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Journalists need to scrutinize the USPSTF’s draft recommendations on statins … and so do patients

iStock_000019994924_SmallThe recent United States Preventive Services Task Force (USPSTF) draft recommendations on cholesterol-lowering drugs known as statins generated some news coverage, but not much and not much of high quality. That’s a shame because these recommendations could affect literally tens of millions of otherwise healthy Americans who are at risk of being medicated for their cholesterol for almost no benefit. Here are the recommendations in a nutshell: People between 40 and 75, with one or more risk factors for cardiovascular disease (CVD) such as high cholesterol, diabetes, high blood pressure or smoking and with a 10-year risk of a CVD “event” of 10% or more should take a low-to moderate-dose statin.

My admittedly unsystematic assessment of the reporting is based on stories from several outlets including US News and World Report , Time Magazine,  Reuters and UPI. I found that they committed some of the usual sins we complain about: Not properly quantifying benefits or harms, failing to note conflicts of interest and generally ignoring key controversies that surround this issue. When the benefits were quantified, as in the Reuters story, relative values were used, which tend to exaggerate the extent to which these drugs might help. The bigger context, which people need when you are talking about preventive medicine, was missed. Essentially there are a myriad of other ways a person might want to reduce their cardiovascular risk instead of swallowing a drug.

To their credit, Stat News, Time, and UPI did feature some critical commentary from Dr. Steven Nissen at the Cleveland Clinic that was quite useful. Nissen said that “these recommendations leave as many questions as they give answers.” He added: “It doesn’t clarify for prescribers and for patients what they should do. I find that exasperating.”

I would add that I find it exasperating that many journalists didn’t dig much below commentator soundbites on an issue that affects so many of their readers. Maybe they should’ve tried a listicle. A “listicle” you say? A listicle is an obvious smashup of ‘list’ and ‘article’, pure popsicle journalism: just a few licks, followed by a mild sugar-high, then it’s gone. Listicles are the answer to our Twitter-fueled, pay-per-click culture. Instead of developing a thesis, raising arguments for and against, and ending with a well-reasoned conclusion, listicles require mere seconds of attention span. And did I say resistance is futile?  While lacking in clickability compared, say, to the “50 cutest things that ever happened,” I’d like to think my “9 reasons to ignore the USPSTF’s draft recommendations on statins” brings some gravitas to the listicle genre. Here they are:   

  1. These recommendations, thankfully, are “draft,” sort of like a test dirigible easily brought down with random shrapnel.  We shouldn’t get excited yet because the USPSTF may soon agree how silly they are and discard them.
  2. We’re talking HEALTHY people here! The best research so far shows that the likelihood statins will benefit people without heart disease is nonexistent. The picture is different if you are higher risk, and have established heart disease. Taking a statin for five years can delay death for about one in 83 high risk people. And the listed ‘risk factors’? Nearly everyone on the planet has one of those, so let the shareholders rejoice.
  3. The recommendation tiptoes around the known and under-reported dangers of statins which include muscle pain, liver injury, memory loss and diabetes. In trials, statin users experience almost 20% more adverse effects than placebo patients. Frankly the depth of our collective ignorance about the whole range of statins adverse effects is bottomless, according to one pundit.
  4. This recommendation lines up nicely with the American College of Cardiology/American Heart Association CVD risk calculator, but does that matter? It does, because there’s pretty good evidence that calculator is flawed and overestimates risk.
  5. Speaking of the ACC and the AHA, let’s remind ourselves that their thoughts on statins can hardly be seen as unbiased seeing as they recruit experts riven with conflicts of interest. Do we really expect the drug companies to put their own people on statin guideline committees if they weren’t satisfying shareholders? Not in this universe. It’s hard to say why the good folks at the USPSTF would want to sully their brand by lining up with these guys.
  6. Even though USPSTF experts do very careful assessments of data, it’s surprising that they didn’t seem to account for the highly problematic evidence behind statin therapy. The big problem is that the drug companies have funded most of the trials, and industry-funded trials are 20 times more likely to give results favoring the test drug.  
  7. The folks at the USPSTF forgot that real people in the real world are affected by this stuff so recommendations that add more murk to the current swamp of statin ignorance, where ‘informed consent’ is rare, are very unhelpful. If people were required to pass a set of skill testing questions before they got their statin, most would fail.
  8. The financial consequences of getting more and more healthy people on statins is ginormous, considering that US citizens currently swallow 264 million statin prescriptions every year, worth about $10 billion. Since statins are almost all off patent, the only real way to buoy profits is by expanding the market and the USPSTF guidelines will increase that market. Just see how excited the investors are.
  9. This flawed recommendation besmirches the USPSTF’s brand, a benchmark of objectivity, in a landscape sullied by conflicts of interest.  When the USPSTF speaks, people listen. Why? Because usually they deliver reliable, evidence-based recommendations that nourish and uplift. Yet their statin blather is like they’ve removed all the fiber and nutrients to leave us with a high fructose corn syrupy sugar high. This is just icky and sticky.

