Tag Archives: FDA

The FDA finally approved a condom for anal sex. Here’s why it’s a good thing

Whether you’re in a committed relationship or prone to the throws of lust (or both, we’re not judging), you need to protect yourself and your partner — which usually means using a condom.

Still, as humans tend to be, we’re not always careful. We like to experiment, we sometimes falter — and pick up sexually-transmitted diseases (STDs). Whatever the reason, condoms are a great way to stay safe and can be used by people of the appropriate age just about anywhere–and they can also be lots of fun. Now, there’s a new type of condom on the block.

A victory for all genders and denominations

There’s never been an approved condom specifically for anal intercourse. Until now, condoms on the market were only approved for vaginal intercourse, which omits a large section of our society.

Condoms for vaginal sex currently on the market are recommended for use during anal or oral intercourse by the Center for Disease Control – meaning they’re legally backed by a drug agency for one activity and informally deemed effective for another in what is known as ‘off-label’ use. But the US Food and Drug Administration (USFDA) has finally approved the first condom for anal sex: the ONE Male Condom.

The approval is seen as a victory for sexual health and especially important for the LGBTQ community, who, until now, have not had a condom aimed specifically at them. Courtney Lias, director of the USFDA’s Office of GastroRenal, Obstetrics-Gynecological, General Hospital, and Urology Devices, says:

“The risk of STI transmission during anal intercourse is significantly higher than during vaginal intercourse. The FDA’s authorization of a condom that is specifically indicated, evaluated, and labeled for anal intercourse may improve the likelihood of condom use during anal intercourse.” 

What’s different with this condom

The newly approved condom is a natural rubber latex sheath that covers the penis. It’s available in three different versions: standard, thin and fitted. The fitted condoms, available in 54 different sizes, incorporate a paper template to find the best condom size for each user to minimize leakage. Global Protection Corp, which makes the condom, stresses that during anal intercourse, users should employ a compatible lubricant with their condom and all other brands.

“We want people to have lots of sex — but we also want them to be empowered and informed,” said Davin Wedel, president of Global Protection Corp.

Scientists studied the safety and efficacy of the condom in a clinical trial comprised of 252 men who prefer sex with men and 252 men who prefer intercourse with women. All volunteers were between 18 and 54 years of age. 

Results show the total condom failure rate was 0.68% for anal sex and 1.89% for vaginal intercourse. Researchers defined the condom failure rate as the number of slippages, breakage, or both slippage and breakage events over the total number of sex acts recorded in a diary by participants.

Disappointingly, the trial didn’t calculate the STD baseline as too many variables (such as not wearing a condom) could cause infection during the trial. Therefore, the rate of STDs was not measured at the beginning of the study and compared with later data. Despite this, the trial center did allow participants to self-report any genital-based infections which could have resulted from the use of a different condom brand before or during tests.

The researchers from Emory University who were behind the study said an essential reason for the trial’s success was that volunteers used lubricant, which prevents slippage and breakage, and the inclusion of instructions.

Taken together, these findings suggest that health bodies should provide lubricant along with the billions of condoms distributed as part of HIV and STD prevention efforts to minimize failure. 

The USFDA will help get more condoms like these on the market

The USFDA is responsible for controlling and supervising food, tobacco, dietary supplements, prescription drugs, blood transfusions, medical devices, cosmetics, and animal & veterinary products. They achieve this by inspecting manufacturing premises and reviewing the safety and effectiveness of a product before a business can sell it on the market after it has undergone extensive clinical trials that can last for over a decade.

A rigid classification, under the terms of a De Novo, the submitting company, must prove that their product presents a ‘medium risk’ to humans. In contrast, under the 510(k) submission, an organization only has to show their device presents no more risk to human health than the approved equivalent product – even where the marketed product has been deemed dangerous. De Novo submissions are also more expensive than the cheaper 510(k).

Surprisingly, even though the ONE condom is already approved by the USFDA using the flexible 510(k) category for vaginal sex, the agency has cleared the new product for anal sex through the De Novo pathway. This fact certainly raises questions regarding the lack of equivalency between condoms used for vaginal sex and anal sex.

On a positive note, they have established special controls so that other devices can now show equivalence to the ONE condom using a 510(k) classification to receive quicker clearance without the need for clinical trials. 

