The 10-page plan, which Vanity Fair has obtained, would enable the U.S. to finally do what many other countries had already done: Put rapid at-home COVID-19 testing into the hands of average citizens, allowing them to screen themselves in real time and thereby help reduce transmission. The plan called for an estimated 732 million tests per month, a number that would require a major ramp-up of manufacturing capacity. It also recommended, right on the first page, a nationwide “Testing Surge to Prevent Holiday COVID Surge.”
The antigen tests at the center of the plan can detect the virus when patients are at their most contagious.
Three days after the meeting, on October 25, the COVID-19 testing experts—who hailed from the Harvard T.H. Chan School of Public Health, the Rockefeller Foundation, the COVID Collaborative, and several other organizations—received a back channel communication from a White House official. Their big, bold idea for free home tests for all Americans to avoid a holiday surge, they were told, was dead. That day, the administration instead announced an initiative to move rapid home tests more swiftly through the FDA’s regulatory approval process.
The rapid-test push, in particular, seems to have bumped up against the peculiar challenges of fighting COVID-19 in the 21st-century United States. Difficulties include a regulatory gauntlet intent on vetting devices for exquisite sensitivity, rather than public-health utility; a medical fiefdom in which doctors tend to view patient test results as theirs alone to convey; and a policy suspicion, however inchoate, that too many rapid tests might somehow signal to wary Americans that they could test their way through the pandemic and skip vaccinations altogether. “It’s undeniable that [the administration] took a vaccine-only approach,” said Dr. Michael Mina, a vocal advocate for rapid testing who attended the October White House meeting. The U.S. government “didn’t support the notion of testing as a proper mitigation tool.”
President Biden, before departing on Marine Force One, Monday:
Q President Biden, why did your administration reject the holiday testing surge in October? Does the buck stop with you there — rejecting the surge?
THE PRESIDENT: We didn’t reject it.
We’re left with the same feeling after President Biden insisted no military adviser recommended to him to keep 2,500 troops in Afghanistan, after U.S. Central Command General Frank McKenzie and Chairman of the Joint Chiefs General Mark Milley told Congress under oath they had recommended that action. Or Biden’s claim that he himself had predicted that the Afghan government would collapse by the end of the year. Or Biden’s claim that his late son Beau served in the U.S. Navy in landlocked Afghanistan, or his claim to have been opposed to the war in Afghanistan from the beginning. Or the number of times Biden stated that vaccinated individuals cannot spread Covid-19, or that “you’re not going to get COVID if you have these vaccinations.”
Sure, maybe Biden is just lying when he says his administration didn’t reject a holiday testing surge. But what if the president genuinely doesn’t remember what he’s been told in briefings, conversations, and decisions?
Or in the case of the rejection of the massive expansion of testing, was this decision made without Joe Biden’s involvement?
It is hard to believe that Spring 2020 was almost two years ago. The empty grocery store shelves and panic buying of toilet paper, hand sanitizer and canned foods feels like both a lifetime ago and also just yesterday. Many actions of that season have had reverberating effects – namely, the panic buying and unparalleled demand for those products.
Hand sanitizer, something that we were told we needed to stay safe and healthy, flew off the shelves faster than major manufacturers could produce it. This led the Trump administration to relax certain regulations and issue emergency guidance to allow producers to ramp up production and help meet the record demand. This was a reasonable approach at the time, as we had severe shortages of hand sanitizer and many stores had none to sell; however, it also led to lax practices in refilling, distributing and labeling hand sanitizers, and even dangerous and harmful products ending up in the hands of Americans. Now that we are almost on the other side of the pandemic, and businesses have their doors back open, the FDA needs to issue guidance on bulk distribution of hand sanitizer, to protect American citizens who are still relying on hand sanitizer for some measure of safety. 0:00 / 48:556 seconds…
Just this month, hand sanitizer manufacturer ArtNaturals had to recall hand sanitizer due to high amounts of “benzene, acetaldehyde and acetal contaminants,” and these are products that are being used on college campuses and in businesses.
