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Worst Pills and Why


Is it this bad???  Are doctors dupes of the pharmaceutical industry (pharma)?  Are guidelines based upon junk science generated by pharma?  Are half the drugs not worth their side effects.   Is bias in journal articles the norm because pharma owns the raw data and thus writes up clinical trials to promote sales, and thus the evidence base for drugs is broken?   Is the FDA a lap dog for pharma?   Obviously, the billions spent on advertising is designed to promote sales counter to the evidence through product recognition.  As a consumer making an informed choice, you must be aware of the state of medicine and thus the fractured evidence base upon which your physician write prescriptions.  What follows is the result of thousands of hours of investigative research to help you make a better choice.  It all starts with your recognition that the system is broken in ways that harm patients and profits pharma.      

At bottom of page is an article on the junk drugs approved by the FDA for 2013, by worstpill.org

     




bell curve and mopts chemo therapy is over sold
bell-curve-sm1.bmp.jpg



AVOID LIST


With position papers: acetaminophen, chemotherapy for cancer (with a few exceptions). 


Other Drugs:  bisphosphonates for osteoporosis, psychotropic drugs (downers), Alzheimer’s disease, protein pump inhibitors for heart burn.


A separate paper here sets out the cholesterol myth and the ineffective treatments for high blood pressure, high cholesterol, irregular heartbeat, and blood clots, with a list of much better alternatives.  The article on the role of diet in chronic conditions contains a list of foods to avoid.  There are links to the longer articles.  For Cardiovascular Disease and drugs.


 


Drugs with position papers:


 Acetaminophen (Paracetamol, APAP):  It is the most widely sold over-the-counter drug for the relief of pain[1], fever, and headaches.  It is found in over a 100 over-the-counter and prescription preparation (mostly opiates).  As a mild analgesic APAP’s inclusion with an opiate cannot be justified given its severe side effect of causing live damage.  The annual percentage of potentially fatal acute liver failure (ALF) hospitalizations caused by acetaminophen rose from 28 percent in 1998 to 51 percent in 2003.  A major cause is that acetaminophen is indicated as APAP on most opiate prescriptions and the common use of the over-the-counter Tylenol as a second drug for relieve of pain.  In a well-designed study it was found that 39% of those taking the recommended dosage of APAP had 3 to 8 times the upper limit for ALT a marker for liver toxicity.  APAP in 2010 caused 56,000 emergency-room visits, 26,000 hospitalizations and 1,600 liver failures, and this is based on a system designed to grossly underestimate the severity of the problem.  New FDA limits and warning goes into effect in 2014.  A study of 205,487 children age 6-7 found that the use of APAP is associated with a 323% increase in the risk of asthma.  Four weeks of prenatal use of APAP is associated with lower motor, cognitive development and more behavioral problems when compared to a sibling by over 70% for each.  Other study found that APAP during pregnancy was associated with hyperactivity (ADHD, another with failure to develop testes (cryptorchidism), and a third with lower masculinization development.  The medical literature on liver toxicity goes back to the 1960s.  Pharma is very good at controlinge information given to doctors and the public. 


Chemotherapy & Cancer:  For simplicity the discussion is limited to the most common types of cancers. Within them are two groups, one with an overall survival of above 50%, colon, prostate and breast; while for small cell lung and pancreatic cancers the 5-year survival is less than 5%.  If fatal, it is metastatic--spreads to distant tissues, and chemotherapy is not curative.  The basic question, once diagnosed, is the prognosis?  Several factors are relevant to estimating how invasive the cancer is.  A biopsy examined under the microscope that reveals many highly abnormally shaped cells has a high statistically association with aggressive (fast growing) cancer, but about 40% are still indolent.  Found in 3 local lymph nodes is associated with metastatic (about 60%), and aggressive (about 80%) of cancers.  Distant metastatic cancer has about a 10% chance of being indolent with about half (5%) living past 5 years.  However, there is no way to know at stages I through III, if that cancer has become metastatic.  If small colonies have already spread to distant tissues, removal of the primary tumor does not change the prognosis.  The clock however is running as to when a cancer will change from indolent or local aggressive to a metastatic cancer.  This change is through the involvement of stem cells.  The prompt removal of the cancer is the prudently choice to prevent stem cell involvement.  If some indolent cancer remains, once discovered it can be removed; chemotherapy does not affect the course of the disease, it just extends life 3 months.  Those few with metastatic cancer who live several years, do so not because of an atypical response, but because the cancer is indolent.  Without strong proof that the chemotherapy is curative, it is not worth taking.  Remember as stated in “Marketing Science”:   the assorted conflicts of interest created by the role of pharm in research, education, treatment guidelines entail that the oncologist is a misinformed patient guide.  Also major Positive bias is the norm:  pharma funds clinical trials, owns the results, write it up, and publish in pharma “friendly” journals.  


