The Whole Truth About Medicines

When you see a news story or read an article about a drug on a website or TV or in a magazine that has ads for that drug, how independent do you think the facts are in that offering? If a drug company is paying to advertise, will that website, magazine or broadcast openly warn you of the medicine’s risks? Common sense tells you that advertising affects whether the whole truth is being told. 

If your doctor is paid to give a talk about a new medicine, will that make the doctor more likely to prescribe it for you? Yes. A $20 lunch from a drug representative leads to higher prescribing rates from the doctor, according to research. 

Why You Should Care About Side Effects

“Take your medicine, you’ll feel better.” Sounds reassuring, doesn’t it? But more and more of us are beginning to question the pills, the injections, the procedures. We wonder, what does a healthy life look like? 

Since the introduction of penicillin in the 1940s our society has believed in handheld miracles. Early chemical medicines were lifesavers; before them, people could and did die of a scratch. Insulin saves the lives of millions of diabetics every day. 

As a society we believe in drugs. And we trust them. Despite the ads on television that race through side effects ranging from rash to death, we believe that all medicines have a net benefit. Sure, there may be some side effects, but those pills will cure my ills, so it’s worth it. But is it? More and more of us are asking, are all these pills a good thing? 

Side Effects Are Life Effects

Drugs taken as prescribed will very often cause mild, manageable side effects but they can occasionally trigger severe side effects (ADRs, or adverse drug reactions). Each year in the United States, about 1 in every 250 Americans, or 12.8 million people, go to a hospital emergency department because of an adverse drug event. 

Here are the drugs most likely to send you or your loved one to the emergency room: 

• Overall, blood thinners (anticoagulants), antibiotics, diabetes drugs, and benzodiazepines.
• Among children and adolescents (19 years old or younger) antibiotics 
• Among adults (45-64 years old) diabetes drugs
• Among younger adults (19-45 old)  benzodiazepines (used non therapeutically)
• Among older adults (65 years old or older) anticoagulants and diabetes drugs
• Statins lower cholesterol, but can increase your risk of diabetes and cause muscle aches and may affect your cognitive reasoning.
• Tylenol (acetaminophen) is effective at relieving muscle aches. However, taking the equivalent of just two extra-strength pills over the recommended dosage for three days in a row can lead to serious liver damage.
• Lavender essential oils have properties that relieve anxiety, but can cause estrogen surges in infants (babies with breasts!).

Medicine Can Help, Heal or Harm

We started MedShadow because we know that the side effects of medicines are too often glossed over and played down. But side effects can affect your quality of life and they can kill. That may sound like an overstatement, but it’s not. Yes, side effects of medicines are the fourth-leading cause of death in the US. 

I founded MedShadow because I was harmed by a medicine. When I was 14, I learned that I would never be able to conceive or carry a child, because when my mother was pregnant with me, her doctor prescribed a medicine called DES (diethylstilbestrol). Millions of pregnant women were given this drug. (For more information about the synthetic estrogen DES, go to the member-supported nonprofit DES Action.)

Many years later my husband and I took guardianship of our nephew. He was 12 and both the school and a medical specialist in ADHD told us he needed to be on Ritalin. There are many people who have benefited greatly from Ritalin, but we wanted to try to work with his nutrition, his habits and counseling. We were able to get in depth cognitive testing that helped identify some learning issues that we could address. For our nephew it worked and we were able to avoid using a medicine that has a lot of side effects. 

Today, MedShadow protects lives by making the hidden and minimized risks of medicines visible, so that you have the facts to make truly informed decisions about the risks, benefits and alternatives to medicines.

At first we focused on prescription medications, and then expanded to cover over-the-counter drugs, nutritional supplements. We also write about which substitutes are available for certain medicines. Some alternative therapies are proven more effective than drugs. Lifestyle changes can ward off and even reverse the course of some diseases. Nutrition can fuel a healthy life.  

Health news and information is especially difficult to get right — medical studies are written using complex and confusing terms. The results of virtually every study are not conclusive and must be taken in context with previous studies. 

Our job is to do that work for you, to help you understand what the study means for you and your family. We talk to doctors, patients and scientists so that we get the entire picture, for you.

These days people talk about “independent journalism,” and we agree that health journalism needs to be independent. However, 15 billionaires and six corporations own the majority of US media outlets. The biggest media companies also tend to own the biggest websites. One in four people look for health information on free websites. Almost all websites and news outlets carry ads for drugs. 

We don’t consider websites and news outlets that run ads “independent news.” No billionaire or pharmaceutical company with their own agenda is limiting or dictating what we write about. 

What to Know About Our Articles 

• MedShadow has a strict “no pharma money” policy. All of our writers are professional health journalists or are telling their personal health story. None of our journalists or personal writers work for or accept assignments from pharmaceutical companies. 
• Our writers are required to make sure that the doctors they interview do not work for or accept gifts from pharmaceutical companies. Our writers meet with patients who have taken the meds, some without trouble, some who had adverse events  caused by the drug. 
• Our major articles are reviewed by our MedShadow Medical Advisory Board. None of our board members works for or receives grants from pharmaceutical companies. 
• We have a policy that every member of MedShadow Foundation’s board be free from pharmaceutical conflicts of interest.

Pharma and Payments to Doctors for Prescriptions 

It’s a sad truth that some doctors accept direct payment from drug companies. Novartis paid a settlement of $678 million in 2020 to settle a lawsuit brought by the US Justice Department. Acting U.S. Attorney Audrey Strauss said:  “For more than a decade, Novartis spent hundreds of millions of dollars on so-called speaker programs, including speaking fees, exorbitant meals and top-shelf alcohol that were nothing more than bribes to get doctors across the country to prescribe Novartis’s drugs. Giving these cash payments and other lavish goodies interferes with the duty of doctors to choose the best treatment for their patients and increases drug costs for everyone.” 

As part of the settlement, Novartis admitted and accepted responsibility for certain conduct. Novartis isn’t the only drug company that has faced such lawsuits and fines, but companies continue to do it and, worse, doctors continue to take the money. 

The scary fact about today’s health news media

The Covid pandemic has shown us the harsh and painful consequences of health information being manipulated or misused to serve political or economic agendas. People are confused and don’t know what source to trust. The concentration of influence and the shrinking space of broadcast, print, and radio–particularly local and independent–also coincides with an ever-expanding world of digital news and social media spaces driven by advertising algorithms. 

When it comes to our health, these trends are especially worrying. How can we trust news about our family’s medicine from the same sources that are selling it or being funded by its makers? Can we count on unskewed evidence or rich nuance on medication safety and side effects from a health site that counts shareholder profits  above readers? The alarming fact is that today’s number one source of online health information, WebMD, is owned by a private equity firm and is valued at over $3 billion based on its ability to sell products through advertising.

Why You Can Trust MedShadow 

MedShadow is a nonprofit and does not accept support from pharmaceutical companies. Independent and reader-supported health journalism is more critical than ever before. We are on a mission to provide you and your family lifesaving, life changing health news and information through our balanced and trusted reporting. 

You deserve health facts independent of pharma control. You deserve MedShadow. 

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Beware of New Alzheimer’s Drug, Aduhelm: Although Approved, It Could Be Dangerous

Editor’s Note 11/23/2021: Researchers recently published data showing that 41% of patients on the therapeutic dose of Adhuhelm in clinical trials experienced brain bleeds. Fewer than a third of those patients experienced symptoms. The New York Times reported one death under investigation. Some researchers worry that clinical trial participants were much healthier and therefore not representative of patients now likely to be prescribed the drug. 

The newly approved drug Aduhelm (aducanumab) won’t cure or reverse the effects of Alzheimer’s disease. It might slow the disease’s progression, but there’s no proof that it will do that either. Even worse is that “more than one-third of trial participants developed brain swelling and 17% to 19% had small bleeds in their brains.” 

