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Pfizer’s Latest Twist on ‘Pay for Delay’

Protecting Brand-Named Drugs

By Marian Wang
ProPublica, November, 14th, 2011, 2:41 pm

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Pharmaceutical companies have sought for years to protect their expensive brand-name drugs by paying generic rivals [1] handsome sums of money to put off efforts to introduce cheaper, generic alternatives that could steal market share.

Pay for Delay

The controversial practice, known as “pay for delay,” occurs as part of patent litigation settlements and typically buys a brand-name drug company more time to sell its blockbuster drug exclusively until its patent on the drug expires. Federal Trade Commission regulators have said the practice costs consumers an estimated $3.5 billion each year [2], and have pushed for a ban.

But now it appears the drug company Pfizer is adding yet another twist to its efforts to delay generic competitors. As The New York Times reports, the company seems to have struck a deal with certain pharmacy benefit managers — the middlemen in the pharmaceutical industry — to block generic versions [3] of Lipitor.

The Block Buster

Lipitor, Pfizer’s blockbuster cholesterol-lowering drug, is among the world’s best-selling pharmaceuticals, and this isn’t Pfizer’s first attempt to protect it.

In 2008, the company settled patent litigation [4] with Ranbaxy, an Indian generic manufacturer, striking a deal that guaranteed that Pfizer would not have to face challenges [5] from Ranbaxy’s generic version of Lipitor until the end of November 2011. Pfizer granted Ranbaxy some incentives [6] as part of the bargain but said it made no payments. Nonetheless, a group of pharmacies filed suit [7] against Pfizer and Ranbaxy last week over the deal, calling it “an extraordinary ripoff” and alleging price-fixing between the two companies.

Big Discounts

Now that it’s November 2011, Ranbaxy and other drugmakers are gearing up to offer cheaper versions of Lipitor. As The Times reports [3], Pfizer has tried to counter this competition by offering big discounts on Lipitor to the middlemen that process prescriptions [8] for pharmacies and other buyers, giving them discounts in exchange for having them block generic versions of Lipitor for another six months. Here’s The Times:

Many drugstores are being asked to block prescriptions for a generic version of Pfizer’s Lipitor starting Dec. 1, when the company loses its patent for the blockbuster cholesterol drug and generic competition begins.

Medco Health Solutions, among the nation’s largest pharmacy benefit managers, is one of the companies issuing instructions, seeking to have pharmacists keep filling prescriptions with the more expensive Lipitor for six months.

See some of those instructions [9] sent to pharmacies by the pharma middlemen. The documents were released by Pharmacists United for Truth and Transparency, a group of independent pharmacists. (We first noticed them posted at the blog Pharmalot [10].)

According to the group, Pfizer’s plan would mean that customers at the pharmacies serviced by these middlemen would receive Lipitor even when they’ve been prescribed a generic version. Because Lipitor co-pays would also be reduced to the level of generic co-pays, customers might not notice, but employers and Medicare Part D would pay the same amount as before, despite the availability of a cheaper alternative.

Assessment

A Pfizer spokesman gave The Times a statement saying that the company was committed to ensuring that customers had access to Lipitor but declined to answer additional questions. We’ve also asked Pfizer for comment and will update when we hear back.

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Does Financial Regulation Kill Jobs?

Perhaps Not!

By Marian Wang
ProPublica, Sept. 12, 2011, 1:20 pm

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With the presidential campaign in motion, and President Obama urging immediate passage of his new jobs bill, the attention in Washington has shifted almost exclusively to the economy and job creation. And, that means a shift away from regulation, right? Not necessarily.

Growth Spurts?

Some regulators and financial industry experts are predicting the opposite—that new financial regulations will spur some growth.

For example, The New York Times’ DealBook blog cited derivatives regulation [1] as one example. Dodd-Frank requires a substantial chunk of the $600-trillion derivatives market to trade on exchanges or on new electronic trading platforms.

“I have no doubt that these new regulations, instituting new types of clearing, trading and reporting platforms, will foster a landslide of hiring in the financial sector,”

Bart Chilton of the Commodity Futures Trading Commission said in a recent speech cited by the Times. As another New York Times piece noted, previous financial regulation laws have resulted in additional jobs for accountants and lawyers [2], at least.

