Dr. John Abramson
"In 2002 the medical journal of the American Heart Association, Circulation, published an article that reviewed the important studies on coronary heart disease prevention through diet and lifestyle interventions. The article concluded that by following the recommendations that emerge from the scientific evidence, 'coronary heart disease can be eliminated to a large extent' among people less than 70 years of age."- Overdo$ed America page 237-238
Dr. John Abramson described in his book in 2005, Overdo$ed America, about the manner that big pharma had affected the medical industry since the 1970s and has led to significant difficulties. We learn that Dr. Abramson left clinical practice because of the irregularities and discrepancies that existed between trying to treat patients with the best medical care in primary care and the interests that existed for pharmaceutical companies. We learn that Dr. Abramson describes in his book the manner that lifestyle changes including exercising every day, eating nutritious and healthy food, and smoking cessation can lead to better health.
Dr. Abramson describes the manner that the medical industry has changed from previous decades due to the interests that big pharma has on medicine. Dr. Abramson describes how even medical journals are not immune to influence from pharmaceutical companies that have the intention to lead to greater amounts of newer medications (new meds that have not been proved to be better than older and generic medication) being prescribed instead of discussing the importance of disease prevention, lifestyle changes, and nutrition and dietary counseling.
"With slight modifications and the inclusion of safety recommendations, here is the list:
1. Avoid tobacco.
2. Exercise moderately for at least 30 minutes or more on most days, engaging in activities such as brisk walking, biking, or gardening.
3. Consume alcohol in moderation, if at all.
4. Eat a healthy diet:
-Cut down on red meat in favor of chicken and fish (including fatty fish at least once a week), and vegetable proteins
-Eat at least a pound of vegetables and fruits every day
-Limit salt to less than a teaspoon a day
-Cut down on sugar (the recommendations in the book of Dr. Abramson suggest no more than 10 teaspoons per day.)
-For cooking, use vegetable oils such as canola and olive oil
-Minimize intake of saturated fats and cholesterol
-Consume less than 2 percent of calories in trans fat ("the partially hydrogenated oil" found in many margarines and many baked goods, cookies, crackers, candy bars, and breakfast cereals; check ingredient labels). The optimal daily intake of trans fat: none.
-Keep your body mass index (BMI) from going over 25 (meaning, do not be overweight for your height). The good news is that if you do the other things on this list, your weight will be much easier to keep in check.
5. Use seat belts and bike helmets. Most important, do not drink and drive.
6. Do not engage in unsafe sex" - Overdo$ed America Page 238
Dr. Abramson describes in his book how credible studies have shown that exercising minimum two hours every week can help decrease the probability of cardiovascular disease, obesity, strokes, diabetes, hypertension, and high cholesterol and also improve health. There is also the importance of nutrition counseling and learning how to prepare nutritious food describing eating protein that has less fat describing chicken and fish (tuna fish has been shown to have mercury), vegetables and fruits with high fiber and nutrition, and avoiding junk food that can have a number of high calories without any nutrition.
This describes the importance of being able to persevere taking care of ourselves by making sure that we exercise almost every day and eat food that has nutrition while avoiding a sedentary lifestyle high in calories and no nutrition. Dr. Abramson describes that pharmaceutical companies have attempted to cause individuals to think that the solution to their health problems is newer medication, aggressive treatment, and interventions when a lifestyle change towards exercise, moderation, and avoiding unhealthy food can help tremendously.
Newer Prescribed Medications That Did Not Offer Health Benefits Compared to Healthy Lifestyle Changes Describing Exercising and Adequate Diet
"The Pravachol article seemed likely to have the effect of exploiting the deeply ingrained trust. Had the purpose of the study truly been to assist doctors in reducing their patient's risk of stroke, it certainly would have mentioned other proven approaches to achieve that goal. Even taken at face value the article's claimed 19 percent reduction in the risk of stroke- just to make this point- other more effective ways to decrease the risk of stroke has been well documented at the time the article was published. For example, simply eating fish once a week reduces the risk of stroke by 22 percent. Controlling high blood pressure reduces the risk of stroke by 35 to 45 percent. And even moderate exercise for less than two hours a week reduces the risk of stroke in an elderly population by about 60 percent."- Overdo$ed America (page 17)
Dr. Abramson described in his book the manner that there were specific newer medications that were not offering health improvements compared to older, generic medication and lifestyle changes describing exercising minimum two hours per week and eating a healthy nutritious diet. We learn that Pravachol was a newer statin drug that offered to help with lowering hypertension while decreasing the likelihood of strokes. We learn that Dr. Abramson was able to describe how true medical studies had demonstrated that Pravachol did not offer better treatment than older generic statins and caused side effects including an increased risk of stroke. We learn that there were also medical journal articles that supported the use of Pravachol. Dr. Abramson describes the manner that there are questions concerning how Pravachol could be prescribed when there were better alternatives for treatment. We learn that the study that favored Pravachol treatment described the sample population averaging 62 years of age while the general population that has strokes is over the age of 70. Half of the men who have strokes are over the age of 71 and half of the women are over 79.