In its press release, the USFDA said the green light could pave the way for more condom makers to apply for faster approval if they show equivalent results. They add that they expect authorization of the ONE Male Condom to help reduce the transmission of STDs, including HIV/AIDS in both anal and vaginal intercourse.

All approved condoms are an easy way to protect yourself

Experts remind all sexually-active couples that they can still use other approved condoms on the market during anal sex:

“This isn’t a groundbreaking advancement in my opinion. All condoms can (and should!) be used to make anal sex safer, so just because this one brand has FDA approval doesn’t make it any better than other condom brands on the market,” says obstetrician-gynecologist and author Jennifer Lincoln who wasn’t part of the trial, for PopSci. “Don’t let the ‘FDA approved’ label sway you when you are at the grocery store—the best condom to use for safe sex is the one you have access to and the one you will actually use.”

Still, this is a galvanizing moment for the LGBTQ movement.

“This authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations. This De Novo authorization will also allow subsequent devices of the same type and intended use to come to the market through the 510k pathway, which could enable the devices to get on the market faster,” Lias added in the USFDA statement.

It remains to be seen whether this will trigger a longer-term movement. In the meantime, stay safe.

The FDA warns public not to use potentially toxic hand sanitizers from Eskbiochem

The Food and Drug Administration (FDA) has issued a warning for the public not to buy or use hand sanitizer produced by a particular company as it contains methanol.

Image credits Harvey Boyd.

Methanol, the simplest molecule in the alcohol family, can be toxic when absorbed through the skin or ingested. According to the FDA, certain hygiene products manufactured by Eskbiochem SA de CV in Mexico can potentially contain methanol. As such, the institution warns people not to use them.

“Substantial exposure” to methanol can cause nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or even death, according to the FDA.

The bad alcohol

“Consumers who have been exposed to hand sanitizer containing methanol should seek immediate treatment, which is critical for a potential reversal of toxic effects of methanol poisoning,” the FDA says in a statement.

“Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

The warning extends to nine products of the company, which the FDA found methanol in samples of. These are All-Clean Hand Sanitizer, Esk Biochem Hand Sanitizer, CleanCare NoGerm Advanced Hand Sanitizer, Lavar 70 Gel Hand Sanitizer, The Good Gel Antibacterial Gel Hand Sanitizer, Saniderm Advanced Hand Sanitizer and three varieties of CleanCare NoGerm Advanced Hand Sanitizer.

Sampling revealed between 28% to 80% methanol and no ethyl alcohol (the last one is the one in beer or other drinks) in some of these products. “methanol and no ethyl alcohol” the agency adds. Products should contain ethyl alcohol (ethanol), isopropyl alcohol (isopropanol), or benzalkonium chloride to be marketed as hand sanitizers.

People who apply the products to their hands are at some risk for methanol poisoning, but the greatest risk comes from ingesting methanol. The FDA notes that children tend to accidentally ingest such products, while others (teens and adults) will sometimes drink them as an alcohol substitute.

If you’ve used these products, seek medical treatment immediately, the FDA advises. Any remaining products should be disposed of as well.

The agency has contacted Eskbiochem to ask them to remove the products from the market but the company has yet to take action, prompting the current public warning.

Methanol is dangerous because our bodies break it down into formic acid, which is toxic to our cells. Around 56 grams of methanol are, on average, the lethal dose for an adult human. Methanol poisoning is most usually associated with unlicensed alcohol production, where methanol isn’t properly removed during the distillation process.

The Food and Drug Administration allows for two uncertified drugs to be administered to COVID-19 patients

The Food and Drug Administration (FDA) has issued an emergency use authorization for chloroquine and hydroxychloroquine for coronavirus cases on Sunday, according to Politico. The two compounds have previously been used against dire COVID-19 infections, but there is still little evidence that they’re safe and that they work.

Image credits Renate Köppel.

The agency allowed for these drugs to be “donated to the Strategic National Stockpile to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible,” according to a statement from the U.S. Department of Health and Human Services. At least 30 million doses of and 1 million doses of chloroquine have been donated to the stockpile so far by pharmaceutical companies Sandoz and Bayer.

