Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Sunday, May 22, 2022

Infant Formula Shortage Fuels Disbelief, Anger

Just when you thought America had run out of crises, the infant formula shortage burst into the headlines. Outraged mothers discovered empty shelves. Exasperated parents drove hundreds of miles to neighboring states in search of formula.  This is a scene out of Venezuela or Burundi.  

How can the wealthiest, most advanced country on earth run out of baby formula?  The answer to that question is prompting political finger pointing, capitalism bashing and administration spin doctoring. None of this is putting infant formula on store shelves for desperate parents. 

To make matters worse the media has ginned up fear with its often uninformed reporting.  The complex situation requires more than a 30-second sound bite or an online click-bait headline with few facts. A crisis of this urgency demands vetted information which helps Americans understand the issues.

As usual, the Biden Administration was slow to react to the shortage. In February, the administration certainly knew there was the likelihood that the supply would be crippled when the Food and Drug Administration shut down the formula plant of the nation's largest producer,  Abbott Laboratories. 

The FDA halted production after several babies who had consumed the formula manufactured at the Sturgis, Michigan, factory fell ill. Two died.  The FDA made the right call. That's the FDA's job.  But the agency and, surely, the administration understood the impact on the supplies of infant formula.

The Sturgis plant is where Abbott manufactures all its formula. The firm has a facility in Ohio, but it makes other products.  It is now shifting some formula production to the Ohio facility.  But closing the Sturgis plant created a 40% shortage in formula.  The FDA knew its action would trigger a shortage. 

In fact, the problems at Sturgis, we now know, surfaced last September during the FDA's routine inspection.  Agency inspections were scrapped during COVID.  After a whistleblower came forward, the FDA returned to the plant on January 31. Inspectors knew there were problems at the plant.

But it took the FDA until February 17 to order the plant closed. Abbott has contended there "is no conclusive evidence to link Abbott's formulas to these infant illnesses." Reuters reports the FDA and CDC "have not disclosed any information that connects the illnesses to the plant." 

The FDA is green lighting the restarting of production at Sturgis, but it will be months before formula reaches store shelves. After reopening the plant, Abbott estimates it will take anywhere from six to eight weeks before the first shipments are delivered to stores.   

A few fair questions: Why didn't the administration alert the public in February?  Why didn't the FDA work with the formula industry to increase production immediately?  Why wasn't the government contacting suppliers in Europe with requests to ramp up production and expedite shipping to the U.S.?

The administration dithered until the formula crisis reached a national emergency.  Belatedly, the president on May 18 announced a plan to airlift formula from overseas producers, using military aircraft.  They administration calls it "Operation Fly Formula."  Let's hope it's more than a catchy name.

But wait until consumers find out formula from overseas producers is subject to U.S. tariffs of up to 17.5%. Prices of formula will rise.  Also, the FDA labeling and ingredient requirements for formula will exclude some overseas products from being imported.  Don't expect stores to have full shelves soon. 

Democrats are planning to hold Congressional hearings as if this will solve the problem. Hectoring CEO's and slamming capitalism is right out of the Democrat playbook. The FDA should be the agency under scrutiny. Hearings are always great television for puffed up politicians, but achieve little.  

It will be interesting to see if Democrats raise a thorny issue no one wants to talk about.  The largest purchaser of formula in the U.S. is the federal government.  Not consumers in grocery stores. Your tax dollars fund a Department of Agriculture program known by its acronym WIC. 

WIC provides nutrition for low-income, nutritionally at risk, mothers of infants. Abbott and Mead Johnson supply 90% of the infant formula for WIC.  The federal government opted to use sole-source contracting in states, which manage distribution of formula for WIC beneficiaries. 

Charges of gouging by Abbott and Mead Johnson are lies.  The firms actually lose money on formula they sell through WIC because the lowest bidder wins the state contract.  The formula producers receive about 20 times as much revenue from each can of formula sold to a non-WIC consumer.

So let's make this clear.  Taxpayers fund WIC.  If those taxpayers are ordinary moms who shop at a pharmacy or grocery store, they are also subsiding WIC recipients because they pay more for each can of formula to keep the producers in business.  This is a political hot potato for Congress. 

The truth is the federal government has contributed to ensuring only a handful of  companies will control most of the U.S. infant formula market. Fully 98% of the formula sold domestically is made in the U.S. Tariffs and FDA regulations restrict overseas competition.  So who created this "monopoly"? 

Abbott holds a 43% share of the formula market. The other dominant players are Mead Johnson, Nestle and Perrigo.  There are few companies in the formula business  because of the high barrier to entry.  Building and staffing a formula plant represents a multi-million dollar investment. 

The formula business is shrinking, particularly in the U.S. Birth rates are falling and the demand for formula is slowing.  Worldwide sales reached $3.65 billion in 2019.  That is another reason more firms are not rushing into formula production. It is a small line of business and marginally profitable.

