The Health Sciences Institute is intended to provide cutting-edge health information.
Nothing on this site should be interpreted as personal medical advice. Always consult with your doctor before changing anything related to your healthcare.

Heart drug trial issues bad news - then patients are mislead by the spin

Chain of Fools

Given the billion-dollar profit levels of drugs that target heart problems, how do you feel about a government employee – whose salary is paid by you and me – schilling for major drug companies who make those drugs?

Angry? Me too!

I’m not saying this employee receives money from drug companies, I’m just saying that she recently went out of her way to put a VERY positive spin on the VERY unimpressive results of a new drug trial.

And guess what? The mainstream media played right along, giving patients with type 2 diabetes the clear impression that aggressively high doses of a cocktail of heart drugs is the logical way to prevent heart disease.

To paraphrase an old Aretha Franklin song: Shame, shame, SHAME – shame of fools.

Sifting through the sands

You can tell this new trial is intended to be important, because it has an acronym: SANDS (Stop Atherosclerosis in Native Diabetics Study). It’s also published in the Journal of the American Medical Association, and was funded by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health. In other words, it’s got mainstream pedigree to spare.

In a nutshell:

  • Researchers recruited 500 American Indians: each subject was over the age of forty, had type 2 diabetes, high cholesterol, and high blood pressure
  • Subjects were divided into two groups: one group aimed to reach “standard” recommended LDL cholesterol and blood pressure targets, and one group was “aggressive” in aiming for substantially lower targets
  • For three years, study clinicians examined each subject once every three months, adjusting doses of cholesterol-lowering statin drugs and blood pressure drugs as needed in order to reach standard or aggressive targets
  • Ultrasound was used to track atherosclerosis in each subjects’ carotid arteries

Results: Subjects in both groups met their standard or aggressive targets. Atherosclerosis decreased in the aggressive group, but actually increased in the standard group. Rates of cardiovascular disease events (such as heart attack) were about the same in both groups.

Before we move on to the mad spinning of these results, let’s stop to put the spotlight on a very revealing detail: About 250 type 2 diabetics with high cholesterol followed a standard statin drug regimen for three years, and their atherosclerosis progression didn’t stop, it ADVANCED. If I’m diabetic and my doctor has convinced me to sign on for a lifetime of statin use, that’s not quite the outcome I would expect to see.

And were there adverse side effects? Absolutely! Here’s how the SANDS authors summed up the risk-benefit ratio in JAMA: “The lack of difference in occurrence of events and the increase in adverse events and serious adverse events attributable to the BP lowering raise the possibility that there may not be favorable long-term outcomes.”

And let the spinning begin!

Welcome to the statins all-you-can-take buffet

Here’s the title of the press release NHLBI sent out to announce the SANDS results: “Cholesterol, Blood Pressure Control May Reverse Atherosclerosis in Adults With Diabetes.”

Right – as long as you don’t mind the “serious adverse events” from the very high doses that you’ll be required to take for the rest of your life.

And here’s the headline Reuters news service went with: “Drug Regime Reverses Heart Disease Risk.” And that’s quite true as long as you completely ignore the details.

Dr. Elizabeth Nabel, NHLBI director, gave Reuters this shiny bright load of happy-talk: “For the first time, we have evidence that aggressively lowering LDL cholesterol and blood pressure can actually reverse damage to the arteries in middle-aged adults with diabetes.” Of course, Dr. Nabel is well aware that a patient must commit to a lifetime regimen of very high doses of statin drugs in order to push LDL levels as low as they went in the SANDS trial.

Way to promote those statins, Dr. Nabel!

The NHLBI press release also offered this quote from the lead author of the study, Barbara V. Howard, Ph.D.: “Our message to doctors, nurses, and patients is that you can reach your goal levels, and we should work together to help you do that.” In other words: We should work together to sign you up for the mega-statin lifetime plan.

Here’s another quote from the NHLBI release: “Medications used in this study were donated by First Horizon Pharmacy, Merck and Co., and Pfizer, Inc.”

And we’ll finish up with this note from MedPage Today: Dr. Howard reported serving on the advisory board of Merck.

There you have it. With friends like these, diabetics don’t need enemies.

