Editor’s note: A recording of the event is embedded below.

Several biosimilar versions of Humira, which for years has been the world’s best-selling medicine, entered the U.S. market over the past year. What has that meant for insurance coverage and the way drugmakers are marketing these medicines? Join leading experts to discuss the impact on the industry and patients.

Sponsor introduction

• Thomas Newcomer, vice president and head of U.S. market access, Samsung Bioepis (sponsor)

Featured speakers

• Chris M. Brown, president, McAteer
• Michael Gonzales, independent health care consultant, Michael Gonzales, LLC; former national and regional account director, AbbVie
• Fran Gregory, MBA, PharmD, vice president of emerging therapies, Cardinal Health
• Ed Silverman, Pharmalot columnist, senior writer, STAT (moderator)

Sponsored By

Jason Barton didn’t want to attend the Super Bowl parade this year. He told a co-worker the night before that he worried about a mass shooting. But it was Valentine’s Day, his wife is a Kansas City Chiefs superfan, and he couldn’t afford to take her to games since ticket prices soared after the team won the championship in 2020.

So Barton drove 50 miles from Osawatomie, Kansas, to downtown Kansas City, Missouri, with his wife, Bridget, her 13-year-old daughter, Gabriella, and Gabriella’s school friend. When they finally arrived home that night, they cleaned blood from Gabriella’s sneakers and found a bullet in Bridget’s backpack.

Gabriella’s legs were burned by sparks from a ricocheted bullet, Bridget was trampled while shielding Gabriella in the chaos, and Jason gave chest compressions to a man injured by gunfire. He believes it was Lyndell Mays, one of two men charged with second-degree felony murder.

“There’s never going to be a Valentine’s Day where I look back and I don’t think about it,” Gabriella said, “because that’s a day where we’re supposed to have fun and appreciate the people that we have.”

One month after the parade in which the U.S. public health crisis that is gun violence played out on live television, the Bartons are reeling from their role at its epicenter. They were just feet from 43-year-old Lisa Lopez-Galvan, who was killed. Twenty-four other people were injured. Although the Bartons aren’t included in that official victim number, they were traumatized, physically and emotionally, and pain permeates their lives: Bridget and Jason keep canceling plans to go out, opting instead to stay home together; Gabriella plans to join a boxing club instead of the dance team.

During this first month, Kansas City community leaders have weighed how to care for people caught in the bloody crossfire and how to divide more than $2 million donated to public funds for victims in the initial outpouring of grief.

The questions are far-reaching: How does a city compensate people for medical bills, recovery treatments, counseling, and lost wages? And what about those who have PTSD-like symptoms that could last years? How does a community identify and care for victims often overlooked in the first flush of reporting on a mass shooting: the injured?

The injured list could grow. Prosecutors and Kansas City police are mounting a legal case against four of the shooting suspects, and are encouraging additional victims to come forward.

“Specifically, we’re looking for individuals who suffered wounds from their trying to escape. A stampede occurred while people were trying to flee,” said Jackson County Prosecutor Jean Peters Baker. Anyone who “in the fleeing of this event that maybe fell down, you were trampled, you sprained an ankle, you broke a bone.”

Meanwhile, people who took charge of raising money and providing services to care for the injured are wrestling with who gets the money — and who doesn’t. Due to large donations from celebrities like Taylor Swift and Travis Kelce, some victims or their families will have access to hundreds of thousands of dollars for medical expenses. Other victims may simply have their counseling covered.

The overall economic cost of U.S. firearm injuries is estimated by a recent Harvard Medical School study at $557 billion annually. Most of that — 88% — represented quality-of-life losses among those injured by firearms and their families. The JAMA-published study found that each nonfatal firearm injury leads to roughly $30,000 in direct health care spending per survivor in the first year alone.

In the immediate aftermath of the shootings, as well-intentioned GoFundMe pages popped up to help victims, executives at United Way of Greater Kansas City gathered to devise a collective donation response. They came up with “three concentric circles of victims,” said Jessica Blubaugh, the United Way’s chief philanthropy officer, and launched the #KCStrong campaign.

“There were folks that were obviously directly impacted by gunfire. Then the next circle out is folks that were impacted, not necessarily by gunshots, but by physical impact. So maybe they were trampled and maybe they tore a ligament or something because they were running away,” Blubaugh said. “Then third is folks that were just adjacent and/or bystanders that have a lot of trauma from all of this.”

PTSD, Panic, and the Echo of Gunfire

Bridget Barton returned to Kansas City the day after the shooting to turn in the bullet she found in her backpack and to give a statement at police headquarters. Unbeknownst to her, Mayor Quinton Lucas and the police and fire chiefs had just finished a press conference outside the building. She was mobbed by the media assembled there — interviews that are now a blur.

“I don’t know how you guys do this every day,” she remembered telling a detective once she finally got inside.

The Bartons have been overwhelmed by well wishes from close friends and family as they navigate the trauma, almost to the point of exhaustion. Bridget took to social media to explain she wasn’t ignoring the messages, she’s just responding as she feels able — some days she can hardly look at her phone, she said.

A family friend bought new Barbie blankets for Gabriella and her friend after the ones they brought to the parade were lost or ruined. Bridget tried replacing the blankets herself at her local Walmart, but when she was bumped accidentally, it triggered a panic attack. She abandoned her cart and drove home.

“I’m trying to get my anxiety under control,” Bridget said.

That means therapy. Before the parade, she was already seeing a therapist and planning to begin eye movement desensitization and reprocessing, a form of therapy associated with treating post-traumatic stress disorder. Now the shooting is the first thing she wants to talk about in therapy.

Since Gabriella, an eighth grader, has returned to middle school, she has dealt with the compounding immaturity of adolescence: peers telling her to get over it, pointing finger guns at her, or even saying it should have been her who was shot. But her friends are checking on her and asking how she’s doing. She wishes more people would do the same for her friend, who took off running when the shooting started and avoided injury. Gabriella feels guilty about bringing her to what turned into a horrifying experience.

“We can tell her all day long, ‘It wasn’t your fault. She’s not your responsibility.’ Just like I can tell myself, ‘It wasn’t my fault or my responsibility,’” Bridget said. “But I still bawled on her mom’s shoulder telling her how sorry I was that I grabbed my kid first.”

The two girls have spent a lot of time talking since the shooting, which Gabriella said helps with her own stress. So does spending time with her dog and her lizard, putting on makeup, and listening to music — Tech N9ne’s performance was a highlight of the Super Bowl celebration for her.

In addition to the spark burns on Gabriella’s legs, when she fell to the concrete in the pandemonium she split open a burn wound on her stomach previously caused by a styling iron.

“When I see that, I just picture my mom trying to protect me and seeing everyone run,” Gabriella said of the wound.

It’s hard not to feel forgotten by the public, Bridget said. The shooting, especially its survivors, have largely faded from the headlines aside from court dates. Two additional high-profile shootings have occurred in the area since the parade. Doesn’t the community care, she wonders, that her family is still living with the fallout every day?