Cancer basics:  cancer is distinguished from a benign tumor by its ability to invade neighboring tissue and sometimes spread to distant tissues (metastasize).  Also benign tumors generally have a slower growth rate and are more differentiated (look like normal cell ).  This is the first area where business has blurred the distinction between benign and malignant by often calling benign “carcinoma”; it isn’t unless there is evidence of invasion to adjacent tissue.  Critics have pointed out the negative consequences of treating benign tumors of the breast prostate, thyroid cancers, and other tissues chemotherapy following excision or radiotherapy.   Such aggressive treatment in long-term trials show no benefit or worse.  Benign breast tumors, called “cancer”, when treated with chemotherapy shorten life over 4.5 years (mostly through the use of an estrogen blocking drugs and the exclusion of those patents from HRT).  In general treating stage I, II, & III cancers aggressively with chemotherapy doesn’t change the course of the disease, but shorten the life of all for who are cancer survivors.  The chemotherapy is pointless because all of it has been removed by excision.  With the exceptions of a few tissue types, chemotherapy doesn’t cure cancer, but rather shuts down an essential biological process that affects the rate of cell reproduction, including in the cancer.  This toxicity limits the chemotherapy.  The average remission (slowing of growth) is 3 months.  About half of the patients will have long-term side effects.  Patients and physicians believe that the chemo destroys cancer missed by excision, it doesn’t, and they also believe that those with metastatic cancer who live pass the average do so because of a typical response to the chemotherapy, but rather it is because that patient had an indolent (slow growing) cancer.   Pharma’s two deception are to deny indolent metastatic cancer, and to claim that chemotherapy can destroy for a few patients the cancer missed by excision.   The oncologists’ greatest source of income is the spread between the discount price they get the chemo and what they bill.  Chemotherapy is thus oversold.



[1] The mechanism for pain reduction is through the reduction of inflammation by blocking only 50% of COX2 & COX1 enzymes and inhibiting the production of prostaglandins (Goodman & Gilman’s pharmacology textbook 2007 edition, p. 693).  This is why they are classified as “mild analgesics” (G & G at 681).  Other claims as to medicinal use is at best only weekly supported. 




 


Drugs with position papers (for heart drugs):


 Acetaminophen (Paracetamol, APAP):  It is the most widely sold over-the-counter drug for the relief of pain[1], fever, and headaches.  It is found in over a 100 over-the-counter and prescription preparation (mostly opiates).  As a mild analgesic APAP’s inclusion with an opiate cannot be justified given its severe side effect of causing live damage.  The annual percentage of potentially fatal acute liver failure (ALF) hospitalizations caused by acetaminophen rose from 28 percent in 1998 to 51 percent in 2003.  A major cause is that acetaminophen is indicated as APAP on most opiate prescriptions and the common use of the over-the-counter Tylenol as a second drug for relieve of pain.  In a well-designed study it was found that 39% of those taking the recommended dosage of APAP had 3 to 8 times the upper limit for ALT a marker for liver toxicity.  APAP in 2010 caused 56,000 emergency-room visits, 26,000 hospitalizations and 1,600 liver failures, and this is based on a system designed to grossly underestimate the severity of the problem.  New FDA limits and warning goes into effect in 2014.  A study of 205,487 children age 6-7 found that the use of APAP is associated with a 323% increase in the risk of asthma.  Four weeks of prenatal use of APAP is associated with lower motor, cognitive development and more behavioral problems when compared to a sibling by over 70% for each.  Other study found that APAP during pregnancy was associated with hyperactivity (ADHD, another with failure to develop testes (cryptorchidism), and a third with lower masculinization development.  The medical literature on liver toxicity goes back to the 1960s.  Pharma is very good at controlinge information given to doctors and the public. 


