The Truth About the Drug Companies: How They Deceive Us and What to Do About It

I was very happy to see a prominent physician has finally taken a stand against the giant global pharmaceutical industry. Angell showed courage, integrity, and clarity in her book about the problems we face with the unethical practices of our large corporations that place profits ahead of our safety.Angell has even clearly and bravely exposed the role of the government in enabling the pharmaceutical industry's unethical practices; per example the passing of the PDUFA Act (Precription Drug Users' Free Act) by Congress in 1992, that constituted in my opinion the ultimate ethical violation and a sell out to the pharmaceutical industry, which I have called in my article (see article below for details about the PDUFA Act)an act of terrorism, because of the blatant complicity of the FDA with the Pharmaceutical companies to allow unsafe drugs to be approved for the public. I have enjoyed Angell's book very much, and I admire her integrity, courage, high ethical standards, and her willingness to speak the truth regardless of the consequences. Her book will provide the readers with an educating and edifying experience.The Federal Drug Administration and the PDUFA Act of Terrorism.Abstract: The purpose of this article is to explore the function of the FDA its relationship with the pharmaceutical industry, its dilemma between protecting the consumer and betraying their financier, and the ethical question regarding the PDUFA Act that was passed by Congress in 1992, and its impact on our citizens.History:The FDA was established in 1906 as a result of the Food and Drug Act.The FDA's primary mission as an independent watchdog agency was to promote, protect, and improve public health.The treasury department financed the FDA until the year of 1992.In the eighties the FDA received lots of criticism from thepharmaceutical industry for being too slow in approving theirnew drugs. However, the pharmaceutical industry has been a majorcontributor for political campaigns, and has increasingly gained clout in Washington. PhRMA (pharmaceutical research and manufacturers of America) is considered one of Washington's most powerful trade groups. They employed about 50 lobbyists in 2001. Senator Dick Durbin a democrat recently stated that "PhRMA has a death grip on Washington."(Frontline, 2003).In 1992, the pharmaceutical industry finally succeeded in pressuring congress to pass a legislation that changed the FDA forever. That year, The PDUFA Act (Prescription Drug Users' Free Act) was passed by Congress authorizing the pharmaceutical companies to hand over money to the FDA, in order to get their drugs quickly approved.PDUFA is a quid pro quo act. If the pharmaceutical company wants a drug to be swiftly approved they would have to pay the FDA an amount of up to $500,000 to hire reviewers that in return would review the product and approve It. (FDA website). This represents a major conflict of interest and the ultimate ethical violation. However, the FDA understaffed and underfinanced welcomed the new legislation and the new partnership with the pharmceutical industry.The majority of the American public has never heard of PDUFAand have no knowledge that the independent agency which was oncecreated to protect them, was sold by congress to the highest bidder.The PDUFA Act has resulted in thousands of deaths and innumerable injuries, due to the careless approval of certain unsafe medications by the FDA, in order to please their new masters, the pharmaceutical companies.How can the monitors regulate their employers and the people that pay for their salaries? And who would monitor the monitors? In these difficult times of economic hardship, wars, and terrorism, the government has expressed an increasing concern over the safety of its citizens. Ironically, PDUFA represents a terrorist act and anti-safety measure that was passed by this same concerned government.According to Frontline a PBS (Public Broadcasting Service) documentary("Dangerous Prescriptions"), the pharmaceutical companies have financed 50 percent or more of the drugs that were approved in the past 10 years, and many of the FDA reviewers were and still are afraid to speak out against some of these dangerous prescription drugs. They were coerced by their administrators to get these unsafe medications quickly approved,despite the prolific evidence of their dangerousness and lack of safety; otherwise, they would face disciplinary actions and become "stigmatized" in the FDA (Frontline, "Dangerous Prescriptions,"2003).The examples of these approved unsafe drugs are many. One recentexample is "Baycol" by the Bayer Corporation. Baycol is anantihyperlipidemic drug also known as a statin a cholesterol-lowering drug. Baycol was responsible for many deaths and injuries, because of its high tendency to cause rhabdomyolysis a deadly condition where the drug induces the destruction of the muscle enzyme. Bayer and the FDA allowed this drug to be aggressively marketed despite their foreknowledge of its dangerousness based on a study of Baycol versus Lipitor (another popular statin). The study showed that for every 100,000 prescriptions given without other cholesterol drugs, Baycol had 20 times more reports of rhabdomyolysis than Lipitor. (Frontline, 2003).Corporate business 101 teaches that it is cheaper to kill and injure few thousand people and pay settlements, than to pull a product off the market.This is a criminal and reprehensible practice that the pharmaceutical companies and other corporate businesses should be held accountable for.Of course, in this case the FDA has become ineffective and impotent in the face of accountability, so who would fill in this safety gap?PDUFA became PDUFA III in 2002, because congress renewed it onceagain and for the third time, disregarding the thousands of deaths that ensued from their irresponsible action.The culture of Narcissism and elitism continues to plague Washington and our government, however this reckless disregard for our citizens' safety should not go unnoticed. I urge every citizen to write their congressman and to address the unethical and dangerous nature of PDUFA and pressure them to repeal/and or cancel this sinister act that has resulted in thousands of deaths and injuries of innocent Americans and on American soil (not counting the damage overseas) for the past eleven years.References:Public Broadcasting Service (PBS), Frontline Documentary, "Dangerous Prescriptions", 2003.FDA website, PDUFA III Act.

