Threat to prescribed pain relief for failed device?

http://bit.ly/LzyYVT

How to intelligently prevent opioid abuse

by GEORGE LUNDBERG, MD AND MARIA A. SULLIVAN, MD, PHD | in MEDS |  (FiDA blog bold)

Acute and chronic pain is bad. Proper pain management is essential and has been strongly emphasized by the American medical establishment for the past nearly two decades.

Simultaneously, during these years, both the quantity of opioids prescribed by physicians and dentists has increased dramatically and prescription opioid abuse has escalated at an alarming rate among chronic pain patients and the general population. Opioid analgesics now result in more American overdose deaths than cocaine and heroin combined.

What should physicians do? For treatment of chronic pain, non-opioid analgesics should be the first-line agents.

Physicians and nurses must discuss with patients common opioid side effects such as constipation and sedation, other risks such as addiction and overdose, and potential long-term risks such as hyperalgesia and sexual dysfunction.

Short-acting opioids such as Dilaudid (hydromorphone) and Vicodin (hydrocodone/paracetamol) may be helpful for initial pain relief, but longer-term dosing can lead to breakthrough pain and withdrawal, and these agents carry a relatively high abuse potential.

Oxycontin (oxycodone CR) is also widely abused, especially in rural areas; its elevated dosage means it is highly addictable, and coverage by insurance makes it cheaper than heroin.

Longer-acting opioid analgesics such as Suboxone (buprenorphine), methadone, and fentanyl have a much lower abuse liability. However, methadone is found in more overdose deaths than any other prescription opioid and should not be prescribed for opioid-naive patients. Because analgesic effects of methadone are of shorter duration (6 to 9 hours) than its half-life (36 hours), levels may accumulate, leading to respiratory suppression or cardiac events.

Patients should be instructed to keep controlled substances safe in a locked location to prevent use or sale by others.

If a physician intends to prescribe opioids for chronic pain, a narcotic protocol – medication contract, psychological evaluation, and urine toxicology – should be considered. Monitoring both urine toxicology and aberrant behaviors will detect more opioid abuse than either strategy alone.

Combining a clinical interview and the SOAPP (Screening and Opioid Assessment for Patients with Pain) yields the highest sensitivity (.90) for abuse detection.

A “universal precautions” approach to minimizing risk includes asking patients about history of substance abuse, written informed consent, and ongoing reassessment of the benefits of opioid therapy. Clinicians can thus triage patients to low-, medium-, and high-risk addiction potential. Treatment agreements should delineate rules such as having no early refills and requiring urine toxicology.

For patients who develop opioid addiction, substitution with buprenorphine or another abuse-deterrent formulation and adherence monitoring can be implemented.

The medical establishment should develop and use effective analgesics with lower abuse potential. Current research efforts to identify better methods to detect patients at heightened risk for developing addiction should be supported.

All prescribers of opioids must actively manage pain control while aggressively and intelligently attempting to prevent opioid abuse.

George Lundberg is a MedPage Today Editor-at-Large and former editor of the Journal of the American Medical Association. Maria A. Sullivan is an Associate Professor of Clinical Psychiatry in the Division on Substance Abuse at Columbia University and the New York State Psychiatric Institute.

 Comment by Joleen Chambers (FiDA blog)

So . . . those innocent patients who received prescription pain medication (e.g. long-term maximum dose hydrocodone) will be side railed into a "new" medical plan to EVALUATE their pain/addiction level (eliminate the current prescription).  How is this new program customized to a victim of a failed implanted medical device (FDA MedWatch #5009052)? The cascading damage of failed device, pharma evasion of untreated serious dry mouth side-effect on dental health,  medical abandonment, insurance abandonment, inaccessible justice, and now potential coercion into withdrawal or alternate medication so that the medical community can move on.  How is this patient-centered? The prescribing doctors need to experience this kind of treatment:  they have no concept.    

Congress Not Protecting Patients: Consumers Union News Release

LINK to CU   (FiDA Blog underline added.)

