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Intermune Executive Convicted of Fraud

Posted on Sep 30, 2009 02:53:00 PM |

From today’s New York Times comes word of an uncommon legal case,

In a verdict that could strike fear into pharmaceutical industry executive suites, the former head of a drug company was convicted of wire fraud Tuesday for issuing what federal prosecutors called a misleading press release that contributed to off-label sales of his company’s drug.

But the executive, W. Scott Harkonen, the former chief executive of InterMune, was acquitted by the federal jury in San Francisco of a related charge of off-label marketing itself, known as ‘misbranding,’ the Justice Department stated.

The case was uncommon because off-label marketing cases are often settled with the company paying a fine. It is rare for prosecutors to press charges against individual executives.

‘Today’s verdict demonstrates that pharmaceutical executives won’t be able to hide behind a corporate shield when they promote drugs using false or fraudulent information,’ Thomas P. Doyle, a special agent in the Food and Drug Administration’s office of criminal investigations, stated in a statement Tuesday.

InterMune’s drug, Actimmune, was approved for two rare genetic conditions. But the main sales of the drug, which peaked at $141million in 2003, came from an unapproved use: treating idiopathic pulmonary fibrosis, a scarring of the lungs that can be fatal.

InterMune conducted a big clinical trial testing Actimmune as a treatment for the lung disease. The drug didn’t achieve the goal of the trial, which was to improve lung function compared with a placebo. But InterMune found that if only the patients in the trial with mild or moderate disease were considered, those who got the drug lived longer than those who received the placebo. The company highlighted the ’survival benefit’ in a news release, issued in August 2002. [Editor’s note - if the primary study outcome was improvement of lung function, and the only ‘positive’ result was improvement of survival in one sub-group, that result might have been due to chance alone, due to multiple statistical comparisons. If one does analyses on multiple sub-groups and for multiple endpoints, the likelihood of finding a ’significant’ result increases with the number of such analyses done.]

Prosecutors said the news release was part of a scheme to induce off-label sales of Actimmune, also known as interferon gamma, which costs about $50,000 a year.

[The company’s attorney] Mr. Topel stated interpretation of the clinical trial results was a matter of debate. ‘One position in a scientific dispute has been criminalized — quite an amazing thing,’ Mr. Topel stated in an interview.

Wire fraud carries a maximum sentence of 20 years in prison and a $250,000 fine. Dr. Harkonen, who remains free on bail, has not been sentenced.

A medical doctor by training, he was chief executive of InterMune from February 1998 until June 2003.

InterMune concurred to pay about $37 million in 2006 to settle charges related to Actimmune marketing. The company, based in Brisbane, Calif., also entered into a five-year corporate integrity agreement with the Department of Health and Human Services.

In 2007, a second large trial of Actimmune found that the drug did not prolong lives of patients with pulmonary fibrosis. Sales of the drug have dwindled year by year. [Editor’s note - this advocates again that the result in the sub-group from the first trial might have been a false positive due to multiple comparisons.]

This case is uncommon because it involved the prosecution of an individual who appeared to be responsible for the allegedly unlawful conduct. In most cases of unethical or unlawful conduct alleged on the part of health care organizations, at most it is the organization itself that has paid the penalty, usually in the form of a fine, sometimes accompanied by a corporate integrity agreement or deferred prosecution agreement. (See relevant posts here.)

We have argued that such penalties applied to corporations do little to deter bad behavior. A fine can just be a cost of doing business. The cost of the fine may diffuse across the whole organization. For public for-profit corporations, the fine may finally be paid by stockholders (through lower dividends or lower stock appreciation), employees as a group (through lower pay), and customers, clients, or patients (through higher prices). So the penalty might ultimately be spread over a huge number of people, hardly any of which were actually responsible for the bad behavior. The few people responsible, who could include people who implemented, directed, or approved the behavior, usually have suffered no consequences. So what is to deter such people from again behaving badly?

So this case seems to be a step forward. One might argue whether off-label marketing should be illegal, but it currently is illegal. Corporate leaders who do not like this law ought to strive to change it, not violate it. If the law is to be upheld, when someone within a corporation implements, directs or approved illegal off-label marketing, then that person should suffer the consequences.

[Source : Health Care Renewal]

The Kelo Case Redux: Pfizer’s "Nice Place" Ends Up Covered with Weeds

Posted on Sep 28, 2009 07:40:00 PM |

Four years ago we posted (here, here and here) about the controversial US Supreme Court decision in the Kelo case. Most discussion of the case at the time focused on individual property rights vs the power of the government to promote economic development, but the case had an important health care angle.

