CounterPunch has just published a great review of The Zyprexa Papers, Jim Gottstein’s book about his battle over Zyprexa (Olanzapine) with drug marketing giant Eli Lilly. Written by Bruce E. Levine, a psychologist and social critic, the review addresses the broad social issues raised by Jim Gottstein’s story. Here is an excerpt from the review:
The Zyprexa Papers: A Legal System for Drug Companies and Lawyers… Not the Public
On November 28, 2006, attorney Jim Gottstein received a phone call that would change his life. It would propel Gottstein into a legal war against the giant pharmaceutical company Eli Lilly, who would retaliate against him for his release of Lilly’s own documents about its drug Zyprexa. A U.S. District Court would rule that Gottstein had conspired to steal these documents, and Lilly would threaten Gottstein with criminal contempt charges. Gottstein’s The Zyprexa Papers (2020) is an account of his odyssey.Lilly had good reasons to be fiercely protective of Zyprexa (the brand name for olanzapine), approved by the Food and Drug Administration (FDA) for people diagnosed with schizophrenia and bipolar disorder. Zyprexa, by 2017, had lifetime sales of $60.6 billion.
Lilly HQ: Photograph Source: Momoneymoproblemz – CC BY-SA 4.0
The Zyprexa Papers is not simply about the harm done by blockbuster psychiatric drugs and drug company illegal marketing. It is also about the perversion of the U.S. legal system, as Gottstein illuminates the courts’ use of secrecy orders in settlement agreements to the detriment of the public.
The review includes this direct quote from Gottstein’s book:
“When lawyers are faced with companies telling them they won’t settle unless everything is kept secret, the lawyers almost always advise (insist) their clients agree. . . .This is a situation where the benefits accrue to one group and the detriments to another. In other words, their clients are not harmed by keeping the information secret, but the public is harmed. Their clients only get benefits, i.e., money. This is also true of the lawyers, who get paid (a lot) if the case is settled but don’t get paid if they lose. The judges are supposed to allow the secrecy only if it is in the public interest, but in practice, they don’t. The secrecy greases the wheels of settlement as well as litigation, and judges want to have cases resolved and off their docket. So the incentives are all pushing towards keeping things secret. Normally, no one is representing the public interest.”
See the full review: The Zyprexa Papers: A Legal System for Drug Companies and Lawyers…Not the Public
Bruce E. Levine, CounterPunch.org
The Zyprexa Papers, Hardcover edition
Publish Date: June 1, 2021
Buy: The Zyprexa Papers on Amazon.com
Author: Jim Gottstein
Edition: Hardcover
Publisher: Samizdat Health Writer’s Co-operative Inc.
Press Inquiries: Please contact author Jim Gottstein at jim.gottstein@psychrights.org.
The Zyprexa Papers (olanzapine) and Study 329 (paroxetine sold as Paxil)
Zyprexa
The authors of the Zyprexa Papers and the re-analysis of the use of the antidepressant paroxetine in children and adolescents posted articles on the Samizdat web site. Both articles allege that safety information was hidden from prescribers and patients. Examination of free publically available US Food and Drug Administration (US FDA) professional product labels and Approval Packages reveal that warnings were issued years before the Zyprexa and paxil articles were written.
The US FDA approved Zyprexa in September 1996. The oldest professional product label found on the US FDA web site was 2003. The Warnings section of this label made the following statement:
“WARNINGS
Hyperglycemia and Diabetes Mellitus
Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including olanzapine.”
The 2009 version of professional label said:
“Pediatric Use — ZYPREXA is not approved for the treatment of Schizophrenia and Bipolar I Disorder (manic or mixed episodes) in children and adolescents. Compared to patients from adult clinical trials, adolescents were more likely to gain more weight and have greater increases in cholesterol and triglycerides.”
“Safety and effectiveness of ZYPREXA in patients under 18 years of age have not been established. Safety and effectiveness of ZYPREXA and fluoxetine in combination in patients under 18 years of age have not been established.”
The US FDA required a Medication Guide for Zyprexa in 2009. Medication Guides are written specially for patients to be distributed at the pharmacy for drugs that present significant public health concerns. The Medication Guide informed the public that Zyprexa was approved for “schizophrenia in people age 13 or older.”
