Tag Archives: FDA

What Would My Mother Say to Donald Trump?

Ever since the coronavirus pandemic began, I have been thinking of my mother. If ever there was a person who was ready for an epidemic, it was my mother. She was the FDA and the CDC combined. Her advice on health matters was prescient. Fearing cancer, she refused to use artificial colorings in food even though the FDA would not study and ban some for six decades. She suspected that fats like margarine, which were solid at room temperature, would stick inside you. When you consider that she was raising children in India in the nineteen-fifties you have to marvel at her audacity.  

Yet she was a middle-class woman with no college education. Not for lack of ambition, mind you, but because women of her generation were not even expected to finish high school. She had worked alongside Anglo Indian girls at the General Post Office in Mumbai during the Second World War however and felt nostalgic for her life as a working woman.

One of my earliest memories is of being taken to the family doctor because she thought one of my legs looked shorter than the other and suspected polio. We lived in the old part of Nagpur then, where stones were covered in saffron paint and worshipped as Gods. Where women wearing nine-yard saris carried offerings of oil to the temple to appease the goddess who had scourged their children with smallpox. The women did not know science, my mother said, so they catered to andhashraddha, blind belief. She was so wary of superstition that she refused to keep the vatasavitri fast she was expected to observe as a Hindu woman in order to obtain the same husband for the next seven incarnations. 

I can see her now, sitting on the doorstep and reading Dr. Spock’s Baby and Childcare, the only mother I knew to do so. Dr. Spock was her bible and her Bhagavad Gita. Dr. Benjamin Spock and Dr. Jonas Salk were household names in our family.   

Sarita Sarvate’s mother

My mother was devoted to science because she lived in a world teetering on the edge of calamity. In his thirties, my father had been diagnosed with tuberculosis and had to move his family from Mumbai to his hometown of Nagpur in case he needed help from his brothers. My father’s plate and eating utensils were kept separate, he never hugged or kissed me, he lay in his cot, resting. His chest X-Rays were stored in a locked trunk and the word TB was never uttered in my earshot, yet I sensed death in the air. Streptomycin, the cure for tuberculosis, was either around the corner or had recently been invented, but not commonplace in India, I suspect. I recall being taken by an aunt to a series of TB-themed Bollywood movies, similar to the cancer movies of a later era in Hollywood. I would cry at the imminent death of the hero or the heroine in these movies, not realizing that the films allowed me much needed catharsis. 

Dangers lurked everywhere. Cholera, typhoid, and malaria were rampant. I had to drop out of preschool because of measles.

After my father recovered, my infant brother was taken ill with diphtheria in the middle of the night and carried to the hospital in a rickshaw by my mother. 

Upon her return, she made a bonfire in the yard and threw into it her clothes, including the best sari she had worn to the hospital. It was the only sure method of sterilization she knew, since alternatives like clothes washers and powerful detergents were not accessible to her.  

Health and hygiene were never far from my parent’s minds. So that when the Nagpur Improvement Trust began to develop land on the outskirts of town, my mother withdrew from her post office savings account the money she had saved from her job in Mumbai and made the down payment. Soon we moved to our new house with running water – cold, not hot – and a flush latrine and the quality of our life made a quantum leap. 

Slowly, India began to catch up with my mother’s ideas. Newly independent after one hundred and fifty years of British rule, the country aimed to build a public health system along the lines of Europe. Public health workers began to come to our door every month to ask if anyone had a fever and if the answer was yes, to offer pills. This was how malaria was eradicated in our region. Later, one of my aunts began working as a public health worker as well, distributing contraceptives to women in remote villages.  

Our community celebrated all of the Hindu rites and rituals while maintaining a firm belief in medicine and science. Thousands of cities and towns like mine thrived across the nation. No wonder then that India began to nurture one of the largest workforces trained in science, medicine, and engineering in the world.  

My mother is long gone from this earth. But I wonder what she would say if she learned that many citizens of the nation of Dr. Spock are denying vaccines and science today. What would she say if she discovered that there does not exist a nationwide public health infrastructure capable of coping with COVID-19 in Dr. Spock’s America? What would she say if she learned that not only is there no such system along the lines of what many European nations have and what India and other developing countries have always aspired to, but that many Americans do not even expect to have it? 

Would she laugh at the jokes many Indians are posting on social media about Americans belonging to the flat earth society?  

Or would she feel incredibly sad?   

Would she be shocked that the US has recorded the highest number of COVID-19 deaths?

What would she say if she learned that in defiance of medical advice, the president of the nation of Dr. Spock and Dr. Salk refuses to wear a mask? That he has suggested that people should drink Lysol to cure COVID19?  Or that they should shine ultraviolet light on their inner organs?  

