Friday, April 26, 2013

Mickelson and KPMG and Barclays and Enbrel

First of all, let me be clear. I admire the career of Phil Mickelson, and I also have great respect for his determination and fortitude as he struggles through some very hard times. I do not wish to tarnish the man nor his reputation. I understand he is suffering greatly, and I pray for his complete recovery from his illness. He is, by all accounts, one of the greatest golfers of all time.

I do, however, want to write a post demonstrating how prescription drugs are marketed and advertised in the United States. All I am asking is that you read this post, watch the commercial featuring Phil Mickelson and Enbrel, and see if you feel any reservations about how drugs are sold in America. I will leave any conclusions up to you. I do feel you may find some of the following post very interesting and, perhaps, you may have some further questions. Thank you.

Phil Mickelson and Psoriatic Arthritis

Pro Golfer Phil Mickelson has psoriatic arthritis, a painful condition where the immune system attacks the joints. It is said to affect about 2% of white males

Mickelson first felt it like a bolt five days before the U.S. Open in June 2010.

"I woke up and I had some intense pain in some areas of my body, so much so that I couldn't walk," he revealed Tuesday. "It was my Achilles and my piriformis muscle. My left index finger was sprained and I couldn't bend it, and my right wrist was sprained.

"It would loosen up throughout the day ...and after two or three hours of stretching I was able to play very effectively, but then it started into the hips and ankle and elbows and that's when I got concerned."

(Hank Gola, "Phil Mickelson Uses Enbrel to Treat Psoriatic Arthritis, Joint Condition That Arose Before U.S. Open," New York Daily News, August 11 2010)
A  doctor prescribed anti-inflammatory medication, but a week after the British Open in mid-July, the condition hit him again on vacation in Hawaii.

"I wasn't on anything. I was just trying to see what was going to happen," he said. "Every joint in my body started to hurt to where I couldn't move."

At the Mayo Clinic in Minneapolis, doctors confirmed the original diagnosis. They prescribed Mickelson  Enbrel, a drug jointly marketed by AMGEN & PFIZER, which blocks the protein that cases the inflammation. He self-administers a once-a-week injection.

"It's very treatable," added Mickelson, 40, who says he is at 90%. "I'll probably take this drug for about a year. I'll stop it and see if it goes into remission."

Yet, Michael Paranzino , president of the nonprofit Psoriasis Cure Now, explains that in many cases, people with psoriatic arthritis find, for reasons still unclear to experts, that their treatments, including the biologics like the one Phil Mickelson is on, lose effectiveness over time. Psoriatic arthritis is a serious disease, and it can be debilitating.

("Phil Mickelson's Arthritis Shocks Golf World, Psoriasis Cure Now Says a Reminder That Psoriatic Arthritis Is a Serious Disease," PR Newswire, August 11 2010)

Sometimes, the sufferers switch to a different biologic treatment and buy more time, but there are patients who have run through all existing treatments. The treatments also carry FDA-required black box warnings for possible rare but serious side effects.

Paranzino says, "In short, there is no guarantee that Phil Mickelson 's psoriatic arthritis troubles are behind him. Psoriatic arthritis is a lifelong disease...  "for many people with psoriasis and psoriatic arthritis, even those who can afford the latest treatments (the cost of which can easily exceed $15,000 annually), their disease is a daily battle. That is why research is so important. We need a cure for psoriasis and psoriatic arthritis."

The sad truth is that psoriatic arthritis could cause him more trouble down the road, even with the world's best doctors and best medical treatments.

Examine the trials of golfer and broadcaster Bob Murphy. He started feeling aches and pains in the early 1980s, more than a decade after he had turned professional and built a respectable career on the PGA Tour. The pain got worse, leaving him almost unable to function by 1986, when he edged Greg Norman by three strokes to win the Canadian Open despite his condition.

Within a year, he concluded that his golf career had run its course. “I had six fingers that swelled up so badly that I just couldn’t play,” Murphy recalled. “The stuff just exploded on me. That’s how quickly it happened; you never knew what was going to hurt next.”

Murphy, 67, was found to have psoriatic arthritis in 1989. After receiving treatment, he recovered to the point that he was able to join the Senior PGA Tour (now the Champions Tour) in 1993 and restart his golf career.

Today, like Mickelson, Murphy takes injections of Enbrel, though they are intended to relieve his skin condition more than his arthritis, from which he has all but recovered thanks to years of treatment.

(Thomas Kaplan, "Immune Disorder Could Be an Enduring Test for Mickelson,"
The New York Times, August 11 2010)

In the early '90s Murphy began taking massive doses of intravenous antibiotics such as tetracycline. The regimen helped. He also took methotrexate. "Lo and behold, it became under control," he says of the arthritis. "I was able to play with no pain or swelling." He won 11 times on the Champions Tour. Today, he takes Enbrel shots once a week and also uses magnet therapy on the parts of his body that hurt.

