An American Vaccine Disaster 65 Years Ago: Lessons for Today

"Remember the Cutter Incident!" The phrase is not exactly the same sort of watch word as "Remember the Alamo." 

But it does have fresh resonance today. The Cutter Incident was a vaccine disaster in America 65 years ago. The case is the keystone of a column yesterday in the Los Angeles Times that said, "History tells us that speed kills."

The comment came from Arthur Caplan, a bioethicist at NYU Langone Medical Center and a co-author of an article this week in the Journal of the American Medical Association (JAMA) that sounded a warning in the rush for a Covid-19 vaccine. 

Caplan spoke about the matter with Michael Hiltzik, a business columnist at the Times and author of "Big Science." Hiltzik's column appeared one day before the California stem cell agency is set this afternoon to consider more applications in its $5 million Covid-19 funding round. (Vaccines also came up at last Friday's meeting of the agency's governing board.)

Hiltzik wrote, 

"If anything is known for sure about the scientific battle against the novel coronavirus, it’s that the quest for a vaccine has been unprecedentedly intense, with rapid development and speedy production the paramount goals."

The Cutter Incident, Hiltzik said, is example of the perils of speed. It involved errors in a polio vaccine produced in 1955 by Cutter Laboratories. An estimated 40,000 children contracted polio from the vaccine. About 200 were permanently paralyzed. Ten died. 

Hiltzik wrote, 

"The so-called Cutter incident was 'one of the worst biological disasters in American history, exploded the myth of the invulnerability of science and destroyed faith in the vaccine enterprise,' observed Paul Offit, a vaccine expert at the University of Pennsylvania whose 2005 book is the definitive account of the episode."

The polio vaccine was halted in its tracks during the summer of 1955. Hiltzik wrote, 

"Public confidence in the vaccine was shattered. 'The summer of 1955 came and went with few children getting their shots,' historian David Oshinsky, a co-author of the JAMA article, recounted in his 2005 history of the epidemic. Major outbreaks occurred in Boston and Chicago. 'It seemed like old times, with beaches and movie theaters once again deserted and people fleeing the cities to escape the evil germs.'"

Hiltzik concluded, 

"Clinical trials won’t be the final hurdle in bringing vaccines to the world. Managing the public’s expectations will be crucial, since no vaccine for anything is 100% effective. So will ensuring that the manufacturing process is airtight.

"With anti-vaxxers and conspiracy theorists already spreading wild stories about the coronavirus, it would be a shame to give them more ammunition.

"'In this world, where there’s so much vaccine hesitancy and doubt,' Caplan said, 'you better get it right, out of the box. You can’t afford a failure. Even knowing that we’re in desperate need of a vaccine and the deaths are happening, I worry that if we don’t do it right, it’s going to be worse.'"

California's $5.5 Billion Stem Cell Countdown: Still Creeping Up Little by Little

The drive to save the California stem cell agency with a $5.5 billion bond measure gathered modest momentum today in the signature count to put the proposal on the November ballot. 

The total number of valid or projected valid signatures late this afternoon advanced to 146,611, up slightly from 98,159 yesterday. The ballot initiative needs 623,212 valid signatures. Backers submitted 924,183 "raw" signatures.  

The signature disqualification rate stood at 21 percent, about the same as yesterday's 22 percent.

Large counties such as Los Angeles and San Diego have not yet reported on their verification efforts. The state deadline for counties to report their figures to the state is June 24 -- 20 business days away. 

The stem cell agency is running out of cash and will begin closing its doors next fall unless it receives a substantial infusion of cash.

Look for an updated count tomorrow evening or early Saturday morning right here on the California Stem Cell Report. 

Rogue Stem Cell Clinics and Covid: California Moves 'Sedately' on Regulation

The state of California and its top medical regulator remain mired in a go-slow posture on regulation of "snake oil" stem cell clinics that are currently riding the Covid crisis to peddle dubious treatments to desperate patients.

The marketing surge by the clinics has drawn increased attention nationally, including in prestigious scientific journals such as Cell Stem Cell whose usual fare deals with such things as "Stem Cell Hierarchy in Colorectal Cancer."

But one article published earlier this month was titled:

 "Preying on Public Fears and Anxieties in a Pandemic: Businesses Selling Unproven and Unlicensed 'Stem Cell Treatments' for COVID-19." 

The quotes around "stem cell treatments" are deliberate. No guarantee exists that the treatments actually include stem cells. 

Leigh Turner, an associate professor of bioethics at the University of Minnesota, authored the piece. He said,

"In the midst of a global public health emergency, some businesses are taking advantage of widespread fears by marketing purported stem cell treatments for Covid-19. 

"Such businesses target prospective clients with misleading claims, expose patients to potentially risky stem cell-based products, and undermine efforts to develop evidence-based treatments for Covid-19."

Nearly two years ago, California's State Medical Board said it was going to tackle the problem of the rogue clinics. But to this date little has occurred. State legislation to develop regulations was also sidelined.

The California Stem Cell Report queried the medical board earlier this month concerning the status of its effort and whether regulations had been drafted and when a draft would be ready. In response, the board last week released the following statement:

"The board is continuing to work toward the goal of providing recommendations on stem cell and regenerative therapies and developing some guidelines that California physicians and patients can follow that will include a sample informed consent document and educational materials for the public to present to the board for review and final approval. 

"In the meantime, pursuant to Business and Professions Code section 684, healthcare practitioners providing stem cell therapy not approved by the Food and Drug Administration (FDA) and who have not obtained approval or clearance for an investigational new drug or device exemption from the FDA for the use of human cells, tissues, or cellular or tissue-based products, must provide notice to their patients indicating the lack of FDA approval, and encouraging their patients to consult with their primary care physician before treatment. Individuals concerned about a physician’s stem cell practice should file a complaint with the Board for review and appropriate action."

The issues with the clinics has drawn attention in the Los Angeles Times from Pulitzer Prize winning columnist Michael Hiltzik  who wrote recently,

"The proliferation of stem cell clinics selling untested and unlicensed therapies has been a public health crisis for years. The Covid-19 pandemic will only deepen the crisis as clinics add the coronavirus to their menu of treatment claims."

The California stem cell agency has also pushed for tighter regulation and partnered to help pass the law for disclosure notices concerning lack of FDA approval. For patients considering stem cell treatments, the agency has posted as rundown on issues concerning the treatments or clinical trials. 

(After this item was posted, the agency posted a blog item dealing with Parkinson's. In addition to information on the search for a cure or treatment, the item carried the following advice for persons seeking some sort of unregulated treatment. Here is what the agency had to say in a Q&A format,

"If you go online you can find lots of stem cells clinics, all over the US, that claim they can use stem cells to help people with Parkinson’s. Should I go to them?

("In a word, no! These clinics offer a wide variety of therapies using different kinds of cells or tissues (including the patient’s own blood or fat cells) but they have one thing in common; none of these therapies have been tested in a clinical trial to show they are even safe, let alone effective. These clinics also charge thousands, sometimes tens of thousands of dollars these therapies, and because it’s not covered by insurance this all comes out of the patient’s pocket.

("These predatory clinics are peddling hope, but are unable to back it up with any proof it will work. They frequently have slick, well-designed websites, and  'testimonials' from satisfied customers. But if they really had a treatment for Parkinson’s they wouldn’t be running clinics out of shopping malls, they’d be operating huge medical centers because the worldwide need for an effective therapy is so great.

("Here’s a link to the page on our website that can help you decide if a clinical trial or “therapy” is right for you.")

California's $5.5 Billion Stem Cell Countdown: No Big Jump Today

New totals tonight show slight progress in the drive to rescue the financially strapped California stem cell agency, adding only 6,717 signatures to qualify a $5.5 billion measure for the November ballot.   

It needs 623,212 valid signatures. Backers submitted 924,183 "raw" signatures. State election officials reported late today that the proposal now has 98,159 valid or projected valid signatures of registered voters. 

The signature disqualification rate remains at about 22 percent. 

Large counties such as Los Angeles and San Diego have not yet reported on their verification efforts. The state deadline for counties to report their figures to the state is June 24 -- 20 business days away. 

The stem cell agency is running out of cash and will begin closing its doors next fall unless it receives a substantial infusion of cash.

Look for an updated count tomorrow evening or early Friday morning right here on the California Stem Cell Report. 

Correction

An item today dealing with the count of signatures for the proposed, $5.5 billion California stem cell initiative incorrectly stated that the disqualification rate was 78 percent. It is 22 percent. The percentage of signatures that have been qualified stands at 78 percent.