Alan Cassels is a drug policy researcher in Victoria, British Columbia and a reviewer with HealthNewsReview.org. The opinions he expresses are his own. Follow his writings on twitter @akecassels.

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Comments (7)

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flem

January 14, 2016 at 1:18 pm

I share your opinion that these new guidelines are not very helpful. Everyone also agrees that lifestyle modification is best to control blood sugar, pressure, and lipids and prevent diabetes, hypertension, and athersclerosis caused by these factors and their associated morbidity and mortality. However you seem to be of the opinion that even if these lifestyle measure aren’t successful it is better to wait for your first CV outcome before taking any preventative medication.
I often wonder what the incidence of CVD would be in the US if every adult who could not control their blood sugars, BP, or LDL with lifestyle were given and tolerate very low cost generic (pennies/daily) metformin; ARBs/ACEI/CCB/duietics; statins (and throw in ASA for good measure). You must admit that, though not all, the majority of patients get more benefit than risk from these well know meds. I’m all for natural and non-pharmaceutical prevention but we have an arsenal of well tolerated, cheap, and potentially useful drugs to help control risky markers that are relatively easy to monitor. Isn’t wasteful if we don’t use these. And don’t talk about conflict of interest in these cases – these largely drugs are off patent and if anything their use limits the use of much more expense new cholesterol drug.

    kitty

    January 15, 2016 at 3:46 pm

    flem – Re: ” if every adult who could not control their blood sugars, BP, or LDL with lifestyle … were given”. I think you need to factor in Numbers Needed to Treat. You are making an obvious mistake of confusing relative risk reduction with absolute risk reduction and ignoring the number of people one needs to treat to benefit 1 person. Given that many people who cannot control LDL cholesterol because of genetics have no other risk factors, I’d suspect for many people the risk is greater than the benefit. In terms of cost – no, it’s not cheaper to treat 100 people for 10 years to prevent 3.3 heart attacks.
    “You must admit that, though not all, the majority of patients get more benefit than risk from these well know meds” — Not necessarily. Even with 10% 10-year heart attack risk and relative risk reduction of 25%, you’ll get only 3.3 percentage point probability that the meds will help. Is the risk of side effects really smaller in this category? The majority of adults have much lower risk.
    Also, don’t confuse also cost effectiveness with cost savings. A lot of articles talk about cost effectiveness, and people who read them often automatically assume that it means that money are saved. But cost effectiveness in this case usually means that the cost of quality-adjusted-life-year gained is under 100,000. (in some cases the number used is 50,000). While you may consider it worth while, it’s not the same as cost saving. In fact, statins are only cost saving for very high risk population.

