Thursday, February 28, 2008
But they don't!
In fact, half of medical evidence is hidden from
your doctors. And the half that's hidden is the
half that shows drugs don't work.
The bad news is that drug companies are not
policed by the Food and Drug Administration
(FDA) the way they should be. A drug should be
proven both effective and safe BEFORE it is
prescribed to millions of people.
Sadly, that often isn't the case.
Let me share with you two recent examples that
highlight the dangerous collusion between drug
companies and our government agency. They show
why the FDA should really stand for "Federal
First, we now know that the cholesterol-lowering
drug Zetia actually causes harm and leads to
faster progression of heart disease DESPITE
lowering cholesterol 58 percent when combined
This challenges the belief that high cholesterol
causes heart attacks and shakes the $40 billion
dollar cholesterol drug industry at its
Second, it's come to light that nearly all the
negative studies on antidepressants - that's
more than half of all studies on these drugs -
were never published, giving a false sense of
effectiveness of antidepressants to treat
Don't get me wrong.
I'm not telling you to blame your doctor.
Instead, blame deceptive scientific practices
and industry-protective government polices.
==> Let's talk a closer look at these findings
and their implications.
I once had a patient who worked in the drug
approval division of the FDA. She taught me a
very important lesson.
When a drug company designs and performs a
study, it has to be registered with the FDA and
ALL the results must be submitted to the FDA.
But it doesn't work that way.
Instead, the pharmaceutical companies ONLY
submit the data they want to get published to
That means that any negative studies are hidden
from the scientific community and from the
And when drug studies are sponsored by drug
companies - as most are - they find positive
outcomes at 4 times the rate of independently
funded studies. This is also true for nutrition
studies funded by the food industry that show
the benefits of dairy or high-fructose corn
The FDA does not release this information.
That was, it didn't until 2004 when all the
major scientific journals banded together and
refused to publish any data from any drug study
that did not list the results of all trials,
either positive or negative, in a central
Well, that sounds good - but listing obscure,
unpublished studies buried deep in a hard-to-
navigate public database run by the National
Institutes of Health is hardly visible public
Sure, the research studies are at least listed,
but try to find out the results.
After a few hours searching around on the
website clinicaltrials.gov, I gave up.
Last year, Congress passed legislation expanding
how much detail must be listed, but at the end
of the day, who even looks at that?
Most doctors don't even have time to read the
medical journals they receive. They get tiny
bits of information from drug reps, who come to
their office with free lunch and a sound bite
about their drug.
They get slightly more information from
researchers who are funded by pharmaceutical
companies and present their findings at
conferences sponsored by pharmaceutical
companies, using presentations prepared for them
by pharmaceutical companies.
Not exactly independent, evidence-based
==> Now let's get back to the news about Zetia.
Zetia is a new drug that lowers cholesterol by a
different mechanism than statin drugs like
Lipitor and Zocor.
Why does this matter?
Well, doctors have been brainwashed to think
that cholesterol is the cause of heart attacks
even though half of all people who have heart
attacks have NORMAL cholesterol.
And it seemed like the statins, which lowered
cholesterol, actually reduced heart attacks.
Seems logical. If you lower cholesterol, you
reduce heart attacks, right?
I believe that the reason statins lower risk is
NOT because they lower cholesterol, but because
they reduce inflammation.
In fact, studies by Dr. Paul Ridker of Harvard
show that the risk of heart attacks was only
reduced if inflammation was lowered along with
LDL cholesterol - but not if LDL cholesterol was
lowered alone. (2)
So then along comes a drug that can be combined
with statins to lower cholesterol even more.
You see, the FDA approved Zetia without any
proof that it lowered heart attacks or reduced
the progression of heart disease. The drug was
approved solely on the basis that it lowered
Yet Zetia was given to 5 million people - and
made the drug companies $5 billion a year.
That's almost $14 million a day!
And once Zetia was approved, its makers had no
incentive to prove that it actually did what it
was thought to do - lower heart attacks.
They dragged their feet doing the studies and
then released the negative data (which they did
only under pressure from news agencies and
Congress) after a long delay.
Wouldn't you drag your feet too if you were
making $14 million a day?
But the FDA had the negative data on Zetia - and
it didn't speak up.
