Personal injury attorneys are important for holding businesses accountable for negligence that harms other people.Without them, businesses could put profits above consumer safety. But who holds these same attorneys accountable for their own negligence? That remains to be seen.

If you watch much television, you’ve very familiar with the numerous ads of personal injury law firms announcing “new information that reveals Drug X may cause cancer in some individuals,” by a “non-attorney spokesman.” Just call the number on the screen if you have been affected because “you may be entitled to significant compensation.”

Ads of this type have been making such claims about the popular heartburn medication Zantac (ranitidine) for several years now. The Wall Street Journal editorial board just exposed these claims are false according to a federal judge who dismissed the claims.

A few years ago, the small laboratory Valisure generated headlines after purportedly finding astronomical levels of the cancer-causing chemical NDMA in Zantac. The Food and Drug Administration’s daily limit for NDMA is 96 nanograms, and Valisure claimed to have found levels exceeding 3,000,000 nanograms! Such an outrageous claim should have been questioned by the tort attorneys, but instead they jumped on the bandwagon and started their relentless advertising campaign seeking clients.

On the same day that Valisure announced a “Citizen Petition” with the FDA urging a recall of ranitidine, numerous lawsuits were filed against drug manufacturers. This timing strongly suggests coordination between plaintiff attorneys and Valisure. The FDA investigated and initiated a recall after finding NDMA in some pills that exceeded 96 nanograms.

Fast forward to today when federal Judge Robin Rosenberg notes in her 341-page ruling, the FDA limit is “conservative” – equivalent to a meal of grilled meat. “If one were to consume 96 ng. of NDMA every day, for 70 years in succession, the risk of cancer would be 1 in 100,000 or 0.001%,” and “even the highest-tested pill (by the FDA) showed NDMA at a tiny fraction of the level reported by Valisure.”

Naturally, this important context was left out of lawsuits and press reports. The same is true of the fact that the FDA found Valisure’s lab equipment actually created NDMA! Judge Rosenberg’s report details that Valisure heated the ranitidine to 266 degrees Fahrenheit – far beyond the roughly 98 degrees found in the human body – to achieve its test result of 3,000,000 ng. When Valisure tested ranitidine at 98 degrees, it found no NDMA. The extremely high temperature may have caused ranitidine to degrade into NDMA. One has to wonder why this didn’t end their investigation of ranitidine right then.

Rather than stop, however, they also tested ranitidine’s reaction with salt in an artificial stomach, which resulted in NDMA levels exceeding 300,000 ng. But the enormous levels of salt in the test might have been enough to kill a human being alone. Clearly, the laboratory was determined to find something wrong, regardless of how artificial the tests.

When Valisure tested ranitidine with salt concentrations approximating what a human could safely ingest, it detected no NDMA. But plaintiff attorneys were not deterred. They also relied on a Stanford University study that reported to find NDMA levels in ranitidine exceeding 47,000 ng. That study was later retracted by its authors after the lab equipment was found to have created the NDMA.

Judge Rosenberg writes, “There is no scientist outside this litigation who concluded ranitidine causes cancer, and the Plaintiff’s scientists within this litigation systemically utilized unreliable methodologies with a lack of documentation on how experiments were conducted, a lack of substantiation for analytical leaps, a lack of statistically significant data, and a lack of internally consistent, objective, science-based standards for the evenhanded evaluation of data.” For the record, Judge Rosenberg was appointed by President Barack Obama.

How big is this decision?

Judge Rosenberg’s decision dismisses some 50,000 lawsuits! The investment firm of Morgan Stanley had estimated potential damages against the various drug makers could reach $45 billion if the lawsuits had been successful. The WSJ editors say, “Drug makers have had to spend tens of millions of dollars to defend themselves and face tens of thousands of more lawsuits in state courts. And progressives complain about high drug costs?”

The remaining question concerns the relationship between Valisure and the plaintiff attorneys filing these cases. WSJ says, “Valisure’s role in the Zantac and other consumer lawsuits deserves more scrutiny. Its report that the diabetes drug metformin contained high levels of NDMA also triggered a blizzard of lawsuits. Valisure made headlines again in recent months after reporting scary-high levels of the carcinogen benzene in sunscreens and dry shampoos.”

