Tips for reporters
The 1-800-GET-THIN ads may be unusual in their sheer ubiquity; they’ve become as much a part of the Los Angeles landscape as the Citgo sign is in Boston, and their television and radio jingle is insidious.
But this case points to several issues I think are relevant for health care reporters generally.
One is the limited scrutiny the FDA gives to medical devices compared to drugs. While we were reporting on the dangers of procedures involving the Lap-Band, the FDA approved a broader use of the device based on clinical data provided exclusively by the manufacturer, Allergan. The data was a fraction of what would have been required for a drug approval. One would think that because the outcome of device use is highly sensitive to the quality of the procedure associated with its use, the quality of training and standards for use would be an important part of FDA consideration. Instead, they’re not examined at all.
Another issue is the proliferation of non-hospital ambulatory surgical clinics, not just in California but across the country. The field is growing because they’re cheaper to run than hospitals; but the regulatory regime is very spotty and outcomes data almost nonexistent. In the case of weight loss surgery, they address a very vulnerable patient population – people who are severely obese and have tried many reducing programs already, without success. These potential patients are psychologically fragile, willing to try any nostrum, and can be bait for marketers whose come-ons allow them to infer that surgery is a quick fix.
We’re told by bariatric experts that successful weight loss even with a Lap-Band requires a real change of habit and lifestyle, and is best undertaken with a professional committed to aggressive and frequent follow up. Creditable bariatric surgeons have told us, moreover, that patient selection is very important – these patients are not good candidates for surgery because of their weight, so it should be a last resort, and not a choice best made based on a freeway billboard come-on.
— Michael Hiltzik
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Michael Hiltzik, a business columnist at the Los Angeles Times, has spent more than two years writing about the company behind 1-800-GET-THIN, advertising Lap-Band surgery in Southern California. His work has triggered a warning from the FDA, investigation from insurance regulators and, finally, action from Allergan, the maker of Lap-Bands. In this article, he discusses his work and the pushback and lawsuits he faced as a result of his reporting. His articles can be found at www.latimes.com/lap-band.
By Michael Hiltzik
The columns and subsequent coverage began as a pretty standard journalistic inquiry. In January 2010, I noticed what seemed to be an explosive proliferation of freeway billboards advertising weight-loss surgery under the number 1-800-GET-THIN.
On one stretch of a few miles I traversed every day, there were at least eight nearly identical billboards, featuring a willowy blond model and advertising an “FDA approved” one-hour weight loss procedure that turned out to be the laparoscopic implantation of a gastric band around the stomach to suppress food intake. (Hence the Lap-Band, which is manufacturer Allergan’s trademark.) Plainly there were scores of these going up all over the southland. I simply asked: Who’s behind this? What are they selling? And what’s the business model?
It didn’t take long to discover that the people behind the ad campaign were Julian Omidi and his brother, Michael Omidi, M.D.
Julian, I learned, is a former doctor whose license had been revoked by the Medical Board of California, which cited, among other factors, his “penchant for dishonesty.” At the time I started looking into this, the medical board had placed Michael on probation for three years, a disciplinary settlement that followed the board’s accusation of “grossly negligent” and “repeatedly negligent” acts in treating several patients. (His probation expired in October.)
The first column, with those details and material questioning their billing practices, ran on Feb. 14, 2010. I followed up a few weeks later with a column documenting that the state Department of Public Health had cited the main surgical clinic owned by the Omidis, in Beverly Hills, for 22 pages worth of health and safety violations in 2009, and that the clinic’s accreditation and its certification to treat Medicare and Medicaid patients had been revoked. In subsequent columns through the rest of 2010, I documented the deaths of two patients that had occurred within days of surgery at that clinic and had been linked to the operations by county coroners.
Public records
My most striking finding was that all this information – including the disciplinary records of the Omidis and other medical professionals working with them, the deficient sanitary and sterility conditions, billing irregularities – was known to state and federal regulators. Indeed, it was all public record and theoretically accessible by patients. We’ve relied exclusively on the public record and quotes from identified sources in all our published columns and articles about 1-800-GET-THIN. The general public doesn’t typically have the knowledge or resources to ferret out such information, even though it’s public, and the agencies that keep the data do almost nothing to reach out to patients to urge them to examine their doctors’ records.
The principal scandal here is that regulators haven’t bothered to connect their own dots. As I observed, following the filing of a whistleblower lawsuit by two employees of associated clinics, what gave credibility to their allegations of poor medical practices is that they tracked so closely to what was already in the public record – in accusations filed by the medical board against doctors or complaints received from patients, and in the public health department’s own files.
Adding to the regulatory morass, a state court ruling in 2007 took jurisdiction over non-hospital medical clinics away from the Department of Public Health and gave it to the Medical Board – but the Medical Board says it has neither the professional expertise nor the resources to oversee clinics, just doctors. Neither the board nor the public health department ever raised an alarm with the legislature to repair the regulatory gap, something I’ve hammered them on.