"This is important because the patients in the study age 70 and older who had been treated with Pravachol actually had 21 percent more strokes than the patients given a placebo."- Overdo$ed America (page 16)
"Eighty three percent of the people included in the study were men, but three out of five stroke victims in the general population are women. The fact that fewer than one out of eight people in the Pravachol study were women turns out to be important because the women in the study who were given Pravachol experienced 26 percent more strokes than the women who were given a placebo."- Overdo$ed America (page 16)
Dr. Abramson also describes about other medications similar to Pravachol that were not an improvement nor prevented side effects from developing. We learn that Celebrex and Vioxx attempted to "help" with rheumatoid arthritis and were two other medications that were described being newer and better meds according to some medical journal articles while actually leading to side effects. Vioxx was a newer medication that may have caused side effects including heart attacks, strokes, and cardiovascular deaths. We learn that compared to Naproxen, Vioxx had greater side effects. Dr. Abramson describes the manner that while the study showed statistical significance meaning Vioxx caused more side effects including heart attacks than naproxen, the language of the article attempted to dismiss the finding by saying that it may have been due to chance. When there is statistical significance in a study, the study is able to prove that the results are not due to chance if p-value is less than .05.
"According to a medical journal article, people who took Vioxx had twice as many heart atacks, strokes, and cardiovascular deaths and four times as many heart attacks as the people who took naproxen (p<.05 and p<.01, respectively.) But then, rather than addressing these serious complications, the authors dismissed them with a most unusual statement: "The difference in major cardiovascular events in the VIGOR trial [of Vioxx] may reflect the play of chance because "the number of cardiovascular events was small (less than 70)." The comment that a statistically significant finding "may reflect a play of chance" struck me as very odd. Surely the experts who wrote the review article knew that the whole purpose of doing statistics is to determine the degree of probability and the role of chance."- Overdo$ed America (page 26)
Concerning Celebrex, the newer medication was said to "help" with rheumatoid arthritis and osteoarthritis while decreasing ulcer complications compared to NSAID's. When Dr. Abramson researched the study findings, he found out that the researchers only published the first half of the study in the Journal of the American Medical Association known as JAMA. They did not report the second half of the study where six of the seven serious gastrointestinal complications were seen. We learn that the first six months of the study were documented showing a reduction of the risk of ulcer complications, yet the data from the last six months were left unreported that described individuals that developed gastrointestinal complications.
"Phase 4 study that included over 8000 people with rheumatoid and osteoarthritis, compared the risk of gastrointestinal problems in people taking Celebrex with the risk in those taking ibuprofen (Motrin, Advil) and diclofenac (Voltaren). The article in JAMA concluded that Celebrex, "when used 6 months... is associated with a lower incidence of clinical upper GI events than comparator NSAID's (ibuprofen and diclofenac)." The accompanying editorial supported this conclusion "The results of this important study... provide promising data to suggest that [Celebrex is] ... effective in reducing, but not eliminating, the risk of symptomatic [minor] ulcers and [major] ulcer complications in the enormous number of individuals who might benefit from these drugs..." "There was, however, one very large problem. The manufacturer's original research plan, as submitted to the FDA had defined the duration of the Phase 4 study that compared Celebrex with ibuprofen as 12 months, and that of the study comparing Celebrex with diclofenac as 16 months. And, indeed, the combined study had run for a full 12 months. The authors, however, submitted only the first 6 months for the article in JAMA. Left unreported (and unmentioned) in the JAMA article were the data from the second 6 months of the study, during which time, as shown in the data of the FDA's website, six of the seven serious gastrointestinal complications that occurred where in patients taking Celebrex."- Overdo$ed America (page 29-30)
We learn that naproxen was a better alternative to Vioxx. We learn that NSAID's were a better alternative to Celebrex. We learn that in the case of fighting high blood pressure and strokes, there was a 60 percent reduction in the risk of stroke when individuals decided to exercise for a minimum of two hours per week compared to the "supposed" 19 percent reduction from Pravachol.