“I’m going to put this as plainly as possible. I’m f—ing pissed because my family went through something traumatic,” Bridget vented in a recent social media post. “I don’t really want anything other [than], ‘Your story matters, too, and we want to know how you’re doing.’ Have we gotten that? Abso-f—lutely not.”

‘What Is the Landscape of Need?’

Helped in part by celebrities like Swift and Kelce, donations for the family of Lopez-Galvan, the lone fatality, and other victims poured in immediately after the shootings. Swift and Kelce donated $100,000 each. With the help of an initial $200,000 donation from the Kansas City Chiefs, the United Way’s #KCStrong campaign took off, reaching $1 million in the first two weeks and sitting at $1.2 million now.

Six verified GoFundMe funds were established. One solely for the Lopez-Galvan family has collected over $406,000. Smaller ones were started by a local college student and Swift fans. Churches have also stepped up, and one local coalition had raised $183,000, money set aside for Lopez-Galvan’s funeral, counseling services for five victims, and other medical bills from Children’s Mercy Kansas City hospital, said Ray Jarrett, executive director of Unite KC.

Money for Victims Rolls In

Donations poured in for those injured at the Super Bowl Parade in Kansas City after the Feb. 14 shootings. The largest, starting with a $200,000 donation from the Kansas City Chiefs, is at the United Way of Greater Kansas City. Six GoFundMe sites also popped up, due in part to $100,000 donations each from Taylor Swift and Travis Kelce. Here’s a look at the totals as of March 12.United Way#KCStrong: $1.2 million.Six Verified GoFundMe AccountsLisa Lopez-Galvan GoFundMe (Taylor Swift donated): $406,142Reyes Family GoFundMe (Travis Kelce donated): $207,035Samuel Arellano GoFundMe: $11,896Emily Tavis GoFundMe: $9,518Cristian Martinez’s GoFundMe for United Way: $2,967Swifties’ GoFundMe for Children’s Mercy hospital: $1,060ChurchesResurrection (Methodist) “Victims of Violence Fund”: $53,358‘The Church Loves Kansas City’: $183,000 

Meanwhile, those leading the efforts found models in other cities. The United Way’s Blubaugh called counterparts who’d responded to their own mass shootings in Orlando, Florida; Buffalo, New York; and Newtown, Connecticut.

“The unfortunate reality is we have a cadre of communities across the country who have already faced tragedies like this,” Blubaugh said. “So there is an unfortunate protocol that is, sort of, already in place.”

#KCStrong monies could start being paid out by the end of March, Blubaugh said. Hundreds of people called the nonprofit’s 211 line, and the United Way is consulting with hospitals and law enforcement to verify victims and then offer services they may need, she said.

The range of needs is staggering — several people are still recovering at home, some are seeking counseling, and many weren’t even counted in the beginning. For instance, a plainclothes police officer was injured in the melee but is doing fine now, said Police Chief Stacey Graves.

Determining who is eligible for assistance was one of the first conversations United Way officials had when creating the fund. They prioritized three areas of focus: first were the wounded victims and their families, second was collaborating with organizations already helping victims in violence intervention and prevention and mental health services, and third were the first responders.

Specifically, the funds will be steered to cover medical bills, or lost wages for those who haven’t been able to work since the shootings, Blubaugh said. The goal is to work quickly to help people, she said, but also to spend the money in a judicious, strategic way.

“We don’t have a clear sightline of the entire landscape that we’re dealing with,” Blubaugh said. “Not only of how much money do we have to work with, but also, what is the landscape of need? And we need both of those things to be able to make those decisions.”

Firsthand Experience of Daily Kansas City Violence

Jason used his lone remaining sick day to stay home with Bridget and Gabriella. An overnight automation technician, he is the family’s primary breadwinner.

“I can’t take off work, you know?” he said. “It happened. It sucked. But it’s time to move on.”

“He’s a guy’s guy,” Bridget interjected.

On Jason’s first night back at work, the sudden sound of falling dishes startled Bridget and Gabriella, sending them into each other’s arms crying.

“It’s just those moments of flashbacks that are kicking our butts,” Bridget said.

Tell Us About Your Experience

We are continuing to report on the effects of the parade shooting on the people who were injured and the community as a whole. Do you have an experience you want to tell us about, or a question you think we should look into? Message KCUR’s text line at (816) 601-4777. Your information will not be used in an article without your permission.

In a way, the shooting has brought the family closer. They’ve been through a lot recently. Jason survived a heart attack and cancer last year. Raising a teenager is never easy.

Bridget can appreciate that the bullet lodged in her backpack, narrowly missing her, and that Gabriella’s legs were burned by sparks but she wasn’t shot.

Jason is grateful for another reason: It wasn’t a terrorist attack, as he initially feared. Instead, it fits into the type of gun violence he’d become accustomed to growing up in Kansas City, which recorded its deadliest year last year, although he’d never been this close to it before.

“This crap happens every single day,” he said. “The only difference is we were here for it.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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This story can be republished for free (details).

The voluntary code of marketing practices for the Indian Pharmaceutical Industry- UCPMP 2024 aims to ensure transparency, integrity, and accountability in the marketing of pharmaceutical products, emphasizing ethical practices within the sector to safeguard the interests of patients and healthcare professionals.

This code governs the conduct of pharmaceutical companies in their marketing practices, duly covering various aspects such as medical representatives, textual and audio-visual promotional materials, samples, gifts, etc.

Further, the code establishes relationships with healthcare professionals, wherein the provisions related to travel facilities, hospitality and cash or monetary grants to doctors or their families have been elaborated.

The code also details the mode of operation of the code, the responsibilities of the Pharmaceutical Associations in constituting the Ethics Committee for Pharmaceutical Marketing Practices (ECPMP) for handling the complaints and the Apex Ethics Committee for Pharmaceutical Marketing Practices (AECPMP) for review, the procedure of lodging complaints, the procedure of handling of complaints by the Pharmaceutical Associations and various penalty provisions.

Salient Features of UCPMP 2024:

The code strictly prohibits the offering or providing of gifts for the personal benefit of any healthcare professional or their family members by pharmaceutical companies, agents, distributors, wholesalers, or retailers.

Further, the code imposes limitations on pecuniary benefits, stating that no financial advantages or benefits in kind may be offered, supplied, or promised to any person qualified to prescribe or supply drugs by pharmaceutical companies or their representatives.

The UCPMP 2024 restricts the provision of travel facilities, including rail, air, ship, or cruise tickets, and paid vacations to healthcare professionals or their family members, unless the individual is a speaker at an event.

“No gift should be offered or provided for personal benefit of any healthcare professional or family member (both immediate and extended) by any pharmaceutical company or its agent i.e. distributors, wholesalers, retailers, etc,” as per the UCPMP guidelines.

Similarly, hospitality such as hotel stays, expensive cuisine, or resort accommodations is prohibited unless the healthcare professional is participating as a speaker.

Cash payments or monetary grants to healthcare professionals or their family members are also prohibited under the UCPMP 2024, reinforcing the commitment to fair and ethical practices within the pharmaceutical industry.

UCPMP specifies the rules of the use of the words “safe’’ and “new’’ for drugs and stated that medical representatives must not employ any inducement or subterfuge to gain an interview and that they must not pay, under any guise, for access to a healthcare professional.

