curing Africa (II)

Pfizer agreed to pay a "reasonable" price of USD 35 million to a Meningitis fund for helping the families of the children that participated in the 1996 study.

Indeed it's a very reasonable price. According to financial information provided, yearly sales of Trovan were around USD 160 million after its launching. The drug was sold for curing several infections (not meningitis as this is mainly an illnes in undeveloped countries).

Unfortunately not very long after it was initially marketed, the FDA issued a report:

1999. FDA report.
Trovan (trovafloxacin / alatrofloxacin) was approved by FDA in 1997 for the treatment of a wide variety of infections. Based on new safety data related to serious liver injury, described below, the Food and Drug Administration is today advising physicians that the drug Trovan should be reserved for use ONLY in the treatment of patients who meet ALL of the following treatment criteria:



-Have at least one of the following infections that is judged by the treating physician to be serious and life- or limb-threatening:
nosocomial pneumonia,
community acquired pneumonia,
complicated intra-abdominal infections (including post-surgical infections)
gynecologic and pelvic infections, or
complicated skin and skin structure infections, including diabetic foot infections;-Receive their initial therapy in an in-patient health care facility (i.e., hospital or long-term nursing care facility); and
-The treating physician believes that, even given the new safety information, the benefit of the product for the patient outweighs the potential risk.It's evident that African children under study complied with all these requirements.

The report continues:

FDA has received reports of over 100 cases of clinically symptomatic liver toxicity in patients receiving Trovan. Some of these patients developed serious liver injury leading to liver transplant and/or death. At present, FDA is aware of 14 cases of acute liver failure that are strongly associated with Trovan exposure. Four of these patients required liver transplant (one of whom subsequently died). Five additional patients died of liver-related illness. Three patients recovered without transplantation, and the final outcome is still pending on two patients. These numbers of patients with acute liver failure, although few, represent a rate that appears to be significantly higher  than would be expected to occur idiopathically in the general population - despite the under-reporting of cases that generally occurs to our post-marketing surveillance system (a nice way to say the drug kills; it's only a coincidence that FDA is  partially financed by the same pharmaceutical companies)

As a consequence of it, Pfizer had to withdraw Trovan. Without sales, it could not obtain profits, and therefore further expenses would result in additional losses; furthermore if we consider that Pfizer had to write off USD 300 million of inventory in 1999 (a lot of money thrown away!)

Apart from that, Pfizer objective is making the world a healthier place, and therefore it has to prioritize its expenses in pursuance of its aim.

For example, its policy with healthcare professionals and marketing costs is clearly explained in its website:

The main purpose of medical congresses, conferences, symposia and similar programs supported by Pfizer must be scientific exchange and/or medical education.

Pfizer even publishes payments to healtchcare professionals in the USA. The last report (2009) shows payments of USD 35 million to more than 4.800 professionals (average payment of 7.216 USD, much less than payments to any of the African families); -yes, payments included meals but only 3 million USD-. As Pfizer indicates: "Pfizer does not work with or pay physicians as either an inducement or a reward for prescribing"

Unfortunately, as always there are ungrateful people. Some Pfizer's employees (whistleblowers) denounced wrongdoing of Pfizer in marketing its products, mainly with Bextra drug. Whistleblowers said that representatives were paying money or inviting doctors to nice events in Bahamas in exchange for prescribing its drugs, even for not authorised uses. Reps also collected its reward. As an example of this supposed practices, two emails from Pfizer management in 2002:

1)
Sharks,
Here are some key points we worked up at the Orlando DM meeting that may help your Bextra presentation over Vioxx.
Matt

2)
Gold,
Roger has done a great job implementing his strategy we talked about at POA-2 and will definitely reap the benefits of this protocall. Great job Roger!. 5000 Ace points on the way.
Derrick

Explanation.
1) Sharks is how they call to the succesful group of reps that sell drugs to doctors. Key points refer to the argument that Bextra's competitor, Vioxx, provokes cardiovascular problems.
2) Great job implementing his strategy is to achieve that a doctor prescribes Bextra for pre-operative dosing (patients to be operated), when its original and approved use was only for treating osteoarthritis and adult rheumatoid arthritis

It's secondary that later Vioxx was withdrawn by Merck and Bextra by Pfizer, because both of them provoked serious cardiovascular problems.

Anyway, whistleblowers prompted an investigation by the US department of Justice. At the end of 2009 Pfizer, although innocent, agreed to settle the case and paid USD 2.3 billion (approximately equal to the cost of 70 studies in Africa).

So, even after prioritizing its expenses, and due to unfortunate and false accusations, could Pfizer run out of cash and put at risk the payment to African families?

It's not that bad. According to the latest financial report, Pfizer sold USD 68 billion in 2010, with a net profit of USD 8 billion.

So African families could relax. They will cash, but after having DNA tested them, just to be certain fraud is avoided.

Integrity is the
foundation of the
trust we need to
work together for a
healthier world. 　
　

　　　

FDA report. 1999.