The FDA has sent Valisure an eight-page letter criticizing its data controls, equipment and failure to “establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods.” This should serve as a warning the next time Valisure, or any other laboratory, makes claims about the safety of any drug or chemical in common usage. The public should ask the question, “Cui Bono – who benefits?”

(Author’s note: Due to technical difficulties with the email server, subscribers stopped getting their regular blog posts by email on 11/11/22. Therefore, I am re-publishing those posts not received by the subscribers from then until Dec. 8 when the problem was corrected. My apologies to those who have been able to read these posts by going directly to my web site.)

There’s a new word being bandied about these days – the tri-epidemic. What does it mean? It refers to the three viruses plaguing our country at this time; Covid, Influenza, and Respiratory Syncytial Virus, or RSV. How did we get to this point? We’re still paying the price for the Covid pandemic and the way healthcare officials bungled its management.

Covid-19 remains a concern, especially if you are elderly and never got vaccinated, although the current strains of the virus are not as virulent. The number of Covid cases has been relatively stable for several weeks, with an average of 4,200 daily hospitalizations the week ending November 29, CDC data show. But for those who did get vaccinated, it represents only a modest concern unless you have significant co-morbidities such as diabetes, heart disease, lung disease, or obesity.

Influenza is rearing its head after a couple of years of lower than usual number of cases. A typical year of influenza produces 40,000 to 60,000 deaths, mostly in the elderly and immunocompromised. Some years are much worse. But during the worst of the Covid pandemic, the number of influenza cases dropped significantly, perhaps because of the mitigation efforts imposed to prevent Covid, or perhaps because many cases were undiagnosed because of the focus on Covid.

The newest virus of concern is RSV because of its heavy predilection in infants and the elderly. Brianna Abbott, writing in The Wall Street Journal, says pediatric hospitals have been strained for weeks by an early surge in common seasonal pathogens including RSV. Hospitalizations for RSV among kids under age five are outpacing those for Covid-19, according to the CDC. Public-health experts said the crush of patients is likely due in part to a larger pool of susceptible children compared with prior seasons, giving the virus more room to spread as people mingle indoors.

“We’re seeing really unprecedented levels of hospitalizations for this time of year, “said Fiona Havers, who is a lead official in tracking RSV at the CDC. The CDC estimates 6.2 million flu cases, 53,000 hospitalizations, and 2,900 deaths have occurred this season including 12 pediatric deaths. Flu-related hospitalizations are at the highest rate for this time of year in a decade, the CDC said. The agency started collecting data in a 14-state surveillance network starting in 2003 for children and 2005 for adults.

RSV hospitalizations are much lower, but there were 1.7 RSV-related hospitalizations for very 100,000 people for the week ended November 26 within the CDC’s 12-state RSV surveillance network, a drop from 4.8 hospitalizations per 100,000 two weeks ago. The CDC said the decline is likely due to a reporting lag because of the high surge volume and the Thanksgiving holiday. There are other signs RSV cases might have peaked in parts of the U.S., including a decline in reported cases from some labs, but Dr. Havers said that it is too early to say whether the virus is in decline for the season.

In a tragic medical irony, the draconian lockdown measures instituted to prevent the very-low risk Covid-19 infections in infants and young children has now made them more susceptible to the higher-risk RSV infection. This is because these mitigation measures, including masking and distancing, appeared to have had a marked effect on the circulation of other viruses, suppressing their spread and throwing them off their seasonal pattern. That likely left lower levels of immunity in the population.

“It reflects the pool of children who hadn’t experienced their first RSV season,” said Maria Asuncion Mejias, a principal investigator in the Center for Vaccines and Immunity at the Research Institute at Nationwide Children’s Hospital. “They’re kind of catching up.” This doesn’t mean their immune systems got weaker; only that they weren’t exposed.

What should people do now to prevent infection with these viruses?

Health officials recommend that people stay updated on Covid-19 and flu shots, stay home if sick, frequently wash their hands, consider wearing masks if you are especially vulnerable, and get tested early.

