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A Fatally Flawed NY Times Article
By
Robin Young
Orthopedics This Week
When will the New York Times settle down and make at least a passing glance at getting a vitally important health care story right? Forty million Americans visit their doctor each year complaining of back pain. More than one million patients will place their backs into the hands of a surgeon for discectomies, fusions, arthroplasties or vertebral compression fractures.
Making the decision to have back surgery requires prodigious amounts of both pain and trust - pain that prevents a patient from fully participating in family and work life and trust in the doctor and the operating room team.
Roughly one week ago, the New York Times and its writer Reed Abelson published a feature article that seriously undermined that foundation of patient-surgeon trust. After reading Abelson's article then doing some elementary fact checking – the kind that Reed Abelson could have easily done (and perhaps did, but ignored) – we have come to the conclusion that this article was fatally flawed and if the Times doesn't run corrections or an outright retraction, then it has made yet another mistake on the order of it's famous Jayson Blair scandal.
Quick note and disclosure. We are about to be highly critical of the New York Times and Reed Abelson. Among her targets is the Viscogliosi Brothers investment firm who own a small percentage (less than 5%) of RRY Publications and are helping us raise equity funds for the PearlDiver business. Our opinions are our own and the VBros have no influence on them. We have disagreed with one or more the VBros from time to time in the past. This time, however, the NY Times has really stepped in it and we are going to pull the curtain back on their recent article and, frankly, we are not going to let the VBros investment stand in our way. Still, we wanted our readers to know about our possible conflicts of interest.
There are four principal areas where author Abelson and the Times fell down on its journalistic duty;
· Abelson and the Times ignored facts that contradicted the main thesis of the article
· Abelson relied on innuendo, not fact, to malign the ProDisc clinical trial and the investigators who conducted it.
· Abelson and the NY Times cited as "experts" professional anti-spine surgery spokesmen who in fact had, at best, cursory knowledge of the subject of the Times article – the ProDisc study.
· Finally, Abelson's selective use of facts regarding two groups of patients not included in the ProDisc study descended to what appears to be an act of falsification.
In short, it is time to shine a light on Reed Abelson's ham handed attempt to discredit and malign not only the ProDisc study but also reputations of scientists and surgeons as well as the pioneering firm, the Viscogliosi Brothers, who brought ProDisc to market with an unfailing dedication to the scientific process.
For the record, it is Reed Abelson of the New York Times who spun, twisted and literally broke the back of the truth in her attempt to land an article on the front page of her newspaper. It is astonishing to see someone break rules of journalistic integrity and then claim that others have broached the integrity of their profession.
Let's dissect the NY Time's attack.
The main thesis of Abelson's NY Times article, " (put hyperlink to article here) " is that some of the investigators in the ProDisc trial had financial ties to Spine Solutions or Synthes, the manufacturer of the ProDisc, or to the Viscogloisi Brothers fund that helped to fund Spine Solutions, the developer of the ProDisc and that those financial ties biased both the clinical trial results and the eventual FDA approval for ProDisc.
Here is what Abelson said in her article (and note how she offers no facts, only innuendo):
The way the Prodisc was tested and approved provides a stark example of conflicts of interest among clinical researchers.
But when doctors are acting as researchers, they should not have money riding on the outcome.
But in the case of the Prodisc clinical trial, as with any clinical research, the doctors were supposed to be acting not as advocates for the product but as objective scientists studying whether the disk was safe and effective enough to be widely sold and used in the United States.
"The surgeons themselves are guilty of being insufficiently critical of products and techniques they are developing," said Dr. Richard A. Deyo, a medical professor at Oregon Health and Science University. "More people are interested in getting on the gravy train than on stopping the gravy train."
Abelson is clearly stating that the ProDisc study was influenced by the financial ties some of the investigators had in Spine Solutions, the inventor of the ProDisc.
Here are the facts about the ProDisc study that somehow failed to appear in Abelson's article:
Not one single investigator in the ProDisc study determined which patient received ProDisc and which patient in the study received fusion. Not one. The study was a randomized, double-blinded study. (Does Abelson even know what those words mean?) So…the day before surgery, each investigator in the ProDisc trial called an 800 number where an independent outside agency told him which device would be implanted in the patient. By the way, even the patient's name was hidden so that the entity assigning ProDisc didn't know who specifically was getting ProDisc.
Not one single investigator in the ProDisc study handled the data from the study. Not one. The radiograph images of each patient's implant (which was used to measure outcomes in the study) were also blinded and sent to an independent, outside agency for measuring and evaluation.