Dr. Abramson described the manner that patients were requesting and demanding that they be prescribed newer medication (Celebrex, Vioxx, Pravachol) when there were better treatment options. Celebrex and Vioxx were included in the leading medical journals of medicine in the U.S., the Journal of the American Medical Association and New England Journal of Medicine describing positive results initially. We learn that Dr. Abramson was able to describe that the data set and results from the FDA actually described that there were side effects to the medication and that there was better treatment. For Vioxx, the researcher from the medical journal stated that the probability that Vioxx caused heart attacks was due to chance while there was statistical significance, and for Celebrex, there were serious gastrointestinal complications when taking Celebrex that were not reported in the medical journal concerning the second half of the study. Dr. Abramson describes that the leading journal articles in the past were authoritative and allowed for the development of treatment plans based on science, sound clinical judgment, and the scientific method. We learn that financial ties between researchers and medical companies were not allowed in the past, yet there were financial ties between the medical researchers in the Vioxx and Celebrex studies and pharmaceutical companies. Dr. Abramson described the manner that medical journals had changed from publishing truth and having integrity to obvious lack of transparency, ethics, and giving preferance to the pharmaceutical companies agenda. Vioxx and Celebrex were among the most prescribed medications in 2001.
"57 percent of all the money spent on prescription arthritis medication in the United States was spent on Celebrex and Vioxx." Overdo$ed America (Page 38)
Additional Treatments That Were Unsafe and Were Prescribed
Hormone Replacement Therapy in Post-Menopausal Women in the 1960s
"The truth about HRT came out very slowly and was difficult for most doctors to accept. Even after the article appeared in JAMA in 2000 showing the 8 percent per year increase in the risk of breast cancer in women taking combined hormone therapy, most experts continued to recommend, and most doctors continued to prescribe, routine hormone replacement for postmenopausal women."- Overdo$ed America (page 68)
Hormone replacement therapy for women was touted as a method to help women in the 1960s with menopause. Dr. Abramson describes the manner that medical journal articles and health studies have shown that HRT actually causes disease instead of helping. We learn that there is a probability of 8 percent increase of breast cancer each year that hormone replacement therapy is used in women taking combined hormone therapy.
The Women's Health Initiative study described how 16,000 women in the study had been "randomly assigned to take either combined (estrogen and progestin) HRT or a placebo. The study had been scheduled to run through 2005, but the women received letters instructing them to stop taking the study medication because the risk (increase in breast cancer, heart attack, stroke, and blood clots) associated with combined HRT had been found to be significantly greater than the benefit. The study found a statistically significant increase (15 percent) in the overall frequency of adverse events in the women taking HRT compared to the women who took a placebo. (page 69)"
"In May 2003 more results from the Women's Health Initiative were published showing that combined HRT not only did not prevent Alzheimer's disease, but actually doubled the risk of developing dementia (primarily Alzheimer's disease) in women aged 65 and older, causing about 1 additional case of dementia for every 100 women treated with HRT for five years."- Overdo$ed America (page 69)
Women were more likely to develop adverse side effects from HRT than benefits. We learn that HRT also can cause Alzheimer's Disease aside from increasing the risk of cardiovascular disease. There were claims that HRT helped fight against Alzheimer's disease when studies showed that the use of HRT increased the risk of developing dementia. Instead of helping with Alzheimer's disease, the use of HRT doubled the risk of getting dementia.
Aggresive Chemotherapy and Bone Marrow Transplant in 1990s
There were questions concerning if aggressive chemotherapy and bone marrow transplant was better than less aggressive chemotherapy. Initially, treatments favored aggressive therapy with bone marrow transplant. Four randomized controlled trials described that bone marrow transplantation was of no benefit. Only a small trial that had fake data was published that supported bone marrow transplantation. The American Society of Clinical Oncology had a meeting and American researchers visited the South African researcher's laboratory that showed that the data was fraudulent (page 52). The researcher's article was retracted by the Journal of Clinical Oncology, and the researcher was dismissed from his university position.
"Finally, in 2000, this unfortunate chapter in medical history was brought to an end when the results of a study published in the New England Journal of Medicine failed to show any benefit from high-dose chemotherapy followed by bone marrow transplantation."
