Johnson and Johnson Pays out in Texas Law Suit

This to be tossed into the "Corruption" file, or the "Follow the Money" file. I guess they're sort of one in the same, except the "Corruption" file contains those who have been caught.

January 19, 2012
J. & J. to Pay $158 Million to End Suit Filed by Texas
By REUTERS

Johnson & Johnson said on Thursday that it would pay $158 million to settle a Texas lawsuit accusing the drug maker of improperly marketing its Risperdal antipsychotic drug to state residents on the Medicaid health program for the poor, including children.

The lawsuit accuses the company of pushing Risperdal as “appropriate and safe to treat a broad range of symptoms in populations and disease states for which it had no F.D.A.-approved indication, including in the child and adolescent population...”

“Johnson & Johnson’s scheme to profit from the Medicaid program by overstating the safety and effectiveness of an expensive drug and improperly influencing officials ended up costing taxpayers millions of dollars,” Texas’s attorney general, Greg Abbott, said in a statement...
The company is in various stages of litigation with several other states.

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Drug Cartel Forced to Report Pay Offs

My title is a bit hyperbolic, but not by much. This blog post to be filed in the "It's about time" file. They are planning on extending this regulation to the medical device industry as well. Note that this law is about direct payment to doctors as well as the funding of medical research, which is also corrupted. I've touched on some of these topics here, here, here and here. Those, unfortunately, are just a few of the many posts on this type of corruption that has occurred. I'm not sure how to evaluate the penalties, $10,000 for failure to report, $100,000 for knowingly failing, for a total of $1,000,000 per year. Seems in the "slap on the wrist" range in absolute dollar amount, but the negative press may be the larger punishment. It's something, at least.(For more information about my practice, please click here.)

U.S. to Force Drug Firms to Report Money Paid to Doctors
By ROBERT PEAR

WASHINGTON — To head off medical conflicts of interest, the Obama administration is poised to require drug companies to disclose the payments they make to doctors for research, consulting, speaking, travel and entertainment.

Many researchers have found evidence that such payments can influence doctors’ treatment decisions and contribute to higher costs by encouraging the use of more expensive drugs and medical devices...

Large numbers of doctors receive payments from drug and device companies every year — sometimes into the hundreds of thousands or millions of dollars — in exchange for providing advice and giving lectures. Analyses by The New York Times and others have found that about a quarter of doctors take cash payments from drug or device makers and that nearly two-thirds accept routine gifts of food, including lunch for staff members and dinner for themselves.

The Times has found that doctors who take money from drug makers often practice medicine differently from those who do not and that they are more willing to prescribe drugs in risky and unapproved ways, such as prescribing powerful antipsychotic medicines for children...

Companies will be subject to a penalty up to $10,000 for each payment they fail to report. A company that knowingly fails to report payments will be subject to a penalty up to $100,000 for each violation, up to a total of $1 million a year...

Allan J. Coukell, a pharmacist and consumer advocate at the Pew Charitable Trusts, said: “Patients want to know they are getting treatment based on medical evidence, not a lunch or a financial relationship. They want to know if their doctor has a financial relationship with a pharmaceutical company, but they are often uncomfortable asking the doctor directly.”

Tragic. High Cost of Failing Artificial Hips

To be filed under "Follow the Money." This has got to be horrendous for patients since you know that the insurance company's costs will be reimbursed first since they can hire more lawyers. And to have to be dealing with these kinds of financial issues and law suits when you're not feeling well. Horrible. Some excerpts follow. I've been following this story for the 6 months and it follows the typical trajectory of the companies ignoring complaints, blaming the physicians and then finally having to cop to the problem. Not good. Not good at all. Recent blog post on topic here.
The High Cost of Failing Artificial Hips
By BARRY MEIER

The most widespread medical implant failure in decades — involving thousands of all-metal artificial hips that need to be replaced prematurely — has entered the money phase.

Medical and legal experts estimate the hip failures may cost taxpayers, insurers, employers and others billions of dollars in coming years, contributing to the soaring cost of health care. The financial fallout is expected to be unusually large and complex because the episode involves a class of products, not a single device or just one company...

The incidents have set off a financial scramble. Recently, lawsuits and complaints against makers of all-metal replacement hips passed the 5,000 mark. Insurers are alerting patients that they plan to recover their expenses from any settlement money that patients receive. Medicare is also expected to try to recover its costs...
Still, some patients are weathering some of the financial impacts on their own. While Charmin McCune, a teacher in Wylie, Tex., is recuperating well from a recent replacement operation, she said that she and her husband, also a teacher, have had more than $12,000 in expenses that have not been covered by insurance.

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New Joint Implants no Better Than Older Ones

Filed under "Follow the Money"
December 22, 2011
New Models of Implants Not Better, Study Finds
By BARRY MEIER

A new study suggests that the recent technology for artificial hips and knees did not perform any better than older, less expensive designs.

