FETAL TISSUE RESEARCH

Recently, the National Institutes of Health (NIH) issued restrictions on obtaining research grants using “fetal tissue” in order to qualify for federal funding.

It is important to note that “fetal research” is generally research that is performed using living fetuses either inside the uterus (in utero) or outside the uterus (ex utero). However, fetal research can also include embryos, which is the earliest stages after fertilization of an ovum by a sperm. In addition, the techniques can be invasive and noninvasive. Most importantly, the outcome has resulted in improved techniques of both in-vitro fertilization and embryo transfer, as well as major advances in the diagnosis and treatment of conditions that threaten the survival of fetuses and pregnant women.

On the other hand, “fetal tissue research” involves cells that are removed from dead fetuses to establish, among other purposes, cell lines or for use as transplantation material. These fetal tissue are obtained from an abortion, either elective, induced or spontaneous (natural). When fetal cells are cultured, they grow and multiply in laboratory dishes. These cells are used to test the efficacy of a drug and whether it causes damage to genetic material or to test the impact of infection. Because the cells continue to grow and multiply, a small number of cells can result in a huge quantity and thereby used as a source of more cell lines or for transplants. “Fetal tissue transplantation” has been more controversial because of legal, ethical and social issues, including the ownership of embryos.

In the 1950’s, fetal tissue research and the use of fetal cell lines produced a major medical breakthrough, the development of polio vaccine.  However, the earliest known use of fetal cells for transplantation occurred when a group of physicians transplanted fetal brain cells into a patient with Parkinson’s disease, which is a progressive disease in which cells degenerate and die. Since that time, many of the human experiments have been done outside the United States, seeking to determine whether transplanting fetal cells can reduce the effects of, if not ultimately cure, a variety of diseases, as well as neurological and blood disorders, including diabetes.

These newest restrictions will require all applications and renewals of grants to perform research that involves tissue collected from elective abortions must provide a detailed justification, documenting why no alternative methods could accomplish the same goals.  In addition,  there must be documentary evidence each woman who is involved first gave permission for her aborted fetus to be donated for biomedical research. Furthermore, the restrictions prohibit graduate and postdoctoral students who receive NIH training funds from “proposing fetal tissue research.”

This subject  remains highly controversial.

Opinions are polarized and naturally emotional, they continue to focus on highly charged religious, ethical, legal and social grounds. Those scientists in favor of fewer restrictions on fetal tissue research claim their studies with mice implanted with tissue from aborted fetuses have proven results, helping to better understand certain diseases as well as to develop therapies for cancer, HIV,  Parkinson’s disease, and the Zika virus.

Opponents argue stem cell research will take place on foreign soil if the ability of scientists to obtain NIH funding is limited. Others contend fetal tissue still needs to be harvested since the only way to make a comparative presentation requires a scientist seeking an NIH grant to document the lack of effective alternative research methods.

DOCTOR’S DISCLOSURE ON PROBATION

On September 19, 2018, our former California Governor Brown approved Senate Bill No. 1448 into law. It is effective July 1, 2019.

Under the current laws, the Medical Board of California issues licenses to, as well as regulates and imposes discipline upon physicians and surgeons. Similarly, there is the Osteopathic Medical Board of California, State Board of Chiropractic Examiners,  Naturopathic Medicine Committee, Acupuncture Board, and the State Board of Chiropractic Examiners that also perform the same functions for their respective applicants and licensees.

Beginning July 1, 2019, and pursuant to Business and Professions Code Section 2228.1 et sec., each of the above professional licensees are required to disclose to each patient, their guardian or health care surrogate, before their first visit if they have been placed on probation on or after July 1, 2019, involving four(4) categories of misconduct, as follows:  criminal conviction involving harm to patients; sexual abuse, misconduct, or relations with a patient; drug or alcohol abuse causing harm to a patient or when such use impairs the ability to practice safely; and inappropriate prescribing that results in patient harm and having been placed on probation for five or more years

The disclosure must set forth the following: (1) the licensee’s probation status; (2) the length of time of the probation; (3) the end date of the probation; (4) all of the practice restrictions or limitations placed on the licensee by the State Agency;  (5) the Agency’s telephone number; and, set forth (6) how the patient can find further information regarding the probation on the Internet Web site

In addition, the respective licensees must obtain from each of their patients, or the patient’s guardian or health care surrogate, a separate and signed copy of the disclosure.

There are some exceptions, such as a situation in which a patient was not known to the doctor until immediately prior to the start of the visit, their guardian or health care surrogate, is unavailable, unconscious or unable to comprehend and sign the disclosure; the visit is unscheduled; occurs in an emergency room; an urgent care facility; and includes consultations in inpatient facilities.

