Talcum Powder Won the Science Battle – But Lost the War

Johnson & Johnson has waved the white flag. Recently they announced they would discontinue sales of talcum-based baby powder in the U.S. and Canada, which they have sold since 1894.

As shocking as this sounds, it should be no surprise to anyone who watches television lately. The airwaves have been filled with trial attorneys soliciting anyone who has used baby powder in their lifetime and suffered from ovarian cancer. These ads would have you believe that talcum powder has been proven as a cause of cancer. Except, it hasn’t.

I wrote about this travesty of the legal system in 2017 in a post called The Talcum Powder Cancer Scare. At that time a jury found for a plaintiff who had terminal ovarian cancer and awarded her $417 million for J & J’s failure to warn her about the risk of using their product. She had been using baby powder for over 40 years.

But the scientific evidence did not support the jury’s findings. The American Cancer Society statement was as follows:

“Many studies in women have looked at the possible link between talcum powder and cancer of the ovary. Findings have been mixed, with some studies reporting a slightly increased risk and some reporting no increase. Many case-control studies have found a small increase in risk. But these types of studies can be biased because they often rely on a person’s memory of talc use many years earlier. Two prospective cohort studies, which would not have the same type of potential bias, have not found an increased risk.”

 

Johnson & Johnson was awarded a new trial at that time by California Superior Court Judge Maren Nelson to appeal the verdict. Judge Nelson stated, “The documents and testimony, granting all evidence in favor of the plaintiff do not support liability . . . much less support a finding of clear and convincing evidence that a punitive damage was appropriate.”

At that time, it seemed this attempt by the tort lawyers to turn talcum powder into the next asbestos racket would be thwarted. But alas, such was not the case. The legal system enthusiasm for suiting J & J has grown, while the scientific evidence to support their claims remains lacking.

A January, 2020 study published in the Journal of the American Medical Association (JAMA) followed more than 250,000 American women for 11 years and found no significant ovarian-cancer risk associated with talcum-powder use.The Centers for Disease Control and Prevention (CDC) does not list talcum powder as an ovarian cancer risk. The Food and Drug Administration (FDA) has consistently found insufficient evidence to mandate an ovarian-cancer warning label on talcum powder.

James R. Copland, writing in The Wall Street Journal, says this disconnect between science and the tort system doesn’t exist in other developed countries. He says regulators would apply the best science and essentially end the matter. But not in the U.S., where claims that a product causes an injury are typically matters of state law. An FDA determination that a product is safe doesn’t usually preclude litigation alleging otherwise.

Juries have often found in favor of Johnson & Johnson. They won 8 jury verdicts in 2019. But five other juries found for the plaintiffs in the same year and awarded heavy damages. Between 2016 and 2018, five different juries in St. Louis returned verdicts totaling almost $5 billion. Two-thirds of the early series of talcum cases were filed in St. Louis, even though the headquarters of J & J is over a thousand miles away in New Jersey. It seems that St. Louis has earned a reputation for plaintiff-friendly and generous juries.

The Covid-19 pandemic has made for empty shelves where hand-sanitizer and sanitary wipes used to sit. Looks like talcum powder is about to be the next item scarce to find.

 

To Mask or Not to Mask?

Do you need to wear a mask to protect yourself from the Covid-19 virus? That is the question on the mind of nearly everyone in the world today.

Advice from government and healthcare officials has been contradictory on this subject.
Dr. Mark Siegel, professor of medicine at NYU Langone Medical Center, addressed this subject recently in The Wall Street Journal. Siegel admits the message from medical authorities has been confusing. Both the U.S. Surgeon General and the Centers for Disease Control and Prevention exhorted Americans not to wear masks in January and February and then reversed their advice in April. What to believe?

Mask wearing has now become mandatory in many environments, including workplaces, airlines, and other public places. People wear masks when they are outside walking and others wear them when driving alone in their cars. When does it really make sense to wear a mask and when is it unnecessary?

The Purpose of the Mask

What exactly is the purpose of the mask? As a surgeon, I have worn a mask for every surgical procedure I have ever performed. That’s over forty years of wearing masks routinely. I wear the mask to prevent spread of my germs into the surgical environment, lest the patient be contaminated by me. I do not wear the mask to prevent contracting disease from the patient except in extreme situations when the patient may be infected with a contagious disease. In such cases I will also wear a face shield.