Where is the ProDisc bias that Abelson is alleging? There are many kinds of bias. Financial bias. Personal bias (as in I'm doing surgery on someone I know). Maybe even good looking patient bias. The fact was that the ProDisc study was designed to eliminate ANY form of bias.
Patients were randomly selected to receive either ProDisc or a fusion and that selection was performed by an independent outside entity. The surgeon had no idea. The Patient's ODI scores and radiographs were passed directly to an independent outside firm. The surgeon could do nothing to influence the outcome of the ProDisc study.
But wait, the facts keep piling up and it gets worse for Abelson.
In her article Abelson said:
"In the study results submitted to the F.D.A., moreover, an unusually large number of patients were not included, and some of those patients have said they fared poorly. As a result, some patients and doctors critical of the research say the study may have cast the Prodisc in an overly flattering light."
Ummm….wrong? Of course, we just mentioned that the study's results were out of the hands of the surgeons who did the study. But, even beyond that (which by itself blows Abelson's thesis out of the water) the ProDisc study had a follow-up rate at 24 months of 98%. For most researchers in most clinical trials that rate of follow up is unbelievably good. Let's repeat, ninety eight percent of the patients in the study were included in the 2 year study results. Who was not included?
Oh, right. Twenty one patients who didn't get insurance coverage and therefore didn't get surgery. Here's how Abelson referred to those 21 patients:
"An additional 21 patients, about 10 percent of those studied, were also excluded from the reported results.
A Medicare official, Dr. Steve Phurrough, said 10 percent was unusually high. While it is impossible to tell what the outcome of the study would have been otherwise, Dr. Phurrough said, "it gives us pause." The agency decided last August not to cover the disk for most Medicare patients".
Impossible to tell what the outcome of the study would have been otherwise???
Not including patients in the ProDisc trial who didn't get surgery was….what….wrong? Biased? They didn't get insurance coverage and therefore couldn't have surgery in the trial. What scientific information were they supposed to exactly provide?
Actually, this is a very serious error on Abelson's part and if she did this intentionally, then she lied in her article. We know Dr. Phurrough at CMS. He is a solid administrator and researcher. Either Abelson didn't provide him with all the background information regarding those 21 patients or she used his quote out of context.
Abelson also noted that 50 patients in the trial were "training patients" and those results were not included in the study data submitted to the FDA. Again, wrong. All 50 training patients met the exact same inclusion criteria as the study patients. The FDA received full data sets on these patients for safety monitoring purposes. And, take note Abelson, those 50 patients did as well (and actually a bit better) than the 162 ProDisc patients in outcome measurements.
None of the 50 training patients required revision surgery.
Why didn't Abelson report this? Why didn't Abelson point out that the FDA DID have this information? Why did Abelson use a Medicare official to comment on the FDA submission?
We think we know the answer.
Another thing…did anyone pay attention to the fusion patient's experience in the ProDisc study? You would think that if the researchers were trying to bias these results that the fusion results would be pretty poor. Right? That way ProDisc looks better in comparison. In fact, the fusion patients reported a satisfaction rate that was higher than the current average in the literature.
Then there was Abelson's soon to be infamous "emergency" patient. In Abelson's own words:
But while doctors may easily move on to the next new thing, some patients are still coping with the aftermath of Prodisc procedures.
Calvin Timberlake, a 50-year-old former forklift operator who lives just outside Victoria, Tex., had a Prodisc implanted in his spine four months after the F.D.A. approved it; his surgeon was not involved in the clinical trial. He says the Prodisc subsequently came apart, forcing him to undergo a second emergency surgery to have it removed.
So, which emergency room was Mr. Timberlake taken to? The answer is none. Was Mr. Timberlake in the ProDisc trial? We also checked that. Our readers, who are now seeing the full scope of Abelson's shoddy work, can probably anticipate the answer. He wasn't in the trial.
In fact, Mr. Timberlake didn't have an emergency at all. He had elective surgery and he is one of only three people (out of 1,500 ProDisc implants post-FDA approval) who've had revision surgery.
That rate (3 out of 1,500) is better than the other disc arthroplasty implant (Charite), is better than the other recently approved FDA spine implant the X-Stop (Medtronic) and better than virtually any fusion surgery.
How did Abelson find this one particular needle in the haystack – this one patient out of 1,500?
