FDA – Health News Updates!

Follow the money

By Terry A. Rondberg

A new study published by JAMA shows that among patients age 65 years and older, rosiglitazone (a medication for treating Type 2 diabetes) is associated with an increased risk of stroke, heart failure, and all-cause mortality (death) when compared with pioglitazone (another medication for diabetes).

In their conclusion, the authors wrote: “…in a population of more than 227,000 patients 65 years or older who initiated treatment with a thiazolidinedione, we found that, compared with pioglitazone, rosiglitazone was associated with an increased risk of stroke, heart failure, and death and the composite of AMI (heart attack), stroke, heart failure or death.” (JAMA.doi:10.1001/jama.2010.954)

Despite trying to put rosiglitazone in the most “favorable” light possible, researchers had to admit that “analysis showed no differences in the risk for heart attack between rosiglitazone and pioglitazone,” even though the study found that rosiglitazone was associated with a 1.25-fold increase in risk of heart failure compared with pioglitazone.

Obviously, BOTH medications have serious negative side effects, but the report’s wording seems somewhat biased to me so I delved a little deeper. Within the past five years, the study’s head researcher, Steven E. Nissen, MD, has received research support from numerous drug companies, including AstraZeneca, Atherogenics, Novartis, Pfizer, Resverlogix, Daiichi-Sankyo, Sanofi-Aventis and — most importantly — Eli Lilly and Takeda.

The drug that fared better in this study (branded name Actos) is manufactured by Eli Lilly and Takeda. Avandia, the branded version of rosiglitazone, is made by GlaxoSmithKline, a name curiously absent from the list of Nissen’s financial benefactors.

Probably just a coincidence, right? Yet, only this month, the BMJ (which used to be called British Medical Journal) published a report that explored a possible link between authors’ financial conflicts of interest and their position on the association of rosiglitazone with increased risk of myocardial infarction in patients with diabetes.

The research abstract noted: “Of the 202 included articles, 108 (53%) had a conflict of interest statement. Ninety authors (45%) had financial conflicts of interest. Authors who had a favourable view of the risk of myocardial infarction with rosiglitazone were more likely to have financial conflicts of interest with manufacturers of antihyperglycaemic agents in general, and with rosiglitazone manufacturers in particular, than authors who had an unfavourable view (rate ratio 3.38, 95% CI 2.26 to 5.06 and 4.29, 2.63 to 7.02, respectively). There was likewise a strong association between favourable recommendations on the use of rosiglitazone and financial conflicts of interest (3.36, 1.94 to 5.83)” (BMJ 2010;340:c1344)

In another, even more chilling report (also published in BMJ), the author writes: “Casually following the fortunes of the blockbuster diabetes drug rosiglitazone (Avandia), you can’t help but imagine a Hollywood thriller. There is the scene where a leading scientist secretly records a meeting with drug company executives, a high powered congressional investigation, and a bitter legal battle waiting in the wings. Yet when you look more closely, the facts are even stranger than fiction. An expensive new drug shown to raise the risk of heart failure and suspected of increasing the chance of heart attacks has been taken by millions of people around the world and is being kept on the market by an industry funded regulatory system, despite calls from senior safety experts to withdraw it.” (BMJ 2010;340:c1848)

I took a look at one other factor as well: pricing. The most common price I could find for Avandia — the drug touted as “safer” by the research paper — was $3.32 per pill (for 30 pills of 8mg, which is considered the normal dose). For Actos, the price was $1.34 per pill (for 30 pills of 30mg, again, considered the normal dose).

When it comes to this type of medical drug research, the saying “follow the money” seems to apply. Perhaps it’s also time to follow the advice of “X-Files” character Fox Mulder: TRUST NO ONE.

About Terry A. Rondberg, DC
Terry A. Rondberg is founder and CEO of the World Chiropractic Alliance. He is an ardent advocate for drug-free chiropractic care not just for back pain, but total body wellness. He has spoken globally on the issue of alternative care and the abuses of our current “health care” system.

How to get FDA approval for anything!

While pharmaceutical companies have boasted for decades that their pills and potions are “approved by the FDA,” does that really mean anything? Apparently, very little, if the story of how one drug — Multaq (dronedarone) — “earned” its approval is any indication.

