When considering possible treatments for a serious illness, more and more of us involve ourselves in the decision-making process. We’re asking other patients what treatments they use, we’re getting second opinions and we’re looking online for information. Doctors and patients alike rely on information they read in medical journals. Are there possible new treatments? How good are the results? What kinds of side effects can a patient expect? But here’s a question you might not think to ask: Can you trust results of medical research? The answer to that is probably, but not definitely. Why? Financial conflicts of interest in medical research can lead to biased results.
What is the problem?
Medical journals are the main method for notifying the public about the latest scientific discoveries. But the information in these articles can be tainted by financial conflicts of interests which can affect the conduct and reporting of clinical trials.
When researchers receive payments from healthcare and drug companies the odds of results that favor the companies paying them increase. Whether these doctors skew results consciously or unconsciously does not matter. The biased reporting is a concern in both scenarios. In fact, research shows that industry-sponsored research tends to be more positive than research financed by other sources.
And as patients, we usually don’t know about these financial ties and possible biased results.
There’s little incentive to report conflicts of interest.
Right now, there is little incentive, other than a sense of professional ethics, to fully disclose financial ties. In general, there are few repercussions for doctors, other than issuing a correction, for those who don’t follow the rules. Although some doctors have faced serious consequences.
Should we worry?
This should concern all of us. The results of clinical trials can determine treatment options. If doctors don’t report financial conflicts of interest (which can lead to skewed results), can we trust the medications and devices?
It’s important to note here that some studies use a double-blind design in which doctors and patients do not know who is receiving the investigational treatment and who is receiving the treatment that is standard-0f-care. In these cases, researcher bias is less likely to be an issue.
How much money are doctors paid?
We’re not talking petty cash. In one study on the subject, a group of 100 doctors received a total of over 12 million dollars, with a median payment of $95,993. Some doctors have received millions of dollars. Moreover, many of those receiving payments are highly-regarded leaders in the medical world.
How common is this conflict?
Although most doctors/authors disclose their ties to corporate interests, not everyone complies. A review by ProPublica and The New York Times found dozens of doctors who did not report their financial relationships with drug and healthcare companies when their studies were published in medical journals.
Recent research found that of the 100 doctors who received the highest compensation from device makers in 2015, “conflicts were disclosed in only 37% of the articles published in the next year.” According to lead author, Dr. Jafari: “The system is broken…The journals aren’t checking and the rules are different for every single thing.”
This is a particular concern for cancer research.
The results of trials for cancer treatments can literally change the path of cancer care. Furthermore, trials for cancer treatments provide prestige and visibility for the journals and the authors, including newsworthy headlines. Additionally, the results and associated report can bring significant revenue for drug companies.
A recent study found that 32% of 344 cancer doctors failed to fully disclose payments from the drug companies whose oncology drugs were researched in clinical trials, the results of which were published in major medical journals.
The journals themselves shoulder some of the blame.
The review by ProPublica and The New York Times found that journals often gave confusing advice on the subject, often leaving it up to the researcher to decide what is relevant and therefore should be disclosed. And journals did not regularly check into disclosures by researchers, although information on the relationships between doctors and drug companies, medical device companies and other healthcare companies is easily found on a federal database.
Why are some journals lax on this topic?
Medical journals and doctors need each other. Writing articles for prestigious journals can improve the reputation and profile of the doctors who write them. On the other hand, journals raise their own reputations when they publish exclusive, breakthrough studies by well-respected researchers. And of course, articles in prestigious journals can greatly improve visibility for the medications and medical devices tested and reported on.
A high profile example.
In September 2018, The Times and ProPublica reported that Dr. José Baselga, one of the world’s top breast cancer doctors at Memorial Sloan Kettering Cancer Center did not disclose that he received millions of dollars in payments from companies involved in medical research. He failed to disclose his financial ties in dozens of research articles, including for prestigious publications like The New England Journal of Medicine and the Lancet. These unreported conflicts of interest led to his resignation as the chief medical officer of the well-known cancer center.
A few other examples.
Dr. Howard Burris III declared that no conflicts of interest in more than 50 recent journal articles, including articles in the prestigious New England Journal of Medicine. But, it turns out that drug companies paid his employer almost $114,000 for consulting and speaking. And almost $8 million for his research. At the time of these payments, medical journals required authors to disclose conflicts of interest, even when the drug or device company gave the money to the employer, not the individual doctor. You likely haven’t heard of him, but Dr. Burris is the president-elect of the American Society of Clinical Oncology. Another twist in the plot? He didn’t disclose a conflict in article published by the Journal of Clinical Oncology, a journal published by the group he will soon lead.
Another prominent doctor, Dr. Robert J. Alpern, the dean of the Yale School of Medicine, didn’t disclose a conflict of interest in a 2017 journal article about an experimental treatment developed by Tricida. The problems? Dr. Alpern served on the company’s board of directors and owned its stock. And, Tricida financed the clinical trial that led to the article.
For more examples, read the article in Fierce Healthcare.
Is anyone trying to tackle this problem?
The concerns regarding the influence of drug companies on medical research are not new. In fact, in 1959 Senator Kefauver held congressional hearings on this topic. Despite the concern, it took until 1991 for the American Medical Association to issue ethics guidelines addressing drug marketing and industry gifts. But that didn’t solve the problem. In 2008, Senator Grassley led another congressional inquiry on the topic after a series of scandals erupted, including a prominent psychiatrist who failed to report over $1 million in payments. In 2009 the Institute of Medicine crafted a report with suggestions to address the conflict of interest in medical research. And in 2010 the US government passed the Physician Payments Sunshine Act requiring drug and device makers to report any payments or other transfers of value made to doctors or teaching hospitals. Yet the problem persists.
There are a few glimmers of hope. The International Committee of Medical Journal Editors is currently considering adopting a policy “that would refer researchers who commit major disclosure errors to their institutions for possible charges of research misconduct.”
And some medical journals are making efforts to address this issue. The New England Journal of Medicine is working with the Association of American Medical Colleges on a new system called Convey to report and evaluate these financial relationships. Other medical journals are considering or testing this program as well. And the Journal of the American Medical Association (JAMA) recently started requiring authors to confirm multiple times throughout the process that they had nothing to disclose.
What can you do?
This is a tough one. But you can use the US Government’s Open Payment database to search for payments made by drug and medical device companies to doctors and teaching hospitals. Are you considering a treatment that is so new there is no proven track record among patients other than clinical trial data? Find the name(s) of the lead researcher(s) and search the database for information on potential financial conflicts of interest. If you find a history of payments to the researcher(s) from a drug or healthcare company, you can discuss your concerns with your doctor. But as you just learned, some doctors don’t report their financial ties, leaving us in the dark about potential conflicts. And that is not a good place to reside.
And you can look for studies using double-blind methodology, which are less likely to be influenced by financial incentives.
For more information to consider when choosing a treatment, read these blog posts:
- Don’t Be Afraid To Make Treatment Decisions With Your Doctor
- The Dangers of Too Many Tests and Treatments for Patients
- Researching New Treatment Options by Evaluating Clinical Trial Results
- What You Need to Know About Clinical Trials Before You Sign the Dotted Line
- Information Lacking in Reports on Side Effects in Clinical Trials