WASHINGTON – Federal health regulators said Friday it’s unclear whether Genentech’s blockbuster cancer drug Avastin significantly shrinks the deadliest type of brain tumor.

The Food and Drug Administration is reviewing the company’s drug for patients with recurring glioblastoma multiforme, a form of brain cancer that is generally fatal within six months.

South San Francisco, Calif.-based Genentech has asked the FDA to give its drug accelerated approval. That designation gives market access based on promising early results.

However regulators said in documents posted online that they are unsure that the company’s results are strong enough to rush out the new indication.

The company’s application relies on imaging scans that claim to show a reduction in tumor size. Patients were considered responsive to the drug if their tumor shrunk at least 50 percent over the course of two consecutive visits to their physician. In two separate studies, Genentech reported that roughly 25 percent and 20 percent of brain cancer patients responded successfully to the drug.

However, FDA reviewers said they have never used “response rate” as a measurement to grant accelerated approval for a brain cancer drug. They noted the difficulty of measuring tumor size via medical imaging.

Avastin is known to decrease swelling caused by excess fluid in the brain, which could give the false impression of tumor reduction, reviewers noted.

In its own briefing documents, Genentech noted that 38 percent of patients treated with its drug were alive after one year. The company said there was a statistically significant connection between response to its drug and survival time.

FDA’s panel of outside cancer experts previously stated that a drug would have to have a response rate above 30 percent — higher than either of Genentech’s studies — to outweigh the uncertainties connected with brain tumor imaging.

Next Tuesday the FDA will ask its panel to weigh in on whether Avastin should be granted accelerated approval for patients whose brain cancer has returned. The agency is not required to follow the panel’s advice, though it usually does.

About 10,000 U.S. patients are affected each year by glioblastoma multiforme, according to the National Cancer Institute. The cancer quickly returns in nearly all patients treated for the disease.

Avastin is already approved to treat colon and breast cancer, along with the most common form of lung cancer. The drug was Genentech’s top-selling product last year with revenue of $2.69 billion, however sales growth has been slowing.

Avastin is marketed in Europe by Swiss drug giant Roche, which completed its $48.6 billion takeover of Genentech on Thursday. Shares of Roche, the parent company of Tucson-based Ventana Medical Systems, rose 2.3 percent to 150 Swiss francs on the Zurich exchange at midday Friday.

In the last quarter, Genentech reported Avastin sales of $731 million, falling short of Wall Street forecasts for $740 million. Analysts said the drug is likely reaching a saturation point in the market and will need additional FDA approvals to continue growing.

Initially approved in 2004, Avastin was the first drug to fight cancer by chocking off blood flow to tumors. Such “targeted therapies” were considered a significant advance beyond older chemotherapy drugs.

WASHINGTON – Express Scripts said Thursday it has received a letter demanding money from the company under the threat of exposing records of millions of patients.

The threat was made in an anonymous letter that the company turned over to federal investigators. The letter, received in early October, included personal information on 75 people covered by Express Scripts, including birth dates, social security numbers and prescription information.

Express manages prescription benefits for roughly 50 million people through thousands of clients, including health insurers, employers and union-sponsored plans.

A company spokesman said Express waited to reveal the breach “to give the investigation time to proceed and get under way.”

“We believe informing the public now was the appropriate time to do so under the circumstances,” said spokesman Steve Littlejohn.

Littlejohn said the company alerted customers whose information appeared in the letter but does not know whether additional information has been exposed. Generally, companies are only legally obligated to contact customers when they are certain their information exposed.

The company has set up a Web site for beneficiaries about the incident at: http://www.esisupports.com

According to the site, company staff believe they have identified the area where the data was stored and “have instituted enhanced controls.”

The company said it has not received any reports of identity theft associated with the problem.

“We are cooperating with the FBI and are committed to doing what we can to protect our members’ personal information and to track down the person or persons responsible for this criminal act,” company Chief Executive George Paz said.

Earlier this year 11 people were indicted for allegedly stealing 41 million credit and debit card numbers. The case — believed to be the largest identity theft on record — involved hacking into wireless computer networks of BJ’s Wholesale Club, Barnes & Noble, and other retailers.

Express Scripts shares fell $3.5, or 5.66 percent, to $58.34 in afternoon trading on a day in which the Dow Jones industrial average fell nearly 5 percent.