Briefly, the case centered on the taking of private property, including a home owned by Susette Kelo, by a not-for-profit organization, the New London (Connecticut) Development Corporation (NLDC) given the power of eminent domain by the New London city government. While the ostensible rationale for the taking was economic development, the action appeared to have been at the behest of Pfizer Inc, the world’s largest pharmaceutical company, which had built a research and development facility in the city, and wanted a suitably upscale and cleansed environment for its workers.

As we previously posted, the NLDC’s leadership had multiple conflicts of interest that involved ties to Pfizer. One board member was a Pfizer vice-president. The board president was married to another Pfizer vice-president. Pfizer wanted the part of New London that included Kelo’s house made more attractive to complement its new research facility. The husband of the NLDC president had stated, “Pfizer wants a nice place to operate. We don’t want to be surrounded by tenements.”

Kelo’s and other property owners’ protest of the taking went all the way to the US Supreme Court. As we posted here, the Court decided against the property owners by a 5-4 vote. Justice John Paul Stevens wrote for the majority that the city’s “determination that the area was sufficiently distressed to justify a program of economic rejuvenation is entitled to our deference. The city has carefully formulated an economic development plan that it believes will provide appreciable benefits to the community, including - but by no means limited to - jobs and increased revenues.” This majority view is important, because the Fifth Amendment to the US Constitution provides “nor shall private property be taken for public use without just compensation.” Many had interpreted this provision to mean that eminent domain could only be used to take property for public use, e.g., to build a road or a public school, but not for private purposes, like building upscale waterfront developments.

The Associated Press just published an ironic follow-up.

Weeds, glass, bricks, pieces of pipe and shingle splinters have replaced the knot of aging homes at the site of the nation’s most notorious eminent domain project.

There are a few signs of life: Feral cats glare at visitors from a miniature jungle of Queen Anne’s lace, thistle and goldenrod. Gulls swoop between the lot’s towering trees and the adjacent sewage treatment plant.

But what of the promised building boom that was supposed to come wrapped and ribboned with up to 3,169 new jobs and $1.2 million a year in tax revenues? They’re noticeably missing.

What happened?

New London the city’s prized economic development plan has fallen apart as the economy crumbled.

The Corcoran Jennison Cos., a Boston-based developer, had originally locked in exclusive rights to develop almost the entire northern half of the Fort Trumbull peninsula.

But those rights expired in June 2008, despite multiple extensions, because the firm was unable to secure financing, according to President Marty Jones.

So that was the result of the economic development plan the Supreme Court majority termed “carefully formulated.” The lesson seems to be that when government makes policy to favor individual corporations, the results are bad policy and little public benefit. Government leaders often seem willing to favor specific health care organizations, rationalizing their actions in terms of economic development or promoting health and health care. Doing so might benefit the corporations involved, but rarely individual or public health.

Even though US local and national government officials have have increasingly practiced such corporate socialism, they have neglected their regulatory roles. Instead of picking winners and losers, government would do superior to act like a combination of an honest policeman on the beat, deterring and punishing dishonest behavior, and in impartial referee, trying to make sure everyone is playing the game honestly. But no doubt government officials used to mingling with the corporate superclass wouldn’t be comfortable in the roles of honest cop or impartial referee.

[Source : Health Care Renewal]

Worldwide Threatening Disease - AIDS

Posted on Sep 28, 2009 01:47:52 PM |

AIDS is such a threatening disease that everyone scare of it but how many of us really understand and take appropriate precaution regarding to this disease? According to the Centers for Disease Control and Prevention (CDC) in US, there is 75% of men and 25% of women are infected with HIV in the 40,000 new infections every year. The number of people get infected of HIV is getting higher and higher and we should look at it seriously.

AIDS is a short form for Acquired Immune Deficiency Syndrome. It is an immune system disease which caused by the virus called HIV (Human Immunodeficiency Virus). Due to this immune system virus, it is able to reduce the effectiveness of the affected immune system and brings more unexpected infections to human body. Antibodies will be generated by human body to fight against with this virus to protect our immune system. Therefore, if you have a HIV positive with your blood test, it means you will have such antibodies in your blood and it’s definitely comes with the HIV as well. If you certified with HIV positive but not necessary is having AIDS. But if the HIV disease prolongs, it will slowly weak your immune system down where all the viruses, fungi, bacteria and etc start to assimilate to your body easily due to the damaged of your immune system and make your weak and lead to AIDS.

