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Yesterday, the Washington Post
had an article
about how the drug industry is the foremost source of fraud-related Department of Justice settlements. Drug companies comprised 8 of the government’s top 10 fraud settlements in the past year, according to the nonprofit organization Taxpayers Against Fraud
. Today, ironically, pharmaceutical giant GlaxoSmithKline (GSK) made headlines
with yet another multi-million dollar settlement over the sale of 20 adulterated drugs.
In this latest case of drug industry fraud, GSK will pay the government $750 million to settle criminal and civil complaints that the company knowingly sold bad drugs from a contaminated plant in Puerto Rico. Cheryl D. Eckard, Glaxo’s former quality control manager and the whistleblower in the case, maintains that she warned the company about problems with its drugs, including Paxil, Tagament, Coreg, and (yet again!) Avandia.
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On Friday, the FDA announced that Abbott Laboratories has withdrawn its diet drug Meridia (also known as sibutramine), stating that the advantage of a small amount of weight loss does not outweigh the heightened risk of heart attack and stroke. The FDA’s request trails a study called the Sibutramine Cardiovascular Outcomes Trial, which found a 16 percent increase in “the risk of serious heart problems” (these “problems” include death).
Yet Meridia has been making appearances in the media for years. Concerns about the drug’s safety date back at least to 2002, when the nonprofit organization Public Citizen petitioned the FDA (it re-petitioned in 2009) to ban Meridia. Then in 2004, GAP client Dr. David Graham testified before a Senate Finance Committee hearing that sibutramine may be more dangerous than the conditions it was being used for. The hearing focused on the latest controversy at the FDA at the time – the FDA’s disastrous handling of the pain medication Vioxx – the horrific effects of which (tens of thousands of Americans died) were exposed by Dr. Graham.
But the hearing also provided an opportunity for Dr. Graham to speak out about additional regulatory failures, and other problematic drugs. From a November 2004 article in the NYT, which covered the hearing:
Dr. Graham, with more than 20 years of service with the Food and Drug Administration, cited the anti-cholesterol drug Crestor, the pain pill Bextra, the obesity pill Meridia, the asthma drug Serevent and the acne drug Accutane. Makers of each drug defended the medicines as safe.
Let’s look at the story of each of these five drugs:
In addition to Meridia, only one other drug in this list – Bextra – has been completely removed from the market. Serevent and Accutane remain available with greater restrictions and public health advisories. Crestor seems to remain both on the market and unrestricted (you can try a free trial here!), despite Dr. Graham’s warnings that the government “should evaluate the occurrence of renal failure and other serious side effects among people taking Crestor.”
In the hearing, Dr. Graham stated that federal drug regulators were “virtually incapable of protecting America.” So take heart – perhaps the FDA isn’t totally incompetent; it’s just incompetently slow. It only took six (!) years for the agency to take action regarding Meridia, despite the abiding existence of evidence of the drug’s dangerous side effects.
How many years will it take before the FDA will be capable of responding to drug safety threats in a timely manner?
Lindsay Bigda is Communications Fellow for the Government Accountability Project, the nation's leading whistleblower advocacy organization.
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The Inspector General of the Department of Health and Human Services, Daniel R. Levinson, is issuing a report today, according to Gardiner Harris in The New York Times, finding that FDA approvals of ten medicines in the US in 2008 were based exclusively on clinical trials conducted abroad. The report found that, overall, fewer than one percent of the foreign trial sites were inspected by the FDA, that 80 percent of the drugs approved for sale in the US in 2008 were based at least in part on trials conducted abroad, and 78 percent of trial participants were enrolled at foreign sites.
Courtesy Flickr User Fillmore Photography
These numbers may be shocking but should not be surprising. Last year GAP published a monograph titled “The ABCs of Drug Safety” (pdf) providing a “Roadmap for Conducting Credible Clinical Drug Trials and Protecting Drug Trial Participants.” Here is an excerpt from that report (please see report for citations):
a) Unaddressed Gap
The federal government only regulates clinical trial research that is under HHS or FDA oversight. Several pre-Phase I, Phase IV, and investigator-initiated trials do not fall under the control of either agency. State, local, or institutional research or health laws may provide some trial participant safeguards, but none of these laws or policies effectively protects all human subjects in all research in this country.
If research is eventually submitted as part of a drug application to the FDA, it must comply with federal human subject regulations. But, clinical trials are increasingly conducted abroad, “where oversight is slim and patients plentiful.” And, drug companies get the results they want: One review found that 99 percent of controlled trials published in China gave the investigative drug the green light. This challenges credulity. The number of foreign clinical investigators seeking FDA approvals increased 16-fold during the 1990s. San Petersburg (Florida) Times reporter Kris Hundley found that in the past three years, FDA had inspected only eight out of thousands of clinical trial sites in India. Hundley writes: “In the burgeoning clinical trial business, says Amar Jesani, a doctor and medical ethicist in Mumbai, every layer of oversight is compromised by cash, and independent monitoring is nonexistent. He has resigned from supposedly independent ethics committees that rubber-stamp drug companies’ proposals and overrule any objections. Said Jesani: ‘We’re sitting on a time bomb that may explode at any time.’”
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A new study of insiders who blow the whistle on drug company fraud has found that all of the whistleblowers were primarily motivated by ethics rather than possible financial rewards.
However, the study also found many of the whistleblowers paid a tremendous personal cost for their disclosures and a vast majority experienced retaliation from employers, including being harassed, blackballed, and fired. Many were unable to secure other jobs during and after the investigations and some experienced personal health problems including panic attacks.
