Tag Archives: treatment

FDA Withdraws Emergency Use Authorization for Hydoxychloroquine

A month ago the skeptical cardiologist detailed the potential for lethal cardiotoxicity of the antimalarial drug hydroxychloroquine  (HCQ) concluding:

  1. HCQ and chloroquine (CQ)  have associated and well-documented, albeit rare cases of potentially lethal cardiotoxicity.
  2. The benefit of these drugs in the treatment of coronavirus infection is currently unproven.
  3. Data from high-quality randomized trials of HCQ treatment in patients with coronavirus is needed before we can assess whether the drug benefits outweigh its risk in COVID-19 patients.

The drugs had been approved by the FDA for emergency use authorization (EUA),  many physicians and hospitals were using them for patients with COVID-19. Even more disturbing,, President Trump was enthusiastically promoting HCQ and revealed that he was taking it as a prophylaxis against COVID-19.

Intense demand for HCQ  led to a shortage for patients who needed it  for proven indications such as systemic lupus erythematosus.

Since I highlighted the drug’s cardiotoxicity a series of papers have either shown a lack of benefit or potential worsening of outcomes with these drugs. Recognizing this the FDA withdrew its EUA for HCQ and CQ yesterday.

On June 15, 2020, based on FDA’s continued review of the scientific evidence available for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) to treat COVID-19, FDA has determined that the statutory criteria for EUA as outlined in Section 564(c)(2) of the Food, Drug, and Cosmetic Act are no longer met.  Specifically, FDA has determined that CQ and HCQ are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of CQ and HCQ no longer outweigh the known and potential risks for the authorized use. This warrants revocation of the EUA for HCQ and CQ for the treatment of COVID-19.

Fortunately, as more data became available over the last month hospitals which were previously routinely giving HCQ (and often azithromycin) dropped these drugs from their treatment protocols.

Hopefully, now we can get back to deliberately and scientifically validating the safety and efficacy of drugs for COVID-19. We still need more data from the dozens of ongoing randomized controlled trials (RCTs) on treatment.

Two large randomized controlled trials will be particularly helpful in determining the best treatment for SARS-CoV2 infection.

One of them, theRandomised Evaluation of COVid-19 thERapY (RECOVERY) Trial   published preliminary findings on 5 June 2020 showing a lack of benefit of HCQ.

In addition to HCQ, RECOVERY is analyzing treatment effects of the antivirals lopinavir-ritonavir, low-dose steroid therapy and interferon.

SOLIDARITY is an international clinical trial to help find an effective treatment for COVID-19, launched by the World Health Organization and partners.

 

The Solidarity Trial will compare four treatment options against the standard of care, to assess their relative effectiveness against COVID-19.

Until we get results from high-quality RCTs like these, the antimalarials  HCQ and CQ should not be utilized for either prevention of or treatment of COVID-19.

Skeptically Yours,

-ACP

What’s The Best Treatment For Seasickness? Part I, What Won’t Work Well

While stocking up on key items for our Galapagos cruise, the eternal fiancée of the skeptical cardiologist (EFOSC) bought an item that set off the skeptical cardiologist’s (extremely sensitive) BS detector.

Once I began looking into the seasickness treatment options and science I soon realized that the vast majority of OTC medications, patches and devices offered are snake oil.

There is one highly effective treatment which requires a prescription, one possibly effective OTC treatment which will likely put you to sleep, and one very slightly effective treatment which will also likely put you to sleep.

First let’s look at the totally bogus patch Jen purchased.

It calls itself a “motion sickness patch.” It is manufactured in China. (Somebody should put a tariff on this junk!)

It also carries the allure of being natural which people (mistakenly) assume means free of side effects.

Since most people have heard of an effective motion sickness patch, they naturally assume that this is legitimate. 

It appears to be highly rated on Amazon with 80% of over a thousand reviewers giving it 4 or 5 stars. However, 10% of reviewers give it 1 star, usually commenting that the MQ patches were useless  and were purchased as they were cheaper than the prescription patch that worked for them before.

And it is no surprise that it doesn’t work for many because the ingredients would not be expected to have any effect on motion sickness.

The main Ingredient are listed as

safflowertall,gastrodia,tuber,sanchi,hairy datura flower,borneol,pinellia tuber,obtuseleaf cinnamon bark,frankincense,dahurian angelica root,etc.

Yes, in these patches you get the added bonus of “etc.” in the formulation!

In case you needed more explanation of how this works, check out the bizarre “working theory” of the mysterious ingredient’s efficacy:

Working theory
1. Adjust the control of the vagal nerve to gastrointestinal tract, inhibit the motility of the gastrointestinal, thus preventing nausea and vomiting.
2. By expanding the capillaries of the skin, to improve the microcirculation of body and increase the amount of oxygen to brain, thus comes to the effect of refreshing your brain.

All I can say about those who have experienced relief with this MQ nostrum is “the placebo force is strong with you!”

After reading the reviews for the MQ patch and  listening to an NPR story on paid Amazon product reviews  my faith in Amazon product reviews is at an all time low.

Similarly, most of the sites on the internet which promise to give you the top 10 products in a certain area I have found to be bogus. For example, the amazingly useless MQ motion sickness patch is ranked #5 on the “Best Reviews” Guide to Motion Sickness.

Bonine

The second product the EFOSC purchased online was the oddly-named Bonine.  Bonine is the brand name for meclizine, a first-generation antihistamine with anti-cholinergic properties which is often prescribed for benign positional vertigo.

There is not much evidence supporting meclizine for sea sickness but it is widely used owing to its accessibility and marketing. Like all first-generation antihistamines, it will make you drowsy. Before the second generation, non-sedating antihistamines were introduced, I would walk around in a zombie-like state when my allergies required an antihistamine.

Keep in mind you can get a prescription for 30 tablets of meclizine 25 mg for about 12$.

Acupressure

More evidence that the placebo force is particularly strong in the motion sickness world is the widespread marketing, sales and testimonials to “acupressure”  devices.

The EFOSC with her Sea Band. She likes to wear it because it is blue and white, her favorite colours.

The EFOSC suffers from car sickness and several years ago purchased something called the  Sea Band.

Wrist bands like the Sea Band claim to reduce nausea and other symptoms of seasickness through stimulation of the “P6/Neiguan” acupuncture point by applying acupressure or electrical acustimulation.

These work primarily through placebo effect and studies have shown a “sham” acupressure band works as well as a real one.

One fascinating study examined  a self-fulfilling prophecy (SFP) approach to combating seasickness:

the authors experimentally augmented the self-efficacy of naval cadets by telling them that they were unlikely to experience seasickness and that, if they did, it was unlikely to affect their performance at sea. Naval cadets (N = 25) in the Israel Defense Forces were randomly assigned to experimental and control conditions. At the end of a 5-day training cruise, experimental cadets reported less seasickness and were rated as better performers by naive training officers than were the control cadets

The EFOSC is gravely concerned about debilitating seasickness during our 8 days on the Samba. To maximize the placebo force in her I should have emphasized how well the Sea Band and the MQ patch work. Hopefully she won’t read this post.

In Part 2 of the Best Seasickness Treatment I’ll discuss transdermal scopolamine and dramamine, the treatments with the best evidence for efficacy, safety and tolerability.

I’ll also examine the evidence for ginger.

What’s been your experience with sea sickness and treatments for sea sickness?

Vertiginously Yours,

-ACP