CONSUMERS UNION NEWS RELEASE

Thursday, April 19, 2012

Medical Device Bills Missing Critical Patient Safety Protections 

Medical Device User Fee Bills Face Key Votes in Congress Next Week

WASHINGTON, D.C. – Key House and Senate Committees will vote next week on legislation to reauthorize the statute governing medical devices at a time when the law has come under increasing criticism for failing to ensure devices are safe and effective.  While the Senate legislation is stronger than the House version, neither bill includes critical reforms needed to protect patients from dangerous or defective devices, according to Consumers Union, the policy and advocacy arm of Consumer Reports.  

 “Our system for overseeing medical implants and other high risk devices is clearly broken and allows too many dangerous devices on the market,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project.  “Tens of thousands of patients have been injured or died in recent years because current law fails to ensure medical devices are safe.  Unfortunately, these bills don’t fix the most serious flaws in our current system and leave patients at risk.”

 The Senate Health, Education, Labor and Pensions Committee will hold a mark-up of its bill to reauthorize the Medical Device User Fee Act on Wednesday, April 25.  The House Energy and Commerce Committee’s Health Subcommittee will mark up its bill on Thursday, April 26.  

 Despite the fact that 78 percent of high-risk medical devices are reviewed through the FDA’s fast track 510(k) process, industry lobbyists have urged Congress to ease federal oversight in order to promote innovation and speed up new device approvals.  But according to a March 2012 Consumer Reports poll, 82 percent of Americans believe that preventing safety problems is more important than limiting safety testing in order to prevent delays and encourage innovation.

“We all want patients to get timely access to effective new medical technologies,” said Lisa Swirsky, senior policy analyst for Consumers Union.  “But Congress needs to make sure that patient safety isn’t sacrificed in the drive to speed up medical device approvals.”

The House bill is particularly weak, according to Consumers Union.  Among other things, it diverts the FDA’s mission of protecting public health to include job creation and innovation and  constrains the FDA’s ability to get needed clinical data from manufacturers.  The Senate bill includes some important reforms, including streamlining the process for “up-classifying” devices so they can be subject to more rigorous review.  But a number of critical protections are missing from both the House and Senate bills, including: 

 Prohibition on clearing new devices based on recalled devices:  The FDA clears more than 90 percent of all medical devices without requiring any clinical testing.  These devices are cleared based on whether they are “substantially equivalent” to existing devices already on the market.  Under the 510(k) process, the FDA has to approve a new device if the manufacturer proves it is similar to a previously cleared one, even when the existing device has been recalled because of safety problems.  

 The Senate and House bills do not include a provision preventing medical devices with known safety problems from being used as the basis for clearing new devices.  Currently, the FDA does not even have the authority to require manufacturers seeking clearance for new devices to demonstrate that they have addressed the flaws of the recalled device. 

Consumers Union has urged Congress to prohibit recalled devices from being used as predicates for new devices.  The Consumer Reports poll found that 71 percent of Americans believe that a new medical device should not be allowed to be sold based on its similarity to an existing implant that has a safety problem or has been recalled.

A system to monitor devices after they are cleared for sale:  The FDA does not have the tools and resources to adequately track and evaluate how patients with implants and other high-risk devices are faring.  The Senate bill provides some improvement in this area while the House bill does not.  Five years ago, Congress required the FDA to create a Unique Device Identifier (UDI) system to monitor what happens to implants once they are on the market, but it is still not in place. UDIs are essential for including devices in the Sentinel Initiative, a surveillance system currently being implemented that monitors how prescription drugs perform once on the market.  The Senate bill officially includes medical devices in the Sentinel Initiative and reaffirms the importance of implementing the existing UDI requirement by establishing a December 31, 2012 deadline for promulgating the UDI regulations. 

UDIs coupled with a national registry of patients with devices would help the FDA more quickly identify problem devices and notify patients when their device has safety problems or has been recalled.  The Senate and House bills do not address the need for a national registry.  The Consumer Reports poll found that 95 percent of Americans believe that effective consumer protections for medical implants should include a nationwide system for tracking medical implants so patients can be notified about safety problems or recalls. 

Stronger authority for the FDA to require post market studies:  The FDA currently does not have the authority to require post market studies of new devices as a condition for clearing them through the 510(k) process.  Further, if the agency issues an order for a “522 study,” which can now be required when safety concerns arise after a device is cleared for the market, it doesn’t have the authority to rescind the clearance of the device if the device maker fails to comply with the order or if the study shows that the device is unsafe or ineffective. Neither the House nor the Senate bill provides the FDA with these needed powers.     

