Are new drugs effective or hazardous?
Researchers have discovered that new prescription drugs have a one in five chance of causing serious reactions after they have been approved, with systematical reviews revealing that 1.9 million hospitalisations a year are attributed to using new medication.
The Harvard Law report explained that 840,000 patients given new drugs had a serious adverse reaction, with experts concluding that prescription drugs are tied with stroke as the 4th leading cause of death in the United States. The European Commission adds that 200,000 patients in the EU die due to prescription medication, ramping the total up to 328,000 deaths across both America and the EU. Independent reviews over the past 35 years have found that only 11-15% of newly approved drugs have significant clinical advantages over existing medication, although it is the 85-89% of other medication that tends to flood the drug market. The experts claim that about four fifths of the $70 billion spent on drugs since 2000 has actually been on effective and innovative medication instead of minor variations.
The pharmaceutical industry has it’s own opinions however, stating that similar drugs have advantages as it offers doctors choice when prescribing, especially if a patient does not respond to one variation of the drug. The industry also claims that even small adjustments and additions show development and improvements and could contribute to bigger achievements. Marc-Andre Gagnon however discusses the ‘hidden business model’ that is used by drug companies, where they minimise risks and do not continue to develop drugs that won’t produce a potential profit. Net return on revenues within the industry escalated from 10% in the 1970’s to 19% in 2010.
New FDA policies to get more drugs reviewed faster so that they can reach patients sooner in fact mean that drugs are approved with less evidence of being safe or effective. A systematic study of shortened reviews found that each 10-month reduction results in an 18% increase in serious adverse reactions, an 11% increases in hospitalisations, and a 7.2% increase in deaths.
A team from the London School of Economics concludes that requiring comparative evidence before approval informs all decision makers of the relative merits of new treatments. Also, it “could encourage manufacturers to concentrate on the development of new drugs in therapeutic areas with few or no alternatives.”