There is a high risk of getting HIV through blood that infected with HIV. For those drug users that depend on the intravenous drug through syringes especially those reusing syringes that might be contaminated with blood that infected by HIV might have the major risk for HIV positive. On the other hand, the breast milk from a mother who infected HIV also can infect others such as their baby who depends on breastfeeding. Those having sex with the HIV infected people also can be infected easily through vaginal fluid and semen. There is some risk on blood transfusion as well, where the blood supply might have contaminated with HIV. Therefore, the blood that collected through donation or etc is being screened through carefully to avoid this disaster.

The symptom of a HIV infected people is fever, headache, joint pain, stomachache and even sometimes come with the skin rash. But then, some people might not have any symptom as mentioned above, therefore they might not know that they had been infected with HIV. The virus will be generated multiple for few weeks or months. During this time, your immune system still unable to respond and will not able to have the blood test for HIV. Therefore, if you suspect yourself have been infected with HIV, then you might need to go for the blood test approximately after 2 months from the suspected timing which can test for the antibody that generated by the human body.

There is no suitable vaccine for HIV to cure for AIDS from previous till nowadays. We only go for the most preservative way where known as prevention method to avoid for virus exposure. The main prevention methods are avoid for un-safe sex life, reduce exposure to the infected body fluids and prevent from any HIV infected mother to get pregnant. The un-safe sex life with the infected HIV sex partner is usually the most high risk ranking in the HIV disease. Condoms are used to reduce the infection of HIV either in male or female if it had been used correctly. For those health care operators or workers, the health awareness shall be promoted where they shall use gloves, masks or any protective apparatus to prevent any exposure to the blood contaminated HIV. Needles, glass and etc shall be handled carefully where to be disposed correctly to avoid any unwanted infection. Lastly, the HIV infected mother shall prevent breastfeeding to their baby.

Since there is no cure for this disease, we shall take good care of ourselves to prevent from this threatening disease. Love ourselves and said no to those unhealthy activities that might cause the HIV infections.

About the Author

Anna has been writing articles online for nearly 3 years now. Not only she does her own research in healthcare, you can also check out her latest website on Fire Pit to find out more about fire pit covers.

Article Source: Content for Reprint

[Source : Full text health articles - Content for Reprint]

H1N1 Influenza

Posted on Sep 28, 2009 12:43:54 PM |

Everyone is discussing about H1N1 Influenza. But how many of us really understand about this virus? Basically the abbreviation of H1N1 is the official name by World Health Organization (WHO) by deriving the combination of medical terms of Hemaglutinin type 1 as well as Neuraminidase type 1. In fact, this H1N1 Influenza is a virus which able to damage human immune system and eventually this name exists from the flu virus that affected the pigs. Therefore, there is a misunderstanding that the cause of H1N1 is through eating the pork but studies shown that it is safe to eat the cooked pork products.

H1N1 can be transmitted through human, virus particles, contaminated objects or surfaces and also the belongings of the infected person. Even through breathing the air also can get transmission of H1N1 into the human body. Due to this wide method of transmission of H1N1, it is not sufficient just to wear a mask to protect ourselves but we shall always clean our hands frequently to prevent from picking up any viruses. We shall avoid the crowded and close-up places as the virus can be spread widely through air. The long life spans of the H1N1 over 12 hours on fabrics and 2 days on the porous surfaces make us live in danger.

The H1N1 influenza always starts with the regular flu as the more frequent symptom of the patient comes with the fever and sore throat as well. Sometimes, the patient might be hard to breathe, headache and also vomit. It is almost the same symptoms as the normal high fever and makes it hard to be detected.

It is better to prevent this disease before it is too late. There is a vaccination against influenza where is higher recommended for the high risk categories such as children, elderly and those asthma, diabetes and heart disease patients. The effectiveness of this vaccine is variable but due to the high ability of mutation for these viruses, normally this vaccine is only able to protect not more than few years. It is very hard to predict the changes and mutation of these viruses and make it even hard to produce the right vaccine. Besides from medical support, good personnel hygiene habits also play a very important role in preventing the H1N1 influenza. The good habits shall be obeyed like hand washing, covering nose and mouth while coughing and sneezing, no spitting also can reduce the spreading of influenza.

For the light infection of the H1N1 influenza patients, they can stay at home for home treatment as normal fever treatment. They shall rest more and drink more water; Acetaminophen can be used to relieve the headache and muscle pain as well. If the fever still consistently at 102F for 3 days and found difficulties in breathing, it shall be sent to the hospital for further treatment. Sometimes the anti-flu medication shall be intake to decrease the length of influenza. The newest medication of influenza such as Relenza and Tamiflu work well and effectively.

We should take this Influenza seriously as it can spread easily and become the un-controlled outbreak over the worldwide. The best way to prevent such influenza is to develop a hygiene habits toward the healthier life.

