Weight Loss Lawsuits Continue [healthcare]
The Federal Trade Commission is again chasing the makers of a reported weight-loss drug. This chase is court, however, and reminiscent of last year's actions against Cortislim and Xenadrine.
As American waistlines grow, marketers continue looking for the magic pill that replaces diet and exercise. Now a California company has been accused of marketing weight loss product that the government says are ineffective for weight loss.
The products are sold with the brand names Zyladex Plus, Questral AC, Questral AC Fat Killer Plus, Rapid Loss 245, and Rapid Loss Rx.
The federal agency says the marketing claims for these products are unsubstantiated and filed suit in San Francisco last week.
We reported over a year ago that the government filed complaints against CortiSlim and three other products. At the time, FTC Chair Deborah Platt Majoras said, "You won't find weight loss in a bottle of pills that claims it has the latest scientific breakthrough or miracle ingredient. Paying for fad science is a good way to lose cash, not pounds."
By October 2007, Cortislim customers had a settlement offer. The deadline for filing for redress in that case was October 27, 2007 (a good reason to subscribe to our blog if you missed it).
Meanwhile, we've contacted representatives for the defendant in this case and will share any comments they make about their products.
Tuesday, February 12, 2008
Wednesday, January 09, 2008
Rate The Restaurant? How About Rating A Radiologist?
Zagat, the favorite foodie survey company that has become ubiquitous online, has moved its technology to a new area -- health care.
Anthem Blue Cross and Blue Shield has announced that a partnership with Zagat that allows consumers to rate their physician experiences. Insurers and managed care companies have compiled physician and hospital metrics for years, and many web sites offering physician "report cards" have launched in the last few years, but the program links two brand name organizations in a new field.
The service will initially be available only in parts of Ohio, but with both companies having national partnerships, one can easily imagine the program spreading if successful.
The results can be a mixed bag, warns Consumer Help Web's George Bounacos. "We find that extreme emotions, either positive or negative, compel people to review or comment on goods and services," said the consumer advocate. "There is a danger inherent in crowd rating versus traditional market research that bias can move the results to consumers who feel strongly about a physician one way or another."
Bounacos advises that the ratings should be a part of a consumer's research and not serve as the only measure to determine whether someone should see a specific physician.
Zagat, the favorite foodie survey company that has become ubiquitous online, has moved its technology to a new area -- health care.
Anthem Blue Cross and Blue Shield has announced that a partnership with Zagat that allows consumers to rate their physician experiences. Insurers and managed care companies have compiled physician and hospital metrics for years, and many web sites offering physician "report cards" have launched in the last few years, but the program links two brand name organizations in a new field.
The service will initially be available only in parts of Ohio, but with both companies having national partnerships, one can easily imagine the program spreading if successful.
The results can be a mixed bag, warns Consumer Help Web's George Bounacos. "We find that extreme emotions, either positive or negative, compel people to review or comment on goods and services," said the consumer advocate. "There is a danger inherent in crowd rating versus traditional market research that bias can move the results to consumers who feel strongly about a physician one way or another."
Bounacos advises that the ratings should be a part of a consumer's research and not serve as the only measure to determine whether someone should see a specific physician.
Labels: Blue Cross, customer satisfaction, medical, survey, Zagat
Friday, October 12, 2007
No Cold Meds For Baby As Regulators Miss Again
In a year where federal regulatory agencies have come under sharp criticism for their delays in protecting American consumers, the business community decided to solve its own issues this week.
The federal Food and Drug Administration has scheduled hearings for next week regarding the safety of children under two using over the counter medicines that treat cold symptoms. The manufacturers of popular brands such as Dimetapp, Tylenol and Robitussin have all voluntarily begun pulling their infant formulations from grocery and drugstore shelves.
Even if the science proves that their formulations were wrong to begin with, we continue to question the effectiveness of nearly every federal agency charged with protecting consumers, especially the USDA and FDA. Attacking the CPSC is a more popular sport these days, but they appear to us to show a bias to action. Meanwhile, the FTC continues doing very well in shutting down the most egregious business operators, and the FCIC does a fine job educating consumers.