The Senate bill improves current law by establishing a timeline for 522 studies. However, the bill allows manufacturers to delay beginning these studies for fifteen months after the FDA orders them.  While these studies are being conducted, doctors can still implant these questionable devices in patients.  

Retaining Existing Conflict of Interest Standards:  Both the House and Senate bills weaken current standards that aim to prevent conflicts of interest on FDA panels that review medical devices and prescription drugs.  The bills eliminate existing limits on the number of waivers the FDA may grant to experts with financial ties to the medical device industry.  These limits were championed by consumer advocates and adopted by Congress just five years ago.  The House bill also eliminates certain disclosure requirements for FDA advisory panelists.  The FDA has provided no substantial evidence to demonstrate a problem with finding experts without conflicts.  The Consumer Reports poll found that 66 percent of Americans had a high level of concern about the safety decisions or recommendations made by expert committees that included doctors who had current financial relationships with medical device makers. 

Michael McCauley, mmccauley@consumer.org, 415-902-9537 (cell)

Daniela Nuñez

Grassroots Organizer

www.SafePatientProject.org

Twitter: @CUSafePatient

512.477.4431 x.117

MDUFMA Public Meeting 3/28/12 - open letter

Docket No. FDA-2010-N-0389

March 28, 2012

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, rm. 1061 

Rockville, MD 20852

The MDUFMA agreement process was not inclusive of patient participation and the lack of funding for regulation of implanted medical devices places patients in medical and legal purgatory.  The medical device industry is lucrative and powerful and entitled.  Patients that have been implanted with failed devices are often in pain, disfigured and debilitated both mentally and financially.  They are the very people who had faith in both the FDA and the medical device industry and whose voices are suppressed.  Much evidence exists showing that the medical device industry orchestrated legislation that reduced patient protections while allowing marketing of devices with questionable value.

I am a tenacious patient advocate that has experienced rejection and barriers rather than access and support from the FDA and the device industry.  My brother, Steven Baker (FDA adverse event MedWatch 5009052 reported on 11/18/08)  had a Tornier lateral elbow prosthesis implanted at the Mayo Clinic on 5/19/2008 to reduce pain and increase function.  It did neither, and on 9/29/2008 (just 4 months later) the surgeon/designer performed “revision” surgery and removed - and confiscated- two components.  My brother was placed on long-term maximum dose hydrocodone (opiate).  His teeth began to disintegrate as he slept at night and he learned that was a side effect of the pain medication.  There was no UDI unique device identifier for the implant.  The surgeon refused to report it to the FDA as an adverse event & legally only a fatality is required to be reported. There is no registry of these devices so a patient cannot make an informed decision based upon post-market data.  Steven was not informed that the Minnesota Medical Board is considered one of the worst in the nation.  Steven was not informed that the FDA allows implanted devices on the market with no clinical testing.  Steven was not informed that 2/2008 the Supreme Court provided even more entitlement to the medical device/pharma companies with Riegel v Medtronic decision.  

All the legal wrangling to give preference to these producers of implanted medical devices loses sight of the need of the patient:  care!  Steven has not filed a lawsuit.  He has not attacked the reputation of the surgeon.  He wants care for the failed implanted device.  It is clear that access to care is also trumped by corporate greed and defensiveness:  the Mayo Clinic sent him a letter stating that only Federally mandated emergency care will be provided.  How many other harmed patients does this experience represent?

As a patient advocate, my goal is to change federal public policy to provide for safe and effective implanted medical devices.  Citizens should be able to expect the U.S. government agency (FDA) and the producers of these medical devices to have the same mission.  Financial investment in regulation should not be disparaged by the very businesses that experience the greatest profit margins of all U.S. market segments.  It cannot expect the taxpayers and harmed patients to absorb the cost of device failures.

Sincerely yours,

Joleen Chambers

Hospital Consent Forms do not inform patients about joint replacement purgatory.

