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Abbott Laboratories Sues Unithroid Distributor Watson Pharmaceuticals
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Synthroid's Manufacturer Denies Safety and Effectiveness Problems and Accuses Competitor of Disseminating Misinformation
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by Mary J. Shomon
In the latest volley in the ongoing contest over the U.S. Food and Drug Administration (FDA) approval process for the synthetic thyroid hormone levothyroxine, Abbott Laboratories, manufacturer of Synthroid, filed suit on June 12, 2001 against Watson Pharmaceuticals, distributor of Unithroid. Abbott has yet to file for or receive FDA approval for Synthroid; Watson's Unithroid product was approved by the FDA in August of 2000.
Synthroid is the third most prescribed medicine in the U.S. Attention was focused on the drug when in late May of this year, the FDA refused the manufacturer's request for GRAS/E (Generally Recognized as Safe and Effective) status, and instead ruled that the drug would need to go through a mandatory new drug application process. The nine-page denial letter sent by the FDA, dated April 26, 2001, included a detailed list of concerns regarding Synthroid's potency, stability and manufacturing processes.
According to today's press release, Abbott is asking a Federal court to stop alleged advertising activities by Watson against Synthroid. Abbott is also asking the court to order Watson to run an advertising campaign to, as Abbott claims in their release, "correct the deliberate misinformation it has created within the medical community."
Abbott's press release alleges that Watson is "inundating patients with alarming, medically-inaccurate information." In an interview conducted by telephone with David Pizzuti, M.D., Abbott's Vice President, Global Medical Affairs by Mary Shomon on June 12, 2001, Pizzuti clarified information of concern, which he says included: "press releases issued by Watson, some before the GRAS/E (Generally Recognized as Safe and Effective) petition was denied; a promotional mailing that contained statements such as 'the FDA is threatening to remove Synthroid due to questionable quality' which misstates the facts; and verbal concerted actions by the Watson sales force."
Rob Funsten, Senior Vice President and General Counsel for Watson Pharmaceuticals, also speaking to Mary Shomon in a June 12, 2001 interview, indicated that Watson had not yet been served with papers by Abbott, and he did not as yet have a copy of the lawsuit, so he would be unable to comment on anything beyond what was outlined in the Abbott press release. Based on the press release, however, Funsten said, "Nothing that has come to my attention would say there is any merit to this whatsoever. It strikes me as an act of desperation.
According to Funsten: "The whole motivation behind this lawsuit may say more about Abbott
and the fact that Synthroid is unapproved than about Watson."
In looking at Abbott's allegations, a review of recent press materials sent out by Watson indicated that they issued a release on May 1, 2001, titled Unithroid (TM) the Only NDA-Approved Levothyroxine Sodium Approved as Safe And Effective by the FDA, Having Demonstrated Stability, Consistent Potency, And Dose Proportionality. That release, however, does not name any competing products -- including Synthroid -- by name.
"The whole motivation behind this lawsuit may say more about Abbott
and the fact that Synthroid is unapproved than about Watson." -- Rob Funsten, Sr. VP & General Counsel, Watson Pharmaceuticals
The May 1, 2001 Watson release also stated that, "To date, only the manufacturer of Unithroid has received NDA approval. This means that there is only 1 levothyroxine sodium currently available that the FDA has approved as safe and effective, having demonstrated stability and consistent potency, as well as dose proportionality." According to FDA reports, that statement was true as of the release date of May 1, 2001, and remained correct until a second levothyroxine drug, Levoxyl, manufactured by King Pharmaceuticals, was approved on May 25, 2001.
In terms of promotional mailings and sales presentations, these are typically targeted to pharmacies, and not patients. Without the more detailed explanation that would be found in the actual lawsuit documents, it's not clear how Abbott plans to demonstrate how such marketing activities are adversely affecting patients, as Abbott has alleged.
"One of the things that surprised a lot of people was the June 1st Wall Street Journal article," says Funsten. "Until then, a lot of people weren't aware of that FDA letter, they weren't aware that Synthroid hadn't received approval. It strikes me that Abbott is afraid of people becoming more informed about this issue."