If consumer safety does not warrant a cabinet-level position, then what does? These are the clothes we wear, the appliances we use, the food we eat and the medicine that heals us. Shouldn't there be some level of oversight at a macro level that helps consumers? Having already done away with the federal Consumer Affairs office, we're left with a bowl of alphabet soup that doesn't work very well.
We would have saved news of an action like this for our weekly recall feature debuting this week, but can't because too much of this medication is not on store shelves, but on medicine cabinet shelves throughout the country. Help your children. Get rid of it now, and ask your pediatrician how to care for your small child.
Last month it was lead in toys -- an understandable if inexcusable issue. Then it was cribs that kill children and playpens that could hurt them. Now the medicine we give them to ease their colds (infant formulations of the medicine tens of millions of Americans ingest each year) are under fire.
And no one is watching out for the children. Let's reinvent government the other way for a change and put some consumer advocates in charge of the helter-skelter, hit and miss efforts of the individual agencies.
In a year where federal regulatory agencies have come under sharp criticism for their delays in protecting American consumers, the business community decided to solve its own issues this week.
The federal Food and Drug Administration has scheduled hearings for next week regarding the safety of children under two using over the counter medicines that treat cold symptoms. The manufacturers of popular brands such as Dimetapp, Tylenol and Robitussin have all voluntarily begun pulling their infant formulations from grocery and drugstore shelves.
Even if the science proves that their formulations were wrong to begin with, we continue to question the effectiveness of nearly every federal agency charged with protecting consumers, especially the USDA and FDA. Attacking the CPSC is a more popular sport these days, but they appear to us to show a bias to action. Meanwhile, the FTC continues doing very well in shutting down the most egregious business operators, and the FCIC does a fine job educating consumers.
If consumer safety does not warrant a cabinet-level position, then what does? These are the clothes we wear, the appliances we use, the food we eat and the medicine that heals us. Shouldn't there be some level of oversight at a macro level that helps consumers? Having already done away with the federal Consumer Affairs office, we're left with a bowl of alphabet soup that doesn't work very well.
We would have saved news of an action like this for our weekly recall feature debuting this week, but can't because too much of this medication is not on store shelves, but on medicine cabinet shelves throughout the country. Help your children. Get rid of it now, and ask your pediatrician how to care for your small child.
Last month it was lead in toys -- an understandable if inexcusable issue. Then it was cribs that kill children and playpens that could hurt them. Now the medicine we give them to ease their colds (infant formulations of the medicine tens of millions of Americans ingest each year) are under fire.
And no one is watching out for the children. Let's reinvent government the other way for a change and put some consumer advocates in charge of the helter-skelter, hit and miss efforts of the individual agencies.
Labels: children, government, medical, safety
Wednesday, September 19, 2007
No, We Haven't Cured The Common Cold
Procter and Gamble is a marketing icon. The conglomerate has not only trained some of the best marketers of the last 50 years, but continues to innovate consumer products.
Sometimes that innovation can get the company in a little hot water.
Today is one such day. The Food and Drug Administration sent a letter yesterday to P&G that essentially said the company's hand sanitizer for kids didn't exactly work as planned.
The letter, signed by FDA District Director Carol A. Heppe, acknowledged that an ingredient in Vicks Early Defense called triclosan is certified for use as an "antimicrobial cleanser", the company's claims about it fighting cold "germs" (sic). Heppe went on to remind P&G President Alan Lafley that colds are caused by viruses and that no evidence existed suggesting that the company's product worked as claimed.
Yes, you can still catch a cold, but Mom said you could go in the pool after eating without waiting 30 minutes.
The agency is apparently reviewing the whole subject of topical cleansers. Meanwhile, the FDA has given Procter and Gamble's smart marketers until early October to start marketing their new hand sanitizer in a way that ensures consumers know what they are buying.
Procter and Gamble is a marketing icon. The conglomerate has not only trained some of the best marketers of the last 50 years, but continues to innovate consumer products.
Sometimes that innovation can get the company in a little hot water.
Today is one such day. The Food and Drug Administration sent a letter yesterday to P&G that essentially said the company's hand sanitizer for kids didn't exactly work as planned.