The study, which draws on data from Australia’s orthopedic registry, covered implants introduced from 2003 to 2007 and was published this week. The findings are significant for patients in the United States because many of the new designs, like so-called metal-on-metal hips, are widely used here. Those implants, which have both a ball and cup made of metal, are expected to fail prematurely in tens of thousands of patients rather than lasting 15 years or more as artificial joints are supposed to do.
The Australian study showed that not a single new artificial hip or knee introduced over a recent five-year period was any more durable than older ones. In fact, 30 percent of them fared worse...


“Not only has the introduction of this technology been potentially detrimental to patient care, but the current approach may be an important driver of increased health care costs,” the review concluded...

That review, by researchers in Austria (mistake, should be Australia), found that surgeons involved in the original published reports are often involved in its development and may have a financial stake in them. In addition, such reviews tend to be short term...
This month, bipartisan legislation was introduced in the Senate that could force manufacturers to track the performance of implants like artificial hips after they have been approved for sale. Proponents of the bill acknowledge that the measure faces an uphill fight.
Both device producers and their allies in Congress have maintained that any additional F.D.A. regulations would slow the development and marketing of innovative products that benefit patients. For his part, Dr. Graves, the Australian official, said he believed that such arguments were misleading.

Where have we heard that before?? That regulation will somehow damage innovation, or hurt business and job creation? Just about every time any sort of regulation is proposed, that's when.
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Approval for Avastin for Breast Cancer Revoked by FDA

I've been putting off posting about this latest article about Avastin for breast cancer. I find the way that these very loaded controversies are settled very depressing. In the case of Avastin, it looks like in the best case scenario it extends life for 5-6 months at a cost of $88,000 per year. Recent studies show that the life span extension is more like 1-2 months. It also comes with many nasty and dangerous side effects. To lobby against the FDA ruling, Genentech and Roche mount a defense including the impassioned pleas of patients themselves. I get queasy even writing about this. Medicine needs to have studies to evaluate treatments, not anecdotes from desperate patients. It brings up the horrors of cancer and how we want to do anything in reason to help fight it. But we have to balance the evidence with the emotion and it's so incredibly difficult. If patients have been harmed, and their lives shortened, those voices should be out there also or should they? Should we really be deciding drug efficacy issues in the court of public opinion? We have always needed to studies to weed out anecdotal results. It is a sad day when questions in medicine are decided much as in politics, that those with the money have an outsized voice. Science is getting sidelined because money speaks loudest. But those heart breaking voices of cancer patients are so compelling, we all get that...
November 18, 2011

F.D.A. Revokes Approval of Avastin for Use as Breast Cancer Drug
By ANDREW POLLACK

The commissioner of the Food and Drug Administration on Friday revoked the approval of the drug Avastin as a treatment for breast cancer, ruling on an emotional issue that pitted the hopes of some desperate patients against the statistics of clinical trials. The commissioner, Dr. Margaret A. Hamburg, said that clinical trials had shown that the drug was not helping breast cancer
patients to live longer or to meaningfully control their tumors, but did expose them to potentially serious side effects like severe high blood pressure and hemorrhaging.

“Sometimes, despite the hopes of investigators, patients, industry and even the F.D.A. itself, the results of rigorous testing can be disappointing,” Dr. Hamburg told reporters Friday. “This is the case with Avastin when used for the treatment of metastatic breast cancer.”

Avastin will remain on the market as a treatment for other types of cancers, so doctors can use it off-label for breast cancer. But insurers might no longer pay for the drug, which would put it out of reach of many women because it costs about 88,000 a year...

Please go to the link to read the whole article.
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Houston Lawyer Suing over Faulty Hip Prostheses

Per my previous post about the Medical Device Industry trying to quash new regulations, there is this story.
A Houston Lawyer is suing a subsidiary of Johnson and Johnson over hip replacement prosthetic devices that were supposed to last 15 years, but resulted in metal on metal friction that could lead to bone and tissue deterioration. That deterioration, if not caught early enough, could make it much more difficult to successfully replace the faulty hip.
Of course, we also know that there has been a decades long push by corporations to do away with this sort of mass action litigation with something called "tort reform." (See the movie Hot Coffee.) So between trying to do away with regulation, and simultaneously doing away with being able to have your day in court, I guess we'll all just be on our own. (info on my practice here.)

Blockbuster Smoking Cessation Drug Linked to Heart Disease

I somehow missed the latest in a series of much-hyped, best-selling drugs turning out to have major problems. This article was released over the July 4th holiday, so I didn't notice it. Long story short, Chantix is still on the market and will be studied further. From the article one critic is quoted as saying, “It causes loss of consciousness, visual disturbances, suicides, violence, depression and worsening of diabetes. To this list we now can add serious cardiovascular events.” Wow, sounds bad. So why would they leave it on the market? Well maybe because it's "a product that has been prescribed to 13 million people and had $755 million in sales last year." Or this "Chantix is selling well overseas. In Japan, for instance, some pharmacies ran out for a while recently, even as the drug failed to meet expectations in the United States because of health warnings and bad publicity." Another fun fact was that physicians who prescribe the drug can expect to get one new cardiac event in every 28 patients taking the drug. But on the bright side, for every ten patients taking it, one will stop smoking (yes, one in ten) . So there's that.