Drug maker Sanofi-Aventis touts Multaq on its website as “a prescription medicine used to lower the chance you would need to go into the hospital for heart problems.” The FDA’s decision to approve the drug was based primarily on a study conducted last year by Richard Page, chairman of the department of medicine at the University of Wisconsin School of Medicine and Public Health. The paper was published in The New England Journal of Medicine.

However, it turns out that Page was pretty much “bought and paid for” by Sanofi-Aventis. The drug company PAID for the research, collected data, and performed the analysis without an external audit. Page put his name on the paper, never having seen the raw data. He simply trusted the company to be honest and ignored the fact that the major financial experts, including Morgan Stanley, estimated the drug could reach nearly $3 billion in revenues.

In addition, Page and four co-authors were Sanofi-Aventis paid consultants and/or speakers, and two co-authors worked directly for Sanofi-Aventis, and owned stock in the company.

Despite all that, Page shrugged it off with a glib, “There is a sense of trust that they won’t falsify data.” Either he’s incredibly naïve, or he thinks the rest of us are.

To add injury to insult, the Multaq branded pill was selling for 47 times as much as its generic equivalent — in Britain Sanofi was selling the drug for £2.25 pounds per day, compared to 5 pence a day for a generic competitor, amiodarone. That equates to $3.30 compared to 7¢!

But wait … it gets better. Another research study (this one, by researchers at the Cedars-Sinai Heart Institute — Journal of the American College of Cardiology, 2010; 55: 1569-76) has concluded that the branded drug is far less effective than the current standard drug, Cordarone (amiodarone) for atrial fibrillation, and has no safety benefits.

That’s pretty much what was known back in 2003, when a drug trial was actually stopped because patients receiving Multaq were dying in greater numbers than those getting a placebo.

Still, the drug was “approved” by the FDA. You have to ask yourself — what would it take for a drug to be rejected?

A “Suicide Pill” of a Different Kind

The first rule of the medical profession is supposed to be “Do No Harm.” I don’t think the pharmaceutical industry ever took that pledge. We’ve known for ages that pills and potions passed out like candy by the medical and drug cartels are seldom effective and often have dangerous side effects.

A study published in the April 14, 2010 issue of the Journal of the American Medical Association (JAMA) puts another layer of concern onto that knowledge: An analysis of prescription and clinical claims data suggests that the use of certain anticonvulsant medications may be associated with an increased risk of suicide, attempted suicide or violent death! Now that’s a side effect that should cause all these drugs to be pulled off the market immediately. But, knowing how strong the drug lobby is in this country, doctors will continue to prescribe these drugs with nothing more than a “warning” attached.

Anticonvulsant medications are a primary therapeutic approach for patients with epilepsy, but labeled indications also include bipolar disorder, mania, neuralgia (sudden occurrences of short, sharp pains along a nerve), migraine, and neuropathic pain.

“The wide range of indications and common use of anticonvulsants in patients with or without psychiatric comorbidities make their safety an issue of great relevance,” the study’s authors wrote. “In 2008, the U.S. Food and Drug Administration mandated warning labeling for anticonvulsant medications regarding the increased risk of suicidal thoughts and behaviors. The decision was based on a meta-analysis not sufficiently large to investigate individual drugs.”

Elisabetta Patorno, MD, of Brigham and Women’s Hospital and Harvard Medical School, Boston, and her colleagues evaluated whether there was an increased risk of attempted or completed suicide, and combined suicidal acts or violent death associated with a range of individual anticonvulsant medications and within patient subgroups.

The researchers analyzed data for 14 states from the HealthCore Integrated Research Database (which includes information on filled prescriptions and clinical encounters) for patients 15 years and older who began taking an anticonvulsant between July 2001 and December 2006.

The study identified 827 suicidal acts (801 attempted suicides and 26 completed suicides) and an additional 41 violent deaths (868 combined suicidal acts or violent deaths) in 297,620 new episodes of treatment with an anticonvulsant. “This exploratory analysis contributes to the understanding of the complex and little-understood relationship between anticonvulsant medication use and suicide risk.”

Sadly, that will be small comfort to the families of the people who die as a result of taking this drug. If any non-medical procedure — chiropractic, acupuncture, etc. — was found to increase the rate of suicides and violent deaths in patients, it would be prohibited. When will we start imposing the same standard of “do no harm” to the profession that supposedly is guided by that principle?

SOURCE: JAMA. 2010;303[14]:1401-1409.