(Cliff Collins, "Pro Golfer Phil Mickelson's Early Diagnosis Could Help Keep the Disease at Bay," Psoriasis Advance and the National Psoriasis Foundation, Fall 2010)  

The same Thomas Kaplan article in New York Times helped Enbrel's cause by supplying the following dire statistics about this medical condition: "As many as 7.5 million people in the United States have psoriasis, according to the National Psoriasis Foundation, and about 30 percent of those with psoriasis develop psoriatic arthritis. While psoriasis often appears between the ages of 15 and 25, the arthritis symptoms usually appear later, often between 30 and 50. When it does, there is no rhyme or reason as to which joints will hurt at any given time."

John Mack, publisher and editor of Pharma Marketing News, believes this bit of information came straight from AMGEN/PFIZER's PR people.

Mack says, "It probably did NOT come from the 'nonprofit Psoriasis Cure Now' group. That group, which includes Amgen and Pfizer as sponsors, claimed ONLY 1 million people (less than half the number cited in the NYT article) in the US have psoriatic arthritis."

(John Mack, "Is Phil Mickelson Shilling for Enbrel?" Pharma Marketing Blog, August 12 2010)

Mack's question -- "Is Phil Mickelson Shilling for Enbrel?" -- was prompted by a couple of news stories, one of which proclaimed "PGA Championship 2010, Whistling Straits: Phil Mickelson Has Psoriatic Arthritis - Uses Enbrel To Help Manage Condition."

This story also included this quote from Mickelson: "I have no aches and pains. My back feels great. I feel stronger and more flexible than I've ever been."

Here is Mack's take on the situation:

"That's quite a claim! If Phil made such a claim while being a paid spokesperson for Enbrel, he would have probably violated FDA regulations regarding unsubstantiated claims. He also would have violated FTC regulations regarding celebrity endorsements and testimonials by not disclosing 'material connections' (payments or free products) between advertisers and endorsers – connections that consumers would not expect."
(John Mack, "Amgen Blows Its Marketing Budget on Phil Mickelson Campaign," 
Pharma Marketing Blog, January 7 2011)

Phil Mickelson, Enbrel and Business

According to a November 2010 AMGEN/PFIZER press release, Phil Mickelson is now a fully branded spokesperson for Enbrel. He is featured prominently on the Enbrel Web site, TV and in third-party publications such as Arthritis Today. He picked up the deal to promote Enbrel after he was diagnosed with the disease in 2010 and used the drug for his treatment.

Mickelson is a great athlete and a very rich man. He was inducted into the World Golf Hall of Fame in May 2012, reflecting a stellar career that includes 40 PGA victories (ninth all-time), $66 million in career prize money (second all-time) and four major titles (second-most during the past 20 years).

Mickelson earns more than $30 million annually from endorsement partners: Callaway, Barclay's, KPMG, Exxon, Rolex and Amgen/Pfizer. Forbes lists Mickelson as #7 in The World's Highest-Paid Athletes and #48 in their Celebrity 100. Forbes also claims Mickelson is #34 in Money Celebrity and #42 in TV/Radio Celebrity.

* Please watch this recent television commercial featuring Phil Mickelson and Enbrel:

(1) About KPMG

All information from Wikipedia article:

KPMG is one of the largest professional service companies in the world and one of the Big Four auditors. Its global headquarters is located in Amstelveen, Netherlands. KPMG employs 145,000 people and has three lines of services: audit, tax, and advisory. Its advisory services are further divided into three service groups – Management Consulting, Risk Consulting, and Transactions & Restructuring

In February 2008, Phil Mickelson, ranked one of the best golfers in the world, signed a three-year global sponsorship deal with KPMG. As part of the agreement, Mickelson will wear the KPMG logo on his headwear during all golf related appearances.

In 2003, KPMG agreed to pay $125 million to settle a lawsuit stemming from the firm's audits of the drug chain Rite Aid. In 2004, KPMG agreed to pay $115 million to settle lawsuits stemming from the collapse of software company Lernout & Hauspie Speech Products NV.

In early 2005, the United States member firm, KPMG LLP, was accused by the United States Department of Justice of fraud in marketing abusive tax shelters. KPMG LLP admitted criminal wrongdoing in creating fraudulent tax shelters to help wealthy clients avoid $2.5 billion in taxes and agreed to pay $456 million in penalties in exchange for a deferred prosecution agreement. KPMG LLP would not face criminal prosecution if it complied with the terms of its agreement with the government.

On 3 January 2007, the criminal conspiracy charges against KPMG were dropped. Before the settlement, the firm, on the advice of its counsel Skadden, Arps, Slate, Meagher & Flom LLP, removed several tax partners and admitted "unlawful conduct" by those partners. The firm agreed to cooperate with the U.S. Department of Justice's investigation and help prosecute former partners who had devised and sold the tax shelters. Additionally, the firm hired former U.S. district judge Sven Erik Holmes to monitor its legal and regulatory affairs.

In February 2007, KPMG Germany was investigated for ignoring questionable payments in the Siemens bribery case.In November 2008, the Siemens Supervisory Board recommended changing auditors from KPMG to Ernst & Young.

Fannie Mae sued KPMG for malpractice for approving years of erroneous financial statements.

In March 2008, KPMG was accused of enabling "improper and imprudent practices" at New Century Financial, a failed mortgage company and KPMG agreed to pay $80 million to settle suits from Xerox shareholders over manipulated earnings reports.

