Business Practices of Big Pharma
Every business is all about the bottomline. A pharmaceutical company's bottom line is closely tied with the number of its active patents, when those patents expire, and what new drugs are in the "pipeline". [Click here to learn about Patents].
Pharmaceutical companies are under constent pressure to maximize the profits from their active patents while simulataneously fighting off challenges to their patents by companies that manufacture generic drugs and keeping their drug "pipelines" full. Companies maximize their patents by selling more than their competitors through a process generally called "detailing". Big pharma also sponsers studies that aim to "find" new conditions that their drugs can treat.
When attempting to fill their pipelines with a new drug approval, Big Pharma can take advantage of a weak and ineffectual regulating agency (FDA) by hiding important data deep within its reports to the agency. I have seen this many times during litigation.
It can become easy to take advantage of the FDA if a company is under so much pressure to maximize sales and maintain a deep pipeline. People that make up Big Pharma are only human and subject to the same deadlines and benchmarks as everyone else.
This section is decidated to providing the reader with a look at the business partices of majority of Big Pharma companies. Enjoy.
Business Practices of Big Pharma
Public Health Disaster: Drug Approval and the Policy of Preemption
There is a fierce debate raging in the legal community over the extent, if any, that the rules created by regulatory agencies like the FDA preempt (or prevent) lawsuits against a manufacturer of a defective product. For injuries caused by pharmaceutical companies the issue is whether or not consumers retain the right to sue a pharmaceutical company for failing to warn about a side effect from their medications.
The FDA and Big Pharma argue that the FDA is fully informed of the potential side effects when approving the drug and that lawsuits add an extra layer of regulation that is above and beyond what the federal government requires. While that argument is conceptually valid it does not make sense in light of the following facts:
1. The FDA does not conduct any of its own studies. The FDA relies on the results and analysis of the data from pharmaceutical companies.
2. The companies that make up Big Pharma do not always release the results of clinical trials to the scientific community. Pharmaceutical companies regularly publish the results of their clinical studies in peer reviewed journals. The issue is that the companies do not always publish all the studies. In fact, pharma companies usually publish only the studies that are most favorable for their product. See the recent news regarding Vytorin for a great example of this.
3. The FDA is understaffed and underfunded. In fact, the a multitude of studies have been released saying that the FDA is incapable of performing its job, including a study by the prestigious Institute of Medicine. The FDA cannot review every single piece of data that comes through the door and pharmaceutical companies have been known to place key study data in the appendices of their reports rather than in the summary. The chances are that if negative data is placed in the appendix of a report then it will not get read for months or years if ever.
There is plenty of opportunity in our current drug approval system to allow unscrupulous companies to take advantage of an overtaxed, understaffed and underfunded agency. In fact, the U.S. Government Accountability Office recently released a study lambasting the FDA for its ineffectiveness in judging whether a prescription drug is safe and efficacious.
Now, Big Pharma is engaging in a campaign to prevent consumers injured by pharmaceuticals from bringing a lawsuit against them.
Does this policy make sense in light of the facts?
I encourage all that are interested in this topic to read the following article in Mother Jones.
PREEMPTION UPDATE
Donna Riegel filed suit against Medtronic after a Medtronic catheter burst inside the artery of her husband Charles causing him to undergo emergency bypass surgery in 1996. Although Charles Riegel survived the surgery, he passed since, and Donna carried the fight all the way to the Supreme Court.
On Wednesday, February 20, 2008, in an 8-1 decision, the Supreme Court ruled against the estate of Riegel stating that devices subject to PMA are preempted insofar as they are not based on the violation of FDA laws. Federal law requires that a company must submit an application to the U.S. Food and Drug Administration (“FDA”) before a medical device can be sold. Medical devices are classified as Class I, II, or III. Generally speaking, Class III devices pose the most danger to the public. The FDA can approve a Class III medical device when a manufacturer shows that the device is either substantially equivalent to a device already on the market through the 510K process or that the device is safe through the pre-market approval process (PMA).
The catheter that caused Charles Riegel’s injuries was approved by the FDA through pre-market approval (PMA). PMA is the most stringent type of review required by the FDA. The main difference between 510K and PMA is that 510K focuses on substantial equivalency to a product already approved to go to market whereas PMA focuses on the safety of a previously unapproved product.
In simple terms: you can no longer sue a company for putting out a bad medical device if it goes through the PMA process.
What does this mean to you?
The Supreme Court dealt the American public a tremendous blow. No longer are you safe from desperate companies looking for patents to please shareholders. The Court wrongly relies on the supposed “scientific prowess” of an inept and dysfunctional federal Food and Drug Agency.
The Art of the Sell: Detailing 101
There is a lot of discussion lately about the influence of pharmaceutical (and medical devices) representatives on the prescribing habits of doctors. To fully understand what the issue is it is important to understand the process of detailing.
Usually very attractive pharmaceutical representatives visit doctors to “inform” them about the company’s product. This is called detailing. Detailing can include presentations from other doctors, free lunches, or dinners, etc. Detailing revolves around a “core message”, which are sound bites regarding the drug’s safety and/or efficacy.
A pharmaceutical representative does not detail blindly. She or he is armed with data about doctors and answers to common questions. Pharmaceutical representatives are able to target “key” doctors by looking at the amount of prescriptions a doctor writes and his/her specialization. [Read this article to see how D.C. tried to control this process of "data mining"]. Doctors that write a lot of prescriptions are highly sought after and are usually “flagged” for followup using aggressive sales tactics. Pharmaceutical companies get doctor’s prescribing information from companies who buy the information from pharmacies. Pharmacies usually do not give out doctor’s names, but will give out something that is called a drug enforcement number. The American Medical Association sells the companies the names associated with the drug enforcement number. Amazing right?
Pharmaceutical representatives are also armed with answers to common questions. These are questions that a doctor would likely ask a representative about the drug they are selling or a competitor drug. The answers always transition back to the drug’s “core message”. If the doctor’s question gets too scientific the representative will refer the question to the home office. A “medical affairs” department will respond with a scientific answer, usually by another doctor, that downplays the concerns of the doctor and transitions the topic back to the core message.
That is detailing in a nutshell.
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