July 4, 2011
Study Links Smoking Drug to Cardiovascular Problems
By DUFF WILSON

Chantix, the best-selling prescription drug for smoking cessation, was linked to an increased risk of a heart attack, stroke or other serious cardiovascular event for smokers without a history of heart disease compared with smokers who did not use the drug, according to a Canadian medical journal report released on Monday.

The finding added to previous warnings about the pill’s connection to psychiatric problems and cardiovascular risks for people with a history of heart disease...
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Genomic Cancer Testing Falls Apart

From today's NYTimes, an article about a technique of using DNA testing to tailor cancer treatment is debunked with law suits ensuing. I flag this article because it falls into the Gold Rush treatment mentality that so pervades the U.S. health care industry. The only way to really make money off of healthcare in our system is to provide treatment once the illness is manifest. (Or to create a condition and then provide treatment for it, i.e. Viagra) There is no money to be made in prevention, so prevention takes a back seat. The only institution with enough heft to counter corporate clout is the government, but with the government itself under attack, and the research and regulatory agencies' budgets being slashed, there's not too much policing going on. So efforts to discover the actual carcinogens involved in the increased cancer rates are meager. The causes of autism are slow to be discovered, and unlikely to be acknowledged if, indeed, a blockbuster drug is implicated. And so it goes. This particular technology also fits into the category of "believing in treatments that don't work." I excerpted parts and highlighted others. (For more info about my practice, please click here.)

July 7, 2011
How Bright Promise in Cancer Testing Fell Apart
By GINA KOLATA

When Juliet Jacobs found out she had lung cancer, she was terrified, but realized that her hope lay in getting the best treatment medicine could offer. So she got a second opinion, then a third. In February of 2010, she ended up at Duke University, where she entered a research study whose promise seemed stunning.

Doctors would assess her tumor cells, looking for gene patterns that would determine which drugs would best attack her particular cancer. She would not waste precious time with ineffective drugs or trial-and-error treatment. The Duke program — considered a breakthrough at the time — was the first fruit of the new genomics, a way of letting a cancer cell’s own genes reveal the cancer’s weaknesses.

But the research at Duke turned out to be wrong. Its gene-based tests proved worthless, and the research behind them was discredited. Ms. Jacobs died a few months after treatment, and her husband and other patients’ relatives are suing Duke.

The episode is a stark illustration of serious problems in a field in which the medical community has placed great hope: using patterns from large groups of genes or other molecules to improve the detection and treatment of cancer.Companies have been formed and products have been introduced that claim to use genetics in this w ay, but assertions have turned out to be unfounded. While researchers agree there is great promise in this science, it has yet to yield many reliable methods for diagnosing cancer or identifying the best treatment.

Instead, as patients and their doctors try to make critical decisions about serious illnesses, they may be getting worthless information that is based on bad science. The scientific world is concerned enough that two prominent groups, the National Cancer Institute and the Institute of Medicine, have begun examining the Duke case; they hope to find new ways to evaluate claims based on emerging and complex analyses of patterns of genes and other molecules.

So far, the Food and Drug Administration “has generally not enforced” its regulation of tests created by individual labs because, until recently, such tests were relatively simple and relied heavily on the expertise of a particular doctor, said Erica Jefferson, a spokeswoman for the agency. But now, with labs offering more complex tests on a large scale, the F.D.A. is taking a new look at enforcement.

Dr. Scott Ramsey, director of cancer outcomes research at the Fred Hutchison Cancer Center in Seattle, says there is already “a mini-gold rush” of companies trying to market tests based on the new techniques, at a time when good science has not caught up with the financial push. “That’s the scariest part of all,” Dr. Ramsey said.



And the Duke researchers continued to publish papers on their genomic signatures in prestigious journals. Meanwhile, they started three trials using the work to decide which drugs to give patients.

Dr. Baggerly and Dr. Coombes tried to sound an alarm. They got the attention of the National Cancer Institute, whose own investigators wanted to use the Duke system in a clinical trial but were dissuaded by the criticisms. Finally, they published their analysis in The Annals of Applied Statistics, a journal that medical scientists rarely read.

The situation finally grabbed the cancer world’s attention last July, not because of the efforts of Dr. Baggerly and Dr. Coombes, but because a trade publication, The Cancer Letter, reported that the lead researcher, Dr. Potti, had falsified parts of his résumé. He claimed, among other things, that he had been a Rhodes scholar.

