April 4, 2011
By Kate Johnson
If it wasn’t for “the Bayer facts”, the new contraceptive guidelines from the Canadian Society of Obstetricians and Gynaecologists (SOGC) would be rather underwhelming.
But stripped down they are alarmingly revealing: “an egregious example of the extreme,” according to Dr. Allan Sniderman, a McGill University cardiology professor who has called for widespread medical guideline reform.
The guidelines, which focus on Bayer’s controversial contraceptives Yaz and Yasmin (drospirenone and ethinyl estradiol ), are an almost identical copy of a consensus statement from a Bayer workshop – which, not surprisingly, endorses the pills’ safety.
But since Yaz and Yasmin are at the center of almost 5-thousand individual and 13 class-action lawsuits in Canada and the U.S. it is hard to believe that the SOGC would not reach beyond a company workshop to furnish Canadian doctors and patients with the facts about the pills’ alleged link to venous thromboembolisms (VTE).
The SOGC guidelines, and the statement from Bayer’s workshop – both written by Dr. Robert Reid, professor of obstetrics and gynecology at Queen’s University, Kingston, Ontario – are identical, aside from the cover page and a few stray paragraphs.
This itself is a concern, since the consensus statement was published months earlier and clearly states it was crafted by an international panel that was hand-picked by Bayer – the majority of whom “will, at one time or another, have received sponsorship and/or funding from one or more manufacturers of contraceptive drugs or products”. A quick Google search confirms a handful of them are in fact Bayer consultants, including the author, Dr. Reid.
While the guidelines are a virtual reproduction of the workshop document, all the Bayer facts are left out – a revealing omission – even though Dr. Reid insists the company had no influence on the manuscript. Dr. Reid’s conflict of interest as a company consultant is also not disclosed, and neither is the fact that the SOGC receives funding from Bayer – a fact which is documented on the SOGC website.
Why would the SOGC choose to omit these facts, when transparency about such industry ties is so strongly recommended by groups like the Institute of Medicine (here), and the Council of Medical Specialty Societies (here)?
As I’ve written in an article for the Canadian Medical Association Journal – the SOGC’s lack of transparency is clearly bucking the trend.
In a five page response to my questions the group’s executive vice-president Dr. André B. Lalonde could give me no clear answers, insisting simply that the guidelines “did not come from the international meeting.”
But, according to Dr. Reid they definitely do. “The reason the SOGC asked me to write the guidelines is that they knew I had been to this meeting,” he said in an interview. “That’s really where I got my information.”
So, with that fact firmly established, yet omitted from the SOGC guidelines, can we trust what the guidelines say?
That’s a thorny question which I have explored in many interviews over the past few months.
Dr. Reid defends the guidelines, saying they reflect the best evidence, “in my opinion and that of the other experts who were attending” the consultant-stacked workshop.
He says any independent epidemiologist would agree.
But he admits he didn’t ask one.
Dr. Susan Jick, DSc, Director of the Boston Collaborative Drug Surveillance Program, and professor of epidemiology and biostatistics at Boston University School of Public Health, says the SOGC’s interpretation of the evidence “demonstrates naiveté about the epidemiology and smacks of consultation.”
The guidelines unfairly emphasize the safety data on Yaz and Yasmin and too easily dismiss the evidence for increased risk, she says.
Indeed, the workshop panel did “scoff at” the risk data, and accepted that safety data as “gold standard”, according to my interview with Dr. Reid.
But Dr. Jick says the safety studies have major methodological flaws such as the inclusion of non-idiopathic cases, and the use of a high-risk reference group. “When you do that you dilute the effect. Anyone who is a good epidemiologist and trained in this area understands that.”
Perhaps if Dr. Jick’s analysis was included in the guidelines, along with a disclosure of the Bayer facts, the SOGC would be helping physicians and patients make informed decisions.
Omitting these details makes the SOGC look like “industry’s puppet”, says Dr. Adriane Fugh-Berman, director of PharmedOut, a Georgetown University organization that examines industry influence on prescribing.
Meanwhile public concern over the safety of these blockbuster contraceptives is mounting.
Between February 15 and October 15, 2010, the number of U.S. lawsuits pending against the company more than quadrupled – from 1,100 to 4,800, and the number of Canadian class-action suits rose from two to 13, according to company records. The FDA has also disciplined the company for misleading advertising.
In light of the ongoing debate, some experts suggest it would be appropriate for guidelines to err on the side of caution until the evidence is clear.
“I would argue that if there’s concern about the safety of these products, even if that hasn’t been proven, there are other products where there isn’t that kind of argument. So I think that doctors should choose those products rather than the ones where there is still controversy,” said Dr. Joel Lexchin professor at York University’s School of Health Policy and Management and research associate at the Canadian Center for Policy Alternatives.
That argument is only valid if the controversy is based on good science, said Dr. Reid.
“When a doubt is based on poor science it should not influence medical practice. The people who have to deal with the fallout of that are obstetrician-gynecologists who start to see women coming in wanting abortions because they stopped the pill after some scary story in the paper,” he said.
Dr. Reid has publicly cautioned Canadian physicians about a potential “pill scare” like the one which occurred in the UK in 1995. That incident, triggered by an official warning about similar risks in the previous third generation oral contraceptives, was followed by mass discontinuations of the pills, a surge in unplanned pregnancies and abortions, and a 25% increase in the national birth rate.
But as journalist Jim Edwards wrote in his blog entitled “This Birth Control ‘Pill Scare’ Warning is Brought To You by Bayer”, “the SOGC’s credibility is undermined when its guidelines fail to mention its conflict of interest or alternatives to the products of its sponsors”.
This week, an editorial by Dr. Steven Nissen in the Archives of Internal Medicine even goes so far as to suggest that authors such as Dr. Reid, who are industry consultants, “essentially become temporary employees of industry, whose duty is the promotion of the company’s products.” According to Dr. Nissen “no conceivable logic can defend the practice of including promotional speakers” on clinical practice guideline committees.
It’s past time for doctors “to recognize the corrosive influence of industry money on the practice of medicine,” writes journalist Alison Bass in a blog about the commentary.
But stories such as this one are complex, well-camouflaged, and thorny to handle – which means the public often remains in the dark.
UPDATE – April 12,2011: See Jim Edwards’ latest piece about my blog “Money Talks: Ob/Gyn Society Allowed Bayer to Write Its Birth Control Guidelines”.