If Dr. David Miller thinks the UBC Therapeutics Initiative is not in the scientific mainstream, he’s welcome to say so. But that doesn’t make it true. (“Therapeutics Initiative is out of mainstream,” comment, March 5)
Understanding what drugs do requires examining and critically appraising all information from clinical trials. What we might “think we know” is not always borne out by the facts. Clinical trials yielding unfavourable results are still unpublished. Others are reported in ways that make it almost impossible to recognize the “spin.” Raising tough scientific questions and trying to ferret out bias does not make us “haters” of drug companies — merely realists.
We do not advise the Pharmaceutical Services Division on what drugs it should fund. We do provide evidence reviews recognized internationally to be of the highest scientific standard. We follow the gold standard Cochrane methodology to systematically review and meta-analyze the benefits and harms of drug therapies.
Our assessments are peer-reviewed, and we ensure they are publicly available, except when drug companies have insisted that the B.C. government protect commercial interests. Similarly, the full Common Drug Review reports are redacted to protect commercial interests. Taxpayers also pay for these reports, but we don’t have the automatic right to see what we buy.
Our Therapeutics Letters to B.C. doctors and pharmacists distil complex information into succinct messages, none of which has been challenged scientifically. By reading and thinking beyond the “spin,” TI has been able to recognize that “blockbuster” drugs such as Aricept, Seroquel, Celebrex, Vioxx and Avandia were not major advances.
In some cases, our thorough research might have saved lives because government chose not to pay for drugs of marginal benefit that turned out to be more dangerous than existing therapies. Anyone can read our letters without charge at ti.ubc.ca.
The need for unconflicted analyses and guidelines is now recognized widely. But it is a need that is hard to satisfy. Drug companies develop wonderful products that improve health, but they also promote “me too” brands, and drugs that are not better than placebos or alternative treatments.
Pharmaceutical companies are in business to make money, and they are notorious for using as salespeople doctors, whom they refer to as Key Opinion Leaders or “KOLs.” In the United States, one can see themoney that leading American KOLs receive (at openpaymentsdata.cms.gov). In Canada we don’t have access to such information about Canadian KOLs.
Around the world, independent drug bulletins similar to the Therapeutics Letter, such as Prescrire in France or IQWIQ in Germany, exist because medical journals often do not provide the healthy skepticism that doctors, medical scientists, health policy-makers, and the consuming public require.
“Peer review” is only as good as the reviewers, and for many journals it’s an almost meaningless term.
What would a rational person want to know about any drug, whether taken for symptomatic relief or to prevent illness? Except in palliative situations, death always trumps other outcomes. Next most important is serious illness and disability.
We consider that the total number of people with at least one serious adverse event (all deaths, serious illness and disability) best captures the net health effect in trials.
These events are captured by all clinical trials, but are often reported confusingly. If a drug improves certain outcomes, but worsens total serious adverse events, we think most people would want to know that information.
Whether it is the example of indacaterol, drugs for Type 2 diabetes, depression or atrial fibrillation, huge scientific uncertainties remain.
The long-term use of opioids for chronic pain provides a good example of how many popular treatments might be doing more harm than good. Learning mainly from KOLs with close ties to industry is a prescription for poor-quality health care and high costs.
Working with taxpayers’ money to distil the highest quality evidence for government and health professions is not something for which we apologize. Independent scientific input to government was threatened by a recent Canadian government, and is now imperilled in the U.S. Since the B.C. government’s reduction of TI funding in 2012, it has been a challenge to preserve the Therapeutics Initiative.
We would welcome a renewed and strengthened partnership of independent science and health policy-making.
James M. Wright, MD, PhD, and Ken Bassett MD, PhD, are co-directors of the UBC Therapeutics Initiative.