Autopsies have revealed that those who suffered from Alzheimer’s harbor a buildup of amyloid protein in their brains. The theory — and the hope — is that a drug such as Aduhelm, that can block the growth of amyloid plaques will also slow the progression of Altzheimer’s. But that has never been proven.

When the Food and Drug Administration (FDA) asked its own independent advisory committee if the benefits of Aduhelm outweighed the risks, not one member voted yes. 

Full disclosure: I’m a member of a different FDA advisory committee. In my experience sitting on an FDA advisory committee for the past four years, seldom has an entire panel voting against the approval of a drug. That is an unusual occurrence and should send a very strong message to the FDA and to the medical community that this drug is not ready to be used on patients. Doctors on the advisory committees will often ask for even a weak drug candidate to be approved, because they want it “in their arsenal,” so that patients who don’t respond to better drugs have a third- or fourth-level medicine to try. But the committee did not ask for Aduhelm to be approved. The doctors don’t even want it in their arsenal as a last resort. 

Protecting patients from drugs with unreasonable risks and unsubstantiated promises of efficacy is the reason the FDA was created. Its job is to ensure that all drugs are effective and safe. Or, at the very least, that the benefits of the drug outweigh its risks of harm.

Eventually, Aduhelm may be proven effective at slowing the progression of Alzheimer’s. However, the “accelerated approval” that the FDA granted Aduhelm gives its manufacturer Biogen nine years to produce a study that shows it’s safe and effective, all while it’s available for doctors to prescribe to any patient. For nearly a decade, an unproven, dangerous drug can be prescribed to people who are desperate for a cure for Alzheimer’s. Patients have the right to assume that a drug approved by the FDA is safe and effective. This approval undermines the entire reason for the FDA’s existence. 

Another drug, Makena, was approved on the “accelerated” pathway by the FDA. It’s a synthetic progesterone given to pregnant women at high risk for preterm birth. After 11 years, the manufacturer was unable to produce a study showing that it helped avoid preterm birth. This year, a study from the Endocrine Society reported that the children who were exposed to Makena in utero have twice as many cancer diagnoses as those who weren’t exposed to the drug.

This is why MedShadow exists: to ensure that the public has the information that some drugs – like Aduhelm — are drugs without proof that it works, with no long-term studies for safety and very high short-term risks. If your doctor recommends this drug, get a second opinion. Just as we reported on Makena, we will continue to report on Aduhelm. 

 

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Need To Know- Alzheimer’s Medications

 This article was reviewed by George Grossberg, MD, member of our MMA Board.

In June, 2021, the FDA fast-tracked approval for a first-of-its kind  Alzheimer’s drug. Aduhelm (Biogen) is extremely pricey and may be effective in targeting and affecting the underlying disease process of Alzheimer’s, writes Patrizia Cavazzoni, M.D., director of the Food and Drug Administration (FDA) Center for Drug Evaluation and Research in a recent statement. The drug was approved through an expedited pathway, which requires that the clinical trial demonstrate the drug’s safety, and that it has an impact on a biomarker (in this case, reducing amyloid plaques) that researchers believe suggest the drug will be clinically effective. The company does not have to show that reducing amyloid actually lessens symptoms. The FDA also asked Biogen, the manufacturer, to do another large study to show that clinical efficacy to be completed by 2030. If that study doesn’t demonstrate efficacy, the drug may be taken off the market.

Previously, there were only a handful of prescription drugs that had been approved by the U.S. Food and Drug Administration (FDA) to slow symptoms.

 These drugs aren’t effective for everyone, they only work temporarily and they don’t stop the disease, but they are often part of a comprehensive treatment plan. 

While no one knows what causes Alzheimer’s, studies show some correlation with certain drugs. See the MedShadow article: The Link Between Dementia, Alzheimer’s and Common Meds. Prior to Aduhelm’s approval, there were only two types of FDA-approved medications to treat Alzheimer’s: An N-methyl D-aspartate (NMDA) antagonist called Namenda (memantine) and a class of drugs called cholinesterase inhibitors, including Aricept (donepezil), Razadyne (galantamine) and Exelon (rivastigmine). There’s also a combo of memantine and donepezil called Namzaric.

How They Work (Method of Action)

Cholinesterase Inhibitors

In Alzheimer’s disease, a brain chemical called acetylcholine that helps with memory, learning and attention, starts to break down. Cholinesterase inhibitors like Aricept, Razadyne and Exelon stop this chemical disruption, increasing acetylcholine levels. The bad news is that as Alzheimer’s progresses and brain cells die, your brain starts making less and less acetylcholine, so these drugs are only effective for a while. Razadyne and Exelon are prescribed for mild or moderate Alzheimer’s, the Exelon patch is for severe Alzheimer’s, and Aricept is approved to treat all stages. Doctors often say Alzheimer’s disease has stages. Here is a breakdown of treatments, the strategies being used currently and their side effects. 

Memantine 

Namenda (memantine) helps regulate glutamate, a brain chemical needed for cognition and memory. Glutamate levels tend to increase in Alzheimer’s disease, which can lead to the death of brain cells. Memantine may help protect your brain from becoming more damaged. It can also help some people perform their tasks of daily living for longer. Namenda is prescribed to treat moderate to severe Alzheimer’s.

Namzaric, a combination of memantine and donepezil, has both effects, stopping acetylcholine breakdown and keeping glutamate levels regular. It’s used to treat moderate to severe Alzheimer’s.

Side Effects and What to Do About Them

Cholinesterase Inhibitors

As a whole, cholinesterase inhibitors have common side effects of nausea, vomiting, diarrhea and appetite loss. It may help to take these medications with food, as well as to start on a low dose and increase slowly as needed.

Along with the gastrointestinal symptoms already mentioned, each cholinesterase inhibitor has its own potential side effects:

• Aricept (donepezil) may cause weight loss, frequent urination, muscle cramps, joint pain and fatigue. You should call your doctor right away or head to the emergency room if you experience serious side effects such as passing out, slow heartbeat, chest pain, difficulty breathing, seizures, pain when urinating, unusual stools or bloody vomit.
• Razadyne (galantamine) can have side effects like dizziness, headache, stomach pain, heartburn and fatigue. Though serious side effects aren’t very common, you should call your doctor immediately if you have any of them, including urination difficulty, bloody urine, pain when urinating, seizures, slowed heartbeat, shortness of breath, fainting or unusual stools or vomit.
• Exelon (rivastigmine) can cause indigestion, muscle weakness, stomach pain, constipation and gas. If you have signs of an allergic reaction like rash, hives or difficulty breathing, unusual stools or vomit, pain with urination, seizures, depression, anxiety or aggression, talk to your doctor right away. The Exelon patch has lower gastrointestinal side effects than the oral capsules, noted George T. Grossberg MD, Director Geriatric Psychiatry at Saint Louis University and MedShadow Medical Advisory Board member. 

Memantine

With Namenda (memantine), the most common side effect is dizziness, but headache, confusion and agitation can also occur. Get emergency help or call your doctor immediately if you have shortness of breath or hallucinations.

Since it contains both memantine and donepezil, Namzaric may cause the same side effects as Namenda, Aricept or both.

Drug Interactions

Alzheimer’s drugs can interact with other medications you take, which may make them less effective or increase your risk of serious side effects. For instance, cholinesterase inhibitors may interact with heart medications like beta blockers and calcium channel blockers.

Namenda is known to interact with many drugs, including:

• Acetazolamide (Diamox)
• Amantadine
• Dextromethorphan (Robitussin, others)
• Methazolamide (Neptazane)
• Potassium citrate and citric acid (Cytra-K, Polycitra-K)
• Sodium bicarbonate (Soda Mint, baking soda)
• Sodium citrate and citric acid (Bicitra, Oracit)

Be sure to tell your doctor about all the prescription medications you’re taking, as well as over-the-counter medications, herbal supplements and vitamins, to prevent drug interactions.

