Tag: side effects

COVID-19 vaccine warnings don’t mean it’s unsafe – it’s proof the system to report side effects is working

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While the COVID-19 vaccines currently available in the U.S. have been proved to be safe and effective, recent reports of rare adverse events, or side effects, have raised concerns. On July 12, 2021, the Food and Drug Administration approved an update to the Johnson & Johnson COVID-19 vaccine fact sheet to include an increased risk of the rare nerve condition Guillain-Barré syndrome. This follows previous reports linking the J&J vaccine with a rare blood clot.

While reports like these can be scary, they’re a sign that the vaccine safety reporting system is working. They also highlight how the relative risks of rare side effects like these need to be put into context…

A rare adverse event may take months or years to identify for a simple reason: It’s rare. For some drugs that are less commonly used, new safety data takes longer to discover because a relatively small number of patients use the drug…For cases like the COVID-19 vaccine, however, millions of people will receive the drug shortly after it’s released to the public, and new issues or patterns often emerge more quickly.

This can lead to two problems.

First, not every reported adverse event is directly related to the vaccine…Second, a plausibly identified adverse event does not necessarily make the vaccine unsafe.

In such extraordinary times as during a pandemic, it’s understandable that people may be hesitant to take on any more risk than they have to. But there are safety nets in place to monitor the COVID-19 vaccines, and they are still working as they should.

Being aware of the risks of a treatment, however rare, can help people make health decisions that work best for them…And in the case of the COVID-19 vaccines, they must be weighed against the consequences of remaining unvaccinated and letting the pandemic rage on.

Emphasis added.

Side effects are worth it…

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…Side effects are a natural part of the vaccination process, as my colleague Sarah Zhang has written. Not everyone will experience them. But the two COVID-19 vaccines cleared for emergency use in the United States, made by Pfizer/BioNTech and Moderna, already have reputations for raising the hackles of the immune system: In both companies’ clinical trials, at least a third of the volunteers ended up with symptoms such as headaches and fatigue; fevers like my husband’s were less common.

Dose No. 2 is more likely to pack a punch—in large part because the effects of the second shot build iteratively on the first. My husband, who’s a neurologist at Yale New Haven Hospital, is one of many who had a worse experience with his second shot than his first.

But much like any other learning process, in this one repetition is key. When hit with the second injection, the immune system recognizes the onslaught, and starts to take it even more seriously. The body’s encore act, uncomfortable though it might be, is evidence that the immune system is solidifying its defenses against the virus.

Side effects generally resolve quickly, whereas COVID-19 can bring on debilitating, months-long symptoms and has killed millions.

Please read the article. Lose the excuse!

Texas sets the standard for Republican lies about abortion

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Click to enlarge — Rena Schild/Shutterstock

❝ Despite suffering a major defeat at the Supreme Court this past June, Texas simply can’t stop — won’t stop — undermining reproductive rights. Earlier this month, the Texas Department of State Health Services released an updated edition of its abortion booklet — ironically titled “A Woman’s Right to Know” — which unapologetically promotes debunked links between abortion, breast cancer, and adverse psychological risks.

❝ A pregnant person considering termination in the Lone Star state may very well believe that her physical and mental health are at risk if she obtains an abortion. Texas already requires a 24-hour waiting period for abortion, after mandated counseling that includes information on breast cancer, fetal pain and mental health effects. But the updated DSHS booklet spreads further misinformation.

With regards to mental health, the booklet says, “Women report a range of emotions after an abortion. This can include depression or thoughts of suicide. Some women, after their abortion, have also reported feelings of grief, anxiety, lowered self-esteem, regret, sexual dysfunction, avoidance of emotional attachment, flashbacks and substance abuse.”…

Everything an otherwise sensible person feels after voting for Trump. Har.

❝ …Not only does promoting such misleading information stigmatize a common medical procedure that 1 in 3 U.S. women will have, but it also directly impacts the quality and availability of abortion care. Anti-choice legislators routinely use the mental health myth to pass restrictions on abortion, from mandatory waiting periods and counseling to gestational limits on abortion…

Ultimately, there is no right or wrong way to feel after having an abortion; every person’s experience is unique and valid. State legislators and governments would do well to finally acknowledge this, and abandon the harmful myths that drive legislation designed to make women feel bad about their decisions.

I wonder if the Republican Party will ever get round to abandoning the 19th Century religious claptrap that mandates their patriarchal War on Women and Women’s Rights? I realize that offering scientific and social proof means nothing to spooky, fearfilled mice. But, just stepping back and peering with open eyes at decades of failed ideology might eventually make an impression. Even on a Texas Republican.

Doctors want a ban on direct-to-consumer advertising

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❝Direct-to-consumer advertising should be banned in order to reduce the demand for expensive, unnecessary drug treatments, the American Medical Association’s House of Delegates voted this week…

The policy also advocates for a campaign to urge prescription drug affordability — including demanding more competition in the drug industry — and for urging more transparency in drug costs; it also calls for convening a physician task force on the issue.

