Novartis and Data Manipulation on $2.1 Million Gene Therapy?

Novartis, one of the world’s largest pharmaceutical firms, is under FDA investigation. Novartis stock is taking a tumble because the company withheld data from the FDA in its application for approval of a gene therapy treatment for spinal muscular atrophy. The FDA investigation is a setback for the company that, as of 2018, was trying to put behind it a generic price-fixing scandal, improper marketing techniques, and a previous allegation of data manipulation.

The $2.1 million gene therapy treatment was given expedited approval by the FDA. Then Novartis revealed that it was conducting an internal investigation into possible data manipulation in the testing of the drug, Zolgensma. Novartis has fired two scientists and maintains that the conduct was isolated. However, there was a two-month delay in announcing the internal investigation, a delay that permitted the drug approval process to end successfully. Novartis has defended the delay by explaining that it did not want to tip AveXis executives on the existence of the internal probe. AveXis produces the drug, and Novartis said that it feared the executives there would interfere with the investigation. Somehow a defense that is based on the fact that you do not trust the executives of your contractor seems slightly off kilter.

Novartis assures that there is no concern for safety of the patients. An FDA commissioner tweeted that he expected there would be a finding of wrongdoing and that there would be consequences. Novartis also assures that the issue was isolated to a couple of rogue scientists. If the Barometer had a nickel for every time the phrase, “These were just a couple of rogues that we have now fired,” well, this blog would not be free.

There is no such thing as isolated-rogue responsibility when it comes to events this big. Given the company’s culture as of 2018, something more than firing a couple of scientists is probably in order.

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Tailhook Deja Vu

Well, here we go again. The Navy parties hardy, as we learned from the Tailhook days, but have obviously forgotten. The Navy terminated the three leaders of SEAL Team Seven (known as the triad) for their failure in leadership. The three did not take action when they learned of a Fourth of July party (in Iraq where the platoon was serving) during which a female service member assigned to the platoon was allegedly raped and another female service member experienced unwanted sexual contact. Needless to say, there was considerable alcohol consumed at the party. The entire platoon has invoked the right to remain silent.

The words of the Navy in announcing the the termination of the three leaders and in sending the entire rights-invoking platoon home to Colorado, “Navy Special Warfare insists on a culture where ethical adherence is equally important to tactical proficiency. Good order and discipline is critical to the mission. We’re actively reinforcing, with the entire force, basic leadership, readiness, responsibility and ethical principles that must form the foundations of operations.”

Let’s hope the lesson is learnt this time.

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Trust Lost: Mechanic Charged with Sabotaging an American Airlines Flight

American Airlines mechanic, Abdul-Majeed Marouf Ahmed Alani, who has worked for AA since 1988, was upset about contracts negotiations for the mechanics’ union. The negotiations have dragged on since 2015, and Mr. Alani felt that the failure to reach an agreement for a wage increase had affected him financially. The whole process has been ugly, with AA suing the union for causing an operational slowdown. However, Mr. Alani is accused of finding his own remedy by trying to sabotage a plane just before it was scheduled to leave Miami for the Bahamas with 150 passengers aboard.

Mr. Alani is accused of supergluing a piece of foam to block a module that reports speed, pitch, and other critical data to pilots. Yes, those would be critical functions. Fortunately, the pilots never took off because when they revved the engines to test their power, they got an error message. The pilots sent the plane for inspection and the mechanics discovered the amateur foam rig.

Mr. Alani was arrested, but says that he did not want to harm the passengers. He explained to investigators that he just wanted to delay or cancel the flight so that he could get overtime to compensate for what he felt he was entitled to if the negotiations had been successful.

Mr. Alani, like all accused criminals, never think through their “perfect” crimes. There are cameras on the jets in the hangars. The cameras taped a white pickup pull up next to the plane slated for the Bahamas flight, a man getting out, and that man opening a compartment under the cockpit. Mr. Alani’s fellow mechanics were able to identify him as the man in the video.

AA vie president of operations referred to the conduct as “extremely serious.” The president of the union said that he was “shocked.” For the Barometer, it was sobering. We are all so dependent on the integrity of others for our safety: that those who build our cars install all the parts and do so correctly, that those who handle or produce our food do so safely, and that those who services our airplanes would not take deliberate action to sabotage a flight. We just lost that last bit of trust. Let’s hope new processes are put in place to keep a more watchful real-time eye on the folks who work on and around the planes. Trust lost means more watching, more regulations, and more cost. Oops, there goes the wage increase.