“It took that to make people sit up and take notice,” said Dr. Steven Goodman, professor of oncology, pediatrics, epidemiology and biostatistics at Johns Hopkins University.

In the end, four gene signature papers were retracted. Duke shut down three trials using the results. Dr. Potti resigned from Duke. He declined to be interviewed for this article. His collaborator and mentor, Dr. Nevins, no longer directs one of Duke’s genomics centers.

The cancer world is reeling.

The Duke researchers had even set up a company — now disbanded — and planned to sell their test to determine cancer treatments. Duke cancer patients and their families, including Mrs. Jacobs’s husband, Walter Jacobs, say they feel angry and betrayed. And medical researchers see the story as a call to action. With such huge data sets and complicated analyses, researchers can no longer trust their hunches that a result does — or does not — make sense.

“Our intuition is pretty darn poor,” Dr. Baggerly said.

Unprecedented. Experts decry Medtronic Studies.

From the New York Times. A few of my other posts on conflicts of interest in corporate research here, here,and here.
Spine Experts Repudiate Medtronic Studies
By BARRY MEIER and DUFF WILSON

In an extraordinary move, a group of spine specialists are publicly repudiating the research of other experts that has backed the widespread use of a Medtronic bone growth product. In a series of reports published in a medical journal on Tuesday, the specialists called the research misleading and biased.
The repudiation, appearing in a full issue of The Spine Journal devoted to the topic, represents a watershed in the long-running debate over conflicts of interest for the sponsorship of scientific studies by makers of drugs and medical devices. It is extremely rare for researchers to publicly chastise colleagues, and editors of leading medical journals said they could not recall an instance in which a publication had dedicated an entire issue for such a singular purpose.

Medtronic, the nation’s biggest maker of medical devices, has been facing intensifying scrutiny over its promotion of Infuse, the bone growth product at the center of the controversy. The bioengineered material is used primarily in spinal fusions, a procedure in which spinal vertebrae are joined to reduce back pain.

Infuse is used in about a quarter of the estimated 432,000 spinal fusions performed in this country each year. The articles published on Tuesday charge that researchers with financial ties to Medtronic overstated Infuse’s benefits and vastly understated its risks by claiming there were none.

“It harms patients to have biased and corrupted research published,” five doctors wrote in a joint editorial that accompanied the reports. “It harms patients to have unaccountable special interests permeate medical research.”

“The spine care field is currently at a precarious intersection of professionalism, morality and public safety,” Dr. Christopher M. Bono, editor of the special edition, said in a statement. “As physicians and journal editors, we felt an obligation to present a thorough examination of this controversial issue.”

It is too early to predict how the articles will affect the financial fortunes of Medtronic, which earned an estimated $900 million from Infuse in its most recent fiscal year. ..


Medtronic officials acknowledged in interviews that it was common for them to review studies of its products before publication. However, they sought to distance themselves from the content of the published reports, and said outside researchers, not the company, had determined the significance of data and how it should be presented. At the heart of the issue are potential side effects related to Infuse’s use that emerged during patient studies conducted about a decade ago by outside researchers with significant financial ties to Medtronic.

Medtronic, as required, reported that data to the F.D.A., and the agency considered the rate of those complications significant enough in some cases to require the company to list them on Infuse’s label. But in reporting on such studies in 13 medical journal articles published during the last decade, researchers whose studies were paid for by Medtronic maintained that Infuse’s use was not tied to any complications.
In one article released Tuesday, experts said those reports played down Infuse’s risks and slanted them to favor Infuse’s performance over a bone graft, the material traditionally used in a fusion. Those experts estimated that the incidence of adverse events in connection with Infuse’s use ranged from 10 to 50 percent, depending on how it was used.

Those side effects, they said, include male sterility, infection, bone loss and unwanted bone growth. A stronger version of Infuse, called Amplify, was recently rejected for approval by the F.D.A. because of concerns about possible cancer risks.

In 2008, the agency warned the public that it had received reports of life-threatening injuries associated with the use of Infuse in the cervical portion of the spine, a use that was not approved by the agency.

Dr. Eugene J. Carragee, editor of The Spine Journal, said he believed that Infuse was a valuable product for patients who were not candidates for a bone graft. But he added that the publication had undertaken the review because he and other experts hoped to cleanse the scientific record.

While Dr. Carragee said some researchers involved in the earlier reports were not influenced by links to Medtronic, he found it difficult to give those with major financial ties to the company such a pass. The median amount of Medtronic money received over time by researchers involved in some studies ranged from $12 million to $16 million, with most of that going to a few individuals, The Spine Journal estimated.
“A consistent number of people involved with these studies got extraordinary sums,” he said.

Tuesday’s articles added to an expanding number of studies pointing to serious side effects suffered by patients given Infuse. The journal also published an editorial by Dr. Charles L. Branch Jr., a Medtronic consultant, who said that the growing controversy over Infuse reflected a need to develop better ways to monitor and examine the off-label uses of medical products.

