Why call it Androgel 1.62%?

Discussion in 'Abbott' started by Anonymous, Jun 7, 2011 at 1:37 PM.

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  1. Anonymous

    Anonymous Guest

    So why did the marketing geniuses decide to name this product Androgel 1.62%? How could a doctor remember that? There must have been some logic behind it but I can't see what it is.
    Yes, it is a 1.62% testosterone gel but that does not explain why doctors have to write that! Wouldn't Androgel Next Generation or Androgel Low Volume make more sense and actually give doctors the chance to remember this new product and write it? Anything but a seemingly random set of numbers would be good.
    Can anyone provide an explanation please because right now I feel like these marketing people are idiots. Many reps and doctors agree that this name at least a hundred million dollar mistake.
     

  2. Anonymous

    Anonymous Guest

    Reps might not be able to remember two significant digits to the right of the decimal point, but I assure you that doctors can.
     
  3. Anonymous

    Anonymous Guest

    Well said. Give the docs some credit.
     
  4. Anonymous

    Anonymous Guest

    If you don't know the logic in this you shouldn't be selling it. Unreal. If I knew who you were I'd make you drink out of the toilet at the next meeting. The problem for us marketing geniuses is that we have to dummy down information for 10% of you sales geniuses that should in reality be selling used cars.
     
  5. Anonymous

    Anonymous Guest

    i love to call it Mandrogel...
     
  6. Anonymous

    Anonymous Guest

    Why call Androgel anything but another a way to steal.... pitiful.


    The Miami Herald
    Posted on Tue, Jun. 14, 2011
    Off-label marketing: How testosterone replacement got big

    By CHRIS ADAMS
    McClatchy Newspapers
    The question for doctors was simple: "When a patient comes in and asks for Viagra, will you first screen for low T?" meaning testosterone.

    The pitch by Solvay Pharmaceuticals Inc. was part of its effort to make its testosterone replacement drug AndroGel "ride (the) coat tails of Viagra."

    But unlike Viagra, AndroGel wasn't approved by the Food and Drug Administration to treat erectile dysfunction.

    Instead, it was approved to treat a relatively specific condition of the sex glands called hypogonadism. According to a significant whistle-blower lawsuit, Solvay wanted to boost AndroGel's sales with an aggressive strategy to push "off-label" - or unapproved - uses of the drug.

    "I can't underscore enough how important off-label sales were," said John King, a former sales manager for Solvay who's involved in the suit. "You can do the math: If we had truly stuck to the FDA-approved indication, AndroGel would never have had anywhere the sales it had."

    While they're a big part of any drugmakers' bottom line, such off-label uses also can run afoul of federal drug-marketing laws. It's legal for physicians to prescribe drugs off-label, often based on their assessment of the latest medical research, but it's illegal for drugmakers to promote such uses.

    The FDA's regulations on prescription medicine are based on researchers proving the safety and effectiveness of individual drugs for treating specific illnesses. Prescribing drugs to combat illnesses they were never approved to treat can be ineffective and risky to patients.

    While off-label marketing long has been commonplace, federal prosecutors in recent years have cracked down on the practice, bringing more than a dozen cases against drugmakers for off-label marketing, and winning billions of dollars in criminal and civil settlements. The cases have revealed how companies and their on-the-ground sales reps ignored drug-marketing laws to convince doctors to prescribe drugs for unapproved conditions. Private whistle-blower suits have been a part of that crackdown.

    The current whistle-blower lawsuit actually involves three of Solvay's drugs - AndroGel, a blood pressure drug, and a mental health drug - and provides an inside look at the world of corporate drug marketing. Although filed several years ago, details in the lawsuits were only recently unsealed at the U.S. federal courthouse in Houston. Dozens of internal company memos, emails and sales presentations were filed in the case, documenting how the company and its sales representatives sweet-talked, cajoled and even paid fees to the doctors in their territories.

    AndroGel, a clear gel that men rub on their shoulders, upper arms and abdomen, has been through three corporate owners in the past dozen years: Unimed Pharmaceuticals Inc., which was bought by Solvay Pharmaceuticals Inc., which was in turn bought by Abbott Laboratories. According to Abbott, it has annual U.S. sales of more than $600 million.

