“Million Dollar Placebos”

“Million Dollar Placebos”

Are you hear any news updates about the research on COVID-19 patients in different Homoeopathic or Ayurvedic medical colleges in any leading print or electronic media?

Have you read any news about thousands of COVID 19 positive patients are recovering from their sickness by using exclusively homoeopathy or Ayurvedic or Unani medicine?

Are you listen about the role of Immunity Booster in arresting the spread of Corona virus in most successful Kerala Model, in INDIA?

Unfortunately the answer is – NO.

Let see the another side……

What you read daily in leading news medias about the COVID medication?

The cost of Remdesivir is so ” high” that we can’t afford, Multinational companies tries to reduce the cost of these  “important life saving drugs” in cheap for us, There are shortage in stock of Favipiravir for its high demand…….

Let’s see the the back of the story…

The Central Drugs Standard Control Organisation (CDSCO) has approved five drugs in the last month for COVID-19 treatment – two antiviral: Remdesivir and Favipiravir – and three for easing the symptoms (Immunomodulators) Dexamethasone, Tocilizumab and Itolizumab.

Price rate? You are used to see them , just take a overview-

Remdesivir costs around Rs 5,000/- per vial with a total treatment cost in the range of Rs 35,000-50,000/-.

Favipiravir costs Rs 103/- per 200 mg tablet; the total treatment cost ranges from Rs 12,000 to Rs 15,000/-.

A vial of Itolizumab costs around Rs 8,000 and the total treatment cost could be between Rs 32,000 and Rs 50,000/-.

Tocilizumab costs Rs 40,000 to Rs 50,000/- per vial.

So,what are the story of these “Celebrity Drugs” ?

Is there any Randomised Clinical Trials (RCT) done?

Evidence-based medicine requires the testing of pharmaceutical drugs through this Randomised Clinical Trials (RCT) wherein one set of patients get a placebo (or an alternate therapy) and the other set of patients gets the investigational drug. Neither the doctors nor the patients know who gets what drug. If the set of patients that gets the investigational drug shows a better outcome, it can be presumed that the drug has a demonstrable therapeutic effect on the disease in comparison to the comparator. This is the gold standard for demonstrating the efficacy of a drug in treating a particular disease.

Let’s see….

Remdesivir

Remdesivir was approved for clinical use for both children and adults as an injection on June 1,2020.

This drug is manufactured by Gilead Sciences Inc.

Is there are any Randomised clinical trial done?

Oh, yes, there are three…..

1st STUDY-

The first randomised double-blind study was done on 237 patients. (only 237!!!)

And what  we get?

It showed no statistically significant treatment efficacy in severe COVID-19 patients. It did not provide any significant clinical or antiviral effects & didn’t improve recovery time or reduce mortality compared to people taking a placebo.

The study published in The Lancet. Yes, in the most prestigious journal in the world of medicine.

2nd STUDY

It was done in 1063 patients

A preliminary report published in The New England Journal of Medicine showed that remdesivir shortened recovery time for people with COVID-19 from an average of 15 days to about 11 days.

4 days difference in recovery!!! Sounds great??

But when the Study sub-investigator Dr. Robert M. Grossberg, an associate professor of medicine at Albert Einstein College of Medicine and an infectious disease specialist at Montefiore Health System, were asked as for whether it keeps people from dying, he said the study “suggested that there might be a mortality benefit, but that wasn’t quite proven yet.”

3rd STUDY

In early June, Gilead announced that other data showed that people with moderate COVID-19 recovered more quickly when given the drug for 5 days, although the benefit was “modest.”

It is Gilead’s own study.

The data from this study hasn’t been published in a peer-reviewed journal

There was also a controversy surrounding the changing of end points of the study, to get a favourable outcome.

Gilead’s quest to secure approval for the drug were also shadowed by reports of lobbying to influence the FDA and other authorities.

Meanwhile, a study published on May 22 – sponsored by NIAID – showed that Remdesivir didn’t affect the recovery of Asians, a result that never entered the media spotlight.

On July 3, an independent expert wrote in a blog post for the British Medical Journal that the US government had purchased Remdesivir doses worth $1.5 billion because, he argued, the drug’s effects could actually be “exaggerated, embellished with unreliable effect measures”.

Now look at another Celebrity Drug…..

Favipiravir

Favipiravir is an oral drug accepted by the CDSCO to treat patients with mild to moderate COVID-19 disease on June 19.

Favipiravir is manufactured and marketed by Glenmark Pharmaceuticals in India. It’s is a generic version of Avigan, an emergency flu medication developed by Toyama Chemical Co. – a subsidiary of Fujifilm – in 2014.

It entered the spotlight after Zhang Xinmin, director of China’s National Centre of Biotechnology Development, announced in March that Avigan was effective against COVID-19 based on two clinical trials, although there is no scientific consensus on the efficacy of the drug.

Following this, on March 31, Fujifilm Corp. announced Avigan would undergo phase 3 clinical trials and phase 2 trials in the US by April 9. By April 28, Avigan was being distributed in 38 countries to treat patients to evaluate the drug’s effects. Later, Glenmark Pharma received its first approval from the Drug Controller General of India (DCGI) for clinical trials of the generic version of Avigan.

Glenmark officially announced the approval for phase 3 clinical trials on May 12.