Untested measures

The two drugs were initially developed to fight malaria, but have recently been touted as a possible treatment against COVID-19 — however, their efficacy and safety in this role are still under investigation. Still, the FDA’s move to allow these drugs to be used in clinical settings was supported by the White House, with President Trump saying that we’ll “see how it works. It may. It may not”.

The FDA has already allowed New York state to test the medication on seriously ill patients, and some hospitals have added it to their treatment protocols. Experts, however, are concerned over the effort, noting that we lack data on whether the drug actually works on coronaviruses and that it could gobble up resources from other patients who need the medication. A more efficient course of action would be to run chloroquine and hydroxychloroquine through clinical tests to first determine their efficacy. Meanwhile, the FDA hopes that their announcement will allow more manufacturers to produce and donate these drugs, which would help more patients access them.

Hydroxychloroquine is available commercially in the United States and used to treat malaria, lupus, and rheumatoid arthritis. The drug is currently being promoted as a cure for the coronavirus by certain political and media figures, but with little scientific research to back the claim. However, a growing number of lupus and arthritis patients have complained that they’ve been unable to fill their prescriptions amid ongoing shortages. Chloroquine, a related compound and also an antimalaria drug, has also been touted as a potential cure for the virus.

President Trump has irresponsibly (because there’s no data to back the claim up) called these two drugs “game-changers” in the fight against COVID-19. So far, this has led to the hoarding of the drugs and at least one death in the US. Even veterinary-grade chloroquine is being hoarded and used by an increasingly anxious public, which is strongly discouraged and potentially deadly, according to the FDA.

MIT develops new, cheap, fast Covid-19 test, is awaiting approval from FDA

A new startup created by members from the Massachusetts Institute of Technology (MIT) is preparing to submit a new and fast Covid-19 test for “emergency use authorization” by the FDA.

SARS-CoV-2 as seen under the transmission electron microscope.
Image credits NIH Image Gallery.

The new test is based on technology developed at MIT’s Institute for Medical Engineering and Science (IMES), reports MIT News. It can provide reliable diagnostics in about 20 minutes, which is extremely fast. The E25Bio startup plans to make the test — which works similarly to a pregnancy test — commercially available as soon as possible in order to help fight the current outbreak under the FDA’s “emergency use authorization” model.

Speed testing

“Our hope is that, similar to other tests that we’ve developed, this will be usable on the day that symptoms develop,” says Lee Gehrke, the Hermann L.F. von Helmholtz Professor at IMES, who led the development of the test.

“We don’t have to wait for antibodies to the virus to come up.”

The team behind the new test has years of experience working on similar diagnostic devices. They used a technology known as lateral flow technology, which is similar to the ones used by pregnancy tests but aimed at identifying viral proteins, to create tests for Ebola, dengue fever, and Zika virus, among other infectious diseases.

The test itself consists of small strips of paper coated with antibodies that bind to specific viral proteins. A solution of gold nanoparticles, a different antibody, and samples harvested from the patient is then mixed, and the test dipped into it. In case the virus is present, its marker protein will attach to the antibodies on the strip of paper together with nanoparticles and antibodies in the solution, creating a colored line on the test. The whole thing takes around 20 minutes, the team explains.

There are two types of Covid-19 tests available so far. One involves testing blood for antibodies against the virus — however, this can be unreliable as antibodies only become detectable a few days after onset of the symptoms — while the other checks for viral DNA in saliva or mucus samples. The latter is more reliable and can be used to detect the virus earlier in the infection, but relies on polymerase chain reaction (PCR), a technique that ‘amplifies’ traces of DNA but takes several hours and specialized equipment to perform.

E25Bio is awaiting FDA approval of the test so that they may begin trials using patient samples. If that proves successful, the next step would involve using it for clinical diagnosis.

One advantage of the study, the team notes, is that it is simple and cheap to produce, making it ideal for quick manufacturing in large quantities.

Spider Monkey.

FDA shuts down nicotine addiction study over allegations of “cruel” treatment of animals

The FDA will be sending twenty-six squirrel monkeys to a long-term sanctuary after four deaths in an experiment that didn’t meet the agency’s animal-welfare standards.

Spider Monkey.

Spider Monkeys.
Image credits Angie Toh.