The letter, signed by FDA District Director Carol A. Heppe, acknowledged that an ingredient in Vicks Early Defense called triclosan is certified for use as an "antimicrobial cleanser", the company's claims about it fighting cold "germs" (sic). Heppe went on to remind P&G President Alan Lafley that colds are caused by viruses and that no evidence existed suggesting that the company's product worked as claimed.
Yes, you can still catch a cold, but Mom said you could go in the pool after eating without waiting 30 minutes.
The agency is apparently reviewing the whole subject of topical cleansers. Meanwhile, the FDA has given Procter and Gamble's smart marketers until early October to start marketing their new hand sanitizer in a way that ensures consumers know what they are buying.
Labels: FDA, medical, Procter and Gamble, Vicks Early Defense
Wednesday, May 09, 2007
Justice Department Settles With Maker Of Loprox For Promoting Use To Children
Medicis Pharmaceutical Corporation of Scottsdale, Ariz., will pay the United States $9.8 million to settle allegations that the company violated the False Claims Act with respect to claims submitted to Medicaid, the Justice Department announced today. The settlement resolves allegations that Medicis promoted the use of a topical skin preparation, Loprox, for use on children under the age of 10, without approval by the Food & Drug Administration (FDA).
The United States and the whistleblowers – former Medicis employees – alleged that from approximately November 2001 through April 2004, Medicis sales personnel targeted pediatricians, urging the doctors to use Loprox as a treatment for diaper rash. The use of Loprox, which is approved by FDA as a fungicide for patients over 10 years of age, is not a “medically accepted indication” for the treatment of diaper dermatitis and other skin disorders in children under 10.
“This settlement demonstrates our ongoing commitment to protecting funds for federal health care programs,” said Assistant Attorney General Peter D. Keisler. “Pharmaceutical companies need to know that they will be held accountable for off-label marketing schemes and other illegal activities that affect those programs.”
The Food, Drug & Cosmetic Act prohibits pharmaceutical companies from marketing or promoting a drug for uses that the FDA has not approved, a practice known as “off-label marketing.” In the case against Medicis, the United States alleged that the Medicaid program paid millions of dollars for Loprox prescriptions that would not have been reimbursed if government authorities had known that the prescriptions resulted from the company’s off-label marketing campaign.
Medicis sold its pediatric sales unit in 2004.
The civil settlement resolves claims brought by four former Medicis sales representatives. As a result of the settlement, the whistleblowers will collectively receive in excess of $1,078,000 as their statutory award. Under the qui tam provisions of the False Claims Act, private parties can file an action on behalf of the United States and receive a portion of the settlement if the government reaches a monetary agreement with the defendants.
Medicis Pharmaceutical Corporation of Scottsdale, Ariz., will pay the United States $9.8 million to settle allegations that the company violated the False Claims Act with respect to claims submitted to Medicaid, the Justice Department announced today. The settlement resolves allegations that Medicis promoted the use of a topical skin preparation, Loprox, for use on children under the age of 10, without approval by the Food & Drug Administration (FDA).
The United States and the whistleblowers – former Medicis employees – alleged that from approximately November 2001 through April 2004, Medicis sales personnel targeted pediatricians, urging the doctors to use Loprox as a treatment for diaper rash. The use of Loprox, which is approved by FDA as a fungicide for patients over 10 years of age, is not a “medically accepted indication” for the treatment of diaper dermatitis and other skin disorders in children under 10.
“This settlement demonstrates our ongoing commitment to protecting funds for federal health care programs,” said Assistant Attorney General Peter D. Keisler. “Pharmaceutical companies need to know that they will be held accountable for off-label marketing schemes and other illegal activities that affect those programs.”
The Food, Drug & Cosmetic Act prohibits pharmaceutical companies from marketing or promoting a drug for uses that the FDA has not approved, a practice known as “off-label marketing.” In the case against Medicis, the United States alleged that the Medicaid program paid millions of dollars for Loprox prescriptions that would not have been reimbursed if government authorities had known that the prescriptions resulted from the company’s off-label marketing campaign.
Medicis sold its pediatric sales unit in 2004.
The civil settlement resolves claims brought by four former Medicis sales representatives. As a result of the settlement, the whistleblowers will collectively receive in excess of $1,078,000 as their statutory award. Under the qui tam provisions of the False Claims Act, private parties can file an action on behalf of the United States and receive a portion of the settlement if the government reaches a monetary agreement with the defendants.
