AbbVie (recently split off from Abbott Laboratories), maker of Humira, and InterMune, maker of Esbriet, have filed a lawsuit against the European Medicines Agency (the European equivalent of the FDA) to block access to clinical trial data on the benefits and harms of their drugs, claiming that these vital facts are “trade secrets” whose release would harm their profits. Medical researches have been denied to clinical trial information.
Of course, when a drug causes cancer, release of clinical data information could potentially harm the profits of the company that makes it. Humira, a drug that is quickly becoming one of the best-selling drugs in the world, mainly because of the marketing techniques used by AbbVie, causes cancer.
Here’s one of their ads – don’t forget to feel bad about your plaque psoriasis.
The FDA warning label on Humira warns of increased risk of “Lymphoma and other malignancies” including “a rare type of cancer called hepatosplenic T-cell lymphoma” that “often results in death,” along with “increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens.” Since the FDA is pretty slow on the uptake of actually putting adverse effects of drugs on their warning labels, I’ll mention that, in addition to Lymphoma, TB and other infections, Humira is also linked to the following:
- Skin Cancer
- Kaposi’s Sarcoma
- Histoplasmosis Cryptosporidium
All of which can lead to death.
No wonder AbbVie wants to hide their data from their clinical trials. The data from their clinical trials is undoubtedly incriminating. And of course it would effect sales if people knew about the risk of cancer and death associated with this drug.
Though the effects of these drugs are horrifying, they are on the warning label, and thus aren’t newsworthy (though they should be, we all should be having fits over what these dangerous drugs are doing to people). What is newsworthy is the fact that AbbVie and InterMune are trying to block access to information about their drugs. This truly is an atrocity. Not only is AbbVie going to make a drug that maims and kills people, but they’re going to block access to the clinical data that describes what happened to the drug’s victims and how it happened, presumably so that they can lie about it, and, worse, Researchers won’t have access to the data and therefore they won’t be able to learn from it.
To hide information is an affront to science and the scientists who are trying to do research into the safety and efficacy of medicines. It is an affront to Doctors who are trying to make the best, informed decisions regarding medicine that they prescribe. It is an affront to Patients who have the right to informed consent before any pharmaceutical is administered or medical procedure is done. Informed consent is a bedrock of medicine, and thus it is an affront to medicine. Informed decisions are even a foundational principle of capitalism, so it is even an affront to capitalism, the thing that AbbVie and InterMune claim that they are trying to optimize. It is an affront to democracy as information is needed in order to hold those in power (sadly, corporations) responsible. Most importantly, it is an affront to the truth.
While the lawsuit is pending, ALL requests for AbbVie’s and InterMune’s clinical trial data, that were to be released on demand, are being denied until the suit is resolved. While I hope that the European courts will decide in favor of transparency, openness and truth over corporate profits, AbbVie and InterMune are benefiting in the meantime. It’s a pretty good bet that they’ll keep several hundred lawyers employed stopping up the system indefinitely, as they’re getting exactly what they want just by filing the suit and delaying.
This sets a horrible precedent in countless ways. It shows that transparency and truth are optional for big pharmaceutical companies, that optimizing profits is not only more important to these drug manufacturers than truth, transparency and safety, but that optimizing pharmaceutical company profits is also something that the European Medicines Agency is willing to protect; that truth, informed consent and access to complete information is something that is optional if a company has enough money, power and lawyers; that consumer protection rules and regulations can be obstructed simply by filing a law suit, etc.
Even though this suit is going on in Europe, don’t for a second think that it doesn’t effect those of us in North America. The European Medicines Agency (EMA) has released more data to North American researchers than to anyone else – so it already is a North American issue. The FDA make much less data available than the EMA, so the only way U.S. Activists or Researchers can access full data-sets is through the EMA. So, this legal action is blocking Americans right to know as well as Europeans. Also, if a big, powerful, rich, American corporation can manipulate the release of information in their favor by tying up the courts with absurd litigation in Europe, you can certainly bet that they can do it here.
An affront to truth and democracy anywhere is a fight that is worth fighting, especially when the truth that is being hidden is something that effects whether humans live or die.
What should be done about this?
First, AbbVie and InterMune should drop their suit. Here’s a petition encouraging them to do so -
Second, the European Medicines Agency should continue to release information while the suit is pending. In stopping the release of clinical trial data they are effectively letting AbbVie and InterMune win before the battle is even fought in the courts.
Third, there should be some screaming about this. The media has been close to silent about this and it’s a failure on their part. Access to information is vital for journalism too, so journalists, get on this.
If AbbVie and InterMune’s suit and their line of thinking that their profits are more important than free access to information for patients, researchers, doctors, etc. is as offensive to you as it is to me, you can certainly join me in writing letters to political leaders, media outlets, etc., asking for outrage. I also took all money out of stock funds that could even possibly be invested in AbbVie or InterMune…. just a suggestion.
Post Script –
A huge thank you needs to go out to those at RxIsk.org RxISK is the first free, independent website where patients, doctors, and pharmacists can research prescription drugs and easily report a drug side effect — identifying problems and possible solutions earlier than is currently happening), Johanna Ryan, Dr. Derelie (Dee) Mangin and Dr. David Healy, author of Pharmagedon. Here are some posts on the topic at hand -
Additional media sources -