Posts tagged with "FDA"

The buddy system: Provider of Trump COVID drug is president’s golf pal

October 11, 2020

New questions have emerged over the circumstances under which Donald Trump was prescribed an experimental antibody drug cocktail to treat his coronavirus infection now that the public knows that the source of the pharmaceuticals was the president’s golfing buddy.

As Trump wrongly hailed his treatment–which included a drug called REGN-COV2 produced by Tarrytown, New York-based Regeneron—as a “cure”, it emerged that the company’s CEO Leonard Schleifer  is a member of the Trump National Golf Club in Westchester County, New York, and had met the president in May to talk about drugs his company was developing The Guardian reports.

REGN-COV2 is a combination of two monoclonal antibodies designed to both treat people with coronavirus and to prevent Sars-CoV-2 infection. The antibodies are designed to prevent the coronavirus spike protein from attaching to Ace2 receptors in the body–the path the virus uses to infect people.

While some ethicists have defended Trump’s privileged access as president to experimental treatments, others have suggested it raises questions of fairness among other concerns, including his history of touting unproven treatments.

Trump’s relationship with Schleifer, whom he reportedly calls “Lenny,” adds to growing questions over the president’s almost exclusive access to experimental treatments unavailable to most other Americans, even as he has continued to downplay the threat of coronavirus based on his own experience.

The price of Regeneron stocks–which Trump has owned in the past–soared after it was revealed the drug had been made available for his treatment and Trump stated it would be made freely available for all, although he didn’t explain how.

“I call that a cure,” Trump said in a video, adding that everyone should have access to the not-yet-approved drug and that he would make sure it was in every hospital as soon as possible.

Trump’s comments were quickly criticized by doctors treating patients on the frontline of the COVID-19 pandemic in the United States.

Frankly, he is an anecdote, and he is an anecdote meaning he is one person who took this drug, but he has also taken dexamethasone,” said ER professional Dr Rob Davidson, who works in west Michigan, on Twitter.

Davidson added in his interview with the Guardian that Dexamethasone (a corticosteroid that prevents the release of substances in the body that cause inflammation) “makes you feel like a million bucks, it makes you feel like you’re on top of the world”.

He concluded: “Do everything the opposite of what this administration is telling you.”

After the president’s comments, Regeneron announced it had applied to the Food and Drug Administration (FDA) for an emergency use authorization.

“There are doses available for approximately 50,000 patients, and we expect to have doses available for 300,000 patients in total within the next few months,” the company said in a statement.

However, America is seeing more than 50,000 new cases of Covid-19 each day. Further, monoclonal antibody therapies are notoriously difficult to produce and expensive. The median cost of monoclonal antibody therapies approved over the last 20 years is more than $96,000 per treatment course.

Regeneron’s therapy has only been tested in 275 people, in a promising study that some scientists nevertheless said, “doesn’t cut it” for emergency use authorization.

The drug has also stirred debate because of how it was developed, The Guardian notes–using an “immortalized” cell line originally derived from an elective abortion in the Netherlands in the 1970s—a common process that the Trump administration opposes.

Republicans opposes embryonic stem cell research, according to the party platform.

The White House doctor, Sean Conley, said Trump had been given a single 8g dose that was made available under a compassionate use clause. Compassionate use requests are decided on a case-by-case basis—and both the drug company and the FDA must agree.

The Regeneron spokeswoman Alexandra Bowie said fewer than 10 of these requests had been granted, and with the drug in limited supply the priority was to use it in ongoing studies. Emergency access was granted “only in rare and exceptional circumstances”, she said.

Regeneron also contacted the Democratic presidential candidate, Joe Biden, to alert him to the availability of the drug under the compassionate use rule.

Alison Bateman-House, an ethicist at New York University Langone Health, told The Guardian that Regeneron’s overture to Biden should raise concerns.

“That crosses lines of appearing to promote a potentially unapproved product,” she told Associated Press, which would violate FDA rules. Rather than directing people to enrol in studies, she said it suggested that “we’ll cut the line for you”.

New questions have emerged over the circumstances under which Donald Trump was prescribed n experimental antibody drug cocktail to treat his coronavirus infection now that the public knows that the source of the pharmaceuticals was the president’s golfing buddy.

