A New Format

We had to change the graphic format of Health Care Renewal. Blogger still has been not come up with a solution of the formatting problems that resulted from their latest soft-ware updates. One such problem put a huge amount of white-space at the top of our blog.
The new format is not perfect, but should be readable, and no longer is dominated by looming white-space.

A Former Rhode Island Legislator Pleads Guilty to Selling His Office to Local Health Care Organizations

Back to a big, and increasingly messy local story... former RI state senator John A. Celona has agreed to plead guilty to federal charges, according to the Providence Journal. Federal prosecutors stated that Celona and "other persons" created a "scheme ... to defraud the State of Rhode Island and its citizens of their intangible right to his honest services and to have those services performed free from deceit, favoritism, bias, conflict of interest and self-enrichment." Celona was previously indicted on similar charges in a state court action. The charges to which Celona has now admitted include:

1. Accepting over $260,000 from Roger Williams Medical Center, (at the recommendation of its Chief Executive Officer (CEO), Robert A. Urciuoli, according to the newspaper,) channeled through its subsidiary assisted living center, to: influence cities to increase their ambulance transports to the hospital; oppose legislation that would have required the hospital to make payments in lieu of taxes; back legislation to extend a moratorium on construction of new nursing facilities; influence other law-makers to oppose formation of a Cancer Council that would have been lead by former Roger Williams Medical Center medical staff members who had feuded with Urciuoli; pressure a company to pay its debt to the hospital; and pressure another to make a favorable contract with the hospital.
2. Accepting $45,000, and free travel to a golf tournament from CVS to: oppose pharmacy choice legislation; favor legislation that would permit electronic prescription of brand-name drugs; and opposing legislation to allow drug re-importation from Canada.
3. Accepting over $13,000 from Rhode Island Blue Cross to: support a bill allowing insurance companies to design affordable benefit plans; support a bill changing health insurance plan parameters for small business; and oppose a bill requiring health insurers to cover prosthetic devices and modifying limits on their investments.

According to the news article, investigations of the roles of Roger Williams Medical Center, CVS, and Rhode Island Blue Cross in this are on-going.
This single case illustrates that mismanagement is not limited to particular types of health care organizations, and that problems at one organization may easily get tangled up with problems in others.
It also illustrates the wide-ranging effects of mismanagement and corruption.

Guidant Executives Sued for Securities Fraud

Those hits just keep on coming for Guidant Corp. The Indianapolis Star reported that Guidant and six of its top executives were named as defendants in a securities fraud lawsuit. The suit charges that the executives "concealed long-standing, life-threatening defects" in its products to prop up its stock price prior to the company's proposed merger with Johnson & Johnson. The suit alleges that the six executives, including Guidant Chief Executive Officer (CEO) Ronald W. Dollens, sold Guidant stock worth $39.5 million this year prior to the publication of the first news article by the NY Times about problems with Guidant's implantable cardiac defibrillators (ICDs).

Another Health Care Executive Pleads Guilty

The Charlotte Observer reported that David M. Hurley, the former Chief Operating Officer (COO) of aaiPharma Inc, agreed to plead guilty of conspiring to commit fraud. In 2003, federal prosecutors charged that Hurley made false ledger entries to overstate sales reports, revenues and earnings. In May, aaiPharma filed for bankruptcy.
An accompanying report noted that investigators are getting busier and busier with health fraud cases. In North Carolina, recoveries from health care fraud went from $2.2 million in 2000, to $18.3 million in 2004, and so far in 2005, the figure is $28 million. The reporter noted, "experts say health care fraud accounts for only a small portion of total health-care spending, but the truth is we don't know how much fraud is taking place."
Readers of Health Care Renewal may conclude that more broadly, conflicts of interest and corruption may add considerably to health care spending, while decreasing access, degrading quality, and demoralizing health care professionals.

Now Stuck Switches for Guidant

The NY Times reported yet another problem with implantable cardiac defibrillators (ICDs) made by Guidant. This time it was a magnetic switch that could become stuck in the "off" position. Apparently, this flaw is not so serious as previous ones (see most recent post here), because it can be fixed without removing the devices. A Guidant consultant suggested that the problem affects about 6000 devices. The models affected were the Contak Renewal 3, Contak Renewal 4, Contak Renewal 3 AVT, Contak Renewal 4 AVT, and Renewal RF. The company "urged doctors ... to stop implanting" the device, but "did not say how it planned to fix the problem, when it expected to do so, or how it would fix units already implanted in patients," according to the Times. Also, "Guidant declined a request to interview its chief executive, Ronald W. Dollens."
Again, one would have hoped that the company could have done better with quality control, given that each of these devices cost about $25,000.

Boston Scientific Settles Case of Defective Stent Systems

The Boston Globe reported that Boston Scientific has settled a suit brought by the US Department of Justice that alleged "a failure by Boston Scientific to take the most appropriate steps in a timely manner to ensure that the devices it was distributing to hospitals nationwide performed properly," per US Attorney Michael J. Sullivan.
Boston Scientific began shipping Nir coronary artery stent systems on August 12, 1998. Coronary artery stents are small devices, often shaped like springs, or wire mesh cylinders, used to hold coronary arteries open. According to the Globe, within five days, Boston Scientific got reports that the balloons attached to the stent catheters were failing when inflated to pressures lower than they were designed to handle. In a September 12, 1998 conference with US Food and Drug Administration (FDA) officials, one said that the FDA was "very uncomfortable" with continuing stent shipments." However, Boston Scientific continued shipping the stents until October 5, 1998, and then began a voluntary recall. The FDA finally received 25 complaints that injuries were caused by failed stent balloons.
The settlement called for Boston Scientific to pay $74 million. Department of Justice officials chose that amount since it significantly exceeded the $61 million revenue the company received from the 34,589 Nir stent systems it sold (i.e., $1764 per system.)
This case, which took almost seven years to resolve, could be compared with the recent case of problems with Guidant implantable coronary defibrillators (ICDs). (See most recent of many posts on Guidant here.) In both cases, the companies appeared to delay notification of device defects, leading to more potentially defective devices to be shipped and implanted in patients. In both cases, the devices seem relatively expensive compared to the complexity of their engineering and manufacturing. (For example, the stents mentioned above are again simple metal devices shaped link springs or mesh cylinders, and the accompanying system consists mainly of a plastic catheter with an inflatable balloon at its tip, sold for, as noted above, more than $1700.) Given how much money the companies charge for these devices, one would think they would be able to afford exemplary quality control, and a system to rapidly notify physicians who implant the devices of any potential problems.

An Australian Survey of Threats to Research Integrity

Another important article on threats to the integrity of clinical research has appeared in the Medical Journal of Australia. (Henry DA et al. Medical specialists and pharmaceutical industry-sponsored research: a survey of the Australian experience. Med J Aust 2005; 182: 557-560.)
The authors sent a survey to 5000 Australian specialists, excluding general practitioners, but also surgeons and anesthesologists, and obtained a 39% response rate. 388 specialists (41% of respondents) had done pharmaceutical industry sponsored research. Of these,

• 100 (25.7% of those engaging in research) reported that the first draft of a research report was written by pharmaceutical company or contract research organization personnel
• 55 (14.2%) reported a delay in presentation or publication of key study findings
• 41 (10.6%) reported failure to publish key findings
• 22 (5.7%) reported editing of the report to make the drug appear better than was justified by the study results
• 18 (4.6%) reported concealment of relevant findings.

This study suggests that manipulation and suppression of research results in favor of commercial research sponsors' products is an international pheonomenon, and one that involves not only academic researchers but those in private practice.
An accompanying editorial (Gotzsche PC. Research integrity and pharmaceutical industry sponsorship. Med J Aust 2005; 182: 549-550) suggested that "testing drugs in patients" should be "a public enterprise." It asked, "who would buy a washing machine that is five or 10 times more expensive than other washing machines just because its manufacturer has compared it with other machines and claims that it is the best?"
Thanks to Sue Pelletier's Capsules blog for the tip.

Two Massachusetts Hospitals to Offer Discounts Off "List Prices" for Uninsured Patients

Two Massachusetts hospital systems will begin offering discounts off "list prices" for uninsured patients, according to the Boston Globe. The systems are Partners HealthCare and UMass Memorial Health Care. The article noted that most hospitals do not routinely give such patients discounts. These two hospitals' policies are "among the first formal, publicized policies in Massachusetts that guarantee discounts to a broad group of patients and don't depend on patients requesting a markdown," according to the Globe.
Not emphasized in this article was how high "list prices" are at most hospitals. For example, see previous posts here, here and here.
This actions by Partners and UMass are a great first step, but the article does underline who widespread the practice of charging uninsured patients full freight has become. Susan Sherry, of Community Catalyst, asserted that many hospitals are either not offering discounts or are keeping them secret (see the report by the Access Project here). She did applaud the actions by Partners and UMass, "this is kind of out there in terms of national leadership. They're doing much more than hospitals in other parts of the country."