There is no RSV vaccine, although several are currently in trials. Older adults and infants, especially those under 6 months old, are at the highest risk for severe infections with RSV, a common virus that nearly all children catch by their second birthday. Children and adults commonly get reinfected throughout their lives.

“Once you’re older than 6 months, the rate of severity declines significantly, even when it’s your first infection,” said Diego Hijano, a pediatric infectious disease specialist at St. Jude Children’s Research Hospital in Tennessee. “Your airway and your pulmonary development are in a better position to handle it.”

Good advice to heed for those parents with infants who are considering flying this Christmas season.

(Author’s note: Due to technical difficulties with the email server, subscribers stopped getting their regular blog posts by email on 11/11/22. Therefore, I am re-publishing those posts not received by the subscribers from then until Dec. 8 when the problem was corrected. My apologies to those who have been able to read these posts by going directly to my web site.)

The price of Chinese Communist Party rule is getting higher. As I write this post, the Chinese people are demonstrating in the streets in protest for the severe lockdowns imposed by the CCP in furtherance of an unrealistic zero Covid policy. But setting aside the protests of the people for the moment, how else has the CCP failed its people in their response to Covid?

Let’s look at the Chinese vaccination program. President Xi Jinping refused to offer his people access to Western-made mRNA Covid vaccines. Instead, he forced China’s 1.4 billion citizens to submit to vaccines made only in China. China’s homegrown vaccines – including Sinovac and Sinopharm – are much less effective against Covid than are the mRNA shots created by Pfizer-BioNTech and Moderna. Sinovac was much less effective initially against symptomatic Covid – only about 50% – compared with more than 90% effectiveness for both mRNA vaccines.

The Wall Street Journal editorial board says the comparison is even worse against serious disease, especially for the most vulnerable. A Brazil BMJ study of those over age 70 found that Sinovac was only 61% protective against death and 55% against hospitalization. That compares to upward of 90% protection against hospitalization for Moderna and Pfizer for seniors.

Another study published in The Lancet, found that Sinovac produces a much inferior memory T-cell response and neutralizing antibodies against the Omicron variant. The memory T-cell response is what protects people against severe illness as variants evolve.

The U.S. government has complained about the lack of vaccination by many Americans, but the Chinese response is worse. Tens of millions of China’s elderly still aren’t vaccinated, perhaps because word has spread that its vaccines are less effective. Some countries also refused to recognize Sinovac as an accepted vaccine, and have suggested that those who received the Chinese shot consider getting an mRNA booster. Naturally, this repressive Chinese government responded with propaganda casting doubt on the safety of the Pfizer shots while boosting homegrown vaccines. In January 2021, as Chinese vaccines were distributed to other countries, the CCP mouthpiece Global Times ran news stories and editorials suggesting that Western vaccines were killing people.

Taking it another step farther, the CCP announced in March, 2021, that the Chinese border would be open to foreigners who received the Sinovac shots, but not for those getting the Western vaccines. They also spread rumors in Hong Kong, where both Chinese and Western vaccines were available, that the Western shots were not safe.

It seems that President Xi’s policy is to promote Chinese nationalism at the expense of the Chinese people. WSJ editors say, “Central to Mr. Xi’s aggressive nationalism is selling the Chinese public on the superiority of China’s political system. China’s leaders may have felt they couldn’t accept Western vaccines lest they concede that the county still trails the West in some areas.”

The editors also suspect the Chinese believed they could steal the mRNA technology, which they have managed to do successfully in other businesses including defense industries. When Moderna sought to sell its vaccine in China, Beijing tried to extort the U.S. biotech leader by demanding it hand over its intellectual property, according to a Financial Times report last month. Moderna wisely declined.

Germany’s chief government spokesperson, Steffen Hebestreit, recently suggested China revisit its rejection of foreign mRNA vaccines. “Perhaps after three years of the pandemic, it must be said that Europe and Germany have had very good experience with administering mRNA vaccinations,” said Mr. Hebestreit. But to do so, the Chinese would have to admit their mistake. It seems they would rather continue to endanger the world – and especially their own people.