If Government Does Not Control Corporations This Is What Happens.

Avandia, a Deadly Case of Déjà vu All Over Again

Once again, a front page report in The New York Times (below) lays bare unseemly facts about the pharmaceutical industry’s deadly norm and practice of concealing fatal risks of drugs that millions of patients consume as a result of aggressive marketing campaigns.

Once again, the FDA is shown to be complicit in turning a blind eye when a drug manufacturer, in this case, GlaxoSmithKline, concealed documented risks of heart attacks linked to its adjuctive diabetes drug, Avandia (rosiglitazone), putting of patients in harm’s way.

Gardiner Harris reports that a fierce debate that has been brewing for years within the FDA about “what to do about Avandia:” inasmuch as the preponderance of evidence shows patients taking the drug suffer cardiac harm.

Once again, a detailed Senate Finance Committee investigation reveals the true magnitude of the potentially deadly cardiac risks involving Avandia, an aggressively marketed diabetes drug whose sales reached $3.2 billion in 2006, but whose deadly risks the manufacturer, GlaxoSmithKline, concealed from patients and physicians for YEARS.” See Senate Finance Committee Press Release packet.

The report, overseen by Senator Max Baucus, a Democrat, and Senator Charles E. Grassley, a Republican, examined 250,000 internal GSK documents, concluded that instead of issuing a warning—as is a drug manufacturer’s duty--“G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.”

See Senate Finance Committee letter to FDA Commissioner (below). The Committee packet posted on its website includes a comprehensive benefit-risk assessment report (2008. 75 pp.) by FDA safety officers, Dr. David Graham and Dr. Kate Gelperin.

They report that the preponderance of evidence showed that "there was no evidence that rosiglitazone [Avandia] confers any unique health benefit over pioglitzone [Actos] while there was strong evidence that [Avandia] confers an increased risk of AMI [acute myocardial infarction] and heart failure compared to [Actos]. The evidence led these expert FDA safety officers to concluded that the drug “should be removed from the market” inasmuch as an estimated 500 heart attacks and 300 cases of heart failure would be averted EVERY MONTH, if patients took another diabetes drug.” See Finance Committee packet Attachment B.

Avandia’s cardiac risk was in evidence as early as November 2003, when GSK completed a study in which “diabetics given Avandia had far more heart problems than those given placebos.” European regulators ordered GSK to conduct a study to examine Avandia’s heart risks, but when the study showed harm (2004), GSK conducted a meta-analysis which it submitted to the FDA in 2005, and updated in 2006. The analysis showed that “Avandia increased the risks of serious heart problems by nearly a third.”

However, despite the totality of evidence, from company studies, adverse event reports filed with FDA’s Medwatch, and FDA safety evaluations corroborating Avandia’s deadly cardiac risks, the agency continued to drag its feet, “negotiating” with GSK, rather than pulling the drug off the
market or, at the very least, issuing public warnings.

Even worse, in 2007, after the New England Journal of Medicine published a report warning of the cardiovascular risk for patients taking Avandia; and after warnings were issued in several countries--including Canada, the European Union, and Australia--that Avandia was CONTRAINDICATED in patients with acute coronary syndrome; FDA officials, in collusion and collaboration with GSK, approved an unethical and exploitative clinical trial—TIDE, which is on-going. See HERE.

The trial does not meet the ethical principle of equipoise—requiring that so far as is known, benefit-risk of each comparator were equal. The accumulated evidence showed that Avandia posed higher risks than Actors. Furthermore, the FDA-approved trial allows the enrollment of very high risk patients with ischemic heart disease—for whom Avandia is contraindicated in several countries See Attachment C

The Informed Consent form given to patients is deceptive by commingling the risks of Avandia with the comparator drug, Actos (pioglitzone), which does not pose the cardiac risk that Avandia does. See Finance Committee Attachment D.

Corporate tactics of intimidation are, once more, in evidence:

The Senate Finance Committee report states that “GSK executives intimidated independent physicians” who suggested in public that Avandia might have serious risks. It’s difficult to tell whether GSK took a leaf from Merck’s tactics of intimidation—such as, Merck’s physician “hit list” of doctors who publicly raised concerns about Vioxx cardiac risks—or whether intimidation of honest physicians is but “the norm and practice” within the pharmaceutical industry.

FDA’s consistent failure to act in the public interest continues unabated under the Obama administration, much as it did under the Bush Administration. Avandia--and an untold number of other drugs that damage the heart--continue to be aggressively marketed, killing thousands of consumers: FDA officials continue to diddle.