Effectiveness and Considerations

Alzheimer’s disease can’t be cured, but cholinesterase inhibitors and memantine can decrease symptoms and may help patients remain independent for a longer period. New treatments are being researched and show promise for the future, but as of right now, these drugs are the only FDA-approved pharmacological options available.

Cholinesterase Inhibitors

Overall, the average person with mild to moderate dementia may experience a small amount of improvement in cognition, activities of daily living and symptoms like depression, anxiety, irritability, aggression and lethargy when taking cholinesterase inhibitors. Some studies have shown that the benefits of these drugs are highly variable and individual. Since all three types work similarly, using a different cholinesterase inhibitor likely won’t create a noticeable difference. However, your doctor might prescribe a different type if you’re having issues with side effects. 

Research on cholinesterase inhibitors for severe dementia, show effects that seem to be similar to those found in people with mild to moderate dementia.

Memantine

Studies have shown that memantine may have some modest benefits for people with moderate to severe dementia, but there’s very little evidence to show that it helps symptoms of mild dementia. Namzaric (memantine and donepezil) can also modestly improve cognition in Alzheimer’s patients with severe dementia.

Because people can respond differently to these drugs, your doctor will make medication decisions based on side effects that you might be experiencing and how you’re responding to the medication. 

User Experiences

Bob Hogan

When Bob Hogan was diagnosed with mild vascular cognitive impairment in 2013, his doctor started him on Aricept. “He hated it, as almost all Alzheimer’s patients I know do,” says his wife and caregiver, Mary Hogan. “In Bob’s early-stage support group, gripes about Aricept were a weekly staple. Bob blamed every negative symptom on that drug — fatigue, memory loss, confusion, diarrhea, constipation, gait problems, you name it. Aricept has a serious PR problem in the Alzheimer community.” In fact, Bob secretly stopped taking the Aricept after about a year. Eventually, his neurologist switched him to galantamine, which he’s still on. “He doesn’t hate it,” says Mary. 

Bob’s disease progressed to vascular Alzheimer’s about a year ago. “Bob’s cognition has been pretty good for a long time, which may or may not be due to that drug. It’s hard to say,” Mary says. Though she tends to be on the anti-drug side, she says, “we live with his disease, not die with it. Whatever medication helps both of us achieve that goal, I’m all in.”

Mary’s bluntly honest about the struggles caregivers face. “Every spousal Alzheimer’s caregiver I know eventually questions their spouse’s drug protocol. As in, ‘Why am I giving my husband a beta blocker and statin only to extend his life into incapacity?’ It’s a national conversation we need to have. Is life at all cost worth life at all cost? Not only financially, but emotionally. Isn’t it cruel to help your loved one live all the way to zombie? Horrible to say, but a very real question that we all face. For me, my goal is to give my husband a happy ending, so to speak. As he enters the later stages of his disease, I want our days to be filled with love and ease.” 

Jeanne

Dori’s mother, Jeanne, was diagnosed with cognitive impairment in 2011 and Alzheimer’s disease in 2016. After Jeanne’s Alzheimer’s diagnosis, her doctor put her on 5 mg of donepezil. At first, she experienced nausea and dizziness, but moving the timing so that she took the medicine with dinner instead helped the nausea. Since Jeanne has been declining slowly and steadily for the last 3-1/2 years, Dori says it’s difficult to determine if the donepezil has been beneficial. 

“In May 2019, we doubled her dose to 10 mg (5 mg, twice a day, with breakfast and dinner) due to a marked decline in behavior and an increase in occasional belligerence,” Dori says. “She tolerated the increase seamlessly, but there was no marked improvement. I have to believe the medication works to slow the decline of this insidious disease.” If nothing else, “we have the comfort and reassurance of knowing we’ve done everything currently possible to preserve Jeanne’s cognitive health,” says Dori. 

Judy
Jocelyn’s mother, Judy, was diagnosed with an unspecified cognitive disorder at the age of 69. She was prescribed Exelon and Namenda together and was on them until her death in November 2019. Though it seemed like the medications helped Judy retain a lot of her memory, “there’s nothing to compare it to,” Jocelyn says. She thinks Judy had side effects of nervousness and being unclear in the morning, but since she was taking other medications for sleep as well, it wasn’t clear which ones were causing these side effects. Jocelyn says it’s important “to work with a neuropsychologist who is experienced with these medications and the patient population.”

Alternatives
There are more and more vitamins, supplements and herbal remedies on the market all the time that claim to boost memory and prevent or delay Alzheimer’s disease. These natural remedies, such as vitamin B, vitamin E, caprylic acid and coconut oil, coenzyme Q10, ginkgo balboa, huperzine-A and Omega-3 fatty acids, must be considered carefully since they have little to no scientific evidence to prove that they work. What’s more, since the FDA has no control over these supplements, there’s no way to know how safe they really are. 

In February 2019, the FDA took action against 17 companies illegally selling supplements that claim to treat, delay or cure Alzheimer’s disease. These brain-enhancing supplements, also known as “nootropics,” “smart drugs” and “cognitive enhancers,” are becoming increasingly popular in the United States. 

One such nootropic called piracetam is commonly prescribed in Europe to treat dementia and other cognitive disorders, but the FDA doesn’t allow piracetam to be sold as a dietary supplement in the United States because its effectiveness is unclear. However, a 2019 small study of over-the-counter supplements for cognitive enhancement found that people who buy them may be getting high doses of piracetam, which can lead to side effects like anxiety, depression, drowsiness, insomnia, agitation and weight gain. Piracetam also has unknown risks, so high doses could be dangerous. Be sure to talk to your doctor about adding any alternative remedy to your treatment plan. There may be drug interactions, side effects or issues you didn’t know about.

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Debate Erupts (Again) Over Women’s Libido Drugs

August 11, 2021 by Teresa Carr

In the fall of 2016, sex therapist and researcher Leonore Tiefer shuttered the New View Campaign, an organization she had founded to combat what she refers to as “the medicalization of sex” — essentially, the pharmaceutical industry’s efforts to define variations in sexuality and sexual problems as medical issues requiring a drug fix.

For 16 years, the group had fought against industry’s involvement in sex research, including its push for a drug to boost women’s sex drives. New View hosted conferences and its members penned papers and testified before the United States Food and Drug Administration. The campaign was prominently featured in an 80-minute documentary called Orgasm Inc, and promoted a clever (if off-pitch) video advising women to “throw that pink pill away,” a reference to the female-libido drug flibanserin (Addyi), which was seeking FDA approval at the time.

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MATTERS OF FACT: Exploring the intersection of science & society.

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New View counted some successes: The FDA didn’t approve an allegedly libido-boosting testosterone patch for women, on the grounds that the patch’s slim benefits didn’t outweigh its risks, and the FDA twice rejected flibanserin for the same reason. But in August 2015, the agency reversed itself and approved the so-called pink Viagra. “I felt we’d said everything we had to say,” said Tiefer of ending the campaign. Advocates predicted FDA approval would be sought for additional women’s libido drugs, but the group felt there was nothing they could do to stop it. “However many more drugs were going to come down the pike,” said Tiefer, “it was just going to be more of the same.”

Indeed, four years later all was quiet when the FDA approved bremelanotide (Vyleesi), a libido drug that women inject into their abdomen or thigh at least 45 minutes before sex. The study results had been decidedly unimpressive: Participants who received the drug didn’t report more satisfying sexual events than those getting a placebo shot, and they scored only slightly better on measures of desire. Further, four out of 10 women taking the drug reported that it made them nauseous.

“There really was no opposition in 2019,” said Tiefer, speaking for herself and others that had spoken out against flibanserin’s approval. “We all had pink Viagra fatigue of one sort or another.”