This landmark new law commonly referred to the “Patient’s Right to Know Act” is the first in the nation to require doctors to tell their patients if they are on probation. It provides an additional means by which a patient can learn of their physician’s disciplinary record, if any.

Restrictions on State Agencies From Utilizing Convictions and False Statements

Effective July 1, 2020, AB 2138 becomes operative as law in California (approved and signed by the Governor 9/30/18), as follows:

Under current law, the licensing and regulation of various professionals and occupations fall within the Department of Consumer Affairs. These state agencies are empowered to take disciplinary action against a licensee, including to deny an applicant a license, or suspend and/or revoke an existing license or on various specified grounds, including but not limited to one having been convicted of a crime. However, they cannot take any such action in the case of a felony the defendant has obtained a certificate of rehabilitation, and/or the person has been convicted of a misdemeanor if (s)he has met the applicable agency requirements of rehabilitation.

In addition, each agency has been mandated to develop objective criteria to consider regarding a denial, suspension, or revocation of a license to determine whether a crime is substantially related to the qualifications, functions, or duties of the business or profession as well as the criteria to evaluate the rehabilitation of any such individual or business.

The above referenced new law places restrictions on a State Agency in denying, suspending or revoking a license to those cases in which the criminal conviction took place within the preceding seven (7) years from the date of application. Moreover, an individual cannot be denied a license based upon the underlying acts surrounding the conviction if the conviction was dismissed or expunged; the individual has provided evidence of rehabilitation; the person was granted a pardon or clemency; or if an arrest resulted in a disposition other than a conviction.

Current law gives a State Agency the authority to deny a license on the grounds that an applicant knowingly made a false statement of fact that is required to be revealed in the application for a license. However, the new law prohibits an agency from denying a license because of false statements made in an application solely on the failure to disclose a fact unless the disclosure of the fact itself would have been cause for denial of the license.

Some have opined this law should have been enacted long ago; and, it should have been made effective July 1, 2019 rather than 2020.

Important Choices To Preserve Humanity

President Harry Truman, on April 11, 1952, signed into law a bill that proclaimed the National Day of Prayer. Thereafter in 1988, President Ronald Reagan amended the law designating the first Thursday of May each year as the National Day of Prayer. While it is not a public holiday, there are countless prayer gatherings across the United States, many of which are non-denominational.  As we all know, these are troubling times when we read about or view news accounts of horrific crimes and mass killings, hate mongers, widespread and highly polarized dissension, along with an increasing number of individuals who can be classified as morally bankrupt and/or lawless, lacking integrity, respect and appreciation of others. The new reality has brought forward the adage (click this link), “If we see something, say something.

Nonetheless, all of us need to underscore the world is a magnificent place and people are basically good, even though there are exceptions which are often characterized as the new norm. Aside from what solid values, positive attitudes as well as divergent ideas, opinions and religious beliefs can bring to humanity, we need to have healthy relationships and strong support systems. We can make important choices to preserve humanity in today’s world,  and make all of our lives better.

Let us start by smiling (click this link), as when it comes from the heart, it can be priceless.  And, if you are not used to or feel comfortable smiling, try to think of a good reason to do so in a genuine way. The social value of a smile is that it shows we are likeable, happy and content. A smile is our gift to others, but most importantly (click this link), smiles are infectious for those in our surrounding to feel important, and appreciated. In addition, smiling can improve our own mood and, therefore, increase our positive thoughts and feelings.

Taking this one step further, we have all heard that “laughter is the best medicine.” And, studies have shown (click this link to read) how laughter can be powerful, referencing among other consequences, happier individuals live longer. In contrast to a “toxic” life filled with, among other emotions,  stress from negativity, exposure to violence, and/or loneliness,  positive thinking can produce a healthier and happier life.

Rabbi Dorsch of the Tifereth Israel Synagogue in San Diego was interviewed by KGTV Channel 10 News on Sunday, April 28, 2019 in response to the horrific killing at a local synagogue was quoted saying (click this link), “We have to give one another hugs and say we are not going to let this destroy us.” There has been a great deal written, considered highly effective and adopted by therapists that hugs have a synergistic effect (the whole is greater than the parts, or 2+2 =5 or 6), including the famous author and psychotherapist Virginia Satir, who is is a pioneer in the messaging value of hugs in family therapy and quoted in “10 Reasons Why We Need at Least 8 Hugs a Day” (click this link).

