Articles Posted in Conflicts of Interest

michblogIn protecting its citizens, Michigan already is taking a deserved drubbing for its shameful government  negligence in allowing the lead pollution of Flint‘s drinking water. Officials now need to get their act together to stop a different kind of public policy embarrassment: Expert medical witnesses who abandon any pretext of objectivity and instead work hard to help insurance companies cheat injured people.

This legal controversy is developing in the Detroit suburbs.  It ought to deeply trouble anyone concerned with the First Amendment, and the civil justice system and its fair application of the law in cases of vulnerable litigants who have suffered medical injuries.

On its face, this looks like a doctor versus lawyer dispute. It’s more than that.

In civil lawsuits in which an injured person is suing the person or company that caused the harm, courts in Michigan and across the country allow defendants or their insurance companies to require the injured person to submit to an “independent medical examination.”

That sounds only fair, doesn’t it? But if you have spent any time in court, as I have, you quickly learn that certain of these so-called independent medical examiners are not independent at all, and lawyers and their injured clients need to prepare and watch out for them.

In the Michigan case, a psychiatrist did an “independent” medical exam on a man who suffered a brain injury in an accident. She wrote a report claiming that the injured man was much better; in fact, she said, he had told her he was “improving.”

The man’s lawyer had taken the trouble to record the doctor’s examination (over the defense lawyer’s objection, and only after the court okayed the recording), and he proved at trial that the patient had actually told the doctor, “I don’t think I’m improving.” That was one of many sharp differences he showed between what the doctor claimed the injured man had told her versus what he actually did say.

So after he won the trial, the lawyer wrote a blog post questioning whether the doctor had perjured herself in her testimony. A strong accusation, but lawyer Steven Gursten presented the recording of the interview and compared it to her report, and asked readers to judge for themselves.

Here’s where it gets problematic: The doctor not only disagreed, she also got mad enough to file a formal complaint against the lawyer with the state’s legal licensing board.

She also happens to sit as a member of that board.

She wants the lawyer investigated as to his fitness to hold his license. She demands that the board act to get the lawyer to pull down his blog post, which she says misrepresents the facts and defames her.

The lawyer isn’t backing down. He’s got a lot at risk.

What’s at stake

So, too, does the state of Michigan and the civil justice system. Pop media don’t provide 100% accurate portrayals. But there are all too many painful depictions in the movies and on TV of hired-gun expert witnesses, shading the truth and harming ordinary folk in court cases. For those with injuries serious enough to pursue claims in a lawsuit, the experience in court can be downright scary, and hard enough already without having to worry about the independence and impartiality of some of the system’s key players. This particular doctor had become so notorious in Michigan before the current kerfuffle that plaintiff lawyers conducted seminars on how to deal with her in court.

I’m also concerned that the part of the government that licenses lawyers could get itself involved in censoring them. This isn’t just about an attorney’s First Amendment rights. It’s about all of our rights as Americans to know, clearly and robustly, what happens in the courts and with the proper administration of the law. As a former journalist and an attorney, I know that the complaining psychiatrist would bear a heavy burden if, instead of seeking to yank the lawyer’s license, she had pursued a defamation-libel case against him and had to ask a judge to pull down his blog post. Courts, rightly, set a sky-high First Amendment-based bar when public officials and public figures  seek to curtail public information about the performance of our government, especially our courts.

If you look at the lawyer’s blog post, it is impressive in its documentation of his assertions of dubious if not false testimony by an expert witness.  Lawyers can rip apart witness inconsistency or falsehood in cross-examination. Judges can assist in bringing forth legally salient facts, in excluding bad evidence or testimony, and in taking steps against witnesses whose credibility falls so far as to make them–and the civil justice system–disreputable.

As for this licensing board, its members should know that attention is growing about this case. Like it or not, they now are subject to judgment in the harsh court of public opinion, where, candidly, they start in the hole: Can the public trust the board to render an impartial judgment on a complaint by one its own members? I hope this board, immediately, gets the complainant to recuse herself. Similar panels have, in my opinion, acted to advance the profession and buttress public confidence. They have rejected law licenses for a noteworthy plagiarist but have allowed them for meritorious candidates who were undocumented immigrants. At the same time, officers of the court also have turned a blind eye to unfolding wrongs in the system, notably in a developing scandal about snitches as witnesses in criminal cases in Orange County, California.

