Intellectually Lazy Or Logically Sound? A Reply To Dr. Donnell On Financial Incentives Affecting Guidelines And Clinical Trials

Dr. Robert Donnell, blogging at, authored a post over at Kevin.MD the other day entitled, “Judging A Guideline Just By Financial Interest Is Intellectually Lazy.”

The post was in response to recent investigative journalism criticisms centering around the fact that that medical societies responsible for authoring treatment guidelines often have a financial stake in their recommendations. For an introduction to some of the investigative journalism on this topic, you can check out ProPublica’s work here on the financial ties between the National Lipid Association and the pharmaceutical industry.

Dr. Donnell thinks the journalists and others who have attacked guidelines based on the financial interests of research authors, etc., are “intellectually lazy.” Dr. Donnell thinks the criticisms of guidelines that point to the financial interests of medical societies and individual researchers also represent a logical fallacy. Donnell writes that these attacks are, “an ad hominem attack (and therefore fallacious) because virtually all of the criticisms of guidelines that have been written are based not on the science or the [journal articles] referenced in the guidelines but on the company they keep.”

Dr. Donnell may be right that a lot of the investigative journalism pieces may not engage with the science; they may simply point to sinister-seeming associations between drug and medical device companies and the illustrious doctors who promulgate the guidelines.

So what does the science say? Is there any scientific, empirical basis for finding a research study or clinical trial to be less trustworthy based on the fact that it was financed by a drug company? The answer is: YES.

For a great starting point, check out an article published by the prestigious British Medical Journal entitled, “Pharmaceutical Industry Sponsorship And Research Outcome And Quality:  A Systematic Overview,” which you can check out here. The authors of the BMJ article found that studies funded by a pharmaceutical company were four hundred percent more likely to give results that were favorable to the drug company than independent studies.

Oftentimes it’s difficult to discern how drug industry funding is influencing the methodology or results of scientific studies. You can read the “primary sources,” as Dr. Donnell, argues and engage with the science on its own merits and still not uncover anything askew, anything scientifically unsound. But nevertheless, there’s no getting around a brute empirical fact:  Scientific research funded by Big Pharma, for whatever reason, produces results that are biased in favor of the drug companies.That’s not ad hominem attack, that’s not casting aspersions on anyone’s integrity — that’s a scientific fact.

Examples of the empirical tendency for drug company-funded research to favor the drug companies’ own product abound. One fascinating meta-analysis compared the results of fifty-six different drug company-funded studies of painkillers. In each of the fifty-six studies, the painkiller marketed by the Big Pharma sponsor funding the study came in first place. How can all of fifty-six different drugs be better than each other? Answer: They can’t. The study authors’ financial ties presumably influenced their work. (You can engage with the science of that study by clicking here).

(For a wonderfully fun tour of drug company research shenanigans, check out Dr. Ben Goldacre’s wonderful book, “Bad Science:  Quack’s, Hacks and Big Pharma Flacks”).

Rather than being illogical or ignorant, assuming that someone’s financial incentives influence his actions is a basic principle of social science. Rule Number 4 of Harvard Professor Gregory Mankiw’s “Ten Principles of Economics” is “People respond to incentives.” Automatically discounting (to a certain degree) the findings of research studies, where the study has a financial motive is a sensible and reliable heuristic device for people who don’t have the time or the abilities to dive into the research firsthand.

Should you engage with the research studies firsthand if you are able to do so? By all means. But as some of the studies cited above illustrate, there are scientific reasons for viewing their results skeptically.

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Medicare Has The Right Idea

As we’re fond of reminding you here, the costs of medical malpractice don’t amount to a hill of beans when it comes to our health care spending. The legal fees and payouts from medical malpractice amount to 0.5% of our health care spending.

It would be a great thing for the tens of thousands of Americans killed each year by medical malpractice if we succeeded in reducing the incidence of medical malpractice (which we can) but it would not help us bend the curve of health care spending.

To get control of health care spending, we need to get a handle on what most experts consider the biggest driver of health care costs: fee-for-service medicine. Under our fee-for-service model, doctors and hospitals get paid according to how many procedures, tests and other services they perform and not according to how healthy they keep their patients. This gives doctors and hospitals an incentive to run up the bill by ordering unnecessary therapies, instead of focusing on the long-term health of the patient.