Sources:
“Effect of Lower Targets for Blood Pressure and LDL Cholesterol on Atherosclerosis in Diabetes” Journal of the American Medical Association, Vol. 299, No. 14, 4/9/08, jama.ama-assn.org
“Cholesterol, Blood Pressure Control May Reverse Atherosclerosis in Adults With Diabetes” National Heart, Lung and Blood Institute press release, 4/8/08, eurekalert.org
“Drug Regime Reverses Heart Disease in Diabetics” Andrew Stern, Reuters, 4/8/08, reuters.com
“Mixed Results with Aggressive Risk Reduction in Diabetic Patients” Charles Bankhead, MedPage Today, 4/8/08, medpagetoday.com

Get a free copy of 5 Household Items that Cause Cancer

By texting HSI to 844-539-1128, you are providing your electronic signature expressly consenting to be called and texted (including by prerecorded messages, using an autodialer, and/or automated means) with alerts, stories, reports, and marketing communications from Institute of Health Sciences, LLC. and its authorized representatives at the phone number you provide, including landlines and wireless numbers, even if the phone number is on a corporate, state or national Do Not Call list. You also consent and unconditionally agree to our Privacy Policy and Terms of Use, including the arbitration provision and class action waiver contained therein. Msg&data rates may apply. 15 Msgs/Month. You are not required to agree to this as a condition of making a purchase.

Terms & Conditions

The following Terms and Conditions apply to your use of the website located at hsionline.com (the “website”) and any text messages that you send to or receive from the Institute of Health Sciences, L.L.C. These Terms and Conditions constitute a binding agreement (“Agreement”) between you (“you”) Institute of Health Sciences, L.L.C (“we”, “us”, etc.)  Please read these terms carefully. 

By providing your telephone number to us, texting us a short code listed on the website, or otherwise indicate your agreement to these Terms and Conditions, you are agreeing to the mandatory arbitration provision and class action waiver below. 

ARBITRATION IS MANDATORY AND THE EXCLUSIVE REMEDY FOR ANY AND ALL DISPUTES RELATED TO THIS WEBSITE, THIS AGREEMENT, AND ANY TELEPHONE CALLS, EMAILS, OR TEXT MESSAGES THAT YOU RECEIVE FROM OR ON BEHALF OF US, UNLESS SPECIFIED BELOW OR UNLESS YOU OPT-OUT.

Text Messaging and Telemarketing Terms and Conditions

When you provide your telephone number on this website or send a text message to us with or from a short-code, you agree to receive alerts and communications, and marketing messages including those sent via automated telephone dialing system, text messages, SMS, MMS, and picture messages from Institute of Health Sciences, L.L.C at the phone number you provide on this website or the phone number from which you text the short code, including on landlines and wireless numbers, even if the phone number is on a corporate, state or national Do Not Call list. You also agree to the mandatory arbitration provision and class action waiver below. Your consent is not required to purchase goods or services. Message & data rates may apply.

You may opt-out at any time by texting the word STOP to the telephone number from which you receive the text messages.  Call 1-888-213-0764 to learn more.  By providing your telephone number, you agree to notify us of any changes to your telephone number and update your account us to reflect this change. Your carrier may charge you for text messages and telephone calls that you receive, or may prohibit or restrict certain mobile features, and certain mobile features may be incompatible with your carrier or mobile device. Contact your carrier with questions regarding these issues.

Dispute Resolution by Binding Arbitration and Class Action Waiver

Any dispute relating in any way to telephone calls, emails, or text messages that you receive from or on behalf of Institute of Health Sciences, L.L.C this website, or this Agreement (collectively “Disputes”) shall be submitted to confidential arbitration and shall be governed exclusively by the laws of the State of Maryland, excluding its conflict of law provisions.  For the avoidance of doubt, all claims arising under the Telephone Consumer Protection Act and state telemarketing laws shall be considered “Disputes” that are subject to resolution by binding individual, confidential arbitration.

If a Dispute arises under this Agreement, you agree to first contact us at 1-888-213-0764 or help@hsionline.com. Before formally submitting a Dispute to arbitration, you and we may choose to informally resolve the Dispute.  If any Dispute cannot be resolved informally, you agree that any and all Disputes, including the validity of this arbitration clause and class action waiver, shall be submitted to final and binding arbitration before a single arbitrator of the American Arbitration Association (“AAA”) in a location convenient to you or telephonically. Either you or we may commence the arbitration process by submitting a written demand for arbitration with the AAA, and providing a copy to the other party.  The arbitration will be conducted in accordance with the provisions of the AAA’s Commercial Dispute Resolutions Procedures, Supplementary Procedures for Consumer-Related Disputes, in effect at the time of submission of the demand for arbitration.  Except as may be required by law as determined by the arbitrator, no party or arbitrator may disclose the existence, content or results of any arbitration hereunder without the prior written consent of both parties. Institute of Health Sciences, L.L.C will pay all of the filing costs.  Without limiting the foregoing, YOU EXPRESSLY AGREE TO SUBMIT TO ARBITRATION ALL DISPUTES RELATING TO ANY TEXT MESSAGES OR TELEPHONE CALLS YOU RECEIVE FROM OR ON BEHALF OF US OR ANY ENTITY WITH WHOM WE MAY SHARE YOUR TELEPHONE NUMBER.  Further, we both agree that all entities with whom we share your telephone numbers shall be third party beneficiaries of this Agreement to Arbitrate Disputes, and that those entities have the same rights as Institute of Health Sciences, L.L.C to enforce this arbitration provision.