Infuse “appears to have been assigned the role of the poster child for all that is wrong with ‘off-label’ or physician-directed use of a novel beneficial technology,” wrote Dr. Branch, a neurosurgeon at the Wake Forest Baptist Medical Center in Winston-Salem, N.C.

Several researchers who were involved in the Medtronic-sponsored studies have defended their reports as scientifically sound and free of company influence, either directly or indirectly.

For example, one of them, Dr. Thomas A. Zdeblick of the University of Wisconsin, said that he did not have a “direct financial interest in the success of Infuse or Medtronic.” Over the years, Dr. Zdeblick has received over $20 million in royalty payments from Medtronic in connection with patents on devices, including one that is used with Infuse...

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Ghost writing Medical Research and Its Repercussions, from the Atlantic

Playing Doctor

How to spin pharmaceutical research
By Carl Elliott

This is another article about the corruption of medical research, but this one focuses on a more subtle aspect of industry sponsored research: the ghost writer. It has an amusing intro where we meet a ghost writer, Dave, and how he is taught to "spin" research findings to highlight the beneficial aspects of a given drug. You should really read the whole article, it's not too long.

The mechanics of the ghostwriter’s job are fairly simple, David says. Early on, a medical-communications agency and its pharmaceutical-company sponsors will agree on a title for an article and a potential author, usually an academic physician with a reputation as a “thought leader.” The agency will ask the thought leader to “author” the article, sometimes in exchange for a fee. The ghostwriter will write the article, or perhaps an extended outline containing the message the company wants to transmit, and send it along to the physician, who may make some changes or simply sign it as written and submit it to a journal, usually scrubbed of any mention of the ghostwriter, the agency, or the pharmaceutical company. David says he rarely even sees the published articles he writes.

Every so often, the issue of ghostwriting moves out of medical schools, where it is generally tolerated or ignored, and into the wider public sphere, where it is treated as a moral scandal. The most recent burst of outrage came in July during an investigation by the U.S. Senate Finance Committee, which has been looking into whether GlaxoSmithKline tried to steer attention away from the cardiac risks of its diabetes drug Avandia (whose use was recently restricted by the Food and Drug Administration). The committee found not merely that GSK had “downplayed scientific findings” to minimize the apparent risks of Avandia, but that it had used a ghostwriting campaign for the drug. (The company had called the ghosting effort “Case Study Publication for Peer Review,” or CASPPER.)

Ghostwritten articles surface again and again in litigation (in cases concerning Vioxx, Fen-Phen, Zyprexa, Premarin, Neurontin, and Zoloft, to mention just a few). Years before the Avandia scandal, GlaxoSmithKline paid $2.5 million to the State of New York to settle a lawsuit alleging that it had concealed studies suggesting an increased risk of suicidal behavior in children and teenagers taking Paxil, most notoriously in an article “authored” by Dr. Martin Keller of Brown University. One 2003 study in The British Journal of Psychiatry found that ghostwriters working for a single medical-communications agency had produced more than half of all medical-journal articles published on Zoloft over a three-year period.

It goes on to say that the moral outrage is often about "plagiarism," when the real crime, as David puts it, is that "spinning the data perverts science." Depressingly enough, it looks as though it is not going to stop any time soon. The journals have some weak rules about acknowledging some "editorial assistance," but allow the practice to continue. As an example, the Paxil article as noted above, has not been retracted in any way, so probably goes on being cited by unwitting practitioners. The ghost writers are well paid, but just tools to the greater enterprise of the pharmaceutical sales, and are not the real problem. As it says in the article " Medical writing has little glamour, and whatever moral purpose it might once have carried has been rubbed away by the constant friction with commerce." So for scientists by training, like Dave, this work can be quite demoralizing. Unfortunately, the whole set up is also quite dangerous.

Here are some previous posts dealing with the similar issues. Here, here, here, and here.

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Big Money in Stents

Doctor Faces Suits Over Cardiac Stents By GARDINER HARRIS

This is an article about a busy cardiologist in Baltimore, who had inserted more than 30 cardiac stents in a single day, and is now facing charges that Dr. Midei “may have implanted 585 stents which were medically unnecessary” from 2007 to 2009. Medicare paid $3.8 million of the $6.6 million charged for those procedures in patients who did not need them.

The case has turned into a legal quagmire for Dr. Midei and St. Joseph, which have been sued by hundreds of patients who claim they received unnecessary implants. Some doctors say the case has revealed a level of inappropriate care that is more common than most patients know.