Would she curl her lips and ask if Donald Trump studied any science in school at all? 

Sarita Sarvate has written op-ed pieces for the Los Angeles Times, the Oakland Tribune, the San Jose Mercury News, the Baltimore Sun, and Salon.com among other publications and has written her Last Word column for India Currents for twenty-five years.  


Featured image is of Sarita Sarvate’s Parents. 

Why Does COVID-19 Testing Take So Long?

After a slow start, testing for COVID-19 has ramped up in recent weeks, with giant commercial labs jumping into the effort, drive-up testing sites established in some places and new products approved under emergency rules set by the Food and Drug Administration.

But even for people who are able to get tested (and there’s still a big lag in testing ability in hot spots across the U.S.), there can be a frustratingly long wait for results — not just hours, but often days. Sen. Rand Paul (R-Ky.) didn’t get his positive test results for six days and is now being criticized for not self-quarantining during that time.

We asked experts to help explain why the turn-around time for results can vary widely — from hours to days or even a week — and how that might be changing.

It’s A Multistep Process

First, a sample is taken from a patient’s nose or throat, using a special swab. That swab goes into a tube and is sent to a lab. Some large hospitals have on-site molecular labs, but most samples are sent to outside labs for processing. More on that later.

That transit time usually runs about 24 hours, but it could be longer, depending on how far the hospital is from the processing lab.

Once at the lab, the specimen is processed, which means lab workers extract the virus’s RNA, the molecule that helps regulate genes.

“That step of cleaning, the RNA extraction step, is one limiting factor,” said Cathie Klapperich, vice chair of the department of biomedical engineering at Boston University. “Only the very biggest labs have automated ways of extracting RNA from a sample and doing it quickly.”

After the RNA is extracted, technicians also must carefully mix special chemicals with each sample and run those combinations in a machine for analysis, a process called polymerase chain reaction (PCR), which can detect whether the sample is positive or negative for COVID.

“Typically, a PCR test takes six hours from start to finish to complete,” said Kelly Wroblewski, director of infectious disease programs at the Association of Public Health Laboratories.

Some labs have larger staffs and more machines, so they can process more tests at a time than others. But even for those labs, as demand grows, so does the backlog.

Capacity Is Expanding, But Not Enough

Initially, only a few public health labs and the federal Centers for Disease Control and Prevention processed COVID-19 tests. Problems with the first CDC test kits also led to delays.

Now the CDC has a better kit, and 94 public health labs across the country do COVID-19 testing, said Wroblewski.

But those labs can’t possibly do all that’s needed. In normal times, their main function is regular public health surveillance — detecting more common threats such as outbreaks of measles or monitoring seasonal influenza — “but not to do diagnostic testing of the magnitude that is required in this response,” she said.

Large commercial labs like those run by companies such as Quest Diagnostics and LabCorp were given the go-ahead late last month by the FDA to start testing, too.

The FDA has said it won’t stop certain private labs — those that are already certified to perform complex testing — and diagnostic companies from developing their own test kits. Labs at some big-name hospital systems, such as Advent Health, the Cleveland Clinic and the University of Washington, are among those doing this.

In addition, the FDA has approved more than a dozen testing kits by various manufacturers or labs under special emergency rules designed to speed the process. Those include tests by Quest Diagnostics, LabCorp, Roche, Quidel Corp. and others. The kits are used in PCR machines, either in hospital labs or large commercial labs.

“Our chief medical officer on the East Coast said that, up until two days ago, on average it was taking 72 hours to get results,” said Susan Van Meter, executive director of AdvaMedDx, a division of the Advanced Medical Technology Association, a device and diagnostics industry trade group. “That will get better as our member companies come on the market.”

Even so, supply is not keeping up with demand, Roche CEO Severin Schwan told CNBC on Monday. Roche won the first approval from the FDA for a test kit under emergency rules, and it has delivered more than 400,000 kits so far.

“Demand continues to be much higher than supply,” Schwan told CNBC. “So we are glad that overall capacity is increasing, but the reality is that broad-based testing is not yet possible.”

How Many Tests Can Be Done At A Time?

That varies. Large commercial labs can do a lot. LabCorp, for example, said it is processing 20,000 tests a day — and hopes to do more soon. Other test kit makers and labs are also ramping up capacity.

Smaller labs — such as molecular labs at some hospitals — can do far fewer per day but get results to patients faster because they save on transit time.

Still, it’s usually only large academic medical centers and some health systems that have their own molecular labs, which require complex equipment.

One of those is Medstar Georgetown University Hospital in Washington, D.C.

“From beginning to results can take five to six hours,” said Joeffrey Chahine, technical director for the molecular pathology division there.