    The attorneys handling the case said that neither they nor Solvay would respond to McClatchy Newspapers' questions, other than to note that federal and state governments, which sometimes join similar cases, have declined to do so in this case.

    The drug's current owner, Abbott, said through a spokesman that the case was filed in 2003, nearly seven years before Abbott's acquisition of Solvay and that, "No specific concerns have been raised in this case about Abbott's sales and marketing of these products." Spokesman Scott Stoffel added that AndroGel is approved for the treatment of men with no or low testosterone and Abbott markets AndroGel according to the medication's label.

    Hypogonadism, the condition that AndroGel got the FDA OK to treat, is defined by low levels of the male hormone testosterone, often because of damage - from injury, chemotherapy or other trauma - to the testes. It can result in low sex drive, low energy levels, muscle loss and depression.

    How many men suffer from this condition? Those numbers are all over the map.

    In 1999, when Unimed asked the government to approve the drug, it announced that hypogonadism was estimated to affect more than "one million American men."

    In 2000, when the FDA approved the drug, the company announced that the market was "four to five million American men."

    But by 2003, when drug was being pushed by its corporate managers, the number drifted to "up to 20 million men," according to information in the lawsuit.

    From the start, Solvay - which then owned the drug - wanted to expand the market. In one document, the company noted it needed to expand the testosterone market by 36.5 percent, particularly by pushing the drug to primary care physicians. It sought to convince doctors that low levels of testosterone were widely under-diagnosed, and that conditions associated with normal aging could be because of those low testosterone levels.

    It's clear from internal memos that Solvay considered some doctors - including those in primary care - to be relatively easy marks.

    A New Orleans district sales memo described primary care doctors as "easily influenced."

    A 2004 memo on AndroGel sales strategies said the sales force was putting extra emphasis on rural areas, since "rural doctors are typically very accessible, give us plenty of time to teach them the right way to diagnose and treat, and they have the patients."

    Treating low testosterone is tricky, in part because experts still struggle to determine what a normal testosterone value should be. A blood testosterone value of more than 300 is considered normal, said Neil Goodman, a Miami endocrinologist and chairman of the reproductive medicine committee of the American Association of Clinical Endocrinologists. A value below 150 or 200 is low. But the meaning of levels between 200 and 300 can be ambiguous, and dependent on a man's age as well as any other underlying medical conditions.

    Beyond that, there are problems with the testosterone test itself. "If you sent the same sample to three different labs, you might get three different results," Goodman said; federal officials and medical experts are working to standardize testing.

    One of Solvay's strategies was to get doctors to rethink the idea that the cutoff between normal and low was 300. Instead, company sales documents discussed what was called "andropause," a condition akin to menopause.

    The FDA had addressed the andropause issue before. In 2000, when reviewing the drug's advertisements, the FDA told the AndroGel's maker that "claims and representation that suggest that AndroGel is indicated for men with 'age-associated' hypogonadism or 'andropause' are misleading." The drug, the FDA said, was only approved for men with hypogonadism.

    In a 2001 sales memo from the company's Mid-Atlantic region, however, a company official suggested that might be too restrictive, the lawsuit says. If a patient's testosterone had dropped over time - even if it still was in the normal range - then he might need AndroGel, documents show.

    "We can help write a new paradigm. One that captures both the andropausal male, as well as the hypogonadal male," a sales document said, according to the lawsuit. Sales reps were told to ask doctors to examine how far a man was "from the top of the normal range, rather than how close he is to the bottom of it."

    Beyond the message itself, Solvay used a range of tactics to connect with and convince doctors to prescribe the three drugs in the lawsuit.

    According to court records, Solvay paid doctors between $150 and $1,000 for "preceptorships," which allowed drug sales representatives to shadow them for a day; held "Lunch-N-Learn" programs, where sales representatives brought food into physicians' offices and would proceed to give them pitches for their drugs; and held "Dine-N-Dash" programs that allowed doctors to pick up a fancy dinner as long as they listened to a short pitch.