The data that was withheld proved that Zetia did
not reduce heart attacks but actually INCREASED
fatty plaques in the arteries despite lowering
Let that sink in for a moment.
That's right: Lowering cholesterol led to more
That turns our whole medical model upside down.
It shows us that high cholesterol is NOT a
disease and may or may not be related to heart
Another recent study put another nail in the
coffin of the Cholesterol Myth.
A major new cholesterol drug, torcetrapib, was
pulled from the pipeline in December 2006
because despite lowering LDL cholesterol and
raising HDL cholesterol in 15,000 people, it
caused MORE heart attacks and strokes. (3)
This was to be the new cholesterol wonder drug.
==> All this points to a big research mess that
is flawed in three ways.
First, what gets studied depends on who is
Since drug companies fund most of the research
in the world, other therapies that work better -
such as diet and lifestyle or nutritional
therapies - never get enough funding.
Second, drug companies are aided by the FDA,
which suppresses, hides, and doesn't publish
negative studies on drugs, only positive ones.
This leads doctors to think they have all the
evidence when they don't.
Third, doctors, patients, and the media believe
they have the whole truth, often until it is too
late, like with Zetia or Premarin or Vioxx.
The evidence was there, but no one looked or
This makes it very difficult for consumers to
get the best treatments for their health and the
whole truth about drugs.
Here's my advice on how to make sense of things.
1. Follow the money. Look carefully at who
funded the study. Be suspicious if it was funded
by drug companies.
2. Call or email your congressperson or Senator
to demand better legislation providing an easy-
to-navigate database of all drug trials, with
consumer-friendly summaries of both published
AND unpublished data submitted to the FDA so you
can look up the drug you are prescribed and have
a balanced opinion.
3. Don't assume that drugs are the answer to
your health problems. Heart disease is NOT a
Lipitor deficiency but the result of your
lifestyle interacting with your genes.
4. Learn to ask the question "why?" - and search
for the answers. Dealing with lifestyle and
environmental factors almost always works better for
chronic illnesses. Drugs are there as a backup
only if needed.
So take a closer look at the information you've
been given about drugs. You might be surprised
by what you find.
Now I'd like to hear from you...
Were you aware of the studies I've mentioned
Which of the steps here do you plan to follow?
What has you experience been with medications
compared to lifestyle measures?
(1) Laine C, Horton R, DeAngelis CD, Drazen JM,
Frizelle FA, Godlee F, Haug C, Hebert PC, Kotzin
S, Marusic A, Sahni P, Schroeder TV, Sox HC, Van
der Weyden MB, Verheugt FW.Clinical trial
registration: looking back and moving ahead.
JAMA. 2007 Jul 4;298(1):93-4.
(2) Ridker PM, Cannon CP, Morrow D, Rifai N,
Rose LM, McCabe CH, Pfeffer MA, Braunwald E;
Pravastatin or Atorvastatin Evaluation and
Infection Therapy-Thrombolysis in Myocardial
Infarction 22 (PROVE IT-TIMI 22) Investigators.
C-reactive protein levels and outcomes after
statin therapy. N Engl J Med. 2005 Jan
(3) Kastelein JJ, van Leuven SI, Burgess L,
Evans GW, Kuivenhoven JA, Barter PJ, Revkin JH,
Grobbee DE, Riley WA, Shear CL, Duggan WT, Bots
ML; RADIANCE 1 Investigators.Effect of
torcetrapib on carotid atherosclerosis in
familial hypercholesterolemia. N Engl J Med.
2007 Apr 19;356(16):1620-30.
Tuesday, February 26, 2008
According to the FDA, the Chinese facility that supplies the active ingredient of the widely used blood thinner heparin was never inspected because the agency confused it with another plant that had the same name.
A team of FDA inspectors is now headed to China to inspect the correct plant, as part of an effort to determine what caused a sudden spike in serious reactions to heparin.
More than 350 adverse reactions to the drug have been reported to the FDA since the end of 2007, including a dangerous drop in blood pressure, breathing difficulties, and vomiting. Four patients who took the drug died.
Federal law does not require inspections of foreign drugmakers, although the agency will in most instances inspect before a new foreign drug or active drug ingredient is allowed in FDA-approved prescription medications. Such an inspection does not necessarily include an on-site visit if the company has passed previous inspections for other drugs.
