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The Next FDA Commissioner

Conflict or Qualified? The NY Times just did a story on the recent Presidential nominee to head the FDA. The title of the article tells the summary of the story, F.D.A. Nominee Califf’s Ties to Drug Makers Worry Some.

The article starts out with a meeting in May 2014, and presentation that Dr. Robert M. Califf gave to a group of biomedical researchers,  pharmaceutical lawyers and industry experts.

His PowerPoint slides showed the importance of speeding up the pace of biomedical innovation by transforming research. Near the end of the presentation, one slide was put up that indicated one barrier to that pace: Regulation.

At the time, no one reacted to that one slide. Now, it has garnered some attention because this Cardiologist/nominee will potentially be the “Police Chief” of medications that get approved and make it to our pharmacies.

He is a renowned clinical researcher who is unquestionably qualified to lead the agency. On the other hand, he will be in charge of an agency that regulates what is responsible for about a quarter of every dollar that we spend.

This agency is now facing such issues as whether/how to regulate electronic cigarettes. Dr. Califf’s previous job was heading up Duke University’s research center, which received more than 60% of its funding directly from pharmaceutical companies. Does that make him too close to them and create a conflict; or does his familiarity with the industry make him more qualified to regulate it.

Dr. Califf personally received $215,000 as a consultant from drug companies from 2009-2015. As a side note, several years ago Frank Luntz did research on the term drug companies and advised them to start calling themselves pharmaceutical companies. Drug Company sounded bad to the public. More on that in his book Words That Work: It’s Not What You Say, It’s What People Hear.

“Pharmaceutical Companies” have always been known to have great ties to government while employing powerful lobbyists. In 2002, the Homeland Security Act that we all knew was going to make us safe as it was signed into law… also contained a provision buried deep in the legislation that protected Eli Lilly and a few other big drug companies against  lawsuits by parents who believed that there children had been harmed by thimersol.

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    So, the question really remains, when is regulation protective and when is it too restrictive? Let’s hope that Dr. Califf knows the balance. As one professor who worked with him observed, “How does he think? We won’t know until we see how he behaves.”

 

 

And for pic o’ day, a bit of surveillance:

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Paid in Crack!

     Here’s a lawsuit that has some unique issues. From Albuquerque, New Mexico, comes a story of a lawsuit (KRQE) filed for damages relating to a drug addiction.

    The lawsuit claims that federal agents paid an addict in crack cocaine for his cooperation in an undercover investigation into a Las Vegas drug operation. According to the lawsuit, the Drug Enforcement Agency (DEA) approached the man and bribed him to help with the undercover operation by promising a portion of the drugs obtained during the investigation. The suit claims that “He was  targeted because he was a known drug addict”. 

     The man was later charged with distribution of drugs, but the charges were dropped by federal prosecutors in January. The lawsuit seeks $8.5 million in damages for the loss of love, familial relationships, and companionship caused by the plaintiff’s renewed drug addiction.

     A DID YOU KNOW from the art world. The Museum of Modern Art in New York City hung artwork from Matisse titled “Le Bateau”. It was hung upside down for 47 days before a student noticed the error.

     And for pic o’ day…

static

 

This and That From the Notebook

A Franklin, Tennessee lawyer named Drew Justice was in a word battle during a criminal trial. The prosecuting attorney filed a motion with the Judge that sought to keep defense lawyer Justice from referring to the prosecutor as “the government” during the trial. Justice filed his own motion that requested that the prosecutor only refer to him as “Captain Justice” or “Guardian of the Realm”. I think the Judge just told both of them to move on… Motions denied!

The NY Times reports that Florida Governor Rick Scott intends to appeal a recent decision of U.S. District Judge Mary Scriven, who overturned a Florida law that required welfare recipients to submit to drug tests. The state had argued that there was a special need to test welfare recipients because there was a perception that the welfare population are drug users. The opposing argument in ruling against required drug testing, per the Judge’s ruling was that it “would allow the rule against warrantless, suspicionless drug testing”.

The drug testing requirement was in effect from July 1, 2011 through October 24, 2011. During that time, 4000 people were drug tested and only 108 tested positive for drug use. Some have also pointed to recent members of Congress for using drugs and driving while intoxicated. The question is then asked, “Since they are being paid by the government, shouldn’t all Congress be drug tested as well?”.

A blog note… I won’t be able to blog next week but I intend to be back the week after. I promise to be back with my pen (well, maybe it’s my typing fingers) in full research and writing mode!

DID YOU KNOW that President William H. Taft had a bathtub installed in the White House that was big enough to hold four people. He did so because he was unable to fit in the one that had already been installed. Yes… he was a big man.

