Here is the “smoking gun”—the proof of what we have been suspecting. Action Alert!
We’ve been telling you about S.959, the Senate compounding pharmacy bill. We and other groups oppose it mainly because it is written in a way that would likely shut off access to important medications like bioavailable estriol and time-released natural thyroid.
Remember the political saying, “Never let a crisis go to waste!” In other words, try to manipulate the political process to get what you want. We thought this was happening with the compounding bill. Now we know it is. And this scheme is fueled by powerful former politicians working for industry and even by a key lobbyist married to a key Senate staffer.
What ANH-USA has feared in particular is that special interests in the pharmaceutical industry would try to use the call for federal regulation of compounding pharmacies to outlaw compounded estriol and thyroid and replace them with standard drugs. Compounded, bioidentical estriol became popular in the first place because the standard drug used for the same purpose was proven to be dangerous, a risk for both heart disease and cancer. It would be understandable that the drug companies would want this huge market back. Here is how some of them have gone about it.
When the call for federal regulation of compounding arose, pharmaceutical companies formed the so-called Working Group on Pharmaceutical Safety to lobby for the bill. The group is led by Tommy Thompson, the former governor of Wisconsin and former Director of Health and Human Services under George W. Bush, and recently a failed Senate candidate, and Sarah Sellers, a former FDA official who worked on compounding pharmacy policy. The group represents some of the drug companies with vested interests in the compounding bill: the “participants” of the Working Group include TherapeuticsMD (a specialty pharmaceutical company), KV Pharmaceuticals, Auxilium Pharmaceuticals, and Mobius Therapeutics.
Not coincidentally, Thompson is chairman of TherapeuticsMD. And until recently, Sellers worked for Ther-RX, the marketing and distribution arm of KV Pharmaceuticals. You may recall our article on KV’s fight against the compounded version of the successful progesterone-based drug 17P, which is used to prevent premature births; KV was displeased by the FDA’s decision (due to grassroots pressure) to allow compounders to continue making the inexpensive 17P when KV wants to control the market with their high-priced version of the drug, Makena.
In other words, the Working Group on Pharmaceutical Safety and their clients have a direct financial interest in language that would allow the FDA to shut down vital compounded medications and thus a vested interest in passing S.959. Even more concerning is that TherapeuticsMD is in the process of developing a new form of the bioidentical hormones estradiol and progesterone; if these receive FDA approval and S.959 passes, it is very likely that these important hormones will no longer be available except in this new form—of unknown safety—and at what will almost certainly be outrageous prices.
Under S.959, all compounded versions of FDA-approved drugs will almost certainly be banned as “copies” of the approved drug, depending on how strictly that term is interpreted. We expect it to be defined broadly in order to ensure market exclusivity by eliminating competition from compounding pharmacies offering natural products. Because they are natural, these products cannot be patent-protected.
In a remarkably candid interview with Bloomberg, TherapeuticsMD CEO Robert Finizio recognized the superior safety of bioidentical hormones. This is important because FDA’s main argument against estriol has been that it is by definition unsafe because it has not won FDA approval, a circular and misleading argument since the FDA knows very well that no one can afford to take an unpatentable product through the FDA process. Finizio’s comment directly refutes critics who claim compounded products are dangerous. But he also admits that his company sees these hormones as a $10 to $12 billion market which they want to control by offering an FDA-approved drug.
Even more telling, ANH-USA has obtained a document in which TherapeuticsMD, pitching itself to potential investors, describes the safety and efficacy of bioidentical hormones. They also give their investors some statistics on the bioidentical HRT market, reveal that well over three-quarters of the market is currently held by compounding pharmacies—and state that this is the market they are going after. If this isn’t a smoking gun, we don’t know what one would look like.
Certain drug companies, it seems clear, want to take advantage of what is supposed to be regulation of the compounding industry by replacing compounded products with their own. Will Congress please take note and amend this legislation before it is too late?
Doing the lobbying for the Working Group on Pharmaceutical Safety is BGR Group, also known as Barbour Griffith & Rogers (the firm was founded by Haley Barbour, former governor of Mississippi). The connections between BGR and the federal government are myriad:
- BGR’s vice president for governmental affairs is Dave Boyer, who worked for Tommy Thompson at HHS, and served as special assistant to the president for legislative affairs under George W. Bush, followed by a stint as senior director of federal affairs for the Pharmaceutical Research and Manufacturers of America (PhRMA), the drug companies’ trade association. BGR now lobbies on behalf of PhRMA.
- David Boyer also represents drugmaker Eli Lilly, which has an animal drug division that would have benefited from an earlier version of the compounding bill that severely limited compounding for dogs, cats, and horses. While that provision has been dropped from the current version of the S.959, an amendment to restore these compounding restrictions is expected when the bill is considered on the Senate floor.
- One of PhRMA’s members is Pfizer (which, you may recall, purchased Wyeth, who started the whole attack on bioidentical hormone replacement therapy with a petition to ban estriol in favor of their synthetic drug). Pfizer would benefit from the very specific language in the bill that would allow FDA to remove estriol from the market.