The Medication Guide also said:
“Weight gain. Weight gain is very common in people who take ZYPREXA. Teenagers (13 to 17years old) are more likely to gain weight and to gain more weight than adults. Children (10 to 17 years old) are also more likely to gain weight and to gain more weight than adults when ZYPREXA is used in combination with fluoxetine. Some people may gain a lot of weight while taking ZYPREXA, so you and your doctor should check your weight regularly. Talk to your doctor about ways to control weight gain, such as eating a healthy, balanced diet, and exercising.”
The Zyprexa Papers were posted in 2020. Professional warnings for the drug were made 17 years ago and safety information for patients were required 11 years ago.
Paroxetine (Paxil)
The re-analysis of the use of paroxetine in younger age groups, Study 329, was published in the British Medical Journal in 2015. Study 329 was originally published in 2001.
Three years before the publication of Study 329, the US FDA in 1998 warned that paroxetine had not been shown to be safe and effective in pediatric patients.
Since the mid-2000s, the professional product label for paroxetine contains a US FDA box warning, the strongest type of safety alert the FDA can require, also stating that the drug is not approved for use in pediatric patients.
Promoting and placing the information from FDA regulatory documents, professional product labels and Approval Packages, in the hands of patients and their parents will better serve public safety in a more timely fashion than the Zyprexa Papers and the re-analysis of Study 329.
It is questionable whether the re-analysis of Study 329 trial, 14 years after the original study was published, would have a positive impact on patient safety.
In a historical context, it is critical to have The Zyprexa Papers and Children of the Cure documented in their entirety to enable everyone to be aware of the devil is in the details.
FDA black box warnings and subsequent qualifying warnings in the US do not tell the story of Data Manipulation, Fraud and Deaths from Akathisia labelled as Emotional Labile.
If the FDA labels and pronouncements had made a difference it would be a different story.
The Zyprexa Papers and Children of the Cure document the revelations and evaluations so that no one can be accused of ignorance.
and there is nothing to lose but everything to gain in so doing…
Annie’s Response
Certainly, historical context supported by rigoursly reviewed verifiable evidence is obviously important. However deflecting the discussion to data manipulation, fraud, and deaths from akathisia with Zyprexa does not move the argument forward.
These deflections are easily addressed. A quick Google search leads to a posting of a list of the largest pharmaceutical company settlements between 1991 and 2012. The violations included off-label promotion, kickbacks, and fraud.
Akathisia is mentioned seven times in the 2020 US FDA approved professional product label for Zyprexa in various patient populations and studies. Akathisia was also mentioned 17 years ago, seven times, in the 2003 professional label for the drug.
Unfamiliarity with US drug law and regulations could result in erroneous opinions about FDA information.
The US FDA paroxetine box warning did make a difference in prescribing. A 2009 nationally representative study showed significant post-warning reductions in the rate of new diagnoses of depression by primary care providers: 44% among children, 37% among young adults, and 29% among all adults.
It must be remembered that children and adolescents prescribed paroxetine have unknowingly been enrolled in an uncontrolled trial without the option of giving informed consent in which no one is recording data.
Those who fail to access free publicly available US FDA safety information can be accused of ignorance and have their health and well being potentially harmed.
The Iconoclasts: Leading with the Action..
Johnny’s in the basement,
Mixing up the medicine…
https://davidhealy.org/a-k-a-thisia-drug-induced-emotional-turmoil-d-i-e-t/
The Perfect Killing Machine
https://www.youtube.com/watch?time_continue=1&v=2RnPN0pAbX8&feature=emb_logo
Got to lose this prescription dope
Akathisia, Akathisia
You freak me out. You freak me out
Akathisia.
You make me wanna
Make me wanna
K-k-k-k
Sources for useful scientifically accurate drug information can be found on the following sites.
Zyprexa’s (olanzapine) FDA Approved Professional Product Label and Medication Guide can be found on the DailyMed web site.
The Zyprexa FDA Approval Package can be accessed from the Drugs@FDA web site.