❝Banning DTC advertising would be a really good idea, said Sunny Linnebur, PharmD, associate professor of clinical pharmacy at the University of Colorado Skaggs School of Pharmacy…“I can see the potential risks that occur when patients watch commercials and immediately think they need to be on that medication,” she said in a phone interview.

“Number one, it puts pressure on providers — doctors, nurse practitioners, and physician assistants — to prescribe those medications. Number two, patients are not always in the best place to make decisions about which medications they should and should not take, and commercials are targeting patients and can make them think that medicine is for them, when it’s not safe for them.”

In addition, such ads can increase providers’ workloads because “we may have to discuss medications that were never going to be on the table to begin with,” said Linnebur…

❝The AMA has grappled with the DTC issue before…the association wrote to the Centers for Medicare and Medicaid Services complaining about the misuse of Medicare’s annual wellness visit by commercial firms…“We note that some consumer groups have asked the Federal Trade Commission to investigate the direct-to-consumer marketing of some of these commercial entities on the grounds that their advertisements contain false or misleading representations or material omissions,”…

Overdue.

In economic terms, advertising is often called an “enforced demand”. In real terms, it means the Pharma giants can bullshit their way to increased sales by selling consumers on the idea of magical cures.

Hospital made legal guardian for Amish girl with cancer

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An Ohio appellate court has appointed a hospital representative as the legal guardian in the case of a 10-year-old Amish girl who has cancer…The Fifth District Court of Appeals ruled Friday in favor of Akron Children’s Hospital over the girl’s parents…

Court documents show that Sarah Hershberger, 10, was receiving chemotherapy, but the girl’s parents, Andy and Anna Hershberger, stopped the treatment after their daughter began having harsh side effects. They opted to treat the girl with natural medicine instead.

Hospital officials have said that the girl will likely die without chemotherapy, but has an 85 percent chance of surviving if she continues with the treatment.

Previously, Medina County Probate Judge John J. Lohn twice ruled in favor of the girl’s parents, Andy and Anna Hershberger.

However, the appeals court said Lohn’s ruling wasn’t “based on competent, credible evidence.”

“While we have no doubt that the parents are acting in according with their principles, beliefs and honest convictions and that their goal may be a laudable one,” the appellate court said, “it does not justify or nullify the right of the state and the probate court to protect the health and wellbeing of a child.”

Maria Schimer, a registered nurse and attorney at the hospital, was granted “limited guardianship” over Sarah, which allows her to make medical decisions for the girl.

Fortunately – and I don’t say that easily – you’re not always afforded the right to love your child to death. I’m one of those who relies to a small extent on natural and folk remedies that seem to have some efficacy in my family’s history. Never for potentially terminal illnesses. Science and the latest in modern medicine get a significant edge there. Just too much data supporting good sense.

I guess that’s one of the reasons I blog a fair piece about medicine and science. I’ve had a lifelong love affair with science [yes, and science fiction] and I’ve lived and worked in and around medical facilities long enough to witness dramatic changes wrought by advances in modern medicine.

Do I have criticisms of the profit structure, especially of corporate pharmaceutical giants? You betcha! That doesn’t affect the systems used to evaluate treatment, chemical or otherwise. It’s why I’m pleased to admit to being a volunteer in human trials in at least one beneficial vaccine – last trial phase before approval. I’d do it again in a heartbeat.

Pfizer cheated, deceived and cherry-picked Celebrex studies

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A research director for Pfizer was positively buoyant after reading that an important medical conference had just featured a study claiming that the new arthritis drug Celebrex was safer on the stomach than more established drugs.

“They swallowed our story, hook, line and sinker,” he wrote in an e-mail to a colleague.

The truth was that Celebrex was no better at protecting the stomach from serious complications than other drugs. It appeared that way only because Pfizer and its partner, Pharmacia, presented the results from the first six months of a yearlong study rather than the whole thing.

The companies had a lot riding on the outcome of the study, given that Celebrex’s effect on the stomach was its principal selling point. Earlier studies had shown it was no better at relieving pain than common drugs — like ibuprofen — already on the market.

The research chief’s e-mail, sent in 2000, is among thousands of pages of internal documents and depositions unsealed recently by a federal judge in a long-running securities fraud case against Pfizer. While the companies’ handling of the research was revealed a dozen years ago, the documents provide a vivid picture of the calculation made by Pfizer at the time and its efforts ever since to overcome doubts about the drug…

In one e-mail, an associate medical director at Pharmacia (which was later bought by Pfizer) disparaged the way the study was being presented as “data massage,” for “no other reason than it happens to look better…”

The importance of Celebrex to Pfizer is indisputable. It is one of the company’s best-selling drugs, racking up more than $2.5 billion in sales, and was prescribed to 2.4 million patients in the United States last year alone.

The drug is the last of the so-called COX-2 inhibitor pain drugs, after Vioxx and Bextra were withdrawn in 2004 and 2005 because of safety concerns.