When you sign the hospital consent form you should be informed

•  the device company has a federal entitlement that prevents you from filing a lawsuit. 
•  the surgeon is only required to report an adverse event to the FDA if you die.
•  you may be in pain and disfigured from a failed device and the hospital/surgeon are legally able to send you a letter stating that only federally mandated medical care will be provided in the future. 
• during "revision" surgery the surgeon can remove components and not be required to give them to you.
• there are no UDI's (unique device identifiers). 
•  the U.S. does not keep a registry of implanted devices.   

Substantially Unsafe Medical Devices: bears repeating !

LINK HERE: Public Citizen- primer on medical device regulation

Feb. 27, 2012

* All of the facts below and additional information are compiled in the Public Citizen report, Substantially Unsafe, available at http://pubc.it/rMDUFA.

MONEY, POLITICS, AND PROFIT, BY THE NUMBERS

(1) In the third and fourth quarters of 2011, Congress, the White House, the Food and Drug Administration (FDA), and other executive branch agencies received visits from at least 225 registered lobbyists for the medical device industry.

(2) Of the 225 registered industry lobbyists, 106 (47.1 percent) previously held positions as congressional staff or in federal agencies.

(3) At least 36 device industry lobbyists hosted campaign fundraisers for members of Congress in 2011. These 36 lobbyists held 40 separate fundraisers for 31 members of Congress.

(4) The record shows that large companies with big profits are invoking the alleged plight of small companies to win a more permissive process for themselves.

(5) Collectively, the U.S. device industry earned $12.4 billion in profits in 2010, a 57 percent increase over its $7.9 billion profits in 2009.

(6) Five of the seven medical device companies spending the most on lobbying since 2007 are members of the Fortune 500.

(7) From 2011 through January 2012, medical device industry representatives had 30 meetings with the FDA, while consumer groups had only 12 meetings.

(8) The device industry made more than $19.9 million in campaign contributions between the 2006 and 2012 election cycles.

FLAWED APPROVAL PROCESSES

(9) Every year, the FDA receives reports of more than 200,000 device-related injuries and malfunctions, and more than 2,000 device-related deaths, according to an FDA consultant.

(10) The FDA’s Premarket Approval (PMA) process is intended to assess the safety and effectiveness of high-risk medical devices, including life-sustaining devices such as pacemakers, heart valves and implantable cardioverter-defibrillators (ICDs). The standard for approving a device under the PMA process is much lower than the one required to approve drugs. The approval of a new drug requires at least three phases of clinical testing, including at least two randomized, controlled, phase 3 clinical trials in most cases. In contrast, a PMA application for a device typically does not require more than one clinical trial, and that trial need not be as scientifically rigorous as would be required for a new drug.

(11) Only 1 in 100 new moderate- or high-risk devices are approved under the PMA process, which is ostensibly for high-risk devices. Most are approved through much less rigorous processes.

(12) Device makers are immune from most product liability claims arising from allegedly defective devices if the device in question was approved under the PMA process. That is, if the FDA approves a dangerous or defective device through the PMA process, federal law generally bars consumers harmed by the device from seeking redress in court.

(13) 510(k) Clearance – A 1976 federal law also allows future proposed medical devices to be cleared under the 510(k) process if applicants demonstrate that the new device is “substantially equivalent” to a device already on the market (a predicate device). As a result, very few products cleared through the 510(k) process are subject to clinical testing. The Supreme Court spelled out the logical flaw in relying on substantial equivalence in a 1996 ruling: “Substantial equivalence determinations provide little protection to the public ... If the earlier device poses a severe risk or is ineffective, then the latter device may also be risky or ineffective.”

(14) Industry’s core claim is that the FDA is taking too long to clear devices. But at least 95 percent of moderate- and high-risk devices are reviewed through the more lenient 510(k) process. The FDA says that it completes 90 percent of 510(k) analyses within 90 days and 98 percent of 510(k) analyses within 150 days.

(15) Predicate Creep: Over time, manufacturers may submit a series of products for approval under the 510(k) process, with each product differing slightly from an earlier product, either in the purported intended use or in technological features. Eventually, this allows the clearance of a device that is substantially dissimilar from the initially marketed product in a chain of sequentially cleared devices. This is called “predicate creep.” An example of this problem was the 2008 clearance of the Pathwork Tissue of Origin Test, which is a device that diagnoses tumors. Ultimately, the FDA’s sequential substantial equivalence rulings of medical devices created “predicate creep” and permitted it to clear a device for diagnosing tumors based on its similarity to a device that screens for illicit drug use.