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Tennis Players Gaming the System

The human mind has no limitations when it comes to figuring out ways around rules. Enter the game of tennis. The Women’s Tennis Association (WTA) and Association of Tennis Professionals (ATP) are in the process of developing and changing the rules for bathroom breaks because, it appears, players are using the the breaks strategically. For example, a claimed bathroom break need not actually be used to go to the bathroom. There are no time limits on bathroom breaks. As the CEO of WTA explained, “The rule is there to provide for a need for the players. It is not meant to be strategic or a momentum changer.”

In addition, there are the stories of players being handed a banana on the way to the bathroom. However, the banana contained a piece of paper with coaching tips. Other players have made calls for help with the match, some even calling mom. The problems have arisen recently because most past players simply did not take breaks. As 1985 U.S. Open Champion, Hana Mandikova, said she never used a bathroom break in her entire career, but “It’s just that there’s so much money involved now, that everybody’s looking for every little edge.” One of today’s players begs to differ, “We do whatever it takes to win the match.” Spoken like a true gamer of the loopholes and ambiguities in the rules.

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USC Spreadsheets Tracked Applicants by Their Relationship to Donors and the Amounts Each Donor Gave

The e-mails are bad enough, “Long-time donors,” $25K to Heritage Hall,” and $15 mil.” The athletic department was using its special admits slots to help the university with its donors. So, the folks gaming the system for admission were not gaming as much as we thought. The admissions folks and athletic department appear to be playing the game as well.

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“In Primes of Careers, Women Bear Burden of Caregiving.” New York Times, September 2, 2019

The headline was striking for a story about women caring for their parents. Even more striking was a quote within the article from a woman who was once a paralegal but dropped that career in order to take care of her mother who has Alzheimer’s disease. She has taken less demanding jobs so that she can be there for her mother. She told the reporter,”I lost ten years of my life. What’s going to happen to me?” A project officer for the Centers for Disease in Atlanta who cared for her mother who has dementia until she was able to get her on Medicaid told the reporter, “Caregivers are physically and mentally and financially dying.”

There can be no doubt that caring for a parent is challenging. However, the article, in its attempt to paint such a hopeless picture for both parent and caregiver neglected to discuss the benefits of the role.

The Barometer had a technician who made and polished hard contacts for her for decades. These skilled individuals are tough to come by in this era of soft lenses and laser corrective surgery. Suddenly, he was no longer at his business. He shut it down for years. When he returned to his business, he explained that he took over caring for his father. He said it was difficult to walk away from a business that could no longer run because he was the nucleus of the operation. But he added, “I would never trade the time that I had with my dad. We developed a great relationship during his last years. I didn’t have that before.” He also explained that after his father died, he came back to his business and was pleasantly surprised by the loyalty of all his ophthalmologists and customers who returned to him for their hard contact lens needs. He was in his tennis shorts that day and explained that he learned through his experience in caring for his father that he could take a little time for himself. He said he had barely visited his father for years before he assumed the role of caregiver. He said that his business was not only back, but better. So also was his life. His experience has been stuck in the Barometer’s mind for nearly ten years. He gave a profound lesson on choices and life.

Nearly all of us have faced or will be caregivers in some form for our parents. Our lives will change in stepping up; new challenges, including job, career, and lifestyle changes will be part of that. However, the Times article presented those challenges as something that no one should face. Worse, the article fell into the either/or conundrum that we use to avoid doing the right thing. Under the either/or conundrum decisions are based on assumed outcomes. Either I find someone else to care for my parent or my career, financial security, and/or life are over. They either/or conundrum commits the ultimate flaw in logic — it assumes the outcome. What the article did not cover are the stories of those who have been caregivers and who can look back, their parents now gone, and realize the impact and importance of stepping up when it was terribly inconvenient, financially draining, and physically exhausting. Those stories could inspire, reassure, and provide perspective on priorities. Funny, how about a description of parenthood? Financially draining, physically exhausting, mentally frustrating, and offering little in the way of career advancement. But, these dear parents did it anyway.

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Ohio State Medical Board Had Evidence in 1996 of Dr. Richard Strauss’s Sexual Abuse of Ohio State Students: No Action

A quote from the review panel report, requested by Ohio Governor Miek DeWine, just released on Friday:

“Documented systemic failures at both The Ohio State University and State Medical Board of Ohio prevented any tangible administrative or criminal consequences from ever being taken against Richard Harry Strauss during his lifetime.”

Dr. Strauss abused hundreds of students, and the Ohio State Medical Board took no action. However, the report also finds that Ohio State University employees also failed to take action. The result was that Strauss moved to California, with no warnings from Ohio officials about his medical board investigation, and began operating a clinic there. He committed suicide there in 2005. Because of inaction by too many professionals and administrators, this demon of a doctor was not stopped and was never held to account criminally for his actions.

So far? Penn State, Michigan State, and Ohio State have all had abuse going on on their campuses. And, perhaps it is a Big 10 thing, but action was either not taken, was insufficient, and/or was delayed. There are layers of lessons to be learned from all three schools and the medical boards.

