The DOJ v Pharma Settlement Planetary System

The DOJ v Pharma Settlement Planetary System

The Department of Justice (DOJ) just released a commemorative poster highlighting the six most-recent multi-million dollar settlements that drug companies have agreed to pay for inappropriately, and in some cases illegally, promoting prescription drugs. The poster represents just the latest version of the "DOJ v Pharma Settlement Planetary System," which still has room for additional members (see unidentified objects in the poster).

Here's a description of the planets and how they were "discovered" as reported by ProPublica (here):

• The smallest "planet" in DOJ's System is AstraZeneca, which was fined $520 million to resolve allegations that it illegally promoted the anti-psychotic drug Seroquel. The drug was approved for treating schizophrenia and later for bipolar mania, but the government alleged that AstraZeneca promoted Seroquel for a variety of unapproved uses, such as aggression, sleeplessness, anxiety, and depression. AstraZeneca denied the charges but agreed to pay the fine to end the investigation. NOTE: The size of the AZ settlement "planet" is so small in comparison to the others in the System that many experts do not consider it a true "planet" at all. (The AZ planet was "discovered" in April 2010).
• Next is Merck, which agreed to pay a fine of $950 million related to the illegal promotion of the painkiller Vioxx, which was withdrawn from the market in 2004 after studies found the drug increased the risk of heart attacks. The company pled guilty to having promoted Vioxx as a treatment for rheumatoid arthritis before it had been approved for that use. The settlement also resolved allegations that Merck made false or misleading statements about the drug's heart safety to increase sales. (The Merck planet was "discovered" in November 2011).
• The fourth largest planet is the DOJ System is Eli Lilly, which was fined $1.42 billion to resolve a government investigation into the off-label promotion of the anti-psychotic Zyprexa. Zyprexa had been approved for the treatment of certain psychotic disorders, but Lilly admitted to promoting the drug in elderly populations to treat dementia. The government also alleged that Lilly targeted primary care physicians to promote Zyprexa for unapproved uses and “trained its sales force to disregard the law.” (The Lilly planet was "discovered" in January 2009).
• Next largest in size is Abbott, which was fined $1.5 billion in connection to the illegal promotion of the anti-psychotic drug Depakote. Abbott admitted to having trained a special sales force to target nursing homes, marketing the drug for the control of aggression and agitation in elderly dementia patients. Depakote had never been approved for that purpose, and Abbott lacked evidence that the drug was safe or effective for those uses. The company also admitted to marketing Depakote to treat schizophrenia, even though no study had found it effective for that purpose. (The Abbott planet was "discovered" in May 2012).
• Pfizer, which up until recently was the largest planet in the DOJ System, was fined $2.3 billion in September 2009, then the largest health care fraud settlement and the largest criminal fine ever imposed in the United States. Pfizer pled guilty to misbranding the painkiller Bextra with "the intent to defraud or mislead", promoting the drug to treat acute pain at dosages the FDA had previously deemed dangerously high. Bextra was pulled from the market in 2005 due to safety concerns. The government alleged that Pfizer also promoted three other drugs illegally: the anti-psychotic Geodon, an antibiotic Zyvox, and the anti-epileptic drug Lyrica.
• GlaxoSmithKline is currently the largest planet in the DOJ v Pharma Settlement Planetary System. GSK agreed to pay a fine of $3 billion to resolve civil and criminal liabilities regarding its promotion of drugs, as well as its failure to report safety data (see "GSK Guilty of Off-Label Marketing from 1999 to 2010: Will Pay $3 Billion Settlement"). This is the largest health care fraud settlement in the United States to date. The company pled guilty to misbranding the drug Paxil for treating depression in patients under 18, even though the drug had never been approved for that age group. GlaxoSmithKline also pled guilty to failing to disclose safety information about the diabetes drug Avandia to the FDA. (The GSK planet was "discovered" in July 2012).

Abbott's Anti-Biosimilar Stance is Anti-Consumer

Abbott's Anti-Biosimilar Stance is Anti-Consumer

The pharmaceutical industry often wonders why it has such a bad reputation with consumers -- nearly as bad as the tobacco industry -- considering it saves lives, as opposed to the tobacco industry, which ends lives. Well, to understand why this is so, you need look no further than actions such as Abbott's April 2, 2012 citizen's petition against FDA approval of biosimilars (read more about that and find a copy of the petition here: "Abbott Labs Petitions FDA to Disallow Biosimilars").

According to the FDA (here):

The Patient Protection and Affordable Care Act (Affordable Care Act), signed into law by President Obama on March 23, 2010, amends the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. This pathway is provided in the part of the law known as the Biologics Price Competition and Innovation Act (BPCI Act). Under the BPCI Act, a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product.

