Health Blog

Here is the latest in the parade of legal settlements of cases of alleged wrong-doing by health care organizations.  As reported by Duff Wilson in the New York Times,

The pharmaceutical company AstraZeneca said Thursday that it had reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its blockbuster psychiatric drug Seroquel.

One of the investigations related to ’selected physicians who participated in clinical trials involving Seroquel,’ AstraZeneca disclosed in a government filing. The other case related to off-label promotion of the drug.

Seroquel was the top-selling antipsychotic drug in America. It had $17 billion in sales in the United States since 2004, according to IMS Health, a research firm.

Tony Jewell, a company spokesman, declined to be more specific about the physicians or clinical trials under investigation. He said the company was in final negotiations to settle the whistle-blower suits and reach a corporate integrity agreement with the Justice Department.

The name of the whistle-blowers and other details of the suits remained sealed in federal court. Stephen A. Sheller, a lawyer in Philadelphia for the whistle-blowers, and Patricia Hartman, a spokeswoman for the United States attorney in Philadelphia, both declined to comment.

Here we go again. As the Times article noted,

AstraZeneca, based in Britain, joins a list of drug makers that have paid billions to settle inquiries initiated by complaints from former company insiders.

Earlier this year, Eli Lilly & Company paid $1.4 billion over its marketing of Zyprexa, another antipsychotic drug. And Pfizer announced it would pay $2.3 billion, including a record $1.195 billion criminal fine, mostly over its painkiller Bextra, which has been withdrawn from the market.

Does anyone really still believe that integrity agreements, and settlements assessed against huge corporations deter such profitable bad behavior? A half a billion dollar one-time settlement is just a small cost of doing business for a company that sold $17 billion worth of the offending drug in the last five years. As in the case of many other previously announced settlements, it appears that nobody who authorized, directed, or implemented the bad behavior that led to the settlement will suffer any sort of negative consequences.

We previously discussed allegations that AstraZeneca manipulated and suppressed clinical research, and organized deceptive marketing campaigns in support of Seroquel sales (here, and here).  If we do not discourage such practices, they will continue to bias the clinical evidence making expensive drugs and devices seem more effective and less dangerous than they really are.  Is it any wonder that we over-use and over-pay for these products?  Anyone seriously interested in reforming health care to improve quality and access while moderating costs ought to pay attention to behavior that leads to such over-use and over-payment. 

(However, there may be hope.  Perhaps in the future there will be more effective deterrence.  A recent indictment named not only the device company Stryker Biotech (a subsidiary of Stryker Corporation), but also its former CEO and three managers.)

A recent article by Gardner Harris in the New York Times focused on the financial links among health care corporations and not-for-profit disease (or patient) advocacy groups.

A majority of the donations made to the National Alliance on Mental Illness, one of the nation’s most influential disease advocacy groups, have come from drug makers in recent years, according to Congressional investigators.

The alliance, known as NAMI, has long been criticized for coordinating some of its lobbying efforts with drug makers and for pushing legislation that also benefits industry.

Last spring, Senator Charles E. Grassley, Republican of Iowa, sent letters to the alliance and about a dozen other influential disease and patient advocacy organizations asking about their ties to drug and device makers. The request was part of his investigation into the drug industry’s influence on the practice of medicine.

The mental health alliance, which is hugely influential in many state capitols, has refused for years to disclose specifics of its fund-raising, saying the details were private.

But according to investigators in Mr. Grassley’s office and documents obtained by The New York Times, drug makers from 2006 to 2008 contributed nearly $23 million to the alliance, about three-quarters of its donations.

Even the group’s executive director, Michael Fitzpatrick, said in an interview that the drug companies’ donations were excessive and that things would change.

However, he tried to downplay the influence of the pharmaceutical industry on the Alliance.

‘I understand that NAMI gets painted as being in the pockets of pharmaceutical companies, and somehow that all we care about is pharmaceuticals,’ Mr. Fitzpatrick said. ‘It’s simply not true.’

Note the careful wording of this denial, though. He did not deny that most of what NAMI cares about is pharmaceuticals.

Moreover, the article suggested how cozy pharmaceutical companies and the Alliance’s leadership have become.