So it is a good thing that, starting next year, Medicare will cut reimbursement rates to hospitals with high levels of patient readmission. Part of the impetus for this move is a recent study from Dartmouth school of medicine, showing that the rate of Medicare patients being readmitted to a hospital within thirty days has increased over the past decade.

Let’s hope this precipitates a broader move to a focus on patients’ long-term health.

Private insurance companies also bear part of the blame here. They will pay top dollar for a cutting-edge surgery but are misers when it comes for paying for recuperative stays after a surgery. But if paying for that extra day of recovery time reduces the risk of complications and, thereby, the rate of readmission, it’s worth paying for.

Please Excuse The Blogging Miscues

You may have noticed that the blog was undergoing maintenance and repairs from Monday to today. As part of that process, I switched over to a WordPress platform. I’m still getting used to everything and hope to get up to speed quickly. In the meantime, please bear with us as the bugs are worked out.

In related news, a slight re-design of the blog will be rolled out sometime within the next couple weeks. Hopefully the new typeface and style will reduce some of the eyestrain of the old design.

I also hope that RSS feed subscribers check to make sure that they receive uninterrupted feeds over the next few weeks.

As always, thank you for reading what is on my mind.

Americans with Disabilities Act Violations Alleged in EEOC Lawsuit Against New Hampshire Company

Discrimination by employers because of an employee’s disability or health condition is a serious problem for American workers. The Equal Employment Opportunity Commission (EEOC), a federal agency that investigates discrimination claims, has filed suit against a Nashua, New Hampshire company, alleging that it fired an employee because she has a heart condition in violation of the Americans with Disabilities Act (ADA).

The lawsuit, filed in a federal court in Concord, New Hampshire, alleges that Windmill International, Inc., a defense contractor, terminated employee Nancy Hajjar, shortly after she gave notice that she would need time off for a surgical procedure related to a heart condition and that she may require heart surgery as well. The EEOC claims that the company terminated her because of “an actual or perceived impairment of her circulatory or cardiovascular functions.” Windmill claims that it fired Ms. Hajjar because of job performance problems, but the EEOC alleges that the company did not follow the same progressive discipline procedures afforded to other employees, concluding that the company’s explanation is false. The EEOC’s Press Release can be viewed here, EEOC Sues Windmill International for Disability Discrimination.

The ADA, which became effective in 1992 and was amended in 2009, protects employees suffering from disabilities from certain types of discrimination in the workplace. Employers with 15 or more employees must provide equal opportunity to disabled employees for all employment opportunities available to other employees. The law prohibits discrimination in hiring, firing, promotions, pay, and terms and conditions of employment. The same holds true under the Massachusetts Fair Employment Practices Act (M.G.L. c. 151B), which also prohibits handicap discrimination in the workplace and which applies to employers with 6 or more employees.

The EEOC is an independent law enforcement agency in the executive branch of the federal government. The agency was created in 1965, after passage of the Civil Rights Act of 1964. It investigates claims of discrimination based on certain protected categories including race, gender, religion, age, and disability. It has authority to bring suit against employers that it suspects violated anti-discrimination statutes. People who believe they are the victims of unlawful discrimination must file a complaint with the EEOC, which will investigate the claim. A prospective plaintiff, before filing a lawsuit, must receive a “right-to-sue” letter from the EEOC when it concludes its review of the case. To learn more about disability discrimination and your rights, the following resources may be helpful:

Handicap Discrimination Overview, The Law Office of Alan H. Crede, P.C.
A Guide to Disability Rights Laws, Civil Rights Division, U.S. Department of Justice
Disability Resources, Americans with Disabilities Act

According to an article by the New Hampshire Business Review entitled, EEOC charges Nashua firm in disability case, approximately 25% of the 100,000 complaints that the EEOC received in fiscal year 2010 involved disability discrimination. According to the Business Review’s research, Ms. Hajjar’s case may be the first disability-based claim filed by the EEOC in New Hampshire in a decade.

