Month: November 2005

Merck Wants a New Drug – Vioxx, Zocor, Gardasil and Cancer

By Michael Dorausch, D.C.

Google News headlines today read… “Merck cutbacks: 7,000 jobs, 5 plants” spurred by an announcement made by Merck yesterday.

According to various news articles, Merck, the world’s third-largest drugmaker, will be closing 5 plants in the wake of 6,400 lawsuits that have been filed related to problems with drugs they manufacture. Merck is the maker of Vioxx and Zocor.

According to one article, Merck has set aside $675 million for legal bills related to Vioxx, but nothing for liability. Wall Street analysts are projecting liability costs at between $5 billion and $30 billion.

Merck is moving forward and focusing on the furutre. According to the former head of Mercks manufacturing operations, the company is looking for ways to “improve the way we discover, develop, manufacture and market our medicines and vaccines and ensure that we get them to patients who need them as quickly, safely and efficiently as possible.”

According to some articles, one of Mercks products in the pipeline is a cervical-cancer and genital wart vaccine called Gardasil. Interesting that is being touted in the press as a cancer vaccine since the information I found states it is a Human Papilloma Virus (HPV) vaccine. Cancer sounds more alarming than HPV, don’t you think?

According to a medical news website recently publishing a report on the Gardasil vaccine, “it is estimated that approximately 20 million American men and women are infected with HPV. In most people, HPV appears to go away on its own. In some, the virus has been linked to cervical cancer, abnormal pap tests and genital warts.”

There are four known types of Human Papilloma Virus, HPV 6, 11, 16, and 18. In the medical review, the senior director of Clinical Research at Merck Research Laboratories states, “HPV types 6 or 11 are not linked to cervical cancer, but they can cause abnormal Pap smears, which then lead to additional tests – and unnecessary worries about cancer.”

Here is how I see it…
Approximately twenty million American men and women = Potential $$$ for Merck
When the marketing hits I bet there will be lots of talk of cancer and ugly, painful genital warts. There will be lots of ads with people that look just like you and me. There will not be any mention (or little if any) that HPV appears to go away on its own. Remember, it is not a cancer vaccine, it is a virus vaccine. At this time it is investigational, meaning it is still undergoing clinical studies. Let’s wait and see what the marketing says. My bet is that it will be that the marketing will up play the cancer and down play the “goes away on its own” part.

Seattletimes: Merck cutbacks: 7,000 jobs, 5 plants
Newsday: Merck to cut 7,000 jobs
Seattlepi: Drug maker to cut 7,000 jobs
Medical News Today: Gardasil HPV Vaccine Reduced Infection and Disease in New Clinical Study

Some interesting chiropractic comparisons to make…
Merck & Co. has been in business for 114 years, established in 1891. Chiropractors have been in business for 110 years, established in 1895.
Merck has nearly 63,000 employees. There are approximately 63,000 licensed chiropractors practicing in the United States.

planetc1.com-news @ 1:09 pm | Article ID: 1133287761

Steroid Awareness Campaign Launched in New Jersey

By Victor Naumov, D.C.

(New Milford, NJ) – The NCADFA will launch their CHOOSE NOT TO USETM steroid awareness campaign the week of November 27 through December 3, 2005 in support of Acting New Jersey Governor Richard Codey’s proclamation of Steroid Awareness Week. The goal of the campaign is to bring awareness and attention to the issue of performance enhancing drug use in sports. Our goal is to encourage athletes to strive to become “true champions” by choosing not to use drugs of any kind. We feel awareness is the first step in the prevention process.

The NCADFA is offering Steroid Awareness Wristbands (are made of high quality 100% silicone) “exclusively” on our website www.NCADFA.org. The wristbands are $2.00 each; as a tax deductible donation. Money raised will go to help support future NCADFA outreach and awareness campaigns. The bands are imprinted with the NCADFA’s trademark slogan; Choose NOT to UseTM (on one side) and www.NCADFA.org (on the other side). The bands are individually packaged, black and yellow color (swirled), one size fits all.

The National Coalition for the Advancement of Drug Free Athletics, Inc. (NCADFA) was formed in 2004 to help fight the use of performance enhancing drugs and recreational drug abuse among athletes. We believe that all kids, athletes or not, feed-off of one another. The decisions they make are based largely on “what other kids” are doing. We want our CHOOSE NOT TO USETM message to be a contagious one, and the first step towards prevention. Please visit our website, www.NCADFA.org for more information.

planetc1.com-news @ 12:25 am | Article ID: 1132723558

Chiropractors Can Help Support Drug-Free Athletes

By Victor Naumov, D.C.