For injured folks like the kind my law firm represent, this case is an eye-opener about how one-sided the process can be, and how “independent” medical examinations are anything but independent much of the time. The lesson for any injury victim must be, if you find yourself in the clutches of a biased, non-objective medical examiner, to make sure that everything said is documented and is 100% accurate and truthful.  Here’s some advice we give our clients about how to approach the “independent medical examination.” Only rigorous preparation and complete accuracy will defeat these biased doctors.

Oh, and a good video or audio recording of the proceedings helps too.

Ask Americans what’s their No. 1 health priority and an unsurprising answer pops up: Across the political spectrum, the Chicago Tribune reports, Americans are expressing growing concern about keeping the affordability of prescription drugs for serious conditions.  The increasing unease certainly reflects that in recent days some of the biggest–and most troubling — reports in health care  are appearing not on the news, medicine, or science pages but rather in financial sections and business information outlets.

It might not have seemed possible. But the emerging picture makes the Wall Street and Big Pharma types look even more execrable that imaginable.

The Internet, for example, can’t seem to find sufficient opprobrium for Martin Shkreli, the hedge funder whose Turing Pharmaceuticals acquired rights to the drug Daraprim and then immediately jacked the price of the infection-fighting medication from $13.50 to $750 in one night. An uproar ensued, especially because specialists said they had few alternatives to the drug in combatting parasites that can afflict patients with HIV, and Shkreli, basically, conceded that his company made its giant price increase because it could and would make a lot of money — not for any other reason, such as a reformulation or product improvement.

Experts quoted by The Times said Shkreli’s action was egregious but not uncommon, citing a new strategy by finance-driven firms acquiring “old neglected drugs and turning them into high-priced specialty” medications. Patients have taken a hit already when this happened with medications for multi-drug-resistant tuberculosis, some heart conditions, and the antibiotic Doxycycline.

Now, in certain quarters, the prescription for medication avarice would be market based, with competitors arising and undercutting egregious charges for drugs in high demand and low supply. But as Forbes points out, don’t hold your breath. A small San Diego firm popped up and said it could churn out its version of Daraprim for $1 a pill. Past experience, the financial news magazine says, suggests that Shkreli will still make a bundle and no matter the outcry, the drug-maker, in the end, turns out just fine — see what happened in the instance involving Makena, a medication intended to prevent pre-term birth.

Meantime, financial journalists and analysts are helping to unwind a deeply disconcerting yarn involving Valeant, a Canadian-based pharmaceuticals company with curious corporate tentacles reaching into many different areas of health care. Recent attention has focused on Valeant’s relationship with Philidor Rx Services LLC, a specialty pharmacy. As the Wall Street Journal observes: “Philidor …operated unlike traditional and specialty pharmacies. While traditional pharmacies dispense medicines made by a number of pharmaceutical companies, Philidor dispensed almost exclusively Valeant drugs, according to former employees. The Pennsylvania firm used unorthodox tactics to ensure payment, such as submitting a prescription over and over at different prices until an insurer would agree to pay, according to former employees and pharmacy industry officials. And the medicines weren’t drugs requiring special handling, pharmacists say.”

The New York Times has reported that, subsequently, the nation’s three largest drug benefits managers — Express Scripts, CVS Health and OptumRx — said they would stop paying for drugs dispensed by Philidor.

Meantime, over at the nonprofit, online journalistic investigations site Pro Publica, reports are appearing that U.S. prosecutors are scrutinizing Valeant’s acquisition of the maker of a key component of rigid contact lenses used by millions.

Although Valeant’s valuation has sunk like a rock as more and more gets revealed about its operations, the head of the hedge fund with a multibillion-dollar stake in the firm has defended it, saying it just needs better PR. In contrast, of course, New York Times columnist Joe Nocera calls Valeant “sleazy” and joins a West Coast-based research firm in asking if the pharma firm is “the next Enron.” Nocera points out that Valeant’s chief has, to the delight heretofore of Wall Street, broken the model for the way even highly profitable Big Pharma has operated, spending big money and seeking new block-buster drugs that millions need to take repeatedly. Instead, the plan of Valeant’s chief “was to acquire pharmaceutical companies, fire most of their scientists and jack up the price of their drugs.”