As Trump wrongly hailed his treatment–which included a drug called REGN-COV2 produced by Tarrytown, New York-based Regeneron—as a “cure”, it emerged that the company’s CEO Leonard Schleifer  is a member of the Trump National Golf Club in Westchester County, New York, and had met the president in May to talk about drugs his company was developing The Guardian reports.

REGN-COV2 is a combination of two monoclonal antibodies designed to both treat people with coronavirus and to prevent Sars-CoV-2 infection. The antibodies are designed to prevent the coronavirus spike protein from attaching to Ace2 receptors in the body–the path the virus uses to infect people.

While some ethicists have defended Trump’s privileged access as president to experimental treatments, others have suggested it raises questions of fairness among other concerns, including his history of touting unproven treatments.

Trump’s relationship with Schleifer, whom he reportedly calls “Lenny,” adds to growing questions over the president’s almost exclusive access to experimental treatments unavailable to most other Americans, even as he has continued to downplay the threat of coronavirus based on his own experience.

The price of Regeneron stocks–which Trump has owned in the past–soared after it was revealed the drug had been made available for his treatment and Trump stated it would be made freely available for all, although he didn’t explain how.

“I call that a cure,” Trump said in a video, adding that everyone should have access to the not-yet-approved drug and that he would make sure it was in every hospital as soon as possible.

Trump’s comments were quickly criticized by doctors treating patients on the frontline of the COVID-19 pandemic in the United States.

Frankly, he is an anecdote, and he is an anecdote meaning he is one person who took this drug, but he has also taken dexamethasone,” said ER professional Dr Rob Davidson, who works in west Michigan, on Twitter.

Davidson added in his interview with the Guardian that Dexamethasone (a corticosteroid that prevents the release of substances in the body that cause inflammation) “makes you feel like a million bucks, it makes you feel like you’re on top of the world”.

He concluded: “Do everything the opposite of what this administration is telling you.”

After the president’s comments, Regeneron announced it had applied to the Food and Drug Administration (FDA) for an emergency use authorization.

“There are doses available for approximately 50,000 patients, and we expect to have doses available for 300,000 patients in total within the next few months,” the company said in a statement.

However, Americais seeing more than 50,000 new cases of Covid-19 EaCH day. Further, monoclonal antibody therapies are notoriously difficult to produce and expensive. The median cost of monoclonal antibody therapies approved over the last 20 years is more than $96,000 per treatment course.

Regeneron’s therapy has only been tested in 275 people, in a promising study that some scientists nevertheless said, “doesn’t cut it” for emergency use authorization.

The drug has also stirred debate because of how it was developed, The Guardian notes–using an “immortalized” cell line originally derived from an elective abortion in the Netherlands in the 1970s—a common process that the Trump administration opposes.

Republicans opposes embryonic stem cell research, according to the party platform.

The White House doctor, Sean Conley, said Trump had been given a single 8g dose that was made available under a compassionate use clause. Compassionate use requests are decided on a case-by-case basis—and both the drug company and the FDA must agree.

The Regeneron spokeswoman Alexandra Bowie said fewer than 10 of these requests had been granted, and with the drug in limited supply the priority was to use it in ongoing studies. Emergency access was granted “only in rare and exceptional circumstances”, she said.

Regeneron also contacted the Democratic presidential candidate, Joe Biden, to alert him to the availability of the drug under the compassionate use rule.

Alison Bateman-House, an ethicist at New York University Langone Health, told The Guardian that Regeneron’s overture to Biden should raise concerns.

“That crosses lines of appearing to promote a potentially unapproved product,” she told Associated Press, which would violate FDA rules. Rather than directing people to enrol in studies, she said it suggested that “we’ll cut the line for you”.

Research contact: @GuardianUS

Roll Call exclusive: States plan to independently vet COVID-19 vaccine data

September 18, 2020

Governors, including New York’s Andrew Cuomo, are publicly raising doubts about the FDA’s and the CDC’s ability to withstand pressure from President Donald Trump to develop a coronavirus vaccine at warp speed, Roll Call reported exclusively on September 17.

Those same officials are expressing skepticism about federal reviews of potential COVID-19 vaccines—with some going so far as to plan to independently analyze clinical trial data before distributing a vaccine, in a sign of how sharply trust in federal health agencies has fallen this year.

The wariness—which public health experts call highly unusual if not unprecedented—could undercut the goal of a cohesive national immunization strategy and create a patchwork of efforts that may sabotage hopes of containing the coronavirus.