Traders work the crude oil options pit at the New York Mercantile Exchange. Some experts warn that banking on ever-rising commodity prices is not a viable long-term strategy, and that if the run-up reverses course, billions of dollars worth of retirement benefits could be wiped out.

WASHINGTON – All those speculators getting the blame for driving up the price of oil these days — just who are they? For part of the answer, look in the mirror.

The retirement savings of workers across the country, entrusted to pension fund managers, are being plowed into one of the few investments that has delivered phenomenal returns in recent years.

For decades, futures contracts were mostly traded by commodity producers and the people who used the actual products, such as crude oil, corn and soybeans. Agreeing to a price today for a commodity to be delivered in, say, two months is a way to smooth out price fluctuations for those supplies.

But large investors faced with the threat of inflation have increasingly used them as protection against the falling dollar. That includes pension funds, along with investment banks, mutual funds and private hedge funds.

Research firm Ennis Knupp and Associates says $139 billion had been funneled into energy commodites, primarily crude oil, by the end of March — and it estimates more than half of that is from retirement money.

The investments have paid off. The Standard & Poor’s GSCI index, which tracks a basket of commodities, is up 19 percent in the past five years, compared with just 9 percent for the S&P 500 stock index.

The risk is that if the remarkable run in oil and other futures markets reverses course, billions of dollars of retirement benefits could be wiped out.

“A pension fund is supposed to be investing money in secure, stable investments for the benefit of the people whose money they are investing,” said Dan Lippe, an energy analyst at Houston-based Petral Consulting Inc.

“When we hit that wall and things start falling,” he said, “they will fall very fast, and the pension funds that invested in commodities will see a tremendous loss of value.”

The retirement system for public employees in California, the largest in the nation, has $1.3 billion invested in commodities. Most of it tracks the S&P commodity index.

That’s still just one-half of 1 percent of the fund’s total $240 billion in assets, said Michael Schlachter, who advises the California pension fund. He said a collapse in oil or other commodity prices would have little effect on retirees.

Still, a growing chorus of experts is convinced retirement investments are enough to distort prices.

Billionaire George Soros, the airline industry and the International Monetary Fund are all pressuring Congress to curb speculation by large investors. Democrats in Congress say they hope to vote on restrictions by August.

“Your pension fund manager may be using your retirement money to drive up the price of oil,” said Rep. Bart Stupak, D-Mich., at a hearing earlier this week on speculation in commodities.

“What would happen if pension fund managers decided to increase their commodity investment by another 20-fold?” he asked.

Speculators put money into commodity markets simply to make money on their investments — unlike commercial investors, who are actually buying or selling orders for physical goods.

Energy analysts say it’s unclear what effect speculators have had on oil prices, which climbed briefly to a new record above $142 on Friday before falling back.

But Stupak and other lawmakers have already dashed off more than a dozen proposals to rein in commodity trading, including limiting how many contracts speculators can hold and closing loopholes that allow them to skirt regulations.

Sen. Joe Lieberman, I-Conn., proposed banning pension funds and other large investors from commodities altogether. He dropped the idea after vigorous opposition by an association of public and private pension funds.

Schlachter, who is also managing director for investment consulting firm Wilshire Associates, called the idea “horrendously bad.” He said pension funds should not be compared to Wall Street speculators, who assume huge risks every day to maximize returns.

“The pension plans we work with are using commodities only as a long-term hedge against inflation,” he said.

Unlike the stock market, where there are a limited number of shares for each company, futures markets have no limits on contracts available. As long as a buyer can find a seller for each contract, investment opportunities are virtually unlimited.

Critics say retirement funds that accumulate contracts are artificially driving up commodity prices. In the case of oil, that means higher gas prices and more expensive food and other goods.

“If they’re going to be in the futures market they need to trade rather than take this buy and hold strategy,” said Michael Masters, portfolio manager of hedge fund Masters Capital Management. “That is the worst possible thing for the futures market.”

Masters and other experts told members of Congress this week that eliminating excessive speculation could drive oil prices down to about $65 a barrel, less than half the current price.

Retirement funds have suffered at the hands of the market before. In 2002, when the stock market swooned after the dot-com crash and 9/11, retirement assets dropped $7 billion, losing 8 percent of their value.

WASHINGTON – Lawmakers continue to blame large investors for their role in propping up oil prices, pointing out Monday that speculation in crude futures has nearly doubled since 2000.