But, separate from the jobs created to actually handle new regulation, others have pointed out that regulations can have a long-term, positive effect on overall economic growth by preventing the types of crises that put an industry on life-support.

The Studies

Last year, two studies by central bankers and regulators found that the short-term impacts of stricter capital requirements were “significantly smaller” than the estimates published by banking groups, the Times reported.

Rather, the studies said that stricter regulation would lead to more long-term growth [3] by preventing future crises.

Banks see higher capital requirements

  • Which require them to have more financial cushion to balance out risk-taking as a damper on profits.
  • And, they have repeatedly warned that tougher rules will hamper lending, reduce investment and slow economic growth.

Assessment

But, not everyone sees it that way. Swiss regulators, for instance, indicated last year that they would impose even tougher capital standards on their country’s banks on the premise that investors would rather put their trust [4]—and their dollars—in safer banks.

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What Does the S&P Downgrade Mean?

If France Is Rated Higher Than the US!

By Marian Wang
ProPublica, Aug. 8, 2011, 5:38 p.m.

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The decision by credit rating agency Standard & Poor’s to downgrade the United States [1] after markets closed on Friday may have kicked up political [2] consternation [3] and triggered a market plunge [4], but it also raises important questions about the reliability of credit ratings and, for that matter, the firms that bestow them.

Just over a dozen countries currently have an AAA [5]—or lowest-risk—rating from each of the three main rating agencies: Moody’s, Fitch, and Standard & Poor’s. Until this weekend, the United States was among them. (It’s now roughly on par with Australia, which also has two AAAs and one AA+.)

So, which countries are among the lucky few that still have perfect ratings from all three firms? The United Kingdom and France, just to name a couple. S&P apparently thinks that both the U.K. and France are safer investments than the United States.

The United States still has a higher per-capita GDP [6] than most countries, including both the U.K. and France. Last year, the U.S. GDP grew 2.9 percent [6]—almost double the U.K.’s 1.4 percent and France’s 1.5 percent. Between April and June of this year, the U.S. GDP grew 1.3 percent [7] while the U.K. economy grew 0.2 percent [8]. A June forecast from the Bank of France estimated that the country’s economy would grow 0.4 percent [9] in the second quarter. (U.S. growth, granted, is still slower than it used to be [10].)

As a percentage of GDP, both the U.K. and France have a higher percentage of external debt [11], or debt owed to outside bondholders. In 2010—the latest year for which the Organization for Economic Cooperation and Development has numbers—U.S. external debt was 61 percent of GDP, compared to France’s 67 percent and the U.K.’s 86 percent. Austria also maintains a lowest-risk rating from all three firms, and its external debt was 66 percent of GDP last year. 

Let’s not forget unemployment. Our July 2011 unemployment rate figure was 9.1 percent [10]. That’s higher than the U.K.’s, which has hovered around 7.7 percent [6], but it’s lower than France, which had 9.7 percent unemployment in June.

S&P, in explaining the historic downgrade—the first in U.S. history—cited both the U.S. debt burden and the political brinksmanship over the debt ceiling as reasons it lowered the credit rating of the United States to AA+, with a negative outlook.

So, what do the ratings mean, really? It seems to be a question that economists and investors are asking, too.

“France is not, in my view, a AAA country,” a UBS economist told Bloomberg [12]. And yet there are no indications [13] that France will face a downgrade, the Wall Street Journal reports. In fact, all three of the rating agencies recently affirmed France’s triple-As [12].

Credit rating agencies have taken a collective hit to their reputations for issuing flimsy triple-A credit ratings on securities that collapsed and helped trigger the financial meltdown. A Senate investigation earlier this year identified the firms as “a key cause [14]” of the financial crisis. Documents released by congressional investigators also pointed to serious conflicts of interest [15] that caused some ratings firms to bend to the wishes of the banks that paid for their ratings. 

Assessment

As we’ve written, some of the same problems with company culture [16] and inaccurate ratings [17] have persisted. Meanwhile, the Office of Credit Ratings—an office created by Dodd-Frank, the financial reform bill, to oversee these firms—hasn’t even been set up because Congress didn’t allocate funds for it. Other efforts written into the measure to lessen U.S. reliance on ratings and open up the firms to more liability have been slowed or stalled altogether.

