Congress is moving quickly to pass a bill that would authorize higher industry fees for the FDA in exchange for speeding up the approval of some drugs and medical devices and eliminating restrictions on financial conflicts of interest among the agency’s advisory scientists.

Consumer groups oppose the bill, saying it would weaken FDA oversight of new drugs and medical devices, allowing more drugs and devices on the market without adequate testing of their safety and effectiveness. It would also eliminate a restriction on the FDA’s use of advisory scientists with financial conflicts of interest, which had been imposed in the last FDA user-fee authorization bill Congress passed in 2007.

The Senate could pass the bill as early as next week, says Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group, one of the consumer groups objecting to the bill, which made it through the House Energy and Commerce Committee last week.

The bill, as Public Citizen argues here, gives companies working on drugs for life-threatening conditions an easier pathway to approval by allowing them to use smaller studies and postpone definitive clinical trials proving effectiveness until after the drug hits the market.  Instead of being required to use end points that show the drugs are effective against the actual disease, the drug companies are allowed to use surrogate end points or markers and much smaller clinical trials to gain FDA approval. Carome argues that this will only increase the number of unsafe and ineffective drugs on the market.

The bill also eliminates a new clinical trial requirement for medical devices that are considered “follow-on” devices. Yet this requirement was imposed precisely because, as gooznews reports, the industry has been plagued in recent years by the recalls of follow-on devices such as metal-on-metal artificial hips and implanted cardio-defibrillators.

Carome tells gooznews that the industry heavily lobbied both sides of Congress to get provisions favorable to industry inserted into the new user-fee bill. And indeed both the Pharmaceutical Research and Manufacturers of America and the Advanced Medical Technology Association, which represents medical device companies, praised the bill in press releases last week.

What all of this reminds me of is the banking industry, which was busy lobbying the feds to weaken restrictions on risky trading activities even as JP Morgan Chase dove off the cliff with a risky bet on credit derivatives and lost at least $2 billion.

What’s at stake here is not just our money (JP Morgan was gambling with its own customers’ money), but the health and well-being of American citizens. Do we have to wait for another drug-related debacle (think Vioxx or Avandia or antidepressants that caused hundreds of suicides), before Congress wakes up and stops weakening the FDA’s ability to protect us?

Hat tip to Gooznews for alerting me to this bill.

Two weeks ago, I headlined my blog with this question: Is the FDA violating its own mandate to approve safe drugs? Four days later, the national Institute of Medicine (IOM) released a 233-page report concluding that FDA’s current approach to drug oversight “is not sufficiently systematic and does not ensure consistent assessment of benefits and risks associated with a drug over its lifecycle.” In other words, the FDA may indeed be violating its own mandate.

The IOM report was mentioned almost in passing near the end of a Nature article today on the debate over an earlier journal study that found significant noncompliance with a 2007 federal law that requires researchers to post clinical trial results on a publicly available website. The Nature article focused on the fact that the FDA and the NIH disagreed with the findings of several researchers who reported in the British Medical Journal that only 22% of trial sponsors posted their results within one year of completion, as the law requires.

The FDA, in response to letters from Congress investigating this lapse, argued, among other things, that the BMJ researchers included some trials that were completed before the 2007 law came into effect, and did not exclude some — such as uncontrolled trials — that are exempt from the reporting requirements. According to Nature magazine, the researchers stand by their results and note that the FDA itself is having trouble determining which trials should be included under the 2007 mandate.

Regardless of who is right in this particular dogfight, the fact remains that the Institute of Medicine, possibly the most respected advisory body in medicine, has determined that the FDA is not doing an adequate job when it comes to drug safety oversight. The IOM report makes a number of recommendations, including:

• that the FDA should “adopt a consistent decision-making framework for regulatory actions across the lifecycle of all drugs…”
• that the agency should require, for each new drug and for already
  approved drugs for which there are questions of safety, “a
  publicly available and understandable document that would capture information about a drug before it is approved and throughout its time on the market.”
• that the FDA should develop more tougher and more consistent guidelines about what kind of controlled trials they consider scientifically valid in determining both efficacy and safety.
• that the FDA should work with other federal agencies in evaluating and resolving concerns about the ethics and quality of the increasing number of clinical trials performed outside of the United States.