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More Gaming the System in Online Reviews

There is an inherent conflict of interest between travel review sites and the targets of those reviews. Travel review sites depend upon those being reviewed for their revenue. So, when those who pay the site ask that a negative review be removed, well, some do succumb. TripAdvisor will delete negative reviews on, for example, facilities, if the hotel can show that the facilities have been updated or repaired. TripAdvisor does notify the poster that the review is being taken down.

Some companies pay people to write reviews. The online review sites have caught on and are now requesting proof of a stay or meal, depending on hotel or dining reservations. Sometimes the threat of suit causes the removal.

In short, you may not be getting either the most-up-to-date information or authentic reviews. Who knows? However, be aware when using travel sites — some are gaming that system.

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Candid Glassdoor: Are Employers Manipulating the Site?

The Wall Street Journalconducted a study of Glassdoor’s site. Glassdoor is a site that permits employees (current and former, happy and disgruntled, short- and long-term) to post feedback on their companies. Employers can then respond to that feedback. The WSJ found more than 400 employers with “unusually high single-month increases in positive feedback.” In the positive-surge months, the proportion of positive feedback was different from other months. Sarah E. Needleman, “Glassdoor Operating Chief to be CEO,” Wall Street Journal, August 27, 2019, p. B4.

Christian Sutherland-Wong, just promoted to CEO of Glassdoor from his position as head of operations, believes that there is a problem with employers trying to game the system. He says that “bad actors are always trying to find new ways to get around our system and around our rules.” Suffice it to say that this ops guy is on the case.

There is no limit to the human imagination when it comes to finding way to game measurements. In this case, the gaming was dumb. Just going on the Glassdoor site and loading it up with positive comments was not going to go undetected. The move was hardly shrewd. Beyond the data the WSJ collected, there is the intuitive ability to go on to employer sites and spot the fake posts — themes repeat, praise is over the top, and there is a stark contrast with real employee feedback on specific issues. Spelling and grammatical errors are laced throughout the negative employee feedback.

A word of advice for employers on Glassdoor. Forget gaming the system. Post meaningful responses to what employees say. More importantly, look into the issues that they raise. You can’t manipulate earnings, you can’t manipulate patient queues at the VA, you can’t fake finishes at marathons, you can’t make up new bank accounts, and you can’t pay bribes to get your non-athletic child as a special athlete admit into a top university. The list is much longer, but you get the idea. Sooner or later, someone finds the manipulation. Then you are back to the hard work of getting real earnings, taking care of patients, training for marathons, building customer trust, and studying. Also, the hard work tends to avoid fines, penalties, jail time, and disgrace.

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Attempts to Hide Bad Water: How Many Times Must We Live (Maybe) Through This

The story of the Flint, Michigan unfolded as follows:
April 2014 – Switch from Detroit to Flint system; no corrosion control testing
May 2014 – complaints from residents about the water
August 2014 – E.coli and coliform bacteria found in the water
October 2014 – GM says it won’t use Flint water because it corrodes its machines (what was it doing to the innards of Flint residents?)_
January 2015 – EPA finds that the water violates federal law
February 2015 – high lead levels– 104 ppb vs. EPA maximum of 15 pbb
April 2015 – Corrosion controls still not added
July 13, 2015 – Flint residents told to relax
August 20, 2015 – Tests excluded lead levels from the sample
September 2015 – Virginia Tech study finds high lead levels
September 24 2015 – High lead levels found in children’s’ blood tests
September 25 2015 – Residents of Flint told to use bottled water
October 16, 2015 – Returned to Detroit system
May 2016 — eight officials charged as part of the investigation into the water switch
September 14, 2016. — Former Michigan official (epidemiologist) enters a no-contest plea to charges of willful neglect of duty by not disclosing dozens of cases of Legionnaires’ disease in the Flint area at the time of the water switch

Now, enter Newark. As it turns out, Senator Cory Booker (Spartacus and former mayor of Newark) was part of the water problem there. In 2013, Mr. Booker staffed the Newark Watershed Conservation and Development Corporation, a private-public agency. A 2014 investigative report found that there was “rampant abuse of public funds and scant oversight.” Nick Corasanti, Corey Kilgannon, and John Schwartz, “Newark Idled As Lead Crept Into Its Water,” New York Times, August 25, 2019, p. A1.

Eight people with the agency faced federal charges, and the head of the agency is currently in federal prison. Not to worry, the new mayor of Newark replaced her with a non-engineer (experts deem this type of appointment to be a dangerous mistake because an engineering degree is necessary to understand regulations and system oeprations) with a man who had served four years for selling cocaine. Not to worry though — he had been released from prison when he got the job.