In the midst of this crisis, Congresswoman Kat Cammarck blew the whistle on the stockpiling of baby formula at the border for illegal immigrants. The disclosure stoked more consumer anger.  Biden's protector, The New York Times, labeled the concern "faux outrage." But was the information true?

While the Times awarded the congresswoman four Pinocchios, it admitted that a 2015 Customs and Border Protection document ordered : "Food must be appropriate for at-risk detainees age and capabilities (such as formula and baby food.") The phrase in parenthesis is in the newspaper's report. 

It turns out infant formula is indeed stocked in warehouses for illegal immigrants at Border Patrol stations.  So why the four Pinocchios? Isn't it obvious?  The Times propaganda mission is to deflect criticism from the administration and tar those who dare point out the truth. 

It begs the question: Why didn't the administration help relieve the shortage months ago  by sending some of the formula stocked in warehouses to stores? 

Biden' surrogates complain the president is not to blame for this situation. Poor Joe. Presidents often get credit for things they can't influence as well as blame for others.  But, aren't the FDA and the Department of Agriculture part of the government Biden runs? Rhetorical question. 

The administration's pity party is well...pitiful.  American moms do not give a a baby poo about who's to blame.  They expect the federal government to fix it.  And immediately.  Is that too much to ask of a government that spends trillions of dollars in taxpayer funds every year? 

Monday, December 13, 2021

President Biden's Failed Attempts To Tame COVID

Omicron.  No one can pronounce the word correctly, but it has an ominous ring. Even President Biden stumbled over the pronunciation. The name conjures a villain in a Marvel graphic novel. Turns out Omicron is the 15th letter in the Greek alphabet and the label for the newest COVID variant.     

When the World Health Organization (WHO) announced the moniker for the Coronavirus variant, the American media incited an epidemic of news hysteria. Their scaremongering reporting included the fact the variant first appeared on the Dark Continent of Africa.  That had to be a grim sign for the world.

President Biden immediately shut down air travel between the U.S. and South Africa and other countries in the region, triggering a pandemic of fear.  Dr. Anthony Fauci supported the decision, saying it was "better to be safe than sorry."  CNN, MSNBC and network news dolts stirred a caldron of anxiety.

United Nations Secretary General Antonio Guterres was not amused. He described the widespread travel bans on southern African countries as "unacceptable," and likened the restrictions to Apartheid. Remember when President Trump was labeled a xenophobic for his China travel ban?  

Question: Does the African travel ban make President Biden a racist?  

The administration that charms the elitist media by bragging it follows science, apparently did not bother to call the medical experts in South Africa.  The South African Medical Research Council had data that showed Omicron may be less severe than the earlier COVID strains, including Delta.

In fact,  Dr. Angelique Coetzee, a practicing physician and head of the South African Medical Research Council, reported most patients displayed mild symptoms and did not require hospital care. Researchers found even hospitalized patients did not require oxygen and had no respiratory symptoms.

The latest WHO weekly update reported zero deaths worldwide from individuals who tested positive for Omicron.  The CDC reported 43 cases in the U.S. as of December 11. Nearly 80% of those infected with Omicron were fully vaccinated, and one-third had received a booster short, according to the CDC.

Despite the science, President Biden seized the news about Omicron to impose new testing rules for international travelers, extend the transportation mask mandate and announce his administration will launch hundreds of vaccination clinics and distribute millions of free home tests. 

The frenzied, hair trigger response reflects Mr. Biden's realization that Americans believe he has failed to deliver on promises to tame COVID. He has awoken to the reality that his political fortunes and those of his fellow Democrats are tied to the administration's disastrous results on stemming the virus.

During the 2020 election, candidate Biden wailed that 225,000 deaths under President Trump made him unfit to lead the nation. Under Biden, there have been 406,000 deaths to date, far eclipsing the toll of 386,000 in 2020. As a result, there is no normal.  Just more of the same, tired solutions.

The administration's default strategy with each new variant is to use the one-size fits all approach to strangle the spread of the virus. Vaccination mandates.  Mask requirements.  More tests.  Shame the unvaccinated. None of it has worked based on the data.  Cases are rising. Deaths are continuing.   

Moreover, courts have dealt a body blow to Biden's onerous vaccination mandates. The administration's ill advised, constitutional overreach has been rebuked by five federal courts, leaving the centerpiece of his vaccine plan in tatters. He has succeeded only in further politicizing the virus.

Meanwhile, the administration has quietly reversed itself by allowing federal employees who were not vaccinated by the November 22 deadline to continue on the job.  This occurred at the same time Mr. Biden was punishing private employees with his mandate.  What science was he following?  

On September 1, days before Mr. Biden issued his stringent mandates, 52.6% of Americans were fully vaccinated. As of December 10, the number had climbed to 60.4%.  The administration takes credit for the rise, but Kaiser Family Foundation reports the momentum had already shifted months earlier.