According to the Clinical Trials Registry of India (CTRI), Glenmark’s study was meant to be carried out on 150 patients at 12 different hospitals in Chhattisgarh, Gujarat, Maharashtra and Delhi with the aim of comparing Favipiravir with “standard care” provided to patients with mild or moderate COVID-19.

150!!!

Patients with mild or moderate COVID-19!!!

Virtually all these “mild” cases often resolve themselves without any intervention. Further, the CTRI does not explain the nature of the “standard care” being provided to the patients.

On May 26 Glenmark said it would be starting phase 3 clinical trials with two antiviral drugs, Favipiravir and Umifenovir, for combined efficacy, and that it had recruited 30 patients out of the 150 to be treated with Favipiravir alone. This triggered several questions.

On May 20, Daike Samura of Jichi Medical University, who conducted the trials in Japan, said there was no data that showed Avigan was efficacious against COVID-19. However, the CDSCO went ahead anyway and approved it for use in India by June 19.

As per Glenmark’s filing with the Bombay Stock Exchange, the company has received “accelerated approval” from the DCGI for “restricted emergency use in India”. On what basis did the DCGI grant approval? Will the underlying data be made publicly available to the medical community?

There is no information on the DCGI’s website explaining the scientific basis of its approval of Favipiravir for COVID-19.

According to more recent reports by Fujita Health University, Avigan has failed to show any ability to treat COVID-19. Japan’s Prime Minister Shinzo Abe also pushed for the drug’s approval but the trial results simply didn’t hold up.

Meanwhile, Fujifilm had announced a partnership with Dr Reddy’s in India, licensing the latter for producing Avigan, and not the generic Favipiravir. Per this agreement, Dr Reddy’s will be able to conduct clinical trials in India and the Middle East, possibly due to a dearth in the number of patients in Japan and regulatory hurdles.

The Japanese regulator, which approved this drug for influenza, mandated a warning to be printed on the packaging of this drug for early embryo toxicity and teratogenicity, specifically cautioning its use in women in the early stages of pregnancy. The exclusion criteria listed on the CTRI list pregnant and lactating women, which is not necessarily the same thing.

Read also- Remdesivir, convalescent plasma use based on limited available evidence, says Health Ministry

Itolizumab

DCGI recently approved Itolizumab to treat moderate to severe COVID-19 infections, announced in a press release by Biocon on July 11. It was earlier marketed as ALZUMAb, to treat moderate to severe chronic psoriasis.

ALZUMAb was first produced by Centre of Immunology at Cuba in 2014. This is an immune modulating drug that can decrease the chances of a cytokine storm. Biocon is hopeful for the same reason that Itolizumab can help patients with severe COVID-19 in India.

Clinical trials for Itolizumab were conducted with just 30 COVID-19 patients at four sites in India. DCGI approved Itolizumab based on the trials’ outcomes.

Again,Thirty is a very small number of participants for a phase 2 clinical trial – too small to lend itself to a statistically significant outcome.

The trial was also open-label without, which means there is good chance that the results were biased towards more favourable outcomes.

In addition, other studies have also reported side effects of this drug, including respiratory and urinary tract infections. COVID-19 patients are already prone to secondary bacterial infections, and treatment with Itolizumab may exacerbate this risk.

Tocilizumab

Tocilizumab is expected to decrease the mortality of severe COVID-19 patients. Preprint papers uploaded to medRxiv show it reduces mortality by only 3.8% – which becomes even less impressive when side effects listed by manufacturer are accounted for.

They include risk of reactivation of tuberculosis along with other latent and bacterial, fungal and viral infections.

Hence these treatment recommendations of immunomodulatory drugs without proper, large-scale randomised, controlled clinical trials will always be the case of risks outweighing the benefits.

Is there are any Drug which gone through a proper RCT??

Yes we have a “Superstar Drug”.….

You know the name, most spotlighted drug, referred by US President also

The Hydroxychloroquine

Studies done on 4674 patients , a good number to approved as a evidence based drug.

But, what we get?

The studies says that hydroxychloroquine had no benefit in patients hospitalised with COVID-19.

In patients with mild Covid-19, also no benefit was observed with HCQ beyond the usual care.

The data collected from such clinical trials are usually published in a peer-reviewed journal where they are subject to scientific scrutiny. In the research fraternity, it is considered a good practice to publish the results of a clinical trial. But none of the companies that declared their formulations as effective in dealing with COVID-19 have published their research in known peer-reviewed journals,  since they announced their findings. Instead, details of the trials are being communicated through press releases and press conferences.

It is important to disclose this information from a scientific and ethical viewpoint.

If we do not know the treatment with which Remdisivir or Favipiravir is being compared, how do we know if it is any better than perhaps a placebo?

OR, they are the “Million Dollar Placebos” for COVID 19!!

Regular discussion on the high price of some “ valuable” products are not only for simple business profit, but it keep your mind to stick with that the product is very precious , respect the product, this effects indirectly on the share value of the manufacturer of the product & if it is medicine, in a pandemic situation ….you will be luckiest person on the earth.

No system of medicine is limitless.

No, only Homoeopathy or only Ayurveda,  any other system of medicine can’t  fight alone with this greatest pandemic situation , but they have a great unquestionable scope in their expertise segment.

a healthy mind to explore them all , to overcome from this pandemic situation is the utmost thing .

A well organised ignorance to AYUSH system of medicine & overshadowing by these type of Drugs , cost more in recent future for mankind.

Read also – Limitation of ongoing treatment procedures in COVID-19

Leave a Reply