For Tankiso, an HIV-positive mother living in rural Lesotho, food has made all the difference.
“When I first learned of my HIV status, I also learned about the services available at my local health clinic, including WFP food assistance,” said Tankiso. “Since 2011, I’ve followed my medical treatment and visited the clinic regularly, where I also benefit from WFP’s nutrition support.”
Scientific evidence and our own experience shows that nutrition activities for people living with HIV—including nutritional assessments, counselling, education and fortified food for malnourished patients—has significant impacts on the health of patients, on their ability to stay on treatment and on the effectiveness of treatment.
On Monday, the Department of Justice announced that drug company GlaxoSmithKline agreed to pay a $3 billion fine, the largest health care fraud fine in the history of the United States. This fine is just the latest in a string of drug company penalties for improper promotion of drugs for “off-label,” or unapproved, uses. Here we take a look at six recent multi-million dollar fines that drug companies have agreed to pay for inappropriately, and in some cases illegally, promoting prescription drugs.
FINE (billions of dollars) ............
Eli Lilly
JAN 2009
Eli Lilly was fined $1.42 billion to resolve a government investigation into the off-label promotion of the anti-psychotic Zyprexa. Zyprexa had been approved for the treatment of certain psychotic disorders, but Lilly admitted to promoting the drug in elderly populations to treat dementia. The government also alleged that Lilly targeted primary care physicians to promote Zyprexa for unapproved uses and “trained its sales force to disregard the law.”
Pfizer
SEPT 2009
Pfizer wasfined $2.3 billion, then the largest health care fraud settlement and the largest criminal fine ever imposed in the United States. Pfizer pled guilty to misbranding the painkiller Bextra with "the intent to defraud or mislead", promoting the drug to treat acute pain at dosages the FDA had previously deemed dangerously high. Bextra was pulled from the market in 2005 due to safety concerns. The government alleged that Pfizer also promoted three other drugs illegally: the anti-psychotic Geodon, an antibiotic Zyvox, and the anti-epileptic drug Lyrica.
AstraZeneca
APRIL 2010
AstraZeneca was fined $520 million to resolve allegations that it illegally promoted the anti-psychotic drug Seroquel. The drug was approved for treating schizophrenia and later for bipolar mania, but the government alleged that AstraZeneca promoted Seroquel for a variety of unapproved uses, such as aggression, sleeplessness, anxiety, and depression. AstraZeneca denied the charges but agreed to pay the fine to end the investigation.
Merck
NOV 2011
Merck agreed to pay a fine of $950 million related to the illegal promotion of the painkiller Vioxx, which was withdrawn from the market in 2004 after studies found the drug increased the risk of heart attacks. The company pled guilty to having promoted Vioxx as a treatment for rheumatoid arthritis before it had been approved for that use. The settlement also resolved allegations that Merck made false or misleading statements about the drug's heart safety to increase sales.
Abbott
MAY 2012
Abbott was fined $1.5 billion in connection to the illegal promotion of the anti-psychotic drug Depakote. Abbott admitted to having trained a special sales force to target nursing homes, marketing the drug for the control of aggression and agitation in elderly dementia patients. Depakote had never been approved for that purpose, and Abbott lacked evidence that the drug was safe or effective for those uses. The company also admitted to marketing Depakote to treat schizophrenia, even though no study had found it effective for that purpose.
GlaxoSmithKline
JULY 2012
GlaxoSmith Kline agreed to pay a fine of $3 billionto resolve civil and criminal liabilities regarding its promotion of drugs, as well as its failure to report safety data. This is the largest health care fraud settlement in the United States to date. The company pled guilty to misbranding the drug Paxil for treating depression in patients under 18, even though the drug had never been approved for that age group. GlaxoSmithKline also pled guilty to failing to disclose safety information about the diabetes drug Avandia to the FDA.
Paris - An experimental once-daily pill that combines four drugs to fight HIV is as safe and effective as commonly-prescribed treatments against the Aids virus, researchers reported in The Lancet on Friday.
Doctors tested the new drug, called Quad, for the third and final phase in which new pharmaceutical products are vetted for safety and effectiveness.
Publication in the British journal follows a recommendation in May by a US Food and Drug Administration (FDA) advisory panel to approve Quad for previously untreated adults infected with HIV-1. A final decision is expected by August.