Monday, February 25, 2008
The U.S. Supreme Court has ruled that medical device manufacturers cannot be sued for injuries caused by their products if those products were pre-approved for use by the FDA.
The court ruled that Charles Riegel, who was injured in 1996 when a balloon catheter made by Medtronic Inc. burst while being inserted into one of his coronary arteries during an angioplasty, could not sue the company for damages. In doing so, the Supreme Court upheld a ruling by a U.S. appeals court and an earlier ruling by a trial court in New York.
Hiding behind a legal technicalityMedtronic, which no longer makes the balloon catheter in question, said that the fault was with the doctor, who used the device contrary to the operating instructions. The company also said that the doctor made an error in using that type of product for a patient in Riegel's condition. But rather than ruling in Medtronic's favor merely for the one specific instance, the court dismissed the case entirely, saying that federal law prohibits suing device manufacturers in state courts if the device was approved as safe by the FDA. The decision is expected to have ramifications for a large number of pending lawsuits against manufacturers of devices such as breast implants, defibrillators, artificial heart pumps and valves, drug-coated stents, spinal cord stimulators, and prosthetic hips and knees.
Because there is no federal law that allows consumers to sue medical device manufacturers for damages, state courts have become a common venue for such suits.
The legal reasoning behind the court's decision centered on the wording of the 1976 Medical Device Amendments law. The law, which set in place an FDA pre-approval process for medical devices, explicitly prohibited states from putting in place "any requirement" that is "different from, or in addition to" FDA requirements. In an 8-1 majority, the court ruled that allowing citizens to sue device companies in state courts amounts to "a requirement" that undermines the FDA approval process.
Writing for the majority, Justice Antonin Scalia wrote that the FDA may approve devices "that present great risks if they nonetheless offer great benefits in light of available alternatives." In other words, there is no requirement that devices actually achieve any reasonable level of safety for all patients. To receive FDA approval and be immunized from lawsuits, medical devices merely have to keep alive slightly more people than they kill.
It would be inappropriate to empower juries second-guess these FDA decisions without full access to data about the benefits of technologies, Scalia said. This is the Supreme Court's way of saying that medical device safety is define solely by the FDA, and if the FDA says something is safe, the fact that such devices actually kill people does not in any way disprove the device's safety.
A jury "sees only the cost of a more dangerous design, and is not concerned with its benefits; the patient who reaped those benefits are not represented in court," he wrote. This is a clever way of saying that products that kill some consumers -- but not all -- are safe enough to be granted blanket immunity because there are some survivors. It's a ridiculous position, of course, and it's never applied to natural remedies.
Note that if an herb kills even ten people in the entire country, the FDA immediately leaps to the conclusion that the herb is "unsafe at any dose." (Google the history of the FDA's ephedra ban for details.) But medical devices and pharmaceuticals are held to an entirely different standard: They must only avoid killing more people than they kill! The fact that some people survived the treatment is apparently sufficient to justify all those who died! This is precisely what Justice Scalia is saying in this decision.
Friday, February 22, 2008
PDUFA was enacted 13 years ago and passed by Congress as a way of providing the FDA with more funds. This way, it could hire more physicians and other scientists to review drug applications so drugs could be approved more quickly.
You see, every day a drug is held up from being marketed to you they lose about $1 million to $2 million. Yes, you read it correctly, $1-2 MILLION for every DAY the drug is held up from being approved.
So the obvious incentive is to approve drugs as quickly as possible and not stand in the way of profit-making.Within the Center for Drug Evaluation and Research, about 80 percent of the resources are geared towed the approval of drugs and 20 percent is for everything else. Drug safety is a measly 5 percent. This speaks loads about their priorities. It is NOT about protecting you -- it is about approving drugs as quickly as possible so the drug companies can reap their profits.
Tuesday, February 19, 2008
Statins such as Lipitor, Zocor, Pavacol and Mevacor lower cholesterol by inhibiting HMG-CoA reductase, a key enzyme in cholesterol synthesis. But they may also activate the gene atrogin-1 gene, which plays a key role in muscle atrophy.