Waxman Summarizes the Marketing of Vioxx

The current issue of the New England Journal of Medicine also continues the journal's new skeptical approach to the business practices of the pharmaceutical industry with a second perspectives article, by Congressman Harvey Waxman, that reviews the results of his committee's investigation of the marketing of Vioxx. (Waxman JA. The lesson of Vioxx - drug safety and sales. N Engl J Med 2005; 352: 2576-2578.) (The most recent of the many Health Care Renewal posts on Vioxx is here.)
Waxman summarized techniques Merck used to try to minimize the cardiovascular adverse effects of Vioxx in its marketing efforts to physicians. Techniques included:

• Avoiding discussion of a specific study, the VIGOR study, which showed that Vioxx increased cardiovascular events
• Distributing outdated data from weaker studies that had not shown cardiovascular adverse effects, on a "Cardiovascular Card"
• Identifying speakers for "educational events" who would be "favorable" to Merck products
• Using "subliminal selling techniques" beyond intellectual persuasion.

Most strikingly, Waxman noted "Merck's marketing practices may be less aggressive and more ethical than those of many of its competitors."
My comment is that this suggests that the pharmaceutical industry ought to inject big doses of ethics and transparency into its marketing. But a quick scan of Health Care Renewal would also suggest that many large health care organizations, not just pharmaceutical manufacturers, could use similar injections of ethics and transparency into their business practices.

"Crying All the Way to the Bank" Revisited: Pfizer's Trials of Torcetapib-Atorvastatin

The current issue of the New England Journal of Medicine continues the journal's recent skeptical approach to the business practices of pharmaceutical companies. A perspectives article (Avorn J. Torcetrapib and atorvastatin - should marketing drive the research agenda? N Engl J Med 2005; 352: 2573-2576) reviews Pfizer's trials of a new drug that may boost HDL ("good") cholesterol, torcetrapib, but only in fixed combination with Pfizer's block-buster "statin," Lipitor (atorvastatin).
Since the US Food and Drug Administration (FDA) has approved this approach, should the trials be succesful, Pfizer would be allowed to market the new torcetrapib-atorvastatin combination as a brand-name drug beyond 2010, when its patent on Lipitor runs out. The FDA approval also would allow Pfizer to avoid the risk of anti-trust litigation, which otherwise might have been engendered by it offering a drug only when "bundled" with another of its products.
The trials would not result in any information about how torcetrapib performs alone, or in combination with a statin other than atorvastatin. Physicians would not have the options of prescribing torcetrapib alone, in combination with generic atorvastatin, or in combination with another statin. Thus this approach would limit scientific data available to physicians and researchers, and would limit therapeutic options for patients.
We previously posted about this issue here, based on a March New York Times article.
Avorn commented,

• "the current trial design may not optimally meet the scientific needs of prescribers, the clinical needs of patients, the economic needs of payers, or the regulatory needs of policymakers. But they superbly meet the business needs of the sponsore - to create new knowledge in a way that will protect the market share of the largest drug company's most important product."

Therefore, he concluded, "the torcetrapib story suggests that we have become too dependent on manufacturers as the predominant source of our scientific knowledge about the effects of medication." He thus advocates having the National Institutes of Health (NIH) start supporting "public-interest" drug trials "fairly comparing competing therapies (especially costly new ones) with clinically realistic alternatives."
Maybe now that the NIH has strict conflict-of-interest rules, and top NIH officials are no longer allowed to get lucrative consulting contracts with pharmaceutical companies, (see post here), this idea will get more welcome reception there.

Secrecy and Censorship

On June 6 I wrote a post entitled "Secrecy," and concluded "we should cultivate transparency and openness in health care. It is hard to conceive of legitimate reasons to keep hospitals' prices, contracts between medical schools and research sponsors, and contracts between doctors and managed care organizations secret. On the other hand, it is easy to think of how such secrecy could hide unethical business practices, and potentially even abuse of patients and corruption.It is time to end this secrecy. "
Since then, in the last 16 days, the following stories about secrecy have appeared on Health Care Renewal:

• Louis Sherwood, A top Merck executive, now retired was accused of trying to intimidate physicians and researchers who had publicly questioned the safety of Merck's Cox-2 inhibitor Vioxx, now withdrawn from the market, or whether data about Vioxx was being withheld. (See post here.)
• A Pfizer executive who had spoken out publicly in favor of drug re-importation charged that the company shut down his cell phone and email. (See post here.)
• After Guidant found out that one of its models of implantable cardiac defibrillators (ICDs) had a defect that may cause them to fail, it kept the flaws a secret until the company found out that the NY Times was writing an article about the problem. (See post here.) It similarly concealed flaws in two other models of ICDs. Finally, it shippped old ICDs with the inventory out of inventory without notifying their recipients that the company had started making improved version without the flaw. (See posts here and here.)
• CIGNA threatened a physician author with legal action because he published a satirical piece in a humor magazine. The threat was based on a provision in CIGNA's contract with the physician's hospital that forbade "disparaging" language. (See post here.)
• Kaiser-Permanente sued a former employee for revealing in a blog that the managed care organization had posted real patient data on a web-site being used to develop an electronic medical record. (See post here.)
• Eli Lilly filed one of its sales representatives after he published a book detailing his exploits prior to working for Lilly as a "slacker" sales representative for Pfizer. (See post here.)

These posts demonstrate that the urge to censor seems to be widespread in health care. The would-be censors noted above included pharmaceutical companies, a device company, a for-profit managed care organization, and a not-for-profit managed care organization. They sought to censor expression critical of their products and practices ranging from outcomes data, through academic and popular opinion, to satire. Their means of censorship ranged from simply keeping information to themselves, to threats, threats of law-suits, and law-suits filed.
These 16 days demonstrated the continuing threats against transparency and openness in health care. They also demonstrate that many threats come from leaders of large health care organizations who don't like information that puts them in a bad light made public. Yet how will we improve health care without access to information about what is going wrong, and opinions about what do to improve things?

Tales of Sales Reps

Two recent news stories about how pharmaceutical companies' sales representatives market to physicians provided some interesting information....
The Philadelphia Inquirer noted that Wyeth has joined GlaxoSmithKline, AstraZeneca, and Pfizer in laying off sales representatives. A pharmaceutical sales consultant remarked, "this may be related to the issue of public trust. What we'ver realized is that we've probably gone too far." On measure of the distance traveled is the figure the Inquirer cited for the number of sales representatives working in the US prior to the lay-offs, over 100, 000, or approximately one for every seven physicians (see this post for numbers of physicians in the US versus numbers of managers). More striking was the statement that "a succesful sales representative can earn $150,000 to $200,000 a year, including a car and other perks. That's more than many primary care physicians make (see this post on physicians' compensation.)
Meanwhile, a reporter for the Los Angeles Times interviewed Jamie Reidy, the author of Hard Sell, described as a "slacker's tale," about Reidy's life as a sales representative for Pfizer. Reidy said, "I was the kid who didn't become a doctor because I almost failed high school chemistry. I was trained for six weeks and considered qualified to tell doctors which drugs to prescribe. Scary, isn't it?"
At the end, this becomes another story about the perils of blowing the whistle about the management of large health care organizations. Reidy had left Pfizer, and was working in the oncology division of Eli Lilly, advancing to a trainer of other sales representatives, until his book came out. Then Lilly fired him.

A Cautionary Tale About Health Care IT in the Real World

The Los Angeles Times reported another cautionary tale about the down-side of health care information technology (IT) in the real world. Apparently the Kaiser Permanente managed care organization, while testing electronic medical record (EMR) software, put up records of about 150 real patients on an unprotected web-site in 1999, and kept the web-site active until January 2005. Kaiser did not tell patients that their unprotected data had been available on the web for years until three months ago, according to the Times.
The problem first became public when a former Kaiser employee, Elisa D Cooper, posted about it, including links to the Kaiser web-site, on her blog. (I can't find her original blog, which may no longer be available on the web, but her current blog is here.) Kaiser then sued Cooper for invasion of privacy and breach of contract, even though, according to the San Francisco Examiner, she had been fired by Kaiser in 2003.
Beth Givens, the director of Privacy Rights Clearinghouse, commented that the incidents shows "just how vulnerable these systems can be." This is just one more case to think about the next time someone touts the EMR as the cure for all health care ills.
And it's also a reminder how large health care organizations, even ones with reputations as benign as Kaiser's is, at least out here in the East, react to whistle-blowers who publicly point out their managers' errors.