Last week, the British Parliament came out with a report concluding that Rupert Murdoch is unfit to run News Corp., and its findings made headlines on this side of the Atlantic. How come when the Institute of Medicine comes out with a 233-page report concluding that the FDA is not doing its job, the only mention I can find of it is near the bottom of a short news article in one scientific journal? Why doesn’t this report merit front-page news too?

Hat tip to Paul Thacker for alerting me to the Nature article.

Is the Food and Drug Administration violating its own mandate to approve safe drugs? That was the question that Donald Light, co-author of The Risk for Prescription Drugs and a long-time medical sociologist, posed at a talk yesterday at Brandeis University. The answer, he concluded, is an unequivocal yes. By allowing drug companies to retain control over clinical trials and test new drugs against a placebo (a sugar pill) rather than an existing (and usually cheaper) drug in too-short studies that are designed to overlook or hide adverse side effects, the FDA is in essence approving drugs without really knowing whether they are safe or effective.

“We’re producing biased medical information in a system that makes it impossible to know what the real story is,” Light said. As a result, “most drugs are approved without clear evidence of clinical safety or effectiveness.”

As an example, Light pointed to the story of the SSRI antidepressants (which I chronicled in Side Effects). A number of recent studies, which combined unpublished data with the published data, show that these second-generation antidepressants are not very effective in treating most depression — see more here. “After 25 years, we get a fairly clear picture of efficacy of SSRIs,” he said. “But why do we have to wait 25 years?”

Not only are many patients harmed by this system — in the case of SSRIs like Prozac, Zoloft, Paxil and Celexa, many children and adults killed themselves because the drug companies hid a dangerous side effect of these drugs: they caused an increased risk of suicidal thoughts and behaviors in some people.  In addition, most of the drugs that are approved by the FDA and other regulatory agencies are minor variations on existing drugs and not the kind of breakthroughs that the public expects from an industry that is routinely given tax breaks, years of patent exclusivity and other privileges.

Light cited a study by French researchers, who analyzed new drug products from 2002 to 2011 and found that only 7.6 percent of the new drugs approved in the last decade were either significant clinical advances or had some therapeutic benefits. The vast majority of new drugs in the past decade had either minimum value, no added value or were actually worse — in terms of efficacy — than existing drugs.

“This isn’t really what the public wants,” Light said. This research shows that “most drug company R&D is devoted to filling the pipeline with minor variations because they’re easier to develop, cheaper and they can command high prices.”

These minor variations (what I and others call me-too drugs) are then marketed heavily to doctors, who, as Light says, seem “surprisingly willing to prescribe them.”  Indeed, Light has found that 80 percent of drug companies’ marketing budget goes to promote the me-too drugs and only 20 percent is spent to promote therapeutically superior drugs.

“I call it the inverse benefit law,” Light said. “The more widely the drugs are marketed, the more diluted their benefits are, but the more widespread the risk of harm.”

Light urged a number of reforms to address this systematic problem:

• Have Congress pass a law requiring public funding of clinical trials so they are not controlled by drug companies that have a vested interest in ensuring positive outcomes — I’ve blogged about this here. According to Light, there is increasing talk in Europe of publicly funding clinical trials. The Netherlands has already announced plans of having independent researchers test every drug against an existing drug (instead of placebo) to ensure that regulators approve drugs that are truly effective, not just better than a sugar pill.

• Delink drug prices from the current system of R&D. A recently introduced bill by Sen. Bernard Sanders (D-Vermont) would reward innovators who come up with a superior drug with a large cash prize — say, $2 to 3 billion paid out over a decade. With such rewards, the drug companies wouldn’t get years of patent exclusivity and generic price competition could kick in almost immediately. That would eliminate what Light calls “extortionist prices” for most new drugs.

• Make it illegal to prescribe drugs for unapproved or off-label uses. Physicians have long been allowed to prescribe any drug for any use, but Light questions why this is permitted, since so many patients are harmed by drugs that have not been tested for their particular condition or demographic.

Light acknowledged that such reforms are a tall order because the Republican-controlled Congress doesn’t seem to be particularly interested in biting the hand that feeds it (the pharmaceutical industry is one of top special interests when it comes to Congressional campaign contributions and lobbying — see here). And it’s not just Republicans. The Democratic-controlled legislature in Massachusetts is also busy sucking up to the deep-pocketed drug and medical device industry. As Pharmalot reported today, the Massachusetts House is trying yet again to overturn the state’s landmark ban on gifts to doctors.