New Milford, NJ – Chiropractors, help us fight addiction. With your purchase of a bracelet/wristband you will be helping support the advancement of drug-free athletes across the country. Your donation will be helping athletes of all ages and levels take a stand against the use and abuse of performance enhancing drugs.

The NATIONAL COALITION FOR THE ADVANCEMENT OF DRUG-FREE ATHLETICS, INC. is a New Jersey based, 501(c)(3) non-profit organization. We are proud to introduce our new, Choose NOT to UseTM Campaign set for the week of November 27 through December 3, 2005. The purpose of this campaign is to bring awareness and attention to the issue of performance enhancing drug use in sports. Our goal is to encourage athletes to strive to become “true champions” by choosing not to use drugs of any kind. We feel awareness is the first step in the prevention process.

The mission of the NCADFA is to support the advancement of drug-free athletes at the national level through the development of educational community out-reach, public service, leadership, and drug awareness programs.

Please help us continue to support the advancement of drug-free athletes. All donations are tax deductible as charitable contributions. 100% of the proceeds will go to help raise awareness about this risk and dangers associated with the use of performance enhancing drugs.

We are currently offering these very popular awareness wristbands available “exclusively” on our website. They are made of high quality 100% silicone. The wristbands are imprinted with the NCADFA’s slogan; Choose NOT to UseTM (on one side) and www.NCADFA.org (on the other side). Individually packaged, black and yellow color (swirled), one size fits all.

The wristbands are $2.00 each.

They are fun to wear and trade and really do help a good cause! We hope you will consider buying one or more of the bracelets for yourself, friends and family! Any one who helps an athlete succeed naturally is a CHAMPION in our eyes!

The NCADFA thanks you for your support!

National Coalition for the Advancement of Drug-Free Athletics, Inc.
P.O. Box 206
New Milford, New Jersey
07646

Tel: 201-265-8688

Website: www.NCADFA.org

planetc1.com-news @ 12:22 am | Article ID: 1132723379

CCE Cited for Violations by U.S. Dept of Education

By Thomas J. Sidoti, D.C.

CCE Cited For Accreditation Violations By U.S. Department of Education
New Jersey and DECE Complaints Spur Two Year Investigation

The United States Department of Education (USDOE) has found the Council on Chiropractic Education (CCE) in violation of criteria necessary to maintain its status as a recognized accrediting agency. The violations were uncovered during a two year investigation initiated by separate complaints filed during 2003 by the Council of New Jersey Chiropractors (CNJC) and Doctors for Excellence in Chiropractic Education (DECE). In a July 5, 2005 letter, the USDOE found CCE in non-compliance of various accreditation criteria, some of which require immediate action.

The complaints centered on the circumstances and appropriateness of CCE’s June 10, 2002 decision to revoke the accreditation of Life University College of Chiropractic (Life). Under the leadership of Founder and President, Sid E. Williams, D.C., Life had become the largest and most successful chiropractic institution in the world. After CCE revoked its accreditation, thousands of its chiropractic students were forced to abruptly uproot themselves and their families and finish their chiropractic education at other institutions. The resulting sudden loss of tuition revenue caused Life to teeter on the brink of insolvency, requiring that it sell some of its property, dismiss many of its faculty, and dismantle its unique championship sports programs.

Upon exhausting CCE’s appeal process, Life filed a lawsuit and requested a preliminary injunction to regain its accreditation in Federal Court. The defendants named in the lawsuit included CCE and Paul D. Walker, CCE’s then Executive Director. On February 10, 2003 the Court granted Life’s motion for injunctive relief and ordered CCE to restore Life’s accreditation.