In March, the Journal of Sex Research published an analysis casting doubt on the methodology behind the two pivotal studies of bremelanotide. The study’s author, Glen Spielmans, a psychology professor at Metropolitan State University in Minnesota, accused industry-sponsored researchers of cherry-picking favorable findings. Reinvigorated by this new paper, Tiefer reached out to a few like-minded colleagues to “make a little noise.”

In explaining the rationale for approving female-libido drugs, the FDA often cites the “unmet medical need.” Yet researchers are fiercely divided over the question of just how many women lack libido and how best to help them. If you believe advertising for Vyleesi, American women suffer from an epidemic of insufficient horniness. More than 6 million premenopausal women — one in 10 — have low sexual desire, the website claims.

Research doesn’t support the notion that millions of women are sexually deficient, said Tiefer, whose long career includes more than three decades as an associate clinical professor of psychiatry at the New York University School of Medicine. “There is no standard of what is ‘normal sexual desire,’” she said, noting that desire varies widely and depends heavily on a woman’s personal situation and culture. After all, she points out, in the 19th and early 20th centuries some doctors diagnosed nymphomania in women deemed to enjoy sex too much.

Everyone I talked to agrees that losing the spark that once kindled enjoyable sex is a real and distressing problem. Some doctors told me that they were glad to have drug options that might help enflame a woman’s lost desire. But Tiefer said in all 40 years as a sex therapist, she has never had a patient complaining of low libido who did not also have physical, emotional, or relationship issues. “If you want to have a better sex life, read some books, and ask some questions, and talk to knowledgeable people,” she said. Just don’t think that a pill or shot will fix it.

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In 2014, the FDA held a two-day meeting to gather perspectives on female sexual dysfunction from scientists and patients. Accounts of the event describe a sea of speakers and attendees wearing teal scarves signifying their association with the advocacy group Even the Score. Sprout Pharmaceuticals, the maker of flibanersin, helped fund the campaign, which enlisted women’s groups and even members of the U.S. Congress in lobbying the FDA to approve the drug on the grounds of gender parity. Men had 26 drugs to treat sexual dysfunction, the group decried, while women had none.

Those claims are misleading. To reach that inflated count, you would need to include both brand name and generic forms of a handful of erectile dysfunction drugs such as sildenafil (Viagra). Of course, these address ability not desire. The FDA has approved numerous forms of testosterone as a replacement therapy for men with low levels of the hormone; but not for treating sexual dysfunction.

Lost in the outrage over sexism was the reality that flibanserin, a failed antidepressant that causes drowsiness, also isn’t a great libido drug. Only about 10 percent more premenopausal women taking it report meaningful improvement compared to those who got a placebo, according to the FDA. And it carries a black box warning cautioning that combining it with alcohol or a long list of medications — including certain antibiotics, as well as drugs to treat yeast infections and high blood pressure — can lead to low blood pressure and fainting. Recently, the FDA announced that it was evaluating the need for regulatory action after a spike in reports of adverse reactions to the drug.

In commentary published in the New England Journal of Medicine, FDA scientists acknowledged the influence of women’s testimony at the 2014 meeting about how low desire affected “their sense of identity, emotional well-being, and relationships.” The authors noted that some members of an independent committee who recommended approval found it a difficult decision. In general, the FDA scientists wrote, those voting yes “acknowledged the small treatment effects and substantial safety concerns but considered the unmet medical need.”

The 2014 meeting also persuaded the FDA to change its criteria for whether a female libido drug works according to the agency’s 2016 guidance to industry. Drugmakers still had to demonstrate that women taking the drug improved their score on questions about sexual desire. But companies no longer had to show that women had more satisfying sexual events, just that they reported less distress — a switch would turn out to be crucial to the approval of bremelanotide.

In his analysis, Spielmans points out that researchers dropped sexually satisfying events as a primary measure of effectiveness in the bremelanotide trials after the studies were complete. Women in the bremelanotide group didn’t report having more good sex, so relying on those results could have sunk chances of approval. That’s only one of the ways the researchers — all of whom had ties to Palatin or AMAG Pharmaceuticals Inc., the company that licensed bremelanotide — failed to adhere to widely accepted guidelines, according to Spielmans. (According to a press release, Palatin and AMAG mutually terminated their license agreement for Vyleesi in January of last year.)

“The risk you run is that they are simply kind of slicing and dicing through the data until they find something that makes the drug look good,” he said.

To prevent that type of cherry picking, researchers are supposed to decide on the endpoints at the beginning of the study. To be fair, the FDA okayed the change in primary outcome measures based on the updated 2016 guidance. And there’s no evidence that anyone “peeked” at the results before changing the endpoints. Still, in its review of the bremelanotide data, the FDA notes that because, overall, women in the study didn’t report more sexually satisfying events, the negative findings for that measure may have been obvious even before analyzing the data to find out who got the drug and who got a placebo.

The research team’s rebuttal published in the Journal of Sex Research was indignant. Researchers said that they changed outcome measures with the FDA’s blessing prior to analyzing results. They also accused Spielmans, who has no research or clinical expertise in sexual medicine, of being out of his depth. (I contacted several of the researchers, all of whom either did not respond to my request for an interview or declined to talk to me.) Spielmans answered in the same journal that he was “disappointed” because the research team “failed to engage with the most pressing concerns raised in my re-analysis.”

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It’s tricky business gauging a woman’s sexual desire. The bremelanotide trials asked women to tally sexually satisfying events (that includes masturbation and fun sexual activities with a partner) each month, but wound up prioritizing more subjective measures. For example, one of the primary endpoints on the bremelanotide trials is based on women’s answers to two questions about their sexual desire over the last month from a 19-item survey:

• Over the past four weeks, how often did you feel sexual desire or interest? [Almost always or always; Most times (more than half the time); Sometimes (about half the time); A few times (less than half the time); or Almost never or never.]
• Over the past four weeks, how would you rate your level (degree) of sexual desire or interest? [Very high; High; Moderate; Low; Very Low, or None at all.]

At the risk of oversharing, I have no idea how to answer those questions. Feeling sexual desire “less than half the time” results in a lower score. But what can I say? I work. We’re in a pandemic. My long-time husband (whom I love dearly) and I have been locked in pretty much 24-7 for a year and a half. Sparks don’t fly every time we pass in the kitchen.

To score high, you need to desire sex all, or nearly all, the time said Adriane Fugh-Berman, M.D., a professor of pharmacology and physiology at Georgetown University in Washington, D.C. “I show that slide in talks because I can usually get laugh from the audience by saying I don’t think this is consistent with having a job or being a full-time student,” she said. “Sexual desire all of the time? Like really?”

Even the FDA is somewhat incredulous of the ratings scale, stating in the 2016 guidance to drugmakers: “it’s unclear whether women experiencing sexual desire all or most of the time would identify this as a benefit, or whether this could represent a different concern to women.”

Still, the agency approved bremelanotide based, in part, on study results showing that women who injected themselves with the drug scored an average of 0.3 points higher on a 6-point scale of desire than the placebo group. The treatment group also scored about 0.3 points better on a 4-point scale measuring how bothered they were by low sexual desire.

The way we attempt to measure sexual dysfunction is heavily influenced by the pharmaceutical industry, said Fugh-Berman, who is an outspoken critic of pharmaceutical marketing practices and medication overuse. So, too, is our notion of the prevalence of the problem, she said. For example, the source of an oft-cited statistic that nearly half of American women are beset by some form of sexual dysfunction is a survey from 1999. As Undark reported in 2016, two of the three researchers were linked to drug companies and other scientists have questioned the methodology. “The so-called epidemic of female sexual dysfunction is a lie,” said Fugh-Berman.