Chemotherapy & Cancer:  For simplicity the discussion is limited to the most common types of cancers. Within them are two groups, one with an overall survival of above 50%, colon, prostate and breast; while for small cell lung and pancreatic cancers the 5-year survival is less than 5%.  If fatal, it is metastatic--spreads to distant tissues, and chemotherapy is not curative.  The basic question, once diagnosed, is the prognosis?  Several factors are relevant to estimating how invasive the cancer is.  A biopsy examined under the microscope that reveals many highly abnormally shaped cells has a high statistically association with aggressive (fast growing) cancer, but about 40% are still indolent.  Found in 3 local lymph nodes is associated with metastatic (about 60%), and aggressive (about 80%) of cancers.  Distant metastatic cancer has about a 10% chance of being indolent with about half (5%) living past 5 years.  However, there is no way to know at stages I through III, if that cancer has become metastatic.  If small colonies have already spread to distant tissues, removal of the primary tumor does not change the prognosis.  The clock however is running as to when a cancer will change from indolent or local aggressive to a metastatic cancer.  This change is through the involvement of stem cells.  The prompt removal of the cancer is the prudently choice to prevent stem cell involvement.  If some indolent cancer remains, once discovered it can be removed; chemotherapy does not affect the course of the disease, it just extends life 3 months.  Those few with metastatic cancer who live several years, do so not because of an atypical response, but because the cancer is indolent.  Without strong proof that the chemotherapy is curative, it is not worth taking.  Remember as stated in “Marketing Science”:   the assorted conflicts of interest created by the role of pharm in research, education, treatment guidelines entail that the oncologist is a misinformed patient guide.  Also major Positive bias is the norm:  pharma funds clinical trials, owns the results, write it up, and publish in pharma “friendly” journals. 


Cancer basics:  cancer is distinguished from a benign tumor by its ability to invade neighboring tissue and sometimes spread to distant tissues (metastasize).  Also benign tumors generally have a slower growth rate and are more differentiated (look like normal cell ).  This is the first area where business has blurred the distinction between benign and malignant by often calling benign “carcinoma”; it isn’t unless there is evidence of invasion to adjacent tissue.  Critics have pointed out the negative consequences of treating benign tumors of the breast prostate, thyroid cancers, and other tissues chemotherapy following excision or radiotherapy.   Such aggressive treatment in long-term trials show no benefit or worse.  Benign breast tumors, called “cancer”, when treated with chemotherapy shorten life over 4.5 years (mostly through the use of an estrogen blocking drugs and the exclusion of those patents from HRT).  In general treating stage I, II, & III cancers aggressively with chemotherapy doesn’t change the course of the disease, but shorten the life of all for who are cancer survivors.  The chemotherapy is pointless because all of it has been removed by excision.  With the exceptions of a few tissue types, chemotherapy doesn’t cure cancer, but rather shuts down an essential biological process that affects the rate of cell reproduction, including in the cancer.  This toxicity limits the chemotherapy.  The average remission (slowing of growth) is 3 months.  About half of the patients will have long-term side effects.  Patients and physicians believe that the chemo destroys cancer missed by excision, it doesn’t, and they also believe that those with metastatic cancer who live pass the average do so because of a typical response to the chemotherapy, but rather it is because that patient had an indolent (slow growing) cancer.   Pharma’s two deception are to deny indolent metastatic cancer, and to claim that chemotherapy can destroy for a few patients the cancer missed by excision.   The oncologists’ greatest source of income is the spread between the discount price they get the chemo and what they bill.  Chemotherapy is thus oversold.


 


Other Dangerous Drugs--without position papers:


A number of different families of drugs are clearly not worth the side effects for which we have not written a position paper, yet we are aware of the tenuous evidence and warning issued by others.  We turn to site such as Worstpill.org, and Cocharanereview.org act as watchdogs.  But they are limited by their sources:  they rely upon the FDA and meta-analysis (combining results of several clinical trials) of the treatments.  They choose their battle and thus repeat the pharma generated errors on aspirin and hormones.  But clinical trials are funded by pharma and positive bias averages 32%, thus meta-analysis reflect this distortion.   Our other sources are critics of treatments that are published in medical journal, older medical textbooks.  Sometimes we find a conflict between the scientific analysis of the condition and the modus operandi (method of action) of the drugs.  Also many on the face of it are suspect:  giving downers to depressed patients, treating osteoporosis with unnatural chemicals that go to the bones rather than calcium compounds, attempting to treat a condition with a drug that doesn’t act upon the underlying cause.  A junk drug does more harm than good, and often there are clearly better alternatives.    Below is the current list of other junk drugs.