The code also bans the supply of free samples to those who are not qualified to prescribe such a product.

Besides, the companies or their representatives, or any person acting on their behalf, should not extend travel facilities inside or outside the country, including rail, air, ship, cruise tickets, paid vacations, etc. to healthcare professionals or their family members for attending conferences, seminars, workshops etc., it stated.

The promotion of a drug must be consistent with the terms of its marketing approval and a drug must not be promoted prior to receipt of its marketing approval from the competent authority, authorizing its sale or distribution, as per the code.

“Information about drugs must be balanced, up-to-date, verifiable, must not mislead either directly or by implication; accurately reflect current knowledge or responsible opinion; and must be capable of substantiation, which must be provided without delay, at request of the members of the medical and pharmacy professions, including members of other professions employed in the pharmaceutical industry,” it stated.

UCPMP further lays down the conduct for MRs in the pharma industry, “The medical representatives must at all times maintain a high standard of ethical conduct in the discharge of their duties. They must comply with all relevant requirements of the Code,” it stated.

Any violations of the code will be addressed by an Ethics Committee for Pharma Marketing Practices (ECPMP) established within each association, ensuring accountability and oversight.

The responsibility for adherence to the code rests with the Chief Executive Officer of pharmaceutical companies, who must ensure compliance with the regulations outlined in the UCPMP 2024.

Additionally, companies are required to submit self-declarations annually, detailing their adherence to the code, which will be made available on the association's website or the UCPMP portal of the Department of Pharmaceuticals.

“All associations are requested to constitute an Ethics Committee for Pharmaceutical Marketing Practices (ECPMP), set up a dedicated UCPMP portal on their website, and take further necessary steps towards implementation of this Code,” the Department of Pharmaceuticals said in the notification addressing associations of drug firms.

Uniform Code for Pharmaceuticals Marketing Practices (UCPMP) 2024General Points

As per the 'Ethical Criteria for Medicinal Drug Promotion' endorsed by the World Health Assembly in 1988, "Promotion" refers to all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medical drugs.

The promotion of a drug must be consistent with the terms of its marketing approval and a drug must not be promoted prior to receipt of its marketing approval from the competent authority, authorizing its sale or distribution.

Information about drugs must be balanced, up-to-date, verifiable, must not mislead either directly or by implication; accurately reflect current knowledge or responsible opinion; and must be capable of substantiation, which must be provided without delay, at request of the members of the medical and pharmacy professions, including members of other professions employed in the pharmaceutical industry.

Claims & Comparisons

Claims for the usefulness of a drug must be based on up-to-date evaluation of all available evidence.

The word "safe" must not be used without qualification, and it must not be stated categorically that a medicine has no side effects, toxic hazards, or risk of addiction.

The word "new" must not be used to describe any drug which has been generally available or any therapeutic intervention which has been generally promoted in India for more than a year.

Comparisons of drugs must be factual, fair, and capable of substantiation. In presenting a comparison, care must be taken to ensure that it does not mislead by distortion, by undue emphasis, by omission, or in any other similar way.

Brand names of products of other companies must not be used in comparison unless the prior consent of the companies concerned has been obtained.

Other companies, their products, services, or promotions must not be disparaged either directly or by implication.

The clinical or scientific opinions of healthcare professionals must not be disparaged either directly or by implication.

Textual and Audio-Visual Promotion

Any promotional material issued by an authorized holder, or with his authority, must be consistent with the requirements of this Code.

Where the purpose of the promotional material is to provide persons qualified to prescribe with sufficient information upon which to reach a decision for prescription or for use, the following minimum information must be given legibly and must be an integral part of the promotional material:

i. The relevant drug, the name and address of the holder of authorization for the drug (or the business name and address of the part of the business responsible for placing the drug on the market);

ii. The name of the drug, along with a list of active ingredients, using the generic name, placed immediately adjacent to the most prominent display of the name of the drug;

iii. Recommended dosage, method of use, and where not obvious, its method of administration;

iv. Adverse reactions, warnings, precautions for use and relevant contraindications for the use of the product;

v. A statement that additional information is available on request, and the date on which the above particulars were generated or last updated.

Promotional material such as mailings and journal advertisements must not be designed to disguise their real nature. Where a pharmaceutical company pays for, or otherwise secures or arranges the publication of some promotional material in journals, such promotional material must not resemble the editorial matter.

All promotional materials appearing in journals, the publication of which is paid for, or secured or arranged by a company, referring by brand name to any product of that company must comply with Clause 3.3 of this Code, irrespective of the editorial control of the material published.

Promotional material must conform, both in text and illustration, to canons of good taste and must be expressed to recognize the professional standing of the recipients and not be likely to cause offence.

The names or photographs of healthcare professionals must not be used in promotional material.

Promotional material must not imitate the devices, copy slogans or general layout used by other companies in a way that is likely to mislead or confuse.

Wherever appropriate (for example, in technical and other informative material), the date of printing, or of the last review of promotional material must be stated.

Postcards, other exposed mailings, envelopes or wrappers must not carry matter which might be regarded as advertising to the lay public, or which could be considered unsuitable for public view.

Audio-visual material must be supported by all relevant printed material so that all relevant requirements of this Code are fully complied with.

Medical Representatives

The term "medical representative" means sales representatives (including personnel retained by way of contract with third parties) and other company representatives who call on healthcare professionals, pharmacies, hospitals, or healthcare facilities in connection with promotion of drugs.

The medical representatives must at all times maintain a high standard of ethical conduct in the discharge of their duties. They must comply with all relevant requirements of the Code.

The medical representatives must not employ any inducement or subterfuge to gain an interview. They must not pay, under any guise, for access to a healthcare professional.

Companies are responsible for the activities of their employees, including the medical representatives, for ensuring compliance of this Code. This should additionally be ensured through an appropriate clause in the employment contract signed between the Company and its Medical Representatives as defined above.

Third parties working for or on behalf of the pharmaceutical companies, including those acting on their behalf (such as joint ventures and licensees), that are commissioned to engage in activities covered by this Code, should also have a sound working knowledge of this Code.

Brand Reminders

Brand Reminders are permitted in the following two categories, viz., (i) Informational and education items and (ii) Free samples provided by the companies to medical professionals.

i. Informational and educational items mean books, calendars, diaries, journals (including e-journals), dummy device models and clinical treatment guidelines for professional used in healthcare settings value of which does not exceed Rs. 1000 per item. Such items should not have an independent commercial value for the healthcare professionals.

ii. Free samples:

• Free samples of drugs shall not be supplied to any person who is not qualified to prescribe such a product.

• Where samples of products are distributed by a medical representative, the sample must be handed directly to the person qualified to prescribe such product, or to a person authorized to receive the sample on their behalf, and the name and address of the healthcare practitioner noted for records.

