FDAReview.org

As the coronavirus pandemic continues to ravage the U.S. healthcare system, many healthcare professionals are struggling to find enough medical supplies to treat patients and to avoid becoming infected themselves. A recent New York Post article finds nurses working in a New York City hospital resorted to covering themselves with garbage bags because the hospital had run out of gowns. The nursing staff also ran out of medical masks and was forced to reuse disposable ones.

Not surprisingly, these makeshift solutions did not prevent these nurses from catching the coronavirus. One of them, an assistant nursing manager named Kious Kelly, recently passed away after becoming infected. Saddened and outraged, one nurse said, “Kious didn’t deserve this…The hospital should be held responsible. The hospital killed him.”

In mid-March a Palo Alto, California, woman’s COVID-19 worsened to pneumonia while being treated at Stanford Hospital. She had already suffered from asthma and diabetes.

In a trial, doctors decided to give her the drug remdesivir, which has been well established as safe and used to treat Ebola. It worked; she’s now home recovering wonderfully.

The outstanding question is: Is it helpful for COVID-19? The answer is: Yes, at least for some coronavirus victims.

So why not let the drug be given to all COVID-19 patients rather than just in trials, as was the case with the Palo Alto woman’s trial? They have everything to gain and nothing to lose. The drug sometimes cures pneumonia and possibly prevents it in the first place.

Governmental medical science, tragically, does not work this way. The Food and Drug Administration requires that, before a drug can be prescribed, it must clear three sets of clinical trials to prove that it is safe and effective; that usually takes a year.

COVID-19 patients usually have anywhere from a few days to a few weeks to live or die. Why can’t patients with the coronavirus take remdesivir to see if it helps?FDA approval for efficacy is largely pointless.

I learned of this sad FDA policy the hard way. I was on the board of the Abigail Alliance that sued the FDA when a terminal cancer patient was denied the right to experimental drugs even though the FDA had found the them clinically safe and promising.

Our argument was that if we have a constitutional right to defend ourselves against an attacker, why can’t we have that same right of self-defense when the attacker is cancer? I based this logic on my own wife’s experience: she had terminal lung cancer and was given an experimental drug that extended her life and eliminated her chronic pain.

Our case was heard in the D.C. Circuit Court of Appeals on August 7, 2007. We lost and would likely lose today because the FDA still mandates three clinical trials to prove drugs safe and effective.

Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases cites frequently the necessity of this three-clinical-trial process referring to any other drug cure of the coronavirus as merely “anecdotal.”

Judge Judith Rogers supported our case and pointed out a cruel irony: In rejecting our appeal to extend cancer patients’ lives, said the judge, “the right to try to save one’s life is left out in the cold despite its textual anchor in the right to life.”

Chief Judge Douglas Ginsburg also supported our case. He argued: Do we have a constitutional “right to eat meat” when the Constitution is silent on the matter?

It is silent on drugs, which does not mean that we can’t take them. It is a right we are given by the Ninth Amendment: “The enumeration in the Constitution, of certain rights, shall not be construed to deny or disparage others retained by the people.”

It is tragic that a patient with COVID-19 and pneumonia or difficulty breathing cannot be given the remdesivir, which is safe and, in some cases, effective.

It sent the Palo Alto woman home rather than to the morgue.

President Trump recently announced he is extending social distancing guidelines to April 30^th. He initially hoped to lift them by Easter. This is far from the first time he has changed his mind on how to best handle the coronavirus pandemic.

Although frustrating, the President’s indecisiveness is understandable. The United States recently surpassed China as the country with the most confirmed cases of COVID-19. Healthcare workers in many areas are overwhelmed, caring for infected patients. Public health experts continue to predict more infections and deaths in the near future.

At the beginning of March, less than 100 cases of COVID-19 and two casualties had been confirmed in the United States. Coronavirus had since infected over 10,000 Americans, with a death toll of over 200.

The coronavirus is spreading at an alarming rate. Many are taking drastic measures to slow it down. But despite thousands of grounded flights, countless businesses and schools closing, and widespread commitment to “social distancing,” public health experts worry it will not be enough. If current trends continue, our health care system will be overwhelmed with infected and dying patients.