CIGNA Can't Take a Joke

The Associated Press reported (see the Washington Post version) that the Dr. Douglas Farrago, the physician who edits the humor magazine Placebo Journal was threatened with legal action for publishing a satirical piece on managed care. The parody was of a patient satisfaction survey, by the imaginary "SICKNA Healthcare" managed care organization, signed by "W. E. Sucque" from the "Medical Thievery and Health Policy Division."
After the piece was published, his employer, Sisters of Charity Health System, received a call from CIGNA Healthcare's lawyers demanding the Farrago "cease and desist." Apparently, CIGNA Healthcare's contract with the hospital system bars physicians from "any false or disparaging communications which could, or are likely to interfere with or otherwise damage any of CIGNA's existing or potential contractual relationships." CIGNA spokesperson Lindsay Shearer suggested that the complaint arose from offended CIGNA employees, "our employees work very hard to provide high quality service to our members, our clients, our providers. And when they see stuff like that it upset them."
Perhaps CIGNA really does have some employees who are easily offended. Perhaps they were educated at some of the insitutions of higher learning, so well documented by FIRE, where a slightly offensive remark is grounds for charges under the local "speech code." (See this link for examples.)
However, it was CIGNA's lawyers, not its line employees, who went after Dr. Farrago. So maybe the company's heavy-handed approach to suppressing free expression will generate more bad publicity for it than Farrago's parody could ever have done.
I agree with Farrago's take on this, "If my hospital, who has allowed me the freedom to be creative, gets bullied to fire me over this then it proves that HMOs are really running our health care system."
File this one under "intimidation and coercion," sub-category "attacks on free expression."

"We'll Manage It the Way We Damn Well Want"

Phoebe Putney Health System is a health care system in Georgia, which boasts of "world-class medicine, hometown commitment." Its stated core values include "people come first," and "relationships are built on honesty and integrity."
Pheobe Putney was the subject of federal lawsuits, now dismissed, and state lawsuits alleging that it over-charged uninsured patients. It is one of the hospital systems that is now subject of congressional investigations of the not-for-profit status of hospitals and health systems. (See news article here.)
Now, the Atlanta Journal-Constitution has reported that top Phoebe Putney executives have run up lavish travel expenses for trips related to a for-profit subsidy. Pheobe Putney set up Grove Pointe Indemnity, based in the Cayman Islands, to provide the system with malpractice insurance. Top Phoebe Putney executives traveled to the Caymans, the Bahamas, and London, UK for Grove Pointe meetings. All travel was by private jet or first class on commercial airliners. Travel expenses included Cuban cigars, ($258 worth for one meal in London meeting), expensive beverages ($538 for one meal), and high-end accomodations (e.g., rooms at the Ritz in London, at 355 pounds sterling a night).
The Journal-Constitution asked Phoebe Putney Chief Financial Officer (CFO) Kerry Loudermilk about these expenses. Loudermilk first said what is lavish "is in the eye of the beholder." He responded to further questions about Grove Pointe, "We own it. We'll manage it the way we damn well want." A search of the GuideStar site for Pheobe Putney's 2002 Internal Revenue Service form 990 revealed that Grove Pointe had an income just under $2.5 million, and a total loss of just over $1.25 million in that year. Meanwhile, Loudermilk's total compensation was just under $3oo,ooo. He was one of eight executives who made more than $200,ooo. Three made over $300,000, and the system's CEO made nearly $600,000.
It will be interesting to see what the congressional investigation discovers about Phoebe Putney. Meanwhile, Loudermilk's response suggests that maybe the hired managers of this not-for-profit health care system feel a bit more ownership of it than they are entitled to. Although Pheobe Putney clearly owns Grove Pointe Indemnity, the managers of a not-for-profit do not own the organization. They should be running the organization in accord with its mission to benefit the public, which may not necessarily be the way they "damn well want." It's not clear that this job entitles them to smoke Cuban cigars on the health system's budget.

More Short Circuits for Guidant

The NY Times reported yet more bad news from the Guidant Corporation. We had previously posted (here) how Guidant had delayed notifiying physicians and patients about the possibility that short-circuits could render one of its models of implantable cardiac defibrillators (ICD), the Prizm 2 DR Model 1861, useless, and then that Guidant had continued to ship the old version of this model from inventory after it had started making a new version less prone to this mode of failure (see post here). Now Guidant is launching a formal recall of 29,000 ICD devices. However, this recall includes two other models of Guidant combinded pacermaker and ICDs, the Contak Renewal and Contak Renewal 2, which Guidant had not previously identified as likely to short circuit. Furthermore, it appears that Guidant delayed notifying doctors and patients about the possibility that these models might fail until now, and that Guidant continued to ship older versions of these two models from inventory even after it began manufacturing newer versions that were designed not to short-circuit.
Again, to make the best possible decisions for individual patients, patients and physicians deserve to hear about problems with devices and drugs as soon as reliable information about them is available.

"Naturopath" Takes the Fifth

The Providence Journal has followed-up on the story of local "naturopath" John E. Curran. (See our previous post here.) Curran requested an administrative hearing at the state Health Department about its suspension of his "natural healing" practice. At the hearing, Curran refused to answer every question put to him, pleading the Fifth Amendment. In particular, he would not answer questions about three diplomas that he allegedly purchased from a "bogus college," nor the $2650 check he used to pay for them; a blue coat he wore at his practice, with a badge that read, "John E. Curran, ND, MD, MPH, PhD'; documents that identified him as an ordained minister, "a fugitive-recovery agent," and a member of the press; and a New York City Police badge with his name on it. Eventually, Curran ended the hearing, and agreed to accept the suspension of his practice. The Journal reported that investigations of Curran by the US Food and Drug Administration, Internal Revenue Service, Postal Service, and Attorney's Office are still pending.
Although Curran may be an extreme example, a quick look at the web will reveal all sorts of complementary and alternative medicine (CAM) practitioners making exaggerated claims about the benefits of their services. Reputable medical schools have allied themselves with CAM institutions which claim they can treat depression with acupuncture, and increase longevity with herbs (see previous post here.) The extent that spending on unproven, useless, and even harmful CAM treatments contributes to rising health care costs remains unexplored.

"Slippery As Oiled Pigs"

The Washington Post followed up on the case of the hospitals that employed used elevator hydraulic fluid rather than detergent to attempt to sterilize surgical instruments. The paper reported comments by the CEO of Duke University Health System, Dr. Victor Dzau. To explain why it took so long for administrators to figure out there was something wrong with the sterilization process, he noted that normally a lubricant is applied to surgical instruments to "make sure they don't develop rust and lock up during surgery." So, "it took us a while to figure out that this was beyond the normal level of oiliness."
Futhermore, Dzau discounted the potential health risks of the exposure, "while we understand that some patients have experience symptoms following their surgeries, everything we know would suggest that no causal connection has been established between any of the these patients outcomes and instruments exposed to the fluid in the presterilization process."
Meanwhile, this case has attracted considerable media attention, most not very flattering to Duke. A local commentator wrote in the News Observer, "what galls most is not the mistake, but the post-mistake arrogance of hospital officials. Hospital regulators accused them of ignoring clear, early distress signals being sent by staff members who knew the instruments weren't supposed to be as slippery as oiled pigs and leave a yellow residue."
Unfortunately, Dzau's remarks did not convince me otherwise. Surgical instruments are made of alloys that do not corrode easily, and its implausible that more than tiny amounts of oil are normally used in their sterilization. Although I am not a surgeon, I have seen plenty of sterilized instruments, and none of them were oily. Hence, if the instruments were really as "slippery as oiled pigs," anyone familiar with the operating room context should have identified this as a big problem.
Furthermore, Dzau's comment about causality is, while probably true, not helpful. The only way to establish that exposure to operating room instruments coated with used elevator hydraulic fluid causes particular health problems would be a controlled trial that randomized some patients to such an exposure. Such a controlled trial would clearly be unethical, and I am sure no previous trial has been done. Yet in the absence of such ultimate proof, it seems reasonable to assume that it is not a good for patients to expose them to surgical instruments washed with used hydraulic fluid.
A more productive approach would require investigating why adminstrators did not identify the oily instruments as a problem sooner.

Michigan Politicians Covet Large Blue Cross Surpluses

The Detroit News reported that the Chairwoman of the State Senate Appropriations Committee is calling on Blue Cross Blue Shield of Michigan to voluntarily contribute some of its large and growing surplus to help state health care programs, or face loss of its tax exemption.
Michigan Blue Cross now has a surplus of $2.24 billion. According to the News, that is 800 percent of the mandated minimum amount.
The article noted that in Pennsylvania, after state politicians noted large surpluses being piled up by in state Blue Cross insurers, the Governor reached an agreement with the plans that they would contribute some of their reserves to state health programs.
Michigan Blue Cross spokeswoman Helen Stojic countered, "we spend tens of millions of dollars already reinvesting in communities."
On the other hand, Tom Clay of the Citizens Research Council of Michigan, noted, "you could make the argument that if the Blues are building up a reserve, they're probably charging more for insurance than they need to."
In my humble opinion, leaders of both not-for-profit insurers like some Blue Cross plans, and not-for-profit hospitals and academic medical centers need to refocus on their missions, or risk rude encounters with politicians who can find other uses for the money these institutions have been accumulating.

Nursing Home Administrator Charged with Patient Neglect

Our local Providence Journal has been following a tragic story of the closing of a large local nursing home, after many reports of sub-standard care and financial difficulties. Today the paper reported that the former administrator of the nursing home, James D. Janetakos, has been charged by the state Attorney General with 11 counts of patient neglect, a felony.
Noteworthy is that this charge has usually been made against health care professionals, not managers. According to the Journal, "this is the first time in recent years that a top administrator has faced charges of patient neglect."
Law enforcement seems to be recognizing that mismanagement of health care organization may have serious effects on patient outcomes. I suspect many doctors, nurses, and other health professionals have know that intuitively for a while, but have rarely been in a position to act on that knowledge. And the concept seems still largely foreign to the health services research literature and in "health policy" circles, as best as I can tell (but I would love to be proven wrong on that, if anyone can do so.)

