DRUG BUST by Alan Cassels
• The people’s briefing note on prescription drugs
In my inaugural column in this magazine almost eight years ago I wrote a story called “The media life cycle of the wonder drug story.” It’s time for an update.
That article concerned the drug Herceptin (trastuzumab), which is prescribed to women who have been treated for breast cancer as a way to stave off future tumours. In terms of the ‘media life cycle’ of Herceptin, as well as quite a few other drugs over the last 20 years, I have found they often carve out a very distinctive, predictable arc. Even if you’re not interested in Herceptin, other drugs (one you or someone in your family may be taking) will follow a similar formula as noted below:
Create the buzz: A big cancer conference swirling with prestigious oncologists (cancer doctors) announces big preliminary results. Their research suggests they’ve made a ‘major advance’ in the treatment of cancer. Investors and clinicians catch the buzz.
Headline: “Trastuzumab trials steal show at ASCO meeting.” (American Society of Clinical Oncology, June 15, 2005)
Create a sense of panic: The breakthrough breast-cancer drug is not yet available in Canada and certainly not available to the thousands of women whose lives could likely be saved by it. Headline: “New cancer drug limited to few.” (June 7, 2005)
Inflate the benefits: The clinical trial underway is halted because the drug appears so wonderfully effective. Reporters regurgitate the impressive statistics showing the drug’s benefit. Headline: “Results of Herceptin studies called stunning. Researcher says drug plus chemotherapy might be a potential breast-cancer ‘cure.’” (October 20, 2005)
Advocacy journalists swallow the bait: A series of compelling stories are published lauding the new wonder-cure and decrying the pesky, bureaucratic obstacles women face in getting it. The pressure mounts and eventually the provincial government decides to cover the $30,000 a year drug. Headline: “Ontario will fast-track breast cancer drug.” (June 24, 2005)
Journalist wins award: One journalist writing for the country’s top paper gets awarded the Michener Award, the top award for “public interest journalism” in Canada. Headline: “Globe wins Michener Award.” (April 12, 2006) In the citation for this 2005 Michener Award for meritorious public service journalism, it reads: “One series about the breakthrough breast cancer drug Herceptin prompted provincial government to fast-track the drug approval process and expand use of the drug. It had been restricted to women who were dying of breast cancer.”
All this activity causes Herceptin sales to soar, buoyed by the heart-wrenching narratives of individuals taking the drug that is helping them defeat their personal war on cancer. The media campaign has been so effective even women who don’t have the disease in question start pestering their doctors for prescriptions. Then a tipping point happens.
The problem is the whole thing was based on a lie. We learn this when the bad news trickles in. After a summer of hype, the USFDA issues a warning. (Note the media now calls the drug by its generic name.) Headline: “FDA, Genentech issue warning for anticancer drug trastuzumab.” (August 31, 2005) This starts a small wave of stories of adverse effects and federally mandated drug warnings appear. It seems to have a predilection to cause heart failure in some patients. The black box warning tells physicians to look out for “Fatal infusion reactions and pulmonary toxicity.” (November 2006)
Now the narrative has shifted completely. Some women are experiencing heart toxicity because of the drug. An overview of large studies of Herceptin shows the drug only ‘works’ in those women who carry the HER-2 gene. About 3.3% more of them are still alive after a year, but 2.6% more develop serious heart toxicity because of it. It’s clear that, despite the hype and the hope, generated by award winning ‘public interest’ journalism, the much-hyped $30,000 a year treatment is a boondoggle. What we don’t know is how many women are dying because of the drug, overall.
Fast forward seven years later to this headline: “Drug giant probed for not disclosing 15,000 patient death reports: Roche under investigation by UK watchdogs after 80,000 ‘adverse reactions.’” (Daily Mail, July 8, 2012) The story refers to how Herceptin’s adverse event data had been kept secret by the company. And so it goes.
New drugs get tested in high-quality, randomized, controlled trials, but prescribers and the public are left with an incomplete picture of the drug. We don’t have full information on how many studies were done, how many patients were harmed or how they were harmed because unlike the award winning headlines, all this information is kept secret.
Incidentally, the best Canadian journalistic report on Herceptin was also found in the Globe and Mail. Andre Picard’s article “Be skeptical about the Herceptin hype” (August 4, 2005) was an example of true public interest journalism, reflecting the fact that both the risks and the benefits of any drug need a full examination and that breathless and unwarranted enthusiasm might sell papers, but ultimately screws patients. Picard didn’t win a Michener that year.
One last headline: “What we know of breast cancer drugs may be spin & bias.” (January 14, 2013) A new Canadian study of major cancer trials uncovers an egregious amount of spin and bias. An analysis of 164 major trials found a third were biased in how they reported the benefits of the treatment and two thirds spun the reporting of the toxic effects, downplaying or ignoring them. In other words, the shameful Herceptin story is not an outlier; it’s how cancer studies have been generally done and reported.
In 2006, I wrote to the Michener awards committee warning them that one of their nominees had produced a series of articles so biased it was likely causing great harm in women and a huge waste of money in our public drug plans. They ignored me.
Two great travesties continue to happen in drug reporting: Original trial reports contain both spin and bias and reporters generally aren’t asking the hard questions like how many people are being hurt by a new drug so consumers are left with an unnaturally rosy picture of it.
The most noteworthy villains in this saga might include the academic researchers who produced slanted reports of the drugs they studied, the advocacy journalists who allow themselves to be employed as part of the drug company’s PR strategy, the journalism awards committees who reward the production of propaganda and the provincial governments whose drug programs succumb to the heart-rendering, biased journalistic reports.
Now it’s my turn to be an activist journalist and I ask you to:
1. Sign a petition: An international petition campaign is underway www.alltrials.net calling on “governments, regulators and research bodies to implement measures to achieve the complete reporting of clinical trials.” This is at least 40 years overdue so don’t delay; sign now.
2. Consider volunteering for a study: If you have a health condition that might be helped by a new treatment, why not volunteer? Medical research would grind to a halt without volunteers. But before you sign the consent form, ask the researchers to show you, in writing, that the trial protocol is registered and publicly available, that a systematic review of current evidence has been done and the trial is actually needed and when it’s over, the entire world can see the full, uncensored results. If they can’t do that, don’t sign. You don’t want to be an accomplice to their crimes. j
Alan Cassels is the author of Seeking Sickness. His next book, due out this year, is about the social history of the Cochrane Collaboration. He has never won a Michener award, but he once wrote a letter to the Michener committee complaining about someone who did win. They never wrote him back.
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Alan Cassels is the author of Seeking Sickness: Medical Screening and the Misguided Hunt for Disease. Follow him on Twitter @AKECassels or www.alancassels.com