Pension funds, Wall Street banks and other large investors that have no intention of taking delivery of fuel have increasingly pumped money into contracts for oil and other commodities as a hedge against inflation when the dollar falls.

After more than a half dozen hearings in Congress on the issue, Democratic House lawmakers said they intend to tighten restrictions on pension funds, investment banks and other large investors that they blame for driving up fuel prices.

Many Republicans, analysts and regulators, however, say soaring oil prices are a reflection of macro-economic factors, including the falling dollar, unrest in the Middle East and increased demand from countries like China and India.

Oil prices rose $1.38 to settle at $136.66 a barrel Monday on the New York Mercantile Exchange on disappointment over Saudi Arabia’s modest production increase and concerns that output from Nigeria will decline.

Saudi Arabia said Sunday it would add 200,000 barrels per day in July to a 300,000 barrel per day production increase it first announced in May. But that pledge at the meeting held in the Saudi city of Jeddah fell far short of U.S. hopes for a larger increase.

“Make no mistake about it, the excessive speculation in commodity markets is having a devastating effect at the gas pump that is rippling through our entire economy,” said Rep. Bart Stupak, D-Mich., who chaired the hearing of a House Energy and Commerce subcommittee.

But Rep. Joe Barton, R-Texas, said insufficient supply is the main driver behind rising energy prices. He called for increased domestic production of oil, natural gas and coal.

Speculators have increased their share of oil futures contracts on the Nymex to 71 percent this year, up from 37 percent in 2000, according to figures released by Stupak’s office. At the same time contracts held by traditional oil users have fallen to less than 30 percent from over 60 percent.

Lawmakers have cited the pain prices are causing airlines, trucking companies, farmers and consumers in calling for restrictions on speculative trading. At the pump, gas prices dipped less than a penny overnight to remain at a national average of over $4.07 a gallon, more than $1 above the year-ago average, according to AAA and the Oil Price Information Service.

A panel of analysts and oil industry experts told lawmakers that the recent influx of institutional dollars has disrupted the futures market’s traditional function as a tool for the buying and selling of commodities.

Panelists said pension funds, sovereign wealth funds and other large investors have taken advantage of loopholes that let them bypass speculative limits imposed by U.S. regulators.

In the last five years, investments in index funds tied to commodities grew to $260 billion from $13 billion, according to testimony from Michael Masters, managing member of the Virgin Islands-based hedge fund Masters Capital Management.

Sen. Joe Lieberman, I-Conn., has floated a proposal to ban pension funds and other institutional investors from futures exchanges altogether.

Northwest Airlines Corp. Chief Executive Douglas Steenland endorsed that idea Monday, and also urged lawmakers to close loopholes that allow traders to dodge U.S. speculation limits by trading on foreign exchanges or through over-the-counter transactions.

“Our highest priority is to tackle the overall price of fuel which is now 40 percent of our cost pie,” Steenland told lawmakers. “Addressing excessive speculation is the most immediate remedy Congress could deliver.”

The debate over oil speculation spilled onto the campaign trail over the weekend with presumptive presidential contenders Sens. Barack Obama, D-Ill., and John McCain, R-Ariz., sparring over who would be tougher on policing energy futures markets.

House Democrats on Monday suggested a range of actions, including: higher margin requirements, stricter position limits and increased disclosure of unregulated over-the-counter trades.

Energy and Commerce Committee Chairman John Dingell, D-Mich., said those measures and more “need to be debated, evaluated, and acted on, sooner rather than later.”

In prepared testimony, New York Mercantile Exchange Chief Executive James Newsome said limits on oil trading are “misguided.” Such restrictions would drive large investors toward less transparent, less regulated markets, doing more harm than good.

WASHINGTON – Responding to concerns about the role of speculation in rising oil prices, federal regulators said Tuesday they will place stricter limits on foreign exchanges that trade U.S. oil.

The Commodity Futures Trading Commission said it will require the London-based ICE Futures Europe exchange to adopt position limits used in the U.S. for the trading of the West Texas Intermediary crude-oil contract, which is linked to a similar contract on the New York Mercantile Exchange.

Under the new agreement, foreign officials also will share daily trading data with U.S. authorities and report violations when they are uncovered. Previously the groups shared data on a weekly basis.

Atlanta-based Intercontinental Exchange Inc., parent company of ICE Futures Europe, plans to comply with the new rules and said the CFTC action would have almost no impact on its customers or business.