THE FEDERAL COURT RULING

In rendering its decision ordering CCE to immediately restore Life’s accreditation, and in explaining its rationale for Life’s likelihood of winning its lawsuit against CCE, the Federal Court ruled in part:

.as to Plaintiff’s (Life) likelihood of success, the Court finds that Plaintiff has demonstrated that it is substantially likely to succeed on the merits for the following reasons: Although decisions of accrediting agencies have historically been given deference, where, as here, accreditation decisions are made by actors with a financial interest in the outcome, little deference should be given. Here, there were admitted conflicting economic financial interests in the decisions that were made. That fact is shown by the recruitment of Life students, after the June 2002 decision, by competitors whose representatives were involved in the decisionmaking on accreditation; an attempt by a competitor whose representative was one of the decisionmakers to buy Life University after its accreditation was withdrawn, at a time when the monetary value of Life University had been reduced by the accreditation decision; the fact that persons with competing financial interests to those of Life University made the accreditation decisions on Life University; the fact that the elimination of Life University as a chiropractic college would increase the number of students and money available to those competitors; that an aggressive group of leaders of the eight liberal chiropractic schools, who had only one-third of the chiropractic students, had undertaken a series of corporate manipulations in order to reduce the representation and dominance of the eight conservative chiropractic schools (of which Life University was one), who had approximately two-thirds of all chiropractic students; that these corporate manipulations, which may very well have violated CCE’s corporate charter, were calculated to give dominance to the liberal minority group over the conservative majority group; that the end result has been the disaccreditation of the largest of all the colleges of chiropractic and the turning loose of hundreds, perhaps thousands, of students to be attracted to the other schools. Actions which would violate the antitrust laws if incorporated in an accreditation procedure, per se, indicate a lack of due process.

COMPLAINT TO CCE

In a letter dated March 24, 2003, CNJC submitted a formal complaint to CCE requesting information concerning compliance with various USDOE accreditation requirements. Included in the complaint were allegations that CCE did not comply with USDOE regulations concerning separate and independent criteria for accrediting agencies and conflicts of interest of its board members involved in the Life accreditation decision. The complaint also requested a list of the names and professional qualifications of CCE’s policy and decision-making bodies.

THE CCE RESPONSE

Rather than properly address the complaint, Paul D. Walker, CCE Executive Vice President, officially responded to CNJC in a rambling, evasive April 8, 2003 letter stating:

.the information presented in your correspondence is somewhat ambiguous with regard to the CCE complaint process. In brief, the information seems not open to the stated Informal Process because you have requested that your complaint be addressed through the Formal Process. However, your material does not meet the requirements of the requested process because it does not cite specific violations of any CCE Bylaws, Policies, or Standards and it does not provide a summary of the actions taken and outcomes of an effort to resolve your complaint at the informal level. .Consequently, your correspondence does not enable the action you have requested.

In concluding his letter, Walker advised the CNJC to address its issues to the office of the proper governmental entity.

COMPLAINTS TO USDOE

Lacking other recourse, CNJC heeded Walker’s advice and submitted its complaint directly to the USDOE on April 30, 2003. Included in its complaint was the original letter to CCE and Walker’s letter in response. On November 20, 2003, DECE filed an additional complaint against CCE also alleging various USDOE violations.

THE USDOE FINDINGS

After lengthy investigation, and correspondence with CCE, the USDOE has now concluded its review of the two complaints. In a July 5, 2005 letter, the USDOE informed CCE of the following:

1. With respect to the allegation that CCE did not comply with specific USDOE criteria concerning conflicts of interest of CCE board members, the USDOE found as follows:

The agency is not in compliance with this criterion. CCE apparently has never directly responded to the allegation of conflicts of interest by its members, commissioners, and evaluation team members despite having received a letter of complaint from CNJC on March 24, 2003. Although the agency identifies policies designed to prevent conflicts of interest, it has apparently not investigated this allegation to determine if violations of its policies took place. In the absence of such an investigation, Department staff must conclude that either CCE does not have clear and effective controls against conflict of interest or has failed to implement such controls where appropriate.

With regard to the DECE allegation, staff is concerned that continuing discrepancies between CCE internal policy documents may compromise the agency’s ability to effectively carry out its accreditation activities.

The CCE needs to review its internal policy documents for discrepancies and take corrective action to correct all discrepancies. The agency also needs to investigate the allegation of conflicts of interest by its members, commissioners, and evaluation team members in its review of LUCC (Life).

2. With respect to the allegation that CCE did not comply with criteria requiring disclosure of the names and professional qualifications of CCE’s decision-making bodies, and in specifically addressing Walker’s response to the CNJC refusing to address their complaints, the USDOE found as follows:

The agency is not in compliance with this criterion. CCE did not fully provide, as requested in a letter dated April 8, 2003, a list of the names, academic and professional qualifications, and employment and organizational affiliations of its policy and decision-making bodies and its administrative staff. In addition, pursuant to this same letter, CCE did not review itself in a timely and fair manner, and apply unbiased judgment to, a complaint against itself. There are no provisions within 602.23(c)(3) that would exempt an agency from responding either to a complaint that lacks particular formatting or that fails to cite specific violations of agency bylaws, policies or standards.

