On Trusting Media Releases from Big Pharma…Pffffzzzz-er’s Media Release

With all due respect to those among you who have done great work in pharmaceutical research over their careers…

I desperately wish it was so…

But having been a keen observer of pharmaceutical manufacturers’ media releases over the years, I’ve seen how drug companies like to shine us on by bending the truth to fit our expectations of new drug cures. This isn’t helped by the fact that major media outlets often just accept top line statements from their pharmaceutical advertisers without due diligence along with a very low degree of skepticism. Current journalistic standards allow the claims in commercial media releases to be repeated over and over again across the media platform echo chamber until it becomes near-irrefutable truth. When their ‘facts’ finally fizzle out over time, they are always replaced by a new hopeful treatment, and we’ve all but forgotten the original measure.

Hard Reminders

Remember in 2009 when Pfizer’s new drug therapy Bapineuzumab for Alzheimer’s was hailed as a possible cure for Alzheimer’s? Probably not. Our memories for such things are short, which is the reason we are suckers who are continually being fooled by reported medical ‘breakthroughs.’ This drug was supposed to be capable of reducing the cerebral β-amyloid peptide burden in patients with Alzheimer’s disease thus halting disease progression — something akin to a cure. Pfizer’s share values soared on the news of a breakthrough drug for Alzheimer’s … It’s all there in the media release. In fact Pfizer acquired the drug company Wyeth on their new financial strength. The ‘expectation’ of an effective treatment for Alzheimer’s went on for 3 years of delaying inevitable outcomes amid growing skepticism in the scientific community. In fact, Bapineuzumab was a spectacular failure as a treatment for Alzheimer’s.

Then came Eli Lilly with the overlapping replacement hope of Solanezumab in 2012. Solanezumab was touted as another anti-amyloid treatment in Alzheimer’s disease. Finally, researchers reported, after a string of clinical setbacks with other drugs (meaning Bapineuzumab among others), Solanezumab appeared to deliver the long-awaited signal to the amyloid field. Researchers described a cognitive benefit overall and a functional benefit on independent activities of daily living in patients with mild Alzheimer’s. Once again the public went wild with optimism despite the fact the announcement was based on a simple press release. But no data was released and subsequent clinical trials by other researchers could not replicate the results of the initial drug company-sponsored trials. The media again had to report the failure and retract several years of favorable media reports.

Eli Lilly share values that had been propped up by years of reassuring media reports suddenly tanked. Essentially they ran out of time to prove the claims of Solanezumab and they had to report the failure of their research on a massive scale.

These are just a few failing examples of drug companies’ media releases intended to make good on the ultimate usefulness of a particular promoted drug therapy. There are many others (as outlined in detail in Peter C. Gotzsche’s book, ‘Deadly Medicines and Organised Crime, How Big Pharma has Corrupted Healthcare.’). So many in fact, that failed promotions of experimental drugs outnumber approved drugs that have been found as marginally more effective than what was currently available for use.

Beyond Skeptical

So forgive me if I’m skeptical about Pfizer’s claims of safety and efficacy with their new RNA vaccine that is purported to contain the genetic information to produce the antigen intended to stimulate the immune system against the Covid-19 virus. The reasons that Pfizer wants to be first to announce a breakthrough despite the ultimate likelihood of failure are numerous and complex.

‘First-to-market’ advantage is always the primary rationale. Currently there are over 200 vaccine candidates for a Covid treatment going through the trial process as pharmaceutical companies, university researchers and national governments rush to develop a safe and effective vaccine across nearly every country world-wide. There’s an urgent global public health crisis after all — and all the stops have been pulled out by every government, university and research organization to find a treatment as quickly as humanly possible.

However…McKinsey and Co., after analyzing 492 different drug launches, concluded that the first successful entrant to a market, especially for a disease like Covid-19, will enjoy a greater market share even 10 years later. This often means billions in bottom line profits, a good reason to risk exaggerated claims and embarrassing failures at any stage of drug development. Secondly, share values can increase and maintain these values for as long as the promise of the breakthrough drug is in the pipeline. Thirdly, promising competitive therapies suddenly find funding for their research drying up once a leading competitor has emerged.

These are the facts of Pfizer’s claim that have presented red flags for me:

Pfizer says its phase 3 trial data shows the vaccine is 90% effective. There is no published data on whether the vaccine protects only against clinical disease or also prevents transmission to other individuals, and one in ten people still won’t be protected. This may make an enormous difference in its ability to prevent community transmission.

Drug companies under the type of pressure they are to produce an effective COVID treatment are not above designing protocols that guarantee a positive outcome (or spin negative ones). They often redefine the endpoints mid-trial in order to come up with outcomes that appear to be statistically significant. Since all data is proprietary, we have no idea if that’s the case here.

Drug company press releases with no data are opinions. As stated above, Big Pharma has a long and controversial history of making things up in press releases to improve their share value. And improve it did. Pfizer share value went up 15% just on the news.

Even if successful, Pfizer knows they are offering false hope that an effective vaccine could be ready in a few months when the actual timeline will be significantly longer. They claim to have made 30 million doses. But a two dose treatment will only treat 15 million people. Who gets the first doses and how long will it take for you and I to be vaccinated? I’m guessing at no time within the next year even with ramped up production.

This drug represents a logistical impossibility. The vaccine requires to be kept at temperatures as low as at least -70°C, which is beyond the capabilities of the usual cold storage and transport used for frozen goods, and well beyond the capacity of any current global cold storage chains. Further, there isn’t enough dry ice-making capacity in the world to assure access to everyone in the US let alone the global population.

The coronavirus accumulates about two changes per month in its genome and a preliminary report suggests mutations since vaccine development could be less susceptible to it. So which version of the Coronavirus will this vaccine treat? According to the linked Nature article these changes appear to be significant to any effective vaccine treatment.

Regulatory approval must be granted before use and we are far from that point.

Finally, according to the New York Times: “A growing number of polls find so many people saying they would not get a coronavirus vaccine that its potential to shut down the pandemic could be in jeopardy. Distrust of it is particularly pronounced in African-American communities, which have been disproportionately devastated by the virus. But even many staunch supporters of immunization say they are wary of this vaccine.” So even if the vaccine is effective, a huge percentage of the population will never agree to be vaccinated, which will complicate community-acquired infections.

In a few words, we’re all going to be masked, distanced and mostly alone for the foreseeable future so we all need to get used to it.