The CFTC rolled out the proposal ahead of a Senate hearing to examine whether it has the necessary resources and authority to properly oversee commodities markets.

Some lawmakers and analysts have blamed increasing speculation by index funds and other large investors for artificially boosting the prices of oil, corn and other commodities.

Light, sweet crude for July delivery was trading near $134 a barrel on the Nymex Tuesday afternoon, up nearly 35 percent since the beginning of the year. Meanwhile, gasoline prices remained just below the record-high national average of $4.08 a gallon set on Monday.

Sen. Dick Durbin, D-Ill., said speculation is a necessary function of the financial markets.

“But excessive speculation, in which large positions are taken that divorce the overall prices of the commodity from its natural price, is problematic for the consumers and the businesses that use that commodity,” Durbin said.

UAL Corp.’s United Airlines on Tuesday endorsed a bill Durbin introduced last week that would give the CFTC additional power and resources to oversee commodities markets. The Chicago-based carrier said its fuel bill this year will hit $9.5 billion based on current prices, more than $3.5 billion higher than last year.

CFTC Acting Chairman Walter Lukken stressed the need for increased funding, telling lawmakers his agency’s staffing levels have dropped 21 percent in the last seven years, while commodity trading has skyrocketed.

“We have reached our limit and cannot uphold our mission without immediate additional resources,” Lukken said.

WASHINGTON – Health regulators reiterated their warning Friday that organ transplant drugs from Roche and Novartis can cause miscarriages and birth defects when used by pregnant women.

The Food and Drug Administration previously said it received reports of miscarriages and infants born with ear and mouth birth defects after their mothers took Roche’s CellCept.

FDA added its most serious warning to CellCept and a similar Novartis AG drug, Myfortic, last October, noting they can cause miscarriage and other serious problems when used by pregnant mothers. The drug is used to suppress the body’s immune system to avoid organ rejection in transplant patients.

In a notice to physicians posted online Friday, FDA recommended “confirming that a pregnancy has not occurred and ensuring that patients use effective contraceptive measures.”

FDA said most of the reported problems came from mothers who were taking the drug before their pregnancies were detected. Some of the patients were taking the drugs for conditions they are not approved to treat — including rheumatoid arthritis and lupus.

A spokesman for Roche said it has not received any new reports of miscarriages or birth defects since updating the drug’s labeling. The company previously reported 25 miscarriages among 77 women exposed to the drug between 1995 and 2007.

The agency said it will continue working with Roche and Novartis to reduce use of the drugs by pregnant women.

Friday’s FDA warning was the second in less than two months for CellCept, which was Roche’s six best-selling drug last year with sales of nearly $2 billion.

Last month FDA said it was investigating 16 patients who developed a rare neurological problems while taking the drug.

The disease, known as progressive multifocal leukoencephalopathy, attacks the brain and central nervous system and is usually fatal. Symptoms include vision problems, loss of coordination and memory loss. Patients who survive are often permanently disabled, according to the FDA.

Shares of Novartis AG rose 9 cents Friday to $51.29.

WASHINGTON – Senate Republicans on Monday asked environmental regulators to use their power to halt the country’s ethanol output expansion plans amid rising food prices.

Twenty-four Republican senators, including presidential candidate Sen. John McCain of Arizona, sent a letter to the Environmental Protection Agency suggesting it waive, or restructure, rules that require a five-fold increase in ethanol production over the next 15 years.

Congress passed a law last year mandating a ramp-up to 15 billion gallons of corn ethanol by 2015 and 36 billion by 2022. But McCain and other Republicans said those rules should be waived to put more corn back into the food supply for livestock, and to encourage farmers to plant other crops.

“This subsidized (ethanol) program — paid for by taxpayer dollars — has contributed to pain at the cash register, at the dining room table, and a devastating food crisis throughout the world,” said McCain, in a statement.

Despite tough rhetoric from lawmakers, analysts say Congress is unlikely to roll back such a popular program during an election year.

Friedman, Billings, Ramsey & Co. analyst Kevin Book argued in a recent note to clients that Congress will not “turn on the corn belt” because of the significant number of votes held by ethanol-producing states. Ethanol subsidies could face greater risks, however, in 2009 and going forward, according to Book.

Republican Sen. Charles Grassley of Iowa said Monday “ethanol is unfairly taking the brunt of the criticism” for escalating food prices. Grassley’s home state is expected to produce a quarter of all U.S. ethanol this year.