• The following conditions shall be observed while providing samples to a person qualified to prescribe such product:

a. Such samples are provided only for the purpose of creating awareness about treatment options and for acquiring experience in dealing with the product;

b. Sample packs should be limited to prescribed dosage for not more than three patients for the required course of treatment and no company should offer more than twelve such sample packs per drug to any healthcare practitioner per year;

c. Each sample should be marked "free medical sample not for sale" or bear another legend of analogous meaning;

d. Each sample pack should not be larger than the smallest pack present in the market;

e. An adequate system of accountability and control must be maintained in respect of supply of such samples;

f. A pharmaceutical company shall not supply a sample of a drug which is a hypnotic, sedative, or a tranquillizer. • Each company should maintain details such as product name, doctor name, quantity of samples given, date of supply of free samples to healthcare practitioners etc, and the monetary value of samples so distributed should not exceed two percent of the domestic sales of the company per year.

Receipt of brand reminders from pharmaceutical companies by healthcare practitioners may not be construed as endorsement activity if it does not amount to recommendation or issuance of a statement by a healthcare professional w.r.t. use of the respective brand.

The giver and recipient of brand reminders should comply with the relevant provisions of the Income Tax Act, 1961 with respect to deductions and reporting of income.

Continuing Medical Education

Engagement of pharmaceutical industry with the healthcare professionals for Continuing Medical Education (CME), Continuing Professional Development (CPD) or otherwise for conference, seminar, workshop, etc. should only be allowed through a well-defined, transparent, and verifiable set of guidelines based on which the pharmaceutical industry may undertake such expenditures.

Such activities or events should operate within the following framework:

i. Conduct of such events in foreign locations is prohibited.

ii. The following are allowed to conduct CME/CPD meetings:

a) Medical Colleges/Teaching Institutions/Universities/Hospitals

b) Professional Associations of Doctors/Specialists

c) NIPERs, Laboratories of ICMR, DBT, CSIR etc, Pharma Colleges/other academic and research institutions

d) Pharmaceutical companies, including their trusts/associations, either alone or in collaboration with professional bodies, institutions as stated in a, b & c above.

iii. All pharmaceutical companies should share the details of such events conducted by them, including the expenditures incurred thereupon, on their website, and may be subject to independent, random, or risk-based audit for this purpose.

iv. All organizers of such events should explicitly spell out the procedure followed in the selection of participants and speakers, display a statement of their funding sources and expenditures on their website, and may be subject to special audit for this purpose.

v. Entities incurring expenditure on such events, as well as participants and speakers, must comply with the relevant provisions of the Income Tax Act 1961 as amended from time to time.

Support for Research

To provide rational support and encouragement to research and innovation through the industry-academia linkage, interaction between pharmaceutical companies and healthcare professionals may be subject to the following:

i. The said study or research should be one that has the requisite approval from the competent authority (such as ICMR, DCGI, Ethics Committee, Institutional Authority etc.) and is conducted, where so applicable, at a recognized site or location. Instructions by relevant bodies like NMC, etc., may be complied with.

ii. Engagement of healthcare professionals in consultant-advisory capacity shall be for bona-fide research services, under a consultancy agreement involving a consultancyfee or an honorarium-based payment, subject to the relevant provisions of the Income-Tax Act, 1961. Such engagements should ensure the patient interest is not compromised and integrity of the healthcare professional is maintained in line with the NMC regulations.

iii. Expenditure on research by pharmaceutical companies is an allowable expenditure subject to the provisions of the Income Tax Act 1961 as amended from time to time.

Relationship with Healthcare Professionals

Gifts: No gift should be offered or provided for personal benefit of any healthcare professional or family member (both immediate and extended) by any pharmaceutical company or its agent i.e. distributors, wholesalers, retailers, etc. Similarly, no pecuniary advantage or benefit in kind may be offered, supplied, or promised to any person qualified to prescribe or supply drugs, by any pharmaceutical company or its agent i.e. distributors, wholesalers, retailers, etc.

Travel: Companies or their representatives, or any person acting on their behalf, should not extend travel facilities inside or outside the country, including rail, air, ship, cruise tickets, paid vacations, etc., to healthcare professionals or their family members (both immediate and extended) for attending conferences, seminars, workshops etc., unless the person is a speaker for a CME or a CPD Program.

Hospitality: Companies or their representatives, or any person acting on their behalf, should not extend hospitality like hotel stay, expensive cuisine, resort accommodation etc., to healthcare professionals or their family members (both immediate and extended) unless the person is a speaker for a CME or a CPD program.

Monetary Grants: Companies or their representatives should not pay cash or monetary grant to any healthcare professional or their family members (both immediate and extended) under any pretext. Where any item missing, the Code as per the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation, 2002, as amended from time to time, will prevail.

Ethics Committee for Pharma Marketing Practices

All the Indian Pharmaceutical Associations will upload the UCPMP on their website along with the detailed procedure for lodging of complaints which will be linked to the UCPMP portal of the Department of Pharmaceuticals.

There will be a committee for handling complaints named as "Ethics Committee for Pharma Marketing Practices (ECPMP)" in each Association, chaired by its Chief Executive Officer. The Committee will have three to five members, and its composition will be approved by the Board of the Association and prominently placed on its website.

If a complaint received in a particular association is not concerned with its members, the receiving association will input the abstract of the complaint and will duly transfer the complaint to such other association where the respondent company is a member of the other association.

In case of companies, who are not members of any Association, or member of more than one Association, the complaint should ordinarily be handled by the Phaiiiia Industry Association to whom the complainant has addressed the complaint; and where necessary, it will seek guidance from the Department of Pharmaceuticals.

All pharma associations will share on their website the details of complaints received i.e. the nature of complaint, the company against whom the complaint has been made, the present status of the complaint, including action taken by the ECPMP, and such details should remain uploaded for five years. Such details should also be uploaded on the UCPMP portal of the Department of Pharmaceuticals.

Lodging of Complaints

All complaints, related to the breach of the Code should be addressed to the "Ethics Committee for Pharma Marketing Practices (ECPMP)", "Chief Executive Officer", "Name of Association".

All complaints related to an activity of breach of the Code should, to the extent practicable, be made at one time. The complaint must be made within six months of the alleged breach of the Code, with a maximum of another six months for reasonable delay that can be explained in writing. Related complaints may be clubbed together by the Ethics Committee to save time and expedite disposal.

Complaints must be in writing and for each case The Complainant should: i. identify himself (whether a company, entity or an individual) with a full mailing address (email and mobile telephone no). ii. identify the company, which is alleged to have breached the Code, including the name of any company personnel, product, or products, which are specifically involved. iii. give the details of the activity which is alleged to be in breach of the Code, give the date of the alleged breach, clauses of the Code which are alleged to have been breached, and provide supporting evidence of the alleged breach(es).

A non-refundable amount of Rs. 1,000/is to be deposited by the complainant along with the complaint. The respective association will elaborate on their website how this payment is to be made. No pseudonymous or anonymous complaints or those made without the prescribed fee will be entertained.

When the complaint is from a pharmaceutical company, the complaint must be signed or authorized in writing by the company's managing director or chief executive officer or a person at an equivalent level.

When it appears from media reports (other than letters to the editor of a publication) that a company may have breached the Code, the matter may be treated as complaint, and the committee may request the concerned publication for further information, and the source or the correspondent may be treated as the complainant.