The first trial entailed testing Quad against a three-in-one pill, Atripla, which since 2006 has been a standard treatment for the human immunodeficiency virus (HIV).
By Saundra Young, CNN
KEY FROM THIS ARTICLES: Most of the more than 40 health care professionals, AIDS advocates and patients who addressed the committee implored its members not to recommend the drug for the new indication.
Did the Government listen?
A drug already approved for treatment of AIDS might one day be approved for prevention of the deadly disease in individuals at high risk.
A U.S. Food and Drug Administration advisory committee recommended Thursday that the agency approve the drug, Truvada, for pre-exposure prophylaxis, or PrEP.
The committee voted 19-3 in favor of approval for the prevention indication -- PrEP for HIV-uninfected men who have sex with men and 19-2 with one abstention for HIV-uninfected partners in couples where the other partner is infected. The committee recommended by 12-8 with two abstentions in favor of approving the drug for individuals who engage in risky sexual behavior that could result in their contracting the virus.
Truvada, manufactured by Gilead Sciences, Inc., is a once-a-day pill used in combination with other HIV drugs. The nucleoside reverse transcriptase inhibitor does not rid the body of HIV. Instead, it prevents the virus from replicating in the body.
The FDA doesn't have to follow the recommendations of its advisory committees, but it often does.
Most of the more than 40 health care professionals, AIDS advocates and patients who addressed the committee implored its members not to recommend the drug for the new indication.
"There is no question that, if efforts on using PrEP is widespread, condom use and other means of preventing HIV infection will decrease," said Robert Elliott, a registered nurse. "At this point we simply don't know enough about how to increase adherence rates to work with the PrEP or how to counteract the risk compensation and the use of PrEP. Until then, PrEP is not and cannot be considered safe and effective for preventing HIV infections."
AIDS Activist Miki Jackson agreed. "A recommendation for the use of Truvada as PrEP is akin to issuing an engraved invitation for lawsuits," she said. "To knowingly recommend a drug as powerful as Truvada with such serious serious side effects and given to people who are perfectly healthy is frightening."
Michael Weinstein, president and founder of the AIDS Healthcare Foundation, said he was concerned that approval could lead a decrease in condom use. "Approving PrEP would be a reckless act," he said.
The FDA panel looked at safety and efficacy data from three clinical trials:
-- iPrEx, a study of men who have sex with men, found 43.8% fewer infections in men who got the drug versus those who got placebo;
-- in a Truvada study carried out by the Centers for Disease Control and Prevention in Botswana, infection rates were reduced by 63% overall in healthy men and women considered to be at high risk of infection;
-- the University of Washington's Partners in PrEP study of serodiscordant couples in Kenya saw 62% fewer infections in those taking Truvada and a 73% reduction in those who took a combination of Truvada and the HIV drug tenofovir.
Committee members also heard concerns about the drug's side effects, which can include nausea, vomiting, dizziness, loss of appetite and diarrhea, liver and kidney toxicity and loss of bone density.
But, after assessing the data, they concluded that Truvada is safe for men and women and effective in preventing infection.
And they had supporters. "What we need currently is additional tools for our powerful tool box," said Dr. Richard Elion, director of clinical research at the Whitman Walker Clinic in Washington. "We are not winning the battle. Please, were asking today to allow a modality that's still being developed to be added to our toolbox."
Kirk Myers, founder and CEO of Abounding Prosperity Inc., made a plea on behalf of African-Americans. "People need to be given the option to choose," said Myers, who is HIV-positive. "This drug is wanted. Another tool we can use. The right thing to do. Without this option, desperation will continue to drive up statistics of new incidents."
Chris Collins, vice president and director of public policy for the American Foundation for AIDS Research, said the data on the drug's prophylactic use were compelling and urged the committee not to limit access to it. "We need new tools to fight this epidemic that include treatment, condoms and education," Collins said. "PrEP is certainly not for everyone, but it may have a role in bringing HIV-infection rates down. It's time to learn how PrEP may be useful in the real world."