About the Author

Anna has been writing articles online for nearly 3 years now. Not only she does her own research in healthcare, you can also check out her latest website on Solar Pond Pump to learn more about solar pond pump .

Article Source: Content for Reprint

[Source : Full text health articles - Content for Reprint]

Malpractices of the multitude revisited: "An outstanding job of educating themselves about clinical issues"

Posted on Sep 27, 2009 10:57:00 AM |

At numerous posts at Healthcare Renewal, we’ve pointed out what we feel to be a serious gap in the credentials of many in biomedical leadership roles.

The gaps are in the form of a near complete lack of any scientific or biomedical education and experience, except perhaps a high school chemistry and biology class or two.

We often receive comments back, usually from “anonymous” posters such as here to our thoughts that this expertise gap impairs the judgment of such leaders on medical matters:

… No. I have met individuals with management training who do an outstanding job of educating themselves about clinical issues. And I have met individuals with clinical training who do an outstanding job of educating themselves about management and business issues.

I feel this “anyone can be an expert” sentiment is an important issue to bring outside of the comments section of our posts.

I raised probing questions in response to such messages here in my post “More On Healthcare Management By Domain Neutral Generalists: CIO’s Running Hospital Pharmacies and Home Healthcare Divisions?

Here are my most current questions to the above anonymous medical self-education proponent:

Re: “I have met individuals with management training who do an outstanding job of educating themselves about clinical issues.

What, exactly, is it that individuals with management training who do an outstanding job of “educating themselves about clinical issues” are professionally or even reasonably qualified to do?

Could they pass medical boards?

Could they reasonably interpret a complex medical article in, say, The Annals, and make truly informed, wise decisions based on that reading?

Could they reasonably evaluate therapeutic alternatives in complex cases, state, someone with a new heart valve who’s just developed fever and a lower GI bleed?

In an emergency could they provide medical care? (mot in the legal sense, just in the skills sense.)

If not, why not, and what do you mean by “outstanding job?”

In comparison, I have no MBA or formal business training (other than working for years in my dad’s pharmacy as a stocker and cashier) but did a good job managing a department of 50+ and a budget of $13 million for an international pharma, solving severe business problems that had been impairing R&D and managing my budget consistently to within 0.5% of EA.

Is there perhaps an asymmetry between medicine and business?

Finally, I ask:

What percentage of a typical medical training curriculum (such as for a Pharm.D. here or a doctor here) can a person with a management background absorb through self-education, and is the medical training curriculum therefore irrelevant? Should we just go back to the days of self-trained practitioners? If not, why not?

The critically thought-out answers to these questions expose the territorial invasion of medicine by ill-suited outsiders and dilettantes quite well.

Echoing an observation I wrote about once before in my eight part series on mission hostile EMR’s, but addressing it to medical administration where it also applies:

Medical administration reminds me of dentistry in its early days, especially when medical administrators lacking biomedical expertise refer to themselves as “medical professionals.”

B.T. Longbothom, author of the second dentistry book published in the U.S. (”A Treatise on Dentistry”, 1802), gave an excellent description in his preface of problems at the time. His observations apply to medical administration in our present age:

The word “dentist” has been so infamously abused by ignorant pretenders, and is in general so indifferently understood, that I can’t forbear giving what I conceive to be its original meaning: viz, the profession of one who undertakes and is capable not only of cleaning, extracting, replacing by transplantation and making artificial teeth, but can also from his knowledge of dentistry, preserve those that remain in good condition, prevent in a very great degree, those that are loose, or those that are in a decayed say, from being further hurt, and can guard against the several diseases, to which the teeth, gums and mouth are liable, a knowledge none but those regularly instructed, and who have had a long, and extensive practice, can possibly attain, but which is completely necessary, to finish the character of a Surgeon Dentist.

Hardly anyone spoke out.

More than thirty years later, untrained practitioners were as prevalent as ever. One of the leading dentists of the time, Shearjashub Spooner, in his “Guide to Sound Teeth, or, A Popular Treatise on the Teeth” (1836) warned the public of a phenomenon I believe now applies to medical administration:

One thing is certain, this profession must either rise or sink. If means are not taken to suppress and discountenance the malpractices of the multitude of incompetent persons, who are pressing into it, merely for the sake of its emoluments, it must sink, - for the few competent and well educated men, who are now upholding it, will abandon a disreputable profession, in a country of enterprise like ours, and turn their attention to some other calling more congenial to the feelings of honorable and enlightened men.

I comprehend that point of view.

– SS

[Source : Health Care Renewal]