Three separate tests showed that even at low concentrations, statin drugs led to atrogin-1 induced muscle damage. As the concentration was increased, the damage increased as well.
The manufacturer has predicted that 5 million to 6 million Americans a year will buy the drug.
The GlaxoSmithKline drug, which was introduced to the market several years ago in a prescription-only form called Xenical, blocks the absorption of about 25 percent of consumed fat. That would eliminate about 225 calories from a 3,000 calorie per day diet.
However, the drug can also result in loose stools and gas with an oily discharge. The drug's official website states that, "It's probably a smart idea to wear dark pants, and bring a change of clothes with you to work," if you take the drug.
Los Angeles Times June 15, 2007
Yet again, another pill promising entry into the magical land of forever-skinny ... The release of the new diet "wonder drug" Alli has prompted a stampede of women throwing all common sense to the wind, chasing the ever-elusive gratification of instantaneous weight loss. Alli, if taken together with a low-fat, reduced-calorie diet, supposedly lets you lose about 50 percent more weight than dieting alone, according to GlaxoSmithKline.
Want Diapers With That?
However, the message of "healthy balanced diet and exercise" is falling on deaf ears. Most of the people buying the drug seem to expect it to work miracles with no effort on their part. And they are also ignoring warnings of side effects such as potentially humiliating anal leakage in the hopes that the drug will finally provide the effortless cure they seek.
Millions of Americans are going to pay $59.99 per box for a myth. At least 31 studies by researchers at UCLA have confirmed that dieting by itself, even aided by a pill, doesn't lead to sustained weight loss or any significant health benefits. On any given diet, people initially lose 5 percent to 10 percent of their weight, but then they gain it back, often with some additional pounds as well.
Dieting is actually a consistent predictor of future weight gain; those who participate in formal weight-loss programs usually gain significantly more weight over a two-year period than those who have never participated in such a program.
The Public Citizen's Health Research Group has voiced concerns about Orlistat’s safety and efficacy for the past 10 years, as it's been shown to cause pre-cancerous lesions of the colon.
In April of 2006, a group of doctors with Public Citizen petitioned the FDA to ban Orlistat and deny OTC status to the lower dosage version Alli, offering testimony that Orlistat raises the risk of both colon cancer and gallstones.
Public Citizen cited unpublished studies on Orlistat, showing:
* Orlistat increases the precursor markers to colon cancer by 60 percent in rats.
* When eating a high fat diet and taking Orlistat, the cancer risk increased 2.4 fold.
* Fat soluble vitamin E depletion, due to Orlistat's fat blocking action, raises the risk of colon cancer even further.
* Recorded adverse reactions to Orlistat include: 39 cases of increased abnormal blood thinning; several cases of bleeding episodes; 10 hospitalizations, four with life threatening reactions, and one death.
* Dangerous thinning of the blood can occur in people taking drugs like Warfarin (an anti-coagulant), or who suffer from vitamin K deficiency.
In addition, the FDA itself found 37 cases of gallstones in patients of all ages, between 1999 and 2006, prior to releasing Alli for over-the-counter sale.
The safety analysis from the Public Citizen's Health Research Group is that Alli "has marginal weight loss benefits, common and bothersome G-I tract reactions, significant decrease in absorption of fat soluble vitamins, and problematic use in the millions of people using Warfarin or Cyclosporine."
The FDA denied Public Citizen's petition on the same day they approved Alli as an OTC.
False and misleading prescription drug advertising is common and dangerous. Prescription drug marketers are inundating doctors, and to a lesser extent, the public, with marketing that misrepresents risks, promotes unproven uses, and makes unsubstantiated claims. The false and misleading messages are communicated through conventional advertising, sales representatives, doctors speaking on behalf of drug marketers, and through clinical trial suppression, manipulation and misrepresentation. Sadly, the Food and Drug Administration (FDA) is ineffective at addressing the problems. This report takes a comprehensive look at all of these facets of the prescription drug marketing problem and suggests effective solutions.
FINDINGS IN BRIEF
We looked at enforcement letters FDA sent to drug marketers from 2001-2005. Our research reveals:
Deceptive drug marketing is pervasive, dangerous, and primarily aimed at doctors.
• From 2001-2005, 85 companies received 170 notices from the FDA explaining that the marketing for 150 different drugs was false and/or misleading.