This describes the importance of researching medical studies to know if there are actual benefits from treatment. We learn that Dr. Abramson described that bone marrow transplantation was an accepted therapy when there was not enough data to know if there was actual improvement by bone marrow transplant or not. Similar to the HRT treatment in post-menopausal women, there was not enough evidence initially to know if the treatment actually helped with Alzheimer's disease, osteoporosis, and hot flashes. Instead, 34 years later after treating post-menopausal women with HRT it was acknowledged that treatment with combined hormone therapy treatment caused side effects and actually led to an increased risk of Alzheimer's disease.
Anti-Arrhythmic Drugs Prescribed in 1980s That Were Not Completely Researched
"These so-called class I antiarrhythmic drugs were routinely prescribed into the 1990s. It turned out that eventhough these drugs do effectively decrease the frequency of extra heartbeats, they increase the risk of death. One study documenting a higher death rate in people treated with these drugs was completed in 1980. The results, however, weren't published until 1993. According to a 2003 article in JAMA, had doctors been aware of these findings earlier, their use may have been stopped sooner. The JAMA article then presents a frightening calculation: 'There are estimates that 20,000 to 75,000 lives were lost each year in the 1980s in the United States alone from inappropriate administration of class I antiarrhythmic drugs.'"- Overdo$ed America (page 114)
Dr. Abramson described that there were specific anti-arrhythmic drugs prescribed in the 1980s that were "supposed" to help the heart prevent additional beats and arrhythmias while they actually caused side effects. We learn that there was a study conducted in 1980 that showed that the medications were dangerous, yet the study was not published until 1993. This describes that medications that caused adverse side effects were prescribed for 13 years without knowing how the medication worked. The study in the 1980s described that the anti-arrhythmic medications (Quinaglute, Norpace, and Pronestyl) caused increased risk of death. This is similar to the other medications that were not fully researched. There is the need to know if the newer drugs cause increased risk of side effects including death.
This allows us to know that we can not trust in medications that have not been fully researched or that have obtained a rapid review and approval similar to Rezulin. While it appeared that the anti-arrhythmic medication helped initially with arrythmias, there was no information published concerning side effects or adverse symptoms from anti-arrhythmic drug use. We are able to see that some of the studies that showed that some newer pharmaceutical drugs were not helpful were removed or not published. The "positive" reviews of the newer pharmaceutical drugs were published. The same was seen in anti-depressant medication.
The Swedish Drug Authority Reviewed Five Newer Antidepressent Drugs and Found Out That Negative Articles Were Not Being Published
"In Sweden, drug applications must include all known studies-published or not- relevant to the new drug. When researchers from the Swedish Drug Authority went through the new drug applications for the five new anti-depressants, they found that a total of 42 studies had been completed. It turned out that exactly half of these showed that the new antidepressants are more effective than the placebos and half found that they are not. The 22 positive articles that had been published represented 19 of the positive studies (3 were published twice). In contrast, only 6 of the 21 studies with negative or inconclusive findings had been published. Even the most conscientious doctor could know only the results of the studies that had been published and would resonably conclude that the weight of the evidence about the new antidepressants was overwhelmingly positive."- Overdo$ed America (page 115)
The Swedish Drug Authority was in the process of reviewing five newer anti-depressant medications for approval. They found out that there were 28 different clinical trial that were published in medical journals that showed that twenty two of the articles were positive although three articles were published twice. In Sweden, the review process includes all the articles of the new medication regardless if they were published or not. The Swedish Drug Authority found out that there were actually 42 completed studies. Only six studies were published that described negative findings when there were twenty one total studies that were not published that had negative findings or inconclusive findings. This describes that there were actually nine-teen favorable studies compared to twenty one unfavorable or negative reviews of the new anti-depressant drugs. This allows us to know that forty percent of studies were not published describing that there could be bias and that the benefits of the medication needed to be questioned.
