The percentage of the U.S. population taking at least one prescription drug during the past 30 days increased from 38% in 1988–1994 to 48% in 2005–2008. During the same period, the percentage taking three or more prescription drugs nearly doubled, from 11% to 21%, and the percentage taking five or more drugs increased from 4% to 11%. These data come from the CDC "Health, Unites States, 2011" report (find it here).
Meanwhile, the prevalence of heart disease, which is the leading cause of death in the U.S., remained steady from 1999–2000 to 2009–2010 among adult women in all age groups, and among men 45–74 years of age. Among men 75 years of age and over, prevalence rose from 39% in 1999–2000 to 45% in 2009–2010.
There goes my rationale for taking statins to lower my risk of heart attack! It seems that the drug industry is not as successful in improving our health as it claims to be.
And new drugs aimed at lowering the risk for heart disease currently being developed may be effective in achieving "surrogate endpoints" in clinical trials but not effective in reducing risk.
That was the takeaway from a new study published online recently in The Lancet. That study provided evidence that increasing the level of HDL ("good cholesterol") does not lead to less risk for heart disease (see "HDL hypothesis is on the ropes right now").
That's not good news for companies that are actively developing and testing drugs that raise HDL -- even if these drugs succeed in that goal they are not likely to help prevent heart disease.
There's lots of other interesting data in the CDC report. I've gathered my favorite charts into the infographic shown here (click here for an enlarged view). read more..
Friday, 18 May 2012
Prescription Drugs-Heart Disease-Heart Attack-Percentage
Thursday, 15 March 2012
Acute Myocardial Infarction-Congestive Heart Failure-Takeda Pharmaceuticals-Whistleblower Lawsuit
A medical doctor and former consultant to Takeda Pharmaceuticals is charging in a whistleblower lawsuit that the company failed to report serious adverse events related to the antidiabetes drug pioglitazone (marketed as Actos).Helen Ge states in her lawsuit that Takeda “instructed medical reviewers not to report hundreds of non-hospitalized or non-fatal congestive heart failure cases as ‘serious’ adverse events and thus avoided its responsibility of accurately analyzing and reporting these hundreds of serious adverse events to the FDA [US Food and Drug Administration].”She also claims that the company failed to report 28 of 100 cases of bladder cancers to the FDA, which she called a “serious discrepancy,” and that Takeda told her to change her notation that the cancers were “related” to “unrelated.” The suit says that she was fired after she complained to her supervisors about the company’s failure to report all serious adverse events.The suit was originally filed in June 2010 but wasn’t publicly disclosed until 24 February, when the federal government declined to join the suit.Dr Ge charges that Takeda “orchestrated” the downfall of its main competitor drug, rosiglitazone (GlaxoSmithKline’s Avandia), which is in the same class of drugs. In her suit she claims that after the New England Journal of Medicine published a study in 2007 (2007;356:2457-71) showing that rosiglitazone increased heart attacks and congestive heart failure, the FDA asked GlaxoSmithKline and Takeda in May 2007 to add warnings about heart failure for both drugs.According to the suit, in November 2007 Takeda “began to run print advertising in 82 major market newspapers and national publications such as Time and Newsweek, advising readers with type 2 diabetes that ‘Actos has been shown to lower blood sugar without increasing your risk of a heart attack or stroke.’” At the same time Takeda stopped reporting non-fatal or non-hospitalised heart failure events as “serious,” while GSK continued to report all heart failure events as serious, unfairly positioning pioglitazone as safer than rosiglitazone.Whether pioglitazone is actually safer than rosiglitazone is controversial. A 2010 meta-analysis by Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic in Cleveland, Ohio, reported that when compared with control treatment rosiglitazone increased heart attacks but not the rate of heart failure or cardiovascular mortality (Archives of Internal Medicine 2010;170:1191-201, doi:10.1001/archinternmed.2010.207). David Graham, a safety officer with the FDA, conducted an observational, retrospective, inception cohort study of 227?571 patients aged more than 65 years to compare rosiglitazone and pioglitazone and reported that rosiglitazone was associated with “an increased risk of stroke, heart failure, and all-cause mortality and an increased risk of the composite of AMI [acute myocardial infarction], stroke, heart failure, or all-cause mortality” (JAMA 2010;304:411-18, doi:10.1001/jama.2010.920). However, a retrospective cohort study published in 2010 in Circulation that assessed 36?628 patients taking either rosiglitazone or pioglitazone found no differences in overall heart failure, acute myocardial infarction and all cause mortality (2010;3:538-45, doi:10.1161/CIRCOUTCOMES.109.911461).Dr Nissen told the BMJ that FDA statisticians “showed unequivocally that pioglitazone is less likely to cause ischaemic events than rosiglitazone.” He said, “These findings were confirmed by the analysis published in JAMA” and that “since several of these analyses” did not rely on data reported by Takeda “the differences are likely [to be] real.” He added that both drugs, however, “can precipitate congestive heart failure and cause fractures.”France suspended pioglitazone in June 2011 over concerns about bladder cancer. Rosiglitazone is available in the United States with severe restrictions (BMJ 2010;341:c5287, doi:10.1136/bmj.c5287), and the Euro read more..