A study by Australian medical researchers is the latest salvo in the battle triggered by the documentary, "Heart of the Matter," which raised questions about the safety and effectiveness of statins, a class of drugs that block the body's ability to synthesize cholesterol.
The study, which appeared in the 15 June issue of the Medical Journal of Australia, found that thousands of Australian patients stopped taking statins after the two-part documentary aired on the 24th and 31st of October 2013 on the science journalism series Catalyst. Citing a 2005 meta-analysis by the Cholesterol Treatment Trialists' Collaboration, the authors wrote "[T]his could result in between 1522 and 2900 preventable, and potentially fatal, major vascular events," such as heart attack and stroke.
Writing in the Australian, science journalist Lara Sinclair told readers "The ABC may have contributed to the deaths of thousands of Australians." The MJA paper did not look at mortality data.
"Heart of the Matter" was presented and produced by Maryanne Demasi, who holds a PhD in medical research from the University of Adelaide and worked for a decade in arthritis research before beginning a second career as a television presenter. In both 2008 and 2009 she was awarded the National Press Club of Australia's prize for Excellence in Health Journalism.
The documentary was divided into two parts. Part 1, "Dietary Villains," challenged the doctrine that a diet high in saturated fat causes heart disease. Part 2, "Cholesterol Drug Wars," examined the efficacy of statins.
The program featured interviews with a number of medical doctors who are statin skeptics, including Beatrice Golomb, Professor of Medicine at the University of California San Diego; Malcolm Kendrick, general practitioner and author of The Great Cholesterol Con; and John Abramson, Professor of Public Health at the Harvard University School of Medicine and author of Overdo$ed America. (Doctor Abramson also describes himself as an expert in litigation, including cases involving harm from statins.)
The stakes are high here. Worldwide, statins are a $29-billion-dollar-a-year industry. One statin, Pfizer's Lipitor, has grossed $141 billion in cumulative sales, making it the best-selling drug of all time. On per-capita basis, Australians are the world's biggest statin users, consuming 137 daily statin doses for every 1,000 people.
Statins are a $29-billion-dollar-a-year industry
The program concluded that while statins do reduce mortality in patients who already have cardiovascular disease ("secondary prevention"), their benefits for patients without pre-existing cardiovascular disease ("primary prevention") are meager or even non-existent, the toxic effects of this class of drugs have been downplayed, and that the drug companies violate the law and manipulate clinical trial data in order to maximize profits.
The episode stated clearly that individuals should not discontinue any prescription medication without first consulting a medical doctor.
The program triggered a firestorm of criticism even before it aired. Emily Banks, a professor at Australian National University and one of the MJA paper authors, told Australian television presenter Peter Lloyd "If this program goes ahead and does unwarranted undermining of statins, then there will be people who didn't have to have a heart attack and didn't have to die from a heart attack who will die through reducing use of statins."
After the two episodes aired, Australian Broadcasting Company health expert Doctor Norman Swan told ABC radio listeners "People will die as a result of the Catalyst program unless people understand at heart what the issues are." The Australian television program Media Watch joined in the fray, calling the documentary "sensationalist" and "grossly unbalanced," although they did not point out any factual errors.
They also took Dr. Demasi to task for failing to smile when she interviewed Professor David Sullivan of the University of Sydney, who represented the pro-statin point of view.
Doctor Kendrick stated "I did tell Maryann Demasi before the program aired that she would be ruthlessly attacked. She didn't realize that this particular area you touch at your peril. I knew she would be found guilty of something."
The ABC's Audience and Consumer Affairs Unit reviewed twelve complaints (for both episodes) involving seventeen possible breaches of conduct. Their final report ran 49 pages. Some of the complaints clearly were without merit. One, from the Merck corporation (manufacturers of the statin drug Zocor, as well as the first commercially available statin, Mevacor) alleged that the program falsely stated it had sought comment from Merck when it had not. The report concluded "We are satisfied that Catalyst contacted [Merck] for comment and they declined to provide specific responses to allegations."
The investigation found no breaches of conduct for the first episode. In regard to the second episode, one complaint was upheld. This complaint did not allege any factual errors on the part of Catalyst, but rather pertained to a matter of emphasis: that the program failed to consider the possibility that statins for primary prevention might provide benefits to certain targeted populations, and that it did not give sufficient emphasis to the role of statins in secondary prevention in preventing non-fatal heart attacks and strokes.