In conclusion, all of us can provide to others, and realize for ourselves, happiness, along with innumerable social and health benefits from a smile; and smiling can turn into laughter, which in and of itself is worth celebrating. Let’s not be part of the problem, but part of the solution, as we take each step today and forever. We can indeed make important choices in today’s world to preserve humanity, one person and one day at a time.

Exceptional Attorney and Essential

There may have been a point when one distinguished between exceptional and essential. Many individuals may have been content in utilizing a physician, dentist, accountant, and/or an attorney, perhaps as long as they were not inferior. However, is it any different in reading or watching the news, utilizing a barber or beautician, going out to dinner, or watching a movie? When the emphasis is on the desired result, it becomes essential to want a higher standard, receive value and choose exceptional as the significant keyword. In this regard, therefore, the number one criterion in selecting the people we retain (and the things we do), becomes very important; doing anything else, such as what may only be “o.k.” becomes tantamount to accepting mediocre and, at times and at best, this is superficial, inadequate, deficient and, even worse, useless and a waste of time.

Most of us want more, with the emphasis on an effective outcome. Yet, some will inevitably place a greater importance on the cost rather than the potential adverse outcome. In other words, they do not automatically ask “what do I have to lose, such as the priceless time I have, my professional career, credibility and/or personal integrity?” Therefore, with all of this in mind, many do not want “just o.k.” and, instead, focus on exceptional as the measurement for the individual with whom they choose to employ and, often, on the things they do with the time they have.

In selecting a lawyer, the same criteria can be critical. The website Avvo provides a profile on all of the attorneys in the United States. Then, one has the opportunity to decide whether (s)he wants an attorney who is exceptional, as well as knowledgeable, skilled and highly experienced, particularly with a proven and written record of ongoing favorable results. For example, it might not at the outset seem as important in choosing a contractor, until one first looks at testimonials to determine whether there are others who have spent their savings or mortgaged their home, only to then experience their contractor departed from the plans and specifications, delayed at great length on the work and/or did not actually complete the project.

In the practice of law, it can be critical the attorney does more rather than less. It is essential in order to diminish the risk or not gamble on the outcome. Hence, in choosing a lawyer, it is recommended you evaluate the advantages of a comprehensive scope in the work to be performed involving, among other things, indispensable steps, such as a risk assessment; an exhaustive factual and legal analysis; focused research; essential strategizing; and utilizing credible experts to evaluate and provide an opinion integrated into an optimum forensic report concerning such issues, including those directly or indirectly, related to the standard of care, prudence, judgment, lawfulness, moral turpitude, competency, etc.

In summary, what some may have previously thought were unnecessary because they did not think they  required selecting an attorney who is exceptional, now are considering the above issues as very important criteria and, therefore, essential characteristics in choosing the best lawyer (and the things they do).

The Future of Healthcare Technologies and Interoperability

The U.S. Department of Health and Human Services (HHS) has recently proposed new Rules in which the concept of INTEROPERABILITY will [continue to] increase the positive impact on our health system in general, and our own health care in particular, by utilizing electronic devices.

What does Interoperability mean? I will summarize it being a process by which different information systems using electronic devices &/or applications produce a resource that can optimally connect and use health data in a coordinated manner for the direct benefit of all of us, including health care providers.  Basically, it becomes the optimal method for diagnoses, tests and other data regarding each of our own health records to be shared for providers to appropriately know, assess and evaluate these facts to better treat any current and/or future patient medical issues. Clearly, these ongoing technological innovations will optimize the health and welfare of our population as a whole, and allow each of us to benefit by having access as well.

HHS Secretary Alex Azar declared: “These proposed rules strive to bring the nation’s healthcare system one step closer to a point where patients and clinicians have the access they need to all of a patient’s health information, helping them in making better choices about care and treatment.” For us, the advantage is a highly efficient system in which we will have access to all of our medical records, and eventually the processes to also assist in interpreting the data, thereby improving our health care.

Also, the proposed Rules will require healthcare providers to implement technologies to ensure patients have easy access to their information, along with the information being easily shared by other plans and providers with whom patients obtain follow-up healthcare, thereby preventing unnecessary and/or redundant procedures and testing….”giving clinicians the time to focus on improving care coordination and, ultimately, health outcomes,” as well as patients having “the tools to shop for and coordinate their own health care.”

Nearly everyone has heard of the iPhone, iPad, Mac Computers, iTunes, iCloud, etc.  Coinciding with the above technologies, Apple has also participated in the transformation of healthcare by developing its own Applications (Apps) for the operating systems in their iPhones and Apple Watch; you can view the online video when you click this Application link and then scroll down to “Watch the Video.”

