The Hidden Costs Of Prescription Drug Development That Nobody Likes To Talk About!

Depending upon the source, the cost of bringing a new prescription drug to market these days ranges from roughly $1.2 to 1.5 billion. While there is no question that clinical studies represent the most costly aspect of getting new drugs approved, the hidden costs—mainly promotion and marketing—are what actually inflate the costs of new drug development. Not surprisingly, drugmakers fail to disclose that these costs are included in the estimates for new drug development. If these costs were eliminated from the total, then the cost of developing new drugs will be significantly less than the current $1.2 to $1.5 billion price tag.

I suspect that many BioJobBlog readers—mainly those who work in the drug industry—will likely write me off as someone who doesn’t know what he is talking about. But, an interesting tidbit that I found in an article in today’s New York Times entitled “A Fight Over How Drugs are Pitched” suggests that my claims ought not be summarily dismissed simply because I am a “left-leaning histrionic democrat.” To wit, according to IMS Health (a competitive intelligence firm that tracks physician prescription rates) in 2009 alone, the branded prescription drug industry spent about $6.3 billion on marketing visits to doctors! This amount does not include costs associated with marketing and advertising that support direct-to-consumer (DTC) advertising campaigns that are run by companies that sell approved prescription drugs. DTC costs are generally much higher than those spent on direct marketing to physicians.

It is important to remember that a drug maker’s main goal is to convince physicians to prescribe “their” drugs. After all, physicians not patients write prescriptions! That said, physician prescribing behaviors are vitally important to the success or failure of a marketed prescription drug. Consequently, it should come as no surprise that marketing costs are factored into the cost associated with new drug development. Obviously, if less money was spent on marketing than the cost of bringing new drugs to market would likely be substantially less.

Interestingly, the States of Vermont, New Hampshire and Maine recently enacted laws to limit the uses of a doctor’s prescription records for marketing. On Tuesday, the US Supreme Court will hear arguments in a case, Sorrell v. IMS Health that tests whether Vermont’s prescription confidentiality law violates the free speech protections of the First Amendment. The federal government, the attorneys general of several dozen states, AARP, professional medical associations, privacy groups and the New England Journal of Medicine have filed briefs in support of Vermont’s law. The National Association of Chain Drugstores, the Association of National Advertisers and news organizations like Bloomberg and The Associated Press have filed briefs aligning themselves with the data firm.

Although a Vermont federal district court upheld the law after a lawsuit challenging the statute brought by IMS Health and the Pharmaceutical Research and Manufacturers of America, an appellate court overturned the decision suggesting that it violates free speech provisions afforded by the First Amendment of the US constitution.

It will be interesting to see how the “Supremes” adjudicate the appeal given the growing recognition that laws and regulations designed to control medical costs and minimize safety risks associated with newly approved drugs are becoming increasingly necessary.

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

Chemotherapy Induced Nausea and Vomiting and Medical Marijuana

For the past month or so I have been working on a piece about chemotherapy induced nausea and vomiting (CINV) that is common among patients being treated for cancer. While not a pleasant topic, it is a reality for many patients who undergo cancer chemotherapy treatment.  Although CINV is less common with some of the newly-developed anti-cancer monoclonal antibody treatments, it is still a troublesome and debilitating problem that must be managed during conventional cancer chemotherapy treatment regimens. 

There is a growing body of evidence that marijuana (delta-9-tetrahydrocannabinol is the active ingredient) and related cannabinoid-like agents may help to effectively manage and control CINV in certain patients who are undergoing cancer chemotherapy. Recognizing this, 14 states have already legalized marijuana for medicinal purposes. Interestingly, according to Newsweek Magazine (November 2, 2009), the US government could save as much as $13.5 billion annually if it stopped enforcing laws against marijuana. To that end, the Justice Department says it will no longer prosecute people who use if for medicinal purposes in the 14 states where that's legal.

While I am not advocating illegal drug use, it seems silly to me that the inherent, medically-beneficial properties of  marijuana haven't been fully utilized to treat patients who are suffering from potentially life-threatening illnesses like cancer.  Further, there are legal and medical precedents for the use of illegal drugs that offer medical benefits. For example, while opium use is illegal in the US but morphine and related products (which are derived from opium and poppy plants) are legal prescription drugs that are regularly used to control acute and chronic pain in millions of Americans. Unfortunately, research on development of cannabinoid-like drugs to treat CINV has been stifled because of the illegality of marijuana.

The number of patients being treated for cancer rises each year. Isn't it time to start offering patients the best and most effective medical treatments available to them rather than continuing to adhere to out dated and unevenly enforced US drug laws?

Until next time...

Good Luck and Good Job Hunting!!!!!!!