Will innovation, the drug industry, and its patients be harmed by Trump’s proposed drug pricing plan? Some experts think it could, including Ian Read, CEO of drug giant Pfizer.
Cutting Drug Costs
A tweet by President Trump led Read to stall planned price increases for certain drugs. Yet, he was still in support of the Administration’s plan to cut drug costs. However, new proposals have been made that run counter to industry interests, leading to some executives to denounce the plan.
Read told CNBC in a phone interview on November 6, 2018, that tying the prices of certain drugs covered by Medicare to an international average was not a beneficial move for patients or innovation. Brent Saunder, the CEO of Allergan said on a CNBC show that the plan was dangerous and called it a ‘slippery slope.”
The Blueprint to Lower Drug Prices
The Trump Administration announced the Blueprint in Spring 2018, and it was generally supported by the industry. In fact, Pfizer was pleased with a plan involving drug rebates, a scheme which drug makers say drives the prices of pharmaceutical drugs and medicines artificially higher.
Read doesn’t believe the plan will be implemented before the end of 2018, saying that he wished the Administration was moving faster in ensuring rebates reach the patient instead of stopping at the middlemen. Currently, discounts given to middlemen are often for better coverage of the medications they manufacturer. The proposed plan would ensure discounts reach patients.
Drug Pricing Has a Long History of Issues
While some experts have noted that drug pricing is a common political campaign issue for both Democrats and Republicans, others are commenting on how close the recent changes to the Blueprint have come to mid-term elections. Read says he’s been in the industry for more than four decades and drug pricing issues have always existed.
Part of the Blueprint calls for increasing competition in Medicare Part B space; a move Read says he feels very positive about. However, Medicare a government program that provides insurance to the elderly and disabled provides Part B coverage for medications administered in a physician’s office or hospital. Part B drugs do not include those that are dispensed by pharmacies.
The new proposal will tie the prices of drugs covered by Medicare Part B to what foreign countries pay, an international price average that is currently lower than the price currently paid in the United States.
Pfizer deferred its planned price increases until the end of 2018 or until the Blueprint to Lower Drug Prices goes into effect.
If implemented, the plan could significantly lower prices, though portions of the plan have been attempted before by previous administrations and failed. The three core parts of the plan include implementing international reference pricing, changing the current reimbursement system to a flat fee (it is currently an Average Sales Price plus six percent system), and substituting the buy and bill practice that is now in place with private pharma vendors.
FDA Orders Zantac Pulled from the Market
On Wednesday April 1, the US Food and Drug Administration (FDA) ordered that Zantac be pulled from the market. Zantac is a well-known drug used to treat heartburn, but it has been in the middle of controversy for the past six months.
The Risks of Cancer with Zantac
About six months ago, several pharmacies began pulling Zantac and its generic versions from shelves due to a potential carcinogen. Now, the FDA supports this decision and has requested any pharmacies still selling the drug to remove the prescription and OTC versions of the drug, which is basically anything with ranitidine in it. Ranitidine is the active ingredient in Zantac and its generic versions.
Studies show that ranitidine has N-Nitrosodimethylamine (NDMA), which is a contaminant. This substance is also found in some foods, such as cured meats. However, the amount present in ranitidine is above what is allowed by federal regulations.
Back in September 2019, the FDA sent out a warning about the possibility of such an issue. Many large-scale pharmacies, such as Walgreens and CVS, stopped selling Zantac and the equivalents.
According to the FDA, the issue is not with the way it has been manufactured. Instead, it’s the way the ingredient breaks down while it’s being stored. The agency conducted tests of samples, which didn’t have any unacceptable levels of the substance. However, the tests showed that the drug was able to degrade into the substance while sitting in storage. Testing showed it could happen while in tablet form or after it had been consumed by humans.
The problem first came to light in the summer of 2019 when a company known as Valisure did a test on the medication. Valisure is a company that does various safety tests on medications. The results showed the presence of NDMA in alarming levels.
Find New Treatment Options
The FDA is going to be sending out letters to all companies that manufacture ranitidine under any name to have them stop production and pull the product from the market. The manufacturer of Zantac, Sanofi, has already issued a recall in the US and Canada.
The FDA recommends that anyone taking the OTC version of Zantac should switch to another type of heartburn medication immediately. For those who are on a prescription version, they need to talk to their doctors right away about what they can switch to. According to the agency, NDMA has not been found in other medications which act similarly to Zantac, such as Prilosec, Pepcid and Prevacid.
Zantac is most often given for gastroesophageal reflux disease, which is when the acid from the stomach backs up into the esophagus. The medication may also be given for peptic ulcers and Zollinger-Ellison syndrome, which is when the stomach produces too much acid. It mainly comes in two forms, Zantac 75 and Zantac 150. The medication reduces the amount of acid the stomach produces.
NDMA doesn’t cause cancer immediately, but it can build up in the system over time. The risk is long-term if a person continues to take this medication while also being exposed from other ways.
Could Johnson & Johnson Start Testing a Vaccine by Fall?
Johnson & Johnson, a major pharmaceutical company, has made plans to begin clinical trials on people of a vaccine for Covid-19 that it has developed. The company suggests it could be ready by September with the first batches of the vaccine ready for public use in an emergency early in 2021.