The agency needs to revise its complaint policy and procedures to ensure that they cannot be used to impede but rather support a thorough and balanced review of the agency itself as well as its accredited institutions.

3. With respect to the allegation that CCE did not comply with specific USDOE mandated separate and independent criteria for accrediting agencies, the USDOE found as follows:

The agency is not in compliance with this criterion. This criterion applies exclusively to the mechanism by which members of an accrediting agency’s decision making body are elected or selected. In the case of CCE, members of the Commission on Accreditation are elected by the CCE Board of Directors. Since members of the Board of Directors may not also serve as officers or board members of affiliated trade associations such as FCLB, there is no possibility that the FCLB president or board can elect members of the Commission on Accreditation in violation of this criterion. However, the same restriction does not apply to the Association of Chiropractic Colleges, whose officers apparently may serve on the Board of Directors, and therefore be in a position to elect members of the Commission on Accreditation.

The CCE needs to revise its policies pertaining to the election of its commissioners such that the CCE Board of Directors cannot serve as officers or board members of any related, associated, or affiliated trade association or membership organization to include the Association of Chiropractic Colleges.

4. The USDOE concluded its letter to CCE by stating:

For those findings for which your agency has been found to be in noncompliance with the Criteria, we request that you take immediate steps to correct the violations identified. Please forward to us by October 17, 2005 your plan of corrective action to include timelines for completion of such actions. A follow-on report of your agency’s corrective actions will be requested.

THE FALLOUT

The fact that the CCE has been found in violation of so many major accrediting criteria has been characterized as a major embarrassment and “another black eye” for the entire chiropractic profession. The findings of the USDOE, many of which mirror those of the federal court, appears to support the prevalent perception that CCE’s decision to revoke Life’s accreditation was based on political objectives and had little to do with the quality of its chiropractic program. Indeed, both the USDOE and the Federal Court’s findings either fault the CCE for apparent financial conflicts of interest, or cite failures to implement controls to prevent conflicts of interest. The Federal Court even speculated that CCE may have violated anti-trust laws.

The USDOE finding that, “continuing discrepancies between CCE internal policy documents may compromise the agency’s ability to effectively carry out its accreditation activities” is now sounding warning alarms throughout the profession. Violations of the USDOE criteria, particularly pertaining to its revocation of Life’s accreditation, may now have placed CCE in serious jeopardy of losing its own status as a recognized accrediting agency. Because many state licensing boards require that candidates for licensure be graduates of CCE accredited colleges, and USDOE recognition of an accrediting agency is required for many student loans, the ramifications to the chiropractic profession of CCE possibly losing its accreditation are enormous.

LICENSING BOARDS UNDER PRESSURE

While some states never mandated that candidates for licensure be graduates of CCE approved schools, many states have statutes or regulations requiring the schools of their candidates retain CCE approval. After the Federal Court detailed the multitude of reasons it ordered CCE to restore Life’s accreditation, some state licensing boards began questioning CCE’s integrity and the wisdom of their mandatory CCE requirement. Nevada was the first state to have the foresight to change its licensure requirements to include specific waivers to its CCE requirement. The USDOE findings will in all likelihood put tremendous pressure on other licensing boards to follow Nevada’s lead and insert waivers into their own CCE requirement language. Such waivers will be a necessary safeguard in the event the USDOE revokes CCE’s accreditation.

RENEWED CALLS FOR A SECOND ACCREDITING AGENCY

After years of relative stability, CCE’s failure to adhere to basic USDOE regulations has justifiably renewed calls for a second chiropractic accrediting agency. Rationale for a second accrediting agency ranges from both the necessity of the chiropractic profession to have a legitimate back-up agency in the event CCE loses its accreditation, to ensuring that future accreditation decisions are not politically motivated. The USDOE has indicated that the chiropractic profession is not constrained to a single accrediting agency, and it will entertain all applications for additional chiropractic accrediting agencies.