Terrifyingly, benzene is linked to blood cancers, including leukemia, and is considered a high-risk carcinogen, and it is being given to Americans, unbeknownst to them. Many businesses purchased hand sanitizer in bulk — in gallon jugs — and then used it to refill existing branded hand sanitizer dispensers. The branded hand sanitizer was effective and safe, but in many instances the bulk sanitizer used to refill the branded dispensers was neither safe, nor effective.
The businesses who did this were not guilty of bad intent. But the effect was nonetheless harmful to the public, as they thought they were protecting themselves and reducing risk to themselves and others when, in fact, they were doing nothing to combat the virus, and even making themselves more at risk for other, more dangerous diseases like cancer.
As Americans are back out in the world and our economy begins to ramp back up, both students and consumers need to know that the hand sanitizer they are using at businesses they visit is effective and won’t put them at risk for other diseases. Ads by
Hopefully, we are overcoming the pandemic, and the crisis will soon be in our past. But hand sanitizer isn’t merely useful in combatting COVID-19. The common cold and the flu can be combatted with effective hand hygiene that includes reliable hand sanitizer. The flu season is coming and having access to safe and effective hand sanitizer is important, even if the risk of COVID-19 is decreasing.
Studies have shown that to effectively kill germs and viruses, the alcohol content needs to be at least 60 percent. Generally, more is better. Some have said that it shouldn’t be less than 70 percent. But there can be no doubt or disagreement that hand sanitizer should not contain known carcinogens at such high levels that their use is actually harmful and exposes people to an increased risk of cancer.
So, the FDA was correct to withdraw the emergency guidance and return to the previous and well-established standards, but the FDA now also must make sure that schools, retailers, restaurants, healthcare facilities, and other frontline businesses are providing safe and effective products, that includes advising against the practice of topping off refillable dispensers with dangerous, mislabeled and ineffective products.
Current science suggests that COVID-19, like the flu, will not be completely eradicated. Thus, we will have to mitigate their impact and harm. U.S. business owners have been through so much, and they fought to stay open, with the hope that they will have the necessary tools to keep their patrons safe. One effective way is through proper hand hygiene, which clearly includes having access to effective and safe hand sanitizer.
In 2007, it was discovered that the People’s Republic of China was shipping children’s toys to America (and other nations) that were painted with lead paint — a poison that can cause severe health consequences — including death. As the scandal expanded, it was learned that it wasn’t just children’s toys that were tainted. A wide variety of products from the PRC — such as pet food, toothpaste, lipstick, and even certain types of food for human consumption — were tainted with various poisons.
China has also poisoned America’s pets. In 2007, the FDA investigated pet food that was believed to have killed dogs and cats, not only in the U.S. but in Canada and Europe, and around the globe. It turned out that Chinese manufacturers secretly added melamine which in nutrition testing looks like protein so that they could claim that their pet food had higher protein content. But melamine isn’t a protein, it simply appears in tests as if it were protein. And in high concentrations melamine apparently can cause organ failure and death. More than 60 million packages of pet food were recalled.
Of course, the Chinese government denied any wrongdoing — just as they did in 2020 with the COVID-19 virus. The totalitarian regime lied about it and blamed others and never accepted any responsibility for the harm that they had done. That’s how dictators and autocrats roll.
Given this history, you’d think that FDA would be on alert for products with potential links to China that could put the health of Americans, especially children, at risk. Unfortunately, a recent congressional report concluded that the FDA has been asleep at the wheel. The report saidthat baby food companies “may be adding ingredients that have high levels of toxic heavy metals into their products, such as vitamin/mineral pre-mix.”
Most people don’t know that in 2019 alone, China produced nearly 350,000 tons of vitamins, which accounted for 77 percent of the total global output.China is also the big player when it comes to sourcing ingredients and raw materials for the global dietary supplement industry. But the country also has a severe problem with soil pollution, which means that its agricultural sector that produces the raw materials for vitamins and dietary supplements and food in general is systematically tainted. Experts say that at least one-sixth of China’s farmland is heavily or severely polluted with heavy metals.
Is anything coming from China safe? China has proven itself over and over to be willing to compromise the health and interests of consumers for its own gain. Even its electronics often contain backdoors that give the PRC access to private information. Most nations would make sure that the products it exports are safe. But the Chinese regime clearly doesn’t care. If it is caught it denies any wrongdoing and often shifts the blame — just as we saw them do last year.