Farmers have responded to federal ethanol incentives by planting the largest crop of corn in 60 years, leaving fewer acres for soybeans, oats and other agricultural staples.

Tighter crop supplies means higher production costs for food processors of all types. In one recent example Pilgrim’s Pride Corp., the nation’s largest chicken producer, said costs rose $200 million in the quarter on higher corn and soybean feed.

And Americans are paying those higher costs at the grocery store, where egg prices have jumped 40 percent in the last year and flour prices have risen 50 percent since January, raising the price of bread and other baked goods.

The EPA has the power to waive or restructure the requirements if they cause unintended harm to consumers or the environment.

“We don’t think it’s the right move to make,” said Liz Friedlander, a spokeswoman for the National Farmers Union.

The group has defended corn-based production of the alternative fuel, saying its impact on the rising food prices has been relatively small. Instead, it says food price inflation is mainly due to higher fuel prices, poor weather conditions and dwindling stockpiles of wheat and other crops.

The ethanol industry said Monday altering the biofuels mandate “would drive the price of oil and gasoline through the roof,” according to Matt Hartwig, a spokesman for the Renewable Fuels Association.

Ethanol is “one of the only solutions for holding down the price of oil in the long-term,” according to Jeff Broin, president and chief executive of Sioux Falls, S.D.-based Poet, the nation’s largest ethanol producer.

While nearly all experts agree increased biofuel production by companies such as Archer Daniels Midland Co. and Pacific Ethanol Inc. has contributed to the run-up in food prices, there is little consensus on the scope of its role.

The ethanol industry says ethanol and other biofuels account for just 4 percent of the price surge, while the Department of Agriculture says the figure is closer to 20 percent.

Last week a group of international scientists recommended halting use of crops for biofuel, saying it would cut corn prices 20 percent.

Shares of VeraSun Energy Corp. fell 41 cents, or 5.9 percent, Monday to $6.50 in morning trading. Shares of Archer Daniels Midland Co. rose 34 cents to $44.32. Pacific Ethanol shares rose 7 cents, or 2 percent, to $3.55.

WASHINGTON – The Agriculture Department’s chief economist told Congress Thursday that prices for corn and other food commodities will remain at “historically high levels” so long as the U.S. ethanol industry continues to grow.

Congress’ Joint Economic Committee met to discuss the causes behind surging food prices that have set off riots abroad and grocery store sticker shock in America.

Joseph Glauber, chief economist for the Department of Agriculture, said that if biofuels like ethanol continue absorbing more U.S. crops, prices for soybeans and other staples will rise, including the grains used to feed livestock.

He also stressed that poor weather conditions, increased demand for food in developing countries and higher fuel costs have greatly contributed to the price rise.

American consumers should eventually see some relief from higher prices as foreign countries increase plantings for wheat and other crops, Glauber said.

But lawmakers are worried about the short-term impact on consumers and the economy.

“The anxiety over higher food prices is going to be just as widespread and will equal or surpass the anger and frustrations so many Americans have about higher gas prices,” said Sen. Charles Schumer, D-N.Y., who chairs the committee.

Farmers and ethanol producers met in Washington Tuesday to try and defend the benefits of their industry, just as some lawmakers begin to reconsider the country’s heavy promotion of ethanol as an alternative to gasoline.

Only four months ago ethanol’s promise to slow climate change and reduce dependence on foreign oil persuaded Congress to mandate a fivefold increase in its production by 2022.

Farmers have responded to government incentives by setting aside nearly a quarter of their corn crop for ethanol production, up from less than 15 percent in 2005.

But this week two Republican lawmakers on Capitol Hill have already proposed curtailing ethanol policies, questioning the wisdom of using crops for fuel amid rising demand for food. The Senate’s Homeland Security Committee has scheduled a hearing on the issue for next Wednesday.

While nearly all experts say increased biofuel production has contributed to the run-up in food prices, there is little agreement on the scope of its role.

The ethanol industry says ethanol and other biofuels account for just 4 percent of the price surge, while the Department of Agriculture says the figure is closer to 20 percent.

Earlier this week a group of international scientists recommended halting use of crops for biofuel, saying it would cut corn prices 20 percent.

WASHINGTON — Federal health regulators on Monday raised safety concerns about an experimental biotech drug from Amgen designed to treat a blood-clotting disorder.