According to Dr. Peter S. Miele, a medical officer in the agency's Center for Drug Evaluation and Research, Truvada's safety and efficacy for the prevention of HIV-1 infection in high-risk individuals is supported by two large clinical trials. "Regular HIV testing, adherence and behavioral counseling on safer sex practices, including condom use, are essential components of healthcare delivery around PrEP," he said.
Truvada is not cheap. A month's supply costs about $1,200.
An advocacy group concerned about costs and possible health problems related to a drug being considered to help stop the spread of HIV infection to healthy people has asked U.S. regulators to delay or deny its approval.
Los Angeles-based AIDS Healthcare Foundation (AHF) has petitioned the Food and Drug Administration on the grounds that studies have shown that the pill, Truvada, made by Gilead Sciences, is only partially effective in preventing transmission. The drug is already approved to treat people infected with the human immunodeficiency virus that causes AIDS.
The FDA has approved updated labeling for tenofovir disoproxil fumarate to include dosing information for the treatment of HIV-1 infection in pediatric patients aged 2 to 18 years.
The FDA has also approved a supplemental New Drug Application for three lower-strength, once-daily tablets of tenofovir (Viread; Gilead Sciences) in doses of 150 mg, 200 mg and 250 mg for children aged 6 to 12 years, as well as an oral powder formulation to support dosing in pediatric patients aged 2 to 5 years.
For the treatment of HIV-1 in pediatric patients aged at least 2 years, the recommended oral dose of tenofovir is 8 mg/kg of body weight (up to a maximum of 300 mg) administered once daily as oral powder or tablets.
I'm debating the HIV hypothesis with some colleagues and need to answer to the charge that HIV is present in 100% of AIDS cases, and because it's found in every case of AIDS, this proves HIV is the cause. Is this true? How would you respond to this argument?
Thanks,
Farrell
Dear Farrell,
With regard to the charge that HIV is present in 100% of AIDS cases and that this proves HIV causes AIDS, here are five points that challenge this idea followed by some detailed information on each point that may help you keep up your end of the debate.
More than 500 pounds of pills were collected throughout Glendale as part of the recent national prescription drug takeback, officials said this week.
The U.S. Drug Enforcement Administration’s third takeback event, which was held Oct. 29, collected more than eight tons, or 16,560 pounds, of prescription pills at numerous collection sites in the Los Angeles area, according to the agency.
Public-health workers in Thika, Kenya, perform a skit to advertise a prophylactic HIV drug trial.Partners PrEP study
When the US Food and Drug Administration approved Viagra in 1998, officials never considered one possible side effect of the drug: higher rates of sexually transmitted diseases among men who, thanks to Viagra, would become more sexually active. A powerful tool in the fight against HIV is raising similar questions about the possibility of unintended public-health consequences if drugs are approved for use in healthy people and cause them to alter their behaviour.
Several studies in the past year have reported that the very drugs used to treat people with HIV can also stop healthy people from becoming infected (see table). But people taking the drugs may adopt riskier behaviours because they feel protected — a phenomenon known as 'risk disinhibition' — undermining the benefit of the drugs and potentially infecting others. Moreover, those who become infected while taking the preventive regimen might develop drug-resistant viruses that they could then transmit to others. "You have this wonderful scientific breakthrough," says Kevin Frost, chief executive of the Foundation for AIDS Research in New York City. "But what are the practical implications?"
By DAN MCCUE (CN) - The Securities and Exchange Commission claims the makers of a so-called HIV treatment made from goat's blood bilked investors of $20 million while concealing that the Food and Drug Administration had twice put human trials of the drug on hold. The SEC says Immunosyn Corp. called its drug SF-1019, and claimed it could treat a variety of diseases, including AIDS, chronic inflammatory demyelinating polyneuropathy, diabetic neuropathy and diabetic ulcers.
The Food and Drug Administration (FDA) approved a new drug to treat HIV infection on Friday. The drug, made by an arm of Johnson & Johnson, will be sold under the name Edurant, and is designed to be used in combination with other antiretroviral drugs in HIV-positive adults who have not received any prior treatment or therapy.
Side effects included depression, insomnia, headache and rash.
Bloomberg reports that the FDA's approval of the first new anti-HIV drug in three years "clears a hurdle for a planned combination pill with Gilead Science Inc.'s Truvada that may generate more than $1 billion in annual sales."