Any complaint received by the Department of Pharmaceuticals may also be forwarded to the concerned Association for necessary action. In such cases, the concerned Association will take up the matter further with the complainant concerned. The Department may order a special audit for the purpose.

Handling of Complaints

Once a complaint is lodged, the process of enquiry should be taken up and completed by the ECPMP. The decision of the Committee will be made by majority. In case of conflict of interest, the member/s concerned should recuse themselves from the proceedings.

When the Committee receives information from which it appears that a company may have contravened the Code, the managing director or chief executive officer of the company concerned will be asked to provide a complete response to the matter.

To assist companies in ensuring that a complete response is submitted, the Committee may suggest to the respondent company the relevant supporting material to be supplied, and it shall be the responsibility of the respondent company to ensure that a full response is submitted within the stipulated timeframe.

Associations may engage the services of professional auditors to facilitate better and independent examination towards arriving at an informed decision.

The respondent company shall submit its comments and supporting documents to the Committee in not more than 30 days after receipt of notice from the Committee.

The company against which the complaint is made should provide supporting evidence even if it thinks that the Code has not been breached.

The Committee should render a decision within 90 days of the receipt of complaint, and having done so, it should promptly notify the parties of its decision, the reasons thereof in writing and send it by recorded mail.

Where the Committee decides there is no breach of the Code, or that matter of complaint is not within the scope of the Code, the complainant will be so advised in writing, including advice on the appropriate forum to approach in such cases.

Where the Committee, after enquiry, decides that there is a breach of the Code, the complainant and the respondent company will be so advised in writing, including the remedial steps that need to be taken in this regard.

If no appeal is filed within the stipulated period, the decision of the ECPMP shall be final and binding, and adherence to such decision shall be a condition of continued membership of the Association. The decisions shall also be uploaded on the website of the Association and the Department of Pharmaceuticals.

Penalties and Reference

Once it is established that a breach of the Code has been made by an entity, the Committee can propose one of the following actions against the erring entity:

i. To suspend or expel the entity from the Association.

ii. To reprimand the entity and publish full details of such reprimand.

iii. To require the entity to issue a corrective statement in the same media (and other suitable media) which was used to issue promotional material, textual or audio-visual (details of the proposed content, mode and timing of dissemination of the corrective statement must be provided by the entity to the Committee for prior approval).

iv. To ask the entity to recover money or items, given in violation of the Code, from the concerned personls, and details of the action taken in this regard must be submitted by the entity to the Committee in writing.

v. In cases where disciplinary, penal, or remedial action lies within the domain of any agency or authority of the Government in accordance with the statute, the Committee may send its recommendations to such agency or authority through the Department of Pharmaceuticals.

Appeal

If a party to the complaint is dissatisfied with the decision of the ECPMP, it may file an appeal before an Apex Committee for Pharma Marketing Practices (ACPMP) headed by the Secretary, Department of Pharmaceuticals, having a Joint Secretary and a Finance Officer dealing with the subject as its members. Explanation: The expression 'party to the complaint' means the complainant or the respondent entity, and the expression 'decision of the ECPMP' includes a lack of decision thereof, or inordinate delay in reaching such a decision.

The time limit for filing such an appeal will ordinarily be 15 days, with an additional 15 days of reasonable time delay permitted for reasons to be recorded in writing.

The ACPMP will give a notice to both the parties, and after giving a reasonable opportunity of being heard, give a final decision or ruling within six months.

The ACPMP may prescribe any penalties or make a reference to an appropriate agency or an authority of the Government in accordance with para- 12 above.

The decision in appeal shall be final and binding on both the parties.

Miscellaneous

The Department of Pharmaceuticals may, for furtherance of the provisions of this Code, or for removal of difficulties in its operation, may issue standing orders from time to time which will be considered an integral part of this Code.

The provisions of this Code, unless exempted, or to the extent modified by standing orders, shall apply mutatis mutandis to medical devices and companies or entities manufacturing or dealing with the sale and distribution of such products.

The Department of Pharmaceutical will notifv a panel of auditors, either audit firms of standing empanelled by the CAG or commercial audit firms of repute having an experience of dealing with such matters.

Finally, the Chief Executive Officer of the company itself is responsible for adherence to this Code, and a self-declaration in the format given in the annexure shall be submitted by the executive head of the company within two months of the end of every financial year to the Association for uploading on their website, or directly on the UCPMP portal of the Department of Pharmaceuticals in case he is not a member of such a body, or a member of more than one such bodies.

To view the official notification, click on the link below:

https://medicaldialogues.in/pdf_upload/ucpmp-2024-234201.pdf

The Ethics and Medical Registration Board (EMRB) of NMC informed in the notice that these applicants have been informed about the deficiencies in their applications more than 5 times. However, despite this, the concerned deficiencies remain unaddressed by the applicants.

Therefore, by releasing the list of applicants, along with their name, father's name, and application tracking number, the Apex Medical Commission has asked them to rectify the deficiencies by March 22, 2024.

NMC clarified that after the deadline, it would not entertain those applications any more and close them for inaction on the part of such applicants.

"With regard to pending online applications for grant of Eligibility Certificate, it has been observed that as on date 320 applicants are lying pending with the applicants despite repeated intimation of the deficiency to the respective applicants more than 5 times the deficiencies pointed out continue to remain unaddressed by the applicants. A list of such applications with tracking no is attached for ready reference," the Ethics Board of NMC mentioned in the notice dated 12.03.2024.

"It is requested that the deficiencies conveyed may please be rectified at the earliest latest by 22nd March, 2024. No correspondence in connection with these applications will be entertained after 22nd March 2024 and all such applications will be closed thereafter. for inaction on the part of such applicants," the Commission clarified.

Medical Dialogues had earlier reported that recently, NMC issued an advisory regarding the eligibility certificates for the FMGs. Referring to the mistakes by the candidates while applying for Eligibility Certificates, the Ethics Board of NMC mentioned in the Advisory, "It has also been observed on previous occasions that various mistakes are made by the candidates while applying for the Eligibility Certificate (EC)."

The Commission suggested the following measures to avoid mistakes:

(i) The applications should preferably be filled by the candidate himself and should ideally avoid proxy for making applications for EC:

(ii) The candidates are also advised to keep their documents handy before filling application for EC; it would be ideal if the entries to be made are verified vis-a-vis entries in the original documents;

(iii) The candidates should provide their active mobile numbers so that alerts/deficiencies can reach them directly for rectification to obviate any delay in rectification. It may also be ensured that once the deficiency is conveyed only the deficiency should be rectified by the respective candidate as expeditiously as possible to avoid last minute rush; and

(iv) Candidates shall scrupulously check entries and ensure conformity with the details in the original documents to ensure quick processing/approval of applications if otherwise eligible.

"The above-mentioned steps are only suggestive and not exhaustive. Candidates are requested to exercise due diligence before submitting applications for Eligibility Certificates and ensure the mobile numbers indicated remain active," clarified the Commission.

To view the NMC notice, click on the link below:

https://medicaldialogues.in/pdf_upload/nmc-eligibility-certificates-234177.pdf

Also Read: NMC Invites Applications for Eligibility Certificate for FMGE, details

MENTAL HEALTH is a state of mental well-being that enables people to cope with the stresses of life, realise their abilities, learn and work well, and contribute to their community. According to Dr Pearnel Bell, clinical psychologist, it is an...