Eli Lilly Documents Show Risks of Zyprexa were deliberately played down_NYT
December 17, 2006
https://ahrp.org/eli-lilly-documents-show-risks-of-zyprexa-were-deliberately-played-down_nyt/
Like the Merck documents in Vioxx litigation, these internal Lilly documents provide evidence of how the giants of this industry aggressively promote–even lethal drugs. Zyprexa showed a high risk of drug-induced diabetes early on, but the company sacrificed safety for profits. Zyprexa is Lilly’s highest selling drug– this $4.5 billion blockbuster poses severe risks of harm and early death:
Lilly, clearly has influential “friends” at the FDA.
Lilly’s documents confirm Robert Whitaker’s assessment of the drug’s safety
hazards–based on data submitted to the FDA. In Whitaker’s ground breaking
book, Mad in America: Bad Science, Bad Medicine…, Perseus Press, 2001,
he reported: Of the 2,500 patients in pre-marketing clinical trials, two-thirds
dropped out; 20 died, 12 by suicide; 22% suffered serious adverse effects
and weight gain was on average 1 lb per week. The Times reports that
30% of patients’ health is undermined by drug-induced weight gain-some
have gained as much as 100lbs.
Those trial results led Dr. David Healy, in April, 2002, to conclude: “The
studies in adults with Zyprexa that Lilly submitted to the FDA demonstrate,
as far as I can establish, a higher death rate on Zyprexa than on any other
anti-psychotic ever recorded. In addition to this Lilly have suppressed data
on suicidal acts on Zyprexa from these trials. The data are not available in
the scientific literature, nor from FOI requests to the FDA, nor from
enquiries to the company. Despite this Lilly are engaged in trials with this
agent in children.”
Who are Lilly’s “friends” at the FDA?
Doctors prescribe Zyprexa, not the FDA.
This is the FDA approved Medication Guide for Zyprexa.
ZYPREXA – olanzapine tablet
ZYPREXA ZYDIS – olanzapine tablet, orally disintegrating
ZYPREXA INTRAMUSCULAR – olanzapine injection, powder, for solution
Eli Lilly and Company
———-
Medication Guide
ZYPREXA® (zy-PREX-a)
(olanzapine)
Tablet
ZYPREXA® ZYDIS® (zy-PREX-a ZY-dis)
(olanzapine)
Tablet, Orally Disintegrating
Read the Medication Guide that comes with ZYPREXA before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. Talk with your doctor or pharmacist if there is something you do not understand or you want to learn more about ZYPREXA.
What is the most important information I should know about ZYPREXA?
ZYPREXA may cause serious side effects, including:
Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis).
High blood sugar (hyperglycemia).
High fat levels in your blood (increased cholesterol and triglycerides), especially in teenagers age 13 to 17 or when used in combination with fluoxetine in children age 10 to 17.
Weight gain, especially in teenagers age 13 to 17 or when used in combination with fluoxetine in children age 10 to 17.
These serious side effects are described below.
Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). ZYPREXA is not approved for treating psychosis in elderly people with dementia.
High blood sugar (hyperglycemia). High blood sugar can happen if you have diabetes already or if you have never had diabetes. High blood sugar could lead to:
a build up of acid in your blood due to ketones (ketoacidosis)
coma
death
Your doctor should do tests to check your blood sugar before you start taking ZYPREXA and during treatment. In people who do not have diabetes, sometimes high blood sugar goes away when ZYPREXA is stopped. People with diabetes and some people who did not have diabetes before taking ZYPREXA need to take medicine for high blood sugar even after they stop taking ZYPREXA.
If you have diabetes, follow your doctor’s instructions about how often to check your blood sugar while taking ZYPREXA.
Call your doctor if you have any of these symptoms of high blood sugar (hyperglycemia) while taking ZYPREXA:
feel very thirsty
need to urinate more than usual
feel very hungry
feel weak or tired
feel sick to your stomach
feel confused or your breath smells fruity
High fat levels in your blood (cholesterol and triglycerides). High fat levels may happen in people treated with ZYPREXA, especially in teenagers (13 to 17 years old), or when used in combination with fluoxetine in children (10 to 17 years old). You may not have any symptoms, so your doctor should do blood tests to check your cholesterol and triglyceride levels before you start taking ZYPREXA and during treatment.
