JustCare

Tag: Drug safety

  • Our drug supply needs an overhaul

    Our drug supply needs an overhaul

    Farah Stockman writes an opinion piece for The New York Times on our “sick” drug supply and why it needs an overhaul. The piece is chilling because it highlights the lack of quality monitoring in the production of prescription drugs. And, of course, pharmaceutical companies’ incentive to cut corners in the production and distribution process.

    Stockman explains that the US used to manufacture many more drugs at home and had significant quality control over the ingredients in our drugs. Today, American manufacturing plants are closing down. Pharmaceutical companies are relying on factories abroad to manufacture our drugs. We have no clue where our drugs are being made or which factories are making them.

    The FDA, for its part, insists that a drug is a drug and that differences among drugs that treat the same condition are not meaningful. But, Stockman argues that some manufacturing plants operate under much higher quality standards than others. And, even the distribution of a drug–does it sit out in the sun and bake for extended periods of time or is it protected?–can lead to differences in its efficacy.

    Americans are left in the dark. The lowest-cost drug in a given category might be the drug we are prescribed or the drug that our health insurer covers. But, it also might not be as effective or safe as another drug that costs more. We just don’t know.

    The FDA inspects drug manufacturing plants around the globe. But, during the pandemic, it inspected only three plants and was unable to inspect 1,000 on its list. What does that mean for the quality of our prescription drugs?

    On top of that, the US does not produce many key ingredients used in a number of drugs. Should we rely on India or China or some other country for those ingredients? The Biden administration apparently seems OK with that reliance.

    What’s clear is that the US needs to rethink its entire prescription drug policy. Drugs don’t work if we can’t afford them. They also don’t work if they are affordable but made with harmful ingredients or in a factory where they are contaminated. As it is, the FDA’s approval process for many new drugs does not indicate whether a drug is truly safe.

    Here’s more from Just Care:

  • Legalization of marijuana without safeguards creates large public health risks

    Legalization of marijuana without safeguards creates large public health risks

    Medical marijuana is now legal in 33 states and Washington D.C. Recreational marijuana is legal in 11 states and Washington D.C. And more than 37 million Americans use marijuana. Without safeguards, marijuana legalization creates large public health risks, writes Rosalie Liccardo Pacula for Stat News.

    States benefit significantly from legalizing marijuana by way of increased tax revenue. And, legalizing marijuana creates more jobs. Americans who use marijuana, in turn, don’t have to fear criminal prosecution in their states.

    But, there are also considerable risks for Americans. Marijuana can be harmful. Like vitamin supplements, most marijuana products are unregulated, so drug safety is a serious issue. The Food and Drug Administration does not ensure their safety, unless they are prescribed. In fact the federal government still considers possession and use of marijuana products a crime.

    States are left to oversee the safety of marijuana products. And, for the most part, they have neither the skills nor the resources to do so, even if they have the will. Lack of oversight can present serious problems.

    Already, four states have recalled marijuana products found to be unsafe. They contained dangerous pesticides. We don’t know how many other marijuana products are unsafe.

    People using marijuana legally in their states are increasingly ending up in hospital emergency rooms. Their ER visits have doubled. They may experience uncontrolled vomiting or acute psychosis. And, some develop vaping-related lung injuries, such as burns from butane hash oil.

    Americans need greater protections in states where marijuana use is legal. One way to protect Americans from overuse of marijuana products would be for states to establish non-competitive markets, permitting the sale of marijuana only from government or non-profit agencies, rather than for-profit businesses.

    States could then better guarantee the safety of marijuana products. States could control their marketing and promotion, reducing their overuse. Today, businesses selling marijuana products are focused on driving revenue and not on public health or safety.

    States could also set stiff financial penalties on producers, dispensaries and companies that provide inaccurate information to people about marijuana products.

    Given the cost involved, it’s unlikely that states will step in to ensure accurate labeling of marijuana products or that they are tested for safety, though states should. (States don’t generally do testing for vitamin supplements, even though several have been found to be unsafe.) States might, however, prevent the sale of high potency waxes and oils.

    States could also require that marijuana dispensaries have someone on staff who can advise people accurately about products. New York, Connecticut and Minnesota require this.

    Here’s more from Just Care:

  • One pharmacy uncovers dangerous chemicals in some common drugs

    One pharmacy uncovers dangerous chemicals in some common drugs

    A small pharmacy based in New Haven is testing the prescription drugs it dispenses for safety. And, it is uncovering dangerous chemicals in some common drugs. Talk to your doctor about the safety of the drugs you’re taking.

    We know that some drugs the FDA has approved have turned out not to be safe. But, how many others are unsafe that have not been reported? Carolyn Johnson reports for  The Washington Post that Valisure, a small online pharmacy, is checking every drug it sells before dispensing it.