New Book on "Olivieri Affair"

The NY Times reviewed a new book on what may be called the "Olivieri affair," one of the most notorious cases of research suppression from the late 1990's. The case, which involved allegations that the Canadian drug manufacturer Apotex attempted to suppress results of Olivieri's research which showed that the drug , defirapone, or L1, had unexpected adverse effects, was investigated by the Canadian Association of University Teachers, who issued an extensive report. The book, The Drug Trial, by Miriam Shuchman, apparently takes a revisionist approach, and is much more critical of Olivieri's role in the case than previously published reports. (See also this article on the book from MacLeans.) I haven't read the book so can't comment on its contents.

Canadian Health Care A Contradiction in Terms

To all those still infatuated with Managed Care:

June 16, 2005
Canadian Health Care A Contradiction in Terms
By Steve Chapman

To critics of the American health care system, Shangri-La is not a fantasy but a shimmering reality, though it goes by another name: Canada. Any debate on health care eventually arrives at the point where one participant says, "We should have what Canadians have. Free care, universal access and low cost -- who could ask for more?"

Well, plenty of people could ask for more -- starting with the Supreme Court of Canada. Last week, ruling on a challenge to the health care in the province of Quebec, the court sent a clear message south: Don't believe the hype.

The program, said the court, has such serious flaws that it is violating constitutional rights and must be fundamentally changed. And the flaws, far from being unique to Quebec, are part of the basic structure of Canada's health care policy.

No one doubts that the American model has serious defects, particularly rising costs and lack of access to medical insurance. But anyone who thinks the Canadians have come up with a magical solution is doomed to disappointment.

The dirty secret of the system is that universal access is no guarantee of treatment. Sick Canadians spend months and even years on waiting lists for surgery and other procedures. In 1993, the average wait to see a specialist after getting a doctor's referral was nine weeks. Since then, according to the Fraser Institute of Vancouver, it's increased to 18 weeks.

The typical patient needing orthopedic surgery has time to get pregnant and deliver a baby before being called. The Supreme Court cited the testimony of one orthopedic surgeon that 95 percent of patients in Canada waited over a year for knee replacements -- with many of them in limbo for two years.

In some cases, the delay lasts longer than the person enduring it. Or as the Supreme Court put it: "Patients die as a result of waiting lists for public health care."

Not only does the government subject its citizens to painful and even fatal delays in the public system, it bars them from seeking alternatives in the private market. You see, it's illegal for private insurers to pay for services covered by the public system.

That policy is what forced the Supreme Court to order changes. "The prohibition on obtaining private health insurance," it declared, "is not constitutional where the public system fails to deliver reasonable services."

The program has created a gap between supply and demand that is wider than Hudson Bay. Its failings, however, go beyond that. The single-payer approach, for example, is often held up as the only way to simultaneously control costs and deliver quality care.

In fact, Canada has somehow managed to do neither.

After adjusting for the age of the population, the Fraser Institute compared 27 countries in the Organisation for Economic Co-operation and Development that guarantee universal access to health care. By some mysterious alchemy, Canada has proportionately fewer physicians than most of these nations but spends more on health care than any except Iceland.

It would be a dubious feat to control costs only by depriving people of treatment. But to forcibly deprive people of treatment while letting costs surge is no achievement at all.

Admirers of our good neighbor to the north say the United States pours money into all sorts of fancy equipment but doesn't get better results by such measures as life expectancy. But life expectancy is affected by multiple factors, including education, crime rates and diet -- with health care playing only a modest role. In those areas where modern medicine can make a big difference, the United States does very well.

Take breast cancer. In Britain, which is famous for its socialized system, close to half of all victims die of the disease, according to a recent Cato Institute study by John Goodman, head of the National Center for Policy Analysis. In Germany and France, almost one-third do. In Canada, the figure is 28 percent -- and here, it's 25 percent. Our mortality rate for prostate cancer is 67 percent lower than Britain's and 24 percent lower than Canada's.

The usual story we hear is that the health care system next door provides first-rate care to all, at low cost. The realities -- dangerous delays, bloated expenditures and mediocre results -- are not so appealing. American liberals may not welcome evidence that the single-payer model works far better in theory than in practice. But for that, they can blame Canada.

Dispute at the American Society of Hypertension Over Industry Involvement

The Boston Globe reported that a dispute has broken out at the American Society of Hypertension over the influence of pharmaceutical companies and conflicts of interest. Things have gotten pretty messy, so it's not easy for an outsider to tell what are at its roots.
There are two factions, one who "expresses wariness about industry participation and a newer faction that embraces it," according to the Globe.
In the first faction is Dr. John H. Laragh, a society cofounder and editor of the American Journal of Hypertension. In an email to the Society's membership, he charged that "the lines separating marketing from education have been fractured." Prof. Curt Furberg, former member of the Society's executive council, agreed that "the society is seen as a marketing tool by industry. There is a lot of money to go around."
Furthermore, Laragh said that industry involvement has increased at the society's annual meeting. This year, industry-sponsored sessions, instead of being isolated as "satellites," were "intertwined with the rest of the program." He noted that one society member, who also is a founding partner of a company that administers clinical trials under contract with the pharmaceutical industry, chaired a meeting to discuss the results of a trial that his company administered.
In the second faction is the President of the Society, Dr. Thomas Giles. He said that industry involvement is "part of a 'partnership' between physicians, corporations, and government and can be managed with appropriate disclosure rules, " according to the Globe. He noted that unrestricted educational grants from pharmaceutical companies, notably Novartis, AstraZeneca, and Pfizer, financed about $1.5 million of the Society's $4.4 million budget. He said, "we will not put ourselves in the position where were [sic] are going to function as the marketing arm for anyone."
Laragh has also acquired "enemies," who questioned his editorial salary ($229,000 in 2003), and whether he "engineered" his wife's new position as President-Elect of the Society.
Not a pretty picture, but I guess that more open discussion about the role of industry in scientific and clinical societies may do some good.

Deferred Prosecution for Bristol Myers Squibb for Fraud Charges

The NY Times reported that federal prosecutors will defer prosecution of Bristol Myers Squibb for alleged manipulation of inventory designed to artificially inflate sales. The company will return $300 million to stockholders; set up an endowed chair of business ethics at Seton Hall University Law School; remove its CEO, Peter R. Dolan, from his additional position as chairman of board; and allow a retired federal judge to continue monitoring company operations, and appoint an additional board member acceptable to him. If the company complies with all obligations to the government, the prosecutors will dismiss criminal complaints already filed without further prosecution.
Two former Bristol Myers Squibb executives, former chief financial officer Frederick S. Schiff, and Richard J. Lane, former head of worldwide medicines, were indicted on charges of conspiracy and securities fraud. Lawyers for both men declared their innocence.
The prosecutors stated that these events resulted from a "corporate culture at Bristol-Myers at the time that emphasized higher sales at all costs...." according to the Times.

A Not-For-Profit Hospital Sues a Former Donor

The Boston Globe reported that the not-for-profit Massachusetts Eye & Ear Infirmary has sued a foundation for failure to deliver a pledged contribution. However, the pledge was apparently made to support a specific research program run by a doctor who has left the hospital, taking his research program with him. The Casey Foundation, run by Washington philanthropist Betty Brown Casey, had been funding work done by Dr. Steven Zeitels. After Zeitels and four other members of his team moved to Massachusetts General Hospital, the foundation asked Massachusetts Eye & Ear Infirmary to return any funds remaining in the grant. The hospital responded by suing the foundation for about half of the $2 million grant which it had not yet received, saying that the money was meant for the institution, not any particular researcher. Zeitels, however, said that the foundation had not meant to provide general funding for the hospital, but "was funding a specific program with unique investigators that was delineated both in the original proposal ... as well as scientific reports."
Suing a former donor seems to be a heavy-handed approach for a not-for-profit institution that presumably wants to receive money from other donors in the future. But it fits in with current US congressional concerns that some not-for-profit hospitals act more like for-profit corporations. (See our previous post here.)

No Federal Standards for Reporting Flawed Medical Devices

The NY Times reported about recent recalls of implanted cardiac devices. One important point the reporter made was that so far the US Food and Drug Administration (FDA) has no uniform standards for notification of physicians when problems are found with implantable devices. Currently, it is up to the device manufacturer to decide when to report problems. Apparently, it is acceptable for the manufacturer to "consider potential loss of business to competitors and legal liability" when making such decisions.
The results of this lack of standards include the decision by Guidant to delay reporting of short-circuits in one model of implantable cardiac defibrillator (ICD). (See previous post here.) Guidant had judged that replacing such defibrillators would "unnecessarily" expose patients to surgical risks. Thus, Guidant justified its decision to withhold information about the possibility of ICD failure, apparently based on a judgment that the reduction in possible benefit due to ICD failure was less important to patients than the risks of ICD replacement.
But by withholding information about ICD reliability, Guidant seemed to be substituting its judgments about how to balance benefits and harms for those made by patients and doctors. As Dr. Eric N. Prystowsky said, "You are not my father. You are not my mother. You are just a company selling products. You have to let me make these decisions."

