The Big Pharma Conspiracy: Are they out to get us?

Having done so much research on the flu vaccine for other posts, I have learned a lot about the science and technology that goes into the flu vaccine every year. I have talked at length about the makeup, effectiveness and target demographics of the flu vaccine, judging whether it really protects us from the influenza virus. 

Now that we have covered all that, I’d like to delve into a more sensitive social topic that surrounds the flu vaccination, and that is whether or not pharmaceutical companies sell vaccines with the best interests of the public in mind, or if they are just out to make a profit.

It is no secret that U.S.  pharmaceutical companies have sweet talked doctors into prescribing their drugs. A story done by National Public Radio entitled “Dollars for Docs” covered this topic by interviewing Matthew Webb, a drug representative in the 1990’s who was accustomed to “entertaining doctors two or three nights a week” with fancy dinners and sports tickets in order to persuade them to buy his product. 

This was a common and accepted practice until 2002, when the “Code on Interactions with Healthcare Professionals” was published by PhRMA, the pharmaceutical industry’s trade group, effectively outlawing this bribery.
 

So, the question remains: Are pharmaceutical companies producing the flu vaccine for their own profit?

An article in the magazine of Johns Hopkins Bloomberg School of Public Health would suggest that this is not true. In fact, the article states that the production and distribution of vaccines is so unprofitable for drug companies that most seem to do it out of sheer goodwill towards the community. Citing a $300 to 400 million dollar start-up price for any vaccine, the article states that the costs of manufacturing have actually discouraged most drug companies from producing them at all.

After this huge initial investment, the Johns Hopkins article also states that drug companies have a lot to do before they can actually administer their vaccine to the public. Due to “conflicting pressures at all stages of their development and distribution,” it is extremely difficult to get a new vaccine approved by the FDA. This applies especially to the flu vaccine, whose construction is so much more complex than a formula because of the annually mutating virus it treats.

Even if the flu vaccine passes all of the stringent FDA regulations, the drug companies are faced with an extremely low profit margin, only 2 to 3% according to an article published in The Atlantic. This is because public agencies in charge of distribution buy at a capped price, which is predetermined and not subject to greediness or other monkey business. In fact, according to the Johns Hopkins magazine, the federal government’s large scale purchases of the flu vaccine at these capped prices are a main disincentive for producing vaccines that “historically have been high-volume, low-profit items anyway.”

Between the huge start up investment, and all of the risks of failure along the way, it is evident that drug companies are not producing vaccines as a sure fire way to make a profit.

Photo Attribution

These risks, however, are incredibly discouraging for drug companies, and have had a negative effect on the supply of vaccinations in the U.S. According to an article published in the U.S. National Library of Medicine, there were 26 manufacturers of the flu vaccine in 1967, a number that dropped to 17 by 1980, then to 12 in 2015, only four of which are large-scale producers, like GlaxoSmithKline, one of the largest U.S. vaccine manufacturers.

Photo Attribution

As drug manufacturers abandon their flu vaccine programs, a nationwide shortage could be taking place. For example, Erin Fox, manager of the drug information services for the American Society of Health System Pharmacists, told the Washington Post in 2011 that the shortage of vaccines was a worsening crisis that unnecessarily “puts patients at risk.”

Now that we’ve ascertained that pharmaceutical companies are not gouging U.S. citizens, we should ask: Can this problem solved?

Phil Russel, an MD and senior adviser at the Office of Public Health Preparedness, tackles this debate by defining the problem. He states that the U.S. market for vaccines is artificially skewed by corporations like the WHO, who both produce and buy vaccines in bulk, essentially cornering the market and creating very little incentive for other drug companies. This, combined with the amount of people who simply refuse to get vaccinated, is why vaccines are so unprofitable.

“We have to come back to some basic understanding of how valuable vaccines are to us, and how we translate that knowledge of value into a market,” Russell states, confronting anyone who protests the importance of vaccines in modern life.

 I think Phil Russell said it well, "We know how valuable fighter aircraft are to our defense and we pay the cost for them. Nobody bitched about the price for the smallpox vaccine. Whatever we needed, we paid." 

