“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
Yesterday… about mid afternoon… my computer just decided to self destruct… This is only the second time in all my decades of using computers that I had to seek “professional help” to put my computer back together… Off to Best Buy today and Geek Squad to the rescue… According to them .. .they have seen a “rash” of “C drives” just self destructing – at least the OS on the drive…they suspect that a update from Windows or Dell… has been sent out.. and they are not saying anything about how their little “bug” has trashed computer’s OS.
The good and bad of it for me… my computer has a solid state C DRIVE and all my data was on a old reliable typical hard drive labeled as “D”… but all the programs had to be downloaded and reinstalled and change their default configurations to my liking… – the ones that I could remember was on the system… I will probably be finding “missing” programs for weeks going forward.. when I need to do something.
If my blog seems rather “silent” over the next few days or I don’t get to your email for a few days… I am not intentionally ignoring anyone…
The United States owes its existence as an independent nation partly to objections over excessive searches by British colonial authorities. Yet today, it is possible for an individual to go to prison as a result of evidence the U.S. government has deliberately kept hidden and that it may have gathered illegally.
Human Rights Watch just published an investigative report documenting parallel construction, a practice in which government agents create an alternative explanation for how evidence in a criminal investigation was found. It does this to avoid disclosing the original sources or methods in open court.
The result is that defense attorneys are unable to discover how evidence was collected and challenge it, and judges are unable to evaluate investigative methods that may have violated fundamental rights. Evidence described in the report suggests that agents may be using this concealment technique regularly and nationwide.
The “fruit of the poisonous tree” doctrine generally requires judges to bar prosecutors from introducing evidence that was obtained illegally. However, the government apparently justifies parallel construction based on exceptions to this doctrine.
For example, the U.S. Supreme Court has found that prosecutors may still introduce such evidence if they had a “genuinely independent” source for it. Human Rights Watch found that the government may be secretly deciding for itself what constitutes an “independent” source—cutting judges, whose role it is to ensure the fairness of trials, out of the picture.
One method the federal government may use to conceal sources entails asking local police to find their own reasons to pull over and search a vehicle for evidence of a criminal offense. We cited numerous avowed instances of such traffic stops, which are known in law enforcement circles as “wall” or “whisper” stops. The report provides links to leaked “be on the lookout” orders that explicitly instruct officers to “develop [their] own probable cause” for stopping and searching vehicles.
We also pointed to the possibility that the government is using orders issued under FISA, or closed proceedings under the Classified Information Procedures Act, to prevent the disclosure of activities or programs. Defense attorneys have had little success in finding out whether these or other techniques were used to conceal investigative methods in their clients’ cases.
While we were able to offer the most thorough portrayal of parallel construction to date, the report should inspire further questions. For example, we provided details about the Drug Enforcement Administration’s (DEA’s) Special Operations Division, which facilitates the sharing of intelligence with law enforcement agents and at least part of which has been nicknamed “the Dark Side.”
But a pair of e-mails from the surveillance software vendor Hacking Team that were leaked to WikiLeaks in 2015 point to the possibility that the Federal Bureau of Investigation (FBI) also contains an entity known as the “Dark Side.” (In the e-mails to which links are provided here, “Phoebe” is Hacking Team’s code name for the FBI, and “Charlie” is apparently a reference to an individual with an FBI e-mail address.)
The report also identifies “wall stops” requested by agencies including the FBI, Immigration and Customs Enforcement, and the Bureau of Alcohol, Tobacco, Firearms and Explosives.
Congress should demand—and the executive branch should provide—complete information about which agencies are engaging in parallel construction, and how. The public needs to know what is being done in its name, and everyone needs to be able to have confidence that the U.S. criminal justice system is respecting rights.
Numerous questions also remain about the DEA Special Operations Division’s “Dark Side.” A former federal prosecutor told us, “The Dark Side does stuff that doesn’t come to the public’s attention.” Another former federal prosecutor who has worked in the division said that members “do everything legally,” but suggested that they are operating under laws that confer vast powers. Such statements suggest a need for much greater transparency about the division’s activities and how they affect rights.
One of the most troubling aspects of parallel construction is that government agents could use it to conceal virtually any behavior, from a potentially unconstitutional National Security Agency surveillance program to untested new biometric technologies, or even run-of-the-mill illegal searches of luggage.