“What was going on in Baltimore is going on right now in every city in America,” said Dr. Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic, who said he routinely treats patients who have been given multiple unneeded stents. “We’re spending a fortune as a country on procedures that people don’t need.”


and

"A landmark 2007 study published in The New England Journal of Medicine showed that many patients given stents would fare just as well without them."


and

"Prosecutors, malpractice lawyers and state medical boards are only now waking up to the issue. The Texas Medical Board last month accused a widely known cardiologist in Austin of inserting unnecessary stents. In September, federal prosecutors accused a cardiologist in Salisbury, Md., of performing unnecessary stent surgeries, and last year a Louisiana doctor was sentenced to 10 years in prison for inserting unneeded stents."


and

"But far from questioning cardiologists who perform an unusually high number of stent procedures, many hospital executives celebrate these doctors because of the revenue they bring, which can be more than $10,000 per procedure."


and

Hospital patients expect their care to be based on medical need, not profits,” said Senator Max Baucus, Democrat of Montana and chairman of the Finance Committee. “Even more disconcerting is that this could be a sign of a larger national trend of wasteful medical device use.”

This is what happens when money can be made by procedures. You get more of them. And hope that no harm is done by them. Yeah right, what could possibly go wrong?
For those really interested, you can read more of the article below.

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A landmark 2007 study published in The New England Journal of Medicine showed that many patients given stents would fare just as well without them. Dr. Christopher J. White, president-elect of the Society for Cardiovascular Angiography and Interventions, said that inappropriate stenting was a problem, but a rare one. The federal Medicare program spent $3.5 billion last year on stent procedures.

Prosecutors, malpractice lawyers and state medical boards are only now waking up to the issue. The Texas Medical Board last month accused a widely known cardiologist in Austin of inserting unnecessary stents. In September, federal prosecutors accused a cardiologist in Salisbury, Md., of performing unnecessary stent surgeries, and last year a Louisiana doctor was sentenced to 10 years in prison for inserting unneeded stents.

J. Stephen Simms, a Baltimore lawyer who successfully pursued a federal whistle-blower lawsuit involving kickbacks for coronary procedures, said such cases were “the flavor of the month right now” with federal prosecutors.

Jay Miller, another Baltimore lawyer, said he was devoting his entire practice to unnecessary stent cases. “And I don’t think this is limited to just a few Maryland hospitals,” Mr. Miller said.

But far from questioning cardiologists who perform an unusually high number of stent procedures, many hospital executives celebrate these doctors because of the revenue they bring, which can be more than $10,000 per procedure.

“Hospital patients expect their care to be based on medical need, not profits,” said Senator Max Baucus, Democrat of Montana and chairman of the Finance Committee. “Even more disconcerting is that this could be a sign of a larger national trend of wasteful medical device use.”

Dr. Midei’s fall was as rapid as it was dramatic. In a June deposition for a lawsuit against him, he said: “I didn’t know what hit me. I was bewildered by what had happened.”

He had been one of the most sought-after clinicians in his region. Trained at Johns Hopkins University, he was a co-founder of MidAtlantic, a practice with dozens of cardiologists that controlled much of the cardiac business in Baltimore’s private hospitals. Dr. Midei was one of the practice’s stars. When MidAtlantic negotiated a $25 million merger with Union Hospital in 2007, the deal was contingent on his continued employment.

St. Joseph was so concerned about losing Dr. Midei’s business that the hospital offered a $1.2 million salary if he would leave MidAtlantic and join the hospital’s staff. When Dr. Midei agreed, the merger with Union collapsed, MidAtlantic sued, and the practice’s former chief executive vowed in a deposition to “spend the rest of my life trying to destroy him personally and professionally.”

In the June deposition, Dr. Midei estimated that in 2005 — before research revealed that many stents were unnecessary — he performed about 800 stent procedures. Instead of dropping in subsequent years, however, the number of stents Dr. Midei inserted rose to as many as 1,200 annually, he estimated. In a 2007 internal document, Abbott Laboratories ranked Dr. Midei’s use of stents behind only five other cardiologists in the Northeast, including those at hospitals four and five times St. Joseph’s size.

That sort of increase in volume was an obvious red flag, said Dr. William E. Boden, clinical chief of the division of cardiovascular medicine at the University of Buffalo and an author of the 2007 stent study. “For him to have this brisk increase over those years is really unusual,” Dr. Boden said.

In stable patients, stents should be used only if X-rays show that most of the artery is blocked, and the patient has symptoms like frequent chest pain. Stent procedures can, in rare cases, cause bleeding, stroke or a heart attack. Once a stent is placed, it can result in a life-threatening clot that emerges weeks to months later. Stent patients must spend a year or more taking blood-thinning medications, which have their own risks.

In April 2009, a patient of Dr. Midei’s who was also a St. Joseph employee complained that he had received an unneeded stent and that many other patients had as well. The hospital engaged a panel of experts who reviewed 1,878 cases from January 2007 to May 2009 and found that 585 patients might have received unnecessary stents.

When asked to review the cases himself, Dr. Midei found far less blockage than he had initially, according to the Maryland Board of Physicians. The hospital suspended his privileges and eventually sent letters to all 585 patients. Hundreds of lawsuits against Dr. Midei and St. Joseph followed, including from patients treated well before January 2007.