Hope for a Successful Vaccine
The company stated it had started work on a vaccine for the coronavirus early in January. It is working with BARDA, Biomedical Advance Research and Development Authority, which is a part of the Department of Health and Human Services. The two partners are committing $1 billion for research and development of the vaccine, along with testing.
The chairman of Johnson & Johnson, Alex Gorsky, says his company wants to do what they can to bring a vaccine to the public as quickly as possible. Manufacturing capacity around the world will be expanded if its approved to begin producing the vaccine immediately.
Early tests show the vaccine to be both safe and effective. The hope is that the partnership with BARDA will allow the vaccine to move through testing and approval faster. If approved, the vaccine would be distributed as not-for-profit.
Other Treatments and Vaccines
Another company has also been working on a vaccine. Moderna, a biotech firm based in the US, shipped a test vaccine to the government in February. The first dose has already been administered in a clinical trial in March. It uses material from DNA, which is injected into the body. Immune cells begin to make proteins that mark the virus cells for destruction.
Testing has also begun on a drug which could be used to treat patients with Covid-19. This drug, known as remdesivir, has been used in treatment of Ebola. It was given in a test to a patient who has Covid-19 and is the first drug to be tested for treatment. Other people who have tested positive for the virus will be part of the study.
The study will include volunteers who will either be given the drug or a placebo and monitored. The drug will be given intravenously over a ten-day period. Tests will be taken every other day to determine the amount of the virus in the system. If the drug shows some ability to prevent the growth of the virus, it could reduce the spread of Covid-19.
Experts warn the public not to rely on these early tests to make vaccines available right away. Even if they are viable, it’s expected that it could take at least a year before they would be readily available to the general public. Before this, specific people, such as medical care workers, may have access. Other methods will be necessary to control the spread of the disease in the meantime. However, a treatment for the disease may reduce the death rate. Researchers are working diligently to develop solutions to the coronavirus, but it’s not expected to see dramatic results overnight.
Opioid Addiction Patients May Take Medications Home
The United States Substance Abuse and Mental Health Services Administration, otherwise known as SMAHSA, has made some significant policy changes for patients who are currently in an opioid treatment program. They are now allowed to take home medication due to the impact of the COVID-19 pandemic.
Treatment Drugs Being Made Available to Recovering Addicts
Patients who are in a treatment program for opioid addiction may have the ability to take home medications, including buprenorphine and methadone. These medications are given to patients as part of the treatment plan. Treatment centers may send home a 28-day supply of the drugs. For those who aren’t quite as stable, they may request up to 14 days of medications.
These medications are given to patients to help wean them off opioid drugs. While the medications contain some opioid ingredients, it is at a lower rate than with heroin and other opioids. It can help the patient stop using drugs without the severe withdrawal symptoms often seen if they stop without the aid of medication. These medicines also help reduce cravings, which can mean the difference in relapse for the patient.
Doctors say it’s critical that patients have access to these medicines with the reality of fewer in-person visits while the pandemic continues. Without the medications, the patients are more likely to regress and return to their former drug use. They also have an increased risk for overdose.
While doctors say there is still some risk for overdose or even abuse of the drugs, the benefits outweigh the disadvantages. They believe it will be a great help to those who are stable in their treatment, but even those who are less stable will benefit, according to many experts.
Another change for drug treatment was announced recently from the Drug Enforcement Administration. Dispensing restrictions are being relaxed while the public health emergency lasts. Instead of just licensed doctors being able to administer or even dispense OUD medications, other professionals will also have that ability. This includes law enforcement and other treatment program staff members as well as members of the national guard.
How Buprenorphine and Methadone Work
Buprenorphine is given to people who are in treatment for opioid use disorder or OUD. It is generally given at the first signs of withdrawal symptoms. If given too soon, it can cause an acute withdrawal. The dosage is adjusted until the person has fewer or no symptoms. A maintenance dose is often continued through treatment.
Methadone is often given during detoxification to lessen withdrawal symptoms. It may also be used as part of maintenance because it helps people stay in treatment. It’s standard practice for the person to go to a treatment center daily to receive the methadone dose to risk them diverting the drug. The medication may be given for months or even years. In fact, some patients continue it throughout their lives to reduce the risk of relapse on heroin or other opioids.
The risk with these medications is in overdose or misuse because they are also opioids. In the time of a pandemic, it causes professionals to change the way they handle the drugs to provide the best care for those who are in treatment for opioid addiction.
Medical Devices1 year ago
Complications from Hernia Mesh
Defective Products6 months ago
Vaping Doesn’t Replace Smoking
Defective Products7 months ago
Toyota Has More Safety Recalls
Covid-192 months ago
Results from Remdesivir Clinical Trial to Come Soon
Covid-193 months ago
Anti-parasite Drug Being Tested for Use Against COVID-19
Defective Products1 month ago
Baby and Toddler Swing Recalled for Fall Hazard
Defective Products1 month ago
Ford Issues New Recall
Prescription Drugs3 months ago
FDA Orders Zantac Pulled from the Market