Public, transparent, fair trials are essential to human rights and democracy, and the rights of criminal defendants lie at the heart of the U.S. Constitution. Our findings should inspire further investigations at both the national and local levels—and a ban on the practice of deliberately hiding the true sources of evidence from people facing the loss of their liberty.
It’s unlikely the city of Augusta will realize much of a windfall, if any, from joining a pack of lawsuits against opioid manufacturers and distributors to recover costs of the epidemic.
For one thing, there’s no assurance any monetary awards will be forthcoming.
For another thing, the lead law firm in the case, Dallas, Texas-based Baron and Budd, is representing some 185 cities and counties around the nation. After the law firm’s take of up to 50 percent of damages, and divvying up what’s left, there isn’t likely to be that much per locality.
We also recoil at the notion of predatory lawsuits, with law firms trolling for victims with which to punish U.S. industries. Not that this is one of them, but such practices have become problematic.
Rather, the chief benefit of the opioid lawsuits, which could take up to five years or more to resolve, might be what lawyers call “discovery.”
In a case such as this, that means the plaintiffs can demand relevant documents, correspondence and testimony from the drug companies about what they knew about the epidemic and when, and what they did or didn’t do about it commensurate with their legal duties.
In short, we may find out whether drug companies have acted responsibly or not in the midst of one of America’s worst modern-day epidemics.
Preliminary information indicates Augusta and environs has seen higher-than average prescribing of opioids, which include such drugs as morphine, hydrocodone, fentanyl and methadone.
“Centers for Disease Control and Prevention statistics (show) opioid prescribing rates in Augusta are above the national average of 66.5 per 100 people,” writes The Chronicle’s Susan McCord. “In 2016, the rate was 86.8 prescriptions per 100 people in Augusta while in neighboring Columbia County, the 2016 rate was 81 prescriptions per 100 people.”
If such lawsuits get to the truth, then they will have been well worth it.
But we should probably be more expectant of answers than money.
The health care industry’s fever for consolidation has shot up with two major deals closing out 2017, but the big question is whether consumers should be feeling any better this year.
DaVita Medical Group, which has nearly 300 medical clinics along with about 40 surgery centers and urgent care clinics, will become part of UnitedHealth’s prescription drug benefits division.
CVS Health’s own pharmacy benefit management (PBM) business and in-store clinics would be merged with Aetna. PBMs negotiate deals with drug makers that include rebates and other compensation to encourage certain drugs and come up with lists of drugs their insurance plans will cover.
The deals will move the industry closer to a model in which doctors and insurers are part of the same company, in a “Kaiser Permanente-esque way,” says Craig Garthwaite, who leads the health enterprise management program at Northwestern University’s Kellogg School of Management.
Under that scenario, there would be no incentive for health care providers to perform more tests and procedures than necessary on people. Instead they would be pushed to make sure patients get the right care from the start and to keep them healthy.
Since it became law under President Obama, the Affordable Care Act’s concept of health care reform focused on “paying for better health rather than the utilization of health care services,” Garthwaite says.
Susan Hayes, founder of Pharmacy Outcomes Specialists, which audits PBM contracts for employers and unions, says the recent deals are just the first of many, and she’s worried about the effects.
“More mergers of insurance companies, chain pharmacies and (health care) providers means less transparency and higher costs — bottom line,” she says.
PBMs are billed as a way to lower drug costs for employers and consumers, but they’ve increasingly come under fire in recent years as drug prices have soared.
PBMs’ slice of the costs and role as a middleman is little understood.
Critics of PBMs say the companies sometimes agree to favor high-cost drugs on the lists of medicines your insurer agrees to pay for and that they agree they won’t place quantity limits — or prior authorization programs — on the drugs. That’s despite the fact doing so could help health plans save money and make medical sense,
How these deals could affect you:
• You might get healthier. The companies will have a strong incentive to make and keep you well. Right now, CVS’ Minute Clinics don’t have that incentive, as the more you show up there, the more money they make. Currently, Aetna, and the employers whose plans they administer, already have a strong profit motive to keep patients healthy. But without employing the doctors or owning the hospitals, they can’t truly control how many tests, prescriptions or visits you get. When the insurer and the health care provider are one and the same, you’re more likely to find things that encourage health to be covered.