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By KEN THOMAS, Associated Press Writer Ken Thomas, Associated Press Writer – 49 mins ago

WASHINGTON – Toyota officials claimed they saved the company $100 million by successfully negotiating with the government on a limited recall of floor mats in some Toyota and Lexus vehicles, according to new documents shared with congressional investigators.

Toyota, in an internal presentation in July 2009 at its Washington office, said it saved $100 million or more by negotiating an "equipment recall" of floor mats involving 55,000 Toyota Camry and Lexus ES350 vehicles in September 2007.

The savings are listed under the title, "Wins for Toyota — Safety Group." The document cites millions of dollars in other savings by delaying safety regulations, avoiding defect investigations and slowing down other industry requirements.

The documents could set off alarms in Congress over whether Toyota put profits ahead of customer safety and pushed regulators to narrow the scope of recalls. Two House committees are holding hearings this week on the Japanese automaker's recall of 8.5 million vehicles in recent months to deal with safety problems involving gas pedals, floor mats and brakes.

The world's largest automaker has been criticized for responding too slowly to complaints of sudden acceleration in its vehicles, threatening to undermine its reputation for quality and safety.

The documents were turned over to the House Oversight and Government Reform Committee and obtained by The Associated Press on Sunday. The presentation was first reported by The Detroit News.

Toyota said in a statement: "Our first priority is the safety of our customers and to conclude otherwise on the basis of one internal presentation is wrong. Our values have always been to put the customer first and ensure the highest levels of safety and quality."

Kurt Bardella, a spokesman for Rep. Darrell Issa, R-Calif., the top Republican on the Oversight Committee, said the documents raise questions on "whether Toyota was lobbying for less rigid actions from regulators to protect their bottom line."

Transportation Department spokeswoman Olivia Alair called the document "very telling. And that's why Secretary (Ray) LaHood has been saying we're going to hold Toyota's feet to the fire and make sure they do what's necessary to make their cars safe for the driving public."

The new documents show the financial benefit of delay. In the presentation, Toyota said a phase-in to new safety regulations for side air bags saved the company $124 million and 50,000 man hours. Delaying a rule for tougher door locks saved $11 million.

On defect regulations, the document boasts that Toyota "avoided investigation" on rusting Tacoma pickup trucks. The National Highway Traffic Safety Administration investigated the case in 2008 but closed it without finding a safety defect. Toyota agreed to buy back certain rusty pickups, inspect other and extend warranties.

The document lists seven "Wins for Toyota & Industry," including "favorable recall outcomes," "secured safety rulemaking favorable to Toyota" and "vehicles not in climate legislation." Another page lists "key safety issues," including "Sudden acceleration on ES/Camry, Tacoma, LS etc."

In one passage, the document says Toyota "negotiated 'equipment' recall on Camry/ES re SA; saved $100M+, w/ no defect found."

NHTSA had launched an investigation in March 2007 over allegations that floor mats were interfering with accelerator pedals. Toyota told the government a month later that there was "no possibility of the pedal interference with the all-weather floor mat if it's placed properly and secured."

By that August, the government had connected the problem to a dozen deaths and a survey of 600 Lexus owners discovered 10 percent reported sudden or unexpected acceleration. But the recall in September 2007 was limited to 55,000 Camry and ES350 vehicles to replace the floor mats.

The 10-page internal presentation was dated July 6, 2009, less than two months before a high-speed crash near San Diego killed a California highway patrol officer and his family and reignited concerns over sudden acceleration in Toyotas.

In October 2009, Toyota issued its largest-ever U.S. recall, involving about 4 million vehicles, over concerns of pedals getting stuck in floor mats.

The presentation lists Yoshi Inaba, Toyota's chief executive in North America, on its cover. Inaba is scheduled to testify before the House Energy and Commerce Committee on Wednesday, along with Toyota president Akio Toyoda and Jim Lentz, president of Toyota Motor Sales USA. The committee is also expected to hear from LaHood, NHTSA Administrator David Strickland and safety advocates.

The Oversight Committee is holding a hearing Tuesday with Lentz, LaHood and Strickland. A Senate committee is planning a March 2 hearing.

Toyota has said it will create an outside review of company operations, do a better job of responding to customer complaints and improve communication with federal officials.

Separately, the government said Sunday it was already investigating reports of sudden acceleration in Toyota vehicles when the nation's largest auto insurer shared complaints about the issue.

