FDA Levies Large Fine Against Johnson & Johnson

It’s not Really the Good News you’d Think it Would be.

Recent press releases from the FDA and Justice Department proudly announced Johnson & Johnson [J&J] had been given a fine of 2.2 Billion [with a “B”] dollars. When I read the media reports about this huge fine, I was impressed. Perhaps the FDA system still has it within themselves to muster up the courage and independence to stand up and police a Big Pharma company such as J&J. Could the FDA actually begin to protect the vulnerable public?

Who is Big Pharma? It is a small group of large international pharmaceutical companies who have taken a large degree of control over what we as doctors and patients are allowed to use in medical care. Many insightful medical investigations have pointed out these companies have an inherent need to make enormous profits simply to exist. This means that the profit potential of a drug often overshadows the risks and effectiveness of the medication.

Overall this represents a great change in medicine during the past 40 years. The reality is that it is a business and marketing plan, not a diabolical plot. However, it is a business plan using high-octane pharmaceuticals that can kill if not rigorously policed by a third party.

As an organization, the FDA has repeatedly been shown to be unable to withstand the public and private pressures put on them by the might of Big Pharma. These campaigns for drug approvals are funded by the immense profits Big Pharma reaps through their sales. This issue is compounded and further muddied by the revolving door that regularly swaps personnel between the FDA and pharmaceuticals companies that it is supposed to regulate. It really has become like putting the fox in charge of the hen house. The book titled Big Pharma: Exposing the Global Healthcare Agenda by Jacky Law provides more of the details.

You may be thinking that if the FDA can levy a $2,200,000,000 fine, things are going to be different now. Right? Not so fast, the details reveal the exact opposite.

The fine is part of a larger settlement which represents a new triumph for J&J and by extension all of Big Pharma. Most importantly this fine sets a precedent, a protocol so to speak. It allows Big Pharma to get away with marketing an immensely profitable medication in spite of being repeatedly warned to stop by the FDA. The FDA rejected the request from J&J to market a drug called Risperdal for off label uses. Besides not believing it was an effective treatment, the FDA also suspected the drug was actually maiming kids and causing strokes and early deaths in the elderly.

Here is why J&J chose to disregard these warnings of strokes, deaths, etc. for up to 9 years. The company was making money, a lot of money, on the sale of Risperdal. The total net profit on this drug alone was 24 BILLION dollars. Therefore the final fine represented only 9% of their profits. That fact was somehow left out of the press releases put out by the FDA and Justice Department emphasizing the size of the fine. Instead, the attorney general indicated that fines of this size would send a message of fear to the entire industry. Instead it sends a message of fear to any of us who discovers the details of this fine. Big Pharma has been reassured, not frightened. It is the people who are supposed to be protected who are now frightened. The settlement dramatizes how much Big Pharma can now do without fear of being held accountable. The watchdog policing arm of the FDA has been neutralized by profits.

There are more disturbing details. Again, one has to ask, where is the outrage?

Who paid J&J these insane profits?

We do, you and I. Most of the patients receiving Risperdal off label were in government assisted medical care.

Some taxpayers have to work two jobs. We pay our income taxes. Some of that money goes to paying the salaries, lucrative pensions and vacations of the same FDA staff that do not have the courage or are compromised to do their job.

J&J targeted doctors managing these government assisted medical programs. The settlement included the information that kickbacks were used to get these doctors to create a need for a drug, which carried warnings of non-effectiveness and dangers. Why did these doctors not step up and ‘just say no’? Finally, who pays for the doctors that provide services for those on government assisted medical care? You guessed it. We do as taxpayers.

Suggested reading: On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Health by Dr. Jerome Kassirer

So we, as taxpayers, ultimately pay for the entire chain of corruption. J&J profits, FDA, and government paid doctors employed by us to care for the infirm and indigent.

Who were the patients? Why is this important?

Pre-teen boys and the elderly needing some form of nursing assistance were the primary patient groups. Strange combination, but notice what these groups have in common. Neither had direct control of the intake of their medications. The current business model of Big Pharma yields more stable revenue and profit when the products are consumed by patients who have someone else obtaining it, giving it to them, and who are not in a position to question its value or safety.

Now From the “It Can’t Get Worse, But It Does” Department: Further Terms of the Settlement

The fine was accompanied by a legally binding document. The settlement document had J&J admitting guilt to criminal activities. The executives involved were then given permanent immunity from prosecution for those criminal activities! What a great deal this was for them; the envy of every illegal drug or narcotics dealer in prison.

Did the fine and settlement ‘send a message’ to J&J and its executives?

The J&J stock price was not affected by the settlement. The message here to the company seems to be “congratulations” for getting such a sweet deal when you broke the law.

What about the executives? Well, one executive in particular deserves special mention. His name is Alex Gorsky. He initiated the off-label marketing plan to expand the use of Risperdal beyond the FDA permitted limits. He was so identified with this drug, that for a time he included the tremendous increase in profits from Risperdal in his personal resume!

What did the company do to teach him a lesson after he brought down the “wrath” of the FDA and the Justice Department on the company? He was promoted by the J&J Board of Directors to be the head of the entire company. He is the new CEO!

What does this mean for you?

So once again, buyer beware when it comes to Big Pharma. With huge profits as the key business driver, their next drug might help you, or it might kill you, but the Big Pharma company that makes the drug will definitely make a killing.