We think we know the answer and we think that answer lies in the "experts" that Abelson selected to comment on the ProDisc Trial. Starting with Mr. Empty suit himself, Dr. Charles Rosen and then continuing to Dr. Richard Deyo, Abelson selected the two most prominent anti-spine technology and surgery spokespeople in the country. Dr. Rosen is also an expert witness in cases against spine surgeons. What is most galling is that Rosen, who holds himself out to be a spokesman for the practice of clinical trials and research, is not listed in PubMed as ever publishing ANY peer reviewed paper regarding ANY clinical trial. Rosen, who has made a career out of trashing his fellow surgeons and scientists, not only has not been in a peer-review trial, nor helped design a trial but got the facts of the ProDisc trial wrong in his quote in Abelson's article.
Could one Rosen's many contacts in the Plaintiff's bar have sent Abelson the one, single example of Mr. Timberlake to malign the entire ProDisc study. Who is Abelson's source and what agenda might they have had in supplying her with this name?
We think we know the answer.
Then there is Abelson's hidden attempt to malign one of the most highly regarded spine surgeons in the U.S. – Dr. Jack Zigler. Dr. Zigler, by the way, is listed in PubMed more than 600 times. He sent Abelson a two sentence quote to use in her article. She used the first sentence. The second sentence, however, contradicted the very premise of her article. Again, given what we now know about Abelson's slanted article, our readers can probably anticipate how she handled Dr. Zigler's inconvenient quote. She ignored it.
We don't. Here is the quote from Dr. Zigler that Abelson didn't want you to read. "Whether a patient needs surgery, what type of surgery they need, and what device I will use are all determined by what I feel is best for that patient."
The mistakes, errors, omissions and falsehoods continue. We now come to the case of patient Kennedy. According to Abelson:
"One Prodisc study patient who says the surgery left her worse off, Patricia Kennedy, asserts her surgeon "seemed more concerned with the prospects for the Prodisc than for her medical care," according to the lawsuit settled on undisclosed terms last year".
Now Kennedy didn't complain about her ProDisc until her disability payments ran out. That, incidentally, is in the court records that Abelson, we guess, based her that paragraph above on. Furthermore, as we guess she probably noticed in the court documents, the Kennedy case was thrown out by the judge. It had no merit (except, of course, as a set of false statements in Abelson's front page New York Times article). The court documents go on to point out that Kennedy reported favorable scores with regards to the ProDisc during her trial.
Did Abelson know this? Did Abelson ignore these pesky facts? We think we know the answer.
Shall we continue? There are several more examples. We'll offer one more. And then, at the end of this article is the name of the New York Times Public Editor whose job it is to field complaints of author inaccuracies if not, as in the Jayson Blair case, intentional falsehood. Our readers know as well as we do other examples that should be brought to the NY Times attention.
Here's our last example.
Again, we start with Abelson's own words;
"The F.D.A. now says it is checking to see whether there was adequate financial disclosure information about the Prodisc researchers during the clinical trial and at the time that the subsequent application for approval was submitted".
Actually, researchers who had any financial ties had their clinical trial results examined and compared with researchers who did not have financial ties. That data is, ahem, at the FDA. Has been at the FDA for at least a couple of years. And what does the data show? It shows that there was no statistically significant difference in the ProDisc results coming from researchers with financial ties and those with none. Furthermore, on a non-statistically significant basis, the data from the researchers with financial ties was actually less-favorable to ProDisc than the data from researchers with no financial connections.
Ok, we'll close with two items. Our comment about spine product research and the name and contact information for the New York Times Public Editor.
The reality is that spine product clinical studies probably earn a C+ or B-. The problems have to do with the paucity of true PMA studies (who will pay for them?) which, under the FDA's scrutiny, require the kind of prospective randomization that leads to solid research like the ProDisc study. Most studies have too few patients, don't have as rigorous a statistical analysis as they should and often the authors have to revise and rewrite several times in order to fully disclose all adverse events or problems.
The other problem with studies is that they exist in a kind of "hot house" environment. Meaning that they are conducted by top surgeons who think long and hard about patient selection and then plan each surgery particularly carefully in order to report results in a paper they know will be reviewed by their peers. But these issues are well known and researchers and editors at the leading Journals (Spine, JBJS, SAS Journal) are all tackling these issues constantly and they are making progress.
Clearly, in choosing the ProDisc study to bash spine surgery, Abelson chose poorly.
Finally, as Abelson's article (not her first on this subject) demonstrates, the surgeons and companies of the spine industry are losing the PR battle. It's time to reverse that situation. The facts are on the side of the surgeon and the companies funding research and trying to figure out how to bring better and better products to market.
Turning the PR tide starts with this article and the New York Times Public Editor's office. Please take 15 minutes and write him a letter about Abelson's article and your own experience with companies and new spinal impant technologies. How do you approach this issue of financial ties? Do make decisions regarding YOUR patients based on which company you advise?
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