"If I'd written a paper on anything in which sixteen out of seventeen complaints are considered to be baseless, I would say that's a vindication of what I'd done, frankly," Dr. Kendrick said.
Dr. Abramson stated there is no justification for considering heart attacks and strokes apart from other non-fatal but serious adverse events. "What if statins did reduce heart attacks and strokes, but caused other serious illness? That wouldn't be a good thing."
He also noted that 26 out of 27 studies included in the CTT meta-analysis were industry-funded. "The best scientific evidence shows that commercially funded trials show better efficacy of the tested manufacturer's drug than non-commercially-funded trials, have more positive conclusions, and show significantly less harm than studies that are not funded by drug manufacturers."
Doctor Golomb concurred. "It's quite clear and compelling from numerous sources that individuals who have industry ties make more favorable judgments about the drug."
Dr. Abramson explained that the CTT researchers had access to patient level data for the benefits of statins, but for harms they had to rely on the published data. "We're not calling anyone dishonest. But if you're not dishonest, why not release the data?"
Nevertheless, the ABC removed both episodes from its website -- even though the first one, by its own reckoning, involved no breach of conduct.
"The first documentary they couldn't find anything wrong with," Dr. Kendrick fumed. "So why did they withdraw that? They just ran away in a cowardly fashion.
"The approach of the ABC to this program just made it seem that everything that was in both programs was complete nonsense and no one should pay any attention to it."
The Medical Journal of Australia itself is no stranger to controversy. Last April, its editor, Professor Emeritus of Public Health Stephen Lederer, was summarily fired after expressing concerns about outsourcing production of the journal to publishing giant Elsevier. Most of the editorial staff resigned in protest. The ABC quoted Professor Lederer as saying "This company [Elsevier] has a history of unethical behavior in publishing."
In 2009, Elsevier drew fire after a class-action suit against Merck in Australian courts revealed that the company had contracted with Elsevier for an undisclosed sum to produce the Australasian Journal of Bone and Joint Medicine, which had the look of a peer-reviewed journal but whose contents in fact consisted solely of reprints or summaries of previously published articles, most of them favorable to Merck products. No mention was ever made of Merck's sponsorship. In addition, several members of the publication's "Honorary Board of Editors" complained that Elsevier never asked permission to use their names and had never given them articles to review. At least six other such bogus journals were produced by Elsevier. All have been discontinued. In a statement, Michael Hansen, CEO of Elsevier's Health Sciences Division, said "This was an unacceptable practice and we regret it took place."
Next: Part 2: "A straight-up question"
List of Sources
John Abramson, telephone interviews, 2 February 2014 and 1 July 2015. 978-314-5409, Harvard Medical School, Health Care Policy, 180 Longwood Avenue, Boston MA 02115.
Beatrice Golomb, telephone interview, 3 July 2015. 888-558-4950x201, School of Medicine, University of California San Diego, 9500 Gilman Drive, La Jolla CA 92093-0995.
Andrea Schaffer, telephone interview, 16 July 2015. 011-61-297473-724, University of Sydney, New South Wales, Australia.
Malcolm Kendrick, telephone interview, 16 July 2015. 011-44-1-625-502-001.
Schaeffer, A.L. 2015. The crux of the matter: did the ABC's Catalyst program change statin use in Australia? Medical Journal of Australia 2015 June 15;202(11):591-4.
Corderoy, A. 2014. ABC will take down two controversial Catalyst episodes on heart disease. Sidney Morning Herald May 12 2014.
Leswing, K. 2014. TV can persuade patients to stop taking their medicine. InternationalBusiness Times June 14 2015.
Sinclair, L. 2015. Catalyst 'Could lead to deaths.' The Australian June 15 2015.
Martin, D. 2013. UK is the statins capital of Europe: With 1 in 8 now taking cholesterol busting drugs, are they being used as a replacement for healthier living? Daily Mail December 25 2013.
Kendrick, M. 2008. The Great Cholesterol Con: The Truth About What Really Causes HeartDisease and How to Avoid It. John Blake.
Abramson, J. 2008. Overdo$ed America: The Broken Promise of American Medicine. Harper Perennial.
Lundh, A. et al. 2012. Industry sponsorship and research outcome (Review). Cochrane Database of Systematic Reviews 2012 Dec 12;12:MR000033. doi: 10.1002/14651858.MR000033.pub2.