The FDA Reviewed Newer Anti-Depressant Medication and Found Out That They Were No Better Than Older Medication
"In another study, researchers in the United States obtained data under the Freedom of Information Act from all of the studies (both published and unpublished) that the FDA had reviewed in the process of approving seven new anti-depressants (Prozac, Zoloft, Paxil, Effexor, Serzone, Remeron, and Wellbutrin SR) between 1987 and 1997- a total of 5200 pages of documents. The results of all the 'pivotal' studies (those deemed to be of high enough quality to be used in the FDA's determinations) for these seven antidepressants were then put together to assess the overall effect of the new drugs. By looking at all the studies, the researchers avoided the distortion of 'publication bias' and were able to determine whether or not the scientific evidence really showed that the new antidepressants are more effective and safer than the older ones. When all the evidence is considered, it turns out that the new antidepressant drugs are no more effective than the older tricyclic anti-depressants (the classic being amitriptyline, brand name Elavil). More important, the new antidepressants were found to be not even 10 percent more effective than the placebos: Symptoms of depression improved by 30.9 percent in the people who took the placebos; by 40.7 percent in the people who took the newer antidepressants; and by 41.7 percent in the people who took the older antidepressants.'"- Overdo$ed America (page 115-116)
Dr. Abramson described the manner that a healthy lifestyle and exercise can help. We learn that there were other studies published that describe that exercising thirty minutes each day can fight off symptoms of depression. We learn that the newer medication was no better than the older medication. We learn that in the controlled randomized trials comparing the antidepressant medications with older medication and the placebo, the placebo caused a 30.9% improvement of symptoms. We learn that instead we are able to see that exercising can not only improve health so that there is no diabetes, hypertension, and high cholesterol, but that exercising also helps against depression.
Possible Risk of Cancer With Prolonged Use of Statins
"The 2001 cholesterol guidelines were reassuring about statins' not causing cancer: 'There is no evidence that currently used cholesterol-lowering drugs promote development of cancer...' However, a paper titled "Carcinogenicity of Lipid-Lowering Drugs," published in JAMA in 1996, was apparently overlooked. This paper pointed out that statins caused cancer in laboratory animals at blood levels only three or four times those typically achieved in cholesterol-lowering therapy for people. The authors raised the possibility that increases in the risk of cancer caused by statins could take many years to be detected, and therefore would not be evident in the large studies that have been done to date. (The average duration of the studies is about five years, and the average age of patients is less than 60.) We can not know whether statins will turn out to increase the risk of cancer when used long term, nor can we know from one study whether older people might be particularly susceptible. The one thing we can know is that the denials of the evidence of such a relationship in the 2001 cholesterol guidelines and by the authors of the PROSPER article (sponsored by Bristol-Myers Squibb) suggest that the principle 'First do no harm,' which should be fresh in our minds from the increased rate of breast cancer caused by HRT, seems, once again, to have been forgotten.'"- Overdo$ed America (page 145-146)
Dr. Abramson described that there was a study in JAMA from 1996 that described that long term use of statins to reduce cholesterol levels could potentially cause cancer. During 2001, there were new cholesterol guidelines that stated that statins did not cause cancer and that statin use could help against heart disease. The 2001 cholesterol guidelines described that lowering cholesterol with statin use was to be prioritized to prevent heart disease. We learn that the guidelines did not describe the importance of exercise and diet counseling in reducing high cholesterol. Instead statin use was prioritized, and possible side effects of statin use were not mentioned or were not given importance.
Dr. Abramson describes how the studies concerning HRT for women describe the importance of studying possible side effects of newer medication. We learn that statin use treatment for high cholesterol began in 1987 with Mevacor that is now a generic medication called lovastatin. Since then there are newer statin drugs that are promoted to help against heart disease and lowering cholesterol levels. We learn that the 2001 cholesterol guidelines attempted to describe the need for more individuals to take statins based on cholesterol levels. This guideline would have increased the number of people who needed to take statins.
The High Cost of Medicine and Lower Quality of Healthcare Since the 1990s
"Yearly increases in health care insurance premiums once again started to balloon out of control, rising steadily from a low 2 percent annual increase in 1996 to 13.9 percent in 2003. The cost containment potential of HMOs and managed care was, initially, a serious threat to drug companies and medical device manufacturers. But the broader coverage offered by the new plans turned out to have the most profound unintended consequences: Instead of containing healthcare costs, HMOs and managed care plans facilitated the almost unrestrained increases in healthcare spending that followed." Overdo$ed America (page 82)
Dr. Abramson describes the manner that healthcare costs in the United States have been increasing since the 1970s while there has not been a significant improvement in quality of care. We learn that while healthcare costs have increased over the decades, the quality of healthcare has actually decreased. Dr. Abramson describes that since the 1980s there were attempts at trying to decrease costs with HMOs and insurance plans that allowed for cheaper co-pays and reduced medication plans. While the healthcare plans were working and helping communities, we learn that there was negative media coverage about the insurance plans since they were actually reducing costs and improving health of communities where individuals had decreased sicknesses, decreased emergency room visits, and decreased number of hospitalizations. This was due to health care providers (primary care and family practice) and health care HMOS and insurance companies working together to decrease costs and improve the quality of care given.