These sorry spectacles couldn’t be occurring, of course, at a worse time for Americans, who had just begun to see some hope that the health care cost-curve finally was bending and trending down. Moreover, partly in response to efficiency demands in the Affordable Care Act, analysts see big consolidations growing even more prevalent in health care providers of all stripes — hospitals, drug store chains, medical groups, and, yes, pharmaceutical companies. So Walgreens and Rite Aid merge, as Allergan and Pfizer move to do so (a tax-saving action, analysts say, with wags calling a possible deal Botox meets Vigra). Anthem tries to buy Cigna, while Aetna pursues Humana.

With all this corporate fever for wheeling and dealing, what happens to ordinary Americans, patients and consumers? With Washington riven by its partisan concerns and focused on a presidential campaign, will someone stand up for the sick?

For patients in our home territory of the District of Columbia, Maryland and Virginia, here are some quick links to look up your doctor’s payments last year from manufacturers of drugs and medical devices.

District of Columbia.



This comes from the ProPublica database, which has obtained the numbers from the federal government in a newly implemented aspect of the Affordable Care Act.

The big players tend to be doctors who use a lot of medical devices like hip implants. For example, Randall Lewis, a Chevy Chase, Maryland orthopedist, and Charles Engh, a Virginia orthopedist, each received seven-figure payments from device makers last year.

Last year, the federal government launched Open Payments, a database that tracks the dollars that flow from drug and medical device manufacturers to medical providers. Last week, it reported that $6.5 billion was paid last year to doctors and hospitals, for a range of services and, well, graft.

More than 600,000 doctors received payments, as well as about 1,100 teaching hospitals.

As reported by the Associated Press (AP), $3.2 billion went to fund research, about $2.6 billion was for miscellaneous items and about $700 million represented investments and ownership stakes.

Approximately 8 in 10 dollars went to doctors, “whose prescribing decisions,” the story noted without editorializing on the potential conflict of interest of this arrangement, “affect the fortunes of pharmaceutical and medical device manufacturers.”

A more thorough analysis of this pay-your-pal arrangement was made by ProPublica and NPR, which identified individuals who reaped the biggest bounty.

Meet Dr. Ana Stankovic of New Hampshire, for whom, according to ProPublica/NPR, “[f]ew days went by last year [when she] didn’t receive a payment from a drug company.

[Note: See postscript at the end of this piece for a response by Dr. Stankovic.]

“All told, 29 different pharmaceutical companies paid her $594,363 in 2014, mostly for promotional speaking and consulting, but also for travel expenses and meals, …”

Although she received payments on nearly every workday of last year, she still ranked only about 250th in her total take among the hundreds of thousands of U.S. doctors who received payments last year.

Although it’s hardly news that providers are well paid by the pharmaceutical industry, the newly released data demonstrate the range of specialists who cash in. They include dentists, optometrists, podiatrists and chiropractors, but, as the story made clear, “What is being seen for the first time now is how ingrained pharmaceutical companies and their sales reps are in the lives of those who write prescriptions for their products. A ProPublica analysis found that 768 doctors received payments on more than half of the days in 2014. More than 14,600 doctors received payments on at least 100 days in 2014.”

Some might not have collected a lot of money, just a little, but almost every day. Dr. Juichih Hsu, a family medicine practitioner in Maryland, received payments on 286 of the 365 days last year, more than anyone else. Sometimes, she received meals from several drug companies … on the same day.

Some observers consider this practice, well, networking. Dr. Aaron Kesselheim, associate professor of medicine at Harvard Medical School, told the reporters, “Every day it’s another drug company coming in for a lunch. Sometimes it may be some drug companies are bringing breakfast and some are bringing lunch and it’s just part of the culture of the practice.”

Uh huh. And sometimes that culture seems rotten.

Dr. John Fritz, of New Jersey logged payments of $232,003 over 256 days last year from drug and device makers. In June, he was charged with fraud and bribery for referring patients over several years to a medical imaging company in exchange for about $500,000 in kickbacks. It’s logical to wonder about the connection.

Such extensive contact with industry reps, Kesselheim told ProPublica/NPR, can signal less than a best-practice approach to how doctors prescribe drugs; that is, they’re getting information from the companies that make the drugs, not necessarily in equal measure with the impartial science that analyzes them. “There’s good evidence that that affects prescribing practices and physician behavior,” Kesselheim said.