Gayle Borne ha cuidado a más de 300 niños en Springfield, Tennessee. Niños que rara vez han visto a un médico y que han sido tan descuidados que ni siquiera pueden hablar.

Una ley que este estado aprobó en 2023 —que requiere el consentimiento de los padres biológicos o tutores legales para que los niños reciban vacunas de rutina— vuelve a estos niños aún más vulnerables.

Los padres temporales, trabajadores sociales y otros cuidadores no pueden otorgar ese permiso.

En enero, Borne llevó a una bebé que estaba cuidando, que nació con poco apenas 2 libras, a su primera cita médica. Los proveedores de salud dijeron que sin el consentimiento de la madre de la niña, no podían vacunarla contra enfermedades como la neumonía, la hepatitis B y la polio.

La madre no ha sido localizada, por lo que un trabajador social tuvo que solicitar una orden judicial para poder vacunarla. “Estamos esperando”, dijo Borne. “Nuestras manos están atadas”.

La ley de Tennessee también impide que las abuelas y otros cuidadores que acompañan a los niños a citas de rutina cuando los padres están trabajando, en rehabilitación, o simplemente no pueden ir, otorguen ese permiso.

La ley pretende “devolverles a los padres el derecho a tomar decisiones médicas para sus hijos”.

Enmarcada en la retórica de la elección y el consentimiento, esta ley es una de más de una docena de propuestas recientes y pendientes en todo el país que usan la libertad para decidir de los padres en contra de la salud comunitaria y de los niños.

En realidad, crean obstáculos para la vacunación, el fundamento de la atención pediátrica. Siembran dudas sobre la seguridad de las vacunas en un clima lleno de desinformación médica.

Esta tendencia ha explotado a medida que políticos e influencers en las redes sociales hacen afirmaciones falsas sobre los riesgos de las vacunas, a pesar de los estudios que muestran lo contrario.

Los médicos tradicionalmente brindan información sobre vacunas a los cuidadores y obtienen su permiso antes de administrar más de una docena de inmunizaciones infantiles que protegen contra el sarampión, la polio y otras enfermedades debilitantes.

Pero ahora, la ley de Tennessee exige que los padres biológicos asistan a citas de rutina y firmen formularios de consentimiento para cada vacuna administrada durante dos años o más.

“Los formularios podrían tener un efecto disuasorio”, opinó el doctor Jason Yaun, pediatra de Memphis y ex presidente del capítulo de Tennessee de la Academia Americana de Pediatría. “Las personas que promueven los derechos parentales sobre las vacunas tienden a minimizar los derechos de los niños”, dijo Dorit Reiss, investigadora de políticas de vacunas en la Facultad de Derecho de la Universidad de California en San Francisco.

Baja en la tasa de vacunación de rutina

La desinformación, junto con un movimiento por el derecho de los padres que aleja la toma de decisiones de la salud pública, ha contribuido a las tasas de vacunación infantil más bajas en una década.

Este año, legisladores en Arizona, Iowa y West Virginia han presentado proyectos de ley relacionados con el consentimiento.

Una enmienda del Parent’s Bill of Rights en Oklahoma busca asegurar que los padres sepan que pueden eximir a sus hijos de los mandatos de vacunación escolar junto con las lecciones sobre educación sexual y el SIDA.

En Florida, el escéptico médico que lidera el Departamento de Salud del estado recientemente desafió las recomendaciones de los Centros para el Control y la Prevención de Enfermedades (CDC) diciéndoles a los padres que podían enviar a los niños no vacunados a la escuela durante un brote de sarampión.

El año pasado, Mississippi comenzó a permitir exenciones de los requisitos de vacunación escolar por motivos religiosos debido a una demanda financiada por la Informed Consent Action Network (ICAN), que está catalogada como una de las principales fuentes de desinformación antivacunas por el Center for Countering Digital Hate.

Aunque algunos proyectos de ley fracasen, Reiss teme que el resurgimiento del movimiento por los derechos de los padres pueda llevar a abolir leyes que requieren vacunas de rutina para asistir a la escuela.

En un reciente mitín de campaña, el candidato presidencial republicano Donald Trump dijo: “No daré ni un centavo a ninguna escuela que tenga un mandato de vacunación”.

Este movimiento se remonta a la pandemia de influenza de 1918, cuando algunos padres se opusieron a reformas progresistas que volvieron obligatorio asistir a la escuela y prohibieron el trabajo infantil. Desde entonces, las tensiones entre las medidas estatales y la libertad de los padres han estallado ocasionalmente sobre una variedad de temas.

Las vacunas se convirtieron en un tema prominente en 2021, cuando el movimiento encontró puntos en común con personas escépticas sobre las vacunas contra covid.

“El movimiento de derechos parentales no comenzó con las vacunas”, dijo Reiss, “pero el movimiento antivacunas se ha aprovechado, ampliando su alcance”.

Cuando legisladores callan a expertos

En Tennessee, los activistas antivacunas y las organizaciones de tendencia libertaria arremetieron contra el Departamento de Salud del estado en 2021 cuando recomendó vacunas contra covid a menores, siguiendo la orientación de los CDC.

Gary Humble, director ejecutivo del grupo conservador Tennessee Stands, pidió a los legisladores que criticaran al departamento por aconsejar el uso de máscaras y la vacunación.

También hubo repercusiones después que Michelle Fiscus, entonces directora de inmunización del estado, envió un aviso a los médicos. Les recordó que no necesitaban el permiso de los padres para vacunar a adolescentes de 14 años o más que dieran su consentimiento, según una regla estatal de décadas llamada Doctrina del Menor Maduro (Mature Minor Doctrine).

En las semanas siguientes, los legisladores estatales amenazaron con retirarle al departamento su financiamiento, y lo presionaron para que redujera la promoción de la vacuna contra covid, según reveló The Tennessean.

Fiscus fue despedida abruptamente. “Hoy me convertí en la vigésimo quinta de los 64 directores de programas de inmunización estatales y territoriales en dejar su puesto durante esta pandemia”, escribió en un comunicado. “Eso es casi el 40% de nosotros”.

La tasa de mortalidad por covid en Tennessee aumentó, convirtiéndose en una de las más altas del país a mediados de 2022.

Para cuando dos legisladores estatales presentaron un proyecto de ley para revertir la doctrina, el departamento de salud guardó silencio sobre la propuesta. A pesar de los obstáculos para los niños en hogares temporales que requerirían de una orden judicial para vacunas de rutina, el Departamento de Servicios Infantiles de Tennessee tampoco dijo nada.

El representante republicano John Ragan, quien presentó el proyecto en abril de 2023, dijo: “Los niños pertenecen a sus familias, no al estado”.

El representante demócrata Justin Pearson habló en contra del proyecto de ley. “No tiene en cuenta a las personas y niños que son descuidados”, le dijo a Ragan. “Estamos legislando desde un lugar de privilegio y no reconociendo a las personas que no tienen estos privilegios”, agregó.