- A top Senate staffer heavily involved in the Senate bill has close personal ties to a top pharmaceutical industry lobbyist. If you think this sounds like a conflict of interest, you’re right: in meetings this staffer has been a strident voice against compounding and has opposed both compounded 17P and estriol.
- Doing much of BGR’s actual lobbying for the Working Group is Bob Wood, president of BGR’s government affairs. Wood worked as Tommy Thompson’s chief of staff when Thompson was governor of Wisconsin; he continued in the same capacity when Thompson directed HHS.
In other words, TherapeuticsMD and the Working Group’s other “participants” are following in footsteps of KV Pharmaceuticals. They’re attempting to change the business playing field legislatively. Unfortunately, if they follow KV’s example too far, they may wind up in trouble.
KV Pharmaceuticals has had a lot of legal trouble—to the extent that we’re amazed any former FDA official or HHS secretary would work with them. In 2011, KV’s former CEO spent time in jail (and is now banned from ever doing business in the US) for falsifying the amount of morphine that was in their pills. The company has also had to settle with numerous state attorneys general for Medicare and Medicaid fraud—to the tune of $17 million.
Action Alert! Sen. Lamar Alexander (R-TN) is calling for a vote on S.959 as quickly as possible. Even if you sent Congress your message on S.959 previously, please write them again. We have added new information to the Action Alert letter, and it’s vital that we fight with all our strength against the powerful lobbyists and deep-pocketed drug companies to preserve our right to safe, inexpensive, effective compounded medicines. Please take action immediately!
Be especially wary if Astra Zeneca signs on. I understand that they have ties to the Israeli military.
We have to do something to stop coorporate america from destroying so many lives. If we could only get the conservitives out we might be able to survive.
Compounding is also important for children, especially those with Autism or ADHD. These conditions are treated with “Medical Nutrition Therapy” (or BioMedical approach) by licensed nutritionists, and must be tailored to the age, size, and conditions of children, who cannot take adult supplements. Removing access to nutrient compounds by nutritionists would severely and unnecessarily restrict nutrition therapy for Autism and ADHD.
Please keep things as they are…….women need this and it’s been so helpful…..I want options that are more helpful and healthy……taking this away and replacing it with what’s in this bill is not fair and healthy for women…….it is a greedy, monetary attempt to take over this industry!
Please listen to what the people/women want for once…..fair competition, healthy natural options, trustworthy practices, etc……..plz do not pass this bill…….I have been using.bio-identical hormone replacement for 8 yrs and it has allowed me to function with my career, life in the way I always have…….I do not what the pharmacutical company’s in the compounding business!!!!No one trusts the FDA and the pharmaceutical company’s…….let women decide what they want!!
Thank you
I had to have an ovary removed. I need to supplement estrogen. I do not want to use synthetic . My sister went that route and ended up with breast cancer. Please do not take away my right to choose.
Eventually we will be forced underground and having to get our alternative medicines on a blackmarket
Eventually we will be forced underground and having to get our alternative medicines on a black market
I am against this bill because it limits my freedom to choose how to care for my own health.
Some of us rely on compounded formulas to stay healthy. The fact that such a bill is being pushed is criminal because of the reputations of people pushing them. Big Pharma has more than enough of this country’s money. Leave those of us alone who pay out of pocket to stay healthy.
Let the interest of the people be over the interest of the pharmaceutical companies. Americans need a goverment of the people and for the people.
When are the that allegedly run this country going to wake up to the fact that our medical choices are being chipped away by lobbyists who formerly were key government officials. I am sick of it.
Hello Russia, hello China. The US medical profession is anxiously wating to hear from you.
I do have a problem with this because I take only that which is natural; however, when Big Pharma is involved, it is only about profits. You mention the FDA, they also are involved with big corporations and care only about profits. Why else would our food supply be contaminated and unacceptable to many other countries?
I have been taking Armour Thyroid for years due to the fact that my doctor recommends it as he knows what is in it. I don’t want to take a synthetic thyroid medication.
More Freedom, less control by BIG PHARMA!
BigPharma has ONE goal—to make HUGE profits off the sick and needy…THEY MUST BE STOPPED !!!!!!!!!!
Just read my modified letter to my representatives and my Facebook-directed note.
-EFG
I use Biodentical hormones and do not want them covered by the FDA an incompetent agency when it comes to drugs. Why is it that you always are in bed with Big Pharma. You should keep your hands off my health care and vote against this controlling bill. It is not about health..but it is about money only. If you vote for this you are not caring about your voters that use this service and believe in natural health.
I am outraged by this legislation and the motives behind it. If passed, it will effect and do harm to millions of citizens. I have written my senators twice about this bill. One of my concerns, apart from what is in this legislation, is that so many people no nothing about this bill but will find out only when it is too late. I sent information to [email protected] with links to this information and asked if they would be interested in getting this out to their audience. This is definitely a liberty issue and the senate has no right to misrepresent citizens with this egregious legislation with no input/consideration or representation of their constituents. This legislation represents only Big Pharma to the detriment of the people.