Wiping out the references to credit ratings in U.S. law is a “harder task than the legislation assumes,” said Barbara Roper, director of investor protection for the Consumer Federation of America. The downgrade, she thinks, may provide just enough impetus to keep those efforts moving. 

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Merrill Lynch Investigated for CDO Deal Involving Magnetar

Hedge Fund Probed

By Marian Wang

ProPublica, June 15, 2011, 3:10 pm

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The Securities and Exchange Commission is investigating whether Merrill Lynch short-changed investors and gave undue influence to the hedge fund Magnetar in the creation of a $1.5-billion mortgage-backed security deal.

The investigation, which was first reported [1] by the Financial Times ($), appears to be the agency’s first probe of Merrill Lynch’s CDO business since the financial crisis. (Check our bank investigations cheat sheet [2] for which other firms are being probed.) Here’s the FT:

The investigation is one of several SEC probes into banks that helped underwrite billions of dollars of collateralised debt obligations, securities comprised of mortgages or derivatives linked to them.

It also marks a broadening of the SEC’s investigation into the role of collateral managers, institutions that help select the assets included in CDOs.

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The deal that the SEC is investigating—a collateralized debt obligation, or CDO, called Norma—was detailed both in our reporting last year [3] and in a report [4] by the Financial Crisis Inquiry Commission released in January. Norma was one of more than two dozen CDO deals [5] done by Magnetar, whose bets against a number of CDOs earned it billions in the waning days of the housing boom.

As the FCIC detailed, Magnetar helped select the assets that went into Norma even though it had a $600 million bet that would pay off substantially if the CDO failed. As we reported [6], Magnetar often invested in the portion of the CDO that was riskiest and hardest for the banks to sell. Banks typically gave such investors—equity investors—more say in how the deal was structured. (Magnetar isn’t named as a target of the investigation and had no responsibility to investors. It has also maintained that it did not have a strategy to bet against the housing market.)

In the offering documents for Norma, there’s no mention of Magnetar’s role in asset selection, according to the FCIC. Investors were told that an independent collateral manager, NIR Capital Management, would be selecting the assets with their best interest in mind. The report concluded: “NIR abdicated its asset selection duties… with Merrill’s knowledge.”

Bank of America

Bank of America, which took over Merrill Lynch in 2008, declined our request for comment. The firm’s general counsel told [4] the Financial Crisis Inquiry Commission that it was “common industry practice” for equity investors to have input during the asset selection process, though the collateral manager had final say.

NIR Capital Management

NIR Capital Management is also being investigated by the SEC, according to the FT. The firm did not immediately respond to our request for comment. (The Wall Street Journal did an impressively detailed story in 2007 on how NIR came to be manager [7] of the Norma deal.)

Magnetar declined our earlier requests for comment on Norma, but FT reports it has denied claims [1] that it selected the assets for Norma.

Assessment

As we reported, the SEC had launched a probe of Merrill’s CDO business 2007, but that investigation petered out without resulting in any charges.

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1 in 7 Hospitalized Medicare Beneficiaries Harmed by their Health Care?

According to a New Government Report

By Marian Wang

ProPublica, Nov: 16, 2010, 3:30 pm

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One out of every seven hospitalized Medicare beneficiaries experiences an “adverse event,” which means the patient is harmed as a result of medical care. That’s according to a study released today [1] by the Department of Health and Human Services’ inspector general. The “adverse events” contribute to an estimated 15,000 patient deaths [2] each month and add at least $4.4 billion [3] to the government’s annual Medicare expenses, the report projected. These findings were based on a nationally representative random sample taken from the nearly 1 million Medicare beneficiaries discharged from hospitals in October 2008.

The report’s findings were “consistent with previous studies” but “nonetheless disturbing [4],” Carolyn Clancy, director of the Agency for Healthcare Research and Quality, said in a written response to the report.

Medicare and Medicaid chief Donald Berwick, in a separate response, said that his agency is working to improve care not only for hospitalized patients, but is also trying to address “issues in dialysis centers and ambulatory and long term care settings.”

Inspector General Report

It’s interesting that he mentions this. Because the inspector general report only covered hospital care, the statistics it contains don’t include many of the adverse events we’ve reported on in a particular subset of Medicare beneficiaries—patients receiving care in dialysis clinics [5].