Then there are the private accreditation agencies, such as The Joint Commission. We documented how clinics, including the one cited by the public health department, would shop for accreditation from another organization after having it revoked by others. Following our reports, the legislature outlawed this practice, mandating that one accreditation agency’s revocation must be honored by all others.
So to close the circle, I’m not surprised that the regulators have taken so long to respond, or haven’t responded at all. Medical regulators seem to be constitutionally disinclined to take an aggressive view of their powers, and this bifurcated jurisdiction in California only provides both agencies with a further excuse for inaction. In this case, the result is a public health crisis.
Praise and lawsuits
The reaction from the public about our pieces has been uniformly positive. We’ve heard from patients, would-be patients, former patients and members of the medical profession. All appreciate our efforts to illuminate the documented facts behind this high-profile advertising campaign and medical enterprise, and provide the public with information it wouldn’t normally get from marketers or medical providers.
My count of lawsuits filed, usually by a different plaintiff each time – the Omidis, 1-800-GET-THIN, or a surgery center – against me, my Times colleague Stuart Pfeifer, the Times, and commenters on our columns and articles on latimes.com, is seven. Four were thrown out by trial judges in federal and state court. One was filed last year, but never served on us. That case asserted antitrust and racketeering claims that the Los Angeles Times advertising department orders the editorial department what to report and publish based on which advertiser pays a premium for advertising that will appear next to negative stories about the advertiser’s competitors. The complaint called this “a Chicago-style shakedown.” They voluntarily dismissed that case without prejudice in January.
The libel suit against our commenters – the first suit they brought – was voluntarily withdrawn by the plaintiff surgery center, after unsuccessfully moving to compel the Times to provide information identifying anonymous commenters, but the surgery center immediately refiled the suit, a new judge was assigned and it is still pending. The plaintiff has been attempting to compel the Times to reveal the commenters’ identities again and, of course, we have resisted. We’ve been awarded attorneys’ fees and costs in three of the cases. In a fourth, we have been instructed by the judge to file for our fees and costs, but the accounting has not yet been submitted or approved. I might add that one of the attorneys who has been involved in bringing these lawsuits was suspended from practice recently because he’s facing disbarment (resulting from unrelated cases).
As we’ve stated publicly and in court, our view is that all this litigation is designed to intimidate us and obstruct our reporting on what is plainly a matter of public concern. Fortunately, California has an anti-SLAPP statute, which bars “strategic lawsuits against public participation” and is designed to address exactly the kind of litigation filed by the 1-800-GET-THIN plaintiffs.
The lawsuits have been distracting and time-consuming, but they haven’t altered our reporting methods or affected our determination to bring the facts about this enterprise to our readers’ attention. Often their threats of litigation and their legal filings have provided more information for our reporting. Pfeifer and I, and our editors, have been confident that the lawsuits were completely baseless, and we’ve had the advantage of a first-class legal team, including Karlene Goller, our inside editorial counsel, and Kelli Sager and her associates at Davis Wright Tremaine, our outside counsel, who have batted a thousand.
They haven’t pursued a legal strategy only against us. When Jonathan Fielding, the county public health director, called for the FDA to investigate their advertising, they filed a complaint with the county Board of Supervisors charging him with a conflict of interest – on the grounds that he held stock in Johnson & Johnson, which makes a gastric band competing with Allergan’s. The supervisors took no action. Despite receiving an opinion from the county attorney that he had no conflict of interest, Fielding voluntarily recused himself from actions involving the Lap-Band anyway.
Turning point
The saga of 1-800-GET-THIN appears to be approaching an important inflection point. I’ve been investigating this enterprise for more than two years, with Pfeifer joining last year. Over that time I’ve urged state and federal regulators to take a close look at an enterprise that has been linked by public records, coroners’ reports, and litigation to at least five deaths. I’ve questioned why Allergan Inc., the chief supplier of its key medical device to affiliated clinics, continues to supply the clinics despite mounting questions about its quality and safety.
Over the past few weeks, the FDA has filed a complaint to the effect that the 1-800-GET-THIN billboards and ads are deceptive in not providing adequate information about the risks of their procedures. Allergan, after insisting for months that it had no legal grounds to cut off supplies of their Lap-Bands, in February abruptly did just that. The state Department of Insurance says it’s investigating insurance billing practices of these promoters, and the private lawsuits from patients and families of deceased patients are proceeding apace. This year could be very interesting.
Pulitzer Prize-winning journalist Michael A. Hiltzik (@latimeshiltzik) writes the twice-weekly “Golden State” column for the Los Angeles Times, where he has worked for more than 20 years. He is the author of “Dealers of Lightning: Xerox PARC and the Dawn of the Computer Age,” in 1999 by HarperCollins. He and colleague Chuck Philips received the 1999 Pulitzer Prize for a series of articles exposing corruption in the entertainment industry, particularly in the recorded music business.
