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Category: Legal Side of Medicine

Stronger Warnings on Heart Failure Risk for Avandia and Actos Type Drugs

Update: “FDA Adds Boxed Warning for Heart Attacks to Anti-Diabetes Drug Avandia. Agency says drug to remain on market, while safety assessment continues”

The US Food and Drug Administration (FDA) is requiring some Type 2 diabetes drugs to change its product label to include a heart failure risk warning. This “boxed” warning emphasizes that the class of thiazolidinedione drugs may cause or worsen heart failure in certain patients. Drugs in this class included Avandia (rosiglitazone), Actos (pioglitazone) Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepride). These drugs are currently approved in the US for treating type 2 diabetes in combination with diet and exercise. Postmarketing surveillance of these drugs is required by the FDA as a condition of approving these drugs and making them available on market. Postmarketing reports have shown cases of warning signs of heart failure: significant weight gain and edema (water retention and accumulation in organs). Source: FDA.

Device Companies Post How Much They Paid Orthopedic Surgeons

Major device companies that have been investigated by the government and entered into settlement were required to post how much they paid to orthopedic surgeons for consulting services. Wall Street Journal’s Health Blog posted the links to the company websites disclosing payment sums:

Stryker Consulting Payments (check out Richard Harrison Rothman in Philly)

J&J’s DePuy must have deep pockets because several orthos earned almost 3 million dollars in consulting fees (PDF file)

Biomet (check out Adolph V. Lombardi)

Smith & Nephew (check out Richard Laskin)

Many of these surgeons earned tens of thousands of dollars in consulting fees, but some received hundreds of thousands of dollars, and a few earned over a million (there was one ortho who earned almost 3 million dollars in consulting fees). WSJ blogged about the investigation on September 2007.

Backgrounder on Diabetes Drug Avandia Controversy

I’ve been tracking the various developments and commentaries on the controversy surrounding diabetes drug Avandia (rosiglitazone, manufactured by GlaxoSmithKline). For those of you interested in background information and commentaries relating to the use of Avandia and increased risk for heart disease, as well as the affordability of chronic medications like diabetes drugs, I’ve compiled a short reading list including abstracts to the original research articles to help you get started. Please read my conflict of interest disclosure at the end of this article. (more…)

Massachusetts Mandatory Health Insurance Law for Young People

I don’t know what your finances looked like when you were when you were 18 or in your early twenties, but I was a starving graduate student barely able to afford rent. If now I have to pay at least $100 each month on top of my expenses, I’d sink deeper into debt unless I move out of that state. Now, MA is requiring all taxpayers to prove that they have health insurance, which would include young adults who are still either in school or starting to chip away at student loans with their first jobs.

Of course, the politicians are going to espouse the wonders of early prevention and encouraging young people to take better care of their health so that they could lead long, healthy lives. One of the reason why HMOs love healthy adults and young people is because the number crunchers have found that they are less likely to use health care simply because statistics show that this population is healthier than an older age group. This means the HMOs will come out ahead in their business of covering for treatment and cost of care. The truth is, the Massachusetts bureaucrats want the young to pay and subsidize health care utilization by the aging population. We’ve seen how well this concept of “taxing one generation to pay for the other generation” has worked for social security; health care is a hegemonic burden that is finding its expenses to all segments of the population (except for illegal immigrants, but that’s another unwieldy topic).

I’m glad I’m not a young person living in Massachusetts.

Medical Malpractice Makes Unaffordable Healthcare

Philip K. Howard is a lawyer, author, and chair of an organization that aims to “restore common sense to American Law” called Common Good. In a recent issue of Wall Street Journal, Mr. Howard suggested that our aims for safer and affordable American healthcare can only come true when we change our current legal system. This legal system has become bloated with administrative costs and malpractice concerns that burden the overall healthcare system. (WSJ original article…)

Suicide and SSRI When Medical Legal Risk is High

By Robert Lamberts, M.D.

I had a tough situation in the office yesterday.

One of my patients is a 17-year old who went to the ER on Sunday for shortness of breath. They said she had a panic attack and should follow-up with me as soon as possible.

When I saw her, she was clearly distressed, but not to the point of needing to be hospitalized. I asked her what was up and she told me that she had been kicked out of school recently because she stabbed someone with a knife – apparently only after that person grabbed her forcibly. She lives with her mother and her father is a homeless alcoholic. Her mother tells her not to talk to him, but he calls regularly and tells her that she is all he has. He also says that he might kill himself. She knows that he shouldn’t say this kind of thing to her, but it puts her in a hard situation. On one hand, she knows that it tears her apart to talk with him. On the other hand, she fears that if she does not talk to him, he will kill himself.

I asked her if she ever thought of killing herself, and she said she had – especially after talking to her father – but was not at this time suicidal. She had a real good friend with her who was very supportive.

So I am stuck in a dilemma. On one hand, she is clearly depressed and needs both medication and psychological counseling. On the other hand, since there is a black-box warning for using SSRI’s in teens, putting her on one would put me at huge risk for a lawsuit should she follow-through and kill herself. I think she is at very high risk of doing that in the long-run, and don’t really have a longstanding relationship with her as her doctor. I did what I could to tell her to talk with either her friend or me if she should feel she is close to killing herself, but I don’t really know her that well. I am trying to reach one of the local child psychiatrists, but most of them are several months out for new patient visits. (more…)

Public Access to Articles on Antidepressant Safety

Journal of Child and Adolescent Psychopharmacology is a peer-reviewed journal published by Mary Ann Liebert, Inc. The February/April issue (Volume 16, 2006) explored the controversial topic of using selective serotonin reuptake inhibitors, or SSRIs to treat depression in children and teens.

Peer Review: Peer review of a scientific publication is considered a rigorous process that makes a published scientific study a credible source of information. A panel of the researcher’s “peers” assess the submitted publication for scientific merit and objectivity.

This topic has been controversial because of the debate around safety and effectiveness of this class of drugs for what is considered a vulnerable population. Based on the potential impact of this controversy, the publisher has made this double issue free for viewing.

View: http://www.liebertonline.com/toc/cap/16/1-2

pills.gif The association between treating teens and children with SSRI drugs and an increased risk of suicide has made this a highly public controversy – including a past episode of Law & Order on television.

This journal is clearly aimed for healthcare professionals, researchers, and industry consultants. The publisher of the journal is a privately held media company that also publishes other magazines in biomedical research and biotechnology.

If readers are particularly interested in a specific article, I will be happy to help decipher it for you.

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