AN EXAMPLE OF HOW THE US HAS MIS-HANDLED A NATIONAL PANDEMIC


…Dr. Rick Bright, Director of the Biomedical Advanced Research and Development Authority, or “­BARDA”

Well before the Coronavirus attack, the US had allowed 90% of US medical supply production to leave the country.

The following story will demonstrate why the current administration under President Trump is not qualified to manage the nation through dealing with the Covid-19 pandemic:

Over twenty years ago, in the 1990’s, Mr. Michael Bowen was a new product specialist at a plant called Tecnol Medical Products in Texas.  The plant was part of a supply operation that produced 9 of 10 medical and surgical masks used in the United States.  

But also in the 1990's, many US companies were involved in industry consolidations and outsourcing was beginning to shift control of the medical mask plant from Tecnol Medical Products to Kimberly-Clark.  And some time after that, the plant was shut down altogether.

According to government reports, in less than a decade, 90% of all US medical supply production had moved out of the country.

Then, in the wake of the terrorist attacks of Sept. 11, 2001, Congress appropriated $6 billion to buy antidotes to bioweapons and the medical supplies the country would need in public health disasters.  An obscure new government organization called the Biomedical Advanced Research and Development Authority, or ­BARDA was formed.  This operation was among the agencies purchasing material for what would become known as the Strategic National Stockpile.

Bowen and a Mr. Dan Reese, a former executive at Tecnol, went into business together in 2005 and bought the plant that they re-named: Prestige AmeritechThey believed at the time that a market remained for a dedicated domestic manufacturer of protective medical gear.

Within BARDA, Bowen was looking for a real contract person. The government had said they would pay a premium to have masks manufactured domestically, so Bowen’s company decided to keep its extra factory lines in working order, meaning production could be ramped up in an emergency.

Bowen said he soon concluded that unfortunately, BARDA’s focus was directed elsewhere, on billion-dollar deals to induce manufacturing of vaccines for the most exotic disasters, such as weaponized attacks with anthrax or smallpox.  Still, as Bowen moved down the supply chain, appealing directly to hospitals to buy his domestic-made masks, his sales pitch often ended with a plea for potential customers to call BARDA and suggest they contact Bowen's company for domestic manufactured masks.

As a sales tool, Bowen also often carried with him, a 2007 PowerPoint presentation from BARDA and from the Office of the Assistant Secretary for Preparedness and Response.  One slide in the presentation had a table showing that, in the event of a pandemic, the country would need 5.3 billion N95 masks, 50 times more than the number in the national stockpile.  The presentation concluded: “Industrial surge capacity of [respiratory protection devices] will not be able to meet need and supplies will be short during a pandemic.” 

Bowen said he felt like a voice in the wilderness.  He said,  The world just looked at me as a medical mask salesman who was like, ‘chicken-little, saying the sky was falling’, and the customers would say, ‘Your competitors aren’t saying that in China.’ ”

But after Trump’s election, Bowen had hoped the new president’s ‘America-First’ mentality might trickle down to operations like his. He wrote a letter to Trump and addressed it to 1600 Pennsylvania Avenue: “90% of the United States protective mask supply is currently FOREIGN MADE!” it began.  “I didn’t think Trump would read it, but I thought someone would and possibly take note,” Bowen said.

Bowen also called Dr. Rick Bright, who had been appointed to lead BARDA just before Trump took office. “In 14 years of doing this, there have been maybe four people in government who I felt like really understood this issue,” Bowen said. “Rick was one of them.”

In Trump’s first year, Bowen grew very disillusioned. During a week when the White House touted its “Buy American, Hire American” initiative, Bowen had lost a military contract worth up to $1 million to a supplier that would make the masks in Mexico.

Shame on the Department of Defense! One of these days the US military will need America’s manufacturers to help win another war or fight another pandemic — and they will not exist,” Bowen wrote on Aug. 17, 2017, to Maj. Gen. Jeffrey Clark, a senior official with the Pentagon’s Defense Health Agency.

Clark, who retired last year, did not respond to a recent message seeking his comment.

Factory equipment that could produce a quarter-million N95 respirator masks a day sat idle at Prestige Ameritech’s factory outside Fort Worth. As expected, their proposal to produce in the US went nowhere

For Bowen, the first signs of trouble came just this January.

Bowen’s online orders through his company’s website, had typically, up until then, totaled approximately $2,000 a year.  It only accounted for a fraction of his business.  But suddenly it skyrocketed to almost $700,000 in just a few days.

On Jan. 20, Bowen also fielded a call from the Department of Homeland Security (DHS), urgently seeking thousands of masks for US airport screeners.  Bowen said he did not have enough masks in stock to fill the order, but the call led him to contact Dr. Bright to tell him about the surge in demand for masks. “Is this virus going to be problematic?” Bowen wrote.