Junk list:   Bisphosphonate for osteoporosis.  They increase the bone density by putting a compound containing two phosphate groups (P03) in the bones,  It isn’t the same as bone building the natural way with hydroxyapatite (Ca10(PO4)6(OH)2) and collagen.   Bisphosphonates don’t prevent fractures long-term and there are side effects. NSAIDs but for aspirin.  They have minimal pain reduction effect, work well as an anti-inflammatory drug by reducing inflammation, thus their affect upon pain is minor, as demonstrate by clinical trials.  Unfortunately they increase with long-term usage the incidents of heart attacks and strokes—from 50% to 400%.  This includes the block buster Celebrex which increases with long-term usage risk 200%.   Psychotropic drugs used for psychiatric conditions are much worse than behavioral therapy and worse than no treatment.  “When both published and unpublished trials are looked at, paroxetine [Paxil] does not appear to be any better than placebo in adults with moderate or severe depression” Wiki. With only a couple of exceptions all psychiatric drugs are tranquilizers (downers):  hinder cognitive function and cause drowsiness.  Since “downer” and “tranquillizer” have negative connotations, they all wear different labels for marketing, such as mood elevator, muscle relaxant, ACE inhibitor, SSRI, etc.  Besides used for behavior issues, tranquilizers are widely prescribed for physical conditions such as for back pain, angina, brain trauma, epilepsy, menopausal hot flashes, hypertension, and so on; even though they don’t affect the core problem and benefits in pharma’s clinical trials are only slightly better than a placebo.  Tranquilizers are spotted by the side effect of drowsiness and their indication for psychiatric conditions.  FDA approval is based on 6-week clinical trial of an ideal population for the goals of the trial—not a real-world clinical population.   By impairing cognitive function, these drugs do not promote long term behavior improvements in the general population (no more than alcoholism or marijuana does).  They do not help people deal the underlying psychiatric behavior problem,  In a 2014 population study, “After excluding deaths in the first year, there were approximately four excess deaths linked to drug use per 100 people followed for an average of 7.6 years after their first prescription” BMJ.  These downers by reducing cognitive function make the patient more dependent upon expert opinion, their doctor and thereby are associated with polypharmacy; and they shorten life.  They negatively affect quality of life, which is why there is low compliance.  Treatment of children psychiatric disorders--before the 70’s quite rare--is unwarranted (with rare exceptions).  Most conditions requiring hospitalization will include a tranquilizer, protein pump inhibitors (PPI) and acetaminophen (APAP).  Sleep and cognitive confusion reduces discussion with staff and thus lightens the work of the care givers, plus they increases profits.  Alzheimer’s disease (AD), drugs do not affect the course of the disease.  Factoring in the side effects, they are worse than a placebo.  Downers are often included in treatment of AD, as if the patient needs more cognitive impairment.   Avoid for AD Aricept (donepezil), tranquilizers, & Cognex (tacrine) and all other drugs given to purportedly slow the progress of AD (they don’t) or make the patient more manageable.  Downers that shorten life and increase signs of dementia.  Acid reflux condition (heart burn) should be treated with over-the-counter antacids; avoid the prescription alternatives, especially protein pump inhibitors which have rebound effect if stopped which increases heart burn.  There is a lack of effective drugs for COPD, restless-leg syndrome and many of the minor complaints that are listed in the Merck Manual, such as fungal infection of the nails.  Tamiflu and other flu medications such as are junk (see Bad Pharma supra 81-91).  Pharma is very good at making a drug not worth taking appear as safe and effective. 


Pharma is also very good at cooking up new indications for drugs and having them used off label.  Over half the prescriptions given are for uses that have not meet the very low FDA hurdle.  Most off-label uses have shoddy marketing research (phase IV clinical trials), which are used to “educate” doctors.  In general, off-label uses are not in the patient’s best interest.  Doctors have been cast in the role of drug pushers through clinical guidelines, clinical administrators, peer pressure, financial rewards from pharma, a lack of reliable information on treatment alternatives, and continuing educations class given by pharma to name the main ones.  The $600 industry is very good at marketing. 


 

[1] The mechanism for pain reduction is through the reduction of inflammation by blocking only 50% of COX2 & COX1 enzymes and inhibiting the production of prostaglandins (Goodman & Gilman’s pharmacology textbook 2007 edition, p. 693).  This is why they are classified as “mild analgesics” (G & G at 681).  Other claims as to medicinal use is at best only weekly supported. 


What is good?

There are a number of very useful drugs, some of treating conditions, others for preventing them.  Once off-patent, the norm is for pharma to do shoddy studies to show their newer patented drugs are superior.  Pharma fund and government funded medical studies of the last 2 decades is all about marketing—significantly more so than earlier studies.  Off-patent drugs that prevent chronic conditions are especially singled out (as our papers on HRT and aspirin demonstrate).  Older drugs are safer than newer drugs because with usage side effects are revealed.  Supported by doggy studies, the newer are hyped as better.  Thus without compelling evidence, don’t take the newer patented drug when an older off-patent drug is available.