Weight gain. Weight gain is very common in people who take ZYPREXA. Teenagers (13 to 17 years old) are more likely to gain weight and to gain more weight than adults. Children (10 to 17 years old) are also more likely to gain weight and to gain more weight than adults when ZYPREXA is used in combination with fluoxetine. Some people may gain a lot of weight while taking ZYPREXA, so you and your doctor should check your weight regularly. Talk to your doctor about ways to control weight gain, such as eating a healthy, balanced diet, and exercising.
What is ZYPREXA?
ZYPREXA is a prescription medicine used to treat:
schizophrenia in people age 13 or older.
bipolar disorder, including:
manic or mixed episodes that happen with bipolar I disorder in people age 13 or older.
manic or mixed episodes that happen with bipolar I disorder, when used with the medicine lithium or valproate, in adults.
long-term treatment of bipolar I disorder in adults.
episodes of depression that happen with bipolar I disorder, when used with the medicine fluoxetine (Prozac®) in people age 10 or older.
episodes of depression that do not get better after 2 other medicines, also called treatment resistant depression, when used with the medicine fluoxetine (Prozac), in adults.
ZYPREXA has not been approved for use in children under 13 years of age. ZYPREXA in combination with fluoxetine has not been approved for use in children under 10 years of age.
The symptoms of schizophrenia include hearing voices, seeing things that are not there, having beliefs that are not true, and being suspicious or withdrawn.
The symptoms of bipolar I disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior, and a decreased need for sleep.
The symptoms of treatment resistant depression include decreased mood, decreased interest, increased guilty feelings, decreased energy, decreased concentration, changes in appetite, and suicidal thoughts or behavior.
Some of your symptoms may improve with treatment. If you do not think you are getting better, call your doctor.
What should I tell my doctor before taking ZYPREXA?
ZYPREXA may not be right for you. Before starting ZYPREXA, tell your doctor if you have or had:
heart problems
seizures
diabetes or high blood sugar levels (hyperglycemia)
high cholesterol or triglyceride levels in your blood
liver problems
low or high blood pressure
strokes or “mini-strokes” also called transient ischemic attacks (TIAs)
Alzheimer’s disease
narrow-angle glaucoma
enlarged prostate in men
bowel obstruction
phenylketonuria, because ZYPREXA ZYDIS contains phenylalanine
breast cancer
thoughts of suicide or hurting yourself
any other medical condition
are pregnant or plan to become pregnant. It is not known if ZYPREXA will harm your unborn baby.
If you become pregnant while receiving ZYPREXA, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
are breast-feeding or plan to breast-feed. ZYPREXA passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take ZYPREXA.
Tell your doctor if you exercise a lot or are in hot places often.
The symptoms of bipolar I disorder, treatment resistant depression, or schizophrenia may include thoughts of suicide or of hurting yourself or others. If you have these thoughts at any time, tell your doctor or go to an emergency room right away.
Tell your doctor about all the medicines that you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. ZYPREXA and some medicines may interact with each other and may not work as well, or cause possible serious side effects. Your doctor can tell you if it is safe to take ZYPREXA with your other medicines. Do not start or stop any medicine while taking ZYPREXA without talking to your doctor first.
How should I take ZYPREXA?
Take ZYPREXA exactly as prescribed. Your doctor may need to change (adjust) the dose of ZYPREXA until it is right for you.
If you miss a dose of ZYPREXA, take the missed dose as soon as you remember. If it is almost time for the next dose, just skip the missed dose and take your next dose at the regular time. Do not take two doses of ZYPREXA at the same time.
To prevent serious side effects, do not stop taking ZYPREXA suddenly. If you need to stop taking ZYPREXA, your doctor can tell you how to safely stop taking it.
If you take too much ZYPREXA, call your doctor or poison control center at 1-800-222-1222 right away, or get emergency treatment.
ZYPREXA can be taken with or without food.
ZYPREXA is usually taken one time each day.
Take ZYPREXA ZYDIS as follows:
Be sure that your hands are dry.