The close ties between the alliance and drug makers were on stark display last week, when the organization held its annual gala at the Andrew W. Mellon Auditorium on Constitution Avenue in Washington. Tickets were $300 each. Before a dinner of roasted red bell pepper soup, beef tenderloin and tilapia, Dr. Stephen H. Feinstein, president of the alliance’s board, thanked Bristol-Myers Squibb, the pharmaceutical company.

‘For the past five years, Bristol-Myers has sponsored this dinner at the highest level,’ Dr. Feinstein said.

He then introduced Dr. Fred Grossman, chief of neuroscience research at Bristol-Myers, who told the audience that ‘now, more than ever, our enduring relationship with NAMI must remain strong.‘

Documents obtained by The New York Times show that drug makers have over the years given the mental health alliance — along with millions of dollars in donations — direct advice about how to advocate forcefully for issues that affect industry profits.

In a letter today to the NY Times, NAMI Executive Director Fitzpatrick tried again to correct “misimpressions.”

First, the National Alliance on Mental Illness, or NAMI, has always disclosed corporate and foundation sources of revenue. Until this year, specific amounts remained private for competitive fund-raising reasons.

Second, your estimate that pharmaceutical companies account for three-quarters of “donations” has been misinterpreted as a share of NAMI’s total annual budget — which is actually about 50 percent.

Perusal of the 2008 NAMI Annual Report does include this impressive list of “Corporate Partners”:

Abbott
Alexza Pharmaceuticals
Amazon
AstraZeneca
Blue Cross Blue Shield
Bristol-Myers Squibb
College of Psychiatric and Neurologic
Pharmacists
Corcept Therapeutics
Cyberonics
Delivery Agent, Inc.
Forest Laboratories
GEO Care
GoodSearch.com
The Health Central Network
Janssen Pharmaceutica
Eli Lilly and Company
Magellan Health Services
McNeil Pediatrics
Neuronetics
Novartis
Otsuka America Pharmaceuticals
Pfizer
PhRMA
RF Binder
Sanofi-Aventis
Shire
Solvay
Validus Pharmaceuticals
WellPoint
Wyeth
YTB Travel Network

The NAMI web-site now includes lists of specific corporate donations that individually exceeded $5000 since the beginning of 2009. So far this year, the biggest pharmaceutical corporate donors appear to be AstraZeneca ($350,000), Bristol-Myers-Squibb ($506,205), and Eli Lilly ($675,500). 

Looking at the latest Form 990 filed on behalf of NAMI with the US Internal Revenue Service (available from GuideStar here)  provides more interesting detail. (Keep in mind that the 2008 form covers July 1, 2007 to June 30, 2008.)   This form listed the organization’s total revenue as $13,788,288, and expenses as $12,796,205.  These expenses included $1,785,060 (13.9%) for management and $1,520,637 (11.9% ) for fund-raising.  The form listed eight NAMI executives who made more than $100,00 a year, including Mr Fitzpatrick ($210,685 total compensation).

So, in summary, it appears that corporate donations, mainly from a few large pharmaceutical companies, supply a substantial portion, (maybe half, if I read the letter by Mr Fitzpatrick correctly) of the annual budget of NAMI. About one-quarter of that budget is spent on administration and fund-raising, including six-figure salaries for at least eight executives.  So who do you expect would more easily get access to the $200K+/year NAMI Executive Director, an executive of a pharmaceutical firm that supplies more than $500,000 a year, or a NAMI member who pays $35 dues?

Here we have another example of a respected patient advocacy organization which gets a substantial portion of its revenue from (presumably the marketing departments of) a few large pharmaceutical companies.  (See another example here.)  Its well-paid executive director can at best bring himself to deny that the only purpose of the organization is to support pharmaceutical marketing and lobbying.  It seems reasonable that for supplying half the budget, the pharmaceutical companies expect considerable help not only with marketing but also with advocacy of policies that favor their corporate goals. 