Linda Fish, who is the caregiver for her husband and brother near Albuquerque, is excited by the prospects of a CVS-Aetna deal. She has gotten good service at CVS and likes that she can get a flu shot and affordable vitamins there. She was also impressed the company took a stand against Mylan’s huge price boost on EpiPens about a year ago when it began offering a low-cost generic version of an EpiPen competitor.
“I’m a strong supporter of wellness first,” she says.
Fish’s husband, Richard, is a retired professional chef and they “eat the right foods prepared the right way,” she says, as “you don’t have to cook things in lard and grease.” The couple also have free membership to gyms in Albuquerque, thanks to their Humana Medicare Managed Care plan, so they work out as much as possible.
Still, Fish hopes she and her family can switch to Aetna’s Medicare plan if the deal goes through.
Dave deBronkart, a cancer survivor and patient safety advocate who blogs as e-Patient Dave, says he is “in favor of any evolution that makes it easier for people with health problems to get the care they need.” But whether that will happen, he acknowledges, is “hard to assess” at the time of a merger.
•Your care could come under one roof. Davita — best known for its dialysis centers — could help launch UnitedHealth into the movement away from high-priced hospital care. Emergency room (ER) visits are the costliest form of health care for insurers, in large part because of the higher costs involved in running a hospital and the fact that, under law, ERs have to at least stabilize all the patients who show up. With more of these clinics, and expanded versions of CVS’ clinics, these insurers will have a place to send patients where they can control most types of care. Within a few years, clinics in or outside of stores, including CVS, could consolidate vision and dental care, as well as primary and specialty care.
• You might save money — or not. If insurers save money on healthier patients, it’s far from clear whether they will pass it along as lower premiums, Garthwaite says. Even if they do, more competition will be needed among big companies such as CVS-Aetna for premiums to truly come down. If there is a worry there, he says it’s that this kind of consolidation means it will be that much harder for new entrants to enter, so prices may not come down.
• Your insurer may still be able to game the system. Insurers have to spend a certain percentage of their premium dollars on claims and other expenses that improve the quality of the health care you receive. But Garthwaite says they still find ways to get around that, and it will be even easier if they own the health providers who treat you. If UnitedHealth is setting the price at the Davita clinics, they will have far less of incentive to make them lower than they would if they were truly negotiating.
• You may not have as much choice. Teresa Stickler, an Arizona pharmacy owner, founded Pharmacists Unity for Truth and Transparency because of what she calls “abusive practices” by PBMs, such as steering consumers to drugs with higher list prices. Now these insurance companies will be able to steer you to the doctors and drug stores they want you to go to, or at least make it even costlier to go elsewhere, Stickler says.
•You may not know who’s profiting. Drugmakers have gotten the brunt of the criticism over soaring drug prices, but the pharmaceutical industry has successfully turned some of that negative attention onto PBMs due to their lack of transparency. These companies make their money on rebates and what’s known as “spread pricing,” or fees charged in addition to maintenance fees that boost drug prices. And they’re doing quite well at it if they’re buying insurance companies, as in the case of CVS’ Caremark.
“I think it is apparent that PBMs are generating so much money through rebates and spread pricing that they are now looking for ways to control the entire vertical,” Hayes says.
Hayes predicts that in the “very near future,” we will see a health care company that includes a drug manufacturer, wholesaler, retail drug chain, insurers, doctors and clinics.
“Then there will be no negotiation possible at arm’s length,” she says
The U.S. Food and Drug Administration plans to focus on reducing opioid misuse
and promoting drug competition as two of its top policy priorities for 2018.
In a list released Thursday, the agency also said it wants to strengthen its scientific workforce and use nutrition to reduce the burden of disease this year.
FDA Commissioner Dr. Scott Gottlieb said the priorities represent the agency’s collective efforts to address public health. “Each one of us has an important role to play in achieving this mission,” he said in a statement.
The opioid crisis was the driver behind another record-setting year for drug overdose deaths in 2016, climbing by 21% over 2015 to nearly 64,000, according to the Centers for Disease Control and Prevention.
One of the actions the FDA plans to take to combat the epidemic will be reassessing how the agency evaluates opioid products before and after they reach the market, including consideration of the risk for misuse. On Thursday, the agency placed new restrictions on the use of opioids in children’s cold and cough products. In June, FDA requested Endo Pharmaceuticals remove its opioid pain medication, Opana ER, from the market due to its potential risk for abuse.
FDA will also encourage drugmakers to develop new abuse-deterrent opioid formulas and medication-assisted treatments. The agency will finalize policies to allow pharmacies to sell the overdose-reversal drug naloxone over the counter, an idea the FDA previously proposed during the Obama administration.
In terms of generics, the FDA wants to streamline the regulatory approval process and bring the lower-priced drugs to the market quicker. FDA will launch a program to promote biosimilar drug development as well.
“By making sure that the barriers to generic entry are not unnecessarily inflated through outdated scientific standards or inefficiencies in the development process — while maintaining the FDA’s gold standard for quality, safety and effectiveness — the agency can help lower the barriers to generic entry, keep costs low for high-quality generic products, ensure an adequate supply of critical generic medicines and promote price competition,” the FDA roadmap said.
FDA also set a goal to reduce preventable disease caused by poor nutrition, which affects approximately half of all American adults and has led to a steady rise in cases of cancer, heart disease and diabetes over the past two decades. The agency will move forward with menu labeling regulations to take place after years of delays.
The rule, finalized in 2014 but not yet implemented, would require chain restaurants, grocery stores and convenience stores to include calorie counts of the food items they serve on menus.
But strong pushback by the restaurant industry led to delays in when the rule would to go into effect. In June, consumer health advocates sued the FDA over the rule’s implementation, and the agency ultimately issued draft guidance last November for industry on how to comply with the menu labeling requirements by May 2018.
Gottlieb said the plan was not intended to be an exhaustive list of items the agency plans to set its focus, but rather an effort to be more transparent on its major goals for the year.
“These goals — and the work we do together in achieving them — go to the heart of our mission of advancing and protecting public health, while maintaining our commitment to the scientific standards that make FDA a recognized global leader, and a gold standard for product review,” Gottlieb said
eadlines declaring that life expectancy in the U.S. has declined for the first time since 1993 because of deaths from opioids are the latest red-flag warning that, as a nation and individually, we need to change both our approach to managing pain with opioids and how we address illicit drug use.
The Centers for Disease Control and Prevention reports that between 2015 and 2016, there was a 28 percent increase in fatal opioid overdoses! In 2016, more than 63,000 Americans died of drug overdose — and 42,249 of those deaths involved opioids. Those drugs are now killing more folks than guns or breast cancer!
To focus the country’s health care providers and YOU on the problem, the Food and Drug Administration asked the National Academies of Sciences, Engineering and Medicine to develop a plan to curb the epidemic. Their report, “Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use,” is out, as are additional publications, Congressional testimonies and journal editorials based on the findings.
They offer guidance that the country and each one of YOU should pay careful attention to.
What You Need to Know and Do If you or a loved one is dealing with acute, chronic or surgery-related pain, it’s important to understand the risks and benefits of using opioids and to learn about the full range of pain-management alternatives that are available.
A new study shows that 60 percent of opioid overdose deaths involve people who suffer from chronic pain.
The Benefits: Severe pain interferes with healing, quality of life and overall health and well-being. Opioids can eliminate severe pain and allow you to heal or participate in activities (such as physical therapy) that will help you banish the source of pain.
The Risks: Unless pain medicines are administered within a pain-management plan that targets tapering off the drugs as you heal and feel better, it is possible to become addicted even at low doses. (Management of chronic pain associated with end of life is another matter; hospice targets comfort for whatever time remains.)
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The Smart Steps: 1. If opioids are the right medication for your pain control, ask your physician to refer you to a pain-management specialist who will guide you through your medication regimen and protect you from addiction. 2. Be conscientious about physical therapy, changing diet to decrease pain/inflammation, adding stress management and other at-home activities when prescribed. It may seem counter intuitive that the strain (and sometimes pain) of physical therapy, along with diet and meditation, can ease chronic pain, but it can! 3. Ask your doctor about taking nonopioid analgesics, including ibuprofen and prescription NSAIDs like celecoxib (Celebrex) and indomethacin (Indocin).