Open the sachet and peel back the foil on the blister. Do not push the tablet through the foil.
As soon as you open the blister, remove the tablet and put it into your mouth.
The tablet will disintegrate quickly in your saliva so that you can easily swallow it with or without drinking liquid.
Call your doctor if you do not think you are getting better or have any concerns about your condition while taking ZYPREXA.
What should I avoid while taking ZYPREXA?
ZYPREXA can cause sleepiness and may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how ZYPREXA affects you.
Avoid drinking alcohol while taking ZYPREXA. Drinking alcohol while you take ZYPREXA may make you sleepier than if you take ZYPREXA alone.
What are the possible side effects of ZYPREXA?
Serious side effects may happen when you take ZYPREXA, including:
See “What is the most important information I should know about ZYPREXA?”, which describes the increased risk of death in elderly people with dementia-related psychosis and the risks of high blood sugar, high cholesterol and triglyceride levels, and weight gain.
Increased incidence of stroke or “mini-strokes” called transient ischemic attacks (TIAs) in elderly people with dementia-related psychosis (elderly people who have lost touch with reality due to confusion and memory loss). ZYPREXA is not approved for these patients.
Neuroleptic Malignant Syndrome (NMS): NMS is a rare but very serious condition that can happen in people who take antipsychotic medicines, including ZYPREXA. NMS can cause death and must be treated in a hospital. Call your doctor right away if you become severely ill and have any of these symptoms:
high fever
excessive sweating
rigid muscles
confusion
changes in your breathing, heartbeat, and blood pressure.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): DRESS can occur with ZYPREXA. Features of DRESS may include rash, fever, swollen glands and other internal organ involvement such as liver, kidney, lung and heart. DRESS is sometimes fatal; therefore, tell your doctor immediately if you experience any of these signs.
Tardive Dyskinesia: This condition causes body movements that keep happening and that you can not control. These movements usually affect the face and tongue. Tardive dyskinesia may not go away, even if you stop taking ZYPREXA. It may also start after you stop taking ZYPREXA. Tell your doctor if you get any body movements that you can not control.
Decreased blood pressure when you change positions, with symptoms of dizziness, fast or slow heartbeat, or fainting.
Difficulty swallowing, that can cause food or liquid to get into your lungs.
Seizures: Tell your doctor if you have a seizure during treatment with ZYPREXA.
Problems with control of body temperature: You could become very hot, for instance when you exercise a lot or stay in an area that is very hot. It is important for you to drink water to avoid dehydration. Call your doctor right away if you become severely ill and have any of these symptoms of dehydration:
sweating too much or not at all
dry mouth
feeling very hot
feeling thirsty
not able to produce urine.
Common side effects of ZYPREXA include: lack of energy, dry mouth, increased appetite, sleepiness, tremor (shakes), having hard or infrequent stools, dizziness, changes in behavior, or restlessness.
Other common side effects in teenagers (13-17 years old) include: headache, stomach-area (abdominal) pain, pain in your arms or legs, or tiredness. Teenagers experienced greater increases in prolactin, liver enzymes, and sleepiness, as compared with adults.
Tell your doctor about any side effect that bothers you or that does not go away.
These are not all the possible side effects with ZYPREXA. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ZYPREXA?
Store ZYPREXA at room temperature, between 68°F to 77°F (20°C to 25°C).
Keep ZYPREXA away from light.
Keep ZYPREXA dry and away from moisture.
Keep ZYPREXA and all medicines out of the reach of children.
General information about ZYPREXA
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ZYPREXA for a condition for which it was not prescribed. Do not give ZYPREXA to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about ZYPREXA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ZYPREXA that was written for healthcare professionals. For more information about ZYPREXA call 1-800-Lilly-Rx (1-800-545-5979).
What are the ingredients in ZYPREXA?
Active ingredient: olanzapine
Inactive ingredients:
Tablets — carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients. The color coating contains: Titanium Dioxide, FD&C Blue No. 2 Aluminum Lake, or Synthetic Red Iron Oxide.