    Since it began testing the drugs it dispenses, Valisure has found a sea of drug safety issues and other prescription drug problems. It rejects more than one in ten drugs it tests because it finds either that they contain contaminants or otherwise do not perform as expected. For its part, the FDA says that drug safety is not an issue with its approved drugs.

    Valisure recently found that Zantac, a best-selling drug, is less safe than many people thought. It contains a cancer-causing chemical. Since Valisure’s discovery, 40 countries have stopped allowing it to be sold.

    The FDA has asked for the recall of Zantac and other products with ranitidine and nizatidine. Pepcid, Tagamet, Nexium, Prevacid and Prilosec don’t contain these dangerous chemicals.

    Valisure also found that rapid release Tylenol gelcaps dissolve far less quickly than the less costly Tylenol uncoated tablets. In this case, the problem was the misleading marketing of the product, not its risks. The manufacturer subsequently clarified that its marketing was suggesting only that the rapid-release gelcaps dissolved more quickly than other gelcaps, another reason not to trust the marketing hype on products.

    Quality and safety may be an issue because many drugs are manufactured abroad, with less stringent regulatory oversight than in the US. In 2016, the Government Accountability Office reported that nearly 1,000 of 3,000 foreign manufacturing sites had not been inspected by the FDA. Some believe that inspections alone are not enough to ensure safety.

    Here’s more from Just Care:

  • How to ensure the drugs you take are safe and effective

    How to ensure the drugs you take are safe and effective

    Drugs recently approved by the Food and Drug Administration–within the last ten years–may turn out not to be safe or effective. How can this be? And, how can you ensure the drugs you take are safe and effective?

    To be clear, the FDA only approves drugs that it finds to be safe and effective.  But, it bases its approval on limited data. So, what might appear to be safe and effective at the drug approval stage, may turn out not to be. One in seven older adults experience harmful drug side effects.

    To get a drug approved, pharmaceutical companies must conduct clinical trials or lab tests that show the drug is safe and works better than a placebo, essentially a sugar pill or nothing. But, clinical trials are usually performed on a small cohort of people, a tiny fraction of the number of people who will end up taking the drug. Often the people in the clinical trials are not elderly or children or otherwise like the people who are prescribed the drug. As a result, in the real world, outside of the clinical trials setting, the drug may be ineffective or, worse still, dangerous for some people who take it. Drug safety is a big issue.

    Sometimes, a drug’s potentially dangerous side effects may only become evident after six months or a year of a person taking it. But, a clinical trial may last for only six months. And, about 10 percent of the time, a drug may be prescribed for off-label use. When prescribed off-label, for a different condition from which it was tested, people may experience dangerous side effects. Keep in mind, as well, that peer-reviewed papers showing the value of the drug for a particular condition, may be biased. Too often the papers’ authors have financial ties to the drug industry.

    Unfortunately, the FDA does not do the job it needs to do monitoring drugs after they are approved and publicly reporting their side effects. Indeed, because it is very hard to prove that people’s side effects stem from a particular drug, drugs with dangerous side effects may not be pulled from the market for many years. Even warnings about these side effects may not be published.

    What can you do? 

    1.  Choose your doctors carefully. Make sure that your doctors listen to you and take the time to know you.
    2. At each doctor’s visit, question whether you still need to be taking the prescription drugs your doctor has prescribed or whether it is possible to stop taking one or more of them.
    3. Check to see whether your doctor is taking money from drug companies on Dollars for Docs. If so, consider talking to your doctor about that in connection with the drugs your doctor has prescribed for you.
    4. If there’s a generic substitute for the drugs you take or a lower-cost alternative, ask your about switching to that drug.
    5. If a drug you are taking was recently approved by the FDA, ask about side effects and whether there is an older drug you could be taking instead. With an older drug, you have a better sense of the drug’s safety and usually pay less for it.

    Ironically, the FDA does not allow people to import drugs for personal use for “safety” reasons. That said, Kaiser Health News reports that 19 million Americans import drugs from abroad every year. No one has ever reported a safety issue from prescribed drugs bought from a verified pharmacy abroad. Indeed, by some counts 70 percent of the drugs we take in the US were manufactured abroad.

    Here’s more from Just Care:

  • Pharma frequently not reporting postmarketing studies

    Pharma frequently not reporting postmarketing studies

    Many recent FDA-approved drugs and biologics turn out not to be safe and effective and eventually are taken off the market or given new warning labels. To help ensure a drug’s effects are well understood after they come to market and protect patient safety, the FDA often requires pharmaceutical companies to perform post-marketing studies. A May 2018 study published in BMJ finds that Pharma frequently does not report postmarketing studies as required. Too often, the study results are a black hole.