A recent study in JAMA found that for “patients presenting to the ED [emergency department] with acute extremity pain, there were no statistically significant or clinically important differences in pain reduction at 2 hours among single dose treatment with ibuprofen and acetaminophen or with 3 different opioid and acetaminophen combination analgesics.”
That matters because it’s reported that nearly 19 percent of people leave EDs with an opioid prescription — and even short-term use can trigger dependence.
We suggest that even for persistent pain, some NSAIDs are more or less equivalent in effectiveness to low-dose opioids.
4. Explore medical massage to ease distress. Consider acupuncture; pain management group therapy; gentle stretching; water therapy; and tai chi or yoga (if the doc says they’re OK).
A bipartisan congressional coalition pushed back on the U.S. Drug Enforcement Administration’s assertion that cannabidiol and extracts derived from hemp are Schedule I substances.
Twenty-eight legislators including Sen. Rand Paul, R-Ky., Sen. Ron Wyden, D-Ore., and Rep. Jared Polis, D-Colo., on Thursday filed an amicus brief in support of the Hemp Industries Association’s lawsuit challenging the DEA’s new rule on “marihuana extracts.”
“While the Farm Bill pilot programs fell short of the full legalization some Members desired, the pilot programs provided enough latitude to allow for a growing body of knowledge regarding the viability of a domestic hemp market. Congress recognized and acknowledged the need for research and development to investigate hemp-derived products, including CBD, and gave states broad discretion to create pilot programs to accomplish this research. The Final Rule is inconsistent with the Farm Bill’s most fundamental purpose: to allow states that wish to experiment with commercial research and development of industrial hemp, including extracts and derivatives therefrom, to do so without interference from the DEA. The Spending Bill reinforced the text of this law.”
DEA officials have told The Cannabist that the drug code rule was an administratively focused action to better track medical research and to put the United States in line with international drug control treaties.
The Hemp Industries Association, its attorneys and, now, the legislators say the move has caused confusion and put at risk a burgeoning U.S. agricultural movement.
The Final Rule (and the SOP), and all DEA statements made in relation to these documents, provide an unreasonable interpretation of the wording of the Farm Bill and Congress’s purpose behind the law, and in turn violate the Bill,” the wrote. “If fully implemented, the Final Rule will serve to criminalize agricultural products and activities which recently-enacted legislation legalized. In the meantime, the Final Rule has already stifled economic development and caused unjust confusion in the nascent U.S. industrial hemp industry.
“Therefore, Amici asks the Court to recognize and honor the actions and purpose of Congress and to hold that the Final Rule was an abuse of DEA’s administrative rulemaking authority and otherwise not in accordance with law.”
Bob Hoban, the Denver-based attorney representing the Hemp Industries Association, lauded the support.
“Congress has spoken, yet again,” he said Friday in an emailed statement. “The industrial hemp industry has seen exponential growth across the United States since the passage of the Farm Bill in 2014, and this case represents the most significant challenge the U.S. hemp industry has seen to date.”
Oral arguments in the case are scheduled for Feb. 15, Hoban said.
Illinois: Sick child can use medical marijuana at school
Author: Aamer Madhani, USA TODAY
Published: 4:10 PM EST January 12, 2018
Jim and Maureen Surin have sued the state of Illinois on behalf of their daughter Ashley (right) over the state’s medical marijuana law. The state of Illinois prohibits the use of medical marijuana on public school property. On Friday, the state’s Attorney General Office assured the Surins and the Schaumburg, Illinois School District 54 that Ashley could use medical marijuana without fear of prosecution. The child was recently prescribed medical marijuana by doctors to help her regulate seizures that she’s struggled with since she was 2.
Surin Family Photo
CHICAGO— Illinois on Friday said it won’t get in the way of an 11-year-old girl whose parents want her to be allowed to use medical marijuana at school to regulate seizures, despite state laws that prohibit the use of prescription cannabis on public school grounds.
Tom Iopollo, an assistant attorney general for the state, assured attorneys for the suburban Chicago school district and the parents of Ashley Surin that Illinois would not prosecute the child or any school officials who may administer medical cannabis products to Ashley.