State plans to review the data indicate how deeply any appearance of political meddling could disrupt vaccination and cost lives Roll Call says.

And it’s not a surprise that some red states appear more likely to rely on the Trump Administration, while blue states may scour the data and be more cautious about vaccinating their residents immediately.

CQ Roll Call contacted state health departments in 50 states and the District of Columbia and received substantive responses from a dozen:

  • Seven jurisdictions indicated that they would analyze the data independently: California, Colorado, the District of Columbia, Michigan, New York, Oregon and West Virginia.
  • Another two—Montana and Wyoming—said they would only administer a vaccine that completed clinical trials and an outside committee’s review.
  • Three states —Arizona, Georgia and Oklahoma— indicated they would accept federal recommendations as usual.

 “The president says he’s going to have a vaccine. CDC is talking about a vaccine in early November. How convenient. It’s going to be an Election Day miracle drug,” New York Gov. Andrew Cuomo, a Democrat, said earlier this month.

Cuomo referenced the FDA’s emergency use authorization earlier this year of a drug touted by Trump, hydroxychloroquine, which the agency later withdrew after finding the drug was not effective against COVID-19 and could lead to dangerous heart conditions. “Some people are concerned that the vaccine may wind up being hydroxychloroquine,” he said, adding that the state health department will review the research before recommending that New Yorkers take any vaccine.

Nearly 200,000 Americans have died of COVID-19, according to the Johns Hopkins University School of Medicine.

Research contact: @rollcall

A shot in the dark? Drug companies issue rare joint pledge on vaccine safety

September 9, 2020

On September 7, nine pharmaceutical companies issued a rare joint pledge—intended to reassure the American public about the safety and efficacy of the coronavirus vaccines that currently are under development.

The statement from the top drug companies working on COVID-19 vaccines—including Pfizer, AstraZeneca, and Moderna—comes amid fears that President Donald Trump will continue to place pressure on the industry to speed up the vaccine approval process without proper oversight, and doubts among the public about taking a vaccine, The Hill reports.

The joint pledge states that the companies will not seek Food and Drug Administration (FDA) approval for their vaccines until a rigorous phase 3 clinical trial shows that it is safe and that it works. 

The companies pledged they would “only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.”

The companies said they would “always make the safety and well-being of vaccinated individuals our top priority.”

Highlighting the fears of political interference, Trump on Monday floated the idea of having a vaccine before Election Day on November 3. “We’re going to have a vaccine very soon. Maybe even before a very special date. You know what date I’m talking about,” he said at a news conference.

Trump has put pressure on the FDA before, saying that the “deep state” at the agency was throwing up roadblocks before the agency issued an emergency authorization for a coronavirus treatment known as convalescent plasma.

According to The Hill, FDA Commissioner Stephen Hahn also has offered reassurances that his agency will base vaccine decisions only on science and not on politics.

But the statement from the pharmaceutical companies is an illustration of how deep the fears are about politicization of the process and the need for companies to try make their own reassurance about science guiding the process.

An NPR-PBS NewsHour-Marist poll last month found that a significant portion of the public (35%) did not intend to receive a coronavirus vaccine.

Research contact: @thehill

FDA alert: At least 75 brands of hand sanitizer contain methanol—and may be toxic

July 27, 2020

Federal regulators have recalled dozens of hand sanitizers—many of them, widely available through Walmart, Costco, and other national retailers—because they contain dangerous and potentially fatal levels of wood alcohol (also known as methanol).

Specifically, the Food and Drug Administration (FDA) has identified at least 75 brands whose labels say they contain ethanol (also known as ethyl alcohol or grain alcohol)—but later proved to contain methanol.

The FDA recommends that consumers should immediately stop using these hand sanitizers and dispose of the bottle in a hazardous waste container, if available, or dispose of as recommended by your local waste management and recycling center. Do not flush or pour these products down the drain or mix with other liquids.

Methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.

Although people using these products on their hands are at risk for methanol poisoning, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. Consumers who have been exposed to hand sanitizer containing methanol and are experiencing symptoms should seek immediate medical treatment for potential reversal of toxic effects of methanol poisoning.

. While methanol-containing hand sanitizers are more life-threatening than others, the FDA urges all consumers not to drink any hand sanitizer product. This is particularly important for young children, especially toddlers, who may be attracted by the pleasant smell or brightly colored bottles. During the pandemic, poison control centers have had an increase in calls about accidental ingestion of hand sanitizer, and it is important that adults keep these products out of reach of children and monitor young children’s use.

Do not use hand sanitizer on pets or allow pets to swallow hand sanitizer. If you believe your pet has eaten something potentially dangerous, call a veterinarian or a pet poison control center immediately.

Consumers are reminded to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing or blowing one’s nose. If soap and water are not readily available, the U.S. Centers for Disease Control and Prevention (CDC) recommends consumers use an alcohol-based hand sanitizer that contains at least 60% ethanol.

The FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program (please provide the agency with as much information as possible to identify the product):

  • Complete and submit the report online, or
  • Download and complete the form, then submit it via fax at 1-800-FDA-0178.

Consumers, manufacturers or distributors who have questions for the FDA regarding hand sanitizers should email COVID-19-Hand-Sanitizers@fda.hhs.gov.

Research contact: @US_FDA

Kroger Health’s home coronavirus test kit cleared for emergency use by FDA

July 2, 2020

Kroger  has received Emergency Use Authorization from the Food and Drug Administration for a home COVID-19 test, The Street reports.

“The testing solution combines the safety and convenience of at-home sample collection with the expert guidance of a telehealth consultation to help improve the quality of the collection process,” the country’s largest grocery store chain, based in Cincinnati, Ohio, said in a statement.

The kit initially will be available for Kroger workers, based on medical need, beginning this week. Kroger is partnering with clinical laboratory Gravity Diagnostics.

According to The Street, the company plans to rapidly expand the availability of the kits to other companies and organizations in the coming weeks, with a goal of processing up to 60,000 tests per week by the end of July.

“Over the past few months, Kroger Health has been providing Americans with access to Covid-19 testing through community test sites across the country,” said Colleen Lindholz, president.

“However, we’ve observed some individuals do not have access to transportation or live near these community testing locations. To help ease this burden and provide greater accessibility, we will be offering a home testing solution.”

A licensed healthcare professional will supervise the tests. “The process is simple and is available at no cost to eligible patients who meet established clinical criteria for likely Covid-19 infection or exposure,” Kroger said.

The kit includes a nasal swab, transport vial, instruction sheet, prepaid shipping label, and packing materials for return shipment of the sample to the laboratory.

Research contact: @TheStreet

Cuomo: Millions and millions of tests needed before U.S. economy can be rebooted

April 13, 2020

New York Governor Andrew Cuomo said on April 10 that millions of COVID-19 tests must be administered nationwide, if the country’s economy is going to reopen safely and effectively, according to a report by The Hill.

“This is going to be a horrendous transformational period for us,” Cuomo said in an appearance on MSNBC‘s Morning Joe.

“I don’t think we ever get back to normal. I think this is one of the new normals now in public health,” he said.

The governor added that just how smoothly American society and its economy will be able to reopen will directly correspond to what the steps the government does or does not take.

“This is such an important period for government and the political discussion,” Cuomo said. “Nothing is pre-charted here. It’s all a function of what we do.”

He added: “How good are we at getting this testing up? Are we better than we’ve been in the past? Is it going to take us months to come to scale on rapid testing? That’s the only way to get people back to work. You have to have millions and millions of tests, frankly, better and faster than we’ve done to date.”

This isn’t the first time that Cuomo has signaled that widespread testing to see who has had the virus is essential to America’s ability to get its people back to work, The Hill said.

Cuomo has said that New York State has developed a test that sees whether a person has developed antibodies to fight COVID-19. It has been well-documented that not everyone who contracted the virus will show outward symptoms consistent with the disease.

“We cannot restart life as we knew it without testing,” he tweeted earlier this week.

But Cuomo’s stance on testing differs from President Trump’s opinion on the matterThe Hill noted. In his daily coronavirus press briefing Thursday, Trump punted when asked about the need for widespread testing—saying that it would be nice but not required.

“We want to have it and we’re going to see if we have it. Do you need it? No. Is it a nice thing to do? Yes,” Trump said. “We’re talking about 325 million people. And that’s not going to happen, as you can imagine, and it would never happen with anyone else either.” 

Trump has expressed optimism that the country could start to ease social distancing recommendations by early May. The White House’s social distancing guidelines run through the end of April.

Cuomo isn’t alone in his call for comprehensive testing, though.

“In a setting where there will still be spread and we’ll still be slowly exiting the epidemic; we need capacity to test several million people a week (and probably more) to get broad enough coverage in community to detect outbreaks early and make case containment strategies work,” Scott Gottlieb, Trump’s former Food and Drug Administration commissioner, tweeted Thursday.

According to the COVID Tracking Project, the United States has tested about 960,000 people in the past week.

Research contact: @thehill

A glimmer of hope: New vaccine against COVID-19, called PittCoVacc, shows promise

April 6, 2020

It won’t help today’s patients (unless they are rats or mice); but, on April 2, University of Pittsburgh School of Medicine scientists announced in a press release that they had produced a potential vaccine against SARS-CoV-2— the new coronavirus causing the COVID-19 pandemic.

Through an expedited testing process, the vaccine, called the PittCoVacc, could be available for use in a little over a year.

When tested in mice, the vaccine—which is delivered through a fingertip-sized patch, not an injection—produces antibodies specific to SARS-CoV-2 at quantities thought to be sufficient for neutralizing the virus. Indeed, PittCoVacc generated a surge of antibodies against SARS-CoV-2 within two weeks of the microneedle prick.

The researchers were able to act quickly to develop the vaccine because they already had laid the groundwork during earlier coronavirus epidemics: “We had previous experience on SARS-CoV in 2003 and MERS-CoV in 2014. These two viruses, which are closely related to SARS-CoV-2, teach us that a particular protein, called a spike protein, is important for inducing immunity against the virus. We knew exactly where to fight this new virus,” said co-senior author Andrea Gambotto, M.D., associate professor of Surgery at the Pitt School of Medicine. “That’s why it’s important to fund vaccine research. You never know where the next pandemic will come from.”

“Our ability to rapidly develop this vaccine was a result of scientists with expertise in diverse areas of research working together with a common goal,” said co-senior author Louis Falo, M.D., Ph.D., professor and chair of Dermatology at Pitt’s School of Medicine and UPMC.

Compared to the experimental mRNA vaccine candidate that just entered clinical trials, the vaccine described in this paper (PittCoVacc, short for Pittsburgh Coronavirus Vaccine) follows a more established approach, using lab-made pieces of viral protein to build immunity. It’s the same way the current flu shots work.

The researchers also used a novel approach to deliver the drug, called a microneedle array, to increase potency. This array is a fingertip-sized patch of 400 tiny needles that delivers the spike protein pieces into the skin, where the immune reaction is strongest. The patch goes on like a Band-Aid and then the needles—which are made entirely of sugar and the protein pieces—simply dissolve into the skin.

“We developed this to build on the original scratch method used to deliver the smallpox vaccine to the skin, but as a high-tech version that is more efficient and reproducible patient to patient,” Falo said. “And it’s actually pretty painless—it feels kind of like Velcro.”

The system also is highly scalable. The protein pieces are manufactured by a “cell factory”—layers upon layers of cultured cells engineered to express the SARS-CoV-2 spike protein—that can be stacked further to multiply yield.

Purifying the protein also can be done at industrial scale. Mass-producing the microneedle array involves spinning down the protein-sugar mixture into a mold using a centrifuge. Once manufactured, the vaccine can sit at room temperature until it’s needed, eliminating the need for refrigeration during transport or storage.

“For most vaccines, you don’t need to address scalability to begin with,” Gambotto said. “But when you try to develop a vaccine quickly against a pandemic that’s the first requirement.”

Importantly, the SARS-CoV-2 microneedle vaccine maintains its potency even after being thoroughly sterilized with gamma radiation — a key step toward making a product that’s suitable for use in humans.

The authors are now in the process of applying for an investigational new drug approval from the U.S. Food and Drug Administration in anticipation of starting a phase I human clinical trial within the next few months.

“Testing in patients would typically require at least a year and probably longer,” Falo said. “This particular situation is different from anything we’ve ever seen, so we don’t know how long the clinical development process will take. Recently announced revisions to the normal processes suggest we may be able to advance this faster.”

Among the additional authors on the study are Eun Kim, Geza Erdos, Ph.D., Shaohua Huang, Thomas Kenniston, Stephen Balmert, Ph.D., Cara Donahue Carey, Michael Epperly, Ph.D., William Klimstra, Ph.D., and Emrullah Korkmaz, Ph.D., all of Pitt; and Bart Haagmans, of Erasmus Medical Center.

Research contact: @UPMCNews

Change of heart: Vets say dogs’ cardiac problems are linked to grain-free food

January 1, 2020

Debbie Turner remembers the shock when a veterinary specialist said her beloved dog, Kanga Lu, had severe heart damage. NBC News reports. For weeks, Kanga had been experiencing odd symptoms— including fatigue, breathing problems and what her local vet assumed were seizures. But now Turner was being told that the Maltese-Chihuahua mix was in late-stage heart failure. The seizures, it turned out, had been fainting spells.

“So I’m sitting with what I thought was a healthy six-year-old dog that was having minor seizures, and now I find out she might only have three months to live,” said Turner, 66, of Orlando, Florida.

She was heartsick and it turned out that something she had done out of love for her pet–buying what she believed to be the very best commercially available food—was doing the damage.

The first question the specialist had asked Turner when she brought in Kanga—whose blood pressure had skyrocketed—was, “Do you feed her grain-free dog food?” The answer was yes.

NBC News is now reporting that Turner is one of a growing list of pet owners whose healthy sounding dog food may have somehow led to a serious heart problem in their pets called dilated cardiomyopathy.

The Food and Drug Administration last year announced a possible link between the condition, which can cause heart failure; and grain-free pet foods, which replace grains with ingredients like peas, lentils ,or potatoes.

By April, the agency said that it had received 524 reports of 560 dogs and 14 cats diagnosed with DCM that appeared to be related to diet. In June, the FDA took the unusual step of listing the 16 brands of dog foodamong them, such popular brands as Blue Buffalo, Natural Balance, NutriSource, Nutro, and Rachael Ray Nutrishnder investigation.

It’s still not known exactly how certain pet foods may be damaging pet hearts, but researchers have found some clues. Possible culprits include deficiencies in certain compounds necessary for heart health, as well as diets with exotic ingredients.

In dogs and cats developing DCM, the “walls of the heart become thin, and its ability to pump blood decreases,” Dr. Bruce Kornreich, a veterinary cardiologist and director of the feline health center at the Veterinary College of Cornell told NBC News. “If this continues, your pet can end up with chronic heart failure.”

DCM is a known genetic issue for certain large breeds of dogs, including great Danes, German shepherds, and Doberman pincers. But when the FDA and veterinarians around the country started to see dogs of all sizes developing this kind of heart damage several years ago, they grew alarmed.

The number of cases of DCM are likely to rise, experts say.

“We continue to see dogs coming into our hospital affected by this problem,” Dr. Lisa Freeman, a veterinary nutritionist and professor at the Cummings School of Veterinary Medicine at Tufts University, told the network news outlet. “It’s not going away.”

Unfortunately, Freeman said, the solution is probably not going to be a simple one, and the suspect foods are not just those described as “grain free.” She and others are now investigating a broader class of foods, dubbed “BEG” foods: ones that are made by boutique companies, contain exotic ingredients, or are grain-free.

The FDA echoes Freeman’s concerns about a complex solution. “At this time, it is not clear what it is about some diets that may be connected to DCM in dogs, but FDA believes it may be multi-factorial,” said Monique Richards, an FDA spokesperson. “There are multiple possible causes of DCM.”

Research contact: @NBCNews

2020 hindsight: LASIK eye surgery should be taken off market, former FDA adviser says

November 15, 2019

Don’t turn a blind eye to the risks involved in LASIK eye surgery, an expert is warning, according to CBS News.

Laser vision correction has been popular for more than 20 years, with an estimated 20 million Americans undergoing the procedure to correct nearsightedness and improve distance vision.

According to an FDA patient survey, more than 95% of patients have been satisfied with their vision after surgery. But some patients say the surgery has ruined their eyesight. Among the complaints: “relentless eye pain,” dizziness, and detached retinas.

“Essentially we ignored the data on vision distortions that persisted for years,” said Morris Waxler— a retired FDA adviser who is now president of Waxler Regulatory Consulting. He voted to approve LASIK devices, but he now says voted to approve LASIK, but he now says that vote was a mistake.

“I re-examined the documentation … and I said, ‘Wow this is not good,'” Waxler told CBS News.

Waxler said his own analysis of industry data shows complication rates between 10%  and 30%. In 2011, he petitioned the FDA to issue a voluntary recall of LASIK. Three years later, the agency denied that request and now tells CBS News it “has not found any new safety concerns associated with LASIK devices.” 

Waxler said he thinks LASIK should “absolutely” be taken off the market. “There’s nothing wrong with a person’s eyes who goes to get Lasik,” he said. “They have healthy eyes. They could go and get a pair of glasses.”

Patient Abraham Rutner agrees, alleging that  LASIK surgery damaged his vision and nearly ruined his life. “It’s a devastation that I can’t even explain,” Rutner told CBS News medical contributor Dr. Tara Narula.

“Things would appear double. Around the lights were like having starbursts,” he added.

After months of not being able to drive or do his job, the Brooklyn electrician finally found help in Miami where optometrist Edward Boshnick fitted him with special contact lenses.

“His cornea is very distorted as a result of his LASIK surgery,” Boshnick told CBS.

Boshnick estimates he’s treated thousands of patients with LASIK complications.

Paula Cofer had surgery 19 years ago, “and from day one my vision was an absolute train wreck and it still is today,” she said.

She started a LASIK complications support group on Facebook and quickly found she was not alone. “You really have to understand you’re risking your only pair of eyes,” Cofer said.

Doctors who perform LASIK surgery said risks can be minimized with pre-surgical screening.

“The most important thing is knowing who to operate on and who not to operate on and there are people who really should not have this procedure,” Dr. Jules Winokur said.

Rutner now believes he was never a good candidate.

Here are FDA’s advisory on risks and how to find the right doctor for the procedure.

Research contact: @CBSNews

Study calculates links between prescription medications and risk for suicide

November 6, 2019

There’s a saying that what doesn’t kill us makes us stronger—but that shouldn’t be true of the FDA-approved drugs prescribed to us by our doctors.

Nevertheless, a review by the Center for Health Statistics at the University of Chicago of 922 medications that had been prescribed to nearly 150 million Americans over an 11-year period recently found that just 10 of these drugs were associated with an increased rate of suicide attempts, the university reported on November 5 in a press release.

Conversely, 44 drugs were linked to a decrease in suicide attempts, including many that carry a “black box” label from the FDA warning of their association with suicidal behavior.

The study findings, published in the Harvard Data Science Review, identifiy several drugs with the potential to prevent suicide attempts that are not currently used for that purpose, including folic acid, a simple vitamin often prescribed to pregnant women.

“There’s an antihistamine that’s associated with decreases in suicide. There’s a Parkinson’s drug associated with decreases,” said Robert Gibbons, PhD, the director of the center and lead author of the study. “If those test out in clinical trials to be real effects, we could be using more of these drugs to treat suicidal people.”

Suicide is now the tenth leading cause of death in the United States, according to the National Institute of Mental Health. Most suicides occur in patients with a psychiatric disorder, such as depression. However, common antidepressant medications such as fluoxetine (Prozac) carry the FDA’s black box warnin— which has led to decreased use of these medications, despite the benefits they might provide.

For the new study, Gibbons and his team developed a statistical tool to measure the links between drugs and suicide attempts. They analyzed data on 922 drugs with more than 3,000 prescriptions in a database of medical claims from 2003 to 2014. The data contained records of 146 million unique patients from more than 100 health insurers in the United States. For each person taking each drug, they counted suicide attempts in the three months prior to filling the prescription and the three months after taking the drug. This approach allowed them to evaluate each drug individually within a single person and see its effect on suicide attempts.

“It’s actually a very simple model that answers the question, ‘Does a suicide attempt occur more frequently after taking the drug than before?'” Gibbons said.=

That analysis found 10 drugs that showed a statistically significant increase in suicide attempts-among them, the opioid painkiller hydrocodone bitartrate and acetaminophen (Vicodin); anti-anxiety drugs alprazolam (Xanax) and diazepam (Valium); and prednisone, a corticosteroid.

 A total of 44 drugs showed a decrease in suicide risk, including a large group of antidepressants with black box warnings like fluoxetine and escitalopram (Lexapro), gabapentin (Neurontin), an anti-convulsant used to treat seizures, and, interestingly, the vitamin folic acid.

Gibbons said the statistical model can be used to calculate the risk of any adverse events that happen before and after taking a medication. The Veterans Administration already has expressed interest in using the tool, and Gibbons hopes other large hospital systems and local health agencies will adopt it to help decide which drugs to prescribe, especially for patients at risk of suicide.

“What we’ve done is come up with an alternative approach to drug safety surveillance that could be used by any agency, country or formulary,” he said. ”

Research contact: @UChicago