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!