The law protects the original biologic drug from copies for 12 years after approval.

"If the challenge succeeds," says WSJ, "less-expensive versions of complex biologic drugs couldn't go on sale in the U.S. for years, and consumers may never have access to facsimiles of existing treatments such as Abbott's rheumatoid arthritis therapy Humira, which had $3.4 billion in U.S. sales last year and is projected to be the world's No. 1-selling drug this year."

Abbott "contends that its drug isn't copyable under the law, because regulators would need its Humira trade secrets to approve a biosimilar and would thereby violate its constitutional rights. The company said it is protecting an investment of 'massive amounts of capital' and the 'great risk' it took developing the drug. In fact, Abbott contends that no biologic approved before the law was signed should be considered copyable."

"Critics of Abbott's position say that the argument lacks merit and is anticompetitive, and that trade secrets aren't necessary to prove that a copy will work like the original. The critics also contend Abbott is backtracking on its support for the legislation and ignoring the potential impact on the country's spiraling health-care spending."

Considering that Abbott Labs will soon have the NUMBER 1 selling drug in the world (see below) -- taking the crown from Pfizer's LIPITOR -- it makes perfect sense that Abbott should act NOW to protect its patented money-maker, years before it finds itself in the not-so-envious position of Pfizer, which fought on even after the bell rang on Lipitor (see "Pfizer Throws In the Lipitor Marketing Towel"). Note: Humira's U.S. patent expires in December 2016

With the filing of this petition, Abbott Labs may also take on another "crown" previously held by Pfizer -- the world's most hated pharmaceutical company. Good luck with that Abbott.

Booming Biologics
Abbott, however, is just the "poster boy" (or "patsy") chosen by the drug industry to take the shots by filing this petition, which really speaks for the entire industry. Patented biologics is a big business and represents the future of the pharmaceutical industry.

According to the WSJ, biologics "had $74.8 billion in U.S. sales last year, up 8.3% from the previous year, according to the IMS Institute for Healthcare Informatics. This year, seven of the 10 top-selling drugs will be biologics, with a total of $50.4 billion in world-wide sales, according to EvaluatePharma, which predicts that Humira will be No. 1 with $9.3 billion in world-wide sales."

Abbott Fetes Barred Cardiologist with High Cholesterol Pig Roast

Abbott Fetes Barred Cardiologist with High Cholesterol Pig Roast

Practically every week I read amazing stories about stupid, immoral, unethical, or illegal activities perpetrated by the pharmaceutical industry. Stories that are bolstered with juicy quotes from internal corporate emails written by dumb executives. And I don't have to wait for Wikileaks to publish this stuff when the U.S. Senate and the Wall Street Journal (WSJ) are already doing it!

Take today for example. A story in the WSJ titled "Abbott Hired Barred Doctor" caught my attention (find it here). At first, I thought it was nothing new -- I already know that pharmaceutical companies have hired questionable physicians in the past, so it's not too exciting to learn that Abbott "hired a Baltimore-area cardiologist as a sales consultant after he was barred from practicing at a local hospital last year for allegedly putting heart stents in hundreds of patients who didn't need them."

What's interesting is the juicy stuff that the Senate learned from internal emails written by Abbott executives.

For example:

"In 2008 Abbott paid more than $1,000 for a pig roast, complete with mobile pig pit, at a party to fete the cardiologist the same week Dr. Midei, then head of the cardiac catheterization lab at St. Joseph Medical Center in Towson, Md., set a possible company record by implanting 30 stents in a single day."

and

"Charles Simonton, the medical director of Abbott's vascular division, said in another email cited by the [Senate report to be released today] that Dr. Midei should 'clearly avoid' the Baltimore area, but Dr. Simonton encouraged colleagues to 'please find key physicians or cath labs you'd like him to get in front of with our data.' Abbott wanted to hire Dr. Midei 'because he helped us so many times over the years,' yet another Abbott executive said in an email."

and

"Around that time, an Abbott executive complained to a colleague by email about one of the [Baltimore] Sun's journalists [who reported on the alleged overuse of stents at St. Joseph] 'Somebody needs to take this writer outside and kick his ass. Do I need to send in the Philly mob?' he wrote, according to the report."

What's really amazing is that a company supposedly dedicated to saving lives of patients with cholesterol-blocked coronary arteries would host a $1,407 pig roast complete with a mobile "Alabama pig pickin' pit," a whole pig smoked for 15 hours, Memphis-style ribs, chicken, hot dogs, cole slaw and two big peach cobblers. The only thing heart-healthy on that menu may have been the cole slaw! I can forgive the threat to kick the reporter's ass, but a pig roast in a cardiologist's back yard? Unforgivable!