Dr. Goldacre writes about a Johnson & Johnson (J&J) artificial hip that had a 40% failure rate and now has generated over 10,000 lawsuits. Various versions of this artificial hip had been sold both inside and outside the US since 2003. In 2008, a senior consultant to J&J suggested that the device be redesigned and in 2010, the artificial hip was recalled. We, the patients are only finding out about these issues now that the court cases are starting.
Dr. Goldcare states: “It would be nice to imagine that this kind of behavior is exceptional, but in reality, the entire evidence base for medicine has been undermined by a casual lack of transparency. Sometimes this is through a failure to report concerns raised by doctors and internal analyses, as was the case with J&J. More commonly, it involves the suppression of clinical trial results, especially when they show a drug is no good.”
The doctor also writes that “this problem has been going on for decades and there are laws on the books such as The Food and Drug Administration Amendments Act of 2007 which is the most widely cited fix. It required that new clinical trials conducted in the United States post summaries of their results at clinicaltrials.gov within a year of completion, or face a fine of $10,000 a day. But in 2012, the British Medical Journal published the first open audit of the process, which found that four out of five trials covered by the legislation had ignored the reporting requirements. Amazingly, no fine has yet been levied.”
He goes on to outline other examples of issues similar to the J&J artificial hip.
Dr Goldcare states,”if I toss a coin, but hide the result every time it comes up tails, it looks as if I always throw heads. This cannot be acceptable. Withholding data not only misleads doctors and patients; it’s an insult to the patients who have participated in clinical trials, believing that they were helping to improve medical knowledge”.
Unfortunately, this cynical patient doesn't t think that these problems will be fixed anytime soon. An example for us NETS would be the PROMID study that was supported by grants from Novartis, the maker of Sandostatin LAR, which found that the maximum recommended monthly dose of Sandostatin LAR (30 mg) given monthly increased the time to progression of tumors to 14.3 months versus 6 months for the placebo group. This study, published in 2009, only had 85 patients in it. Many doctors use the PROMID study to justify the use of Sandostatin LAR. I’m wondering if there have been other studies done on this drug and suppressed either before or after 2009. I am and will always be concerned when the drug company sponsors a study that has the best results in patients using the highest dose of their drug. In my opinion, it’s an enormous conflict of interest and should not be relied on as the basis for treatment without some independent studies or evidence.