Even at such hospitals, the tests are often prioritized for patients who have been admitted and staff who might have been exposed to COVID-19, said Chahine. His lab can process 93 samples at a time and run a few cycles a day, up to about 280, he said. Last week, it did 186 a day, three days in a row.

But hospitals with this ability are generally “not testing from their outpatient centers or the ER,” he said. In other words, the in-house labs aren’t running tests from walk-in patients.

Those tests are sent to large outside labs “so as not to overwhelm the hospital lab.” While those outside labs have large staffs, “the demand is so high that these outpatient clinics and ERs say the turnaround time can be four to seven business days,” he said.

Supply Shortages Are Slowing Test Production

As the worldwide demand for testing has grown, so, too, have shortages of the chemical agents used in the test kits, the swabs used to get the samples, and the protective masks and gear used by health workers taking the samples.

“There is an inadequate supply of so many things associated with testing,” said Wroblewski, which is why her group, along with officials in states including New York and cities including Los Angeles, recommend prioritizing who should be tested for COVID-19.

At the front of the line, she said, should be health care workers and first responders; older adults who have symptoms, especially those living in nursing homes or assisted living residences; and people who may have other illnesses that would be treated differently if they were infected. Bottom line: prioritizing who is tested will help speed the turnaround time for getting results to people in these circumstances and reduce their risk of spreading the illness.

Still, urgent shortages of some of the chemicals needed to process the tests are hampering efforts to test health care workers, including at hospitals such as SUNY Downstate medical center in hard-hit New York.

Looking forward, companies are working on quicker tests. Indeed, the FDA in recent days has approved tests from two companies that promise results in 45 minutes or less. Those will be available only in hospitals that have special equipment to run them. One of those companies, Cepheid of Sunnyvale, California, says about 5,000 U.S. hospitals already have the equipment needed to process these tests. Both firms say they will ship to the hospitals soon but have given few specifics on quantity or timing.

But many public health officials say doctors and clinics need a truly rapid test they can use in their offices, one like the tests already in use for influenza or strep throat.

A number of companies are moving in that direction. Late Friday, for instance, Abbott Laboratories announced that the FDA has given emergency-use authorization for the company’s rapid, point-of-care test, which can deliver positive results in as little as five minutes and negative results in 13.

The tests are processed on a small device already installed in thousands of medical offices, ERs, urgent care clinics and other settings. Abbott said it will begin this week to make 50,000 tests available per day.

“That’s going to make a meaningful difference,” said Van Meter at AdvaMedDx, who believes the rapid tests are a critical piece in the continuum of available testing.

Even though lab-based PCR tests, which are done at large labs and academic medical centers, can take several hours to produce a result, the machines used can test high numbers of cases all at once. The rapid test by Abbott — and other, similar tests now under development — do far fewer at a time but deliver results much faster.

“This can be provided in a doctor’s office or an ER, helping to triage patients who are waiting to get in,” said Van Meter. “It’s a very fine complement to the testing that exists.”

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.</>

Skin Lightening Cream Put a Woman in a Coma

She had been buying face cream through a friend of a friend for 12 years. This time, it was Pond’s “Rejuveness,” a version of the company’s anti-wrinkle cream that is made and sold in Mexico. But someone in the Mexican state of Jalisco laced the cream with a toxic skin-lightening compound, and it had a devastating effect on the 47-year-old Sacramento resident. She showed up at the emergency room this summer slurring her speech, unable to walk or feel her hands and face, public health officials said. She now lies semi-comatose in a hospital. Authorities aren’t releasing her name, but they say she is the first known victim of methylmercury poisoning from a cosmetic in the U.S.

Methylmercury is a heavy metal used in things like thermometers, batteries and mirrors, and long-term exposure can cause kidney damage, loss of peripheral vision and lack of coordination. The chemical — along with a less potent, but still toxic, form of mercury known as calomel — is also a key ingredient in skin-lightening products. A bustling market for these products is driven by immigrants who buy them from their home countries. The face cream that sickened the Sacramento woman was tampered with after manufacture, but some other skin-lightening products made overseas intentionally contain mercury as an active ingredient, said Bhavna Shamasunder, an associate professor at Occidental College in Los Angeles who studies skin-lightening cosmetics. While mercury removes skin pigmentation, Shamasunder said, the side effects are toxic.

Pond’s, owned by the international consumer products giant Unilever, said it doesn’t use mercury in its products. It encourages consumers to buy their products only from authorized retailers to avoid tampering. The company said it is working with authorities to investigate the Sacramento woman’s case.