Monday, March 26, 2007
Drug Price Increases Double Inflation
Brand name prescription drug prices continue to rise at about twice the rate of inflation, according to the latest AARP Watchdog Report.
AARP’s Watchdog Report found that ten of the brand name drugs it tracks increased at least four times the rate of general inflation during 2006. Ambien led the pack with a 29.7 percentage increase in manufacturer price, followed by Combivent at 18.3 percent and Atrovent Inhaler at 16.9 percent.
"The report highlights that drug prices continue to skyrocket,' said David Sloane, Senior Managing Director, Government Relations & Advocacy. "Over time escalating drug prices will make Medicare drug plans unaffordable for older Americans. One way to address high drug prices is to take full advantage of Medicare’s bargaining power and allow Medicare to negotiate lower drug prices."
Bob Elliott, a 75-year-old retiree from Kentucky, enrolled in a Medicare drug plan in 2006 after losing retiree prescription drug coverage from his former employer. He takes six prescriptions daily and by July 2006 reached the coverage gap, also known as the “donut hole” at which time he began paying full price for his medications. Only two of his medications are available in a generic version. “It was real sticker shock,” said Elliot. "I went from paying a co-payment to full price. My out-of pocket expenses on drugs alone in six months reached $2,000. Prescription drug prices are too high and hit older Americans’ wallets the hardest." As brand name drug prices continue to rise more and more Americans can expect a similar fate.
"We need to send a loud and clear message to the pharmaceutical industry that Americans cannot afford to continue to pay the highest prices for prescription drugs in the world," continued Sloane.
The Watchdog Report shows that nearly 200 of the most commonly used brand name drugs for older adults rose 6.2 percent in 2006, nearly twice the general rate of inflation, which was 3.2 percent. 2006 also marked the first year that the new Medicare drug benefit was in effect.
In contrast, manufacturer list prices in 2006 for 75 generic drugs tracked by AARP’s Watchdog Report fell by 2.0 percent. This continues a downward trend for manufacturer price increases for already lower-priced generic drugs that began in 2003.
Brand name prescription drug prices continue to rise at about twice the rate of inflation, according to the latest AARP Watchdog Report.
AARP’s Watchdog Report found that ten of the brand name drugs it tracks increased at least four times the rate of general inflation during 2006. Ambien led the pack with a 29.7 percentage increase in manufacturer price, followed by Combivent at 18.3 percent and Atrovent Inhaler at 16.9 percent.
"The report highlights that drug prices continue to skyrocket,' said David Sloane, Senior Managing Director, Government Relations & Advocacy. "Over time escalating drug prices will make Medicare drug plans unaffordable for older Americans. One way to address high drug prices is to take full advantage of Medicare’s bargaining power and allow Medicare to negotiate lower drug prices."
Bob Elliott, a 75-year-old retiree from Kentucky, enrolled in a Medicare drug plan in 2006 after losing retiree prescription drug coverage from his former employer. He takes six prescriptions daily and by July 2006 reached the coverage gap, also known as the “donut hole” at which time he began paying full price for his medications. Only two of his medications are available in a generic version. “It was real sticker shock,” said Elliot. "I went from paying a co-payment to full price. My out-of pocket expenses on drugs alone in six months reached $2,000. Prescription drug prices are too high and hit older Americans’ wallets the hardest." As brand name drug prices continue to rise more and more Americans can expect a similar fate.
"We need to send a loud and clear message to the pharmaceutical industry that Americans cannot afford to continue to pay the highest prices for prescription drugs in the world," continued Sloane.
The Watchdog Report shows that nearly 200 of the most commonly used brand name drugs for older adults rose 6.2 percent in 2006, nearly twice the general rate of inflation, which was 3.2 percent. 2006 also marked the first year that the new Medicare drug benefit was in effect.
In contrast, manufacturer list prices in 2006 for 75 generic drugs tracked by AARP’s Watchdog Report fell by 2.0 percent. This continues a downward trend for manufacturer price increases for already lower-priced generic drugs that began in 2003.