Are you surprised that the drugs Stankovic got paid to promote are unusually expensive for the patient? H.P. Acthar Gel, prescribed for multiple sclerosis, runs about $39,000 per prescription, despite no evidence that it works better than less expensive drugs. (Stankovic also was paid to promote a drug for serious a kidney disease called Soliris. It’s among the most expensive drugs in the world, but is considered highly effective.)

ProPublica/NPR found big differences in the number of industry interactions among physicians in different specialties. Rheumatologists, who specialize in the treatment of arthritis, lupus and scleroderma, averaged 40 days of interactions with drug and device companies, the most of any other large specialty. Next were endocrinologists (who treat diabetes, among other disorders) and two kinds of heart specialists, electrophysiologists and interventional cardiologists. Specialists with the fewest drug and device maker interactions were dentists, chiropractors, neonatologists and pathologists.

Among the commercial participants, Genentech Inc. spent the most on general payments (that is, not for research), $387.7 million, mostly royalties for its cancer drugs Rituxan, Avastin and Herceptin to City of Hope National Medical Center in Duarte, Calif., a major cancer center. AstraZeneca, Pfizer and Allergan were other big spenders in the category of general payments.

Royalty fees accounted for $803.5 million in general payment spending in 2014, more than any other category. Those fees, based on sales of a product, are paid by device manufacturers to physicians who work with the company to invent the device. Next came promotional speaking ($632.4 million) and consulting ($369.4 million). Food and beverages accounted for the highest number of payments by far, 9.4 million, but these had a relatively low value of $224.5 million.

Open Payments does not report the value of drug samples left at doctors’ offices nor most of the money companies spend on independently administered continuing medical education, which they support with unrestricted grants.

ProPublica has been tracking industry payments to doctors since 2010 through its online database, Dollars for Docs. (Research and ownership payments are not shown in Dollars for Docs.)

Professional networking can yield benefits for all participants, and in the case of medicine, patients, too, can benefit from productive relationships their providers have with the companies that make therapeutic products. But because those relationships are ripe for abuse, patients must be bold when their doctors recommend or prescribe any drugs or devices: Ask why he or she chose that particular therapy, what is expected from its use and how soon, what are the risks and potential side effects, and, if the provider has ever accepted payment from the manufacturer. If so, find out what it was for, and over what period of time. Ask if your doctor submits reports to Open Payments, which is voluntary for providers.

The answers will help you know whether your doctor is recommending something because it’s scientifically a good idea, because they want to keep their business relationship in good shape or both.

Postscript: Dr. Stankovic contacted me about the references to her in this blog post. The dollar numbers appear to be accurate, but she says the piece makes some misleading statements. I’m happy to correct anything that is not right.

* She says most of the money she was paid last year was for reimbursement of travel.

* She says she has a consulting practice that explains why she is paid this much.

* She believes she is not promoting expensive drugs because she has been paid to do so, but that she is educating doctors about certain orphan drugs for rare conditions within her specialty of kidney diseases. That explains the multiple sclerosis drug mentioned in the piece, which apparently also has a use for some rare kidney troubles.

There are plenty of doctors in the District of Columbia, Virginia and Maryland — our home turf – who receive large sums from drug and device makers. A few of them have been paid well into seven figures. I placed links to the ProPublica database so readers can check those out.

There is no justification for conflicts of interest in any business, but they’re particularly dangerous in medicine, where people’s lives are at stake. A recent airing of differences within the medical community about such conflicts hasn’t gotten much consumer play, but it should.

The prestigious New England Journal of Medicine (NEJM) recently published a series of articles about physicians who have relationships with the medical industry, and who submit their research articles in the hope of being considered for inclusion in the journal. It purported to analyze whether such scientific reviews were acceptable journal material if their writers had financial interests in the subjects they covered.

The series’ conclusion was, basically, that perceived problems with doctor-company ties are overblown.

The NEJM followed up with a poll of the journal’s readers that, as described on (HNR), asked them to judge the suitability of three hypothetical potential contributors. Each supposed expert had some kind of financial arrangement with the pharmaceutical industry (for example, speaking fees or research funding).

But the readers weren’t given the option to judge a potential author who had no conflict of interest. “This is striking,” said HNR, “considering that during the 1990s and up until 2002, the NEJM would not publish editorials or review articles by authors with any conflict of interest.”