    HockeyDoc Dave

    January 15, 2016 at 6:45 pm

    I very much disagree with your statement, “You must admit that, though not all, the majority of patients get more benefit than risk from these well know meds.” I am a doc, who, 15 years ago, thought we should put statins in the water supply. However, I was wrong. The side effects are MUCH more numerous than we previously realized. Why? Because with things like muscle aches, diabetes, and memory loss, these symptoms are easily attributed to things other than statins. Any doctor that prescribes statins, myself included, has ignored or attributed these signs and symptoms to things other than the statins. The number needed to treat (especially for primary prevention) is, in my opinion, far too high. I have pulled WAY back on the statins. I still use them for secondary prevention.

      pharmaceutical reasearch scientist

      January 17, 2016 at 10:57 am

      I’ve known for years that Merck was well aware that the use of statins would cause the loss of Coenzyme Q10 (CoQ10), which resulted in the fibromyalgia symptoms (muscle pain and fatigue), since they had a patent in 1990 for co-administration of CoQ10 with HMG-CoA reductase inhibitors. See: http://www.google.com/patents/US4933165
      While many were saying that statins are the best thing since sliced bread around 2000, I was not at all keen about “putting it in the drinking water.” I was wondering how long it would take before the public became aware of the dangers of statins and that Merck did not add the CoQ10 simply because it was not as profitable.
      Scientists in my industry widely agree that it is the ratio of LDL to HDL that is the most telling parameter in cardiovascular risk, not any single parameter, so doctors who prescribe statins when they see that the LDL >100 mg/dl are not doing what is in the best interest of the patient.

      Lastly, the statement, “The big problem is that the drug companies have funded most of the trials, and industry-funded trials are 20 times more likely to give results favoring the test drug.” and other such suspicions that study results are tainted because the drug manufacturer funded them is very confusing to me. Pharmaceutical companies must fund the studies for a new drug to submit to the FDA for review to have it passed. The FDA does not conduct studies, they review them. Even some studies conducted by the NIH are funded by pharmaceutical companies. If they didn’t pay for them, no drugs would get passed. The cost for these studies is the risk the companies take. When I started in the industry in the 1980’s, one in 100,000 new drug entities made it to the market. With the help of computer modeling, the ratio is down to one in about 10,000. That’s a lot of work for one drug to get to market. As one of those researchers, I must tell you that as a group, we are extraordinarily dedicated, hard working, honest folk, Look at those Merck scientists who sued them for fudging the data for the mumps vaccine.

      flem

      January 19, 2016 at 2:24 pm

      I’d gladly pay $100/yr on generic statins, metformin, ARB or CCB; ASA to prevent a first or fatal CV event…even if the absolute risk is 3-5%. I believe about 10% of lifelong smokers get lung cancer. Does that mean I should smoke if I enjoyed it? (and boy did I enjoy it and would go back to it in a second if the risks were lower!) Furthermore I insure my home and car for far more money and with far less risk than a CV event!
      Are you telling me you would not treat pharmacologically a male 62 yrs; BMI 31; untreated LDL 190; fasting glucose 115; BP 89/145 with no history of CVD? He eats well but limited exercise and a stressful job. He has no apparent side effects from his med’s. I bet you got a lot of similar patients.

kitty

January 15, 2016 at 3:37 pm

Good points, but one good thing about USPSTF recommendations is that make a lot more sense than previous recommendations from some other organization (forgot who it was). The previous recommendations drew the line at 7.5%, but only if the LDL is less than 180 and suggested prescribing high intensity statin right away for LDL >=180 regardless of risk. Given that it was perfectly possible for a person to have LDL >=180 yet have extremely low risk (use the calculator for say a 55 year old female with say HDL of 55, trig of 63, no other risk factors, normal blood pressure without meds, no diabetes or family history and you’ll get about 2% 10-year risk). These guidelines begged the question what was so magical about 180, and why would someone with 10-year risk of heart attack being around 2% want to take statins. USPSTF guidelines make more sense in that regard, even though with 10-year risk of 10%, the absolute probability of benefit from drugs is only 3.3 percentage points. In this light USPSTF guidelines are much better.

Laurence Alter

January 18, 2016 at 8:37 am

Dear Staff,
Read the linked article (“skilled test questions” in your article) and had the usual laugh at this One-Way Concept, “informed consent” and explaining in detail. This is truly meaningless without knowing if the other party understands and, as important, has been understood. “Understood” is the work, unheard, among professionals and specialists. Additionally, no established criteria is used to ensure one is understood (listener, included). “I understand” is misunderstood, un-understandably.
Yours,
Laurence