The Boston employment discrimination attorneys at The Law Office of Alan H. Crede, P.C. represent people who are the victims of workplace discrimination based on a handicap or disability. To schedule a confidential consultation to discuss your case, contact the Firm through our website or at (617)973-6434.

More Handicap Discrimination Blog Posts by The Law Office of Alan H. Crede, P.C.:
ADA Amendments Act Provides Employees with Greater Protection, Boston Employment Lawyer Blog (December 15, 2009)
Handicap Discrimination Claim Succeeds Against Wal-Mart, Boston Employment Lawyer Blog (August 12, 2008)
Disability Discrimination Suit Against Wal-Mart Settles for $250,000, Boston Employment Lawyer Blog (July 13, 2008)

Age Discrimination Lawsuit Brought by EEOC Against Texas Roadhouse Restaurant Chain

Age discrimination claims continue to be on the rise. Texas Roadhouse, a Kentucky-based chain of more than 350 restaurants in 46 U.S. states, faces a lawsuit from the Equal Employment Opportunity Commission (EEOC) over claims of alleged widespread age discrimination in hiring for host, bartender, and server positions. The suit, filed in U.S. District Court for the District of Massachusetts, requests anti-discrimination training for managers and employees aimed at preventing further alleged age discrimination. The lawsuit also requests monetary damages for people denied employment based on discriminatory reasons.

The EEOC alleges that the restaurant chain discriminates against older job applicants. According to a press release issued by the EEOC, the number of complaints received by the agency has increased significantly since at least 2007, prompting the agency to commence an investigation at the end of 2010. That investigation led to the current lawsuit. According the lawsuit:

Defendants’ hiring officials have told older unsuccessful applicants that “there are younger people here who can grow with the company”; “you seem older to be applying for this job” and “do you think you would fit in?”; the restaurant was “a younger set environment”; “we are looking for people on the younger side… but you have a lot of experience”; “How do you feel about working with younger people?”; “we think you are a little too old to work here… we like younger people”; “we’re hiring for greeters but we need the young, hot ones who are ‘chipper’ and stuff”; “our age group is in their young 20s, college students”; “I’m basically looking for young teenagers”; and “we really go with a younger crowd and have a younger establishment.”

The lawsuit is premised on the Age Discrimination in Employment Act (ADEA), a federal statute that protects employees 40 years old or older from discrimination based on age. The ADEA prohibits favoring a younger person over a person who is at least 40 years old solely based on age in all aspects of employment. This includes hiring, firing, promotions, layoff, job duties and assignments, benefits, and other features or requirements of employment.

The ADEA further prohibits harassment based on age in the workplace for people 40 years old or older. This includes offensive comments about an employee’s age. The conduct must rise to the level of creating a “hostile work environment” for the law to apply, and can apply against a supervisor, co-worker, or even a customer or client if the employer fails to take reasonable steps to prevent the harassment. The law also prohibits policies that negatively impact employees 40 years old or older if those policies do not have some reasonable basis other than age.

The Law Office of Alan H. Crede, P.C. assists employees who have suffered unlawful discrimination in the workplace. We devote our practice to employment law and exclusively represent the rights of employees. To schedule a confidential consultation to discuss your case, contact the Firm through our website or at (617)973-6434.

More Age Discrimination Blog Posts by The Law Office of Alan H. Crede, P.C.:

Age Discrimination Misconceptions: A Little Knowledge Is A Dangerous Thing, Boston Employment Lawyer Blog (April 1, 2011)
Age Discrimination Mixed Motive Standard Before the Supreme Court, Boston Employment Lawyer Blog (January 1, 2009)
Age Discrimination in Employment Act (ADEA) Fails to Account for Emotional Distress Damages, Boston Employment Lawyer Blog (August 13, 2008)

Should Your Doctor Be Taking “Smart Drugs” And Other Medical Malpractice Hypotheticals

smart drugs.jpgIn this week’s news were a couple of stories that I thought made neat medical malpractice hypotheticals.
The first comes from a new research study showing that doctors who take so-called “smart drugs” (drugs that improve focus and concentration like ADHD drugs and anti-narcoleptic drug Modafinil) perform better than doctors who don’t. The study prompted Instapundit’s Glenn Reynolds to ask, “If ‘smart drugs’ improve doctors’ performance, is it malpractice not to take them?” The answer is “Certainly not,” for reasons explained in this earlier blog post of mine. But perhaps medical malpractice law should move in the direction of sanctioning sleep-deprived doctors, as I argued in this post.
The week’s other interesting (to me at least) med mal hypothetical comes to us courtesy of Spencer v. Roche, a case decided this week by the First Circuit Court of Appeals. Spencer was a case in which the plaintiff sued for alleged violations of his right to be free from unreasonable search and seizure under both the US Constitution and Massachusetts Declaration of Rights. In 2005, the Plaintiff, Spencer, was stopped by police for driving without a license. Upon learning from a confidential informant (CI) that Spencer had supposedly placed a bag of cocaine into his rectum a short time before, police arrested Spencer and obtained a search warrant to search his anal cavity.
Police then transported Spencer to Saint Vincent’s hospital, where a doctor took a KUB x-ray of Spencer’s anal cavity and stomach area against Spencer’s will and apparently while Spencer was handcuffed. Lo and behold, the ultra-reliable criminal snitch was wrong and no drugs were found on Spencer. He was released and sued under 42 USC 1983 and the Massachusetts Civil Rights Act for violations of his Fourth Amendment and Article XIV rights to be free from unreasonable search and seizure. This week, the First Circuit Court of Appeals ruled against Spencer, holding that the search was reasonable under the federal and Massachusetts constitutions.
The Spencer case raises the question of whether any medical malpractice claims would have succeeded. One element of a medical malpractice case is the existence of a doctor-patient relationship and, while that element would be problematic here, let’s assume for the moment we pass that threshold. At that point, issues of informed consent would come into play.
A couple of years ago, American Medical News reported on a medical malpractice lawsuit against a Texas surgeon who performed surgery on a patient, evidently against his will, in order to recover a bullet that implicated the patient in the commission of a crime. As the article noted, “According to American Medical Association policy, physicians should honor informed consent policy, both in ethics and law, “unless the patient is unconscious or otherwise incapable of consenting and harm from failure to treat is imminent.” The article suggested that the doctor might rely on Rule E-2.065 of the American Medical Association’s ethical guidelines, which pertains to “Court-Initiated Medical Treatments In Criminal Cases.” But it seems plain, from reading the rule, that it is meant to apply in cases where, for example, the court orders forceful medication of a mentally ill criminal.
British medical ethics are much clearer. It seems clear under the British Medical Association’s guidelines for “Intimate Body Searches,” which state that, “no medical practitioner should take part in an intimate body search of a subject without that subject’s consent.”
Overall, a week’s worth of interesting tort news.

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The Worst Medical Malpractice Is The Surgery You Did Not Need In The First Place

spinal surgery medical malpractice.jpgLast week, The Wall Street Journal ran a chilling story on the prevalence of doctor-owned medical device companies and the conflicts of interest that arise when doctors are implanting medical devices whose sales they profit from.
The heart of the story involved a 48-year old Baptist preacher named Gary Steven Moore. Moore died on the operating room table in the midst of a 360-degree spinal fusion surgery. Medically speaking, Moore was a poor candidate for spinal fusion surgery because he had had 11 previous bowel surgeries and suffered from diabetes and heart disease.
But Moore’s surgeon, Dr. Adam Lewis, recommended the surgery to Moore, never disclosing that he was part owner of a company named Spinal USA, whose hardware would be implanted during the surgery. On this single surgery, Spinal USA would earn tens of thousands of dollars for its hardware.
Unfortunately, the specter of doctors profiting from the medical hardware they use during surgery is not an uncommon one. Doctors are able to get around anti-kickback laws by starting small medical device companies of their own. And the FDA’s 510(k) loophole, which allows medical device makers to market products without FDA approval if they resemble devices already on the market, means that it is cheap for doctors to do so.
As The Wall Street Journal story noted:

Critics of such arrangements say they give surgeons an incentive to do more operations, and that the conflict of interest has led to a spate of unnecessary back surgeries that waste health-care dollars and often do patients more harm than good. “Patients are having huge operations that are un-indicated because of this,” says Scott Lederhaus, a neurosurgeon in Pomona, Calif., and member of the Association for Medical Ethics, an organization of doctors that focuses on conflicts of interest.