Many reader/physicians weighed in on the poll and the original series, and they weren’t complimentary.

According to HNR, one emergency physician said, “Pharmaceutical company money, and the purchase of influence, has been the single most powerful distorting force in health care in a generation – this is undisputed. This overwhelming and uncontested monetary force has come between guideline panels and recommendations, government agencies and quality markers, health-care policies and subjects, and doctors and patients …. There is a reason more than two-thirds of Americans are taking a prescription drug, an embarrassing statistic,” and he wondered why the poll didn’t offer a nonconflicted contributor as a fourth candidate for review.

“The only reason to choose any of the individuals in these cases would be if there were no available alternatives,” he said.

Other NEJM respondents were concerned that the journal had not given editorial space for people opposed to its conflict-of-interest posture.

As HNR saw it, the reason is because the journal wanted to “frame” the discussion.

That’s sort of what drug companies do when they’re seeking FDA approval of a drug whose clinical trial results aren’t as persuasive as they should be, either in terms of effectiveness or safety; they present consumer witnesses to panels considering approval who speak more from emotion than science, as in the recent hearing about the “female Viagra” drug, for example, and in the worst cases, hide negative study results they know would doom their chances.

A day after HNR’s analysis of the mess at the NEJM, it reported about another journal, BMJ (British Medical Journal) that published the views of three former NEJM editors, who wrote, simply, “Justifying conflicts of interest in medical journals: a very bad idea.”

The three said it was “sad that the medical journal that first called attention to the problem of financial conflicts of interest among physicians would now backtrack so dramatically and indulge in personal attacks on those who disagree.”

They referred to an extensive body of literature the NEJM series mostly ignored that concluded that physician conflicts of interest had measurably negative effects on medicine and medical journals. They offered comparisons of such conflicts in other professions:

Judges are expected to recuse themselves from hearing a case in which there are concerns that they could benefit financially from the outcome. Journalists are expected not to write stories on topics in which they have a financial conflict of interest. The problem, obviously, is that their objectivity might be compromised, either consciously or unconsciously, and there would be no easy way to know whether it had been. Yet [NEJM ] seem[s] to think it is insulting to physicians and medical researchers to suggest that their judgment can be affected in the same way. Doctors might wish it were otherwise, but none of us is immune to human nature.”

The BMJ does not accept educational articles by authors with industry ties. The three former NEJM editors who wrote for it, according to HNR’s follow-up, predicted that the NEJM’s acceptance of these murky associations could either signal a decline in journal quality or galvanize strong opposition to them.

Let’s hope it’s the latter. This isn’t just a closed-club squabble; this is about scientific objectivity, and that affects everybody who will ever need medical care.

To learn more about financial relationships between medical professionals and industry, link to ProPublica’s data base, Dollars for Docs.

Psychotropic drugs are powerful agents that address a variety of mental issues. And although they are lifesavers for some people, antidepressants, antipsychotics and other such meds remain the subject of debate among medical professionals, most recently within the pages of BMJ (British Medical Journal).

Some people want antipsychotic meds to be heavily restricted, explained, while others insist they are safe for most users. In the BMJ article, some researchers claimed that the long-term side effects of many psychiatric drugs do more harm than good, and suggested that many drug trial designed purposefully underestimate their harms and overestimate their benefits.

For example, after reviewing several studies, Professor Peter C. Gotzsche, who helped found the venerable research nonprofit known as the Cochrane Collaboration, estimated that there are 15 times more suicides among people taking antidepressants than reported by the FDA because, he said, the FDA tallies suicides reported only within 24 hours of when patients stop taking these types of meds.

He cited figures from one study showing that nearly 2 in 3 deaths were unaccounted for among people taking antipsychotics. Another study that specifically analyzed users of benzodiazepine (tranquilizers, including Xanax and Valium) could be responsible for nearly 540,000 deaths annually in the U.S. and Europe.

These drugs are especially risky, as Patrick discussed in a recent newsletter, among older people for making them more prone to falls.

Gotzsche said the benefits of these drugs are widely overstated and that randomized trials don’t properly evaluate their effects. He went so far, according to, as to call them “biased,” because they include patients who already take other psychiatric drugs, which could corrupt the results.

Patients who take psychotropics long term, then stop cold turkey, often are given a placebo, or fake drug. Prescribers hope it will ease their transition, but Gotzsche said that instead, many patients experience withdrawal symptoms that drive them to suicide.