All of this is one more reason why this election year is so important. Consumers who are concerned about the way unsafe and inadequately tested drugs routinely get approved by the FDA should vote out any politician who is taking loads of money from the drug and medical device industry and rally for campaign reform so we can actually start improving the system. A tall order, yes. Impossible, no.

I’ve been reading Dr. David Healy’s new book, Pharmageddon, and while some of it may seem like old news, I was struck by his fresh analysis of how the pharmaceutical industry has turned the original purpose of clinical trials inside out. As Healy, a noted historian of psychiatry who was among the first to call attention to the side effects and relative ineffectiveness of the SSRI antidepressants points out, clinical trials were originally devised by academic researchers to debunk snake-oil treatments. But the drug industry, who knows a marketing opportunity when it sees one, has managed to market randomized clinical trials as the “gold standard” of research and convince regulatory agencies (such as the FDA) and doctors that if a trial shows that a new drug is more effective than a placebo, then it must be so.

The major flaw with this so-called evidence-based approach (what Healy snidely refers to evidence-biased medicine) is that the drug companies have perfected the art of publishing only those handful of clinical trials that show efficacy and making sure that all the negative trials that didn’t show efficacy of the same drug are not published. As Jonah Lehrer points out in his controversial New Yorker piece, if you do enough clinical trials, one or two are bound to show some statistical significance, particularly when you skew the data by changing primary outcome measures mid-stream and miscoding patient data (as researchers did with Paxil study 329).  So if you only publish those supposedly positive trials and hide the rest (as companies did time and again with Paxil and other SSRI antidepressants, along with atypical antipsychotics like Risperdal and Zyprexa and many other drugs), then it’s easy to convince doctors that these drugs are safe and effective when they are anything but.

Under a law passed by Congress in 2007, drug companies are supposed to post the data from all their clinical trials (unpublished as well as published) on publicly available websites, so at the very least doctors intent on finding the full story on a particular treatment can sift through the data themselves. This, of course, is not an easy exercise, particularly for busy doctors and consumers who don’t know what they’re looking for among the reams of technical data posted. The other problem is that many companies (particularly those not based in the U.S.) are not complying with this law. As Healy points out in Pharmageddon, in reality, no one in the scientific community, not even the individual researchers involved in these studies, gets to see the raw data from multi-site clinical trials except the clinical research organization (CRO) under contract to the maker of the drug.

Take, for example, the flu medication, Tamiflu. Earlier this week, in an opinion piece posted on New York Times online, two researchers, one from John Hopkins and the other affiliated with the Cochrane Collaboration, wrote about their efforts to obtain all the raw data in clinical trials of Tamiflu. Based on the limited clinical data published in medical journals, they reported, it looked as if “the country’s most widely used and heavily stockpiled influenza drug appeared no more effective than aspirin.” After publishing that conclusion in the British Medical Journal in 2009, they said, “Roche promised access to data about Tamiflu from 10 clinical trials, eight of which had not been published a decade after completion.” But the drug maker has yet to comply with that request.

Why does all this matter? As one very witty doctor/epidemiologist put it in a recent TED talk — see this video – if as the evidence seems to suggest, Tamiflu only shortens the duration of a flu for four hours but does not reduce the risk of serious complications (like pneumonia and death) as Roche says it does, then billions of dollars should probably not be spent stockpiling the drug and prescribing it to patients around the world. Indeed, according to Peter Doshi and Tom Jefferson, the researchers who wrote the opinion piece in the Times website, say, “there is suggestive evidence that Tamiflu interfered with the body’s ability to produce antibodies against influenza — which could affect the body’s response to influenza vaccine and its ability to fight off future influenza infections.”

The FDA has all the raw data on Tamiflu and could clear up the question of its efficacy easily, but for reasons I and most of the scientific community don’t understand, it will not release the data on any drug without the express permission of the drug makers.  As Doshi and Jefferson say, “the F.D.A. — guardian of arguably more trial data than any other entity in the world — appears stuck in the era of data secrecy.”

And who suffers? As usual, it’s us: the patients and consumers who are prescribed drugs that not only don’t work but can have dangerous side effects.

Hat tip to Marilyn Mann who first posted the Tamiflu opinion piece on Facebook.