Maureen Whelihan, a gynecologist in Greenacres, Florida who specializes in sexual medicine, also doesn’t take much stock in the questionnaires used in clinical trials. In practice, she may use short screeners to check for anxiety, depression, and how satisfied a woman is with her sex life. Then she dives into a conversation with patients about how to address their concerns. Sexual dysfunction is a complex problem that is often intertwined with mood disorders, but along with diet, exercise, and counseling, female-libido drugs can also play a role in treatment, she told me: “I’m always a believer of an approach that really includes all parts.”

If women do have a vast unmet need to boost libido, the available medications apparently aren’t filling it. Shortly after the FDA approved flibanserin, Valeant Pharmaceuticals (now Bausch Health Companies) bought Sprout for $1 billion. After two years of dismal flibanserin sales, and facing a lawsuit, Valeant sold the company to a group of former Sprout shareholders in exchange for a small royalty on future sales. Sales have since increased with doctors writing more than 27,000 prescriptions for the drug so far this year compared to only about 6,000 prescriptions in 2018, according to the health analytics company IQVIA. Still, that would treat only a fraction of the women Sprout claims suffer from low desire. “In fact, there was not this groundswell of women clamoring for this drug,” said Fugh-Berman. “That was a public relations fiction.”

In the third quarter of 2021, Palatin reported netting only about $89,000 from sales of Vyleesi.

Whelihan routinely prescribes flibanserin, she said, although most patients don’t wind up taking it long term. She has offered to prescribe bremelanotide, but when women hear that it’s a shot that frequently causes nausea, most want no part of it, she said: “It went across sort of like a lead balloon.”

As for Tiefer, she’s still looking for ways to “make noise” about female libido drugs, through journal articles and editorials as well as talking to journalists like me. At this point, she’s not expecting to have much impact on the FDA’s decision making. “The goal is to raise the public’s awareness that these drugs are promoted by interested, profit-oriented parties,” she said, “and that the consumer, the patient, needs to be smart and not duped.”

This article was originally published on Undark. Read the original article.

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Women May Need Lower Drug Doses Than Men

Monica Gandhi, who treats patients with HIV, has noticed that some of her female patients skipped or adjusted their doses due to side effects, she told MedShadow in 2020. One reason, explained Gandhi, an MD, MPH, professor of clinical medicine at University of California, San Francisco, is that the doses of many HIV drugs were designed for and tested primarily in men.

It’s not just something that’s happening with HIV drugs. Women report nearly double the number of adverse effects as men across most types of medications. Women absorb and metabolize many drugs differently than men do, meaning that determining the optimal dose takes more than adjusting based on a person’s weight. Women may be “routinely overmedicated,” researchers concluded from a study published in 2020, showing that despite an increase in women participants in clinical trials, scientists still rarely analyzed gender differences in medication response.

Factors That Influence the Magnitude of a Drug’s Effects

Stomach Acid and Contents

A lot of factors can determine how strong a drug’s intended—or unintended—effects are on each person. When you swallow a pill, it travels down the esophagus and into your stomach. For some drugs to work, they need to be absorbed in a receptive environment, explains Eileen Hoffman MD, a MedShadow Medical Advisory Board member. “Some drugs require a more acidic environment for absorption, like certain antibiotics -[do].”

That situation generally works better for men, who tend to produce more stomach acid than women.

Additionally, having more food in your stomach can slow down the absorption process. Ever had someone tell you not to drink alcohol on an empty stomach? It’s good advice. When you drink without having eaten first, alcohol is absorbed faster. That’s why you might feel more intoxicated after having a couple of glasses of wine if you skipped dinner rather than eating, for example, a big bowl of pasta first. The same is true of some drugs our doctors prescribe for us, though that fact stands for both men and women.

To be safe, always ask your doctor or pharmacist if a drug should be taken on a full or empty stomach. 

How It’s Stored in Your Body

Once a drug is absorbed, it makes its way around your body to its intended target. It also gets stored in water or fat cells before it’s broken down by enzymes in the kidneys and liver. Those drugs stored in fat are broken down more slowly than their waterlogged counterparts. That means two things: first, any side effects are likely to last longer and, second, subsequent doses can build on any drug still left in your tissue, exposing your body to higher levels of it. Women have a higher proportion of fat tissue than men do, which can lead to differences in drug storage and metabolism. 

The Food and Drug Administration (FDA) recommended in 2013 lowering the dose of Ambien (zolpidem), a popular, powerful sleep drug, after many people were found to still be impaired the morning after taking it. Researchers discovered that women were especially susceptible to maintaining higher levels of the drug in their blood the morning after taking it, which has led to some car accidents.

Which Drugs Should Women Watch Out For?

Many other factors influence the way our bodies interact with drugs from our diets, hormonal fluctuations and more. In the 2020 study, researchers found that the dosage of 86 different drugs should be different for men and for women. When men and women received the same doses, women had higher levels of the drug in their blood, and it stayed there longer. This led to women reporting worse side effects in everything from nausea to hallucinations and heart rhythm problems. Those drugs included a variety of classes, from antidepressants to pain medications to cardiovascular drugs.

Hoffman offered some examples. For pain, women respond to lower doses of opioids than men. For heart arrythmias, women do well with lower doses of Digoxin than men. When it comes to treating depression, she says, women are much more sensitive to the most common antidepressant drugs, selective serotonin reuptake inhibitors (SSRIs) like Zoloft, but men tend to have stronger responses to tricyclic antidepressants, such as Nopramin.

What to Ask Your Doctor

1. How and when were the clinical trials for this drug done in both men and women?
2. What have researchers found in how the drug affects men and women?
3. How does it interact with hormones? How does being premenopausal, postmenopausal or on hormonal birth control make a difference in the drug’s side effects?
4. Where does the drug sit in the body? If it stays in the fat tissue, how might that affect me?

 

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Kids with obesity need acceptance from family and friends, not just better diet tips, to succeed at managing their weight

Hundreds of programs over the past four decades – from the removal of junk food from school vending machines to Michelle Obama’s “Let’s Move” campaign – have tried to get kids in the U.S. to eat healthier food and exercise more often.

But none of these efforts lowered national child obesity rates. In fact, child obesity has continued to increase. This has been particularly true during the pandemic.

We think we know why. Most programs that seek to lower children’s body mass index, or BMI, focus on healthy food and physical activity. But as child obesity researchers who specialize in human development and family science, we know that slimming down requires much more than attention to diet and exercise.

Those factors are important, but we found that acceptance from family and friends also plays a critical role in slowing the rate of weight gain for children with obesity.

To reach this conclusion, we collaborated with colleagues to follow almost 1,200 children in first through fourth grades in rural Oklahoma to find out more about the lives of kids who are overweight or obese. Our intervention programs allowed us to compare a traditional food and exercise approach to managing child obesity with approaches that also targeted the social and emotional aspects of children’s lives.

Family and peer acceptance

We conducted a randomized controlled trial in 29 Oklahoma schools. More than 500 first graders who were at-risk for obesity – meaning their BMI was above the 75th percentile – were assigned to either a control group or a group that received a combination of three interventions.

These interventions focused on family lifestyle, family dynamics and the peer group.

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The family lifestyle intervention focused on healthy food and physical activity. Participants learned to use a color-coded food reference guide similar to this one when selecting food. Parents tracked their children’s food consumption and physical activity, and also learned how to avoid conflict over food. This conflict might involve arguing about how much the child is eating, whether the child can have dessert or whether the child has eaten enough of everything else on the table to get a second helping of a favorite food.

The family dynamics intervention added parenting skills and healthy emotion management. Children’s emotion regulation and emotional eating are significantly related, so teaching children to manage their feelings may reduce their tendency to eat when they are stressed out or upset. Children were taught how to deal with negative emotions, express their feelings and value their uniqueness. Parents were taught to value their children’s emotions, provide comfort and understanding, support children’s problem-solving and accept their children as they are.