The lead author of the study, Dr. Aaron Kesselheim, an instructor in medicine at Harvard Medical School, stated:
"A lot of them express a very strong ethical compass that they think guides them but, boy, they really do suffer a lot for the public good that they perform."
Kesselheim also stated:
"The whistle-blowers need more support in the process of bringing the case forward."
As the article notes, the Justice Department currently has more than 1,000 whistleblower cases waiting to be investigated. From 1996 through 2005, health care fraud whistleblowers have led to the recovery of more than $9 billion.
GAP has long known that whistleblowers come forward because they "want to right a wrong, or bring to light something that was ethically compromised."
We have seen many whistleblowers come forward with no possibility of any financial reward. Instead, many are either forced to leave their jobs or choose to leave after experiencing retaliation.
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GAP coalition partner Public Citizen is calling on the FDA to stop a trial that compares the effects of diabetes drugs Avandia and Actos.
The group argues that the study, named TIDE, endangers the health of the 16,000 participants it intends to study because "a wealth of data now suggests" that Avandia poses significant risk to the heart. Public Citizen contends that TIDE is "exposing thousands of high-risk patients with diabetes to a drug with an unfavorable safety profile and no clinical advantage over [Actos]."
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An interesting article in the New York Times
today discusses the rise of the phrase "If You See Something, Say Something,"
which is prominently seen throughout the New York City subway system, and has spread to other public transportation systems around the world. The slogan also includes the phone number for a counter-terrorism unit.
According to the article, a New York advertising executive wrote the slogan on September 12, 2001, before the Metro Transit Authority, a former client, even asked for a new phrase to respond to the to the World Trade Center attacks. The executive says of the slogan:
“I’m proud of what it’s done and the potential it has to do more. Some things you just can’t stop. But if it is stoppable, and that thought makes someone think twice and say something that stops something, that’s its reason for being.”
Which got us here at GAP thinking, what if this slogan was posted on the wall in workplaces around the world, instead of just in transportation systems?
What if society encouraged workers to blow the whistle on fraud, waste, and bureaucratic carelessness, as enthusiastically as it encouraged people to report a suspicious package?
According to the CDC, an estimated 76 million Americans endure foodborne illness every year. Of those 76 million people, up to 9,000 die. Simply for comparison’s sake, 2,669 Americans perished in the horrific September 11 attacks.
However, when GAP clients have seen wrongdoing and said something about dangerous handling of food product, they have faced retaliation and backlash, and even public disdain.
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A new study by the Mayo Clinic shows how since 2007, when concerns were first raised about the safety of the diabetes drug Avandia, 94 percent of experts who provided favorable opinions about the drug have ties to drug companies. Nearly half of the experts had financial ties to drug companies that presented a conflict of interest. From Reuters:
"It was almost three to four times more likely that somebody who had a relationship with a pharmaceutical company had a favorable opinion about the medication," Dr Victor Montori of the Mayo Clinic, whose study appears in the British Medical Journal, said in a telephone interview.
In addition, a quarter of authors did not report their relationship with drugmakers in articles about Avandia.
Last month, Senator Max Baucus and Senator Charles Grassley released a report and internal FDA documents about Avandia. One author of an internal FDA report has a tremendous amount of respect throughout the industry as a drug safety advocate and expert – GAP client Dr. David Graham, who had previously blown the whistle on Vioxx.
FORUM FOR THE FUTURE
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Over the weekend, The New York Times broke the news that internal FDA reports question the safety of Avandia – a controversial (and explosively popular) diabetes medication. The confidential report details how:
…if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart.
The article spells out how the issue has created great debate within the FDA. However, one author of the internal FDA report has a tremendous amount of respect throughout the industry as a drug safety advocate and expert – GAP client Dr. David Graham, who successfully blew the whistle on Vioxx several years ago. That arthritis drug caused some 40,000 fatal heart attacks in America alone.
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When meeting yesterday to discuss possible changes to its system for approving moderate-risk medical devices, the FDA said that it lacks substantial power over the industry and may ask Congress to approve more authority.
The FDA currently has limited power to recall and oversee medical products such as orthopedic knee and hip replacements. Under the current system, called the 510K system, devices can be approved quickly and cheaply if they are based on a product already on the market. The system is popular among manufacturers, but has been criticized for too quickly approving risky devices.
Many concerns over the medical device approval process have existed for years. For example, under the current system, the FDA is not told when one company sells the rights to their products to another company. In one instance, a company sold the ownership of more than a dozen medical devices to another. However, while reviewing the devices, the purchasing company found that "all of it was fraudulent" and reported the fraud to the FDA. However, the FDA would not have found out if it wasn't for the vigilance of the purchasing company.
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Wikileaks.org, a website on which whistleblowers may anonymously break stories of government and corporate transgressions, has gone offline and will remain so while it looks for funding. The home page featured a message saying that Wikileaks had received "hundreds of thousands of pages from corrupt banks and other information pertaining to the Iraq war, China, the United Nations” and that it does not currently have the resources to release the documents. Wikileaks has featured thousands of sensitive documents regarding the September 11 attacks, Guantánamo Bay and the Church of Scientology, among others. Neil Gordon of the Project on Government Oversight commented on Wikileaks, saying: "We think there's nothing but good that can come from sites like Wikileaks. It provides places for whistleblowers to provide documents anonymously, which is often the only way you can uncover corruption."
In a controversial move, drug maker GlaxoSmithKline has decided to finance a documentary about eating habits in order to increase its sale of a weight loss drug they produce. While corporations often financially support films, as a rule they do not directly finance films with the hope of translating that support into profit. Some in the film industry are worried that the film will function more like a commercial for the weight loss drug and less like a documentary.