I am outraged by this ,this is against people choice and only support big pharma
This was very informative but I could not follow anything hs used from his computer.
P.S. I have already received a letter from our insurance provider that they will no longer be covering a compounded pain cream, on which I rely heavily, because it contains “objectionable bulk ingredients”, one of which is baclofen, a muscle relaxant. I currently take this med ( supplied by big pharma ) orally. It seems totally disingenuous that baclofen is safe orally, but not trans-dermally. Moreover, it is not necessary for the pharmaceutical industry to decimate the entire compounding industry (and by extension, millions of your constituents and their health) in order to bring forth patented drugs, even though those drugs may be deadly,and of a far greater magnitude of harm, than anything of an equivocal and often superior compounded nature. This is simply unmitigated greed and theft by legislation. I assure you this is not a victimless crime. The victims are your constituents who will go without the good, effective compounded medications on which they so heavily and economically rely. Let Big Pharma patent all the drugs they want, and let the marketplace sort it out. Leave. The. Compounders. Alone.
Big Pharma – they put the “harm” in pharmaceuticals.
It won’t be long before they ban all natural suppliments and vitamins too…this Is the start of a methodical plan in the making since the turn of the century…you see the less people on earth, the more gained by the select few evil entities running the show…pharma,world banks,oil and government….we, the people, know what is going on and we will fight it until our demise….
Act now, tell anyone who will listen, while we still have the right to survive
Tiffany, I agree entirely.
This taking away a American rights!!! We are becoming communists!
No, we are becoming fascists, not communists.
We have routinely obtained IV constituents from our local compounding pharmacy to be preservative-free for sensitive patients. We’re having much more difficulty getting them due to some new policies from, I assume, the FDA. their new rules and regulations are seriously impairing our ability to do business with multiple IV therapies that we’ve offered for many years, We will have to greatly reduce types of therapies we’ve offered our patients since the supplies are no longer dependably available. Now I understand what is going on, thanks to ANH-USA.
If this bill passes you are condemning me to a life time (of what is left) living in h***. I have NO ovaries and without the hormones in a natural state (the only ones my body recognizes) I can only hope and pray for a short quick death. Try living without you rboy hormones and see how well you can tolerate life. Oh and BTW I have used pharma hormones, they swell my breasts with cysts or do not work at all as if I am not taking any hormones at all. I can’t even use the creams that compounding pharmacies use I have to have the hormones placed in coconut oil in order not to get blisters!
where are you going to get your testosterone – from big pharma with a list of side effects or a compounding pharmacy that uses a simple two ingredient of a natural testosterone and a cream to apply it to your skin.
All this bill is is an attempt by the big pharma corporations to control a market and BTW cost the government more in payouts for said drugs that only mane, kill …..thousands yearly when taken these chemical drugs as prescribed! There is the crime and outrage by the FDA. Are there still people who believe the FDA works for the safety of the people including YOU! Do you guys still believe what comes out of the minds and mouths of FDA and pharmaceutical chemical drug corporations?
I need a personalized way to get my hormones and many other drugs being sentive to the point that most pharma drugs either do not work on me or nearly kill me. It is not fair to condemn people preventing them from having access to something that works, costs less, for people and insurance (tri-care, medicare, etc)
I am so sick and tired with present and government officials with FDA collaborating with big pharmaceutical companies because for profits. I myself got hurt badly with pharmaceutical drugs with dangerous reaction. When are you greedy people going to stop or can be stop. I will use everything I got and the power of internet to spread the word thru blogs and other venue and reach anyone that will listen to stop everyone who place a dangerous game and only think to put money in their over flowing pockets with greed. STOP STOP AND POWER TO THE PEOPLE WILL BE RESTORED TO THE PEOPLE OF USA. IN GOD, WE TRUST.
At the age of 84, soon I will not have to put up with this crap from the US government anymore. You all will have to live in a system wherein uninformed Washington knows what is best for you. The lifespan in years vs time will soon become a parabola with an open bottom. After having my life destroyed by accepting my doctor’s recommendation about use of a medication, the FDA and pharma party line, I no longer accept anything that any medical professional says without in depth research, In short, be more knowledgeable than your doctor to survive the medical profession. Most either didn’t learn or have forgotten what they learned in school and now trust the detail people who give them perks for prescribing the latest most profitable pill for which the data was rigged to get FDA approval. 2 rigged studies is all that is required. It matters not how many died in studies which are not required to be reported. .
Remember that KV Pharmaceutical has one of the worst FDA records in history for violations and have had their president convicted of multiple egregious violations and as a result they have had to reorganize several times. Living in and working in the pharmaceutical industry St. Louis, I know several high level execs as well as several individuals who were laid off by the repeated shutdowns of this company. How can you trust someone like Sellers if she was a high-ranking employee of a company that has been so flagrant in violation of FDA regulations?