The peer group intervention taught social acceptance in the children’s school classrooms. Our research has shown that the more children weigh, the more their classmates tend to dislike them. However we’ve also demonstrated that we can decrease the rejection that happens in elementary school classrooms by teaching children to be more accepting of one another.

Teaching kids to be more accepting of one another can reduce weight stigma and rejection.
kali9/E+ Collection via Getty Images

Effect on obesity

We measured children’s heights and weights at the beginning of first grade and then after the intervention – in first, second, third and fourth grades. Only those children with obesity who received all three interventions – family lifestyle, family dynamics and peer group – had significant decreases in BMI gains compared with the control group.

Ongoing analysis indicates that the peer group intervention was particularly important for children who were severely obese, with a BMI in the 99th percentile.

Our results show that to reduce BMI gains in the early school years, kids need more than healthy food and physical activity. They need parents who encourage their healthy choices and accept their emotions. Knowing you can come home and talk about how angry and sad you are is essential to healthy physical and mental growth. And children must also have friends and peers who accept them for who they are – regardless of how much they weigh.

Amanda Harrist, Professor in Human Development and Family Science, Oklahoma State University and Laura Hubbs-Tait, Professor of Human Development and Family Science, Oklahoma State University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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COVID-19 Vaccine: Your Questions Answered

The FDA has now authorized three COVID-19 vaccines. Both of the first two authorized vaccines rely on an immunity-building strategy that hasn’t been used in any other vaccine. As many of us start rolling up our sleeves to get a shot, here are answers to some of the most frequently asked questions.

What is mRNA? Why does it matter?

All previous vaccines have been based on weakened virus molecules or proteins from the disease (pathogen) that our immune systems can easily overcome while learning to recognize it. The new vaccines from Moderna and Pfizer — the first two to make it to market so far in the U.S. — contain mRNA (messenger RNA), which is a genetic template that instructs our cells to build the viral proteins that our immune systems can then recognize. Its main perk is that by allowing our bodies to produce the proteins (rather than growing them in a lab like in traditional vaccines), it slashes the time it takes to produce the vaccine (as done in the past) in the lab. For nearly 20 years, researchers have been interested in using mRNA in vaccines. Some were even tested in early clinical trials for rabies, influenza and Zika. However, the vaccines for COVID-19 are the first mRNA vaccines ever authorized by the FDA. This long history of studying the mRNA concept is why the vaccine could be developed so quickly. mRNA is new to you and me, but it is well-known to scientists.

Will the COVID-19 vaccine change my DNA?

mRNA is a messenger in your body. It’s the way your DNA tells the rest of your body what proteins to create for various functions. In your body, mRNA is created in the nucleus of your cells, based on the DNA that resides there. Then the mRNA exits the nucleus to be used as a template for protein-making in the rest of the cell, and it has no way back in. Soon, it degrades without ever re-entering the nucleus or coming in contact with DNA. mRNA lives in the body between a few hours and a couple of days.

Like naturally occurring mRNA that has already left the nucleus of your cells, the mRNA vaccine isn’t able to enter your cell’s nucleus. Because of that process, it can’t come in contact with or change your DNA. Click here to see  a video that explains the process more fully.

The Johnson & Johnson vaccine uses a viral vector — a harmless virus-turned-delivery system that’s been used in vaccines before — to introduce the gene that encodes a protein found on the surface of the COVID-19 virus. Our cells then create just this protein (not the whole COVID-19 virus) so our immune systems learn to recognize it. It also will not change your DNA.

Why do I need two shots of the Pfizer or Moderna vaccines?

Multiple doses of the vaccine expose our immune systems to more of the viral proteins, giving it the chance to develop more antibodies and protection. The immunity takes time to develop. Researchers believe that 10 days after the first dose, patients develop about immunity that is 52% effective. About a month after receiving their second dose, immunity can reach 94%. A similar strategy is used for other vaccines, like Shingrix, developed to prevent shingles.

Since the initial assessment, new analysis of the research suggests that two weeks after the injection, a single dose of Pfizer or Moderna’s vaccines is more protective than previously thought, potentially up to 92%.

Will I need a third shot?

Third shots were first authorized for the subset of patients who are immunocompromised due to organ transplants or high doses of corticosteroids. That’s because many of these patients didn’t mount a full-fledged response to the first two shots to begin with, but some studies have shown they respond well to a third. Now, however, as researchers are finding evidence of immunity waning over time, they are recommending third shots for a wider swath of the population, especially those over the age of 65 who are at higher risk, and likely had weaker responses to the first two shots. See the CDC’s guidance on who should get a booster shot here.

How does the FDA decide if a side effect is severe?

The FDA has a toxicity grading scale to rate adverse events related to preventive vaccines. It ranks both local events (like injection site pain) and systemic events (like fever and nausea) as mild (Grade 1), moderate (Grade 2), severe (Grade 3) or life- threatening (Grade 4.) Several effects, like pain at the injection site, headache, fatigue and nausea, are considered Grade 1 if they do not interfere with your activity at all. If side effects do prevent you from doing ordinary tasks, they may be designated Grades 2 or 3. If the symptoms cause you to go to the emergency room for treatment, they are Grade 4.

Is the COVID-19 vaccine safe?

The most common side effects for all three vaccines — headache, fatigue, fever, chills and muscle and joint pain — are more common and intense than those for the flu shot, for example. And the side effects caused by the COVID-19 vaccine tend to be worse after the second shot than the first.

The FDA reported that up to 4.6% of Pfizer vaccine patients, 9.6% of Moderna’s patients, and 2% of Johnson & Johnson’s patients experienced severe (Grade 3) adverse effects. Grade 3 effects are those serious enough to interrupt a person’s life — for example, by causing them to take a day off of work — but not so severe that the person is hospitalized. Younger patients were more likely than older ones to experience severe adverse effects. No life-threatening effects were linked to the Pfizer vaccine and less than 0.1% of patients experience Grade 4 adverse effects to Moderna’s vaccine. Swelling, pain, rashes and redness at the injection site are common.

While some patients have experienced anaphylaxis, all have recovered.

The vaccine will need to be tested on millions of more people for scientists to understand how the vaccine may interact with certain chronic illnesses or other drugs.

Check out MedShadow’s vaccine side-effects tracker for more details and frequent updates on side effects. You can also check out MedShadow’s COVID-19 topic page to find more in-depth reporting on specific findings, like what doctors say about the risk of myocarditis for kids.

How long were test patients followed and why?

The FDA required that patients in the Phase 3 trials be followed for a median of two months after the second shot before the data would be reviewed for its approval.

When it comes to side effects, the CDC considers vaccinations different from other medicines, because they aren’t taken continuously. In general, the CDC designates adverse events that happen within six weeks of administration to be potentially linked to vaccines. In the case of the Pfizer and Moderna vaccines, the mRNA is broken down within days of the injection, so it doesn’t remain in your body long term.

The CDC is tracking possible adverse reactions in early recipients through its V-safe app. The agency initially announced that it would follow these patients for six weeks but has since said it will check in on them at three months, six months and one year after receiving the vaccine. Individuals can also report adverse effects through VAERS, the government’s vaccine adverse event reporting system.

Who has been tested for the vaccine?

The vaccines have been authorized for adults. While Moderna’s and Johnson & Johnson’s vaccines have the okay for patients 18 and older, Pfizer’s original trial included a small number (163) of 16- and 17-year-olds and has been recommended for patients 16 and older. On March 31, the company announced that the vaccine was safe and effective for patients 12-15 years old, and it received emergency use authorization for these patients shortly after. In October 2021, the FDA authorized the Pfizer vaccine for use in children age 5-11. In younger patients, Moderna’s vaccine has been associated with a heightened risk for myocarditis, and regulators are still reviewing data.