When Dr. Irving Kirsch published his meta-analysis in PLoS Medicine in February 2008 showing that antidepressants were no more effective than a placebo in treating mild or moderate depression, the national news media ignored his explosive findings, for the most part. And when I published Side Effects a few months later, exposing the deception behind the making of the bestselling antidepressant Paxil, they were similarly unresponsive. While my book received great reviews and a lot of attention from regional radio outlets, the national broadcast media pretty much ignored the story. Indeed, a studio interview I did with Kai Ryssdal on American Public Media’s Marketplace never aired, perhaps because of the pressure Paxil’s maker, GlaxoSmithKline, brought to bear on Marketplace’s producers.

So it was with some bemusement that I watched the 60 Minutes segment on antidepressants, which focused on Kirsch’s 2008 finding that antidepressants are no better than placebo in treating most forms of depression. In the segment, Kirsch, who is now associate director of the Program in Placebo Studies at Beth-Israel Deaconess Hospital, noted that the reason many patients feel better after taking antidepressants is not because of the drug’s effect, but because of the powerful placebo effect in making them feel better.

Why, I wondered, was 60 Minutes taking note of this now, four years after Kirsch published his meta-analysis and two years after he published his own book on the subject, The Emperor’s New Drugs?

Here is one very plausible reason, as articulated by Dr. Stephen Greer in a CurrentTV column today: because the patents for most of these blockbuster antidepressants (like Paxil and Prozac) have expired and the drug companies, who advertise heavily on television, are no longer pressuring the national media to stay mum.

As Greer notes, “it is quite rare for national TV news to report on any data critical of blockbusters despite plenty of research over the last several decades questioning the risk/benefit profile of numerous commonly used drugs.”

So why now? As he points out:

The most likely explanation is that the same drugs now being exposed as unsafe and ineffective have also lost patent protection and therefore, are no longer generating the huge advertising revenue for the networks. A significant portion of the revenue for the broadcast networks is derived from pharmaceutical advertisements.

I think Greer’s on to something. Don’t you?

I was hesitant to weigh in at first when I learned that Brown University’s School of Medicine had decided not to pressure a psychiatric journal to retract the seriously flawed Paxil study that I wrote about in Side Effects. After all, Brown has been covering up misconduct by the study’s principal investigator, Martin Keller, for decades; so why would it suddenly change its tune now?

What bothers me as much as Brown’s refusal to do the right thing (and provide an ethical example to its students) is the stance that the Office of Research Integrity at the Department of Health and Human Services has taken in response to the study. As I and many others have noted, researchers misrepresented data in study 329 to make Paxil look safer and more effective than it really is — see here, here and here.

The Paxil study, which was published in August 2001 by the Journal of the American Academy of Child and Adolescent Psychiatry, purported to show that Paxil was safe and effective in treating depression in adolescents, when in fact actual data from the trial showed the opposite. Even the FDA concluded that study 329 was a negative finding — that it failed to show Paxil was more effective than a placebo.

So what reason does the federal Health and Human Services’ Office of Research Integrity give for why they won’t investigative allegations of scientific misconduct here? As Pharmalot reports, the director of that office falls back on old rhubarb: a statute of limitations. In a letter to Jon Jureidini, the Australian researcher who has led the effort to win a retraction, John Dahlberg writes: “…allegations of falsification, fabrication or plagiarism must be made within six years of the alleged misconduct…”

Yet investigators for the FDA and HHS were well aware of potential misconduct with regard to study 329 before any statute of limitations expired. Not only had I been in touch with federal officials asking questions about serious flaws in the study while I was doing research for my book in 2006 and 2007 (my book was published in June 2008), but Jureidini and Leemon McHenry published a paper in early 2008 pointing that the study 329′s researchers had changed the primary outcome measures and skewed data in other ways to make Paxil look safer and more effective than it really was. As I mentioned earlier, the FDA had decided as far back as 2004 that study 329 didn’t show efficacy despite its published claims.

So all the clues to scientific misconduct were there well before any six-year statute of limitations. This is why Dahlberg’s argument seems completely specious to me.

As for Brown University School of Medicine, its dean should be hanging his head in shame. Joel Lexchin, a professor of health policy at York University in Toronto and one of the academics who signed the letter to Brown University pressing for a retraction, says it best, according to Pharmalot:

“I find it very disturbing that a university that is suppose to be standing up for the highest academic values is unwilling to take any action when its faculty members violate those values.”

