We first posted about the Sovaldi debate on March 27, 2014, and its focus on price rather than the quality of the evidence underlying loud claims about the miraculous qualities of the drug. We suggested that there is no good evidence supporting claims that most hepatitis C patients have very bad outcomes if untreated, treatment prevents most bad outcomes, Sovaldi cures nearly all patients, and Sovaldi has very few side effects.
In a subsequent post we wrote that initially, "no one but your humble blogger seemed to be publicly skeptical about published assertions that the drug was some sort of modern miracle, and a triumph of medical science."
On May 7, we noted an assessment by the German Institute for Quality and Efficiency in Health Care (IQWiG) of information submitted by "industry" (presumably Gilead) to the German government. This assessment found multiple problems with the evidence, including limited generalizability, problems with randomization, lack of information about important outcomes, and lack of ability to quantify benefit. Also the US based Institute for Clinical and Economic Review noted that there was little evidence that compared to previous treatments, Sovaldi is better, and no evidence that Sovaldi produces cures in the long term.
Nonetheless, the notions that the evidence supporting Sovaldi (and perhaps other similar drugs) is weak, and that the drugs therefore should not yet be considered miracle cures have not seemingly affected the public discussion.
Examples of the Latest Discussion
Washington Post/ Kaiser Health News
On May 12, 2014, in an article on the dilemma the drug's US price of $1000/ pill presents to Medicare, Richard Knox wrote this about a patient with the infection:
Previous drug treatments didn't clear the virus from Bianco's system. But it's almost certain that potent new drugs for hep-C could cure him.
In other words, the article asserted that Sovaldi and similar drugs cure nearly everyone with hepatitis C, even those not cured by previous treatment.
On May 20, 2014, in an article about how US health insurers are balking at the price of Sovaldi, was this statement by the main trade organization for US for-profit health care insurers, America's Health Insurance Plans (AHIP),
Sovaldi has shown tremendous results, and it's the kind of medical innovation we need to sustain.
In the article's text was the assertion,
The new drug has demonstrated an ability to cure well over 90 percent of patients in just 12 weeks or less with few side effects.
Prior to the Sovaldi approval, hepatitis C treatments took 24 or 48 weeks, cured about 75 percent of patients and involved many more pills as well as injectable interferon that causes flu-like symptoms and other side effects that led many people to avoid or discontinue treatment.
In other words, the article asserted that Sovaldi can cure over 90% of patients compared to the cure rate of 75% provided by previously available treatments, and implied Sovaldi has fewer side effects.
On May 22, 2014, in an article on the high costs of new drugs, a quote from Dr Douglas Dieterich, "a liver disease specialist at Mount Sinai Hospital," who "has consulted for pharmaceutical companies, including Gilead," appeared,
I don’t think there’s any question that treating patients with hepatitis C will lower overall health-care costs in the coming 20 years,...
If we could get rid of the liver disease in these patients with hepatitis C, prevent them from dying of liver cancer, cirrhosis and liver failure, then there’s no question the cost will be less.
The implication was that the new drugs can get rid of the disease, that is, cure it, and in doing so prevent early mortality, cirrhosis, and liver failure.
The discussion of Sovaldi in Canada seems similar. On May 25, 2014, an article on the high cost of hepatitis C drugs in Canada from CTV, "Canada's largest private broadcaster," (look here) quoted a Canadian physician,
Dr. Curtis Cooper, director of the viral hepatitis program at the Ottawa Hospital, said the drugs Sovaldi and Galexos offer a revolution for patients with the hepatitis C virus (HCV).
'It only requires 12 weeks of treatment and (they) are producing cure rates of 90 to even 100 per cent,' he told CTV News.
And later, addressing the treatment of a particular patient,
We're talking about curative therapies, which could potentially save her from liver failure, save her from liver cancerThe review had this summary,
The FDA compiled reports of adverse events from four trials.... There were no treatment-related deaths reported [note that we found there were deaths in the one trial that compared sofosbuvir to PEG, look here].
Approximately 78% of patients receiving placebo, 88% of patients on SOF + RBV treatment and 95% of patients receiving PEG + SOF +RBV reported a side effect from treatment. The most common side effects were fatigue, anemia, nausea, rash, headache, insomnia and pain....
Thus it seems likely that Sovaldi has a lot of side effects, and whether it has fewer than standard treatment is unclear. Furthermore,
studies on sofosbuvir were small, included populations that were healthier than the general hepatitis C population, were of short duration and had limited follow-up. In many of the studies, the manufacturer was responsible for recording and reporting adverse events. In general, reporting of adverse events is often incomplete and discrepancies between clinical trial reports and publications are common.... All of these factors would lead to a bias in under-reporting the true nature of adverse events.
Thus there is no good evidence that sofosbuvir has few side effects, or is dramatically safer than older treatments.
While there continues to be concern, if not outrage, that the latest treatment for hepatitis C is priced at $1000 per pill, most of those expressing concern seem to assume that the pill is a wonder drug, promising nearly everyone a cure without major side effects. However, as we first noted in March, 2014, there is no strong evidence to that effect. In fact, now three skeptical looks at the evidence by people with more resources and perhaps more expertise than we possess have shown similar conclusions.
It is a tribute to the power of the anechoic effect that there has been almost no recognition by physicians and other health professionals, journalists, and most amazingly, insurance companies who stand to lose billions paying for Sovaldi, that there is little good evidence that Sovaldi works, much less is superior to previous treatments. Instead, even America's Health Insurance Plans thought the drug had "tremendous results," not very different from the assertion by the drug's manufacturer that the drug provides "a finite cure," (as reported by Reuters). One might think that the insurance companies have enough money to invest in some real evidence-based medicine experts who could provide a skeptical assessment of the pricy new drugs and devices for which these companies may pay. Is it that the commercial insurers are so now so dominated by generic managers who know nothing about health care, medicine, or biomedical science, much less evidence-based medicine that they are unable to resist the marketing and public relations hype?
The Sovaldi case is a signal example of how our health care system is awash in marketing hype and public relations buzz that has swamped rational skeptical thinking about logic and evidence. That marketing and PR is ever enriching managers while it will send the rest of us, health care professionals included, to the poor house. And all the money we spend will not buy us the promised miracles and triumphs.
As we have said until blue in the face, true health care reform would bring some skeptical thinking and regard for evidence and logic into the health policy discussion.
ADDENDUM (25 July, 2014) - Web link added for CEBP report.