According to a recent report by the Department of Health and Human Services’ Inspector General, at least twenty states are home to surgeon-owned medical device companies. And these companies are branching out, from spine surgery to hip, knee and cardiac surgery.
It’s bad enough to be a victim of medical malpractice. But when the surgery was unnecessary in the first place — that’s the worst kind of medical malpractice.

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Link Roundup


  • A couple of weeks ago, I blogged about “Paradise Lost,” a documentary about the “West Memphis Three,” three men convicted of the crime who were recently released from prison after winning the right to a new trial on appeal. To me, one of the most amazing parts about the documentary was the access that the defense lawyers allowed the documentary camera crews. At the tail end of my post, I beseeched Professor Alberto Bernabe (on whose blog recommendation I viewed “Paradise Lost”) to give his take on the ethics of the lawyers’ inviting in the camera crews and giving them such access, professional ethics being one of Professor Bernabe’s areas of specialty.
    Well, my request earned a response and that response is now available here. As Prof. Bernabe, explains there are several ethical considerations that come into play when lawyers cooperate with media accounts of their cases, including rules prohibiting lawyers from profiting from literary deals made while still representing their clients. You should read Prof. Bernabe’s full treatment of the ethical issues for yourself.
    Ultimately, I guess, whether the lawyers’ actions were ill-advised, as I had initially thought, or whether they were completely prudent, things worked out for the clients’ benefit: the documentary attracted the attention of rock stars and other celebrities who helped finance the costs of their appeals.
  • At the risk of Professor Bernabe dominating this week’s roundup, a post of his about a new Alien Tort Statute case making its way to the Supreme Court, inspired me to wonder why these Armenian-American attorneys are trying to apply the Third Amendment extra-territorially instead of making claims under the ATS. The Third Amendment claim seems highly dubious to say the least.
  • Also from the Concurring Opinions blog, Professor Frank Pasquale with a very good post on Occupy Wall Street.

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If We Get Rid Of Lawyers Will We Have More Lawsuits? And A Thought About Brain Drain

lawyer-salary.jpgThere’s been a lot of chatter in the blogosphere lately about whether there should be any professional requirements connected with lawyering. The issue has been brought front-and-center by the publication of a new book by libertarian authors arguing that anyone should be able to provide legal services for a fee, regardless of whether he’s attended law school, passed the bar or obtained any sort of credential. Over the course of a couple of blog posts, I chimed in with my own two cents, essentially backing the idea.
I wasn’t planning on blogging any further about the topic but last weekend The Press of Atlantic City cited me in an editorial piece addressing the controversy. The piece also cited Chidem Kurdas, a NYU economist, worrying that deregulation of the legal profession would lead to an influx of a large amount of new lawyers and spawn a gigantic new wave of litigation. Overlawyered’s Walter Olson opposes the idea for pretty much the same reasons.
I wish to raise two arguments in reply.
The first is that I think the idea that deregulating the legal profession will lead to a huge influx of new lawyer/amateurs and a huge wave of new litigation is a bit silly — especially in the long run. Kurdas and Olson’s thinking suggests to me a mistaken belief in a stable equilibrium of lawyer salary, even in a deregulated world. The moment that anyone is free to provide legal services is the moment when the bottom drops out of lawyers’ incomes. When the supply of lawyers goes up, their prices will go down. There won’t be a long-lived influx of new lawyers ginning up all kinds of new lawsuits if they discover there isn’t as much money to be made as they had hoped. They’ll return to their prior occupations.
The second point I wish to make is that driving down lawyers’ salaries will have another beneficial effect on the economy: it will prevent the brain drain of science PhDs into intellectual property law that we are currently witnessing.
Over the past decade or so, we’ve heard a lot of commentators bemoaning the fact that a lot of the nation’s best and brightest head to Wall Street. This includes a number of “quants” — the geeky math and science PhDs who head to Wall Street because otherwise they’d have a hard time eking out a living with their astrophysics degrees.
Once on Wall St., these young men and women, some of the nation’s best and brightest, put their talents to use in devising complex stock trading algorithms. The tragedy is that, if Wall Street weren’t such a big part of this nation’s life, these young scientists would be in a lab somewhere developing ideas that add to the nation’s wealth. But, given the fact that Wall St. salaries are so hard to resist, these talented young people instead spend their careers in zero-sum games where one trader’s loss is another’s gain and there is no net gain to anyone’s wealth.
The same trend is going on in the nation’s law schools. Lots of top science and engineering PhDs are abandoning their science careers and heading to law school to become patent lawyers. As patent lawyers, they generally start out making double or more what they made before.
In my own law school “section” (the contingent of your law school class with whom you take all your first-year classes), there were roughly a half-dozen science PhDs, a couple of top-notch engineers and one Harvardmathematics PhD, who had been a tenured professor at a major research university. I can’t speak to what drew these extremely talented people to law school – whether it was the potential for earning a higher salary than they could in their first careers, or whether it was intellectual interest – but I do remember feeling sad that so many truly remarkable minds were giving up careers where they might discover the cure for some disease for a career of staking out the boundaries of patent holders’ monopolies.
Allowing anyone to become a lawyer would partially drive down the salaries that lure some of our best and brightest into becoming lawyers and divert their talents into wealth-creating enterprises. It would also lower the costs for scientists who decide, after a taste of the law, that they are more suited to the laboratory. Once a lawyer-scientist has acquired six figures of student loan indebtedness, it’s hard to go back to the lab bench. If no law school were required for lawyering, the decision would be a much easier one.