    Indeed, the BMJ research finds that more than one out of four required studies were not published on clinicaltrials.gov. That’s correct. The results of the postmarketing studies were not publicly available in more than one out of four instances.

    Moreover, the results of clinical studies published on clinicaltrials.gov contained so little information, with an average length of 44 words, as to be unhelpful. The FDA gives pharmaceutical companies a lot of freedom to design these studies. So, the studies often do not address the issues that doctors and patients want to understand.

    Between 2009 and 2012, the FDA required pharmaceutical companies to do follow-up studies of 97 out of 110 new drugs and biologics it approved, imposing 437 post-marketing requirements, including 110 clinical trials. Many study results were not reported by their deadline. Fewer than six in ten post-marketing study results were published in peer-reviewed journals.

    The researchers concluded: “These findings highlight the need for more detailed postmarketing requirement study descriptions, increased FDA transparency, and clearer and more consistent registration and results reporting standards for these critical FDA required studies.”

    Here’s more from Just Care:

  • How effective are the drugs Pharma promotes most heavily?

    How effective are the drugs Pharma promotes most heavily?

    A new study by Joel Lexchin in the Canadian Medical Association Journal finds that the overwhelming majority of drugs that pharmaceutical companies promote to doctors have little or no clinical benefits. For his research, Lexchin, a professor emeritus at York University in Canada, reviewed pharmaceutical company spending on marketing in Canada, through sales representations and journal advertisements. It makes you wonder how effective are the drugs Pharma promotes most heavily to consumers in the U.S.

    Lexchin aimed to determine whether prescription drug promotion helps doctors make smart drug choices. To do so, he identified the 50 drugs that pharmaceutical companies invested most heavily in promoting over three years. He then used the findings of two independent review agencies to assess the therapeutic value of these drugs. Of the 42 drugs these agencies had reviewed, they found that ninety percent delivered little or no clinical benefit.

    Lexchin concludes that meetings with drug company sales representatives and drug company advertisements in journals are not helpful in educating doctors about prescription drugs that deliver clinical benefits.

    Tyler Greenway and Joseph Ross conducted a similar study of the 25 most heavily promoted drugs in the U.S., published in the BMJ. They looked at the 25 drugs associated with the largest payments to doctors and teaching hospitals. And, they found that these 25 most-promoted prescription drugs were less likely than top-selling and top-prescribed drugs to be “effective, safe, affordable, novel, and represent a genuine advance in treating a disease.” They recommend that physicians “should question the value of drugs being most heavily promoted by pharmaceutical manufacturers before prescribing them.”

    While neither Lexchin nor Greenway and Ross looked at the efficacy of drugs promoted to consumers, their findings suggest that consumers should not assume that the prescription drugs Pharma heavily promotes are safe and effective. Whenever your doctor prescribes a drug, it would be wise to ask how long the drug has been on the market and what the data says about the drug’s safety and efficacy.

    Here’s more from Just Care:

  • Rheumatoid arthritis drug has dangerous side effects

    Rheumatoid arthritis drug has dangerous side effects

    If you think drugs approved by the FDA can’t kill you, think again. A recent article in Stat News explains that Actemra, a rheumatoid arthritis drug, has dangerous side effects, possibly killing hundreds of patients who took it. But, the FDA warning label made no mention of its risks of stroke, heart and lung disease, or pancreatitis. And, the FDA seems to be incapable of determining the drug’s safety or of acting to warn patients now that the drug shows signs of having dangerous side effects.

    Somehow Actemra’s manufacturer, Genentech, a subsidiary of Roche, was able to persuade the FDA that, unlike other treatments for rheumatoid arthritis, Actemra did not have serious side effects. As it turns out, just like other drugs for rheumatoid arthritis, the data suggests that Actemra can cause stroke, heart disease, heart attack, lung disease and pancreatitis.

    In fact Stat, which studied more than 500,000 reports of Actemra’s side effects, found that patients taking Actemra may be more likely to suffer a heart attack or a stroke than patients taking a competitor drug. Stat further reports that the FDA has been notified of 1,128 people taking Actemra who subsequently died.

    The FDA doesn’t have the capability to determine whether Actemra was the cause of death, and the FDA is not responsible for determining the accuracy of Actemra’s side effects, as reported by Genentech. But, Stat learned through a Freedom of Information Act (FOIA) request that several doctors ascribe their patients’ deaths to Actemra. Experts Stat enlisted to review the FOIA information say that the evidence suggests that the Actemra warning should include risk of heart failure and pancreatitis.

    Stat quotes oncologist and medical ethicist Vinay Prasad, Oregon Science University: “We’ve done a very good job of making it easier to approve drugs, often based on very preliminary evidence. But we haven’t ramped up the standards of post-marketing surveillance to make sure that what’s been out there for several years is safe and effective.” Prasad continues: “The system is broken, and all the financial incentives are lined up to keep it broken.”

