"A virus that causes cancer..."

So I just viewed the commercial for the one billionth time. I’m sure you all know what I’m talking about… “a virus that causes cancer”. The ad is for Gardasil, the relatively new vaccine for HPV, a group of viruses that we have been aware of for quite some time that can, in fact, induce changes on the cervix leading to cervical cancer. Merck Pharmaceuticals is the manufacturer and they have launched a marketing campaign with one objective in mind…fear. I have long been a skeptic of Gardasil and I will not immunize my children unless some new evidence emerges that changes my mind. I simply don’t think it’s necessary.

Some of you may remember my post roasting Texas governor Rick Perry for his proposal to mandate Gardasil for all girls. I think such a policy is ridiculously authoritative and irresponsible. Perry has since backed down, but the issue remains very much alive. 41 states have taken the matter into consideration, including 24 legislatures that are considering mandatory vaccination. Most notable is Virginia, under some rather shady circumstances. In Decemeber 2006, Merck announced it would invest $57 million to expand its plant in Elkton, Virginia to manufacture Gardasil. Two months later, Governor Kaine signs legislation that makes the vaccine mandatory for school attendance. Four months after that, Merck announces an additional expansion of $193 million in Elkton. You decide.

So why would a physician – a family physician at that – be opposed to such action? Well, it’s a simple matter of risk versus benefit.

First, Gardasil is expensive, upwards of $1000 for the vaccine series. And it has been a boom for Merck, bringing in $1.5 billion for the drug company last year alone. Naturally, much of this tab is paid by governmental entities since the poorest families can’t afford the vaccine. Even if you assume that Gardasil would eliminate all deaths from cervical cancer (which it doesn’t) then you see that it costs about $70K for each year of life saved. This is a big number when you compare it to other anti-cancer measures. The natural question is: What are we getting for our investment?

Merck’s answer is cancer prevention. We are vaccinating young women against cervical cancer, thus saving money on treatment and lost productivity. But there are more questions about this vaccine - and Merck’s marketing - yet unanswered. If you watch the commercials you will get the impression that cervical cancer is a major public health threat. The actors do a good job of expressing fear and concern that we are all at risk. The message: get immunized now. This is just one reason why I oppose allowing drug companies to advertise on television. For years, doctors acted as a buffer between patients and drug makers. Now, the drug companies can take their pitch straight to the customer and the result is a lot of misinformation, fear, unnecessary doctor visits and uninformed decision making.

The fact is cervical cancer isn’t the big danger that Merck wants us to believe. Last year 3,600 people died from it in the US. Not a big number compared to other diseases. Pap smear screening has been very effective in reducing cancer rates and saving lives. Since we started routinely using pap screening, the rate of cervical cancer has dropped 74%. It is the most successful cancer screening tool ever discovered. Basically, if one maintains their routine screening then cervical cancer becomes less of a threat. The vast majority of deaths are in people who don’t get screened.

So, perhaps the vaccine could eliminate the need for these tests, again saving money. Wrong. The vaccine only covers viruses that cause 70% of cervical cancer. So, pap smear screening STILL must be done even if you’ve been immunized. You’re still at risk. The problem is – and what many doctors fear – that many people will assume that immunization incurs 100% protection or would he happy with the 70% number, and these people will fail to continue their pap tests. This would be dangerous. I could easily argue that cervical cancer rates are in danger of INCREASING from the use of this vaccine. Another danger would be a decrease in regular physician visits that lead to screening for other diseases. In comparison, breast cancer is 16 times more common than cervical cancer, and women are 10 times more likely to die from it. Often breast cancer screening is done during routine women’s health and pap smear visits. So, if women aren’t getting their paps done, they may be missing out on important other screening tools.

Then there’s the question of effectiveness. Merck expeditiously pushed this thing through the approval process, again stressing the urgency of cervical cancer in America. The FDA gave in. Gardasil only took 6 months from application to approval, whereas most vaccines take 3 years. This is concerning. Some clinical data shows the vaccine may not last, with evidence that immunity wanes after only 3 years. A longer approval process may have brought this further into light. Even the fine print on their commercials says: “duration of protection has not been established”.

Not that Merck is too concerned about waning immunity. That simply means regular booster shots would be required. More shots equals more money. See how it works?

Yet the fear-mongering continues. The American College Health Association has joined in. This from one of their campaigns: “You, the female students sitting in your class, your sorority sisters, your teammates and your best friends could all be at risk.” Sounds a lot like Merck’s commercial. Now, the ACHA recommends all female students get immunized, despite the fact that many women this age are sexually active, already have HPV, and getting immunized would be minimally effective if at all. What the heck is going on here?

Don’t get me wrong. I’m all for preventive medicine. In fact, it’s the backbone of family medicine. But that doesn’t mean that I am willing to recommend my patients do things that would be costly and of little benefit. Protecting against cervical cancer is important. This can be done by getting regular pap smear tests as recommended by the American College of Obstetrics and Gyn. Do this, and cervical cancer isn’t much of a threat. Paying a lofty price for a vaccine that, at best, only grants you 70% protection that may or may not last for only 3 years isn’t in the patient’s best interest. Until new evidence emerges, my opinion won’t change.

In Merck’s defense, it is true that cervical cancer remains a global problem. It is the second leading cause of cancer death in women worldwide, mainly because of high rates in developing countries where pap screening is seldom available. So here is my challenge to Merck: Stop advertising Gardasil in the West and instead take that money and use it for a free vaccination or pap program in the third world. Any chance this will happen? If so, I will be the first to echo praise for this company.

I’m not beating up on the drug companies. In fact, I support our pharmaceutical industry. They’re one reason why we have the best health care in the world. But allowing them to advertise directly to consumers is wrong. It presents too much opportunity to distort facts for the purpose of financial gain. Any health care plan that doesn’t stop this practice is incomplete in my mind. The drug companies have lots of money, and that money can be spent better than on misleading commercials and fear-mongering.