The U.S. Food and Drug Administration (USDA) has shut down an experiment that used squirrel monkeys (genus Ateles) to study nicotine addiction among allegations of animal cruelty. The Washington Post reports that twenty-six monkeys — 20 of which were involved in the study and a further six which were not — will be moved from Arkansas’ National Center for Toxicological Research to an animal sanctuary.

The FDA hasn’t yet announced precisely which sanctuary will receive the primates, although it did note that the process could take a long time.

A smoking gun

The study began in 2014 and aimed to get a better understanding of nicotine addiction. The early stages involved adolescent and adult squirrel monkeys self-administering the substance by pulling on a lever which they, unsurprisingly, did until addiction set in. Then, the team lowered the doses received with each hit, and set out to observe the effects.

In the span of three years (by the summer of 2017), four of these monkeys had died. Three of them succumbed to anesthesia complications when catheters were inserted, and the fourth “was related to [gastric] bloat, the cause of which is often unclear,” according to the agency.

The experiment was brought to the public’s attention last March, after a Freedom of Information Act request was filed for the study’s records by the White Coat Waste Project, a group which opposes taxpayer-funded animal experimentation. They obtained 64 pages of documents pertaining to the study, following their request.

The group’s efforts came to fruition in September, when high-profile primatologist Jane Goodall wrote an open letter to FDA Commissioner Scott Gottlieb. The document called the testing carried out at Arkansas center “shameful,” citing “unnecessary and cruel” practices such as restraining the monkeys and subjecting them to the side effects of nicotine — including vomiting and diarrhea

Gottlieb put the study on hold the same month, and ordered a review be carried out to assess the well-being of the animals involved.

On Friday, he released a statement announcing the end of the study. The commissioner said that while the monkeys were “safe and being well cared for,” the review has raised concerns. Chief among these were a “generalized lack of adequate oversight” and “repeated reported deficiencies” from a third-party animal welfare contractor.

“It is clear the study was not consistent with the agency’s high animal welfare standards,” Gottlieb said, adding that the FDA “will place the monkeys involved in a new permanent sanctuary home, which will provide them with appropriate long-term care.”

With the statement, Gottlieb added that the agency is working on adapting various modeling and technological tools to reduce the need for animal testing. However, some experiments will still require work with animals, including the development of childhood vaccines. With that in mind, the FDA will take further steps to improve its animal program, including the establishment of an Animal Welfare Council to keep watch on all animal research it conducts.

Electron microscope scan of HIV (Photo: Creative Commons)

HIV prevention drug approved by the FDA, decision criticized by AIDS support organization

The U.S. Food and Drug Administration recently gave its seal of approval for the introduction of  Truvada on the pharmaceutical market, a drug which allegedly can prevent HIV infection with an effectiveness rate as high as 75 percent when used in combination with safe sex practices. The Aids Healthcare Foundation (AHF), which is largest Aids support organisation in the world, however called the decision reckless, citing previous studies which suggested possible kidney damage.

Electron microscope scan of HIV (Photo: Creative Commons)

Electron microscope scan of HIV (Photo: Creative Commons)

Truvada, a combination of two antiretroviral drugs used in HIV treatment – emtricitabine and tenofovi, was previously tested on two groups. The first was comprised of homosexual and bisexual couples of men from the US, in which one of the partners was infected with HIV and the other was clean of the virus. The results of the three year long study showed that the uninfected men taking the pill had a 42% protection rate. There are  1.2 million people who are HIV-positive in the US and infections are increasing. It’s estimated about 50,000 US adults and adolescents are diagnosed with HIV infection each year, despite numerous efforts from behalf of the government and NGOs to educate the populace on the risks of infection, offer prevention information and counsel those already inflicted by the disease.

The second trial was made in Africa, where the University of Washington’s international clinical research centre recruited more than 4,700 discordant heterosexual couples, since 2008, in what’s one of the largest HIV prevention trials in history. Results were better here, as individuals who had taken the drug were able to reduce the risk of infection by 75 percent. Participants from both US and Africa were counseled encouraged to use condoms to protect themselves whether they were given Truvada or not.