I should start with a disclaimer. I'm a Vice President within one of the largest drug companies in the world and I have spent close to twenty years marketing drugs. So I guess I'm not supposed to like this book. But the truth is I thought it was fantastic.First, for those of you who are not familiar with the healthcare industry, you should know that Ms. Angell is better capable of writing this masterpiece than any other author. She used to be Editor-in-Chief of The New England Journal of Medicine, which is considered the most prestigious medical journal in the world. Don't let her credentials scare you off, though. This is easy reading and the book captures your attention like a true business thriller, only this is real life suspense.But this volume is much more than simple entertainment. It is quite possibly one of the best analyses of the state of the U.S. drug industry today, complete with footnotes backing up every statement the author makes. You will learn not only that in 2002 the top ten drug companies made a higher profit than the other 490 businesses together on the Fortune 500 list. You will also understand how the drug industry has been able to achieve such a business success and how this success, as is often the case throughout history, will likely be their downfall.A political tidal wave is building which will forever change both the industry and many of its infamous business practices. It is sad to note that the drug industry today is equally poorly regarded as the tobacco companies, and this is a testament not only to the shortsighted foolishness of their management, but also to the fact that you can fool some of the customer some of the time, but not all of them all the time.So is there no hope? Well, Ms. Angell doesn't only state the problem she also presents solutions and ends her story with several thoughtful suggestions on how to change the way we discover, market and distribute new drugs. Her advice is wise and absent of quick fixes. Only time will tell if there will be a movement so strong that it can defeat ingrained business practices of the richest companies in the world.What may help is that the drug companies are their own worst enemies. They have antagonized grannies all over the US with their work to stop reimportation of cheaper drugs into the US, a practice that has been in place for many years in Europe. And anyone in marketing or public relations can tell you that no money in the world can help you win against millions of mad grandmothers.

Must read book

This book deals with the abuses of the pharmaceutical industry thoughtfully and thoroughly. The author’s claims are bold but well documented. We have been unwitting victims of the pharmaceutical industry for decades. I will be very sceptical of all prescriptions from now on. In fact, I will be far more likely to err on the side of failing to take drugs I should than to take drugs I don’t need.

great book, deep insights and very helpful in the daily clinical work

Interesting. Good companion to Ben Goldacre's 'Bad Pharma' (which I'd actually recommend over this), but Angell's book is an easier read—especially if you're not in academia.

J'ai utilisé ce livre pour rédiger mon mémoire de Master sur le marketing scientifique, il m'a été très utile, Marcia Angell est une personne légitime sur le sujet avec beaucoup d'expérience et si elle utilise parfois l'humour noire dans son livre, cela reflète bien la situation actuelle des industries pharmaceutiques qui privilégient bien trop souvent le marketing au profit de la recherche et du développement avec des conséquences inévitables sur la santé des patients/consommateurs. Je trouve le sujet encore trop peu abordé en France, dommage que le livre soit rédigé en anglais et donc limité à un public maitrisant l'anglais.