New California Law: Use and Abuse of Drugs

Effective January 1, 2019, Business and Professions Code Section 740 became new California law (Assembly Bill  2760 was signed by then Governor Brown on September 10, 2018) requiring those who prescribe medication to be more vigilant of patients who have an increased risk of substance abuse.

A prescriber is now required to provide education to a patient for overdose prevention, as well as the use of Naloxone Hydrochloride (commonly referred to as Narcan, which is available in generic form, is an opioid antagonist used for the reversal of opioid overdose, including respiratory depression. Narcan is also used for diagnosis of suspected or known acute opioid overdose) or a comparable drug approved by the United States Food and Drug Administration [FDA].

Business & Professions Code section 740 specifies the applicable criteria as the following:

  1. the prescription dosage for a patient is 90 or more morphine milligram equivalents of an opioid medication per day; and/or
  2. an opioid medication is prescribed concurrently with a prescription for benzodiazepine; and/or
  3. a patient has the indications of an increased risk for overdose.

Section 741(a)(1)(C) offers the following examples that indicate an” increased risk of overdose,” including but not limited to:

  1. a patient with a history of overdose;
  2. a patient with a history of substance use disorder; or
  3. a patient at risk for returning to a high dose of opioid medication to which the patient is no longer tolerant

Business & Professions Code section 742 states that a prescriber who fails to abide by the prescription or education requirements shall be referred to the appropriate state licensing board for the disciplinary action. Notably, the focus of Spital and Associates is on representing those who have a professional license in California, whether in the investigative stage or written and published Accusation, such as one filed by the Medical Board of California.

All opiates come from the poppy plant. Opioids have a similar effect to an opiate, but are often synthetic or partially synthetic. Both opiates and opioids are classified by the U.S. Drug Enforcement Agency as Schedule II drugs, which are considered acceptable for certain medical purposes, such as for relief of pain, but are deemed highly addictive, including Dilaudid (hydromorphone), Demerol (meperidine), Dolophine (methadone), Duragesic or Sublimaze (fentanyl), morphine, opium, OxyContin and Percocet (oxycodone), Vicodin and other medications with hydrocodone, and various drugs with Codeine. On the other hand, Heroin, LSD, marijuana (cannabis) and Ecstasy are Schedule I drugs, and these are considered the most dangerous and have no acceptable medical or safe use.

There is no question but that acute and chronic pain are debilitating medical conditions. Approximately two (2) million individuals in the United States suffer from SUBSTANCE USE disorders related to prescription opioid pain relievers. It is noteworthy that prescription drugs are the “second” most commonly abused substances, alcohol being number one. The number of deaths from opioid pain relievers that have been prescribed by physicians represent more than the number of overdose deaths involving heroin or cocaine.

Some individuals are predisposed to develop problems as a result of using drugs because they have lower levels of self-control. Notwithstanding the above, there are others who become addicted because of one or more set of personality behaviors when utilizing certain narcotics, even though lawfully prescribed by a physician.  It is hoped the mandate set forth above and a new law in California will result in a substantial decline in deaths and, of course, it will increase the nature and scope of effective and alternative modalities for pain management.

 

LINGUISTICS AND THE PRACTICE OF LAW

Linguistics is the study of language. It is reflected in everything we say and what we do. Essentially, it impacts how we communicate with others. In this regard, every word can have significance; many of which are like a double-edged sword, in which there can be two completely different meanings.

To be effective in the practice of law, one must truly understand the impact EACH word has, which includes knowing how and when to be concise instead of wordy; and, to know whether we are in fact, as well as how to be, convincing instead of unpersuasive.

There is a distinction between “effective” counsel and “competent” legal representation in that the latter is legal advice and counsel without errors, such as whether the advice and representation would result in the denial of a fair trial. This is often classified as malpractice or negligence. On the other hand, one may not have departed from the elementary standards applicable to the practice of law and, therefore, not be negligent. However, one can still be “ineffective” by failing to obtain a winning result. In the practice of law and to be effective, a lawyer should strive for superior advocacy; this should apply to how one drafts legal documents; presents oral and written arguments; drafts and finalizes written communications; as well as the basic dialogues we have with those with whom we know and/or those with whom we want to influence by producing a positive response, feeling, or opinion.

It is the “art of communications” to know what to say, how to say it, when to say it, and, where is it acceptable or beneficial to do so. Additionally, one needs to know when to say no more, if only to allow the other individual an opportunity to digest what has been said and to reply, if desired.