As I have said before, I do not have a problem with pharmaceutical and other health care corporations marketing their products, and expressing their views on policy. I do have a problem with corporate marketing or policy advocacy is disguised as grass-roots, not-for-profit education and advocacy.  If ostensibly not-for-profit disease (or patient) advocacy organizations like NAMI want to continue to accept corporate money, they should make it clear that they speak for their corporate donors as well as, and probably with priority over their members and patients with the diseases of interest.  Well-intentioned people who pay their dues, and/or make small contributions to NAMI to help the mentally ill might want to consider whether they are likely to have any influence compared to the individual pharmaceutical executives who oversee $500,000+ a year corporate donations. 

San Diego 24 hour fitness the way to exercise for those people who want open hours. This will work great for those people who work odd hours as well, and may not be able to head to a regular gym. Offering you many programs that will help you get into shape, with the great thing of being open all the time.

Just like a normal fitness center that will offer specialized classes. Things that you can't find at a gym or most health clubs as well. Many fitness centers will have these programs that will help kick start a program that may have stalled in the results you've been seeing.

Boot camps, boxing classes and more can be found at some of these San Diego 24 hour fitness locations. Boot camps are very intense workouts that can show you results in four or six week sessions. The boxing class can have you burning up to 1, 000 calories in just an hour. You can see how both of these options will have you in the best shape of your life.

Some fitness centers will even have a pool and offer classes in the pool. Swimming classes will have less resistance being felt by your body, and are a great option to get into shape. Plus they have a wide variety of other classes that you can take. Things like Pilates, step classes, or yoga, and those are only a few of the choices you will have.

This San Diego 24 hour fitness locations will also offer specials when you sign up for a membership. They aren't near as expensive as you may imagine either. Especially when you consider everything that you can get with a membership to one of these places.

The great thing about a San Diego 24 hour fitness club is that you have the option to exercise at any time of the day. Maybe you have a young child at home and during the day your spouse is at work, and you won't be able to get out. Wait until they get home, or later on at night when you child is asleep and head in to get a workout.

Consider adding the services of one of the professional trainers that are employed by your San Diego 24 hour fitness club. They can provide you with not only a cardio program, but nutrition as well. Setting up a specific program that will be figured out by finding out your health history, and goals that you want to meet. Personal trainers are also great motivators for making into the location and working out. Knowing that they are waiting to meet with you, you will be less likely to skip a session.

Picking a location that is close to you will have a better chance of going more frequently.

Getting into a San Diego 24 hour fitness club could be one of the best choices you make for your health. Look into those different classes they offer and see how many you can join. Or hire a personal trainer to help reach goals you've been hoping to get to for years.

About the Author: Find a San Diego 24 Hour Fitness Center and visit it to see what it looks like inside. Ask about the membership fees, and see what is included in that 24 Hour Health Fitness Center membership. Don't forget to ask about special classes they may offer in that location as well.

As people live longer, and as lifestyles become less healthy, so-called diseases of affluence are becoming more prevalent in certain areas of the world. Heart disease and diabetes can kill, whether slowly or suddenly. People have been looking for different ways to counter and prevent the onset of these diseases.

There has been some buzz recently about a compound that could help address this problem. Resveratrol, a chemical some plants use to fight disease or attack, has been tested on laboratory animals and proven to lower their blood sugar. It has also helped to re-balance their bodies' processing of carbohydrates, which not only leads to lower blood sugar but also lower body fat and better cardiovascular health.

Resveratrol also seems to have effects that increase metabolism. This means that your body will store less sugar and fat, even if you eat the same amount of food and do the same amount of exercise as usual. Yet again, most of this information comes from tests on laboratory animals, rather than on humans. Still, studies of human metabolism show that a similar metabolic pathway can be found in a human body, and may also respond to Resveratrol. With less cholesterol, especially in your veins, your heart will not have to work as hard to pump blood around, so heart attacks and burst blood vessels may be less of a risk. Resveratrol is definitely worth thinking about, especially if your metabolism is slow, and/or your family has a history of obesity or cardiovascular disease.

The good news is that it does not appear to matter whether you get your Resveratrol from a pill or from "natural" sources like wine or Japanese knotweed. After all, the food may contain other substances that might be harmful to you. It does seem rather counterproductive to be getting drunk regularly in order to improve the condition of your heart, since regular high alcohol consumption can actually lead to heart failure. Resveratrol will have more or less the same effect on your body whether or not it comes from a pill. However, the pill brings with it less "excess baggage," and allows you more control of your diet because you will not have to be packing your meals with Resveratrol-high foods in order to get the benefits. Keep in mind that researchers have suggested that you might need a few grams of Resveratrol per day in order to see a noticeable drop in your blood sugar.