Inside HHS, Bright quickly passed Bowen’s on-the-ground observations to a group that included Laura Wolf, the director of the HHS agency’s Division of Critical Infrastructure Protection.

“Can you please reach out to Mike Bowen at Prestige Ameritech? He is a great partner and a really good source for helpful information,” Bright wrote on Jan. 21.

“Thanks Rick,” she replied. “We are tracking and have begun to coordinate with the Food and Drug Administration (FDA) and the National Institute for Occupational Safety (NIOSH)  and all the medical manufacturers today. More to follow tomorrow. Thinking about masks, gowns (inc those in shortage), gloves, and eye protection.”

Within a day, Bowen sent an email to Ms. Wolf, laying out what Prestige could do. “The company’s four mothballed manufacturing lines could be restarted with large non-cancelable orders.  This is NOT something we would ever wish to do and have NO plans to do it on our own,” he wrote. “I’m simply letting you know that in a dire situation, it could be done.”

Over the next three days, Bowen kept HHS officials informed as orders for a million masks came in from buyers in China and Hong Kong.  On Jan. 26, he sent the email warning that the US mask supply was at “imminent risk.”

Bright forwarded it that day to Dr. Robert Kadlec the Assistant Secretary for Preparedness and Response (ASPR) and others, urging action: “We have been watching and receiving warnings on this for weeks,” he wrote.

The next day, Bright wrote to his deputy asking him to explore whether BARDA could divert money earmarked for vaccines and other bio-defense measures to instead buy masks.  The Senior US official said the idea was considered, but funding could not easily be obtained without diverting it from other projects.

From his end, Bowen said his proposal to divert funding seemed to be going nowhere. “No one at HHS ever did get back to me,” Bowen said.

Bowen started talking to reporters about the mask shortage in general terms. He was soon invited to appear on former Trump adviser, Stephen Bannon’s podcast: “War Room: Pandemic.”

On that Feb. 12 podcast, the two commiserated over the beleaguered state of US manufacturing. “What I’ve been saying since 2007 is, ‘Guys, I’m warning you, here’s what is going to happen, let’s prepare,’ ” Bowen said on the program. “Because if you call me after it starts, I can’t help everybody.”

Bowen said Bannon then put him in touch with Dr. Peter Navarro, the Director of the Office of Trade and Manufacturing Policy (OTMP), he was also the White House economic adviser.

Dr. Navarro was quick to see the problem, Bowen said.  After talking with Bowen, he wrote to Bright that he should soon expect a call from the White House. “I’m pretty sure that my mask supply message will be heard by President Trump this week,” Bowen wrote. “Trump insider reading yesterday’s Wired.com article, the ball is screaming toward your court.”

According to Bright, he soon began attending White House meetings and was helping Dr. Navarro write memos describing the supply of masks as a top issue. Emails and memos show Bright reporting back to Kadlec and others about his work with Dr. Navarro. 

Unfortunately, still, nothing happened and none of this turned the tide for Bowen and his company

Nearly a month after his e-mailed offer, Bowen received his first formal communication about possibly helping to bolster the US supply. The five-page form letter from the Food and Drug Administration (FDA), the one Bowen said he suspected was also sent to many other manufacturers.  He then asked how his company could help with what was by then a “national emergency response” to the shortage of protective gear.

Bowen, then on Feb. 16, fired off a terse email to FDA and HHS officials.  He directed the agencies to a US government website listing approved foreign manufacturers of medical masks. “There you’ll find a long list of approved Chinese respirator mask companies,” he wrote. “Please send your long list of questions to them.”

In March, Bowen submitted a bid to supply masks to the Federal Emergency Management Agency (FEMA), which by then had taken over medical supply purchasing.

The government soon spent over $600 million on contracts involving masks. Big companies like Honeywell and 3M were each awarded contracts totaling over $170 million for protective gear. One distributor of tactical gear (a company with no history of procuring medical equipment ) was still awarded a $55 million deal to provide masks for as much as $5.50 each.  That is eight times what the government was paying just months earlier.

On April 7, FEMA finally awarded Bowen's Prestige Ameritech a $9.5 million contract to provide a million N95 masks a month for one year, an order the company could fulfill without activating its still dormant manufacturing lines. For those masks, Prestige only charged the US government, 79 cents apiece.

The aforementioned information is the story from a US company that had warned Trump's White House back in 2017 that the US was not prepared to deal with a medical pandemic, especially if vast amounts of medical supplies and equipment were required, as they are today.  It wasn’t until the pandemic had been going for months that this American manufacturer was recognized with a purchase order for American made masks and medical supplies.  And the US manufacturer wasn’t charging as others did, 5 times the normal price for the emergency needs in the nation, of masks and other medical supplies.

Please note that in addition, the Trump  administration had early on disbanded the organization within the NSA that the Obama administration had developed for dealing with a possible pandemic.

Copyright G. Ater 2020  


Comments

Popular Posts