Here are some considerations to help illustrate the above:

  • Is the same writing style and techniques in sending or responding to texts satisfactory in writing a letter, greeting card, etc.?
  • Do you communicate the same when conferring with a loved one, family member and/or friend? Are there differences when applying for a job; writing an essay or term paper for school or college; or submitting written arguments to the adversary in a case; to an organization; an arbitrator; judge; and to an administrative agency?
  • The tone of our communications can have a different impact, perhaps one that is not intended at all. The way words are expressed can lead to different meanings. For example, stating “I love you” in an angry or sarcastic voice vs. gently and softly saying the words “I love you.” Can you “hear” the difference? Try saying the same words in a different tone and you will see the reaction [the former angry tone likely will cause  a baby to cry, out of fear].
  • What about language in politics, in newspapers and television broadcasts? Are they fair and balanced?
  • In addition, should one consider the source of the communication; the activity and context in which the communication is made; as well as the credibility of the speaker or writer?
  • When is it appropriate to make a complimentary remark in contrast to ignoring what others may say or do that truly is, or seems improper?

Whether through linguistics and/or superior advocacy, the goal of a lawyer is to evoke an acceptance of an argument or obtain support for his/her argument. It is fair to say, effective legal counsel utilizes a combination of compelling and cogent language with logic and reasoning. Essentially, this involves both the “art of communication (linguistics)” and the “art of negotiation.”

 

Canadian Government Legalizes Marijuana

On October 17, 2018, the Federal Government of Canada legalized cannabis. At best, this is a national experiment and controversial legislation. Clearly, the tax profits available to the Canadian government are enormous,  and the vast numbers of businesses devoted to the production, distribution and sales of marijuana seem boundless.  And, the question of health to adults and youth using cannabis continues to be in dispute.

The proliferation of businesses engaged in the promotion and marketing are restricted from using techniques and procedures to attract younger demographics, however, opponents contend this is a slippery slope in which  informational materials and brand marketing are sending a message to Canadians that marijuana is acceptable, perhaps confusing those who might otherwise have decided to not smoke cigarettes. And, there still remains doubt as to whether and to what extent one’s ability to safely operate equipment, machinery, and automobiles may be impaired.

While there are unanswered questions regarding the short and long term consequences of using marijuana,  many in the health profession continue to develop campaigns to alert the public as to the health and other risks associated with cannabis. Undoubtedly, this is a topic under consideration now and in the future by the representatives in the United States Government, and other countries.

Mandatory Patient Prescription Reporting Data Base

On July 1, 2016, Health and Safety Code Section 11165.1 required all designated California licensed professionals who are authorized to prescribe, order, administer and/or furnish Schedule II, III and IV controlled substances to register, on a database that is commonly referred to as CURES 2.0,  the Controlled Substance Utilization Review and Evaluation System. CURES is the prescription drug monitoring program mandated in California. Practitioners can access tips and  Registration pointers as well. Other critical and substantive information is available in the form of a Practitioner’s Manual.

Effective October 2, 2018, it is mandatory for Physicians (MD); Osteopathic Doctors (DO); Dentists (DDS); Podiatrists (DPM); Naturopathic Physicians (NP);  Physician Assistants (PA); Optometrists (OD); Nurse Practitioners (NP); Nurse Midwives (either CNM and/or CM); and Veterinarians (DVM) to consult CURES prior to performing any of the above services. After the initial consultation and at least once every four months thereafter, each of these practitioners must consult Cures 2.0  if the controlled substance continues to be part of the respective patient’s treatment. It is noteworthy that the CURES data collection vendor has published data submission instructions. The consultation requirement as such is inapplicable to Pharmacists (RPh); however, as other dispensing practitioners are obligated to monitor prescriptions of controlled substances, Pharmacists are also required to report on a weekly basis information regarding Schedule II, III and IV controlled substances being dispensed. The applicable Health and Safety Code, however, sets forth limited and designated exemptions.

It is noteworthy that a patient can obtain his or her CURES prescription history through the IPA, commonly referred to as the Information Practices Act. Each Patient Activity Report contains the following record: the patient’s name; date of birth; address; name of the prescriber and DEA number; name and license number of the pharmacy; date the prescription was filled; prescription number; drug name, drug form, drug quantity and strength; number of days of the supply, and each refill number. One may obtain the IPA Request form by contacting the CURES Help Desk.

The goal of Cures 2.0 is to ensure patient safety. Additionally, each particular licensing agency has access to the IPA information to regulate those whom they issue a professional license to ensure they follow the law and maintain proper standards and practices. Spital and Associates is an award winning law firm that provides legal advice and representation in investigations and disciplinary actions brought against individuals and entities that wish to obtain or currently have a professional and occupational license in California.

Ratings and Reviews