In addition, Resveratrol may have similar effects on the body as calorie restriction, minus the loss of strength, amenorrhea and near starvation. Scientists are still somewhat baffled by the benefits of calorie restriction, such as better heart condition and a potentially longer life, but Resveratrol could be one way to get a piece of them without the rather disturbing side effects.

If you are looking for a natural way to improve your heart condition, but cannot afford to radically alter your lifestyle, try to look into what Resveratrol can do for you.

About the Author: The latest Health Craze Resveratrol has been shown to have great anti aging and blood sugar lowering abilities. Anyone that wants to benefits from Resveratrol may want to try an HGH Supplement such as Genf20 Plus with resveratrol.

This past Sunday night, 60 Minutes ran an excellent exposé on the $60 billion Medicare Fraud crime wave sweeping the country. 60 Minutes correspondent Steve Kroft spent some time in Miami this past August with FBI Special Agent Brian Waterman getting an overview of how Medicare fraud is perpetrated by DME scammers.

South Florida is the epicenter of Medicare fraud, so there was plenty to report. DOJ prosecutor and Healthcare Fraud Strike Force leader, Kirk Ogrosky was also interviewed and said Medicare fraud is “way bigger than the drug business in Miami now.” Waterman and Ogrosky agreed that the criminals perpetrating Medicare fraud are more sophisticated than before.

“They’ve figured out that rather than stealing $100,000 or $200,000, they can steal $100 million. We have seen cases in the last six, eight months that involve a couple of guys that if they weren’t stealing from Medicare might be stealing your car,” Ogrosky explained.

“You know, we were the king of the drugs in the ’80s. We’re king of healthcare fraud in the ’90s and the 2000’s,” Waterman added, speaking about South Florida.

To read the transcript of the 60 Minutes segment click here.

To watch, click here.

We have frequently advocated the evidence-based medicine (EBM) approach to improve the care of individual patients, and to improve health care quality at a reasonable cost for populations. Evidence-based medicine is not just medicine based on some sort of evidence. As Dr David Sackett, and colleagues wrote [Sackett DL, Rosenberg WM, Muir Gray JA, Haynes RB, Richardson WS. Evidence-based medicine; what it is and what it isn't. BMJ 1996; 312: 71-72. Link here. ]

Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research.

One can find other definitions of EBM, but nearly all emphasize that the approach is designed to appropriately apply results from the best clinical research, critically reviewed, to the individual patient, taking into account that patient’s clinical characteristics and personal values.

When making decisions about treatments for individual patients, the EBM approach suggests using the best available evidence about possible benefits and harms of treatment, so that the treatment chosen is most likely to maximize benefits and minimize harms for the individual patient. The better the evidence about specific benefits and harms applicable to a particular patient, the greater will be the likelihood that a particular decision based on this evidence will result in the best possible outcomes for the patient.

A new study in the Archives of Internal Medicine focused on how articles report adverse effects found by clinical trials. [Pitrou I, Boutron I, Ahmad N et al. Reporting of safety results in published reports of randomized controlled trials. Arch Intern Med 2009; 169: 1756-1761. Link here.] The results were not encouraging.

The investigators assessed 133 articles reporting the results of randomized controlled trials published in 2006 in six English language journals with high impact factors, that is, the most prestigious journals, including the New England Journal of Medicine, Lancet, JAMA, British Medical Journal, and Annals of Internal Medicine. They excluded trials with less common designs, such as randomized cross-over trials. The majority of trials (54.9%) had private, or private mixed with public funding.

The major results were:
15/133 (11.3%) did not report anything about adverse events
36/133 (27.1%) did not report information about the severity of adverse events
63/133 (47.4%) did not report how many patients had to withdraw from the trial due to adverse events
43/133 (32.3%) had major limitations in how they reported adverse events, e.g., reporting only the most common events (even though most trials do not enroll enough patients to detect important but uncommon events).

The authors concluded, “the reporting of harm remains inadequate.”