Big Conflicts of Interest Alleged at Small Massachusetts Hospital

The Boston Globe reported on the travails of tiny Hubbard Regional Hospital in Webster, MA, allegedly brought on by mismanagement.
The 76-year old, 24-bed hospital was run for over 10 years by Quorum Helath Resources, which says it "provides management support services, consulting, education and training programs to independent hospitals and health systems nationwide." Quorum billed the hospital $500,000 a year for its services. The hospital lost money in nine of the last 10 years.

The Globe article suggests that the hospital's management during this time suffered from important conflicts of interest:

• In 2003, the hospital sold a medical office building for $450,000 to a real-estate company owned by three directors of Hometown Bank. The Bank was a major creditor of the hospital. The bank's CEO, Matthew S. Sosik, was on the hospital's board of directors. The hospital leased back space in the building, but allegedly paid $3250/month for 3000 square feet while it was only using 1200.
• In 2004, the hospital sold a house for $250,000 to a real estate trust controlled by Daniel B. Flynn, a real estate developer, who was also a borrower from Hometown Bank. Legal work for Flynn was handled by Michael L. Jalbert's law firm. Jalbert was the hospital's board chairman. Again, the hospital leased back the property at $1700/month.
• In 2001, Flynn had leased land from the hospital for $2000/month, and built a building on it in which the hospital rented space for $7500/month. The firm that surveyed this property was owned by Jalbert's father.
• Jalbert's law firm also handled legal work for the hospital, at the same time he handled legal work for Hometown Savings, and another hospital creditor.

Last year, the hospital's entire board resigned. A new board terminated Quorum's contract, and hired Christopher Rich, a lawyer, to be the new CEO. Rich had no experience in health care. Among his early decisions were hiring Joseph J. LaFratta as security director, and Arnold E. Benson as chief operating officer for th hospital. He had to fire LaFratta when it became public that LaFratta was convicted in 2000 of stealing $42,000 in donations from Tufts University School of Medicine. Rich admitted the decision to hire LaFratta was "very stupid." Benson is still working, even though it turned out he had pled guilty of tax evasion in 2001. Rich's comment was "why not give Arnie a second chance?"
One former Hubbard nurse, who was born in the hospital, called the events "a slap in the face." A member of the Hubbard Regional Hospital Guild, an auxiliary fund-raising organization, was more graphic, "The hospital was gradually being raped by various entitities."
Even small community hospitals in the US are not safe from leadership by the inept and the conflicted.

Not Very Slick Management: Administrators Alleged to Ignore Surgical Instruments "Disinfected" with Used Hydraulic Fluid

From the Associated Press, via the Charlotte Observer, came the story that a mix-up at Duke Health Raleigh and Durham Regional hospitals, both run by the Duke University Health System, caused surgical instruments used for operations on 3800 patients to be "disinfected" by immersion in hydraulic fluid drained from a hospital elevator system, rather than detergent.
According to the version reported in the Raleigh News and Observer, operating room staff complained to administration that their instruments were covered with oil. Sometimes, the staff had to wipe down tools because they were too slick to be usable. However, according to a Center for Medicare and Medicaid Services (CMS) report, "Administrative staff failed to heed the multiple complaints of staff sterilizing and using the instruments, thus delaying the discovery of the error and needlessly exposing patients to these instruments over a longer time period." So far, Duke has refused to reveal results of analyses of the content of the used hydraulic fluid. Duke officials declined interviews, but insisted that the surgical infection rate has not increased since the mix-up. A patient who suffered various maladies after surgery with the oily instruments requested information about the exposure from Duke, but received a letter from its risk-management department stating, they were "not in a position to respond at this time."
Not such slick managerial work on this one... Sorry, I couldn't help making these terrible puns, but sometimes we try to laugh to keep from crying. This story is so bizarre that it sounds like an urban legend. What kind of hospital manager would ignore repeated reports that surgical instruments came out of the sterilizer coated with oil? But with 422 related posts on Google News by June 14, this story appears all too real.

MedRants Blogger's Op-Ed Against Direct to Consumer Drug Advertising

Fellow health care blogger Robert Centor MD (of MedRants) published an op-ed in USA Today advocating that direct to consumer (DTC) advertisements for pharmaceuticals should be banned.
I do worry that DTC ads push people to get drugs for mild conditions, for which the drugs' benefits may not outweigh their harms, and push people to get expensive name-brand drugs when cheaper generic drugs may work just as well. (Many people with indigestion or GERD will do just as well with the little purple pill than with a generic or over-the-counter H2 blocker, or even simple antacids.)
I am also concerned that banning DTC ads does infringe on free speech. But as I have said before, I wonder why there has been no organized effort to develop counter-advertising, especially by government agencies and managed care organizations who proclaim their interests in cutting costs and improving health care?

How Johnson & Johnson Marketed Propulsid

The NY Times reported on the events leading up to Johnson & Johnson's withdrawal of Propulsid, based on documents made available by related lawsuits. Propulsid was withdrawn from the market after its use was related to serious cardiac rhythm disturbances.
MedRants commented on the story here, saying " we cannot rely on Big Pharma to tell us the truth about efficacy or side-effects. Yet we need the truth." MedRants was then taken to task by a commentator who asserted (here) that doctors continued to prescribe Propulsid despite warnings that were eventually added to its label, and hence "we have no room to complain that we weren’t given the truth."
In this case, as in many others within our dysfunctional health care system, "we have met the enemy and he is us." Doctors have often been far too enthuisiastic about particular treatments, whether pharmaceutical or procedural. I would like to think that most of this time this over-enthusiasm comes from their fervent wishes to make their patients better. Maybe physicians would make more realistic treatment decisions were they to be better educated about evidence-based medicine (EBM). Although doctors also must shoulder some blame for resistance to EBM, there has been little support for its dissemination from the many large organizations, including pharmaceutical manufacturers, managed care organizations, and academic medical centers who have publicly endorsed it.
Nonetheless, there is also reason to complain, in my humble opinion, about how truthful Johnson & Johnson was in its marketing of Propulsid. Johnson & Johnson had failed to prove efficacy of the drug in children, and its label did not include use in children.
However, according to the NY Times, the company paid to distribute 10,000 copies of a pediatric gastroenterology text-book that recommended Propulsid for children; had the text's author address a company seminar meant to train other doctors to talk about the drug; and financed a support group for parents with children with gastrointestinal diseases while that group's focus shifted to gastro-esophageal reflux disease (GERD), and while that group actively promoted Propulsid to treat this common, and usually not very serious condition.
So, the Times' summary seems reasonable: "It is a story that has particular resonance now, as troubled arthritis painkillers - Vioxx, Celebrex, and Bextra - have again focused attention on what critics say is the federal Food and Drug Adminstration's inability to monitor and regulate pharmaceuticals effectively once they are on the market. "

The AMA may be "getting it"

AMA pursues doctor hiring reform
Miami Herald
June 10, 2005

In a move that could have widespread effects on the nation's healthcare industry, the American Medical Association's Board of Trustees is recommending the development of proposed legislation that would forbid corporations and hospitals from directly employing physicians.

-- SS

Government officials who "get it"

I heard Department of Health and Human Services Secretary Michael Leavitt speak at the AHRQ Annual Patient Safety and Health Information Technology conference this week. The linked article summarizes his plans for spearheading standardization on electronic medical records data.

It is with great pleasure that I can report this government official seems to know the issues, challenges and benefits of such an initiative quite well.

US moves to spur digital health records nationwide
By Lisa Richwine
Mon Jun 6, 5:11 PM ET

The U.S. government is taking steps to help spawn a nationwide network of electronic medical records that are easily accessible but protect patient privacy, Health and Human Services Secretary Michael Leavitt said on Monday.

A new advisory panel will make recommendations aimed at prodding the private sector to establish standards so medical records can be shared throughout the health-care system, Leavitt said.

"In order for health IT (information technology) to move forward, we have to have interoperable standards ... creating a system where information is digital, privacy protected and interchangeable," Leavitt said in an interview ... the new panel, announced by Leavitt at a health IT meeting in New York, will have 17 government and private sector members, plus Leavitt as chairman. The group will give recommendations on how to make health records compatible among varying computer systems while keeping patient information secure. The panel will exist for at least two years and possibly as long as five years ... President Bush has set a goal for most Americans to have electronic health records by 2014.

The last paragraph was particularly interesting:

Leavitt said the technology also would be a boost to the Food and Drug Administration's efforts to monitor drug side effects because reports from throughout the country could be gathered quickly for analysis.