INDEPENDENT REVIEW OF CCE’S ACTIONS

According to the USDOE, CCE has apparently never directly responded to the allegation of conflicts of interest, as a result it has now ordered CCE “to investigate the allegation of conflicts of interest by its members, commissioners, and evaluation team members in review of LUCC (Life).” Based on its prior conduct, an open question is whether CCE is capable of objectively investigating itself. It appears that despite the 2003 Federal Court ruling, and complaints by DECE and CNJC, CCE has yet to investigate or fully acknowledge the allegations detailed in the Court ruling. As more chiropractors and chiropractic organizations learn of the USDOE violations, calls for an independent review of CCE’s actions appear to be gaining momentum. Many believe that an objective review of all concerns raised by both the Court and the USDOE be performed by an objective outside agency unrelated to the chiropractic profession. Such a review may be the only way to restore credibility to the CCE and the entire chiropractic profession.

CONCLUSION – A LINE IN THE SAND

If the chiropractic profession is to be viewed as a respected and credible member of the health care community, the agencies that govern it must be beyond reproach. When a court grants an injunction based on conflicts of interest, reversing the decision of the chiropractic’s sole accrediting agency, the profession’s credibility suffers. When the same agency refuses to answer proper complaints from the profession it serves, credibility erodes further. When that agency is finally found in violation of its own accreditation criteria, credibility becomes non-existent.

Has the chiropractic profession matured enough to put politics aside and demand accountability when warranted? Should actions gravely detrimental to the credibility of the entire profession go unchecked, or should calls for an independent review be heeded? The profession has reached yet another crossroad, we can take the road of denial and dismiss the court ruling and USDOE violations as trivial, or we can take the road of responsibility and demand accountability. The profession must take a good hard look at itself and draw a line in the sand. We can either stand on the side of corruption and political agendas, or the side of integrity and honesty, the decision is ours.

******
Dr. Tom Sidoti is a 1984 graduate of Life Chiropractic College and maintains a family practice in Passaic, NJ. He currently serves on the Board of Directors of both the regional Council of NJ Chiropractors (CNJC) and statewide Association of NJ Chiropractors (ANJC). Dr. Sidoti was recently instrumental in helping develop the unique structure that allowed six disparate NJ chiropractic groups to come together and function as a single unified organization.

Dr. Sidoti is a former Vice President of the NJ State Board of Chiropractic Examiners, and served as chairman of its Rules and Regulations Committee. During his term he was selected as one of NJ’s representatives to the Federation of Chiropractic Licensing Boards (FCLB), and was also selected by the National Board of Chiropractic Examiners (NBCE) to help write one of its Part III National Board Examinations. Some of Dr. Sidoti’s accomplishments include Life University “Alumnus of the Year” and CNJC “Chiropractor of the Year.”

planetc1.com-news @ 10:34 am | Article ID: 1132673679

NSAIDs & Antibiotics Increasing Risk of Non-Hodgkin’s Lymphoma

By Michael Dorausch, D.C.

Some of todays news briefs regarding NSAIDS or non-steroidal anti-inflammatory drugs…

A study recently published in the American Journal of Epidemiology found that using antibiotics more than 10 times during childhood or being a heavy user of non-steroidal anti-inflammatory drugs (NSAIDs) increases the risk of developing non-Hodgkin’s lymphoma (NHL).

While, according to the study, there was a strong association between antibiotic use and NHL, heavy NSAID use increased the overall risk of NHL.

Study shows people unaware of harmful effects of painkillers

According to a study, an alarming number of people are ignorant to the potential side effects of non-steroidal anti-inflammatory drugs (NSAIDs). The study found that both over-the-counter and prescription painkillers are often used inappropriately. The study is published in the November issue of the Journal of Rheumatology.

More than 50% of people involved in the study were not aware of the potential side effects of NSAID drugs. According to the study, more than 36 million people are taking NSAIDs, prescription and over-the-counter, and nearly 25% of those are exceeding the recommended dosage.

According to some estimates, the side effects of long-term NSAID use cause nearly 103,000 hospitalizations and 16,500 deaths per year.

Link: Study shows people unaware of harmful effects of painkillers
Link: Study shows people unaware of harmful effects of painkillers

Interestingly, children receiving regular chiropractic care are less likely to take antibiotics are also less likely to use non-steroidal anti-inflammatory drugs. Many adults receiving chiropractic care find they decrease their use of anti-inflammatories and NSAIDs as they correct the cause of the problem by utilizing chiropractic regularly rather than treating the symptoms with outside-in, dangerous drug use.

– – – – – – – – – –
Dr. Michael Dorausch maintains an active chiropractic practice in Los Angeles, California.
You can visit his website at: www.adiola.com

planetc1.com-news @ 4:22 pm | Article ID: 1132608129