Welcome to the Pharmablogger page. My mission here is to showcase information relating to the negative practices of the pharmaceutical industry, particularly focusing on the legal issues that arise from fraud, defective products and labeling, and so forth. I will also comment and link to any aspects of health care that tickle my fancy. It's my space, after all.
The passage of the Medicare Prescription Drug Improvement and Modernization Act of 2003, and the related lobbying effort that went into the passage of this ridiculous giveaway bill was the catalyst for my immersion into the literature of Pharma fraud. Much of that material I was already familiar with, but recent publications have pulled a lot of material together well, and I will be recommending titles and articles as I go along.
I've also witnessed truly innovative medicines being developed and brought to market, but frankly, that's such a small part of what the Pharmas do that I almost hesitate to mention it. But I've seen the faces of people whose lives had been improved or even saved by medications, and I can't discount that. I'll talk about that in the future as well, and talk about where those innovative meds really come from.
To get started, I would like to direct you to sources of material on the internet, so you can see what lies behind the nice Lance Armstrong ads and The World brought to you by Merck (NPR). Let's start with something provided by the companies themselves (because they have to!)
My favorite part of any Pharma annual report is the Contingency section in the Financials, where you can find information regarding ongoing and potential litigation. Any Pharma company is going to have a significant (and growing every year) section that details suits against them by class action plaintiffs, shareholders, the Department of Justice, various Attorneys General, or in the case of Merck, all of the above! (and more!) You have to look deep for this stuff, though. For Merck, the litigation liabilities is found in Note 9 of the financial section, not widely read. It starts on page 42 - http://www.merck.com/finance/annualreport/ar2003/pdf/merck2003ar.pdf
If you follow that link, you'll see a reference to lots of different kinds of litigation. However, the headlines all come from civil cases involving personal injury. It's important to understand the unique position that drugs have in the realm of product liability. Think for a moment - if you buy just about any kind of consumer product, use it as intended, and you end up in the hospital or a morgue due to an injury that unmistakably results from the use of that product, you've got a case, and that product won't be around for long, thanks to product recalls, voluntary or otherwise. But this happens to hundreds of people everyday who take prescription or OTC (Over The Counter) drugs. These drugs are not removed from the market, yet for the most part, these hundreds of people every day have no compensation for their injuries. Why? Pharmaceuticals have a type of immunity that just about no other product has. I'll provide further information about this concept later. I'll also have a numbers day, to provide the scale of some issues I'm bringing up.
Here's a few more Annual Reports available online:
AstraZeneca - Page 104, inside the section "Assets pledged, commitments and contingent liabilities"...enough to make any casual reader flop unconscious on his/her keyboard. Note the Zoladex Corporate Integrity Agreement at the bottom of page 106, resulting from when they were very bad. This will be a future topic of discussion, concerning fraud against the government.
Pfizer - Page 49, Note 20 of the financial section. Items to note include the patent action "against the manufacturers of competing PDE5 inhibitors for infringement" of their "broad patent...covering the use of orally-effective PDE5 inhibitors for the treatment of male erectile dysfunction." Say what? Pfizer makes Viagra, which is an "orally-effective PDE5 inhibitor." They have a patent on the Viagra molecule, naturally. But in October 2002, they got a patent not just for that molecule, but for the entire method of treatment of impotency. So Cialis and Levitra manufacturers (surely you've seen the ads!) have their own molecule patents, dating prior to October 2002, but are infringing on Pfizer's patent on an entire disease "target." Incredible. Imagine if the first manufacturer of the fork had received a patent not only on the fork itself, but on the method of using an implement to bring food from the plate to your mouth, and got that second patent after the spoon had also been invented by someone else!
Schering-Plough - Starting on page 62. Take a look particularly at the "Investigations" sections starting on page 64. Under the "Pennsylvania Investigation" and "Massachusetts Investigation" heading, there's information regarding attempts to defraud the government by failing to report information that would impact what Medicaid programs would be charged for their drugs. Also note the US Attorneys who are investigating these issues - Eastern District of Pennsylvania, and Massachusetts (Philadelphia and Boston offices). You'll see these folks again and again, as they are the most aggressive (and successful) litigators against Pharma fraud.
Just pick any company that you can think of, put their names in front of www. and put .com at the end, go to the investor relations section of the site, and look for the Annual Reports. I picked the above companies at random, and was not disappointed!
Get an idea of what a huge product liability suit can cost from this Businessweek article on Merck and Vioxx. The two analysts cited disagree on the costs, but the lower figure is $15 billion (ouch!). But with earnings (EBITDA) of $8.76 billion in 2003, don't look for bankruptcy proceedings anytime.
The Washington Post has a review article on those five drugs cited by David Graham of the FDA as being potential Vioxx - type disasters, and discussed alternative to the meds. All of the companies are rigorously defending their franchises, including this rather extraordinary attempt at public disclosure of safety issues regarding the AstraZeneca drug Crestor.
Again regarding AstraZeneca - new trial results showing that their drug Anastrozole (Arimidex) cuts the risk of breast cancer recurrence over the standard therapy of Tamoxifen. This is good news of course - estimates of lives saved by Tamoxifen (despite life-threatening side effects of blood clots and uterine cancer) are enormous when added up over the years, and Anastrozole does not seem to have the negative estrogenic effects that result in the clots and uterine cancer. Curious how the drug name is not mentioned in this article until Paragraph 9, while the Associated Press article, likely to be printed by most newspapers, mentions the name in Paragraph 2. You would think that these results would be bad for the Tamoxifen manufacturers (generics are available) except for the fact that Tamoxifen is also sold by AstraZeneca.
As I've said before, I'll visit all of the liability issues in future posts, as well as post links to the daily news coverage of Pharma issues. The examples above were meant to whet your appetite. Have I succeeded?