In the past nine years, there have been more than 60 poisonings in California linked to “foreign brand, unlabeled, and/or homemade skin creams” that contained calomel, Sacramento County officials said. While it is illegal to sell cosmetics in the U.S. with more than 1 part per million (ppm) of mercury — except eye products, which can have up to 65 — the Food and Drug Administration can’t keep up with the imports, whether they’re shipped, tucked into suitcases or purchased online. Nor does it have the regulatory power to enforce recalls or require preapproval of cosmetic products and ingredients before they’re sold, Shamasunder said.

“The FDA has extremely poor oversight over our beauty products,” she said. “The burden of proof is on the consumer to get sick first.”

The FDA declined to comment on the record for this story.

Skin-lightening products are popular throughout the world, and the market is projected to grow to $31.2 billion by 2024, according to Global Industry Analysts, a publisher of market research. Products made outside the U.S. aren’t subject to the same standards as American-made ones and may contain poisonous chemicals, like mercury, or have higher proportions of potentially dangerous ingredients, such as steroids.

Skin-lightening products are advertised for their ability to even out blemishes and skin tone, but some consumers feel pressure to use them on their whole face or body in cultures that tend to confer more money and social status on people with lighter skin. Nearly 40% of women surveyed in Taiwan, Hong Kong, Malaysia, the Philippines and Korea said they used skin lighteners, while 77% of women in Nigeria and 25% in Mali said they did so, according to the World Health Organization. In the U.S., potentially hazardous skin-lightening products can be purchased in some ethnic beauty stores, in ethnic supermarkets and at swap meets. They can even be found online at sites like Amazon and eBay.

It’s difficult to estimate how many people have been affected by mercury poisoning from cosmetics because screening for the heavy metal is not routine, said Tracey Woodruff, a professor of reproductive sciences at the University of California-San Francisco. The problem appears to be concentrated among certain ethnic groups. A recent Minnesota study measuring mercury in the urine of 396 pregnant women from 2015 to 2017 revealed that nine had elevated levels, mostly linked to skin-lightening product use among Hmong and Latina women. Ongoing testing is revealing even more cases, said Jessica Nelson, program director for the state’s biomonitoring project.

Often, poisoning victims get their spiked products from people they trust, Woodruff said.

Woodruff co-authored a report about a pregnant woman in San Francisco who had unusually high levels of mercury in her blood. The source was a jar of Pond’s face cream that had been adulterated in the Mexican state of Michoacán. “A family member gave it to her, so it was a trusted source of information,” Woodruff said. A 2013 study that sampled 367 skin-lightening products purchased in Chicago, Los Angeles, New York and Phoenix turned up at least a dozen products with exceptionally high levels of mercury, ranging from 1,729 ppm to 38,535 ppm.

In the Sacramento woman’s case, the contaminated face cream contained a methylmercury concentration of over 12,000 ppm. The level of methylmercury in her blood was 2,630 micrograms per liter, according to Sacramento County Public Health. Normal values are less than 5. It’s unclear whether the FDA could have done anything to prevent her poisoning, said Melanie Benesh, legislative attorney for the Environmental Working Group, a nonprofit advocacy organization.

While the FDA has been able to intercept some high-mercury imports and turn them away, the agency lacks the authority to require companies to register their products and ingredients with the agency. That would make it easier to screen shipments that have a higher risk of being poisonous, Benesh said.

In a 2017 letter to Congress, the agency said it had six full-time inspectors to monitor 3 million cosmetics shipments annually. “Right now, the FDA is really flying blind,” she said. So it’s up to public health officials to catch poisoning cases as they happen and then trace their way back to the source.

In California, state public health officials are developing a campaign to educate shopkeepers and consumers. They also train volunteer community health workers like Sandra Garcia, 63, to meet with families to discuss the symptoms of mercury poisoning. Garcia, who lives in Tulare County and picks and packs grapes for a living, estimates that she has purchased creams from 40 stores to send to public health officials for testing since March. And she has visited 60 homes to hand out brochures and help residents identify poisonous products. “There are people that get angry and say that the cream is good and that nothing bad has happened to them,” she said. “But the majority of people are frightened and give me their creams.”

Leads on retailers that sell mercury-laced products may be handed over to law enforcement for potential follow-up, said California Department of Health spokesman Corey Egel. Public health officials recommend consumers avoid buying cosmetics at swap meets and flea markets, and check that products are properly sealed and labeled.

At a discount store near MacArthur Park in Los Angeles, shop worker Lili Garcia dismissed the notion that consumers should avoid skin creams manufactured abroad. She sells unopened jars of Pond’s Rejuveness cream from Mexico for $5 and $10, depending on the size, while Target lists American versions for $8 and $15, respectively. Garcia, who uses the same cream herself, said she had heard about the Sacramento woman on the news and felt sorry for her. But she said it’s up to consumers to check that products are sealed; beyond that, there isn’t much else they can do. “Well, the buyer buys the product, and they don’t know what’s inside,” she said.

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.