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.

Would FDA officials protect drug sales before protecting consumers?

Government Bailout

Given the choice, would FDA officials actually choose to protect the sales of a drug rather than protect consumers?

I’ll tell you a story – you be the judge.

Not exactly what they had in mind…

We’ll start with some back-story details.

Last year, the New England Journal of Medicine published the ENHANCE STUDY – a two-year trial that compared the effects of Zocor (a statin) with Vytorin (a combination of Zocor and Zetia – a drug that blocks cholesterol absorption) in 720 subjects with high cholesterol.

Results: Zocor and Vytorin both reduced LDL cholesterol, but in spite of the length of the study, there was no “significant difference in changes in intima-media thickness” (that is, in the thickness of artery walls) in the Zocor group compared to the Vytorin group.

Okay – here’s where it starts to get interesting.

There was no significant difference in changes in intima-media thickness. But what exactly were those changes? You’ll have to dig deep into the study to come up with this surprising note: “There was a slight increase in the mean intima-media thickness over time in both groups.”

Yeah! Devastating! Both drugs lowered LDL, and with both drugs, on average, subjects’ arteries became NARROWER.

As I noted in a couple of 2008 e-Alerts, this research was deeply controversial for the medical mainstream because statins are supposed to prevent arteries from narrowing by (all together now!) lowering cholesterol.

So the FDA stepped in and said, Okay, everyone calm down now. We’ll take a closer look at the study and get back to you when we figure out what’s REALLY going on here.

Well…the FDA just got back to us. Care to guess what they had to say?

Down the tunnel

I’ve got to hand it to the FDA – their ENHANCE report doesn’t ignore the elephant in the room. The report comes right out and admits that with both Vytorin and Zocor, thickness of artery walls increased.

But the report goes on to put greater stress on the “good” news: LDL dropped by more than 50 percent in the Vytorin group and nearly 40 percent in the Zocor group.

And this is presented like: So there! Ha! Is this stuff fantastic or what? High five!

Then the report takes a surprising turn. Based on a previous study, researchers anticipated two things: 1) that LDL would be lowered, and 2) that Zocor would increase artery wall thickness. That’s right: A similar two-year study, released in 2001, actually showed that Zocor reduced cholesterol, but artery walls narrowed.

So…at what point do we start acknowledging that Zocor might be dangerous? You would think the 2001 study would be a red flag, but researchers went ahead with the second study and gave the drug to hundreds of subjects for two years, even though (according to the FDA report), narrowing of artery walls was EXPECTED!

Is this insane tunnel-vision focus on using statins to lower cholesterol so pervasive that they don’t see the danger in narrowed arteries?

The answer to that question appears to be yes.

And then the FDA report offers this absolutely predictable advice: “Based on current available data, patients should not stop taking Vytorin or other cholesterol lowering medications.”

Sure! Go right ahead! And while you’re having your heart attack, you’ll be comforted by the knowledge that your LDL cholesterol is impressively low. Enjoy!

Sources:
“Follow-Up to the January 25, 2008 Early Communication about an Ongoing Data Review for Ezetimibe/Simvastatin (marketed as Vytorin, Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor), Food and Drug Administration, January 2009, fda.gov
“Simvastatin With or Without Ezetimibe in Familial Hypercholesterolemia” The New England Journal of Medicine, Published online ahead of print, 3/30/08, content.nejm.org
“Drug Has No Benefit in Trial, Makers Say” Alex Berenson, The New York Times, 1/14/08, nytimes.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.