Abbott responded to the controversy by hiring Dr. Midei as a consultant. “It’s the right thing to do because he helped us so many times over the years,” an Abbott executive wrote in a January e-mail cited in the Senate report.

The company sent Dr. Midei to Japan, but news of the controversy made his duties impossible, and he flew home. After one particularly critical story in The Baltimore Sun, David C. Pacitti, an Abbott executive, wrote in an e-mail, “Someone needs to take this writer out and kick his ass!”

Edward Chaid, 68, a semiretired general contractor from Timonium, Md., is among those who have sued. Five years ago, Mr. Chaid decided to get his first physical examination in decades. Just to be safe, his doctor sent him for a cardiac stress test at MidAtlantic, which revealed a small “squiggle” of concern, Mr. Chaid said. He was sent to Dr. Midei to get his arteries X-rayed, and he emerged from the procedure with two stents.

“Dr. Midei said: ‘You sure are lucky. You had 90 percent blockage.’ And the nurse said, ‘Oh yeah, you were blocked in your widow-maker.’ And I said: ‘Thank God. I guess I’m really lucky you got it when you did,’ ” Mr. Chaid said in an interview.

Five years later, another doctor concluded that Mr. Chaid’s blockage had been minimal. “I was really shocked,” Mr. Chaid said. “I’m from a generation where doctors are thought very highly of.”

But Mr. Snyder, Dr. Midei’s lawyer, said that his client’s care had been entirely appropriate, that doctors often interpret X-rays differently and that St. Joseph was using him as a scapegoat. A Web site created by friends of Dr. Midei lists dozens of testimonials like this one: “Plain and simple, Dr. Midei saved my life.”

Medical Research Corruption Continues

http://www.nytimes.com/2009/09/11/business/11ghost.html?_r=1&ref=health
September 11, 2009 Ghostwriting Is Called Rife in Medical Journals, By DUFF WILSON and NATASHA SINGER

Following up on a previous blogpost (http://ksparrowmd.blogspot.com/2009/04/corruption-between-drug-companies-and.html) about the common practice of drug companies facilitating and, at times, even doing the research studies for their own products, the NYTimes is reporting that six of the top medical journals had a significant number of articles that were written by "ghostwriters." "Ghostwriters" are authors from drug companies whose names do not appear on the list of authors on a research study. This is an obvious blow to transparency, since the authors could not be traced to the company they work for. From the article-

"Six of the top medical journals published a significant number of articles in 2008 that were written by ghostwriters financed by drug companies, according to a study released Thursday by editors of The Journal of the American Medical Association.

Among authors of 630 articles who responded anonymously to an online questionnaire created for the study, 7.8 percent acknowledged contributions to their articles by people whose work should have qualified them to be named as authors on the papers but who were not listed.

In the scientific literature, ghostwriting usually refers to medical writers, often sponsored by a drug or medical device company, who make major research or writing contributions to articles published under the names of academic authors.

The concern, the researchers said, is that the work of industry-sponsored writers has the potential to introduce bias, affecting treatment decisions by doctors and, ultimately, patient care.

According to the study, responding authors reported a 10.9 percent rate of ghostwriting in The New England Journal of Medicine, the highest rate among the journals.

Editors of the Boston-based journal said Thursday that they were “puzzled” and “skeptical” of the findings. "

Doctor Groups Urge End to Corporate Ties to Research

An article in the JAMA (Journal of the American Medical Association) published yesterday, April 1, was widely reported on the radio and today in the NYTimes and other publications http://www.nytimes.com/2009/04/02/health/policy/02journal.html?_r=1&ref=health.
A group of physicians and physicians groups are advocating for the elimination of funding by pharmaceutical companies for medical research because of the flagrant conflicts of interest. The concern is that these restrictions "were essential if physician associations are to maintain their scientific integrity and the trust of their patients."

This trust is clearly eroding. I see more evidence of this every day in my practice.

More discussion at a previous blogpost http://ksparrowmd.blogspot.com/2009/04/corruption-between-drug-companies-and.html

For more information about my practice, please click here.

Corruption between Drug Companies and Doctors

After I started my medical acupuncture practice 10 years ago, I was struck by something within my first year. I noticed that many of my patients were on antidepressants, and many of them had gained 30 pounds on them. Why were so many patients on anti-depressants? Why hadn't their doctors noticed the weight gain? It could hardly be a new, I had a tiny new practice and if I noticed this phenomenon, how could it not be apparent to established physicians? It was quite remarkable. The article reviewed here explains some of the biases in prescribing revealed by my small experience.
(for more information about my practice, please click here.)
This excellent review in the New York Review of Books(http://www.nybooks.com/articles/22237) discusses three new books a(see below) about the sordid corruption that has occurred in the production and dissemination of medical research. The review is written by an editor of the New England Journal of Medicine. Her conclusion echoes what I have been worried about for some time now--that you can't trust medical studies anymore. To quote the author, Marcia Angell, "It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidleines. I take no pleasure in this conclusion which I reached slowly and reluctantly over my two decades as an editor of The New England Journal Of Medicine."