The Obama administration recently made it clear that it will require drug companies to disclose the payments they make to doctors for research, consulting, speaking, travel and entertainment under the new health care law — see the New York Times. Large numbers of American doctors receive payments from drug and device companies every year –  sometimes amounting to hundreds of thousands or millions of dollars — and the new standards will hopefully have a deterrent effect on these financial conflicts of interest.

However, the new disclosure standards only apply to products covered by Medicare and Medicaid. And federal law does not prohibit doctors from accepting such largesse; it only mandates that the companies disclose the payments to the federal government, which will then post the payment data on a publicly available website. Hence, doctors in the private sector can continue to take what some call “kickbacks” in exchange for promoting drugs and medical devices at conferences and in medical journal articles.

This may explain why researchers have recently called for both stricter enforcement of anti-kickback statutes already on the books and for the passage of federal legislation that would prohibit such kickbacks to doctors in the private sector. In a recent overview article in the Journal of Law, Medicine and Ethics, Mark Rodwin, a professor of law at Suffolk University, notes that the U.S. (unlike France, for instance) only prohibits kickbacks — in the form of gifts, speaking and consulting fees, entertainment and travel reimbursement — for publicly employed doctors, not for the majority of U.S. physicians working in the private sector. So Rodwin, who is also an Edmund J. Safra Fellow at Harvard University, urges Congress to ban such kickbacks to all physicians.

Most physicians object to what he calls “abnormal corruption: explicit kickback payments” for prescribing or purchasing drugs, he notes. Yet many accept what he calls “normal corruption: influence through gifts and financial support.”

Not only should Congress ban kickbacks for all doctors, Rodwin argues, but the U.S. (along with France and other countries) should create an alternative to pharmaceutical industry funding for professional medical activities. He suggests that policy makers tax drug companies and other commercial interests that support continued medical education (CME) activities and then have an independent government or quasi-government agency distribute those funds for such activities. As Rodwin explains:

“When consumers and public authorities pay these expenses directly, they eliminate a major source of dangerous conflicts of interest that compromise medical practice.”

Consumers, after all, are already paying for the huge investment drug and device companies make to influence physicians — in the form of high drug prices. So why not use this approach to keep drug and device companies at arms’ length from medical education? Are you listening, Congress?

In the meantime, federal and state officials could do much more to deter what Rodwin calls “institutional corruption” by enforcing anti-kickback and false claims laws that are already in the books. In an article published Tuesday in PLoS Medicine, three researchers argue that physicians who attach their names to journal articles ghost-written by medical contractors working for the drug industry may be legally liable under these existing statutes.

They argue that prominent physicians or key opinion leaders who are paid speaking and consulting fees by drug companies and then attach their names to ghost-written articles that tout company products could be named as co-conspirators in a False Claims Act (whistleblower) lawsuit, along with the manufacturer. Physicians could also be charged with receiving kickbacks in exchange for appending their names to ghost-written articles, under the current anti-kickback statute. Right now, guest authors are rarely named as defendants in either personal injury lawsuits or government cases alleging the illegal marketing of off-label drugs.

As I mentioned earlier, both of these statutes only apply to drugs that are covered by Medicare and Medicaid, but since most new drugs are covered by these government programs, that would encompass the vast majority of physicians who attach their names to articles ghost-written at the behest of drug companies.

As the PLoS Medicine authors argue, merely attaching the names of KOLs to such lawsuits would create a powerful deterrent against an unethical but still widespread practice in medicine — ghostwriting. So why the heck not?

Allen Jones, the whistleblower in an ongoing landmark trial against the pharmaceutical giant Johnson & Johnson, was very much on my mind this past weekend. I was participating in a workshop to develop curriculum to teach college students about the importance of standing up for their ethical values and if necessary, blowing the whistle on wrongdoing in their place of employment. The workshop in Washington, D.C. was sponsored by the Government Accountability Project (GAP), a nonprofit organization that represents whistle-blowers of all stripes from Daniel Ellsberg, who leaked the Pentagon Papers, to Allen Jones, who blew the whistle on the illegal payments Johnson & Johnson was making to state employees to promote the off-label use of its anti-psychotic drug, Risperdal, in children.