Gotzsche said the benefits would need to be “colossal” to justify the use of psychiatric drugs, and that in some cases, such as drugs meant to treat attention deficit hyperactivity disorder (ADHD), there’s often no benefit, never mind one that’s minimal, much less “colossal.”

“We could stop almost all psychotropic drugs without causing harm – by dropping all antidepressants, ADHD drugs and dementia drugs and using only a fraction of the antipsychotics and benzodiazepines we currently use,” Gotzsche is quoted as saying on

Of course, his position drew significant backlash from other researchers, who claimed that evidence supporting the long-term use of antipsychotic medications was solid.

“More than one-fifth of all health-related disability is caused by mental ill health, studies suggest,” wrote Allan H. Young, professor of mood disorders at the Institute of Psychiatry and Psychology and Neurosciences at Kings College in London.

He said that the poor physical health typically associated with poor mental health raises the risk of mortality and lowers the life expectancy of mental health patients. The opposition researchers said that the increased death rate is only partly due to suicide, and mostly due to co-existing health disorders.

He supported monitoring by regulatory agencies after the drugs reach the consumer market to ensure they not only work as promised, but are safe. He said the success of such oversight was demonstrated by studies that looked at clozapine, a sedative prescribed to treat schizophrenia. They showed that long-term treatment was associated with lower mortality compared with patients who took no antipsychotic drugs.

But, according to, the BMJ editors also noted that Young has served as an advisor for major drug companies that manufacture drugs to treat some mental disorders, including AstraZeneca, which makes Seroquel, Lundbeck, which makes Abilify and Lexapro, and Eli Lilly, which makes Prozac.

Which makes us wonder about his credibility.

That’s what one drug industry skeptic is calling the successful effort last week to persuade an FDA advisory committee to reverse itself and recommend the agency approve a drug for “female hypoactive sexual desire disorder” called flibanserin.

The objective evidence is that the drug, which has to be taken daily, is only a smidgeon more effective than placebo and carries with it a raft of disturbing side effects such as the possibility of dangerously low blood pressure when taken with alcohol.

But a “grassroots” campaign called Even the Score (get it? nudge nudge) sent “activists” to the FDA advisory meeting to propose the idea that since men have Viagra and Cialis, women needed a drug too, despite concerns about its marginal efficacy.

In a blog piece on Health News Review, author Alan Cassels wrote:

These campaigners were, of course, the type normally found when there is a backer with deep pockets, in this case the manufacturer of flibanserin, whose care and feeding of the activists was important to keep reinforcing the mantra that we need an FDA-approved aphrodisiac for women.

This activity is classic faux-advocacy. The vocal and articulate activists and the specialists-for-hire are all part of what my coauthor Ray Moynihan and I called “Astroturf Activists” in our book Selling Sickness. Astroturf looks and feels like real grass, but as we know, it’s plastic, has no real grassroots, and really represents no community other than the one created by the big industry (be it tobacco, oil or in this case, the drug industry) that pays their bills. I can assure you, having seen this dozens of times over the last two decades, if there was no drug company funder, there would be no Even the Score campaign.

The FDA reviewers, clearly interested in hearing all sides of the issue, were astonishingly swayed by the Even the Score astroturfers. These advocates skillfully employed all the tools of slick, tech-savvy modern PR – schmoozing with Congress, as well as Tweeting and Facebooking under the banner of “gender equity” – to convince the panel that women with low sexual interest should be considered very sick people who need a daily drug to make their sex drive more “normal” (as if such a thing as “normal” actually exists).

Read more from Cassels here.

Substituting one drug for another – say, a generic version for a brand name – often is perfectly fine in terms of what’s best for the patient. But when a Veterans Affairs hospital in West Virginia replaced certain psychotropic drugs with older versions, it put patients at risk, because the priority wasn’t good care, it was cheaper care.

As told by the Washington Post, a federal investigation last month concluded that the drug switch was a violation of VA policy, and that it resulted in a “substantial and specific danger to public health and safety,” according to the VA’s Office of Medical Inspector. The probe was aided by a whistle-blower within the department.

The U.S. special counsel acknowledged the important role of the whistle-blower, which is doubly interesting, given that so often, as we wrote recently, people working in military medicine who identify its shortcomings often are ignored at best, and suffer retribution at worst.