Then there's this from the New York Times:

Drug Safety System Is Broken, a Top F.D.A. Official Says
By Gardiner Harris

WASHINGTON, June 8 - A top federal drug official told a medical advisory board on Wednesday that the nation's drug safety system had "pretty much broken down" and that there was room for "a lot of improvement" in the government's approach to uncovering dangers in drugs already on the market.

The official, Dr. Janet Woodcock, deputy commissioner of operations at the Food and Drug Administration, made her remarks before a committee of experts at the Institute of Medicine, who had been asked by the agency to suggest safety improvements after a year of well-publicized troubles, including the withdrawal of two big-selling painkillers.

... She said the drug agency had long known that it needed to improve systems for learning about problems with drugs on the market. One way to do that, she said, is to take advantage of electronic health records from managed-care organizations.

As I wrote here, I agree with these assessments. Unfortunately, based on my experiences in pharma (where my experience in EMR and views on its use for drug safety surveillance were quite completely ignored, or perhaps I should say discarded), I predict there will be significant initial opposition by pharma to use of data collected on adverse drug events from EMR's. It is not data from a RCT, after all, and will invariably cause major headaches after the rollout of new drugs.

-- SS

"Scientists Behaving Badly" and "Unreasonable Managerial Demands"

An article in Nature reports on "Scientists Behaving Badly."(1) This was a broadly based anonymous survey, with a 52% response rate, and a sample size of 3247. Of note, the numbers of respondents who reported engaging in the following behaviors in the last three years were:

• Falsifying or "cooking" research data - 0.3%
• Ignoring major aspects of human-subject requirements - 0.3%
• Failing to present data that contradicts one's own previous research - 6.0%
• Improperly assigning authorship credit - 10.0%
• Changing the design, methodology, or results of a study in response to pressure from a funding source - 15.5%

The authors noted "a proper understanding of misbehaviour requires that attention be given to the negative aspects of the research environment. The modern scientist faces intense competition, and is further burdened by difficult, sometimes unreasonable, regulation, social, and managerial demands."
This assertion was probably written before the publication in the New England Journal of Medicine of an article that showed what a large proportion of medical schools and academic medical centers are willing to sign away faculty members' control of their research to research sponsors (see our previous post here.) That article showed that about 2/3 of schools and medical centers were willing to sign away their faculty members' ability to alter research methods specified by the sponsor, and about 1/2 were willing to let the sponsor write up the research reports, which faculty could comment on, but not change, even though they were likely to be listed as principle authors. The data in the NEJM article is certainly compatible with the proportion of respondents to the Nature study who noted "pressure from a funding source." Thus, the "managerial" demands that researchers face may often go beyond merely being difficult, or even unreasonable.
This is just another reminder of the spectre of powerful health care organizations acting in conflict with physicians' and medical researchers' core values.
How much more evidence will be needed before something is done about how such organizations are lead?
Reference
1. Martinson BC, Anderson MS, deVries R. Scientists behaving badly. Nature 2005; 435: 737-8.

Pfizer Dissident Unplugged

The New York Times reported that Dr. Peter Rost, a Pfizer executive who publicly spoke out in favor of importation of low cost drugs, lost his company email and cell-phone service after he appeared on "60 Minutes," again speaking in favor of drug importation.
A Pfizer spokesman, Paul Fitzhenry, implied that Dr. Rost's communication problems were technical, "there have been cases, through a change of vendor, where some employees have lost service for a period of time." However, Rost also claimed that he no longer has employees who report to him, a secretary, or an identified supervisor, and he now works out an isolated office next to the company security department.
After Rost first publicly came out in favor of drug importation, a Pfizer spokesperson had said, "Dr. Rost has no qualifications to speak on importation."
Rost formerly worked for Pharmacia until it was acquired by Pfizer. He was in charge of the marketing of genotropin.
Rost must have thought he was on the faculty of a university, and thus had free speech and academic freedom (but then again, a look at the FIRE web-site might suggest that university faculty may not always be so privileged either.)

Canadian Ban on Private Health Insurance Struck Down

The Globe and Mail reported that the Canadian Supreme Court has just struck down as unconstitutional a law in Quebec that makes private health care insurance illegal. Dr. Albert Schumacher, the President of the Canadian Medical Association, said, "this is indeed a historic ruling that could substantially change the very foundation of medicare as we know it."
The court found "in sum, the prohibition on obtaining private health insurance is not constitutional where the public system fails to deliver reasonable services."
Health Care Renewal has frequently discussed the excesses of the for-profit and private not-for-profit organizations that comprise a major chunk of the US health care system, so Canada's impending leap into a multi-centric health care system may not be an unalloyed success. However, throwing caution about commenting about another nation's politics aside, I can't help but think that putting a little more control of health care into the hands of individual Canadians may not be entirely a bad thing. Maybe some of our friends north of here will comment more knowledgeably.

More Exaggerated Hospital List Prices

The Opinion Journal (the on-line opinion site of the Wall Street Journal) has a long article about one family's experience in the UK and US health care systems. Of note, the author noted that the charges for 10 physical therapy sessions at Cornell University Hospital in New York City were $27,000. As the author said, "there is something seriously out of whack about 10 therapy sessions that cost more than month's worth of hospital bills in England."
These prices are comparable to the list prices that a Tenet hospital was charging for physical therapy in Florida, but are more than an order of magnitude (i.e., ten times) higher than prices quoted as reasonable by a leader of the American Physical Therapy Association (see previous post here).
So everybody still thinks the reason for rising US health care costs is a mystery?

Local "Naturopathic Doctor" Shut Down

Our own Providence Journal reported that the RI Health Department shut down the office of a "naturopathic doctor," John E. Curran, after federal agents raided two of his offices. Before reading the news article, it's instructive to look at Curran's web-site, which was still up, at least through today.
On it he:

• claims he can treat "catastrophic" or "unusual or rare" diseases;
• implies that his treatments are harmless, and, in comparison to standard medicine, "Treatments are more natural, gentler, and more easily accepted by our bodies;"
• implies he is a licensed ND, naturopathic doctor;
• claims that his version of naturopathy is "evidence-based;" and
• provides a testimonial of a patient who seems to say that Curran put his Stage 4 head and neck cancer into remission.

The Providence Journal reported that Curran is under federal investigation for wire fraud, mail fraud, and money laundering. The order to shut down his office came after a patient with liver disease was "sickened" by an alcohol based medicine that Curran prescribed. Undercover agents who visited Curran were subjected to a "live blood analysis," which Curran said revealed "parasites" in their blood, or malformed blood cells; and a "biomeridian stress assessment." The treatments Curran proposed for these problems would cost about $10,000.
Curran's practice is listed on a this web-site which has links to a variety of New England based "holistic" practitioners. Some make claims to treat real diseases that seem far from evidence based, for example:

• "The Way to Balance," whose practitioners claim they can treat arthritis, seizures, and asthma
• "The Circle of the Light Studio, " whose practitioners claim that therapeutic touch can treat asthma and cardiac problems, and relieve AIDS symptoms

And the claims found on the web-site for the Tai Sophia Institute, the organization that recently announced a formal collaboration with the University of Pennsylvania Medical School, are only somewhat less sweeping (see our previous posts here and here.)
At a time when health care is derided for its rising costs, declining accessibility to patients, and stagnant quality, I wonder why do there is so little concern about the costs incurred by these so-called complementary and alternative medicine practitioners, and so little skepticism about the expansive claims they make about the tests and treatments they provide?

Allegations That Merck Threatened Researchers Who Expressed Doubts About Vioxx

The Philadelphia Inquirer reported a series of allegations that a top Merck executive threatened and intimidated physicians who questioned the safety of its Cox-2 inhibitor drug Vioxx, now off the market.
Louis M. Sherwood, who retired as a Senior Vice President of Medical and Scientific Affairs for Merck, had been known as "the epitome of an upstanding guy, smart and well-respected." The Inquirer reported that "Sherwood earned accolades from both worlds [academia and industry]. At retirement in March 2002, he was given two lifetime achievement awards, one from industry physicians and one from medical-schol professors."
Nonetheless, evidence discovered in one of the cases against Merck revealed:

• Lee Simon, a former Harvard faculty member, after lecturing about the risks of Vioxx, said he was threatened by Sherwood: "he would hurt my career if I continued to lecture." Sherwood also charged that Simon was biased against Vioxx. However, the Inquirer reported that Simon's "boss at Harvard, Steven Weinberger, now a Vice-President at the American College of Physicians in Philadelphia, confirmed getting Sherwood's call but said it had 'nothing to do' with Simon's promotion." Weinberger stated, "Lou Sherwood was not at all threatening me." Yet, John Yates, Sherwood's successor at Merck, contacted Simon, and said, according to him, that Sherwood's behavior "would never happen again, that it was unnecessary, that it was not the behavior of Merck." [Note that Dr. Weinberger has appeared in Health Care Renewal posts in the past, here, here, and here, on the subject of declining interest in primary care, which he has suggested is due more to shortcomings in how medical schools promote the field to students and due to inadequate current "chronic care models" than to pressures faced by practicing physicians, including external threats to their core values.]
• M. Thomas Stillman, from the University of Minnesota Medical School, also questioned the safety of Vioxx. A Merck "sales executive" described him as a "vocal adversary of Merck and Vioxx" in an email. A memo documented that Sherwood had "complained to Stillman's boss." Yates also called Stillman to apologize.
• Gurkirpal Singh, from Stanford University, questioned whether data about Vioxx was being hidden. A memo by Sherwood described Singh as "perceived as an advocate for Searle," which was then the manufacturer of the competing drug, Celebrex. The Inquirer reported that Sherwood called Singh's supervisor, Professor James F. Fries, at home, labeled Singh "anti-Vioxx," suggested Singh would "flame out," and threatened Fries with "consequences for myself and for Stanford," according to Fries. Fries wrote Merck to complain, noting all the above cases and those of two other researchers. Fries then got a call from David Anstice, President of the Human Health-Americas division of Merck, saying that Sherwood's behavior was "not the norm," and promising to take action.