The vaccines were effective in both men and women, regardless of weight or race. While Pfizer’s vaccine appears to be just as effective in older patients (65 and older) as in younger ones, Moderna’s vaccine offered slightly less protection (86% compared to 96%) in older patients versus younger ones.

What do we know about how the vaccines work in kids and teens?

Pfizer’s vaccine received Emergency Use Authorization for 12 to 15-year-olds. The company reported that common adverse effects like chills and fever were more common in this age group than adults. Adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%). These effects generally subsided within 1-2 days. While data on syncope (fainting) was not included, the announcement mentioned that fainting after vaccination is more common in teens than adults, and that safety measures should be in place to reduce this risk.

Moderna announced on May 6 that preliminary data suggest its vaccine is also safe and effective in teens, but has not yet published the data or sought approval. In March the company started a trial in patients as young as 6 months to 11 years old. The trial started with very low doses and will increase them to find the lowest effective dose for children. The children will be followed for a full year.

Is it safe for pregnant women? Will it protect the baby?

None of the initial trials included pregnant or lactating women, but since then, several studies have found positive results. Simultaneously, researchers have found that pregnant patients who contract COVID-19 are at high risk for severe complications, preterm birth, and mortality.

The CDC published an analysis of data on from the first few months of voluntary V-safe surveys on April 22 that suggested that the Moderna and Pfizer vaccines are safe for pregnant women. Pregnant patients self-reported slightly fewer side effects like fever, headache and chills than the general population, but more said they experienced nausea and injection site pain. Rates of adverse pregnancy outcomes such as pre-term birth were similar to rates seen before the pandemic. While promising, officials noted that more studies will be required.

Two more studies published in May found that the vaccine does not damage the placenta and that pregnant women developed sufficient immune responses. Antibodies were passed to their babies through blood and breast milk.

An August 2021 study found the vaccines led to antibodies being transferred to the fetus through cord blood.

A study published in October 2021 in the New England Journal of Medicine found that vaccination was not associated with an increased risk of spontaneous abortion.

Is the vaccine protective for everyone?

Recent studies have suggested that in some patients who take strong immunosuppressants for organ transplants, the vaccine may offer little to no protection. After the second shot, only about half of patients who had received an organ transplant developed sufficient antibody responses. It’s unclear how effective the vaccine will be for other groups who are immunocompromised. Catherine Liu, MD, a vaccine and infectious disease researcher at the Fred Hutchinson Cancer Research Center, suggests this is one reason it’s especially important for healthy people who spend time with patients who have cancer or take immunosuppressants (family members and caregivers, for example) to be vaccinated themselves. A clinical trial is underway to determine if other patients with suppressed immune systems mount a sufficient response to the vaccines.

Will the COVID-19 vaccine protect me from mutated versions of the virus?

Researchers have identified several mutated forms of the virus spreading in the UK, South Africa, Brazil, India and elsewhere. While some variants have been associated with a higher portion of breakthrough infections–infections in people who have been fully vaccinated–these patients usually did not end up seriously ill or hospitalized. So far, the vaccines seem to provide substantial protection from these variants, even if that protection is slightly lower than it is for the original SARS-CoV-2 virus. It’s unclear whether or not we’ll need booster shots to protect against future variants, but vaccine manufacturers are studying them now.

Ok, but what about the Delta and Delta Plus Mutations?

The Delta variant is believed to be far more contagious than previous forms of the virus that causes COVID-19. Researcher have suggested it may be more likely to send you to the hospital as well. So far, scientists say that the Pfizer, Moderna and Astrazeneca vaccines are still likely to protect you from the variant—provided you’ve received both doses and two weeks has passed since that second dose.

While a single dose provided pretty high protection from previous variants, its only generates about 33% efficacy against the Delta variant. After both doses, however, a recent Lancet study suggested that Pfizer’s vaccine is 79% effective against Delta, and Astrazeneca’s is 60%. Protection against hospitalization with Delta was higher, at 96% and 92% for Pfizer and Astrazeneca’s vaccines, respectively. Many studies report different numbers because real-life studies lack the controls of clinical trials, but scientists emphasize that the vaccines do seem to provide protection, especially from hospitalization.

“Their overall implications are consistent: that protection against severe disease remains very high,” said Naor Bar-Zeev, an associate professor at the Johns Hopkins Bloomberg School of Public Health told the New York Times.

Moderna released results of a small lab study that suggests its vaccine is still effective against the variant. Johnson and Johnson also released data from small studies suggesting its vaccine is effective against Delta.

In the meantime, social distancing and face masks can still help protect you against Delta and any other variants.

Can I Throw Away My Masks After I Get the Vaccine?

Initially, the CDC recommended that everyone continue to wear masks after being vaccinated because it was unclear whether you could transmit the disease after vaccination. The initial trials only tested those patients who displayed symptoms, so there’s a chance that you could contract the virus and pass it on without getting sick. Newer, real world data suggests that the vaccines do prevent about most transmission. In Israel, where nearly the entire population is vaccinated, data suggest the vaccines prevent 86% of transmission. A hospital study in the U.S. that tested nearly 4,000 employees weekly regardless of symptoms, demonstrated the vaccines prevented 90% of cases.

On May 13, the CDC announced that fully vaccinated individuals (you are fully vaccinated two weeks after you receive the second dose) could lose their masks in most settings. They’re still recommended in certain circumstances, like when visiting hospitals, nursing homes or jails.

Still, no vaccine is 100% effective and it can be less effective especially in people with weakened immune systems. You’ll want to keep protecting those around you who are elderly, have cancer or other conditions that cause immunodeficiencies. You should continue to follow any local or state guidelines regarding mask wearing. These guidelines could change if larger outbreaks occur.

 

Got more questions you want MedShadow to answer? Contact us.

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From DES to Makena and More: The Dangers of Endocrine Disruptors

On this day, half a century ago, a study showed that a drug called diethylstilbestrol (DES) given to pregnant mothers to reduce preterm births, instead raised the risk of a rare vaginal cancer in their daughters to 40 times that of the general population. Since then, scientists have discovered that these so-called DES daughters, sons, grandchildren and the DES mothers are also more likely to experience malformed reproductive organs, breast cancer and a slew of reproductive problems. MedShadow’s founder, Suzanne Robotti, is one of those daughters.  

“Between five and 10 million pregnant women were prescribed DES over 30 years,” says Robotti, who is also executive director of DES Action, a member organization for those exposed to DES. “Mothers trusted their doctors when they were told they needed to take this drug to have a healthy baby. Those mothers were devastated when they discovered how misled they’d been, and how they’d taken a drug that harmed their child.” 

The study was the first to demonstrate that exposure to particular types of chemicals could disrupt a person’s endocrine system, the glands and organs in our bodies that release hormones responsible for guiding our growth, development, metabolism, reproduction and more.  

Since 1971, researchers have continued to follow the women and their children and grandchildren. In April of 2021, 50 years after that initial study, researchers presented results from a study at the Endocrine Society’s annual meeting about the drug Makena, a synthetic progesterone. DES is a synthetic estrogen. The study, finally published on Nov 8, 2021 showed that the children of women who were prescribed Makena during pregnancy had higher rates of cancer than those who were not exposed to the drug in utero. The research also revealed that children, now ages 18 to 58, born to the 181 mothers in the study who had been prescribed the drug, were twice as likely to have any cancer diagnosis, four times as likely to have had prostate cancer and five times as likely to have had colon or rectal cancers.   

But it’s not just DES and the various newer-generation versions of the drug that can disrupt a person’s endocrine system. These exposures are just the easiest to study. “The model endocrine disruptor has always been [DES], which is a synthetic estrogen,” says Barbara Cohn, PhD, an epidemiologist and the senior author of the new study. The drug has helped researchers understand how chemicals can mess with our endocrine systems, but it is far from the only chemical capable of doing so.