“At a time when many veterans are grappling with mental-health issues, this VA facility was cutting corners on needed drug therapy to save money,” the counsel said in a statement.

The Department of Veterans Affairs is not allowed to restrict drugs based solely on how much they cost, The Post story said. It’s required to supply certain medications when they are necessary for a patient’s health.

But that’s not what happened at a VA clinic in Beckley, W.Va. It had established what the investigation called a “blanket restriction” on administering two antipsychotic drugs, aripiprazole and ziprasidone, to help meet its cost-saving goals for fiscal 2013.

Aripiprazole is the generic name for the brand drug Abilify. It’s prescribed for schizophrenia, bipolar disorder and depression. Ziprasidone, which also can treat those disorders, is known by the brand name Geodon. Drugs in this class alter the activity of certain substances in the brain.

The West Virginia clinic’s pharmacy committee, which makes decisions about what drugs may be used, restricted the use of those two without allowing doctors to make a clinical determination about potential health effects on their patients. The sole reason the panel said “no” was to help meet cost-saving goals for its fiscal year (2013). To add insult to arrogant injury, when the committee made the decision, its chair wasn’t even a physician.

According to The Post, the Office of Medical Inspector “recommended” that the clinic study how the drug substitutions affected patients’ health. Wouldn’t you expect the adults in the room to demand such analysis?

The inspector also sought discipline of the pharmacy committee’s leadership, and installation of a physician as its leader. That seems to be the least anyone could do to rectify such a breach of medical ethics and patient safety.

The U.S. special counsel called these recommendations “immediate and appropriate measures” for resolving the drug-substitution problem, but also said that the whistle-blower has claimed that wrongdoing might be ongoing at the clinic.

The VA said it has initiated an investigation based on the findings and recommendations of the medical inspector’s report. In a statement, it said, “We will immediately take action where it is warranted to ensure the most current medical standards are strictly followed. We applaud the VA employee who contacted the OSC on this matter. [VA] Secretary [Robert A.] McDonald has made clear that employees who step forward to raise concerns have a direct bearing on the veteran outcomes we deliver, and this is an example of why that is important.”

The special counsel has closed the case “conditionally,” pending a follow-up report to address the allegations of continued wrongdoing. The analysis is due to be completed by May 11.

Wow, that’s fast even for a balky, bureaucratic federal agency that’s responsible, responsive and efficient (are there any?), so let’s hope this glass is half full and will be topped off this month not only with problem resolution, but by sending a strong message throughout the system of military medicine that such serious issues of patient safety will not go unnoticed or unpunished.

Learn more about military malpractice here.

We’ve often written about the conflicts of interest that can compromise patient safety when doctors and other medical providers are paid for promoting drugs, devices or services. In another case of cross-my-palmism, the Texas Department of State Health Services (DSHS) has outed two doctors whose priorities appeared to have drifted away from patient safety.

As reported earlier this month by the Texas Tribune, when two psychiatrists at Terrell State Hospital were told they would be disciplined for accepting hundreds of thousands of dollars to promote the drugs Seroquel and Seroquel XR, they resigned.

Terrell State Hospital is one of 10 psychiatric hospitals operated by DSHS. Seroquel, made by AstraZeneca, is an antipsychotic often prescribed to treat schizophrenia, major depressive disorder and bipolar disorder. Several years ago, the drug earned an FDA “black box” warning, a mandatory alert on the label signifying an extreme risk; in this case, it was issued because the FDA determined that patients with dementia had an elevated risk of death by taking this drug.

Documents from the Texas agency showed that Dr. Anthony Claxton, Terrell’s clinical director, and Dr. Lisa Perdue, a psychiatrist, received massive amounts of money from AstraZeneca to promote the company’s drugs to other doctors and state regulators. When informed that they had violated department rules, both doctors resigned.

Claxton is accused of taking $231,000 from AstraZeneca for “promotional speaking and consulting services” at least 166 times since 2005. Perdue allegedly received $615,525 for 460 occasions since 2005. Texas state law forbids employees from accepting outside compensation that could affect their official duties.

Given the amounts involved here, and the time it takes to earn it, you have to wonder when these people had time to practice medicine … you know, their “official duties”?

