Thursday pharma headlines

SUMMARY: The industry is facing several challenges on several fronts. Amgen is laying off people because of their poor financial outlook. Merck’s old drugs are under more scrutiny, and anti-vaxxers are causing problems by cherry-picking unreliable information.

Amgen announced that it’s laying off a significant number of people, most from the salesforce, under the guise that they’re going “digital.” Let’s be honest: this is a way to inflate a company’s stock price whose past policies have all but removed all innovation.

When a new employee goes thru orientation at Amgen, they are reminded that Amgen is a “right to work” company, which means they can terminate your employment anytime for any reason.

I am reminded of a business colleague who left a company in the midwest after being recruited heavily by Amgen. She moved to the area and was excited at, what she thought, were new and exciting opportunities. After receiving a glowing review in her second year, she was called into a room with HR and told her employment was over. She had to agree that she would not pursue litigation and was escorted back to her office to clean out her desk.

She later learned that her manager’s boss was behind the termination because she feared for her own job. She recovered very nicely and is now in charge of a team at Amazon.com.

Amgen CEO Bob Bradway racked up a 2018 pay package of $18.6 million, his first big raise since 2015, thanks to incentive pay that jumped by about $1.2 million while the company’s pipe line falters.

I asked her why some reviews of working at the company are so positive, to which she replied, “these are people who are worker bees and don’t dare do anything innovative because they will be seen a not being a team player.” Ouch.

What?

Newly unsealed court documents show that Merck and U.S. regulators knew about reports of suicidal behavior in men taking the anti-baldness treatment Propecia when they decided not to warn consumers of those potential risks in a 2011 update of the popular drug’s label.

Annual U.S. prescriptions of finasteride, as the drug is known, for hair loss increased to over 2.4 million in 2020, more than double the number in 2015, according to health data company IQVIA.

As early as 2009, Merck knew of more than 200 reports of depression, including suicidal thoughts, in men taking Propecia, according to an internal “risk management” assessment from that year. The company decided there were too few reports of serious depression and suicidal behavior and not enough specifics about those cases to warrant more than “routine” monitoring of safety data.

Misuse Federal Data to Falsely Claim COVID Vaccines Are Dangerous

The national vaccine safety surveillance program run by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) is meant to help patients and warn of potential drug side effects but a Vice report indicates something more.

Since its inception in 1988, anti-vaccine groups have cherry-picked VAERS data and twisted it out of context to show the supposed dangers of vaccines. 

Now, with several COVID-19 vaccines being administered, and vaccine hesitancy and misinformation on the rise worldwide, VAERS is being used yet again by those same groups—as well as a crop of new bad actors—as a vehicle for claims that various vaccines cause serious side effects like Bell’s palsy, hospitalizations, or death. (A CDC review of safety data to date found this week that Bell’s palsy is no more common in COVID-vaccinated populations than unvaccinated; nor is the rate of death, or other severe health complications.) 

Established anti-vaccine activists and groups are newly interested in mining VAERS data to suggest that matters are even worse than what it shows. Vaccine-critical organizations like the National Vaccine Information Center (NVIC) have repeatedly referred to VAERS reports as a source of information without explaining that they’re unverified.

In order to use VAERS data to show the supposed dangers of vaccines, anti-vaccine groups have to avoid mentioning two crucial things: Anyone can submit a report to the program, and all of those data—unverified, unresearched, often anecdotal—are immediately available to the public. 

This isn’t science it’s a group of people who are against vaccines cherry picking information that’s unreliable.

COVID Dashboards

This week I had a long talk with someone who has been working in pharma R&D for over 30 years about Covid vaccines. Here are some points..

1ne: Developing a vaccine for COVID-19 was relatively easy because the virus has been studied in some form for over ten years.

2wo: Covid-19 statistics are not reliable. They should be reported as people who tested positive, of the people who test positive, the number who are reporting symptoms and are hospitalized, and finally, the comorbid conditions of patients who died. He said it would take years to analyze all the data.

3hree: He also suggested that long-term studies need to be conducted on the immune systems of the U.S. population to determine if our immune systems are being compromised and potential causes.

I am grateful that many pharma companies have developed a Covid vaccine, but I’m also very disappointed at the vaccine’s rollout. When the news consistently runs stories of desperately trying to get vaccinated and can’t get appointments, we have failed.

However, with every failure, comes opportunities and I am heartened by the number of people entering the industry who are bound and determined to change the status quo.