The Food and Drug Administration said studies of Amgen’s drug Nplate showed a range of adverse reactions, from bone-marrow abnormalities to dangerous blood clots. On Wednesday FDA will ask a panel of outside experts whether the drug should be approved and, if so, under what conditions. The agency is not required to follow its panel’s recommendations.

Thousand Oaks, Calif.-based Amgen has asked the government to approve Nplate for patients with a disorder that causes the body to attack its own platelets, which are red blood cells that help blood clot. The condition, which causes bruising and bleeding after minor injuries, affects about 200,000 people in the U.S., according to the Platelet Disorder Support Association.

FDA said patients treated with the drug showed significantly higher platelet levels than those taking placebo in two, six-month studies conducted by Amgen. Patients received weekly injections of Nplate, which is a genetically engineered version of the protein that encourages red blood cell production.

However, FDA reviewers noted several adverse reactions seen in small numbers of patients, according to briefing documents posted online Monday.

FDA noted that 14 of 204 patients had dangerous blood clots after beginning treatment with Nplate. Agency reviewers said the risk of such clots could increase after patients stop taking the drug, though Amgen’s studies have not yet addressed the issue.

Agency staff also expressed concern that eight percent of patients taking Nplate developed a resistance to the drug. Only four percent of patients taking placebo showed the similar results.

FDA also expressed concerns about abnormal bone marrow growth and malignant tumors seen in some patients.

FDA will ask its experts on Wednesday whether the drug’s benefits outweigh its risks, and whether it should be approved on a limited basis. For example, panelists will be asked if the drug should only be approved for patients who have not responded to other drugs.

Lehman Bros. analyst Jim Birchenough said he believes FDA will eventually approve the drug because there are few options for patients who have failed other treatments, which include removal of the spleen. Birchenough projects peak sales of $500 million for Nplate.

In its application to FDA, Amgen laid out a plan for managing Nplate’s risks through drug-warning labels, educational outreach and follow-up studies.

Under the proposal, Nplate’s label would warn of safety problems seen in company studies. The company would distribute additional guides on the risks to patients. For doctors, Amgen would hold workshops on proper drug use.

Amgen proposed studying irregular bone marrow growth and other adverse reactions in four follow-up studies.

The company also said it would not advertise the drug directly to consumers.

Shares of Amgen Inc. rose 66 cents, or 1.5 percent, to $44.84 in afternoon trading.

WASHINGTON – A government investigator said Sanofi-Aventis had evidence that a safety study of its antibiotic contained fake data, but submitted it to the Food and Drug Administration anyway.

“Catastrophic failure” was how FDA investigator Douglas Loveland described the company’s handling of the study in a hearing on Tuesday.

“The decision making process Aventis used to investigate these problems was illogical and ineffective and it could have led them to come to the wrong conclusion,” Loveland told House lawmakers.

The investigator stopped short of saying Aventis, Sanofi-Aventis’ predecessor, knew the results were false when they submitted them, but said it “should have known.” Loveland said the data contained all the hallmarks of illegitimacy, including forged signatures and crossed out results.

Tuesday’s hearing was the fifth time the Energy and Commerce Committee focused on Ketek, which showed links to death and liver failure in 2006.

Loveland and two other government investigators appeared Tuesday after receiving subpoenas, because administration officials refused to let them to testify. Robert West, the FDA investigator who first handled Ketek, said he tried to get permission to probe whether Aventis was aware of fraudulent data when it submitted the study. However, West said his request was blocked by senior FDA officials, though he said he didn’t know which ones.

FDA eventually issued a warning letter to Sanofi in 2007 over its handling of the trial.

Democrat Bart Stupak and other Democrats have alleged for months that FDA approved Ketek despite knowing the key safety study was fraught with problems.

Stupak also had harsh words for Aventis’ management.

“Only a company intent on ignoring the obvious could have missed the evidence of fraud in the study,” said Stupak, who chairs the Energy and Commerce Subcommittee on Oversight.

Sanofi President for Research and Development Paul Chew testified that the company submitted the study in “good faith.”

Sanofi wasn’t able to spot the fake patient results, Chew said, but has since put in place extra steps to verify data.

Ketek, approved in 2004, received FDA’s most serious warning last February after reports of liver failure appeared. FDA later went back and found that several physicians hired by Aventis falsified data in the 2002 study. One is now serving a four-year sentence after pleading guilty to making up results.