The wearing of masks today is to prevent contracting or spreading the Covid-19 virus. To prevent contracting the virus, you must understand how the virus is spread. This virus is spread by droplets and not by aerosolized virus particles. That means your risk for contracting the virus is directly related to contact with virus droplets, not inhaling virus particles. The typical spread occurs when virus droplets contaminate a surface, or skin, and your hands touch that surface or skin. Then your hands touch your face and you contaminate yourself. Therefore, it is crucial that you be aware of what surfaces your hands touch and then you avoid touching your face. The main value of wearing the mask is to prevent you from touching your face. It will also reduce the chance of spreading infection to others if you happen to be an asymptomatic carrier of the virus.

Masks are mostly useful for preventing infected individuals from spreading their virus particles to others through coughing, sneezing, or spitting. Surgical masks and even cloth masks can be effective. A study published in Nature Medicine in April examined 246 people with acute upper respiratory illness and found that wearing a surgical mask did decrease spread of genetic material from respiratory viruses, including coronaviruses. However, another study published in the Annals of Internal Medicine in April revealed that the force of sick patients’ coughs propelled droplets through both surgical masks and cloth. This highlights the importance of isolating those infected individuals who are coughing or sneezing.

What about those N-95 masks we have heard so much about?

The N-95 masks are actually more like respirators which are made to form a tight seal around the face and to maximize filtration of the air. When properly fitted, these masks prevent inhalation of non-filtered air. They are only needed by healthcare workers in close contact with infected patients during procedures such as intubation, suctioning of airways and giving respiratory therapy.

In summary, wear a mask to keep from touching your face when potentially in contact with contaminated surfaces in public places. Wear a mask when you’re sick to prevent the spread of your germs or virus particles to others. Wear a mask when you’re in public places that require them. Don’t wear a mask in your home unless you’re sick. Don’t wear a mask when you’re outdoors and not in close contact with others. Be aware of everything you touch in public places and keep hand sanitizer readily available. You can do this!

Vaccines are Coming!

 

The Dow Jones Industrial Average jumped 912 points yesterday on the news that there is progress in the development of a Covid-19 virus vaccine. Even the mainstream media couldn’t find bad news in that announcement.

America has been shut down for over two months due to the virus pandemic, and nothing short of an effective vaccine is going to approach returning life to normal again. This promising news gives us all hope that day may come sooner rather than later.

The biotech firm Moderna has taken the early lead in developing a vaccine for Covid-19. The Wall Street Journal editorial board reports that Moderna used rapid genetic sequencing and its nimble mRNA manufacturing platform to develop and deliver a vaccine to the National Institutes of Health for clinical trials in late February.

Phase One of a clinical trial examining whether the vaccine is safe and provokes an immune response began in mid-March. Forty-five healthy volunteers ages 18 to 55 received varying doses. Moderna reported this week that all participants who had been evaluated after receiving two doses developed antibody levels at or above levels of those seen in patients who have recovered from the virus.

This is strong evidence the vaccines could be effective and there were no serious side effects reported. These promising results prompted the surge in the stock market.

Moderna also reported that its vaccine “provided full protection against viral replication in the lungs” in mice infected with the corona virus. On May 7, the FDA cleared the company to begin Phase Two trials with 600 participants including individuals over age 55 to determine whether they also muster a robust immune response.

The FDA also granted Moderna fast-track designation on May 12 which will allow the company to begin Phase Three trials to assess the vaccine’s efficacy in thousands of people by July. If results are promising, it is anticipated that vaccines could be available for high-priority groups such as healthcare workers as early as the fall.

This vaccine from Moderna is only one of over 100 vaccines in development worldwide. The Gates Foundation and the National Institutes of Health are investing heavily to accelerate those vaccines with the most scientific potential based on early evidence.  Moderna is working hard to upscale their manufacturing potential and estimates it could produce 100 million doses a year. Other drug companies are also making plans for increasing manufacturing capability to produce vaccines if their candidates are successful.

Johnson & Johnson plans to begin clinical trials in September and hopes to produce its first batches of vaccine by early next year. Its Netherlands plant could produce 300 million doses annually. Pfizer is also testing several vaccine candidates and plans to have 10 to 20 million doses ready for emergency use this fall.

This is a testament to the ingenuity of the private sector in responding to this healthcare crisis. Fortunately, there is bipartisan support for this effort which has expedited the process. Thirty-five House Democrats and Republicans last month wrote a letter urging the FDA to act more rapidly and nimbly. President Trump has already appointed a task force to shepherd the approval of these new vaccines through the regulatory process.

America can accomplish much when we work together, unleash the “arsenal of democracy” of our private sector, and government facilitates the process. The stock market recognized the significance of this promising news and it should give hope to every American, too.