ZYDIS — gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propyl paraben.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Medication Guide revised October 22, 2019
Marketed by: Lilly USA, LLC
Indianapolis, IN 46285, USA
Copyright © 2009, 2019, Eli Lilly and Company. All rights reserved.
ZYP-0002-MG-20191022
Revised: 4/2020Eli Lilly and Company
Why didn’t the bureaucrats bark? As we shall see in later posts, bureaucrats from the regulatory apparatus seem to miss an astonishing amount of what is going on.
The Bureaucrat That Didn’t Bark
https://davidhealy.org/the-bureaucrat-that-didnt-bark/
Adding the original Prozac, Paxil, and Zoloft figures together as of 1991 would have shown an absolutely conclusive picture of suicide risk on this group of drugs. Cynics might say that it’s clear why FDA didn’t permit these extra data in: the hazard would have killed the SSRIs. But at the same time, FDA licensed Clozapine despite the lethal risk of agranulocytosis it posed, and a case can be made that this risk helped create a perception of greater efficacy for Clozapine and may have increased sales and profitability.
If a class-wide labeling had been applied to all antidepressants, no individual drug would have been disadvantaged, and the market would likely have developed in almost exactly the same way as it did. We know that senior FDA figures considered the option of a class-wide warning. This seems to put them into a position of being aware that the risks did not come from just one drug and seems to position them in a management of perceptions domain.
Healy went on: “Zyprexa has since turned out to be one of the drugs most likely in all of medicine to increase cholesterol levels in man … There was arguably a better case to be made for patenting it to raise cholesterol than to treat psychosis
The Astonishing Zyprexa Cover-Up
https://www.madinamerica.com/2015/02/zyprexa-astonishing-betrayal/
It would be another six years before I learned more about the background of the Zyprexa story in a book called Pharmageddon. Author David Healy recounted: “The first generation of antipsychotics ran into problems in the 1970s with million-dollar legal settlements against their manufacturers for a disfiguring neurological side effect of treatment – tardive dyskinesia [a disorder resulting in involuntary, repetitive body movements]. This led to a period of almost twenty years when no new antipsychotic came on the market. The only antipsychotic that did not cause this problem was clozapine [Clozaril was the brand name], but clozapine had been withdrawn in 1975 because it was associated with a higher rate of mortality than other antipsychotics. The way forward seemed to lie in producing a safe clozapine.”
One way to do so was “to make minor adjustments to the clozapine molecule. Tweaking a molecule risks producing a compound with all the hazards and none of the benefits of the parent. This is what Lilly did: in 1974 the company produced a series of compounds that were all abandoned because of toxicity.” The company was in “serious financial trouble, facing potential takeover … On April 29, 1982, they opted to move forward with a compound from the original series that by definition was not novel – olanzapine, later branded as Zyprexa. To make Zyprexa commercially viable, they needed a new patent, which meant demonstrating some benefit not found with other antipsychotics. In 1991, the only novelty presented in the company’s new patent application, which was approved, was a study in dogs in which Zyprexa produced less elevation of blood cholesterol levels than another never-marketed drug.
Eli Lilly pays record $1.4bn for promoting off-label use of olanzapine
https://www.bmj.com/content/338/bmj.b217
“To make Zyprexa commercially viable, they needed a new patent, which meant demonstrating some benefit not found with other antipsychotics.”
This misleading statement, either done purposely or because of lack of background understanding, confuses a patent application with a New Drug Application (NDA). Manufacturers can legally promote information in an FDA approved professional product label, not in a patent application.
“Tweaking a molecule risks producing a compound with all the hazards and none of the benefits of the parent.” This is also a misleading statement. Even a cursory familiarity with new drug development reveals that the opposite can be true.
“ … the only novelty presented in the company’s new patent application, which was approved, was a study in dogs in which Zyprexa produced less elevation of blood cholesterol levels than another never-marketed drug.”
There are no studies in the free publicly available approval package for Zyprexa that cites a dog study.
Best,
Larry
Larry
For the compound to be commercially viable, it has to have a patent. No patent, no NDA. The package applying for patent can be and was in this case extensive and did have a dog study. The Canadian Courts squashed the patent some years after the drug came on the Canadian market
David