Power Saw Accidents And Safety Standards: Important Decisions From CPSC And A Federal Court

power-saws-1.jpgLast Wednesday was a watershed day for preventing power saw accidents. On Wednesday, the Consumer Product Safety Commission voted unanimously formulate new rules that would make power saws safer. Also on Wednesday, the First Circuit Court of Appeals upheld a $1.5 million jury verdict in favor of a worker whose hand was severely injured in a power saw accident, due to the fact that the Ryobi saw that he was using was not equipped with SawStop “flesh detection” technology.
We’ve blogged quite a bit about SawStop before. This incredible new (and old-fashioned) technology makes power saw accidents completely avoidable. But the major power saw manufacturers, companies like Black & Decker, Delta, Rigid and Ryobi, have not licensed the patented technology behind SawStop and so woodworkers, contractors and tradesman continue to lose fingers and suffer approximately 67,300 serious power saw accidents a year.
The principle behind the patented SawStop technology available in SawStop-brand saws is relatively easy to understand. Have you ever seen one of those old-fashioned touch lamps where you touch the base of the lamp and the light turns on and off? The way those lamps work is that a small electrical current passes through the base of the lamp and when your hand (which is largely water, a good electrical conductor) touches the base of the lamp, it interrupts the current and triggers the off switch. SawStop brand technology works in a similar way: the saw blade carries a small electrical current and, when that current gets interrupted, it triggers a brake mechanism that stops the blade, reducing its speed from 5,000 rpm to 0 rpm in several milliseconds.
The CPSC may or may not mandate SawStop-equivalent technology when it decides its new rules. But SawStop-type flesh detection technology is one option that CPSC is weighing. CPSC has 60 days to formulate its new rules and, during that period, will be welcoming comments from industry groups and consumers.
Regardless of whether CPSC decides to mandate the SawStop technology in all saws, product liability lawsuits will be able to continue.
On Wednesday, in Osorio v. One World Technologies, the First Circuit Court of Appeals (the federal appeals court seated in Boston), granted an expected boost to those lawsuits when it affirmed a $1.5-million jury verdict in favor of a worker whose fingers were injured while using a Ryobi BTS-15 table saw.
Even though SawStop does not presently manufacture a smaller saw like the Ryobi BTS, the First Circuit held that the jury could have concluded that it was feasible to incorporate SawStop technology into light-weight portable saws, as SawStop’s founder, Steve Gass, Ph.D., testified could be done.
The First Circuit also ruled that the plaintiff counsel’s urging the jury to “send a message,” although inadvisable, was a harmless error.
To read more about SawStop and preventable power saw accidents, click here, here and here.

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