Cardiologist testifies Merck withheld data

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#1

Cardiologist testifies Merck withheld data

By Bloomberg News | March 10, 2006

ATLANTIC CITY – A cardiologist told a New Jersey jury that Merck & Co. distorted data on the safety of the painkiller Vioxx and failed to conduct proper clinical trials on the drug.

Dr. Eric Topol, former provost at the Cleveland Clinic, said Merck withheld information about the drug’s dangers before a 2004 study showed it doubled the risk of heart attacks and strokes after 18 months of use. Topol testified on behalf of Thomas Cona and John McDarby, who blame their heart attacks on Vioxx.

''I believe that the data has been seriously misrepresented," Topol said in the videotaped deposition shown here.

Topol sought to counter Merck’s claims that it properly researched Vioxx and warned doctors of the risks. Merck, the fourth-largest US drug maker, says Cona, 59, and McDarby, 77, suffered heart attacks because of preexisting conditions, not the drug.

Topol, who left the Cleveland Clinic this year to join the faculty at Case Western Reserve University in Cleveland, has published 16 articles and editorials criticizing Merck’s marketing of Vioxx.

Topol, on the videotape, spoke about an e-mail he sent to Food and Drug Administration scientist David J. Graham, who testified to Congress in November 2004 that between 88,000 and 139,000 people likely were hurt by Vioxx. Merck had withdrawn the drug in September of that year.

Topol’s e-mail, sent days after Graham’s testimony, said Merck engaged in ''scientific misconduct" by withholding data in 2000 about a clinical trial known as the Vigor study. It found that Vioxx caused five times more heart attacks than the painkiller naproxen.

''I am bothered by the continued outrageous lies of Merck with the full-page multiple ads that ‘they published everything’ and that they never had a trial which showed any harm of Vioxx" before September 2004., the e-mail said. ''This cannot stand and truth about Vioxx needs to come out."

He also disputed Merck’s explanation of the Vigor data. The company said the study showed naproxen protected the heart, rather than Vioxx harmed it.

''There are no data that I’m aware of to show that naproxen in any randomized trial is cardioprotective," Topol said in the deposition, which was taped Nov. 22.

Merck has denied that Vioxx poses a risk if used for less than 18 months. Topol said his interpretation of several Merck studies showed the risk was ''immediate and early," and was stronger for those with health problems.

© Copyright 2006 Globe Newspaper Company.

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#2

After reading this article, it’s not a huge surprise that they habitually withhold or manipulate data with scant consequence from regulating authorities

FDA medical adviser: 'Congress is owned by pharma’

Dr. Raeford Brown, a pediatric anesthesia specialist at the UK Kentucky Children’s Hospital and chair of the Food and Drug Administration (FDA) Committee on Analgesics and Anesthetics, has been openly critical of big pharma and the lack of proper oversight from the FDA.

“The pharmaceutical industry pours millions of dollars into the legislative branch every single year,” he told Yahoo Finance. “In 2016, they put $100 million into the elections. That’s a ton of money.”

During the ‘17-’18 election cycle, Kevin McCarthy, now the House minority leader after midterms, received the second-highest amount of funds in Congress. The California-based politician received a total of $380,350 in campaign contributions, with a large sum coming from pharma companies such as Abbott Laboratories (ABT), Pfizer (PFE), Johnson & Johnson (JNJ), Eli Lilly (LLY), Amgen (AMGN), and Merck (MRK).

“I’m really much more concerned because Congress is supposed to have oversight for the FDA,” Brown said. “If the FDA isn’t going to hold pharma accountable, and Congress is getting paid to not hold pharma accountable, then it really doesn’t matter who the president is because it’s really about Congress.”

Paul Ryan (R-Wis.), the former speaker of the House, was ranked 10th among members of Congress. He received $222,070, seeing most of the funds coming from Merck.

Fourteen out of the top 20 recipients in the House were Republicans.

Beto O’Rourke (D-Texas), a former congressman who almost upset Senator Ted Cruz (R-Texas) in the 2018 midterms, was 18th on the list. O’Rourke, seen as a potential 2020 Democratic presidential candidate, received $171,255.

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#3

Yeah but how the hell do they keep getting away with it. They now exactly how to work the system because they are getting legal input from somebody to explain how to do it. Probably someone who worked for the FDA or still does.

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