• 62% of the false or misleading messages targeted doctors, and those messages were expressed by 38 different types of advertising. By contrast, the public was exposed to 17 different types of false or misleading ads.
• The false messages were serious: 35% misrepresented risk; 22% promoted unproven uses; and 38% made unsupported or misleading claims. For deceptive messages targeting doctors, 37% misrepresented risk; 24% promoted unproven uses; and 36% made unsupported or misleading claims.
Recidivism is rampant.
• 28 companies—approximately 1/3 of the total— received more than one letter declaring their ads false or misleading in the five years we examined. In fact, these companies accounted for two-thirds of all the letters received.
• 26 companies received more than one letter relating to advertising for the same drug that was deemed false or misleading in the same way.
Deceptive marketing includes sales representatives.
• Sales representatives, as a group, form long and deep relationships with doctors, beginning in medical school. Research suggests those early relationships increase doctors’ receptiveness to sales representatives once they are in practice.
• Perhaps reflecting those relationships, other research has shown that sales representatives have a profound influence on prescribing decisions.
• Sales representative statements accounted for 30 of the 869 deceptive messages in the FDA letters, an amount that is enormous given the very small percentage chance that the FDA will detect such statements. Other research suggests that as much as 11% of sales representative statements are false and favorable to the product they pitch.
Deceptive marketing includes clinical trials.
• In the letters identifying advertising as false or misleading because it contained unsupported claims, FDA highlighted at least 82 times that the advertising cited clinical trials for propositions they did not support. In some instances, the cited trials even contradicted the claims.
• Drug marketers turn clinical trials into marketing tools by suppressing some unfavorable data; by using PR firms to write favorable reports (the PR firm does not appear as an author of the report, instead a doctor is retained to be the named author); by misrepresenting unfavorable data that is published; and, most subtly, by designing studies to get only the results they want.
Our numbers dramatically understate the problem.
The FDA letters we examined do not address anywhere near the full universe of prescription drug marketing.
• The FDA routinely reviews only “classic” advertising and does not comprehensively monitor sales representatives, doctors acting as pitchmen, or clinical trial data manipulation. Moreover, the FDA’s review of classic advertising is not complete; not all ads are submitted to it, and of those that are, the FDA only reviews some.
• The FDA letters rarely identify how many times, or where, an ad was used. A deceptive print ad may have run in several newspapers and magazines. Each of those print runs would be another dissemination of the deceptive messages in the ads.
• The FDA reviews advertising after it has been disseminated and only requires corrective measures a quarter of the time.
• The best measure is how many people internalized the deceptive measure, an impossible figure to determine. The 869 disseminations of deceptive messages that we were able to count from 2001- 2005 included TV ads, print ads, and other mass media. How many people are deceived by a single deceptive TV ad watched by a million viewers? Similarly, a single sales representative may convey deceptive messages to hundreds or thousands of doctors in a year.
States Can Solve the Problem
• To address the scientific misconduct that is the suppression, manipulation and misrepresentation of clinical trial data, states should establish a comprehensive, searchable database of clinical trials. Drug marketers would register every clinical trial done in humans for every drug they sell in the state. To be successful, the clinical trial registry must include all the clinically significant aspects of the trial design and trial results. Such a registry would be placed in the state’s department of health, and could be financed with registration fees from the drug marketers.
• To address the problem of deceptive classic advertising, deceptive sales representative statements and deceptive doctor-to-doctor marketing, states can create a new type of citizen lawsuit. This would allow citizens to sue for injunctive relief—stopping the false advertising and conducting corrective advertising—reasonable attorney’s fees, and, at the judge’s discretion depending on the circumstances of the case, civil penalties payable only to the state. Suits could only be won if the deceptive advertising created a public health risk; deceptive advertising that misleadingly, but not dangerously, hypes a drug’s properties would not qualify. Doctors, their patients, attorneys general, and in certain instances, the public, would have standing to sue, depending on the type of marketing.
Examples of sufficiently dangerous advertising might include promoting a drug for illnesses for which the company knows it’s not effective, or denying or consistently minimizing serious risks. The advantage of this approach is it enables the recipients of deceptive advertising—the people who can most easily detect it—a way to address the problem but it avoids creating financial incentives that would distort enforcement.