The Transportation Department released documents showing that in December 2003 it began investigating 39 complaints of sudden acceleration involving 2002-03 Toyota Camry sedans. That was about three months before State Farm shared with NHTSA complaints of sudden acceleration in 2003-04 Lexus ES300s and 2002-04 Camrys.

The document released by LaHood said the department had received allegations of 26 crashes and 4 injuries involving drivers complaining of their vehicles surging when backing up, pulling in and out of parking spaces and shifting gears.

Reports of deaths in the U.S. connected to sudden acceleration in Toyota vehicles have surged in recent weeks, with the toll of deaths allegedly attributed to the problem reaching 34 since 2000, according to new consumer data gathered by the U.S. government.

Congress
Launches Investigation Into Gas Drilling Practices.

Two of the largest companies involved in natural gas drilling have acknowledged pumping hundreds of thousands of gallons of diesel-based fluids into the ground in the process of hydraulic fracturing, raising further concerns that existing state and federal regulations don't adequately protect drinking water from drilling.

Rep. Henry A. Waxman, D-Calif., who released the information in a statement Thursday, announced that the House Committee on Energy and Commerce, which he chairs, is launching an investigation into potential environmental impacts from hydraulic fracturing.

The process, which forces highly pressurized water, sand and chemicals into rock to release the gas and oil locked inside, gives drillers unprecedented access to deeply buried gas deposits and vastly increases the country's known energy reserves.

But as ProPublica has detailed in more than 60 articles, the process comes with risks. The fluids used in hydraulic fracturing are laced with chemicals -- some of which are known carcinogens. And because the process is exempt from most federal oversight, it is overseen by state agencies that are spread thin and have widely varying regulations.

In 2004, the U.S. Environmental Protection Agency examined hydraulic fracturing and determined it can be safe as long as diesel fuel isn't added to the drilling fluids. The agency based its decision in part on a non-binding agreement it struck with the three largest drilling service companies -- Halliburton, Schlumberger and B.J. Services -- to stop using diesel. But the agreement applied only to gas drilling in a specific type of geologic formation: shallow coal deposits. The EPA study has since been widely criticized.

The information obtained by Waxman's group shows that B.J. Services violated that agreement and that Halliburton continued to use diesel in other geologic formations not governed by the agreement. All three companies acknowledged using other potentially harmful chemicals, such as benzene, toluene, ethylbenzene and xylene.
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A memo released by the Energy and Commerce Committee on Thursday said B.J. Services acknowledged that between 2005 and 2007 it injected 2,500 gallons of diesel-based fuels into coal bed methane wells.

Jeff Smith, CFO for B.J. Services, told ProPublica the incidents in which diesel was used were isolated, and that the company has been vigilant in making sure that it has not been used since.
"The company has taken this very seriously," he said.

The memo said Halliburton reported using more than 807,000 gallons of diesel-based fuel to fracture wells in 15 states during the three-year period. But in a statement released Thursday night Halliburton said any suggestion that it had violated the agreement was "completely inaccurate," because none of the fuel was used in coal bed methane wells.
"Halliburton is firmly committed to full compliance" with the agreement, the statement said.

The information about the companies came from an investigation Waxman launched when he was chairman of the House Committee on Oversight and Government Reform during the last Congress.

As part of the new investigation by the Energy and Commerce Committee, Waxman and subcommittee chairman Edward Markey, D-Mass., sent letters to eight companies, including Halliburton, B.J. Services and Schlumberger, asking for more information about the drilling process and the chemicals it requires. The five other companies -- Frac Tech Services, Superior Well Services, Universal Well Services, Sanjel Corp. and Calfrac Well Services – are smaller companies that make up a growing share of the market. They are not included in the 2003 memorandum of agreement with the EPA.

"As the use of these technologies expands, there needs to be oversight to ensure that their use does not threaten the public health of nearby communities," said the memo from Waxman and Markey.

The letters ask the companies for detailed information, including documentation of all the wells they hydraulically fractured from 2007 to 2009, the proximity of those wells to underground drinking water sources, the volumes and types of chemicals used in the process, and any health and environmental effects of the drilling. If the companies comply, the committee will have created the most complete picture to date of hydraulic fracturing.

Smith said B.J. Services will fully respond to the request. When asked if the company has used petroleum distillates and benzene in its drilling process, he said, "I'm not going to get into the details in terms of what the chemicals are." He said that the information will be disclosed in the company's response to the committee's letter.

Halliburton also said it will respond to the committee's request for information.
Schlumberger spokesman Stephen Harris said in an e-mail that officials at the company "have received the Committee's request and are reviewing it," but he declined to comment further.