What clearly works (prescriptions):  Antibiotics work for bacterial infection; antifungal preparations may be effective.  The claim of microbial tolerance is supported by doggy studies.  Opiate family of pain medications.  Local anesthetics such as procaine and lidocaine, anti-infective medicines to deal with immune reactions such as antihistamines and hydrocortisone,  anti-AIDS drugs, for edema diuretics, insulin for diabetes, levothyroxine for thyroid hormone, vaccines, nitroglycerin for angina and myocardial infarction (MI), streptokinase for MI and other thrombosis, drugs for worm invasions, body lice, amoebic and such.  Of course there are more for special situations such as anemia, genetic conditions, ear infection, and so on.    

For the major health issues the best treatment is defensive.  For diet that lowers the risk of obesity, cardiovascular disease, and metabolic syndrome a 2 page summation.   For drugs that prevent major health issues with compelling evidence with links (which of course pharm attacks with their marketing studies) CoQ10, aspirin325 mg, and natural hormone replacement therapy for women, and for elderly men testosterone in sufficient dose.   And if you are in doubt about the extent of corruption worked by pharma in the information system and medical practice, please read Marketing Science.  Also go to the video page for convincing documentaries, including YouTube links and there is a list of books.

This list is from the website worstpills.org.   This is a conservative site which relies upon warning issued by the FDA concerning drugs.  Thus the site doesn’t expose the effects of the broken evidence by relying upon older studies that challenge current practices, look into the evidence base for the ever expanding basis of the use of prescription drugs such as the lowering of blood pressure and blood level of cholesterol for treatment with drugs.  Saying this, worstpill.org can steer doctors and patients away from inferior and dangerous drugs, but it won’t expose the junk science behind the assault upon aspirin, estrogen, and testosterone. 

http://www.worstpills.org/member/newsletter.cfm?n_id=893

Of the 27 new drugs approved by the Food and Drug Administration (FDA), Public Citizen’s Health Research Group has identified many as dangerous or ineffective. This article reviews those drugs, as well as dangerous newly approved uses for two drugs already on the market.

New drugs approved in 2013: Do Not Use:  All me-too drugs

Alogliptin
(approved January 2013

Alogliptin is the latest in a class of diabetes drugs known as incretin mimetics. The FDA approved three versions of alogliptin, each with a different brand name: NESINA, a single-drug pill containing only alogliptin; KAZANO, a combination pill containing alogliptin and the diabetes medication metformin; and OSENI, a combination pill containing alogliptin and the older diabetes drug pioglitazone. Alogliptin and other incretin mimetics are associated with severe side effects, including pancreatitis and possible pancreatic cancer. Due to these and other safety concerns, all incretin mimetics are classified as Do Not Use drugs by Worst Pills, Best Pills.

Mipomersen
(approved January 2013)

Mipomersen (KYNAMRO) was approved to treat an extremely rare, fatal genetic condition called homozygous familial hypercholesterolemia (HoFH), which causes very high blood-cholesterol levels. Its approval followed closely on the heels of a similar drug, lomitapide (JUXTAPID), approved for the same disease in December 2012. Public Citizen testified against mipomersen’s approval due to its liver toxicity and because studies of the drug did not compare it with the current standard and life-prolonging treatment for HoFH, LDL apheresis (a procedure in which a patient’s blood is passed through a specialized filter that removes LDL or “bad” cholesterol directly from the blood).

Canagliflozin
(approved March 2013)

Canagliflozin (INVOKANA) was the first of a new class of medications for type 2 diabetes known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. (The second drug in this class, dapagliflozin [FARXIGA], was approved in January 2014.) For more information on canagliflozin, see the top story in the February 2014 edition of Worst Pills, Best Pills News.

Fluticasone/Vilanterol 
(approved May 2013)

The combination inhaler (BREO ELLIPTA) contains the steroid fluticasone (a drug used to suppress inflammation in the lungs) and the bronchodilator vilanterol (a drug that dilates the large airways in the lungs, known as bronchi). It was approved to treat chronic obstructive pulmonary disease (COPD). Public Citizen’s Health Research Group testified before the FDA’s Pulmonary and Allergy Diseases Advisory Committee, strongly opposing approval of the combination of fluticasone and vilanterol because it did not provide any substantial benefit over vilanterol alone in improving COPD symptoms, but it did lead to an increased number of serious side effects, including bone fractures and infections such as pneumonia.