El proyecto de Ragan obtuvo la mayoría y el gobernador republicano Bill Lee lo firmó en mayo, haciéndolo efectivo de inmediato.

Deborah Lowen, entonces subcomisionada de salud infantil en el Departamento de Servicios Infantiles, recibió decenas de llamadas de médicos que ahora enfrentan pena de cárcel y multas por vacunar a menores sin un consentimiento adecuado. “Me sentí, y me siento, muy descorazonada”, dijo.

Derecho a la salud

Yaun, el pediatra de Memphis, dijo que se sintió conmocionado cuando se negó a administrar una primera serie de vacunas a un bebé acompañado por un trabajador social. “Ese niño está entrando en una situación en donde está rodeado de otros niños y adultos”, dijo, “donde podría estar expuesto a algo y fracasamos en protegerlo”.

“Hemos tenido muchos abuelos enojados en nuestra sala de espera que traen a sus nietos a las citas porque los padres están trabajando o pasando por un mal momento”, dijo Hunter Butler, pediatra en Springfield, Tennessee. “Una vez llamé a una instalación de rehabilitación para encontrar a una madre y hablar con ella por teléfono para obtener su consentimiento verbal para vacunar a su bebé”, dijo. “Y no está claro si eso estuvo bien”.

Las tasas de vacunación infantil han disminuido por tres años consecutivos en Tennessee. A nivel nacional, las tendencias en baja de la vacunación contra el sarampión llevaron a los CDC a estimar que un cuarto de millón de niños de jardín de infantes están en riesgo de contraer la enfermedad altamente contagiosa.

Las comunidades con tasas bajas de vacunación son vulnerables a medida que el sarampión aumenta a nivel internacional. Los casos confirmados de sarampión en 2023 fueron casi el doble que en 2022, un año en el que la Organización Mundial de la Salud (OMS) estima que más de 136,000 personas murieron por la enfermedad en todo el mundo.

Cuando los viajeros infectados en el extranjero llegan a comunidades con bajas tasas de vacunación infantil, el virus altamente contagioso puede propagarse rápidamente entre personas no vacunadas, así como entre bebés demasiado pequeños para ser vacunados y personas con sistemas inmunes debilitados.

“Existe un aspecto de libertad en el otro lado de este argumento”, dijo Caitlin Gilmet, directora de comunicaciones del grupo de defensa de vacunas SAFE Communities Coalition and Action Fund. “Deberías tener el derecho de proteger a tu familia de enfermedades prevenibles”.

A finales de enero, Gilmet y otros defensores de la salud infantil se reunieron en una sala del Capitolio de Tennessee en Nashville y ofrecieron un desayuno gratuito. Distribuyeron folletos mientras los legisladores y sus asistentes llegaban a comer. Un folleto describía el costo de un brote de sarampión en 2018-19 en el estado de Washington que enfermó a 72 personas, la mayoría de las cuales no estaban vacunadas. El brote costó $76,000 en atención médica, $2,3 millones para la respuesta de salud pública y aproximadamente $1 millón en pérdidas económicas debido a la enfermedad, cuarentena y atención.

Barb Dentz, defensora del grupo de base Tennessee Families for Vaccines, repitió que la mayoría de los constituyentes del estado apoyan políticas sólidas a favor de las vacunas. De hecho, siete de cada 10 adultos estadounidenses sostuvieron que las escuelas públicas deberían exigir la vacunación contra el sarampión, las paperas y la rubéola, en una encuesta del Pew Research Center realizada el año pasado.

Pero las cifras han estado disminuyendo. “Proteger a los niños debería ser algo tan obvio”, le dijo Dentz al representante republicano Sam Whitson. Whitson estuvo de acuerdo y reflexionó sobre una explosión de desinformación antivacunas. “El Dr. Google y Facebook han sido un desafío tan grande”, dijo. “Combatir la ignorancia se ha convertido en un trabajo de tiempo completo”.

Whitson fue uno de los pocos republicanos que votaron en contra de la enmienda de vacunas de Tennessee del año pasado. “La cuestión de los derechos de los padres realmente se ha afianzado”, dijo, “y puede ser utilizada a nuestro favor y en nuestra contra”.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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A doctor confirmed that Hyatt had covid-19 and sent him to CVS with a prescription for the antiviral drug Paxlovid, the generally recommended medicine to fight covid. Hyatt handed the pharmacist the script, but then, he said, “She kept avoiding me.”

She finally looked up from her computer and said, “It’s $1,600.”

The generally healthy 76-year-old went out to the car to consult his wife about their credit card limits. “I don’t think I’ve ever spent more than $20 on a prescription,” the astonished Hyatt recalled.

That kind of sticker shock has stunned thousands of sick Americans since late December, as Pfizer shifted to commercial sales of Paxlovid. Before then, the federal government covered the cost of the drug.

The price is one reason Paxlovid is not reaching those who need it most. And patients who qualify for free doses, which Pfizer offers under an agreement with the federal government, often don’t realize it or know how to get them.

“If you want to create a barrier to people getting a treatment, making it cost a lot is the way to do it,” said William Schaffner, a professor at Vanderbilt University School of Medicine and spokesperson for the National Foundation for Infectious Diseases.

Public and medical awareness of Paxlovid’s benefits is low, and putting people through an application process to get the drug when they’re sick is a non-starter, Schaffner said. Pfizer says it takes only five minutes online.

It’s not an easy drug to use. Doctors are wary about prescribing it because of dangerous interactions with common drugs that treat cholesterol, blood clots, and other conditions. It must be taken within five days of the first symptoms. It leaves a foul taste in the mouth. In one study, 1 in 5 patients reported “rebound” covid symptoms a few days after finishing the medicine — though rebound can also occur without Paxlovid.

A recent JAMA Network study found that sick people 85 and older were less likely than younger Medicare patients to get covid therapies like Paxlovid. The drug might have prevented up to 27,000 deaths in 2022 if it had been allocated based on which patients were at highest risk from covid. Nursing home patients, who account for around 1 in 6 U.S. covid deaths, were about two-thirds as likely as other older adults to get the drug.

Shrunken confidence in government health programs is one reason the drug isn’t reaching those who need it. In senior living facilities, “a lack of clear information and misinformation” are “causing residents and their families to be reluctant to take the necessary steps to reduce covid risks,” said David Gifford, chief medical officer for an association representing 14,000 health care providers, many in senior care.

The anti-vaxxers spreading falsehoods about vaccines have targeted Paxlovid as well. Some call themselves anti-paxxers.

“Proactive and health-literate people get the drug. Those who are receiving information more passively have no idea whether it’s important or harmful,” said Michael Barnett, a primary care physician at Brigham and Women’s Hospital and an associate professor at Harvard, who led the JAMA Network study.

In fact, the drug is still free for those who are uninsured or enrolled in Medicare, Medicaid, or other federal health programs, including those for veterans.

That’s what rescued Hyatt, whose Department of Veterans Affairs health plan doesn’t normally cover outpatient drugs. While he searched on his phone for a solution, the pharmacist’s assistant suddenly appeared from the store. “It won’t cost you anything!” she said.