“The data clearly demonstrate that Truvada as pre-exposure prophylaxis is effective at reducing the risk of HIV infection acquired through sexual exposure,” Dr. Connie Celum, a professor of global health and medicine at the University of Washington who led the heterosexual couples trial, told Boston Globe’s Daily Dose. “It is exciting to consider the potential impact of this new HIV prevention tool, which could contribute to significantly reducing new HIV infections as part of a combination HIV prevention strategy.”

Despite the drug showing promising results, it’s rather ironic that an one year treatment is estimated at costing $13,900, considering most people diagnosed positive with HIV are linked with poverty and have no healthcare. Truvada is already used for Aids treatment, and Gilead Sciences, the manufacturer, discounts the drug in the developing world, bringing the price as low as $100 a year.

“Today’s approval marks an important milestone in our fight against HIV,” said FDA Commissioner Dr. Margaret Hamburg. “Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease.”

The Aids Healthcare Foundation (AHF), the largest Aids support organisation, has rushed to label the FDA decision as reckless, pointing towards studies linking the drug with kidney damage. Also, the organization argues that Truvada should not be given without an HIV test to ensure the person taking the pills is not already infected – otherwise the virus could become resistant to the drug.

Michael Weinstein, AHF president, called the FDA decision “completely reckless and a move that will ultimately set back years of HIV prevention efforts”.

He added: “From the beginning, we believe there was a rush to judgment by government officials and others in favour of such approval despite decidedly mixed studies offered in support.

“The FDA’s move today is negligence bordering the equivalence of malpractice which will sadly result in new infections, drug resistance and serious side effects among many, many people.”

Safety risks for pregnant woman are still unknown. Other known side effects of Truvada include diarrhea, nausea, abdominal pain, headache, and weight loss.

Cigarettes get slapped with bigger and harsher warnings

Remember the days when cigarettes didn’t have to feature labels of all the bad things that can happen if you smoke ? Well, I don’t; but then again, maybe in a few decades people won’t remember the days when cigarettes used to have such ‘light warnings’.

Practically, in just a generation or so, things have switched from ‘cigarettes may cause illnesses in some persons’ to ‘you will get cancer and die, or be impotent, or both’ – and this is a really good thing, at least if you ask me. Thing is, in June, Food and Drug Administration (FDA) plans to implement even tougher warnings, on an even larger part of the pack. According to a few studies conducted this month, this will have a significant impact on at least some of the 20 percent still smoking in the US.

To say that smoking is bad is like saying that going out in the rain will get you wet; everybody knows this, but even so, some choose to do it. How do they deal with the problem of knowing this ? Well, smokers typically fall into three categories: the ‘so what if it kills me’; the ones who know it’s bad, but just don’t want to know how bad it is, and the ones who are trying to quit, but for one reason or another, they don’t do it. The FDA is targeting the latter two groups, trying to make the 2nd group more aware of what they are doing to themselves, and give the last ones the extra budge they need to make the big step and quit smoking.

In June 2009, president Barack Obama, who used to be a smoker himself (and he smoked quite more than cigarettes) signed into law the Family Smoking Prevention and Tobacco Control Act, basically giving the FDA the possibility to control all tobacco sales and marketing campaigns. Now, two years after that, they are close to making the first major move, after a planification stage that took about one and a half years. Here are just a few of the proposed labeling types.

Another thing the cigarettes pack will have to do is display some direct information about the cigarettes inside them, rather than the chemical information that is displayed now; for example, ‘cigarettes contain carbon monoxide’ will be replaced with ‘cigarettes cause heart attacks and strokes’.

Among the developed countries, Canada has one of the lowest smoking rates (18 percent and dropping), and they have been using graphic images instead of messages for years, with very powerful messages, such as ‘smoking makes you impotent’ – best argument if you ask me. The thing is, tobacco companies are extremely good at going around the corners and finding new solutions to the problems they have to face. For example, when the FDA limited the use of terms such as “light,” “mild,” and “low” on packaging, the tobacco companies struck back with “silver”, “gold” and “white”.

The FDA tobacco act however is not without its contestants – out of which, of course, tobacco companies have to be mentioned. The 2009 act banned all the flavoured cigarettes except for menthol (which accounts for some 30% of the market and is especially popular among African Americans and young people.

Of course, you might just feel sorry about the tobacco industry – but then you have to remember that they lied for 50 years, indirectly killed tens of millions of people, and gave your dad that nasty cough.

Via Livescience