The controversy centers on concerns over Synthroid that came to light with the publication of the FDA's letter denying the GRAS/E petition for Synthroid, a development which forced the manufacturer to announce that it would make a new drug application. The nine-page denial letter sent by the FDA to Synthroid's manufacturers detailed a history of potency, stability and manufacturing problems.
"The FDA letter is not saying that Synthroid not safe," said Pizzuti, "It is saying 'we think you need to file the NDA, we can't approve the GRAS/E.'" According to Pizzuti, "We thought it was irresponsible and medically incorrect to imply that the drug is not safe and effective."
In June 6 and 7, 2001 letters from Abbott to patients, pharmacists and healthcare practitioners, (Letter to Pharmacists, Letter to Healthcare Providers,
Letter to Customers) Abbott wrote: "Abbott wants to reassure physicians and patients that the safety and efficacy of Synthroid has been extensively studied and the results have been published in peer-reviewed journals such as the New England Journal of Medicine."
In addition, they have written: "Recently, FDA informed Abbott that it would not grant GRAS/E status for Synthroid under Knoll's citizen petition. This only means that an NDA will be required for Synthroid. This is not a reflection of the safety and efficacy of the product, but a regulatory issue."
The Abbott letters fail to mention, however, the nine pages of product safety, efficacy, potency and stability concerns detailed by the FDA in the denial of the GRAS/E status, or why the FDA would choose to so extensively outline these concerns. The FDA's letter regarding Synthroid provides a detailed accounting of specific safety and effectiveness problems the agency found with Synthroid, and reasons why the citizen's petition for Synthroid was denied.
Said the FDA: "Although you claim that Synthroid has been carefully manufactured, the violations of current good manufacturing practices discussed above indicate that Knoll has not always manufactured Synthroid in accordance with current standards for pharmaceutical manufacturing."
The FDA's letter also goes on to say that : "...patients using Synthroid have experienced significant, unintended variations in their doses of levothyroxine sodium...these variations are not conducive to proper control of hypothyroidism."
"The FDA letter is not saying that Synthroid not safe. It is saying 'we think you need to file the NDA, we can't approve the GRAS/E.'" -- David Pizzuti, M.D., Vice President, Global Medical Affairs, Abbott Pharmaceuticals
Dr. Pizzuti had no comment when asked why the FDA chose to deny Synthroid's request with a detailed and extensive nine-page accounting of product problems, rather than a simple denial of the GRAS/E request and statement that the new drug application would need to be filed.
Abbott's press release cites support for Synthroid from various professional and patient groups, including the American Association of Clinical Endocrinologists, the American Thyroid Association, the Thyroid Foundation of America and the Thyroid Cancer Survivors' Association. When asked whether or not the financial support provided by Synthroid to each of these groups has an impact on their public support for Synthroid's FDA battles, Pizzuti indicated: "From what we know, they're supported by a lot of different sources; the degree to which we support them is relatively small. We're not the only company that gives to them."
The influence pharmaceutical companies typically wield over physicians and professional organizations -- and in particular, the case of Synthroid -- was profiled in a cover story in the Nation magazine in March of 1999. In "Money + Science = Ethics Problems on Campus," writer David Shenk interviewed Drummond Rennie, who at the time was the West Coast deputy editor of the Journal of the American Medical Association.
In talking about the research study, Shenk wrote:
Knoll also used its near-omnipotence in the thyroid community to keep the study under wraps, Rennie says. Perhaps the most vivid illustration of this came when the American Thyroid Association considered a resolution urging the company to allow the study to be published. "That vote was on an absolute no-brainer, which was, 'Should we, as the Thyroid Association, write to the manufacturer and say, Please publish this paper?' I can't think of any easier question. It's a matter of basic academic freedom. And it was turned down. That is most extraordinary." One inescapable conclusion is that the defeat had something to do with the fact that Knoll provides more than 60 percent of the Thyroid Association's funding. Indeed, Rennie claims that three people present for the fateful vote later told him that as they considered the proposition, one member openly remarked, "We mustn't kill the golden goose."
One key point in Abbott's press release detailing their lawsuit stated that Watson was "making false assertions that Synthroid will be unavailable after the August deadline."
