDA recognized narrow approval. Basically, that’s code for “Doctor, if you prescribe this for a lot of different reasons, then we will pay you 50K a year as a consultant and fly you to Hawaii to discuss your thoughts on your thousands of prescriptions for the year”.

     This investigation was triggered by a “whistle-blower”. It usually takes someone on the inside to find out that this kind of fraud is going on. As a result, under the Whistleblower statute, you get a portion of the recovery for the bad conduct. In this instance, the share paid was $45 million, a tidy sum for helping to find the truth and stopping fraud. The fraud was created as a result of this medication being paid by  insurance such as medicare and that goes into the extent of the fine. Tax payers were really paying for this.

     Despite the boring title, I had to pass on the full story, even if you had seen a bit about the large fine. Now, you can go back to your regularly scheduled programming!

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