And that, at root and cause, is what it’s all about. Pfizer – like their peers – doesn’t care if the wonderful new pharmaceutical they’re preparing to inflict upon unhealthy Americans and citizens of every other nation cures warts on your genitals or prevents death by drowning. It’s a commodity and coming from the Pharma industry it is designed to produce mammoth profits on the order of billion$.

Ethics have little to do with it. Aid to individuals struggling with ill health only define the market. Profiteering is the name of the game and if that involves deceit and outright deception – hey, we’re all grownups in the boardroom.

The shingles vaccine Is shown to be very, very safe

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A study of people who received the shingles vaccine has found that it is safe and well tolerated, with an extremely low rate of side effects.

More than 99 percent of Americans over age 40 have had chicken pox and are therefore at risk for shingles, an acute and painful nerve inflammation that usually strikes older adults. In one study, the vaccine reduces the odds of an outbreak by 55 percent in people over age 60.

But although the vaccine is approved by the Food and Drug Administration for people over age 50, fewer than 10 percent of them have been vaccinated…

Researchers studied medical records of 193,083 people age 50 and older, following them for six weeks after getting the vaccine. They found no increased risk for stroke, heart disease, heart attack, meningitis or encephalitis.

There was no increased risk for Bell’s palsy or Ramsay Hunt syndrome, possible complications of infection with herpes zoster, the virus that causes shingles and chicken pox. The most common side effect was swelling or redness at the site of the injection.

Which can happen with just about any injection – vaccination or otherwise.

I can heartily endorse the vaccine. I’ve had it in my system longer than most because I was part of the human trials for final FDA certification. And I’d be a cautious candidate for side effects like Bell’s Palsy – which has a history in my family on my father’s side.

Nary a problem.

Genetically engineered virus kills tumor cells – alone!

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Researchers have shown for the first time that a single intravenous infusion of a genetically engineered virus can home in on cancer, killing tumor cells in patients without harming healthy tissue.

Scientists have been intrigued for decades with the idea of using viruses to alert the immune system to seek and destroy cancerous cells. That interest has taken off in recent years as advances in genetic engineering allow them to customize viruses that target tumors…

In a study published in the journal Nature on Wednesday, scientists at institutions including the University of Ottawa and privately held biotech company Jennerex said a small, early-stage trial of experimental viral therapy JX-594 found that it consistently infected tumors with only minimal and temporary side effects.

The experimental virus will next be tested in a mid-stage trial of patients with liver cancer.

“With chemotherapy you get drastic side effects,” said Dr. John Bell, chief scientific officer at Jennerex and senior scientist at the Ottawa Hospital Research Institute. “Patients on this treatment only had 24-hour flu symptoms, and nothing after that.”

The trial, which involved 23 patients with various types of advanced cancer, was designed to assess the safety of JX-594. It also found that six of the eight patients given the two highest doses saw their tumors stabilize or shrink…

He also said that because the Jennerex virus can be given intravenously, spreading throughout the body, it may hold promise for limiting the ability of cancer cells to metastasize and spread.

Bravo. Especially in the dramatic reduction of side effects.

U.S. to decide – if we’re allowed to decide – to eat redesigned fish

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Two fish the same age. Same-size portions on the dinner plate? No differences.

U.S. health officials are set to rule on whether a faster-growing, genetically engineered fish is safe to eat in a decision that could deliver the first altered animal food to consumers’ dinner plates.

The fish, made by Aqua Bounty Technologies Inc, is manipulated to grow twice as fast as traditional Atlantic salmon, something the company says could boost the nation’s fish sector and reduce pressure on the environment.

But consumer advocates and food safety experts are worried that splicing and dicing fish genes may have the opposite effect, leading to more industrial farming and potential escapes into the wild. Side effects from eating such fish are also unknown, with little data to show it is safe, they say…

There are no data which say, however, that eating these fish is unsafe at all. The rest is pundit-babble.

The small Massachusetts-based biotechnology company is seeking Food and Drug Administration approval to sell its salmon, called AquAdvantage, to fish farmers nationwide.

If given the green light, the salmon could be followed by the company’s engineered trout and tilapia…

“This is an Atlantic salmon in every measurable way,” said Aqua Bounty Chief Executive Ronald Stotish. “When you look at the fish, it’s impossible to see the difference.”

And that’s the kicker. As it is with GM beef or pork – or any other genetically-engineered animal protein that’s moved far enough along towards production to sit on a platter before the FDA.

My enviro brothers and sisters have one serious question to answer before this old political insurgent is convinced to back their fears. Prove to me you can come up with any test which can differentiate between the engineered protein and the stuff swimming past my kinfolk’s farm up on PEI. Let’s cook it and eat it, smell it and taste it, feed it to test animals for several years [again?] and show me where it’s different.

Then, I won’t think you’re wasting my time – and that of a public who could use a break on the cost of good food.