Generic Androgel?

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So hear I sit, just recently told I need to take AndroGel. And I don't have insurance coverage for meds. Even with a special cash discount, I still spend 250+ per month on the stuff. Then I read here how the pharma world revels in its protectionism tactics - and knowing the industry is generally surviving this economic crisis. I suppose that buying off the generic producers is good business but there are real people out here that are hurting. I have heard all the arguments about product development costs but I also know (first hand) about the huge lobbying costs -- not all your money goes to science or marketing. Illegal or not, it is hard for me to not side with the person that got into a psuedo black market venture. I wish I could stumble onto his/her business.
 






I'm sorry to hear that you do not have insurance and with all branded medications..they are expensive. 25% of all revenue does go back into R&D and it takes on average 10 to 15 years for a drug to come to market at which time it has 5 to 10 of sales life before going generic. 95% of drugs do not ever make to the market, so think about al the costs that are accumulated over that time and then the drug never makes it. Yes drugs are expensive and yes this is a for profit industry( as all businesses are) but there are many costs that the patient doesn't realize. Good luck to you and you can apply for the drug to be given to you at no cost if you qualify.
 






If you want a low cost alternative, use injectable testosterone replacement therapy. It's the drug companies in search of profits (as in every other major American industry) that provided you with T gel in the first place. There is no altruistic answer. We live in a market economy. If you want the best newest products it will cost you. If you want lower cost but older options, those are there too.

Not everyone eats filet mignon every night, not everyone drives a BMW, not everyone gets to live in a 5000 square foot custom made home, and not everyone gets the best medicine available.
 






I'm sorry to hear you have difficulty paying for Androgel.

If you are in need of drugs but have no coverage, try visiting this website:

www.needymeds.com

look for the hyperlink on left side of main page that states something like "branded drugs"

choose the first letter of the name of the drug from the A-Z row across the top of the next page and then scroll down to find out if your drug has some sort of patient assistance available. I know that Androgel is available and the form link is on www.needymeds.com as are many other drugs from many different companies - not just Solvay.

There are many ways to reduce the cost of drugs but it is ultimately up to the consumer to find out how. This patient assistance program is just one option. $avings cards, vouchers, free trials, and samples are other ways to receive free medications. Ask your doctor or perhaps a social worker at the hospital about these programs.

I hope this helps.
 
























Anonymous said:
So hear I sit, just recently told I need to take AndroGel. And I don't have insurance coverage for meds. Even with a special cash discount, I still spend 250+ per month on the stuff. Then I read here how the pharma world revels in its protectionism tactics - and knowing the industry is generally surviving this economic crisis. I suppose that buying off the generic producers is good business but there are real people out here that are hurting. I have heard all the arguments about product development costs but I also know (first hand) about the huge lobbying costs -- not all your money goes to science or marketing. Illegal or not, it is hard for me to not side with the person that got into a psuedo black market venture. I wish I could stumble onto his/her business.
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I do feel bad for your situation. But please remember that you live in a country where AndroGel is even available. The flip side of that is a country where only the oldest and most outdated products are available. At least in America there are choices of top line most up-to-date drugs AND the opportunities to make money to afford them. People who whine about the cost of drugs forget that it took a lot of financial investment on the part of pharma companies to bring those drugs to market. And then the public expects them to be available for free! It doesn't happen that way. If Mercedes created a car that guaranteed that no one would ever die in a crash because of its safety features would the public expect that it be given to every citizen for free so that they would never die in a crash? NO! People would find a way to buy one because they saw the value in it. But everyone forgets that medicine is a business, too. And the day it stops being a business is the day we all need to be afraid. Because there will be no incentive to bring innovative and effective drugs to market. We will be stuck with archaic drugs that have less efficacy and LOTS more side effects. That is why everyone should be paying attention to what the current administration is trying to sneak past the American people with regard to healthcare reform!
 






At least in America there are choices of top line most up-to-date drugs AND the opportunities to make money to afford them. People who whine about the cost of drugs forget that it took a lot of financial investment on the part of pharma companies to bring those drugs to market. And then the public expects them to be available for free!
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Point taken... but $8.50 per day or $3000 a year cost to consumers using a 5gm gel pack is like highway robbery.
 






I just wanted to thank the individual that suggested using the services of a compound pharmacy to obtain a “generic” version of Androgel. The current price for Androgel is +/-$330.00 for a one month supply and the compound pharmacist has provided me with the same dosage and duration for $50.

I certainly understand the attitude of some of the posters to this discussion board, since it appears that many of you work in the industry, but if Solvay was not so greedy, I would not be forced to go outside the normal channels for my prescription.

I realize that we live in a capitalist system and I think that system, in addition to allowing drug manufacturers the right to overcharge, also provides me with the option of going outside the normal channels if I feel that I am being taken advantage of.
 












It would be great if the product actually worked appropriately. I used this product for almost one year at a very high cost per mo and had little luck with it. My numbers where all over the place...started off really low then went rocket-way off the charts. It did not have a nice gradual rising effect with me. I was either really low-ball or blast off the charts highs way over 3000, also caused me all kinds of mental focus issues, made me feel crazy at times. I thought it would make me feel better, and also as an adjunct help to lose weight instead it took the oposite route. I gained weight and did not feel the improvement promised. My doctor could not explain the out of control highs other than saying it could cause me longterm problems if I stayed on the product. Also, I did not like the transdermal method of application it was a PITA. I don't feel it is appropriate to just rub a product on your skin and expect precision. I am now off the product for good. Doc said this was the only method available at the time. Glad to hear there is another method through injection I think that could hopefully be more precise. Just wish there was a genuine natural supplement or an accurate sublingual product that would work.
 












Yes. Lets add a generic to an already made up disease mongering market targeted at every single man who can answer "yes" to at least one question on the ADAM questionnaire. Even the family dog (male or female) would qualify. They might as well add "Are you breathing?" to the ADAM..... Read on


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/...marketing-how-testosterone.html#ixzz1PINcaG2U
 






Without going too deep or too long into it, I was diagnosed with an endocrine disease when I was 25 which means I will enjoy a state of hypogonadism for the duration of my life. When I was 25 I started with the injections. If you want to talk about a rocket ride of too much Testosterone followed by too little, by all means, get yourself on the injections. Try to remember to deliver the injection to a different place over time, because the injections run you the risk of calcification in the muscles where you inject. Oh, and enjoy stabbing yourself every 2-3 weeks forever with a needle that if you look head on at the point does a convincing imitation of a straw. Not to mention the pain of injecting a viscous ball of oil into your quads or glutes.

Alas, I digress. The point is... I'm 41 now. I've been taking Testosterone injections and/or topical gel formulations for 16 years. So, can someone please explain to me how standard US Patent protection for pharmaceuticals supposed to allow for 7 years of exhorbitant profits in the US Market, but for this particular delivery method seems to have not only lasted for the last 16 years that I've been taking it, but for some years before that, and still isn't available as a generic (now pushed out to 2015/2016).

I don't generally allow myself to get worked up about things I can't control, but I just about laid an eggroll earlier this evening when I saw an Ad on TV for a NEW 1.62% concentration of Androgel. Which, naturally, means that Androgel is once again restarting their 7-year clock for US Patent Protection on the same agent. I expect 7 years from now, they'll make some other tiny change, like replacing the current oil with some other kind of oil, which technically changes their formulation so they can get another 7 years of patent protection for their cash cow.
 






I'm not sure what your beef is? It costs drug companies hundreds of millions of dollars to develop drugs. R and d, and clinical trials and eventually FDA approval, then they file a patent to protect their investment. However long, the patent life, the company has to recoup their costs before generic companies copy the formula, and every Tom dick and harry can produce the drug, driving the price down.

If the company is smart, they continue to reinvest in developing a better product they can roll out to improve patient care and yes, remain profitable when patent life expires.

So what is your issue? There are a half dozen legit products for hypodonadism now..your treatment options are no doubt inherently better than they were 16 years ago, and cheaper too.




Anonymous said:
Without going too deep or too long into it, I was diagnosed with an endocrine disease when I was 25 which means I will enjoy a state of hypogonadism for the duration of my life. When I was 25 I started with the injections. If you want to talk about a rocket ride of too much Testosterone followed by too little, by all means, get yourself on the injections. Try to remember to deliver the injection to a different place over time, because the injections run you the risk of calcification in the muscles where you inject. Oh, and enjoy stabbing yourself every 2-3 weeks forever with a needle that if you look head on at the point does a convincing imitation of a straw. Not to mention the pain of injecting a viscous ball of oil into your quads or glutes.

Alas, I digress. The point is... I'm 41 now. I've been taking Testosterone injections and/or topical gel formulations for 16 years. So, can someone please explain to me how standard US Patent protection for pharmaceuticals supposed to allow for 7 years of exhorbitant profits in the US Market, but for this particular delivery method seems to have not only lasted for the last 16 years that I've been taking it, but for some years before that, and still isn't available as a generic (now pushed out to 2015/2016).

I don't generally allow myself to get worked up about things I can't control, but I just about laid an eggroll earlier this evening when I saw an Ad on TV for a NEW 1.62% concentration of Androgel. Which, naturally, means that Androgel is once again restarting their 7-year clock for US Patent Protection on the same agent. I expect 7 years from now, they'll make some other tiny change, like replacing the current oil with some other kind of oil, which technically changes their formulation so they can get another 7 years of patent protection for their cash cow.
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I think his issue, as well as many of the rest us, is that the drug companies always find a way to screw over the consumer. Yes they sometimes make good products that some of us greatly need & yes, they also have to recoup the cost of R&D, marketing, etc. etc. That's not the point. The point is that they charge exorbitant amounts of money for certain drugs marketed at men. Especially sex drugs [ie: Viagra ($20 a pill?) & Androgel ($360 for a one bottle?)] I'm sure they do this becuz 1.) They can geta way with it 2.) They have no competition from other companies & they do whatever they possibly can to guarantee there will be NO competition for decades. And 3.) Becuz they know that us men will pay almost anything to feel younger, more energetic & also be a stud in the bedroom. So it's not that we are complaining or (whining as you said earlier) that these drugs are expensive. We're complaining that they are so expensive that they are almost out of reach of the avg joe or can be bought but put a major financial burden on the consumer. You can'ty tell me that after all these yrs & all the money that major drug companies like Pfizer & Abbot have made from selling the aforementioned drugs that they actually NEED to charge these ridiculous prices. This is greed plain & simple.
 






Zach71 said:
I think his issue, as well as many of the rest us, is that the drug companies always find a way to screw over the consumer. Yes they sometimes make good products that some of us greatly need & yes, they also have to recoup the cost of R&D, marketing, etc. etc. That's not the point. The point is that they charge exorbitant amounts of money for certain drugs marketed at men. Especially sex drugs [ie: Viagra ($20 a pill?) & Androgel ($360 for a one bottle?)] I'm sure they do this becuz 1.) They can geta way with it 2.) They have no competition from other companies & they do whatever they possibly can to guarantee there will be NO competition for decades. And 3.) Becuz they know that us men will pay almost anything to feel younger, more energetic & also be a stud in the bedroom. So it's not that we are complaining or (whining as you said earlier) that these drugs are expensive. We're complaining that they are so expensive that they are almost out of reach of the avg joe or can be bought but put a major financial burden on the consumer. You can'ty tell me that after all these yrs & all the money that major drug companies like Pfizer & Abbot have made from selling the aforementioned drugs that they actually NEED to charge these ridiculous prices. This is greed plain & simple.
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Do you have any idea of the average cost to bring a new pharmaceutical drug to market is these days? Do you know what % of the products that companies invest in actually get approved? People love to bring up that it can't cost very much to make these pills and its not the manufacturing expense but rather the cost of developing these drugs in the first place. Very few drugs even make enough money to even pay for itself yet alone for all the other drugs that never even got the chance to be approved.
 






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