"Even the public anger at the witholding of care by overly aggressive or greedy "gatekeepers" turned out to be largely a myth: a study conducted by a nationwide managed company, United Healthcare, showed that fewer than 1 in 100 requests for referals were being denied, leading the insurer to drop its requirement for primary care approval of referrals. Still, as an American researcher in a Canadian medical journal, "Regardless of the evidence, there is a strong sentiment among both physicians and patients that managed care is harming quality of care." So what was the real problem? Initial cost savings had come fairly easy. Doctors, hospitals, and other healthcare providers had little choice but to accept discounted fees in order to be included in the newly formed networks of healthcare providers; otherwise they risked losing access to their patients. These so called volume discounts controlled prices during the transition to managed care, but the apparent solution was short-lived. Once the discounts had been factored in, this apparently exquisite solution to controlling costs- local health care budgets set by the market place instead of the government- became the problem. When there were no more cost savings to be squeezed out of the fees paid to healthcare providers, HMOs and managed care companies had only one avenue open: they had to start to really "manage" care, that is, control costs by eliminating unnecessary or wasteful care. Almost overnight, the hyperbolic hopes for managed care and appreciation of the greater coverage quickly turned into hyperbolic villification. In one survey, 59 percent of the people expressed negative feeling about HMOs and managed care in general, but 69 percent of the same people were satisfied by the actual care they were receiving from their own HMO or managed care plan."- Overdo$ed America (page 81-82)
We learn that Dr. Abramson states that it is possible that the pharmaceutical companies, medical equipment industries, hospital services, and specialty care physicians may have caused there to be a negative perception on news media about insurance plans that were actually created to instruct preventative care and provide optimal healthcare. We learn that negative news coverage of healthcare plans was negative compared to positive after the integration of HMOS and health insurances that decreased costs of healthcare and improved quality of care. We learn that the negative coverage by the news media caused there to be a false perception that people were disliking their medical care with fake stories about patients being rushed from doctor visits when medical journal articles in the 1990s described that doctors were spending additional minutes with patients instead of decreasing their patient visit times. Physicians were still seeing their patients with the same frequency. These fake stories caused people to think that the HMO and health coverage was sub-standard when people were enjoying their healthcare. After the 1990s, the costs of healthcare increased significantly leading to healthcare plans increasing in costs along with prescription medications and treatments. By 2003, the health premiums had increased annually to 13.9 percent from a low 2 percent in 1996. The high cost of medical care in the U.S. can be explained partially by rising premium costs, decreased number of primary care providers compared to specialty physicians, and increased risk of litigation leading to more labs and studies ordered based on litigation prevention than health concerns. These are some of the reasons that the cost of health care has increased over the years while not necessary improving the quality of care received. There is also big pharma's influence on leading medical journals leading to physicians prescribing more expensive and newer drugs already described in the Vioxx and Celebrex examples. The pharmaceutical companies have gained influence over the years even leading to regulators being influenced by financial ties with big pharma.