Ashley has suffered from seizures for years. She was diagnosed with leukemia when she was 2, and subsequent chemotherapy triggered debilitating seizures and brain trauma that she continues to experience as an adolescent, said her father Jim Surin. For months last year, Ashley had to use a wheelchair after hitting her head during a particularly bad seizure.
Traditional medicines had limited success in helping Ashley with the seizures — she would suffer one to three seizures per day. Late last year, a physician prescribed a ketogenic (high fat, low carbohydrate) diet and medical marijuana for Ashley — what her parents say is proving to be a “golden cure.”
The state attorney general’s office set out their position at a brief court hearing two days after Ashley’s parents filed a federal lawsuit against Illinois and the Schaumburg School District 54. They took the legal action after the district said it could not allow the child to wear a medical cannabis patch or use cannabis oil drops prescribed by her physicians.
“This is not just going to help her but hopefully other kids down the road who have to take cannabis at school for a disease … they need to treat,” said the child’s mother Maureen Surin. “It’s not a drug. It’s a medicine.”
“It’s a law that’s antiquated,” she said of the state’s medical marijuana rules. “It hasn’t caught up with reality.”
Illinois passed a medical marijuana law in 2014, but the statute prohibits the consumption or possession of cannabis on public school property. The family argued in the lawsuit that the state’s medical marijuana law as written denies the child due process and violates the federally mandated Individuals with Disabilities Education Act and the Americans with Disabilities Act.
In the month since she began using a cannabis patch, she has only suffered one major seizure, he father said.
“She’s more responsive,” Surin said. “She’s more energetic. She speaks in longer sentences. She is more aware of her surroundings.”
Darcy Kriha, an attorney for the school district, said the school system felt it was in a bind because of how the law was written. The district, with more than 15,000 elementary school students, helps more than 1,700 of its students administer prescriptions and school officials are confident they can safely assist Ashley as needed with medical cannabis, Kriha said.
Kriha credited Ashley’s family for pressing her case and the state’s attorney general’s office for showing flexibility. Ultimately, she said, state legislators need to come up with a permanent fix.
“As long as the district can be reassured that there will be no criminal or civil prosecution of the school nurse and district personnel, it satisfies the school district for the time-being,” Kriha said. “The school would like to see legislative change so just not Ashley can benefit, but other students can as well.”
The issue in Illinois is somewhat analogous to a situation that surfaced in Colorado, where a public school student in 2015 was prohibited from using a doctor-prescribed cannabis patch.
The student, Jack Splitt, successfully lobbied the state legislature to amend Colorado’s medical marijuana law to permit its use in that state’s schools.
Colorado amended its law in 2015. Jack, who had cerebral palsy, died in 2016.
Follow USA TODAY’s Aamer Madhani on Twitter: @AamerISmad
It will take several months of workshops to iron out regulations that implement Nevada’s new controls over opioid drug prescriptions.
The Nevada Board of Medical Examiners issued a statement Thursday saying a public workshop on the proposed disciplinary regulations revealed considerable confusion about how to implement AB474’s mandates including, potentially, negative impacts on patients as well as medical practitioners.
According to the board statement, they’re forming a working group to study how the mandates of AB474 will impact all those involved. The group will include at least two medical board members, a representative from the legislature, representatives from the state Medical association as well as industry stakeholders.
Their goal, according to the board will be to produce a draft regulation that meet the intent of AB474 while serving the needs of patients and support licensees in their medical practices.
Once approved, the proposed regulations will be submitted to the full board of medical examiners, then begin the formal approval process through the Legislative committee that reviews regulations.
AB474 is designed to get a better handle on the opioid crisis by putting controls in place over prescribing practices including requiring treatment plans that move patients off of the extremely addictive drugs. It limits new patients to a 14-day initial prescription for opioids and says without valid cause, no patient should be on those drugs for more than a year.
It also requires much more extensive discussions with patients about the use, dangers and potential abuse of opioid drugs.
In addition, it mandates much more extensive reporting of who’s prescribing the drugs and how much practitioners are prescribing and builds an extensive database to prevent patients from doctor shopping to get multiple prescriptions from several doctors as well as identify doctors prescribing to much of those drugs.