The state claims that both doctors contacted members of the Executive Formulary Committee, the body that oversees drug standards in Texas, to advocate for adding AstraZeneca’s products to the state’s list of approved drugs. Perdue supposedly used a pitch in that effort that was written by an AstraZeneca employee.

If your loved one was a patient at Terrell, how good would you feel knowing that his or her drug regimen might have been determined not by best medical practice, but by best promotion speech?

Remarkably, Claxton was surprised by the recent events. In a letter to the DSHS reviewed by The Tribune, he wrote, “I do not deny that I presented these programs,” adding that he thought he had received permission to do so. He also objected to “the timing of this action” because he was scheduled to retire in 76 days.

Perdue’s lawyer suggested that the state had violated her legal rights by demanding an immediate response to the allegations, and questioned the amount of money DSHS says she received. He didn’t deny she received payment, just how much. The lawyer defended her by saying she had promoted the drugs “on her own personal time” because she thought they “offered less toxic side effects for some patients.”

Then why didn’t she do it for free?

A spokeswoman for the Texas agency told The Tribune that the violations were discovered during an investigation into AstraZeneca by the Texas Attorney General, and that there was no evidence that the psychiatrists had compromised their patients’ health by overprescribing the drug.

Who knows if anyone looked for such evidence, and because the doctors resigned, we’ll never know because the state isn’t pursuing the case further.

Find out more about who takes money from drug companies, how much and for what at’s, data base, Dollars for Docs.

When a doctor calls out a whole field of medical specialists for conflicts of interest that risk harming patients, things must really be rotten in the state of orthopedics.

Dr. James Rickert, an Indiana orthopedist, has launched what he calls a “moral persuasion” campaign in the hope of getting his colleagues to stop performing needless surgeries, as reported on

The medical profession in general is vulnerable to financial conflicts of interest, but Rickert, who founded the Society for Patient Centered Orthopedic Surgery, calls orthopedics “one of the worst offenders.”

Following is Rickert’s list of procedures that are frequently performed, are usually unnecessary, cost a lot and sometimes are harmful. If you or a loved one has had one of these surgeries without relief of symptoms, would that qualify you for a medical malpractice suit against the orthopedic surgeon? Not likely, unless you suffered a serious complication that left you worse off than before the surgery. Unfortunately, malpractice lawsuits are too complex, time-consuming and expensive to be worthwhile unless you suffered permanent, life-changing harm.

So be careful before going under the knife for any of Rickert’s questionable “treatments”:


Cost: $10,000
Cement is injected into a fractured vertebra. About 100,000 patients have it every year. It’s falsely marketed as relieving pain quickly, a claim not proved in clinical trials. Risks include compression fractures in adjacent vertebrae, dural tears (tissues covering the spinal cord and nerves), infections, cement migration (the material moves outside of the repair region) and nerve pain requiring subsequent surgery.

Rotator cuff repairs in elderly people

Cost: $15,000
The number of these surgeries increased by 141% between 1996 and 2006; about 600,000 occur every year in the U.S. It’s vastly overused on people with no symptoms. Complications include infection, bleeding, re-rupture of the rotator cuff, nerve damage, blood clots and the need for repeat surgery to correct problems with the first procedure.

Clavicle (collarbone) fracture repair (“plating”) in adolescents
Cost: $13,000
Some adolescents get this treatment to improve athletic function, but Rickert said, “I don’t know of any good indication, especially with conservative care being so successful.”

Regardless of patient age, sports/activity and final clavicle shortening, there’s generally no difference in pain, strength or range of motion. Risks include deep infections, pneumothorax (collapsed lung) and other complications.

Anterior cruciate ligament tear repair in low-risk people
Cost: $10,000
ACL surgeries are performed on about 100,000 patients’ knees every year. Many show no difference in rates of return to pivoting-activity sports one year later when compared with noninvasive rehabilitation and activity modification. Complications include infection, instability, stiffness, pain, patellar (kneecap) fracture and growth plate injury in children (ends of the bones are damaged).

Surgical removal of part of a torn meniscus
Cost: $6,000
About 700,000 patients with knee arthritis and no mechanical symptoms have this procedure every year. It doesn’t result in significant benefit in terms of pain relief or function compared with fake surgery in patients with degenerative meniscal tears.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
Washingtonian Top Lawyer 2011
Avvo Rating 10.0 Superb Top Attorney Best Lawyers Firm

Contact Information