As Hyatt’s case suggests, it helps to know to ask for free Paxlovid, although federal officials say they’ve educated clinicians and pharmacists — like the one who helped Hyatt — about the program.

“There is still a heaven!” Hyatt replied. After he had been on Paxlovid for a few days his symptoms were gone and his surgery was rescheduled.

About That $1,390 List Price

Pfizer sold the U.S. government 23.7 million five-day courses of Paxlovid, produced under an FDA emergency authorization, in 2021 and 2022, at a price of around $530 each.

Under the new agreement, Pfizer commits to provide the drug for the beneficiaries of the government insurance programs. Meanwhile, Pfizer bills insurers for some portion of the $1,390 list price. Some patients say pharmacies have quoted them prices of $1,600 or more.

How exactly Pfizer arrived at that price isn’t clear. Pfizer won’t say. A Harvard study last year estimated the cost of producing generic Paxlovid at about $15 per treatment course, including manufacturing expenses, a 10% profit markup, and 27% in taxes.

Pfizer reported $12.5 billion in Paxlovid and covid vaccine sales in 2023, after a $57 billion peak in 2022. The company’s 2024 Super Bowl ad, which cost an estimated $14 million to place, focused on Pfizer’s cancer drug pipeline, newly reinforced with its $43 billion purchase of biotech company Seagen. Unlike some other recent oft-aired Pfizer ads (“If it’s covid, Paxlovid”), it didn’t mention covid products.

Connecting With Patients

The other problem is getting the drug where it is needed. “We negotiated really hard with Pfizer to make sure that Paxlovid would be available to Americans the way they were accustomed to,” Department of Health and Human Services Secretary Xavier Becerra told reporters in February. “If you have private insurance, it should not cost you much money, certainly not more than $100.”

Yet in nursing homes, getting Paxlovid is particularly cumbersome, said Chad Worz, CEO of the American Society of Consultant Pharmacists, specialists who provide medicines to care homes.

If someone in long-term care tests positive for covid, the nurse tells the physician, who orders the drug from a pharmacist, who may report back that the patient is on several drugs that interact with Paxlovid, Worz said. Figuring out which drugs to stop temporarily requires further consultations while the time for efficacious use of Paxlovid dwindles, he said.

His group tried to get the FDA to approve a shortcut similar to the standing orders that enable pharmacists to deliver anti-influenza medications when there are flu outbreaks in nursing homes, Worz said. “We were close,” he said, but “it just never came to fruition.” “The FDA is unable to comment,” spokesperson Chanapa Tantibanchachai said.

Los Angeles County requires nursing homes to offer any covid-positive patient an antiviral, but the Centers for Medicare & Medicaid Services, which oversees nursing homes nationwide, has not issued similar guidance. “And this is a mistake,” said Karl Steinberg, chief medical officer for two nursing home chains with facilities in San Diego County, which also has no such mandate. A requirement would ensure the patient “isn’t going to fall through the cracks,” he said.

While it hasn’t ordered doctors to prescribe Paxlovid, CMS on Jan. 4 issued detailed instructions to health insurers urging swift approval of Paxlovid prescriptions, given the five-day window for the drug’s efficacy. It also “encourages” plans to make sure pharmacists know about the free Paxlovid arrangement.

Current covid strains appear less virulent than those that circulated earlier in the pandemic, and years of vaccination and covid infection have left fewer people at risk of grave outcomes. But risk remains, particularly among older seniors, who account for most covid deaths, which number more than 13,500 so far this year in the U.S.

Steinberg, who sees patients in 15 residences, said he orders Paxlovid even for covid-positive patients without symptoms. None of the 30 to 40 patients whom he prescribed the drug in the past year needed hospitalization, he said; two stopped taking it because of nausea or the foul taste, a pertinent concern in older people whose appetites already have ebbed.

Steinberg said he knew of two patients who died of covid in his companies’ facilities this year. Neither was on Paxlovid. He can’t be sure the drug would have made a difference, but he’s not taking any chances. The benefits, he said, outweigh the risks.

Reporter Colleen DeGuzman contributed to this report.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Have you ever wondered what gives your body the power to function daily? It is glucose, your body's ultimate source of energy. Glucose is to cells what gas is to cars, i.e., fuel. The body manages blood glucose levels via insulin, a hormone that enables blood glucose to enter cells, where it is used to produce energy.

In 2021, an estimated 101 million people in India had diabetes, and nearly 135 million had prediabetes. When not detected and treated early, diabetes can lead to serious and potentially life-threatening complications such as vision loss, cardiovascular disease, kidney disease, nerve damage, and even complications in pregnancy.

The alarming numbers emphasize the pressing need for increased awareness, interventions, and management.

In both type 1 and 2 diabetes, taking medication, a healthy lifestyle, diet, and exercise are essential parts of therapy that affect patients' quality of life.

Here are some lifestyle changes for controlling blood glucose levels, especially at home.

1) Drink Water

Proper hydration is essential to support the kidney function of flushing out excess glucose from the body. Drinking water regularly throughout the day can aid digestion and ensure efficient processing of carbohydrates while preventing dehydration, without which the glucose concentration in the blood rises significantly. Staying hydrated can help reduce glucose levels.

2) Eat Healthy

Being mindful of dietary choices is the cornerstone of managing and maintaining glucose levels. It is crucial to include a variety of fibre-rich foods like vegetables, whole grains, cereals, and lean proteins to receive essential vitamins, minerals, and fibre that contribute to stabilizing glucose levels. Contrary to popular myth, consuming carbohydrates mindfully in a balanced and controlled manner prevents a sharp spike in glucose levels.

3) Exercise Daily

Regular exercise plays a crucial role as physical activity pushes the body to use glucose for energy, which lowers glucose levels. Simple physical activities like walking or jogging can significantly impact insulin sensitivity, enabling the use of the available glucose in the blood more effectively. Regular physical exercise also aids in weight management, another critical factor in managing glucose levels.

4) Get Sleep

Adequate sleep, at least 7–8 hours of quality sleep, is crucial to keeping glucose levels in check. Poor sleeping habits can cause insulin sensitivity, affecting how glucose levels are managed. Sleep deprivation increases cortisol, the stress hormone, increasing glucose levels. Experts suggest following a sleep schedule with meditation to ensure good quality sleep.

5) Manage Stress

Stress increases levels of hormones like adrenaline and cortisol, which, coupled with other lifestyle patterns, cause fluctuating glucose levels, necessitating managing stress. Simple everyday activities like yoga and meditation help improve emotional health and reduce stress, thereby reducing glucose levels.

Living with diabetes isn't easy, but it is essential to remember that you are not alone but only in need of your partner-in-care, Humrahi. In addition to being guided by healthcare professionals, one can join support groups and educational programs to understand how to lead everyday life utilizing disease management skills, adopting a healthy lifestyle, and making necessary modifications.

One can start slowly by developing a balanced eating plan with the help of a registered dietitian, engaging in regular physical activity, and incorporating stress management techniques. Diabetes management should be seen as a long-term commitment to maintaining overall health and well-being.

Disclaimer: The views expressed in this article are of the author and not of Medical Dialogues. The Editorial/Content team of Medical Dialogues has not contributed to the writing/editing/packaging of this article.