Examples:

But, the report did highlight the story of one hospitalized dialysis patient who almost died when the tube feeding blood back into his body dislodged—an incident that as we’ve noted, is potentially deadly but also preventable [6]: [O]ne beneficiary had excessive bleeding after his kidney dialysis needle was inadvertently removed, which resulted in circulatory shock, a transfer to the intensive care unit, and emergency insertion of a tube into the trachea (windpipe) to ease breathing. When the tube was removed the following day, the patient aspirated (inhaled foreign material into his lungs), which required a life-sustaining intervention.

Assessment

Of the adverse events it identified, the inspector general’s report judged about 44 percent to be preventable. The inspector general called on both the Centers for Medicare and Medicaid Services and the Agency for Healthcare Research and Quality to broaden the definition of adverse events and better measure such incidents, noting that “to date, no adverse event reporting system exists, and there are no Federal standards regarding State systems.”

Link: http://www.propublica.org/blog/item/read-govt-report-showing-1-in-7-hospitalized-medicare-beneficiaries-harmed-

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Bank Deals Similar to Goldman Sach’s Gone Awry

Other Major Banks Participated, Too?

By Marian Wang, ProPublica – April 16, 2010 1:36 pm EDT

As you may have heard, or read on this ME-P, Goldman Sachs is being sued for fraud [1] by the Securities and Exchange Commission [2] for allegedly misleading investors about a deal that Goldman helped structure and sell. In the civil suit, the SEC specifically faulted Goldman for failing to disclose that a hedge fund was helping create the investment while betting big the deal would fail.

According to the SEC, Goldman Sachs knew about the hedge fund’s bets, knew it played a significant role in choosing the assets in the portfolio, and yet did not tell investors about it. (Goldman Sachs has called the SEC’s accusations “completely unfounded in law and fact.” And in another more detailed statement [3], it said it “did not structure a portfolio that was designed to lose money.”) 

[picapp align=”none” wrap=”false” link=”term=Goldman+Sachs&iid=8541566″ src=”0/4/f/8/The_Goldman_Sachs_7d6f.jpg?adImageId=12513388&imageId=8541566″ width=”380″ height=”568″ /]

In ProPublica

As we reported at ProPublica last week, many other major investment banks were doing a similar thing [4].

Investment banks including JPMorgan Chase [5], Merrill Lynch [6] (now part of Bank of America), Citigroup, Deutsche Bank and UBS also created CDOs that a hedge fund named Magnetar was both helping create and betting would fail. Those investment banks marketed and sold the CDOs to investors without disclosing Magnetar’s role or the hedge fund’s interests.

Here is a list of the banks that were involved [7] in Magnetar deals, along with links to many of the prospectuses on the deals, which skip over Magnetar’s role. In all, investment banks created at least 30 CDOs with Magnetar, worth roughly $40 billion overall. Goldman’s 25 Abacus CDOs — one of which is the basis of the SEC’s lawsuit — amounted to $10.9 billion [8].

One reporter Jake Bernstein explained the investment banks’ disclosure failures on Chicago Public Radio’s This American Life [9]:

On the Magnetar Hedge Fund

The role of Magnetar, both as equity investor and in their bets against the very CDOs they helped create were not disclosed in any way to investors in the written documents about the deals. Not the marketing materials, not the prospectuses, not in the hundreds of pages that an investor could get to see information about the deal was it disclosed that it was in fact Magnetar who’d helped create the deal, and who’d bet against.

That is, of course, along the lines of what the SEC is suing Goldman Sachs for now. The SEC’s suit also says CDOs like the ones Goldman built “contributed to the recent financial crisis by magnifying losses associated with the downturn in the United States housing market.”

Notably, the SEC did not sue the hedge fund [10] involved in Goldman’s Abacus deals — Paulson & Co. — or its manager, John Paulson. Instead, it’s going after Goldman. And as we pointed out in our reporting, there’s no evidence that what Magentar did was illegal [11].

Assessment

We’ve called the major banks involved in Magnetar CDO deals to see if they were concerned about similar lawsuits. Thus far, Bank of America, Citigroup, Deutsche, Wells Fargo (which bought Wachovia) and UBS have responded and have all declined our requests for comment. Here is Magnetar’s response [12] to our original reporting.

Conclusion

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