Real world experiences apparently do not count as "science" in guiding Mr. Biden's vaccination obsession. France has one of the highest immunization rates in Europe: 76.8% of the population are fully vaccinated. Yet the virus cases are rising, prompting officials to enforce strict restrictions.

Does the virus only end when 100% of the population is vaccinated? Or do vaccinations and boosters lose potency faster than expected? Following the Biden doctrine to its illogical conclusion, no one is safe as long as one person remains unvaccinated.  This is not common sense, much less science.

Scapegoating the unvaccinated is a favorite weapon of Dr. Fauci and his ideological disciples.  But scientific data offers a more nuanced picture.  The Virginia Department of Health released figures on the rate of viral infections from January 17 through December 4 of this year.

According to state data, which is more reliable than CDC numbers, here are the rates of infection per 100,000 Virginians: Vaccinated: 1,212; Partially Vaccinated 2,336; and Unvaccinated 5,228.  There is no disputing the unvaccinated are more likely to contract the virus. The data proves it. 

But remember the figures include the early part of this year when few were vaccinated. Viewed another way, the unvaccinated are 2.2 times more likely than the vaccinated and partially vaccinated to be infected, which is lower than previous reports when vaccination rates were below 30%.    

After almost two years of pandemic histrionics, Americans are weary of masking, insolation, and restrictions on travel. Normalcy appears to be a a faint glow in a galaxy far, far away. To make matters worse, the federal government and its agencies have not been transparent. 

One example: More than 30 American academics, professors and scientists requested data about the information submitted to the FDA by Pfizer for further study. The agency's response was appalling. The FDA  asked a federal judge to wait until the year 2076 to release Pfizer's vaccine data.

This is the scientific research the FDA relied upon to license the drug firm's vaccine. Why is the FDA so hesitant?  Is the administration's shielding Pfizer from liability?  Americans deserve an answer now, especially in light of Dr. Fauci's statements about the need for more Big Pharma booster shots.  

Perhaps, the answer lies in a massive study conducted in Israel late this year. The findings concluded that immunity against the potent Delta variant waned in all vaccinated  groups only a few months after receipt of the second dose of the Pfizer vaccine. Was the FDA forewarned?  We may never know.  

Another example is the refusal of most in the scientific community to recognize the immunity conferred upon people who recovered from confirmed cases of COVID.  Once the vaccine mandate was in place, the science was rejected because of worries if word seeped out, people might not get vaccinated.  

There have been three studies that show patients with confirmed cases of COVID develop natural immunities to the virus more powerful than the vaccinated. Research at Rockefeller University discovered recovered patients developed increasing antibodies for up to one year.

This finding matters because many of the unvaccinated, including police and medical workers, who had recovered from COVID, requested to be exempted from Biden's oppressive mandate.  They were turned down.  What science was relied upon in making this decision?  That is a rhetorical question. 

Even more concerning, the administration keeps repeating its same plan to stop COVID, hoping for a different outcome.  In the face of the spread of Omicron, the health experts on Team Biden are working with Big Pharma to produce yet another booster vaccine, this one targeting the new variant.

Israel, the global leader in COVID research and study, is taking a different approach. The Israel Institute for Biological Research is shepherding the development of a new vaccine based on a platform used by Merck & Co. for its Ebola vaccine, which has proven both safe and effective.

What's different about this vaccine is that it binds to the exact cell in the lung that is targeted by the virus.  Lab tests show the vaccine antibodies retain their potency against four of the most serious variants, including Delta.  More testing is needed, but at least the Israelis are searching for new solutions.

Don't expect creative ideas from the Biden Administration. Business lockdowns, school closures, more boosters, masking and unconstitutional mandates are in favor because the administration and its allies in Democrat states crave the authoritarian power a health crisis offers. 

In the latest pronouncement from his perch on high, Dr. Fauci rhapsodized on the subject of Christmas gatherings.  The doctor lectured that it is perfectly fine to gather indoors with vaccinated relatives.  But be forewarned that any unvaccinated guests, including children, pose a health risk.

This is Orwellian.  A government scientist is pontificating on the appropriate guest list for Christmas?  Freedom to associate with family is in danger as long as Dr. Fauci and Biden are in charge. Be honest. Did you ever think the government would weigh in on your Christmas gathering?

More Americans are growing disgruntled by the day with Biden's approach.  Polls find Bidens's approval rating for handling the virus has plunged 20 points since his inauguration.  Americans want normal. The administration appears to prefer prolonging the agony to extend its authority.  

President Biden should admit failure and reboot his COVID strategy. New variants are on the way.  Team Biden needs a dose of reality, based on years of science which reveals some viruses never completely disappear.  Once Mr. Biden accepts that, perhaps common sense solutions might prevail.