Increasing Enforcement at FDA
To make the FDA a potent regulator able to prevent and correct deceptive advertising, it needs more power and financial resources to:
• Review all advertising submitted to it before it is disseminated, in a commercially relevant timeframe, so that deceptive classic advertising is not used;
• Review sales representative training materials and make unannounced inspections of training sessions;
• Review the presentation materials for talks given by doctors on behalf of drug marketers and make unannounced visits to the talks;
• Require and oversee corrective advertising in every situation where deceptive marketing occurs;
• Require drug marketers to get the FDA’s approval before citing any study as support for any claim; and finally,
• Levy significant fines against drug marketers, fines that escalate to truly punitive levels, to serve as a deterrent and eliminate today’s rampant recidivism.
The Medical Profession’s Role: Improve Prescriber Education and Information Resources
Th e medical profession and the independent organizations and academic institutions that service it can help.
• Doctors need better access to independent, accurate, digested information about drugs. The information produced by the clinical trial registry should be packaged by an independent group or agency into a form easily useable by prescribers who want information about treatment options. The information provided should include not only the clinically important information about each drug, but also how the drug compares to other treatments in terms of safety, efficacy, and cost. The Drug Effectiveness Review Project (DERP) generates this information, but it is aimed more at policy makers than prescribers. Similarly, Consumers Union takes DERP’s data and packages it for patients, as part of its BestBuyDrugs project. To the extent that the information is already accessible (for example, The Medical Letter), the profession must find a way to ensure that doctors use it. Only by breaking their reliance on sales representatives and other sources of promotional information can doctors ensure they are getting unbiased information.
• Medical schools and teaching hospitals should heavily invest in training students and residents to be skeptical of pharmaceutical sales representatives and to rely on independent sources of information.
After introducing the problem and laying out the regulatory context, the report presents the results of our analysis of the most comprehensive database on false and misleading advertising available: FDA’s enforcement letters to pharmaceutical companies engaging in deceptive marketing practices. We look at five years of letters to see what kinds of false messages pharmaceutical companies are directing toward whom and how. We also explain why those numbers are grotesque understatements of the problem. One reason they are understatements is that they mostly address conventional advertising, such as ads in professional journals or on TV; they rarely address sales representative statements or the presentations made by doctors consulting for the drug marketer. The latter activities are currently beyond the FDA’s resources to monitor.
Then we look at the ways the FDA currently fails to address even the classic advertising slice of the false marketing problem, the one it monitors as closely as it can. As part of our evidence of the FDA’s failure, we describe the high rates of “general recidivism,” that is, drug marketers that have received multiple letters from the FDA about their false or misleading marketing, and “specific recidivism,” that is, drug marketers who have received multiple letters about their advertisements for a single drug, advertisements that are all false or misleading in the same way.
We complete our analysis of the deceptive marketing problem by focusing on the marketing outside of the FDA’s routine review. Specifically, we focus on prescription drug sales representatives and clinical trials. Sales representatives are powerful marketing forces because they have many opportunities to interact with physicians, and the evidence shows that they give false and misleading information far too often. As disturbing as our findings in this area are, they may be mitigated to some extent, given that doctors may expect sales representatives to present misleading information. After all, their job is to sell drugs, not educate physicians. Clinical trials, however, are the cornerstone of prescription drug science, and few physicians let alone patients would anticipate the extent to which drug marketers shape and control them.
We conclude with concrete solutions that states can take now and offer recommendations for addressing FDA’s problems. Fortunately, steps the states can take are powerful enough to rein in the drug marketers to the point where the public can again be confident that they and their doctors are consistently receiving accurate information. Best of all, the state steps are inexpensive.
THE APPENDIX—CASE STUDIES
To fill in the big picture of deceptive marketing we sketch, we present six case studies of deceptive marketing of prescription drugs in the appendix, located in the center spread. Four—Vioxx, OxyContin, Paxil, and Neurontin—are offered primarily to illustrate different features of the problem and to convey how deceptive messages can permeate drug marketing. Two other case studies, Accutane and Tindamax, are included to highlight the FDA’s inability to police drug marketers.
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- ▼ February (9)