Flutemetamol F18 injection
(approved October 2013)  A pointless, inconclusive test for a condition for which there is no effective treatment (Alzheimer’s disease)

Flutemetamol F18 injection (VIZAMYL) is the second radioactive tracer drug to be approved for use with a positron emission tomography (PET) scan of the brain to rule out a diagnosis of Alzheimer’s disease (AD), which is associated with the buildup in the brain of a substance known as beta amyloid.

As acknowledged by the FDA in announcing flutemetamol F18’s approval, beta amyloid tracers used in PET imaging can only help rule out AD with a negative result. However, as Public Citizen has previously noted, a positive test indicating the presence of beta amyloid is essentially useless because it cannot specifically identify a cause of the cognitive impairment, meaning patients must always be assessed for additional causes regardless of whether the imaging test is negative or positive. Moreover, no clinical trial has demonstrated that PET imaging for beta amyloid changes the health outcomes of patients displaying early signs of cognitive dysfunction or of any other patient population. Indeed, even if a test existed that was 100 percent accurate in diagnosing AD, it would not lead to any tangible health benefits for patients because there are currently no available therapies to reverse or substantially slow the progression of AD.

Umeclidinium/Vilanterol  Another drug affecting neurons  beta-2 agonists open large conductance calcium-activated potassium channels and thereby tend to hyperpolarize airway smooth muscle cells
(approved December 2013)

This drug (ANORO ELLIPTA), an inhaled combination of two long-acting bronchodilators, umeclidinium and vilanterol, was approved as a once-daily, long-term maintenance treatment for COPD. It represents the first time two different classes of long-acting bronchodilators, long-acting muscarinic antagonists and long-acting beta agonists, had been approved as a single combination drug. However, because of troubling potential cardiac risks, Public Citizen’s Health Research Group testified before the FDA’s Pulmonary and Allergy Diseases Advisory Committee that the drug should not be approved until a larger trial was conducted to further clarify the nature of this potential side effect.

New indications: Do Not Use

Oxybutynin (granted over-the-counter status in January 2013) Another tranquilizer (anticholinergeic)

In January 2013, the FDA approved over-the-counter status for oxybutynin (OXYTROL FOR WOMEN), available by prescription since 1975 for overactive bladder. In so doing, the FDA ignored the advice of its own advisory committee, which in November 2013 had warned that it was too dangerous to use the drug without a physician’s supervision, especially for the elderly. Because of a litany of side effects and the need to rule out potentially serious causes of symptoms similar to those of overactive bladder, Public Citizen warned consumers not to use oxybutynin without first seeing a doctor and discussing the benefits and risks of the drug (for more details, see the article about over-the-counter oxybutynin in the August 2013 issue of Worst Pills, Best Pills News).

Paroxetine for menopausal symptoms (approved for this new indication in June 2013)  An SSRI tranquilizer, nothing new.  Prozac in 2001 was approved for premenstrual dysphoric disorder under the name of Sarafem at 3 times the price.

Paroxetine has been on the market as an antidepressant (PAXIL) since 1992. In March 2013, the FDA’s Advisory Committee on Reproductive Health Drugs considered an application for approval of a lower dose of the drug as a treatment for hot flashes and flushing in menopausal women. Public Citizen’s Health Research Group testified that there was insufficient evidence from the pre-approval clinical trials that the drug provided meaningful benefits for menopausal symptoms, but it did come with several serious risks, including seizures and possible suicidal tendencies.

In June, the FDA approved paroxetine (BRISDELLE) for the treatment of moderate to severe hot flashes. The company secured approval for a 7.5 milligram (mg) dose, making it more difficult for patients to obtain this dose by simply breaking in half cheaper 10 mg or 20 mg pills of generic paroxetine. A 30-day supply of BRISDELLE costs $135, compared to just $7 for 30 tablets of the 10 mg dose of generic paroxetine. An article in the January 2014 issue of Worst Pills, Best Pills News advises against the use of paroxetine for treatment of hot flashes.

Conclusion

There were slightly fewer new drugs approved in 2013 than in 2012, which had the highest number of approvals (39) since 1997. Yet there are no indications that this small decline represents a harbinger of improved approval standards at Obama’s FDA.

With so many dangerous and ineffective drugs already slipping through the FDA’s lax approval process, it may just be a matter of time before we experience a new wave of drug safety disasters.

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