    In a memo to people on his sales team, King - the former sales rep involved in the lawsuit - laid out the rationale for such "peer influence programs."

    "Here is the bottom line with these programs: THEY WORK. They have worked in a big way in the Houston district and the recent feedback from Raleigh is extremely positive. Think about it ... the doctor is away from the office, not stressed, and he is getting to do something nice for himself and his family."

    If successful, King and another plaintiff could get a cut of any drug-company payout.

    In a recent court reply, attorneys representing the drugmaker scoffed at the allegations of a "decade-plus, multi-drug, nationwide scheme of False Claims Act violations. ... Despite page after page of narrative about these purported 'schemes,' (the lawsuit) offers no particularized allegation of false claims that (Solvay) 'caused' anyone to submit by improperly promoting a drug off-label, paying a kickback, or 'manipulating' a diagnosis code."


    © 2011 Miami Herald Media Company. All Rights Reserved.
    http://www.miamiherald.com

    Read more: http://www.miamiherald.com/2011/06/14/v-print/2265786/off-label-marketing-how-testosterone.html#ixzz1PINcaG2U
     
  7. Anonymous

    Anonymous Guest

    Why call Androgel anything but another a way to steal.... pitiful.


    The Miami Herald
    Posted on Tue, Jun. 14, 2011
    Off-label marketing: How testosterone replacement got big

    By CHRIS ADAMS
    McClatchy Newspapers
    The question for doctors was simple: "When a patient comes in and asks for Viagra, will you first screen for low T?" meaning testosterone.

    The pitch by Solvay Pharmaceuticals Inc. was part of its effort to make its testosterone replacement drug AndroGel "ride (the) coat tails of Viagra."

    But unlike Viagra, AndroGel wasn't approved by the Food and Drug Administration to treat erectile dysfunction.

    Instead, it was approved to treat a relatively specific condition of the sex glands called hypogonadism. According to a significant whistle-blower lawsuit, Solvay wanted to boost AndroGel's sales with an aggressive strategy to push "off-label" - or unapproved - uses of the drug.

    "I can't underscore enough how important off-label sales were," said John King, a former sales manager for Solvay who's involved in the suit. "You can do the math: If we had truly stuck to the FDA-approved indication, AndroGel would never have had anywhere the sales it had."

    While they're a big part of any drugmakers' bottom line, such off-label uses also can run afoul of federal drug-marketing laws. It's legal for physicians to prescribe drugs off-label, often based on their assessment of the latest medical research, but it's illegal for drugmakers to promote such uses.

    The FDA's regulations on prescription medicine are based on researchers proving the safety and effectiveness of individual drugs for treating specific illnesses. Prescribing drugs to combat illnesses they were never approved to treat can be ineffective and risky to patients.

    While off-label marketing long has been commonplace, federal prosecutors in recent years have cracked down on the practice, bringing more than a dozen cases against drugmakers for off-label marketing, and winning billions of dollars in criminal and civil settlements. The cases have revealed how companies and their on-the-ground sales reps ignored drug-marketing laws to convince doctors to prescribe drugs for unapproved conditions. Private whistle-blower suits have been a part of that crackdown.

    The current whistle-blower lawsuit actually involves three of Solvay's drugs - AndroGel, a blood pressure drug, and a mental health drug - and provides an inside look at the world of corporate drug marketing. Although filed several years ago, details in the lawsuits were only recently unsealed at the U.S. federal courthouse in Houston. Dozens of internal company memos, emails and sales presentations were filed in the case, documenting how the company and its sales representatives sweet-talked, cajoled and even paid fees to the doctors in their territories.

    AndroGel, a clear gel that men rub on their shoulders, upper arms and abdomen, has been through three corporate owners in the past dozen years: Unimed Pharmaceuticals Inc., which was bought by Solvay Pharmaceuticals Inc., which was in turn bought by Abbott Laboratories. According to Abbott, it has annual U.S. sales of more than $600 million.

    The attorneys handling the case said that neither they nor Solvay would respond to McClatchy Newspapers' questions, other than to note that federal and state governments, which sometimes join similar cases, have declined to do so in this case.