(16) Under both the PMA and 510(k) processes, the FDA is obliged to fashion its requests for information in the “least burdensome” manner possible to the manufacturers from which the information is sought. Currently, the FDA asks only 8 percent of device manufacturers seeking clearance under 510(k) (excluding makers of in vitro devices) to provide clinical data from studies in patients.

SYSTEM TO RECALL DEFECTIVE DEVICES, DEFECTIVE

(17) The agency primarily depends on manufacturers and users, such as hospitals, to report events of injury or death related to the use of their devices. Manufacturers, in turn, are often unable to locate patients implanted with dangerous devices because there is not an adequate system to track which patients have received their products.

(18) Recalls are rising. The number of recalls for moderate- and high-risk devices in fiscal year 2011 (1,201) more than doubled from 2007 (566). (A recall may involve actions such as inspecting the device for problems, repairing or re-labeling the device, issuing notifications of a problem, or monitoring patients for health issues. Most recalls are initiated voluntarily by device manufacturers).

(19) The FDA lacks an internal system to analyze recall trends, which it might otherwise use in future decisions when reviewing a device for PMA approval or 510(k) clearance.

(20) Under the Safe Medical Devices Act of 1990, hospitals and healthcare facilities are required by statute to file a medical device report to the FDA and the manufacturer if there is a suspected device-related death. However, when there is a serious injury related to device use, facilities must only notify the manufacturer or, if the manufacturer is unknown, the FDA.

(21) There have been times when manufacturers chose not to send reports to the FDA when the facts of an adverse reporting to them clearly warranted disclosure. This occurred in the cases of Teleflex Medical’s Hem-o-lok ligating clips and Guidant’s Ventak Prizm ICDs. When the FDA reviewed the two companies’ adverse event reports, it found many instances in which a device reasonably could have caused harm to a patient but in which the companies determined the device was not to blame. Although user-facilities may have reported the adverse incidents to the FDA, both manufacturers withheld information that impeded the agency from taking appropriate action.

(22) The recall process does not remove defective devices from market in a timely manner. In 2009, a sixth patient died as a result of malfunctions of the Hem-o-lok surgical clip, which had been the target of a series of recalls since 2004.

(23) There is no reliable system in place for manufacturers to locate actual patients who have received their devices. Most manufacturers trace products only to distributors or healthcare facilities. Facilities, in turn, are charged with contacting the patients. Because of complications in this process, warnings sometimes fail to reach the right doctors or patients in time. For example, the manufacturer of a recalled hip implant said it could not trace the implants to the specific patients who received them.

(24) According to an October 2009 finding by the Department of Health and Human Services inspector general, the FDA does not adequately use adverse event reporting to identify trends in problematic devices.

(25) The FDA does not have clear policies in place to determine whether a recall really worked.

INDUSTRY-FRIENDLY LEGISLATION INTRODUCED

(26) As the reauthorization of the Medical Device User Fee Act approaches, members of Congress have introduced industry-friendly legislation aimed at further easing the approval and clearance processes for medical devices which would:

• further reduce the already weak standards for clearing and approving medical devices;

• raise the priority of promoting of medical innovation in relation to the FDA’s core mission of protecting public safety;

• substantially weaken the “conflict of interest” prohibition for serving on the FDA advisory committee that oversees device approvals, allowing more people who have a financial interest in the medical devices under review by the committee to review applications;

• expand the pool of third-party companies that can review a device application to include those that have financial relationships with the device industry;

• require the FDA to rule on third-party reviews of a device within 30 days or granting automatic approval of the device on the 31st day, which would result in the elimination of independent oversight by FDA officials for many devices;

• prohibit the FDA from disapproving the methods used in any type of clinical trial conducted by a medical device company, including clinical trials conducted on human subjects.

PRESCRIPTIONS

(27) No future medical device premarket review system should rely on “substantial equivalence” to a device already on the market as evidence of safety and effectiveness.