These are serious allegations, involving apparent efforts by a pharmaceutical company to stifle free speech and academic freedom to suppress unfavorable comments about the company's products. Such behaviors threaten core academic and scientific values. If physicians and researchers cannot openly discuss scientific findings, science will not advance. If they cannot openly discuss possible harms to patients, patients may be harmed.
Unfortunately, if these allegations are true, they will become just another entry in the sorry catalog of threats to free speech and academic freedom in medicine, (which may relate to the many threats to free speech and academic freedom in colleges and universities, such as those that have been documented by FIRE.)
Physicians and scientists must learn how to defend themselves against such threats, or science, and worse, patients will suffer.

Bristol-Myers-Squibb Settling Case of Inflated Sales Figures

The NY Times reported that Bristol-Myers-Squibb will soon be paying about $300 million in exchange for the US Department of Justice deferring prosecution of its alleged criminal conduct. The allegations were that the company inflated sales figures that it reported to investors. The company's current CEO, Peter R. Dolan, has acknowledged that the company inflated revenue by about $2.5 billion from 1999 to 2002. (See this Forbes article for more on Dolan's record.)

More on the Alliance Between the University of Pennsylvania and the Tai Sophia Institute

The Associated Press has done a follow-up of the new relationship between the University of Pennsylvania Medical School and the Tai Sophia Institute, "an alternative medicine school." (See our previous post here.)
The new article quoted the leader of Tai Sophia, "the goal is that the Penn medical school graduates will be highly able to speak with patients about how to guide these things [acupuncture, herbalism] in overall care."
Furthermore, Dr. Alfred P Fishman, "co-director of the collaboration," noted, "today, we're moving away from being completely focused on preventing disease and toward looking at what it takes to [achieve and maintain] wellness... I think patient care will improve enormously."
In particular, the article reported that "cardiologists at Penn's Presbyterian Medical Center are working with Tai Sophia to integrate alternative therapies into traditional care for heart patients. The idea is to teach the cardiology staff how to develop personalized therapy plans - including everything from meditation and message to reflexology and aromatherapy - to decrease patient stress, pain and anxiety."
However, the article also included a riposte by Steven Barrett, who runs Quackwatch. Barrett charged that alternative medicine is not being accepted into medical schools because of good evidence that it works, but because "skeptical voices are squelched and 'administrators see it as a way to jump on the bandwagon and get grant money.'"
I wonder what sort of data exists on the benefits of reflexology or aromatherapy for patients with heart disease? I would bet not much. Quick PubMed searches did not reveal anything convincing. For Quackwatch's take, see their page on reflexology, and their page on aromatherapy.
I am still waiting for any rationale for the University of Pennsylvania's embrace of the Tai Sophia Institute that fits with the University's scientific mission.

Georgia State Senator, Charged with Defrauding Hospital and Medical School, Convicted

The Atlanta Journal-Constitution reported that Georgia State Senator Charles W Walker was convicted of 127 counts in a 137 count indictment. We had previously posted about the scope of the indictment, which included charges that Walker had defrauded both Grady Memorial Hospital, Georgia' largest public hospital, and the Medical College of Georgia in schemes to get these institutions to use personnel from Walker's temporary employment agency.

Opinions About the Regulating the Pharmaceutical Industry

Two major newspapers have published opinion pieces condemning current pharmaceutical industry practices, and calling for better regulation of the industry.
The Atlanta Journal-Constitution noted how pharmaceutical companies promised to supply clinical trial data to a government sponsored web-site, but often provided data too limited to be meaningful. The editorial suggested "given the results so far, the next step would be to convert the voluntary government Web site to a national registry and threaten stiff financial penalties for companies that fail to comply."
The paper also published a response by Peter S Kim, President of Merck Research Laboratories, who said "given its track record of publishing data, the implication that Merck has hidden data is both unfair and inaccurate." He didn't address specific charges that Merck has hidden or manipulated data (for links to posts on these charges, see this.)
Meanwhile, an op-ed in the Denver Post stated "drug-making has become a very competitive industry, which may be putting profits before our health." Furthermore, it suggested that the US Food and Drug Administration is "too outdated, inadequate, and riddled with conflicts of interest to regulate the business of medical drugs." Instead, it proposed a new regulatory structure to ensure "that medical drugs would have to be safe for their intended use, that full information about potential harmful effects would be given to consumers and the medical community, and that harmed consumers would have the right to redress under exisiting product liability laws."
Clearly, there seems to be increasing sentiment for a renewal of the regulatory structure for the pharmaceutical industry. It may also be reasonable to suggest that other health care sectors, especially hospitals/ academic medical centers, and managed care organizations/ insurers, may be called upon to quickly clean up their acts, or also be subject to new and more rigorous regulation.

Secrecy

I'm trying to catch up after a busy weekend, and there is a lot to catch up on...
Last week in the Hartford Courant, an op-ed article entitled "Medically Unnecessary" offered an ear, nose and throat surgeon's heart-felt complaints about the brave new world of practice dominated by managed care.
In particular, he recounted how his practice tried to negotiate with a prominent insurance company. As a prerequesite to negotiating, the company sent the doctors a "confidentiality contract," which included penalties up to $100,000 per person for any "breach of confidentiality, [decided] solely at the insurer's discretion." The doctors refused to sign.
Here is another example of the secrecy rampant in US health care. Earlier, we had posted about how hospitals keep their often stratospheric "list prices" secret, even from patients who may later be liable to pay these prices if they have no health insurer who can negotiate discounts. We also had posted about how medical schools and academic medical centers are often willing to negotiate research contracts with sponsors whose provisions are kept confidential, perhaps to hide provisions that give the corporate sponsor, not the ostensibly academic investigators control of most aspects of the research.
There are some instances in which secrecy in health care is justifiable. Keeping patients' personal data confidential is a a core value for most physicians. It also seems reasonable for companies that manufacture products used in health care to be able to maintain trade secrets about their manufacturing processes.
However, for the most part, we should cultivate transparency and openness in health care. It is hard to conceive of legitimate reasons to keep hospitals' prices, contracts between medical schools and research sponsors, and contracts between doctors and managed care organizations secret. On the other hand, it is easy to think of how such secrecy could hide unethical business practices, and potentially even abuse of patients and corruption.
It is time to end this secrecy.

New Marketing Campaign "To Build Emotional Ties Between Merck and Consumers"

The NY Times reported that Merck is embarking on a big $20 million marketing campaign to "help burnish its corporate brand rather than sell its products."
Len Taconi, executive director for corporate communication for Merck, said, "It's an important time for people to know who Merck is and what we stand for as a company."
Robert Passikoff, President of Brand Keys, described by the Times as "a brand and customer-loyalty consultant," said "Merck would be wise to make sure it has more friends than disgruntled patients. Ultimately, you're better off having a tighter emotional bond to your customer base." The Times also reported that the "campaign will try in several ways to build emotional ties between Merck and consumers."
Of course, Merck is a firm that has been around for a long time, and has produced many important products that we physicians have been happy to use> Merck certainly seemed, at least through the start of the 1990's, to be one of the great American companies.
However, in the last year, Merck has come under substantial fire for putting marketing before science, and in particular for manipulating scientific evidence about its formerly hot selling drug Vioxx, now withdrawn from the market.
For example, we have posted about how Merck tried to "neutralize" Vioxx opponents; about how Merck tried to downplay negative results of studies about Vioxx; about how Merck had a New England Journal article reporting a key trial of Vioxx ghost-written; and about how Merck marketed Vioxx as a general-purpose pain reliever in the absence of evidence that it any better in this role than a variety of cheaper drugs, while again down-playing data about its adverse effects.
So perhaps rather than trying to "build emotional ties," in my humble opinion, if Merck wants to regain the profession's and the public's trust, it should rededicate itself to doing valid, honest research about its products, and then presenting its results clearly and honestly. Merck should promote evidence-based health care, rather than spending $20 million on emotion-based marketing.