    The drug's current owner, Abbott, said through a spokesman that the case was filed in 2003, nearly seven years before Abbott's acquisition of Solvay and that, "No specific concerns have been raised in this case about Abbott's sales and marketing of these products." Spokesman Scott Stoffel added that AndroGel is approved for the treatment of men with no or low testosterone and Abbott markets AndroGel according to the medication's label.

    Hypogonadism, the condition that AndroGel got the FDA OK to treat, is defined by low levels of the male hormone testosterone, often because of damage - from injury, chemotherapy or other trauma - to the testes. It can result in low sex drive, low energy levels, muscle loss and depression.

    How many men suffer from this condition? Those numbers are all over the map.

    In 1999, when Unimed asked the government to approve the drug, it announced that hypogonadism was estimated to affect more than "one million American men."

    In 2000, when the FDA approved the drug, the company announced that the market was "four to five million American men."

    But by 2003, when drug was being pushed by its corporate managers, the number drifted to "up to 20 million men," according to information in the lawsuit.

    From the start, Solvay - which then owned the drug - wanted to expand the market. In one document, the company noted it needed to expand the testosterone market by 36.5 percent, particularly by pushing the drug to primary care physicians. It sought to convince doctors that low levels of testosterone were widely under-diagnosed, and that conditions associated with normal aging could be because of those low testosterone levels.

    It's clear from internal memos that Solvay considered some doctors - including those in primary care - to be relatively easy marks.

    A New Orleans district sales memo described primary care doctors as "easily influenced."

    A 2004 memo on AndroGel sales strategies said the sales force was putting extra emphasis on rural areas, since "rural doctors are typically very accessible, give us plenty of time to teach them the right way to diagnose and treat, and they have the patients."

    Treating low testosterone is tricky, in part because experts still struggle to determine what a normal testosterone value should be. A blood testosterone value of more than 300 is considered normal, said Neil Goodman, a Miami endocrinologist and chairman of the reproductive medicine committee of the American Association of Clinical Endocrinologists. A value below 150 or 200 is low. But the meaning of levels between 200 and 300 can be ambiguous, and dependent on a man's age as well as any other underlying medical conditions.

    Beyond that, there are problems with the testosterone test itself. "If you sent the same sample to three different labs, you might get three different results," Goodman said; federal officials and medical experts are working to standardize testing.

    One of Solvay's strategies was to get doctors to rethink the idea that the cutoff between normal and low was 300. Instead, company sales documents discussed what was called "andropause," a condition akin to menopause.

    The FDA had addressed the andropause issue before. In 2000, when reviewing the drug's advertisements, the FDA told the AndroGel's maker that "claims and representation that suggest that AndroGel is indicated for men with 'age-associated' hypogonadism or 'andropause' are misleading." The drug, the FDA said, was only approved for men with hypogonadism.

    In a 2001 sales memo from the company's Mid-Atlantic region, however, a company official suggested that might be too restrictive, the lawsuit says. If a patient's testosterone had dropped over time - even if it still was in the normal range - then he might need AndroGel, documents show.

    "We can help write a new paradigm. One that captures both the andropausal male, as well as the hypogonadal male," a sales document said, according to the lawsuit. Sales reps were told to ask doctors to examine how far a man was "from the top of the normal range, rather than how close he is to the bottom of it."

    Beyond the message itself, Solvay used a range of tactics to connect with and convince doctors to prescribe the three drugs in the lawsuit.

    According to court records, Solvay paid doctors between $150 and $1,000 for "preceptorships," which allowed drug sales representatives to shadow them for a day; held "Lunch-N-Learn" programs, where sales representatives brought food into physicians' offices and would proceed to give them pitches for their drugs; and held "Dine-N-Dash" programs that allowed doctors to pick up a fancy dinner as long as they listened to a short pitch.

    In a memo to people on his sales team, King - the former sales rep involved in the lawsuit - laid out the rationale for such "peer influence programs."

    "Here is the bottom line with these programs: THEY WORK. They have worked in a big way in the Houston district and the recent feedback from Raleigh is extremely positive. Think about it ... the doctor is away from the office, not stressed, and he is getting to do something nice for himself and his family."

    If successful, King and another plaintiff could get a cut of any drug-company payout.

    In a recent court reply, attorneys representing the drugmaker scoffed at the allegations of a "decade-plus, multi-drug, nationwide scheme of False Claims Act violations. ... Despite page after page of narrative about these purported 'schemes,' (the lawsuit) offers no particularized allegation of false claims that (Solvay) 'caused' anyone to submit by improperly promoting a drug off-label, paying a kickback, or 'manipulating' a diagnosis code."


    © 2011 Miami Herald Media Company. All Rights Reserved.
    http://www.miamiherald.com

    Read more: http://www.miamiherald.com/2011/06/14/v-print/2265786/off-label-marketing-how-testosterone.html#ixzz1PINcaG2U
     
  8. Anonymous

    Anonymous Guest

    because 2% was taken. With Erx does it really matter. point n click
     
  9. Anonymous

    Anonymous Guest

    What would the Auxillium off-label suit look like. I should have saved all of their homemade detail pieces I turned to regulatory.
     
  10. Anonymous

    Anonymous Guest

    this is crazy! What we end users want is a gel that is 10 or even 20% strength not 1 or 2 or some other silly piddling little amount! Androgel missed out here I think 'cos if they had gone for MUCH stronger they would clean up the sales! We hate having to cover ourselves in smelly sticky goo every day! It would be nice to just have to apply a small amount of very fast drying gel.
    What good is increasing the strength by 0.62%? Mental!
     
  11. Anonymous

    Anonymous Guest

    Because it is then "different" then the soon to be generic version. Get it? If it wasn't "different" it would get zero sales. Now it will get Zero plus a little when the generic older version comes out.
     
  12. Anonymous

    Anonymous Guest

    So they're losing the patent on Androgel, and reformulated it to 1.62%. Less gel, but probably 100 times the price. What a scam. I want to scream when I see that commercial and they say it could save you money on your copay. Yeah and stick it to the insurance companies. BIG NEWS. I'm sure they're smart enough to not cover it unless they're getting a sweet kickback at the end of the year. Innovation and research at work.
     
  13. Anonymous

    Anonymous Guest


    Not losing the patent this year, or next most likely. and 1.62 is the same price as 1%
     
  14. Anonymous

    Anonymous Guest

    Hypogonadal male? Low testosterone? Sounds like that describes the forum idiot who posts all those stupid "what's your favorite" questions, along with his tuna helper menus his mommy makes him every day.
     
  15. Anonymous

    Anonymous Guest

    Who cares about price , it makes my peepee big!
     
  16. Anonymous

    Anonymous Guest

    Cause we got nothing else to sell!
     
  17. Anonymous

    Anonymous Guest

    Clever
     
  18. Anonymous

    Anonymous Guest

    Peepee? What are you, six years old? You're the same little boy who posts his mommies recipes every few days aren't you? Get off this board and go read a book, school is coming in 4 weeks.
     
  19. Anonymous

    Anonymous Guest

    I am one of the 10% who feel that 1.62% is not as easy to remember as "The Marketing Wizards" think. As an example: A typical primary care doctor will see 1.5 cases of Low T every week. My top endo has 69 rx's through 13 weeks thats 1 a day. A primary care doctor sees 20 high blood pressure and cholesterol patients per day. Abbott being the assclowns that they are, don't understand this point.
    Hypogonadism is rare "within" a practice. When you look up Androgel in an ERX system there can be upto as many as 6 different choices and the 1.62 is listed differently depending on if its in as grams, milligrams, pump presses, or pumps. Then add in the 1% packets and you have an ERX clusterphuck. If it was clearly called Androgel ____ it would have been better. Abbott needs to leave "Solvay" people alone and let us keep developing the brand and marketing without their input. Just write the check. As to the offlabel lawsuit. This guy wrote the emails that he is citing in the lawsuit so is he suing himself. We were never instructed to sell off label and always positioned it as a benefit of being within the normal range.