It's not clear how Abbott plans to support this claim. The original FDA notice calling for all levothyroxine products to go through the new drug application process, which was issued in 1997, stated:
After August 14, 2000, any orally administered drug product containing levothyroxine sodium, marketed on or before the date of this notice, that is introduced or delivered for introduction into interstate commerce without an approved application, unless found by FDA to be not subject to the new drug requirements of the act under a citizen petition submitted for that product, will be subject to regulatory action.
That notice was later amended to extend the deadline one year until August 14, 2001.
With a nine to ten month typical timeframe for approval of a levothyroxine product, Synthroid, which according to Pizzuti will apply "sometime before August 14th," is clearly not likely to obtain approval by the August 14, 2001 deadline.
Dr. Pizzuti says that Abbott has interpreted the FDA to mean that the act of applying before the August 14, 2001 will ensure that Synthroid remains available on the market with no interruption. Says Pizzuti, "We are working directly with the FDA to clarify exactly what to do to keep it on the market."
While the initial Federal Register notice threatens "regulatory action" against any unapproved products being marketed after the deadline, in a letter dated April 26, 2000 to Synthroid manufacturer Knoll Pharmaceuticals, the FDA makes it clear that they viewed the August 14, 2001 deadline is a firm one, saying:
"The FDA denies Knoll's request to set a date by which NDAs must be submitted rather than approved...We believe the additional year the Agency is allowing for all sponsors to obtain NDA approval grants in substantial part Knoll's request for additional time to comply with the 1997 notice.
(To read the full letter, download the Portable Document Format (PDF) version at the FDA website:
http://www.fda.gov/ohrms/dockets/dailys/00/may00/050400/pav0001.pdf)
More recent verbal statements by the FDA have been more vague, however, and this ambiguity leaves open the question of whether the deadline will be interpreted as applying to approval and not application, and whether an unapproved Synthroid product will be pulled off the market by the FDA in August until such time as FDA approval is granted. The FDA's letter indicating that the deadline will not be extended also calls into question Abbott's ability to legally demonstrate that Watson's assertions that "Synthroid will be unavailable in the near future" are false, as Abbott maintains.
Tim Fuller, Executive Director of the Gray Panthers, has said in a press release in May, "The FDA clearly stated that a New Drug Application for Synthroid must be approved by August, not just submitted. We should not allow Abbott to ignore the law for its own convenience while patient safety is at risk, especially since safe, effective, and approved alternatives are available.''
The Gray Panthers have targeted Abbott in a consumer and patient advocacy effort against companies it perceives to be engaged in anti-competitive or anti-consumer behavior.
In response to the news regarding the Abbott lawsuit against Watson, Fuller had this comment: "I can't imagine why it is that one company would restrain the other company from telling the truth. There's nothing I've heard or read from any side that been unclear."
It's likely that the battle over FDA approval for Synthroid will be a hot topic at next week's Endocrine Society annual meeting, Endo 2001, taking place from June 20-23, 2001 in Denver. According to preliminary exhibitor lists, the manufacturers of Synthroid, Levoxyl and Unithroid all will have booths at the event. It was just announced on June 13, 2001 that Gray Panthers will also have a booth at Endo 2001, to represent consumers, speak to the issues raised by the FDA's denial of GRAS/E status, pass out the FDA letter and other relevant information, and answer questions regarding the levothyroxine controversy.
In addition, the Gray Panthers have just announced that on June 21, 2001, they will be sponsoring the Gray Panther's Town Hall meeting at the Hyatt Regency Denver, 1750 Welton Street, near the Convention Center. This meeting, open to the public, will be held in the Mount Elbert Room, from 2 p.m. to 4 p.m. Titled "Synthroid: Addressing consumer concerns about safety and efficacy," the panel discussion, which will be moderated by Tim Fuller, is inviting representatives from the various drug companies to speak to the issues that have been raised by the FDA regarding levothyroxine drugs and Synthroid.
Above all, the question on most patients' minds is what will happen to Synthroid after the August 14, 2001 deadline. Watson's Funsten doesn't know. When asked whether he thought the FDA would allow Synthroid to continue to be sold, he said: "As to what reason there would be to allow an unapproved product to stay on the market, I can't speculate."
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