"The most dangerous consequence of these changes was that the number of drugs approved by the FDA but later withdrawn from the market for safety reasons increased by 1.6 percent of drugs approved between 1993 and 1996 to 5.3 percent between 1997 and 2000."- Overdo$ed America (page 86)
Regulators including FDA and NIH Did Not Prevent Rezulin From Being Approved When There Were Results of Liver Toxicity and Truthful Facts
"The blood sugar-lowering diabetes drug Rezulin is one of the drugs that were approved in haste by the FDA- and later withdrawn, but much too late for many americans. The details of the story were first presented by David Willman of the Los Angeles Times. Also in 1996 Warner-Lambert submitted Rezulin to the FDA for approval, and it became the first diabetes drug to be given an accelerated review. The medical officer evaluating the new drug application, Dr. John L. Gueriguian, was a 19-year veteran of the FDA. His review recommended that Rezulin not be approved: the drug appeared to offer no significant advantage over other diabetes drugs already on the market, and it had a worrisome tendency to cause inflammation of the liver. Warner-Lambert executives 'complained about Gueriguian to the higher-ups at the FDA." Dr. Gueriguian was then removed from the approval process for this drug. When the Advisory Committee met to decide on the approval of Rezulin, they were not informed of Dr. Gueriguian's concerns about liver toxicity. The FDA approved Rezulin in February 1997, and brisk sales soon earned it 'blockbuster' status. Despite the mounting reports of liver problems in the United States, Rezulin was not withdrawn from the U.S. market until March 2000. By that time, $1.8 billion worth of the drug had been sold. The Los Angeles Times reported that, all told, Rezulin was suspected in 391 deaths and linked to 400 cases of liver failure."- Overdo$ed America (page 86-87)
Rezulin was a diabetes drug that was "supposed to help" with blood sugar levels. We learn that it was given preferance to be in a clinical study where the difference between medication treatment or lifestyle interventions would be seen by the NIH. The FDA reviewed the application of the drug and the reviewer in charge of the application found out that the drug, Rezulin, was not better than previous diabetes medication and actually caused liver disease. When Dr. Gueriguian offered a real and truthful review about the drug, the executives of the drug company complained to the FDA and he was removed from the reviewer position having 19 years experience. We learn that when the FDA made the decision to approve the drug, the FDA was not informed about Dr. Gueriguian's review of Rezulin causing liver disease. We learn that even regulators were affected by the financial ties with pharmaceutical companies.
This describes the importance of integrity and ethics even amidst the supposed hope of new drug medications. Rezulin lasted four years on the market before being removed after individuals were harmed by the diabetes drug. This helps us know that we can not trust new medications that are approved in haste not knowing the side effects of newer medication. The drug application process took almost a decade to know the effects of drug therapy and if the drug therapy is beneficial. Dr. Abramson helps us understand the importance of lifestyle changes describing exercising and diet counseling to improve health and the need to be cautious about newer drug medication that has not been approved within the normal timeline of testing 8-10 years minimum.
Health Recommendations Concerning Sex
In the health recommendations, we also read about the need to not practice unsafe sex. The guidelines were from 2002, and there are news from previous years that speak about the increase of antibiotic resistant sexually transmitted diseases. From a Christian perspective, safe sex means sex in a marriage consisting of a man and a woman. We learn that because of the practice of polyamorism and adultery, the antibiotics that were created less than a hundred years ago are not helping against antibiotic resistant STD's describing Gonorrhea, Chlamydia, and Syphilys. This describes new variants of antibiotic resistance.
There is the need to protect oneself from fornication and adultery knowing that there are new strains of STD's that do not have treatment. We learn that antibiotics do not help if individuals get such STD's. We learn from Scripture that sex is only allowed in a marriage. If individuals are single, there is the need to avoid lust, fornication, adultery, and homosexuality that attempt to lead to difficulties and diseases. We can make sure to know the difference being able to know that we can use our time and resources for the worship of GOD Almighty and not believe the temporary lies of evil that want to lead to the practice of vices.
Updates Concerning covid "vaccines"
We are able to see from the previous years about the manner that covid news attempted to say that the immune system could not fight against covid being that the immune system is able to combat viruses, parasites, bacteria, and fungus. We learn that the news media stated on repeat that the only manner to fight against covid was to get the covid "vaccine". We learn from biology that the immune system is able to combat viruses and can even develop immunity from infections. The news media described the need to "vaccinate" in order to fight covid and prevent covid infection when exercise and nutrition can help our immune system fight viruses. The news media did not mention the importance of exercise and diet on helping the immune system nor on being able to trust the immune system.
We learn that we can not believe everything that the news media says because of how they tried to make it seem that the immune system could not fight covid and the only manner to fight covid was with the covid "vaccine". We are able to know that we can instead trust in our immune system that GOD Almighty has created in amazing wonder and have healthy skepticism about the covid "vaccines" since there is no information concerning the source, no decade long studies on how the covid "vaccine" functions or if it provides health benefits, and we still do not know the source of the covid variants. All of this causes questions regarding on the need to "vaccinate" against covid and instead allows us to trust in our immune system.
(I recently began to read the book from Dr. Abramson since I had bought the book several years back yet did not read it thinking that it was about the opioid epidemic. Upon reading the book in the past few days, I am able to understand why individuals are skeptical of pharmaceutical companies and why healthy lifestyle changes describing exercise and dietary changes are of great importance.)