And for pic o’ day and feeling good with appearance:

looking good

The CrossFit Question

A travel back in my lawyer time machine takes me to the early 2000’s, when I started representing several clients relating to problems from a statin drug. It was a drug taken to lower cholestorol. It was the first time that I had heard of a medication causing muscle weakness known as a condition called rhabdomyolysis.

Once I learned about this muscle weakness that related to the kidneys. I started to pay attention more closely. In 2005, The NY Times reported on this same condition in an article titled “Getting Fit, Even If It Kills You”. This same condition was now also being linked to an exercise program called CrossFit.

For this blog, I don’t want to spend the entire time bashing this exercise program. Instead, I hope that you will draw your own conclusion.

I am attaching an article from the Huffington Post titled CrossFit’s Dirty Little Secret.  In their exercise literature, they even warn of the condition with a cartoon called “Uncle Rhabdo”.  The premise of the exercise is to push yourself. The possible result that is known even to the founder is the high risk of rhabdomyolysis. This is a blog for you to draw your own conclusion. Is this workout worth the risk?

DID YOU KNOW that the character of “Uncle Sam” was orginally a meat packer from Troy, New York. He became famous for supplying rations for the soldiers in the war of 1812.

Uncle Sam

And for pic o’ day, how about some encouragement.

dog encouragement

Baseball’s Fraud Role Models

     “Don’t talk about it, be about it”. I remember hearing a motivational speaker implore that action. I was reminded of that saying, when I heard about Alex Rodriguez saying that he just wants to be a role model; when he was asked about being suspended from baseball for taking  performance enhancing drugs. (ESPN)AFraud

     Does that mean that seeing is believing?

Seahors

          Recently, Milwaukee Brewer baseball player and former MVP, Ryan Braun, agreed to a suspension for the rest of the baseball season. In response, a fan decided to wear a Braun T- shirt and make a few changes to the back:    

Braun Fraud

     That brings us to the question of a fan’s rights at the ballpark. When Karen Eldem wore her shirt into the stadium, a security guard tapped her on the shoulder and asked her to leave. Apparently, the guard did not like the “Braun to Fraud” name change.

     Security told her that the modified shirt violated the fan code of conduct and that the only way that she could stay and watch the game… turn the shirt inside out. She wanted to stay, so she did. However, when the story hit the airwaves and news, the Brewers later issued an apology and offered her another game ticket.

     Don’t you find it curious that it was the Brewers to claim that she was violating the fan code of conduct. A team that has glorified drinking into a team name. As the Baltimore Orioles’ announcer used to say over the intercom after a fan would catch a foul ball, “Give that fan a contract!”  

      And  now to today’s “Did you Know”,   it takes us to the alphabet. Take a look at the letters ” H I O X”. They are the only letters in the alphabet that look the same, when reading them from the front, back or upside down.  

     For pic o’ day, I am posting a “driving picture” that was recently sent.

another rider

 

 

 

 

 

 

 

Chocolate, Donuts and Pilot’s Salt

This is a Food and Drug blog. First, the fun stuff. Yes… that would be the food.

I decided that I needed to build some momentum with important news. Friday, June 7, is National Chocolate Ice Cream and Doughnut Day. How’s that for momentum. Yep, I am clearing my calendar. I know what you are thinking, “When is Jelly-Filled Donut Day?”.

Now to the Drug part of the blog which takes us back to World War II. The story of “Pilot’s Salt” from The Atlantic.

ervitin

In 1972, Heinrich Boll won the Nobel Prize for literature. Before gaining fame as a writer of novels, short stories and essays; he gained fame for a letter that he wrote his family on May 20, 1940. In it he asked that “Perhaps you could obtain some more Pervitin for my supplies”.

It turns out that millions of tablets of Pervitin were distributed to German soldiers during the war. It is estimated that more than 35 million three-milligram doses of Pervitin were manufactured for the German army and air force.

The pills were taken for heightened awareness; increased self confidence; willingness to take on dangerous risks; increased concentration; reduced sensitivity to pain, hunger and thirst and reduced need for sleep. Hitler was even given intravenous injecti0ns by his personal physician.

Why don’t we see TV ads for Pervitin? Wouldn’t better concentration and awareness seem to be good marketing ideas? Well, unfortunately, this pill and drug had side effects. The side effects included heart failure, difficulty sleeping, long stretches of wakefulness and even suicide.

Other symptoms that were reported included sweating, dizziness, hallucination and depression. That’s because the drug was really an early form of crystal meth. Still, I can almost hear a TV ad for this with a fast voice and small print that identifies the side effects, and then tells you to “Ask your doctor if Pervitin is right for you”. Have drug companies changed?