Notwithstanding the foregoing, the following shall not be subject to arbitration and may be adjudicated only in the state and federal courts of Maryland: (i) any dispute, controversy, or claim relating to or contesting the validity of our or one of our family company’s intellectual property rights and proprietary rights, including without limitation, patents, trademarks, service marks, copyrights, or trade secrets; (ii) an action by us for temporary or preliminary injunctive relief, whether prohibitive or mandatory, or other provisional relief; (iii) any legal action by us against a non-consumer; or (iv) interactions with governmental and regulatory authorities.  You expressly agree to refrain from bringing or joining any claims in any representative or class-wide capacity, including but not limited to bringing or joining any claims in any class action or any class-wide arbitration.

The arbitrator’s award shall be binding and may be entered as a judgment in any court of competent jurisdiction. To the fullest extent permitted by applicable law, no arbitration under this Agreement may be joined to an arbitration involving any other party subject to this Agreement, whether through a class action, private attorney general proceeding, class arbitration proceedings or otherwise.

YOU UNDERSTAND THAT YOU WOULD HAVE HAD A RIGHT TO LITIGATE IN A COURT, TO HAVE A JUDGE OR JURY DECIDE YOUR CASE AND TO BE PARTY TO A CLASS OR REPRESENTATIVE ACTION.  HOWEVER, YOU UNDERSTAND AND AGREE TO HAVE ANY CLAIMS DECIDED INDIVIDUALLY AND ONLY THROUGH ARBITRATION.  You shall have thirty (30) days from the earliest of the date that you visit the website, the date you submit information to us through the website, or the date that you send a text message to us, to opt out of this arbitration agreement, by contacting us by email at help@hsionline.com or by mail Health Sciences Institute, PO Box 913, Frederick, MD 21705-0913. If you do not opt out by the earliest of the date that you visit the website, the date you submit information to us through the website, or the date that you send a text message to us, then you are not eligible to opt out of this arbitration agreement.

Electronic Signatures

All information communicated on the website is considered an electronic communication.  When you communicate with us through or on the website, by text message or telephone, or via other forms of electronic media, such as e-mail, you are communicating with us electronically.  You agree that we may communicate electronically with you and that such communications, as well as notices, disclosures, agreements, and other communications that we provide to you electronically, are equivalent to communications in writing and shall have the same force and effect as if they were in writing and signed by the party sending the communication.

You further acknowledge and agree that by clicking on a button labeled “ORDER NOW”, “SUBMIT”, “I ACCEPT”, “I AGREE”, “YES”, by texting a short code to us in response to a request on this website, or by clicking or similar links or buttons, you are submitting a legally binding electronic signature and are entering into a legally binding contract.  You acknowledge that your electronic submissions constitute your agreement and intent to be bound by this Agreement.  Pursuant to any applicable statutes, regulations, rules, ordinances or other laws, including without limitation the United States Electronic Signatures in Global and National Commerce Act, P.L. 106-229 (the “E-Sign Act”) or other similar statutes, YOU HEREBY AGREE TO THE USE OF ELECTRONIC SIGNATURES, CONTRACTS, ORDERS AND OTHER RECORDS AND TO ELECTRONIC DELIVERY OF NOTICES, POLICIES AND RECORDS OF TRANSACTIONS INITIATED OR COMPLETED THROUGH THE WEBSITE.  Furthermore, you hereby waive any rights or requirements under any statutes, regulations, rules, ordinances or other laws in any jurisdiction which require an original signature, delivery or retention of non-electronic records, or to payments or the granting of credits by other than electronic means You may receive a physical paper copy of this contract by contacting us at help@hsionline.com.

Privacy Policy

Please read our Privacy Policy, which is incorporated herein by reference.  In the event of any conflict between these Terms and Conditions and the Privacy Policy, these Terms shall control.

Contact Us

You may contact us by telephone at 1-888-213-0764 or by email at help@hsionline.com.