Since that first study in 1971, scientists have identified more than 1,000 similar chemicals in our plastics, cosmetics and even foods. It’s more difficult to isolate the effects of these everyday exposures on our bodies, but the research on DES and similar drugs made it clear that these chemicals can cause myriad birth defects and cancers, not only in those exposed, but also in their children and even their children’s children.

The DES Story

After DES was invented in 1938, doctors began prescribing it to pregnant women almost immediately, in hopes of prolonging their pregnancies and increasing the likelihood of a healthy birth. “It was marketed as a way to make normal pregnancy more normal,” says Martha Cody, a DES daughter who has suffered endometriosis and an ectopic pregnancy, likely as a result of her exposure to the chemical.

The first hints that the drug didn’t actually help prolong pregnancy or prevent miscarriages came in 1953. However, with few other options, many doctors continued to prescribe the drug, thinking that it caused no harm, and could possibly help.

“Doctors believed that they were helping people. It was true that this clinical trial in the fifties suggested it didn’t do much. But clinical trials were new in the 1950s,” says Cohn. “And we also have on the other side, patients who are desperate to have babies, who want help. It’s a formula for potential disaster.”

In the late 1960s, eight girls between the ages of 15 and 22 were diagnosed with a rare vaginal cancer, adenocarcinoma (CCA). The cancer was rare for all ages, but especially in a group this young. Researchers made the connection that these girls had been exposed to DES in utero, when their mothers were pregnant and published that  observation in the New England Journal of Medicine on April 22, 1971. The Food and Drug Administration (FDA) then notified doctors that they shouldn’t prescribe the drug. That caused many doctors to reach out to patients to let them know they should be screened for vaginal cancer. Since then, researchers have uncovered increased risks of breast cancer, endometriosis, infertility, malformed uteruses and more.

The Problem Continues

That wasn’t the end of endocrine disruptors. It wasn’t even the end of using synthetic estrogen during pregnancy. After DES was taken off the market in1971, manufacturers introduced a new version, Delalutin. In 2008, the FDA removed that drug, too. Later, the agency approved a  new version called Makena. 

Makena, like its predecessors, has been shown to be ineffective. The Center for Drug Evaluation and Research (CDER) proposed that it, and its generic forms, be removed from the market in March 2021. DES Action advocated for this decision.

“Preterm birth is a really terrible thing that has awful consequences. There aren’t any easy treatments for recurrent preterm birth,” says Cohn. For that reason, Makena had been approved through a special accelerated approval pathway for medicines that treat conditions for which there are no other choices. It was approved long before releasing the Phase III clinical trial results. As it turns out, the trials demonstrated the drug’s lack of efficacy. 

“People are wanting to prevent this and to do a better job at helping women avoid this outcome of their pregnancies,” adds Cohn. She explained that the naturally occurring hormone progesterone is known to “contribute to the quieting of the uterus and to the ability to contain the pregnancy and keep it there. That’s how these treatments were devised.” 

Unfortunately, we’ve seen time and time again that, in practice, these synthetic hormones don’t act upon the body in the identical manner as do naturally produced hormones.

The new study may just be the start of our understanding of the harms that Makena may have caused. As the women age, more effects may become clear, just as they did with DES.

Cohn explains that she and her researchers were inspired to look at Makena’s impacts because the rate of colon cancer in people under 50 has doubled over the past 30  years. However, even the fivefold increase in risk of colon cancer they found among those exposed to Makena in utero can’t explain all 18,000 cases that experts estimate will be diagnosed this year. There must be other factors at play, one of which may be endocrine disruptors seeping into our everyday lives.

Endocrine Disruptors All Around Us

While DES and Makena were designed to have biological effects on our bodies, many endocrine-disrupting chemicals (EDCs) came about by accident. Most were never intended to be consumed, but now they find their way into our bodies as pesticides on food, BPA in our water bottles and  even absorbed through our skin in lotions and cosmetics. We continue to learn about more EDCs , like polyfluoroalkyl substances (PFASs) in our food packaging or the microplastics leaching into the ocean. In the early 2010s, several national and international organizations, including the World Health Organization (WHO) and the United Nations Environment Programme recognized EDCs as a serious threat to the health of both humans and wildlife. 

In 2018, a trio of researchers set out to advance our understanding of endocrine disruptors beyond the synthetic estrogens given to pregnant women. The team researched a variety of chemicals thought to interfere with our endocrine system and published a study outlining four different categories of endocrine disruptors, using bisphenol A (BPA), phthalates, polychlorinated biphenyls (PCBs) and vinclozolin, thereby laying the groundwork for major progress in the field. 

One well-known endocrine disruptor is dichlorodiphenyltrichloroethane (DDT)—the now-banned pesticide. Cohn and her team published a study in April 2021 that showed that the grandchildren of women who’d been exposed to DDT went through puberty at a younger age and were more likely to develop obesity than those who weren’t exposed. The team has been following women who had DDT in their blood during and shortly after pregnancy for decades. A previous study showed that the women and their daughters were both at higher risk for breast cancer than women who were not exposed to the chemical. Since the granddaughters in the current study were a median age of 26, it’ll probably be another couple decades before we know if, like their mothers and grandmothers, they’re at higher risk for breast cancer. 

Other endocrine disruptors in the environment have been linked with lower sperm levels in men and attention deficit hyperactivity disorder (ADHD) in adolescents.

“We know that endocrine disruptors can affect at least three generations. We need a lot more research on what level of endocrine exposure, if any, is safe: can endocrine disruptors accumulate in the body over time to toxic levels? Do different endocrine disruptors have differing effects on the body and the children of those exposed?” says Robotti. “And, most importantly, we need to know how each individual can limit their exposures.” 

Researchers have identified thousands of different chemicals that may act as endocrine disruptors. They’re in canned foods, detergents, toys and brake fluid. One of the most well-known today is bisphenol-A (BPA), found in water bottles, canned foods and other plastics. Since laboratory tests showed that the chemical was capable of disrupting hormones, several countries have restricted its use. The FDA as well as some states have banned BPA in some products, such as baby bottles, but it is still legally used in many others. 

Simultaneously, many companies now make products labeled “BPA-free,” even if they aren’t designed for babies. Researchers have pointed out, however, that exposure to the chemicals used to replace BPA, such as bisphenol S (BPS) and bisphenol F (BPF), may be just as bad for our health as BPA.

What You Can Do

The Endocrine Society offers a  list of ways to minimize your and your children’s exposure to endocrine disruptors at home. The Environmental Working Group provides one as well. Some of the suggestions include: 

• Read labels
  • On plastic bottles, a #1, #2 or #4 in the recycling sign means that the product is free of BPA, a still commonly used EDC. Shower curtains, raincoats, flooring and outdoor furniture will be similarly labeled for polyvinyl chlorides (PVCs) or “PVC-free,” as will canned food with BPA-free liners. Labels on cleaning supplies, facial washes and detergents also indicate the presence or absence of some EDCs, such as phthalates, known to be a potential risk.
• Reduce plastic use
  • Use plastic rarely and limit your exposure to it.
  • Keep plastic containers out of the heat and sun, which can cause chemicals to leak from the plastic into food or water.
  • Use only phthalates-free face wipes and cleaning supplies, whose toxic products will be indicated on labels. .
• Avoid bottled water. Drink filtered instead, whenever possible.
• Reduce pesticide use at home; bugs have a role in the environment, so try to put up with them. 
• Wash fruits and vegetables from the store with tap water.
• Avoid canned food. Cans can be lined with BPA or similar toxic products.

The Endocrine Society regularly advocates for legislation  that helps the public understand endocrine disruptors in their environment and minimize their risks. You can keep up to date on its website. 

if you were exposed to DES through your mother or grandmother, or think you might have been, go to the DES website to learn more. 

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