    Psychiatrist, Jean Roiphe M.D., says: “It is safest to assume, until proven otherwise, that a new drug, from a given class of medication, is likely to have similar side effects and risks as other members of its class, even if there is no specific warning to that effect. Before deciding to take a newly approved drug, I recommend that patients consider taking a drug that has been around for a longer period of time, whose side effects are more well known.”

    About 1.5 million Americans have rheumatoid arthritis. It causes swelling of the joints and, sometimes, physical disabilities. It can be extremely painful. (Click here for a post on managing arthritis pain.) There is no cure for the disease, but there are several types of treatments, including therapy and a range of medications.

    You can watch Mike Papantonio, a trial lawyer, describe the dangerous side effects of Actemra here.

    Here’s more from Just Care:

  • One in three FDA-approved drugs have safety risks

    One in three FDA-approved drugs have safety risks

    A new JAMA study finds that one in three novel therapeutics approved by the FDA between 2001 and 2010 have safety risks detected only after they were approved. The study authors make a compelling case that to ensure patient safety the FDA should be monitoring drugs throughout their lifetime. Often safety issues do not arise until several years after drugs are approved.

    For the study, the researchers analyzed 222 novel therapeutics, including 183 pharmaceuticals and 39 biologics). Most of them were for the treatment of cancer, hematology and infectious disease. Three of the drugs were taken off the market. The FDA acted to address drug safety issues for 71 (32 percent) of them, in many cases as much as four years or longer after their approval. In 61 cases, the FDA required serious “black box” warnings on the packaging for the drugs.

    The FDA only approves drugs that are found to be safe and effective, generally based on clinical trials. But, the Washington Post reports that often relatively few patients are involved in these trials, and these patients are not representative of the general population. Safety issues often arise only after large numbers of people take the medications.

    Typically, it took 4.2 years from FDA approval for the detection of the new risk for the novel drug. In the case of one of the withdrawn drugs, efalizumab, it took 5.4 years from approval to withdraw it from the market. Because it can take so long from FDA approval to understand the safety risks of new therapeutics, it is generally advisable to try all other treatments that have been on the market for a substantial period of time before taking a novel therapeutic drug or biologic.

    Speeding up the drug approval process will only make it more important for the FDA to assess the benefits and risks of drugs after they are approved as well as to find ways to let people know about safety issues as quickly as possible. The researchers found the greatest number of safety issues among the drugs approved most quickly–under a speedy approval process–along with biologics and drugs that treat psychiatric disease.

    To best ensure patient safety, the FDA should collect data on the safety of drugs post approval from all patients using them.

    Here’s more from Just Care:

  • Link found between researchers’ financial ties to drug industry and study outcomes

    Link found between researchers’ financial ties to drug industry and study outcomes

    Financial ties to the pharmaceutical industry are common among researchers, guideline panelists, and physicians. A financial tie is the direct compensation (e.g. consulting fees, honorarium, travel fees, etc.) of a principal investigator (PI) by the manufacturer of their study’s drug of interest. My research team’s study, published in the BMJ this past week, examined the relationship between researchers’ financial ties to the drug industry and their study outcomes.

    Past studies have examined the financial ties between principal investigators studying drug efficacy and the pharmaceutical company for the drug studied. However, many have not separated financial ties from the research funding source and many have been focused on one specialty, journal, or type of drug. For this study, our research team created a one-year snapshot of randomized controlled trials (RCTs) studying drug efficacy published in 2013.

    To identify financial ties, our research team looked at both the disclosure section of the paper and several online databases (Medline, Google, Pro Publica’s Dollars for Doctors, and the US Patent Office) for each PI in every RCT. Financial ties between PIs and the drug manufacturer of interest were present in 67.7% of the RCTs in our sample.

    Our team was concerned specifically with the influence of drug industry funding on study outcome. We found that studies with a principal investigator with a financial tie were more likely to have a study with a positive outcome. 75.7% of positive studies and 49.2% of negative studies had one or more of their principal investigators with a financial tie to the pharmaceutical company of the study’s drug of interest.

    The cross-sectional nature of our study does not let us draw conclusions about causality. However, we attempted to identify any potential confounding variables and control for them. As a result, we controlled for study funding and found that PI financial ties with industry were associated with positive study outcomes, independent of study funding. Additionally, we controlled for study characteristics such as specialty, size, and study design.

    RCTs shape the evidence base in drug safety and efficacy studies because they are considered the most reliable form of evidence. While collaboration between industry and academia serves an important role, RCT results shape clinical practice and, it is therefore imperative that they are not influenced by this relationship.

     

    Here’s more from Just Care: