Sunday, February 8, 2015

I support vaccines- but I am somewhat surprised that more parents don't

As a medical student, I strongly support vaccination. It works, it's safe, and it doesn't cause autism. But I also understand why many parents don't believe me and the medical community when we beg them to vaccinate their kids.

Medicine has come a long way from "Do No Harm". Now we talk about risks and benefits: and none of our tests, medicines, or procedures are without risks. Increasingly, pharmaceutical companies have been caught concealing those risks from doctors and the public.



Around 2000, Merck (the manufacturer with a monopoly on the MMR vaccine which protects against measles- more on that later) published a study called VIGOR which showed that their new drug called Vioxx effectively treated pain from arthritis. But they concealed data from the medical community which showed that it also caused heart attacks. Merck employees literally joked about destroying doctors who raised the alarms about the drug. Some estimates put the number of lives shortened as high as 100,000. They were caught, and have paid almost $1 Billion in fines so far.

Was Merck just one bad actor? In 2006, GlaxoSmithKline was found to have concealed data about Avandia, a diabetes drug. An email was discovered stating: "Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK" GlaxoSmithKline was fined $3 Billion, and is believed to have contributed to over 80,000 deaths.

That's not all. Novartis was caught trying to blatantly falsify data on the efficacy of it's blood pressure drug, Diovan, by secretly inserting one of it's employees into the data analysis process. And just this year, controversy exploded when Boehringer Ingelheim was found have concealed safety data about it's new blood thinner, Pradexa.

And to top it all off, there is an ongoing federal lawsuit by whistleblowers that Merck faked the data about the MMR vaccine's efficacy in order to maintain it's monopoly- the same vaccine that everyone is being urged to get to fight the outbreak. (A separate lawsuit is underway by doctors on the East Coast that Merck is abusing it's monopoly power to jack up prices on the vaccine). To be clear, we're talking about whether it's 95% effective vs something probably more like 85%- it's still does work, as shown by the total absence of measles from Mississippi and West Virginia, two states with near 100% vaccination rates in comparison to the national average of 95%. But the FDA has allowed Merck to monopolize the market so long as the vaccine works at 95%- if it doesn't, Merck loses it's monopoly. All viruses and bacteria evolve somewhat over time, and different strains gain prominence. The question is, has the vaccine lost it's potency? The two whistleblowers from Merck say yes, and that Merck has hidden that fact.

In this environment, the surprising thing isn't that parents are refusing the vaccine- it's that anyone still trusts doctors when we tell them to give their kids our medicines.

Why do I personally still support the vaccine? A few reasons, starting with the fact that the older a medication is, the harder it is for a company to conceal safety data and the more well-studied it is. While Pradexa (Boehringer Ingelheim's new anti-coagulant) is under suspicion; warfarin- a far older drug- has done the same job for generations without any surprises. That's not to say that warfarin is better- it has it's own risks: starting with the fact that being on it requires lifelong monitoring, blood draws, and dietary awareness. Pradexa is far easier to dose, and far less likely to leave someone dangerously prone to either bleeding or throwing clots if they eat the wrong food or take a new drug. But warfarin's risks are known- Pradexa's and other new medications' risks may have been concealed.

The MMR vaccine is decades old. If there were any initially concealed risks, we would have heard about them by now. In addition, the intense problem of vaccine denalism has led to many independent, non-pharma funded trials of all vaccines, which are much harder to influence and fake than Pharma-funded trials which form the basis of FDA approval in this country. Finally, evidence of the MMR vaccine's efficacy is found in the near elimination of Measles in this country decades ago, relative to the rates at which they were happening.

I am not proposing that anyone stop using new vaccines or drugs. Nor am I proposing that we nationalize pharmaceutical companies. But it doesn't take a medical student to realize that a company that wants to make a profit on a drug has a clear conflict of interest if it is conducting a scientific study to determine if that drug is safe and effective.

How can we fix this problem? Simple: an independent agency that takes pharmaceutical companies' money and products and independently conducts the safety trials to determine if drugs and vaccines are safe and effective. Companies should be required to use this agency to study their drugs in humans, and have no control whatsoever over which researchers and what techniques are used to study their products.

But that is a distant pipe dream indeed. Perhaps simple open access to clinical trial data (which unbelievably is not required) is a better place to start. Such open access was forced upon GlaxoSmithKline by a court settlement, and other companies should be required to follow suit.

This measles crisis was (probably) not caused by any one pharmaceutical company's misbehavior. But the lack of trust many parents and patients have in corporate healthcare is very justified, and it needs to be addressed.