Friday, March 17, 2006

Are You Experienced?

Timeline and Milestones in Planned Parenthood/Washington State Pharmacy Association/Barr Laboratories Partnership and Drug Distribution Plan

Program for Appropriate Technology (PATH), PPWW and other public health agencies form Northwest Emergency Contraception Coalition (NECC).*see link below (page i)

Women's Capital Corporation, a privately help company is organized to bring Plan B to market. Five Planned Parenthood affiliates make equity investments in WCC, including Planned Parenthood of Western Washington (PPWW).

July 1997 – A pharmacist particpant at a NECC meeting pitches the idea of helping NECC to promote Emergency Contraception (EC) through collaborative practice legislation. Planning begins on The Emergency Contraception Collaborative Agreement Pilot Project (ECCAPP). The Project’s goal is to introduce and market Plan B through pharmacies and test the drug on women in Washington state.

The Washington State Pharmacists Association (WSPA) board of directors is reluctant to take on the Project. WSPA is shown data showing that almost half of the 56,000 unintended pregnancies in Washington State resulted in induced abortions. (Source for this data is not provided.)* (page i)

In a stroke of brilliance and insight the WSPA decides after reviewing the data that partnering with the state’s largest abortion chain to distribute an abortafacient drug and refer potentially pregnant women to the chain’s abortion centers would be a good way to help decrease the number of abortions in the state.* (see page i).

Several large, important and prominent groups filled with highly educated people sign off on the Project or agree to be part of the project advisory committee:
Washington State Trial Lawyers Association
Washington State Medical Association House of Delegates
Largest malpractice insurer in Washington
University of Washington School of Pharmacy
Various professional, legal, and state and county health organizations

Some members of the Washington state legislatures are also asked to serve on the committee.

Interestingly enough, parents, pharmacy patrons, child protective groups, parent groups, civic organizations, youth group counselors, school officials of schools near prescribing pharmacies, sexual predator watch groups, and abstinence educators are not asked about the Project nor asked to serve on the advisory committee.

Pilot Project is launched.

Training program for pharmacists is launched. Planned Parenthood and other ECCAPP members help craft training materials.

To increase pharmacist participation, low-cost training is offered to pharmacists on weekends and evenings. Pharmacists are taught how to facilitate parent-minor discussions regarding the child’s contraceptive use. Training program includes instructing pharmacists that they may not inform parents of minor children about their child’s use of the drug. Pharmacists are taught to refer patients out for further contraceptive and “family planning” services. Patients are given a list of “local physicians or clinics where they can be seen."* (page ii)

Advertising campaign is launched.

July 1998
Due to the Pilot Project’s aggressive marketing, advertising, and public awareness campaign, Plan B is now carried in 111 pharmacies in Washington State.

June 1999
The Pilot Project helps facilitate Collaborative Practice Agreements (CPA) by matching Planned Parenthood affiliates and state and local county health departments with pharmacists. Pharmacists are overwhelmed with willing collaborators. They are tickled and a bit amazed that they would get such a positive response.

The Project streamlines and simplifies the process for hooking-up pharmacists with their local Planned Parenthood or state government collaborator.* (page ii)

The WSPB institutes a fast-track review of EC collaborative practice agreement protocols that adhere to a protocol template designed by a "WSPB consultant (and collaborative agreement specialist.)"* (page ii and page 17)

143 pharmacists carry and prescribe Plan B.* (page iii)

July 1999
FDA approves sales of Plan B on July 28, 1999 and the Pilot Project ends. Planned Parenthood continues marketing and merchandising of Plan B through pharmacy visits and collaboration with schools of pharmacy and pharmacy trade groups to train pharmacists as "Certified ECP Providers."

January 2002 -- Scottish Council on Human Bio-ethics' "Briefing Paper on the Morning-After-Pill," is released showing that despite a sharp increase (almost 300%) in the number of EC prescriptions in Glasgow between 1992-1999, the abortion rate did not decline.

November 11, 2002 -- FDA Warning Letter to Women's Capital Corporation for ads that are "false, lacking in fair balance, or otherwise misleading in violation of the Federal Food, Drug, and Cosmetic Act (Act) and applicable implementing and print ads overstate efficacy, fail to convey important limitations on use, and minimize important information about risks associated with the use of Plan B..."

October 2003 -- Barr Laboratories submits a letter of intent to purchase WCC.