The bottom line is that China cannot be trusted. The PRC doesn’t even care about keeping its own children safe from contaminated baby food. The FDA needs to treat everything that comes from China with suspicion. The U.S. government must realize that everything in China is done to advantage the PRC and the communist regime. We simply cannot trust in their goodwill.
Hopefully, the Biden Administration will not turn a blind eye to the very real and very serious risks posed by China. It simply will not do to dismiss China’s horrific record as a matter of “different norms.” And it is not acceptable to downplay the threat that China poses by telling Americans “they’re not bad folks.” The evidence is overwhelming and America must wake up and protect itself — its children, its babies, its dogs, and cats. We must see the PRC for what it is.
One of the problems in health care today is that it turns Oscar Wilde’s quip on its head: In the United States, everyone knows the value of health care, but nobody knows the price of anything (because most spending is covered by insurance or by federal programs such as Medicare).
Pricing information is crucial in any system, because when people know what price they’re paying for a good or service, they can make informed decisions. Also, prices tend to come down over time as people demand better service at lower prices.
However, unlike Walmart or Amazon.com, the federal government isn’t especially good at negotiating lower prices. And now, crony health care interests are fighting to eliminate one of Medicare’s few pricing successes.
The issue involves prescription medicines. Since Medicare Part D was put into place to cover prescription drugs, generic and biosimilar medicines have usually been added to the program as soon as the FDA approved them. That’s given seniors access to safe, effective drugs at a much lower cost. In 2018, for example, generic drugs saved consumers almost $300 billion, with $90 billion of that going to Medicare recipients.
Sadly, though, they could have saved much more. In 2016, the Obama administration changed Medicare policy so that many generics would be priced in the same band as name brand drugs. That’s increased prices for seniors by more than $6 billion.
A good chunk of that money flowed to Pharmacy Benefit Managers (PBMs), which negotiate to get the generic meds priced in a higher band, then pocket “rebates” (kickbacks) from the big drug companies that make name brand drugs. Consumers, meanwhile, miss out on potential savings.
Under the Trump administration, the Center for Medicare & Medicaid Services (CMS) is finally taking steps to roll back the price increases. Next year, it wants to stop Medicare Part D plans from moving generic drugs into branded drug tiers. Instead, it plans to create a new tier reserved just for generics and biosimilars.
Many lawmakers support this sensible policy. “I am pleased to find that CMS is considering an ‘alternative’ policy,” Sen. Bill Cassidy of Louisiana wrote to HHS Secretary Alex Azar. “I applaud CMS for considering these cost-effective policies and urge the Agency to make them final for CY2020.”
Cassidy is a doctor and a leader in the fight for a more conservative approach to health care. He also joined fellow Republican Senators Steve Daines and James Lankford and Democrats Sherrod Brown and Robert Menendez in sponsoring an amendment to The Prescription Drug Pricing Reduction Act of 2019 that would have “ensured lower-cost generic drugs are placed on generic tiers and higher-cost brands stay on brand tiers.” They dropped that amendment for internal reasons, because Finance Committee Chairman Charles Grassley told them he’ll make certain the language makes it into the final bill.
Many other lawmakers are also pushing for the reform. “We encourage CMS to move forward with this policy effective CY2020 to lower out-of-pocket costs for millions of Americans, ensuring that they receive the full value of generic and biosimilar competition,” a bipartisan group of House lawmakers wrote to Azar. “Price competition is vital in the Part D program and beneficiaries deserve a choice at the pharmacy counter when possible.”
Seniors can thank these lawmakers, and should keep a sharp eye on Sen. Grassley. He has a chance to move forward in a bipartisan fashion with a plan that would save Medicare recipients money. That ought to be an easy sell in these divided times.
Conservatives are wary about expanding Medicare, of course. But we’re eager to use pricing power to improve the state of American health care. Let’s not allow PBMs to block this important step toward systemic reform.
It’s beginning to look like the Republicans have pretty much abandoned their promise to “repeal and replace” Obamacare. Considering they don’t have the votes to do it this does not come as a big surprise. If they want to remain in power though, they have to come up with something.