As panic escalates, many are calling for more government control to manage the pandemic. And government officials have answered the call by passing draconian measures.

Italy’s government has placed nearly 16 million citizens on lockdown, arresting thousands for traveling without state permission. France has mobilized 100,000 policemen to enforce its mandated lockdowns. Spain is taking a similar approach and recently nationalized all of its hospitals. Chinese government officials are forcefully removingcitizens from their homes to be quarantined.

We might be next. Political figures have called for the government to shut down businesses, use the military to manage hospitals, and take control of “crucial factories and industry.” President Trump has taken a big first step in this direction by invoking the Defense Protection Act to force businesses to produce medical goods that are in short supply.

These efforts are well intended, but they have their limitations, to say the least.

Italy’s lockdowns haven’t demonstrated much success. Recent headlines indicate that Italy is unable to treat older infected patients, who face the highest risk of dying. Further, research conducted by the Imperial College COVID-19 Response Team in the U.K. finds that the most effective ways to mitigate the spread of coronavirus do not involve government restrictions.

Lockdowns and other heavy-handed measures also severely damage our economy. Robin Brooks, the chief economist of the Institute for International Finance, believes the U.S. response to the coronavirus outbreaks will decrease GDP by 3.6 percent in the coming months.

So what’s the alternative?

Instead of pushing for more severe restrictions on our lives, we should look to markets to battle the pandemic.

Previously considered one of the countries most affected by the coronavirus, South Korea is now one of the few places in the world where new cases are in sharp decline. And this has happened without citywide lockdowns.

South Korea’s success is due to innovation. As the virus spread through China, the biotechnology company Seegene began developing tests. The company’s entrepreneurship has led to over 230,000 tests. South Koreans are also able to use mobile apps to track newly reported cases and highly contagious areas. During the height of the outbreak, coronavirus-tracking apps received more than 20,000 downloads per minute.

Inexplicably, private efforts to test for the coronavirus in the U.S. wereprohibited without certification from the Food and Drug Administration and Centers for Disease Control, which often took months. Until recently, only a few commercial labs were able to test for the coronavirus.

Not only did onerous regulations create a shortage of tests, but they also likely made the outbreak worse. As the virus first spread from Washington state, federal regulators ordered a private laboratory in Seattle to stop testing—even after it had submitted information indicating the virus was spreading. Washington state remains one of the hardest-hit parts of the country.

Thankfully, the FDA has since granted private laboratories the freedom to test for coronavirus. Testing has increased dramatically ever since. Popular retailers like Target, Walgreens, and CVS-Health are opening space for laboratories to make tests available to a concerned public.

The race is on to get medical supplies to struggling patients as COVID-19 continues to get worse. In repeated press conferences, the Trump administration has promised the continued, large-scale manufacture and delivery of products such as masks, gloves, and coronavirus tests. While President Trump rightly refuses to invoke the Defense Production Act to directly produce these supplies via nationalization, he has used the threat of this far-reaching statute to keep companies at maximum production. But all of the expedited manufacturing in the world won’t make much difference as the Food and Drug Administration (FDA) continues to drag its feet in inspecting, testing, and approving life-saving products and medicines. The agency must roll back the red tape holding up care for millions of Americans.

Needless to say, the FDA isn’t moving quickly enough to protect people during the coronavirus pandemic. After the Centers for Disease Control and Prevention bungled the early rollout of Coronavirus testing, the FDA waited weeks to allow laboratories across America to develop their own tests. But, even with this green light, the FDA continues to hold up the public health response to the pandemic. According to Washington Examiner journalist Tom Rogan, “At this very moment, stockpiles of masks, hand sanitizer, and other supplies are sitting in warehouses waiting for FDA inspectors to get around to them…I spoke to one significant medical supplier who talked to me on the condition of anonymity, for fear of FDA retaliation. In one location on the Pacific coast, this supplier has had more than 20 pallets of coronavirus-specific medical supplies waiting in a warehouse for five days. Yes, five days.” This couldn’t come at a worse time, as protective gear shortages are compromising care for the estimated 35,000 Americans who have the coronavirus.