It was announced in December that two of Tremont Group’s Rye Select funds, audited by KPMG, had $2.37 billion invested with the Madoff "Ponzi scheme." Class action suits were filed.

In April 2013, Scott London, a former KPMG LLP partner, admitted passing on stock tips about clients to a friend who gave him cash and gifts, in a scandal that led the big accounting firm to resign as auditor for two companies. Mr. London said the person gave him a discount on a watch, bought him dinners from time to time and "on a couple of occasions" gave him $1,000 to $2,000 in cash.

(2) About Barclays

All information taken from Wikipedia article:

Barclays is a British multinational banking and financial services company headquartered in London, United Kingdom. It has operations in over 50 countries and territories and has around 48 million customers. As of 31 December 2010 it had total assets of US $2.33 trillion, the third largest of any bank worldwide. Founded in 1690, it is the 6th oldest bank in the world still in existence.

Barclays is organised within two business 'clusters': Corporate and Investment Banking, Wealth and Investment Management; and Retail and Business Banking.

Barclays has a primary listing on the London Stock Exchange and is a constituent of the FTSE 100 Index. It had a market capitalisation of approximately £21.8 billion as of 23 December 2011, the 22nd-largest company of any company with a primary listing on the London Stock Exchange. It has a secondary listing on the  New York Stock Exchange.

Barclays is a major sponsor of professional golf tournaments worldwide, the Barclays Scottish Open on the PGA European Tour at Loch Lomond since 2002, the Barclays Classic on the PGA Tour from 2005–2006, which became The Barclays in 2007, the first of four playoff tournaments for the FedEx Cup, and since 2006 Barclays has been title sponsor to the Singapore Open, the richest national open in Asia, and since 2009 has been co-sanctioned with the European Tour. Barclays also sponsors PGA Tour star Phil Mickelson and Europena Tour player Darren Clarke.

In March 2009, Barclays was accused of violating international anti-money laundering laws. According to the NGO Global Witness, the Paris branch of Barclays held the account of Equatorial Guinean President Teodoro Obiang's son, Teodorin Obiang, even after evidence that Obiang had siphoned oil revenues from government funds emerged in 2004. According to Global Witness, Obiang purchased a Ferrari and maintains a mansion in Malibu with the funds from this account.

A 2010 report by the Wall Street Journal described how Credit Suisse, Barclays, Lloyds Banking Group, and other banks were involved in helping the Alavi Foundation, Bank Melli, the Iranian government, and/or others circumvent US laws banning financial transactions with certain states. They did this by 'stripping' information out of wire transfers, thereby concealing the source of funds. Barclays settled with the government for US$298 million.

In March 2009, Barclays obtained an injunction against The Guardian to remove from its website confidential leaked documents describing how SCM, Barclays' structured capital markets division, planned to use more than £11bn of loans to create hundreds of millions of pounds of tax benefits, via "an elaborate circuit of Cayman Islands companies, US partnerships and Luxembourg subsidiaries."

In an editorial on the issue, The Guardian pointed out that, due to the mismatch of resources, tax-collectors (HMRC) have now to rely on websites such as WikiLeaks to obtain such documents, and indeed the documents in question have now appeared on WikiLeaks. Separately, another Barclays whistleblower revealed several days later that the SCM transactions had produced between £900m and £1bn in tax avoidance in one year, adding that "The deals start with tax and then commercial purpose is added to them."

In February 2012 Barclays was forced to pay back £500 million in tax which it had tried to avoid. Barclays was accused by HMRC of designing two schemes that were intended to avoid substantial amounts of tax. Tax rules forced the bank to tell the UK authorities about its plans.

David Gauke, Exchequer Secretary to the Treasury, said that "We do not take today's action lightly, but the potential tax loss from this scheme and the history of previous abuse in this area mean that this is a circumstance where the decision to change the law with full retrospective effect is justified."

One tax scheme involved Barclays claiming it should not have to pay corporation tax on profits made when buying back its own IOUs. The second tax avoidance scheme, also designed by Barclays, involved investment funds claiming that non-taxable income entitled the funds to tax credits that could be reclaimed from HMRC. The treasury described this as "an attempt to secure 'repayment' from the Exchequer of tax that has not been paid."

What Do You Think About Selling Drugs In This Manner?

High power celebrity endorsements for drugs? Wearing gear that advertises KPMG and Barclays in drug advertisements? Possible oversimplification of the severity of a disease and the distortion of facts in promoting the means of controlling its painful symptoms? Skewed promotion and inaccurate fairy-tale videos? Misrepresentation or outstanding marketing?

I promised to leave the evaluation of this entire business up to you, and I will. If nothing else, I believe you may see a very fine line between proper and improper representation and responsible marketing.

Direct-to-Consumer Pharmaceutical Advertising  (DTCPA) can be defined as an effort (usually via popular media) made by a pharmaceutical company to promote its prescription products directly to patients. At this time, the U.S. and New Zealand are the only countries that allow DTCPA that includes product claims. Most other countries don’t allow DTCPA at all; however, Canada does allow ads that mention either the product or the indication, but not both.


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