According to him, if the federal government gave more subsidies for the flu vaccine, drug companies could afford to spend more time matching them to each annual strain, and if people stopped doubting drug companies motives, perhaps the flu wouldn't be spread so commonly every year. 

What do you think?

How effective is the flu shot?

Last week, I discussed the side effects of the flu vaccine, which can range from anything mildly uncomfortable to more serious illnesses. In that post, I also mentioned which groups of people are considered “high risk” for flu-related complications and should definitely be vaccinated, including babies, pregnant women, and seniors.This week, let us delve into the effectiveness of the flu vaccine in fighting influenza.

According to the CDC, how well the shot works, or the vaccine’s “efficacy,” depends on a few different factors. The two main influences, however, are the characteristics of the person being vaccinated and how well “matched” the vaccine is to that particular strain of the flu.

First and foremost, the vaccine’s efficacy relies on the age and health status of the recipient. By studying polls taken after every flu season, doctors and scientists at the CDC estimate that the flu shot is effective in preventing this illness in about 60% of healthy individuals under the age of 65 years.

The graphs shown below were made after the 1982-1983 flu outbreak in Genesee County, Michigan. By comparing the incidence rate of infection amongst vaccinated and unvaccinated Nursing Home residents, the results suggest that the flu shot was largely effective in immunizing healthy adults surrounded by sick patients.

Graph Attribution

Although they also say that the flu shot is less effective in older individuals, the CDC holds that this vaccine reduces complications related to the flu and other common illnesses. Some studies show that the shot was 50-60% effective in reducing hospitalization and 80% effective in lowering the death rate amongst older recipients.

Now, why would the vaccine have a different effect on older individuals?

Human immune defenses naturally become weaker with age. With this in mind, the standard flu shot can actually be risky for older people because they may have a diminished immune response and might not produce as many antibodies as they could have in the past.

This is why a different kind of vaccination is given to people over 65 years old. Called the Fluzone High-Dose influenza vaccine, this injection contains four times the amount of antigen, otherwise known as the substance that causes your body to produce antibodies, than the standard flu shot administered to younger people. This is intended to create a stronger immune response in the recipient, and would explain why the flu shot is so useful in preventing complications related to the flu virus.

One question remains: Does this special shot actually bring about a better immune response?

According to data from clinical trials of older recipients, it definitely results in levels of antibodies being produced. Whether or not these antibodies actually reduce the chances of getting the flu virus, however, is subject to ongoing debate. According to a study in the New England Journal of Medicine, though, the high dose vaccine was 24.2% more effective in preventing the flu amongst older individuals, so scientists are confident that the higher antigen dose is a good idea.

After having explored how age and health status influence the effectiveness of the flu vaccine, let us discuss the second factor that I mentioned before: the relationship between the shot and the strain of virus it is fighting.

Earlier in this post I mentioned how well “matched” the vaccine and the illness are. What did I mean by this?

Well, the vaccine has proven to be most effective when its antigens match those of circulating strains. If they match, then the pathogens introduced to the body by the vaccine will bring about an initial production of antibodies that will successfully fight off the current flu virus.

That being said, it is very difficult to predict which strain of the virus will break out each year and created a corresponding flu vaccine, so sometimes the vaccinations do not “match” and are less effective at fighting the illness.

This exact situation occurred during the 2014-2015 flu season when the CDC released a warning that the flu season would be particularly unpredictable and harsh due to an outbreak of the H3N2 virus.

According to CDC officials, a vaccine was made and ready to go until the virus “drifted” in March, a mutation that came too late to be included in the vaccine.

"It's clear that the laboratory tests we're using to understand how closely related this virus is to the vaccine virus are good, but they're imperfect markers of how well the vaccine will function in the field," said Joseph Bresee, chief of the CDC's Influenza Epidemiology and Prevention Branch.

Although this seems scary for recipients of the flu vaccine, we can rest assured that, even when the shot is not perfectly “matched” to the strain, they still provide some protection against the harsher effects and complications of the flu virus.