(28) The standard for approving any high-risk (class III) device under the PMA process should be changed to “substantial evidence” of safety and effectiveness from the current “reasonable assurance” that the device is safe and effective. The current low standard threatens patient safety because it accepts data from poorly designed and uncontrolled clinical trials as acceptable evidence for establishing the safety and effectiveness of a device during the review process.

(29) Drop the least-burdensome requirement. For all submissions, the requirement that the FDA evaluate devices in a manner that is “least burdensome” upon manufacturers should be eliminated. It is in the best interests of patients and device manufacturers alike for the FDA to make its judgments based on all necessary information.

(30) Implement a requirement for all moderate- and high-risk devices to have unique device identifiers to allow for efficient and effective tracking of medical devices, particularly in the event of a recall.

Study finds improved patient health care delivery a must for orthopedic surgeons

Chair of Orthopedic Surgery at Mayo Clinic: Daniel J. Berry

Study finds improved patient health care delivery a must for orthopedic surgeons

ORLANDO, Fla. — For the specialty to survive, orthopedic surgeons must provide patients with new methods ofhealth care delivery in the form of improved safety, value and care, according to a presentation at the Current Concepts in Joint Replacement 2011 Winter Meeting, here. “We will not thrive as a profession if the population cannot afford our care,” Daniel J. Berry, MD, said. In his presentation, Berry, who chairs the orthopedic department at the Mayo Clinic in Rochester, Minn., outlined five ways that he believes orthopedic medicine can “out distance” other specialties: innovations in patient safety, fostering research and development, creating affordable and accessible care, improving quality of work, and attracting the best talent to the profession.

The tendency to rush to adopt new technology has hurt the specialty in the past, Berry noted, citing the recent metal-on-metal hip implant recalls as an example of this problem.

The public is also aware of these controversies, he said. Berry also mentioned that surgeons should collectively fight for more funds for musculoskeletal research, noting that such scientific efforts are under-funded in orthopedics compared with other medical professions, despite the prevalence of orthopedic care throughout our society. “We keep people working [and] we keep them independent,” Berry said. Reference: Berry DJ. Optimizing health care delivery: best in class. Paper #35. Presented at the Current Concepts in Joint Replacement 2011 Winter Meeting. Dec. 7-10. Orlando, Fla. Disclosure: Berry receives royalties from DePuy.

Insurance decision delayed is treatment denied for patients . . . profit for industry.

Link to Huffington Post story about insurance shenanigans that hurt patients/consumers.
Tom Wilson, CEO of Allstate, earned $9.3 million in 2010.

Insurance Claim Delays Deliver Massive Profits To Industry By Shorting Customers

First Posted: 12/13/11 05:24 PM ET Updated: 12/13/11 05:52 PM ET

WASHINGTON -- Unlike many other businesses, the insurance industry is bound by law to act in good faith with its customers. Because of their protective role in the lives of ordinary citizens, insurers have long operated as semi-public trusts. But since the mid-1990s, a new profit-hungry model, combined with weak regulation, has upended that ancient social contract.

"Claims has been converted into a money-making process," said Russ Roberts, a New Mexico-based management consultant and former business professor at Northwestern University who has studied the insurance industry's evolution from a service business to a profit-driven machine.

The change started when consulting giant McKinsey & Company sold Allstate and other leading insurance companies on a new system to boost the bottom line: Rather than adjusting claims the traditional way, which gave claims managers wide latitude to serve customers, insurers embraced a computer-driven method that produced purposefully low offers to claimants.

Those who took the low-ball offers received prompt service, while those who didn't had their claims delayed and potentially were reduced to bringing expensive lawsuits to fight for their benefits. As former Allstate agent Shannon Kmatz told the American Association for Justice, the trial lawyers' lobby, the strategy was to make claims "so expensive and so time-consuming that lawyers would start refusing to help clients." The strategy was dubbed "Good Hands or Boxing Gloves" by the consultants, riffing on Allstate's advertising slogan.

McKinsey, which was reportedly hired by Allstate in 1992, prepared about 12,500 PowerPoint slides to present its plan. The slides were introduced in litigation in 2005, when the insurer turned them over under a temporary protective order. David Berardinelli, a New Mexico-based trial lawyer who was working on the case, detailed the slides in his 2008 book, "From Good Hands to Boxing Gloves: The Dark Side of Insurance."