Jones first noticed these illegal payments when he was investigator for the state of Pennsylvania’s Office of Inspector General. He discovered that the state’s top pharmacist, the guy in charge of deciding what drugs should be included in its Medicaid formulary, was receiving hidden payments from J&J, the maker of Risperdal. Jones was fired when he brought those illegal payments to light, but he persevered, and with the help of GAP, won a lawsuit against the state of Pennsylvania and eventually saw the state pharmacist who was on the take fired from his job.

As 1boringoldman and others have detailed, Jones went on to sue J&J in the state of Texas, where public officials were also being paid to fly all over the country and promote the off-label use of Risperdal in children — see my blog on that case here. J&J has settled a number of other state lawsuits for the illegal and deceptive marketing of Risperdal — as I’ve blogged about here, a South Carolina judge fined the company $327 million last year, calling J&J’s actions “detestable” — but this is the first time the company has gone on trial for its illegal actions in hiding the serious side effects of Risperdal in children — weight gain, diabetes, even causing breast lactation in teenage boys — and illegally marketing the drug off-label.

And it’s all because of Allen Jones. As I sat around the conference table this weekend and heard one horror story after another about folks who spoke truth to power and ended up losing their jobs and being permanently blacklisted from employment in their chosen field, it made me wonder why it’s so difficult to be a whistle-blower in our society. (In the case of former Department of Justice lawyer Jesselyn Radack, whose book A Canary in the Coal Mine I just finished reading, the Bush administration was so bent on retaliating against her for blowing the whistle on the administration’s failure to give an American citizen arrested in Afghanistan his due rights to legal counsel that they not only prevented her from getting another legal job in the private sector but they also put her name on the No Fly list, making her subject to humiliating body searches every time she tried to board a plane). Yet like Radack, most whistle-blowers are people who are simply trying to do the right thing and stand up to injustice, corruption or abuses in the corporate or public sector.

So why it is so difficult to raise ethical concerns today? It’s true that derogatory words like snitch, rat and tattle-tale have always been a part of our culture, and there’s no question that corporations put a premium on loyalty and conformity. But despite Congressional efforts to protect whistle-blowers (with the Whistleblower Protection Act), it seems to be more difficult than ever to speak up. Even though more workers are witnessing violations of company rules, retaliation against employees has risen to a new high, the 2011 National Business Ethics Survey found. More than a fifth of employees who reported a violation at work said they experienced some kind of retaliation, according to the Huffington Post. Most of those employees, of course, never went any further and leaked the information to the media, as Radack and Ellsberg did, subjecting both of them to enormous retaliatory pressures, such as concocted criminal charges.

Even the mainstream media seems to have tacitly accepted the idea that whistle-blowers are villains, belonging in the same category as evil plaintiff’s lawyers. Exhibit A: in yesterday’s page-one New York Times story about the Obama administration’s plans to require drug makers to disclose fees to doctors under the landmark Physician Payment Sunshine Act, which I’ve blogged about here, the reporter quotes an official with the medical technology association, a trade group for medical device companies, as saying that the required payment data “could be used by federal law enforcement agencies, plaintiffs’ lawyers and whistleblowers.”

Heaven forbid!

In preparing for the holidays, you may have missed the French scandal over the defective artificial breasts implanted in hundreds of thousands of women. According to NPR, an estimated 400,000 women worldwide have received the faulty implants, and 30,000 women in France have been urged to have them removed because the implants used an inferior, industrial-grade silicone and are more likely to rupture than those made from surgical silicone, causing damaging tissue inflammation. One woman with ruptured implants recently died of cancer, NPR reports.

The defective implants, made by a French company, should come as no surprise, says French public health specialist Dr. Alain Braillon. More than a year earlier, he published a letter in the Archives of Internal Medicine calling attention to the fact that the chief executive officer of the French regulatory counterpart to the FDA had an extremely cozy relationship with Medtronics, a medical device company. He and a Medtronics official apparently collaborated on a book about medical devices that criticized regulatory oversight as getting in the way of innovation.

While this amazingly conflicted official was eventually forced out and French regulations tightened in the wake of another drug scandal — see here – Braillon says the French response is late in coming and little more than “window-dressing.”