And for pic o’ day… I can’t stop laughing about this one:

furniture

Lance Armstrong’s Class Action Suit

Do you remember the old joke about the definition of an autobiography? Answer: the life story of a car. Yes, I know it’s not funny. But, Lance Armstrong also doesn’t think that his autobiography is bringing him much joy either.

    He is now probably hearing angry voices in his head over a lawsuit filed against him, because of his best-selling co-authored book.

The Los Angeles Times and USA Today  are both reporting that a lawsuit has been filed by two individuals against Lance over his book “It’s Not About the Bike: My Journey Back to Life”.

The plaintiffs claim that they would not have purchased his book if they had known the true facts about his involvement “in a sports doping scandal”. They are seeking class action status against Armstrong and in that petition, they have indicated that the lawsuit could involve in excess of 100 people.

The lawsuit is also being filed against his book publishers, which includes the publisher of Armstrong’s other book “Every Second Counts”,  which was published back in 2003.

This raises an interesting legal question of whether an author can be held accountable for misconduct, so as to allow past purchasers to seek their money back for a product. Armstrong won seven Tour de France victories between 1999 and 2005; it was during that period that he now has acknowledged that he used banned substances.

Our pic o’ day gives us another idea. Maybe he would rather be in the box of shame instead of facing lawsuits!

 

South Carolina City Attorney Accused

Quid pro quo is sometimes a way to get by. “You scratch my back and I’ll scratch yours”. It all sounds good on the morning radio “Swap Shop” unless you are applying it as a City Attorney.

The ABA Journal reports that Charles Cushman, City Attorney for Camden , S.C., has turned himself in at the Kershaw County jail and was released on personal recognizance bond, after being accused of trading prosecutions for donations to the Camden drug fund. According to the arrest warrant, Cushman allegedly dismissed some criminal cases when a donation was made to the fund.

Law enforcement agents claim to have financial records to support the warrant. They also added that the drug fund maintains an average monthly balance of $20,000 to combat drugs in Camden.

Hard to understand the thinking. Is this one of those stories where “two wrongs don’t make a right?” I know, it’s easy to finish it with “But, three lefts make a right”.

For pic o’ day I went with a good thought/bad idea:

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”.

A Topamax Recall and Reminder

     “Something The Lord Made” is the HBO movie about controversial open heart surgery on an infant. At the time, it was extremely controversial to operate on the heart. Outside the United States, there had been some heart repairs as early as 1895.

     The movie discusses the religious opposition to open heart surgery at the time. There were some that allegedly believed that the soul resided in the heart and thus, should not be tampered with. Others believed that such medical conditions should be left to the determination of our Creator.

     I was reminded of this movie when I saw the recall for Topamax. Topamax is a medication that is prescribed primarily for epilepsy. According to the announcement by the manufacture, Ortho-McNeil Neurologics, the recall stems from four consumer complaints.

     The complaints resulted from an uncharacteristic odor in  pill bottles, that is thought to be TBA (tribromoanisole). TBA is a byproduct of a chemical preservative that is sometimes used on chemically treated wood. It could have gotten into a batch of Topamax, from wood pallets where the medication had been stored.

     Epilepsy  is one of the most common neurologic disorders. History tells us that it used to be sometimes known as the “Sacred Disease” because the resulting symptoms were believed to be a result of such things as demonic possession, or an attack by “other wordly” beings.  A 5th century treatise by Hippocrates discussed the attacks and their possible relationships to visions.

     Because the condition was not understood, some considered it to be contagious or poisonous. Treatments went as far to include literally drilling a hole in a person’s skull, to possibly attempt to either let the poison out or the evil spirit.

     This recall serves to remind us of how fortunate that we are with medical treatment and understanding today. Past medical conditions that were not understood, were given explanations that are obviously considered outrageous today. Maybe some of the treatments today, will also be deemed as an archaic to future medical care providers. 

     The other reason I blogged on this recall, is that it serves as a reminder to pay attention to our personal medications. A bad odor is cause for concern. Some may simply ignore their pill bottle when taking the medication. Also, medications are transported like other cargo and subject to issues beyond the manufacturing.

     In this instance, Ortho-McNeil is saying that the recall is related to fewer than 6000 bottles. Probably there’s a bit of a “conspiracy theory nut” in me, to always question the immediate discounting of any concern.

     I’m glad medicine has made such strides. I’ve been a benefactor of those advancements. Personal vigilence is also important and this recall is a reminder of that.

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