Sure enough, there were problems. By 2016, tests revealed elevated lead levels. So, Newark switched water-testing firms in 2017. No change — same lead levels. The ex-felon head of the agency said the press reports about the lead levels were false, and he won re-election. In June 2018, Newark received its third consecutive notice that its lead level had been above federal limits for 18 months. In December 2018, Newark officials spent $225,000 to hire a public relations firm to manage the water issue.
Might be better to spend the money on reducing the lead.

Here are some safety tips for city and water officials: Do not try to hide water test results. Do withhold water test results. Do not falsify test results. Do not hire alternative testing companies to try for different results. When the state sends a warning on lead levels, good time for action.

One final tip: Read the news about what is happening in other cities — the problems and issues that arise. Then check internally to see if you might have the same problems. When you read about corruption, deception, and falsification by city and state officials, make a note. Do not go down the same path.

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“Overstock Chief Resigns a Week After Disclosing His Romance With a Russian Agent”

New York Times, August 23, 2019. One of those headlines that you never thought you would read. Of course, the Wall Street Journal was more measured, to wit, “Overstock CEO Ends Turbulent Tenure, August 24-25, 2019.

How exactly do these folks climb to the top of the heap? And in this case, how did Patrick Byrne manage to remain at the top of the Overstock heap for 20 years? Even in departing, the man poked investors in the eye with hints at suitors (for the company, and not from Russia). Where were the directors as the company’s stock dropped 31% over the past year even as sales dropped each quarter? And did Byrne’s tales of the Wall Street demon Sith Lord, Warren Buffett being his romance advice provider, and “Men in Black” deep state not intrigue the directors enough to pull the plug? Perhaps most importantly, did the strategic shift from selling rugs, chairs, and furniture to cryptocurrency not concern them?

Behind every bizarre CEO is a lackluster board with hopes that it will all go away. It never does until the CEO does. Think Uber, and even then, the damage may be too great. Rein them in, folks, rein in these iconic CEOs and save yourselves and the company.

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The Great McDonald’s Straw Caper Continues

The queen was not pleased, and the Irish seemed upset as well. So, McDonald’s halted its use of plastic straws and put paper straws in its franchises in Ireland and the U.K. However, it turns out that the high-and-mighty and marketable switch to paper from plastic turned out to be, well, silly. The paper straws are recyclable, but they are too difficult to process. So, McDonald’s ends up just throwing the paper straws away. Those old, evil, environmentally unconscious plastics straws were 100% recyclable. In the meantime, customers are signing a petition to bring back the plastic straws. One Irishman put it this way when asked why he wants a return to plastic, “So I can drink my milkshake proper.”

Thanks to the Washington Examiner for highlighting this tale of good intentions gone south.

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Why the World Should Go On: Diesel Pippert

Diesel Pippert has a novel-worthy name and a heavenly-worthy soul. The young lad sold his hog at the Huron County (Ohio) Fair, and donated the $15,000 he received at the auction to St. Jude Children’s Research Hospital. His mother, Erin Sanders, said of her son’s generosity, “Our hearts are full of joy. He’s a remarkable young man.” Indeed he is, Mom, indeed is.

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Justin Trudeau and Obstruction of Justice

The ethics commissioner for Canada has issued a report that concludes that Prime Minister Justin Trudeau broke Canada’s ethics laws (and is that not an interesting thing that there are laws on ethics in Canada?). The conclusion comes on the basis of Mr. Trudeau’s intervention in a criminal case against the Canadian firm, SNC-Lavalin, for allegedly bribing Libyan officials in order to obtain contracts with the Libyan government. The report concludes that Mr. Trudeau had used his office “to circumvent, undermine and ultimately attempt to discredit the now-former justice minister, Jody Wilson-Raybould, to seek only a civil penalty, not a criminal conviction, for SNC-Lavalin. Ms. Wilson-Raybould said that she was “bullied” by Mr. Trudeau, and was eventually demoted. She later resigned from the cabinet, and another member resigned in solidarity. Both were removed from the Liberal caucus by Mr. Trudeau. They are running in the October elections as independents.

Interestingly, Mr. Trudeau does not deny that he tried to influence Ms. Wilson-Raybould. Rather, he was simply trying to save jobs. If SNC-Lavalin had been convicted, thousands of employees would have been laid off because a criminal conviction would bar the company from all government contracts. Nice try, but the old ends-and-means strategy does not justify interference with the criminal and/or civil justice system. Mr. Trudeau said that he disagrees with the ethics report because he is not prohibited from having contact with the justice minister. Nice try again, but unless Canadian ethics are now haywire, executive selective influence exerted over prosecutorial decisions on behalf of well heeled constituents is generally thought to be corrupt.

How the enlightened are fallen!

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