Marketing Normal Pressure Hydrocephalus

Joseph Friedman, a neurologist here in Rhode Island, wrote an op-ed in the Providence Journal that documented yet another story about apparently deceptive marketing, this time of devices. He recounted his discovery of a marketing campaign for the device used to shunt fluid for patients with the relatively rare condition of normal pressure hydrocephalus (NPH).
He first saw a segment on a television magazine show on NPH, and then "an avalanche of TV advertisements about the disorder." Then patients with previously diagnosed Parkinson's Disease began to show up in his office, wondering if they didn't have the much more rare condition, NPH. Since the diagnosis of Parkinson's Disease is usually clear-cut, and NPH is very uncommon, these ads may lead to a lot of unnecessary tests. Furthermore, as Dr. Friedman pointed out, "patients suffer twice: first, when they wonder if they've been mistreated for 10 years by their clueless doctor; then, when they're disappointed to learn that they haven't been misdiagnosed."
Dr. Friedman forcefully conceptualized the issues: "what I think: that the dirtbags who run the shunt company, the increasingly politicized U.S. Food and Drug Administration, and the executives who run television are willing to create false hope if it creates a market."

Guidant's Short Circuit, Reloaded

The NY Times reported that after Guidant discovered a defect in its implantable cardiac defibrillator (ICD) that allowed the device to short-circuit and fail, it continued to ship ICDs with the defect even after it had started manufacturing redesigned devices without the flaw.
Our post about the discovery of the flaw is here.
Guidant's statement about the matter was, "After making these improvements, Guidant sold product manufactured before the improvements because the reliability data showed that the original PRIZM 2 DR, like the enhanced version, was a highly reliable life-saving device. Current data continues to support the reliability of the product."
The Times reported, "some doctors said they would be dismayed if the company allowed them to implant a device with a known flaw that had been corrected in other units."
As I said before, the decision about how to treat a patient's illness should be up to the doctor and patient, and be based on the best available data, as well as the patient's values. For a company to withold data relevant to the decision, which just happens to be unfavorable to the company's product, is plain wrong.

CPOE cybernetic miracles not yet achieved

Lest hospital executives believe that computers are going to be a cure-all for all that ails medicine, here's another sobering report on computerized physician order entry (CPOE):

Medical errors kill nearly 100,000 American each year, with lethal drug interactions accounting for most of these deaths. Computerization -- which hospitals have been slow to embrace -- was supposed to eliminate most problems, but new research published Wednesday indicates that even the best computer system can’t save you from a doctor’s catastrophic screw-up. Harmful medication-related mishaps cropped up in a quarter of all patients at the Veterans Affairs Medical Center in Salt Lake City, one of the most high-tech hospitals in the country, according to a study published in Archives of Internal Medicine.

"If you were on an airplane and a quarter of the time it crashed, that would be a problem," said study co-author Dr. Jonathan Nebeker, a physician at the VA Medical Center.

Even though the hospital's computers were supposed to protect against dangerous drug interactions, illegible prescriptions and bedside mix-ups, nine of the 937 patients studied died as a result of medication problems, the study found.

As a medical informaticist, I have always been somewhat skeptical about the "syndrome of inappropriate confidence in computers" and related beliefs in "computational alchemy." While clinical IT progress in undeniable and must proceed, one must temper expectations about the technology to realistic levels. This is especially true for those involved in clinical operations. (Similar issues occur in the pharmaceutical R&D sector, as I have observed). We are still in an era when, paraphrasing Chuck Yeager, who shot down a faster German jet in his propeller-driven P51 Mustang, "it's the [person], not the machine."

This study also suggests that when implementing clinical IT, it best be done right by those with experience in both medicine and computing, because if it's done wrong, even worse problems can result.

More Accusations of Harsh Bill Collecting Tactics: Intermountain Health Care

Intermountain Health Care (IHC, in Utah) is another large health care system that has been accused of employing harsh collection tactics against poor patients who don't pay their bills. Earlier this month it announced kinder, gentler collection processes. It is unclear if these were a response to charges heard in the state legislature last year that the system operates like a for-profit company, and threats that it then should be taxed like one. (See news articles here and here.)
Nonetheless, a state legislative tax force will be investigating IHC, prompted by "recurring perceptions of monopolistic practices, ... of heavy-handed collection practices." (News article here.)
Ironically, a tiny news item appearing early in May suggested that this apparently tough-minded organization could not prevent Ralph Jay Hansen, its former retirement account fund director, from embezzling $2.6 million between 1996 and 2004. (See article here.)

Drug Studies Required by FDA Fast Track Process Never Completed

Help, help, there is so much going on I a can't keep up with it anymore....
The Los Angeles Times just revealed a report by the staff of US Rep. Edward J Markey (D-Mass) about the US Food and Drug Administration (FDA) fast-track drug approval process. This process, created in part as a response to demonstrations by AIDS activists in the late 1980's (see previous post here), allows rapid marketing of drugs after a limited number of studies, contingent on manufacturers' willingness to perform future studies.
Apparently, many of these studies are never finished.
Markey's report said that of 91 studies promised since 1992, 42, almost half, were not completed, and 21 were never started.
Markey is calling for new legislation to impose penalties on pharmaceutical companies that do not complete promised studies.

Medical Whistleblowers' Roundtable

PLoS Medicine just published a summary of a round-table discussion by notable whistleblowers about pharmaceutical companies' research and marketing practices, with an accompanying editorial. (The on-line journal stepped in as a sponsor 10 days before the conference, after the unnamed journal that originally was going to sponsor the meeting pulled out on its lawyers' advice.)
The conference underlined some of the issues that have appeared on Health Care Renewal. Some notable quotes:

• Betrayal of Mission: According to David Graham (who raised concerns about the safety of Vioxx), The US Food and Drug Administration (FDA) is in a "collaborative relationship" with pharmaceutical companies. A senior FDA official told Graham, "industry is our client." The public may be excused for thinking that they are supposed to be the FDA's clients.
• Tactics to Increase Likelihood of Favorable Results: Several participants talked about specific tactics used by some pharmaceutical companies to increase the likelihood that research results will be favorable to their products. An anonymous industry scientist noted that it takes only two positive studies to get FDA approval. But if a study has bad results, "typically a company is not going to publish the study at all." Furthermore, he said "drug companies assiduously avoid acquiring information about side effects." Patients who have increased risks of side-effects "are excluded from studies deliberately, even though, when the drug is approved, these patients will be targeted for sales." He also charged that studies are deliberately designed to be too small, or be over too quickly to detect serious adverse effects.
• Conflicts of Interest: Several participants suggested how drug companies convey money to public officials to influnce state level decisions about drugs. One charged that officials who were responsible for writing state guidelines about psychiatric treatments could access a secret account financed by drug companies. He was told, "Look, drug companies write checks to politicians, they write checks to politicians on both sides of the aisle - back off." He was then advised, "quit being a salmon, swimming against a stream."
• Ghost-Writing: The anonymous industry scientist described the process of ghost-writing, "When studies are published, they are frequently written not by the trained research scientist, who might have designed and analyzed the study, but by a designated medical writer with little if any backgroun in research, but who is trained instead to craft the findings of the study in the best possible way for the company."

This is important additional evidence about how deep these problems run. Solving them will take a lot of salmon.

More Fall-Out From Start of Congressional Hearings on Not-For-Profit Hospitals

The beginning congressional investigations of not-for-profit hospitals' tax exemptions are raising interest in the business practices of these institutions.
A New York Sun editorial and related news article reported that some of the questions put to the small sample of hospitals being investigated were about compensation perks given to top executives, including country club memberships: and about offshore investments and relationships with for-profit entities. The editorial provided some more information about the generous compensation given to hospital executives: four New York-Presbyterian executives (three of whom are physicians) got more than $1 million in total compensation in 2003, and several others got nearly that much. The hospital also had 3 surgeons who earned more than $1 million.
Newspapers in other states have been prompted to look into the operations of local hospitals named in the investigation. The Cleveland Plain Dealer reported data about high "list prices" charged by the Cleveland Clinic. The San Francisco examiner reported complaints about the dominance of local health care markets by Sutter Health, and allegations about the system's inflated prices and poor quality.
There thus seems to be a growing awareness that some large not-for-profit hospitals have not always been managed in ways compatible with their missions. Again, I hope that these investigations can distinguish between the importance of these institutions' underlying missions and how some current leaders may have veered from their responsibilities to uphold them. Furthermore, I hope the committees' recognize that the hospitals operate within a larger health care system, and are subject to pressures from other large organizations within the system that also have been acting at odds with physicians' core values. Although these pressures should not excuse hospital leaders' failure to uphold their missions, the hospitals (and physicians) must develop defenses against them.
The New York Sun editorial concluded, "the Congress - and the taxpayers footing the bills for the subsidy [effectively provided by not-for-profit status] - are entitled to ask and to rethink the question of whom these institutions exist to serve." Furthermore, "Senator Grassley and Frist and Chairman Thomas of the House Ways and Means Committee will have to be careful not to wreck the crown jewel of the American health-care system. But it's not only Congress that could cripple America's hospitals with clumsy or heavy-handed oversight. The doctors, administrators, and hospital trustees themselves could ruin things by forgetting that, through Medicare, Medicaid, and tax exemptions, the American taxpayers are the ones who are paying."