An accompanying editorial [Ioannidis JP. Adverse events in randomized controlled trials: neglected, distorted, and silenced. Arch Intern Med 2009; 169: 1737-1739. Link here] raised concerns about why the reporting of adverse events is so shoddy:

Perhaps conflicts of interest and marketing rather than science have shaped even the often accepted standard that randomized trials study primarily effectiveness, whereas information on harms from medical interventions can wait for case reports and nonrandomized studies. Nonrandomized data are very helpful, but they have limitations, and many harms will remain long undetected if we just wait for spontaneous reporting and other nonrandomized research to reveal them. In an environment where effectiveness benefits are small and shrinking, the randomized trials agenda may need to reprogram its whole mission, including its reporting, toward better understanding of harms.

Pitrou and colleagues have added to our knowledge about the drawbacks of the evidence about treatments that is publicly available to physicians and patients when making decisions about treatment. Even reports of studies with the best designs (randomized controlled trials) in the best journals seem to omit important information about the harms of the treatments they test.

It appears that the majority of the reports that Pitrou and colleagues studied received “private” funding, presumably meaning most were funded by drug, biotechnology, or device companies and were likely meant to evaluate the sponsoring companies’ products. However, note that this article did not analyze the relationship of funding source to the completeness of information about adverse effects.

Nonetheless, on Health Care Renewal we have discussed many cases in which research has been manipulated in favor of the vested interests of research sponsors (funders), or in which research unfavorable to their interests has been suppressed. Therefore, it seems plausible that sponsors’ influence over how clinical trials are designed, implemented, analyzed and reported may reduce information about the adverse effects of their products reported in journal articles. Trials may be designed not to gather information about adverse events. Analyses of some adverse events, or some aspects of these events may not be performed, or if performed, not reported. The evidence from clinical research available to make treatment decisions consequently may exaggerate the ratios of certain drugs’ and devices’ benefits to their harms.

Patients may thus receive treatments which are more likely to hurt than to help them, and populations of patients may be overtreated. Impressions that treatments are safer than they actually are may allow their manufacturers to overprice them, so health care costs may rise.

The article by Pitrou and colleagues adds to concerns that we physicians may too often really be practicing pseudo-evidence based medicine when we think we are practicing evidence-based medicine. We cannot judiciously balance benefits and harms of treatments to make the best decisions for patients when evidence about harms is hidden. Clearly, as Ioannidis wrote, we need to “reprogram.” However, what we need to reprogram is our current dependence on drug and device manufacturers to pay for (and hence de facto run) evaluations of their own products. If health care reformers really want to improve quality while controlling costs, this is the sort of reform they need to start considering.

NB – See also the comments by Merrill Goozner in the GoozNews blog.

The AP does an interesting story on the influence of organized crime on Medicare Fraud, including some violence associated with the schemes. Former drug dealers and mobsters are getting more involved in the fraud due to the lower criminal penalties and larger amounts of money available than drug dealing, loan sharking or other organized crime activities. I recall one case in which a former drug trafficker explained why he moved to Medicare Fraud, “I got older, didn’t want to run around so much and no one shoots at you.”

For more, click here.

This past Sunday night, 60 Minutes ran an excellent expose on the $60 billion Medicare Fraud crime wave sweeping the country. 60 Minutes correspondent Steve Kroft spent some time in Miami this past August with FBI Special Agent Brian Waterman getting an overview of how Medicare fraud is perpetrated by DME scammers.

South Florida is the epicenter of Medicare fraud, so there was plenty to report. DOJ prosecutor Kirk Ogrosky was also interviewed and said Medicare fraud is “way bigger than the drug business in Miami now.” Waterman and Ogrosky agreed that the criminals perpetrating Medicare fraud are more sophisticated than before.

“They’ve figured out that rather than stealing $100,000 or $200,000, they can steal $100 million. We have seen cases in the last six, eight months that involve a couple of guys that if they weren’t stealing from Medicare might be stealing your car,” Ogrosky explained.

“You know, we were the king of the drugs in the ’80s. We’re king of healthcare fraud in the ’90s and the 2000’s,” Waterman added, speaking about South Florida.

To read the transcript of the 60 Minutes segment click here.

To watch, click here.

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