For example, at Barnes Jewish Hospital in St. Louis, The New York Times reports that physicians undertaking invasive surgeries have had to use loose-fitting surgical masks in lieu of tight, recommended respirator masks. But fear not – the FDA “may consider expedited review of manufacturing site changes or premarket submissions” and companies are welcome to discuss mitigation approaches for products in shortages. While the FDA is committing to an “open door” approach, not much will happen unless the FDA allows boxes of critical supplies to be shipped to healthcare facilities and opened by experienced care providers. Since the agency is already permitting licensed pharmacists and doctors to make their own hand sanitizer, surely it isn’t a stretch to let doctors ascertain the quality of masks and gloves for themselves.

The clock is ticking for the FDA to prove to the nation that it’s willing to abandon the agency’s past risk aversion. There’s already plenty of discussion over expediting potential cures to the coronavirus, especially after President Trump tweeted on March 21 that anti-malaria drug hydroxychloroquine and antibiotic azithromycin “have a real chance to be one of the biggest game changers in the history of medicine” as a one-two punch. The agency recently allowed patients access to hydroxychloroquine (along with the investigational antiviral medication remdesivir) under its “compassionate use” framework, which allows patients with a serious or life-threatening illness access to experimental medications following a formal request process.

But the surge in requests for access to remdesivir has forced drug manufacturer Gilead to bar new requests following the treatment of just 250 patients. The company states that, “we are focused now on processing previously approved requests and anticipate the expanded access programs will initiate in a similar expected timeframe that any new requests for compassionate use would have been processed.”

Drug manufacturers such as Gilead are doing their best but are stymied by a bureaucratized system that prevents patients in harm’s way from getting access to promising medications. It’s time to let patients and their doctors come to informed decisions about how to treat a deadly disease without applications and middlemen getting in the way. Clinical trials are an absolute must, but in the meantime, countless patients have little to lose by giving medications such as hydroxychloroquine a try. The FDA should consider allowing the use of unapproved medications as long as patients sign a waiver and understand the risks.

The FDA should be leading the way in waiving inspection requirements and allowing greater use of promising drugs. Millions of lives depend on it.

As Newsweek reports, people are sewing their own face masks to protect themselves against the coronavirus. Readers might wonder why something as simple as a face mask might be in short supply. As it turns out, such masks are strictly regulated.

The federal Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) must certify masks. The division of the CDC that certifies masks is the National Institute for Occupational Safety and Health (NIOSH), not the same as OSHA, the Occupational Safety and Health Administration.

Nearly three weeks ago, the United States reported 230 confirmed cases of the Covid-19 virus and a dozen fatalities. On March 24, the United States reached 64,645 confirmed cases and 908 deaths. In New York City the death toll hit 192.

As anyone with a TV or digital news feed knows, the virus is spreading alarmingly fast and widespread efforts are underway to slow its progress. Unfortunately, too many people accept that the United States healthcare system is not ready for a pandemic without asking why. Answering this question involves looking at current healthcare regulations.

Three months ago, the novel coronavirus first appeared in Wuhan, China. Now, it is considered a global pandemic. As of March 18^th, the virus has infected over 169,000 individuals, resulting in 8,732 deaths—and counting.

The United States as of this writing has approximately 7,769 confirmed cases of the coronavirus and at least 125 related deaths. But those numbers are already history. The death toll is expected to increase exponentially.

The first outbreak of the coronavirus occurred in China nearly two months ago. The disease quickly spread through the country. As of March 5th, the coronavirus is responsible for over 80,000 confirmed cases and nearly 3,400 deaths across China. Globally over 98,000 people are infected, resulting in nearly 4,000 deaths.

At this time, the United States reports 230 confirmed cases and 12 deaths. And the effects of the virus extend well beyond public health. Fear of a nationwide outbreak has negatively impacted financial markets, motivating the Federal Reserve to cut interest rates. Numerous flights are canceled until further notice. Stores are running out of hand sanitizer, bottled water, and other emergency goods.

In 2015, Turning Pharmaceuticals CEO Martin Shkreli increased the price of the drug Daraprim nearly 5,000 percent from $13.50 to $750 per pill. The price hike generated widespread outrage, earning Shkreli the moniker “Pharma Boy” and the designation, “pharmaceutical greed villain.” Daraprim became “the poster child for the issue of high drug prices.”