Pneumonia Vaccine Approved as Deaths Mount During Trial

The vaccine trial is ongoing in Argentina. Parents agreed under threats of losing their children and without informed consent. GSK says it's not the vaccine—but where's the proof?

by Heidi Stevenson

6 March 2011

As deaths were mounting from GlaxoSmithKline's ongoing vaccine study in Argentina, the European Union's Medicine Agency, EMEA, approved it for mass use on infants. The pneumonia vaccine, Synflorix, is expensive and recognized as ineffective for those most in need. With no real explanation, GSK has announced that they won't market it in the US.

In 2008, the Daily Mail reported that the deaths of at least 14 children could have been caused by GSK's Synflorix vaccine.⁽¹⁾ Naturally, GSK denied that the vaccine was the cause, but to this date, we have nothing better than their claim. Their history, including the recent settlement to pay $750 million for knowingly distributing adulterated Paxil,⁽²⁾ and the EU's suspension of Avandia's license for causing heart attacks,⁽³⁾ which it was supposed to prevent, in diabetes patients.

GSK's Synflorix is a blockbuster. It became that the day it was approved. Sales in the billions are rolling in. With so much money at stake, it would be a wonder if there weren't any shenanigans in the testing and approval process. In the case of GSK, there's a history of such behavior. In spite of that, EMEA gave its approval based on studies produced by GSK alone.⁽⁴⁾ Though the cost of £37.30 per single dose reported on DocSimon is certainly higher than countries pay, the cost to taxpayers is enormous.⁽⁵⁾

Oddly, GSK does not plan to market Synflorix in the United States. CEO Andrew Witty stated:

It's clear that Synflorix versus Prevnar is a much more competitive innovation outside of the US because of the presence of different pneumococcal subtypes. We haven't finally decided, but I think we are more likely to tackle the US with a different type of vaccine to Synflorix. My expectation, subject to some further analysis, is it probably won't be Synflorix we take to the U.S.⁽⁶⁾

If it's true that children in the US get different types of pneumonia, it would certainly be interesting to know what differences exist, and why they exist. Of course, that sort of study doesn't benefit GSK or any other Big Pharma company. All that matters is finding products that can bring in tons of money.

Yet again, we have a new pharmaceutical product with questionable safety and efficacy trotted out as if it were both safe and effective. The fact that it's neither is not a secret, though the EMEA and GSK would certainly like it to be. EPG Online provides some information that should be noted by every parent before accepting Synflorix:⁽⁷⁾

• One of the primary points noted is that children receiving immunosuppressive drugs are unlikely to achieve an adequate response. Immunosuppressive drugs include some very common ones, most notably steroids, which are routinely given to children with asthma.
• It's okay to give Synflorix with other vaccines. Well, sorta. They advise that an antipyretic should be given prophylactically if a whole cell pertussis vaccine is given at the same time. They also suggest that an antipyretic be given if a child has a history of seizures.
• Don't give paracetamol to a child getting Synflorix, as it might negate the vaccine's effects.
• Children with blood coagulation disorders—bleeding problems—should not be given Synflorix.
• The pneumonia-causing bacterium Haemophilus influenzae (Hib) is unaffected by Synflorix. Therefore, it won't replace the Hib vaccine that's given so routinely at birth.
• Even the testing doesn't demonstrate anywhere near full coverage against the disease Synflorix purports to prevent.

If you take a look at the New Product Focus for Synflorix in the South African Pharmaceutical Journal⁽⁸⁾, you'll see that not a single one of these concerns is noted. Obviously, not even the limitations and risks that are officially known are being clarified to some of the people who most need to know.

Finally, of course, is that the EMEA is ignoring the reports of children dying in the vaccine trial being conducted in Argentina. It's been nearly two years since the report, and there have been no updates. It's being treated as if nothing happened. The only argument against the claim that 14 children have died as a result of GSK's Synflorix test is the weak statement from GSK that the deaths weren't caused by the vaccine. That statement has never been backed up with facts. The Argentinian department that has said it would investigate is run by the brother of one of GSK's lead investigators.⁽⁹⁾

So, for all practical purposes, there are no safety studies for Synflorix. That's not unusual in the world of vaccines. In fact, it would be unusual if there were a study. That, though, does not justify the lack in this case. What's clear is that the public's safety is not of much concern to the regulators.

The truth of Synflorix seems to be contained within the first syllable of its name.