McKinsey's strategy put profits above all. One slide in the McKinsey presentation illustrated this philosophy by painting the insurance business as a zero-sum game: "Improving Allstate's casualty economics will have a negative economic impact on some medical providers, plaintiff attorneys, and claimants. ... Allstate gains -- others must lose."

Allstate has certainly gained: It made $4.6 billion in profits in 2007, double its earnings in the 1990s. The stunning increase, said Russ Roberts, came through "driving down loss values to an average of 30 percent below the actual market cost" -- that is, paying dramatically less on claims.

"An insurance company can make a lot of money on the small claims," said Jay Feinman, a professor at Rutgers University School of Law, "because if you save a few dollars on a huge number of claims, it's worth more than saving a lot of dollars on a very small number of claims."

Allstate is the best-known user of the McKinsey model, topping the list of the "Ten Worst Insurance Companies in America" published by the American Association for Justice. But Allstate's rise in profits has led most of the industry to adopt the same approach. McKinsey has worked with State Farm, another insurance giant, and other companies in redesigning their claims systems. Feinman cautioned in his book "Delay, Deny, Defend" that the two major names "are just the largest players in the industry ... [the ones] whose involvement with McKinsey & Company in the transformation of claims is the best documented."

Roberts told HuffPost that, by his estimate, the companies that take in 70 percent of total insurance profits in the United States now abuse their obligations to their policyholders. When Allstate CEO Tom Wilson earned $9.3 million last year, he was not even on the top 10 list of best-paid insurance executives, compiled by New York Law School's Center for Justice and Democracy. (The top 10 list was led by William R. Berkley of W.R. Berkley, who made $24.6 million in 2010.)

Yolande Daeninck, spokeswoman for McKinsey & Company, said, "In line with our firm's longstanding policy to not discuss our client work, we decline to comment."

A HOUSE BURNS DOWN

According to an unpublished Harris Interactive Poll conducted in September, 16 percent of surveyed adults have experienced financial hardship while waiting for an insurance claim to be settled or know someone who has. The same poll found that 59 percent of adults believe that most insurers intentionally delay claims -- and those with an income of $35,000 or less were more likely to agree.

With 15.3 percent of Americans -- about 46.2 million people -- living in poverty, close to 10 percent unemployment, and roughly 2 million people who've been looking for work for more than two years, Allstate's business model is profiting off many consumers at their most vulnerable. A claim delayed by even a month can spell financial disaster for a family. As a National Bureau of Economic Research study found, about 25 percent of Americans could not come up with $2,000 in a 30-day period.

Madeleine Burdette, a retiree, is an Allstate customer who reported her experience on the popular website AllstateInsuranceSucks.com. When her Georgia home burned in November 2010, Burdette was in Ohio, where she lives most of the year. She said the fire marshal in Georgia told her that her house would have to be torn down. "The entire middle of the house was gone," Burdette said. "It took out everything. Just the outside walls were left untouched."

The next day, she said, Burdette's Allstate adjuster told her the house could be repaired. Allstate also said it would have to do a thorough investigation to determine if the fire was caused by arson. If it was arson, the adjuster told Burdette, Allstate would not pay for any damages. According to former employees, such investigations are a common practice at Allstate and are encouraged by supervisors as a way to avoid paying claims quickly.

Burdette, who lives on her Social Security checks, flew from Ohio to survey the damage herself. While in Georgia, she contacted public adjuster Anita Taff. Public adjusters serve as advocates for individuals who feel they need another set of eyes on a claim. Taff met with Burdette at the house, Burdette said, and discussed the damage with the contractor Burdette had hired. Upon returning to Ohio, Burdette spoke with Taff over the phone to find out what her impression was. Burdette said Taff warned her that the contractor might go along with Allstate's insistence that the house could be repaired.

"I believe [delaying claims] is an effort to put the squeeze on policyholders," Taff told HuffPost. She explained that while a claim is being held up, the insurance company may stop paying the policyholder's additional living expenses, forcing the policyholder to cover mortgage and rent entirely out of pocket. "That's something that many people cannot afford to do, so they're forced to take a lower settlement," Taff said.