Fortunately, President Donald Trump is leading and may announce as soon as Thursday a plan to bring the cost of prescription drugs down using market forces rather than mandates. Working through Health and Human Services Secretary Alex Azar, the administration is expected to strongly endorse price competition though the formulary process (developing a list of approved drugs selected to provide the most value) as the key to controlling drug costs.
This is what the voters want. According to several recent polls controlling drug costs is one of the three or four issues most important to people deemed likely to vote in the next elections. Therefore, it’s fortunate good policy and good politics are intersect this way.
Even common-sense approaches to controlling costs — like moving prescription drugs from Medicare Part B to Medicare Part D to increase the government’s ability to negotiate on price — will face fierce opposition on Capitol Hill from drug makers (PhRMA spent $150 million in advertising in favor of Obamacare passage) and from those who believe a Bernie Sanders-style single payer approach is the only reform Congress should even think about enacting.
It’s up to House Speaker Paul Ryan and Senate Majority Leader Mitch McConnell whether they want to follow Mr. Trump’s lead and go further. They’ve been burned, badly, by their failure to “repeal and replace” and with their colleagues are reluctant to take up the issue again.
From a political standpoint, that would be an epic fail leading to serious consequences for the GOP’s congressional majority. Rather than wipe the slate clean, they can utilize now-proven concepts used by pharmacy benefits managers, or PBMs, to produce savings for consumers. Again, this is something the voters want.
No one has to go all in at first. Moving drugs to Medicare Part D as a demonstration project for certain therapeutic classes could be the first step toward future, system-wide reform if, as it is almost certain to do, it works.
On the formulary side, the idea of allowing approved plans to cover just one drug per category or class within Medicare’s protected classes rather than two would also increase the government’s bargaining power on behalf of patients. That could be a tough sell in a town where drug companies spend millions on lobbyists to make sure that profits stay high, but as part of a package of reforms coming out of HHS to lower drug prices and reduce out-of-pocket costs it would just be one of many changes producing cheaper health care without compromising quality or access.
The changes the administration is expected to make can be enacted quickly and efficiently. Costs will come down in the near term in a way meaningful to most consumers. In the long run there’s still much to be done.
Obamacare did not deliver on its promise: People lost the health care they liked, what they could get was more expensive, year by year, and the range of choices available to them contracted. The only way to fix that permanently, as health care experts Grace-Marie Arnett and Marie Fishpaw explained recently, is for Congress to take up a plan addressing three big goals: 1) lower costs and improve patient choices, 2) give states flexibility and resources to achieve these goals, and 3) set federal guardrails so people can choose private coverage if they don’t like the options their state provides.
As Ms. Arnett and Ms. Fishpaw put it, America needs health care reform that recognizes “what works in Massachusetts will not work in Mississippi or Missouri or Montana. What works in big cities will not work in rural areas. In response, we would provide states with greater flexibility and new resources to serve as stewards in returning freedom and choice over health decisions to patients.”
To get to that point, the GOP needs a bigger majority in the U.S. Senate and to hang on in the U.S. House of Representatives. Right now, the Republicans look to be losing seats in the House and probably the majority. That would be the end of real reform. A Democratic majority will define reform as an increase in the role for government and a taxpayer-funded bailout of insurance plans.
What Mr. Trump is supposedly getting ready to propose may not just save health care but may also save the Republican majority, which cannot get through the election without addressing the issue. Finding and supporting ways to cut the cost of prescription drugs may be, in the short run, the only option left.
Tobacco products are understandably a hot and controversial regulatory issue. But what is surprising is that vapor products, only some of which have a visual appearance similar to cigarettes, but all of which contain no tobacco and provide a much healthier and safer choice for smokers, seem to be attracting an even greater level of interest from federal regulators.
A final rule is under review by the Office of Management and Budget which would deem vapor products, like electronic cigarettes, to be subject to even more heavy duty FDA regulation than the rules to which traditional tobacco cigarettes are subjected. This makes no sense, and it is a huge loss for public health and is counter-productive to over-regulate a new, innovative product that satisfies adult consumers without subjecting them to the health risks of traditional burning tobacco. Continue reading