The French debacle serves as a vivid reminder of what’s at stake on this side of the Atlantic, as lobbyists for the medical device industry continue to push hard against recommendations by the national Institute of Medicine (IOM) to tighten up our own oversight of new medical devices. As the New York Times reported last fall, Republicans in Congress, at the industry’s bidding, have introduced a flurry of bills designed to speed up the FDA approval process for medical devices. Their legislative action flies in the face of the nation’s medical experts, who argue that we need to strengthen the process of approving new medical devices, not weaken it.

The IOM recommendations, of course, come in the wake of our own uniquely American scandals — faulty metal to metal hip implants that have injured thousands of Americans and a host of other unsafe medical devices that have made it to market. Here’s hoping that Congress and the FDA do the right thing in the New Year and adopt the IOM recommendations, instead of waiting for our own breast implant scandal.

On another note, a landmark trial against Johnson & Johnson is slated to begin Monday (January 9) in a Texas courtroom. As I and many others have blogged about here and here, J&J is charged with illegally marketing the off-label use of Risperdal and “subverting scientific integrity” by paying off academic psychiatrists and state officials to boost the use of its antipsychotic among children and adults. The case, as 1boringoldman writes, is more ambitious than previous state lawsuits against off-label drug marketing:

It’s about an active campaign to undermine Medicine itself and medical learning, and to bilk state governments.

1boringold man (a.k.a. psychiatrist Mickey Nardo) is hoping for a Watergate-sized expose to emerge from the trial. So stay tuned…

A few weeks before Thanksgiving, my husband, a hospice social worker, was told that his hours were being cut back from full to part-time. The explanation given to him, a six-year employee with solid performance reviews, was that the hospice’s census had declined and could no longer support a full-time bereavement counselor. The fact that my husband had taken on an extra caseload of individual hospice patients and families (on top of his bereavement duties) didn’t seem to register with his new bosses.

It was only after reading this recent article that I understood the real reason behind the reduction in pay foisted on my husband and another social worker at the same hospice. They worked for a subsidiary of the for-profit health care company, UnitedHealth Group, whose CEO has the highest CEO-to-worker pay ratio of any Fortune 50 company in the United States. According to the Minneapolis Business Journal, Stephen Hemsley made 1731 times what the typical UnitedHealth worker made last year, or $1731 for every dollar they made. Hemsley was paid nearly $102 million last year, while the median annual pay among the company’s 80,000 employees was $58,700, according to a survey done by PayScale.com.

That salient fact may also explain why UnitedHealth Group went after my husband, essentially forcing him to look for another job. As a seasoned social worker, he was earning well more than the median income most UnitedHealth nurses and social workers make. And he was not the only “over-paid” UHG employee to feel the heat. A colleague of his at the same hospice who was also earning more than the median income was made to feel so uncomfortable that she read the tea leaves and found another job before the axe fell on her as well.

Now, there’s no question that in the current economic environment, hospices, along with nursing home facilities and home health care services, face a challenging future. Even though hospice and palliative care for dying people is much less expensive than the end-of-life care routinely given to terminally ill patients in hospitals, the federal Centers for Medicare and Medicaid Services (CMS) are implementing drastic cuts in hospice reimbursement, which will amount to about $12 billion in total cuts to the hospice industry over the next few years, according to the National Association for Home Care and Hospice. So both non-profit and for-profit hospices have reason to worry about their bottom lines.

But why take those cuts out of the hides of the nurses and social workers on the front lines of hospice care every day? Why not do something about the exorbitant pay for top executives at for-profit health companies? I don’t care how successful UnitedHealth Group is on Wall Street; there is no reason why its CEO should be earning $102 million a year when its front-line workers are being put out of work. And indeed, one article I read in the Hospice Management Advisor, (a subscription-only journal), cautioned hospices not to lay off or reduce the hours of its caregivers because that hurts the morale of the entire organization and prompts other employees to seek employment elsewhere (which is exactly what’s happening at my husband’s former hospice).

To me, this case illustrates the fundamental problem with for-profit health care. In hospice (as in all of health care), the needs of patients and their families should be the first priority. But in for-profit companies, the first priority is creating wealth for top executives (like Stephen Hemsley) and its shareholders, and when that results in lay-offs and pay reductions for front-line workers, continuity of care is disrupted and patients and their families suffer. My husband was lucky enough to find another full-time job fairly quickly, but the patients and families at his former hospice lost a compassionate caregiver days before the holidays. That’s no way to run a hospice.