Burdette said she immediately called the contractor and told him not to go near her house. According to Burdette, she received a phone call within 10 minutes from her Allstate adjuster asking her not to hire Taff or any other public adjuster. "He said, 'If you hire a public adjuster, I'm going to deny and delay this claim for as long as possible,'" Burdette told HuffPost. Taken aback, she then asked if it wasn't in his best interest to settle the claim. "Not really," he replied, according to Burdette.

Although the Allstate adjuster eventually agreed to work with Taff on Burdette's claim, her troubles did not end. The contractor who had been banned from her property nevertheless worked on the house and billed Allstate for $22,000. Burdette had explicitly told Allstate not to pay the contractor a dime, she said, but the company paid him under her policy anyway. The contractor couldn't be reached for comment.

More than a year later, Burdette's home is still being repaired and Allstate refuses to reimburse the $22,000. She consulted four different lawyers to see if she had a legal case. While she said they all agreed that she was entitled to reimbursement, she said they also agreed that she lacked the funds to fight the insurance giant. "They told me, 'You'll run out of money,'" she said.

NO FLUKES

Roberts, the management consultant, said that companies like Allstate attempt to pass off claims delays as fluke occurrences. But, he said, they are actually routine and intentional products of the McKinsey system: "The Allstate/McKinsey system for 'lowballing' claims payments ... is driven by the claims performance management and pay systems from the top to the bottom of the organization."

Feinman, the Rutgers law professor, also suggested the deck is stacked against individuals who make claims. "You have an accident or a fire in your house. You call up the insurance company. You describe the circumstances. Maybe they send an adjuster out, and they say it's not covered, or it's covered but here's the dollar amount that we're obligated to pay you," he said. Most people, Feinman said, do not have the expertise "to know whether or not that's right."

Allstate spokeswoman Laura Strykowski said the company can't comment on specific cases because of privacy requirements, but considers its claims process both legal and effective. "Our customers and claimants receive prompt and courteous claim service and our goal is to settle each claim fairly and efficiently," she wrote to HuffPost. "As a regulated company, Allstate's claim practices are available to and regularly reviewed by state departments of insurance."

But experts like Feinman argue that insurance regulation has become little more than a fig leaf. State insurance departments are usually understaffed and overwhelmed. And even if they had the legal firepower to contend with giant insurance companies, Feinman said, "the regulators are closer to the industry than they are consumers." Eleven of the past 15 presidents of the National Association of Insurance Commissioners (NAIC) went on to work for the insurance industry after leaving office, while a 17-year study from two Georgia State University professors found that around half of state-level insurance commissioners did so as well.

When combined with penalties that Feinman described as "laughably low" in many states, this close relationship means that regulation does not provide an effective check on insurance companies. And state governments themselves have incentive to place consumers on the backburner. Because insurance taxes are a major source of revenue for the states, said Roberts, insurance oversight commissions are usually more concerned with keeping companies solvent than resolving the problems of policyholders.

With the exception of the federal Affordable Care Act, insurance is regulated on a state-by-state basis. Although most states set a specific timeline for how quickly an insurance company must initially respond to claims, there is much more leeway when it comes to settling those claims. For example, in Missouri, an insurer must acknowledge receipt of a claim within 10 days and either pay or deny it within 15 days of receiving all necessary documentation. However, if the insurer decides it needs more time to investigate, it may keep delaying as long as it updates the policyholder every 45 days. In Georgia, where Burdette's house burned down, the insurer must notify the policyholder if it will affirm or deny a claim within 60 days. However, the insurer does not have to settle the amount it will pay within that period. Many states have similar provisions that allow insurers to put off paying claims indefinitely.

According to NAIC data, claim delays have long been the most frequent cause of policyholder complaint. As of Nov. 28, 2011, the NAIC had received 11,053 delay-related complaints this year alone, comprising almost a quarter of the year's total complaints. These data only reflect confirmed complaints -- the ones that the state insurance commission has investigated -- so the actual number of delayed claims is likely much higher.

Complaining to state regulators about the insurer's delay is always an option, but its effectiveness is questionable at best. "I have not seen it be successful," said Taff.