The Statins War

      Statin Wars

      Next weekend at an American Heart Association meeting in Chicago, we’ll get new guidelines for treating high cholesterol, the first big update since 2013. Past guidelines have said more and more of us should take cholesterol-lowering drugs called “statins” to prevent heart attacks and save lives. But the recommendations aren’t without controversy. And they raise a larger debate in medicine— over who’s paying the doctors and groups deciding what’s good for us.

      Our search to learn about the Statin Wars takes us to the town wharf in South Freeport, Maine where we catch a ferry to Bustins Island. That’s where we find one of the foremost experts in the whole controversy over statin drugs: Harvard’s Dr. John Abramson.

      Dr. Abramson: The story of statins is that they are now the most widely prescribed class of drugs to adults over 40 in the United States.

      Dr. Abramson has been tracking the Statin Wars for well over a decade.

      Dr. Abramson: The approach to how doctors try to help their patients be well— has been really taken over by the drug industry, so that issues that ought to be broadly about how we live our lives become very narrowly about what medicine you should or shouldn't take.

      Dr. Abramson entered the fray in 2004 after a sea change. Eight doctors had written new government guidelines saying Americans’ cholesterol levels should be much lower than what physicians recommended for years. The result? There were millions more customers for statin drugs —overnight.

      Dr. Abramson: Even though there were no conflicts of interest that were declared in the guidelines when the guidelines were published, it turned out with just a little bit of research that we found that seven out of the eight authors had ties to the drug companies.

      Sharyl: Statin makers?

      Dr. Abramson: Statin makers.

      Sharyl: What does that tell you?

      Dr. Abramson: It tells me that the guidelines are written by people who have an approach to preventing cardiovascular disease that is consistent with the goals of the drug companies.

      So after those guidelines written by doctors connected to statin makers, Dr. Abramson and three dozen independent scientists took an unusual step. They signed a petition asking the National Institutes of Health to reject the new cholesterol guidelines and seek a new “objective, independent” review. They said it would likely “lead to different conclusions” than the doctors who’d been paid by the statin makers.

      Sharyl: Shouldn't those conflicts of interest have been disclosed?

      Dr. Abramson: Well, two things, Sharyl. One is that of course they should have been disclosed— eventually they were because of the letter we wrote. But the much more important thing is those people shouldn't be writing guidelines.

      The National Institutes of Health rejected the calls for an independent look at the cholesterol guidelines but— under pressure— disclosed the doctors’ ties to 29 drug companies. Meantime, statins reached near mythical status in the minds of many. Lipitor, made by Pfizer, became the most profitable drug in history.

      Sharyl: I’ve heard people say almost everybody ought to take them. Does that concern you?

      Dr. Abramson: Yes. It does. The problem with that is there's no question that they lower cholesterol, nobody ever debated that. The question is whether people who have their cholesterol levels lowered like that, whether they do better than people who don't.

      Adding to the debate studies showing too little cholesterol increases risk for cancer, brain issues, and other serious illnesses. In 2012, following long denials by statin-makers, the FDA required statin labels to warn of possible liver damage, memory disorders, type 2 diabetes and potentially fatal muscle problems. Ann Horn, a science teacher, says after she started taking a statin, she developed headaches, a body rash and muscle weakness.

      Ann Horn: And when I got to the point when I couldn't stand in line at the grocery store, it all started to click. And I looked up the side effects of the statin I was on, and all of those were side effects. And I stopped taking them, and within a week, everything went back to normal. Sharyl: After that, she consulted her doctor. Ann Horn: I explained to her what happened, and she said, "Oh, no, if you can't take this statin, you can't take any statins."

      For all of statins' problems— doctors like Jennifer Robinson of the University of Iowa, have reported positive results for millions.

      Dr. Robinson: So I was quite excited when you invited me to come here and talk about, I hope this turns out to be a pro-statin piece because...

      Sharyl: I don't see it as pro- or anti-. It will be informational.

      Dr. Robinson: Yeah, but to just say there are all these benefits for statins.

      In 2013, Dr. Robinson helped write updated cholesterol guidelines that further expanded the number of people who should be prescribed statins.

      Dr. Robinson: Statins reduce deaths from any cause. They reduce heart attacks, they reduce strokes, and when we look at them in totality, the more we lower cholesterol, the more risk reduction we get.

      But much like 2004— the 2013 recommendations were seen as controversial. Half of the advisers who worked on them—including Dr. Robinson— had received compensation from statin makers.

      Sharyl: So how do you keep your professional opinions independent?

      Dr. Robinson: Yeah. I think that's always a challenge, isn't it? And I think we always need to fully disclose what those relationships are so that people can take what we say in context and you know, it's all transparent.

      It’s not just individual doctors and scientists getting paid by the makers of medicines they promote Drugmakers also give millions of dollars to groups that promote medical guidelines— and can turn a drug into a blockbuster. All of the statin makers have donated to the American Heart Association, which develops the cholesterol recommendations. As it happens, some of the bigger companies donating to the American Heart Association, are also developing new generation heart medicines that stand to possibly benefit from whatever the Heart Association recommends. Novartis, Sanofi-Regeneron and Amgen recently committed more than five million dollars each to the American Heart Association. AstraZeneca gave over $27 million.

      We asked Dr. Robinson how much she's made from drug company relationships, as she's promoted stations and worked on the government guidelines, but she declined to answer directly. Her office referred us to a government web site that tracks the last 5 years. It shows she received about 5 million dollars in compensation and associated research funding related to the pharmaceutical industry.

      With all the companies promoting medical treatments, it’s easy to forget that most heart disease can be prevented by healthy habits.

      Sharyl: So you've made a lot of diet and exercise changes.

      Ann Horn: Yeah.

      Horn told us she's slashed her so-called bad cholesterol using natural supplements and lifestyle changes.

      Ann Horn: I came down 20 points in my LDL cholesterol last I checked.

      As far as conflicts of interest among doctors who develop government recommendations while getting paid by certain drug makers, Dr. Robinson says the system has become far more transparent since those controversial statin guidelines back in 2004.

      Dr. Robinson: And now the most recent guidelines, which will be coming out here in 2018, there's no one with relationships with industry. So I mean, I think over time they get, you know, we get approximate the truth better and better. You know, we learn more and we figure out how to do things better.

      Dr. Abramson says the Statin Wars have proven one thing: there needs to be more conversation about the influence of money on those who decide what’s good for us.

      Sharyl: You’re a prominent Harvard physician. What do you face in your community when you speak out about these sorts of things?

      Dr. Abramson: Many of the docs that I interact with have a relationship with the drug companies. The kind of discussion that we're having right now is not polite in many of the academic circles that I'm in. I have to zip it, because what I'm saying is going to be offensive to people. I think that's a real problem.

      Statin sales are expected to reach a trillion dollars by 2020.