Her review covers a number of topics.

Drug Companies make direct payments to physicians to tout their medicines at medical conferences and to patients. One Harvard physician had received $1.6 million between 2000 and 2007. The Chairman of the psychiatry department at Stanford controlled $6 million in stock of a pharmaceutical company that makes RU-486. He cofounded the company and was doing studies on using RU-486 for psychotic depression.
These are just two examples of a rampant practice of of MD's being paid at conferences or to "ghost study" medications. ("Ghost study" refers to a study set up by the drug company and the physician puts his/her name on the study to lend credence.) Estimates are that tens of billions of dollars are spent per year on this type of promotion. To wit, the drug companies have gained enormous sway over how doctors evaluate and prescribe medications.

Drug Companies now are intimately involved in the clinical studies which before 1980 were the sole purview of academic institutions. Not surprisingly most of the studies published are favorable for their products and are clearly NOT unbiased scientific studies. It has been shocking to hear testimony of drug companies admitting that they buried any negative studies because they would be "commercially unacceptable." There was a hair-raising story of the giant GlaxoSmithKline burying evidence that Paxil was ineffective and even harmful to children as an example.

Many popular drugs on the market may be no better than placebo. It has been difficult to find out because of the buried negative studies, but a Freedom of Information Act request obtained FDA reviews of every placcebo-controlled clinical trial for the initial approval of the six most widely used antidepressants approved between 1987 and 1999. (Prozac, Paxil, Zoloft,Clexa, Serzone, and Effexor.) They found that on average, placebos were 80 percent as effectivs as the drugs i.e. clinically ineffective. But because the negative results were buried, the public and the prescribing doctors believed that these were potent antidepressants. The studies are skewed also, by comparing them to another drug but at different dosing levels, or to a placebo and not a existing drug, or in young people instead of old so that side effects won't show up.

Practice Guidelines have been corrupted since the medical experts writing them have been shown to have conflicts of interest. It was revealed that the National Cholesterol Education Program in 2004 called for sharply lowering the levels of "bad" cholesterol, it was revealed that eight of the nine members had financial ties to the makers of cholesterol-lowering drugs. 95 of 170 contributors to the most recent edition of the American Psychiatric Associations DSM(manual of psychiatric diagnoses) had financial ties to drug companies.

Drug companies have now become shameless in efforts to expand the markets for their drugs. Instead of promoting their drugs, they now promote diseases to fit their drugs. They rename common conditions with technical or ominous sounding names to cast a larger net for their wares. (Heartburn is now GERD, PMS is now "premenstrual dysphoric disorder," shyness is "social anxiety disorder." Anyone remotely familiar with medical practice as patient or physician cannot help but be struck by the myriad of uses of Neurontin. An anti-epileptic drug now used for pretty much anything-bipolar,PTSD,insomnia, restless leg, hot flashes,migraines, any and all pain. (I've never seen it work yet. Doesn't mean it hasn't...) The new condition to watch for is "pre-diabetes."

The author blames the medical community more than the drug companies, in that physicians first responsibility should be to patients. Her suggested reforms include getting all subsidies from drug companies out of medical clinical trials. Any researchers performing studies should accept no payments from drug companies and should not let the companies have any control whatsoever over the design and implementation of the studies.

It is about time that medical research studies became "scientific" again and not just a marketing ploy.

When I was at a UCSF conference on Issues in Women's Health last December, one of the presenters admitted that she was so impressed with a colleague of hers who was studying breath control and hot flashes because there certainly was no money for that...

The books under discussion were "Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial" by Alison Bass
"Our Daily Meds:How the Parmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs" by Melody Petersen
"Shyness:How Normal Behavior Became a Sickness" by Christopher Lane

The F.D.A. Neglected Testing Standards for Medical Devices

Apparently the Food and Drug Administration endangered countless patients' lives when it stopped enforcing 30-year-old requirements that medical device makers meet federal lab standards before testing their products on humans. The report was by the non-profit Project on Government Oversight.
The rules cover studies on defibrillators, pacemakers, heart valves and coronary stents.
The repercussions of faulty defibrillators, pacemakers, heart valves and stents could be quite horrific if you consider that all of these devices are aimed at the smooth functioning of the heart.
This is another result of cutting back on regulatory agencies bending to corporate interests at the expense of the public. We saw the same dangerous result with the FDA fastracking big time drugs like Vioxx.
With Vioxx, there were alternatives (I always counsel my patients to wait at least 7 years after a new drug release), but with heart devices, there are very few alternatives, so their safety is paramount.
Thank goodness that there are watchdog groups out there.
(For more information about my practice, please click here.)