December 12, 2003
Barr Laboratories submits "Overview of Existing State Distribution Mechanisms and Barr's Proposed Educational Program and Distribution for Plan B." Includes sample "Collaborative Protocol Agreement" (CPA) for pharmacists prescribing Plan B that is amazingly similar to the one used by ECCAPP and Planned Parenthood.

Protocol recommends, among other things: referring patients out to "family planning clinics" no less than five times; administering Plan B as a first course of action in the case of sexual assault, then contacting CPS; referring patient to another ECP provider if ECP is not available; allowing for a patient to maintain a supply of ECPs at home. The Protocol mandates training to ensure pharmacists follow the above procedures and requires that the pharmacist have a "crisis plan if the pharmacy operations are disrupted by individuals opposing emergency contraception."The Protocol does not allow for the prescribing of pre-natal vitamins or the referral out to a crisis pregnancy center. Protocol does not allow for referral out to appropriate professionals who can help address any ambivalence a patient may be experiencing regarding a possible pregnancy. The protocol offers no guidelines for addressing coercive or abusive situations. Parents or guardians will not be notified when minors seek this drug. There are no provisions in the Protocol for a pharmacist to request a history of the patient's use of oral or other hormonal based contraceptives to consider whether Plan B may elevate her risk for breast cancer, blood clots, stroke, depression, heart attacks and Cervical dysplasia.

In order to mitigate legal risks to the manufacturer, identify pharmacists who become disillusioned with the CPA, don’t believe Plan B is helping patients, notice abuse of the drug, become concerned about health effects of Plan B, want to limit its use, or want to cease their CPA, pharmacists must meet with their prescriber quarterly.

No plan is made to track or study effects of Plan B on STD and abortion rates in Washington.

February 26, 2004
Barr Completes Acquisition of Women's Capital Corporation and Plan B Emergency Contraceptive. Barr agrees to pay a total of approximately $21 million, net of cash acquired, including approximately $9 million of assumed liabilities.

2004 California law suit reveals that Planned Parenthood cut a secret deal with Barr Laboratories that would enable the nation's largest abortion provider to make millions of dollars in profits selling Plan B kits.

July 2005
According to a July 29 press release by the Lyon, France-based International Agency for Research on Cancer (IARC), which is part of the World Health Organization (WHO) says that women increase their risk of breast, cervical and liver cancer if they use oral contraceptives Other recent studies show the greatest cancer risk is to young women, particularly teenagers, who use the pill. Planned Parenthood denies link or cause for concern.

Fissures develop in relationship between WSPA and PPWW. PPWW and NWWLC now attack pharmacists who refuse to fill prescriptions for Plan B as religious fanatics who are trying to impose their morality on others. Planned Parenthood Federation of America leans harder on the FDA and Bush Administration to approve over-the-counter sales, by-passing pharmacists altogether.

March 10, 2006
In meeting before the State Board of Pharmacy, Planned Parenthood fights against conscience clause for pharmacists in Washington and uses argument eerily similar to that surrounding demand for legal abortion saying EC must be given "on demand" with no restrictions.

Planned Parenthood says they now have 400+ pharmacies in the state of Washington who carry Plan B. State abortion lobby (WA-NARAL) speaks against conscience clause and in favor of drug alleged to reduce the need for abortion.

March 12, 2006
KING 5 "Up Front" program on conscience clause controversy quotes spokeswoman from local abortion clinic repeating undocumented allegation that Plan B reduces the abortion rate.

No spokesperson or expert available to explain why the abortion industry would be promoting a drug that supposedly reduces their primary source of revenue.

Standard CPA Protocol used to train pharmacists is almost an exact copy of the one put forward by Barr Laboratories and ECCAPP 8 years ago.

Mainstream media and major state newspapers completely clueless about any of the above, instinctively latch on the arguments put forward by PPWW.

March 14 – US Senate candidate Mike McGavick (R) refuses to comment publicly on the controversy affecting his state.

March 17, 2006 – Washington senator Patty Murray, along with NY senator Hilary Clinton, put pressure on Bush administration to approve OTC sales of Plan B. Threatens to hold up president’s new nominee to FDA.

Planned Parenthood continues to run ads in Washington state, which the FDA previously described as "false, lacking in fair balance, or otherwise misleading in violation of the Federal Food, Drug, and Cosmetic Act (Act)", for overstaing efficacy, failing to convey important limitations on use, and minimizing important information about risks associated with the use of Plan B.

*Pharmacist Prescribing of Emergency Contraception: The Washington State Experience

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